[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44805-44807]
[FR Doc No: 2014-18111]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0007]

Outsourcing Facility Fee Rates for Fiscal Year 2015

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the rates for fiscal year (FY) 2015 for the establishment
and reinspection fees related to human drug compounding outsourcing
facilities (outsourcing facilities) that elect to register under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act). The FD&C Act
authorizes FDA to assess and collect an annual establishment fee from
outsourcing facilities that have elected to register, as well as a
reinspection fee for each reinspection of an outsourcing facility. This
document establishes the FY 2015 rates for the small business
establishment fee ($5,103), the non-small business establishment fee
($16,442) and the reinspection fee ($15,308) for outsourcing
facilities, provides information on how the fees for FY 2015 were
determined, and describes the payment procedures outsourcing facilities
should follow.

FOR FURTHER INFORMATION CONTACT:
    For information on pharmacy compounding and pharmacy compounding
user fees: Visit FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm.
    For questions relating to this notice: Rachel Richter, Office of
Financial Management Food and Drug Administration, 8455 Colesville Rd.,
COLE-14216, Silver Spring, MD 20933-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, President Obama signed the Drug Quality and
Security Act (DQSA), legislation that contains important provisions
relating to the oversight of compounding of human drugs. Title I of
this law, the Compounding Quality Act, creates a new section 503B in
the FD&C Act (21 U.S.C. 353b). Under section 503B, a human drug
compounder can become an ``outsourcing facility.''
    Outsourcing facilities, as defined in section 503B(d)(4) of the
FD&C Act, are facilities that meet all of the conditions described in
section 503B(a), including registering with FDA as an outsourcing
facility and paying an annual establishment fee. If these conditions
are satisfied, a drug compounded by or under the direct supervision of
a licensed pharmacist in an outsourcing facility is exempt from two
sections of the FD&C Act: (1) Section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with adequate directions for use) and
(2) section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)). Drugs compounded in outsourcing facilities are
not exempt from the requirements of section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing
practice for drugs).
    Section 744K of the FD&C Act (21 U.S.C. 379j-62) authorizes FDA to
assess and collect the following fees associated with outsourcing
facilities that elect to register under section 503B of the FD&C Act:
(1) An annual establishment fee from each outsourcing facility; and (2)
a reinspection fee from each outsourcing facility subject to a
reinspection (see section 744K(a)(1) of the FD&C Act). Under
statutorily defined conditions, a qualified applicant may pay a reduced
small business establishment fee (see section 744K(c)(4) of the FD&C
Act).
    On April 1, 2014, FDA announced in the Federal Register of April 1,
2014 (79 FR 18297) the availability of a draft guidance for industry
entitled ``Fees for Human Drug Compounding Outsourcing Facilities Under
Sections 503B and 744K of the FD&C Act.'' The draft guidance provides
additional information on the annual fees for registered outsourcing
facilities and adjustments required by law, reinspection fees, how to
submit payment, the effect of failure to pay fees and how to qualify as
a small business to obtain a reduction of the annual establishment fee.
This draft guidance can be accessed on FDA's Web site at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf.

II. Fees for FY 2015 1
---------------------------------------------------------------------------

    \1\ FY 2015 runs from October 1, 2014 through September 30,
2015.
---------------------------------------------------------------------------

A. FY 2015 Rates for Small Business Establishment Fee, Non-Small
Business Establishment Fee, and Reinspection Fee

1. Establishment Fee for Qualified Small Businesses \2\
---------------------------------------------------------------------------

    \2\ To qualify for a small business reduction of the FY 2015
establishment fee, entities had to submit their exception requests
by April 30, 2014. See section 744K(c)(4)(B) of the FD&C Act.
Although the time for requesting a small business exception for FY
2015 has now passed, an entity that wishes to request a small
business exception for FY 2016 should consult section 744K(c)(4) of
the FD&C Act and section III.D of FDA's draft guidance for industry
entitled ``Fees for Human Drug Compounding Outsourcing Facilities
Under Sections 503B and 744K of the FD&C Act,'' which can be
accessed on FDA's Web site at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf.
---------------------------------------------------------------------------

    The amount of the establishment fee for a qualified small business
fee is equal to $15,000 multiplied by the inflation adjustment factor
for that fiscal year, divided by three (see section 744K(c)(4)(A) and
(c)(1)(A)). The inflation adjustment factor for FY 2015 is 1.020558.
See section II.B.1, below, for the methodology used to calculate the FY
2015 inflation adjustment factor. Therefore, the establishment fee for
a qualified small business for FY 2015 is one third of $15,308, which
equals $5,103 (rounded to the nearest dollar).
2. Establishment Fee for Non-Small Businesses
    Under section 744K(c)(1)(A) of the FD&C Act, the amount of the
establishment fee for a non-small business fee is equal to $15,000
multiplied by the inflation adjustment factor for that fiscal year,
plus the small business adjustment factor for that fiscal year. The
inflation adjustment factor for FY 2015 is 1.020558. (See section
II.B.1). The small business adjustment amount for FY 2015 is $1,134.
See section II.B.2, for the methodology used

to calculate the small business adjustment factor for FY 2015.
Therefore, the establishment fee for a non-small business for FY 2015
is $15,000 multiplied by 1.020558, plus $1,134, which equals $16,442.
3. Reinspection Fee
    Section 744K(c)(1)(B) of the FD&C Act provides that the amount of
the FY 2015 reinspection fee is equal to $15,000, multiplied by the
inflation adjustment factor for that fiscal year. The inflation
adjustment factor for FY 2015 is 1.020558. See section II.B.1.
Therefore, the reinspection fee for FY 2015 is $15,000 multiplied by
1.020558, which equals $15,308. There is no reduction in this fee for
small businesses.

B. Methodology for Calculating FY 2015 Adjustment Factors

1. Inflation Adjustment Factor
    Section 744K(c)(2) of the FD&C Act specifies the annual inflation
adjustment for outsourcing facility fees. The inflation adjustment has
two components: One based on FDA's payroll costs and one based on FDA's
non-pay costs for the first 3 years of the 4 previous FYs. The payroll
component of the annual inflation adjustment is calculated by taking
the average change in the FDA's per-full time equivalent (FTE)
personnel compensation and benefits (PC&B) in the first 3 years of the
4 previous FYs (see section 744K(c)(2)(A)(ii) of the FD&C Act). FDA's
total annual spending on PC&B is divided by the total number of FTEs
per FY to determine the average PC&B per FTE. The data on total PC&B
paid and numbers of FTEs paid, from which the average cost per FTE can
be derived, are published in FDA's Justification of Estimates for
Appropriations Committees.
    Table 1 summarizes the actual cost and FTE data for the specified
FYs, and provides the percent change from the previous FY and the
average percent change over the first 3 of the 4 FYs preceding FY 2015.
The 3-year average is 1.8829 percent.

                                Table 1--FDA PC&B's Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
           Fiscal year                   2011                20112               2013           3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B......................      $1,761,655,000      $1,824,703,000      $1,927,703,000  ..................
Total FTE.......................              13,331              13,382              13,974  ..................
PC&B per FTE....................            $132,147            $136,355            $137,949  ..................
Percent change from previous                 1.2954%             3.1843%             1.1690%             1.8829%
 year...........................
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this
1.8829 percent should be multiplied by the proportion of PC&B to total
costs of an average FTE of FDA for the same 3 FYs.

                      Table 2--FDA PC&B's as a Percent of FDA Total Costs of an Average FTE
----------------------------------------------------------------------------------------------------------------
           Fiscal year                   2011                20112               2013           3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B......................      $1,761,655,000      $1,824,703,000      $1,927,703,000  ..................
Total Costs.....................      $3,333,407,000      $3,550,496,000      $4,151,343,000  ..................
PC&B Percent....................            52.8485%            51.3929%            46.4356%            50.2257%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.8829 percent multiplied by 50.2257
percent, or 0.9457 percent.
    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that the
portion of the inflation adjustment for non-payroll costs for FY 2015
is equal to the average annual percent change in the Consumer Price
Index (CPI) for urban consumers (U.S. City Average; Not Seasonally
Adjusted; All items; Annual Index) for the first 3 years of the
preceding 4 years of available data, multiplied by the proportion of
all costs other than PC&B costs to total costs of an average FTE of the
FDA for the first 3 years of the preceding 4 fiscal years.
    Table 2 provides the summary data for the percent change in the
specified CPI for U.S. cities. These data are published by the Bureau
of Labor Statistics and can be found on its Web site at http://data.bls.gov/cgi-bin/surveymost?cu by checking the box marked ``U.S.
All items, 1982-84 = 100-CUUR0000SA0'' and then clicking on the
``Retrieve Data'' button.

