[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44792-44795]
[FR Doc No: 2014-18178]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0007]

Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2015

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for fiscal year (FY) 2015 generic new
animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of
2013 (AGDUFA II), authorizes FDA to collect user fees for certain
abbreviated applications for generic new animal drugs, for certain
generic new animal drug products, and for certain sponsors of such
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs. This notice
establishes the fee rates for FY 2015.

FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm, or contact Lisa Kable, Center for Veterinary Medicine
(HFV-10), Food and Drug Administration, 7529 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER>. For general questions, you may also email the
Center for Veterinary Medicine (CVM) at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three
different types of user fees: (1) Fees for certain types of abbreviated
applications for generic new animal drugs; (2) annual fees for certain
generic new animal drug products; and (3) annual fees for certain
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). When certain conditions are met, FDA will waive or reduce
fees for generic new animal drugs intended solely to provide for a
minor use or minor species indication (21 U.S.C. 379j-21(d)).
    For FY 2014 through FY 2018, the FD&C Act establishes aggregate
yearly base revenue amounts for each of these fee categories. Base
revenue amounts established for fiscal years after FY 2014 may be
adjusted for workload. Fees for applications, products, 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.
    For FY 2015, the generic new animal drug user fee rates are:
$189,200 for each abbreviated application for a generic new animal drug
other than those subject to the criteria in section 512(d)(4) of the
FD&C Act (21 U.S.C. 360b(d)(4)); $94,600 for each abbreviated
application for a generic new animal drug subject to the criteria in
section 512(d)(4); $8,500 for each generic new animal drug product;
$80,900 for each generic new animal drug sponsor paying 100 percent of
the sponsor fee; $60,675 for each generic new animal drug sponsor
paying 75 percent of the sponsor fee; and $40,450 for each generic new
animal drug sponsor paying 50 percent of the sponsor fee. FDA will
issue invoices for FY 2015 product and sponsor fees by December 31,
2014. These fees will be due by January 31, 2015. The application fee
rates are effective for all abbreviated applications for a generic new
animal drug submitted on or after October 1, 2014, and will remain in
effect through September 30, 2015. Applications will not be accepted
for review until FDA has received full payment of related application
fees and any other fees owed under the Animal Generic Drug User Fee
program.

II. Revenue Amount for FY 2015

A. Statutory Fee Revenue Amounts

    AGDUFA II, Title II of Public Law 113-14, specifies that the
aggregate revenue amount for FY 2015 for abbreviated application fees
is $1,736,000 and each of the other two generic new animal drug user
fee categories, annual product fees and annual sponsor fees, is
$2,604,000 each (see 21 U.S.C. 379j-21(b)).

B. Inflation Adjustment to Fee Revenue Amount

    The amounts established in AGDUFA II for each year for FY 2014
through FY 2018 include an inflation adjustment; therefore, no further
inflation adjustment is required.

C. Workload Adjustment Fee Revenue Amount

    For each FY beginning after FY 2014, AGDUFA provides that statutory
fee revenue amounts shall be further adjusted to reflect changes in
review workload. (See 21 U.S.C. 379j-21(c)(2).)
    FDA calculated the average number of each of the four types of
applications and submissions specified in the workload adjustment
provision (abbreviated applications for generic new animal drugs,
manufacturing supplemental abbreviated applications for generic new
animal drugs, investigational generic new animal drug study
submissions, and investigational generic new animal drug protocol
submissions) received over the 5-year period that ended on September
30, 2013 (the base years), and the average number of each of these
types of applications and submissions over the most recent 5-year
period that ended on June 30, 2014.
    The results of these calculations are presented in the first two
columns in Table 1. Column 3 reflects the percent change in workload
over the two 5-year periods. Column 4 shows the weighting factor for
each type of application, reflecting how much of the total FDA generic
new animal drug review

workload was accounted for by each type of application or submission in
the table during the most recent 5 years. Column 5 is the weighted
percent change in each category of workload, and was derived by
multiplying the weighting factor in each line in column 4 by the
percent change from the base years in column 3. At the bottom right of
Table 1, the sum of the values in column 5 is calculated, reflecting a
total change in workload of 18.8 percent for FY 2015. This is the
workload adjuster for FY 2015.

                                     Table 1--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
                                                                                Column 5
                                   Column 1  5-      Column 2        Column 3        Column 4        Weighted
        Application type           year average    Latest 5-year      Percent        Weighting        percent
                                   (base years)       average         change          factor          change
----------------------------------------------------------------------------------------------------------------
Abbreviated New Animal Drug                 25.0            28.0              12          0.4075            4.89
 Applications (ANADAs)..........
Manufacturing Supplements ANADAs           128.0           137.2               7          0.2721            1.96
Generic Investigational Study               23.0            30.8              34          0.2004            6.80
 Submissions....................
Generic Investigational Protocol            17.2            24.6              43          0.1199            5.16
 Submissions....................
FY 2015 AGDUFA Workload Adjuster  ..............  ..............  ..............  ..............           18.80
----------------------------------------------------------------------------------------------------------------

    Over the last year FDA has seen more sponsors getting involved in
the generic new animal drug approval process including pioneer
sponsors. There is also an increased interest in seeking single
ingredient and combination Type A medicated article approvals. These
factors have contributed to an increase in the number of ANADAs
submitted. Additionally, more sponsors are pursuing drug approvals that
do not qualify for a waiver of the requirement to conduct an in vivo
bioequivalence study. For this reason we are seeing an increase in the
number of generic investigational new animal drug study submissions.
Generic investigational new animal drug protocol submissions have
significantly increased due to FDA encouraging sponsors to submit
protocols for concurrence prior to conducting these bioequivalence
studies. Also, in AGDUFA II the base years were changed from FY 2004
through FY 2008 to FY 2009 through FY 2013.
    As a result, the statutory revenue amount for each category of fees
for FY 2015 ($1,736,000 for application fees and $2,604,000 for both
product and sponsor fees) must now be increased by 18.8 percent, for a
total fee revenue target in FY 2015 of $8,250,000 (rounded to the
nearest thousand dollars) for fees from all three categories.

III. Abbreviated Application Fee Calculations for FY 2015

    The term ``abbreviated application for a generic new animal drug''
is defined in 21 U.S.C. 379j-21(k)(1).

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

    The application fee must be paid for abbreviated applications for a
generic new animal drug that is subject to fees under AGDUFA and that
is submitted on or after July 1, 2008. The application fees are to be
set so that they will generate $2,062,000 in fee revenue for FY 2015.
This is the amount set out in the statute (21 U.S.C. 379j-21(b)(1))
after applying the workload adjuster.
    To set fees for abbreviated applications for generic new animal
drugs to realize $2,062,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2015.
    The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates significantly from
year to year. FDA is making estimates and applying different
assumptions for two types of full fee submissions: Original submissions
of abbreviated applications for generic new animal drugs and
``reactivated'' submissions of abbreviated applications for generic new
animal drugs. Any original submissions of abbreviated applications for
generic new animal drugs that were received by FDA before July 1, 2008,
were not assessed fees (21 U.S.C. 379j-21(a)(1)(A)). Some of these non-
fee-paying submissions were later resubmitted on or after July 1
because the initial submission was not approved by FDA (i.e., FDA
marked the submission as incomplete and requested additional non-
administrative information) or because the original submission was
withdrawn by the sponsor. Abbreviated applications for generic new
animal drugs resubmitted on or after July 1, 2008, are subject to user
fees. In this notice, FDA refers to these resubmitted applications as
``reactivated'' applications.
    Also, under AGDUFA II, an abbreviated application for an animal
generic drug subject to the criteria in section 512(d)(4) of the FD&C
Act and submitted on or after October 1, 2013, shall be subject to 50
percent of the fee applicable to all other abbreviated applications for
a generic new animal drug.
    Regarding original submissions of abbreviated applications for
generic new animal drugs, FDA is assuming that the number of
applications that will pay fees in FY 2015 will equal the average
number of submissions over the 5 most recent completed years (2009-
2013). 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 complete years of experience
with this program.
    The average number of original submissions of abbreviated
applications for generic new animal drugs over the 5 most recently
completed years is 9.6 applications not subject to the criteria in
section 512(d)(4) of the FD&C Act and 2.6 submissions subject to the
criteria in section 512(d)(4). Each of the submissions described under
section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by
the other applications, and will be counted as one half of a fee.
Adding all of the applications not subject to the criteria in section
512(d)(4) of the FD&C Act and 50 percent of the number which are
subject to such criteria results in a total of 10.9 anticipated full
fees.
    Under AGDUFA I, FDA estimated the number of reactivations of
abbreviated applications for generic new animal drugs which had been
originally submitted prior to July 1, 2008. That number has decreased
over the years to the point that FDA no longer expects to receive any
reactivations of applications initially submitted prior to July 1,
2008, and will include no provision for them in its fee estimates.
Should such a submission be made, of course, it will still be expected
to pay the appropriate fee.
    Based on the previous assumptions, FDA is estimating that it will
receive a total of 10.9 fee-paying generic new

animal drug applications in FY 2015 (9.6 original applications paying a
full fee and 2.6 applications paying a half fee).

