[Federal Register: September 15, 2008 (Volume 73, Number 179)]
[Notices]
[Page 53254-53258]
[DOCID:fr15se08-78]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0480]

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2009

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
and payment procedures for fiscal year (FY) 2009 for user fees under
the Animal Drug User Fee Act program (ADUFA). The Federal Food, Drug,
and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act
of 2003 (ADUFA I), and the Animal Drug User Fee Amendments of 2008
(ADUFA II), authorizes FDA to collect user fees for certain animal drug
applications, on certain animal drug products, on certain
establishments where such products are made, and on certain sponsors of
such animal drug applications and/or investigational animal drug

submissions. This notice establishes the fee rates for FY 2009.
    For FY 2009, the animal drug user fee rates are: $246,300 for an
animal drug application; $123,150 for a supplemental animal drug
application for which safety or effectiveness data is required and for
an animal drug application subject to certain criteria; $4,925 for an
annual product fee; $59,450 for an annual establishment fee; and
$52,700 for an annual sponsor fee. FDA will issue invoices for FY 2009
product, establishment, and sponsor fees by December 31, 2008, and
these invoices will be due and payable on or before January 31, 2009.
FDA will issue invoices in November 2009 for any products,
establishments, and sponsors that are subject to fees for FY 2009 but
that qualified for fees after the December 2008 billing.
    The application fee rates are effective for applications submitted
on or after October 1, 2008, and will remain in effect through
September 30, 2009. Applications will not be accepted for review until
FDA has received full payment of application fees and any other animal
drug user fees owed.

FOR FURTHER INFORMATION CONTACT:  Visit the FDA Web site at http://
www.fda.gov/oc/adufa or contact Roxanne Schweitzer, Center for
Veterinary Medicine (HFV-10), Food and Drug Administration, 7529
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>. For general questions,
you may also e-mail the Center for Veterinary Medicine at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 740 of the act (21 U.S.C. 379j-12) establishes four
different kinds of user fees: (1) Fees for certain types of animal drug
applications and supplements, (2) annual fees for certain animal drug
products, (3) annual fees for certain establishments where such
products are made, and (4) annual fees for certain sponsors of animal
drug applications and/or investigational animal drug submissions
(section 740(a) of the act). When certain conditions are met, FDA will
waive or reduce fees (section 740(d) of the act).
    For FY 2009 through FY 2013, the act establishes aggregate yearly
base revenue amounts for each of these fee categories. Base revenue
amounts established for years after FY 2009 are subject to adjustment
for workload. Fees for applications, products, establishments, and
sponsors are to be established each year by FDA so that the revenue for
each fee category will approximate the level established in the
statute, after the level has been adjusted for workload.

II. Revenue Amount for FY 2009

A. Statutory Fee Revenue Amounts

    ADUFA II (Public Law 110-316 signed by the President on August 14,
2008) specifies that the aggregate revenue amount for FY 2009 for each
of the four animal drug user fee categories is $3,815,000, before any
adjustment for workload is made (see section 740(b)(1) through (b)(4)
of the act).

B. Inflation Adjustment to Fee Revenue Amount

    Because the amounts established in ADUFA II for each year for FY
2009 through FY 2013 include an inflation adjustment, no further
inflation adjustment is required.

C. Workload Adjustment to Fee Revenue Amount

    For each FY beginning after FY 2009, ADUFA II provides that
statutory fee revenue amounts shall be further adjusted to reflect
changes in review workload (section 740(c)(1) of the act). No workload
adjustment is to be made in fee revenue amounts for FY 2009.

III. Adjustment for Excess Collections in Previous Years

    Under the provisions of ADUFA I, if the agency collects more fees
than were provided for in appropriations in any year, FDA is required
to reduce its anticipated fee collections in a subsequent year by that
amount (section 740(g)(4) of the act). Table 1 of this document shows
the amount of collections realized and the amount provided in
appropriations acts, and the amount to be offset in a subsequent year,
as of the end of the latest complete fiscal year, 2007.

     Table 1--Fees Collected, Fees Appropriated, and Offset for Future Collections as of September 30, 2007
----------------------------------------------------------------------------------------------------------------
                                                                                Amount to Offset Future
           Fiscal Year            Collections Realized    Fees Appropriated               Collections
----------------------------------------------------------------------------------------------------------------
2004                                        $5,154,700            $5,000,000                            $154,700
----------------------------------------------------------------------------------------------------------------
2005                                        $8,519,101            $8,354,000                            $165,101
----------------------------------------------------------------------------------------------------------------
2006                                       $10,945,866           $11,318,000                                  $0
----------------------------------------------------------------------------------------------------------------
2007                                       $12,946,515           $11,604,000                          $1,342,515
----------------------------------------------------------------------------------------------------------------
Total                                                                                $1,662,316
----------------------------------------------------------------------------------------------------------------
Amount offset when fees for FY 2008 were determined                                                     $320,000
----------------------------------------------------------------------------------------------------------------
Remaining balance to be offset in FY 2009                                                             $1,342,316
----------------------------------------------------------------------------------------------------------------

    When ADUFA fees were established for FY 2008, the amount of fee
revenues for FY 2008 was reduced by a total of $320,000 of excess
collections. That leaves a total of $1,342,316 to be offset against FY
2009 revenue collections, lowering the net amount that would otherwise
be collected. One-fourth of this amount, rounded to the nearest
thousand, or $336,000, rounded to the nearest thousand dollars, will be
subtracted from the statutory fee revenue amounts for each of the four
fee categories in setting the FY 2009 adjusted revenue amount for each
fee category. Thus, after adjustment for prior-year excess collections,
the adjusted FY 2009 revenue target for each fee category is as
follows:
    Application Fee Revenue Amount: $3,479,000 ($3,815,000 minus
$336,000)
    Establishment Fee Revenue Amount: $3,479,000 ($3,815,000 minus
$336,000)
    Product Fee Revenue Amount: $3,479,000 ($3,815,000 minus $336,000)
    Sponsor Fee Revenue Amount: $3,479,000 ($3,815,000 minus $336,000)

Thus, the adjusted revenue amount from all four categories after this
adjustment totals $13,916,000.

IV. Application Fee Calculations for FY 2009

    The terms ``animal drug applications'' and ``supplemental animal
drug applications'' are defined in section 739(1) and (2) of the act
(21 U.S.C. 379j-11(1) and (2)).

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    The application fee must be paid for any animal drug application or
supplemental animal drug application that is subject to fees under
ADUFA and that is submitted on or after September 1, 2003. The
application fees are to be set so that they will generate $3,479,000 in
fee revenue for FY 2009. This is the amount set out in the statute
after it has been adjusted for excess collections in previous years as
set out in section III of this document. The fee for a supplemental
animal drug application for which safety or effectiveness data are
required and for an animal drug application subject to criteria set
forth in section 512(d)(4) of the act (21 U.S.C. 360b(d)(4)) is to be
set at 50 percent of the animal drug application fee (see section
740(a)(1)(A)(ii) of the act, as amended by ADUFA II).
    To set animal drug application fees and supplemental animal drug
application fees to realize $3,479,000, FDA must first make some
assumptions about the number of fee-paying applications and supplements
it will receive in FY 2009.
    The agency knows the number of applications that have been
submitted in previous years. That number fluctuates significantly from
year to year. In estimating the fee revenue to be generated by animal
drug application fees in FY 2009, FDA is assuming that the number of
applications that will pay fees in FY 2009 will equal the average
number of submissions over the 4 most recent years (including an
estimate for the current year). This may not fully account for possible
year to year fluctuations in numbers of fee-paying applications, but
FDA believes that this is a reasonable approach after 5 years of
experience with this program.
    Over the past 4 years, the average number of animal drug
applications that have been subject to the full fee was 7.5, including
the number for the most recent year, which is estimated at 4. Over this
same period, the average number of supplemental applications and
applications subject to the criteria set forth in section 512(d)(4)
that would have been subject to half of the full fee was 13.25,
including the number for the most recent year, which is estimated at 9.
    Thus, for FY 2009, FDA estimates receipt of 7.5 fee paying original
applications and 13.25 fee-paying supplemental animal drug applications
and applications subject to the criteria set forth is section
512(d)(4), which pay half of the full fee.

