12. 4 Mandatory Inspection Frequencies What will be different? FDA will not be able to meet requirements with current resources Utilize Federal, State, and Local regulatory partners (domestic facilities) Utilize third party certification (foreign facilities) Agreements with foreign governments Deny import of food from firms refusing inspection What does this mean Greater regulatory presence Increased oversight of and focus on imported food
17. 8 Mandatory Recall Authority What is new? Gives FDA authority to require a mandatory recall of product if responsible party refuses to voluntarily recall If FDA orders mandatory recall, informal hearing with the responsible party due within 2 days Failure to comply subject to civil penalties and criminal prosecution Incident Command Operation for each recall to coordinate government activities Who is impacted? Registered facilities that manufacture, process, pack, or hold food Farms, restaurants, and retail food establishments that are exempt from registering under Section 415 of the Food, Drug, and Cosmetic Act will not be directly impacted, but may be involved in recalls
18. 9 Mandatory Recall Authority What will be different Previously, if a firm refused to recall, FDA could issue press and pursue a court order, in each applicable jurisdiction, to seize the product Gives FDA authority to take action without prior court approval What does this mean? Majority of recalls occur voluntary and quickly because firms to not want to risk making consumers sick Fills a gap in FDA authority Probably will not be used on a routine basis
75. Required plan for building capacity with foreign governments should include provisions for the multilateral acceptance of laboratory methods and testing and detection techniques