[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Proposed Rules]
[Pages 3525-3527]
[FR Doc No: 2015-00946]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-1045; Directorate Identifier 2014-NM-031-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus Model A310 and Airbus Model A300 B4-600, B4-600R, and F4-600R
series airplanes, and Model A300 C4-605R Variant F airplanes
(collectively called Model A300-600 series airplanes) series airplanes.
This proposed AD was prompted by a report of skin disbonding and damage
found on the composite side panel of the rudder, located between the
rudder core and skin of a previously repaired area. This proposed AD
would require an inspection for disbonding or damage of certain
rudders, and related investigative actions and corrective actions if
necessary. We are proposing this AD to detect and correct disbonding
and damage of the rudder, which could result in reduced structural
integrity of the rudder and consequent reduced controllability of the
airplane.

DATES: We must receive comments on this proposed AD by March 9, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
1045; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-1045;
Directorate Identifier 2014-NM-031-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0026, dated January 28, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    A case of skin disbonding was reported on a composite side of a
rudder installed on an A310 aeroplane.
    The investigation results revealed that this disbonding started
from a skin panel area previously repaired in-service in accordance
with the Structural Repair Manual (SRM).
    The initial damage has been identified as a disbonding between
the core and the repaired area. This damage may not be visually
detectable and likely propagates during normal operation due to the
variation of pressure during ground-air-ground cycles.
    This condition, if not detected and corrected, could affect the
structural integrity of the rudder, possibly resulting in reduced
control of the aeroplane.
    For the reasons described above, this [EASA] AD requires a one-
time thermography inspection of each repaired rudder or rudder whose
maintenance records are incomplete and, depending on findings,
accomplishment of applicable corrective and follow-up actions.

    Related investigative actions include doing a pulse thermography
inspection for disbonding or damage of the left- and right-hand rudder
side shells; a core ventilation through the inner skin, an elasticity
laminate checker or ultrasonic inspection around the identified repairs
in the booster area, and around identified fluid ingress; and a Tap
test inspection of the glass fiber reinforced plastic area to identify
skin-to-core disbonding and on identified repairs.

Corrective actions include repairing or replacing any disbonded or
damaged rudder.
    Depending on configuration and inspection results, the repetitive
inspection intervals are 750 or 1,000 flight cycles; or 500 flight
hours or 4 months, whichever occurs later.
    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
1045.

Related Service Information

    Airbus has issued Service Bulletins A300-55-6050; and A310-55-2051;
both Revision 01, dated August 20, 2014. The service information
describes procedures for inspecting the left- and right-hand rudder
side shells for disbonding or damage, and related investigative actions
and corrective actions if necessary. The actions described in this
service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Difference Between This Proposed AD and the MCAI or Service Information

    Airbus Service Bulletins A300-55-6050; and A310-55-2051; both
Revision 01, dated August 20, 2014; do not provide corrective action
for certain conditions. This proposed AD would require repairing the
damage using a method approved by the Manager, International Branch,
ANM-116, Transport Airplane Directorate, FAA; or the European Aviation
Safety Agency (EASA); or Airbus's EASA Design Organization Approval
(DOA).

Costs of Compliance

    We estimate that this proposed AD affects 199 airplanes of U.S.
registry.
    We also estimate that it would take about 4 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost about $0 per
product. Based on these figures, we estimate the cost of this proposed
AD on U.S. operators to be $67,660, or $340 per product.
    We have received no definitive data that would enable us to provide
a cost estimate for the on-condition actions specified in this proposed
AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus: Docket No. FAA-2014-1045; Directorate Identifier 2014-NM-
031-AD.

(a) Comments Due Date

    We must receive comments by March 9, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus Model A310-203, -204, -221, -222,
-304, -322, -324, and -325 airplanes; Model A300 B4-601, B4-603, B4-
620, and B4-622 airplanes; A300 B4-605R and B4-622R airplanes; and
A300 F4-605R and F4-622R, and A300 C4-605R Variant F airplanes;
certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 55, Stabilizers.

(e) Reason

    This AD was prompted by a report of skin disbonding and damage
found on the composite side panel of the rudder, located between the
rudder core and skin of a previously repaired area. We are issuing
this AD to detect and correct disbonding and damage of the rudder,
which could result in reduced structural integrity of the rudder,
and consequent reduced controllability of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Rudder Assembly Identification

    Within 4 months after the effective date of this AD: Check the
applicable rudder maintenance records to determine if any composite
side shell panel repair has been done since first installation of
the rudder, and do the applicable actions specified in paragraph
(g)(1) or (g)(2) of this AD at the time specified in paragraph 1.E.,
``Compliance,'' of Airbus Service Bulletin A300-55-6050; or A310-55-
2051; both Revision 01, dated August 20, 2014; as applicable, except
as provided by paragraph (j)(3) of this AD.
    (1) If a repair is identified based on the maintenance records:
Perform a rudder thermography inspection of the repaired area only
for disbonding or damage, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A300-55-6050; or A310-55-
2051; both Revision 01, dated August 20, 2014; as applicable.
    (2) If the rudder maintenance records are unavailable or
incomplete: Perform a rudder

thermography inspection of the complete side shell panels to
identify and mark the repair locations for disbonding or damage, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A300-55-6050; or A310-55-2051; both Revision 01, dated
August 20, 2014; as applicable.

(h) Related Investigative Actions/Repair or Replace

    If any disbonding or damage is found during any inspection
required by paragraph (g)(1) or (g)(2) of this AD: Do the actions
required by paragraphs (h)(1) and (h)(2) of this AD, as applicable.
    (1) At the time specified in paragraph 1.E., ``Compliance,'' of
Airbus Service Bulletin A300-55-6050; or A310-55-2051; both Revision
01, dated August 20, 2014; as applicable, except as required by
paragraph (j)(2) of this AD; do the applicable related investigative
actions identified in Tables 3, 4A, 4B, 4C, 4D, and 5 of paragraph
1.E., ``Compliance,'' of Airbus Service Bulletin A300-55-6050; or
A310-55-2051; both Revision 01, dated August 20, 2014; as
applicable, to determine the type and extent of the disbonding or
damage, in accordance with the Accomplishment Instructions of Airbus
Service Bulletin A300-55-6050; or A310-55-2051; both Revision 01,
dated August 20, 2014; as applicable. Repeat the applicable
inspection at the time specified in paragraph 1.E., ``Compliance''
of Airbus Service Bulletin A300-55-6050; or A310-55-2051; both
Revision 01, dated August 20, 2014; as applicable.
    (2) Before further flight: Repair any disbonding or damage found
during any inspection required by paragraph (h)(1) of this AD, or
replace any affected rudder, as applicable, in accordance with the
Accomplishment Instructions Airbus Service Bulletin A300-55-6050; or
A310-55-2051; both Revision 01, dated August 20, 2014; as
applicable, except as required by paragraph (j)(4) of this AD.

(i) Repair Using SRM Procedure Not Allowed

    As of the effective date of this AD, do not accomplish a
composite side shell panel repair on any rudder using an SRM
procedure identified in Figure A-GBBAA (Sheet 01 and 02) or Figure
A-GBCAA (Sheet 02) of Airbus Service Bulletin A310-55-2051; or
Figure A-GBBAA (Sheet 01, 02, or 03) or Figure A-GBCAA (Sheet 02 or
04) of Airbus Service Bulletin A300-55-6050; as applicable.