B. Fee Rates for FY 2009

    FDA must set the fee rates for FY 2009 so that the estimated 7.5
applications that pay the full fee and the estimated 13.25 supplements
and applications subject to the criteria set forth in section 512(d)(4)
that pay half of the full fee will generate a total of $3,479,000. To
generate this amount, the fee for an animal drug application, rounded
to the nearest hundred dollars, will have to be $246,300, and the fee
for a supplemental animal drug application for which safety or
effectiveness data are required and for applications subject to the
criteria set forth in section 512(d)(4) will have to be $123,150.

V. Product Fee Calculations for FY 2009

A. Product Fee Revenues and Numbers of Fee-Paying Products

    The animal drug product fee (also referred to as the product fee)
must be paid annually by the person named as the applicant in an animal
drug application or supplemental animal drug application for an animal
drug product submitted for listing under section 510 of the act (21
U.S.C. 360), and who had an animal drug application or supplemental
animal drug application pending before FDA after September 1, 2003 (see
section 740(a)(2) of the act). The term ``animal drug product'' is
defined in section 739(3) of the act. The product fees are to be set so
that they will generate $3,479,000 in fee revenue for FY 2009. This is
the amount set out in the statute after it has been adjusted for excess
collections in previous years as set out in section III of this
document.
    To set animal drug product fees to realize $3,479,000, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2009. FDA developed data on all animal drug products
that have been submitted for listing under section 510 of the act, and
matched this to the list of all persons who had an animal drug
application or supplement pending after September 1, 2003. As of August
2008, FDA estimates that there are a total of 785 products submitted
for listing by persons who had an animal drug application or
supplemental animal drug application pending after September 1, 2003.
Based on this, FDA estimates that a total of 785 products will be
subject to this fee in FY 2009.
    In estimating the fee revenue to be generated by animal drug
product fees in FY 2009, FDA is assuming that 10 percent of the
products invoiced, or about 78.5, will not pay fees in FY 2009 due to
fee waivers and reductions. Based on experience with other user fee
programs and the first 5 years of ADUFA, FDA believes that this is a
reasonable basis for estimating the number of fee-paying products in FY
2009.
    Accordingly, the agency estimates that fees for a total of 706.5
products (785 minus 78.5) will be paid in FY 2009.

B. Product Fee Rates for FY 2009

    FDA must set the fee rates for FY 2009 so that the estimated 706.5
products for which fees will be paid will generate a total of
$3,479,000. To generate this amount will require the fee for an animal
drug product, rounded to the nearest 5 dollars, to be $4,925.

VI. Establishment Fee Calculations for FY 2009

A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments

    The animal drug establishment fee (also referred to as the
establishment fee) must be paid annually by the person who: (1) Owns or
operates, directly or through an affiliate, an animal drug
establishment; (2) is named as the applicant in an animal drug
application or supplemental animal drug application for an animal drug
product submitted for listing under section 510 of the act; (3) had an
animal drug application or supplemental animal drug application pending
before FDA after September 1, 2003; and (4) whose establishment engaged
in the manufacture of the animal drug product during the FY (see
section 740(a)(3) of the act). An establishment subject to animal drug
establishment fees is assessed only one such fee per FY (see section
740(a)(3) of the act). The term ``animal drug establishment'' is
defined in section 739(4) of the act. The establishment fees are to be
set so that they will generate $3,479,000 in fee revenue for FY 2009.
This is the amount set out in the statute after it has been adjusted
for excess collections in previous years as set out in section III of
this document.
    To set animal drug establishment fees to realize $3,479,000, FDA
must make some assumptions about the number of establishments for which
these fees will

be paid in FY 2009. FDA developed data on all animal drug
establishments and matched this to the list of all persons who had an
animal drug application or supplement pending after September 1, 2003.
As of August 2008, FDA estimates that there are a total of 65
establishments owned or operated by persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. Based on this, FDA believes that 65 establishments
will be subject to this fee in FY 2009.
    In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2009, FDA is assuming that 10 percent of the
establishments invoiced, or 6.5, will not pay fees in FY 2009 due to
fee waivers and reductions. Based on experience with the first 5 years
of ADUFA, FDA believes that this is a reasonable basis for estimating
the number of fee-paying establishments in FY 2009.
    Accordingly, the agency estimates that fees for a total of 58.5
establishments (65 minus 6.5) will be paid in FY 2009.

B. Establishment Fee Rates for FY 2009

    FDA must set the fee rates for FY 2009 so that the estimated 58.5
establishments for which fees will be paid will generate a total of
$3,479,000. To generate this amount will require the fee for an animal
drug establishment, rounded to the nearest 50 dollars, to be $59,450.

VII. Sponsor Fee Calculations for FY 2009

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

    The animal drug sponsor fee (also referred to as the sponsor fee)
must be paid annually by each person who: (1) Is named as the applicant
in an animal drug application that has not been withdrawn or has
submitted an investigational animal drug submission that has not been
terminated or otherwise rendered inactive and (2) had an animal drug
application, supplemental animal drug application, or investigational
animal drug submission pending before FDA after September 1, 2003 (see
sections 739(6) and 740(a)(4) of the act). An animal drug sponsor is
subject to only one such fee each FY (see section 740(a)(4) of the
act). The sponsor fees are to be set so that they will generate
$3,479,000 in fee revenue for FY 2009. This is the amount set out in
the statute after it has been adjusted for excess collections in
previous years as set out in section III of this document.
    To set animal drug sponsor fees to realize $3,479,000, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2009. Based on the number of firms that would have met this
definition as of August 2008, FDA estimates that a total of 140
sponsors will meet this definition in FY 2009.
    Careful review indicates that about one-third or 33 percent of all
of these sponsors will qualify for a minor use/minor species waiver or
reduction (section 740(d)(1)(C) of the act). Based on the agency's
experience with sponsor fees, FDA's current best estimate is that an
additional 20 percent will qualify for other waivers or reductions, for
a total of 53 percent of the sponsors invoiced, or 74 sponsors, who
will not pay fees in FY 2009 due to fee waivers and reductions. FDA
believes that this is a reasonable basis for estimating the number of
fee-paying sponsors in FY 2009.
    Accordingly, the agency estimates that a total of 66 sponsors (140
minus 74) will pay sponsor fees in FY 2009.

B. Sponsor Fee Rates for FY 2009

    FDA must set the fee rates for FY 2009 so that the estimated 66
sponsors that pay fees will generate a total of $3,479,000. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest 50 dollars, to be $52,700.

VIII. Fee Schedule for FY 2009

    The fee rates for FY 2009 are summarized in table 2 of this
document.

                       Table 2--FY 2009 Fee Rates
------------------------------------------------------------------------
         Animal Drug User Fee Category             Fee Rate for FY 2009
------------------------------------------------------------------------
Animal Drug Application Fee.............................................
  Animal drug application......................                 $246,300
  Supplemental animal drug application for                      $123,150
   which safety or effectiveness data are
   required or animal drug application subject
   to the criteria set forth in section
   512(d)(4) of the act........................
  Animal drug product fee......................                   $4,925
Animal drug establishment fee\1\...............                  $59,450
Animal drug sponsor fee\2\.....................                  $52,700
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
  FY.
\2\ An animal drug sponsor is subject to only one such fee each FY.

IX. Procedures for Paying the FY 2009 Fees

A. Application Fees and Payment Instructions

    The appropriate application fee established in the new fee schedule
must be paid for an animal drug application or supplemental animal drug
application subject to fees under ADUFA II that is submitted after
September 30, 2008. Payment must be made in U.S. currency by check,
bank draft, U.S. postal money order payable to the order of the Food
and Drug Administration, by wire transfer, or electronically using
Pay.gov (the ``Pay Now'' button on the cover sheet). On your check,
bank draft, or U.S. postal money order, or wire transfer, please write
your application's unique Payment Identification Number, beginning with
the letters AD, from the upper right-hand corner of your completed
Animal Drug User Fee Cover Sheet. Also write the FDA post office box
number (P.O. Box 953877) on the enclosed check, bank draft, or money
order. Your payment and a copy of the completed Animal Drug User Fee
Cover Sheet can be mailed to: Food and Drug Administration, P.O. Box
953877, St. Louis, MO, 63195-3877. If payment is made via wire
transfer, send payment to US Department of Treasury, TREAS, NYC, 33
Liberty St. New York, NY 10045, Account Name: Food and Drug
Administration, Account Number: 75060099, Routing Number: 021030004,
Swift Number: FRNYUS33. If payment is made via Pay.gov, you will first
create and submit a cover sheet for your organization, then click on
the ``Pay Now'' button. You will then be taken to the Pay.gov site to
make your payment electronically.
    If you prefer to send a check by a courier such as FEDEX or UPS,
the courier may deliver the check and printed copy of the cover sheet
to: US Bank, Attn: Government Lockbox

953877, 1005 Convention Plaza, St. Louis, Missouri 63101. (Note: This
address is for courier delivery only. If you have any questions
concerning courier delivery contact the US Bank at<PHONE_NUMBER>. This
phone number is only for questions about courier delivery.)
    The tax identification number of the Food and Drug Administration
is 530196965. (Note: In no case should the check for the fee be
submitted to FDA with the application.)
    It is helpful if the fee arrives at the bank at least a day or two
before the application arrives at FDA's Center for Veterinary Medicine
(CVM). FDA records the official application receipt date as the later
of the following: the date the application was received by CVM, or the
date US Bank notifies FDA that your check in the full amount of the
payment due has been received, or when the United States Treasury
notifies FDA of receipt of an electronic payment. US Bank and the
United States Treasury are required to notify FDA within 1 working day,
using the Payment Identification Number described previously.

