FDA Security Program for Foods and Cosmetics – What Is It?

The FDA’s Guidance is designed as an aid to operators of food establishments (firms that produce, process, store, repack, re-label, distribute, or transport food or food ingredients). This is a very diverse set of establishments, which includes both very large and very small entities. This guidance identifies the kinds of preventive measures operators of food establishments may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions. It is relevant to all sectors of the food system, including farms, aquaculture facilities, fishing vessels, producers, transportation operations, processing facilities, packing facilities, and warehouses. It is not intended as guidance for retail food stores or food service establishments.

Recommended Actions

A. Management    
1. Preparing for the possibility of tampering or other malicious,
criminal, or terrorist actions.
2. Supervision
3. Recall Strategy
4. Investigation of Suspicious Activity
5. Evaluation Program

B. Human Element – Staff
1. Screening (pre-hiring, at hiring, post-hiring)
2. Daily Work Assignments
3. Identification
4. Restricted Access
5. Personal Items
6. Training in Food Security Procedures
7. Unusual Behavior
8. Staff Health

C. Human Element – Public

1. Visitors (for example, contractors, supplier representatives, delivery drivers, customers, couriers, pest control representatives, third-party auditors, regulators, reporters, tours)

D. Facility
1. Physical Security
2. Laboratory Safety
3. Storage and Use of Poisonous and Toxic Chemicals

E. Operations
1. Incoming Materials and Contract Operations
2. Storage
3. Security of Water and Utilities
4. Finished Products
5. Mail Packages
6. Access to Computer Systems