This is an overview of the FDA draft rulemaking released last Friday on “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration ” – the FDA press release title was the “New Food Defense Rule ”. We are pleased that several of our research articles were referenced and contributed to the discussion. We will conduct a deeper review later but here are the highlights of this FDA draft rulemaking:
(1) This “Intentional Adulteration” (IA) draft rulemaking will “address hazards that may be intentionally introduced by acts of terrorism”. This states that IA will be addressed by FDA in in traditional Food Defense programs.
(2) Economically Motivated Adulteration (EMA) will be addressed in other FSMA Preventative Controls sections. This states that EMA will be addressed by FDA in traditional Food Safety programs.
In general, there are three areas in the draft rulemaking that were important to Food Fraud and EMA. These are:
1. Food Defense and Acts of Terrorism. The Food Defense focus, recommended actions, and direction are consistent with previous and current counter-terrorism or attack regulations and practices. We’ve added emphasis to the excerpts below to highlight a few key points.
From the FDA press release:
- “Acts of intentional adulteration may take several forms, including those where the intention is to cause large-scale public health harm ; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration. Acts of disgruntled employees, consumers, or competitors are generally directed at attacking the reputation of the company and not at causing public health harm. The primary purpose of economically motivated adulteration is to obtain economic gain, and not to impact public health, although public health harm may occur.”
- “The proposed rule is aimed at preventing intentional adulteration from acts intended to cause massive public health harm, including acts of terrorism.
- “Facilities are also required to complete a written food defense plan.”
From the Federal Register:
- “The Food and Drug Administration (FDA or we) is proposing [companies] address hazards that may be intentionally introduced by acts of terrorism. … We expect the proposed rule, if finalized as proposed, would help to protect food from intentional adulteration caused by acts of terrorism.”
2. Non-Terrorism including Economically Motivated Adulteration (EMA). FDA notes they will address non-terrorism related topics later. Specifically, they will not address EMA in this current document. FDA notes that they intend to address EMA under the Food Safety Plan requirements (and not a Food Defense Plan). This counter-terrorism Food Defense focus is consistent with the original Presidential Directives (HSPD-7 and -9). This is a departure from “The Expanding Umbrella of Food Defense” shift, which included “Intentional Contamination” such as EMA, tampering, and counterfeiting. This organizational and conceptual structure under Food Safety rather than Food Defense is consistent with the direction of the likes of the Global Food Safety Initiative (GFSI) and the European Parliament/ European Union (see our previous blog posts).
From the Federal Register:
- “1. Acts of disgruntled employees, consumers, or competitors intended to attack the reputation of a company, and not to cause public health harm, although public health harm may occur. … Not within the scope of intentional adulteration covered under proposed 21 CFR 121. … Not considered “high risk” because not intended to cause wide-spread, significant public health harm.”
- “2. Economically motivated adulteration (EMA) intended to obtain economic gain, and not to cause public health harm, although public health harm may occur. … Not within the scope of intentional adulteration covered under proposed 21 CFR 121. … Considering addressing as part of hazard analysis in a preventive controls framework where EMA is “reasonably likely to occur”.”
Later they discuss:
- “[We] have tentatively concluded that economically motivated adulteration would be best addressed under the regulatory regime described in the PC [preventative controls FSMA draft rulemaking that was previously released] and Animal Food PC proposed rules and thus best addressed in those rulemakings.
- “In addition, the elements of a preventive control system, including hazard analysis, preventive controls, monitoring, corrective actions, verification, and recordkeeping would be documented in a food safety plan that would include control of economically motivated adulteration.
- “We have tentatively concluded that this hazard-analysis type approach is better suited to address economically motivated adulteration than the vulnerability assessment-type approach we are proposing to address intentional adulteration related to terrorism.”
FDA makes it clear that they are not legally “proposing” this – this is just a discussion of their current thinking that will need to be more formally addressed at a later time in a separate draft rulemaking document.
3. Terms and Definitions. There are some new terms, along with some terms that are being more clearly defined. These include:
- Actionable process step
- Contaminant (though adulterant is not defined)
- Focused mitigation strategies
- Significant vulnerability
- Significantly minimize
- Prudent person (carried over from the Preventative Controls documents)
- Reasonably likely to occur
The Food Safety Modernization Act continues to be a major focus of FDA and USDA. To remain a part of the process you should review what other people are saying, but go to the source document to draw your own conclusions. Make an effort to follow the discussion and submit comments to help influence the direction – or even attend the Public Meeting on February 20, 2014 at CFSAN headquarters in the DC area. We have a tremendous opportunity to help shape the future food safety and food defense landscape. Join in. Participate. Help lead the charge. JWS.
21 CFR Parts 16 and 121, (2013). (2013) Focused Mitigation Strategies to Protect Food against Intentional Adulteration, Proposed rule, US Food and Drug Administration, Department of Health and Human Services, [Docket No. FDA-2013-N-1425], RIN 0910-AG63, 4160-01-P, https://www.federalregister.gov/articles/2013/12/24/2013-30373/focused-mitigation-strategies-to-protect-food-against-intentional-adulteration?source=govdelivery&utm_medium=email&utm_source=govdelivery
MSU Articles Referenced in the FSMA Report:
• 7. Everstine, K., S. Kennedy, and J. Spink, “Economically Motivated Adulteration (EMA) of Food: Common Characteristics of EMA Incidents,” Journal of Food Protection, 76(4):723-735, 2013.
• 9. Spink, J. and D.C. Moyer, “Defining the Public Health Threat of Food Fraud,” Journal of Food Science, 75(9):R157-R163, 2011.