2010-11450. Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory.” This guidance is intended to advise food manufacturers that once a boil-water advisory has been issued they should stop using the water subject to the advisory until the water again meets the applicable Federal and State drinking water quality standards. Further, this guidance is intended to assist food manufacturers in evaluating food that already was produced with water subject to the advisory. The guidance is in response to the recent major water pipe break in Massachusetts that interrupted service to 30 Massachusetts Water Resources Authority (MWRA) customer communities (serving approximately 2 million residents).

DATES:

Submit electronic or written comments on the guidance at any time.

ADDRESSES:

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance 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 guidance to the Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1700

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance entitled “Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory.” This guidance is intended to advise food manufacturers that once a boil-water advisory has been issued they should stop using the water subject to the advisory until the water again meets the applicable Federal and State drinking water quality standards. Further, this guidance is intended to assist food manufacturers in evaluating food that already was produced with water subject the advisory.

FDA is issuing this guidance as Level 1 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). Consistent with FDA's good guidance practices regulation, the agency will accept comment, but is implementing the guidance document immediately in accordance with 21 CFR 10.115(g)(2) because the agency has determined that prior public participation is not feasible or appropriate in light of the need to respond expeditiously to the recent major water pipe break in Massachusetts that interrupted service to 30 MWRA customer communities (serving approximately 2 million residents). The guidance represents the agency's current thinking on the use of water by food manufacturers in areas subject to a “Boil-Water Advisory.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate 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 the guidance. 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. 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 draft guidance at http://www.fda.gov/​FoodGuidances or http://www.regulations.gov.

Dated: May 10, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.