By Ilana R. Morady

The U.S. Food and Drug Administration recently released for public comment a proposed rule on Preventive Controls for Human Food. The proposed rule (78 Fed. Reg. 3646, January 16, 2013), is mandated by the Food Safety Modernization Act (FSMA). The FSMA was signed into law by President Obama in 2011 and allows the FDA to take a more proactive approach to food safety.

Under the proposed rule, owners and operators of covered facilities would be required to prepare and implement a written food safety plan which would include the following elements: 

  1. A hazard analysis that identifies and evaluates hazards for each type of food manufactured, processed, packed or held at the facility.
  2. Preventive controls such as sanitation controls and food allergen controls.
  3. Monitoring procedures to ensure that preventive controls are performed.
  4. Corrective actions to be used if preventative controls are not properly implemented.
  5. Verification activities including a mandatory reassessment of the facility’s written food safety plan at least every three years.
  6. Recordkeeping to document the development and implementation of the required elements.

The proposed rule would apply to both foreign and domestic facilities that manufacture, process, pack and/or hold human food for consumption in the U.S., including dairy products, canned foods, bakery goods, bottled water, and other common food products. Restaurants and retail food establishments would generally not be covered by the rule, and farms would be specifically exempt. Certain low risk activities such as making jams and jellies would also be exempt. Additionally, foods that are already subject to the FDA’s Hazard Analysis and Critical Control Points (HACCP) regulations would be exempt from inclusion in a facility’s food safety plan.

The compliance date under the proposed rule would be one year after publication of the final rule. Small businesses and very small businesses would have two to three years to comply. Comments on the proposed rule, due by May 16, 2013, can be submitted in writing or electronically.