. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/410
4 April 2001
(01-1697)
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:  Bottled water
4. Title and number of pages of the notified document:  Beverages: Bottled Water (Direct
Final Rule); and  Beverages: Bottled Water; Companion Document to Direct Final Rule
(Proposed Rule). (11 and 10 pages respectively)
5. Description of content:  The Food and Drug Administration (FDA) is amending its bottled
water quality standard regulations by establishing allowable levels for three residual
disinfectants (chloramine, chlorine, and chlorine dioxide) and three types of disinfection by-
products (DBP's) (bromate, chlorite, and haloacetic acids (HAA5)).  FDA also is revisingthe existing allowable level for the DBP total trihalomethanes (TTHM).  Finally, FDA is
revising, for the three residual disinfectants and four types of DBP's only, the monitoring
requirement for source water found in the current good manufacturing practice (CGMP)
regulations for bottled water.  As a consequence of FDA's amending the quality standard for
these residual disinfectants and DBP's, bottled water manufacturers are required to monitor
their finished bottled water products for these disinfectants and DBP's at least once each
year under the CGMP regulations for bottled water.  Bottled water manufacturers also arerequired to monitor for these contaminants at  least once each year in their source water,
unless the bottlers meet the criteria for source water monitoring exemptions under the
CGMP regulations.  This direct final rule will ensure that the minimum quality of bottled
water, as affected by the previously mentioned disinfectants and DBP's, remains comparable
with the quality of public drinking water th at meets the Environmental Protection Agency's
(EPA's) standards.  FDA is issuing a direct final rule for this action because the agency
expects that there will be no significant adverse comment on this rule.  Elsewhere in this
issue of the Federal Register, FDA is publishing a companion proposed rule under the
agency's usual procedure for notice-and-comment rulemaking to provide a procedural
framework to finalize the rule in the event th e agency receives significant adverse comment
and withdraws this direct final rule. The companion proposed rule and direct final rule are
substantively identical.
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           G/SPS/N/USA/410
Page 2
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 16858,
28 March 2001 (Available in English)
9. Proposed date of adoption:  This rule is effective 1 January 2002.
10. Proposed date of entry into force:  This rule is effective 1 January 2002.
11. Final date for comments: Submit written comments by 11 June 2001.  If FDA receives no
significant adverse comments during the specified comment period, the agency will publish
a document in the Federal Register no later than 5 July 2001, confirming the effective date
of the direct final rule.  If the agency rece ives any significant adverse comment during the
comment period, FDA intends to withdraw this direct final rule by publication in the
Federal Register no later than 5 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, including
directions for submitting objections, 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 10271400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov