2010-6699. Small Entity Compliance Guide: Bottled Water: Total Coliform and E. coli

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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. 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 § 129.35(a)(3)(i) and § 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.