Will Your Company Be Ready For FSMA?
By Sam Lewis
By fall 2015, the FDA will have finalized key rules for food manufacturing and produce safety. The FDA also wants your company to prescribe its own safety protocols once implementation happens and enforcement begins. Will your company be prepared?
The New Year marks the beginning of the second phase of the FDA’s implementation of the Food Safety Modernization Act (FSMA). Phase one’s focus was to develop food-safety standards and revise them based on industry feedback. Phase two of the legislation will focus on educating food producers, processors, and manufacturers, eventually leading to implementation in 2016. However, implementation will be gradual, allowing food makers a year to comply with published, final regulations. According to the FDA’s Seattle district compliance director, Miriam Burbach, “the FDA plans to educate before and while we regulate.” This approach lets the agency help companies with compliance and getting food-safety practices up to speed.
What To Expect From The FDA & FSMA This Year
In addition to assistance, the FDA will offer food makers incentive to comply with FSMA. Companies that have proven track records of following rules will be rewarded with fewer, less time consuming inspections. On the other side of the coin, companies with poor track records will be met with great scrutiny during audits “until we’re on the same page regarding public health,” says Burbach.
While food manufacturers, in general, have the proper tools and protocols to prevent contamination, farmers will be newcomers to federal regulations and supervision of food-safety practices. “Our greatest implementation challenge is going to be the produce rules,” says Stephanie Page, food safety and animal welfare program director for the Oregon Department of Agriculture. Many states farm agencies will help implement FSMA, but the extent of their role will be dependent on federal funds. “It’s not something we can take on without federal resources to support that work,” says Page. “Our existing food safety staff has very full plates.”
A concern of many farmers is the requirement for irrigation water testing. The FDA has been listening to these concerns and has been willing to work with farmers to address concerns. Originally, the FDA required weekly irrigation water tests with hard limits for bacteria levels—if water was found to exceed those limits, the water would need to be treated or irrigation would come to a halt — which many farmers felt were burdensome. The FDA has since changed the methodology, which no allows farmers to take water samples over longer timeframes and perform analyses to conclude if it is safe for irrigation. However, while the FDA is listening to concerns and compromising, this new rule is more complicated than the original proposal. Page furthers this notion, saying “Just because FDA has backed off a little bit, they’re not giving you a free pass.”
Taking The First Steps Toward FSMA Compliance
The FDA is offering the food industry more freedom in its practices instead of prescribing exact methods and protocols to be followed. However, with that freedom comes responsibility. According to Donna Garren, vice president of regulatory and technical affairs at the American Frozen Food Institute, “the agency expects companies to understand their safety systems and be able to defend them.”