November 3, 2000

FDA Approves Ionizing Radiation for Seeds for Sprouting

On Oct 30, 2000, in Fed Reg vol 65, pages 64605-07, FDA announced that it had approved the use of ionizing radiation on seeds to be used for producing sprouts to reduce the amount of pathogens in and on the seeds. While the process cannot assure elimination of every organism, it can achieve a considerable reduction. The likelihood of any remaining viable pathogen will depend on both the original microbial load and the dose applied.

The new regulation allows a dose up to 8 kGy. The actual dose applied to various seeds for sprouting will depend on the particular seeds and their ability to tolerate irradiation and remain able to sprout.

Elimination of pathogens (e.g. Salmonella, E. Coli O157:H7) that have been associated with sprouts can reduce the incidence of foodborne illness outbreaks. The petitioner demonstrated that when E. coli O157:H7 and Salmonella serotype Stanley were added to seeds, there were no detectable viable organisms remaining after irradiation at 5kGy. Because both the initial microbial load and the irradiation dose applied will determine whether any viable pathogenic organisms remain on the seed, and because irradiation does not leave any residual effect that could protect against recontamination, FDA recommends that seed distributors and sprout producers continue to follow good manufacturing practices to ensure protection against recontamination. These practices are available on CFSAN Websites: http://www.cfsan.fda.gov/~dms/sprougd1.html and http://www.cfsan.fda.gov/~dms/sprougd2.html.

Seeds for sprouting must be labeled according to 21 CFR 179.26(c)(3) to inform the sprout producer that the seeds have been irradiated and must not be re-irradiated. This information can appear either on the label, the invoice, or the bill of lading. Sprouts grown from irradiated seeds for sprouting will not require a label.

Egg Safety Research Public Meeting

The Transcript of Proceedings from the Public Meeting on Salmonella Enteritidis Research is available on the CFSAN Website at http://www.cfsan.fda.gov/~dms/egg0900.html.

CFSAN Enhances its Dietary Supplement Web Site

CFSAN has redesigned and improved the look and contents of its Dietary Supplement Web site. The site located at http://www.cfsan.fda.gov/~dms/supplmnt.html is now organized to help you quickly and easily find information related to dietary supplements. By updating and more accurately identifying items, clarifying categories or adding new ones, it is easier to locate documents or links to other sites. These changes mark the beginning of a redesign process that will continue to evolve as new information becomes available and outdated information is archived.

Inquiries should be directed to the Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) Outreach and Education Coordinators at the following e-mail addresses: JLatham@cfsan.fda.gov or NKulakow@cfsan.fda.gov.

Food Safety Initiative Staff E-mail: chammett@cfsan.fda.gov

Office Number: (202) 260-8920 · FAX (202) 260-9653 CFSAN Web site: http://www.cfsan.fda.gov/