                   Table 3--Annual and 3-Year Average Percent Change in U.S. City Average CPI
----------------------------------------------------------------------------------------------------------------
              Year                       2011                2012                2013           3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................             224.939             229.594             232.957  ..................
Annual percent change...........             3.1565%             2.0694%             1.4648%             2.2302%
----------------------------------------------------------------------------------------------------------------

    Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this
2.2302 percent should be multiplied by the proportion of all costs
other than PC&B costs to total costs of an average FTE of the FDA for
the same 3 FYs. The proportion of all costs other than PC&B costs to
total costs of an average FTE of FDA for FYs 2011-2013 is 49.7743
percent (100 percent minus 50.2257 percent equals 49.7743 percent).
Therefore, the non-pay adjustment is 2.2302 percent times 49.7743
percent, or 1.1101 percent.
    To complete the inflation adjustment, the payroll component (0.9457
percent) is added to the non-pay component (1.1101 percent), for a
total inflation adjustment of 2.0558 percent (rounded), and then one is
added, making 1.020558.
2. Small Business Adjustment Factor
    Section 744K(c)(3) of the FD&C Act specifies that in addition to
the inflation

adjustment factor, the establishment fee for non-small businesses is to
be further adjusted for a small business adjustment factor. Section
744K(c)(3)(B) provides that the small business adjustment factor is the
adjustment to the establishment fee for non-small businesses that is
necessary to achieve total fees equaling the total fees that FDA would
have collected if no entity qualified for the small business exception
in section 744K(c)(4) of the FD&C Act.
    Therefore, to calculate the small business adjustment to the
establishment fee for non-small businesses for FY 2015, FDA must
estimate: (1) The number of outsourcing facilities that will pay the
reduced fee for small businesses for FY 2015; and (2) the total fee
revenue it would have collected if no entity had qualified for the
small business exception (i.e., if each outsourcing facility that
registers for FY 2015 were to pay the inflation-adjusted fee amount of
$15,308). With respect to (1), FDA estimates that 5 entities will
qualify for small business exceptions for FY 2015. Accordingly, FDA
estimates that 5 entities will pay the reduced fee for small businesses
for FY 2015. With respect to (2), to estimate the total number of
outsourcing facilities that will register for FY 2015, FDA used data
submitted to date by outsourcing facilities through the voluntary
registration process, which began in December 2013. Accordingly, FDA
estimates that 50 outsourcing facilities, including 5 small businesses,
will register with the Agency in FY 2015.
    If the projected 50 outsourcing facilities paid the full inflation-
adjusted fee of $15,308, this would result in total revenue of $765,400
in FY 2015 ($15,308 times 50). However, because 5 of the outsourcing
facilities expected to register for FY 2015 are estimated to qualify
for the small business exception and will pay one-third of the full fee
($5,103 x 5), totaling $25,515 instead of paying the full fee ($15,308
x 5), which totals $76,540, this would leave a shortfall of $51,025
($76,540 - $25,515). Dividing $51,025 by 45 (the number of estimated
non-small businesses) yields $1,134 (rounded to the nearest dollar).
Therefore, the FY 2015 small business adjustment to the establishment
fee for non-small businesses is $1,134.

C. Summary of FY 2015 Fee Rates

                   Table 4--Outsourcing Facility Fees
------------------------------------------------------------------------

------------------------------------------------------------------------
Qualified Small Business Establishment Fee....................    $5,103
Non-Small Business Establishment Fee..........................    16,442
Reinspection Fee..............................................    15,308
------------------------------------------------------------------------

III. Fee Payment Options and Procedures

A. Establishment Fee

    Once an entity submits registration information and FDA has
reviewed the information and determined that it is complete, the entity
will incur the annual establishment fee. FDA will send an invoice to
the entity via email, to the email address indicated in the
registration file, or via regular mail if email is not an option. The
invoice will contain information regarding the obligation incurred, the
amount owed, and payment procedures. A facility will not be deemed
registered as an outsourcing facility until it has paid the annual
establishment fee under section 744K of the FD&C Act. Accordingly, it
is important that facilities seeking to operate as registered
outsourcing facilities pay all fees immediately upon receiving an
invoice. If an entity does not pay the full invoiced amount within
fifteen calendar days after FDA issues the invoice, FDA will consider
the submission of registration information to have been withdrawn and
adjust the invoice to reflect that no fee is due.
    Outsourcing facilities that registered in FY 2014 and wish to
maintain their status as an outsourcing facility in FY 2015 must
register during the annual registration period that lasts from October
1, 2014 to December 31, 2014. Failure to register and complete payment
by December 31, 2014, will result in a loss of status as an outsourcing
facility on January 1, 2015. Entities should submit their registration
information no later than December 10, 2014 to allow enough time for
review of the registration information, invoicing, and payment of fees
before the end of the registration period.

B. Reinspection Fee

    FDA will issue invoices for each reinspection via email, to the
email address indicated in the registration file, or via regular mail
if email is not an option.

C. Fee Payment Procedures

    Entities may remit payments via check or wire transfer.
    1. If paying with a paper check: Checks must be in U.S. currency
from a U.S. bank and made payable to the Food and Drug Administration.
Payments can be mailed to: Food and Drug Administration, P.O. Box
956733, St. Louis, MO 63195-6733. If a check is sent by a courier that
requests a street address, the courier can deliver the check to: U.S.
Bank, Attn: Government Lockbox 956733, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery
only; do not send mail to this address.)
    2. If paying with a wire transfer: Use the following account
information when sending a wire transfer: New York Federal Reserve
Bank, U.S. Dept of Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Road, Silver Spring, MD 20993. The
originating financial institution may charge a wire transfer fee. An
outsourcing facility should ask its financial institution about the fee
and add it to the payment to ensure that the order is fully paid. The
tax identification number of FDA is 53-0196965.

    Dated: July 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18111 Filed 7-31-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53239-53240]
[FR Doc No: 2018-22944]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-The-Record Communications Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).7
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link.

Enter the docket number, excluding the last three digits, in the docket
number field to access the document. For assistance, please contact
FERC Online Support at [email protected] or toll free at (866)
208-3676, or for TTY, contact<PHONE_NUMBER>.

------------------------------------------------------------------------
                                                        Presenter or
            Docket No.                 File date          Requester
------------------------------------------------------------------------
Prohibited:
    1. P-405-106..................       10-3-2018  Alex Balboa
Exempt:
    1. CP17-495-000...............       10-1-2018  FERC Staff \1\
    2. CP17-101-000...............       10-5-2018  FERC Staff \2\
    3. CP18-46-000................      10-12-2018  FERC Staff \3\
------------------------------------------------------------------------
\1\ Memorandum dated October 1, 2018 forwarding letter from the Oregon
  State Historic Preservation Office.
\2\ Addendum to meeting minutes for interagency teleconference on August
  13, 2018 with the U.S. Environmental Protection Agency, the New York
  State Department of Environmental Conservation, and the New Jersey
  Department of Environmental Protection.
\3\ Memorandum for project conference call on October 10, 2018 with
  Adelphia.

    Dated: October 16, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-22944 Filed 10-19-18; 8:45 am]
 BILLING CODE 6717-01-P


148240   80   6 Fatty acids, C18 unsatd., trimers, 2[ methyl[( tridecafluorohexyl) sulfonyl] amino] ethyl esters 148240   82   8 Fatty acids, C18 unsatd., trimers, 2[ methyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl esters 182700   90   9 1 Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N methyl, reaction products with benzene chlorine sulfur chloride ( S2Cl2) reaction products chlorides VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72857 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations TABLE 1.   CHEMICAL SUBSTANCES COVERED BY THIS RULE   Continued CAS No./ PMN CAS Ninth Collective Index Name L   92   0151 2 Propenoic acid, 2 methyl, butyl ester, polymer with 2[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2[ ethyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ ethyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ ethyl[( tridecafluorohexyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate and 2 propenoic acid P   80   0183 192662   29   6 Sulfonamides, C4 8 alkane, perfluoro, N[ 3( dimethylamino) propyl], reaction products with acrylic acid P   83   1102 306973   46   6 Fatty acids, linseed oil, dimers, 2[[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl esters P   84   1163 306975   56   4 Propanoic acid, 3 hydroxy 2( hydroxymethyl) 2 methyl, polymer with 2 ethyl 2( hydroxymethyl) 1,3 propanediol and N, N', 2 tris( 6 isocyanatohexyl) imidodicarbonic diamide, reaction products with N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N( 2 hydroxyethyl) 1 octanesulfonamide and N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7 pentadecafluoro N( 2 hydroxyethyl) 1 heptanesulfonamide, compds. with triethylamine P   84   1171 306975   57   5 Propanoic acid, 3 hydroxy 2( hydroxymethyl) 2 methyl, polymer with 1,1' methylenebis[ 4 isocyanatobenzene] and 1,2,3 propanetriol, reaction products with N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N( 2 hydroxyethyl) 1 octanesulfonamide and N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7 pentadecafluoro N( 2 hydroxyethyl) 1 heptanesulfonamide, compds. with morpholine P   86   0301 306973   47   7 Sulfonamides, C4 8 alkane, perfluoro, N( hydroxyethyl) N methyl, reaction products with 12 hydroxystearic acid and 2,4 TDI, ammonium salts P   86   0958 306975   62   2 2 Propenoic acid, 2 methyl, dodecyl ester, polymers with 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl acrylate and vinylidene chloride P   89   0799 160901   25   7 Sulfonamides, C4 8 alkane, perfluoro, N ethyl N( hydroxyethyl), reaction products with 2 ethyl 1 hexanol and polymethylenepolyphenylene isocyanate P   90   0111 306974   19   6 Sulfonamides, C4 8 alkane, perfluoro, N methyl N[( 3 octadecyl 2 oxo 5 oxazolidinyl) methyl]

