In an industry traditionally anxious to be self policing and oppose regulation, the tide has turned. The first evidence of this was in 2006 after the large E. coli O157:H7 outbreak linked to spinach, when the produce industry was seriously requesting that the U.S. Food and Drug Administration develop regulations around fresh produce. Since then, we have seen repeated outbreaks and recalls in which whole commodities have suffered (such as peanuts, pistachios, tomatoes, cantaloupes and now mangoes). Many of these post-2006 situations drove the desire to update the food safety regulations and, thus, had an impact on both the content of the 2011 Food Safety Modernization Act and the desire by the food industry to make the new regulations a reality. As the delays with FSMA-proposed rules have continued through 2012 and now move into the ninth month, we have continued to see pressure from the industry in conjunction with consumer groups literally begging for regulation. In the most recent action, a joint lawsuit was filed against the FDA last week by the Center for Food Safety (CFS) and the Center for Environmental Health. The suit is “an action for declaratory and injunctive relief regarding the failure by [FDA] to promulgate final regulations by mandatory deadlines contained in the FDA Food Safety and Modernization Act (FSMA).” Stating that “FDA has missed not one, not two, but seven critical deadlines, and counting,” the suit affirms that regulations have been submitted to the Office of Management and Budget (OMB) where they are awaiting approval. However, it adds, “FDA has authority to promulgate the regulations without OMB approval” and seeks “to require FDA to immediately promulgate the FSMA regulations … and enforce self-executing sections of FSMA even without finalized regulations.” While the Centers may be the first to bring a case against FDA for FSMA delay, they are far from the first to call for action. The joint lawsuit is, in fact, simply the latest in what the Washington Post called a “united front by this unusual alliance” – that is, consumer advocates joining with industry groups. In May, the Grocery Manufacturers Association and Pew Health Group co-wrote a letter to FDA regarding the delay, and since that time letters have descended on Washington from a variety of camps, such as that from the Peanut and Tree Nut Processors Association and the Snack Food Association among others. Is it a Failing of the Current Administration? In the CFS statement on the lawsuit, Executive Director Andrew Kimbrell said, “If the Obama Administration has lost the political will to make FSMA a reality, we’re here to help them find it.” The Washington Post article notes the hold-up as especially puzzling due to the president’s previous enthusiastic endorsement of the legislation. And with OMB reporting directly to the president, current endorsement – or command – directly from the boss would certainly have an impact on the prioritization of FSMA review and approval. Or Would a Romney Administration Be Any Different? However, we can only conjecture whether there would be a difference if a Romney administration were to take over after the November election. With no mention of food safety made at the Republican National Convention, there is little indication that there would be much more attention paid to FSMA. But without movement being made on the current front, perhaps a change of administration would speed things up? … or slow it down? We will speculate more on this in a future newsletter. It would certainly be progress were we to see any focus by either victor once the over-arching focus on campaigning is in the past. A Time-Consuming Process While the industry can’t be faulted for taking action to get the rules implemented, response to the current lawsuit (along with the ongoing FDA time needed to respond to the letters) is one more thing that will burn FDA’s already extremely limited resources. And consumer group assertion that on-time passage would have prevented any of the recent recalls and outbreaks is simply wishful thinking. Getting the rules out is merely the first step in a very long road. As detailed in a previous newsletter section “FDA’s Rulemaking Process,” FDA must first publish a notice of the proposed rule or an interim final rule, then allow a period for public comment – generally 30 to 120 days. FDA must then consider any revisions based on comments prior to publishing the final rule, then there is typically up to one year allowed for implementation for large businesses and often three years for small businesses. From our experience, the food industry is falling into three general camps: The most forward-leaning companies are already moving forward with FSMA preventive control preparation. This is partly because these companies want to be ahead and partly because much of FSMA preventive control requirements make a lot of sense for protecting a company’s brand. The second group is the “wait and see” group – those who simply don’t want to take FSMA seriously until they have to; and the third group are those who simply have not seen FSMA coming and happily have their heads in the sand – for now. Obviously having the proposed rules out will be helpful, but, as noted above and frequently in past (Leavitt Partner’s Food Safety) newsletters, prevention is an area that industry can and should be implementing regardless of such regulation. Finally, all the recent noise pushing for the FSMA rules to be published will likely have zero impact on either OMB or FDA. It will waste resources and creates a false impression that proposed rules published today will prevent outbreaks next week. This process takes time, and I have every reason to believe that the FSMA rules will be published under either the current or a future administration – so sit tight and focus on building good preventive controls. Because while being in compliance is important to business continuity, robust preventive controls are important to business survival. David Acheson, former Assistant Commissioner for Food Protection in the FDA, is a partner at Leavitt Partners. This commentary was originally posted September 6, 2012 on the Leavitt Partners Food Safety blog.