On December 23, 2013, the FDA released a proposed rule titled Mitigation Strategies to Protect Food from Intentional Adulteration. The proposed rule falls under the Food Safety Modernization Act (FSMA) and as written, would require domestic and foreign food facilities to identify and implement focused mitigation strategies to reduce the risk of intentional adulteration, sabotage, or contamination in FDA-regulated facilities and of FDA-regulated products.
Under the proposed rule, a food facility would be required to:
- have a written food defense plan that addresses significant vulnerabilities in its food production process.
- identify and implement strategies, measures, and countermeasures to reduce, eliminate, or mitigate the identified vulnerabilities.
- establish monitoring procedures and corrective actions.
- verify that the system is working.
- ensure that personnel assigned to the vulnerable areas receive appropriate training.
- maintain specified records.
The FDA has proposed exemptions to the rule based on size of business, sales, and certain types of operations, such as holding and repacking food. The proposed rule does not apply to these facilities:
- farms.
- holders of food except those holding food in liquid storage tanks.
- facilities packing or re-packing, labeling, or related holding of the food where the container that directly contacts the food remains intact.
- alcoholic beverages produced at a facility that meets certain conditions.
- manufacturers, processers, packers, or holders of food for animals.
As with other proposed rules, there are staggered compliance dates based on the size of the facility—ranging from one to three years from publication of the final rule. Facilities would be required to consider vulnerabilities for sabotage as well as economically motivated intentional adulteration, referred to as food fraud.
Major Provisions
It is imperative that food facilities develop and implement a food defense plan and measures to protect against intentional product adulteration.
According to the proposed rule, management must prepare and implement a written plan that includes actionable process steps that focus on strategies and procedures for monitoring corrective actions and verification of those vulnerabilities identified in the assessment. Identifying and implementing mitigation strategies helps facilities assure that significant vulnerabilities will be reduced and the likelihood of intentional product adulteration will be diminished.
Key Activity Types
The FDA is proposing a targeted approach focused on certain processes within a food facility that are most likely to be vulnerable to attack. The proposed rule identifies the following four activities as key activity types, which result in a facility being considered at high risk for intentional adulteration. The key activity types are intended to serve as a guide, not a replacement for a facility’s vulnerability assessment. Actionable steps must be outlined in the food defense plan for each of these key activities to address mitigation:
- Bulk liquid receiving and loading. Incoming or outgoing bulk liquid is considered at risk for introduction of an intentional contaminant. If an adulterant or contaminant is introduced, it is likely that it would be distributed throughout the liquid due to sloshing, movement, or turbulence caused by receiving and unloading or loading activities.
- Liquid storage and handling. If a contaminant or adulterant is intentionally introduced in bulk liquid storage tanks, it could potentially be distributed in the food supply.
- Secondary ingredient handling. This refers to staging areas, preparation areas, or rework steps where a contaminant could be intentionally introduced to the product and eventually distributed into the food supply.
- Mixing and similar activities. Mixing rooms, blending, homogenizing, and grinding areas where a contaminant could be intentionally introduced, and if it is, it is likely the contaminant will be distributed in the food supply.
Training
It is important to ensure that personnel and supervisors assigned to actionable processes receive specific training on how to implement mitigation strategies. Food defense awareness training should be provided for all employees at the facility, from senior management to hourly workers.
Record Keeping
Facilities that are subjected to this proposal must establish and maintain certain records including a written food defense plan and results of the vulnerability assessment (which should include the evaluation done to identify threats and the actionable steps). According to the proposed rule, records should be maintained anywhere from one to three years, depending on the type of record.
Food Fraud
As an organization, how do you know that the products and ingredients that you have paid for are actually what you have received? Economically motivated adulteration (food fraud) is when ingredients are switched with those that were expected. The well-known melamine incident in China from a few years ago is a classic example of economically motivated adulteration. In that case, certain products were introduced with near lethal levels of melamine to enhance the perceived level of protein in the product, when, in fact, the protein levels were only boosted because of the addition of melamine.
