"King, Heidi R."<EMAIL_ADDRESS>
01/09/2008 01:43 PM

To

Ron Evans/RTP/USEPA/US@EPA

cc

Subject

Ron, a EPA final rule example of Energy EO text

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

Distribution, or Use

Executive Order 13211, “Actions Concerning Regulations That
Significantly Affect

Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)),
requires EPA to prepare

and submit a Statement of Energy Effects to the Administrator of the
Office of Information and

Regulatory Affairs, Office of Management and Budget, for certain actions
identified as

“significant energy actions.” Section 4(b) of Executive Order 13211
defines “significant energy

actions” as “any action by an agency (normally published in the
Federal Register) that

promulgates or is expected to lead to the promulgation of a final rule
or regulation, including

notices of inquiry, advance notices of proposed rulemaking, and notices
of proposed rulemaking:

(1)(i) that is a significant regulatory action under Executive Order
12866 or any successor order,

and (ii) is likely to have a significant adverse effect on the supply,
distribution, or use of energy;

or (2) that is designated by the Administrator of the Office of
Information and Regulatory Affairs

as a significant energy action.” We have prepared a Statement of
Energy Effects for this action

as follows.

This rule’s potential effects on energy supply, distribution, or use
have been analyzed and

are discussed in detail in section 5.8 of the RIA. In summary, while we
project that this rule

would result in an energy effect that exceeds the 4,000 barrel per day
threshold noted in E.O.

13211 in or around the year 2022 and thereafter, the program consists of
performance-based

standards with averaging, banking, and trading provisions that make it
likely that our estimated

impact is overstated. Further, the fuel consumption estimates upon which
we are basing this

energy effect analysis, which are discussed in full in sections 5.4 and
5.5 of the RIA, do not

reflect the potential fuel savings associated with automatic engine
stop/start (AESS) systems or

other idle reduction technologies. Such technologies can provide
significant fuel savings which

Locomotive and Marine FRM Preamble

178/181

could offset our projected estimates of increased fuel consumption.
Nonetheless, our projections

show that this rule could result in energy usage exceeding the 4,000
barrel per day threshold

noted in E.O. 13211.


[Federal Register: December 18, 2007 (Volume 72, Number 242)]
[Notices]
[Page 71729]
[DOCID:fr18de07-83]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56938; File No. SR-Phlx-2007-63]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Order Granting Approval of a Proposed Rule Change Relating to Short
Interest Reporting

December 10, 2007.

I. Introduction

    On August 16, 2007, the Philadelphia Stock Exchange, Inc.
(``Phlx'') filed with the Securities and Exchange Commission
(``Commission'') proposed rule change SR-Phlx-2007-63 pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'').\1\
On September 20, 2007, Phlx amended the proposed rule change.\2\ Notice
of the proposal was published in the Federal Register on October 3,
2007.\3\ No comment letters were received. For the reasons discussed
below, the Commission is granting approval of the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ Amendment No. 1, which replaced the original proposed rule
change in its entirety, made clarifying changes to the original
proposed rule change.
    \3\ Securities Exchange Act Release No. 56541 (September 26,
2007), 72 FR 56427 (October 3, 2007) (Phlx-2007-63).
---------------------------------------------------------------------------

II. Description

    The proposed rule change conforms Phlx Rule 786 to rule changes
made by other self-regulatory organizations (``SROs'') to implement
uniform changes to the short interest reporting requirements across
SROs.
    First, Phlx is making a technical change to the text of Phlx Rule
786, Supplementary Material .01. Supplementary Material .01 provides
that, subject to certain limited exceptions, short positions required
to be reported under the rule are those resulting from short sales as
the term is defined in Rule 200 of Regulation SHO. The term ``short
sale'' is actually defined in Rule 200(a) of Regulation SHO.\4\
Therefore, Phlx is amending the text of Supplementary Material .01 to
reference Regulation SHO Rule 200(a), instead of Rule 200, in order to
eliminate any confusion.
---------------------------------------------------------------------------

    \4\ 17 CFR 242.200(a).
---------------------------------------------------------------------------

    Second, Phlx is adding a new section, Supplementary Material .02,
to Phlx Rule 786. The new language adopts exceptions to the short
interest reporting requirement. Phlx is also adding conforming language
relating to the new section to Rule 786, Supplementary Material .01.
Currently, any transaction that is marked ``sell short exempt'' is
exempt from the reporting requirement. Beginning on July 6, 2007, the
``short exempt'' marking requirement was eliminated by the
Commission.\5\ Therefore, beginning on July 6, 2007, all transactions
marked short will be covered by Phlx's reporting requirement. However,
other SROs have modified their short interest reporting rules to
exclude five specific transactions that were previously contained in
the now eliminated Rule 10a-1 under the Act.\6\ The rule change is
designed to conform Phlx's reporting requirement to those of other SROs
and increase uniformity for broker-dealers as they comply with various
rules across SROs, which should reduce costs and increase efficiency
for those broker-dealers.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 55970 (June 28,
2007), 72 FR 36348 (July 3, 2007).
    \6\ See, e.g., Securities Exchange Act Release No. 56300 (August
22, 2007), 72 FR 49342 (August 28, 2007) (NYSEArca-2007-63).
---------------------------------------------------------------------------

III. Discussion

    Section 6(b)(5) of the Act \7\ requires, among other things, that
the rules of an exchange be designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in general
to protect investors and the public interest. The rule change is
designed to conform Phlx's reporting requirement to those of other SROs
and increase uniformity for broker-dealers as they comply with various
rules across SROs, which should reduce costs and increase efficiency
for those broker-dealers. Accordingly, because the rule change will
lead to greater uniformity in SRO rules, the Commission finds that the
rule change meets the requirements of Section 6(b)(5) of the Act
because it is designed to promote just and equitable principles of
trade, to remove impediments to and perfect the mechanism of a free and
open market and a national market system, and, in general to protect
investors and the public interest.
---------------------------------------------------------------------------

