The deadly Salmonella outbreak linked to Indiana-grown cantaloupe in 20 states is the latest in a series of foodborne illness crises that underscore the need to implement rules in the Food Safety Modernization Act (FSMA), the Pew Health Group told Food Safety News on Tuesday. Parts of FSMA — signed into law by President Obama in January 2011 — require the U.S. Food and Drug Administration to establish a number of food safety rules, including new standards for growing fruits and vegetables. Those rules were originally supposed to come out at the beginning of 2012, but eight months later, they are still languishing behind government doors. The current snag in the process is at the White House’s Office of Management and Budget (OMB), the cabinet-level office that assists in preparing the federal budget. After FDA drafted its rules, it sent them for review to the OMB, which is now still in the process of reviewing and revising them. In the meantime, the public has not seen exactly what these rules might entail or how they will work. While consumers and food safety experts wait for the rules to come out, more preventable produce outbreaks keep cropping up, Pew said. “Until we get these rules finalized, we’re going to keep seeing these outbreaks,” said Sandra Eskin, project director of the Pew Health Group’s Food Safety Campaign. While it is impossible to say whether new FDA rules would have prevented any particular outbreak, Pew and other food safety advocates believe new standards could go a long way in preventing illness and death caused by foodborne pathogens. Eskin said that instead of reviewing the new FDA rules internally, the OMB should release the proposed ideas for public review. “The only way you’re going to get it right is to let everyone provide some input so that we know the final rule is workable,” Eskin said. “Yes, it’s complicated, but it’s the only way we’re going to get these rules implemented.” Federal agencies will often present their proposed rules for public comment periods, and Eskin hopes that’s the case with these FSMA rules. But the question remains of when the proposals might get released. OMB’s review has no clear timeframe. Last August — eight months after the passing of the FSMA — Colorado-grown cantaloupes contaminated with Listeria monocytogenes sickened at least 147 people and killed 33 in one of the deadliest foodborne illness outbreaks in U.S. history. Now, a year later and in the shadow of missed release dates, another 141 people have fallen ill from Salmonella-tainted cantaloupes and two have died. “As these proposals continue to be delayed, there have been numerous outbreaks that could have been prevented with new standards,” Eskin said. “Let’s get the proposals released. Let’s see what they say. Let’s get them right by starting a robust commenting period. “

  • Ben

    Big Food organizations don’t want FSMA and their members are not doing anything as long as OMB does not release the rules. As long as you don’t have records and a labeled product, who is to blame for an incident? Pretty simple! A lot of FDA investigations end on a dead end. Not releasing the rules and putting the facts on the table may have sickened people unnecessarily and led to some deaths.

  • Michael

    The bottom line is that private industry is already WAAYYYYY ahead of the FDA. Most private industry food safety programs far exceed ANYTHING that FSMA has even discussed. If there are industries that have not moved forward then they will not be in the food industry for long. This is especially true for ingredient manufacturers who supply value added food manufacturers. Those 2nd party audits make FDA visits look like a housewarming party.
    The biggest problems are not the rules as they currently exist. The problem is that many of the rules that we apply have little to no scientific backing (The scientific requirements is what FSMA gets right). In addition, the rules are enforced by individuals who have little to no food industry experience or know how. Two of my most recent inspectors NEVER worked in the sector. One was a Lab Tech for a Crime Lab, and the other was someone who worked for the Port Authority. How prepared do you think they are for someone who has 15 years of food safety experience? You might as well bring in a mechanic, brick layer, or a financial adviser. If we want to improve food safety then it starts with paying professionals who truly understand the industry.
    Finally, BIG companies LOVE FSMA!!!! They could care less. 99% of what will be in FSMA big companies already perform, have already invested in, or can afford to change. Its the little guys that FSMA will eat up, and the Big guys LOVE IT. Why? Because what little market share the little guys have will fall into their laps because the little guys will get crushed under the weight of FSMA.