B. Fee Rates for FY 2015

    FDA must set the fee rates for FY 2015 so that the estimated 10.9
abbreviated applications that pay the fee will generate a total of
$2,062,000. To generate this amount, the fee for a generic new animal
drug application, rounded to the nearest hundred dollars, will have to
be $189,200, and for those applications that are subject to the
criteria set forth in section 512(d)(4) of the FD&C Act 50 percent of
that amount, or $94,600.

IV. Generic New Animal Drug Product Fee Calculations for FY 2015

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

    The generic new animal drug product fee (also referred to as the
product fee) must be paid annually by the person named as the applicant
in an abbreviated new animal drug application or supplemental
abbreviated application for generic new animal drugs for an animal drug
product submitted for listing under section 510 of the FD&C Act (21
U.S.C. 360), and who had an abbreviated application for a generic new
animal drug or supplemental abbreviated application for a generic new
animal drug pending at FDA after September 1, 2008 (see 21 U.S.C. 379j-
21(a)(2)). The term ``generic new animal drug product'' means each
specific strength or potency of a particular active ingredient or
ingredients in final dosage form marketed by a particular manufacturer
or distributor, which is uniquely identified by the labeler code and
product code portions of the national drug code, and for which an
abbreviated application for a generic new animal drug or supplemental
abbreviated application for a generic new animal drug has been approved
(21 U.S.C. 379j-21(k)(6)). The product fees are to be set so that they
will generate $3,094,000 in fee revenue for FY 2015.
    To set generic new animal drug product fees to realize $3,094,000,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2015. FDA gathered data on all generic
new animal drug products that have been submitted for listing under
section 510 of the FD&C Act, and matched this to the list of all
persons who FDA estimated would have an abbreviated new animal drug
application or supplemental abbreviated application pending after
September 1, 2008. FDA estimates a total of 383 products submitted for
listing by persons who had an abbreviated application for a generic new
animal drug or supplemental abbreviated application for a generic new
animal drug pending after September 1, 2008. Based on this, FDA
believes that a total of 383 products will be subject to this fee in FY
2015.
    In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2015, FDA is assuming that 5 percent of the
products invoiced, or 19, may qualify for minor use/minor species fee
waiver (see 21 U.S.C. 379j-21(d)). FDA has kept the estimate of the
percentage of products that will not pay fees at 5 percent this year,
based on historical data over the past 5 years.
    Accordingly, the Agency estimates that a total of 364 (383 minus
19) products will be subject to product fees in FY 2015.

B. Product Fee Rates for FY 2015

    FDA must set the fee rates for FY 2015 so that the estimated 364
products that pay fees will generate a total of $3,094,000. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest 5 dollars, to be $8,500.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2015

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

    The generic new 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 abbreviated application for a generic new animal
drug, except for an approved application for which all subject products
have been removed from listing under section 510 of the FD&C Act, or
has submitted an investigational submission for a generic new animal
drug that has not been terminated or otherwise rendered inactive and
(2) had an abbreviated application for a generic new animal drug,
supplemental abbreviated application for a generic new animal drug, or
investigational submission for a generic new animal drug pending at FDA
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-
21(a)(3)). A generic new animal drug sponsor is subject to only one
such fee each fiscal year (see 21 U.S.C. 379j-21(a)(3)(C)). Applicants
with more than six approved abbreviated applications will pay 100
percent of the sponsor fee; applicants with two to six approved
abbreviated applications will pay 75 percent of the sponsor fee; and
applicants with one or fewer approved abbreviated applications will pay
50 percent of the sponsor fee (see 21 U.S.C. 379j-21(a)(3)(C)). The
sponsor fees are to be set so that they will generate $3,094,000 in fee
revenue for FY 2015.
    To set generic new animal drug sponsor fees to realize $3,094,000,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2015. FDA now has 5 complete years of experience
with collecting these sponsor fees. Based on the number of firms that
meet this definition and the average number of firms paying fees at
each level over the 5 completed years of AGDUFA (FY 2009 through FY
2013), FDA estimates that in FY 2015, 12 sponsors will pay 100 percent
fees, 13 sponsors will pay 75 percent fees, and 37 sponsors will pay 50
percent fees. That totals the equivalent of 40.25 full sponsor fees (12
times 100 percent or 12, plus 13 times 75 percent or 9.75, plus 37
times 50 percent or 18.5).
    FDA estimates that about 5 percent of all of these sponsors, or 2,
may qualify for a minor use/minor species fee waiver (see 21 U.S.C.
379j-21(d)). FDA has kept the estimate of the percentage of sponsors
that will not pay fees at 5 percent this year, based on historical data
over the past 5 years.
    Accordingly, the Agency estimates that the equivalent of 38.25 full
sponsor fees (40.25-2) are likely to be paid in FY 2015.

B. Sponsor Fee Rates for FY 2015

    FDA must set the fee rates for FY 2015 so that the estimated
equivalent of 38.25 full sponsor fees will generate a total of
$3,094,000. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest $50, to
be $80,900. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $60,675, and the fee for those paying 50
percent of the full sponsor fee will be $40,450.

VI. Fee Schedule for FY 2015

    The fee rates for FY 2015 are summarized in Table 2 of this
document.

                       Table 2--FY 2015 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
        Generic new animal drug user fee category             FY 2015
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug         $189,200
 except those subject to the criteria in section
 512(d)(4)..............................................

Abbreviated Application Fee for Generic New Animal Drug           94,600
 subject to the criteria in section 512(d)(4)...........
Generic New Animal Drug Product Fee.....................           8,500
100 Percent Generic New Animal Drug Sponsor Fee \1\.....          80,900
75 Percent Generic New Animal Drug Sponsor Fee \1\......          60,675
50 Percent Generic New Animal Drug Sponsor Fee \1\......          40,450
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one fee each fiscal year.

VII. Procedures for Paying FY 2015 Generic New Animal Drug User Fees

A. Abbreviated Application Fees and Payment Instructions

    The FY 2015 fee established in the new fee schedule must be paid
for an abbreviated new animal drug application subject to fees under
AGDUFA that is submitted on or after October 1, 2014. Payment must be
made in U.S. currency from a U.S. bank by check, bank draft, or U.S.
postal money order payable to the order of the Food and Drug
Administration, by wire transfer, or by automatic clearing house using
https://www.pay.gov. (The Pay.gov payment option is available to you
after you submit a cover sheet. Click the ``Pay Now'' button). On your
check, bank draft, U.S. or postal money order, please write your
application's unique Payment Identification Number, beginning with the
letters ``AG'', from the upper right-hand corner of your completed
Animal Generic 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 Generic
Drug User Fee Cover Sheet can be mailed to: Food and Drug
Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
    If payment is made via wire transfer, send payment to U. S.
Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Account Name: Food and Drug Administration, Account No.:
75060099, Routing No.: 021030004, Swift No.: FRNYUS33, Beneficiary:
FDA, 8455 Colesville Rd., Silver Spring, MD 20993-0002. You are
responsible for any administrative costs associated with the processing
of a wire transfer. Contact your bank or financial institution about
the fee and add it to your payment to ensure that your fee is fully
paid.
    If you prefer to send a check by a courier, the courier may deliver
the check and printed copy of the cover sheet to: U.S. Bank, Attn:
Government Lockbox 979033, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier delivery only. If you have any
questions concerning courier delivery contact the U.S. Bank at 314-418-
4013. This phone number is only for questions about courier delivery.)
    The tax identification number of FDA is 53-0196965. (Note: In no
case should the payment 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 abbreviated application arrives at FDA's Center for
Veterinary Medicine (CVM). FDA records the official abbreviated
application receipt date as the later of the following: The date the
application was received by CVM, or the date U.S. Bank notifies FDA
that your payment in the full amount has been received, or when the U.
S. Department of the Treasury notifies FDA of payment. U.S. 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 AGDUFA
Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and scroll down the
page until you find the link ``Create AGDUFA User Fee Cover Sheet.''
Click on that link and follow the directions. 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 you use this site. Online
instructions will walk you through this process.
    Step Two--Create an Animal Generic 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 Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated animal drug application. 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 VII.A of this document.
    Step Four--Please submit your application and a copy of the
completed Animal Generic 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 and Sponsor Fees

    By December 31, 2014, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2015 using this fee
schedule. Fees will be due by January 31, 2015. FDA will issue invoices
in November 2015 for any products and sponsors subject to fees for FY
2015 that qualify for fees after the December 2014 billing.

    Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18178 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

                                                                      OFFICE OF

                                                                  PREVENTION, PESTICIDES AND

                                                                    TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 								 PC Code 	129098

				 DP Barcode	D334948, D334950

MEMORANDUM

DATE:	February 7, 2007

SUBJECT:	Tier I Estimated Drinking Waters Concentrations of Fluazinam and Total Residues for the Use in the Human Health Risk Assessment; IR4 Petition for the Use of Fluazinam on Edible-Podded Legume Vegetables (except peas), Bushberry (crop subgroup 13B), Brassica (Cole) Leafy Vegetables, Ginseng, and Dry, and Succulent Bean Crop Subgroup 6B (except peas)

TO:		Shaja Brothers, Risk Manager Reviewer

		Daniel Rosenblatt, Chief

		Barbara Madden, Chief

		Minor Use Branch

		Registration Division (7505P)

AND:		Kelly Schumacher

		Cristina Swartz, Chief

		Registration Action Branch II

		Health Effects Division (7509P)

FROM:	José Luis Meléndez, Chemist

		Environmental Risk Branch V

		Environmental Fate and Effects Division (7507P)

THROUGH:	Mah T. Shamim, Ph.D., Chief

Environmental Risk Branch V

		Environmental Fate and Effects Division (7507P)

            This memo presents the Tier I Estimated Surface Drinking Water Concentrations and Estimated Ground Water Concentrations (EDWCs) for Fluazinam (CAS name 3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoro methyl)-2-pyridinamine, CAS no. 79622-59-6) and Fluazinam Total Residues (fluazinam plus its major transformation products), calculated using the Tier I aquatic models FIRST and SCI-GROW, respectively, for use in the human health risk assessment.

            The Estimated Drinking Water Concentrations (EDWCs) for Fluazinam and Fluazinam Total Residues were calculated based on a maximum application rate of 3.90 lb a.i./A/season of fluazinam.  In addition to the EDWC’s for Fluazinam, EDWC’s were calculated for Total Fluazinam Residues because the environmental fate studies indicated that the parent compound forms transformation compounds which are similar in structure to the parent under most conditions.

For parent Fluazinam, the surface water acute value is 71.0 ppb, and the chronic value is 0.7 ppb.  The groundwater screening concentration is 0.187 ppb of Fluazinam.  These values represent upper-bound estimates of the concentrations of the chemical that might be found in surface water and groundwater due to the use of Fluazinam on bushberries at the maximum application rate of 3.90 lb a.i./A/season.

            For Total Fluazinam Residues, the surface water acute value is 71.0 ppb and the chronic value is 17.7 ppb.  The groundwater screening concentration is 0.187 ppb.  These values represent upper-bound estimates of the concentrations of  Total Residues of Fluazinam that might be found in surface water and groundwater due to the use of Fluazinam on bushberries at the maximum application rate of 3.90 lb a.i./A/season.

            Should the results of this assessment indicate a need for further refinement, please, contact EFED as soon as possible so that we may schedule a Tier II assessment.

Data Gaps:

Additional data has been requested to upgrade the Photolysis in Water and Photodegradation on Soil data requirements.  The additional information will refine the information about the quantitation of the parent and degradates.  In addition, EFED believes that the available Terrestrial Field Dissipation Studies provide useful information about the parent fluazinam.  However, poor recoveries for two of the transformation products upon storage stability cast doubts over the results obtained for them in the field.  At this time, only one new study is required, on a typical site, with a concurrent storage stability study.

EXECUTIVE SUMMARY

Fluazinam, CAS Name: 3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoro methyl)-2-pyridinamine, and IUPAC Name: 3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2,6 -dinitro-p-toluidine, has a CAS Number of 79622-59-61 and a PC Code of 129098.  It is a pyridine (dinitroaniline) fungicide.  The structure consists of one phenyl ring with two nitro groups, and a pyridine ring.  Both rings have a trifluoromethyl group.  The rings are attached by a nitrogen (amine).

Fluazinam is a new protectant and contact fungicide, a phenyl pyridinamine.  It is an uncoupler of oxidative phosphorilation in the respiration chain involving protonation/deprotonation (it inhibits fungal respiration, and the production of energy within the fungus).

Fluazinam is currently used only on potatoes and peanuts.  The product name is Omega 500F Agricultural Fungicide (EPA Reg. No. 71512-1).  It contains 40.0% fluazinam.  It is being proposed in a Section 3 (IR4) petition, for use on edible-podded legume vegetables (except peas), bushberry (crop subgroup 13B), brassica (cole) leafy vegetables, ginseng, and dry, and succulent bean crop Subgroup 6B (except peas).  The application methods vary with the crops.  For example, aerial applications are prohibited, but the material may be applied by sprinkler irrigation, or, for brassica leafy vegetables, it may be applied by soil incorporation prior to transplanting.

This is a Tier I screening assessment using Tier 1 aquatic models SCI-GROW and FIRST, and maximum application rates for fluazinam, with minimum application intervals.  It was found that the worse case scenario was bushberry, with the highest application rate, and the highest PCA.  In addition to the parent fluazinam, the total residues were modeled because fluazinam is transformed relatively rapidly into various transformation products that resemble the parent structure.

At this time, the persistence of fluazinam transformation products is uncertain because the information about these compounds from terrestrial field dissipation studies has been deemed invalid.  The aquatic metabolism studies signal high persistence of such degradates.  A new terrestrial field dissipation study has been required.  In addition, the extent and importance of photolysis is not very clear because the supplemental data available is not quantitative.  EFED requested additional data from such studies to clarify this point.

Table 1 provides a summary of the Tier I modeled drinking water concentrations.  In addition to the EDWC’s for Fluazinam, EDWC’s were calculated for Total Fluazinam Residues because the environmental fate studies indicated that the parent compound forms transformation compounds which are similar in structure to the parent under most conditions.  Should there be a need for additional refinements, the EFED can perform a Tier II aquatic assessment, for surface waters.

Table 1.  Maximum Tier I Estimated Drinking Water Concentrations (EDWCs) for drinking water assessment based on ground application of fluazinam.

DRINKING WATER SOURCE (MODEL USED) 	USE (rate modeled)	MAXIMUM ESTIMATED DRINKING WATER CONCENTRATION  (EDWC)  ( ppb)

Groundwater

(SCI-GROW) Fluazinam and Total Residues of Fluazinam	Bushberries (3.90 lb a.i./A)	Acute and Chronic	0.187

Surface Water

(FIRST) Fluazinam	Bushberries (3.90 lb a.i./A)	Acute	71.0

	Bushberries (3.90 lb a.i./A)	Chronic	0.7

Surface Water

(FIRST) Total Residues of Fluazinam	Bushberries (3.90 lb a.i./A)	Acute 71.0

	Bushberries (3.90 lb a.i./A)	Chronic	     17.7

PROBLEM FORMULATION

This is a Tier I drinking water assessment that uses modeling and available monitoring data to estimate the ground water and surface water concentrations of pesticides  in drinking water source water (pre-treatment) resulting from pesticide use on sites that are highly vulnerable.  This initial tier screens out chemicals with low potential risk and provides estimated exposure concentrations for the human health dietary risk assessment.

ANALYSIS

Use Characterization

A summary table of all use patterns, new uses and modeled uses, is illustrated below (Table 2).  The crop groups bolded are the proposed ones.

  SEQ CHAPTER \h \r 1 Table 2.  Summary use information for fluazinam, based on Omega 500F label (EPA Reg. No. 71512-1).

USE	SINGLE  APP. RATE (lb. a.i./A)	NUMBER OF APPS.	SEASONAL APP. RATE (lb. a.i./A)	INTERVAL BETWEEN APPS. (days)	APP. METHOD	PHI (days)

Peanut 	0.78	~2.66	2.10	21	Sprinkler irrigation	0

Potato	0.26	7	1.82	7	Sprinkler irrigation	0

Crop Subgroup 6A, Edible-Podded Legume Vegetables except peas, such as, but not limited to: Phaseolus spp. Such as: runner bean, snap bean, wax bean; Vigna spp. Such as: asparagus bean, Chinese longbean, moth bean, yardlong bean; jackbean, and sword bean	0.44	2	0.91	7	Sprinkler irrigation	14

Dry Bean, and Succulent Bean Crop Subgroup 6B, except Peas (such as, but not limited to lima bean)	0.44	2	0.91	7	Sprinkler irrigation	30

Crop Subgroup 13B, Bushberry, such as, but not limited to: Aronia berry, blueberry (highbush and lowbush), Chilean guava, currant (Buffalo, black, red, and Native), elderberry, European barberry, gooseberry, highbush cranberry, honeysuckle, huckleberry, jostaberry, juneberry, lingonberry, salal, and sea buckthorn	0.65	6	3.90	7	Sprinkler irrigation 30

Crop Group 5, Brassica (Cole) Leafy Vegetables, such as, but not limited to: broccoli; broccoli raab (rapini); Chinese cabbage (napa); cauliflower; collards, kale; mizuna; mustard spinach; turnip greens; Chinese broccoli; Brussels sprouts; Chinese cabbage (bok choy); Chinese mustard cabbage; cavalo broccoli; kohlrabi; mustard greens; rape greens [Trans-plant 6.45 fl oz/100 gal or presu-mably 0.64 lb a.i./A]

Soil incorpo-ration 1.36 at a soil depth of 6-8 in	1	2.00	N/A	Soil drench or soil incorpo-ration	20;

50 for heading vegeta-bles such as cabbage and broccoli

Ginseng	0.78	4	3.12	7	Sprinkler irrigation	30

The usual application method for fluazinam is sprinkler irrigation; however, it can be soil incorporated before transplant, for soils with low infiltration rates, for Crop Group 5, Brassica (Cole) Leafy Vegetables.  Fluazinam may not be applied aerially.

The label specifies a buffer zone of 25 ft within aquatic areas (lakes, reservoirs, rivers, permanent streams, marshes or natural ponds, and estuaries) so as to allow growth of a vegetative filter strip.

The use pattern selected for modeling was bushberry.  It has the maximum total application rate, and it is applied by sprinkler irrigation, which may cause more drift towards the standard pond than the soil incorporated brassica group 5, it also has the highest PCA (default, 87%).   With six applications, at seven-day interval, it is likely that this scenarios will provide the highest chronic exposure as well.

Fate and Transport Characterization

A detailed summary of physical/chemical and environmental fate/transport properties of the pesticide, including measured parameters, values, data sources, and comments, is included in Table 3.

Table 3.  Summary of physical/chemical and environmental fate and transport properties of <pesticide>.  <EXAMPLE>

PARAMETER	VALUE(S) (units)	SOURCE	COMMENT

  Chemical Name 3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoro methyl)-2-pyridinamine	EPA Pesticide Fact Sheet	–

  Molecular Weight	465.1	PMRA Regulatory Note REG2003-12, 10/27/03	–

  Solubility (20 oC)	0.025 mg/L @ pH 5.5; 0.071 mg/L @ pH 7.0	MRID: 42208403.	–

  Vapor Pressure (20 oC)	8.25 x 10-6 mm Hg	MRID: 42248403.	–

  Henry’s Law constant	1.81 x 10-3 atm-m3/mol

MRID: 46235701.	Estimated from vapor pressure and water solubility.

  pKa (20 oC)	7.22 in 50% ethanol-water	EPA Pesticide Fact Sheet	–

 Octanol-Water Partition Coefficient

 (KOW,  at 20 oC)	3620; log POW = 3.56	EPA Pesticide Fact Sheet	–

  Hydrolysis Half-life

  (pH 5, 7, 9; (25 oC))	pH 5  stable              pH 7  42 days            pH 9  6 days	MRID: 42208412.	Fluazinam + degradates: Stable at all pHs.

  Aqueous Photolysis Half-life	t1/2  = 2.5 days           dark control = stable	MRID: 44807312, 43521009(s).	One degradate was a tricyclic compound.

  Soil Photolysis Half-life	t1/2  = 35.0 days,    value corrected for dark control	MRID: 44807313(s).	Degradates at ≤10% of the applied.

  Aerobic Soil Metabolism Half-life	t1/2  = 132 days	MRID: 42208413(c). Degradates at ≤10% of the applied.

  Anaerobic Aquatic Metabolism

  Half-life	~⅓ day (or approximately 8 hours)

	MRID: 43521010(c).	Fluazinam + degradates ~ stable

  Aerobic Aquatic Metabolism

  Half-life	t1/2  = 4.0-7.4 hours

	MRID: 44807314(c).	Fluazinam + degradates = 51-71 days

  FLUAZINAM Soil Partition Coefficient (Kd)	11.12, 43.48, 27.19, 37.88 ml/g

	MRID: 42248628, 42974913.	–

  FLUAZINAM Soil Partition Coefficient (KOC)	2316, 1705, 1915, 1894 mL/g MRID: 46235732.	–

  AGED FLUAZINAM Column Leaching	0.66%; >>80% remained in the top soil MRID: 42208415.	–

  HYPA Soil Partition Coefficient (Kd)	14, 13, 26, 8.1, 4.3, 19 ml/g

	MRID: 43528201.	–

  HYPA Soil Partition Coefficient (KOC)	450, 700, 1700, 450, 920, 1300 mL/g	MRID: 43528201.	–

  CAPA Soil Partition Coefficient (Kd)	28, 11, 4.9, 67 ml/g

	MRID: 44807315.	–

  CAPA Soil Partition Coefficient (KOC)	1289, 1317, 1876, 3784 mL/g MRID: 44807315.	–

  Terrestrial Field Dissipation

  Half-life	Range from 9 to 49 days:  Ephrata, WA: DT50~9 days loamy sand, pinto beans; Kempton, ND: half-life=49 days, sandy loam, beans;  Porterville, CA: half-life=20 days, loamy sand, beans;                    Montezuma, GA

The degradation was biphasic.	MRID: 44807318, 44807320, 44807316, 44807319, 44807317.	–

Bioaccumulation in Fish	348X  Fillet              1220X  Whole fish        ≥67% of residues depurated after 21 days from the fillet	MRID: 43521012.	_

Based on the properties of the chemical, applications of fluazinam are likely to reach the target (the crop), but drift is also possible.  The chemical has a low vapor pressure, and a moderate Henry’s Law constant.  Due to the fact that it appears to show relatively short half lives in aquatic media, and it binds to soils, EFED believes that the chemical would not volatilize substantially.

EFED concludes that fluazinam appears to degrade at moderate to low rates in aerobic soils, but it is more rapidly transformed into other compounds of similar backbone structure in high pH solutions or in aquatic media, both, aerobic or anaerobic.  Fluazinam may be photolyzed relatively rapidly (2.5 days) to form a tricyclic compound (G-504).  The total fluazinam residues (fluazinam and its transformation products) are persistent in most environments (aerobic aquatic metabolism 51-71 days, relatively stable in anaerobic aquatic environment) and are likely to reach aquatic media as a totality through runoff.  Since fluazinam does not alter substantially its backbone structure in the environment, but instead, goes through a slight transformation of functional groups, EFED considered parent and transformation products together when making assessments.

While the parent and two transformation products, HYPA and CAPA, have relatively low mobility, indicating a relatively low potential for ground water contamination, further information on the other transformation products should be required in a new terrestrial field dissipation study.

Fluazinam shows a potential to bioaccumulate in fish (BCF=1220X for whole fish; ≥67% of residues depurated in 21 days).

The fate and transport characterization also summarizes the various degradation products formed by each process in the studies reviewed in tabular form. (Table 4)

Table 4.  Summary of degradate formation from degradation of fluazinam.

STUDY TYPE	DEGRADATE and MAXIMUM CONCENTRATION	SOURCE

	CAPA (% applied)	HYPA (% applied)	AMPA (% applied)

	  Hydrolysis	34% at 28 days pH 7; 84-85% at 20 days at pH 9	–	–	  MRID: 42208412.

  Aqueous Photolysis	G-504 was 14.0-17.1% by 7-10 days	_	–	  MRID: 444807312, 43521009.

  Soil Photolysis	_	Detected at more than dark control	Detected at more than dark control	  MRID: 44807313.

  Aerobic Soil Metabolism	_	Detected 	MAPA and DAPA also detected	  MRID: 42208413.

  Aerobic Aquatic Metabolism	_	–	24.2% at 0.2 day; DAPA: at day 30; SDS-67200 39.6%by day 14	MRID: 43521010.

 Anaerobic Aquatic Metabolism

	12.6% at 72 hr	–	DAPA: 19.0% by 240 hr; DCPA: 11.3% at 24 hr	MRID: 44807314.

 Terrestrial Field Dissipation	MAPA, CAPA, and HYPA were monitored; however, there were problems with the storage stability data	MRID: various.

