By Ashley Ellixson
Today we will complete our look at the Food Safety Modernization Act (FSMA) with a more detailed explanation of the response and enhanced relationships elements of the rule. To date, we have previously looked at the preventive controls rule, the produce safety rule, and inspection and compliance. In no way have my blog posts covered every item laid out in the FSMA, but over the last few weeks we have covered the five major elements labeled as critical to the rule. Hopefully the FSMA blog post series has given you an introduction to the rules and shed some light on what this piece of legislation spells out.
My colleague Sarah Everhart has also detailed the Maryland Department of Agriculture’s Good Agricultural Practices (GAP) program and the Good Handling Practices (GHP) program. Both program certifications are geared towards assisting fruit and vegetable producers in meeting the upcoming FSMA produce rule requirements.
Turning to our discussion for today, let’s now look at the response element of the FSMA. The Food and Drug Administration (FDA) will have mandatory recall authority for all food products as a result of the FMSA. According to FDA, it does not expect to use this authority often since the food industry largely honors its requests for voluntary recalls. Food industry entities will have an opportunity for an informal hearing before an order to require recall is made. Under the Food, Drug, and Cosmetic Act (FDCA) §423(a), FDA is required to first give the company the opportunity to discontinue distribution and issue a voluntary recall of the article of food at issue. If the company refuses to or does not voluntarily stop distribution within the time and manner prescribed by FDA, FDA may proceed under the mandatory recall authority as set forth in FDCA §423. Section 206 of the FSMA sets out the procedure FDA will follow when exercising its mandatory recall authority. (FDA Guidance Document)
If any of these details sounds familiar it is because I have discussed them under the implementation and compliance post as well. You can see that many of the FSMA sections go hand-in-hand and need each piece to make sure the rules are followed correctly.
The FSMA also calls for enhanced relationships and integration between state, local, territorial, and tribal entities. The Partnership for Food Protection (PFP), of which FDA is a member, has been working to develop an integrated food safety system (IFSS) with strengthened inspection, laboratory, and response capacity. The integration team is designed to work closely with state, local, tribal, and territorial partners to develop and implement the IFSS. Some examples of current ongoing activities include efforts to standardize training and expertise levels of food safety inspectors. Another example of integration is the effort to develop national standards for Federal, state, and local laboratories. The national standards are designed to increase the efficiency of the laboratories in responding to outbreaks. (FDA Guidance Document).
This concludes our blog post series for the FSMA. We will continue to give updates on the FSMA as it moves forward so please check in for the updates. Again, if you have any questions about the FSMA, feel free to contact me at anewhall@umd.edu.