WORLD TRADE G/SPS/N/USA/122
14May1998
ORGANIZATION
(98-1923)
Committee onSanitary andPhytosanitary Measures
NOTIFICATION
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocal government involved:
2. Agency responsible: USFood andDrug Administration
3. Products covered (tariff item number(s) asspecified innational schedules deposited with
theWTO. ICSnumbers may beprovided inaddition, where applicable): Bottled water
4. Title andnumber ofpages ofthenotified document: Beverages: Bottled Water (Direct
Final Rule); andCompanion Document toDirect Final Rule(Proposed Rule).
5. Description ofcontent:
TheFood andDrug Administration (FDA) isamending itsregulations toliftthestayof
theeffective datefortheallowable levels inthebottled water quality standard fornine
chemical contaminants, i.e.,antimony, beryllium, cyanide, nickel, thallium, diquat,
endothall, glyphosate, and2,3,7,8-TCDD (dioxin), thatwasimposed inafinalrule
published onMarch 26,1996. Bylifting thestayoftheeffective date, bottled water
manufacturers willberequired tomonitor source waters andfinished bottled water
products atleastonceayearforthese ninechemical contaminants under thecurrent
good manufacturing practice (CGMP) regulations forbottled water. These bottled
water products willalsobesubject topossible testing byFDA tothese standards. FDA
isrequired toissue monitoring requirements fortheninechemical contaminants under
theSafeDrinking Water ActAmendments of1996. FDA isusing direct final
rulemaking forthisaction because theagency expects thatthere willbenosignificant
adverse comment ontherule. FDA isalsopublishing today acompanion proposed
ruleunder FDA’susual procedure fornotice-and-comment rulemaking toprovide a
procedural frame work tofinalize theruleintheevent theagency receives significant
adverse comments andwithdraws thisdirect finalrule. Thecompanion proposed rule
anddirect finalrulearesubstantively identical. Ifnotimely significant adverse
comment isreceived inresponse tothedirect finalrule,theagency willpublish a
confirmation notice nolaterthan6August 1998 confirming theeffective dateofthe
direct finalrule.
./.G/SPS/N/USA/122
Page2
When therulebecomes effective andthestayislifted thetableinTitle21CFR,
Part165.110 willshow thefollowing maximum levels fortheabove mentioned
contaminants inbottled water: antimony 0.006 parts permillion (PPM); beryllium
0.004 PPM; cyanide 0.2PPM; nickel 0.1PPM; thallium 0.002 PPM; diquat
0.02PPM; endothall 0.1PPM; glyphosate 0.7PPM; anddioxin 0.03parts per
trillion (PPT).
6. Objective andrationale: Food safety.
7. Aninternational standard, guideline orrecommendation does notexist [X].
Ifaninternational standard, guideline orrecommendation exists, whenever possible,
identify deviations:
8. Relevant documents andlanguage(s) inwhich these areavailable: 63FR25764 and
25789, 11May1998 (Available inEnglish -11pages); 21CFR Part165.110.
9. Proposed date ofadoption: Tobedetermined.
10. Proposed date ofentry intoforce: 9November 1998.
11. Final date forcomments: 27July1998.
Agency orauthority designated tohandle comments: Food andDrug Administration
12. Texts available from: National enquiry point []oraddress, telefax number andE-mail
address (ifavailable) ofother body:
United States SPSEnquiry Point
USDA/FAS/FSTSD
Attn: Carolyn F.Wilson
Room 5545 South Agriculture Building
Stop1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250
Phone (202) 720-2239
Fax(202) 690-0677
E-mail ofsts@fas.usda.gov