Whether you like him or hate him, former U.S. Secretary of State Donald Rumsfeld is recognized to this day for explaining reality to war-waiting reporters by saying: “There are known knowns. There are things we know that we know. There are known unknowns. That is to say, there are things that we now know we don’t know.” In the past decade, food safety has been on a pretty predicable course. It was a time of “known knowns.” It was after 2006 that pressure was being brought on Congress for a new food safety law. Major outbreaks of foodborne illness were followed by Congressional hearings. By 2010, Congress and the new administration was ready to pass the Food Safety Modernization Act (FSMA). President Obama signed it into law in January 2011. The time between then and now was taken up getting as much consensus as possible about the rules. With that period over, the promise now is that we are going to reduce the 1-in-6 annual rate of Americans sickened by foodborne illness each year. We’ve turned a page. Thousands of large food processes are now covered by the new prevention-based FSMA regulations. Many were subject to the first compliance date, which was Sept. 19. The Pew Charitable Trusts, which was more involved in the FSMA than any other non-governmental organization, recently reported that the FSMA now “requires companies growing and processing food (to) have an affirmative, legally enforceable responsibility to take steps to prevent contamination of their products. Many Americans may assume that these FDA-regulated businesses already had such an obligation, but in fact, they have not until now.” Pew also reports that FDA will be able to stop a large processing facility from making or distributing tainted products if it fails to meet these requirements, before a single person gets sick. “No longer,” it says, “will the agency have to wait to act until a firm’s unsafe practices cause serious illness.” Yet, many ‘known unknowns’ remain The top “unknown” comes with America’s scheduled political changes. With a new President and new members of Congress months away from being sworn in, FDA, which regulates 80 percent of the food consumed in the U.S., might be under entirely new leadership. ParTech sidebar for Sept. 12FDA’s recent announcement to postpone some compliance dates for the various FSMA rules in the name of “education” could just end up causing procrastination by many food businesses. Another “unknown” is the amount of business-to-business investment that will occur in the immediate years ahead to manage FSMA compliance. It’s likely this investment will shape how compliance is achieved. It’s entirely possible more investment in technology will help lessen the need for third-party review services from “pen and paper” bearing humans. Whether a food company is clear or confused at the moment pretty much depends on size, according to The Association for Packaging and Processing Technologies (PMMI) Large food companies and their original equipment manufacturers (OEMs) are well on their way toward FSMA compliance, but many other food companies are still struggling to understand all aspects of the new law. The association’s latest FSMA Update Report analyzes responses from 47 food industry stakeholders on FSMA preparedness and identifies what food manufacturers need from supplier partners. According to the PPMI report, fresh fruit and vegetable processors and small food companies are expected to have the most difficulty with compliance. With only limited regulatory oversight before FSMA, these businesses have been making more investments in new equipment to help meet compliance. Additionally, small food companies and farms are challenged with overhead costs while those that source ingredients from foreign-based suppliers must now ensure that their suppliers comply with the law’s food supplier program. The PMMI report notes that many managers still need clarification on deadlines, as well as specifics on what parts of the law are relevant to their facilities. “Understanding FSMA compliance and documentation requirements present significant challenges to implementation” says Jorge Izquierdo, vice president of Market Development at PMMI. “As a result, about 30 percent of participating companies – particularly smaller ones – plan to use OEMs as a consulting resource to help figure out how FSMA applies to their operations.” An additional challenge with FSMA is the continuing roll-out of new documentation requirements. Some companies are still awaiting guidance on that from the Food and Drug Administration (FDA). Because FSMA is performance-based and does not require specific equipment designs, preparation activities focus mainly on internal staff training on new procedures and protocols, establishing preventive controls and implementing documentation procedures. Drivers for new equipment are mostly business growth and creation of new projects – but designs and services must address current food safety objectives. This period of “known unknowns” may be dominated by food company executives deciding how much to spend on food safety investments. If the rules are clear enough, investments might follow. Many suggest that may happen because of a heightened interest in FSMA by food industry executives. David Acheson, president and CEO of the consulting firm the Acheson Group, says interest by top food industry executives is increasing, but not because of the FSMA. As FDA’s former associate commissioner for foods, Acheson developed the 2007 Food Protection Plan, which outlined the authorities eventually granted to FDA by the FSMA. Acheson says food industry executives are waking up to the value of their brands and the values they contribute to the company’s economics. He sees executive suite interest in new regulatory strategies, managing supply chain risks, and responding to consumers needs such as with so-called clean foods. Earlier this year in Phoenix, dairy industry executives met to foster a “culture of food safety.” Terry Brockman, president and COO of Saputo Cheese Division USA, told industry media he believe food safty is now at the top of each food company’s mind. “One thing I really see with the culture of food safety is that it’s not one person’s job within organizations,” Brockman said. “It’s the organization from CEO all the way down to the janitor. Everyone now has to have input and buy-in because it’s so important.” (To sign up for a free subscription to Food Safety News, click here.)