Beverages: Bottled Water

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