The third major compliance dates will soon arrive for the preventive controls for animal food rule under the FDA Food Safety Modernization Act (FSMA). By September 17, 2018, both large and small animal food facilities must comply with preventive controls requirements mandated by FSMA.
The compliance dates for the Preventive Controls (PC) and Current Good Manufacturing Practice (CGMP) requirements are staggered for animal food companies. Large and small facilities previously had to meet the CGMP requirements earlier- by September 2016 and September 2017, respectively. Also on this date, very small animal food facilities will be required to meet the CGMPs.
Jenny Murphy, a consumer safety officer at FDA’s Center for Veterinary Medicine, has explained what animal food producers can anticipate in this next phase in the implementation of the rule entitled Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The following are excerpts from her conversation:
This will be the first year in which all three business sizes (large, small, and very small) have reached at least one of their compliance dates. This will also be the first year in which we begin routine regulatory inspections to ensure compliance with the preventive controls requirements. For facilities that are large businesses, we will be conducting both CGMP and preventive controls inspections. For small and very small businesses, our focus this year is going to be on continuing to increase the level of oversight of CGMPs with more routine inspections.
Last year we delayed the start of routine regulatory inspections to ensure compliance with the PC requirements for large facilities to allow them time to develop, implement, and then fine tune their food safety plans. As we hit the preventive controls compliance date for small facilities, we recognize that both small and very small businesses would also benefit from additional time prior to the start of preventive control inspections. While facilities that are small businesses will be required to comply with the preventive controls requirements this September, we do not intend to conduct routine regulatory inspections to ensure compliance with those specific requirements until the fall of 2019. For facilities that are very small businesses, we intend to delay inspections for compliance with the provisions for qualified facilities until the fall of 2020.
There are times that FDA will conduct preventive controls inspections at facilities that are small businesses since they will have reached their compliance date in September 2018. What we are planning to delay is the start of routine regulatory inspections, which are mostly considered surveillance type inspections. When we become aware of a food safety problem and we need to conduct an inspection to further investigate the issue, we consider those inspections “for-cause.” This type of inspection is an important tool we use to carry out our responsibility for public health protection.
Click here to read the complete interview with Jenny Murphy
