[Federal Register: September 15, 2008 (Volume 73, Number 179)]
[Notices]
[Page 53320-53321]
[DOCID:fr15se08-139]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Receipt of Noise Compatibility Program and Request for Review;
Mobile Regional Airport, Mobile, AL

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces that it is
reviewing a proposed amendment to the Noise Compatibility Program that
was submitted for Mobile Regional Airport under the provisions of 49
U.S.C. 47504 et seq. (the Aviation Safety and Noise Abatement Act
hereinafter referred to as ``the Act'') and 14 CFR Part 150 by the
Mobile Airport Authority. This program was submitted subsequent to a
determination by FAA that the associated Noise Exposure Maps submitted
under 14 CFR Part 150 for Mobile Regional Airport were in compliance
with applicable requirements effective May 1, 2006, and was published
in the Federal Register on May 18, 2006. The proposed amendment to the
Noise Compatibility Program will be approved or disapproved on or
before February 21, 2009.

DATES: Effective Date: The effective date of the start of FAA's review
of the amendment to the noise compatibility program is August 29, 2008.
The public comment period ends October 29, 2008.

FOR FURTHER INFORMATION CONTACT: William Schuller, Federal Aviation
Administration, Jackson Airports District Office, 100 West Cross
Street, Jackson, Mississippi 39208,<PHONE_NUMBER>. Comments on the
proposed amendment to the noise compatibility program should also be
submitted to the above office.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA is
reviewing a proposed amendment to the Noise Compatibility Program for
Mobile Regional Airport which will be approved or disapproved on or
before February 21, 2009. This notice also announces the availability
of this amendment for public review and comment.
    An airport operator who has submitted Noise Exposure Maps that are
found by FAA to be in compliance with the requirements of Federal
Aviation Regulations (FAR) Part 150, promulgated pursuant to the Act,
may submit a Noise Compatibility Program for FAA approval which sets
forth the measures the operator has taken or proposes to reduce
existing non-compatible uses and prevent the introduction of additional
non-compatible uses.
    The FAA previously approved the Noise Compatability Program for
Mobile Regional Airport. The FAA has formally received the amendment to
the Noise Compatibility Program for Mobile Regional Airport, effective
on August 29, 2008. The airport operator has requested that the FAA
review this material and that the amended noise mitigation measures, to
be implemented jointly by the airport and surrounding communities, be
approved as part of the Noise Compatibility Program under section 47504
of the Act. Preliminary review of the submitted material indicates that
the amendment conforms to the requirements for the submittal of Noise
Compatibility Programs, but that further review will be necessary prior
to approval or disapproval of the program. The formal review period,
limited by law to a maximum of 180 days, will be completed on or before
February 21, 2009.
    The FAA's detailed evaluation will be conducted under the
provisions of 14 CFR part 150, section 150.33. The primary
considerations in the evaluation process are whether the proposed
measures may reduce the level of aviation safety or create an undue
burden on interstate or foreign commerce, and whether they are
reasonably consistent with obtaining the goal of reducing existing non-
compatible land uses and preventing the introduction of additional non-
compatible land uses.
    Interested persons are invited to comment on the proposed program
amendment with specific reference to

these factors. All comments relating to these factors, other than those
properly addressed to local land use authorities, will be considered by
the FAA to the extent practicable. Copies of the Noise Exposure Maps,
the FM's evaluation of the maps, and the proposed amendment to the
Noise Compatibility Program are available for examination at the
following locations: Federal Aviation Administration, Jackson Airports
District Office, 100 West Cross Street, Suite B, Jackson, Mississippi
39208.
    Questions may be directed to the individual named above under the
heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Jackson, Mississippi on August 29, 2008.
Rans Black,
Manager, Jackson Airports District Office.
[FR Doc. E8-21187 Filed 9-12-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Notices]
[Page 17240]
[FR Doc No: 2017-07087]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4451-020]

Somersworth Hydro Company, Inc., City of Somersworth, Green
Mountain Power Corporation; Notice of Application for Partial Transfer
of License and Soliciting Comments, Motions To Intervene, and Protests

    On February 27, 2017, Somersworth Hydro Company, Inc. and the City
of Somersworth (transferors/co-licensees) and Green Mountain Power
Corporation (transferee) filed an application for the transfer of
license of the Lower Great Falls Project No. 4451. The project is
located on the Salmon Falls River in Strafford County, New Hampshire
and York County, Maine. The project does not occupy Federal lands.
    The transferors and transferee seek Commission approval to
partially transfer the license for the Lower Great Falls Project from
the Somersworth Hydro Company, Inc. and the City of Somersworth as co-
licensees to the City of Somersworth and Green Mountain Power
Corporation as co-licensees.
    Applicant's Contacts: For Transferors: Mr. Stephen Pike, Vice
President, Operations, Somersworth Hydro Company, Inc. and the City of
Somersworth, c/o Enel Green Power North America, Inc., 1 Tech Drive,
Suite 220, Andover, MA 01810, Email<EMAIL_ADDRESS>General
Counsel, Enel Green Power North America, Inc., 1 Tech Drive, Suite 220,
Andover, MA 01810.
    For Transferee: Ms. Charlotte Ancel, Vice President, Power Supply &
General Counsel, Green Mountain Power Corporation, 163 Acorn Lane,
Colchester; VT 05446, email<EMAIL_ADDRESS>
Ms. Elizabeth Kohler, Esq., Downs Rachlin Martin PLLC, 199 Main Street,
P.O. Box 190, Burlington, VT 05402, email<EMAIL_ADDRESS>and General
Counsel, Enel Green Power North America, Inc., 1 Tech Drive, Suite 220,
Andover, MA 01810, Email<EMAIL_ADDRESS>    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-4451-020.

    Dated: April 4, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-07087 Filed 4-7-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Rules and Regulations]
[Pages 66136-66138]
[FR Doc No: 2018-27756]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2018-0559; FRL-9987-78-Region 9]

Air Plan Approval; California; Feather River Air Quality
Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a revision to the Feather River Air Quality
Management District (FRAQMD) portion of the California State
Implementation Plan (SIP). This revision concerns emissions of oxides
of nitrogen (NOX) from natural gas-fired water heaters,
small boilers, and process heaters. We are approving a local rule that
regulates these emission sources under the Clean Air Act (CAA or the
Act).

DATES: This rule will be effective on January 25, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID

No. EPA-R09-OAR-2018-0559. All documents in the docket are listed on
the https://www.regulations.gov website. Although listed in the index,
some information is not publicly available, 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 through
https://www.regulations.gov, or please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Robert Schwartz, EPA Region IX, (415)
972-3286<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action

    On October 3, 2018 (83 FR 49870), the EPA proposed to approve the
following rule into the California SIP.

----------------------------------------------------------------------------------------------------------------
             Local agency                  Rule No.            Rule title             Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
FRAQMD................................            3.23  Natural Gas-Fired Water       10/03/2016      05/08/2017
                                                         Heaters, Small Boilers,
                                                         And Process Heaters.
----------------------------------------------------------------------------------------------------------------

    We proposed to approve this rule because we determined that it
complies with the relevant CAA requirements. Our proposed action
contains more information on the rule and our evaluation.

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received five (5) comments supporting the
limitation of NOX emissions. One commenter asked, ``If this
is approved what kind of program will be provided to replace these
systems to ones that follow code?'' In response, there is no EPA-
sponsored program to replace currently installed natural-gas fired
water heaters, small boilers or process heaters. The FRAQMD Rule 3.23
prohibits any person in the District to offer for sale, sell, or
install applicable units that exceed the NOX emission limits
established by the rule. Resellers or manufacturers of any unit subject
to Rule 3.23 will be required to submit to the FRAQMD a report that
demonstrates compliance with the NOX emission limits
established by the rule. Alternatively, the reseller or manufacturer of
any unit subject to Rule 3.23 will have the option to submit to the
FRAQMD an approved South Coast Air Quality Management District (SCAQMD)
certification, in accordance with SCAQMD Rule 1121 or Rule 1146.2.