Drinking Water Exposure Modeling

  SEQ CHAPTER \h \r 1

Models

Brief description of the models used:

SCI-GROW (v 2.3, 8/5/03) (Screening Concentration in Ground Water) is a regression model used as a screening tool to estimate pesticide concentrations found in ground water used as drinking water.  SCI-GROW was developed by fitting a linear model to groundwater concentrations with the Relative Index of Leaching Potential (RILP) as the independent variable.  Groundwater concentrations were taken from 90-day average high concentrations from Prospective Ground Water studies; the RILP is a function of aerobic soil metabolism and the soil-water partition coefficient.  The output of SCI-GROW represents the concentrations that might be expected in shallow unconfined aquifers under sandy soils, which is representative of the ground water most vulnerable to pesticide contamination likely to serve as a drinking water source.  (Ref. 1 and 2)

FIRST (v 1.1.0, 12/18/07) (FQPA Index Reservoir Screening Tool) is a metamodel of PRZM and EXAMS used as a screening tool to estimate pesticide concentrations found in surface water used as drinking water.  FIRST was developed by making multiple runs of PRZM using varying sorption coefficients and determining the concentration in the EXAMS index reservoir scenario after a two-inch single storm event.  (The Index Reservoir is a standard water body used by the Office of Pesticide Programs to assess drinking water exposure (Office of Pesticide Programs, 2002).  It is based on a real reservoir (albeit not currently in active use as a drinking water supply), Shipman City Lake in Illinois, that is known to be vulnerable to pesticide contamination.)  The single runoff event moves a maximum of 8% of the applied pesticide into the reservoir.  This amount can be reduced by degradation or effects of binding to soil in the field.  Additionally, FIRST can account for spray drift and adjusts for the area within a watershed that is planted with the modeled crop (Percent Cropped Area).   Spray drift (modeled as direct deposition of the pesticide into the reservoir) is assumed to be 16% of the applied active ingredient for aerial application, 6.3% for orchard air blast application, and 6.4% for other ground spray application. Despite being a single event model, FIRST can account for spray drift from multiple applications.  The default agricultural Percent Cropped Area (PCA) is 87%.  The PRZM scenario used for FIRST development was among the most vulnerable, and thus resulting surface water concentrations represent the upper bound values on the concentrations that might be found in drinking water from the use of a pesticide.  (Ref. 1, 3 and 4)

For volatile and semi-volatile compounds, Tier I modeling will tend to over-estimate surface water EDWCs because there are no parameters in FIRST that explicitly take into account volatility (ie., no vapor pressure or Henry’s Law constant inputs).  Therefore, in reality, more of the compound will be volatilizing than Tier I can account for.  If drinking water levels of concern are exceeded for over-estimated Tier I surface water EDWCs, Tier II modeling will be able to refine these EDWCs by including volatility, Henry’s Law, diffusion in air, and enthalpy considerations.  Since SCI-GROW is a regression model developed from actual pesticide data with a range of volatilities, systematic conclusions cannot be drawn about over or underestimation of groundwater EDWCs at Tier I.

Modeling Approach and Input Parameters

Tables of modeling parameter input values for SCI-GROW and FIRST (Tables 5 and 6, respectively) based on the current input parameter guidance (Ref. 5) are included.

In addition to the EDWC’s for Fluazinam, EDWC’s were estimated for Total Fluazinam Residues because the environmental fate studies indicated that the parent compound forms transformation compounds which are similar in structure to the parent under most conditions.  The input parameters were selected according to the similarity observed in the mobility characteristics of fluazinam, HYPA, and CAPA.

It was observed that the KOC model was better to describe the mobility of fluazinam.  Only one value of aerobic soil metabolism was available, but two values of aerobic aquatic metabolism were available.  It is noted that the aerobic aquatic metabolism is only 10.9 hours.  A ground application method was utilized.

For the total residues, the half-life was calculated taking into consideration the transformation products plus fluazinam.  This applied for the aerobic aquatic metabolism (91.8 days for total residues, in contrast to 10.9 hours for fluazinam), and the hydrolysis (relatively stable for total residues vs. 42 days for fluazinam).  For the hydrolysis study, the transformation product that is formed is CAPA.  In the aerobic aquatic metabolism study, the transformation products formed are DCPA, CAPA, and DAPA, plus various minor transformation products. For other parameters, in the absence of a suitable value, it was assumed that the value for fluazinam was similar to that for the total residues because they had similar structures.

Table 5. SCI-GROW (v 2.3) input parameter values for fluazinam and total residues of fluazinam, use on bushberries1.

PARAMETER (units)	FLUAZINAM	TOTAL RESIDUES	SOURCES AND COMMENTS

Maximum Application Rate (lb a.i./A)	0.65	Proposed label.

Number of Applications per Year	6	Proposed label.  Represents most-conservative scenario in which the total maximum rate is applied in six applications.

Organic Carbon Partition Coefficient (Koc; mL/g)	1904.5	Represents the median value of four values ranging from 1705 to 2316 mL/g for the parent compound.

Aerobic Soil Metabolism Half-life (days)	132	Represents one value for the aerobic soil metabolism of the parent compound.

1 Parameters are selected as per Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides; Version II, February 28, 2002.

Table 6. FIRST (v 1.1.0) input parameter values for fluazinam and total residues of fluazinam, use on bushberries1.

PARAMETER (units)	FLUAZINAM	TOTAL RESIDUES	SOURCES AND COMMENTS

Application Rate (lb a.i./A)	0.65	0.65	Proposed label.

Number of Applications	6	6	Proposed label.

Interval between Applications (days)	7	7	Proposed label.

Percent Cropped Area (decimal)	0.87	0.87	National default.

Soil Partition Coefficient (Kd; (mL/g) or KOC (mL/gOC))	1894	1894 Represents the lowest non-sand KOC value among four values ranging from 1705 to 2316 mL/g.  The KOC model is better for this chemical.

Aerobic Soil Metabolism Half-life (days)	396	396	Determined by multiplying the calculated half-life (132 days) by 3 to account for the uncertainty associated with using a single value.

Wetted in?	No	No	Proposed label.

Depth of Incorporation (inches)	0	0	Proposed label.

Method of Application	Ground application	Ground application	Proposed label.

Solubility in Water @ 20 OC, unbuffered (mg/L or ppm)	0.071	0.071 Maximum available value, at pH 7.

Aerobic Aquatic Metabolism Half-life (days)	0.454	91.8	 Represents the 90th percentile of the upper confidence bound on the mean of two half-life values (4.0 hr and 7.4 hr: mean 5.7 hr, std. dev. 2.40 hr, the value is 10.9 hr or 0.454 days).  For total residues two half-lives (51 and 71 days: mean 61 days, std. dev. 14.14 days)

Hydrolysis Half-life @ pH 7 (days)	42	Stable	The transformation product CAPA reaches a maximum at the end of the study at pH 7.

Aquatic Photolysis Half-life  @ pH 7 (days)	2.5	2.5	From aqueous photolysis study

1 Parameters are selected as per Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides; Version II, February 28, 2002

The Percent Cropped Area (PCA) used was the National Default of 0.87, it is intended for use on other crops for which no PCA has been developed.  Options for Tier I are national scale cotton, wheat, corn, soybeans, or default; regional PCAs are a Tier II tool intended for refined assessment. (Ref. 6)

Modeling Results

Table 7 summarizes the modeling results for all model runs.

Table 7.  Maximum Tier I Estimated Drinking Water Concentrations (EDWCs) for drinking water risk assessment based on ground application of fluazinam.

DRINKING WATER SOURCE (MODEL USED) 	USE (rate modeled)	MAXIMUM ESTIMATED DRINKING WATER CONCENTRATION  (EDWC)  ( ppb)

Groundwater

(SCI-GROW) Fluazinam and Total Residues of Fluazinam	Bushberries (3.90 lb a.i./A)	Acute and Chronic	0.187

Surface Water

(FIRST) Fluazinam	Bushberries (3.90 lb a.i./A)	Acute	71.0

	Bushberries (3.90 lb a.i./A)	Chronic	0.7

Surface Water

(FIRST) Total Residues of Fluazinam	Bushberries (3.90 lb a.i./A)	Acute 71.0

	Bushberries (3.90 lb a.i./A)	Chronic	     17.7

SCIGROW concentration (ppb) represents the groundwater concentration that might be expected in shallow unconfined aquifers under sandy soils. Output is used for both acute and chronic endpoints.

FIRST concentrations (ppb) represent untreated surface water concentrations.

The one-in-10-year peak day concentration is used for acute endpoints and the one-in-10-year annual average concentration is used for chronic endpoints.

The estimated concentrations provided in this assessment are conservative estimates of concentrations in drinking water.  If dietary risks require refinement, higher tiered crop-specific and location-specific models and modeling scenarios can be used.

Monitoring Data

No monitoring data are available for fluazinam.

Drinking Water Treatment

It is likely that primary treatment may reduce the levels of fluazinam due to its tendency to bind.  However, there is no information available at this time to determine the levels of reduction.  On the other hand, fluazinam is very short lived in aquatic environments, forming various other transformation products. (Ref. 9)

CONCLUSIONS

This is a Tier I level analysis, refinements may be available should they be needed.  The acute levels of surface drinking waters was 71.0 ppb, the chronic level of drinking waters was 0.7 ppb of fluazinam.  The groundwater concentration of fluazinam, suitable for acute and chronic is 0.187 ppb.  The peak concentration was limited by the solubility limit of fluazinam.  It was assumed that the maximum application rate was used on bushberries, with the minimum interval between applications.

