We anticipate publication of four proposed rules to implement the Food Safety Modernization Act (FSMA) in the January 4 Federal Register.
The four rules are:
The preventive control regulations will direct the industry to control for intentionally introduced hazards. Environmental controls may be part of the preventive controls section or it might be in the verification program section.
The Produce Safety bill may include new standards for animal intrusion in growing fields.
Here is a status update on other FSMA regulations:
The Office of Management and Budget is reportedly reviewing FDA’s interim final rule on record availability requirements of FSMA. This law gives FDA power beyond the authority given in the Bioterrorism Act of 2002 and allows FDA to access and copy records when “there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious health consequences or death to humans or animals”.
We anticipate publication of the 3rd party accreditation/certification rules in the early spring.
Later regulations will be published on
FDA may define what constitutes a “high risk” facility sometime in the future. FDA has stated some of the criteria they were looking at such as post-inspectional data, compliance record history, establishment type and commodity type.