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Benefits of collaboration

Posted: 31 January 2005 | Ronald J. Triani, Senior Director of Scientific & Regulatory Affairs, Kraft Foods North America | No comments yet

Advances in food science, product development and analytical chemistry continuously drive the need for state-of-the-art food safety evaluations by both the food industry and regulators. Considering the scope and complexities involved in this process, industry and regulators are beginning to form collaborations to enhance the food safety evaluation process and, ultimately, enhance public health.

In the United States, the Food and Drug Administration (FDA) maintains cooperative research programs with the Illinois Institute of Technology and the University of Maryland. It is important for the food industry to understand why these programs were established and what impact they have on regulatory policy. What benefits do these programs offer to the regulatory agency and the food industry? Are there additional benefits to food companies as members ofthese cooperative agreements?

Advances in food science, product development and analytical chemistry continuously drive the need for state-of-the-art food safety evaluations by both the food industry and regulators. Considering the scope and complexities involved in this process, industry and regulators are beginning to form collaborations to enhance the food safety evaluation process and, ultimately, enhance public health. In the United States, the Food and Drug Administration (FDA) maintains cooperative research programs with the Illinois Institute of Technology and the University of Maryland. It is important for the food industry to understand why these programs were established and what impact they have on regulatory policy. What benefits do these programs offer to the regulatory agency and the food industry? Are there additional benefits to food companies as members ofthese cooperative agreements?

Advances in food science, product development and analytical chemistry continuously drive the need for state-of-the-art food safety evaluations by both the food industry and regulators. Considering the scope and complexities involved in this process, industry and regulators are beginning to form collaborations to enhance the food safety evaluation process and, ultimately, enhance public health.

In the United States, the Food and Drug Administration (FDA) maintains cooperative research programs with the Illinois Institute of Technology and the University of Maryland. It is important for the food industry to understand why these programs were established and what impact they have on regulatory policy. What benefits do these programs offer to the regulatory agency and the food industry? Are there additional benefits to food companies as members ofthese cooperative agreements?

New products are the growth engine of the global food industry. Marketplace business success is driven by new, innovative foods that deliver superior taste, health and wellness benefits and convenience at a reasonable price. Around the world, successful new food products do not just meet consumer needs, but delight consumers in ways beyond their expectations. Within the food processing industry, science and technical innovation in new ingredients and ingredient functionality, new processes, new packages and new preservation systems deliver the product attributes that drive product marketplace success. These technological advances often raise questions and concerns about the safety and nutrition of new food products. It is the food industry’s responsibility to address these questions and concerns.

In addition to changes in the way food is processed, packaged and distributed, the global food industry needs to be responsive to unintended and unanticipated events that may raise significant concern with regard to food safety and nutritional quality across a large segment of food products. Whether real or not, scientific issues will continue to emerge across the range of chemical, microbiological and toxicological hazards. Recent examples include the discovery of acrylamide in food and a variety of man-made and naturally-occurring chemical food contaminants and toxins such as dioxin, 3-monocholoropropane-1, 2 diol, furan, chloroamphenicol, bisphenol A, semicarbizide, aflatoxin and ochratoxin. Outbreaks of foodborne illness due to pathogens in foods, such as L. monocytogenes and Campylobacter jejuni, have caused widespread illness. Finally, zoonotic initiated threats, such as new variant Creutzfelt-Jacob disease (first documented in 1996) from bovine spongiform encephalopathy (suspected clinical cases first appeared in 1985) have only recently appeared as potentially devastating forms of food borne illness.

Externally-driven technological advances contribute to the list of significant scientific questions. There is great worldwide concern about the long-term health effects resulting from the application of modern biotechnology to agricultural production. The ever increasing power of analytical chemistry to detect minute amounts of harmful materials in food, often the result of heating and cooking, has outpaced our ability to assess the public health risk of having these materials present in the foods we eat. Advances in nutrition and health sciences have begun to show that nutrients have both positive and negative impacts on human health. For example, in the United States the release of a report on macronutrients from the US National Academy of Sciences has contributed to increased consumer and regulatory attention on the trans fatty acid content of processed foods.

