[Federal Register Volume 75, Number 92 (Thursday, May 13, 2010)]
[Notices]
[Pages 26967-26968]
From the Federal Register Online via the Government Publishing 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