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Vibrating or Tumble. FORM FDA 2541a 4/12 OB OT NOTE No commercial processor shall engage in the processing of low-acid or acidified foods unless completed Forms FDA 2541 and FDA 2541a have been filed with the Food and Drug Administration 21 CFR 108. DEPARTMENT OF HEALTH AND HUMAN SERVICES A. PRODUCT PUBLIC HEALTH SERVICE Use FDA booklet titled Instructions for Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods for completing Form FDA 2541a. FOOD AND DRUG...
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Hi I'm Susan Brecker team leader of the food processing evaluation team at the Center for Food Safety and applied nutrition and this is Robin Jones compliance officer within the office of compliance in this presentation we're going to discuss the regulations for low acid and acidified shelf-stable canned foods commonly referred to as the LA CF regulations la CF regulations require that manufacturers of these foods register their facility and file their schedule processes with the FDA we will discuss how to comply with these regulations in further detail in this presentation the best way to start is with definitions first the definition of a low acid canned food is a food with the finished equilibrium pH that is greater than 4.6 a water activity value greater than 0.85 and thermally processed in a hermetically sealed container definitions pertaining to low acid canned foods can be found in the code of federal regulations or CFR 21 CFR one 13.3 the references to the CFR are indicated on the slides to help you find specific information acidified foods are low acid foods to which an acid or acid food has been added to lower the pH of the product so that the finished equilibrium pH is 46 or below they also have a water activity of greater than 0.85 once the low acid food is acidified it does not become an acid food it remains an acidified food this is a consideration when repacking product a repack er of acidified products may need to file as well as the original acidifier definitions pertaining to acidified foods can be found in 21 CFR one 14.3 examples of foods excluded from these regulations are acid foods foods with the water activity of 0.85 or below such as peanut butter naturally fermented foods such as some olives foods kept under refrigeration all along the distribution chain which includes frozen foods carbonated beverages and foods containing more than three percent raw meat red meat and or raw poultry or contains two percent or more cooked meat red meat and or cooked poultry in the formulation meat and poultry products are under the jurisdiction of the US Department of Agriculture or USDA when looking at these regulations it's helpful to know the public health issues surrounding their development in the early 1970s several life-threatening botulism outbreaks occurred as a result of inadequate thermal processing of commercially prepared low acid foods in hermetically sealed containers this led to the establishment of 21 CFR 108 the emergency permit control and 21 CFR 113 thermally processed low acid foods packaged in hermetically sealed containers or what we call the LA CF regulations in the late 1970s after these regulations were established there were several incidences of botulism outbreaks and acidified foods as well so in 1979 a separate regulation addressing acidified foods was developed 21 CFR 114 acidified foods along with an acidified addition to 21 CFR 10 8.25 there are three regulations that are specific to LA CF and acidified...