scope:

This standard applies to both U.S. and Canadian firms engaged in manufacturing, packaging, storing, and/or distributing food gases. It outlines regulatory requirements and industry practices in the United States utilized to ensure compliance with 21 CFR Part 121 with respect to acts of intentional adulteration intending to cause wide scale harm to public health. This standard does not apply to very small businesses as defined in 21 CFR Part 121.3 or other exemptions listed in 21 CFR Part 121.5. This standard provides guidance on the steps required for a food defense plan and how to incorporate it into their food and safety management system. It provides inspectors and auditors with an understanding on where and how defense against intentional adulteration is implemented at food gas facilities.

The food defense plan is a set of written documents based upon food defense principles and incorporates a vulnerability assessment, includes mitigation strategies, and delineates food defense monitoring, corrective action, and verification procedures to be followed.

This standard assists the food gas industry with the development of a plan on how to assess and identify internal and external threats for intentional adulteration and then implement appropriate control measures to mitigate those threats during the manufacture, storing, and distribution of food gases.

The standard does not cover economically motivated adulteration. See PS-63, Position Statement on Mitigating Food Fraud Risk in Food Gases [7].