[Federal Register Volume 74, Number 103 (Monday, June 1, 2009)]
[Notices]
[Page 26252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0224]


Small Entity Compliance Guide: Bottled Water: Residual 
Disinfectants and Disinfection Byproducts; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Bottled Water: 
Residual Disinfectants and Disinfection Byproducts--Small Entity 
Compliance Guide'' for a direct final rule published in the Federal 
Register of March 28, 2001. This small entity compliance guide (SECG) 
is intended to set forth in plain language the requirements of the 
regulation and to help small businesses understand the regulation.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written comments on the SECG to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
on the SECG to http://www.regulations.gov. Submit written requests for 
single copies of the SECG to the Division of Plant and Dairy Food 
Safety (HFS-317), Office of Food Safety, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or fax your request to 301-436-2651. 
Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1639.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 28, 2001 (66 FR 16858), FDA issued 
a direct final rule amending its bottled water quality standard 
regulations 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 by revising the existing allowable level 
for the DBP total trihalomethanes (TTHM). FDA 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. On July 5, 
2001 (66 FR 35373), FDA issued a technical amendment to correct an 
editorial error and confirmed the effective date of January 1, 2002.
    FDA examined the economic implications of the direct final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and 
determined that the rule would have a significant economic impact on a 
substantial number of small entities. In compliance with section 212 of 
the Small Business Regulatory Enforcement Fairness Act (Public Law 104-
121), FDA is making available this SECG stating in plain language the 
legal requirements of the March 28, 2001, direct final rule set forth 
in 21 CFR parts 129 and 165 concerning the allowable levels and 
monitoring requirements for the three residual disinfectants 
(chloramine, chlorine, and chlorine dioxide) and four types of DBPs 
(bromate, chlorite, HAA5, and TTHM).
    FDA is issuing this SECG as level 2 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents the agency's current thinking on this topic. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this SECG. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The SECG and received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.cfsan.fda.gov/guidance.html or http://www.regulations.gov.

    Dated: May 22, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12671 Filed 5-29-09; 8:45 am]
BILLING CODE 4160-01-S