P   91   1419 306975   84   8 Poly( oxy 1,2 ethanediyl), . alpha. hydro. omega. hydroxy, polymer with 1,6 diisocyanatohexane, N ( hydroxyethyl) N methyl perfluoro C4 8 alkane sulfonamides blocked P   93   1444 306975   85   9 2 Propenoic acid, 2 methyl, dodecyl ester, polymers with N( hydroxymethyl) 2 propenamide, 2 [ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl methacrylate, stearyl methacrylate and vinylidene chloride P   94   0545 306976   25   0 1 Hexadecanaminium, N, N dimethyl N[ 2[( 2 methyl 1 oxo 2 propenyl) oxy] ethyl], bromide, polymers with Bu acrylate, Bu methacrylate and 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl acrylate P   94   0927 306976   55   6 2 Propenoic acid, 2 methyl, 2 methylpropyl ester, polymer with 2,4 diisocyanato 1 methylbenzene, 2 ethyl 2( hydroxymethyl) 1,3 propanediol and 2 propenoic acid, N ethyl N( hydroxyethyl) perfluoro C4 8 alkanesulfonamides blocked P   94   2206 306974   28   7 Siloxanes and Silicones, di Me, mono[ 3[( 2 methyl 1 oxo 2 propenyl) oxy] propylgroup] terminated, polymers with 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl acrylate and stearyl methacrylate P   95   0120 306980   27   8 Sulfonamides, C4 8 alkane, perfluoro, N, N'[ 1,6 hexanediylbis[( 2 oxo 3,5 oxazolidinediyl) methylene]] bis[ N methyl

P   96   1262 306974   45   8 Sulfonic acids, C6 8 alkane, perfluoro, compds. with polyethylene polypropylene glycol bis( 2 aminopropyl) ether P   96   1424 306977   10   6 2 Propenoic acid, 2 methyl, 2( dimethylamino) ethyl ester, telomer with 2[ ethyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl methacrylate and 1 octanethiol, N oxides P   96   1433 * 178094   69   4 1 Octanesulfonamide, N[ 3( dimethyloxidoamino) propyl] 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro , potassium salt P   97   0790 251099   16   8 1 Decanaminium, N decyl N, N dimethyl, salt with 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro 1 octanesulfonic acid ( 1: 1)

P   98   0251 306978   04   1 2 Propenoic acid, butyl ester, polymers with acrylamide, 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl acrylate and vinylidene chloride VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72858 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations TABLE 1.   CHEMICAL SUBSTANCES COVERED BY THIS RULE   Continued CAS No./ PMN CAS Ninth Collective Index Name P   98   1272 306977   58   2 2 Propenoic acid, 2 methyl, 3( trimethoxysilyl) propyl ester, polymers with acrylic acid, 2 [ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl acrylate and propylene glycol monoacrylate, hydrolyzed, compds. with 2,2'( methylimino) bis[ ethanol]

P   99   0188 306978   65   4 Hexane, 1,6 diisocyanato, homopolymer, N( hydroxyethyl) N methyl perfluoro C4 8 alkane sulfonamides and stearyl alc. blocked P   99   0319 306979   40   8 Poly( oxy 1,2 ethanediyl), . alpha.[ 2( methylamino) ethyl]. omega.[( 1,1,3,3 tetramethylbutyl) phenoxy], N [( perfluoro C4 8 alkyl) sulfonyl] derivs.

* Manufacturer requested change in chemical identity based on interpretation of current data. Former CAS No. 179005   06   2 is being deleted from the Inventory.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPPT 2002 0043. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102 Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is ( 202) 566   1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is ( 202) 566   0280. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 721 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr721_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background A. What Action is the Agency Taking?

This action promulgates the supplemental proposed SNUR published in the Federal Register of March 11, 2002 ( 67 FR 11014) ( FRL   6823   7), which modified the original proposed SNUR published in the Federal Register of October 18, 2000 ( 65 FR 62319) ( FRL   6745   5). This rule requires persons to notify EPA at least 90 days before commencing the manufacture or import of the chemical substances identified in Table 1, Unit I. A., for the significant new uses described in this document. The chemical substances identified in Table 1, Unit I. A., are 75 chemical substances, including PFOSH, PFOSS, POSF, certain higher and lower homologues of PFOSH and POSF, and certain other chemical substances, including polymers, that are derived from PFOSH and its homologues. These chemicals are collectively referred to throughout this rule as PFAS. In the original proposed SNUR, these chemicals were referred to collectively as perfluorooctyl sulfonates, or PFOS, but commenters noted that this generic usage of the term PFOS was inconsistent with the use by the manufacturer of PFOS, 3M, to refer only to chemicals with an eight carbon, or C8, chain length. Many of the chemicals in this SNUR include a range of carbon chain lengths, although most include C8 within the range. Accordingly, EPA uses the generic term PFAS to refer to any carbon chain length, including mixed ranges and higher and lower homologues as well as C8, and the term PFOS to represent only those chemical substances which are predominantly C8. The significant new uses described in this document are: 1. Any manufacture or import for any use of any chemical listed in Table 1, Unit I. A., on or after January 1, 2003, except as noted in Unit II. A. 2. 2. Manufacture or import of any chemical listed in Table 1, Unit I. A., solely for one or more of the following specific uses shall not be considered as a significant new use subject to reporting under this section: i. Use as an anti erosion additive in fire resistant phosphate ester aviation hydraulic fluids. ii. Use as a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices. iii. Use in coatings for surface tension, static discharge, and adhesion control for analog and digital imaging films, papers, and printing plates, or as a surfactant in mixtures used to process imaging films. iv. Use as an intermediate only to produce other chemical substances to be used solely for the uses listed in Unit II. A. 2. i., ii., or iii. The chemical substances subject to this SNUR are listed in Table 1, Unit I. A. Most of these PFAS chemical substances include the C8 chain length characteristic of PFOS and thus have the potential to degrade to PFOSH in the environment or to be converted to PFOSH via incomplete oxidation during the incineration of PFOS containing materials. Once PFOSH has been released to the environment, it does not undergo further chemical ( hydrolysis), microbial, or photolytic degradation. PFOS is highly persistent in the environment and has a strong tendency to bioaccumulate. Studies have found PFOS in very small quantities in the blood of the general human population as well as in wildlife, indicating that exposure to the chemicals is widespread, and recent tests have raised concerns about their potential VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72859 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations developmental, reproductive, and systemic toxicity ( Refs. 1, 2, and 3). These facts, taken together, raise concerns for long term potential adverse effects in people and wildlife over time if PFOS should continue to be produced, released, and built up in the environment. 3M, the principal manufacturer of PFAS worldwide, voluntarily committed to discontinue the production of the specific PFOS based PFAS chemicals covered by this rule by December 31, 2002 ( Ref. 4). Based on the information EPA possessed when the original proposed SNUR was published, EPA concluded that this action by 3M would reduce manufacture and importation of these chemicals to zero, with a corresponding reduction in the type, form, and duration of exposure to these chemicals. EPA therefore concluded that any subsequent new manufacture or importation of these chemicals would constitute a significant new use. Commenters on the original SNUR proposal provided information confirming that, contrary to the information available to the EPA when the original proposed SNUR was published, 3M was not the sole manufacturer of certain of the chemical substances on Table 1, Unit I. A. These commenters were importing a few of these substances in small quantities below mandatory reporting thresholds for their specific uses from non 3M sources outside the United States prior to the publication of the proposed SNUR. The identities, amounts, and suppliers of those specific chemicals were claimed as CBI, and thus cannot be specifically identified in this rule. To the extent that specific PFAS chemical substances on the proposed SNUR lists were being obtained from sources other than 3M for specific uses prior to the publication of the proposed SNUR, and thus would not be affected by 3M's unilateral decision to discontinue production, the manufacture of those specific chemicals for particular uses is considered to be ongoing and would not be subject to a significant new use determination. These specific uses are as a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices. Accordingly, this SNUR identifies the manufacture or importation of chemicals listed in Table 1, Unit I. A., for these specific uses as not being a significant new use. Commenters on the original SNUR proposal who had obtained listed chemicals only from 3M sources prior to the publication of the proposed SNUR also identified non 3M sources for specific PFAS chemicals that were essential to their specific uses in the semiconductor, aviation hydraulics, and imaging industries. Based on the information presented by these commenters about the limited volume of their uses, the extent of controls on exposure and releases, and the absence of viable alternatives for these specific chemicals, some of which are claimed as CBI and thus cannot be specifically identified in this rule, this SNUR identifies the manufacture of chemicals in Table 1, Unit I. A., for these specific uses as not being significant new uses. Manufacture or importation of these chemicals for these uses is thus not subject to this SNUR. Because certain of the SNUR chemicals are intermediates required in the manufacture of the specific listed chemicals associated with these excluded uses, the use of PFAS chemicals listed in Table 1, Unit I. A., as intermediates solely to produce other chemicals for one or more of the specific excluded uses is also excluded from the definition of a significant new use.