(j) Exceptions to Service Information

    (1) Where Airbus Service Bulletins A300-55-6050; and A310-55-
2051; both dated September 11, 2012; specify a compliance time
``from original service bulletin issue date,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.
    (2) Where Airbus Service Bulletins A300-55-6050; and A310-55-
2051 both dated September 11, 2012; specify to contact Airbus for
appropriate action: Before further flight, repair using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the European Aviation Safety Agency
(EASA); or Airbus's EASA Design Organization Approval (DOA).
    (3) Airplanes on which a rudder is installed having a serial
number that is not in the range HF-1005 through HF-1323, inclusive;
HF-1325, HF-1327, HF-1329, HF-1331, HF-1332, HF-1340, TS-1324, TS-
1326, TS-1328, TS-1330, TS-1333 through TS-1339, inclusive; TS-1341
through TS-1420, inclusive; or TS-2001 through TS-2197, inclusive;
are not affected by the requirements of paragraphs (g) and (h) of
this AD, provided that no repairs have been done on the composite
side shell panel of that rudder since installation in accordance
with the applicable structural repair manual (SRM).
    (4) The compliance time for the initial detailed inspection of
the restored area for loose or lost tape identified in Tables 3 and
4 of paragraph 1.E., ``Compliance,'' of Airbus Service Bulletins
A300-55-6050 and A310-55-2051, both Revision 01, dated August 20,
2014; specifies ``within 500 FH or 4 months after closing holes.''
This AD requires this action within 500 flight hours or 4 months,
whichever occurs later after the holes are closed.

(k) Credit for Previous Actions

    This paragraph provides credit for actions required by
paragraphs (g) and (h) of this AD, if those actions were performed
before the effective date of this AD using Airbus Service Bulletin
A300-55-6050; or A310-55-2051; both dated September 11, 2012; as
applicable; which are not incorporated by reference in this AD.

(l) Parts Installation Limitations

    As of the effective date of this AD, no person may install any
affected rudder on any airplane, unless the actions required by
paragraphs (g) and (h) of this AD have been accomplished.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or
Airbus's EASA DOA. If approved by the DOA, the approval must include
the DOA-authorized signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information EASA
Airworthiness Directive 2014-0026, dated January 28, 2014, for
related information. This MCAI may be found in the AD docket on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2014-1045.
    (2) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may view this service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on January 13, 2015.
John P. Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-00946 Filed 1-22-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Pages 46975-46976]
[FR Doc No: 2018-20076]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84077; File No. SR-NYSE-2018-33]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Approving a Proposed Rule Change To Amend Rule 2 To Remove Requirement
That a Registered Broker-Dealer Be a Member of the Financial Industry
Regulatory Authority, Inc. or Another National Securities Exchange

September 11, 2018.

I. Introduction

    On July 25, 2018, the New York Stock Exchange LLC (``Exchange'' or
``NYSE'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Rule 2, ``Member,'' ``Membership,''
``Member Firm,'' etc., to remove the requirement that a registered
broker-dealer be a member of the Financial Industry Regulatory
Authority, Inc. (``FINRA'') or another national securities exchange.
The proposed rule change was published for comment in the Federal
Register on August 3, 2018.\3\ The Commission received one comment
letter on the proposed rule change.\4\ This order approves the proposed
rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 83740 (July 30,
2018), 83 FR 38195 (August 3, 2018) (``Notice'').
    \4\ See Letter from Ray Delao, The Michael's Copanys.Inc [sic],
dated August 15, 2018. The letter does not address the change that
the NYSE is proposing to make to Rule 2.
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II. Description of the Proposed Rule Change

    As described in more detail in the Notice,\5\ the Exchange proposes
to amend Rule 2 to remove a requirement that a registered broker-dealer
be a member of FINRA or another national securities exchange to become
a member of the Exchange. The Exchange proposes to amend Rule 2(b)(i)
to define ``member organization'' as a ``registered broker or dealer
(unless exempt pursuant to the Securities Exchange Act of 1934) . . . ,
including sole proprietors, partnerships, limited liability
partnerships, corporations, and limited liability corporations,
approved by the Exchange pursuant to Rule 311. A registered broker or
dealer must also be approved by the Exchange and authorized to
designate an associated natural person to effect transactions on the
floor of the Exchange or any facility thereof.'' Furthermore, the
Exchange proposes to amend Rule 2(b)(ii) to state: ``[t]he term `member
organization' also includes any registered broker or dealer which does
not own a trading license and agrees to be regulated by the Exchange as
a member organization and which the Exchange has agreed to regulate.''
The Exchange noted that this proposed change will not result in ``any
regulatory impact because member organizations will continue to be
subject to a comprehensive regulatory regime regardless of whether they
are a member of another [self-regulatory organization] or not'' and
that the Exchange ``performs the necessary regulatory oversight of
member organizations.'' \6\
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    \5\ See Notice, supra note 3.
    \6\ Id. at 38196.
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act \7\ and the rules
and regulations thereunder applicable to a national

securities exchange.\8\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(2) of the Act,\9\
which states that ``any registered broker or dealer or natural person
associated with a registered broker or dealer may become a member of
such exchange and any person may become associated with a member
thereof.'' The rule, as revised, is consistent with the statutory
requirement. Thus, the Commission finds that the proposed amendment to
Rule 2 is consistent with the Act.
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    \7\ 15 U.S.C. 78f.
    \8\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(2).
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IV. Conclusion

    It is therefor ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-NYSE-2018-33) be, and hereby
is, approved.
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    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-20076 Filed 9-14-18; 8:45 am]
BILLING CODE 8011-01-P


--------------------------------------------------------------------------------
 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
--------------------------------------------------------------------------------
REGION 8
--------------------------------------------------------------------------------
1595 Wynkoop Street
--------------------------------------------------------------------------------
Denver, CO   80202-1129
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Phone<PHONE_NUMBER>
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www.epa.gov/region8

Ref:  8ARD-PM

Mr. Mike Natchees
Director
Air Quality Program
Ute Indian Tribe
P.O. Box 70
Fort Duchesne, Utah  84026

Re:	Table Rock Minerals, LLC, Gilsonite Mine, Permit # TMNSR-UO-007057-2021.002, Proposed True Minor New Source Review Permit

Dear Mr. Natchees:

The U.S. Environmental Protection Agency Region 8 is proposing to issue a permit in accordance with the Tribal Minor New Source Review (MNSR) Permit Program at 40 CFR part 49, for the Table Rock Minerals LLC's proposed modification involving the construction of a new generator engine and pneumatic conveyance at a gilsonite mining operation, on Indian country lands within the Uintah and Ouray Indian Reservation. The proposed project is estimated to be a true minor source with respect to MNSR regulated pollutants. The proposed permit would revise the current effective permit issued in 2017 and would contain production and operating hours limits and emission control efficiency requirements, and associated monitoring, recordkeeping and reporting requirements for the mine and/or certain pollutant emission-generating units or activities approved for construction and installation.

A public comment period for the proposed permit will begin on August 10, 2021, and end on September 9, 2021.

Due to the COVID-19 pandemic, online electronic copies of the draft permit, technical support document and supporting materials may be viewed at: http://www.epa.gov/caa-permitting/caa-permit-public-comment-opportunities-region-8. The proposed permit and supporting documentation are also available in the electronic docket at regulations.gov (Docket ID # EPA-R08-OAR-2021-0239).

Please submit any written recommendations you may have concerning the terms and conditions of the draft permit to Colin Schwartz, of my staff, at<EMAIL_ADDRESS>Comments may also be submitted via email to<EMAIL_ADDRESS>or through regulations.gov (Docket ID # EPA-R08-OAR-2020-0134).

