[Federal Register: January 18, 2011 (Volume 76, Number 11)]
[Rules and Regulations]
[Page 2807]
[DOCID:fr18ja11-8]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2010-N-0002]

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for hemoglobin
glutamer-200 from Biopure Corp. to OPK Biotech, LLC.

DATES: This rule is effective January 18, 2011.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Biopure Corp., 11 Hurley St., Cambridge, MA
02141 has informed FDA that it has transferred ownership of, and all
rights and interest in, NADA 141-067 for OXYGLOBIN (hemoglobin
glutamer-200) to OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA
02141. There is no change in drug labeler code.
    Following this change of sponsorship, Biopure Corp. is no longer
the sponsor of an approved application. In addition, OPK Biotech, LLC,
is not currently listed in the animal drug regulations as a sponsor of
an approved application. Accordingly, Sec.  510.600 is being amended to
reflect these changes.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is
amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry
for ``Biopure Corp.''; and alphabetically add a new entry for ``OPK
Biotech, LLC''; and in the table in paragraph (c)(2), revise the entry
for ``063075'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                                  Drug
                    Firm name and address                       labeler
                                                                  code
------------------------------------------------------------------------

                                * * * * *
OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141..     063075

                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
   Drug
 labeler                       Firm name and address
   code
------------------------------------------------------------------------

                                * * * * *
   063075  OPK Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141

                                * * * * *
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    Dated: January 11, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2011-904 Filed 1-14-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 84 (Tuesday, May 4, 2021)]
[Notices]
[Pages 23773-23774]
[FR Doc No: 2021-09349]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-66, OMB Control No. 3235-0066]

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Form S-8.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form S-8 (17 CFR 239.16b) under the Securities Act of 1933 (15
U.S.C. 77a et seq.) is the primary registration statement used by
eligible registrants to register securities to be issued in connection
with an employee benefit plan. We estimate that Form S-8 takes
approximately 27 hours per response to prepare and is filed by
approximately 2,140 respondents. In addition, we estimate that 50% of
the preparation time (13.5 hours) is completed in-house by the filer
for a total annual reporting burden of 28,890 (13.5 hours per response
x 2,140 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given

to comments and suggestions submitted in writing within 60 days of this
publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Cynthia
Roscoe, 100 F Street NE, Washington, DC 20549 or send an email to:
<EMAIL_ADDRESS>
    Dated: April 29, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09349 Filed 5-3-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 28, 2010 (Volume 75, Number 18)]
[Rules and Regulations]
[Page 4488-4490]
[DOCID:fr28ja10-9]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30705 ; Amdt. No 3356]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final Rule.

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SUMMARY: This establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective January 28, 2010. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of January 28, 2010.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability--All SIAPs and Takeoff Minimums and ODPs are available
online free of charge. Visit http://www.nfdc.faa.gov to register.
Additionally, individual SIAP and Takeoff Minimums and ODP copies may
be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420), Flight Technologies and Programs Divisions,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169. (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS.
The complete regulators description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA

Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, in addition
to their complex nature and the need for a special format make
publication in the Federal Register expensive and impractical.
Furthermore, airmen do not use the regulatory text of the SIAPs,
Takeoff Minimums or ODPs, but instead refer to their depiction on
charts printed by publishers of aeronautical materials. The advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP, Takeoff Minimums and ODP listed on
FAA forms is unnecessary. This amendment provides the affected CFR
sections and specifies the types of SIAPs and the effective dates of
the associated Takeoff Minimums and ODPs. This amendment also
identifies the airport and its location, the procedure, and the
amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as contained in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts. The
circumstances which created the need for some SIAP and Takeoff Minimums
and ODP amendments may require making them effective in less than 30
days. For the remaining SIAPS and Takeoff Minimums and ODPS, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPS contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPS and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedures before adopting these SIAPS, Takeoff Minimums and
ODPs are impracticable and contrary to the public interest and, where
applicable, that good cause exists for making some SIAPs effective in
less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule '' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (air).

