New Food Safety Rules Unfold
February 26, 2012 
In January 2011, President Obama signed the most sweeping food safety reform in the nation’s history. The Food Safety Modernization Act (FSMA) set the FDA into action implementing more than 50 new rules and regulations that will impact produce from the field all the way to consumer’s retail purchases.
By law, FDA was mandated to provide a one-year report to track progress in developing the new rules, which it did in January. The agency characterizes its efforts as significant in the first year since FSMA was signed into law. But, despite the progress on FSMA, FDA has postponed the release of other important rules that will directly impact the fruit and vegetable industries.
According to David Gombas, senior vice president for food safety and technology for United Fresh Produce Association, that is cause for some disappointment, but on the other hand, with such a large change in new regulations, it is best to take the time to get it right.
“Part of me wants to take FDA to task for not being able to get the proposed rules out on time,” says Gombas. “But another smarter part of me wants them to take as long as necessary to get them as ‘right’ as they can. The Produce Safety Rule has been at least two years in the making, and the Preventive Controls rule (also known as GMP Modernization) has been in process for closer to a decade. But publishing rules for the sake of publishing rules helps no one.
“We can argue about whether FDA should have kept their other agencies’ counterparts informed of the details of the proposed rules during their development, rather than dropping it in their laps at the last minute, or whether those agencies should have taken a more active and aggressive role in being involved in the development of the rules. But hindsight is 20/20, and the rules now have to go through review by other government agencies before the industry and public get to see them. We can only hope that more cooks in the kitchen, just before dinner is done, makes for a better meal.”
What We Do Know
Gombas credits FDA for showing unprecedented transparency while developing the Produce Safety Rule, which should give an idea of what is coming. However, FDA cautions anything could change before the rule is published. First and foremost, FDA says the rule will be risk-based and commodity specific, not one-size-fits-all. The Tester Amendment will exempt smaller operations from provisions of the FSMA. The law will tighten up gray areas in current law, which will force all packinghouses and other handlers to follow good manufacturing practices (GMP). In addition, FDA indicates it plans to stagger the implementation of the new rules. Large operations have one year to implement regulations after the final publication of rules. Small operations have two years and very small operations have three years.
“FDA struggled with how to rank fresh commodities by risk,” says Gombas. “Some of the commodities we’ve seen involved in foodborne outbreaks in the past few years (e.g., hot peppers and papayas) were never involved in outbreaks the day before. Instead, they settled on ranking risk by the practices involved in growing and harvesting. For example, they’ve said that leafy greens are not inherently ‘high risk.’ Instead, some of the practices that can be used in growing leafy greens (e.g., fertilizing with raw manure instead of compost, overhead irrigation rather than drip, pond water for irrigation instead of well) are more or less ‘risky.’ But recognizing that regions, commodities, and specific operations may be limited in what practices they can use, they intend to allow for all practices but require a greater regulatory burden on practices that they consider ‘risky.’ To what degree has yet to be shared.”
New Food Safety Rules Unfold ctd
FSMA: First Steps Completed
During the first year of the Food Safety Modernization Act (FSMA), FDA reports it has completed a number of initial implementation steps, including:
• Consumer Friendly Web Search For Recalls: FDA launched a more consumer friendly recall search engine on the FDA website.
• Guidance To Seafood Industry On Food Safety Hazards: FDA issued its updated guide to the seafood industry on hazards associated with fish and fishery products and appropriate controls for those hazards.
• Administrative Detention Of Foods: Allows FDA to administratively detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed. FDA has begun using this authority.
• Prior Notice Of Imported Food: FDA issued an interim final rule that requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.
• Joint Anti-Smuggling Strategy: FDA and the Department of Homeland Security issued a joint anti-smuggling strategy to help to identify and prevent smuggled foods from entering the U.S. and posing a threat to national security and consumer safety.
• Fee Schedule: FDA announced the fiscal year 2012 fee schedule for certain domestic and foreign facility re-inspections and for failure to comply with recall orders.
• Authority To Suspend The Registration Of Food Facilities: FDA has the authority to suspend the registration of food facilities to prevent the import and export into the U.S. in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
• Product Tracing Pilots Launched: FDA announced that the Institute of Food Technologists (IFT) will carry out two new pilot projects aimed at enhancing the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks.
Growers Get Ready
Gombas says that everyone in the fresh produce industry needs to monitor the development of these four rules (Produce Safety Rule; Preventive Controls for Human Food; Preventive Controls for Animal Feed; and Foreign Supplier Verification), because everyone who grows, handles, sells, or buys fresh produce will be affected by these new regulations.
“This will be the biggest food safety regulatory change in the U.S. in almost a century,” he says. “It is absolutely critical that every company affected by these rules (and that is pretty much everyone in the fresh produce supply chain) stop and pay attention to what the rules propose. While we may get 30 to 90 days to comment on the rules and maybe longer, that time will go fast. After the comment periods close, FDA will make whatever changes they have been convinced to make and will publish the final rules. Once published, the regulations will be very difficult to change, and they will be the rules of the land, as well as the rules for all imported produce into the U.S.”
When reviewing and commenting on the proposed rules, Gombas points out three areas that are important to consider. The first is digging for and understanding the details buried in hundreds of pages of text.
“We expect the proposed rules will be lengthy, likely hundreds of pages each,” he says. “The key will be the proposed codified rules themselves, which will likely be tucked in the middle or in the final pages. That’s where the detail will be, and that’s what matters. The rest of the documents will be largely ‘preamble’ that explains why FDA chose to do what they did.
“These explanations will be important, especially for items that someone disagrees with. If you’re going to argue with FDA on a requirement, you have to take their rationale into consideration. The devil is in the details, and the details will be in the codified rule.”
Saying you don’t like a proposed regulation and that it is just wrong won’t cut it in terms of moving the FDA’s position. “FDA has already given each of these rules their best efforts, and they are going to need a compelling alternative in order to justify a change,” says Gombas. “If you have a better idea, FDA wants to know. If you don’t have a better idea, FDA will consider theirs the best.
“Every company/individual is entitled and encouraged to comment, and there is strength in numbers. But uncoordinated comments may come across as just noise. I recommend that operations work together through their commodity, regional, or national trade associations to develop common messages to FDA. These should be well thought out to address the concern and what is the proposed fix. United Fresh intends to call our members and allied associations to develop our comments soon after the proposed rules are published.”
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