For the total residues of fluazinam, the acute levels of surface drinking waters was 71.0 ppb, the chronic level of drinking waters was 17.7 ppb of total residues.  The groundwater concentration of total residues of fluazinam, suitable for acute and chronic is 0.187 ppb.  The peak concentration was also limited by the solubility limit of fluazinam.

It was assumed that for the total residues of fluazinam, the properties of fluazinam were applicable, for example, the solubility, which is the limiting factor in the peak concentration.  Another example is the mobility.  It may be slightly different for each transformation product, while it was assumed that it was the same than the parent fluazinam.  These assumptions make the assessment uncertain.  A more definitive assessment could be made with the expenditure of additional resources, and given the availability of additional data.

The total residues approach is conservative with uncertainties due to unavailability of degradate information.  A Tier II assessment could involve input from additional studies (not available at this time) and refine the risk assessment.

APPENDIX

Molecular structure of fluazinam and its degradation products.

FLUAZINAM

CAPA

SCIGROW and FIRST model output files.

                           SCIGROW

                          VERSION 2.3

            ENVIRONMENTAL FATE AND EFFECTS DIVISION

                 OFFICE OF PESTICIDE PROGRAMS

             U.S. ENVIRONMENTAL PROTECTION AGENCY

                        SCREENING MODEL

                FOR AQUATIC PESTICIDE EXPOSURE

 SciGrow version 2.3

 chemical:Fluazinam

 time is  1/23/2007   8:40: 1

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

  Application      Number of       Total Use    Koc      Soil Aerobic

  rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism (days)

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

      0.650           6.0           3.900      1.90E+03      132.0

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

 groundwater screening cond (ppb) =   1.87E-01

 *********************************************************************** *

   RUN No.   1 FOR Fluazinam        ON   Bushberrie    * INPUT VALUES *

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

    RATE (#/AC)   No.APPS &   SOIL  SOLUBIL  APPL TYPE  %CROPPED INCORP

     ONE(MULT)    INTERVAL    Koc   (PPB )   (%DRIFT)     AREA    (IN)

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

   .650(  3.783)   6   7    1894.0   71.0   GROUND( 6.4)  87.0    .0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

    396.00        2          N/A      2.50-  310.00      .45       .45

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.0 DEC 12, 2005

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

             71.000                       .660

   RUN No.   2 FOR Fluaz. Res.      ON   Bushberrie    * INPUT VALUES *

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

    RATE (#/AC)   No.APPS &   SOIL  SOLUBIL  APPL TYPE  %CROPPED INCORP

     ONE(MULT)    INTERVAL    Koc   (PPB )   (%DRIFT)     AREA    (IN)

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

   .650(  3.431)   6   7    1894.0   71.0   GROUND( 6.4)  87.0    .0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

     91.80        2          N/A       .00-     .00    91.80     91.80

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.0 DEC 12, 2005

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

             71.000                     18.542

   RUN No.   3 FOR Fluaz. Res. Conf ON   Bushberrie    * INPUT VALUES *

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

    RATE (#/AC)   No.APPS &   SOIL  SOLUBIL  APPL TYPE  %CROPPED INCORP

     ONE(MULT)    INTERVAL    Koc   (PPB )   (%DRIFT)     AREA    (IN)

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

   .650(  3.783)   6   7    1894.0   71.0   GROUND( 6.4)  87.0    .0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

    396.00        2          N/A      2.50-  310.00    91.80     70.83

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.0 DEC 12, 2005

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

             71.000                     17.697

*****************************************************************

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␃愀$ᨀPolicy Establishing Current Versions of Exposure Models and Responsibility for Model Maintenance (11/06/2002)

SCIGROW: Users Manual (11/01/2001, revised 08/23/2002)

FIRST Users Manual (08/01/2001)

FIRST: A Screening Model to Estimate Pesticide Concentrations in Drinking Water (05/01/2001)

Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version II (02/28/2002)

  SEQ CHAPTER \h \r 1 Use of the Index Reservoir and Percent Crop Area in EFED Drinking Water Assessments (12/01/1999)

Golf Course Adjustment Factors for Simulated Aquatic Exposure Concentrations (06/01/2005)

  SEQ CHAPTER \h \r 1 Policy for Estimating Aqueous Concentrations from Pesticides Labeled for Use on Rice (10/29/2002)

The Incorporation of Water Treatment Effects on Pesticide Removal and Transformations in Food Quality Protection Act (FQPA) Drinking Water Assessments  (10/25/2001)

*****************************************************************


[Federal Register: December 12, 2008 (Volume 73, Number 240)]
[Rules and Regulations]
[Page 75600]
[DOCID:fr12de08-10]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2008-0166; FRL-8750-2]

Approval and Promulgation of Implementation Plans; Alaska;
Interstate Transport of Pollution

AGENCY: Environmental Protection Agency (EPA).

ACTION: Correcting amendment.

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

SUMMARY: EPA issued a direct final rule on October 15, 2008, entitled
``Approval and Promulgation of Implementation Plans; Alaska; Interstate
Transport of Pollution.'' This document makes a minor correction to the
October 15, 2008, action to correct a typographical error in the
regulatory text for the rule.

DATES: Effective Date: This document is effective on December 15, 2008.

FOR FURTHER INFORMATION CONTACT: For questions regarding this
correction, contact Donna Deneen, Office of Air, Waste, and Toxics,
Mail Code (AWT-107), Environmental Protection Agency Region 10,
Seattle, WA 98121; telephone number:<PHONE_NUMBER>; fax number: (206)
553-0110; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The EPA issued ``Approval and Promulgation of Implementation Plans;
Alaska; Interstate Transport of Pollution'' as a direct final rule on
October 15, 2008, 73 FR 60955. This direct final rule approved the
State of Alaska's demonstration that its emissions do not significantly
contribute to nonattainment or interfere with maintenance of the NAAQS
in another state, or interfere with measures required to be included in
the SIP for any other State to prevent significant deterioration of air
quality or to protect visibility. For more information about this
action, please see the proposed and final rulemaking actions which are
available at www.regulations.gov and also in the Federal Register at 73
FR 60955 and 73 FR 60996.

Need for Correction

    As published, the regulatory text in the direct final regulation
contains a minor error that, if not corrected, prevents publication of
the regulatory amendment in the Code of Federal Regulations. EPA finds
that there is good cause to make this correction without providing for
notice and comment because neither notice nor comment is necessary and
would not be in the public interest due to the nature of the correction
which is minor, technical and does not change the obligations already
existing in the rule. EPA finds that the corrections are merely
correcting the numbering in the amendatory language so that the
provision may be published in the Code of Federal Regulations.

Corrections of Publication

    In the regulatory text to the direct final rule for ``Approval and
Promulgation of Implementation Plans; Alaska; Interstate Transport of
Pollution,'' October 15, 2008, 73 FR 60955, EPA is correcting an
inadvertent minor error in instruction number 2. Instruction number 2
reads ``Section 52.97 is added to read as follows:'', but in the actual
text just below that statement the added section is designated
inadvertently as ``Section 52.70.'' EPA is correcting this inadvertent
minor error so that the amendatory instruction number 2 continues to
read ``Section 52.97 is added to read as follows:'', but the actual
text just below that statement ``Sec.  52.70'' is changed to read
``Sec.  52.97.''

Sec.  52.97  [Corrected]

    In FR Doc. E8-24279 published October 15, 2008 (73 FR 60955), make
the following correction. On page 60957, in the center column, the
section heading following amendatory instruction 2 is corrected to read
as follows:

Sec.  52.97  Interstate Transport for the 1997 8-hour ozone and PM2.5
NAAQS.

* * * * *

    Dated: December 3, 2008.
Elin D. Miller,
Regional Administrator, Region 10.
 [FR Doc. E8-29231 Filed 12-11-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Rules and Regulations]
[Pages 51010-51013]
[FR Doc No: 2021-19448]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1983-0002, EPA-HQ-SFUND-1986-0005, EPA-HQ-SFUND-1987-
0002, EPA-HQ-SFUND-1989-0011, EPA-HQ-SFUND-1990-0010, EPA-HQ-SFUND-
1990-0011, EPA-HQ-SFUND-1993-0001, EPA-HQ-SFUND-2000-0004, EPA-HQ-
SFUND-2002-0008, EPA-HQ-SFUND-2003-0010, EPA-HQ-SFUND-2005-0011, EPA-
HQ-SFUND-2006-0759, EPA-HQ-SFUND-2009-0587, EPA-HQ-SFUND-2011-0076,
EPA-HQ-SFUND-2011-0077; FRL-8923-03-OLEM]

Deletions From the National Priorities List

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) announces the
deletion of nine sites and the partial deletion of eleven sites from
the Superfund National Priorities List (NPL). The NPL, created under
the Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA) of 1980, as amended, is an appendix of the National Oil
and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and
the states, through their designated state agencies, have determined
that all appropriate response actions under CERCLA, other than
operation and maintenance, monitoring, and five-year reviews, where
applicable, have been completed. However, this deletion does not
preclude future actions under Superfund.