B. Application Cover Sheet Procedures

    Step One--Create a user account and password. Log onto the ADUFA
Web site at http://www.fda.gov/oc/adufa and, under the ``Forms''
heading, click on the link ``User Fee Cover Sheet.'' For security
reasons, each firm submitting an application will be assigned an
organization identification number, and each user will also be required
to set up a user account and password the first time they use this
site. Online instructions will walk you through this process.
    Step Two--Create an Animal Drug User Fee Cover Sheet, transmit it
to FDA, and print a copy. After logging into your account with your
user name and password, complete the steps required to create an Animal
Drug User Fee Cover Sheet. One cover sheet is needed for each animal
drug application or supplement. Once you are satisfied that the data on
the cover sheet is accurate and you have finalized the Cover Sheet, you
will be able to transmit it electronically to FDA and you will be able
to print a copy of your cover sheet showing your unique Payment
Identification Number.
    Step Three--Send the payment for your application as described in
section IX.A of this document.
    Step Four--Please submit your application and a copy of the
completed Animal Drug User Fee Cover Sheet to the following address:
Food and Drug Administration, Center for Veterinary Medicine, Document
Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855.

C. Product, Establishment and Sponsor Fees

    By December 31, 2008, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2009
using this fee schedule. Payment will be due and payable on or before
January 31, 2009. FDA will issue invoices in November 2009 for any
products, establishments, and sponsors subject to fees for FY 2009 but
that qualified for fees after the December 2008 billing.

    Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21450 Filed 9-12-08; 8:45 am]

BILLING CODE 4160-01-S


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Shaja B. Joyner,<PHONE_NUMBER>

Syngenta Crop Protection, LLC, PO Box 18300, Greensboro, NC 27419

Petition 2F8986

	EPA has received a pesticide petition 2F8986 from Syngenta Crop Protection, LLC, PO Box 18300, Greensboro, NC 27419 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of Sedaxane in or on the raw agricultural commodity Vegetable, cucurbit, group 9 at 0.01 parts per million (ppm) and Vegetable, dry bulb, crop subgroup 3-07A at 0.01 parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. Plant metabolism data were studied for corn, wheat, soybean, Swiss chard, and canola to support the seed treatment uses of sedaxane. Studies for all commodities reflected labeling in both the phenyl and pyrazole rings. Application rates were equal to, or exaggerations of, the currently proposed use rates, and application techniques reflect the requested use patterns.
      The metabolic pathway in wheat, soybeans, and Swiss chard is substantially similar. Radioactivity levels were too low from corn and canola samples to elucidate the metabolic pathways in these crops. Following seed treatment use of sedaxane in wheat, soybean, and Swiss chard, sedaxane metabolism may be summarized as follows: 1) oxidative metabolism of the phenyl and cyclopropane rings, 2) N-demethylation of the pyrazole ring, and 3) cleavage between pyrazole and phenyl rings. Among the three crops studied, there is variation in the extent of the three reaction processes and the nature of the observed conjugates found.
The seed treatment data on the metabolism of sedaxane in wheat, soybean, and Swiss chard demonstrate that residues are generally low but do translocate throughout the plants. The highest residues are generally found in the foliage or forage portions of plants, and not in the seeds or grains of these commodities. Crop field trial residue data were consistent with the results of the plant metabolism studies. Specifically, the magnitude of the residue studies showed no quantifiable residues of sedaxane in any human food plant parts, but low-level residues were found in some livestock feedstuffs associated with these plants.

	2. Analytical method.  Various crops were analyzed for sedaxane (parent only) using a procedure for analysis of sedaxane (SYN524464) that can distinguish between its trans and cis isomers (SYN508210 and SYN508211). Plant matrices using method GRM023.01A or modified method GRM023.01B are taken through an extraction procedure with final determination by high-performance liquid chromatography with triple quadrupole mass spectrometric detection (LC-MS/MS).
      Method GRM023.01A (and therefore GRM023.01B, which uses the same procedure) was validated on a range of plant commodities fortified with the trans and cis isomers SYN508210 and SYN508211 at the proposed limit of quantification (LOQ) of the method (0.005 mg/kg for SYN508210 and SYN508211) and either at 10 times the LOQ or at the potential MRL.
      The plant matrices included plants from each of the crop commodities identified in OECD Guidance ENV/JM/MONO(2007)17, including wheat grain, wheat straw, wheat whole plant, lentils, and oilseed rape seed as a few of those crops tested. The mean SYN508210 and SYN508211 recoveries for both primary quantification and confirmatory transitions at each fortification level and overall, for each crop commodity tested during method validation were 76%  -  102%. The limit of quantification for SYN508210 and SYN508211 residues in crop commodities using method GRM023.01A was established at 0.005 mg/kg.

	3. Magnitude of residues. 1) Adequate plant metabolism data have previously been submitted to establish the residue definition for enforcement purposes and risk assessment for sedaxane, and 2) the proposed labelled seed-treatment rates are <=10 g ai/100 kg seed for all proposed new crop uses, so a reduction in data requirements is appropriate based on the EPA Memorandum entitled Reduced Residue Chemistry Data Requirements for Seed-Treatment Uses, dated January 26, 2018.

B. Toxicological Profile

	1. Acute toxicity. Sedaxane has low acute toxicity by the oral, dermal and inhalation routes. It is not a dermal sensitizer, causes no skin irritation, and causes only slight eye irritation.

	2. Genotoxicity. Sedaxane was negative (non-mutagenic) in an in vitro bacterial reverse mutation assay, an in vitro gene mutation assay in mammalian cells, an in vitro cytogenetics study, an in vivo unscheduled DNA synthesis study, and an in vivo rat bone marrow micronucleus assay.

	3. Reproductive and developmental toxicity. Sedaxane was evaluated for potential to cause effects on reproductive and developmental toxicity in a multi-generation reproductive toxicity study in the rat and in pre-natal developmental toxicity studies in the rat and rabbit. There were no adverse effects on reproduction or fertility up to the top dose level of 127 mg/kg/day (1500 ppm). Therefore, this high dose represented the NOAEL for reproductive toxicity.
      There were no indications of any differences in sensitivity to sedaxane between the different generations or between parental animals and offspring. There were no adverse effects at a dose level of 42 mg/kg/day (500 ppm) in adults or pups, indicating that this was the NOAEL for parental and offspring toxicity.
      Data from both the rat and rabbit developmental toxicity studies with sedaxane showed no potential for teratogenic effects, and the fetal NOAEL values were equal to or higher than the maternal NOAEL values, indicating a lack of sensitivity of developing offspring to the effects of sedaxane.

