Homeland Security Presidential Directive 7 and Homeland Security Presidential Directive 9 were signed on December 2003 and January 2004 (HSPD7 and HSPD9). These documents directed the Secretary of Agriculture and Homeland Security Office to conduct vulnerability assessments on the food sector and update them every two years. Section 108 of The Food Safety Modernization Act (signed into law on January 4, 2011) required various government offices to conduct research and publish reports on the United States food defense strategy. These policies and regulations led the FDA in conjunction with USDA, FBI, Homeland Security, and others to conduct nearly 50 vulnerability assessments from 2005 to 2012. They used the CARVER+SHOCK assessment method to conduct these assessments. Various food products were assessed and these assessments were conducted on a voluntary basis from different food facilities.
A 2013 report titled “Analysis of Results for FDA Food Defense Vulnerability Assessments and Identification of Activity Types” identified four processing steps that are conducted in most food facilities. The results of these individual assessments, detailed in the report almost always identified significant risk with four specific process steps within a facility’s production process. The FDA then identified these processing steps as key activity types (KAT) and included them in the proposed Focused Mitigation Strategies to Protect Food Against Intentional Adulteration, which was released in draft in December 2013 for industry review and comments.
Key Activity Types
- Bulk liquid receiving and loading - If an adulterant is intentionally added at this processing step, uniform mixing would likely occur due to sloshing and mixing during the loading or unloading operations. Additionally, equipment and product will most likely be accessible during this process.
- Liquid storage and handling - If an adulterant is intentionally added at this processing step, uniform mixing would likely occur because agitation is usually required to prevent separation of liquid ingredients. This processing step is usually conducted in isolated areas not always monitored and lids are not normally locked or secured, granting access to product.
- Secondary ingredient handling - If an adulterant is intentionally added at this processing step, uniform mixing could occur because the combining of ingredients is usually conducted after this processing step. Ingredients may be left in areas unsecured, opened, and not under some form of regular monitoring.
- Mixing and similar activities - If an adulterant is added intentionally at this processing step, uniform mixing would likely occur. A large amount of servings in this processing step would be affected if an adulterant were added intentionally.
What actions can facilities take to mitigate risk at these 4 KATs?
The FDA has provided guidance on how to conduct a vulnerability assessment using the KAT method. It is important to understand that you could have one or multiple KATs throughout your process. If a facility has these KATs in their process and has identified them as a significant vulnerability, then mitigation strategies are required. The remarkable thing about this regulation is a facility gets to identify and decide on strategies that will work for their facility. The FDA has not required specific strategies for identified KATs. They do provide assistance for facilities that may need help developing mitigation strategies. It's called the FDA Mitigation Strategy Database. This database provides potential strategies that may reduce or eliminate significant vulnerabilities at many processing steps, including KATs.
How can a facility know they are prepared to meet FDA’s Intentional Adulteration requirements for these KATs?
The best way is to conduct a thorough vulnerability assessment as required by the regulation. This assessment should only be conducted by qualified and trained personnel. If a KAT or all KATs are identified as having a significant vulnerability, then a mitigation strategy or strategies are required to significantly minimize or eliminate the risk. If a mitigation strategy is identified, then procedures need to be developed that include how it will be monitored, what corrective actions will need to be implemented if a deviation occurs, and what verification activities need to be implemented. Once these procedures are developed, then all individuals involved will need to be trained and qualified for their specific roles. Training for your entire food defense team is highly recommended so that they understand the regulatory requirements. AIB International offers Food Defense Coordinator Certification for your entire team. Additionally, once the program is developed it is encouraged to routinely audit and test this program to ensure it is working as written. AIB’s trained food defense experts can provide an on-site vulnerability assessment to identify potential gaps in your food defense plan as related to your facility, programs, and operational procedures.
Does AIB International recommend including any additional KATs in a Food Defense Plan?
Depending on the products produced and the equipment used, there may be other KATs that FDA has not idenfitied that need to be addressed. Our experts have conducted numerous vulnerability gap assessments for a wide variety of facilities in the beverage, baking, confectionary, and milling industries to name a few. The areas with significant vulnerabilities involve handling and receiving bulk materials. Some examples of this include secondary holding containers of liquids and dryer and coating systems that hold a large amount of product. The most significant gap observed at these processing steps was accessibility. However, not all of these process steps in all facilities had significant vulnerabilities.
References
- Homeland Security Presidential Directive / HSPD-9 https://fas.org/irp/offdocs/nspd/hspd-9.html
- Vulnerability Assessments of Food Systems Final Summary Report June 2009 – February 2012 https://www.fda.gov/downloads/food/fooddefense/ucm317547.pdf
- FSMA section 108 https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247548.htm#SEC108
- Analysis of Results for FDA Food Defense Vulnerability Assessments and Identification of Activity Types http://wayback.archive-it.org/7993/20170111073929/http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm347023.htm
When developing our food safety plan we undertaook a risk assessment using the HACCP methodogy to determine those points which are critical to ensuring food quality and meeting customers' specifications. An auditor made a coment that there were a lot (we wish there were less) but when reviewing the plan we can only reduce the number by one.. Some examples of CQP include finished product weight (Regulatory), size, color, moisture, batter pick-up, free fatty acid concentration, percentage of salt, pH, Fryer temperature, Packaging integrity and coding etc etc and more according to the specific processing line. When I answered the auditor that they were the identified by the HACCP Team so we would not change them unless there was something valid to change them for he agreed. Have other people found they have many more QCP's than CCP's?
Thank you
