Over the last few years B&R Compliance (brcompliance.com) has been providing CryoGas International subscribers with periodic status reports on the impending changes to FDA regulations related to the processing and packaging of foods. We have been predicting the FDA would be making major changes in their approach to regulating this marketplace.
It appears that day has finally dawned. In January of this year the agency released a 680-page Notice of Public Rulemaking (NPR), laying out in writing the direction and scope of their proposed changes to food regulations for the first time. This article will discuss some of the key proposed regulatory changes and assess how these are likely to affect independent manufacturers of food and beverage grade gases.
Background
The current requirements in the Code of Federal Regulations which apply to the food industry, (CFR) – 21 CFR § 110, date to 1986. This was the last time the FDA “revisited” the Food Current Good Manufacturing Practices (cGMPs). Generally 21 CFR § 110 is a very basic set of requirements. Over the years the FDA has added requirements to the food GMPs, which focused on a single industry such as seafood. Pressure on the US Congress to give the FDA the tools and mandates they need to update and modernize the regulatory approach to food safety has been building since the late 90s.
While most of us are familiar with the media coverage of certain high profile instances of product contamination in the American food supply, we may not be aware of the true magnitude of the issue. The FDA estimates there are more than nine million episodes of food-borne illnesses, nearly 56,000 hospitalizations, and more than 1,300 deaths each year, which are directly attributable to issues in the food supply chain.
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