If you have any questions concerning the proposed permit or technical support document, please contact Colin Schwartz, of my staff, at<PHONE_NUMBER> or at<EMAIL_ADDRESS>

                                       Sincerely,

                                      Carl Daly
                                      Acting Director
                                      Air and Radiation Division


[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Rules and Regulations]
[Page 20785-20794]
[DOCID:fr17ap08-7]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 189 and 700

[Docket No. 2004N-0081]
RIN 0910-AF47

Use of Materials Derived From Cattle in Human Food and Cosmetics

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule and request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations on the use of materials derived from cattle in human food
and cosmetics. In these regulations, FDA has designated certain
materials from cattle as ``prohibited cattle materials'' and has banned
the use of such materials in human food, including dietary supplements,
and in cosmetics. Prohibited cattle materials include specified risk
materials (SRMs), the small intestine of all cattle unless the distal
ileum is removed, material from nonambulatory disabled cattle, material
from cattle not inspected and passed for human consumption, or
mechanically separated (MS) (Beef). Specified risk materials include
the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral
column (excluding the vertebrae of the tail, the transverse processes
of the thoracic and lumbar vertebrae, and the wings of the sacrum), and
dorsal root ganglia of cattle 30 months of age and older, and the
tonsils and distal ileum of the small intestine of all cattle. FDA is
amending its regulations so that FDA may designate a country as not
subject to certain bovine spongiform encephalopathy (BSE)-related
restrictions applicable to FDA regulated human food and cosmetics. A
country seeking to be so designated must send a written request to the
Director of FDA's Center for Food Safety and Applied Nutrition,
including information about the country's BSE case history, risk
factors, measures to prevent the introduction and transmission of BSE,
and any other relevant information.

DATES: This interim final rule is effective July 16, 2008. Submit
written or electronic comments on this interim final rule by July 16,
2008. Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 by May 19, 2008 (see the ``Paperwork
Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. 2004N-0081
and RIN 0910-AF47, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously in the ADDRESSES portion of
this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No. and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see
section IV of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rebecca Buckner, Center for Food
Safety and Applied Nutrition (HFS-316), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 14, 2004 (69 FR 42256), FDA issued
an interim final rule entitled ``Use of Materials Derived From Cattle
in Human Food and Cosmetics'' (``the 2004 IFR'') to address the
potential risk of BSE in human food and cosmetics. In the 2004 IFR, FDA
designated certain materials from cattle as ``prohibited cattle
materials'' and banned the use of such materials in human food,
including dietary supplements, and in cosmetics. These restrictions
appear in Sec. Sec.  189.5 and 700.27 (21 CFR 189.5 and 21 CFR 700.27)
of FDA's regulations.
    The 2004 IFR designated the following as prohibited cattle
materials: SRMs, the small intestine from all cattle, material from
nonambulatory disabled cattle, material from cattle not inspected and
passed for human consumption, or MS (Beef). SRMs include the brain,
skull, eyes, trigeminal ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the transverse processes of the
thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal
root ganglia of cattle 30 months of age and older, and the tonsils and
distal ileum of the small intestine from all cattle. The Food Safety
and Inspection Service (FSIS) of the United States Department of
Agriculture (USDA) designated the same list of materials as SRMs in its
interim final rule entitled ``Prohibition of the Use of Specified Risk
Materials for Human Food and Requirements for the Disposition of Non-
Ambulatory Disabled Cattle'' (69 FR 1862, January 12, 2004).
    In the Federal Register of September 7, 2005 (70 FR 53063), FDA
amended the 2004 IFR to permit the use of the small intestine in human
food and cosmetics provided the distal ileum portion of the small
intestine has been removed. FDA also clarified that milk and milk
products, hide and hide-derived products, and tallow derivatives are
not prohibited cattle materials, and cited a different method for
determining impurities in tallow. Also in the Federal Register of
September 7, 2005 (70 FR 53043), FSIS published a similar amendment to
its interim final rule, permitting the use of the small intestine in
human food provided the distal ileum is removed.

II. Amendments to the Interim Final Rule's Provisions on Prohibited
Cattle Materials

    In the 2004 IFR, FDA requested comment on whether materials from
countries believed to be free of BSE should be exempt from the
``prohibited cattle materials'' requirements. FDA further solicited
comment on what standards it should apply in determining whether to
exempt a country and how it should determine whether a country meets
such standards (69 FR 42256 at 42263). FSIS requested similar comment
on the issue of equivalence in applying its BSE requirements in an
advance notice of proposed rulemaking (ANPR) entitled ``Federal
Measures to Mitigate BSE Risks: Considerations for Further Actions,''
jointly published by USDA's Animal and Plant Health Inspection Service
(APHIS) and FSIS, and FDA on July 14, 2004 (69 FR 42299-42300).

A. Comments Received

    In response to FDA's solicitation on this issue, FDA received
comments from representatives of several foreign countries that export
cattle materials or products derived from such materials into the
United States and from several trade associations. The comments take
issue with the uniform application of FDA's BSE-related measures to all
human food and cosmetics imported into the United States, without
regard to the BSE risk status of the originating country. Several
comments state that their countries have a comprehensive range of
control measures in place to prevent the entry and/or amplification of
the BSE agent. These comments maintain that countries classified as
BSE-free do not present a BSE risk and therefore should not be expected
to comply with FDA's BSE-related restrictions. These comments further
maintain that U.S. requirements are forcing establishments and firms in
countries considered to be free of BSE to carry out costly and
unnecessary measures that are not scientifically justified so that they
can export cattle materials to the United States.
    These comments also state that providing an exemption from BSE-
related restrictions for countries classified as free of BSE would be
consistent with guidelines established by the World Organization for
Animal Health (referred to as ``OIE,'' based on its previous name,
Office International des Epizooties), an international standard-setting
body with 169 member countries, that publishes health standards for
international trade in animal products. These comments state that the
OIE recommends that countries restrict the importation of cattle
material of potential concern on the basis of the BSE risk
classification of the country or zone of origin. (See Terrestrial
Animal Health Code, Ref. 1). These comments also point out that OIE
recommends the removal of SRMs for imports from countries classified as
minimal, moderate, and high risk for BSE but not for imports from
countries with BSE-free status.\1\ Further, these comments

point out that the World Trade Organization Agreement on the
Application of Sanitary and Phytosanitary Measures (the SPS Agreement)
requires member countries to recognize regionalization of diseases and
not put in place measures that are more trade restrictive than
necessary to achieve public health goals.
---------------------------------------------------------------------------

    \1\ At the time the comments were submitted, OIE classified
countries for purposes of BSE into one of five categories: ``free,''
``provisionally free,'' ``minimal,'' ``moderate,'' and ``high
risk.'' OIE subsequently revised its categories and now uses only
three categories: ``negligible,'' ``controlled,'' and
``undetermined'' risk. Countries previously categorized as ``BSE-
free'' or ``provisionally free'' are now categorized as having
``negligible'' BSE risk.
---------------------------------------------------------------------------

    Several of the comments also note that Canada and the European
Union (EU) do not apply all of their BSE-related restrictions to
countries recognized as BSE-free. For example, EU food and cosmetic
regulations exclude countries that fall within the EU's lowest risk
range of BSE risk categories from restrictions on the use of SRMs.
Canada provides a similar exemption from its BSE-related restrictions
for countries it considers to be free from BSE.\2\
---------------------------------------------------------------------------

    \2\ Since these comments were submitted, Canada has adopted the
OIE BSE risk categorization system of negligible, controlled, and
undetermined risk. The EU is in the process of transitioning from
its geographical BSE risk (GBR) system, which includes four levels
of risk, to the OIE 3-tiered risk categorization system.
---------------------------------------------------------------------------

    One comment suggests that in considering the BSE risk status of
another country, FDA should refer to available country assessments
already completed by USDA's APHIS in carrying out its BSE-related
restrictions on imports of meat and edible products from ruminants
(codified at 9 CFR 94.18), or otherwise rely on criteria provided by
OIE for determining BSE-free countries. One comment recommends that if
the assessment is conducted by U.S. authorities, it should be conducted
by a single U.S. agency, preferably APHIS, given its prior experience
in conducting this type of assessment.