	4. Subchronic toxicity. The short-term toxicity of sedaxane has been evaluated by the oral route of administration in rats, mice and dogs. In addition, dermal toxicity was evaluated in rats in a 28-day study.
      Sedaxane is generally of a low order of toxicity in all species tested in short-term studies. Rats were slightly more sensitive to the general systemic effects of sedaxane treatment than were dogs. Mice were relatively non-responsive except at a limit dose for studies of this type, 1268 mg/kg/day in males and 1800 mg/kg/day in females (7000 ppm). A NOAEL of 28 mg/kg/day (300 ppm) was achieved in the second 90-day rat study for female rats.
      In rats, treatment-related effects were seen consistently in the liver, indicating that this is a target organ for sedaxane. At dose levels of 2000 ppm and 1000 ppm in the 90-day rat studies, slight increases in liver weight were seen in males and females, with no micropathological findings. The increases are therefore consistent with adaptive changes and were considered non-adverse. No effects on liver weights or micropathology were seen at 250 or 300 ppm in these studies.
      In male and female rats, increased incidence of thyroid follicular cell hypertrophy was observed only at the 325 mg/kg/day in males and 350 mg/kg/day in females (4000 ppm) dose level in the second 90-day rat study. There were no effects in this organ in the first 90-day rat study. A chronic/carcinogenicity study in rats also showed similar low- level changes of follicular cell hypertrophy in male and female rats after 52 weeks of treatment at 1200 and 3600 ppm concentration levels. Overall, the response in the thyroid of rats was relatively mild and was variable between studies and laboratories.
      In mice, no adverse effects of treatment were observed in the 28-day study at concentration levels up to 7000 ppm. Decreased bodyweight gain and food utilization were observed in male mice at 1167 mg/kg/day (7000 ppm) in the 90-day study, but not in females. No micropathology changes were observed in either study and the few differences in certain hematology, clinical chemistry, or organ weight values were not considered adverse. In the 90-day study, a NOAEL of 567 mg/kg/day (3500 ppm) was achieved in male mice.
      In dogs, liver weights were higher than control values in male and female dogs after one year at 200 mg/kg/day, but, in the absence of micropathology findings, this was considered non-adverse. In the 90-day dog study, there were no effects on liver weights and no differences from control animals in liver micropathology. There were no adverse effects on the thyroid in any study in the dog, including the 1-year study. A NOAEL of 50 mg/kg/day was achieved in both the 90-day and 1-year dog studies, based on initially lower food consumption and consistently lower cumulative bodyweight gains at >=150 mg/kg/day.
      In a 28-day dermal toxicity study in rats, no treatment-related effects were observed at any dose level up to the limit dose of 1000 mg/kg/day.
      In an acute neurotoxicity study in rats, no neuropathology was observed at any dose level, and the NOAEL for neurotoxicity was 2000 mg/kg. The NOAEL for general toxicity in this study was 30 mg/kg, based on effects on body weight, food consumption, and clinical signs at 250 mg/kg. For use in acute risk assessments, EPA derived an acute reference dose (aRfD) of 0.30 mg/kg/day based on the NOAEL of 30 mg/kg from this acute neurotoxicity study.
      In a subchronic neurotoxicity study, sedaxane did not produce any evidence of neurotoxicity in rats at concentration levels of 0, 300, 1000 and 4000 ppm for 90 days. A NOAEL for general toxicity was observed at 1000 ppm, equivalent to 66.0/79.7 mg/kg/day in male and female rats, respectively.

	5. Chronic toxicity. Sedaxane has been evaluated for chronic toxicity in the rat and for carcinogenic potential in the rat and the mouse.
      In a 2-year combined rat chronic toxicity/carcinogenicity study conducted at dietary inclusion levels of 0, 200, 1200 and 3600 ppm, there were no treatment related effects on survival. There was a marked deficit in body weight gain at 3600 ppm which was evidenced throughout the entire study. The extent of the body weight effect increased substantially during the course of the study and by the end of the study represented a 24% and 50% decrease in body weight gain in males and females, respectively. The magnitude of the effect at 3600 ppm was considered to be greater than that required for an adequate evaluation of carcinogenic potential. At 1200 ppm, body weight gain was a maximum of 11% lower than control in females, which was considered to be of sufficient magnitude to provide a robust assessment of carcinogenic potential. The NOEL was 200 ppm for both males and females, equating to 11 mg/kg/day in males and 14 mg/kg/day in females. The LOAEL was 1200 ppm.
      In a carcinogenicity study in the mouse, groups of 50 male and 50 female CD-1 mice were fed diets containing 0, 200, 1250 and 7000 ppm of sedaxane for a period of at least 80 weeks. There were no treatment related effects on survival and no treatment-related clinical signs. Effects at the LOAEL and above included decreased body weight and body weight gain and food utilization in males and females. The NOAEL for this study was 1250 ppm for both sexes, equating to achieved dose levels of 157 mg/kg/day in males and 185 mg/kg/day in females.
      For non-cancer risk assessments of chronic exposures, a chronic reference dose (cRfD) of 0.11 mg/kg/day was assigned, based on the NOAEL of 11 mg/kg/day in the 2-year rat study.

	6. Animal metabolism. In both poultry and goat, the majority of the dosed radioactivity was excreted (mainly in the feces of the goat) and residues in tissues, milk and eggs were low. In the goat study, milk residues reached a plateau very rapidly, after just 2 days (reaching a maximum of 0.045 mg/kg). Residues in eggs from the hen study reached a plateau after approximately 9 days (reaching a maximum of 0.015 mg/kg in egg white and 0.089 mg/kg in egg yolk).
	In both species, the highest tissue residues were observed in liver: 0.26 mg/kg in hen and 0.61 mg/kg in goat. Residues in muscle were <0.006 mg/kg and in fat were <0.016 mg/kg. In the goat, kidney residues represented <0.19 mg/kg.
	Metabolic profiles observed in livestock commodities and excreta arise from just a few types of biotransformation. The principal routes of metabolism are oxidation resulting in hydroxylation of the phenyl ring or at the cyclopropane moiety. Additionally, the same oxidations are observed following demethylation of sedaxane. Overall results showed that the biotransformation pathway of sedaxane in ruminants and poultry is very similar to that observed in the rat.

	7. Metabolite toxicology. CSCD465008 (formed via cleavage of the carboxamide link in the pyrazole labeled aerobic soil study) has been assessed for acute oral toxicity, in vitro genotoxicity (bacterial reverse mutation, in vitro cytogenics and mammalian gene cell mutation), and repeat oral toxicity for up to 28 days. CSCD465008 was not acutely toxic by the oral route, not genotoxic in vitro, and did not result in any toxicologically significant effects at dose levels exceeding 1000 mg/kg-bw/day, the limit dose for a 28-day toxicity study in rats. Based on the toxicity data on CSCD465008, this metabolite less toxic than parent, sedaxane.

	8. Endocrine disruption. Sedaxane does not belong to a class of chemicals known or suspected of having adverse effects on the endocrine system. Furthermore, supporting developmental toxicity studies in rats and rabbits, and a reproduction study in rats, gave no indication of any effects on endocrine function related to development and reproduction. Subchronic and chronic treatment did not induce any morphological changes in endocrine organs and tissues.

C. Aggregate Exposure

	1. Dietary exposure. Tier I acute and Tier II chronic aggregate exposure assessments were performed for sedaxane (SYN524464), a mixture of its cis- (SYN508210) and trans- (SYN508211) isomers using the Dietary Exposure Model (DEEM-FCID(TM) Version 4.02, Evaluation Copy) and CARES NG Food Model (Creme Global, Version 1.2.0). Consumption data were from the USDA NHANES "What We Eat in America" survey; 2005-2010 was used for both models. Side-by-side comparison of the two dietary models resulted in effectively no differences for acute and chronic exposures. The definition of the residue for tolerance enforcement and risk assessment purposes for crops is parent sedaxane (SYN508210 plus SYN508211). Assessments were conducted for all current uses and proposed seed treatment uses on cucurbits (Crop Group 9) and bulb onions (Crop Subgroup 3-07A). The Tier I acute assessments incorporated established (40 CFR 180.665) or proposed tolerances values for all crops where sedaxane was applied at the maximum intended seed treatment use rate and crops harvested at the minimum pre-harvest interval (PHI) to obtain the maximum expected residues. Percent of crop treated (%CT) was conservatively assumed to be 100% for the acute assessments. The Tier II chronic assessments incorporated field trial residue values where sedaxane was applied at the maximum intended use rate and crops harvested at the minimum PHI to obtain the maximum expected residues. Percent of crop treated (%CT) was conservatively assumed to be 100% for the chronic assessments. Anticipated residues in meat, milk, and eggs were estimated based on "maximum reasonably balanced diets" and transfer information from goat and hen metabolism studies and includes parent sedaxane (SYN508210 plus SYN508211) plus the metabolite CSCD658906 for risk assessment purposes. Drinking water estimates were selected using the higher of the estimated drinking water concentrations (EDWCs) for surface and ground water.

	i. Food. Acute Exposure. Acute food-only risk assessments for parent sedaxane (SYN508210 plus SYN508211) were performed for all population sub-groups using an acute reference dose of 0.30 mg/kg-bw/day, based upon a neurotoxicity study in rats with a no observed adverse effect level (NOAEL) of 30 mg/kg-bw/day and an uncertainty factor of 100X. The 100X safety factor includes intra- and inter-species variations; no additional FQPA safety factor was applied. For aggregate risk assessment, the exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup. In addition, exposure was expressed as a percent of the acute reference dose (%aRfD). Acute food exposure to the U.S. population resulted in a MOE of 200,711 (0.1% of the aRfD of 0.30 mg/kg-bw/day). The most exposed sub-population was children (1-2 years old) with an MOE of 89,779 (0.1% of the aRfD of 0.30 mg/kg-bw/day). Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from acute food exposures to residues arising from all current and proposed uses of sedaxane.

