. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/460
29 June 2001
(01-3271)
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, where
applicable).  Regions or countries likely to be affected, to the extent relevant or
practicable:  Food additives
4. Title and number of pages of the notified document:  Secondary Direct Food Additives
Permitted in Food for Human Consumption; Ozone (2 pages)
5. Description of content:  The Food and Drug Administrati on (FDA) is amending the food
additive regulations to provide for the safe use of ozone in gaseous and aqueous phases asan antimicrobial agent on food, including meat and poultry.  This action is in response to a
petition.  (The original petition for this action was published in the 13 September 2000,
Federal Register and inadvertently not notified.)
The proposed use would include the use of this additive on raw agricultural commodities
(RACs) in the preparing, packing, or holdin g of such commodities for commercial purposes,
consistent with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 321(q)(1)(B)(i)), as amended by the Antimicrobial Regulation Technical
Corrections Act of 1998 (ARTCA) (Public Law 105-324).  The petitioner is not proposing
that the additive be intended for use for any application under section 201(q)(1)(B)(i)(I),
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the ac t, which use would be subject to regulation by
the Environmental Protection Agency (EPA) as a pesticide chemical.  The proposed use of
the additive includes the use to reduce the microbial contamination on RACs.  Under
ARTCA, the use of ozone as an antimicrobial agent on RACs in the preparing, packing, or
holding of such RACs for commercial purposes, consistent with section 201(q)(1)(B)(i) of
the act, and not otherwise included within the definition of "pesticide chemical" under
section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) is subject to regulation by
FDA as a food additive.  Although this use of ozone as an antimicrobial agent on RACs isregulated under section 409 of the act (21 U.S.C. 348) as a food additive, the intended use
may nevertheless be subject to regulation as a pesticide under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA).  Th erefore, manufacturers intending to market
ozone for such use should contact the EPA to determine whether this use requires a
pesticide registration under FIFRA.
FDA has evaluated data in the petition and other relevant material.  Based on this
information, the agency concludes that the proposed use of the additive is safe and that the
additive will achieve its intended technical effect.G/SPS/N/USA/460
Page 2
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 33829,
26 June 2001 (Available in English)
9. Proposed date of adoption:  This rule is effective 26 June 2001.
10. Proposed date of entry into force:  This rule is effective 26 June 2001.
11. Final date for comments:  Submit written objections and requests for a hearing by
26 July 2001.
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, which includes instructions
for submitting objections and request for hearing, will be sent upon request to the address in
paragraph 12.
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. WilsonRoom 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720-2239Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov