WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1522 
16 April 2007 
 (07-1520) 
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:  Food and Drug Administration (FDA) 
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):   All foods including dietary supplements regulated by FDA for which 
irradiation has been approved that are marketed  in the US.  This proposal does not include 
meat, poultry and certain egg products that are regulated by the US Department of 
Agriculture.  
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Trading partners 
5. Title, language and number of p ages of the notified document:  Irradiation in the 
Production, Processing and Handling of Food (a vailable in English;  15 pages in PDF 
format) 
6. Description of content:  FDA issued a proposed rule at 
http://www.fda.gov/OHRMS/DOCKETS/98fr/07-1636.pdf  to amend its regulations by 
revising 21 Code of Federa l Regulations Section 179.26 (c)(1) and (c) (2) governing 
irradiated foods.   The proposed provisions would apply to all foods including dietary supplements regulated by FDA for which irradia tion has been approved that are marketed in 
the United States including those domestically produced and imported.  The proposed rule 
provides that only those irradiated foods in wh ich the irradiation causes a material change in 
the food, or a material change in the conseque nces that may result from the use of the food, 
bear the radura logo and the term "irradiated", or a derivative thereof, (e.g., "irradiate", "irradiation", "radiation", etc.) in conjuncti on with explicit language describing the change 
in the food or its conditions of use.  The proposal would also allow a firm to petition FDA 
for use of an alternate term to "irradiation" (other than "pasteurized ").  In addition, the 
proposal permits a firm to use the term "pasteu r i z e d "  i n  l i e u  o f  " i rradiated", provided it 
notifies the agency that the irradiation process being used meets the criteria specified in the 
Federal Food, Drug, and Cosmetic Act. 
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/1522 
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  8. International standard, guideline or recommendation: 
[ X ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [  ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
The Codex General Standard for the Labelli ng of Prepackaged Foods (Codex Stan 1-1985 
(Rev. 1-1991)  http://www.codexalimentarius.net ), which was established in 1981 and 
subsequently revised in 1985 and 1991.   
The difference between the proposed FDA revision of existing regulations governing 
irradiated foods and  the existing Codex standard are: 
• FDA's proposed rule provides that only those irradiated foods in which the irradiation 
causes a material change in the food, or a materi al change in its conditions of use bear the 
raduro logo (the international food irradiati on symbol) and the term "irradiated", or a 
derivative thereof, in conjunction with la nguage describing the material change.  In 
comparison, the existing Codex standard provides that the use of the raduro logo on the label of an irradiated food is optional.   
• FDA's proposed rule provides that for the labelling of an irradiated food not in packaged 
'form in which the irradiation causes a material  change in its characteristics or conditions 
of use, the raduro logo and the term "irradiated",  a derivative thereof, or an alternate term 
and language describing the material change in the food, must be displayed to the 
purchaser with either the labelling of the bulk container plainly in view or on a counter sign, card, or other appropriate device.  Th e labelling requirement applies only to a food 
that has been irradiated, not to a food that merely contains an irradiated ingredient but 
that has not itself been irradiated.  In co mparison, the existing Codex standard provides 
that when an irradiated product is used as an ingredient in another food, it is declared as 
an irradiated ingredient in the list of ingredients. 
9. Relevant documents and language(s) in which these are available:  The proposed rule 
was published in the Federal Register (72 FR 16291) on 4 April 2007, can be electronically 
accessed at http://www.fda.gov/OHRMS/DOCKETS/98fr/07-1636.pdf , and is available 
only in English. 
10. Proposed date of adoption:  Not yet determined.  A final rule is expected to be published 
in the future which will specify the effective date of implementation. 
11. Proposed date of entry into force:  Not yet determined.  A final rule is expected to be 
published in the future which will specify the effective date of implementation.  G/SPS/N/USA/1522 
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  12. Final date for comments:  3 July 2007 
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 comments, referencing the docket number 2005N-0272, 
either electronically at http://www.regulations.gov  or 
http://www.fda.gov/dockets/ecomments  by following the instructions at the selected 
website, or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 106 1, Rockville, MD 20852;  Fax: 301-827-6870. 
 
13. Texts available from:  [ X ] National notifi cation authority, [   ] National enquiry 
point, or address, fax number and E-mail address (if available) of other body:  SPS 
National Notification Authority, USDA Foreign Agricultural Service, Food Safety & 
Technical Services Division, Stop 1027, W ashington D.C. 20250.  Tel: 202-720-9124; Fax: 
202-690-0677; Email: fstsd@fas.usda.gov .  
 http://www.fda.gov/OHRMS/DOCKETS/98fr/07-1636.pdf