In June, a federal judge in California ordered the U.S. Food and Drug Administration (“FDA”) to issue proposed rules for the Food Safety Modernization Act (“FSMA”) by November 30, 2013. In July, the agency requested an extension for two of five rules that must be proposed by the November deadline. One of the primary areas at issue is known as the “intentional adulteration” or “anti-terrorism” rule related to contamination of food primarily from foreign markets. The agency requested an additional two years to develop this rule, indicating it had not previously regulated in this area.
Additionally, the agency sought a shorter extension for a proposed rule related to the sanitary transportation of food. The FDA argued that the current November deadline would result in proposed rules that were not fully evaluated and which may lead to delays in ultimate implementation as more areas of debate or concern would arise from hastily prepared rules. In fact, certain industry organizations, such as those representing produce groups at Fresh Summit 2013, recently called for a second comment period following the November deadline. These groups are citing the need for further industry input prior to publication of proposed rules.
In August, the judge declined to grant any extension for the adulteration rule, noting that the two years requested was too long. The judge also indicated the FDA’s dispute is with Congress, which she believed had established a “closed-end process” for implementation of FSMA rules. The judge noted she would not grant delay after delay continually lengthening the rulemaking process. The judge did, however, grant a 60-day extension of the agency’s deadline to propose a rule related to sanitary transportation.
In September, the FDA appealed the original June order to the Ninth Circuit Court of Appeals, and in a recent motion to the Ninth Circuit for a stay, the FDA noted that the October federal government shutdown further impacted its ability to meet the November deadline. The agency has indicated that in addition to the work yet to be done to prepare the proposed rules, the agency must now make up for 16 days of lost time. This lost time includes catching up on missed routine inspections of food and drug facilities that were suspended during the shutdown. The agency is even claiming lost time in the days leading up to the shutdown as agencies prepared for the closing of the federal government. The Ninth Circuit is considering the FDA’s request for a stay of the November deadline.