The sky did not fall on September 19, 2016, the compliance date for larger human food facilities to meet FSMA preventive controls and Current Good Manufacturing Practice (CGMP) requirements, and for larger animal food facilities to comply with CGMPs.
In a September 19 poston the agency’s website, Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, gave some good insights about what agency oversight of compliance might look like in the next few months for human food facilities required to comply with the CGMP and preventive controls requirements and animal food facilities required to comply with the CGMP requirements.
“We know that this is new territory for food companies; it’s new territory for us too,” she said. But the agency’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.
She cited the agency’s recently issued draft guidanceon implementation of preventive controls and CGMP requirements and promised there are more guidances to come, “about two dozen planned over the next few years.”
She advised that the best thing companies can do at this time is to “take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system.” This should include promptly responding to problems, “even if they aren’t yet violations,” to prevent them becoming food safety issues.
She also emphasized the need for “a thorough system” for companies to document what they do. “If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?”
It is up to the management of a company to make sure everyone in the production chain understands what is expected and has the training and education they need to get the job done, she said.
Speaking of guidance, I suggest you mark your calendar to attend FDA’s October 14, 2016webinarin which agency staff will discuss the draft guidances for current good manufacturing practices requirements for food for animalsand the human food by-products for use as animal food. The webinar will offer an overview of the two draft guidances and will also include a question and answer session. These Q&A sessions often provide key insights into the agency’s thinking on specific issues, so I encourage you to listen in.