Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters of Conjugated Linoleic Acid (Cis-9, Trans-11 and Trans-10, Cis-12-Octadecadienoic Acids), 64197-64199 [E8-25719]
Download as PDF
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Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Rules and Regulations
retirement age (age 60 or older). See
§ 404.1568(d)(4).
*
*
*
*
*
■ 3. Amend § 404.1568 to revise the
heading and the fifth sentence of
paragraph (d)(4) to read as follows:
§ 404.1568
Skill requirements.
*
*
*
*
*
(d) Skills that can be used in other
work (transferability). * * *
(4) Transferability of skills for persons
of advanced age. * * * If you are
closely approaching retirement age (age
60 or older) and you have a severe
impairment(s) that limits you to no
more than light work, we will find that
you have skills that are transferable to
skilled or semiskilled light work only if
the light work is so similar to your
previous work that you would need to
make very little, if any, vocational
adjustment in terms of tools, work
processes, work settings, or the
industry. * * *
■ 4. Amend part 404, subpart P,
appendix 2, as follows:
■ a. In section 202.00, revise paragraph
(f) to read as follows:
■ b. In section 203.00, revise paragraphs
(b) and (c) to read as follows:
Appendix 2 to Subpart P of Part 404—
Medical-Vocational Guidelines
*
*
*
*
*
202.00 Maximum sustained work
capability limited to light work as a result of
severe medically determinable
impairment(s).
*
*
*
*
*
(f) For a finding of transferability of skills
to light work for persons of advanced age
who are closely approaching retirement age
(age 60 or older), there must be very little, if
any, vocational adjustment required in terms
of tools, work processes, work settings, or the
industry.
*
*
*
*
*
*
*
*
*
*
203.00 Maximum sustained work
capability limited to medium work as a result
of severe medically determinable
impairment(s).
mstockstill on PROD1PC66 with RULES9
*
*
*
*
*
(b) The functional capacity to perform
medium work represents such substantial
work capability at even the unskilled level
that a finding of disabled is ordinarily not
warranted in cases where a severely impaired
person retains the functional capacity to
perform medium work. Even the adversity of
advanced age (55 or over) and a work history
of unskilled work may be offset by the
substantial work capability represented by
the functional capacity to perform medium
work. However, we will find that a person
who (1) has a marginal education, (2) has
work experience of 35 years or more doing
only arduous unskilled physical labor, (3) is
not working, and (4) is no longer able to do
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17:40 Oct 28, 2008
Jkt 217001
this kind of work because of a severe
impairment(s) is disabled, even though the
person is able to do medium work. (See
§ 404.1562(a) in this subpart and § 416.962(a)
in subpart I of part 416.)
(c) However, the absence of any relevant
work experience becomes a more significant
adversity for persons of advanced age (55 and
over). Accordingly, this factor, in
combination with a limited education or less,
militates against making a vocational
adjustment to even this substantial range of
work and a finding of disabled is appropriate.
Further, for persons closely approaching
retirement age (60 or older) with a work
history of unskilled work and with marginal
education or less, a finding of disabled is
appropriate.
PART 416—SUPPLEMENTAL
SECURITY INCOME FOR THE AGED,
BLIND, AND DISABLED
Subpart I—[Amended]
5. The authority citation for subpart I
of part 416 continues to read as follows:
Authority: Secs. 221(m), 702 (a)(5), 1611,
1614, 1619, 1631(a), (c), (d)(1), and (p), and
1633 of the Social Security Act (42 U.S.C.
421(m), 902(a)(5), 1382, 1382c, 1382h,
1383(a), (c), (d)(1), and (p), and 1383(b); secs.
4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L. 98–
460, 98 Stat. 1794, 1801, 1802, and 1808 (42
U.S.C. 421 note, 423 note, and 1382h note).
6. Amend § 416.963 to revise
paragraph (e) to read as follows:
■
§ 416.963
Your age as a vocational factor.
*
*
*
*
*
(e) Person of advanced age. We
consider that at advanced age (age 55 or
older), age significantly affects a
person’s ability to adjust to other work.
We have special rules for persons of
advanced age and for persons in this
category who are closely approaching
retirement age (age 60 or older). See
§ 416.968(d)(4).
*
*
*
*
*
■ 7. Amend § 416.968 to revise the
heading and the fifth sentence of
paragraph (d)(4) to read as follows:
§ 416.968
Skill requirements.
