Another Onion Layer

The U.S. Food & Drug Administration (“FDA”) implemented the Reportable Food Registry (“RFR”) in September. The RFR was designed in response to recent outbreaks of food-borne illnesses (caused by, among others, peanuts, spinach, and cookie dough). The system requires any facility that manufactures, possesses, or stores food for consumption in the U.S. (a “responsible party”) to advise the FDA if it finds a “reasonable probability that a food item will cause severe health problems to a person or an animal.”

A responsible party is required to submit an initial report with the RFR system and follow up with additional reports as necessary. The FDA will use the information to track the source and recipients of the tainted food article, and issue public notifications about items that pose a risk to the public.

What does this have to do with alcohol manufacturers? Anyone that manufactures, processes, packs, or holds alcoholic beverages is now required to comply with the requirements of the RFR.

Requirement

If a manufacturer (responsible party) determines that a food article is adulterated, and that there is a reasonable probability that exposure to the adulterated food article will cause adverse health consequences (e.g. spinach contaminated with salmonella), then it must report the issue through the RFR within 24 hours after determining that the adulterated food article poses a risk to the public health. This includes any ingredients received from suppliers, or a food article produced by the manufacturer.

A food article is all “articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.”

Exemptions

A responsible party is not required to submit a report on an adulterated item if: the adulteration originated at the responsible party’s facility; and the responsible party detected the adulteration before the product was transferred to another person; and the responsible party corrected the adulteration or destroyed the product.

Testing

The RFR necessarily requires testing of all food articles. The FDA requires test methods that are “sufficiently reliable to trigger the reporting requirement.”

What this Means

The chances of a brewery, winery, or distillery having to report an adulterated food article are low. If the facility receives something contaminated from a supplier, and it is a threat to health, it must be reported. If, however, there is a bad batch of alcohol, that poses a health threat, but it never leaves the facility, that does not need to be reported.

The FDA's guidance on the reporting requirements can be found here.