May 13, 2005

FDA Plans Public Meetings on Recordkeeping Final Rule

FDA has announced a series of domestic meetings to discuss the final Recordkeeping regulation implementing Section 306 (Maintenance and Inspection of Records) of the Bioterrorism Act of 2002. The final Recordkeeping rule was published in the Federal Register on December 9, 2004. The purpose of these meetings is to provide information on the rule to the public and to provide the public an opportunity to ask questions of clarification.

The five public meetings will be held as follows:

To register, please submit your registration information (including name, title, firm name, address, telephone number, e-mail address, and fax number) at least 5 workdays before the meeting date. We encourage you to register online or by fax at (202) 479-6801. We will accept registration on-site; however, space is limited and registration will be closed at each site when maximum seating capacity for that site is reached at 300 persons per site location. All participants must present a valid photo ID when entering a federal building and parking facility.

For further information, please contact Marion V. Allen, Center for Food Safety and Applied Nutrition (HFS-32), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, PHONE: 301-436-1584, FAX: 301-436-2605, email: , for general questions only about the meeting.

The complete Federal Register notice announcing the public meetings is available for online viewing. Additional information about the provisions of the Bioterrorism Act under FDA's jurisdiction can be accessed at The Bioterrorism Act of 2002 and FDA Actions on New Bioterrorism Legislation.

FDA Proposes In-Lid Labeling for Eggs

FDA has proposed to amend its food labeling regulations to permit the egg industry to place the safe handling statement for shell eggs on the inside lid of egg cartons if the statement "Keep Refrigerated" appears on the top or side panel. This proposed rule applies to shell eggs that have not been treated to destroy Salmonella bacteria that can cause foodborne illness. If the rule is finalized, consumers may see the safe handling statement every time they open the egg carton. Currently, the safe handling statement must appear on either the top or any side panel of egg cartons.

FDA proposed to amend the egg labeling regulations after the egg industry asked FDA to allow safe handling statements to be placed on the inside lid of egg cartons. Although the placement of the safe handling statement on the inside lid of egg cartons is optional, the statement remains the same: "To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly."

An estimated 118,000 illnesses per year are caused by consumption of eggs contaminated with Salmonella, a bacterium that can cause an intestinal infection if ingested. Persons with salmonellosis (the illness caused by the bacterium) may experience diarrhea, fever, abdominal cramps, headache, nausea, and vomiting. Children, the elderly and persons with weakened immune systems are most vulnerable.

This proposed rule amends the federal regulation first published in December 2000, which also requires retail establishments to refrigerate shell eggs promptly when they are received and to store the eggs at 45° F (7.2° C) or cooler. The complete Federal Register notice announcing the proposed rule may be viewed online.

FDA is providing a 75-day comment period on the proposed rule. Interested persons can submit comments electronically or in writing to the Division of Dockets Management Branch (HFA-305), 5630 Fishers Lane, room 1061, Rockville, MD 20852.