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

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the rule
change is consistent with the requirements of the Act, in particular
Section 6(b) of the Act \8\ and the rules and regulations
thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (File No. SR-Phlx-2007-63) be and hereby
is approved.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-24465 Filed 12-17-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Pages 13657-13659]
[FR Doc No: 2020-04753]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0043]

Contact Dermatitis From Topical Drug Products for Cutaneous
Application: Human Safety Assessment; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Contact
Dermatitis From Topical Drug Products for Cutaneous Application: Human
Safety Assessment.'' This draft guidance provides recommendations for
the characterization, during product development, of local safety of
topical drug products regarding the risk for contact dermatitis. These
recommendations are specifically directed to development of topical new
drug products intended for cutaneous application.

DATES: Submit either electronic or written comments on the draft
guidance

by May 8, 2020 to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-0043 for ``Contact Dermatitis From Topical Drug Products for
Cutaneous Application: Human Safety Assessment.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jennifer Harmon, Center for Drug
Evaluation and Research (HFD-540), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 5239, Silver Spring, MD 20993; 240-
402-4880.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Contact Dermatitis From Topical Drug Products for Cutaneous
Application: Human Safety Assessment.''
    Historically, FDA requested sponsors of new topical drug products
to characterize local safety with regard to cutaneous irritation,
sensitization, phototoxicity, and photoallergy (the latter two only for
products that absorb ultraviolet radiation at relevant wavelengths)
through the conduct of dedicated ``dermal safety studies.'' These
studies were conducted in healthy volunteers by repeated application of
the drug product under occlusion on the skin of the back or upper arm.
The studies are considered provocative in that the test condition of
occlusion is used to evoke the adverse reaction at a greater rate than
might be observed under labeled conditions of use.
    The Division of Dermatology and Dental Products (DDDP) became
concerned that these provocative studies, conducted under augmented
conditions, were not informative for drug development, did not provide
information that was useful for labeling, and induced adverse reactions
in study subjects that might result in permanent harm. DDDP convened a
scientific workshop in September 2018 during which outside experts
provided input on the utility of these studies for development of new
topical drugs. The consensus of the workshop was that the dedicated
dermal safety studies, previously requested by FDA, were not needed to
evaluate local cutaneous safety of topical new drug products.
    DDDP intends to publish this draft guidance to inform sponsors of
new topical drug products intended for cutaneous application of our
recommendations for evaluating local (cutaneous) safety of topical drug
products with regard to contact dermatitis. These recommendations will
be specifically directed to developing topical new drug products; the
draft guidance will not address over-the-counter drugs under monograph,
generic drugs, or nondrug cosmetic products or ingredients.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Contact
Dermatitis From Topical Drug Products for Cutaneous Application: Human
Safety Assessment.'' It does not establish any rights for any person
and is not binding

on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 312 and 314 have been
approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04753 Filed 3-6-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Page 26922]
[FR Doc No: 2017-12049]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC17-117-000.
    Applicants: Dynegy Zimmer, LLC, Dynegy Miami Fort, LLC, The Dayton
Power and Light Company, AES Ohio Generation, LLC.
    Description: Supplement to May 12, 2017 Joint Application for
Authorization of Disposition of Jurisdictional Assets Under Section
203(a)(1) of the Federal Power Act of Dynegy Buyers and AES Sellers.
    Filed Date: 6/5/17.
    Accession Number: 20170605-5116.
    Comments Due: 5 p.m. ET 6/26/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER15-414-002.
    Applicants: ISO New England Inc., Eversource Energy Service Company
(as ag, Emera Maine, Central Maine Power Company, New Hampshire
Transmission, LLC, New England Power Company, The United Illuminating
Company, Unitil Energy Systems, Inc., Vermont Transco, LLC.
    Description: Compliance filing: Filing of New England Transmission
Owners to Return Rates to the Status Quo Ante to be effective 6/6/2017.
    Filed Date: 6/5/17.
    Accession Number: 20170605-5166.
    Comments Due: 5 p.m. ET 6/26/17.

    Docket Numbers: ER17-42-001; ER17-43-001; ER17-962-001.
    Applicants: Portal Ridge Solar B, LLC, Portal Ridge Solar C, LLC,
MS Solar 2, LLC.
    Description: Notice of Change in Status of the DESRI MBR Sellers
ER17-42, et al.
    Filed Date: 6/2/17.
    Accession Number: 20170602-5165.
    Comments Due: 5 p.m. ET 6/23/17.

    Docket Numbers: ER17-1663-002.
    Applicants: Elwood Energy LLC.
    Description: Compliance filing: Informational Filing Regarding
Compliance With PJM Schedule 2 to be effective N/A.
    Filed Date: 6/2/17.
    Accession Number: 20170602-5124.
    Comments Due: 5 p.m. ET 6/23/17.

    Docket Numbers: ER17-1754-000.
    Applicants: Albertsons Companies, LLC.
    Description: Compliance filing: Refile Market-Based Rate Tariff to
be effective 6/19/2017.
    Filed Date: 6/5/17.
    Accession Number: 20170605-5063.
    Comments Due: 5 p.m. ET 6/26/17.

    Docket Numbers: ER17-1755-000.
    Applicants: Albertsons Companies, LLC.
    Description: Tariff Cancellation: Cancellation to be effective 6/
19/2017.
    Filed Date: 6/5/17.
    Accession Number: 20170605-5065.
    Comments Due: 5 p.m. ET 6/26/17.

    Docket Numbers: ER17-1756-000.
    Applicants: Midcontinent Independent System Operator Inc., Ameren
Illinois Company.
    Description: Sec.  205(d) Rate Filing: 2017-06-05_SA 2276 Ameren-
Dynegy Amended DFSA to be effective 6/1/2017.
    Filed Date: 6/5/17.
    Accession Number: 20170605-5108.
    Comments Due: 5 p.m. ET 6/26/17.

    Docket Numbers: ER17-1757-000.
    Applicants: Entergy New Orleans, LLC.
    Description: Baseline eTariff Filing: ENOL MBR Application to be
effective 12/31/9998.
    Filed Date: 6/5/17.
    Accession Number: 20170605-5118.
    Comments Due: 5 p.m. ET 6/26/17.

    Docket Numbers: ER17-1758-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: ISA No. 4723; Queue No. AA2-
173/AB1-112 to be effective 5/15/2017.
    Filed Date: 6/5/17.
    Accession Number: 20170605-5128.
    Comments Due: 5 p.m. ET 6/26/17.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES17-20-000.
    Applicants: ITC Midwest LLC.
    Description: Errata to April 27, 2017 Application [Exhibits C, D,
and E] of ITC Midwest LLC under Section 204 of the Federal Power Act
and Part 34 of the Commission's Regulations.
    Filed Date: 5/26/17.
    Accession Number: 20170526-5116.
    Comments Due: 5 p.m. ET 6/9/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 5, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-12049 Filed 6-9-17; 8:45 am]
 BILLING CODE 6717-01-P


 Charge Questions to the SAP

SAP Charge Questions on the use of the CASM Model

(1) 	Please comment on the use of a community simulation model for
assessing the relative effects of different exposure time series. Please
provide any recommendations for a community response model other than,
or along with, CASM that could be used for assessing the effects of
atrazine. What are the strengths and weaknesses associated with the
other model(s). Please comment on approaches that do not require an
aquatic community response model and discuss the advantages and
disadvantages of any alternative non-modeling approaches for
extrapolating the effects seen in micro/mesocosm data to the effects
resulting from field exposure.

(2) 	The general methodology employed in this analysis consists of (a)
correlating model outputs to micro/mesocosm data to determine a model
LOC and (b) applying the model to chemographs of interest to determine
whether the LOC is exceeded.  Please comment on the scientific strengths
and limitations of this approach.

(3) 	Please comment on the reasonableness of the general CASM_Atrazine
model formulation and parameterization, and the various options selected
for the base model configuration.

(4) 	Please comment on whether the described sensitivity analyses are
suitable for characterizing uncertainties associated with the choice of
options for configuration of the base model and the input variables.
What additional sources of uncertainty alternatives should be examined
in this analysis?  Please comment on whether the sensitivity of results
to the slope of the toxicity curve, as well as the EC50, should be
examined to address possible effects on responses to short pulses.

(5)	During its review of the CASM_Atrazine model, the Agency found that
the model appears to overestimate the effects of low, chronic
concentrations possibly due to the way the model simulates population
levels and decline of macrophytes early in the year.

The Agency sees two approaches for addressing this issue: (1) exclude
early season atrazine exposures from the chemograph inputs, or (2)
modify the model to better account for the impacts of early-season
exposures. Please comment on the strengths and weaknesses of the
Agency’s approaches and provide recommendations for any alternatives.

Given that the Agency identified this issue during the exposure
evaluation, please provide recommendations on additional steps the
Agency could take for quality assurance for the model and methodology.

SAP Charge Questions on the Atrazine Monitoring Results

(6)	The monitoring program used a tool (WARP) designed to assess the
vulnerability of watersheds and stream segments to (1) identify
watersheds within the corn/sorghum growing region that are likely to be
most vulnerable to atrazine exposure and, (2) select sampling sites
within the watersheds that are likely to be more susceptible to atrazine
runoff.

Please comment on the use of WARP predictions for hydrologic units (HUC
10/11) to restrict the survey design to those HUCs in the upper 20th
percentile and then (1) to stratify by WARP predictions between 80th –
95th percentiles and above 95th percentile and (2) to select HUCs with
probability proportional to higher atrazine use rates.

Comment on the use of survey design population estimation approach for
estimating the number (and %) of HUCs that may have LOC exceedances.

(7)	Once the vulnerable HUC 10/11 watersheds were selected for
monitoring, specific monitoring sites were selected within each
watershed using criteria that were designed to maximize the potential
for selecting the streams most vulnerable to atrazine exposure.
However, with only a single point monitored per watershed, estimates of
within-HUC variability for detections of atrazine could not be
calculated. The resulting population estimates reflect variability
across watersheds but not within the monitored watersheds. Please
comment on this approach and identify and discuss any alternative
approaches to extend the results of the monitoring sites.

(8)	Three monitoring sites in NE experienced low- or no-flow conditions
that precluded sampling. While Hampton et al. (2007a) suggest that these
sites with intermittent or low flow are already stressed by other
factors, Meyer et al. (2007) indicate that such aquatic communities are
rich in diversity. The Agency has generated statistics for these three
sites as a separate stratum, however the meaning of these separate
population estimates is uncertain.

Please comment on whether the Agency should consider the low flow sites
and/or intermittent streams as a part of the population estimates or
treat them separately.

Please comment on whether the aquatic systems and exposure conditions of
the existing microcosm and mesocosm studies adequately represent these
low flow and/or intermittent stream communities.  If not, how could EPA
determine an LOC for low flow conditions?