    Issued in Washington, DC, on January 8, 2010.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or revoking Standard Instrument
Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure
Procedures effective at 0902 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

* * * Effective 11 FEB 2010

Enterprise, AL, Enterprise Muni, VOR RWY 5, Amdt 4
Chino, CA, Chino, ILS OR LOC RWY 26R, Amdt 8
Stockton, CA, Stockton Metropolitan, ILS OR LOC RWY 29R, Amdt 19
Avon Park, FL, Avon Park Executive, GPS RWY 4, Orig-A, CANCELLED
Avon Park, FL, Avon Park Executive, GPS RWY 9, Orig-A, CANCELLED
Avon Park, FL, Avon Park Executive, RNAV (GPS) RWY 5, Orig
Avon Park, FL, Avon Park Executive, RNAV (GPS) RWY 10, Orig
Titusville, FL, Space Coast Rgnl, RNAV (GPS) RWY 36, Orig-A
West Palm Beach, FL, Palm Beach Intl, RNAV (RNP) Z RWY 10L, Orig
West Palm Beach, FL, Palm Beach Intl, RNAV (RNP) Z RWY 14, Orig
West Palm Beach, FL, Palm Beach Intl, RNAV (RNP) Z RWY 28R, Orig
West Palm Beach, FL, Palm Beach Intl, RNAV (RNP) Z RWY 32, Orig
Kailua-Kona, HI, Kona Intl at Keahole, ILS OR LOC/DME RWY 17, Amdt 1
Kailua-Kona, HI, Kona Intl at Keahole, LOC RWY 17, Amdt 6B,
CANCELLED
Clarion, IA, Clarion Muni, NDB RWY 14, Amdt 4
Clarion, IA, Clarion Muni, RNAV (GPS) RWY 14, Orig
Clarion, IA, Clarion Muni, RNAV (GPS) RWY 32, Orig
Clarion, IA, Clarion Muni, Takeoff Minimums and Obstacle DP, Amdt 1
Emmetsburg, IA, Emmetsburg Muni, NDB RWY 13, Amdt 3
Emmetsburg, IA, Emmetsburg Muni, NDB RWY 31, Amdt 3
Emmetsburg, IA, Emmetsburg Muni, RNAV (GPS) RWY 13, Orig
Emmetsburg, IA, Emmetsburg Muni, RNAV (GPS) RWY 31, Orig
Emmetsburg, IA, Emmetsburg Muni, Takeoff Minimums and Obstacle DP,
Amdt 1
Forest City, IA, Forest City Muni, GPS RWY 33, Orig, CANCELLED
Forest City, IA, Forest City Muni, RNAV (GPS) RWY 33, Orig
Le Mars, IA, Le Mars Muni, GPS RWY 18, Orig-A, CANCELLED
Le Mars, IA, Le Mars Muni, RNAV (GPS) RWY 18, Orig
Le Mars, IA, Le Mars Muni, RNAV (GPS) RWY 36, Orig
Mapleton, IA, James G Whiting Memorial Field, Takeoff Minimums and
Obstacle DP, Amdt 1
Carbondale/Murphysboro, IL, Southern Illinois, ILS OR LOC RWY 18L,
Amdt 13
Carbondale/Murphysboro, IL, Southern Illinois, NDB RWY 18L, Amdt 13
Carbondale/Murphysboro, IL, Southern Illinois, RNAV (GPS) RWY 36R,
Orig
Carbondale/Murphysboro, IL, Southern Illinois, Takeoff Minimums and
Obstacle DP, Orig
Greenville, IL, Greenville, GPS RWY 18, Orig, CANCELLED
Greenville, IL, Greenville, RNAV (GPS) RWY 18, Orig
Bardstown, KY, Samuels Field, GPS RWY 20, Amdt 1A, CANCELLED
Bardstown, KY, Samuels Field, RNAV (GPS) RWY 2, Orig
Bardstown, KY, Samuels Field, RNAV (GPS) RWY 20, Orig
Taunton, MA, Taunton Muni-King Field, NDB RWY 30, Amdt 5
Taunton, MA, Taunton Muni-King Field, RNAV (GPS) RWY 30, Orig
Allegan, MI, Padgham Field, RNAV (GPS) RWY 11, Orig
Allegan, MI, Padgham Field, RNAV (GPS) RWY 29, Orig
Allegan, MI, Padgham Field, Takeoff Minimums and Obstacle DP, Amdt 2
Minneapolis, MN, Minneapolis-St Paul Intl/Wold Chamberlain, RNAV
(GPS) RWY 30L, Amdt 2
Wolf Point, MT, L.M.Clayton, Takeoff Minimums and Obstacle DP, Orig