B. USDA Amendment

    USDA's FSIS received similar comments in response to its interim
final rule published on January 12, 2004, and the ANPR published July
14, 2004, regarding the application of its BSE-related restrictions for
imported products without taking into account a country's BSE risk
status. Based in part on these comments, FSIS, in its affirmation of
interim final rules with amendments published on July 13, 2007 (72 FR
38699), amended its regulations to exclude from its definition of SRMs
those materials from cattle that come from foreign countries that can
demonstrate that their BSE risk status can reasonably be expected to
provide the same level of protection from exposure to the BSE agent as
does prohibiting the use of SRMs in the United States.

C. Response to Comments

    FDA agrees with the views expressed by the comments and has
determined that it is not necessary for all BSE-related restrictions to
apply to human food and cosmetics regardless of a country's BSE status.
FDA's BSE-related restrictions for human food and cosmetics are
intended to address the potential presence of BSE in a country's cattle
population. SRMs are prohibited because they are the tissues most
likely to harbor infectivity in cattle with BSE. The small intestine is
prohibited unless the distal ileum portion of the small intestine,
which is considered an SRM, is effectively removed. Material from
nonambulatory disabled cattle are prohibited because evidence has
indicated that this segment of the cattle population is more likely to
have BSE than healthy-appearing cattle and the typical clinical signs
of BSE having to do with gait and movement cannot be observed in
nonambulatory cattle. MS (Beef) is included in the definition because
it may contain concentrated amounts of the following SRMs: spinal cord,
dorsal root ganglia, and vertebral column. Material from cattle not
inspected and passed is prohibited because they are at higher risk of
harboring undetected BSE.
    As described in the 2004 IFR, epidemiological evidence indicates
that the BSE epidemic in the United Kingdom (U.K.) was a result of
consumption of animal feed contaminated by the BSE agent. The spread of
BSE outside the U.K. has been attributed to the export of BSE-
contaminated feed from the U.K. to other countries prior to the
realization of the role of feed in transmitting the disease and the
implementation of restrictions on such trade. However, a country may
not have engaged in trade in animal feed with the U.K. or other
affected countries, and it may have had preventive measures in place
for a length of time adequate to make the chance remote that BSE
currently is present in its national herds.
    Such a country may be able to demonstrate to FDA that its BSE case
history, risk factors, and measures to prevent the introduction and
transmission of BSE make certain BSE-related restrictions unnecessary.
Not restricting cattle materials inspected and passed for human
consumption from such a country to be used in human food and cosmetics
is consistent with all applicable statutory standards. Further, this
approach is consistent with OIE's recommendation that cattle materials
from negligible risk countries not be restricted.
    Material from cattle not inspected and passed for human consumption
will continue to be prohibited, regardless of the country of origin. We
are retaining this provision as a universal requirement because the
exception for designated countries in this amendment is predicated on
application of a country's food safety controls, including inspection
of source animals, to human food or cosmetics made with cattle
materials and imported into the United States. It is critical to
ensuring safety that, regardless of the country of origin, source
cattle have been evaluated and determined appropriate for human
consumption. In addition, applying this requirement universally is
consistent with OIE recommendations, which recognize the importance
that cattle pass antemortem and post-mortem inspections even in
``negligible risk'' countries.
    Therefore, FDA is amending its regulations in Sec. Sec.  189.5 and
700.27 to provide that FDA may designate a country as not subject to
the restrictions applicable to human food and cosmetics manufactured
from, processed with, or that otherwise contain SRMs, the small
intestine of cattle, material from nonambulatory disabled cattle, or MS
(Beef). Cattle materials inspected and passed from a designated country
will not be considered prohibited cattle materials and their use will
not render a human food or cosmetic adulterated. The amendment further
provides that a country seeking to be so designated must send a written
request to the Director of FDA's Center for Food Safety and Applied
Nutrition, including information about a country's BSE case history,
risk factors, measures to prevent the introduction and transmission of
BSE, and other information relevant to determining whether SRMs, the
small intestine of cattle (unless the distal ileum has been removed),
material from nonambulatory disabled cattle, or MS (Beef) should be
considered prohibited cattle materials.
    In its application, the requesting country will be expected to
provide information to FDA on its BSE case history, including whether
cattle in that country have tested positive for BSE, and if so, the
circumstances and the country's response. In addition, FDA will review
information that addresses the extent to which the requesting country
has identified and taken into account relevant risk factors such as the
following:
     Possible presence of BSE in indigenous and/or imported
cattle;

     Geographic origin of imported cattle;
     Materials used in the production of ruminant feed and feed
ingredients; and
     Importation of ruminant feed and feed ingredients.
    FDA will consider information relating to the possible presence of
BSE in indigenous and imported cattle in the requesting country as well
as the requesting country's production and importation of ruminant feed
and feed ingredients. With respect to imported cattle, relevant
information includes the identification of any countries where imported
cattle were born or raised and the dates any cattle were imported. With
regard to ruminant feed, FDA will consider, among other things, how
ruminant feed was produced in the requesting country, including what
animal origin materials were allowed to be included. FDA will also
consider whether ruminant feed and feed ingredients were imported, and
if so, the source countries and dates of import.
    In addition to reviewing risk factors such as those identified
previously, FDA will assess how the requesting country has addressed
and managed any identified BSE risks through the implementation of
appropriate measures to prevent the introduction and transmission of
BSE. FDA will consider how long such preventive measures have been in
place and whether they have been effectively carried out. Examples of
preventive measures include the following:
     A prohibition on the use of ruminant feed that might carry
a risk of transmitting the BSE agent;
     A prohibition on the importation of cattle and cattle-
derived products that might carry a risk of transmitting the BSE agent;
     Surveillance systems for BSE in cattle populations with
appropriate examination of brain or other tissues collected for
surveillance in approved laboratories;
     Mandatory notification and examination of all cattle
showing signs consistent with BSE; and
     Protocols or other written procedures for investigating
potential cases of BSE, including ability to trace former herdmates of
BSE-positive animals.
    As part of its evaluation of feed restrictions, FDA will consider
factors including whether appropriate feed restrictions are in place
and the adequacy of enforcement of those restrictions (e.g., the
frequency of facility inspections and level of compliance). FDA also
will consider a requesting country's import controls for cattle
material. Such consideration will include whether the country
effectively monitors and controls potential pathways of SRMs and other
potentially infective materials into its country from other countries
for whom such controls are necessary.
    In addition, FDA will consider the requesting country's
surveillance and monitoring efforts with respect to BSE. For example,
FDA will evaluate the level at which the country performs surveillance
and monitoring, whether tissue samples are collected and examined at
approved laboratories, and whether recognized diagnostic procedures and
methods are used, such as those procedures and methods provided in the
OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
(Ref. 2).
    FDA also will consider whether the country has an ongoing program
for notification and investigation of all cattle showing signs
consistent with BSE. In evaluating such a program, FDA will consider,
among other factors, whether notification and investigation are
mandated, whether veterinarians, producers, and others involved in
cattle production have been provided sufficient information about BSE,
such as through an awareness program, and whether there are additional
measures in place to stimulate reporting of suspect cattle, such as
compensation or penalties.
    FDA also will consider a country's written procedures for
investigating potential cases of BSE. Such a consideration will include
whether the country has written procedures for the investigation of
suspect animals and whether the country has the investigative
capability to followup positive findings by tracing former herdmates of
animals determined to be BSE positive. Finally, FDA also will consider
any other information relevant to determining whether the country
should be designated under Sec. Sec.  189.5(e) and 700.27(e).
    FDA and the USDA agencies, APHIS and FSIS, have different
regulatory responsibilities with respect to preventing BSE and ensuring
food safety. Further, it is not necessary or practical for one of the
three agencies to conduct every evaluation of a country's BSE status,
regardless of the purpose of the evaluation. FDA will, however, consult
with APHIS and FSIS as part of its evaluation process. Further, FDA
will take into consideration available risk assessments of other
competent authorities in conducting its evaluation. Though it is not
required, a previous BSE evaluation by USDA, OIE, or by another country
or another competent authority, will be helpful to FDA in its review
and may decrease the time needed for FDA to make a determination.
    Upon completion of its review, FDA will provide written
notification of its decision to the applicant country, including the
basis for the decision. FDA may impose conditions in granting a request
for designation. Further, any designation granted under Sec.  189.5 or
Sec.  700.27 will be subject to future review by FDA to ensure that the
designation remains appropriate. As part of this process, FDA may ask
designated countries to confirm that their BSE situation and the
information submitted by them in support of their original application
remain unchanged. Further, FDA may revoke a country's designation if
FDA determines that it is no longer appropriate.
    FDA will provide further information on its evaluation process, the
scope of the review, and the types of supporting information that it
would find helpful in reviewing a country's submission at the time of
the request.

