[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29767-29769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12616]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0238]
Preventive Controls for Registered Human Food and Animal Food/
Feed Facilities; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a docket to obtain information about preventive controls and
other practices used by facilities to identify and address hazards
associated with specific types of food and specific processes. FDA is
establishing this docket to provide an opportunity for interested
parties to provide information and share views that will inform the
development of guidance on preventive controls for food facilities that
[[Page 29768]]
manufacture, process, pack, or hold human food or animal food/feed
(including pet food).
DATES: Submit either electronic or written comments by August 22, 2011.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
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 20740-3835, 301-436-2166; or Kim
Young, Center for Veterinary Medicine (HFV-230), Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9207.
SUPPLEMENTARY INFORMATION:
I. Background
On March 19, 2009, President Barack Obama established a new Food
Safety Working Group (FSWG), chaired by the Secretaries of the
Department of Health and Human Services and the Department of
Agriculture. In announcing the creation of the FSWG, the President said
the group would advise him on how to upgrade U.S. food safety laws for
the 21st century, foster coordination of food safety efforts throughout
the Government, and ensure laws are being adequately enforced to keep
the American people safe from foodborne illness (Ref. 1).
On July 1, 2009, the FSWG recommended a new public health-focused
approach to food safety based on three core principles: (1)
Prioritizing prevention; (2) strengthening surveillance and
enforcement; and (3) improving response and recovery (Ref. 1). The FSWG
emphasized the importance of setting rigorous standards for food safety
and providing regulatory agencies the tools necessary to ensure that
the food industry meets these standards. The FSWG also recommended that
food regulators move aggressively to implement sensible measures
designed to prevent food safety problems before they occur.
On January 4, 2011, President Barack Obama signed into law the FDA
Food Safety Modernization Act (Pub. L. 111-353), which requires the
owner, operator, or agent in charge of a facility required to register
under section 415 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350d) to take certain actions, including to evaluate the hazards
that could affect food manufactured, processed, packed, or held by the
facility and to identify and implement preventive controls to
significantly minimize or prevent the occurrence of such hazards. A
written plan must be prepared to describe the procedures used by the
facility to comply.
FDA is required to issue guidance with respect to hazard analysis
and preventive controls. Given the diversity of registered facilities
and regulated foods, FDA will use guidance to assist the food and feed
industries in complying with the preventive controls regulations, when
finalized. We plan to leverage, where appropriate, the best practices
for hazards and controls identified by the food and feed industries for
specific types of food and specific methods to manufacture, process,
pack, and hold food.
Representatives of the food and feed industries have told FDA the
food safety information they have developed is not proprietary and have
committed to sharing with us the best practices relating to hazards and
control measures they have identified. FDA is interested in making
appropriate best practices relating to identified hazards and control
measures for specific industry segments publicly available.
FDA is establishing a docket to provide an opportunity for
interested parties to provide information and share views that will
inform the development of guidance on the following: (1) Hazard
identification and (2) control measures associated with specific types
of food or specific methods of manufacturing, processing, packing, or
holding food. FDA is particularly interested in preventive controls
practices that are practical for small and very small businesses to
implement.
II. Request for Comments and Information
We are requesting comments that will inform the development of
guidance on the following: (1) Hazard identification (biological,
chemical, radiological, and physical) and (2) control measures
associated with specific types of food or specific methods of
manufacturing, processing, packing, or holding food. In particular, we
welcome input on any of the following general categories with respect
to human food or animal food/feed (including pet food):
Conducting a hazard analysis to determine the hazards
associated with specific human food or animal food/feed and processes
(e.g., the procedures used to determine potential hazards and to assess
whether they are reasonably likely to occur).
Implementing process controls (e.g., processes employed to
prevent, eliminate, or reduce to acceptable levels the occurrence of
any hazards that are reasonably likely to occur).
Validating food/feed safety controls (e.g., information on
procedures used to determine that control measures are capable of
controlling the identified hazards).
Implementing sanitation controls (e.g., procedures and
practices utilized to minimize the risk of contamination) for human
food and animal food/feed.
Implementing supplier controls (e.g., procedures and
practices used to ensure raw materials and ingredients are safe for
their intended use).
Allergen control (human food), including procedures to
ensure that ingredients are accurately declared on the label,
procedures to ensure the proper label is applied to the food, and
procedures and practices to prevent the unintentional incorporation of
a major food allergen into a food by cross contact during
manufacturing, processing, and holding food.
Environmental monitoring for Salmonella and for Listeria
monocytogenes for specific types of food facilities (e.g., ready-to-eat
food facilities, pet food facilities).
Microbiological and other testing used to help ensure the
safety of specific human food and animal food/feed.
Specific biological, chemical, radiological, and physical
hazards and controls for food types such as (but not limited to)
spices, nuts, ready-to-eat food, bakery products, fresh-cut produce,
milk products, and medical food.
Specific biological, chemical, radiological, and physical
hazards and controls for animal food/feed including feed ingredients.
Preventive control approaches and practices (e.g., for
validation, supplier controls) that are practical for small and very
small businesses to implement.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
IV. References
FDA has placed the following reference on display in FDA's Division
of Dockets Management (see ADDRESSES)
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and it may be seen between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site address, but FDA is not responsible for
any subsequent changes to the Web site after this document publishes in
the Federal Register).
1. Food Safety Working Group, ``Food Safety Working Group: Key
Findings'' (July 1, 2009), Available at http://www.foodsafetyworkinggroup.gov/ContentKeyFindings/HomeKeyFindings.htm. Accessed and printed on April 1, 2011.
Dated: May 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12616 Filed 5-20-11; 8:45 am]
BILLING CODE 4160-01-P