B. What is the Agency's Authority for Taking this Action? Section 5( a)( 2) of TSCA ( 15 U. S. C. 2604( a)( 2)) authorizes EPA to determine that a use of a chemical substance is a `` significant new use.'' The Agency makes this determination by rule after considering all relevant factors, including those listed in TSCA section 5( a)( 2). These factors include the volume of a chemical substance's production or importation; the extent to which a use changes the type, form, magnitude, or duration of exposure to the substance; and the reasonably anticipated manner of producing or otherwise managing the substance. Once EPA makes this determination and promulgates a SNUR, TSCA section 5( a)( 1)( B) requires persons to submit a significant new use notice ( SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that significant new use ( 15 U. S. C. 2604 ( a)( 1)( B)). As noted in the proposed SNUR, EPA believes that the intent of TSCA section 5( a)( 1)( B) is best served by designating a use as a significant new use as of the proposal date of the SNUR, rather than as of the effective date of the final rule. If uses begun after publication of the proposed SNUR were considered to be ongoing, rather than new, it would be difficult for EPA to establish SNUR notice requirements, because any person could defeat the SNUR by initiating the proposed significant new use before the rule became final, and then argue that the use was ongoing. Accordingly, persons who may have begun commercial manufacture or import of the PFAS chemicals listed in Table 1, Unit I. A., for the significant new uses listed in this final SNUR after the initial proposal was published on October 18, 2000, must stop that activity before the effective date of this final rule. Persons who cease those activities will have to meet all SNUR notice requirements and wait until the end of the notice review period, including all extensions, before engaging in any activities designated as significant new uses. If, however, persons who may have begun commercial manufacture or import of these chemical substances between the proposal and the effective date of the SNUR meet the conditions of advance compliance as codified at 40 CFR 721.45( h), those persons will be considered to have met the final SNUR requirements for those activities.

C. Summary of and Response to Comments Eight parties submitted timely comments on the supplemental proposed SNUR. All of the comments generally supported the SNUR, although several of them requested clarification of specific points. Two parties submitted late comments addressing broader issues of EPA's SNUR authority. Three of the comments, from Solutia, Inc., ExxonMobil Biomedical Sciences, Inc., and Boeing Company, supported the approach and language of the proposed SNUR with respect to the aviation hydraulics use. The Semiconductor Industry Association and Semiconductor Equipment and Materials, Inc. ( SIA/ SEMI), submitted joint comments generally approving the proposed SNUR, but requested clarification on two issues, including the scope of the proposed exclusion of the semiconductor photomicrolithography use from the rule and the application of the section 12( b) export notification requirements of TSCA to the export of chemicals and products intended for the excluded use. SIA/ SEMI noted that the photomicrolithography processes used in the semiconductor industry are used to produce not only semiconductors, but also electronic components of disk drives, electronics packaging, micromachines, and optoelectronic devices and circuits. SIA/ SEMI indicated that they read the proposed exclusion to apply to such production activities, which were included in the industry mass balance materials they VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72860 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations supplied to the Agency, and asked EPA to confirm that understanding. EPA acknowledges that the language of the exclusion, which describes ``... a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices,'' is intended to apply to all of these activities for which the semiconductor industry, in its data submissions to the Agency, detailed the current need to use PFAS to achieve the technical requirement of fineness of lines requiring sharp definition in the submicron area. EPA agrees that the specific items listed by SIA/ SEMI are `` components of electronic or other miniaturized devices.'' Broader photolithography uses are not intended to be covered by this exclusion, and manufacture or importation of listed PFAS chemicals for such uses is considered to be a significant new use subject to this rule. With respect to TSCA section 12( b), SIA/ SEMI stated that it assumes that a person who exports one of the chemicals covered by the SNUR for a use that is excluded from the SNUR would not need to meet export notification requirements for such exports. EPA does not concur with this interpretation. Section 12( b)( 2) of TSCA provides that, `` If any person exports or intends to export to a foreign country a chemical substance or mixture for which ... a rule has been proposed or promulgated under section 5 ..., such person shall notify the Administrator of such exportation or intent to export and the Administrator shall furnish to the government of such country notice of such rule ...'' Regulations implementing TSCA section 12( b) are at 40 CFR part 707, subpart D. The TSCA section 12( b) export notification requirement for a chemical is not contingent on whether the intended use of the chemical has been regulated under the SNUR, and EPA does not interpret TSCA section 12( b) to include an exemption for uses that are not regulated. In promulgating the original TSCA section 12( b) regulations, EPA explained its position, `` that the export notification requirement for a chemical is not contingent on whether the intended use of the chemical has been regulated . . . Notice must be given to EPA even though the chemical is being exported for a use, or in a manner, that is not regulated domestically under the relevant TSCA section 5, 6, or 7 action, rule or order.'' ( 45 FR 82844, 82846, December 16, 1980.) Under TSCA section 12( b), the Agency is responsible for informing the importing country about actions taken with respect to a chemical that is the subject of a proposed or final SNUR. This notice includes information about any exempt uses within the United States. It is up to the foreign government to determine what action, if any, should be taken with respect to the substance in that country. The Agency also notes that, in many cases, the exporter will not know the use of the substance or mixture being exported. Requiring the exporter to make a use determination would be unnecessarily burdensome, and could be impossible in some cases. Accordingly, EPA believes its current interpretation of TSCA section 12( b) best furthers the intent of the statute. Air Products Electronic Chemicals ( APEC) requested that the Agency clarify specifically whether the semiconductor photomicrolithography exclusion would apply to developer products with a PFAS component. This exclusion applies only to `` components of photoresist substances'' and `` components of anti reflective coatings.'' Developers are not components of either `` photoresist substances'' or `` anti reflective coatings,'' and thus are not included within the scope of the exclusion. The manufacture or importation of PFAS for use in developers and polyimides is considered a significant new use under this rule. The Eastman Kodak Company filed comments and supporting materials on behalf of the International Imaging Industry Association ( I3A), requesting minor changes to the language of the proposed exclusion for certain imaging uses and providing substantial information on the industry's reductions in PFAS use and on the details of PFAS use, exposures, and releases by the industry. I3A also met twice with the Agency to present information and answer questions, and materials and correspondence from those meetings were included in the rulemaking record. The language changes requested by I3A help to clarify the intended application of the exclusion, and have been incorporated into the regulatory text of the rule. The specific imaging uses excluded from the significant new use definition are uses in coatings for surface tension, static discharge, and adhesion control for analog and digital imaging films, papers, and printing plates, or as a surfactant in mixtures used to process imaging films. Coatings for surface tension control allow the rapid spreading of multiple thin layers of light sensitive materials at high speed to prevent drying of materials as they are laid down. This prevents irregularities in the coating which would make the films, papers, or printing plates unuseable. Coatings to control static discharge help to repel dirt, reduce friction, and thus prevent the discharge of static electricity otherwise built up during the transport of imaging materials through manufacturing and image processing equipment. This prevents light sensitive imaging materials from being fogged and rendered useless by light from a static discharge. Because tape is the primary way in which imaging materials are attached to spools and to each other during processing, adhesion control coatings help to ensure that the bond between the tape and the coating will be strong enough to withstand transport during use and processing, but will separate before it would damage either the imaging material or the equipment. The exclusion for use of PFAS as a surfactant in mixtures used to process imaging films involves incorporation of a PFAS material into a mixture that is used as a photoprocessing solution where its surfactant properties function to prevent discoloration of films while the films are being processed through the solution. This exclusion applies only to processing films. Use as a surfactant in mixtures to process papers and printing plates would be a significant new use under the rule. The I3A comments and supporting documents characterized the specific uses, exposures, and releases of PFAS materials in the imaging industry in such a way as to greatly improve the Agency's understanding. The submission also reflected a significant reduction in the use of the chemicals subject to the SNUR. Comments on the original SNUR proposal indicated that the annual worldwide usage volume of these chemicals was approximately 36,000 kilograms ( kg) ( 79,200 pounds), of which the U. S. consumption was approximately 18,000 kg/ year ( yr). The recent I3A comments reported that the United States demand for these chemicals is expected to be down to 3,000 kg/ yr by the end of 2002. Of this amount, I3A estimates that less than 50 kg/ yr are used for paper products and less than 300 kg/ yr are used for printing plates, with the remainder being used for various film products in the United States. Of the remaining 2,650 kg/ yr that are used for film, I3A estimates that 30 kg/ yr are used as a surfactant in processing solutions and 2,620 kg/ yr are used in film coatings. I3A reported that the industry has pursued alternative chemicals aggressively, indicating that the PFAS usage volumes are expected to continue to decline over time. EPA commends the members of I3A for the significant steps made in reducing the use of the PFAS chemicals listed in the VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72861 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations SNUR, and for the effort expended in supplying the Agency with a substantial base of information on which to make its decision. 3M requested clarification of the SNUR scope and nomenclature to emphasize that the hazard assessment supporting the proposed rule addressed only PFOS, the C8 chain length, not the entire range of PFAS chemicals covering all carbon chain lengths. 3M also stated that all of the chemicals voluntarily discontinued by 3M and subject to the SNUR would be properly characterized as being predominantly C8, or PFOS, and expressed concern that using the PFAS term in connection with the regulation of these specific chemicals could be confusing because many PFAS chemicals exist that are not subject to this rule. In this final rule, EPA has continued to use the PFAS name for the entire category, but has attempted to make clear that most of the chemicals subject to this rule do include the C8 chain length specifically of concern, although individual chemicals on the list include a range of higher and lower homologues in addition to C8. EPA acknowledges that the hazard assessment supporting the original proposed rule addressed only C8, or PFOS, chemicals, and not the full range of homologues. 3M requested that EPA clarify its future regulatory intentions with respect to these related chemicals. As indicated in the supplemental proposed SNUR, EPA is evaluating and assessing other PFAS and PFAS related chemicals not listed in this rule. It is true that other PFAS chemicals, including lower homologues, have distinct hazard profiles and may not present the same concerns expressed by EPA with respect to PFOS. However, EPA is reviewing data on those other homologues, and, if warranted, will take action as appropriate on other PFAS chemicals. Because of the unique properties of perfluorinated compounds, EPA is currently assessing a variety of these compounds to determine their hazard profiles, including not only PFAS chemicals but also perfluorooctanoic acid ( PFOA) and its salts, as well as fluorinated telomers. That these chemicals are currently under assessment does not necessarily indicate that regulation will follow; it indicates only that EPA is seeking answers to questions that have been raised about these chemicals and their behavior. 3M also requested that EPA acknowledge the substantial amount of data on PFOS submitted by 3M since the drafting of the original hazard assessment, and acknowledge the effort underway by the Organization for Economic Cooperation and Development ( OECD) to prepare an international hazard assessment on PFOS. EPA has been an active contributor to the OECD assessment effort, and toward that end, has been reviewing all of the data submitted by 3M and others with respect to PFOS. EPA commends 3M for the extensive research it has conducted and continues to pursue to improve the understanding of these unique chemicals. When the OECD assessment document is released, it will be included in both the docket for this rule, and in Administrative Record ( AR) file AR   226. AR   226 is the nonregulatory public access file for information on all the related fluorinated chemicals being assessed by the EPA, including PFOS, PFAS, PFOA and its salts, and fluorinated telomer chemicals. Copies of the index to and all documents contained within AR   226 can be obtained through the docket facility identified in Unit I. B. 1. Waste Not questioned whether PFAS chemicals previously on the list of pesticide inerts would continue to be listed, whether one named chemical on the inerts list was included in the SNUR, and whether its understanding of the status of sulfluramid products was correct. Waste Not also asked whether EPA would identify crops on which these products were used. EPA confirms that none of the PFAS chemicals on the inerts list identified by Waste Not, including the named chemical without a CAS number provided, are currently formulated into pesticide products, and they will all be removed from the EPA List 3 Inerts list the next time that list is updated. EPA notes that, although these PFAS chemicals will remain on the List 3 Inerts list until that list is updated, the manufacture or import of chemicals listed in this rule for use as inert ingredients in pesticide products would be a significant new use subject to this rule. Although TSCA does not regulate chemicals manufactured for use solely as pesticide active ingredients, chemical intermediates and pesticide inert ingredients are subject to regulation under TSCA. With respect to Waste Not's comment concerning the current status of registered insecticide products containing sulfluramid, EPA concurs with the list of active and cancelled products provided by Waste Not. There are currently 16 products listed as active and 3 products cancelled. Three of the four products listed as transferred, EPA Registration Nos. 11540   21, 1812   330, and 1812   329, are the same as the three products listed as cancelled. The fourth product listed as transferred, EPA Registration No. 11540   20, is the same as the active product under EPA Registration No. 499   45. All pesticide products containing sulfluramid are under a specific timeline to be phased out by 2016. The pesticide products that are registered are for use in a variety of enclosed termite, ant, and roach bait stations. These products are pre filled and sold only in child resistant packaging. Products containing sulfluramid have not been registered for food or crop uses. The American Chemistry Council ( ACC) filed late comments supporting the effort by EPA and industry to address concerns pertaining to PFAS compounds on a cooperative basis, but also expressed the opinion that an increase in manufacture or importation for an existing use should not be considered a `` new use'' within the meaning of TSCA section 5( a)( 2). ATOFINA Chemicals, Inc. filed late comments supporting the comments of ACC. As no volume cap or trigger on manufacturing or importation for an existing use has been incorporated into this rule, EPA will not address this issue in the context of this rule. In addition, EPA believes ACC's and ATOFINA's comments present a broader legal issue regarding EPA's authority under TSCA section 5, rather than specific issues related to PFAS. EPA does not believe it is necessary or appropriate to engage in a broader legal discussion in the context of this specific SNUR.