(9)	The monitoring study sampled for atrazine concentrations at 4-day
intervals to characterize the atrazine chemograph in these low-order
Midwestern streams. The CASM_Atrazine model used these chemographs with
a stair-step interpolation between samples dates to relate atrazine
exposures in the streams to microcosm/mesocosm studies in order to
determine whether the exposures triggered LOC thresholds.

What other approaches for interpolation should be considered?  Given the
concentration-duration endpoint, how frequently must sampling occur to
appropriately capture the magnitude and durations of exposure associated
with atrazine?

Sensitivity analysis of CASM_Atrazine model inputs suggests that some
uncertainty bound on model results is appropriate.  The Agency used a 2x
multiplication factor from the model sensitivity analysis  to estimate
uncertainty in model output.  The sample frequency analysis indicates
that there is uncertainty associated with monitoring data that may not
be accounted for by the model uncertainty factor of 2x.  Given the
importance of sample frequency and interpolation, please comment on
whether consideration should be given to placing additional uncertainty
bounds on monitoring data to account for uncertainty in the ability of
the sampling strategy to capture the magnitude and duration of atrazine
exposures. Please provide any suggestions for how to proceed with this
approach.

SAP Charge Questions Relating to Identifying Where Atrazine Exceedances
Are Likely to Occur

(10) 	While the monitoring study was based on a watershed vulnerability
assessment, the ultimate value is in identifying water bodies where
atrazine concentrations exceed the LOC. One approach is to use the
updated version of the National Hydrography Database (NHDPlus) and apply
the criteria used to select the monitoring locations to identify streams
that appear to have the potential to exceed the LOC.

Please comment on the strengths and weaknesses of the Agency’s
proposed approach for identifying streams within watersheds that
exceeded the LOC.

In what ways can the preliminary approach be improved?

Please recommend alternative approaches, if any, that may be better
suited to apply the watershed-based assessment to streams?

(11) 	In order to identify areas beyond the 40 study sites where higher
atrazine exposures are likely to occur, the Agency must determine
whether the watersheds that exceeded the LOC in multiple years are
randomly distributed within the 1,172 vulnerable watersheds or represent
a unique subset of conditions. If the latter and the conditions can be
identified, monitoring could be focused only in watersheds where those
conditions exist.The Agency has proposed evaluating WARP parameters and
other sub-watershed soil and hydrologic properties to determine the
extent to which the monitoring results can be used to identify other
water bodies exceeding the LOC.

To what extent can WARP be used to identify other watersheds of concern?
Given the influence of atrazine use on vulnerability and exposure,
please comment on whether the extrapolation should be limited to the
original 1,172 watersheds or include a broader atrazine use area?

Please comment on the soil and hydrology parameters the Agency is
evaluating for extrapolation to vulnerable watersheds. What additional
soil and hydrologic parameters should the Agency consider?

What additional approaches to the identification of watersheds that may
have atrazine levels that exceed the LOC should the Agency consider?

 PAGE

 PAGE   4


[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Notices]
[Pages 65034-65037]
[FR Doc No: 2012-26146]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68068; File No. SR-ISE-2012-86]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend Maker Fees for Certain Complex Orders Executed on the
Exchange

October 18, 2012.
    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 October 10, 2012, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') 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.
---------------------------------------------------------------------------

    \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 ISE is proposing to amend maker fees for certain complex orders
executed on the Exchange. The text of the proposed rule change is
available on the Exchange's Web site (http://www.ise.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 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 Exchange currently assesses per contract transaction fees and
provides rebates to market participants that add or remove liquidity
from the Exchange (``maker/taker fees and rebates'') in a number of
option classes (the ``Select Symbols'').\3\ The Exchange's maker/taker
fees and rebates are applicable to regular and complex orders executed
in the Select Symbols \4\ and in the Special Non-Select Penny Pilot
Symbols.\5\ The Exchange also currently assesses maker/taker fees and
rebates for complex orders in symbols that are in the Penny Pilot
program but are not a Select Symbol (``Non-Select Penny Pilot
Symbols'') \6\ and for complex orders in all symbols that are not in
the Penny Pilot Program (``Non-Penny Pilot Symbols'').\7\ The purpose
of this

proposed rule change is to amend the complex order maker fees charged
by the Exchange for certain complex orders executed on the Exchange.
Specifically, the Exchange proposes to adopt complex order maker fees
for orders that trade against Priority Customer orders in the Select
Symbols, SPY, Non-Select Penny Pilot Symbols and Non-Penny Pilot
Symbols. Section II of the current Schedule of Fees provides the fees
and rebates for complex orders traded on the Exchange, with the rebates
provided in one table and the fees in another. With this proposed rule
change, the Exchange is separating the fees table into two tables, one
for maker fees and another for taker fees with the latter retaining the
other fees applicable to complex orders, i.e., Fee for Crossing Orders
and Fees for Responses to Crossing Orders. The Exchange is not
proposing any change to the complex order taker fees or rebates
applicable for executions in these symbols.
---------------------------------------------------------------------------

    \3\ Options classes subject to maker/taker fees and rebates are
identified by their ticker symbol on the Exchange's Schedule of
Fees.
    \4\ These fees also apply to SPY. While the Exchange currently
has a distinct taker fee for SPY, the maker fee for SPY is currently
the same as the maker fee for all Select Symbols, as SPY is a Select
Symbol.
    \5\ See Exchange Act Release Nos. 67201 (June 14, 2012), 77 FR
37082 (June 20, 2012) (SR-ISE-2012-49); and 67627 (August 9, 2012),
77 FR 49046 (August 15, 2012) (SR-ISE-2012-70).
    \6\ See Exchange Act Release No. 65724 (November 10, 2011), 76
FR 71413 (November 17, 2011) (SR-ISE-2011-72).
    \7\ See Exchange Act Release Nos. 66084 (January 3, 2012), 77 FR
1103 (January 9, 2012) (SR-ISE-2011-84); 66392 (February 14, 2012),
77 FR 10016 (February 21, 2012) (SR-ISE-2012-06); 66961 (May 10,
2012), 77 FR 28914 (May 16, 2012) (SR-ISE-2012-38); and 67400 (July
11, 2012), 77 FR 42036 (July 17, 2012) (SR-ISE-2012-63).
---------------------------------------------------------------------------

