. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/279
17 May 2000
(00-2016)
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:  US Food and Drug Administration
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 contact substances
4. Title and number of pages of the notified document:  National Environmental Policy
Act; Food Contact Substance Notification System - Direct Final Rule (2 pages)
5. Description of content:  The Food and Drug Administra tion (FDA) is amending its
regulations on environmental impact considerations as part of the agency's implementation
of the FDA Modernization Act (FDAMA) of 1997.  FDAMA amended the Federal Food,
Drug, and Cosmetic Act (the act) to establish a notification process for food contact
substances (FCS); this process will be the primary method for authorizing new uses of food
additives that are FCS, and it will largely replace the existing food additive petition processfor such substances.  The regulations will expand the existing categorical exclusions to
include allowing a notification submitted under the act to become effective and will amend
the list of those actions that require an environmental assessment (EA) to add allowing a
notification under the act to become effective in cases where a categorical exclusion does
not apply.  This will allow notifiers of FCS to claim the categorical exclusions now
available to sponsors of other requests for authorization of FCS. Elsewhere in this issue of
the Federal Register, FDA is publishing a companion proposed rule (notified asG/SPS/N/USA/280), under FDA's usual procedures for notice and comment to provide a
procedural framework to finalize the rule in the event the agency receives any significant
adverse comment and withdraws the direct final rule.
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: 65 FR 30352,
11 May 2000 (Available in English)
9. Proposed date of adoption:  To be determined.G/SPS/N/USA/279
Page 2
10. Proposed date of entry into force:  This rule is effective 24 August 2000. Submit written
comments by 25 July 2000.  If FDA receives no significant adverse comments within the
specified comment period, the agency intends to publish a document confirming the
effective date of the final rule in the Federal Register within 30 days after the comment
period on this direct final rule ends.  If timely significant adverse comments are received,the agency will publish a document in the Federal Register withdrawing this direct final rule
before its effective date.
11. Final date for comments:  25 July 2000
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:  Detailed instruction on where
and how to send comments is in the body of the full text - which 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. Wilson
Room 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.Washington, D.C. 20250
Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov