From the report:
"We asked representatives from industry associations and other organizations we interviewed about their experiences submitting questions to the TAN. These representatives generally told us that wait times for answers from the TAN can be long, and some had not yet received answers to their questions. For example, representatives from one industry association told us it took 4 months to get an answer through the TAN."While FDA is working on reducing the response times, there are questions that are not as easy to answer. In some cases, the rule is still under development or the questions are more complex.
".....according to FDA officials, response times to TAN questions may be longer in some cases because agency guidance on the produce rule and other FSMA rules is still under development, and the agency does not want to provide information through the TAN that might conflict with the subsequent guidance. In addition, officials said that while simpler questions can often be addressed immediately by FDA staff that monitor the TAN, about 95 percent of the questions are more complex. These questions are forwarded to subject matter experts within the agency and, consequently, require more time for a response. According to FDA, median response time for questions forwarded to subject matter experts is 22 business days. FDA officials told us that if a question is still unaddressed after 30 days, FDA will send an automated message saying the agency is working on a response; a second automated message is sent after 60 days if the question is still unresolved."These rules are new for many including the FDA, and many components of the rule have not yet been worked out for every permutation So while delays in response times are completely understandable, I think that FDA officials and their surrogates need to acknowledge this when suggesting people go to the TAN for answers. And considering that FDA technical support staff have a hard time answering these questions, this needs to be taken into account when inspectors are doing facility inspections.
GAO Release
http://www.gao.gov/products/GAO-17-98R
Food Safety:
FDA's Efforts to Evaluate and Respond to Business Concerns Regarding the Produce Rule
GAO-17-98R: Published: Nov 28, 2016. Publicly Released: Nov 28, 2016.