Minot, ND, Minot Intl, RNAV (GPS) RWY 8, Orig
Minot, ND, Minot Intl, RNAV (GPS) RWY 26, Orig
Minot, ND, Minot Intl, VOR RWY 8, Amdt 11
Minot, ND, Minot Intl, VOR RWY 26, Amdt 13
Whitefield, NH, Mount Washington Rgnl, RNAV (GPS) Y RWY 10, Orig
Whitefield, NH, Mount Washington Rgnl, RNAV (GPS) Z RWY 10, Orig
Newark, NJ, Newark Liberty Intl, GLS RWY 11, Orig
Newark, NJ, Newark Liberty Intl, GLS RWY 22L, Orig
Newark, NJ, Newark Liberty Intl, GLS RWY 22R, Orig
Monticello, NY, Sullivan County Intl, RNAV (GPS) RWY 15, Orig
Monticello, NY, Sullivan County Intl, RNAV (GPS) RWY 33, Amdt 1
Ashland, OH, Ashland County, NDB RWY 19, Amdt 11
Ashland, OH, Ashland County, RNAV (GPS) RWY 19, Orig
Ashland, OH, Ashland County, VOR-A, Amdt 9
Athens/Albany, OH, Ohio University Snyder Field, RNAV (GPS) RWY 7,
Amdt 1
Athens/Albany, OH, Ohio University Snyder Field, RNAV (GPS) RWY 25,
Amdt 1
Athens/Albany, OH, Ohio University Snyder Field, Takeoff Minimums
and Obstacle DP, Orig
Celina, OH, Lakefield, NDB RWY 8, Amdt 5
Celina, OH, Lakefield, RNAV (GPS) RWY 8, Orig
Celina, OH, Lakefield, RNAV (GPS) RWY 26, Orig
Celina, OH, Lakefield, Takeoff Minimums and Obstacle DP, Amdt 2
Celina, OH, Lakefield, VOR/DME RNAV OR GPS RWY 26, Amdt 6, CANCELLED
Lima, OH, Lima Allen County, ILS OR LOC RWY 28, Amdt 4
Lima, OH, Lima Allen County, NDB OR GPS RWY 9, Amdt 2A, CANCELLED
Lima, OH, Lima Allen County, RNAV (GPS) RWY 10, Orig
Lima, OH, Lima Allen County, RNAV (GPS) RWY 28, Amdt 1
Lima, OH, Lima Allen County, Takeoff Minimums and Obstacle DP, Amdt
1
Lima, OH, Lima Allen County, VOR RWY 28, Amdt 16
Ardmore, OK, Ardmore Downtown Executive, Takeoff Minimums and
Obstacle DP, Amdt 2
Lawton, OK, Lawton-Ft Sill Rgnl, Takeoff Minimums and Obstacle DP,
Orig
Collegeville, PA, Perkomen Valley, VOR RWY 9, Amdt 5, CANCELLED
Collegeville, PA, Perkomen Valley, VOR-A, Orig
Saluda, SC, Saluda County, RNAV (GPS) RWY 1, Orig
Saluda, SC, Saluda County, RNAV (GPS) RWY 19, Orig
Greeneville, TN, Greeneville-Greene County Muni, Takeoff Minimums
and Obstacle DP, Amdt 3
Abilene, TX, Abilene Rgnl, ILS OR LOC RWY 35R, Amdt 7
Abilene, TX, Abilene Rgnl, LOC RWY 17R, Orig
