[Federal Register Volume 75, Number 58 (Friday, March 26, 2010)]
[Notices]
[Pages 14607-14608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6699]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0141]


Small Entity Compliance Guide: Bottled Water: Total Coliform and 
E. coli; 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: Total 
Coliform and E. coli--Small Entity Compliance Guide'' for a final rule 
published in the Federal Register of May 29, 2009. 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 electronic or written comments on the SECG at any time.

ADDRESSES: Submit electronic comments on the SECG to http://www.regulations.gov. 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 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 May 29, 2009 (74 FR 25651), FDA issued a 
final rule amending its bottled water regulations to require that 
bottled water manufacturers test source water for total coliform, as is 
required for finished bottled water products, and to require, if any 
coliform organisms are detected in source water, that bottled water 
manufacturers determine whether any of the coliform organisms are 
Escherichia coli (E. coli), an indicator of fecal contamination. FDA 
also amended its bottled water regulations to require, if any coliform 
organisms are detected in finished bottled water products, that bottled 
water manufacturers determine whether any of the coliform organisms are 
E. coli. FDA also amended the adulteration provision of the bottled 
water standard to reflect the possibility of adulteration caused by the 
presence of filth. Under the amended regulations, bottled water 
containing E. coli will be considered adulterated, and source water 
containing E. coli will not be considered to be of a safe, sanitary 
quality and will be prohibited from use in the production of bottled 
water. FDA also amended its bottled water regulations to require that, 
before a bottler can use source water from a source that has tested 
positive for E. coli, the bottler must take appropriate measures to 
rectify or eliminate the cause of E. coli contamination of that source, 
and that the bottler must keep records of such actions. Existing 
regulatory provisions require bottled water manufacturers to keep 
records of new testing required by this rule. The effective date of the 
final rule is December 1, 2009.
    FDA examined the economic implications of the final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). Because 
the costs per entity of this rule are small, the agency believes that 
the final rule will not have a significant economic impact on a 
substantial number of small entities. However, FDA could not certify 
that the final rule would not have a significant economic impact on a 
substantial number of small entities. Therefore, 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 May 29, 2009, final rule 
set forth in 21 CFR parts 129 and 165 concerning the monitoring 
requirements for total coliform and E. coli in source water and 
finished bottled water products, the allowable levels of total coliform 
and E.

[[Page 14608]]

coli in finished bottled water products, and requirements for 
recordkeeping and corrective measures.
    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) electronic or written 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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in Sec.  129.35(a)(3)(i) and Sec.  129.80(g) 
and (h) have been approved under OMB control no. 0910-0658.

IV. Electronic Access

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

    Dated: March 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6699 Filed 3-25-10; 8:45 am]
BILLING CODE 4160-01-S