III. References These references have been placed in the official record that was established under docket ID number OPPT   2002   0043 for this rulemaking as indicated in Unit I. B. 1. Reference documents identified with an AR number are crossindexed to non regulatory, publicly accessible information files maintained in the OPPT Docket. Other documents which the Agency considers relevant to this final rule have previously been identified in the Federal Register in the proposed and supplemental proposed SNURs discussed in Unit II. A. Copies of these documents can be obtained as described in Unit I. B. 1. 1. ( AR226   0620) Sulfonated Perfluorochemicals in the Environment: Sources, Dispersion, Fate, and Effects. 3M. St. Paul, MN. March 1, 2000. 2. ( AR226   0547) The Science of Organic Fluorochemistry. 3M. St. Paul, MN. February 5, 1999. 3. ( AR226   0548) Perfluorooctane Sulfonate: Current Summary of Human Sera, Health and Toxicology Data. 3M. St. Paul, MN. January 21, 1999. 4. ( AR226   0550) Fluorochemical Use, Distribution, and Release Overview. 3M. St. Paul, MN. May 26, 1999.

VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72862 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations IV. Statutory and Executive Order Reviews Under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993), the Office of Management and Budget ( OMB) has determined that SNURs are not a `` significant regulatory action'' subject to review by OMB, because SNURs do not meet the criteria in section 3( f) of the Executive order. According to the Paperwork Reduction Act ( PRA), 44 USC 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after initial display in the Federal Register and in addition to its display on any related collection instrument, are listed in 40 CFR part 9. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070   0038 ( EPA ICR No. 1188.06). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 98.96 and 118.92 hours per response at an estimated reporting cost of between $ 5,957 and $ 7,192 per SNUN. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review and submit the required SNUN, and maintain the required records. This burden estimate does not include 1 hour of technical time at $ 64.30 per hour estimated to be required for customer notification of SNUR requirements, or the $ 2,500 user fee for submission of a SNUN ($ 100 for businesses with less than $ 40 million in annual sales). Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information, Environmental Protection Agency ( 2822), 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. Pursuant to section 605( b) of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. A SNUR applies to any person ( including small or large entities) who intends to engage in any activity described in the rule as a `` significant new use.'' By definition of the word `` new,'' and based on all information currently available to EPA, it appears that no small or large entities currently engage in such activity. Since a SNUR requires merely that any person who intends to engage in such activity in the future must first notify EPA ( by submitting a SNUN), no economic impact will even occur until someone decides to engage in those activities. As a voluntary action, it is reasonable to presume that this decision would be based on a determination by the person submitting the SNUN that the potential benefits would outweigh the costs. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. EPA's experience to date is that, in response to the promulgation of over 530 SNURs, the Agency has received fewer than 15 SNUNs. Of those SNUNs submitted, none appear to be from small entities. In fact, EPA expects to receive few, if any, SNUNs from either large or small entities in response to any SNUR. Therefore, EPA believes that the economic impact of complying with a SNUR is not expected to be significant or adversely impact a substantial number of small entities. This rationale has been provided to the Chief Counsel for Advocacy of the Small Business Administration. Based on EPA's experience with past SNURs, State, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). This rule does not have tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3( b) of Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments ( 63 FR 276755, May 19, 1998), do not apply to this rule. Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000), which took effect on January 6, 2001, revokes Executive Order 13084 as of that date. EPA developed this rulemaking, however, during the period when Executive Order 13084 was in effect; thus, EPA addressed tribal considerations under Executive Order 13084. For the same reasons stated for Executive Order 13084, the requirements of Executive Order 10175 do not apply to this rule either. This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. This rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use. In addition, since this action does not involve any technical standards, section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note), does not apply to this action. This action does not involve special considerations of environmental justice related issues as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994). EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights ( 53 FR 8859, March 15, 1988), by VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72863 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations examining the takings implications of this rule in accordance with the `` Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the Executive order. In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform ( 61 FR 4729, February 7, 1996).