Chronic Exposure. Chronic food-only risk assessments for parent sedaxane (SYN508210 plus SYN508211) were performed for all population sub-groups using a chronic reference dose of 0.11 mg/kg-bw/day, based upon a chronic rat study with a no observed adverse effect level (NOAEL) of 11 mg/kg-bw/day and an uncertainty factor of 100X. The 100X safety factor includes intra- and inter-species variations; no additional FQPA safety factor was applied. For the purpose of aggregate risk assessment, the exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup. In addition, exposure was expressed as a percent of the chronic reference dose (%cRfD). Chronic food exposure to the U.S. population resulted in a MOE of 214,754 (<0.1% of the cRfD of 0.11 mg/kg-bw/day). The most exposed sub-population was children (1-2 years old) with an MOE of 82,075 (0.1% of the cRfD of 0.11 mg/kg-bw/day). Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from chronic food exposures to residues arising from all current and proposed uses of sedaxane.

	ii. Drinking water. The drinking water concentrations (EDWCs) of sedaxane were determined as combined residues of parent sedaxane isomers, CSCD668094 and CSCD668095, using a total toxic residue (TTR) approach for a screening-level estimation. For terrestrial uses, Tier I and Tier II Pesticides in Water Calculator (PWC, v. 2.001) was used to calculate EDWCs for surface water and groundwater. For the rice use, the Pesticides in Flooded Applications Model (PFAM v. 2.0) was used to model drinking water exposure. The crop uses evaluated in this assessment include all currently registered seed treatments and the proposed seed treatments on cucurbit vegetables (crop group 9) and onion (crop subgroup 3-07A). The registered seed treatment use for potato generated the highest EDWCs in groundwater for acute and chronic exposure, which were 20.2 ppb and 19.2 ppb, respectively. These EDWCs were used for risk assessment purposes and are considered protective for any surface water exposure concerns.

Acute Exposure from Drinking Water. The acute surface water EDWC of 20.2 ppb was input directly into the DEEM-FCID(TM) software as "water, direct and indirect, all sources" to model the acute drinking water exposures. Exposure contributions at the 95% percentile of exposures were determined by taking the difference between the aggregate (food + drinking water) exposures and the food (alone) exposures for each population subgroup. Acute drinking water exposure U.S. population resulted in an MOE of 29,674 (0.3% of the acute RfD of 0.30 mg/kg-bw/day). The most exposed sub-population was all infants (<1 year old) with an MOE of 8,399 (1.2% of the acute RfD of 0.30 mg/kg/day). Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the acute RfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute drinking water exposure to residues arising from the current and proposed uses for sedaxane.

Chronic Exposure from Drinking Water. The chronic surface water EDWC of 19.2 ppb was input directly into the DEEM-FCID(TM) software as "water, direct and indirect, all sources" to model the chronic drinking water exposures. Chronic drinking water exposure to the U.S. population resulted in an MOE of 28,356 (0.4% of the chronic RfD of 0.11 mg/kg-bw/day). Chronic drinking water exposure to the most exposed sub-population (infants, <1 year old) resulted in an MOE of 7,591 (1.3% of the chronic RfD of 0.11 mg/kg-bw/day). Since the Benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the chronic RfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic drinking water exposure to residues arising from the current and proposed uses for sedaxane.

	2. Non-dietary exposure. There are no currently registered residential uses for sedaxane, so a non-dietary residential exposure assessment was not conducted.

D. Cumulative Effects

	Cumulative Exposure to Substances with a Common Mechanism of Toxicity.  Section 408(b)(2)(D)(v) 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". Syngenta did not perform a cumulative risk assessment as part of this tolerance action for sedaxane because HED has not yet determined that there are any other chemical substances that have a mechanism of toxicity common with that of sedaxane.

E. Safety Determination

	1. U.S. population. The acute aggregate exposure analysis (food plus water) for all current and proposed uses of sedaxane resulted in an MOE of 25,855 for the U.S. population (0.4% of the aRfD of 0.30 mg/kg-bw/day) which exceeds the Benchmark MOE of 100. The chronic aggregate exposure analysis (food plus water) for all current and proposed uses of sedaxane resulted in an MOE of 25,049 for the U.S. population (0.4% of the cRfD of 0.11 mg/kg-bw/day) which exceeds the Benchmark MOE of 100. Based on the completeness and reliability of the toxicity data supporting these petitions, Syngenta believes that there is a reasonable certainty that no harm will occur to the U.S. population from acute and chronic aggregate exposures arising from all current and proposed uses of sedaxane.

	2. Infants and children. The acute aggregate exposure analysis (food plus water) for all current and proposed uses of sedaxane resulted in an MOE of 7,883 (1.3% of the aRfD of 0.30 mg/kg-bw/day) for the most sensitive population subgroup, all infants, which exceeds the Benchmark MOE of 100. The chronic aggregate exposure analysis (food plus water) for all current and proposed uses of sedaxane resulted in an MOE of 7,219 (1.4% of the cRfD of 0.11 mg/kg-bw/day) for the most sensitive population subgroup, all infants, which exceeds the Benchmark MOE of 100. Based on the completeness and reliability of the toxicity data supporting these petitions, Syngenta believes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to residues arising from all current and proposed uses of sedaxane.

F. International Tolerances

	Codex maximum residue levels (MRLs) have been established for residues of sedaxane on cereals, potato, pulses, rape seed, sweet corn, animal feeds, and animal commodities.


[Federal Register Volume 87, Number 5 (Friday, January 7, 2022)]
[Notices]
[Pages 959-962]
[FR Doc No: 2022-00068]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9302-01-OMS]

Privacy Act of 1974; System of Records

AGENCY: Office of Land and Emergency Management (OLEM), Environmental
Protection Agency (EPA).

ACTION: Notice of a modified system of records.

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SUMMARY: The U.S. Environmental Protection Agency's (EPA), Office of
Land and Emergency Management (OLEM) is giving notice that it proposes
to modify a system of records pursuant to the provisions of the Privacy
Act of 1974. Environmental Assessments of Residential Properties (EARP)
is being modified to further clarify the nature of the information, and
the ways in which that information may be used and shared with parties
who are part of the evaluation and coordination process. This system of
records contains information of individuals that is collected in the
course of response and environmental assessment actions, including
actions taken under a variety of EPA authorities. The information
maintained under this System of Records Notice (SORN) is needed to
support EPA's decision-making process on what actions may be necessary
to address potential environmental impacts at residential properties,
including necessary investigation and cleanup activities. This
information is collected to ensure an appropriate and cohesive response
to situations that may require EPA response activities, and to protect
the health and welfare of residents who may be affected by conditions
that present a potential environmental or public health threat. The
information is maintained as needed for consideration and coordination
of environmental response activities. This information may include
individuals' contact information, information related to their address
or place of residence, correspondence, and related environmental and
public health information collected in the course of investigation,
sampling, and cleanup work, as described in further detail below. All
exemptions and provisions included in the previously published SORN for
EARP will transfer to the modified SORN for EARP.