The FDA realizes that this is an increasing concern that needs to be addressed. In fact, economic adulteration is much more likely to occur than intentional sabotage or intentional product contamination, according to the FDA. This provision in the proposed rule is still up for debate.
According to the proposed rule, economically motivated adulteration can be best identified and controlled by food facilities conducting a hazard analysis type of food safety audit, with particular emphasis on trying to identify which ingredients could be reasonably adulterated. This is based on several factors, such as:
- Which types of food or ingredients would be considered likely targets for intentional adulteration, based on the attributes of the food (e.g., the nature of the food, its production system, and its supply chain)?
- What are the perpetrators’ capabilities? Would they have access to adulterants that can be readily disguised and undetected by currently accepted testing methods?
- Have there been previous occurrences of economically motivated adulteration with the supplier?
- Is the supply chain considered highly complex?
- Have there been sudden changes in commodity prices?
- Are there known inadequacies in identification and assay-testing methods for potential adulterants?
- What about the high cost or scarcity of an ingredient?
According to the FDA, the four categories that best describe acts of food adulteration are poisonous or deleterious substances, filth and foreign matter, economically motivated adulteration, microbiological contamination and adulteration.
Food Defense FAQs
Are the rules the “final version” of the new law with which we must comply?
No. These are proposed rules. The comment period runs through March 31, 2014, during which citizens and members of the food and agricultural industry can provide input. Rules are often amended based on feedback received.
When the new rule is finalized, there will be a period of time, typically about one year, to comply with the new law. However, this doesn’t mean you should wait. Many companies are taking steps now to comply with the law to prevent any delay or non-compliance issues once the proposed rules become law.
Keep in mind, if you are a co-packer, that your customer is likely to encourage you to comply with the new rules now, instead of waiting for the final version.
Some parts of the rule seem likely to become law, such as conducting a vulnerability assessment, writing a defense plan, and providing employee training. Should I begin those now?
Now is a great time to conduct a security vulnerability assessment and develop a written defense plan.
I’ve never worked in the security field before. How do I do a security assessment?
FDA has a number of excellent help and do-it-yourself documents on its website that can help you conduct a security vulnerability assessment and write a defense plan.
There is also good material to help you meet the requirement of training your personnel on security awareness.
I’ve read the new proposed rules, but they are very confusing. I’m not sure where to start.
The first step is to conduct a vulnerability assessment and start writing your defense plan. If you begin with these two tasks, you will be well on your way to success.
Will I need to invest in security devices, such as cameras and card access systems?
FDA does not specify what you should or should not invest in. However, it does emphasize that food plants need to show actionable steps that they have implemented to reduce or mitigate risks.
Security devices are a great resource to better control, monitor, and facilitate movement in and around your facility. It is a good idea to consider using cameras and card access systems at your plant.
Could new or additional requirements be included in the final rule?
Yes! At any time prior to the publication of the final rule, FDA can modify the requirements based on industry changes, economic conditions, and security intelligence. Just as with the current proposed rules, there will be a comment period and a period of time given for compliance if any changes are made to the proposed rules.
What can I do at the plant level to prevent food fraud or economically motivated adulterated products?
First, know your suppliers, domestic and foreign. Establish a good working relationship with them. Visit their facilities. Ensure that they comply with the same level of food safety, food quality, and defense that you require of your own facility. Ask questions about their business history and check with industry peers who have possibly used the suppliers. A good investigation surrounding your suppliers is paramount to ensuring that you are dealt with fairly and honestly.
Are the four activity types the only areas with which I need to be concerned at my facility?
No. All areas of the facility are a concern. This includes transportation, storage, water and ice security, employee security, and all other areas. FDA specifically addressed the four activity types, because these are the areas where government and industry assessments indicated that the food supply is most vulnerable.
Conclusion
This is the first time our government has required that food facilities have a food defense program. Food defense takes a different type of expertise than food safety. Food defense team members, especially the facility food defense coordinator, will need specific training on how to conduct a vulnerability assessment and implement a food defense program. Ensure your foreign suppliers exporting to the United States are aware of the proposed requirements. And, most importantly, don’t wait for the final rule to start taking action.
The author is homeland security, food and facility defense specialist, AIB International.