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

List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous materials, Recordkeeping and reporting requirements.

Dated: November 27, 2002. Charles M. Auer, Director, Office of Pollution Prevention and Toxics.

Therefore, 40 CFR chapter I is amended as follows: PART 721   [ AMENDED]

1. The authority citation for part 721 continues to readas follows:

Authority: 15 U. S. C. 2604, 2607 and 2625( c).

2. By revising § 721.9582 to read as follows:

§ 721.9582 Certain perfluoroalkyl sulfonates.

( a) Chemical substances and significant new uses subject to reporting. ( 1) The chemical substances listed in Table 1 and Table 2 of this section are subject to reporting under this section for the significant new uses described in paragraph ( a)( 2) of this section.

TABLE 1.   PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2001 CAS No./ PMN CAS Ninth Collective Index Name 2250   98   8 1 Octanesulfonamide, N, N', N''[ phosphinylidynetris( oxy 2,1 ethanediyl)] tris[ N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro

30381   98   7 1 Octanesulfonamide, N, N'[ phosphinicobis( oxy 2,1 ethanediyl)] bis[ N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro, ammonium salt 57589   85   2 Benzoic acid, 2,3,4,5 tetrachloro 6[[[ 3[[( heptadecafluorooctyl) sulfonyl] oxy] phenyl] amino] carbonyl], monopotassium salt 61660   12   6 1 Octanesulfonamide, N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N[ 3( trimethoxysilyl) propyl]

67969   69   1 1 Octanesulfonamide, N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N[ 2( phosphonooxy) ethyl], diammonium salt 68608   14   0 Sulfonamides, C4 8 alkane, perfluoro, N ethyl N( hydroxyethyl), reaction products with 1,1' methylenebis[ 4 isocyanatobenzene]

70776   36   2 2 Propenoic acid, 2 methyl, octadecyl ester, polymer with 1,1 dichloroethene, 2 [[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl 2 propenoate, N( hydroxymethyl) 2 propenamide, 2 [ methyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( tridecafluorohexyl) sulfonyl] amino] ethyl 2 propenoate and 2 [ methyl[( undecafluoropentyl) sulfonyl] amino] ethyl 2 propenoate 127133   66   8 2 Propenoic acid, 2 methyl, polymers with Bu methacrylate, lauryl methacrylate and 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl methacrylate 148240   78   2 Fatty acids, C18 unsatd., trimers, 2[[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl esters 148684   79   1 Sulfonamides, C4 8 alkane, perfluoro, N( hydroxyethyl) N methyl, reaction products with 1,6 diisocyanatohexane homopolymer and ethylene glycol 178535   22   3 Sulfonamides, C4 8 alkane, perfluoro, N ethyl N( hydroxyethyl), polymers with 1,1' methylenebis[ 4 isocyanatobenzene] and polymethylenepolyphenylene isocyanate, 2 ethylhexyl esters, Me Et ketone oxime blocked P   94   2205 Polymethylenepolyphenylene isocyanate and bis( 4 NCO phenyl) methane reaction products with 2 ethyl 1 hexanol, 2 butanone, oxime, N ethyl N( 2 hydroxyethyl) 1 C4 C8 perfluoroalkanesulfonamide P   96   1645 306974   63   0 Fatty acids, C18 unsatd., dimers, 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl esters VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72864 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations TABLE 2.   PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2003 CAS No./ PMN CAS Ninth Collective Index Name 307   35   7 1 Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro

307   51   7 1 Decanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10 heneicosafluoro

376   14   7 2 Propenoic acid, 2 methyl, 2[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl ester 383   07   3 2 Propenoic acid, 2[ butyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl ester 423   50   7 1 Hexanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,6 tridecafluoro

423   82   5 2 Propenoic acid, 2[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl ester 754   91   6 1 Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro

1652   63   7 1 Propanaminium, 3[[( heptadecafluorooctyl) sulfonyl] amino] N, N, N trimethyl, iodide 1691   99   2 1 Octanesulfonamide, N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N( 2 hydroxyethyl)

1763   23   1 1 Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro

2795   39   3 1 Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro, potassium salt 2991   51   7 Glycine, N ethyl N[( heptadecafluorooctyl) sulfonyl], potassium salt 4151   50   2 1 Octanesulfonamide, N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro

14650   24   9 2 Propenoic acid, 2 methyl, 2[[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl ester 17202   41   4 1 Nonanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9 nonadecafluoro, ammonium salt 24448   09   7 1 Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N( 2 hydroxyethyl) N methyl

25268   77   3 2 Propenoic acid, 2[[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl ester 29081   56   9 1 Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro, ammonium salt 29117   08   6 Poly( oxy 1,2 ethanediyl), . alpha.[ 2[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl]. omega. hydroxy

29457   72   5 1 Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro, lithium salt 31506   32   8 1 Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N methyl

38006   74   5 1 Propanaminium, 3[[( heptadecafluorooctyl) sulfonyl] amino] N, N, N trimethyl, chloride 38850   58   7 1 Propanaminium, N( 2 hydroxyethyl) N, N dimethyl 3[( 3 sulfopropyl)[( tridecafluorohexyl) sulfonyl] amino], inner salt 55120   77   9 1 Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6 tridecafluoro, lithium salt 67584   42   3 Cyclohexanesulfonic acid, decafluoro( pentafluoroethyl), potassium salt 67906   42   7 1 Decanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10 heneicosafluoro, ammonium salt 68156   01   4 Cyclohexanesulfonic acid, nonafluorobis( trifluoromethyl), potassium salt 68298   62   4 2 Propenoic acid, 2[ butyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl ester, telomer with 2 [ butyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 propenoate, methyloxirane polymer with oxirane di 2 propenoate, methyloxirane polymer with oxirane mono 2 propenoate and 1 octanethiol 68329   56   6 2 Propenoic acid, eicosyl ester, polymer with 2[[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl 2 propenoate, hexadecyl 2 propenoate, 2[ methyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( tridecafluorohexyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( undecafluoropentyl) sulfonyl] amino] ethyl 2 propenoate and octadecyl 2 propenoate 68541   80   0 2 Propenoic acid, polymer with 2[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate and octadecyl 2 propenoate 68555   90   8 2 Propenoic acid, butyl ester, polymer with 2[[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl 2 propenoate, 2[ methyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( tridecafluorohexyl) sulfonyl] amino] ethyl 2 propenoate and 2 [ methyl[( undecafluoropentyl) sulfonyl] amino] ethyl 2 propenoate VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72865 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations TABLE 2.   PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2003   Continued CAS No./ PMN CAS Ninth Collective Index Name 68555   91   9 2 Propenoic acid, 2 methyl, 2[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl ester, polymer with 2 [ ethyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ ethyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ ethyl[( tridecafluorohexyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ ethyl[( undecafluoropentyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate and octadecyl 2 methyl 2 propenoate 68555   92   0 2 Propenoic acid, 2 methyl, 2[[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl ester, polymer with 2 [ methyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ methyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ methyl[( tridecafluorohexyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ methyl[( undecafluoropentyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate and octadecyl 2 methyl 2 propenoate 68586   14   1 2 Propenoic acid, 2[[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl ester, telomer with 2 [ methyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 propenoate, . alpha.( 2 methyl 1 oxo 2 propenyl). omega. hydroxypoly( oxy 1,2 ethanediyl), . alpha.( 2 methyl 1 oxo 2 propenyl). omega.[( 2 methyl 1 oxo 2 propenyl oxy] poly( oxy 1,2 ethanediyl), 2[ methyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 propenoate, 2[ methyl[ ( tridecafluorohexyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( undecafluoropentyl) sulfonyl] amino] ethyl 2 propenoate and 1 octanethiol 68649   26   3 1 Octanesulfonamide, N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N( 2 hydroxyethyl), reaction products with N ethyl 1,1,2,2,3,3,4,4,4 nonafluoro N( 2 hydroxyethyl) 1 butanesulfonamide, N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7 pentadecafluoro N( 2 hydroxyethyl) 1 heptanesulfonamide, N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,6 tridecafluoro N( 2 hydroxyethyl) 1 hexanesulfonamide, N ethyl 1,1,2,2,3,3,4,4,5,5,5 undecafluoro N( 2 hydroxyethyl) 1 pentanesulfonamide, polymethylenepolyphenylene isocyanate and stearyl alc.