III. Summary of Amendments to the Interim Final Rule

    FDA is amending its regulations in Sec. Sec.  189.5(a) and
700.27(a) by revising the definition of ``prohibited cattle materials''
to exclude cattle materials inspected and passed for human consumption
from a country designated by FDA under Sec.  189.5(e) or Sec.
700.27(e). New Sec. Sec.  189.5(e) and 700.27(e) provide that a country
seeking such a designation must send a written request to the Director,
Office of the Center Director, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740-3835. Further, the request shall include
information about a country's BSE case history, risk factors, measures
to prevent the introduction and transmission of BSE, and other
information relevant to determining whether SRMs, the small intestine
of cattle (unless the distal ileum has been removed), material from
nonambulatory disabled cattle, or MS (Beef) should be considered
prohibited cattle materials. The new sections further provide that FDA
shall respond in writing to any such request and that FDA may revoke a
country's designation if FDA determines that it is no longer
appropriate.

IV. Effective Date and Opportunity for Public Comment

    In the 2004 IFR, FDA solicited comment on whether materials from
countries believed to be free from BSE should be exempt from the
``prohibited cattle materials'' requirements. FDA

addresses the comments it received in this document. This amendment is
effective on July 16, 2008. FDA invites public comment on the current
amendment to the interim final rule; submit written or electronic
comments on the interim final rule by July 16, 2008. The agency will
consider modifications to the current amendment to the interim final
rule based on comments made during the comment period. Interested
persons may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
    FDA will address other comments received in response to the 2004
IFR and comments received in response to this document in further
rulemaking.

V. Executive Order 12866 and Regulatory Flexibility Act

A. Interim Final Regulatory Impact Analysis

    FDA has examined the economic impacts of the interim final rule
under Executive Order 12866. Executive Order 12866 directs 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). Executive Order 12866 classifies a rule as significant if
it meets any one of a number of specified conditions, including having
an annual effect on the economy in a material way, adversely affecting
competition, or adversely affecting jobs. A regulation is also
considered a significant regulatory action if it raises novel legal or
policy issues. FDA has determined that this interim final rule is not a
significant regulatory action as defined by Executive Order 12866.
1. Need for Regulation
    FDA agrees with FSIS and the international community that cattle
materials imported from countries that can demonstrate that their BSE
case history and their having in place effective measures to prevent
the introduction and transmission of BSE may be such that they should
not be subject to the same BSE-related restrictions applied to cattle
materials imported into the United States from other countries.
Restricting the importation of potentially infective materials on the
basis of the BSE risk of the region of origin is more efficient than an
approach that does not consider a country's circumstances regarding
BSE.
    As comments on the 2004 IFR have noted, the World Trade
Organization Agreement on the Application of Sanitary and Phytosanitary
Measures (the SPS Agreement) requires member countries to recognize
regionalization of diseases and not put in place measures that are more
trade restrictive than necessary to achieve public health goals. Thus,
the uniform application by FDA of BSE-related restrictions to all
imports of food and cosmetic products into the United States without
taking into account a country's BSE case history, risk factors,
measures to prevent the introduction and transmission of BSE, and other
relevant information means that other countries must implement costly
and unnecessary measures that may not be scientifically justified.
Providing this exception from certain requirements relating to human
food and cosmetics for designated countries is more efficient in the
sense that it achieves essentially the same protection of public health
with fewer restrictions on the market for cattle-derived materials.
2. Interim Final Rule Coverage
    Foreign countries need to make formal application to FDA in order
to be considered for this exception from the provision on prohibited
cattle materials in Sec. Sec.  189.5 and 700.27. FDA will make a
determination as to a country's request based on an evaluation that is
carried out in consultation with the USDA's APHIS and FSIS. FDA will
take into consideration relevant technical information provided by the
requesting country with respect to its BSE case history, including
whether cattle in that country have tested positive for BSE, and if so,
the circumstance and the country's response. In addition, FDA will
review information that addresses the extent to which the requesting
country has identified and taken into account relevant risk factors
such as the following:
     The possible presence of BSE in indigenous and/or imported
cattle;
     Geographic origin of imported cattle;
     Materials used in the production of ruminant feed and feed
ingredients; and
     Importation of ruminant feed and feed ingredients.
FDA will also assess how the requesting country has addressed and
managed any identified BSE risks through the implementation of
appropriate measures to prevent the introduction and transmission of
BSE, such as the following:
     A prohibition on the use of ruminant feed that might carry
a risk of transmitting the BSE agent;
     A prohibition on the importation of cattle and cattle-
derived products that might carry a risk of transmitting the BSE agent;
     Surveillance systems for BSE in cattle populations with
appropriate examination of brain or other tissues collected for
surveillance in approved laboratories;
     Mandatory notification and examination of all cattle
showing signs consistent with BSE; and
     Protocol or other written procedures for investigating
potential cases of BSE, including ability to trace former herdmates of
BSE-positive animals.
Number of Countries Affected
    We do not know how many countries will take advantage of the option
to petition FDA for a designation under Sec. Sec.  189.5(e) and
700.27(e). According to information from the OIE, countries that are
officially recognized as having a ``negligible BSE risk'' in accordance
with the requirements of the OIE Terrestrial Animal Health Code (16th
edition 2007) include the following: Australia, Argentina, New Zealand,
Singapore, and Uruguay. Two countries, Iceland and Paraguay, are
recognized as ``provisionally free''\3\ from BSE. For these two
categories of countries, OIE does not recommend the removal of SRMs
(Ref. 4).
---------------------------------------------------------------------------

    \3\ The OIE ``provisionally free'' designation is in accordance
with the 2004 edition (13th edition) of the Terrestrial Animal
Health Code, and remains in effect for Iceland and Paraguay until
May 2008. See Ref. 3.
---------------------------------------------------------------------------

    Table 1 presents data from the U.S. International Trade Commission
(Ref. 5) showing for 2006 the top 10 exporters of meat products\4\ and
animal fats, oils, and by-products to the United States.
---------------------------------------------------------------------------

    \4\ The data sorted by NAICS code does not allow for the
separation of beef products that are imported from other imported
meat products such as pork.

