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Proposed Rule

FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.


Notice of public meeting; request for comment.


The Food and Drug Administration (FDA) is announcing a public meeting entitled “FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities.” The purpose of the public meeting is to provide interested persons an opportunity to discuss implementation of the preventive controls for facilities provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is seeking information on preventive controls used by facilities to identify and address hazards associated with specific types of food and specific processes. The public will have an opportunity to provide information and share views that will inform the development of guidance and regulations on preventive controls for food facilities that manufacture, process, pack or hold human food or animal food and feed (including pet food).


See “How to Participate in the Meeting” in the SUPPLEMENTARY INFORMATION section of this document.

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Patricia M. Kuntze, Office of External Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5322, Silver Spring, MD 20993, 301-796-8641,

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I. Background

FSMA (Pub. L. 111-353) amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation for a modernized, prevention-based food safety system and gives FDA for the first time a legislative mandate to require comprehensive, science-based preventive controls across the food supply.

In particular, section 103 of FSMA requires the owner, operator, or agent in charge of a facility that is required to register under section 415 of the FD&C Act (21 U.S.C. 350d) to take certain preventive 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. FDA is required to develop regulations to establish science-based standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting their implementation.

In addition, 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 the guidance to assist the food and feed industries in complying with the preventive controls regulations, when they are finalized. FDA will leverage, where appropriate, best practices for hazards and controls identified by industry for specific types of food and feed and specific methods in manufacturing, processing, packing, and holding food and feed. FDA is interested in making appropriate best practices publicly available. FDA is particularly interested in preventive control practices that are applicable and practical for small and very small businesses to implement.

II. Purpose and Format of the Meeting

If you wish to attend and/or present at the meeting scheduled for April 20, 2011, please register by e-mail at​FDAPreventiveControls by April 15, 2011. FDA is holding the public meeting on section 103 of FSMA to receive input from the public to inform the development of the regulations and guidance identified previously in this document. FDA will also consider input it has received previously through its engagement of stakeholders as part of the process to examine and update current good manufacturing practice requirements and to develop an animal feed safety system.

In general, the meeting format will include introductory presentations by FDA. Listening to our stakeholders is the primary purpose of this meeting. In order to meet this goal, FDA will provide multiple opportunities for individuals to actively express their views by making presentations at the meeting, participating in a total of three 75-minute break-out sessions on the provisions discussed at the meeting, and submitting written comments to the docket within 30 days after this meeting. (Participants can select up to three of the following five break-out sessions: Preventive Controls Guidance, On-Farm Manufacturing and Small Business, Product Testing and Environmental Monitoring, Training and Technical Assistance, and Preventive Controls and the Relationship to cGMPs.) There will be an interactive Webcast; see section III of this document, “How to Participate in the Meeting.” In order to provide Webcast participants with information before and after the meeting, we request attendees provide their name, their affiliation, and email when registering.

III. How To Participate in the Meeting

Stakeholders will have an opportunity to provide oral comments. Due to limited space and time, FDA encourages all persons who wish to attend the meeting, including those requesting an opportunity to make an oral presentation during the time allotted for public comment at the meeting, to register in advance and to provide the specific topic or issue to be addressed and the approximate desired length of their presentation. Depending on the number of requests for such oral presentations, there may be a need to limit the time of each oral presentation (e.g., 3 minutes each). If time permits, individuals or organizations that did not register in advance may be granted the opportunity for such an oral presentation. FDA would like to maximize the number of stakeholders who make a presentation at the meeting and will do our best to accommodate all persons who wish to make a presentation or express their views at the meeting. FDA anticipates that there will be several opportunities to speak in break-out sessions and an interactive Webcast will also be available for stakeholders who are not onsite.

FDA encourages persons and groups who have similar interests to consolidate their information for presentation through a single representative. After reviewing the presentation requests, FDA will notify each participant before the meeting of the amount of time available and the Start Printed Page 20589approximate time their presentation is scheduled to begin.

There is no fee to register for the public meeting and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. Onsite registration will be accepted after all preregistered attendees are seated.

Table 1 of this document provides information on participating in the meeting and on submitting comments to the docket.

Table 1—Information on Participation in the Meeting and Submitting Comments

DateElectronic addressAddress (non-electronic)Other information
Date of Public MeetingApril 20, 2011, 9 a.m. to 5:30 p.mFDA White Oak Campus, The Great Room, Bldg. 31, rm. 1503, 10903 New Hampshire Ave., Silver Spring, MD 20993Registration begins at 7:30 a.m.
WebcastApril 20, 2011, 9 a.m. to 5:30 p.m​preventivecontrols/​• If you have never attended a ConnectPRO meeting: Test your connection:​common/​help/​en/​support/​meeting_​test.htm. Get a quick overview: http://www.adobe.comgo/​connectpro_​overview.1 • The webcast will provide closed captioning.
Advance RegistrationBy April 15, 2011​FDAPreventiveControlsRegistration to attend the meeting will also be accepted onsite on the day of the meeting, as space permits. Registration information may be posted without change to, including any personal information provided.
Request special accommodations due to disabilityBy April 15, 2011Patricia M. Kuntze, 301-796-8641, email:
Make a request for oral presentationBy April 15, 2011​FDAPreventiveControlsRequests made on the day of the meeting to make an oral presentation may be granted as time permits. Information on requests to make an oral presentation may be posted without change to, including any personal information provided.
Provide a brief description of the oral presentation and any written material for the presentationBy April 15, 2011​FDAPreventiveControlsWritten material associated with an oral presentation should be submitted in Microsoft PowerPoint, Microsoft Word, or Adobe Portable Document Format (PDF) and may be posted without change to, including any personal information provided.
Submit electronic or written commentsSubmit comments by May 20, 2011Federal eRulemaking Portal: Follow the instructions for submitting commentsFAX: 301-827-6870. Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852All comments must include the Agency name and the docket number in brackets in the heading of this document. All received comments may be posted without change to, including any personal information provided. FDA encourages the submission of electronic comments by using the Federal eRulemaking Portal. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.
1 Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.
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IV. Comments

Regardless of attendance at the public meeting, interested persons may submit to the Division of Dockets Management (see table 1 of this document) either electronic or written comments for consideration at or after the meeting in addition to, or in place of, a request for an opportunity to make an oral presentation. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Transcripts

Please be advised that as soon as a transcript is available, it will be accessible at and​Food/​FoodSafety/​FSMA/​default.htm. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

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Dated: April 7, 2011.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.

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[FR Doc. 2011-8785 Filed 4-12-11; 8:45 am]