. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/441
17 May 2001
(01-2536)
Committee on Sanitary and 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 may be provided in addition, whereapplicable).  Regions or countries likely to be affected, to the extent relevant or
practicable:  Food
4. Title and number of pages of the notified document:  Food Irradiation Coalition c/o
National Food Processors Association; Filing of Food Additive Petition and Amendment
(2 pages and 1 page)
5. Description of content: The Food and Drug Administration (FDA) is amending the filing
notice for a food additive petition filed by the National Food Processors Association
(NFPA) on behalf of The Food Irradiation Coalition, to provide for the safe use of ionizing
radiation for control of food-borne pathogens, and extension of shelf-life, in a variety ofhuman foods up to a maximum irradiation dosage of 4.5 kilograys (kGy) for non-frozen and
non-dry products, and 10.0 kGy for frozen or dry products.
In a notice published in the Federal Register of 5 January 2000 (65 FR 493) and
inadvertently not notified to the WTO, FDA announced that a food additive petition had
been filed by the NFPA on behalf of The Food  Irradiation Coalition proposing that the food
additive regulations in part 179 Irradiation in the Production, Processing and Handling of
Food (21 CFR part 179) be amended to provide for the safe use of ionizing radiation forcontrol of food-borne pathogens, and extension of shelf-life, in a variety of human foods up
to a maximum irradiation dosage of 4.5 kGy for non-frozen and non-dry products, and 10.0
kGy for frozen or dry products, including: (1) Pre-processed meat and poultry; (2) both raw
and pre-processed vegetables, fruits, and other agricultural products of plant origin; (3)
certain multi-ingredient food products.  The notice stated that the petition does not coverproducts composed in whole or in part of raw meat, poultry, or fish nor does it cover
"ready-to-eat" fish products or ingredients made from fish.  Subsequent to the publication of
the filing notice, FDA learned from discussions with NFPA that the petitioner intended to
include in the scope of the petition certain multi-ingredient products that contain uncooked
meat or poultry.
In particular, the petitioner noted a clarifying letter, dated 18 October 1999, that it had
submitted prior to FDA's filing the petition, that mentioned certain foods, such as country
hams and dry and semi-dry sausages, as examples of foods intended to be within the scope
of the petition. In preparing the filing notice, FDA did not recognize that these products are
uncooked and, thus, mistakenly excluded such products by virtue of the exclusion for foodcontaining raw meat or poultry.  The petitioner recently informed FDA that the
January 2000 filing notice would appear to restrict the scope of the petition and that it wasG/SPS/N/USA/441
Page 2
(and is) the petitioner's intent that multi-in gredient meat products (whether containing
cooked or uncooked meat or poultry) be included in the scope of the pending petition.
Therefore, FDA is amending the filing notice of 5 January 2000, to indicate that the
petitioner has requested that the food additive regulations be amended to permit the
irradiation of multi-ingredient foods containing uncooked meat or poultry.
6. 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           
7. An international standard, guideline or recommendation does not exist [  X ].
If an international standard, guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
8. Relevant documents and language(s) in which these are available:  66 FR 23943,
10 May 2001 and 65 FR 493, 5 January 2000 (Available in English)
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  To be determined.
11. Final date for comments:  FDA will accept comments at any time.
Agency or authority designated to handle comments:  Food and Drug Administration  [  
 ] National notification authority, [     ] National enquiry point, or address, fax number
and E-mail address (if available) of other body:  The full text on the original petition
Federal Register notice and this amendment will be sent upon request to the address in
paragraph 12.  Instructions for commenting will be made available through the contact
person listed in the full text.
12. Texts available from: [  X ] National notification authority, [  X ] National enquiry point
or address, fax number and E-mail address (if available) of other body:
United States SPS Enquiry Point/Notification Authority
USDA/FAS/FSTSD
ATTN: Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 10271400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov