Public Meetings on Current Good Manufacturing Practice Regulations

Dear Colleague:

The Food and Drug Administration invites you to attend a public meeting concerning modernization of the agency's current good manufacturing practice (CGMP) regulations for human food (21 CFR Part 110.) These regulations cover the manufacturing, packing, and holding of human food, and include sanitary practice requirements for personnel, buildings, facilities, and equipment, and production and process controls.

FDA last revised its CGMP regulations for food in 1986 (51 FR 22458; June 19, 1986). The primary purpose of the revision was to establish new or updated provisions concerning food industry personnel; plants and grounds; sanitary facilities, controls, and operations; equipment and utensils; warehousing and distribution; and natural or unavoidable defect levels. FDA designed the revised CGMP regulations to help ensure the safe and sanitary manufacturing, processing, and holding of food for human consumption.

In the almost twenty years since the food CGMPs were revised, the food industry has undergone considerable change, and the agency believes that it is now time to revisit these regulations to determine whether they are ensuring a safe and sanitary food supply. FDA believes that a good first step is to obtain input from the industry and the public generally by holding a series of public meetings. To this end, the FDA has recently announced three public meetings in the Federal Register (69 FR 29220; May 21, 2004). The purpose of the meetings is to solicit comments from relevant stakeholders and other members of the public regarding specific areas of the regulations that need to be modernized. To help focus comments at the meetings, FDA included in the Federal Register notice a set of questions.

The meetings will be held at the following locations and times.

• College Park, Maryland (Washington, D.C. area):  Friday, June 11, 2004 ^(*) 9:00 a.m. to noon, at the Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835.
• Monterey, California: Friday, July 2, 2004, from 1:00 p.m. to 4:00 p.m., at the Monterey Conference Center, One Portola Plaza, Monterey, CA 93940. ^(*)
• Chicago, Illinois: Wednesday, July 21, 2004, from 2:00 p.m. to 5:00 p.m., at the Marriott Chicago Downtown, 540 North Michigan Avenue, Chicago, IL 60611.

For security and space limitation reasons, we ask participants to register in advance.

When registering, please include your name, title, firm name, address, and telephone and fax numbers. Also, if you wish to make a statement during a meeting, please notify FDA of your interest when you register. Finally, FDA will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please include your request in your registration or contact Peter Vardon at 301-436-1830 (Updated contact number: 240-402-1830), 301-436-2626 (fax), or by email (Peter.Vardon@fda.hhs.gov) at least seven days in advance of the meeting.

In addition to receiving oral comments at the meetings, FDA will also accept written comments through September 10, 2004. The Federal Register notice announcing the meetings provides detailed information on how to comment in writing.

We look forward to your participation in this important effort.

  ^* July 2, 2004: See Federal Register notice for revised meeting information.