*
*
*
*
*
(d) Skills that can be used in other
work (transferability). * * *
(4) Transferability of skills for persons
of advanced age. * * * If you are
closely approaching retirement age (age
60 or older) and you have a severe
impairment(s) that limits you to no
more than light work, we will find that
you have skills that are transferable to
skilled or semiskilled light work only if
the light work is so similar to your
previous work that you would need to
make very little, if any, vocational
adjustment in terms of tools, work
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
processes, work settings, or the
industry. * * *
[FR Doc. E8–25532 Filed 10–28–08; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA–2003–F–0398] (formerly
Docket No. 2003F–0048]
Food Additives Permitted in Feed and
Drinking Water of Animals; Methyl
Esters of Conjugated Linoleic Acid
(Cis-9, Trans-11 and Trans-10, Cis-12Octadecadienoic Acids)
AGENCY:
■
64197
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
regulations for food additives permitted
in feed and drinking water of animals to
provide for the safe use of methyl esters
of conjugated linoleic acid (cis-9, trans11 and trans-10, cis-12 octadecadienoic
acids) as a source of fatty acids in swine
diets. This action is in response to a
food additive petition filed by BASF
Corp. (BASF), 100 Campus Dr., Florham
Park, NJ.
DATES: This rule is effective October 29,
2008. Submit written or electronic
objections and requests for a hearing by
December 29, 2008. See section V of this
document for information on the filing
of objections.
ADDRESSES: You may submit objections
and a request for a hearing, identified by
Docket No. FDA–2003–F–0398, by any
of the following methods:
Electronic Submissions
Submit electronic objections in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written objections in the
following ways:
• FAX: 301–827–6870.
• 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
objections, FDA is no longer accepting
objections submitted to the agency by email. FDA encourages you to continue
to submit electronic objections by using
E:\FR\FM\29OCR1.SGM
29OCR1
64198
Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Rules and Regulations
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(s). and Regulatory
Information Number (RIN) (if a RIN
number has been assigned) for this
rulemaking. All objections received may
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
objections, see the ‘‘Objections and
Hearing Requests’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
objections received, go to https://
www.regulations.gov and insert the
docket number(s), 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:
Michaela G. Alewynse, Center for
Veterinary Medicine (HFV–228), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–453–
6866, e-mail:
mika.alewynse@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal
Register of March 11, 2003 (68 FR
11567), FDA announced that a food
additive petition (animal use) (FAP
2250) had been filed by BASF, 100
Campus Dr., Florham Park, NJ 07932.
The petition proposed to amend the
food additive regulations to provide for
the safe use of methyl esters of
conjugated linoleic acid (cis-9, trans-11
and trans-10, cis-12 octadecadienoic
acids) as a source of fatty acids in swine
diets. The notice of filing provided for
a 60-day comment period on the
petitioner’s environmental information.
No comments have been received.
mstockstill on PROD1PC66 with RULES9
II. Conclusion
FDA concludes that the data establish
the safety and utility of methyl esters of
conjugated linoleic acid (cis-9, trans-11
and trans-10, cis-12-octadecadienoic
acids) for use as proposed with
modification and that the food additive
regulations should be amended as set
forth in this document.
III. Public Disclosure
In accordance with § 571.1(h), the
petition and the documents that FDA
VerDate Aug<31>2005
17:40 Oct 28, 2008
Jkt 217001
considered and relied upon in reaching
its decision to approve the petition are
available for inspection at the Center for
Veterinary Medicine by appointment
with the information contact person. As
provided in § 571.1(h), the agency will
delete from the documents materials
that are not available for public
disclosure before making the documents
available for inspection.
IV. Environmental Impact
The agency has determined under 21
CFR 25.32(r) 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.
V. Objections and Hearing Requests
Any person who will be adversely
affected by this regulation may file with
the Division of Dockets Management
(see ADDRESSES) written or electronic
objections by (see DATES). Each
objection must be separately numbered,
and each numbered objection must
specify with particularity the provision
of the regulation to which objection is
made and the grounds for the objection.
Each numbered objection on which a
hearing is requested must state that a
hearing is requested. Failure to request
a hearing for any particular objection
will constitute a waiver of the right to
a hearing on that objection. Each
numbered objection for which a hearing
is requested must include a detailed
description and analysis of the specific
factual information intended to be
presented in support of the objection in
the event that a hearing is held. Failure
to include such a description and
analysis for any particular objection will
constitute a waiver of the right to a
hearing on the objection. Three copies
of all documents must be submitted and
must be identified with the docket
number found in brackets in the
heading of this document. Any
objections received in response to the
regulation may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 573 is amended as follows:
■
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Fmt 4700
Sfmt 4700
PART 573—FOOD ADDITIVES
PERMITTED IN FEED AND DRINKING
WATER OF ANIMALS
1. The authority citation for 21 CFR
part 573 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348.