 Table 1.--Top 10 Countries Exporting Specified North American Industry
  Classification System (NAICS) Code Products to United States for 2006
NAICS 311611\1\--Meat Products (Excluding       Quantity (thousands of
 Poultry)                                            kilograms)\2\
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Canada                                        681,899
------------------------------------------------------------------------
Australia                                     376,585
------------------------------------------------------------------------
New Zealand                                   211,873
------------------------------------------------------------------------
Uruguay                                       103,305
------------------------------------------------------------------------
Brazil                                        83,897
------------------------------------------------------------------------
Denmark                                       46,652
------------------------------------------------------------------------
Mexico                                        35,553
------------------------------------------------------------------------
China                                         28,530
------------------------------------------------------------------------
Argentina                                     22,353
------------------------------------------------------------------------
Nicaragua                                     21,303
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
NAIC 311613--Animal Fats, Oils, & By-                (thousands of
 Products                                            kilograms)\3\
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Canada                                        94,306
------------------------------------------------------------------------
New Zealand                                   32,550
------------------------------------------------------------------------
China                                         7,809
------------------------------------------------------------------------
Australia                                     6,807
------------------------------------------------------------------------
Brazil                                        6,589
------------------------------------------------------------------------
Mexico                                        2,130
------------------------------------------------------------------------
Colombia                                      1,826
------------------------------------------------------------------------
Germany                                       1,642
------------------------------------------------------------------------
Ecuador                                       1,149
------------------------------------------------------------------------
Japan                                         1,138
------------------------------------------------------------------------
\1\ The NAIC code 31161 covers the animal slaughtering and processing
  industry. The industry is composed of establishments that are
  primarily engaged in one or more of the following: (1) Slaughtering
  animals, (2) preparing processed meats and meat by-products, and (3)
  rendering and refining animal fat, bones, and meat scraps. The
  subcategory 311611 comprises those establishments primarily engaged in
  slaughtering animals (except poultry and small game). Establishments
  that slaughter and prepare meats are included in this classification.
  (Ref. 5) We use this data as an indicator of the countries that are
  most likely to petition FDA regarding their BSE status.
\2\ These figures do not include exports measured in ``clean yield
  kilograms'' and ``pieces.''
\3\ These figures do not include exports measured in ``grams,''
  ``liters,'' ``metric tons,'' and ``pieces.''

    We do not know how many countries might petition the FDA. However,
taking into consideration the previous information on countries
officially recognized as having a negligible BSE risk or being
provisionally free of BSE under OIE, as well as the information in
table 1 on countries that export large amounts of meat products and
animal fats, oils, and byproducts to the United States, we are
estimating for this analysis that 10 countries may be interested in
petitioning FDA to be excepted from certain BSE-related restrictions
applicable to human food and cosmetics. Our estimate is not intended to
suggest that all of these countries would be able to qualify for a
designation under Sec. Sec.  189.5(e) and 700.27(e).
3. Costs and Benefits of Exemption Provision
    Countries that petition the FDA to be designated as excepted from
certain BSE-related restrictions applicable to human food and cosmetics
may also petition USDA for exclusion from USDA's BSE-related
requirements. Some of the costs to countries to petition FDA may be
shared with costs to petition USDA because of similarities regarding
how countries' products can qualify for the exceptions. Even so, we
will outline here a potential scenario for calculating the costs of
petitioning FDA for an exception from certain provisions of the
agency's BSE regulations.
    a. Assumptions and costs associated with this interim final rule.
We would expect countries that wish to petition FDA to be excepted from
certain BSE-related restrictions applicable to human food and cosmetics
to have already completed a risk assessment and put risk management
strategies into place.\5\ Whether these risk assessment and mitigation
strategies are sufficient for a country to be so designated by FDA will
be determined on a case-by-case basis.
---------------------------------------------------------------------------

    \5\ We assume such measures were necessary to continue marketing
cattle products following the surge of BSE cases in the U.K. and the
rulemakings that followed.
---------------------------------------------------------------------------

    b. Petition process. We assume petitions to FDA for this
designation would include an already developed risk assessment or other
technical information on the country's BSE situation, a detailed
outline of risk mitigation strategies, and information on the country's
cattle-derived products that are exported to the United States. The
petition is assumed to take 80 hours per country for assembly of the
information and the wage for a government employee earning a GS-14 step
1 (Ref. 6) is used to estimate the costs. The cost of assembling a
single petition is estimated to be about $5,400 (80 hours x $67.44 per
hour including overhead). The petition will also be reviewed by higher
level government managers before being sent to the FDA. We assume the
wage for a high level government executive is a GS-15 step 3 (Ref. 6)
and that they will spend 40 hours reviewing the petition. The cost of
review by a government manager is estimated to be about $3,400 (40
hours x $84.62 per hour including overhead). Thus, the total cost to
each country to prepare and submit a petition to FDA to be considered
for this designation would be about $9,000.
    c. Petition review by FDA. It will take FDA approximately 80 hours
to review a petition. The cost of each petition review would be about
$3,700 (80 hours x $45.65 per hour).\6\
---------------------------------------------------------------------------

    \6\ Pay for an employee earning a GS-13 step 7 adjusted to
include locality pay for Washington D.C. and surrounding area (Ref.
6).

     Table 2.--Total Cost of Initial Petition Application and Review
Petition Assembly and Review per Country         $9,000
------------------------------------------------------------------------
FDA Review per Petition                          $3,700
------------------------------------------------------------------------
Total Cost per Country                           $12,700
------------------------------------------------------------------------
Cost for 10 Countries                            $127,000
------------------------------------------------------------------------

    d. Petition success uncertainty. It is possible that some countries
that petition the FDA to be designated as excepted from certain BSE-
related restrictions applicable to human food and cosmetics will not be
successful. We do not know how likely it will be that countries with
insufficient BSE risk assessment and mitigation strategies will
petition the FDA.
    e. Future petitions to FDA. It is likely that those countries that
currently sell a significant amount of cattle-derived material will be
most interested in seeking possible relief under this change to FDA's
prohibited cattle materials requirements. It is possible in the future,
if new markets for cattle derived products develop, that other
countries may want to petition FDA to be designated as not subject to
certain BSE-related restrictions applicable to human food and
cosmetics. We do not attempt to forecast new markets for cattle derived
products here. We also do not attempt to forecast the frequency of, or
estimate the costs associated with, FDA review in the future of
successful petitions.
    f. Future review of successful petitions by FDA. Countries that
successfully

petition the FDA to be designated as excepted from certain BSE-related
restrictions applicable to human food and cosmetics will be subject to
future review by FDA to ensure that their designation remains
appropriate. As part of this process, FDA may ask designated countries
to confirm that their BSE situation and the information submitted by
them in support of their original application remain unchanged. FDA may
revoke a country's designation if FDA determines that it is no longer
appropriate.
    FDA has not yet determined the method by which the agency will
conduct these future reviews. One possible method would be for FDA to
send a letter to designated countries asking whether there has been a
change in their status or circumstances relative to their BSE history,
surveillance, import activities, or other relevant criteria and then
compare any changed information with the information that was
originally submitted. The OIE requires that countries it has recognized
in regard to their BSE status ``should annually confirm during the
month of November whether their status and the criteria by which their
status was recognized have remained unchanged.'' In some cases, the FDA
reviewer might rely on this information, if available, in conducting a
future review of the country's designation.
    We assume it will take FDA and the designated country undergoing a
review in the future about one third the time and effort it did when
the original information was submitted. Thus, if the total cost to
initially submit a petition and have it reviewed by FDA was $12,700,
then a future review of the petition by FDA and the submitting country
will cost about $4,200 (see Table 3).

