April 22, 2005

FDA Announces Public Meeting on Sprout Safety

FDA will hold a public meeting on sprout safety on May 17, 2005, in College Park, Maryland. The goal of the meeting is to elicit information on the current science related to foodborne illness associated with the consumption of sprouts. In October 2004, FDA released a produce safety action plan entitled "Produce Safety from Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption" (Produce Action Plan). One item in the Produce Action Plan is to initiate rulemaking to minimize foodborne illness associated with the consumption of sprouted seeds. However, because of the complexities of the issues and the uncertainty about what the current science could support, FDA believes that it would be of value to hold a public meeting to gather information relevant to a possible regulation. FDA requests that those who speak at the meeting, or otherwise provide FDA with their comments, focus on the questions relating to the microbial safety of seeds destined for sprouting and sprouted seeds set out in the complete Federal Register notice.

The public meeting will be held at the Harvey W. Wiley Federal Bldg. (5100 Paint Branch Pkwy.) in College Park, MD, on May 17, 2005, from 8:30 a.m. to 5 p.m. Those planning to attend the meeting should register prior to the meeting. For security reasons and due to space limitations, we recommend that you register at least 5 business days before the meeting. In addition to participating in the public meeting, you may submit written or electronic comments until July 18, 2005. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to Dockets Open for Comment.

For further information, contact Amy L. Green, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 301-436-2025, FAX: 301-436-2651, or e-mail: .

FDA Posts New Guidance for Prior Notice Submissions

On April 7, 2005, a guidance document was posted titled "Guidance for Industry: Prior Notice of Imported Food Entry Types and Entry Identifiers." This guidance is being provided to assist those submitting prior notice of imported food shipments in determining which entry types are associated with which entry identifiers. The identity of the entry type and entry identify is information required in §§ 1.281(a)(b) & (c) (3) and §§ 1.281(a) & (c) (4) of the Prior Notice interim final rule. The guidance is in the form of a chart which shows the acceptable relationships between Entry Types and Entry Identifiers.

Prior Notice Summary Information

On April 20, 2005, FDA posted new prior notice summary information about submission of prior notice, including data on the types of errors. This information will also be analyzed to help FDA take appropriate enforcement action when necessary. The summary information is presented in two categories: General Interest - Information about the number and types of prior notices that are being submitted, and which systems are being used to submit them; and Specific requirements - Information about submission of the required information. This is the fourth posting of summary information describing prior notice submissions. The August 2004 update included some summary information from December 2003 through April 2004 and some snapshots of activity in July 2004. While this fourth posting also contains updates of some of the same information, it now also includes information on specific information requirements such as registration number and carrier information.

Over 170,000 prior notices are submitted to FDA each week. From December 2003 through December 2004, about 77 percent of prior notices were submitted as additional information on transactions submitted to the Customs and Border Protection (CBP) through its Automated Broker Interface of the Automated Commercial System (ABI/ACS). About 22 percent of prior notices were submitted through FDA's Prior Notice System Interface (PNSI). About half of those received through PNSI could have been submitted through ABI/ACS. The remainder was submitted for transactions that could not be accommodated by ABI/ACS. The percentage of PNSI submissions has risen steadily.