■
2. Add § 573.637 to read as follows:
§ 573.637 Methyl esters of conjugated
linoleic acid (cis-9, trans-11 and trans-10,
cis-12-octadecadienoic acids).
The food additive, methyl esters of
conjugated linoleic acid (cis-9, trans-11
and trans-10, cis-12 octadecadienoic
acids), may be safely used in swine feed
in accordance with the prescribed
conditions:
(a) The food additive is manufactured
by the reaction of refined sunflower oil
with methanol to produce fatty acid
methyl esters, which then undergo
conjugation to yield methyl esters of
octadecadienoic acid. The additive
consists of not less than 28 percent
methyl ester of cis-9, trans-11octadecadienoic acid, and not less than
28 percent methyl ester of trans-10, cis12-octadecadienoic acid with the sum of
the other methyl esters of
octadecadienoic acid not to exceed 4
percent. The additive shall contain not
less than 35 percent of other fatty acid
esters composed of oleic acid, palmitic
acid, stearic acid, linoleic acid, and
other associated acid esters.
(b) The additive is used or intended
for use in the feed of growing and
finishing swine as a source of fatty acids
at levels not to exceed 0.6% in the
finished feed.
(c) The additive meets the following
specifications:
(1) Free methyl alcohol not to exceed
0.015%.
(2) Insoluble impurities not to exceed
0.1%.
(3) Moisture not to exceed 0.5%.
(4) Unsaponifiable matter not to
exceed 1.0%.
(d) To assure safe use of the additive,
in addition to the other information
required by the act:
(1) The label and labeling of the
additive and any feed premix shall bear
the following:
(i) The name of the additive.
(ii) A statement to indicate that
methyl esters of conjugated linoleic acid
(cis-9, trans-11 and trans-10, cis-12
octadecadienoic acids) must not be
added to vitamin or mineral premixes.
(2) The label and labeling of the
additive, any feed premix, or complete
feed prepared therefrom shall bear
adequate directions for use.
E:\FR\FM\29OCR1.SGM
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Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Rules and Regulations
Dated: October 23, 2008.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. E8–25719 Filed 10–28–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade
Bureau
27 CFR Part 9
[Docket No. TTB–2007–0066; T.D. TTB–71;
Re: Notice No. 76]
RIN 1513–AB49
Establishment of the Leona Valley
Viticultural Area (2007R–281P)
Alcohol and Tobacco Tax and
Trade Bureau, Treasury.
ACTION: Final rule; Treasury decision.
AGENCY:
SUMMARY: This Treasury decision
establishes the 13.4-square mile ‘‘Leona
Valley’’ American viticultural area in
northeastern Los Angeles County,
California. We designate viticultural
areas to allow vintners to better describe
the origin of their wines and to allow
consumers to better identify wines they
may purchase.
DATES: Effective Date: November 28,
2008.
N.A.
Sutton, Regulations and Rulings
Division, Alcohol and Tobacco Tax and
Trade Bureau, 925 Lakeville St., No.
158, Petaluma, CA 94952; telephone
415–271–1254.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Background on Viticultural Areas
mstockstill on PROD1PC66 with RULES9
TTB Authority
Section 105(e) of the Federal Alcohol
Administration Act (FAA Act), 27
U.S.C. 205(e), authorizes the Secretary
of the Treasury to prescribe regulations
for the labeling of wine, distilled spirits,
and malt beverages. The FAA Act
requires that these regulations, among
other things, prohibit consumer
deception and the use of misleading
statements on labels, and ensure that
labels provide the consumer with
adequate information as to the identity
and quality of the product. The Alcohol
and Tobacco Tax and Trade Bureau
(TTB) administers the regulations
promulgated under the FAA Act.
Part 4 of the TTB regulations (27 CFR
part 4) allows the establishment of
definitive viticultural areas and the use
of their names as appellations of origin
on wine labels and in wine
VerDate Aug<31>2005
17:40 Oct 28, 2008
Jkt 217001
advertisements. Part 9 of the TTB
regulations (27 CFR part 9) contains the
list of approved viticultural areas.
Definition
Section 4.25(e)(1)(i) of the TTB
regulations (27 CFR 4.25(e)(1)(i)) defines
a viticultural area for American wine as
a delimited grape-growing region
distinguishable by geographical
features, the boundaries of which have
been recognized and defined in part 9
of the regulations. These designations
allow vintners and consumers to
attribute a given quality, reputation, or
other characteristic of a wine made from
grapes grown in an area to its
geographical origin. The establishment
of viticultural areas allows vintners to
describe more accurately the origin of
their wines to consumers and helps
consumers to identify wines they may
purchase. Establishment of a viticultural
area is neither an approval nor an
endorsement by TTB of the wine
produced in that area.
