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  1. Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements

Questions and Answers from the 2004 Public Meetings on Current Good Manufacturing Practice Regulations

May 21, 2004

FDA is initiating an effort to modernize its Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMPs) regulations (21 CFR Part 110). The agency is hosting three public meetings to solicit comments, data, and scientific information about the current state of quality management techniques, quality systems approaches, and voluntary industry standards concerning CGMPs as well as other controls used by food manufacturers and processors to prevent, reduce, control, or eliminate food borne hazards that may occur during food production, processing, or storage. FDA will review the information obtained through the meetings and use it in determining appropriate revisions to the CGMP regulations.

The following questions and answers provide additional information about the meetings and the agency’s goals.

Which sectors of the food industry should attend these meetings and provide comments?

Although the food CGMPs cover all foods regulated by FDA (including infant formula and dietary supplements), the focus of this effort is the general food CGMPs set out in 21 CFR Part 110. At these public meetings, the agency is not soliciting comments on other CGMP efforts (such as those specific to dietary supplements or to infant formula). In addition, FDA is not soliciting comment on other food safety regulations, such as the fish and fishery Hazard Analysis Critical Control Points (HACCP) rule (Part 123), the juice HACCP rule (Part 120), or the rule governing low-acid canned foods (Part 113).

Should small businesses attend these meetings and comment?

Yes. A portion of each public meeting will be designed to address the special issues related to small businesses.

What does FDA intend to do with the comments, data, and other information submitted at these meetings?

FDA will consider all of the information it receives at the public meetings as well as any written comments received in response to the Federal Register notice announcing the meetings in determining what revisions to propose to the current CGMP regulations.

What is the purpose of the three FDA research papers that have been made available on FDA’s web site?

FDA conducted three separate studies to examine the types of hazards associated with current food manufacturing and processing practices and the available controls to prevent these hazards. FDA has made these studies available to give meeting participants some background on the usefulness of current good manufacturing practices. One study examines food product recalls to determine which may have been caused by basic failures of sanitation or good manufacturing practice. A second paper is a comprehensive review of the scientific and technical literature with the goal of determining the current state of knowledge on CGMPs, the application of CGMPs to manufacturing, processing, and holding food, and the impact of CGMPs on food safety. The third paper summarizes FDA’s expert elicitation. To conduct this elicitation, FDA asked food safety experts from around the country to identify the kinds of hazards CGMPs should address and how such hazards could be best addressed.

What is the agenda for the three Public Meetings and will the agenda be the same at all three meetings?

All three meetings will have the same agenda, although the invited speakers are likely to be different at each meeting. Each meeting will include an overview of the issues from FDA's perspective, and a brief explanation of the agency’s goals for the meeting. The next part will consist of short presentations on the issues posed by CGMPs by each of three invited panelists. FDA will follow these speakers with a section addressing the particular needs of small business. The balance of the meeting will be used to receive oral comments from the members of the audience; FDA requests that those who wish to make a statement at the meeting notify FDA of their interest when registering.

May members of the public have a chance to comment in writing?

Yes, the agency will accept written comments until September 10, 2004. You may submit written comments even if you do not attend a public meeting. You may consult the Federal Register notice announcing the public meetings for directions about how to submit written comments.

Must I register to attend?

Because space is limited and for security reasons, we request that you register at least five days in advance of the meeting that you wish to attend. You may register electronically. We will also accept registration at the door of each meeting if space still is available.

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