[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
