Attached you will find the MSU Food Fraud Initiative’s Public Comment on FDA’s “Proposed Rule” for the Food Safety Modernization Act (FSMA) section “Intentional Adulteration” (our submission will eventually be posted publically at www.Regulations.gov). See a PDF of our comments here.
Our summary comments are consistent with our previous public statements, presentations, research findings, and publications.
While the shift to focusing on prevention is extremely interdisciplinary and crosses many agency boundaries, it is critical. In our public comments we stated:
“The shift to prevention will not be easy but our food industry can learn from previous efforts. The healthcare field has a major focus on prevention through the focus on public health. The law enforcement field has balanced prosecution with crime prevention. More directly applicable to Food Fraud, the food industry can learn from the last 20 years of anti-counterfeiting efforts in the pharmaceutical segment.”
Please see the summary of our comments below. JWS.
To: Food and Drug Administration, Department of Health and Human Services
Re: Proposed Rule – Focused Mitigation Strategies to Protect Food against Intentional Adulteration; Document Citation: 78 FR 78013, Page: 78013 -78061, Docket No. FDA-2013-N-1425
Date: June 20, 2014
This response is to the request for public comments regarding the proposed rule regarding the Focused Mitigation Strategies to Protect Food against Intentional Adulteration by the Food and Drug Administration.
To note, our research is specifically focused on Food Fraud – including Economically Motivated Adulteration of food. This research includes an interdisciplinary approach including Food Safety, Food Science, Criminology, Public Health, Agricultural Economics, Supply Chain Management, Food Law, Consumer Behavior, Social Anthropology, Political Science, and others. Our previous research was cited in the original Federal Register notice for the Intentional Adulteration Section (see Everstine, Spink & Kennedy, 2012 and Spink & Moyer, 2011).
Our Comments – General Principles:
“Food fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product, for economic gain” (Spink & Moyer, 2011). A subset of Food Fraud includes adulteration commonly referred to as economically motivated adulteration (EMA). It is important to emphasize that while the motivation is economic, for every incident there always an economic threat and always a real and significant public health vulnerability. The following comments to the proposed rule addresses specific text from the Federal Register – which do not necessarily accompany a request for comment – and requests for input that pertain to Food Fraud and EMA. “ Our previous FSMA comments submitted and posted on Regulations.gov: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-1067.
Our 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 in a law or by FDA. Also, there are terms used by various stakeholders that often overlap the descriptions of the same 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 with a different and confusing definition.
”The Food Safety Modernization Act is the most significant food law since the Food, Drug & Cosmetics Act of 1938. A major shift to prevention will be complex. FDA has been very proactive in public meetings and in publishing extensive draft rulemaking. There has been an excellent opportunity to participate.
The shift to prevention will not be easy but our food industry can learn from previous efforts. The healthcare field has a major focus on prevention through the focus on public health. The law enforcement field has balanced prosecution with crime prevention. More directly applicable to Food Fraud, the food industry can learn from the last 20 years of anti-counterfeiting efforts in the pharmaceutical segment.
At Michigan State University and within the Food Fraud Initiative, we are pleased to participate in the process and to contribute to the research. We look forward to continuing to be a part of the process of protecting the food supply chain.
This represents the opinion and insight of the individual authors and not of the overall Programs, Schools, Colleges, or University.
John Spink, PhD
Director & Assistant Professor
Food Fraud Initiative
Master of Science in Food Safety Program
College of Veterinary Medicine
Michigan State University
Douglas C. Moyer, PhD, CPP
Program in Public Health – Counterfeit Medicines
College of Human Medicine
Food Fraud Initiative
College of Veterinarian Medicine