[Federal Register Volume 66, Number 129 (Thursday, July 5, 2001)]
[Rules and Regulations]
[Page 35373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 129 and 165

[Docket No. 01N-0126]


Beverages: Bottled Water; Technical Amendment; Confirmation of 
Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; technical amendment; confirmation of 
effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of January 1, 2002, for the direct final rule that 
appeared in the Federal Register of March 28, 2001 (66 FR 16858). The 
direct final rule amends the bottled water quality standard regulations 
(part 165 (21 CFR part 165)) by establishing allowable levels for three 
residual disinfectants (chloramine, chlorine, and chlorine dioxide) and 
three types of disinfection byproducts (DBPs) (bromate, chlorite, and 
haloacetic acids (HAA5)) and revised the existing allowable level in 
part 165 for the DBP total trihalomethanes (TTHM). The direct final 
rule also revised, for the three residual disinfectants and four types 
of DBPs only, the monitoring requirement for source water found in the 
current good manufacturing practice (CGMP) regulations for bottled 
water in part 129 (21 CFR part 129). FDA is also making a technical 
amendment to part 165 to correct an editorial error introduced in the 
direct final rule of March 28, 2001 (66 FR 16858 at 16866). This 
document confirms the effective date of the direct final rule.

DATES: The effective date for the regulation confirmed: January 1, 
2002. The technical amendment to part 165 is also effective January 1, 
2002.

FOR FURTHER INFORMATION CONTACT: Lauren Posnick, Center for Food Safety 
and Applied Nutrition (HFS-306), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-358-3568.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 28, 2001 
(66 FR 16858), FDA gave interested persons until June 11, 2001, to 
comment on the direct final rule. FDA stated that the effective date of 
the direct final rule would be January 1, 2002, and, if the agency 
received no significant adverse comment, it would publish a notice of 
confirmation of the effective date no later than July 5, 2001. FDA 
received no significant adverse comments within the comment period. 
Therefore, FDA is confirming that the effective date of the regulation 
is January 1, 2002.
    As noted in the direct final rule, FDA is publishing this 
confirmation notice 180 days before the effective date to permit 
affected firms adequate time to take appropriate steps to bring their 
product into compliance with the standard imposed by the new rule. 
However, FDA recognizes that some bottled water products may be in the 
marketplace and remain there for 2 or more years. Thus, there may be 
some products already in interstate commerce on the effective date that 
have not been tested under the new part 129 requirements for 
disinfectants and disinfection by-products and that do not meet the 
revised standard of quality.
    Under 403(h)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343 (h)(1)), such products are considered to be misbranded if 
they do not meet the revised quality standard for the three residual 
disinfectants and the four types of DBPs unless they bear a statement 
of substandard quality. However, FDA believes that it would be 
appropriate to exercise its enforcement discretion as to those bottled 
water products that: (1) Are already in interstate commerce before 
January 1, 2002; (2) do not meet the revised quality standard for the 
three residual disinfectants and the four types of DBPs; and (3) do not 
bear a statement of substandard quality-provided that such products are 
not adulterated. Therefore, the agency does not plan to take 
enforcement action against such bottled water products, provided that 
such products are safe.
    FDA is making a technical amendment to part 165 to correct an 
editorial error introduced in the direct final rule of March 28, 2001 
(66 FR 16858 at 16866). In Sec. 165.110(b)(1)(ii), the agency is 
correcting the phrase ``three significant figures'' to read ``two 
significant figures.'' The error also appears in 21 CFR part 165.100 
(21 CFR revised as of April 1, 2001), on page 535, in the first column, 
under ``Effective Date Note.'' Publication of this document constitutes 
final action of this change under the Administrative Procedure Act (5 
U.S.C. 553). FDA has determined that notice and public comment are 
unnecessary because this amendment is nonsubstantive. Therefore, under 
the Federal Food, Drug, and Cosmetic Act and under authority delegated 
to the Commissioner of Food and Drugs, notice is given that no 
objections or requests for a hearing were filed in response to the 
March 28, 2001, direct final rule. Accordingly, the amendments issued 
thereby, including the technical amendment below, are effective January 
1, 2002.

List of Subjects in 21 CFR Part 165

    Beverages, Bottled water, Food grades and standards.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
165 is amended as follows:

PART 165--BEVERAGES

    1. The authority citation for 21 CFR part 165 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 343, 343-l, 348, 349, 371, 379e.

    2. Section 165.110 is amended by revising paragraph (b)(1)(ii) to 
read as follows:


Sec. 165.110  Bottled water.

* * * * *
    (b) * * * 
    (1) * * * 
    (ii) Total trihalomethanes (TTHM) means the sum of the 
concentration in milligrams per liter of the trihalomethane compounds 
(trichloromethane, dibromochloromethane, bromodichloromethane, and 
tribromomethane), rounded to two significant figures.
* * * * *

    Dated: June 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-16909 Filed 7-2-01; 4:22 pm]
BILLING CODE 4160-01-S