III. EPA Action

    No comments were submitted that change our assessment of the rule
as described in our proposed action. Therefore, as authorized in
section 110(k)(3) of the Act, the EPA is fully approving this rule into
the California SIP.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
FRAQMD rules described in the amendments to 40 CFR part 52 set forth
below. The EPA has made, and will continue to make, these documents
available through www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    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 to the Comptroller General of the United
States. The EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by February 25, 2019. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: November 30, 2018.
Deborah Jordan,
Acting Regional Administrator, Region IX.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraph (c)(509)(i)(B) to read
as follows:

Sec.  52.220  Identification of plan-in part.

* * * * *
    (c) * * *
    (509) * * *
    (i) * * *
    (B) Feather River Air Quality Management District.
    (1) Rule 3.23, ``Natural Gas-Fired Water Heaters, Small Boilers,
and Process Heaters'' adopted on October 3, 2016.
* * * * *
[FR Doc. 2018-27756 Filed 12-21-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Notices]
[Pages 79466-79467]
[FR Doc No: 2016-27290]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: EC17-28-000.
    Applicants: Innovative Solar 43, LLC, Innovative Owner 43, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, et al. Innovative Solar 43, LLC, et al.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5197.
    Comments Due: 5 p.m. ET 11/28/16.

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

    Docket Numbers: ER16-1827-000.
    Applicants: GenOn Energy Management, LLC.
    Description: Report Filing: Refund Report, Informational Filing to
be effective N/A.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5098.
    Comments Due: 5 p.m. ET 11/28/16.

    Docket Numbers: ER16-1955-001.
    Applicants: Antelope DSR 2, LLC.
    Description: Compliance filing: Antelope DSR 2, LLC MBR Tariff to
be effective 6/18/2016.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5106.
    Comments Due: 5 p.m. ET 11/28/16.

    Docket Numbers: ER16-2194-001.
    Applicants: Clinton Battery Utility, LLC.
    Description: Compliance filing: Clinton Battery Utility Revised
Tariff to be effective 11/8/2016.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5143.
    Comments Due: 5 p.m. ET 11/28/16.

    Docket Numbers: ER16-2363-001.
    Applicants: Bluestem Wind Energy, LLC.
    Description: Compliance filing: Bluestem Wind Energy MBR Tariff
Update to be effective 11/8/2016.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5140.
    Comments Due: 5 p.m. ET 11/28/16.

    Docket Numbers: ER16-2602-001.
    Applicants: 4C Acquisition, LLC.
    Description: Tariff Amendment: Supplement to Application for
Market-Based Rate Authorization of 4C Acquisition to be effective 11/
17/2016.
    Filed Date: 11/2/16.
    Accession Number: 20161102-5142.
    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER16-2708-001.

    Applicants: Exelon West Medway II, LLC.
    Description: Compliance filing: Exelon West Medway II LLC Revised
Tariff to be effective 11/8/2016.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5139.
    Comments Due: 5 p.m. ET 11/28/16.

    Docket Numbers: ER17-3-001.
    Applicants: ESS Lewes Project, LLC.
    Description: Tariff Amendment: Amendment to 1 to be effective 12/2/
2016.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5208.
    Comments Due: 5 p.m. ET 11/28/16.

    Docket Numbers: ER17-94-001.
    Applicants: ESS Snook Project, LLC.
    Description: Tariff Amendment: Amendment to 1 to be effective 12/
13/2016.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5205.
    Comments Due: 5 p.m. ET 11/28/16.

    Docket Numbers: ER17-313-000.
    Applicants: AEP Texas Central Company.
    Description: Sec.  205(d) Rate Filing: TCC-Patriot Wind Farm Second
Amend & Restated IA to be effective 10/13/2016.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5149.
    Comments Due: 5 p.m. ET 11/28/16.