DATES: Persons wishing to comment on this system of records notice must
do so by February 7, 2022. New routine uses for this modified system of
records will be effective February 7, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OLEM-2021-0038, by one of the following methods:
    Federal eRulemaking Portal: https://www.regulations.gov. Follow the
online instructions for submitting comments.
    Email: [email protected]. Include the Docket ID number in the
subject line of the message.
    Fax:<PHONE_NUMBER>.
    Mail: OMS Docket, Environmental Protection Agency, Mail Code:
2822T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    Hand Delivery: OMS Docket, EPA/DC, WJC West Building, Room 3334,
1301 Constitution Ave. NW, Washington, DC 20460. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OLEM-
2021-0038. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at https://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Controlled Unclassified Information (CUI) or other information
for which disclosure is restricted by statute. Do not submit
information that you consider to be CUI or otherwise protected through
https://www.regulations.gov. The https://www.regulations.gov website is
an ``anonymous access'' system for the EPA, which means the EPA will
not know your identity or contact information. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comment. If the EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, the EPA may not be able to consider your
comment. If you send an email comment directly to the EPA without going
through https://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the internet.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses. For additional
information about the EPA public docket, visit the EPA Docket Center
homepage at https://www.epa.gov/dockets.
    Docket: All documents in the docket are listed in the https://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CUI or other information
for which disclosure is restricted by statute. Certain other material,
such as copyrighted material, will be publicly available only in hard
copy. Publicly available docket materials are available either
electronically in https://www.regulations.gov or in hard copy at the
OMS Docket, EPA/DC, WJC West Building, Room 3334, 1301 Constitution
Ave. NW, Washington. DC 20460. The Public Reading Room is normally open
from 8:30 a.m. to 4:30 p.m., Monday through Friday excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OMS Docket is (202) 566-
1752.

Temporary Hours During COVID-19

    Out of an abundance of caution for members of the public and our
staff, the EPA Docket Center and Reading Room are closed to the public,
with limited exceptions, to reduce the risk of transmitting COVID-19.
Our Docket Center staff will continue to provide remote customer
service via email, phone, and webform. We encourage the public to
submit comments via https://www.regulations.gov or email, as there may
be a delay in processing mail and faxes. Hand deliveries and couriers
may be received by scheduled appointment only. For further information
on EPA Docket Center services and the current status, please visit us
online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Joseph Schaefer, Office of Land and
Emergency Management (OLEM), Office of Superfund Remediation and
Technology Information (OSRTI), Mail Code 205A-ERT, Raritan Depot 2890
Woodbridge Avenue, Edison, NJ 08837; telephone number<PHONE_NUMBER>;
[email protected].

SUPPLEMENTARY INFORMATION: EPA created a Privacy Act system of records
to allow the agency to maintain records that are necessary to conduct
environmental assessments at

residential properties in order to respond to emergency situations and
during environmental assessment activities conducted by EPA under many
different programs including Superfund (42 U.S.C. 9601 et seq.), the
Resource Conservation and Recovery Act (42 U.S.C. 6901 et seq.), and
the Safe Drinking Water Act (42 U.S.C. 300f et seq.). This system of
records promotes transparency, efficiency, and improved environmental
and health outcomes by encompassing all records associated with EPA
residential assessment and response work, including the database
repositories, field documentation, and analytical reports.
    The previous notices concerning this system of records highlighted
that EPA is often required to support or work closely with state and
local agencies or other federal agencies evaluating the health and
welfare of affected communities. This cooperation and coordination also
extends to tribes and tribal agencies.
    The previous notices included a list of the types of information
commonly gathered in environmental assessments and responses,
including: Names of residents; address information; phone number or
other contact information; test results from environmental sampling;
information about the building structure, such as the age of the
structure, information about the service lines, plumbing and pipe
information, and building materials in the structure; information about
the length of residence or ownership of the structure; and geographic
information system (GIS) coordinates. Typical types of information may
also include: Age; medical and health information; property ownership
and property management information; information about physical
dimensions of the property and structures present on the property;
information about wells on the property; information about how the
property is used; information about sampling locations; and information
about prior environmental issues at the property, including prior test
results and actions taken. Other site-specific data elements may also
be collected if needed for the environmental assessment or response
activity.
    As described in more detail in the previous notices, information
and data collected in environmental assessments and responses will
generally be stored in an agency-approved electronic database, which
will be managed by EPA system administrators. Other associated records
may also be stored in other agency-approved electronic or paper
formats, such as Microsoft Excel spreadsheets, Microsoft Word documents
or tables, or in file folders in secure locations. During the course of
the assessment and response, records may also be temporarily stored off
site in secure facilities such as incident command posts or EPA field
offices which are maintained and secured by EPA staff.
    The previous notices identified the EPA staff and contractors who
might have access to the information in the system of records. The
notices also stated that in appropriate circumstances, limited access
to the database systems may be provided to state and local public
health authorities in conformity with federal, state, and local laws
when necessary to protect the environment or public health or safety.
To clarify and emphasize the value of inter-governmental coordination
and communication, the previous notices are now clarified to confirm
that routine uses may include disclosure to any appropriate federal,
state, local, and tribal authorities when necessary to protect the
environment or public health or safety, including carrying out an
investigation or response. Information may also be shared with state
agencies and with the public as part of their participation in the
Superfund evaluation and decision-making process. This may include
public disclosure of addresses where EPA determines cleanup actions are
required. In cases of emergency, EPA may also need to share information
with members of the public to assure protection of the environment, and
public health and safety.

SYSTEM NAME AND NUMBER:
    Environmental Assessments of Residential Properties (EARP), EPA-74.

SECURITY CLASSIFICATION:
    Unclassified.

SYSTEM LOCATION:
    The system is managed by EPA's Office of Land and Emergency
Management (OLEM), 1200 Pennsylvania Ave. NW, Mail Code 5103 T,
Washington, DC 20460. Information maintained pursuant to this notice
may be located at EPA Headquarters Offices or at EPA Regional Offices,
or at field offices established as part of the residential assessment
field work, depending upon the location where the environmental
assessment is conducted or where computer resources are located.
Databases may be hosted at the EPA's National Computer Center located
at 109 T.W. Alexandra Drive, Durham, NC 27709, or in OLEM's emergency
response cloud hosting environment.

SYSTEM MANAGER(S):
    Joseph Schaefer, Physical Scientist (Environmental), Office of Land
and Emergency Management (OLEM), Office of Superfund Remediation and
Technology Information (OSRTI), Mail Code 205A-ERT, Raritan Depot 2890
Woodbridge Avenue, Edison, NJ 08837; telephone number<PHONE_NUMBER>;
[email protected].

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6981;
Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA), 42 U.S.C. 9604, 9660; Clean Air Act (CAA), 42 U.S.C. 7403;
Safe Drinking Water Act (SDWA), 42 U.S.C. 300i; 300j-1; Federal Water
Pollution Control Act, (FWPCA) 33 U.S.C. 1254, 1318, 1321; Toxic
Substances Control Act (TSCA), 15 U.S.C. 2609; Federal Insecticide,
Fungicide, and Rodenticide Act, (FIFRA) 7 U.S.C. 136r.

PURPOSE(S) OF THE SYSTEM:
    The EPA has created a Privacy Act system of records to allow EPA to
maintain records that are necessary to conduct environmental
assessments at residential properties in order to respond to emergency
situations and during environmental assessment activities conducted by
EPA under many different programs including Superfund, RCRA, and the
SDWA. This system of records promotes transparency, efficiency, and
improved environmental and health outcomes by encompassing all of the
records associated with EPA residential assessment and response work,
including the database repositories, field documentation and analytical
reports. Over the course of these assessments EPA is often required to
support or work closely with state and local agencies or other federal
agencies to evaluate the health and welfare of affected communities.
EPA's environmental assessment activities at residential properties
include: Obtaining and tracking legal access to the properties;
gathering environmental data through sampling activities, such as
sampling air, water, soil, or other environmental media at sites;
collecting structural information such as the age of the structure,
information about the service lines, plumbing and pipe information, and
building materials in the structure, information about the length of
residence or ownership of the structure, and GIS coordinates; and
collecting residential contact information such as name, address, and
phone number to allow response teams

to correspond with individuals affected by environmental contamination.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Members of the public such as residents, property owners, property
managers, and other individuals who may be associated with a property
whose information needs to be collected as part of EPA's environmental
assessment and response activities. In addition, EPA staff,
contractors, grantees, or any other individuals engaged in response
activities (including state, local, and tribal employees) may have
their information in the system such as name, office address, and
contact information to facilitate assessment and response activities.

CATEGORIES OF RECORDS IN THE SYSTEM:
    The types of data collected in environmental assessments and
responses include names of residents; names of property owners; tenant
information; names of property managers; address information; phone
number or other contact information; test results from environmental
sampling; medical and health information; information about residential
structures such as the age of the structure, information about the
service lines, plumbing and pipe information, and building materials in
the structure; information about the length of residence or ownership
of the structure; GIS coordinates; age; property ownership and
management information; information about physical dimensions of the
property and structures present on the property; information about
wells on the property; information about uses of the property;
information about sampling locations; and information about prior
environmental issues at the property, including prior test results and
actions taken. Other site-specific data elements may also be collected
if needed for the environmental assessment or emergency response
activity.

