Yes and yes.


If you submit a food product under fermented or refrigerated categories, be aware that both are exempt from acidified and low acid foods FDA regulations in canning in 21 CFR 133 and 21 CFR 114.  That means you do not need to file any process letters with them.  So, it is not a requirement to have the food tested.  Instead, the risk analysis letter can be used for state or local regulators and retailers who wish to sell your food products.  


For fermented meats, vegetables, and other foods, we will run a risk analysis.  Most fermented meats (charcuterie, etc) have guidance provided by the USDA.  The FDA provides little guidance on fermented foods.  Therefore, we can only look at the risks and controls of your product.  Your risk analysis letter will outline risks and controls and significant risks and critical controls (CCPs).  Be aware that some traditional fermented foods are not without some risk.  Because of the greater time involved this analysis is $100.


For refrigerated foods, the main hazard is the growth of the cold-loving foodborne illness bacteria, Listeria monocytogenes (LM).  Generally, foods will have a 7-day shelf life refrigerated unless there is food safety data demonstrating that LM cannot grow.  We will look at pH and water activity.  If pH ≤ 5 and storage is ≤ 41F, LM cannot grow.  There are also some pH/Aw interactions that prevent LM growth as well.  With this assessment, we cannot guarantee your refrigerated food product will have a shelf life > 7 days.