FDA Proposes Regulations to Guard Against Food Supply Contamination

The US Food and Drug Administration recently published a proposed rule relating to food defense, as part of its implementation of the FDA Food Safety Modernization Act of 2011 (FSMA or the Act). Section 106 of the Act requires the agency to develop regulations to protect food for which there is a high risk of intentional contamination and for which such intentional contamination could cause serious adverse health consequences or death to humans or animals.
 
Purpose:  The proposed rule seeks to protect food from intentional adulteration aimed at large-scale public health harm, such as hazards that may be introduced into the food supply by acts of terrorism. The impact of acts of intentional adulteration intended to cause large-scale public health harm includes not only illness or death, but also the economic disruption of the food supply and the loss of public confidence in the food supply. 
 
Businesses Affected:  With its proposed regulations, FDA is seeking to shore up vulnerabilities in the activities of both domestic and foreign facilities that manufacture, process, pack, or hold food and are required to register with the agency as a food facility. 
 
Exemptions:  Farms or food facilities not required to register with FDA under Section 415 of the Federal Food, Drug, and Cosmetic would not be subject to the rule. Other exemptions include animal food facilities and “very small businesses” (as defined in the proposal).
 
Proposed Requirements:  The proposed rule would create a new Part 121 in FDA’s regulations and require each covered food facility to prepare and implement a written food defense plan. A facility’s food defense plan would have to include the following items:

• Actionable process steps.  Food facilities would first need to identify “actionable process steps,” meaning points, steps, or procedures in the food process that require focused mitigation strategies to reduce the risk of intentional adulteration. To aid facilities with this task, FDA has identified four key activities within the food system as being the most vulnerable to intentional adulteration: (1) bulk liquid receiving and loading; (2) liquid storage and handling; (3) secondary ingredient handling (i.e., the step where ingredients other than the primary ingredient of the food are handled before being combined with the primary ingredient); and (4) mixing and similar activities. A facility may identify actionable process steps by using the aforementioned FDA-identified key activity types or by performing its own vulnerability assessment.  
• Focused mitigation strategies.  After identifying actionable process steps, covered food facilities would need to identify and implement focused mitigation strategies at each actionable process step. Those strategies should be designed to ensure that the significant vulnerability at each step will be significantly minimized in order to prevent the intentional adulteration of food.
• Monitoring.  Facilities also would need to establish procedures for monitoring the implementation of the focused mitigation strategies, including the frequency at which these monitoring procedures should be performed.  
• Corrective actions. These are actions that should be taken if the focused mitigation strategies are not properly implemented and the facility’s significant vulnerabilities are not being minimized. 
• Verification.  Facilities would need to verify that monitoring is being conducted, appropriate decisions about corrective actions are being made, and focused mitigation strategies are being implemented and are effectively and significantly minimizing or preventing any significant vulnerabilities. These verification requirements would have to include a reanalysis of the food defense plan every three years or under certain conditions (e.g., following a significant change in the activities of the facility).
• Training.  The food defense plan also would need to include training for employees who are responsible for implementing the focused mitigation strategies.

Finally, food facilities would be required to keep records to document their compliance with the proposed rule. The required records include the written food defense plan, records documenting monitoring, verification activities and corrective actions, and documentation related to the training of personnel.

 
Timing:  Once the final rule is published, most covered food facilities would have one year to comply with the new requirements. Small businesses (proposed to be defined as businesses that have fewer than 500 employees) would have two years to comply.  Very small businesses (proposed to be defined as businesses with less than $10,000,000 in total annual sales of food) would be exempt from preparing a food defense plan but would need to be able to provide certain documentation to FDA within three years after publication of the final rule.
 
The proposed rule was published in the Federal Register on December 24, 2013, and the deadline for submitting comments to the agency is March 31, 2014. FDA is also holding a public meeting to obtain stakeholder input on the proposal on February 20, 2014. Arent Fox urges interested clients and friends to read the proposal in its entirety and to submit comments to the relevant docket (Docket No. FDA-2013-N-1425).  

If you have any questions, we would be happy to discuss further at your convenience. Please contact Joanne Hawana,  Georgia Ravitz, or  Brian Waldman.