    For Select Symbols (including SPY) and Penny Pilot symbols, the
Exchange currently charges a complex order maker fee of: (i) $0.10 per
contract for Market Maker,\8\ Firm Proprietary/Broker-Dealer and
Professional Customer \9\ orders; (ii) $0.20 per contract for Non-ISE
Market Maker \10\ orders; and (iii) $0.00 per contract for Priority
Customer \11\ orders. For Non-Penny Pilot Symbols, the Exchange
currently charges a complex order maker fee of: (i) $0.10 per contract
for Market Maker, Firm Proprietary/Broker-Dealer, Professional Customer
and Non-ISE Market Maker orders; and (ii) $0.00 for Priority Customer
orders.
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    \8\ The term ``Market Makers'' refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See ISE Rule
100(a)(25).
    \9\ A Professional Customer is a person who is not a broker/
dealer and is not a Priority Customer.
    \10\ A Non-ISE Market Maker, or Far Away Market Maker
(``FARMM''), is a market maker as defined in Section 3(a)(38) of the
Securities Exchange Act of 1934, as amended (``Exchange Act''),
registered in the same options class on another options exchange.
    \11\ A Priority Customer is defined in ISE Rule 100(a)(37A) as a
person or entity that is not a broker/dealer in securities, and does
not place more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s).
---------------------------------------------------------------------------

    The Exchange now proposes to amend the maker fee for the group of
symbols noted above when orders in these symbols trade against Priority
Customer complex orders. Specifically, the Exchange proposes to adopt
the following maker fees for complex orders that trade against Priority
Customer orders in the Select Symbols (excluding SPY):
     $0.37 per contract for Market Maker orders;
     $0.39 for Firm Proprietary/Broker-Dealer, Professional
Customer and Non-ISE Market Maker orders;
     $0.00 for Priority Customer orders.
    For complex orders that trade against Priority Customer complex
orders in SPY, the Exchange proposes to adopt the following maker fees:
     $0.38 per contract for Market Maker orders;
     $0.40 for Firm Proprietary/Broker-Dealer, Professional
Customer and Non-ISE Market Maker orders;
     $0.00 for Priority Customer orders.
    For complex orders that trade against Priority Customer complex
orders in Non-Select Penny Pilot Symbols, the Exchange proposes to
adopt the following maker fees:
     $0.37 per contract for Market Maker orders;
     $0.39 for Firm Proprietary/Broker-Dealer, Professional
Customer and Non-ISE Market Maker orders;
     $0.00 for Priority Customer orders.
    For orders that trade against Priority Customer complex orders in
Non-Penny Pilot Symbols, the Exchange proposes to adopt the following
complex order maker fees:
     $0.80 per contract for Market Maker orders;
     $0.83 for Firm Proprietary/Broker-Dealer, Professional
Customer and Non-ISE Market Maker orders;
     $0.00 for Priority Customer orders.
    The Exchange also proposes to increase the maker fee for Non-ISE
Market Maker orders in the Non-Penny Pilot Symbols from $0.10 per
contract to $0.20 per contract when trading against a non-Priority
Customer. With this change, the Exchange seeks to standardize the maker
fee for complex orders in Non-Penny Pilot Symbols with the fee
currently charged for complex orders in Select Symbols and Penny Pilot
Symbols for Non-ISE Market Maker orders when trading against a non-
Priority Customer order.
    Additionally, the Exchange provides Market Makers with a two cent
discount when trading against Priority Customer orders that are
preferenced to them. This discount is currently applicable when Market
Makers remove liquidity in the Select Symbols, SPY, Non-Select Penny
Pilot Symbols and Non-Penny Pilot Symbols from the complex order book.
The Exchange also currently provides Market Makers with a two-cent
discount when they make liquidity in a select group of option classes
(``Complex Quoting Symbols'').\12\ The Exchange now proposes to provide
Market Makers with a two-cent discount when they also add liquidity in
the Select Symbols, SPY, Non-Select Penny Pilot Symbols and Non-Penny
Pilot Symbols when trading against Priority Customer orders.
Accordingly, Market Makers that add or remove liquidity from the
complex order book by trading against Priority Customer orders that are
preferenced to them will be charged: (i) $0.35 per contract in the
Select Symbols; (ii) $0.36 per contract in SPY; (iii) $0.35 per
contract in the Non-Select Penny Pilot Symbols; and iv) $0.78 per
contract in the Non-Penny Pilot Symbols Select Symbols.
---------------------------------------------------------------------------

    \12\ See Exchange Act Release Nos. 65958 (December 15, 2011), 76
FR 79236 (December 21, 2012 [sic]) (SR-ISE-2011-81); 66406 (February
16, 2012), 77 FR 10579 (February 22, 2012) (SR-ISE-2012-07); and
67316 (June 29, 2012), 77 FR 40136 (July 6, 2012) (SR-ISE-2012-59).
---------------------------------------------------------------------------