    Docket Numbers: ER17-314-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA SA No.
3333; Queue No. W3-003 to be effective 6/24/2014.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5154.
    Comments Due: 5 p.m. ET 11/28/16.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:

    Docket Numbers: QM17-2-000.
    Applicants: East Kentucky Power Cooperative, Inc.
    Description: Application of East Kentucky Power Cooperative, Inc.
for the termination of the obligation to purchase power from qualifying
facilities.
    Filed Date: 11/4/16.
    Accession Number: 20161104-5214.
    Comments Due: 5 p.m. ET 12/2/16.

    Take notice that the Commission received the following electric
reliability filings

    Docket Numbers: RD16-6-001.
    Applicants: North American Electric Reliability Corporation.
    Description: Revisions of the North American Electric Reliability
Corporation to the Violations Risk Factors for Reliability Standards
IRO-018-1 and TOP-010-1.
    Filed Date: 11/7/16.
    Accession Number: 20161107-5195.
    Comments Due: 5 p.m. ET 12/7/16.

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

    Dated: November 7, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-27290 Filed 11-10-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Rules and Regulations]
[Pages 50591-50593]
[FR Doc No: 2012-20609]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 500

[Docket No. FDA-2010-N-0612]

Animal Drugs, Feeds, and Related Products; Regulation of
Carcinogenic Compounds in Food-Producing Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations regarding compounds of carcinogenic concern used in food-
producing animals. Specifically, the Agency is clarifying the
definition of ``So'' and revising the definition of
``Sm'' so that it conforms to the clarified definition of
So. Other clarifying and conforming changes are also being
made.

DATES: This rule is effective September 21, 2012.

FOR FURTHER INFORMATION CONTACT: Kevin Greenlees, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On December 20, 2010, FDA issued a proposed rule (75 FR 79320) to
amend its regulations regarding compounds of carcinogenic concern used
in food-producing animals. Specifically, the Agency clarified the
definition of ``So'' and revised the definition of
``Sm'' so that it would conform to the clarified definition
of So. The Agency also proposed a number of clarifying and
conforming changes.
    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) contains
three anticancer, or Delaney, clauses: Sections 409(c)(3)(A),
512(d)(1)(I), and 721(b)(5)(B)(i) (21 U.S.C. 348(c)(3)(A),
360b(d)(1)(I), and 379e(b)(5)(B)(i)), pertaining to food additives, new
animal drugs, and color additives, respectively. These clauses prohibit
approval of substances that have been shown to induce cancer in man or
animals. However, each clause contains an exception, termed the
``Diethylstilbestrol (DES) Proviso,'' that permits administration of
such substances to food-producing animals where: (1) The food additive,
color additive, or new animal drug will not adversely affect the animal
and (2) no residue of the food additive, color additive, or new animal
drug will be found in any edible portion of that animal by a method of
examination prescribed or approved by the Secretary of Health and Human
Services by regulation. The regulations under part 500 (21 CFR part
500), subpart E entitled ``Regulation of Carcinogenic Compounds Used in
Food-Producing Animals'' (Sec. Sec.  500.80 through 500.92), implement
the DES Proviso. To elaborate on how to determine that there is no
residue, and thus demonstrate that the second prong of the DES Proviso
has been satisfied, the regulations define several terms, including
So and Sm.
    So is currently defined as the concentration of the
compound of carcinogenic concern in the total diet of test animals that
corresponds to a maximum lifetime risk of cancer to the test animals of
1 in 1 million, and is calculated from tumor data of the cancer
bioassays using a statistical extrapolation procedure. The definition
of So also provides that FDA will assume that the
So corresponds to the concentration of residue of
carcinogenic concern in the total human diet that represents no
significant increase in the risk of cancer to people. The
concentration, derived from the So, of residues of
carcinogenic concern in a specific edible tissue is termed the
Sm.
    This rule changes the definition of So so that it is
primarily defined as ``the concentration of a residue of carcinogenic
concern in the total human diet that represents no significant increase
in the risk of cancer to the human consumer * * *'' and secondarily as
``the concentration of test compound in the total diet of test animals
that corresponds to a maximum lifetime risk of cancer in the test
animals of 1 in 1 million.'' The change in this rule to the definition
of So is intended to enable the Center for Veterinary
Medicine to consider allowing the use of alternative procedures to
satisfy the DES Proviso (See 75 FR 79320 at 79321) without requiring
the development of a second, alternative, set of terminology. FDA
believes that the original intent of 21 CFR part 500, Subpart E, as
reflected in the preamble to the final rule establishing that
regulation, was to place an emphasis on no significant increase in the
risk of cancer to the human consumer, rather than on the specific 1 in
1 million risk of cancer to the test animals approach (See e.g., 52 FR
49572 at 49575 and 49582). Therefore, FDA has concluded that the
redefinition of So is consistent with this original intent
of the regulation.