Requirements
Section 4.25(e)(2) of the TTB
regulations outlines the procedure for
proposing an American viticultural area
and provides that any interested party
may petition TTB to establish a grapegrowing region as a viticultural area.
Section 9.3(b) of the TTB regulations
requires the petition to include—
• Evidence that the proposed
viticultural area is locally and/or
nationally known by the name specified
in the petition;
• Historical or current evidence that
supports setting the boundary of the
proposed viticultural area as the
petition specifies;
• Evidence relating to the
geographical features, such as climate,
soils, elevation, and physical features
that distinguish the proposed
viticultural area from surrounding areas;
• A description of the specific
boundary of the proposed viticultural
area, based on features found on United
States Geological Survey (USGS) maps;
and
• A copy of the appropriate USGS
map(s) with the proposed viticultural
area’s boundary prominently marked.
Leona Valley Petition
Mr. Ralph Jens Carter submitted a
petition for establishment of the 13.4square mile Leona Valley viticultural
area on behalf of the Antelope Valley
Winegrowers Association, the Leona
Valley Winery, and Donato Vineyards.
The area currently includes 20 acres of
vineyards, and more acreage for wine
grape growing is under development.
The proposed Leona Valley viticultural
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
64199
area boundary line does not affect or
overlap any other proposed or
established viticultural area.
The proposed boundary line defines
an area where viticulture is already
established or has potential for
establishment. Consequently, the area
defined is limited to the valley floor and
side slopes. The distinguishing features
of the proposed viticultural area include
the physical characteristics of the San
Andreas Fault system, the faultcontrolled Leona Valley, and the
surrounding, high-elevation mountains.
The climate, geology, and soils
distinguish the proposed viticultural
area from areas outside of the proposed
boundary line.
Name Evidence
According to the petitioner, the name
‘‘Leona’’ derives from an early rancher
named Miguel Leonis, and in the 1880s,
a homesteader from Nebraska called the
area ‘‘Leona Valley.’’ The ‘‘Leona
Valley’’ name identifies a valley, a town
within the valley, a ranch (the Leona
Valley Ranch), and a festival (the annual
Leona Valley Cherry Festival).
The petitioner provides maps that
show that the Leona Valley is located in
the northeast part of Los Angeles
County, California. The ‘‘Leona Valley’’
name appears on the USGS Ritter Ridge,
Sleepy Valley, and Del Sur quadrangle
maps, which the petitioner uses to
define the boundary line of the
proposed viticultural area. The Sleepy
Valley map also identifies a small town
in the valley as ‘‘Leona Valley.’’ A
recent atlas identifies both a valley and
small town within the proposed
viticultural area as ‘‘Leona Valley’’ (The
DeLorme Southern and Central
California Atlas and Gazetteer, 2005,
page 79).
Boundary Evidence
According to the petitioner, and as
evidenced by the written boundary
description and the USGS Sleepy Valley
quadrangle map, the proposed
viticultural area includes the town and
valley which are both named ‘‘Leona
Valley.’’ The proposed boundary line
borders the Angeles National Forest to
the west and the Antelope Valley and
the Mojave Desert to the northeast.
Mountains and hills surround all sides
of the valley. The floor and side slopes
of the Leona Valley influence the shape
of the proposed viticultural area, which
includes vineyards in remote, but
suitable, areas, but excludes steep
slopes where erosion is a hazard.
According to the petitioner,
historically, the Native American
Shoshone Tribe lived as hunters and
gatherers in the Leona Valley area. In
E:\FR\FM\29OCR1.SGM
29OCR1
]]>Agencies
[Federal Register Volume 73, Number 210 (Wednesday, October 29, 2008)]
[Rules and Regulations]
[Pages 64197-64199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25719]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2003-F-0398] (formerly Docket No. 2003F-0048]
Food Additives Permitted in Feed and Drinking Water of Animals;
Methyl Esters of Conjugated Linoleic Acid (Cis-9, Trans-11 and Trans-
10, Cis-12-Octadecadienoic Acids)
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
regulations for food additives permitted in feed and drinking water of
animals to provide for the safe use of methyl esters of conjugated
linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic
acids) as a source of fatty acids in swine diets. This action is in
response to a food additive petition filed by BASF Corp. (BASF), 100
Campus Dr., Florham Park, NJ.
DATES: This rule is effective October 29, 2008. Submit written or
electronic objections and requests for a hearing by December 29, 2008.
See section V of this document for information on the filing of
objections.
