Thursday, January 2, 2014

FDA's Proposed Rule on Prevention of Intentional Contamination (Food Defense)

On December 20, 2013, FDA rolled out the proposed rule on food defense – Proposed Rule for Protecting Food against Intentional Adulteration. In this rule, facilities will need to develop and implement a food defense plan. In doing this, they will identify any actionable process steps and implement mitigation strategies that will protect food from intentional contamination.
Of the FSMA sections proposed thus far, this is one that should receive sufficient debate. Requiring facilities to have a written food defense plan is one thing, but the sticking points will be on enacting mitigation strategies for actionable steps is where there can be some controversy. Adulteration is a low risk event, so how much resources should a facility commit to putting in control measures. And there can be significant difference of opinions on which steps truly represent a risk, and then which control measures should be used for those steps.
For example, a facility may have a bulk mixing tank. People who work in the facility may not see any significant risk due to the fact that it is out in the open and only employees have access. But from the CARVER analysis, this process step was deemed the highest risk area within the facility. The facility management may not think that further mitigation is needed, outside of limiting visitors in the facility. But an inspector may want more control, like a cover (which would making cleaning difficulty), a gate to limit access (not practical if the batch operator has to constantly access the batch area), or hire an extra employee for two batch operators. Maybe all would be suggested.
In doing a Food Defense Plan, there are a number of factors that come into play in preventing adulteration in a facility. But a motivated assailant can pose a risk to even the most secure facilities. So in the case of the mix tank, what if a subversive terrorist was hired, what if they paid an employee millions of dollars, what if…..
So it is important that facility management and regulatory inspectors understand the true risks associated with intentional adulteration and that resources be judiciously applied. Otherwise, the ‘what ifs’ that can be posed the security of any operation or any process can get way out of hand and pose a significant financial burden to the facility, or create a bigger food safety risk.
Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
Link to the proposed regulation.
 The Link to the proposed rule website.
Here are a few sections from that summary page:
FDA’s proposed rule on food defense would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm. The proposed rule, which is required by the FDA Food Safety Modernization Act, would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation.
The FDA is proposing that the requirements be effective 60 days after the final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, the FDA is proposing tiered compliance dates based on facility size. The proposed rule was published on December 24, 2013, and comments are due by March 31, 2014. The FDA will hold a public meeting on February 20, 2014, to explain the proposal and provide additional opportunity for input.
Who is Covered?
With some exceptions, this proposed rule would apply to both domestic and foreign facilities that manufacture, process, pack, or hold food and are required to register as a food facility under section 415 of the FD&C Act. This rule does not apply to farms or other food facilities not required to register under section 415 of the FD&C Act. More information about exemptions from this proposed rule can be found in the chart at the end of this fact sheet.
Highlights of the Proposed Rule
The subject of this proposed rule is to protect food from intentional adulteration when the intent is to cause large-scale public harm. The FDA has identified four key activities within the food system that are most vulnerable to such forms of adulteration. They include: 
  1. bulk liquid receiving and loading;
  2. liquid storage and handling;
  3. secondary ingredient handling (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.
Facilities would be required to review their production system to determine if they have any of these activity types or complete their own vulnerability assessment. Once that is completed, they would need to identify actionable process steps, which are points, steps, or procedures in a food process that will require focused mitigation strategies to reduce the risk of intentional adulteration. Facilities are also required to complete a written food defense plan. Once in place, this proposed rule would establish measures that a food facility would be required to implement to protect against the intentional adulteration of food.
Food Defense Plan
Each facility covered by this rule would be required to prepare and implement a written food defense plan, which would include the following:
Actionable process steps: Identify any actionable process steps, using one of two procedures. The FDA analyzed data from vulnerability assessments conducted using the CARVER+Shock methodology and identified four key activity types, as described above. The FDA has determined that the presence of one or more of these key activity types at a process step indicates a significant vulnerability to intentional adulteration aimed at large-scale public harm. Facilities may identify actionable process steps using the FDA-identified key activity types or conduct their own facility-specific vulnerability assessments.
Focused mitigation strategies: Identify and implement focused mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and that food manufactured, processed, packed, or held by the facility will not be adulterated.
Monitoring: Establish and implement procedures, including the frequency with which they are to be performed, for monitoring the focused mitigation strategies.
Corrective actions: Using corrective actionsif focused mitigation strategies are not properly implemented.
Verification: Verification activities would ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made. It would also help ensure that the focused mitigation strategies are consistently implemented and are effectively and significantly minimizing or preventing any significant vulnerabilities. In addition, the rule includes requirements for periodic reanalysis of the food defense plan every three years or under certain conditions.
Training: Personnel and supervisors assigned to the actionable process steps would be trained in food defense awareness and in their responsibilities for implementing focused mitigation strategies.
Recordkeeping: Establish and maintain certain records, including the written food defense plan; records documenting monitoring, verification activities and corrective actions, and documentation related to training of personnel.
Exemptions and Modified Requirements for Focused Mitigation Strategies to Protect Food against Intentional Adulteration*

Type of facility or operation
Exempt Status
A very small business (a business that has less than $10,000,000 in total annual sales of food, adjusted for inflation)
Exempt, but would be required to provide to FDA, upon request, documentation relied on to demonstrate that the business is very small.
The holding of food, except the holding of food in liquid storage tanks
The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact
Activities that fall within the definition of “farm”
Manufacturing, processing, packing, or holding of food for animals
Alcoholic beverages under certain conditions

·         * This chart does not contain all of the information necessary to determine the proposed requirements for compliance in a particular circumstance. Consult the proposed rule for specific requirements.

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