Bottled Water: Monitoring Requirements

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