Revised provisions to four proposed rules in the FDA’s Food Safety Modernization Act (FSMA) surprised few industry experts, but they say the changes clarify the original rules, first proposed in 2013, and could give them more teeth.
“The FSMA and its rules are meant to dramatically change and improve our food safety system. The watchword now is prevention,” says Doug Karas, health communication specialist at the FDA’s Office of Food and Veterinary Medicine, College Park, Md.
He says the rules need to be flexible and feasible. So far, the FDA has evaluated about 25,000 comments on the four rules. FDA scheduled the closing date to submit comments for the revised rules as Dec. 15, 2014.
The four revised rules cover preventative controls of human food, produce safety, preventive controls for animal food, and foreign supplier verification programs.
“These supplemental rules are complex and contain significant changes from the original rules,” says Patricia A. Wester, president of P.A. Wester Consulting, Gainesville, Fla.
“It’s atypical for the FDA to put out a supplement, but they felt it was unfair to make very dramatic changes before the final rule,” adds Jennifer McEntire, PhD, vice president and chief science officer of The Acheson Group, a strategic food and beverage consulting firm in Washington, D.C. “Each rule will have a substantial impact for suppliers.”
She adds that the FDA will provide guidance documents on how to implement the finalized rules.
“The main point is the rules individually are multifaceted and have many nuances and contingencies,” Dr. McEntire says. “We have to look at how they intersect, where one rule drops off and another picks up. This will have a major impact on the food
Key revisions to the preventative controls for human food include not making farms that pack or hold food from other farms subject to the preventative control rule, defining a very small business at less than $1 million in total annual sales of human food adjusted for inflation, and language covering economically motivated adulteration.
The changes for produce safety now include more flexible water quality standards and a tiered approach to water testing. Also, the raw manure strategy will be studied further, and covered farms will be better defined.
The revisions aim to make current Good Manufacturing Practice regulations more applicable to animal food and to get comments on feed mills associated with farms.
In terms of foreign supplier verification programs, the FDA is proposing more comprehensive hazard analysis, a hybrid verification of suppliers, and consistency with other proposed FSMA rules.
“What’s significant about the rules are they are tied to public health outcomes,” Wester adds. “The FSMA makes each person in the supply chain accountable. We are looking at food distribution more holistically.”