Date: Oct 01, 2013
The federal government began to “shutdown” this morning as a result of Congress’s failure to reach agreement on funding federal agencies.
Prior to the shutdown, the Department of Health and Human Services (HHS) explained its contingency plans in the event of a shutdown of the government. A copy is available here. According to the release, the Food and Drug Administration (FDA), which is a subordinate agency of HHS, will be unable to support the majority of its food safety, nutrition, and cosmetics activities under a government shutdown.
“FDA will also have to cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making,” HHS stated in the document (emphasis added).
Speaking at Keller and Heckman’s Annual Food Packaging Law Seminar, Dennis M. Keefe, Ph.D., Director of FDA's Office of Food Additive Safety (OFAS), Center for Food Safety and Applied Nutrition (CFSAN), provided further explanation of what would happen with food-contact notification (FCN) program under a government shutdown. He explained on September 18, 2013, that if the government shutdown occurred, FDA would send formal objection letters to submitters of pending FCNs, effectively terminating their review because the Agency would not have sufficient funds to operate the FCN program and, thus, would not be able to meet the statutory requirement that FCNs be acted upon within 120 days. (For more information on Dr. Keefe’s presentation, see the PackagingLaw.com article, Submitters of Active FCNs Will Receive Objection Letters if the Government Shuts Down, FDA’s Keefe Says at Keller and Heckman Conference.)
FDA activities that would continue under a government shutdown, according to HHS are ones related to the Agency’s user fee funded programs, including the activities in the Center for Tobacco Products; and select vital activities, including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.