. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/701
6 May 2003
(03-2405)
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 should be provided in addition, where
applicable):  Infant Formula (Harmonized Ta riff  (HS) code number – 1901.10)
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:  Current Good
Manufacturing Practice, Quality Control Procedures, Quality Factors, NotificationRequirements, and Records and Reports for the Production of Infant Formula;  Reopening
of the Comment Period (3 pages, available in English)
6. Description of content:   The Food and Drug Administration (FDA) is reopening until June
27, 2003, the comment period for the proposed rule, published in the Federal Register  of
July 9, 1996 (61 FR 36154), to revise its infant formula regulations in 21 CFR parts 106
and 107.  The proposal would establish requirements for current good manufacturingpractice (CGMP) and audits, establish requirements for quality factors, and amend its
quality control procedures, notification, and records and reports requirements for infant
formula.  FDA is reopening the comment period to update comments and to receive any
new information.
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
8. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:G/SPS/N/USA/701
Page 2
9. Relevant documents and language(s) in which these are available:  Notice of Proposed
Rulemaking; reopening of the comment period published in the Federal Register at 68 FR
22341-22343 (available in English) ( http://www.fda.gov/OHRMS/DOCKETS/98fr/03-
10301.pdf ).  Notice of Proposed Rulemaking published in the Federal Register  at 61 FR
36154 (available in English) ( http://www.access.gpo.gov/su_docs/aces/aces140.html ).
21 CFR Part 106 – Infant Formula Quality Control Procedures (available in English)
(http://www.access.gpo.gov/nara/cfr/waisidx_02/21cfr106_02.html ).  21 CFR Part 107 –
Infant Formula (available in English)
(http://www.access.gpo.gov/nara/cfr/waisidx_02/21cfr107_02.html ).
10. Proposed date of adoption:  September 2004
11. Proposed date of entry into force:  120 days after date of publication of the final rule in the
Federal Register
12. Final date for comments:  27 June 2003
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 comments on the document to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, U.S.A.  It is possible to submit electronic comments to:
http://www.fda.gov/dockets/ecomments .  Submit comments by indicating Docket
No. 95N-0309 and Current Good Manufacturing Practice, Quality Control Procedures,
Quality Factors, Notification Requirements, and Records and Reports, for the Production of
Infant Formula
13. Texts available from:  [   ] 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 Point
Mr. William Janis
U.S. Department of Agriculture
Stop 1027Washington, DC 20250
Tel:  (202) 720-9047
Fax:  (202) 720-0677
E-mail:  fstsd@usda.gov
Complete text can be also be found on the Internet
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by looking under Docket
No. 95N-0309