Preventive Controls for Registered Human Food and Animal Food/Feed Facilities

This Notice document was issued by the Food and Drug Administration (FDA)

For related information, Open Docket Folder  Docket folder icon


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.

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 thatmanufacture, 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 (seeADDRESSES) 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 (seeADDRESSES)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 theFederal 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
 
 
Comment Period Closed
Aug 22 2011, at 11:59 PM ET
ID: FDA-2011-N-0238-0001
View original printed format:
PDF

Document Information

Date Posted: May 23, 2011
Federal Register Number: 2011-12616
Show More Details  

Comments

61
Comments Received*
See attached file(s)
Attached is the statement submitted by the National Grain and Feed Association (NGFA) in response to FDA's request for information about preventive controls and...

Docket Information

This document is contained in
Related Dockets: None
Related RINs: None
Related Comments:

* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.

Document text and images courtesy of the
Federal Register