RECORD SOURCE CATEGORIES:
    Records within this system of records are obtained by EPA
employees, contractors, or grantees collecting environmental assessment
data and sample information at residential sites, or from state or
local governments who have collected environmental assessment
information as part of their response authorities. Environmental
assessment data is received from interviews with residents, property
owners, property managers, and other individuals who may be associated
with a property, local public records such as property tax data, from
inspections of residential properties, from residential property
records or other public records, and from other on-site sources such as
EPA or contracted laboratories and EPA or contracted GIS systems.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND PURPOSES OF SUCH USES:
    The routine uses below are both related to and compatible with the
original purpose for which the information was collected. The following
general routine uses apply to this system:
    A. Disclosure for Law Enforcement Purposes: Information may be
disclosed to the appropriate Federal, State, local, tribal, or foreign
agency responsible for investigating, prosecuting, enforcing, or
implementing a statute, rule, regulation, or order, if the information
is relevant to a violation or potential violation of civil or criminal
law or regulation within the jurisdiction of the receiving entity.
    B. Disclosure Incident to Requesting Information: Information may
be disclosed to any source from which additional information is
requested (to the extent necessary to identify the individual, inform
the source of the purpose of the request, and to identify the type of
information requested,) when necessary to obtain information relevant
to an agency decision concerning retention of an employee or other
personnel action (other than hiring,) retention of a security
clearance, the letting of a contract, or the issuance or retention of a
grant, or other benefit.
    D. Disclosure to Office of Management and Budget: Information may
be disclosed to the Office of Management and Budget at any stage in the
legislative coordination and clearance process in connection with
private relief legislation as set forth in OMB Circular No. A-19.
    E. Disclosure to Congressional Offices: Information may be
disclosed to a congressional office from the record of an individual in
response to an inquiry from the congressional office made at the
request of the individual.
    F. Disclosure to Department of Justice: Information may be
disclosed to the Department of Justice, or in a proceeding before a
court, adjudicative body, or other administrative body before which the
Agency is authorized to appear, when:
    1. The Agency, or any component thereof;
    2. Any employee of the Agency in his or her official capacity;
    3. Any employee of the Agency in his or her individual capacity
where the Department of Justice or the Agency have agreed to represent
the employee; or
    4. The United States, if the Agency determines that litigation is
likely to affect the Agency or any of its components,
    Is a party to litigation or has an interest in such litigation, and
the use of such records by the Department of Justice or the Agency is
deemed by the Agency to be relevant and necessary to the litigation
provided, however, that in each case it has been determined that the
disclosure is compatible with the purpose for which the records were
collected.
    G. Disclosure to the National Archives: Information may be
disclosed to the National Archives and Records Administration in
records management inspections.
    H. Disclosure to Contractors, Grantees, and Others: Information may
be disclosed to contractors, grantees, consultants, or volunteers
performing or working on a contract, service, grant, cooperative
agreement, job, or other activity for the Agency and who have a need to
have access to the information in the performance of their duties or
activities for the Agency. When appropriate, recipients will be
required to comply with the requirements of the Privacy Act of 1974 as
provided in 5 U.S.C. 552a(m).
    K. Disclosure in Connection With Litigation: Information from this
system of records may be disclosed in connection with litigation or
settlement discussions regarding claims by or against the Agency,
including public filing with a court, to the extent that disclosure of
the information is relevant and necessary to the litigation or
discussions and except where court orders are otherwise required under
section (b)(11) of the Privacy Act of 1974, 5 U.S.C. 552a(b)(11).
    The two routine uses below (L and M) are required by OMB Memorandum
M-17-12.
    L. Disclosure to Persons or Entities in Response to an Actual or
Suspected Breach of Personally Identifiable Information: To appropriate
agencies, entities, and persons when (1) the Agency suspects or has
confirmed that there has been a breach of the system of records, (2)
the Agency has determined that as a result of the suspected or
confirmed breach there is a risk of harm to individuals, the Agency
(including its information systems, programs, and operations), the
Federal Government, or national security; and (3) the disclosure made
to such agencies, entities, and persons is reasonably necessary to
assist in connection with the Agency's efforts

to respond to the suspected or confirmed breach or to prevent,
minimize, or remedy such harm.
    M. Disclosure to Assist Another Agency in Its Efforts to Respond to
a Breach of Personally Identifiable Information: To another Federal
agency or Federal entity, when the Agency determines that information
from this system of records is reasonably necessary to assist the
recipient agency or entity in (1) responding to a suspected or
confirmed breach or (2) preventing, minimizing, or remedying the risk
of harm to individuals, the recipient agency or entity (including its
information systems, programs, and operations), the Federal Government,
or national security, resulting from a suspected or confirmed breach.
    Additional routine uses that apply to this system are:
    1. Records may be disclosed to federal, state, local, and tribal
authorities in conformity with federal, state, local, and tribal laws
when necessary to protect the environment or public health or safety,
including carrying out an investigation or response. Personal medical
records will not be shared. Information sharing agreements may be used
as a mechanism to define appropriate limitations on use and disclosure
of Privacy Act information by state, tribal, and local officials.
Relevant federal, state, tribal, and local laws may also provide
assurance that the information will be kept confidential. Information
may also be shared with state agencies and with the public as part of
their participation in the Superfund evaluation and decision-making
process. This may include public disclosure of addresses where EPA
determines cleanup actions are required.
    2. In case of emergency, EPA may need to share information with
members of the public to assure protection of the environment or public
health and safety.

POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
    These records are maintained electronically on computer storage
devices such as computer tapes and disks. The computer storage devices
are located at EPA OLEM. Backup will be maintained at a disaster
recovery site. Computer records are maintained in a secure password
protected environment. Access to computer records is limited to those
who have a need to know. Other associated records may also be stored in
other electronic or paper formats, such as Microsoft Excel
spreadsheets, Microsoft Word documents or tables, or in file folders.
During the course of the assessment, records may also be temporarily
stored off-site in secure facilities such as incident command posts or
EPA field offices which are maintained and secured by EPA staff.
Permission level assignments will allow users access only to those
functions for which they are authorized. All records are maintained in
secure, access-controlled areas or buildings.

POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
    Information may be retrieved by any collected data element, such as
a resident's name or address, or information may be retrieved by GIS
coordinates or by identifying numbers assigned to a person, sampling
location, or residence.

POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
    Records maintained in this system are subject to record schedule
1036, which is still being finalized.

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
    Security controls used to protect personal sensitive data in
Environmental Assessments of Residential Properties are commensurate
with those required for an information system rated MODERATE for
confidentiality, integrity, and availability, as prescribed in National
Institute of Standards and Technology (NIST) Special Publication, 800-
53, ``Security and Privacy Controls for Information Systems and
Organizations,'' Revision 5.
    ADMINISTRATIVE SAFEGUARDS
    For documents in EPA database systems, those systems have a single
point of access via a front-end Portal. All users are required to
complete a new user form (signed by their supervisor) and take online
security training before they are provided with access. All authorized
users of the EARP application are required to take an annual security
training identifying the user's role and responsibilities for
protecting the Agency's information resources, as well as, consequences
for not adhering to the policy. Similarly, those documents maintained
on Agency computers prior to placement in EARP are protected by
passwords and/or Personal Identity Verification, and all agency users
are required to complete a new user form (signed by their supervisor)
and take computer security training.
    TECHNICAL SAFEGUARDS
    Electronic records are maintained in a secure, password protected
electronic system.
    PHYSICAL SAFEGUARDS
    Paper files are maintained in locked file cabinets when not in use
by EPA emergency response staff. All records are maintained in secure,
access-controlled areas or buildings.

RECORD ACCESS PROCEDURES:
    Individuals seeking access to information in this system of records
about themselves are required to provide adequate identification (e.g.,
driver's license, military identification card, employee badge or
identification card). Additional identity verification procedures may
be required, as warranted. Requests must meet the requirements of EPA
regulations that implement the Privacy Act of 1974, at 40 CFR part 16.

CONTESTING RECORD PROCEDURES:
    Requests for correction or amendment must identify the record to be
changed and the corrective action sought. Complete EPA Privacy Act
procedures are described in EPA's Privacy Act regulations at 40 CFR
part 16.

NOTIFICATION PROCEDURES:
    Any individual who wants to know whether this system of records
contains a record about him or her, should make a written request to
the EPA, Attn: Agency Privacy Officer, MC 2831T, 1200 Pennsylvania Ave.
NW, Washington, DC 20460, [email protected].

