. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/280
17 May 2000
(00-2012)
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 – Companion to Direct Final Rule
(2 pages)
5. Description of content:  The Food and Drug Administration (FDA) is proposing to amend
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 newuses of food additives that are FCS, and it will largely replace the existing food additive
petition process for 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 doesn't apply.  This will allow notifiers of FCS to claim the categorical
exclusions now available to sponsors of othe r requests for authorization of FCS.  This
proposed rule is a companion document to the direct final rule (notified as
G/SPS/N/USA/279) published elsewhere in the same issue of the Federal Register.
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 30366,
11 May 2000 (Available in English)
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  To be determined.G/SPS/N/USA/280
Page 2
11. Final date for comments: Submit written comments on this proposed rule by 25 July 2000.
If FDA receives no significant adverse comment on the provisions of these regulations
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 in the direct final rule ends. The direct final rule will be effective 24 August 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/FSTSDAttn: Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov