Final “Preventative Controls” Rulemaking-Related Questions for Economically Motivated Adulteration Questions – MSU FFI Public Submission for the “Request for Comments”

Written by: John Spink

Primary Source: Food Fraud Initiative

Fed Reg Notice cover pgHow and where should FDA address Economically Motivated Adulteration (EMA) or Food Fraud? Regardless of the US Congressional Research Service (CRS) and US Governmental Accountability Office (GAO) recommendations, is there an underlying question of whether FDA has to address Food Fraud/EMA at all? Since there are many global Food Fraud activities it is a very positive sign that FDA is asking more questions, rather than just deciding on a regulatory course of action.

We just submitted our FDA Request for Comments on the “Food Safety Modernization Act” (FSMA) publication on the “Preventative Controls” section final rulemaking. FDA specifically asked about how and where to address EMA. After FDA reviews the comments, the public submissions are posted on Regulations.gov. For now, our public comments are available HERE .

FDA is not Restricted to “EMA”

The most significant insight we provided in our submission is that FDA is not restricted to the concept of Economically Motivated Adulteration (EMA). EMA is only defined in a public meeting invitation and EMA is not mentioned in the Food Safety Modernization Act (FSMA) or any other law or regulation. During FSMA Rulemaking FDA re-interpreted the term “intentional adulteration” to not include EMA, and moved EMA from the “Intentional Adulteration” section to “Preventative Controls,” so it would be a logical time to re-assess the efficiency of using the term “EMA”. The “Food Fraud” concept is consistent with activities by the Global Food Safety Initiative, (GFSI/ industry), UK Food Standards Agency, European Commission, INTERPOL/ EUROPOL, International Standards Organization TC 247 on Product Fraud, and others. Other related activities are underway by SSAFE/ GFSI, Grocery Manufacturers Association (GMA), and US Pharmacopeia/ Food Chemicals Codex (USP).

Our Summary Comments

We began by presenting summary comments that we submitted in June 2014 to a very similar “Request for Comments”:

Comments – Summary:

  • Focus on Food Fraud and Address Economically Motivated Adulteration. To holistically embrace prevention, it is recommended to support a broader scope covering all Food Fraud and then defining a more specific focus on adulterants and adulteration. This is consistent with current FDA drug initiatives which are focusing on security rather than a detail such as counterfeiting.
  • Food Fraud and Economically Motivated Adulteration should be addressed separately from Food Safety or Food Defense. This is consistent with FDA comments as well as current activity by other governments, non-governmental organizations, and industry. Many of those activities were mentioned in the Draft Rulemaking or previous US Government Accountability (GAO) of US Congressional Research Service (CRS) report.
  • Expand Definitions and Harmonize Terminology. There are important terms that are not currently defined by FDA or in a law. Also, there are terms used by various stakeholders that often overlap the descriptions of the same type of incidents. It is efficient to harmonize terminology both within the US Government and with outside stakeholders. In some cases the harmonization may lead to a changing the basic terms. There are examples of the US Government and FDA adapting to new terminology. For example, the US previously adjusted from the term Food Security to Food Defense. The term Food Security was already in use globally with a different and confusing definition.

Adulteration Without an Adulterant

Regarding the harmonization of terms, and specifically addressing “adulterants,” “adulteration,” and “adulterated”, our new comments included:

  • There is confusion with the use of the terms adulterant, adulteration, and “Adulterated Foods”. Using the “Food Fraud” term – and an “Adulterant” as one type of Food Fraud – is less confusing. Food Fraud and “Adulterant” are also terms harmonized with industry and global initiatives. The term “Adulteration” should not be used due to confusion with “Adulterant” and the Food Drug and Cosmetics Act definition of “Adulterated Foods.” These terms and concepts are confusing especially when translating to a foreign language. We recently published a journal article simultaneously in English, Korean, Chinese, and Russian. During the development of the article we had many discussions about “Adulterated Foods” that did NOT include an “Adulterant.” Also, the term “Economically Motivated Adulteration” includes the term “Adulteration” which would insinuate an “Adulterant” but would also insinuate the “Adulterated Foods” definition from the Food, Drug, and Cosmetics Act.

With the Intentional Adulteration (Food Defense) and Preventative Controls FSMA sections finalized, it appears FDA will move on to complete the EMA rulemaking. There are so many ongoing international and industry projects that it will be interesting to see how FDA engages and develops the rulemaking. In a previous GAO report regarding EMA, an “FDA official” stated they “do not have the range of expertise… with a background in intelligence gathering or law enforcement” (addressed in a previous blog post HERE ). FDA will continue to reach out and rely on industry, associations, and academia. To support the rulemaking that will efficiently and effectively protect our global food supply chain we must all continue to be engaged in the process. JWS.

Reference:

  • 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], http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0920
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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.