DATES: Effective on September 14, 2021.

ADDRESSES:
    Docket: EPA has established a docket for this action under the
Docket Identification included in Table 1 in the SUPPLEMENTARY
INFORMATION section of this document. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through https://www.regulations.gov or
in hard copy at the corresponding Regional Records Centers. Locations,
addresses, and phone numbers-of the Regional Records Centers follow.
    Regional Records Centers:
     Region 2 (NJ, NY, PR, VI), U.S. EPA, 290 Broadway, New
York, NY 10007-1866; 212/637-430842.
     Region 3 (DE, DC, MD, PA, VA, WV), U.S. EPA, Library, 1650
Arch Street, Mail code 3SD42, Philadelphia, PA 19103; 215/814-3024.
     Region 4 (AL, FL, GA, KY, MS, NC, SC, TN), U.S. EPA, 61
Forsyth Street SW, Mail code 9T25, Atlanta, GA 30303; 404/562-8637.
     Region 5 (IL, IN, MI, MN, OH, WI), U.S. EPA Superfund
Division Records Manager, Mail code SRC-7J, Metcalfe Federal Building,
7th Floor South, 77 West Jackson Boulevard, Chicago, IL 60604; 312/886-
4465.
     Region 7 (IA, KS, MO, NE), U.S. EPA, 11201 Renner Blvd.,
Mail code SUPR, Lenexa, KS 66219; 913/551-7956.
     Region 8 (CO, MT, ND, SD, UT, WY), U.S. EPA, 1595 Wynkoop
Street, Mail code Records Center, Denver, CO 80202-1129; 303/312-7273.
     Region 10 (AK, ID, OR, WA), U.S. EPA, 1200 6th Avenue,
Suite 155, Mail stop OMP-161, Seattle, WA 98101; 206/553-4494.
    The EPA is temporarily suspending Regional Records Centers for
public visitors to reduce the risk of transmitting COVID-19.
Information in these repositories, including the deletion docket, may
not be updated with hardcopy or electronic media. For further
information and updates on EPA Docket Center services, please visit us
online at https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID.

FOR FURTHER INFORMATION CONTACT:
 Mabel Garcia, U.S. EPA Region 2 (NJ, NY, PR, VI),
<EMAIL_ADDRESS>212/637-4356
 Andrew Hass, U.S. EPA Region 3 (DE, DC, MD, PA, VA, WV),
<EMAIL_ADDRESS>215/814-2049
 Leigh Lattimore or Brian Farrier, U.S. EPA Region 4 (AL, FL,
GA, KY, MS, NC, SC, TN<EMAIL_ADDRESS>or
<EMAIL_ADDRESS>404/562-8768 or 404/562-8952.
 Karen Cibulskis, U.S. EPA Region 5 (IL, IN, MI, MN, OH, WI),
<EMAIL_ADDRESS>312/886-1843
 David Wennerstrom, U.S. EPA Region 7 (IA, KS, MO, NE),
<EMAIL_ADDRESS>913/551-7996
 Linda Kiefer, U.S. EPA Region 8 (CO, MT, ND, SD, UT, WY),
<EMAIL_ADDRESS>303/312-6689
 Linda Meyer, U.S. EPA Region 10 (AK, ID, OR, WA),
<EMAIL_ADDRESS>206/553-6636
 Chuck Sands, U.S. EPA Headquarters<EMAIL_ADDRESS>
703/603-8857

SUPPLEMENTARY INFORMATION: The NPL, created under section 105 of
CERCLA, as amended, is an appendix of the NCP. The NCP establishes the
criteria that EPA uses to delete sites from the NPL. In accordance with
40 CFR 300.425(e), sites may be deleted from the NPL where no further
response is appropriate. Partial deletion of sites is in accordance
with 40 CFR 300.425(e) and are consistent with the Notice of Policy
Change: Partial Deletion of Sites Listed on the National Priorities
List, 60 FR 55466, (November 1, 1995). The sites to be deleted and
partially deleted from the NPL are listed in Table 1, including docket
information containing reference documents with the rationale and data
principally relied upon by the EPA to determine that the Superfund
response is complete. The NCP permits activities to occur at a deleted
site, or that media or parcel of a partially deleted site, including
operation and maintenance of the remedy, monitoring, and five-year
reviews. These activities for the site are entered in Table 1 in this
SUPPLEMENTARY INFORMATION section, if applicable, under Footnote such
that; 1=site has continued operation and maintenance of the remedy,
2=site receives continued monitoring, and 3=site five-year reviews are
conducted. As described in 40 CFR 300.425(e)(3) of the NCP, a site or
portion of a site deleted from the NPL remains eligible for Fund-
financed remedial action if future conditions warrant such actions.

                                                     Table 1
----------------------------------------------------------------------------------------------------------------
            Site name              City/county, state           Type              Docket No.         Footnote
----------------------------------------------------------------------------------------------------------------
Reich Farms.....................  Pleasant Plains, NJ  Full.................  EPA-HQ-SFUND-1983-            2, 3
                                                                               0002.
Butler Mine Tunnel..............  Pittston, PA.......  Full.................  EPA-HQ-SFUND-1987-  ..............
                                                                               0002.
Airco...........................  Calvert City, KY...  Full.................  EPA-HQ-SFUND-2005-         1, 2, 3
                                                                               0011.

Chemfax, Inc....................  Gulfport, MS.......  Partial..............  EPA-HQ-SFUND-1993-         1, 2, 3
                                                                               0001.
Kerr-McGee Chemical Corp-Navassa  Navassa, NC........  Partial..............  EPA-HQ-SFUND-2009-  ..............
                                                                               0587.
T.H. Agriculture & Nutrition      Montgomery, AL.....  Partial..............  EPA-HQ-SFUND-1990-         1, 2, 3
 (Montgomery).                                                                 0011.
US Finishing/Cone Mills.........  Greenville, SC.....  Partial..............  EPA-HQ-SFUND-2011-  ..............
                                                                               0077.
Arrowhead Refinery Co...........  Hermantown, MN.....  Full.................  EPA-HQ-SFUND-2005-            2, 3
                                                                               0011.
Barrels, Inc....................  Lansing, MI........  Full.................  EPA-HQ-SFUND-1989-            1, 3
                                                                               0011.
Bennett Stone Quarry............  Bloomington, IN....  Full.................  EPA-HQ-SFUND-2005-         1, 2, 3
                                                                               0011.
Lemon Lane Landfill.............  Bloomington, IN....  Full.................  EPA-HQ-SFUND-1983-         1, 2, 3
                                                                               0002.
South Minneapolis Residential     Minneapolis, MN....  Partial..............  EPA-HQ-SFUND-2006-  ..............
 Soil Contamination.                                                           0759.
United Scrap Lead Co., Inc......  Troy, OH...........  Full.................  EPA-HQ-SFUND-2005-            1, 3
                                                                               0011.
Neal's Landfill (Bloomington)...  Bloomington, IN....  Full.................  EPA-HQ-SFUND-1983-         1, 2, 3
                                                                               0002.
Missouri Electric Works.........  Cape Girardeau, MO.  Partial..............  EPA-HQ-SFUND-1990-            1, 3
                                                                               0010.
Omaha Lead......................  Omaha, NE..........  Partial..............  EPA-HQ-SFUND-2003-            1, 3
                                                                               0010.
Riverfront......................  New Haven, MO......  Partial..............  EPA-HQ-SFUND-2000-         1, 2, 3
                                                                               0004.
Libby Asbestos..................  Libby, MT..........  Partial..............  EPA-HQ-SFUND-2002-            1, 3
                                                                               0008.
Eagle Mine......................  Minturn/Redcliff,    Partial..............  EPA-HQ-SFUND-1986-            1, 3
                                   CO.                                         0005.
North Ridge Estates.............  Klamath Falls, OR..  Partial..............  EPA-HQ-SFUND-2011-            1, 3
                                                                               0076.
----------------------------------------------------------------------------------------------------------------

    Information concerning the sites to be deleted and partially
deleted from the NPL, the proposed rule for the deletion and partial
deletion of the sites, and information on receipt of public comment(s)
and preparation of a Responsiveness Summary (if applicable) are
included in Table 2 as follows:

                                                                         Table 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Full site deletion
                                       Date,                                                                                (full) or media/
             Site name                proposed          FR citation              Public comment          Responsiveness summary     parcels/description
                                        rule                                                                                for partial deletion
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reich Farms.......................    5/14/2021  86 FR 26452.............  Yes.......................  No........................  Full.
Butler Mine Tunnel................    5/14/2021  86 FR 26452.............  Yes.......................  Yes.......................  Full.
Airco.............................    5/14/2021  86 FR 26452.............  No........................  No........................  Full.
Chemfax, Inc......................    5/14/2021  86 FR 26452.............  No........................  No........................  11-acres of soils,
                                                                                sediments.
Kerr-McGee Chemical Corp-Navassa..    5/14/2021  86 FR 26452.............  No........................  No........................  20.2-acres Operable
                                                                                Unit (OU) 1 soils.
T.H. Agriculture & Nutrition          5/14/2021  86 FR 26452.............  No........................  No........................  16.4-acres soils/
 (Montgomery).                                                                                sediments.
US Finishing/Cone Mills...........    5/14/2021  86 FR 26452.............  No........................  No........................  150-acres OU 2 with
                                                                                soils, sediments and
                                                                                surface water.
Arrowhead Refinery Co.............    5/14/2021  86 FR 26452.............  No........................  No........................  Full.
Barrels, Inc......................    5/14/2021  86 FR 26452.............  No........................  No........................  Full.
Bennett Stone Quarry..............    5/14/2021  86 FR 26452.............  Yes.......................  No........................  Full.
Lemon Lane Landfill...............    5/14/2021  86 FR 26452.............  Yes.......................  No........................  Full.
South Minneapolis Residential Soil    5/14/2021  86 FR 26452.............  No........................  No........................  Five of remaining
 Contamination.                                                                                nine properties on
                                                                                NPL.
United Scrap Lead Co., Inc........    5/14/2021  86 FR 26452.............  No........................  No........................  Full.
Neal's Landfill (Bloomington).....    5/14/2021  86 FR 26452.............  Yes.......................  No........................  Full.
Missouri Electric Works...........    5/14/2021  86 FR 26452.............  No........................  No........................  6.4-acre site
                                                                                property OU 1 soils
                                                                                and OU 3 sediments.
Omaha Lead........................    5/14/2021  86 FR 26452.............  No........................  No........................  96 residential
                                                                                parcels.
Riverfront........................    5/14/2021  86 FR 26452.............  No........................  No........................  1.4-acre OU 3 Old
                                                                                City Dump soil,
                                                                                groundwater, surface
                                                                                water, seeps.
Libby Asbestos....................    5/14/2021  86 FR 26452.............  No........................  No........................  OU 8 Roads and
                                                                                Highways (30 miles
                                                                                of roads and right-
                                                                                of-way).
Eagle Mine........................    5/14/2021  86 FR 26452.............  Yes.......................  Yes.......................  50-acre OU 2 Town of
                                                                                Gilman soils.
North Ridge Estates...............    5/14/2021  86 FR 26452.............  No........................  No........................  125-acre OU 1
                                                                                includes Northridge
                                                                                Estates and former
                                                                                Marine Recuperation
                                                                                Barracks soils.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    For all sites proposed for deletion, the closing date for comments
in the proposed rule was June 14, 2021. The EPA received comments on
six of the sites included for deletion or partial deletion in this
final rule. The Bennett Stone Quarry site and the Lemon Lane Landfill
site each received one public comment supportive of the proposed
deletion. The Neal's Landfill (Bloomington) site received two public
comments supportive of the deletion. Because no adverse comment was
received for these three sites, no Responsiveness Summaries were
prepared.
    The Reich Farms site received an inquiry concerning the proposed
deletion action. EPA responded to the inquiry by providing information
available in the deletion docket to the

commenter. Because the comment was not adverse to the proposed deletion
of the Reich Farms site, EPA did not prepare a Responsiveness Summary.
EPA still believes the deletion action is appropriate. EPA placed the
comment and a memorandum explaining EPA's response to the inquiry in
the docket, EPA-HQ-SFUND-1983-0002, on https://www.regulations.gov, and
in the Regional repository listed in the Addresses section.
    The Butler Mine Tunnel site received one written comment and EPA
prepared a Responsiveness Summary. The commentor did not agree with
EPA's decision to delete the Butler Mine Tunnel Site from the NPL. The
commentor did express concern that the storm drains in their town may
be connected to boreholes which convey stormwater into underground
mines. The commentor requested an investigation of their concerns,
including the collection of air samples and use of camera system.
Finally, the commentor expressed concern that cancer cases in their
community are located near storm drains. The commentor did not specify
what boreholes or underground mines they are concerned about, and did
not provide their address/location, or the name of the town they refer
to in their comment. The commentor did not offer any information
specific to the Butler Mine Tunnel site to demonstrate that NPL
deletion criteria were not met. EPA has determined that it is
appropriate to proceed with the deletion because all response actions
at the site are complete and the criteria for deletion have been met. A
Responsiveness Summary was prepared and placed in the docket, EPA-HQ-
SFUND-1987-0002, on https://www.regulations.gov, and in the Regional
repository listed in the ADDRESSES section.
    The Eagle Mine site received one comment. The commenter requested
clarification regarding the purpose of the proposed partial deletion of
OU2, the Town of Gilman, and an explanation as to what differentiates
the Gilman portion of OU2 from other sources of contamination at the
site. The purpose of the proposed deletion is to document cleanup
completion of the Eagle Mine Superfund Site OU2. All response
requirements in the OU2 Record of Decision are implemented and as such,
OU2 qualifies for partial deletion from the NPL. EPA has determined
that it is appropriate to proceed with the deletion because all
response actions at the site are complete and the criteria for partial
deletion have been met. A Responsiveness Summary was prepared and
placed in the docket, EPA-HQ-SFUND-1986-0005, on https://www.regulations.gov, and in the Regional repository listed in the
ADDRESSES section.
    For all other sites not specified above, no adverse comments were
received.
    EPA maintains the NPL as the list of sites that appear to present a
significant risk to public health, welfare, or the environment.
Deletion from the NPL does not preclude further remedial action.
Whenever there is a significant release from a site deleted from the
NPL, the deleted site may be restored to the NPL without application of
the hazard ranking system. Deletion of a site from the NPL does not
affect responsible party liability in the unlikely event that future
conditions warrant further actions.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Natural resources, Oil pollution, Penalties, Reporting and
recordkeeping requirements, Superfund, Water pollution control, Water
supply.

    Dated: September 2, 2021.
Larry Douchand,
Office Director, Office of Superfund Remediation and Technology
Innovation.
    For reasons set out in the preamble, the EPA amends 40 CFR part 300
as follows:

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1251 et seq.; 42 U.S.C. 9601-9657; E.O.
13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR
54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR,
1987 Comp., p. 193.

0
2. In appendix B to part 300 amend Table 1 by:
0
a. Revising the entries for ``AL, T.H. Agriculture & Nutrition
(Montgomery), Montgomery''; ``CO, Eagle Mine, Minturn/Redcliff'';
0
b. Removing the entries for ``IN, Bennett Stone Quarry, Bloomington'';
``IN, Lemon Lane Landfill, Bloomington''; ``IN, Neal's Landfill
(Bloomington), Bloomington''; ``KY, Airco, Calvert City''; ``MI,
Barrels, Inc., Lansing''; ``MN, Arrowhead Refinery Co., Hermantown'';
0
c. Revising the entries for ``MO, Missouri Electric Works, Cape
Girardeau''; ``MO, Riverfront, New Haven''; ``MS, Chemfax, Inc.,
Gulfport''; ``NC, Kerr-McGee Chemical Corp-Navassa, Navassa'';
0
d. Removing the entries for ``NJ, Reich Farms, Pleasant Plains''; ``OH,
United Scrap Lead Co., Inc., Troy'';
0
e. Revising the entry for ``OR, North Ridge Estates, Klamath Falls'';
0
f. Removing the entry for ``PA, Butler Mine Tunnel, Pittston''; and
0
g. Revising the entry for ``SC, US Finishing/Cone Mills, Greenville''.
    The revisions read as follows:

Appendix B to Part 300--National Priorities List

                   Table 1--General Superfund Section
------------------------------------------------------------------------
         State              Site name         City/county     Notes (a)
------------------------------------------------------------------------
AL....................  T.H. Agriculture   Montgomery......           P
                         & Nutrition
                         (Montgomery).

                              * * * * * * *
CO....................  Eagle Mine.......  Minturn/Redcliff           P

                              * * * * * * *
MO....................  Missouri Electric  Cape Girardeau..           P
                         Works.

                              * * * * * * *
MO....................  Riverfront.......  New Haven.......           P

                              * * * * * * *
MS....................  Chemfax, Inc.....  Gulfport........           P

                              * * * * * * *
NC....................  Kerr-McGee         Navassa.........           P
                         Chemical Corp-
                         Navassa.

                              * * * * * * *
OR....................  North Ridge        Klamath Falls...           P
                         Estates.

                              * * * * * * *
SC....................  US Finishing/Cone  Greenville......           P
                         Mills.

                              * * * * * * *
------------------------------------------------------------------------
* P = Sites with partial deletion(s).

[FR Doc. 2021-19448 Filed 9-13-21; 8:45 am]
BILLING CODE 6560-50-P