EXEMPTIONS PROMULGATED FOR THE SYSTEM:
    None.

HISTORY:
    86 FR 23958 (May 5, 2021), 81 FR 23488 (April 21, 2016).

Vaughn Noga,
Senior Agency Official for Privacy.
[FR Doc. 2022-00068 Filed 1-6-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Notices]
[Pages 14709-14710]
[FR Doc No: 2017-05698]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER14-1656-010.
    Applicants: CSOLAR IV West, LLC.
    Description: Notification of Change in Status of CSOLAR IV West,
LLC.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5116.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-756-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Tariff Amendment: 2017-03-07_SA 2884 Amendment of
Otter Tail-Crowned Ridge GIA (G736) to be effective 1/7/2017.
    Filed Date: 3/7/17.
    Accession Number: 20170307-5155.
    Comments Due: 5 p.m. ET 3/28/17.

    Docket Numbers: ER17-1123-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to Service
Agreements re: MAIT Assignment--Partially Executed Consents to be
effective 7/17/2008.
    Filed Date: 3/8/17.
    Accession Number: 20170308-5174.
    Comments Due: 5 p.m. ET 3/29/17.

    Docket Numbers: ER17-1124-000.
    Applicants: Consumers Energy Company.
    Description: Compliance filing: Compliance with Letter Order to be
effective 10/7/2016.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5078.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1125-000.
    Applicants: The Order of St. Benedict of New Hampshire.
    Description: Sec.  205(d) Rate Filing: Notice of Name Change to be
effective 12/31/9998.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5082.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1127-000.
    Applicants: Public Service Company of Oklahoma.
    Description: Sec.  205(d) Rate Filing: PSO-OGE Cemetery Road
Delivery Point Agreement to be effective 2/22/2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5147.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1128-000.
    Applicants: AEP Texas North Company.
    Description: Sec.  205(d) Rate Filing: TNC-White Camp Solar PDA
Cancellation to be effective 3/1/2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5148.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1129-000.
    Applicants: Duke Energy Progress, LLC, Duke Energy Florida, LLC,
Duke Energy Carolinas, LLC.
    Description: Sec.  205(d) Rate Filing: OATT Attachment C-1 Intra-
Day Amendment to be effective 6/1/2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5154.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1130-000.
    Applicants: AEP Texas Central Company.
    Description: Sec.  205(d) Rate Filing: TCC-Petronila Wind Farm PDA
Cancellation to be effective 3/1/2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5158.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1131-000.
    Applicants: AEP Texas Central Company.
    Description: Sec.  205(d) Rate Filing: TCC-Midway Farms Wind PDA
Cancellation to be effective 3/1/2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5165.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1132-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2017-03-09 Tariff
Clarifications Amendment to be effective 3/10/2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5169.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1133-000.
    Applicants: AEP Texas Central Company.
    Description: Sec.  205(d) Rate Filing: TCC-Javelina Wind Energy SUA
Cancellation to be effective 3/1/2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5171.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1134-000.
    Applicants: AEP Texas Central Company.
    Description: Sec.  205(d) Rate Filing: TCC-EC&R Development PDA
Cancellation to be effective 3/1/2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5176.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1135-000.
    Applicants: AEP Texas Central Company.
    Description: Sec.  205(d) Rate Filing: TCC-Anacacho Wind SUA
Cancellation to be effective 3/1/2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5180.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1136-000.
    Applicants: AEP Texas North Company.
    Description: Sec.  205(d) Rate Filing: TNC-Blue Summit Wind SUA
Cancellation to be effective 3/1/2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5187.
    Comments Due: 5 p.m. ET 3/30/17.

    Take notice that the Commission received the following electric
reliability filings.

    Docket Numbers: RD17-4-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Petition of the North American Electric Reliability
Corporation for Approval of Proposed Reliability Standards IRO-002-5
and TOP-001-4.
    Filed Date: 3/6/17.
    Accession Number: 20170306-5233.
    Comments Due: 5 p.m. ET 4/5/17.

    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: March 9, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-05698 Filed 3-21-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Notices]
[Page 55268-55269]
[DOCID:fr28se07-142]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56496; File No. SR-ISE-2007-85]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to PrecISE Fees

September 21, 2007.

    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder, \2\ notice is hereby given
that on September 17, 2007, the International Securities Exchange, LLC
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by ISE. ISE filed the proposal pursuant to section
19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2) \4\ thereunder, as
establishing or changing a due, fee, or other charges applicable to a
member, which renders the proposed rule change effective upon filing
with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    ISE is proposing to amend its Schedule of Fees to establish fees
to: (i) Raise its PrecISE through VPN fees; and (ii) adopt a PrecISE
Sponsored Customer fee. The text of the proposed rule change is
available at ISE, http://www.iseoptions.com, and the Commission's

Public Reference Room.

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

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

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

1. Purpose
    The purpose of this proposed rule change is to amend the Exchange's
Schedule of Fees to: (i) Raise its PrecISE through VPN fees; and (ii)
adopt a PrecISE Sponsored Customer fee.
    ``PrecISE'' is ISE's internally-developed proprietary order-routing
terminal used by Electronic Access Members (``EAMs'') to send order
flow to the Exchange. The Exchange currently permits EAMs to access the
Exchange through a VPN connection from their PrecISE terminals for
which the Exchange currently charges $250 per month per terminal.\5\
VPN is an internet-based ``virtual private network'' that allows secure
access to the ISE through the internet. PrecISE through VPN provides
PrecISE functionality without requiring dedicated network lines and is
a cost-efficient means of access for small and mid-sized broker-
dealers. The Exchange notes that EAMs may also use PrecISE through VPN
as a back-up or disaster recovery connection to the Exchange. The
Exchange now proposes to increase its PrecISE through VPN fee from $250
per month per terminal to $300 per month per terminal to offset the
Exchange's costs for maintaining these connections.\6\
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    \5\ See Securities Exchange Act Release No. 54121 (July 10,
2006), 71 FR 40566 (July 17, 2006) (SR-ISE-2006-31).
    \6\ The Exchange notes that this proposed fee increase will
bring the PrecISE through VPN fees in line with the fee the Exchange
currently charges EAMs for a network connection. See Securities
Exchange Act Release No. 55960 (June 26, 2007), 72 FR 36531 (July 3,
2007) (SR-ISE-2007-42) (notice of filing and immediate effectiveness
of proposed rule change adopting a per user per month fee for the
Exchange's PrecISE Trade[reg] terminal).
---------------------------------------------------------------------------

    The Exchange also proposes to adopt a PrecISE Sponsored Customer
fee of $300 per month per terminal. The Exchange currently operates a
program that permits sponsored customers of Members to access the
Exchange directly via a PrecISE trade terminal, provided certain
conditions are met.\7\ The proposed Sponsored Customer fee shall only
apply to sponsored customers that are not affiliates of the ISE member
who sponsors its access. For example, an ISE member that sponsors five
of its customers, all of whom are not affiliated with it, will be
charged $1,500 per month for the five sponsored terminals through which
the Member's customers

will be able to directly connect to the Exchange.
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    \7\ See Securities Exchange Act Release No. 55586 (April 5,
2007), 72 FR 18701 (April 13, 2007) (SR-ISE-2007-19) (notice of
filing and immediate effectiveness of proposed rule change relating
to access to the Exchange by Sponsored Customers).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of section 6 of the Act,\8\ in general, and
furthers the objectives of section 6(b)(4),\9\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees, and other charges among its members and issuers and other
persons using its facilities. In particular, these fees will permit the
Exchange to recover the costs of developing, maintaining, and
supporting PrecISE Trade terminals and its various functionalities.
Additionally, the Exchange believes the proposed fees are equitable in
that they only apply to those members that elect to use PrecISE.\10\
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
    \10\ Telephone amendment between Samir Patel, Assistant General
Counsel, ISE, and Richard Holley, Senior Special Counsel, Division
of Market Regulation, Commission, September 21, 2007.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes that 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 interested parties.

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

    The foregoing proposed rule change has become effective upon filing
with the Commission pursuant to section 19(b)(3)(A)(ii) of the Act \11\
and Rule 19b-4(f)(2) \12\ thereunder, because it establishes or changes
a due, fee, or other charge applicable only to a member.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \12\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-ISE-2007-85 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2007-85. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of ISE. 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-2007-85 and should be
submitted on or before October 19, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-19164 Filed 9-27-07; 8:45 am]

BILLING CODE 8010-01-P