Abilene, TX, Abilene Rgnl, LOC BC RWY 17L, Amdt 3D, CANCELLED
Brenham, TX, Brenham Muni, Takeoff Minimums and Obstacle DP, Amdt 1
Dumas, TX, Moore County, GPS RWY 19, Orig-A, CANCELLED
Dumas, TX, Moore County, RNAV (GPS) RWY 1, Orig
Dumas, TX, Moore County, RNAV (GPS) RWY 19, Orig
Dumas, TX, Moore County, Takeoff and Minimums and Obstacle DP, Orig
Henderson, TX, Rusk County, RNAV (GPS) RWY 17, Amdt 1
Hereford, TX, Hereford Muni, GPS RWY 20, Orig-A, CANCELLED
Hereford, TX, Hereford Muni, RNAV (GPS) RWY 2, Orig
Hereford, TX, Hereford Muni, RNAV (GPS) RWY 20, Orig
Hereford, TX, Hereford Muni, Takeoff and Minimums and Obstacle DP,
Orig
Bridgewater, VA, Bridgewater Air Park, NDB OR GPS-A, Amdt 4B,
CANCELLED
Bridgewater, VA, Bridgewater Air Park, RNAV (GPS) RWY 15, Orig
Bridgewater, VA, Bridgewater Air Park, RNAV (GPS) RWY 33, Orig
Olympia, WA, Olympia Rgnl, ILS OR LOC RWY 17, Amdt 11
Racine, WI, John H. Batten, NDB OR GPS RWY 4, Amdt 3B, CANCELLED
Racine, WI, John H. Batten, RNAV (GPS) RWY 4, Orig
Racine, WI, John H. Batten, RNAV (GPS) RWY 22, Orig
Racine, WI, John H. Batten, RNAV (GPS) RWY 32, Orig
Racine, WI, John H. Batten, Takeoff Minimums and Obstacle DP, Amdt 5
Racine, WI, John H. Batten, VOR RWY 4, Amdt 1
Racine, WI, John H. Batten, VOR/DME RNAV OR GPS RWY 22, Amdt 3A,
CANCELLED
Stevens Point, WI, Stevens Point Muni, RNAV (GPS) RWY 12, Orig
Stevens Point, WI, Stevens Point Muni, RNAV (GPS) RWY 30, Orig
Stevens Point, WI, Stevens Point Muni, VOR/DME RWY 30, Amdt 18
West Bend, WI, West Bend Muni, Takeoff Minimums and Obstacle DP,
Orig
Martinsburg, WV, Eastern WV Rgnl/Shepherd, ILS OR LOC RWY 26, Amdt 8
Moundsville, WV, Marshall County, RNAV (GPS) RWY 6, Orig-A
Spencer, WV, Boggs Field, RNAV (GPS) RWY 10, Orig-A
Spencer, WV, Boggs Field, RNAV (GPS) RWY 28, Orig-A
Cody, WY, Yellowstone Rgnl, Takeoff Minimums and Obstacle DP, Amdt 4
    On December 28, 2009 (74 FR 68523) The FAA published an
Amendment in Docket No. 30701; Amdt No. 3352 to Part 97 of the
Federal Aviation Regulations under section 97.20. The following
entries are hereby rescinded in their entirety:

Little River, CA, Little River, LITTLE RIVER ONE Graphic Obstacle DP
Little River, CA, Little River, Takeoff Minimums and Obstacle DP,
Orig

    On January 7, 2010 (75 FR 917) The FAA published an Amendment in
Docket No. 30703; Amdt No. 3354 to Part 97 of the Federal Aviation
Regulations under section 97.33. The following entries are hereby
rescinded in their entirety:

Elim, AK, Elim, RNAV (GPS) RWY 1, Orig
Elim, AK, Elim, RNAV (GPS) RWY 19, Orig

[FR Doc. 2010-1289 Filed 1-27-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Pages 50862-50863]
[FR Doc No: 2023-16404]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2021-0562; FRL-11245-01-ORD]

Availability of the Draft IRIS Toxicological Review of
Perfluorohexane Sulfonate (PFHxS) (PFHxS) and Related Salts; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period; correction.

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SUMMARY: The Environmental Protection Agency (EPA) published a document
in the Federal Register of July 24, 2023, concerning request for
comments on the release of the draft IRIS Toxicological Review of
Perfluorohexane Sulfonate (PFHxS) and Related Salts. The document
contained the incorrect chemical name six times, including the document
heading.

DATES: The public comment period began on July 24, 2023. Comments must
be received on or before September 22, 2023.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the ORD Docket at the EPA Headquarters Docket Center;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
[email protected].
    For technical information on the draft IRIS Toxicological Review of
Perfluorohexanesulfonic acid (PFHxS) and Related Salts, contact the
IRIS Hotline; email: [email protected]. The IRIS Program will
provide updates through the IRIS website (https://www.epa.gov/iris) and
via EPA's IRIS listserv. To register for the IRIS listserv, visit the
IRIS website (https://www.epa.gov/iris) or visit https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect.
    For questions about the peer review, please contact: Laurie Waite,
ERG, by email at [email protected] (subject line: EPA PFAS assessments
peer review); or by phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register issue of July 24, 2023, in FR Doc. 2023-
15613, on page 47496, make the following corrections:
    1. In the first column correct the document heading to read:

Availability of the Draft IRIS Toxicological Review of
Perfluorohexanesulfonic Acid (PFHxS) and Related Salts

    2. In the first and second columns remove the text
``Perfluorohexane Sulfonate'' five times and add in its place the text
``Perfluorohexanesulfonic Acid''.

Wayne Cascio,
Director, Center for Public Health and Environmental Assessment.
[FR Doc. 2023-16404 Filed 8-1-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 5, 2008 (Volume 73, Number 173)]
[Rules and Regulations]
[Page 51722-51727]
[DOCID:fr05se08-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0491; FRL-8379-6]

Linuron; Pesticide Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of linuron and its metabolites in or on lentils. This
action is in response to EPA's granting of an emergency exemption under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) authorizing use of the pesticide on lentils. This regulation
establishes a maximum permissible level for residues of linuron in the
food commodity, lentils. The time-limited tolerance expires and is
revoked on December 31, 2011.

DATES: This regulation is effective September 5, 2008. Objections and
requests for hearings must be received on or before November 4, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0491. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA),
any person may file an objection to any aspect of this regulation and
may also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must

identify docket ID number EPA-HQ-OPP-2008-0491 in the subject line on
the first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
4, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0491, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a
time-limited tolerance for combined residues of the herbicide linuron,
(3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea) and its metabolites
convertible to 3,4-dichloroaniline, calculated as linuron, in or on
lentils at 0.1 parts per million (ppm). This time-limited tolerance
expires and is revoked on December 31, 2011. EPA will publish a
document in the Federal Register to remove the revoked tolerance from
the CFR.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related time-limited tolerances to set binding precedents
for the application of section 408 of FFDCA and the new safety standard
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Linuron on Lentils and FFDCA Tolerance

    The applicants from Idaho and Washington petitioned for an
emergency exemption, stating that the development of herbicide-
resistant biotypes of prickly lettuce and mayweed chamomile has led to
an emergency situation. After having reviewed the submissions, EPA
determined that emergency conditions exist for these States, and that
the criteria for an emergency exemption are met. EPA has authorized
under FIFRA section 18 the use of linuron on lentils for control of
mayweed chamomile and prickly lettuce in Idaho and Washington.
    As part of its evaluation of the emergency exemption applications,
EPA assessed the potential risks presented by residues of linuron in or
on lentils. In doing so, EPA considered the safety standard in section
408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under
section 408(l)(6) of FFDCA would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6) of FFDCA. Although this time-
limited tolerance expires and is revoked on December 31, 2011, under
section 408(l)(5) of FFDCA, residues of the pesticide not in excess of
the amount specified in the tolerance remaining in or on lentils after
that date will not be unlawful, provided the pesticide was applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by this time-limited tolerance at the time of
that application. EPA will take action to revoke this time-limited
tolerance earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
    Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
linuron meets FIFRA's registration requirements for use on lentils or
whether a permanent tolerance for this use would be appropriate. Under
these circumstances, EPA does not believe that this time-limited
tolerance decision serves as a basis for registration of linuron by a
State for special local needs under FIFRA section 24(c). Nor does this
tolerance serve as the basis for persons in any State other than Idaho
and Washington to use this pesticide on this crop under FIFRA section
18 absent the issuance of an emergency exemption applicable within that
State. For additional information regarding the emergency exemption for
linuron, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes

exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(C) of FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
    Consistent with the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of this emergency exemption request and
the time-limited tolerance for combined residues of linuron on lentils
at 0.1 ppm. EPA's assessment of exposures and risks associated with
establishing the time-limited tolerance follows.

A. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for linuron used for human
risk assessment can be found at http://www.regulations.gov in the
document Linuron Human Health Risk Assessment to Support a Section 18
Emergency Exemption for Use on Lentils in Washington and Idaho, page 6
in docket ID number EPA-HQ-OPP-2008-0491.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to linuron, EPA considered exposure under the time-limited
tolerance established by this action as well as all existing linuron
tolerances in (40 CFR 180.184). EPA assessed dietary exposures from
linuron in food as follows:
    i. Acute exposure. In estimating acute dietary exposure, EPA used
food consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, for
blended commodities, an average of the field trial data corrected for
the maximum percent of crop treated (PCT) was used in the assessment.
For non-blended or partially-blended commodities, all values from the
field trials were included along with the use of maximum PCT. For the
new use on lentils, field trial values were included and 100 PCT was
assumed. For all commodities, residues reported at or below the
analytical method limit of quantitation (LOQ) were incorporated into
the assessment at the LOQ level. Concentration/reduction factors were
incorporated for some commodities based on empirical data; for all
other processed commodities, default processing factors were used. A
single high end modeled peak surface water estimated drinking water
concentration (EDWC) of 38 ppb was used as a point estimate for
drinking water, and directly incorporated into the assessment. There
were no significant toxicological effects attributable to a single
exposure (dose) for the general population or any other population
subgroups other than the population subgroup of females 13-49 years
old. Therefore, only this subgroup was included in this assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. For the chronic assessment, an average of the field
trial data and PCT information were used to derive anticipated residue
values. For the new use on lentils, the average of the field trial data
was used and 100 PCT was assumed. Concentration/reduction factors were
incorporated for some commodities based on empirical data; for all
other processed commodities, default processing factors were used. The
annual mean surface water estimate of 18 ppb was used as a chronic
exposure estimate for drinking water and was directly incorporated into
the dietary assessment.
    iii. Cancer. Linuron has been classified as Group C chemical and
quantification of human cancer risk is not required; therefore a cancer
dietary risk assessment was not conducted.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as

required by FFDCA section 408(b)(2)(F), EPA may require registrants to
submit data on PCT.
    For the acute assessment the maximum PCT was used as follows:
sorghum and soybean at 2.5%, and wheat and lentils at 100%. For the
chronic assessment, the average PCT was used as follows: sorghum and
soybean at 1%, and wheat and lentils at 100%. Although usage on wheat
is likely negligible, since there were no usage data reported for this
crop, a default of 100 PCT was used for both acute and chronic
assessments, which is likely an overestimate.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.B.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. As to Conditions b and c, regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available reliable information on the
regional consumption of food to which linuron may be applied in a
particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for linuron in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of linuron. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentration (EDWC) of
linuron for acute exposures is estimated to be 38 ppb for surface
water. For chronic exposures for non-cancer assessments the EDWC is
estimated to be 18 ppb for surface water. Groundwater sources were not
included in this assessment, as the EDWCs for this water source are
minimal in comparison to surface water (0.7 ppb for both acute and
chronic concentrations). Modeled estimates of drinking water
concentrations were directly entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of
38 ppb was used to assess the contribution to drinking water. For
chronic dietary risk assessment, the water concentration value of 18
ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Linuron is not registered for any specific use patterns that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found linuron to share a common mechanism of toxicity
with any other substances, and linuron does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that linuron does not have
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/
cumulative.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The data from the multi-
generation reproduction study in rats show that linuron has weak
affinity for androgen receptors and causes dose-related alterations in
androgen-dependent reproductive organ development in male rats. While
there is evidence of increased susceptibility seen in rats, the anti-
androgenic effects of linuron are well established and there is a clear
NOAEL for the effects. Further, the toxicity endpoint selected for risk
assessment is protective of both the hematological effects seen
(increased methemoglobin levels, selected as the chronic endpoint) as
well as the anti-androgenic effects of linuron. EPA has determined that
the available linuron database is adequate for assessing the
potentially increased susceptibility of the young to linuron exposure
and the possible need for a FQPA safety factor to protect the young
from the effects of linuron.
    3. Conclusion. EPA concludes that the FQPA safety factor of 10X is
not warranted, and it is reduced to 1X for the following reasons:
    EPA has determined that reliable data show that the safety of
infants and children would be adequately protected if the FQPA SF were
reduced to 1X. That decision is based on the following findings:

