NMPF Pleased with FDA on NCIMS Plant Ownership Issue
October 2, 2020
NMPF is pleased with FDA’s response to an Interstate Milk Shipment (IMS) listing issue for dairy processing plants that change ownership. On Sept. 28 FDA responded to an NMPF letter challenging an agency Memorandum of Information (M-I) which stated that a change in ownership of a Grade “A” plant would trigger revocation of the IMS status and require the facility to be re-inspected and re-rated prior to being relisted.
The M-I, drafted five years ago, held the potential for real problems for Grade “A” dairy plants in situations in which ownership was changing, especially as, according to the M-I, after delisting “the facility would need to await the issuance of a new permit to operate after the facility is re-inspected and re-rated.” The process, as described, could take a week or more depending on state workload and staff availability, during which time the facility for would be shut down.
After identifying 58 dairy plants and 56 Bulk Tank Units (BTU’s) that could be impacted by this complicated process, NMPF wrote to FDA to question the validity of the M-I and the legal authority it was based upon. NMPF also reminded FDA of the challenging times the industry is facing, an argument for flexibility. Finally, NMPF reminded FDA of a recent interpretation by the Department of Justice that guidance documents, such as M-I’s, should not be treated as creating legal rights or obligations.
FDA in its response agreed that the process needed to be streamlined and that the dairy industry should not suffer economic hardship due to a change of ownership. FDA has agreed to rescind the language. NMFP questioned and is informing FDA Milk Specialists, State Regulatory/Rating Agencies, State Rating Officers and dairy industry stakeholders to provide immediate clarification.