ABA and 17 other industry partners have requested that FDA formally provide enforcement discretion on the FSMA effective date for preventative controls provisions in the absence of anticipated agency policy.
By law, these provisions are to become effective 18 months after enactment on July 3. FDA has informally stated that the agency will not enforce these new requirements until it issues final regulations and allows time for implementation by the food industry. Additionally, this holds true with respect to small businesses where FDA has noted that it will issue final regulations defining “small business” and “very small business” and issue final regulations on the substantive requirements for preventive controls. Therefore, in the absence of such definitions and regulations, the coalition – which has a variety of members including small and very small businesses – is left without the ability to know for sure when the new provision becomes effective. To read full letter….
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