[Federal Register Volume 73, Number 210 (Wednesday, October 29, 2008)]
[Rules and Regulations]
[Pages 64197-64199]
From the Federal Register Online via the Government Publishing 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: http://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 http://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 http://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: 
[email protected].

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