    i. The toxicity database for understanding the toxicity of linuron
is complete.
    ii. The information on linuron's effects on differentiating male
reproductive system (antiandrogenic action) is well established, and
the dose levels where these effects occur are known. A clear NOAEL was
established for the effects on the reproductive system. At this time,
the point of departure for risk assessment purposes is protective of
the linuron's action on this target tissue (differentiating male
reproductive system) as well as the hematological effects described in
Unit IV.C.2.
    iii. The linuron database does not show any neurotoxicity in all
the submitted and published studies at doses as high as 100 mg/kg. The
current developmental neurotoxicity (DNT) study focuses on the
neurobehavioral and brain histological changes and will not provide
additional information for understanding the toxicity of linuron;
therefore, this study is no longer required.
    iv. Exposure estimates are unlikely to underestimate risk.
    v. There are no residual uncertainties identified in the exposure
databases. For estimation of exposure, the analysis incorporated PCT
estimates, which are derived from Federal and private market survey
data, which are reliable and have a valid basis. EPA believes that
using these estimates will not underestimate the exposure and risks.
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to linuron in drinking
water. These assessments will not underestimate the exposure and risks
posed by linuron.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate UFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. There were no significant toxicological effects
attributable to a single exposure (dose) for the general population
other than the population subgroup Females 13-49 Years Old; therefore
only this population subgroup was included in this assessment. Using
the exposure assumptions discussed in this unit for acute exposure, the
acute dietary exposure from food and water to linuron will occupy 6.0%
of the aPAD at the 99.9th percentile of exposure distribution for
Females 13-49 Years Old.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
linuron from food and water will utilize 22% of the cPAD for All
Infants, the population subgroup receiving the greatest exposure. There
are no residential uses for linuron. For the general U.S. population
the existing and new uses for linuron resulted in an estimated chronic
dietary exposure and risk equivalent to 7% of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Linuron is
not registered for any use patterns that would result in residential
exposure. Therefore, the short-term aggregate risk is the sum of the
risk from exposure to linuron through food and water and will not be
greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term non-dietary, non-occupational
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Linuron is not registered for any use
patterns that would result in intermediate-term residential exposure.
Therefore, the intermediate-term aggregate risk is the sum of the risk
from exposure to linuron through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Linuron has been
classified as Group C carcinogen and quantification of human cancer
risk is not required.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to linuron residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    The Pesticide Analytical Manual (PAM) Vol. II lists a colorimetric
method (Method I) and a paper chromatographic method (Method II) for
the enforcement of tolerances for linuron residues. Residues of diuron
may interfere in Method I. A modified version of Method I (H. L. Pease,
Journal of Agric. and Food Chem., 1962, Vol. 10, p. 279), which
includes a cellulose column step to separate linuron from diuron, has
been used for tolerance enforcement purposes. Both these methods
determine linuron and all metabolites hydrolyzable to 3,4-
dichloroaniline and have limits of detection of 0.05 ppm and are
adequate to enforce the tolerance expression.

B. International Residue Limits

    There are no Codex MRLs for linuron on lentils.

VI. Conclusion

    Therefore, a time-limited tolerance is established for combined
residues of linuron, (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea)
and its metabolites convertible to 3,4-dichloroaniline, calculated as
linuron, in or on lentil at 0.1 ppm. This tolerance expires and is
revoked on December 31, 2011.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and
408(l)(6) of FFDCA in response to a petition submitted to the Agency.
The Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this final
rule has been exempted from review under Executive Order 12866, this
final rule is not subject to Executive Order 13211, Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income

Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: August 22, 2008.
 Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.184 revise paragraph (b) to read as follows:

Sec.  180.184  Linuron; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for combined residues
of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-
methylurea) and its metabolites convertible to 3,4-dichloroaniline,
calculated as linuron, in or on the specified agricultural commodities,
resulting from use of the pesticide pursuant to FIFRA section 18
emergency exemptions. The tolerance expires and is revoked on the date
specified in the table.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per   revocation
                                                  million       date
------------------------------------------------------------------------
Lentil                                                 0.1    12/31/2011
------------------------------------------------------------------------

[FR Doc. E8-20627 Filed 9-4-08; 8:45 am]

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