The rule is intended to guide the food industry in reducing the risk of exposure to IA in food facilities, such as terrorist acts. Unlike other FSMA regulations for specific foods or hazards, IA needs to take precautions to reduce the vulnerability of all domestic and foreign companies that are registered with FDA food facilities.
About the requirements of the protection plan
This is the first time a company must provide a written food protection plan that details how they will implement the rule.
FDA Director Gottlieb said, "Food companies within the FDA's regulatory framework will be required to develop and implement a food protection program to identify vulnerable parts of the company and develop preventive and control measures." Companies must also ensure that control measures are effective. This is the new regulatory area for the FDA. He will work directly with relevant parties to address food manufacturer concerns.
Gottlieb said: "The overall goal of this draft guidance is to help manufacturers who need to take more steps to comply with this requirement, to increase transparency and predictability." "We want to help ensure that new requirements have costs." Benefits, not too heavy, while protecting the food system."
In the guidance document, the FDA provides a selection of food facilities to prevent deliberate adulteration. In one part, the agency recommends conducting a background check on potential employees to see if new employees pose a threat to food companies. Companies can also choose to monitor vulnerable activities such as handling bulk liquids. Transportation and reception are another area of concern, as is the handling of food storage containers.
The guide says that every company or facility has a responsibility to determine the frequency of monitoring, and a written defense plan is required every three years.
More contents will be released before the end of the year
The second and third parts of the rule will be released later this year. The second part of the draft guide will focus on vulnerability assessment methods for food staff facilities and training. The third part of the guide will detail the corrective actions, including how to verify that the facility's system is working properly.