New Food Production Requirements from the FDA

The Food and Drug Administration (FDA) has taken steps to reduce the number of food borne illnesses. Most food borne illnesses are caused by bacteria, order though infections due to norovirus are also very common. The CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases.

On January 4th, the FDA issued a press release announcing two new rules intended to reduce food borne illnesses implementing changes under the Food Safety Modernization Act (FSMA).

The first rule applies to food manufacturers, packers and handlers and takes a ‘Quality Assurance’ approach by amending the FDA’s Current Good Manufacturing Practice. The new rule requires food manufacturers and handlers to implement an improved quality program that includes “implement hazard analysis and risk-based preventive controls for human food.” These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Further details including the exemptions from these requirements can be found in the text of the proposed rule.

In the second rule the FDA is proposing to establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. There are several aspects to this rule:

  • Worker Training and Heath and Hygiene: Establish qualification and training requirements for all personnel who handle (contact) covered produce or food-contact surfaces and their supervisors, document the training and establish hygienic practices and other measures needed to prevent persons, including visitors, from contaminating produce.
  • Agricultural Water: Require that all agricultural water, i.e. water intended to, or likely to, contact the harvestable portion of covered produce or food-contact surfaces, is shown by testing to be safe and sanitary quality for its intended.
  • Prohibit use of human waste as fertilizer and limit use of animal waste as fertilizer and limit access of grazing animals to land where food is grown/produced.
  • Establish cleaning/sanitizing standards for equipment used to process food crops and prevent contamination from workers, toilets, animal waste etc.
  • Additional procedures and water quality tests for sprouts.

Further details and those produces who are exempt from these regulations can be found in the text of the proposed rule. The public is invited to comment over the next 120 days on these proposed rules.