The Food and Drug Administration (FDA) has issued draft guidance on acidified and fermented foods, such as pickles, relishes and olives, to provide recommendations on manufacturing and quality control.
The FDA said that specific regulations are necessary for acidified foods in order to control Clostridium botulinum (C. botulinum), which can cause botulism. The microorganism cannot grow in foods with a pH lower than 4.6 but acidified foods can pose a risk of botulism if certain conditions, including pH, are not controlled during production.
“The draft guidance, when finalized, will assist commercial food processors in determining whether their food products are subject to FDA’s regulations for acidified foods, and will provide recommendations on quality control procedures to ensure that finished foods do not present a health hazard,” the FDA said.
The guidance covers the manufacturing, packaging, storage, distribution and quality control procedures used for acid, fermented and acidified foods. It clarifies that the process used to produce an acidified food should destroy spores of microorganisms that could raise the product’s pH about 4.6, and also destroy other pathogens, such as E. coli, salmonella and listeria.
Acidified foods are defined as low-acid foods to which acid or acid foods are added, while fermented foods are low-acid foods “subjected to the action of acid-producing microorganisms to reduce the pH of the food to 4.6 or below.”
The guidance also includes a voluntary registration program for processors of non-acidified foods. Companies that manufacture such products – not covered by the guidance – could opt to voluntarily file their processing procedures with the FDA.
“From past experience, FDA believes that many processors of foods that are not subject to the regulations for acidified foods would choose to submit information to the agency, because doing so would facilitate decisions by FDA investigators about the regulatory status of specific food products,” the agency said.
The FDA said it will consider comments on the draft guidance submitted within the next 60 days. It is available online here .