Proposed FDA Regulation on Intentional Contamination

On December 24, 2013, FDA published its Food Safety Modernization Act (FSMA) proposed regulation on Intentional Contamination (Food Defense) to the Federal Register.  Below, please find an overview of the proposed regulation. Contact the ACS office at 720-328-2788 or [email protected] with any questions.

What: FDA FSMA proposed regulation on Intentional Contamination (Food Defense) with comments accepted until March 31, 2014.  FDA has scheduled a public meeting in College Park, MD to take verbal comments on February 20, 2014. The proposed regulation would require that affected companies processing food have a written food defense program that includes actionable processing steps, strategies at these same steps to significantly reduce or eliminate intentional contamination of raw materials, packaging, in-process products, and finished products, plus monitoring records to provide evidence the strategies are working, written corrective actions when it is found that the strategies are not working, and verification of the monitoring records.

When: This regulation would be effective 60 days after FDA publishes the final Intentional Contamination regulations (possibly as early at October 2014).

Who would be exempted? Companies with a food processing plant generating less than $10 million in total annual sales would be exempt from having a written Intentional Contamination program. Other exempt facilities include warehousing facilities, unless they contain liquid storage tanks; distributors that keep food in original packaging; plants that make food for animals only; and plants that make alcoholic beverages. Farms may or may not be exempt depending on what they produce, if they process on-farm, and if they produce raw milk or some other foods.

Who would be affected? Food processing plants that will need to have a written Intentional Contamination program under this proposed regulation include companies with a food processing plant with annual sales of more than $10 million, but with less than 500 employees. These companies would need to have a written Intentional Contamination program operational within two years of the publication of the final regulation. All other companies (large processing plants) would have one year from the publication of the final regulation to have their written Intentional Contamination program operational.

Key areas of highest risk for Intentional Contamination, as per the proposed regulation, include: bulk liquid receiving and storage areas, liquid storage and handling, secondary ingredient handling, and ingredient mixing/blending areas. A written Intentional Contamination program would need to address these areas, at a minimum, if they exist within the plant.

What is the impact on dairy farms? FDA has requested comment from industry members on whether additional requirements need to be placed on dairy farms, and what requirements they might be, to decrease the possibility of someone intentionally contaminating raw milk while still on a farm. FDA is also requesting comments on whether on-farm processing, packaging, or holding of foods or food ingredients (raw milk) should be exempt from the FSMA Intentional Contamination requirements.

How can I comment on this proposed regulation? Interested individuals may comment on the proposed regulation via the Federal Register through March 31, 2014.


Published on December 28, 2013

Information provided by:
Allen R. Sayler
Center for Food Safety & Regulatory Solutions
Member, ACS Regulatory & Academic Committee