Review of EMA Aspects of New FDA FSMA Preventative Controls Rule

Written by: John Spink

Primary Source: Food Fraud Iniative

EMA revisionWould the horsemeat incident be an EMA violation? Would it be regulated by FDA? TBD. Earlier today FDA released their updated Proposed Rule on “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” – this includes their direction on Economically Motivated Adulteration (EMA). EMA is a subcategory of Food Fraud. In the updated Proposed Rule (PC Rule) there are some definitive statements — some not so definitive — and a request for comments.

Before getting into a review of the PC rule it is important to review some background.

History of EMA and FSMA

FDA Public Meeting on EMA: In May 2009, in response to the Melamine in infant formula and pet food, FDA conducted a Public Meeting  on Economically Motivated Adulteration. The Federal Register published notice for this Public Meeting is the first – and only – place that FDA has stated a definition of EMA. It would seem that EMA was not more widely adopted across FDA for several reasons. For one, “adulteration” is not a common term used in medicines and I’ve never heard it used for medical devices. Also, for medicines, the acronym “EMA” is most commonly understood to be the European Medicines Agency (EMA) of the European Commission. The EMA term is defined by FDA to cover all FDA regulated products. Other than the introduction to the EMA Public Meeting, EMA is only applied to food. (See Note 2)

FSMA: In January 2011, the Food Safety Modernization Act (FSMA) was signed into law. Reviewing the original FSMA text is important to an understanding of how FDA is addressing EMA (though it is important to note that EMA is not mentioned in – and not a specific requirement of – FSMA):

  • FSMA Section 103: Hazard Analysis and Risk-Based Preventative Controls (“Preventative Controls” or PC) defines a requirement to “identify and implement preventative controls” that “identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism;”. At the end, the section does mention the Department of Homeland Security (counter-terrorism) where “The Secretary [of DHHS/FDA] may require a reanalysis under this section to respond to new hazards and developments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment” and “the Secretary shall coordinate with the Secretary of Homeland Security, as appropriate.”  DHS is noted as a possible partner.
  • FSMA Section 106: Protection Against Intentional Adulteration (“Intentional Adulteration” or IA). The law is defined to “determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.” The applicability is “Regulations promulgated under subsection (b) shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary…”. The section starts with defining the Department of Homeland Security stating “conduct a vulnerability assessment of the food system, including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments;”.  DHS is noted as a partner from the start.

The Updated Proposed Rule (see Note 1 below)

EMA was addressed in the PC rule section “XII. Potential Requirements for the Hazard Analysis to Address Economically Motivated Adulteration.”

Part A was: “Our Request for Comment on Whether the Final Rule Should Address Economically Motivated Adulteration.” This was a review of how FDA has addressed EMA in the past.

  • PC Rule: In January 2013, the original FSMA Preventative Controls rule  was published. The comment period ended February 2014. The original rule stated an “[FDA] intent to implement the statutory requirements for hazards that may be intentionally introduced” not in the PC rule but, later in the FSMA “Intentional Adulteration” rule (“IA rule”). FDA stated a conclusion that “intentional hazards, which are not addressed in traditional HACCP or other food safety systems, likely will require different kinds of controls and would be best addressed in a separate rulemaking.”
  • IA Rule: Then in December 2013, the FSMA “Intentional Adulteration” rulemaking stated EMA would be addressed back in the PC rule. The comment period closed June 2014 for that draft rulemaking and the final rule has not been published as of September 2014 so there cannot legally be an FDA conclusion yet. The draft rule stated “we tentatively concluded that economically motivated adulteration would be best addressed through the approach in the preventive controls rules…”. Their reasoning was that preventative controls would be more efficient for assessing and preventing the EMA act “rather than through the vulnerability assessment-type approach for intentional adulteration, where the intent is to cause wide-spread public health harm, such as acts of terrorism.”

Part B was: “Comments on Economically Motivated Adulteration.” These were just reviews of the submitted comments:

FDA: “Some comments oppose including requirements directed to economically motivated adulteration in the preventive controls rule. These comments assert that the vast majority of economically motivated adulterants affect quality and value rather than safety.”