ADDRESSES: You may submit objections and a request for a hearing,
identified by Docket No. FDA-2003-F-0398, by any of the following
methods:
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written objections in the following ways:
FAX: 301-827-6870.
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 objections, FDA is no longer
accepting objections submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic objections by using
[[Page 64198]]
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(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All objections received
may be posted without change to https://www.regulations.gov, including
any personal information provided. For additional information on
submitting objections, see the ``Objections and Hearing Requests''
heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
objections received, go to https://www.regulations.gov and insert the
docket number(s), 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: Michaela G. Alewynse, Center for
Veterinary Medicine (HFV-228), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-453-6866, e-mail:
mika.alewynse@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of March 11, 2003 (68
FR 11567), FDA announced that a food additive petition (animal use)
(FAP 2250) had been filed by BASF, 100 Campus Dr., Florham Park, NJ
07932. The petition proposed to amend the food additive regulations to
provide for the safe use of methyl esters of conjugated linoleic acid
(cis-9, trans-11 and trans-10, cis-12 octadecadienoic acids) as a
source of fatty acids in swine diets. The notice of filing provided for
a 60-day comment period on the petitioner's environmental information.
No comments have been received.
II. Conclusion
FDA concludes that the data establish the safety and utility of
methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-
10, cis-12-octadecadienoic acids) for use as proposed with modification
and that the food additive regulations should be amended as set forth
in this document.
III. Public Disclosure
In accordance with Sec. 571.1(h), the petition and the documents
that FDA considered and relied upon in reaching its decision to approve
the petition are available for inspection at the Center for Veterinary
Medicine by appointment with the information contact person. As
provided in Sec. 571.1(h), the agency will delete from the documents
materials that are not available for public disclosure before making
the documents available for inspection.
IV. Environmental Impact
The agency has determined under 21 CFR 25.32(r) 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.
V. Objections and Hearing Requests
Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) written or
electronic objections by (see DATES). Each objection must be separately
numbered, and each numbered objection must specify with particularity
the provision of the regulation to which objection is made and the
grounds for the objection. Each numbered objection on which a hearing
is requested must state that a hearing is requested. Failure to request
a hearing for any particular objection will constitute a waiver of the
right to a hearing on that objection. Each numbered objection for which
a hearing is requested must include a detailed description and analysis
of the specific factual information intended to be presented in support
of the objection in the event that a hearing is held. Failure to
include such a description and analysis for any particular objection
will constitute a waiver of the right to a hearing on the objection.
Three copies of all documents must be submitted and must be identified
with the docket number found in brackets in the heading of this
document. Any objections received in response to the regulation may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is
amended as follows:
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
0
1. The authority citation for 21 CFR part 573 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
0
2. Add Sec. 573.637 to read as follows:
Sec. 573.637 Methyl esters of conjugated linoleic acid (cis-9, trans-
11 and trans-10, cis-12-octadecadienoic acids).
The food additive, methyl esters of conjugated linoleic acid (cis-
9, trans-11 and trans-10, cis-12 octadecadienoic acids), may be safely
used in swine feed in accordance with the prescribed conditions:
(a) The food additive is manufactured by the reaction of refined
sunflower oil with methanol to produce fatty acid methyl esters, which
then undergo conjugation to yield methyl esters of octadecadienoic
acid. The additive consists of not less than 28 percent methyl ester of
cis-9, trans-11-octadecadienoic acid, and not less than 28 percent
methyl ester of trans-10, cis-12-octadecadienoic acid with the sum of
the other methyl esters of octadecadienoic acid not to exceed 4
percent. The additive shall contain not less than 35 percent of other
fatty acid esters composed of oleic acid, palmitic acid, stearic acid,
linoleic acid, and other associated acid esters.
(b) The additive is used or intended for use in the feed of growing
and finishing swine as a source of fatty acids at levels not to exceed
0.6% in the finished feed.
(c) The additive meets the following specifications:
(1) Free methyl alcohol not to exceed 0.015%.
(2) Insoluble impurities not to exceed 0.1%.
(3) Moisture not to exceed 0.5%.
(4) Unsaponifiable matter not to exceed 1.0%.
(d) To assure safe use of the additive, in addition to the other
information required by the act:
(1) The label and labeling of the additive and any feed premix
shall bear the following:
(i) The name of the additive.
(ii) A statement to indicate that methyl esters of conjugated
linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic
acids) must not be added to vitamin or mineral premixes.
(2) The label and labeling of the additive, any feed premix, or
complete feed prepared therefrom shall bear adequate directions for
use.
[[Page 64199]]
Dated: October 23, 2008.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E8-25719 Filed 10-28-08; 8:45 am]
BILLING CODE 4160-01-S
