The FDA has released a proposed rule “(Focused Mitigation Strategies to Protect Food Against Intentional Adulteration”) that requires domestic and foreign facilities to address potentially vulnerable processes in their operations to prevent acts on the food supply intended to cause what they term, ” large scale public harm,” (terrorism). The rule requires that large businesses have a written food defense plan that addresses vulnerabilities in a food operation. The rule proposes tiered compliance to allow smaller businesses a longer period to comply with the requirements. Comments on the draft rule are due by March 31, 2014.
Section 418 of the Federal Food, Drug and Cosmetic Act as amended by the Food Safety Modernization Act (“FSMA”), addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food (facilities that are required to register under the Act); Section 419 of the Act addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities. Finally Section 420 of the Act addresses intentional adulteration with respect to high risk foods and exempts farms except those that produce milk ( this is one of the areas that FDA is seeking comment).
The FDA in their proposed rules identify four key activities that are most vulnerable:
1) Bulk liquid receiving and loading;
2) Liquid storage and handling;
3) Secondary ingredient handling-that is the step when ingredients other than the primary ingredient are handled before being combined with the main ingredient;
4) Mixing and other similar activities.
Each facility under the rule must develop and implement a written food defense plan that would include:
1) Identify Actionable process steps using one of two procedures described in the rule.;
2) Focused mitigation measures at each step;
3) Monitoring the strategies;
4) Corrective actions;
7) Record keeping.
The effective date of the rule will be 60 days after the final rule will be promulgated and then phased in depending on the size of the operation. Compliance for Very Small (less than 10 million in total sales) entities is within three years, within two years for Small Businesses (less than 500 persons) and other businesses would have to comply within one year of the running of the sixty day period.
Within six months of publication of the final rule a guidance document written in “plain language,” to help businesses particularly small businesses is to be provided by the FDA.
There are also a number of exemptions that include very small businesses, facilities holding food, repackers, certain farm activities, manufacturing, processing, packing or holding of food for animals and alcoholic beverages under certain conditions. For ease in reading the rule, the FDA has included Flow Diagrams .