
[Federal Register Volume 75, Number 92 (Thursday, May 13, 2010)]
[Notices]
[Pages 26967-26968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11450]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0236]


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.

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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

[[Page 26968]]

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.
[FR Doc. 2010-11450 Filed 5-10-10; 4:15 pm]
BILLING CODE 4160-01-S


