The Food and Drug Administration’s implementation of the Food Safety Modernization Act is not yet complete. The last of the foundational rules, dealing with Intentional Adulteration, has been published. FDA hosted a public meeting to explain its impact to industry on April 17 at the FDA offices in College Park, Md.
Simply, the IA Rule establishes requirements to prevent or significantly minimize acts intended to cause widescale public harm. It covers all facilities that manufacture, process, pack, or hold human food. Facilities must create a Food Defense
Plan that details vulnerability to intentional adulteration, the strategies to combat that vulnerability, and how the company will monitor and verify those procedures to make sure they are effective.
Compliance dates are staggered based on business size. Large businesses, defined as businesses with more than 500 employees, had an original compliance date of July 2019, with the date for small businesses (less than 500 full-time equivalent employees) set for July 2020. Very small businesses, defined as those with less than $1 million in revenue, are exempt from the rule, although they do need to file documentation proving they are a very small business. FDA is expected to extend those compliance dates.
The Need for a Food Defense Plan
The FDP is a set of written documents based on food defense principles. It incorporates a vulnerability assessment, mitigation strategies, and delineates food defense monitoring, corrective action, and verification procedures to be followed. The FDP must include:
- Vulnerability assessment
- Mitigation strategies and explanations
- Food defense monitoring procedures
- Food defense corrective action procedures
- Food defense verification procedures
- Owner/operator signature
The FDP must be put together by a Qualified Individual, defined in the Preventive Controls for Human Food regulations as “an individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.” FDA recommends that manufacturers put together a Food Defense Team, which could include people from security, maintenance, food production, sanitation, etc.
Conducting a Vulnerability Assessment
The first step is to conduct a vulnerability assessment, to look at each point, step, or procedure to identify the highest risk for adulteration. It should focus on people and places where they come directly in contact with the food. A facility must analyze the potential public health impact, degree of physical access to product, and the ability of an attacker to successfully contaminate the product(s). Inside attacks are more likely than adulteration from the outside.
There are three methods recommended by FDA to do a vulnerability assessment—Key Activity Types, 3 Fundamental Elements, and the Hybrid Approach.
The Key Activity Types and general categories of manufacturing that have been identified as most vulnerable to intentional adulteration include:
- Bulk liquid receiving and loading
- Liquid storage and handling
- Secondary ingredient handling
- Mixing and similar activities
Manufacturers are expected to analyze each point, step, or procedure related to these key activity types to see where intentional adulteration could occur and to develop and implement a plan so that does not happen. The plan must be written.
3 Fundamental Elements
The three fundamental elements are another means to identify vulnerability. They are:
- Potential public health impact
- Degree of physical access
- Ability of an attacker to contaminate the product
Even though it is uncomfortable for family-owned and employee-friendly specialty food businesses, FSMA stresses that the food defense plan must address the possibility of an insider attack and protect against that threat. Insiders are more dangerous because they have access to the facility and understand how it operates.
FDA has put together a worksheet that can assist manufacturers in determining the potential public health impact. Element 1 utilizes aspects of production such as batch size, amount of product in final servings, servings per batch, and so on.
FDA has put together a template so they can calculate vulnerability. For instance, a 10 represents over 10,000 people and/or servings at risk; a 5 means between 100 and 1,000 people and/or servings at risk. Element 1 also takes into account information on contaminants that could be used to adulterate the product.
Element 2 addresses the degree of physical access to the product. Again, a score is assigned. A 10 would mean that the product is easily accessible, such as:
- Inside attacker can easily touch the product
- There are no inherent characteristics that make access to the product difficult
- Product is open and unsecured by packaging, equipment, or other physical barriers
- Product is handled, staged, or moved in easily accessible manner
Element 3 relates to the ability of an attacker to contaminate the product. Bulk liquid receiving and breading score high in that a contaminant could easily spread in these steps.
After scoring the 3 Elements, manufacturers can determine their vulnerability to an attack. FDA also accepts a Hybrid Approach, which combines the 3 Fundamental Elements and Key Activity Types. The Agency stresses that there is flexibility in each facility’s approach, and that the person making the food understands where and how a product can be adulterated better than anybody.
Mitigation Strategies
The mitigation strategies requirement states that manufacturers must identify and implement mitigation strategies at each actionable process step to provide assurances that the vulnerability at each step will be significantly minimized or prevented. FDA defines mitigation strategies as “risk-based, reasonably appropriate measures that a person knowledgeable about food defense would employ to significantly minimize or prevent significant vulnerabilities identified at actionable process steps, and that are consistent with the current scientific understanding of food defense at the time of the analysis.”
Minimizing accessibility is the primary goal of the mitigation strategies. These can start as facility-wide security measures to protect personnel, property, or product. Security can serve as a foundation for a mitigation strategy but, by itself, is not a mitigation strategy. It needs to be supplemented with other strategies, which can be personnel, operations, or technology-based. Examples in the guidance include techniques such as using tamper-evident tapes or seals for partially used ingredient containers, installing locking mechanisms on equipment access points, and so on. Other examples include requiring workers at actionable process steps to wear uniforms or clothing without pockets or other means to conceal items and increased observation of highly vulnerable areas. Placing cameras in the facility is not a mitigation strategy unless the cameras are monitored regularly.
In the food defense plan, each mitigation strategy must include an explanation of how it significantly minimizes or prevents the vulnerabilities associated with the actionable process step.
Food Defense Monitoring
Food defense monitoring consists of observations or measurements that assess whether mitigation strategies are operating as intended. The monitoring must be written recorded. FDA recommends that monitoring be periodic but is more effective at irregular intervals, so a potential attacker cannot determine when the monitoring is taking place. The guidance states that facilities must:
- Document monitoring in records that are subject to verification
- Record information at time of observation, and
- Capture observations and actual values, along with the time and date observation was made, and the signature or initials of the person who made the observation
FDA’s Food Defense Plan Builder
FSMA requires that many people involved in the production of food be made aware of the Intentional Adulteration Rule. The Food Safety Preventive Controls Alliance has developed several programs which meet the regulation’s training requirements. The Food Defense Awareness Program is required of all frontline food workers and supervisors of frontline food workers. It is an online course that takes about 30 minutes to complete and is free. FSPCA also offers a course entitled Overview of the IA Rule, which will inform employees of the regulation but is not required. An in-person training program launched this spring for those interested in in-depth training.
As mentioned previously, the food defense plan must be overseen by a food defense qualified individual. Their responsibilities include:
- Preparation of the Food Defense Plan
- Conducting the Vulnerability Assessment
- Identifying and explaining the Mitigation Strategies, and
- Performing the reanalysis
FDA has put together an online tool called the Food Defense Plan Builder. Version 1 was introduced in 2013 and has had more than 56,000 downloads. Version 2 was tested in April 2019 and will soon be introduced.
Conclusion
In our increasingly complex world, the intentional adulteration of our food supply could happen, causing widescale sickness and panic. Plus, it could impact the public’s confidence in the food system. As specialty foods become an increasingly significant part of the food world, all in the industry should comply with this final rule of FSMA, to make the world a safe place for specialty food.
Ron Tanner is vice president, philanthropy, government, and industry relations for the Specialty Food Association.
from Industry Operations http://bit.ly/311RXHD
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