Oser Communications Group

GOURMET NEWS DECEMBER 2014 www.gourmetnews.com GENERAL NEWS 9 Food Safety Continued from PAGE 1 steroids," referring to the Hazard Analysis and Critical Control Points system with which food companies are currently re- quired 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 haz- ards. 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 com- ments it received regarding this rule con- cerned the fact that farms that pack and hold their own Raw Agricultural Com- modities and food facilities that simply hold RACs for other farms are erroneously subject to the same food hazard require- ments. Under the new Supplemental Pro- posed 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 an- nual sales of human food, increasing the number of businesses that are exempt from complying with the Preventive Con- trols Rule. For the first time, under the Supplemen- tal 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 sam- pling and testing. The FDA said that public comment generally demonstrated support for including a provision in FSMA that would require food companies to docu- ment 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 con- duct 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 them- selves immediately host to a cavalcade of foreign inspectors. "Consumer groups want the boots on the ground in every fa- cility," said Detlefsen. "I frequently made the argument to the Food and Drug Ad- ministration – 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 appropri- ate verification activities and the frequency of such verification based on a risk evalua- tion. Possible verification activities may in- clude 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 con- trolling a known serious hazard, in which case annual onsite auditing will be manda- tory. Another criticism Detlefsen and others have of the original Proposed Rule on For- eign Supplier Verification Program con- cerns the fact that importers are tasked knowledge – a place where you guys can turn to with your questions. It's also sup- posed 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 indus- try sectors. The idea is to come up with in- dustry-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 possi- ble. "Market demands are now requiring these types of plans anyway, so, although you might be exempt from the govern- ment, 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 ex- emptions. If you're suspected of a food- borne illness, they could withdraw your exemption. So you might want to be pre- pared 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. GN with controlling hazards at the level of the supplier. Detlefsen likens this requirement to a grocery store being required to docu- ment 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 control- ling the hazard. I think this is totally bizarre, and it's going to cause a lot of fric- tion." The revised rule is more nuanced, re- quiring importers to consider risks on a case-by-case basis in determining appropri- ate supplier verification activities. The lion's share of FSMA public com- mentary centered on the Proposed Pro- duce 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 Form- ing Units of E. coli per 100 milliliters of water. In addition, the maximum allow- able concentration in a single sample was limited to 235 CFU per 100 milliliters. After consideration, the FDA has revised these figures. The statistical mean require- ment 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 con- tentious piece of FSMA negotiations, with the agency clearly demonstrating a prefer- ence 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 Pro- posed Rules, however, FDA officials have admitted that more scientific testing is necessary before such a rule can be estab- lished. 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 con- cerns, 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 Admin- istration's Center for Food Safety and Ap- plied 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 Verifica- tion Program Rules will be an- nounced. 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 com- panies 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 mil- lion 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 require- ments 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 standard- ized, accepted, recognized curriculum. And we don't have that yet." D'Amico is currently working with both the FDA and the Illinois Institute of Tech- nology's Institute for Food Safety and Health as part of the newly created Food Safety Preventive Controls Alliance, an or- ganization tasked with creating training ma- terials and courses that will educate people on how to implement FSMA rules in U.S. food production operations. When com- pleted, the FSPCA curriculum will be pub- licly available online for use by anyone. The agency will also create FSPCA certificates, identifying those who go through the nec- essary training as "qualified individuals." "The Alliance, as it exists, is supposed to serve as a hub for preventive controls

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