68867   60   7 2 Propenoic acid, 2[[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl ester, polymer with 2 [ methyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( tridecafluorohexyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( undecafluoropentyl) sulfonyl] amino] ethyl 2 propenoate and . alpha.( 1 oxo 2 propenyl). omega. methoxypoly( oxy 1,2 ethanediyl)

68867   62   9 2 Propenoic acid, 2 methyl, 2[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl ester, telomer with 2 [ ethyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ ethyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ ethyl[( tridecafluorohexyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ ethyl[( undecafluoropentyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 1 octanethiol and . alpha.( 1 oxo 2 propenyl). omega. methoxypoly( oxy 1,2 ethanediyl)

68891   96   3 Chromium, diaquatetrachloro[. mu.[ N ethyl N[( heptadecafluorooctyl) sulfonyl] glycinato. kappa. O:. kappa. O']] . mu. hydroxybis( 2 methylpropanol) di

68909   15   9 2 Propenoic acid, eicosyl ester, polymers with branched octyl acrylate, 2 [[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl acrylate, 2[ methyl [( nonafluorobutyl) sulfonyl] amino] ethyl acrylate, 2[ methyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl acrylate 2[ methyl[( tridecafluorohexyl) sulfonyl] amino] ethyl acrylate, 2 [ methyl[( undecafluoropentyl) sulfonyl] amino] ethyl acrylate, polyethylene glycol acrylate Me ether and stearyl acrylate 68958   61   2 Poly( oxy 1,2 ethanediyl), . alpha.[ 2[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl]. omega. methoxy

70225   14   8 1 Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro, compd. with 2,2' iminobis[ ethanol] ( 1: 1)

71487   20   2 2 Propenoic acid, 2 methyl, methyl ester, polymer with ethenylbenzene, 2 [[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl 2 propenoate, 2 [ methyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( tridecafluorohexyl) sulfonyl] amino] ethyl 2 propenoate, 2 [ methyl[( undecafluoropentyl) sulfonyl] amino] ethyl 2 propenoate and 2 propenoic acid 73772   32   4 1 Propanesulfonic acid, 3[[ 3( dimethylamino) propyl][( tridecafluorohexyl) sulfonyl] amino] 2 hydroxy, monosodium salt 81190   38   7 1 Propanaminium, N( 2 hydroxyethyl) 3[( 2 hydroxy 3 sulfopropyl)[( tridecafluorohexyl) sulfonyl] amino] N, Ndimethyl hydroxide, monosodium salt VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72866 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations TABLE 2.   PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2003   Continued CAS No./ PMN CAS Ninth Collective Index Name 91081   99   1 Sulfonamides, C4 8 alkane, perfluoro, N( hydroxyethyl) N methyl, reaction products with epichlorohydrin, adipates ( esters)

94133   90   1 1 Propanesulfonic acid, 3[[ 3( dimethylamino) propyl][( heptadecafluorooctyl) sulfonyl] amino] 2 hydroxy, monosodium salt 98999   57   6 Sulfonamides, C7 8 alkane, perfluoro, N methyl N[ 2[( 1 oxo 2 propenyl) oxy] ethyl], polymers with 2 ethoxyethyl acrylate, glycidyl methacrylate and N, N, N trimethyl 2[( 2 methyl 1 oxo 2 propenyl oxy] ethanaminium chloride 117806   54   9 1 Heptanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7 pentadecafluoro, lithium salt 129813   71   4 Sulfonamides, C4 8 alkane, perfluoro, N methyl N( oxiranylmethyl)

148240   80   6 Fatty acids, C18 unsatd., trimers, 2[ methyl[( tridecafluorohexyl) sulfonyl] amino] ethyl esters 148240   82   8 Fatty acids, C18 unsatd., trimers, 2[ methyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl esters 182700   90   9 1 Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N methyl, reaction products with benzene chlorine sulfur chloride ( S2Cl2) reaction products chlorides L   92   0151 2 Propenoic acid, 2 methyl, butyl ester, polymer with 2[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2[ ethyl[( nonafluorobutyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ ethyl[( pentadecafluoroheptyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate, 2 [ ethyl[( tridecafluorohexyl) sulfonyl] amino] ethyl 2 methyl 2 propenoate and 2 propenoic acid P   80   0183 192662   29   6 Sulfonamides, C4 8 alkane, perfluoro, N[ 3( dimethylamino) propyl], reaction products with acrylic acid P   83   1102 306973   46   6 Fatty acids, linseed oil, dimers, 2[[( heptadecafluorooctyl) sulfonyl] methylamino] ethyl esters P   84   1163 306975   56   4 Propanoic acid, 3 hydroxy 2( hydroxymethyl) 2 methyl, polymer with 2 ethyl 2( hydroxymethyl) 1,3 propanediol and N, N', 2 tris( 6 isocyanatohexyl) imidodicarbonic diamide, reaction products with N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N( 2 hydroxyethyl) 1 octanesulfonamide and N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7 pentadecafluoro N( 2 hydroxyethyl) 1 heptanesulfonamide, compds. with triethylamine P   84   1171 306975   57   5 Propanoic acid, 3 hydroxy 2( hydroxymethyl) 2 methyl, polymer with 1,1' methylenebis[ 4 isocyanatobenzene] and 1,2,3 propanetriol, reaction products with N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro N( 2 hydroxyethyl) 1 octanesulfonamide and N ethyl 1,1,2,2,3,3,4,4,5,5,6,6,7,7,7 pentadecafluoro N( 2 hydroxyethyl) 1 heptanesulfonamide, compds. with morpholine P   86   0301 306973   47   7 Sulfonamides, C4 8 alkane, perfluoro, N( hydroxyethyl) N methyl, reaction products with 12 hydroxystearic acid and 2,4 TDI, ammonium salts P   86   0958 306975   62   2 2 Propenoic acid, 2 methyl, dodecyl ester, polymers with 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl acrylate and vinylidene chloride P   89   0799 160901   25   7 Sulfonamides, C4 8 alkane, perfluoro, N ethyl N( hydroxyethyl), reaction products with 2 ethyl 1 hexanol and polymethylenepolyphenylene isocyanate P   90   0111 306974   19   6 Sulfonamides, C4 8 alkane, perfluoro, N methyl N[( 3 octadecyl 2 oxo 5 oxazolidinyl) methyl]

P   91   1419 306975   84   8 Poly( oxy 1,2 ethanediyl), . alpha. hydro. omega. hydroxy, polymer with 1,6 diisocyanatohexane, N ( hydroxyethyl) N methyl perfluoro C4 8 alkane sulfonamides blocked P   93   1444 306975   85   9 2 Propenoic acid, 2 methyl, dodecyl ester, polymers with N( hydroxymethyl) 2 propenamide, 2 [ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl methacrylate, stearyl methacrylate and vinylidene chloride P   94   0545 306976   25   0 1 Hexadecanaminium, N, N dimethyl N[ 2[( 2 methyl 1 oxo 2 propenyl) oxy] ethyl], bromide, polymers with Bu acrylate, Bu methacrylate and 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl acrylate P   94   0927 306976   55   6 2 Propenoic acid, 2 methyl, 2 methylpropyl ester, polymer with 2,4 diisocyanato 1 methylbenzene, 2 ethyl 2( hydroxymethyl) 1,3 propanediol and 2 propenoic acid, N ethyl N( hydroxyethyl) perfluoro C4 8 alkanesulfonamides blocked P   94   2206 306974   28   7 Siloxanes and Silicones, di Me, mono[ 3[( 2 methyl 1 oxo 2 propenyl) oxy] propylgroup] terminated, polymers with 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl acrylate and stearyl methacrylate VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72867 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations TABLE 2.   PFAS CHEMICALS SUBJECT TO REPORTING ON OR AFTER JANUARY 1, 2003   Continued CAS No./ PMN CAS Ninth Collective Index Name P   95   0120 306980   27   8 Sulfonamides, C4 8 alkane, perfluoro, N, N'[ 1,6 hexanediylbis[( 2 oxo 3,5 oxazolidinediyl) methylene]] bis[ Nmethyl