This is a great comment and very insightful. This questions whether EMA should be addressed by FDA at all. FDA did not address this directly but the answer would be based in the statutory scope of FDA. Also an important consideration is the concept of an “Adulterant” and “Adulterated Food” per the Food Drug & Cosmetics Act (it’s a confusing nuance since legally an “Adulterated Food” does not need to include and “Adulterant”).

When faced with a confusing concept it is important to review how others are facing the challenge. The Global Food Safety Initiative (GFSI) approached the responsibility from the opposite direction. GFSI stated their goal to increase the safety of food. GFSI focuses on the root causes of incidents – any incident that could lead to a human health threat – and on prevention. This is consistent with the quality management philosophies of Six Sigma and other programs. Thus, GFSI has defined their scope to cover Food Fraud including economically motivated adulteration. Regardless of the human health threat, it was evident in the UK Elliott Review and the European Commission response to horsemeat – which didn’t have human health threat – that their government agencies were instructed to address all aspects of Food Fraud. Actually in the USA, the GAO and CRS have also published reports holding FDA accountable for preventing EMA and Food Fraud.

FDA: “These comments also point out that the majority of food products could, in theory, be subject to economically motivated adulteration but that it would be difficult to determine if such adulteration is reasonably foreseeable. One comment recommends that we draw a clear distinction between hazards that are intentionally introduced and those that are not.”

Our previous comments pointed out the challenge of the concepts of “reasonably likely to occur” as well as the “credible threat.” In our previously submitted public comments on the IA rule we stated “Defining a credible threat or a reasonably foreseeable hazard is arguably the greatest challenge and the key to implementing this [IA] section of FSMA. To emphasize this point, without clear definitions of these limits, the threshold of regulation could be very low. Implementation – e.g. companies taking action for compliance with the regulation – could be indefinitely delayed if these expectations are not clearly defined.”

There could be different criteria for “reasonably likely to occur” for Food Fraud, Food Safety, or Food Defense. It would be confusing to have different criteria for “what is a reasonably foreseeable hazard“ in each of those areas. In our research we avoided this conundrum by assessing a “fraud opportunity” based on the Criminology theory of Situational Crime Prevention. Whether there has been an incident or not, there is some level of a “fraud opportunity” based on the characteristics of the environment (i.e. victim, fraudster, and guardian or hurdle gaps). This assessment of the fraud opportunity must be connected to an Enterprise Risk Management system of some kind so it can be judged against other resource requiring activities. Whether addressing a CFO or Congress, issues need to be compared by some standardized metric (FDA is a public health focused agency and their stakeholder Congress does not have unlimited resources).

FDA: “Another comment expresses the view that food fraud is fundamentally different from both food safety and food defense.”

As far as I know, this is the first time “Food Fraud” has been mentioned in the main text of an FDA rulemaking document (I just searched FDA.gov, FederalRegister.gov and Regulations.gov). Whether Food Fraud or EMA, FDA has had previous statements about addressing EMA differently than addressing Food Safety and Food Defense.   Specifically, preventing or mitigating Food Fraud (intentional, no intent to harm, not trying to get caught) is fundamentally different from the countermeasures combating Food Safety (unintentional, no intent to harm, want to catch it as soon as possible) or Food Defense (intentional, intent to harm, trying to have the act caught).

FDA “However, some comments do support including “expected intentional adulterants” in the preventive controls rule and note that the U.S. Pharmacopeial Convention (USP) has a free online food fraud database.” 

This is an interesting statement regarding “expected” intentional adulterants. This might be an alternate term to “reasonably foreseeable hazard.” After reading some of the public comments, many comments did support addressing EMA in the PC section.

Part C was: “Potential Requirements to Address Economically Motivated Adulteration.” FDA stated that they were requesting comments on “a potential requirement for the hazard identification to consider hazards that may be intentionally introduced for purposes of economic gain.” They add, “… with respect to our previous request for comment on whether to include potential hazards that may be intentionally introduced for economic reasons.” This insinuates that EMA may not be a requirement in FSMA.

The specific request for comments includes:

  • Request for Comment 1: “… whether this preventive controls rule would be the most appropriate rule to address FSMA’s requirements to address hazards that may be intentionally introduced (for purposes of economic gain) and, if so,
  • Request for Comment 2: “what (if any) modifications to the proposed regulatory text would be appropriate. … We are seeking comment on alternative ways to control such hazards.”