    For clarification purposes, FDA is also redefining Sm in
Sec.  500.82 to conform this definition with the redefinition of
So as described previously. Specifically, Sm will
mean the concentration of a residue of carcinogenic concern in a
specific edible tissue corresponding to no significant increase in the
risk of cancer to the human consumer. However, the definition of
Sm will also retain the existing reference to a maximum
lifetime risk of cancer in the test animals of 1 in 1 million.
    Finally, FDA is amending Sec.  500.84(c) to clarify that for each
compound that is regulated as a carcinogen, FDA will analyze the data
submitted using either a statistical extrapolation procedure as
provided in Sec.  500.84(c)(1) or an alternate approach as provided in
Sec.  500.90.
    FDA's goal in these changes is to clarify that the terms
So and Sm apply even when the alternative
procedures provided for in Sec.  500.90 are used to satisfy the DES
Proviso, not to alter the usual process for approving compounds of
carcinogenic concern. As such, in the absence of a waiver of the
requirements of Sec.  500.84(c)(1), FDA maintains that sponsors must
meet the conditions for approval set for in Sec.  500.84, including the
default approach of a 1 in 1 million lifetime risk to the test animal.

II. Comments

    FDA received six comments in response to the proposed rule. Two of
these comments were outside the scope of the rule as they advocated in
one case that FDA hold a public hearing regarding the drug
Avastin[supreg], and the other comment concerned veterinary
compounding.
    (Comment 1) Of the remaining comments, one generally supported the
rule, but mistakenly believed that the rule ``will limit carcinogenic
compounds in food producing animals to 1 in 1 million.''
    In fact, the rule clarifies the definition of So in 21
CFR 500.82 to mean primarily ``the concentration of a residue of
carcinogenic concern in the total human diet that represents no
significant increase in the risk of cancer to the human consumer * *
*'' and secondarily, ``So will correspond to the
concentration of test compound in the total diet of test animals that
corresponds to a maximum lifetime risk of cancer in the test animals of
1 in 1 million.'' The rule also clarifies the definition of
Sm to mean primarily ``the concentration of a residue of
carcinogenic concern in a specific edible tissue corresponding to no
significant increase in the risk of cancer to the human consumer * *
*'' and secondarily ``the concentration of test compound in the total
diet of test animals that corresponds to a maximum lifetime risk of
cancer in the test animals of 1 in 1 million.''
    (Comment 2) A comment from a veterinary association generally
supported the rule and its goal to allow the use of alternative
procedures to satisfy the DES Proviso without requiring the development
of a second, alternative, set of terminology. The comment advocated the
use of ``statistically valid risk assessment procedures in its
evaluation and consideration of the compounds of carcinogenic
concern.'' The comment continued, ``That if alternative procedures are
allowed, they should be also definable and data driven.'' FDA generally
agrees with the comment that an alternative procedure should be
definable and data driven in order to be acceptable. However, the
recommendation is also outside the current scope of the current rule as
it clarifies the definition of So and Sm and will
not address alternative procedures.
    (Comments 3 and 4) Another commenter opposed the rule, advocating a
ban on all carcinogens in animal food, even in minute quantities. A
second comment mistakenly stated that the rule ``is a proposal to
remove any carcinogen from any drugs or feed that are given to animals
that are generally eaten by humans.''
    As previously stated, the FD&C Act contains three anticancer, or
Delaney, clauses: Sections 409(c)(3)(A), 512(d)(1)(I), and
721(b)(5)(B)(i), pertaining to food additives, new animal drugs, and
color additives, respectively. These clauses prohibit approval of
substances that have been shown to induce cancer in man or animals,
with the following exceptions termed the ``DES Proviso.'' The DES
Proviso permits FDA to approve carcinogenic compounds for use in food-
producing animals if it concludes that, when used in accordance with
its label directions: (1) The compound will not adversely affect the
animal; and (2) ``no residue'' of the compound will be found in any
edible portion of the animals using a method of detection prescribed by
FDA. FDA's approach to implement the Delaney clause and the DES Proviso
is described in part 500, subpart E, entitled ``Regulation of
Carcinogenic Compounds Used in Food-Producing Animals,'' Sec. Sec.
500.80 through 500.92. As described earlier, the current rule clarifies
the definitions within this set of regulations.

III. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. FDA concluded that the proposed rule would not
impose any direct or indirect costs on industry or government through
the changes to the definitions of So and Sm and
to Sec.  500.84(c), but rather would clarify these definitions to
enable FDA to consider using alternative procedures to satisfy the DES
Proviso without requiring the development of a second, alternative, set
of terminology. FDA did not receive any public comments that challenged
this conclusion. As such, FDA certifies that the final rule will not
have a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $139 million, using the most current (2011) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

V. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
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. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

VI. Paperwork Reduction Act of 1995

    This final rule refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec.  500.84 have been approved under OMB
control number 0910-0032.

List of Subjects in 21 CFR Part 500

    Animal drugs, animal feeds, Cancer, Labeling, Packaging and
containers, Polychlorinated biphenyls (PCBs).

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
500 is amended as follows:

PART 500--GENERAL

0
1. The authority citation for 21 CFR part 500 is revised to read as
follows:

    Authority:  21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371, 379e.

0
2. In Sec.  500.82(b), revise the definitions of ``Sm'' and
``So'' to read as follows:

Sec.  500.82  Definitions.

* * * * *
    (b) * * *
    Sm means the concentration of a residue of carcinogenic concern in
a specific edible tissue corresponding to no significant increase in
the risk of cancer to the human consumer. For the purpose of Sec.
500.84(c)(1), FDA will assume that this Sm will correspond
to the concentration of residue in a specific edible tissue that
corresponds to a maximum lifetime risk of cancer in the test animals of
1 in 1 million.
    So means the concentration of a residue of carcinogenic concern in
the total human diet that represents no significant increase in the
risk of cancer to the human consumer. For the purpose of Sec.
500.84(c)(1), FDA will assume that this So will correspond
to the concentration of test compound in the total diet of test animals
that corresponds to a maximum lifetime risk of cancer in the test
animals of 1 in 1 million.
* * * * *

0
3. In Sec.  500.84, revise paragraph (c) introductory text to read as
follows:

Sec.  500.84  Conditions for approval of the sponsored compound.

* * * * *
    (c) For each sponsored compound that FDA decides should be
regulated as a carcinogen, FDA will either analyze the data from the
bioassays using a statistical extrapolation procedure as outlined in
paragraph (c)(1) of this section or evaluate an alternate procedure
proposed by the sponsor as provided in Sec.  500.90. In either case,
paragraphs (c)(2) and (3) of this section apply.
* * * * *

    Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20609 Filed 8-21-12; 8:45 am]
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