P   96   1262 306974   45   8 Sulfonic acids, C6 8 alkane, perfluoro, compds. with polyethylene polypropylene glycol bis( 2 aminopropyl) ether P   96   1424 306977   10   6 2 Propenoic acid, 2 methyl, 2( dimethylamino) ethyl ester, telomer with 2[ ethyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl methacrylate and 1 octanethiol, N oxides P   96   1433 178094   69   4 1 Octanesulfonamide, N[ 3( dimethyloxidoamino) propyl] 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro , potassium salt P   97   0790 251099   16   8 1 Decanaminium, N decyl N, N dimethyl, salt with 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8 heptadecafluoro 1 octanesulfonic acid ( 1: 1)

P   98   0251 306978   04   1 2 Propenoic acid, butyl ester, polymers with acrylamide, 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl acrylate and vinylidene chloride P   98   1272 306977   58   2 2 Propenoic acid, 2 methyl, 3( trimethoxysilyl) propyl ester, polymers with acrylic acid, 2[ methyl[( perfluoro C4 8 alkyl) sulfonyl] amino] ethyl acrylate and propylene glycol monoacrylate, hydrolyzed, compds. with 2,2'( methylimino) bis[ ethanol]

P   99   0188 306978   65   4 Hexane, 1,6 diisocyanato, homopolymer, N( hydroxyethyl) N methyl perfluoro C4 8 alkane sulfonamides and stearyl alc. blocked P   99   0319 306979   40   8 Poly( oxy 1,2 ethanediyl), . alpha.[ 2( methylamino) ethyl]. omega.[( 1,1,3,3 tetramethylbutyl) phenoxy], N [( perfluoro C4 8 alkyl) sulfonyl] derivs.

( 2) The significant new uses are: ( i) Any manufacture or import for any use of any chemical listed in Table 1 of paragraph ( a)( 1) of this section on or after January 1, 2001. ( ii) Any manufacture or import for any use of any chemical listed in Table 2 of paragraph ( a)( 1) of this section on or after January 1, 2003, except as noted in paragraph ( a)( 3) of this section. ( 3) Manufacture or import of any chemical listed in Table 2 of paragraph ( a)( 1) of this section for the following specific uses shall not be considered as a significant new use subject to reporting under this section: ( i) Use as an anti erosion additive in fire resistant phosphate ester aviation hydraulic fluids. ( ii) Use as a component of a photoresist substance, including a photo acid generator or surfactant, or as a component of an anti reflective coating, used in a photomicrolithography process to produce semiconductors or similar components of electronic or other miniaturized devices. ( iii) Use in coatings for surface tension, static discharge, and adhesion control for analog and digital imaging films, papers, and printing plates, or as a surfactant in mixtures used to process imaging films. ( iv) Use as an intermediate only to produce other chemical substances to be used solely for the uses listed in paragraph ( a)( 3)( i), ( ii), or ( iii) of this section. ( b) [ Reserved]

[ FR Doc. 02   31011 Filed 12   6   02; 8: 45 am]

BILLING CODE 6560   50   S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [ I. D. 112602A]

Fisheries of the Northeastern United States; Atlantic Surf Clam and Ocean Quahog Fishery; Suspension of Minimum Surf Clam Size for 2003 AGENCY: National Marine Fisheries Service ( NMFS), National Oceanic and Atmospheric Administration, Commerce. ACTION: Notice of suspension of surf clam minimum size limit.

SUMMARY: NMFS suspends the minimum size limit of 4.75 inches ( 12.07 cm) for Atlantic surf clams for the 2003 fishing year. This action is taken under the authority of the implementing regulations for this fishery, which allow for the annual suspension of the minimum size limit based upon set criteria. The intended effect is to relieve the industry from a regulatory burden that is not necessary, as the majority of surf clams harvested are larger than the minimum size limit. DATES: Effective January 1, 2003, through December 31, 2003. FOR FURTHER INFORMATION CONTACT: Douglas W. Christel, Fishery Management Specialist, 978   281   9141. SUPPLEMENTARY INFORMATION: Section 648.72( c) of the regulations implementing the Fishery Management Plan ( FMP) for the Atlantic Surf Clam and Ocean Quahog Fisheries allows the Administrator, Northeast Region, NMFS ( Regional Administrator) to suspend annually, by publication of a notification in the Federal Register, the minimum size limit for Atlantic surf clams. This action may be taken unless discard, catch, and survey data indicate that 30 percent of the Atlantic surf clam resource is smaller than 4.75 inches ( 12.07 cm) and the overall reduced size is not attributable to harvest from beds where growth of the individual clams has been reduced because of densitydependent factors. At its June 2002, meeting, the Mid Atlantic Fishery Management Council ( Council) voted to recommend that the Regional Administrator suspend the minimum size limit. Commercial surf clam shell length data for 2002 were analyzed to determine the percentage of surfclams landed that were smaller than the minimum size requirement. The analysis indicated that 14 percent of the samples taken overall were composed of surf clams that were less than 4.75 inches ( 12.07 cm). Based on these data, the Regional Administrator adopts the VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1


[Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)]
[Notices]
[Page 23914]
[FR Doc No: 2018-11042]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-151-000]

Notice of Petition for Partial Waiver: Minnkota Power
Cooperative, Inc.; Northern Municipal Power Agency

    Take notice that on May 16, 2018, pursuant to section 292.402 of
the Federal Energy Regulatory Commission's (Commission) Regulations, 18
CFR 292.402, Minnkota Power Cooperative, Inc. (Minnkota) and Northern
Municipal Power Agency (Agency) on behalf of themselves, Minnkota's 11
rural electric cooperative member-owners (collectively, the Members)
and 10 of Agency's 12 municipal members (collectively, the Municipals),
filed a petition for partial waiver of certain obligations imposed on
Minnkota, Agency, the Members, and the Municipals under sections
292.303(a) and 292.303(b) of the Commission's Regulations \1\
implementing section 210 of the Public Regulatory Policies Act of 1978,
as amended, all as more fully explained in its petition.
---------------------------------------------------------------------------

    \1\ 18 CFR 292.303(a) and 292.303(b).
---------------------------------------------------------------------------

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426. This filing is accessible on-line at http://www.ferc.gov, using
the ``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the website that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on June 6, 2018.

    Dated: May 17, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-11042 Filed 5-22-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Page 28595]
[FR Doc No: 2021-11240]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD21-13-000]

Climate Change, Extreme Weather, and Electric System Reliability;
Supplemental Notice of Technical Conference

    As announced in the Notice of Technical Conference issued in this
proceeding on March 5, 2021, Federal Energy Regulatory Commission
(Commission) staff will convene a technical conference to discuss
issues surrounding the threat to electric system reliability posed by
climate change and extreme weather events. The conference will be held
on Tuesday, June 1, 2021 and Wednesday June 2, 2021, from approximately
1:00 p.m. to 6:00 p.m. Eastern Time each day. The conference will be
held virtually via WebEx. Commissioners may attend and participate.
    We note that discussions at the conference may involve issues
raised in proceedings that are currently pending before the Commission.
These proceedings include, but are not limited to:

California Independent System Operator Corp., Docket No. ER21-1536-000
California Independent System Operator Corp., Docket No. ER21-1551-000
California Independent System Operator Corp., Docket No. ER21-1790-000
CAlifornians for Renewable Energy v. California Independent System
Operator Corp., Docket No. EL20-69-001
Central Hudson Gas & Elec. Corp., et al. v. New York Independent System
Operator, Inc., Docket No. EL21-66-000
Complaint of Michael Mabee, Docket No. EL21-54-000
Duke Energy Carolinas, LLC, et al. , Docket No. ER21-1579-000
George Berka v. Andrew Cuomo, et al., Docket No. EL21-61-000
New York Independent System Operator, Inc., Docket Nos. ER21-502-002,
ER21-502-003
New York Independent System Operator, Inc., Docket Nos. ER21-1018-000,
ER21-1018-001
New York Transmission Owners, Docket No. ER21-1647-000
NV Energy v. California Independent System Operator Corp., Docket No.
EL21-74-000
PJM Interconnection, L.L.C., Docket No. ER21-278-001
PJM Interconnection, L.L.C., Docket Nos. EL19-100-000, ER20-584-000
PJM Interconnection, L.L.C., Docket No. ER21-1635-000

    Attached to this Supplemental Notice is an agenda for the technical
conference, which includes the final conference program and expected
speakers. The conference will be open for the public to attend
virtually. Information on the technical conference will also be posted
on the Calendar of Events on the Commission's website, http://www.ferc.gov, prior to the event. The conference will be transcribed.
Transcripts of the conference will be available for a fee from Ace-
Federal Reporters, Inc.<PHONE_NUMBER>).
    For more information about this technical conference, please
contact Rahim Amerkhail,<PHONE_NUMBER><EMAIL_ADDRESS>for
technical questions or Sarah McKinley,<PHONE_NUMBER>,
<EMAIL_ADDRESS>for logistical issues.

    Dated: May 21, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
 [FR Doc. 2021-11240 Filed 5-26-21; 8:45 am]
 BILLING CODE 6717-01-P