By Lucas Witman
After receiving thousands of comments (including 15,000 unique responses to the Proposed Produce Safety Rule alone), the Food and Drug Administration recently released its Supplemental Proposed Rules for the pending Food Safety Modernization Act, and many stakeholders are still dissatisfied with how the Act is developing.
FSMA, first signed into law in 2011, was created as a mechanism for preventing foodborne illness in the United States by modernizing the regulatory framework under which both domestic and foreign food companies operating in this country are required to conform. The Act covers the establishment of mandatory preventive control standards and produce safety standards for food facilities, the mitigation of the risk of intentional contamination of the food supply and the maintenance of food importer accountability. Although lawmakers originally intended FSMA to be fully implemented just a couple of years after it was established, deadlines have been pushed back several times, and public commenting on the Act is ongoing.
After further consideration, and in response to comments it received from the public, the FDA has announced Supplemental Proposed Rules for FSMA in four key areas, including changes to the Foreign Supplier Verification Program, Preventive Controls for Human Foods, Produce Safety and Preventive Controls for Animal Food rules.
According to Clay Detlefsen, Vice President of Regulatory Affairs and Council for the International Dairy Foods Association, the most substantial of all FSMA rules for his industry is the Proposed Rule for Preventive Controls for Human Food. Detlefsen calls the rule “HACCP on steroids,” referring to the Hazard Analysis and Critical Control Points system with which food companies are currently required to comply. The Preventive Controls for Human Food rule mandates that every food facility implement a written food safety plan that details how that facility is working to eliminate potential food hazards.
The FDA received 8,000 comments on the original Proposed Rule for Preventive Controls for Human Food, and as a result, it is offering several alterations. According to the FDA, one of the most frequent comments it received regarding this rule concerned the fact that farms that pack and hold their own Raw Agricultural Commodities and food facilities that simply hold RACs for other farms are erroneously subject to the same food hazard requirements. Under the new Supplemental Proposed Rules, farms and facilities that hold RACs for other farms are not subject to the Preventive Controls Rule. In addition, the FDA has amended its definition of a “very small business,” to mean a business that has less than $1 million in total annual sales of human food, increasing the number of businesses that are exempt from complying with the Preventive Controls Rule.
For the first time, under the Supplemental Proposed Rules, the FDA is creating guidelines for a risk-based requirement for a written supplier verification program, with risks determined through appropriate activities, such as onsite auditing or sampling and testing. The FDA said that public comment generally demonstrated support for including a provision in FSMA that would require food companies to document and verify the safety of their domestic suppliers when potential hazards exist.
Regarding changes to the Proposed Rule on Foreign Supplier Verification Program, the original FSMA language was criticized for requiring domestic companies to conduct in-person audits of foreign facilities, a process that could be burdensome to many companies as well as difficult to implement at foreign facilities that might find themselves immediately host to a cavalcade of foreign inspectors. “Consumer groups want the boots on the ground in every facility,” said Detlefsen. “I frequently made the argument to the Food and Drug Administration – if that foreign supplier is supplying 500 importers, what’s it going to look like as far as how many people are going to have to go to that facility?”
In the Act’s new language, the importer will be tasked with determining appropriate verification activities and the frequency of such verification based on a risk evaluation. Possible verification activities may include annual onsite auditing, but it may also involve remote sampling and testing or some other activity. The one exception to this would be if the foreign supplier is controlling a known serious hazard, in which case annual onsite auditing will be mandatory.
Another criticism Detlefsen and others have of the original Proposed Rule on Foreign Supplier Verification Program concerns the fact that importers are tasked with controlling hazards at the level of the supplier. Detlefsen likens this requirement to a grocery store being required to document the safety of the food one’s customers are preparing. “If we were talking about ground beef, and the supplier was Safeway, and I was the customer, Safeway would have to come to me at least annually and get paperwork that basically said yeah, Clay Detlefsen – he’s cooking those burgers just fine,” he said. “That would be controlling the hazard. I think this is totally bizarre, and it’s going to cause a lot of friction.” The revised rule is more nuanced, requiring importers to consider risks on a case-by-case basis in determining appropriate supplier verification activities.
The lion’s share of FSMA public commentary centered on the Proposed Produce Safety Rule, where interested parties focused their criticisms on the microbial quality standards for agricultural water and the use of raw manure in agriculture. Regarding agricultural water, the original FSMA rules stated that farmers must demonstrate through extensive testing that water being used contains a statistical mean of no more than 126 Colony Forming Units of E. coli per 100 milliliters of water. In addition, the maximum allowable concentration in a single sample was limited to 235 CFU per 100 milliliters. After consideration, the FDA has revised these figures. The statistical mean requirement remains unchanged, but the single sample maximum allowable concentration requirement has been scrapped in favor of a new statistical threshold requirement whereby the mean average of the upper 10 percent of samples cannot exceed 410 CFUs per 100 milliliters.