    The maker fees proposed herein are identical to the taker fees
currently charged by the Exchange.\13\ With this proposed rule change,
complex orders that trade against Priority Customer orders in the
Select Symbols, SPY, Non-Select Penny Pilot Symbols, and Non-Penny
Pilot Symbols will now be charged the same fee for making and taking
liquidity.
---------------------------------------------------------------------------

    \13\ The Exchange has submitted a proposed rule change to
increase the taker fees for complex orders in Select Symbols, SPY,
Non-Select Penny Pilot Symbols and Non-Penny Pilot Symbols that
mirror the proposed maker fees in this filing. See SR-ISE-2012-85.
---------------------------------------------------------------------------

    With this proposed rule change, the Exchange will be better
positioned to maintain its attractive rebate structure for Priority
Customer complex orders. The number of non-Priority Customer maker
participants has continued to grown, separately and in addition to the
growth in symbols where the Exchange allows complex quoting and has
already implemented a fee structure where makers trading against
Priority Customer orders pay the taker fee equivalent. This has
resulted in an increased number of non-Priority Customer complex maker
orders trading with Priority Customer Complex orders. Charging non-
Priority Customer orders the equivalent of the taker fee when
interacting with Priority Customer complex orders will allow the
Exchange to support this model and continue to attract additional
orders and liquidity to its Complex Orderbook.
    Since the rate changes to the Schedule of Fees pursuant to this
proposal will be effective upon filing, for the transactions occurring
in October 2012 prior to the effective date of this filing members will
be assessed the rates in effect immediately prior to those proposed by
this filing. For transactions occurring in October 2012 on and after
the effective date of this filing, members will be

assessed the rates proposed by this filing.
    The Exchange's maker/taker fees and rebates for complex orders have
proven to be an effective method of attracting order flow to the
Exchange. The Exchange believes this proposed rule change will also
serve to enhance its competitive position and enable it to attract
additional volume in these symbols.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the Exchange Act \14\ in
general, and furthers the objectives of Section 6(b)(4) of the Exchange
Act \15\ in particular, in that it is an equitable allocation of
reasonable dues, fees and other charges among Exchange members and
other persons using its facilities. The impact of the proposal upon the
net fees paid by a particular market participant will depend on a
number of variables, most important of which will be its propensity to
add or remove liquidity in the symbols that are subject to the fees
proposed herein.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes it is reasonable and equitable to charge a
maker fee of $0.37 per contract for Market Maker orders that trade
against Priority Customer interest in the Select Symbols and Penny
Pilot symbols and $0.39 per contract for Non-ISE Market Maker, Firm
Proprietary/Broker-Dealer, and Professional Customer orders that trade
against Priority Customer interest in the Select Symbols and Non-Select
Penny Pilot Symbols. The Exchange believes it is reasonable and
equitable to charge a maker fee of $0.38 per contract for Market Maker
orders that trade against Priority Customer interest in SPY and $0.40
per contract for Non-ISE Market Maker, Firm Proprietary/Broker-Dealer,
and Professional Customer orders that trade against Priority Customer
interest in SPY. The Exchange believes it is reasonable and equitable
to charge a maker fee of $0.80 per contract for Market Maker orders
that trade against Priority Customer interest in the Non-Penny Pilot
Symbols and $0.83 per contract for Non-ISE Market Maker, Firm
Proprietary/Broker-Dealer, and Professional Customer orders that trade
against Priority Customer interest in the Non-Penny Pilot Symbols.
    The Exchange notes that it already charges an identical maker and
taker fee for Complex Quoting Symbols and is now simply extending that
pricing model to complex orders in the Select Symbols, SPY, in the Non
Select Penny Pilot Symbols and in the Non-Penny Pilot Symbols. The
Exchange believes that it is reasonable and equitable to charge the
fees proposed herein as they are already applicable to complex orders
in the Complex Quoting Symbols; with this proposed rule change, the
Exchange is simply extending its current pricing model to complex
orders in a larger group of option classes.
    The complex order pricing employed by the Exchange has proven to be
an effective pricing mechanism and attractive to Exchange participants
and their customers. The Exchange believes that adopting distinct maker
fees for orders that trade against Priority Customer orders in the
Select Symbols, SPY, Non Select Penny Pilot Symbols and Non-Penny Pilot
Symbols will attract additional business to the Exchange. Moreover, the
Exchange believes that the proposed fees are fair, equitable and not
unfairly discriminatory because the proposed fees are consistent with
price differentiation that exists today at other options exchanges. The
Exchange believes it remains an attractive venue for market
participants to trade complex orders despite its proposed fee change as
its fees remain competitive with those charged by other exchanges. The
Exchange operates in a highly competitive market in which market
participants can readily direct order flow to another exchange if they
deem fee levels at a particular exchange to be excessive. For the
reasons noted above, the Exchange believes that the proposed fees are
fair, equitable and not unfairly discriminatory.

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

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

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\16\ 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 to determine whether the
proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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-ISE-2012-86 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-ISE-2012-86. 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-ISE-2012-86 and should be
submitted on or before November 14, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-26146 Filed 10-23-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Rules and Regulations]
[Page 2812-2816]
[DOCID:fr16ja08-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0461; FRL-8346-6]

Mandipropamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
alpha-(2-propynyloxy)-benzeneacetamide in or on Brassica, head and
stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; vegetable,
cucurbit, group 9; vegetable, fruiting, group 8; okra; vegetable, leafy
except brassica, group 4; vegetable, tuberous and corm, subgroup 1C;
grape; grape, raisin; onion, dry bulb; onion, green; and potato, wet
peel. Syngenta Crop Protection Inc. requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 16, 2008. Objections and
requests for hearings must be received on or before March 17, 2008, 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-2007-0461. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rose Mary Kearns, 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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 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 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 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 EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0461 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 March 17, 2008.
    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-2007-0461, 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'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. Petition for Tolerance