There were a series of comments that could significantly alter the rulemaking (my emphasis added):

FDA: “Under the definitions that would be established in the rule, a hazard would be an agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the focus of the potential requirement would be on those economically motivated adulterants that are reasonably likely to cause illness or injury in the absence of their control, not on economically motivated adulterants that solely affect quality and value with little or no potential for public health harm.”

Would the horsemeat incident not be covered by FSMA? There was no human health threat in that incident. That statement hinges on the definition “reasonably likely to occur” and adds a consideration of “reasonably likely to cause illness.”

FDA: “We believe that it is practicable to determine whether economically motivated adulteration is reasonably foreseeable. Importantly, we would not expect facilities to consider hypothetical economically motivated adulteration scenarios for their food products.” 

The “hypothetical… scenario” is a new concept. The use of Situational Crime Prevention is based on known incidents and known system vulnerabilities. In essence, a “hypothetical scenario” is critical to the value of this method. The question raised from the PC rule goes back to the “reasonably foreseeable” and “reasonably likely to cause illness” concepts.

FDA: “As discussed in the 2013 proposed intentional adulteration rule, we would expect facilities to focus on circumstances where there has been a pattern of such adulteration in the past, suggesting a potential for intentional adulteration even though the past occurrences may not be associated with the specific supplier or the specific food product.” 

The FDA statement is consistent with the fundamentals of Situational Crime Prevention theory and the application of the Crime Triangle. It is important to note that there are macro- and micro-level “circumstances.” The fraud act is conducted by an individual and based on a fraud opportunity to that individual. Global, market, or population-wide opportunities – such as a change in a commodity price – influences the “fraud opportunity” at the macro-level. This is the “horizon scanning.” This is taking global insight and applying it to the local fraud opportunity act. The fraud opportunity—which would be considered a “vulnerability” not a “risk” – is the foundation of efficient and effective Food Fraud prevention countermeasures (see Defining the Public Health Threat of Food Fraud ).

The fraud opportunity is influenced by that macro-level attribute but the final decision is based on micro-level issues, such as access to raw materials or ability to infiltrate the supply chain. The characteristic of an individual fraud act are analyzed when we “deconstruct the crime” when using the Crime Triangle. The details of exactly why an individual fraudster perceived a unique fraud opportunity can be clustered and then applied more broadly (see our blog on our Product Counterfeiting Incident Clustering Tool ). That “pattern of adulteration” would be a combination of macro- and micro-level “circumstances” that can be analyzed using the Crime Triangle. Those universal fraud opportunities are reduced, prevented, or mitigated based on preventive controls.

There is a lot of activity on Food Fraud and Economically Motivated Adulteration. The food industry is making amazing strides in protecting our supply chain. Many groups are moving forward on actions and countermeasures and we’re forming a solid theoretical foundation. We’re focused on actually preventing, not just detecting or enforcement. We’re focused through to implementation and global integration. We’re collaborating and defining our scope before we make final decisions. With the global, public-private collaboration on Food Fraud, FDA is taking a very proactive step by continuing to seek comments on the subject. Don’t let FDA down. Submit your own comments or engage through your trade associations, but don’t miss your opportunity to participate in helping protect the food supply chain.  Here is the link  to submit your comments. JWS.

Note (1): For clarity, FDA issues “Rules ” as to how they will implement laws and regulations. FSMA is a “Public Law ” and a “regulation”  is how a law is carried out. FDA publishes “Rules” about specific Sections of FSMA. FSMA is divided into Sections which are like chapters..

Reference:

FDA, Food and Drug Administration (2014). Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, Proposed rule; supplemental notice of proposed rulemaking. USA Department of Health and Human Services, 21 CFR Parts 1, 16, and 117, [Docket No. FDA–2011–N–0920], RIN 0910–AG36, https://www.federalregister.gov/articles/2014/09/29/2014-22446/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-food-for

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John Spink
Dr. Spink has been focused on product fraud since the Michigan State University’s Food Safety Program and the School of Packaging began research on the topic in 2006. This work expanded to the behavioral sciences and criminology and led to the establishment of the Anti-Counterfeiting and Product Protection Initiative in 2008. In 2009 the work shifted to the School of Criminal Justice where the Initiative evolved into a Program.