
[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29767-29769]
From the Federal Register Online via the Government Printing 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

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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