    In the Federal Register of July 25, 2007 (72 FR 40877) (FRL-8137-1)
and October 31, 2007 (72 FR 61637) (FRL 8154-8) EPA issued notices
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions (PP7F7184 and 6F7057) by
Syngenta Crop Protection Inc., P.O. Box 18300, Greensboro, NC 27419.
The petition (6F7057) requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the fungicide mandipropamid, 4-
chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-alpha-(2-
propynyloxy)-benzeneacetamide, in or on Brassica, head and stem,
Subgroup 5A at 3 parts per million (ppm); Brassica, leafy greens,
subgroup 5B at 30 ppm; vegetable, cucurbit, group 9 at .3 ppm;
vegetable, fruiting, group 8 at 1 ppm; vegetable, leafy except
Brassica, group 4 at 20 ppm; vegetable, tuberous and corm, subgroup 1C
at 0.01 ppm; grape at 2 ppm; grape, raisin at 4 ppm; onion, dry bulb at
0.05 ppm; onion, green at 4 ppm; and tomato paste at 1.3 ppm. That
notice referenced a summary of the petition prepared by Syngenta Crop
Protection, Inc., the registrant, which is available to the public in
the docket, http://www.regulations.gov. Comments were received on the

notice of filing. EPA's response to these comments is discussed in Unit
IV.B..
    Based upon review of the data supporting the petition, EPA has
recommended the inclusion of okra in Crop Group 8 (Vegetable,
Fruiting). However, a separate tolerance for okra must be listed in the
40 CFR 180.637, until the new crop group regulation is published. A
tolerance for tomato paste was requested. However, the maximum expected
residue in tomato paste and puree resulting from the proposed use will
be covered by the recommended tolerance for vegetable, fruiting, crop
group 8. A separate tolerance is being established for potato, wet
peel, even though it was not requested. The maximum expected residue in
potato, wet peel resulting from the proposed use is 0.03 ppm which was
calculated by multiplying the HAFT of < 0.01 ppm by the observed
concentration factor of >3x. Potatoes have a separate tolerance under
the vegetable, tuberous and corm subgroup 1C.

III. Aggregate Risk Assessment and Determination of Safety

    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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 tolerance
for residues of mandipropamid on Brassica, head and stem, subgroup 5A
at 3 ppm; Brassica, leafy greens, subgroup 5B at 25 ppm; vegetable,
cucurbit, group 9 at 0.6 ppm; vegetable, fruiting, group 8 at 1 ppm;
okra at 1.0 ppm; vegetable, leafy except Brassica, group 4 at 20 ppm;
vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; grape at 1.4
ppm; grape, raisin at 3 ppm; onion, dry bulb at 0.05 ppm; onion, green
at 4 ppm; and okra at 1 ppm and potato, wet peel at 0.03 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 adverse effects caused by mandipropamid 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 in the
docket established by this action, which is described under ADDRESSES,
and is identified as ``Mandipropamid: Human Health Risk Assessment for
Proposed Uses'' in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (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) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC 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
risks by comparing aggregate 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 LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability

of occurrence of additional adverse cases. Generally, cancer risks are
considered non-threshold. 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 mandipropamid used for
human risk assessment is shown in Table 1 of this unit.

Table 1.--Summary of Toxicological Dose and Endpoints for Mandipropamid for Use in Dietary Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                          RfD, PAD, Level of       Study and
        Exposure/Scenario         Point of Departure   Uncertainty/FQPA    Concern for Risk      Toxicological
                                                        Safety Factors        Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General            N/A                 N/A                 N/A                 No appropriate
 Population, including Infants                                                                 endpoint was
 and Children)                                                                                identified.
----------------------------------------------------------------------------------------------------------------
Acute Dietary(Females 13-49       N/A                 N/A                 N/A                 No appropriate
 years of age)                                                                                endpoint was
                                                                                identified.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All              NOAEL = 5 mg/kg/    UFA = 10X.........  Chronic RfD = 0.05  Chronic toxicity -
 Populations)                      day                UFH = 10X.........   mg/kg/day           dogs
                                                      FQPA SF = 1X......  cPAD = 0.05 mg/kg/  LOAEL = 40 mg/kg/
                                                                           day.                day, based on
                                                                                evidence of liver
                                                                                toxicity
                                                                                (increased
                                                                                incidence and
                                                                                severity of
                                                                                microscopic
                                                                                pigment in the
                                                                                liver and
                                                                                increased
                                                                                alkaline
                                                                                phosphatase
                                                                                activity in both
                                                                                sexes as well as
                                                                                increased alanine
                                                                                aminotransferase
                                                                                activity in
                                                                                males).
----------------------------------------------------------------------------------------------------------------
Cancer                                             ``Not Likely to be Carcinogenic to Humans.''
                                    No treatment-related tumors observed in carcinogenicity studies in rats and
                                                   mice. A cancer risk assessment is not needed.
----------------------------------------------------------------------------------------------------------------
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). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose
  (c = chronic). RfD = reference dose. N/A = not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mandipropamid, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
mandipropamid 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
mandipropamid; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996,
or 1998; CSFII. As to residue levels in food, EPA relied upon tolerance
level residues and percent crop treated (PCT) information for all
commodities A unrefined chronic exposure assessment that assumes 100%
crop treated was conducted for the proposed Section 3 uses of
mandipropamid. The DEEM analysis incorporates estimates of drinking
water concentrations from the Environmental Fate and Effects Division
directly into the analysis. The chronic dietary exposure analysis for
mandipropamid results in dietary risk estimates for food and water that
are below the Agency's level of concern for chronic dietary exposure.
    iii. Cancer. There were no treatment-related tumors observed in
carcinogenicity studies in rats and mice. Mandipropamid is classified
as not likely to be a human carcinogen. Therefore, a cancer dietary
exposure assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for mandipropamid 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 environmental
fate characteristics of mandipropamid. 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.

    Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated environmental concentrations (EECs) of mandipropamid for
acute exposures are estimated to be 25.2 parts per billion (ppb) for
surface water and 0.05 ppb for ground water. The EECs for the aquatic
degradates SYN500003 and SYN504851 are estimated to be 2.32 and 8.99
ppb for surface water and 0.6 and 1.7 ppb for ground water. The
combined level of mandipropamid and the degradates in surface water is
36.5 ppb.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the acute water concentration of value 36.5 ppb was used to
conservatively assess the contribution to drinking water.
    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).
    Mandipropamid is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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 mandipropamid and any
other substances and mandipropamid 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 mandipropamid has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see 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 (``10X'') 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 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 safety factor. 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 FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence
(quantitative or qualitative) of increased susceptibility and no
residual uncertainties with regard to prenatal toxicity following in
utero exposure to rats or rabbits (developmental studies) and pre and/
or post-natal exposures to rats (reproduction study).
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicological database for mandipropamid is complete.
    ii. The toxicity data showed no increase in qualitative or
quantitative susceptibility in fetuses and pups with in utero and post-
natal exposure.
    iii. The toxicity data indicates that there are no neurotoxic
effects.
    iv. The dietary food exposure assessment is based on tolerance-
level residues and assumes 100% crop treated for all commodities, which
results in very high-end estimates of dietary exposure.
    v. The dietary drinking water assessment is based on values
generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations.
    vi. No residential uses are proposed at this time.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
    1. Acute risk. No acute dietary endpoint based on effects
attributable to a single dose could be identified based on the
toxicology data currently available for mandipropamid. Therefore,
mandipropamid is not expected to pose an acute risk.
    2. Chronic risk. There are no residential uses proposed or
registered for mandipropamid, and therefore aggregate risk is equal to
that from consumption of food and water. Chronic aggregate risk
estimates associated with exposure to mandipropamid residues in food
and water do not exceed the Agency's level of concern. For
mandipropamid, the chronic dietary exposure estimate was 22% of the
cPAD for the U.S. population and was 30% of the cPAD for the highest
exposed population subgroup, children 1-2 years of age.
    3. Short-term and intermediate-term risk. Short and intermediate-
term dermal exposures and risks were not assessed for mandipropamid,
since mandipropamid is not registered for use on any sites that would
result in residential exposure.
    4. Aggregate cancer risk for U.S. population. Aggregate cancer risk
was not assessed because mandipropamid is not likely to be carcinogenic
in humans.
    5. 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 mandipropamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology Analytical Method RAM 415/01
Residue Analytical Method for the Determination of Mandipropamid in
Crop Samples. Final Determination by LC/MS/MS and the Analytical Method
Development and Validation (German S-19) for the determination of
residues of MA Mandipropamid in or on Plant Matrices is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no specific CODEX, Canadian or Mexican maximum residue
limits (MRLs) for mandipropamid.

C. General Response to Comments

    Several comments were received from a private citizen objecting to
establishment of tolerances. The agency has received similar comments
from this commenter on numerous previous occasions. Refer to Federal
Register 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), 69
FR 63096-63098 (October 29, 2004) for the Agency's response to these
objections. In addition, the commenter noted several adverse effects
seen in animal toxicology studies with mandipropamid and claims because
of these effects no tolerance should be approved. EPA has found,
however, that there is reasonable certainty of no harm to humans after
considering these toxicological studies and the exposure levels of
humans to mandipropamid.

V. Conclusion

    Therefore, the tolerances are established for residues of
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
alpha-(2-propynyloxy)-benzeneacetamide, in or on Brassica, head and
stem, subgroup 5A at 3 ppm; Brassica, leafy greens, subgroup 5B at 25
ppm; vegetable, cucurbit, group 9 at 0.6 ppm; vegetable, fruiting,
group 8 at 1.0 ppm; okra at 1.0 ppm; vegetable, leafy, except Brassica,
group 4 at 20 ppm; vegetable, tuberous

and corm, subgroup 1C at 0.01 ppm; grape at 1.4 ppm; grape, raisin at
3.0 ppm; onion, dry bulb at 0.05 ppm; onion, green at 4 ppm; and
potato, wet peel at 0.03 ppm. A tolerance for tomato paste is not being
established because residue expected will be covered by the vegetable,
fruiting crop group 8.

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, 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) 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 6, 2000) do not apply to this rule. In addition, This
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).

VII. 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: January 8, 2008.
Debra Edwards,
Director, 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 180.637 is added to read as follows:

Sec.  180.637  Mandipropamid; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide mandipropamid, 4-chloro-N-[2-(3-methoxy-4-(2-
propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide in or
on the following commodities.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.................                  3
Brassica, leafy greens, subgroup 5B..................                 25
Vegetable, cucurbit, group 9.........................                0.6
Vegetable, fruiting, group 8.........................                1.0
Vegetable, leafy except Brassica, group 4............                 20
Vegetable, tuberous and corm, subgroup 1C............               0.01
Grape................................................                1.4
Grape, raisin........................................                3.0
Okra.................................................                1.0
Onion, dry bulb......................................               0.05
Onion, green.........................................                  4
Potato, wet peel.....................................               0.03
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent tolerances. [Reserved]
[FR Doc. E8-677 Filed 1-15-08; 8:45 am]

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