The Food and Drug Administration (FDA) has denied requests to delay a final rule amending food additive regulations “to provide for the safe use of ionizing radiation for the control of Vibrio species and other foodborne pathogens in fresh or frozen molluscan shellfish.” According to FDA, it has reviewed opposition to the final rule and requests for a hearing, but concluded that objections filed by groups such as Public Citizen and the Center for Food Safety did not “justify a hearing or otherwise provide a basis for revoking the regulation.”

In particular, the agency’s latest decision dismisses allegations that (i) FDA failed to consider evidence indicating “harmful effects from consumption of irradiated molluscan shellfish”; (ii) the final rule does not ensure a product “that is microbiologically safe”; (iii) there is no reasonable certainty of no harm; (iv) FDA failed to consider “several factors that could make irradiated molluscan shellfish unsafe”; (v) FDA improperly failed to apply a “100-fold safety margin for 2-alkylcyclobutanones [2-ACBs]” produced during irradiation; (vi) FDA ignored “in vivo or in vitro mutagenicity studies”; (vii) FDA misrepresented “important published or unpublished warnings” about 2 ACBs; (viii) FDA failed to follow critical guidelines for food additives; (ix) FDA failed to address studies indicating that irradiating oysters “may cause unpleasant—perhaps unwholesome—byproducts”; (x) FDA made errors in the review memoranda used to support the final rule; (xi) FDA ignored “the fact that irradiation can dramatically increase the concentration of many potentially toxic chemicals.” Rejecting these claims, FDA has thus reconfirmed August 16, 2005, as the effective date of the final rule. See Federal Register, March 22, 2011.

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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