From: Federal Regulations Advisor
By Leland E. Beck
Food safety – what could be more important? The FDA Food Safety and Modernization Act (FSMA), signed into law on January 4, 2011, requires a significant regulatory shift by the Food and Drug Administration (FDA). FSMA imposed numerous deadlines for FDA to adopt regulations and those deadlines have passed into history without rules. Given those facts, a number of advocacy blogs and the press have complained recently that rules are “stuck” at theOffice of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA). Demanding action, two organizations filed suit to compel the FDA to publish the rules. Is there something to this issue of legislative deadlines? Or is the holdup another example of bad analysis leading to a potentially worse result? Is the suit improvident?
Editor’s Note: For the complete article, please see here.