. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1778 
27 February 2008  
 (08-0856) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Member to Agreement notifying:  UNITED STATES
  
If applicable, name of local government involved:     
2. Agency responsible:  US Food and Drug Administration 
3. Products covered (provide tariff item numb er(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Foods containing barley betafiber for food labeling health claims.  Barley 
betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley.  Barley betafi ber is produced by hydrolysis of whole grain 
barley flour, with a cellulase and alpha-amylase enzyme preparation, to produce a clear aqueous extract that contains mainly partia lly hydrolyzed beta-glu can and substantially 
hydrolyzed starch.  The soluble, partially hydrolyzed beta-glucan is separated from the 
insoluble material by centrifuga tion, and after removal of the in soluble material, the partially 
hydrolyzed beta-glucan soluble fiber is se parated from the other soluble compounds by 
precipitation with ethanol.  The product is then dried, milled and sifted. Barley betafiber shall 
have a beta-glucan soluble fiber content of at least 70 percent on a dry weight basis.  Whole 
grain barley flour is as defined in the Barl ey Glossary (AACC Method 55-99), published in 
Approved Methods of the American Association of Cereal Chemists, 10
th ed. (2000) pages 1 
and 2. 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  Trading 
partners 
5. Title, language and number of pages of the notified document:  Food Labeling:  Health 
Claims:  Soluble Fiber from Cert ain Foods and Risk of Coronary  Heart Disease (available in 
English, 10 pages) 
6. Description of content:  The Food and Drug Administration is amending the health claim 
regulation entitled "Soluble fiber from certain foods and risk of coronary heart disease" to add barley betafiber as an additi onal eligible source of soluble fiber.  The Food and Drug 
Administration previously concluded, based on the totality of publicly available scientific 
evidence, that soluble fiber from certain foods redu ces the risk of coronary heart disease.  The 
Food and Drug Administration has now concluded that in addition to certain whole oat and 
whole grain barley products, barley  betafiber is also an appropr iate source of soluble fiber.  
7. Objective and rationale:  [ X ] food safety, [   ] animal health,  [   ] plant protection, [  
 ] protect humans from animal/plant pest or disease,  [   ] protect territory from other damage from pests    G/SPS/N/USA/1778 
Page 2  
 
  8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [ X ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:    
9. Relevant documents and language(s ) in which these are available:   This document is 
available in the Federal Register  volume, 73, number 37, pages 9938-9947, published on 
Monday, 25 February 2008, available in Eng lish, 10 pages.  Docket No. [FDA–2008–P–
0090] (formerly Docket No. 2006P–0393).  The pdf of the document is available at 
http://a257.g.akamaitech.net/7/257/2422 /01jan20081800/edocket.access.gpo.gov/2008/pdf/E8
-3418.pdf  
For access to the docket to read backgr ound documents or comments received, go to 
http://www.fda.gov/ohrms /dockets/default.htm  and insert the Docket No. [FDA–2008–P–
0090] (formerly Docket No. 2006P–0393) into th e "Search" box and follow the prompts. 
10. Proposed date of adoption:  Not determined. 
11. Proposed date of entry into force:  Not applicable. 
12. Final date for comments:  12 May 2008 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body: 
Submit written or electronic comments  identified by Docket No. [FDA–2008–P–0090] 
(formerly Docket No. 2006P–0393), by any of the following methods: 
• Federal eRulemaking Portal:  http://www.regulations.gov .  Follow the instructions 
for submitting comments. 
• Agency Web site:  http://www.fda.gov/dockets/ecomments .  Follow the instructions 
for submitting comments on the agency Web site. 
Submit written submissions 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. 
Instructions:  All submissions received must include the agency name and docket number for 
this rulemaking.  All objections received  will be posted without change to 
http://www.fda.gov/ohrms /dockets/default.htm . 
13. Texts available from:  [ X ] National notificati on authority, [   ] Na tional enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
United States SPS National Notification Aut hority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division (IRSD), Stop 1027, Washington D.C. 
20250;  Tel:  +(1 202) 720-1301;  Fa x:  +(1 202) 690-0677;  E-mail:  
us.spsenquirypoint@fas.usda.gov