[Federal Register Volume 63, Number 151 (Thursday, August 6, 1998)]
[Notices]
[Page 42199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21136]



  Federal Register / Vol. 63, No. 151/ Thursday, Augus5 6, 1998 / 
Notices  

[[Page 42199]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0294]


 Bottled Water: Monitoring Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
monitoring requirements under the national primary drinking water 
regulations (NPDWR's) found in 40 CFR part 141 for antimony, beryllium, 
cyanide, nickel, thallium, diquat, endothall, glyphosate, and 2,3,7,8-
TCDD (dioxin), will be considered to be the standard of quality 
regulations applicable to these chemical contaminants in bottled water.
DATES: Effective February 2, 1999.

FOR FURTHER INFORMATION CONTACT: Henry Kim, Center for Food Safety and 
Applied Nutrition (HFS-306), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-260-0631.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 26, 1996 
(61 FR 13258), FDA published a final rule (the March 1996 final rule) 
in which it amended the bottled water quality standard in 21 CFR part 
165 by establishing allowable levels for 24 chemical contaminants in 
bottled water. In that final rule, FDA stayed the effective date for 
the allowable levels for nine of the chemical contaminants, 
specifically, antimony, beryllium, cyanide, nickel, thallium, diquat, 
endothall, glyphosate, and 2,3,7,8-TCDD (dioxin). As a result, the 
current good manufacturing practice (CGMP) regulations under part 129 
(21 CFR part 129) for bottled water were not in effect for these nine 
contaminants during the period of the stay.
    Subsequent to the March 1996 final rule, on August 6, 1996, the 
Safe Drinking Water Act (SDWA) Amendments were enacted. Under the SDWA 
Amendments (section 410(b)(1) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 349(b)(1)), for contaminants covered by a 
standard of quality regulation promulgated by FDA before the enactment 
of the SDWA Amendments for which an effective date had not been 
established (i.e., standard of quality regulations for the nine 
chemical contaminants: antimony, beryllium, cyanide, nickel, thallium, 
diquat, endothall, glyphosate, and dioxin), FDA is required to 
promulgate monitoring requirements for such contaminants not later than 
2 years after the date of enactment of the SDWA Amendments, i.e., by 
August 6, 1998. If FDA does not meet this statutory time period, the 
NPDWR's for the nine chemical contaminants are considered to be the 
standard of quality regulation, and therefore, the monitoring 
requirements under the NPDWR are applicable to bottled water, and are 
to take effect no later than February 2, 1999.
    Under this statutory mandate, FDA published a direct final rule on 
May 11, 1998 (63 FR 25764), to lift the stay of the effective date for 
the allowable levels in the bottled water quality standard for nine 
chemical contaminants. An effect of the direct final rule would have 
been to promulgate FDA's existing monitoring requirements for bottled 
water as the monitoring requirements for these nine contaminants in 
bottled water. By lifting the stay of the effective date, bottled water 
manufacturers would have been required to monitor source waters and 
finished bottled water products at least once a year for these nine 
chemical contaminants under the CGMP regulations for bottled water in 
part 129. FDA also published a companion proposed rule in the same 
issue of the Federal Register.
    Because FDA received significant adverse comment about monitoring 
requirements for these nine contaminants, FDA is unable to promulgate 
monitoring requirements for the nine contaminants by August 6, 1998. 
Therefore, the monitoring requirements under the NPDWR's for these nine 
contaminants shall be considered, under section 410(b)(4)(A) of the 
act, to be the standard of quality regulation for bottled water. FDA is 
giving notice, as required by section 410(b)(4)(B) of the act, that the 
monitoring requirements for these nine contaminants in the NPDWR's in 
40 CFR part 141 are the monitoring requirements for these nine 
contaminants in bottled water, effective February 2, 1999. FDA intends 
to provide guidance concerning how it will apply these requirements to 
bottled water in the near future. Furthermore, FDA plans to publish a 
withdrawal of the companion proposed rule (63 FR 25789, May 11, 1998) 
that published on the same day as the direct final rule. The direct 
final rule is discussed elsewhere in this issue of the Federal 
Register.

    Dated: August 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Commissioner.
[FR Doc. 98-21136 Filed 8-5-98; 8:45 am]
BILLING CODE 4160-01-F