         Table 3.--Cost of Future Review of Successful Petitions
Submission of Additional Information and         $3,000
 Response by Country
------------------------------------------------------------------------
FDA Review per Country                           $1,200
------------------------------------------------------------------------
Total Cost per Country                           $4,200
------------------------------------------------------------------------
Cost for 10 Countries                            $42,000
------------------------------------------------------------------------

4. Other Options Considered
    FDA considered the following options when examining the costs and
benefits of this IFR.
Option 1--Do nothing.
    This option is the baseline for which the costs and benefits of
other options are compared. The costs and benefits of this option have
already been realized. Firms buying and selling cattle-derived
materials in the United States and other countries have found
alternatives to using products covered by the definition of prohibited
cattle materials in the manufacture of their products.
Option 2--Amend definition of prohibited cattle materials (the chosen
option).
    The costs and benefits of this option are outlined previously. The
main benefit of this option is that it is more efficient than the
current regulation because it achieves essentially the same protection
of public health with fewer restrictions on the market for cattle-
derived materials. With this interim final rule, FDA can continue to
prevent the potential introduction and transmission of BSE from cattle
materials from non-designated countries, while at the same time
reducing the restrictions on the market for cattle-derived materials
from designated countries.
Option 3--Amend the definition of prohibited cattle materials to allow
material from cattle not inspected and passed for human consumption for
use in human food and cosmetics.
    This option is less stringent than option 2, which would reduce the
costs of cattle-derived materials used in the manufacture of human food
and cosmetics, but it would not provide the same public health benefits
as options 1 and 2. Material from cattle not inspected and passed for
human consumption has not been approved by a regulatory authority (USDA
or other) and thus we cannot make the determination that, among other
things, the cattle material is from an animal that was evaluated for a
neurological disorder such as BSE. In requiring that material from
cattle for use in FDA-regulated human food and cosmetics be inspected
and passed for human consumption, we are minimizing the risk of
exposure to the agent that causes BSE, and therefore maximizing the
protection of public health from variant Creutzfeldt-Jakob disease, the
human disease linked to consumption of BSE-infected cattle material.
5. Benefits
    Under this interim final rule, foreign countries would have the
option of demonstrating (through information submitted to FDA) that
their BSE case history, their identifying and taking into account
relevant risk factors, their implementing appropriate measures to
prevent the introduction and transmission of BSE, and any other
relevant information shows that certain BSE-related restrictions, in
their case, are unnecessary. Countries that successfully petition FDA
would be able to again export human food and cosmetics to the United
States without the removal of the following items:
     SRMs
     Small intestine (including the distal ileum)
     Material from nonambulatory disabled cattle
     MS (Beef)
6. Effect on Food Supply in the United States
    We expect this interim final rule amendment will increase the
availability of certain cattle materials (and products containing those
materials) for sale in the United States. The most significant gain in
supply will probably occur from the increased availability of FDA-
regulated products that contain MS (Beef) and material from
nonambulatory disabled cattle for use in human food regulated by FDA.
Few, if any, human food or cosmetic products use SRMs as an ingredient,
but to the extent that these materials are needed, they will again be
available in the United States.

B. Final Regulatory Flexibility Analysis

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) imposes
certain requirements with respect to Federal rules that are subject to
the notice and comment requirements of section 553(b) of the
Administrative Procedure Act (5 U.S.C. 551 et seq.) and that are likely
to have a significant economic impact on a substantial number of small
entities. Unless an agency certifies that a proposed rule will not have
a significant economic impact on a substantial number of small
entities, section 603 of the RFA requires that the agency present an
initial regulatory flexibility analysis at the time of the publication
of the notice of proposed rulemaking describing the impact of the rule
on small entities and seeking public comment on such impact. Because
this rule is being issued as an interim final rule, the RFA does not
apply and FDA is not required to either certify that the rule will not
have a significant impact on a substantial number of small businesses
or conduct an initial regulatory flexibility analysis. Also, FDA does
not have information on how many small firms in foreign countries
designated by the agency may benefit from this rule. Examining the
effect this interim final rule has on small foreign firms is outside
the scope of the RFA requirements.
    The extent to which small firms within the United States are
affected by this rule is unknown. FDA

acknowledges that small U.S. businesses that use imported cattle
materials in manufacture or for sale as final products will likely
benefit from this rulemaking as costs of these inputs are expected to
decrease as supply increases. Small U.S. firms that compete with
foreign firms in order to supply cattle-derived inputs and products to
U.S. business and markets may be adversely affected if foreign firms
can more cheaply supply these materials and products. FDA seeks public
comment on the question of whether such small U.S. businesses will be
adversely impacted by this rule.

C. Unfunded Mandates

    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law
104-4) requires cost-benefit and other analyses before any rule making
if the rule would include a ``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 $127 million, using the most current (2006)
Implicit Price Deflator for the Gross Domestic Product. FDA has
determined that this interim final rule does not constitute a
significant rule under the Unfunded Mandates Reform Act.

VI. Paperwork Reduction Act of 1995

    This interim final rule contains information collection
requirements that 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 title, description, and respondent description of these
provisions are shown in the following paragraphs with an estimate of
the annual recordkeeping burden. Included in the estimate is the time
for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing each
collection of information.
    FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
    Title: Petition To Be Designated as Not Subject to Certain BSE-
Related Restrictions Applicable to FDA Regulated Human Food and
Cosmetics
    Description: FDA is amending the interim final rule on use of
materials derived from cattle in human food and cosmetics published in
the Federal Register of July 14, 2004, and then amended on September 7,
2005. In the 2004 interim final rule and its amendments, FDA designated
certain materials from cattle as ``prohibited cattle materials'' and
banned the use of such materials in human food, including dietary
supplements, and in cosmetics. Prohibited cattle materials include
SRMs, the small intestine of all cattle unless the distal portion of
the ileum is removed, material from nonambulatory disabled cattle,
material from cattle not inspected and passed for human consumption,
and MS (Beef). SRMs include the brain, skull, eyes, trigeminal ganglia,
spinal cord, vertebral column (excluding the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the
wings of the sacrum), and dorsal root ganglia of cattle 30 months and
older; and the tonsils and distal ileum of the small intestine of all
cattle. Therefore, FDA is amending its regulations at Sec. Sec.  189.5
and 700.27 to provide that FDA may designate a country as not subject
to the restrictions applicable to human food and cosmetics manufactured
from, processed with, or that otherwise contain SRMs, the small
intestine of cattle, material from nonambulatory disabled cattle, or MS
(Beef). The interim final rule, as amended, provides that these
materials, when from cattle from a designated country, are not
considered prohibited cattle materials, and their use does not render a
human food or cosmetic adulterated. The amendment further provides that
a country seeking to be so designated must send a written request to
the Director of FDA's Center for Food Safety and Applied Nutrition,
including information about a country's BSE case history, risk factors,
measures to prevent the introduction and transmission of BSE, and other
information relevant to determining whether SRMs, the small intestine
of cattle (unless the distal ileum has been removed), material from
nonambulatory disabled cattle, or MS (Beef) should be considered
prohibited cattle materials.
    Description of Respondents: Countries with firms that would like to
use SRMs, the small intestine of cattle, material from nonambulatory
disabled cattle, or MS (Beef) in products exported to the United
States.
Information Collection Burden Estimate
    FDA estimates the burden for this information collection as
follows:

                         Table 4.--Estimated One-Time and Recurring Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of         No. of Responses       Total Annual        Hours per
  21 CFR Section      Respondents        per Respondent         Responses           Response        Total Hours
----------------------------------------------------------------------------------------------------------------
189.5 and                         10                     1                 10                 80             800
 700.27\2\
----------------------------------------------------------------------------------------------------------------
189.5(e) and                      10                     1                 10               26.4             264
 700.27(e)
----------------------------------------------------------------------------------------------------------------
Total one time burden                                                                                800
----------------------------------------------------------------------------------------------------------------
Total recurring burden                                                                                264
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the collection of information
  under this interim final rule.
\2\ One-time burden.

One Time Reporting Burden
    There will be a one time burden to countries that apply to FDA
seeking to be designated as not subject to restrictions applicable to
SRMs, the small intestine of cattle, nonambulatory disabled cattle, or
MS (Beef). We estimate that each country that applies for an exclusion
will spend 80 hours putting information together to submit to FDA.
Table 4 row 3 of this document presents the one-time burden expected
for countries who apply for the exclusion.
Recurring Burden

    Countries that successfully petition the FDA to be designated as
excepted from certain BSE-related restrictions applicable to human food
and cosmetics will be subject to future review by FDA to ensure that
their designation remains appropriate. As part of this process, FDA may
ask designated countries from time to time to confirm that their BSE
situation and the information submitted by them in support of their
original application remain unchanged. We assume it will take FDA and
the designated country undergoing a review in the future about one
third the time and effort it did when the information was submitted.
Table 4 row 4 of this document presents the expected recurring burden.
    The information collection provisions of this interim final rule
have been submitted to OMB for review. Interested persons are requested
to fax comments regarding information collection by (see DATES), to the
Office of Information and Regulatory Affairs, OMB. To ensure that
comments on information collection are received, OMB recommends that
written comments be faxed to the Office of Information and Regulatory
Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>.
    Prior to the effective date of this interim final rule, FDA will
publish a notice in the Federal Register announcing OMB's decision to
approve, modify, or disapprove the information collection provisions in
this interim final rule. 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 OMB control number.

VII. Environmental Impact Analysis

    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.

VIII. Federalism

    FDA has analyzed this interim final rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive Order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' FDA has determined that the interim final 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, we conclude that the interim
final 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.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web site after this document
publishes in the Federal Register.)
    1. World Organization for Animal Health, Terrestrial Animal
Health Code (2007), Chapter 2.3.13, Bovine Spongiform
Encephalopathy. See also Appendix 3.8.4 (Surveillance for Bovine
Spongiform Encephalopathy) and Appendix 3.8.5 (Factors to Consider
in Conducting the Bovine Spongiform Encephalopathy Risk Assessment
Recommended in Chapter 2.3.13). Accessed online at http://
www.oie.int/eng/normes/mcode/en_sommaire.htm.
    2. World Organization for Animal Health, Manual of Diagnostic
Tests and Vaccines for Terrestrial Animals 2004 (updated 2006).
Accessed online at http://www.oie.int/eng/normes/mmanual/A_
summry.htm.
    3. World Organization for Animal Health (OIE), Recognition of
the Bovine Spongiform Encephalopathy Status of Member Countries, OIE
Resolution No. XXIV, adopted by the International Committee of the
OIE on May 22, 2007. See http://www.oie.int/eng/info/en_
statesb.htm?eld6, accessed August 30, 2007.
    4. United States International Trade Commission, Interactive
Tariff and Trade Dataweb, http://dataweb.usitc.gov/, accessed April
6, 2007.
    5. NAICS Association, http://www.naics.com/censusfiles/
NDEF311.HTM, accessed August 27, 2007.
    6. U.S Office of Personnel Management Salaries and Wages 2007
General Schedule, http://www.opm.gov/oca/07tables/indexGS.asp,
accessed on April 11, 2007.

List of Subjects

21 CFR Part 189

    Food additives, Food packaging.

21 CFR Part 700

    Cosmetics, Packaging and containers.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
189 and 700 are amended as follows:

PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD

0
1. The authority citation for 21 CFR part 189 continues to read as
follows:

    Authority: 21 U.S.C. 321, 342, 348, 371, 381.

0
2. Section 189.5 is amended by revising paragraph (a)(1) and by adding
paragraph (e) to read as follows:

Sec.  189.5  Prohibited cattle materials.

    (a) * * *
    (1) Prohibited cattle materials means specified risk materials,
small intestine of all cattle except as provided in paragraph (b)(2) of
this section, material from nonambulatory disabled cattle, material
from cattle not inspected and passed, or mechanically separated (MS)
(Beef). Prohibited cattle materials do not include the following:
    (i) Tallow that contains no more than 0.15 percent insoluble
impurities, tallow derivatives, hides and hide-derived products, and
milk and milk products, and
    (ii) Cattle materials inspected and passed from a country
designated under paragraph (e) of this section.
* * * * *
    (e) Process for designating countries. A country seeking
designation must send a written request to the Director, Office of the
Center Director, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, at the address designated in 21 CFR 5.1100. The
request shall include information about a country's bovine spongiform
encephalopathy (BSE) case history, risk factors, measures to prevent
the introduction and transmission of BSE, and any other information
relevant to determining whether specified risk materials, the small
intestine of cattle except as provided in paragraph (b)(2) of this
section, material from nonambulatory disabled cattle, or MS (Beef) from
cattle from the country should be considered prohibited cattle
materials. FDA shall respond in writing to any such request and may
impose conditions in granting any such request. A country designation
granted by FDA under this paragraph will be subject to future review by
FDA, and may be revoked if FDA determines that it is no longer
appropriate.

PART 700--GENERAL

0
3. The authority citation for 21 CFR part 700 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 352, 355, 361, 362, 371, 374.

0
4. Section 700.27 is amended by revising paragraph (a)(1) and by adding
paragraph (e) to read as follows:

Sec.  700.27  Use of prohibited cattle materials in cosmetic products.

    (a) * * *
    (1) Prohibited cattle materials means specified risk materials,
small intestine of all cattle except as provided in paragraph (b)(2) of
this section, material from nonambulatory disabled cattle, material
from cattle not inspected and passed, or mechanically separated (MS)
(Beef). Prohibited cattle materials do not include the following:
    (i) Tallow that contains no more than 0.15 percent insoluble
impurities, tallow derivatives, hides and hide-derived products, and
milk and milk products, and
    (ii) Cattle materials inspected and passed from a country
designated under paragraph (e) of this section.
* * * * *
    (e) Process for designating countries. A country seeking
designation must send a written request to the Director, Office of the
Center Director, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, at the address designated in 21 CFR 5.1100. The
request shall include information about a country's bovine spongiform
encephalopathy (BSE) case history, risk factors, measures to prevent
the introduction and transmission of BSE, and any other information
relevant to determining whether specified risk materials, the small
intestine of cattle except as provided in paragraph (b)(2) of this
section, material from nonambulatory disabled cattle, or MS (Beef) from
cattle from the country should be considered prohibited cattle
materials. FDA shall respond in writing to any such request and may
impose conditions in granting any such request. A country designation
granted by FDA under this paragraph will be subject to future review by
FDA, and may be revoked if FDA determines that it is no longer
appropriate.

    Dated: April 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. 08-1142 Filed 4-15-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: October 3, 2005 (Volume 70, Number 190)]
[Notices]
[Page 57583-57584]
[DOCID:fr03oc05-77]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EG05-101-000]

Prime Energy Limited Partnership; Notice of Application for
Commission Determination of Exempt Wholesale Generator Status

September 23, 2005.
    Take notice that on September 12, 2005, Prime Energy limited
Partnership (Prime) filed with the Commission an application for
determination of exempt wholesale generator status pursuant to Part 365
of the Commission's regulations. Prime states it is a limited
partnership that owns and operates a 64 MW generating facility located
in Elmwood Park, New Jersey. Prime states that all of the electric
energy produced by the Prime Facility will be sold at wholesale.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

    Comment Date: 5 p.m. eastern time on October 6, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5366 Filed 9-30-05; 8:45 am]

BILLING CODE 6717-01-P