The FDA has also amended its original requirement that farms test agricultural surface water every seven days during growing season, instead creating a tiered testing model. A farm will have to create a baseline through repeated testing over an initial two-year period, but after that, the farm will simply be required to fill out an annual verification survey to demonstrate safe water quality. The baseline must be reestablished through further testing every ten years.
The FDA’s treatment of how raw manure is to be used in agriculture has been a contentious piece of FSMA negotiations, with the agency clearly demonstrating a preference for the use of compost in agriculture over the use of manure. Under the original FSMA rules, farms would be required to wait a minimum of 9 months to harvest crops after raw manure had been applied to the field. Under the Supplemental Proposed Rules, however, FDA officials have admitted that more scientific testing is necessary before such a rule can be established. Officials have pledged to defer any decision on the 9-month interval issue until a comprehensive scientific study is conducted – a process that could take as much as five years.
“We’re going to try collectively across the produce community to address these concerns, and I think there is agreement across the board that composting is the way to go, but there are limitations to composting,” said Samir Assar, Director of the Produce Safety Staff in the Food and Drug Administration’s Center for Food Safety and Applied Nutrition. “Stay tuned now. We are currently working on a framework, and we hope at some point soon we will be able to provide that framework.”
The deadlines for the final FSMA rules are now staggered throughout the second half of 2015 and the first half of 2016. On August 30, 2015, the FDA is scheduled to publish its final Preventive Controls for Human Food Rule. On October 31, 2015 the final Produce Safety and Foreign Supplier Verification Program Rules will be announced. The final Third-Party Accreditation rule is scheduled for March 31, 2016. And the Sanitary Transport Rule will be finalized on May 31, 2016. Larger farms and food companies will be required to comply with these rules within one year after they are published, but small businesses (those with fewer than 500 employees) would not be required to be in compliance for two years. Very small businesses with less than $1 million in annual revenues for food sales will be subject to modified preventive controls requirements and will not be required to comply with FSMA for three years.
For those companies hoping to begin preparations to be in compliance with FSMA rules, the task is currently somewhat complicated due to fluctuating requirements and the lack of a specific framework for demonstrating compliance. According to FSMA rules, preventive controls must be implemented by “qualified individuals,” but critics argue that this requirement itself presents a conundrum.
“[Qualified individuals] don’t exist,” said Dennis D’Amico, Assistant Professor in the College of Agriculture, Health and Natural Resources at the University of Connecticut. “We don’t have a training yet, so we have nothing to compare it to. Right now, there are no qualified individuals, by definition, because it has to be related to a standardized, accepted, recognized curriculum. And we don’t have that yet.”
D’Amico is currently working with both the FDA and the Illinois Institute of Technology’s Institute for Food Safety and Health as part of the newly created Food Safety Preventive Controls Alliance, an organization tasked with creating training materials and courses that will educate people on how to implement FSMA rules in U.S. food production operations. When completed, the FSPCA curriculum will be publicly available online for use by anyone. The agency will also create FSPCA certificates, identifying those who go through the necessary training as “qualified individuals.”
“The Alliance, as it exists, is supposed to serve as a hub for preventive controls knowledge – a place where you guys can turn to with your questions. It’s also supposed to be a direct link between FDA and industry. So you don’t have to call the FDA. You can go right to the Alliance members,” said D’Amico. “We’re also charged with coming up with guidance for major industry sectors. The idea is to come up with industry-specific … hazards you should be looking for: These are some preventive controls that are common. This is how we verify those.”
D’Amico argues that even for smaller companies that do not have to comply with FSMA rules for several years or which may be exempt from certain rules altogether, it makes sense to think about getting into compliance as soon as possible. “Market demands are now requiring these types of plans anyway, so, although you might be exempt from the government, your market may demand it. Case in point: Whole Foods’ new push for third party audits is just one example. There’s going to be many markets that are going to have demands for food safety plans,” he said. “You also have to remember that FDA maintains the power to withdraw exemptions. If you’re suspected of a foodborne illness, they could withdraw your exemption. So you might want to be prepared if that exemption gets pulled.”
Those interested in commenting on the FDA’s FSMA Supplemental Proposed Rules can do so online at www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm. For more information on FSPCA, visit www.iit.edu/ifsh/alliance/.