[Federal Register Volume 63, Number 151 (Thursday, August 6, 1998)]
[Rules and Regulations]
[Page 42198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21135]
[[Page 42197]]
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Part IV
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
CFR Part 165
Beverages: Bottled Water; Final Rule
Bottled Water: Monitoring Requirements; Notice
Federal Register / Vol. 63, No. 151 / Thursday, August 6, 1998 /
Rules and Regulations
[[Page 42198]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 165
[Docket No. 98N-0294]
Beverages: Bottled Water
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation.
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SUMMARY: The Food and Drug Administration (FDA) is confirming the
provisions in the direct final rule that published in the Federal
Register of May 11, 1998, to lift the stay of the effective date for
the allowable levels in the bottled water quality standard for nine
chemical contaminants, i.e., antimony, beryllium, cyanide, nickel,
thallium, diquat, endothall, glyphosate, and 2,3,7,8-TCDD (dioxin),
which were published on March 26, 1996.
DATES: The effective date for the rule published at 63 FR 25764 (May
11, 1998) and corrected at 63 FR 30620 (June 5, 1998) is confirmed as
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: FDA published a direct final rule on May 11,
1998 (63 FR 25764), that was intended to lift the stay of the effective
date for the allowable levels in the bottled water quality standard
(Sec. 165.110 (21 CFR 165.110)) for nine chemical contaminants, i.e.,
antimony, beryllium, cyanide, nickel, thallium, diquat, endothall,
glyphosate, and dioxin, that the agency established in a final rule
that published on March 26, 1996 (61 FR 13258). By lifting the stay of
the effective date, each lot of bottled water would be required to
comply with the allowable levels for these nine chemical contaminants
and bottled water manufacturers would be required to monitor source
waters and finished bottled water products at least once a year for
these nine chemical contaminants under the current good manufacturing
practice (CGMP) regulations for bottled water in part 129 (21 CFR part
129). In response to the direct final rule, FDA received no significant
adverse comment about lifting the stay of the effective date for the
allowable levels for the nine chemical contaminants in the quality
standard for bottled water (Sec. 165.110). However, FDA received a
significant adverse comment about the monitoring requirements in part
129 that would apply to these nine chemical contaminants as a result of
the lifting of the stay. Because of the significant adverse comment
received, FDA is unable to promulgate monitoring requirements within
the statutory time period, i.e., by August 6, 1998, set forth in
section 410(b)(1) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 349(b)(1)). Therefore, each lot of bottled water will be
required to comply with the allowable levels for these nine chemical
contaminants, however, the monitoring requirements in part 129 do not
apply to the nine chemical contaminants in bottled water and instead,
under section 410(b)(4)(B) of the act, FDA is addressing monitoring
requirements for the nine chemical contaminants in bottled water in a
companion notice published elsewhere in this issue of the Federal
Register.
FDA is confirming the lifting of the stay of the effective date for
the allowable levels in Sec. 165.110 for the nine chemical
contaminants, effective February 2, 1999.
Dated: August 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-21135 Filed 8-5-98; 8:45 am]
BILLING CODE 4160-01-F
