As the first five final rules for FDA Food Safety Modernization Act (FSMA) regulations are anticipated in August and October 2015, the stage is set for the impending policy and education/training discussion.
Representatives joined PMA’s VP of Food Safety and Technology Dr. Jim Gorny on a recent webinar to explore an integrated federal/food safety system to implement FSMA regulations and verify compliance, and to learn what education outreach and training resources are being developed to assist you with making your business compliant with applicable FSMA regulations.
Implementing FSMA Regulations and Verifying Compliance
Jennifer Thomas, U.S. Food and Drug Administration (FDA)
Thomas described a phased approach to FSMA implementation. Phase 1 involves developing regulations for FSMA rules. FDA has a responsibility for implementing more than 50 regulations that came out of FSMA. Phase 2 involves operationalizing the rules and designing strategies to implement the standards. Phase 3 will involve monitoring, evaluating and refreshing the rules once they’re in effect. Stakeholder engagement remains important throughout all three phases.
“We’re investing in regulator training to promote consistent inspections and ensure decision-making is also consistent,” said Thomas. “We’re also looking at better, different ways of capturing data and analyzing the data, and then sharing that data. FDA does a lot of inspections now, but we don’t always provide feedback, capture trends or do the level of data analysis we think we want to do with the FSMA rules.”
FDA will also be looking at better public health metrics and will be working closely with government counterparts and other food safety system stakeholders to create an integrated food safety system, Thomas said.
FDA wants all regulators to go through the same training program and intends to provide real-time technical assistance while investigators are in the field. States need to be engaged in that process as well, she said.
Stephen Stitch, Association of Food & Drug Officials (AFDO)
In the proposed 2016 FDA budget (see slide 7 in presentation) , the single largest category is dedicated to the national integration of the food safety system, Stitch emphasized.
“AFDO recognizes FSMA places a large burden on FDA,” Stitch said. “FDA is not in a position to hire thousands of new inspectors. Most states already are conducting inspections. State and local inspectors conduct almost 90 percent of inspections for food safety. States will differ in adoption, and some states will adopt entire rules, while others might adopt certain pieces and others might not adopt at all. Our greater concern right now is, how will we establish our programs, and how will we fund them?”
Bob Ehart, National Association of State Departments of Agriculture (NASDA)
The gold standard for FSMA implementation, as NASDA has heard from industry members, is for the state departments of agriculture to have a clear role between the produce industry and FDA.
“Congress has made it pretty clear they want a change in culture – one that says we’re interested in prevention,” said Ehart. “This can’t end up being an unfunded mandate. It’s the right thing to do to pay for the programs to be competent and capable of doing those particular things.”
Programs at the state level will be based to a large degree on what is in the rules, he said. Some states will want to get involved in education and outreach, and NASDA is looking at what a state operational plan would need to look like. Consistency and uniformity of inspections is high on NASDA’s list of priorities as training and food safety programs are developed.
Education Outreach and Training Resources
Betsy Bihn, Produce Safety Alliance (PSA)
PSA was established in 2010 as a cooperative agreement between FDA and USDA. Primary goals include education and outreach to improve understanding and implementation of good agricultural practices (GAPs) and co-management strategies.
PSA has collected information so growers could access it more easily, and in doing so has developed a standardized educational curriculum, Bihn said. The curriculum will take about seven hours, so it can be delivered in one day.
Education is required in some of the rules. For example, in the Produce Rule, at least one supervisor from the farm must complete food safety training.
“We’re building a national network to get this information out to farmers,” Bihn said. “There are 186,000 farmers nationwide, and reaching them in rural locations is going to be a challenge. We’re building a network and training trainers to get growers up to speed.”
If you want to get involved in that collaborative network, join PSA’s listserv at producesafetyalliance.cornell.edu.
Purnendu Vasavada, Food Safety Preventive Control Alliance (FSPCA)
FSPCA was formed in late 2011, and its main mission is to support safe food production for the U.S. market by developing a core curriculum and corresponding technical educational materials about food safety risk-reduction preventive controls that comply with relevant federal regulations.
FSPCA is working to provide the expertise and training so the food industry can understand the basic aspects and can comply by finishing the course. The curriculum cannot be completed until the final rule is published.
A minimum of two training days will be required, and FSPCA is looking at a blended program so part could be done online and the second segment could be done in person.
Visit iit.edu/ifsh/alliance for more information about FSPCA.
View the full presentation, and watch the entire webinar:
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