Food safety collaborations in the United States

In the late 1980s the US FDA realised that keeping pace with the increasing rate of technological change and the complexity of food safety issues was becoming a significant challenge. Previously, the Agency had relied upon an interdisciplinary approach across the various research units, supplemented with extramural research to develop the science needed to make sound regulatory decisions. Limited resources and the high cost of developing in-house expertise in new fields of science led the agency to consider new ways to meet high priority needs. Cooperation with industry and academia was seen as a potential solution. The government looked at industry and university research as a successful model in developing the science and knowledge needed to address science-based issues, especially in times of crisis. A number of successful programs were the result of these cooperative agreements. A few examples include the development of processing criteria for low acid canned foods, the voluntary reduction of lead in canned foods and the development of rapid microorganism detection techniques and automated testing equipment1.

As a consequence, the agency embarked on a process to increase their ability to deal with the growing complexity of food safety and nutrition issues by proposing a unique agreement with academia and industry to mutually develop relevant scientific knowledge and expertise. FDA projected several major benefits to such a program if successful.2 The most obvious is the establishment of scientific competencies outside the agency. Readily available knowledge, equipment and expertise could be easily diverted to address an unexpected food issue. For example, a research effort may be underway in the area of food processing. If a food safety issue occurred, regulators would likely have access to food engineering resources and pilot plant commercial equipment that could be used to identify the root cause and develop solutions rapidly to solve the issue.

Collaborative research also enables dialogue and discussion on the underlying science of regulatory issues. FDA’s vision for collaboration between public and private sectors was that these types of programs would produce generic knowledge and expertise that can be used by all segments of the food processing and packaging industry, public health organisations, regulatory agencies and academic institutions3.

The first cooperative agreement was awarded in late 1990 to the Illinois Institute of Technology to establish and support the National Center for Food Safety and Technology (NCFST). The establishment of this centre was also supported by 38 food and food-related companies (Kraft Foods was one of the founding companies and continues to participate as a sustaining member). At the time of the announcement, the FDA stated that the centre was founded to create a common ground for scientific excellence in the study of the effects of food processing and packaging on food safety.4 Founding the centre was enhanced by CPC International’s (now part of Unilever) donation of their former corporate research and development centre at Argo, Illinois, known as the Moffet Center. This provided NCFST with offices, laboratories and pilot plants. The Centre continues to be the home of NCFST and has been developed into a unique facility focused on food process and packaging research (the facilities are suitable for complex process research, including scale up and downstream processing and purification).

NCFST is focused on four areas: food biotechnology, food processing, food packaging and Hazard Analysis and Critical Control Points (HAACP). Since its founding, NCFST has provided valuable scientific knowledge to the FDA and to the food industry, related to the food safety impact of advanced food processing techniques that include laser heating, high voltage pulse processing, high pressure processing and cold sterilisation. The following are two examples: with input from industry, NCFST has provided FDA with data related to compounds found in food as a result of irradiation of food in flexible plastic packages. This data will be critical to the regulatory decision of whether or not to allow irradiation of ready-to-eat foods after packaging. In addition, by conducting research that fills existing gaps in knowledge and expertise associated with recycled materials, the centre has enabled more plastic recycling.

In 1996, Dr. David Kessler, then Commissioner of the FDA, established a second cooperative agreement with the University of Maryland. The agreement established The Joint Institute for Food Safety and Applied Nutrition (JIFSAN). JIFSAN’s broad goals are to expand research and education programs to provide expertise and knowledge to the FDA to recognise and effectively deal with food safety issues and to enhance its regulatory review capabilities. Collaborative activities include research in microbial pathogens and toxins; food constituents and nutrition; animal health sciences; food safety and food safety risk analysis. JIFSAN has taken on more of a global role by encouraging participation in setting the scientific agenda for cooperative research on issues of food safety.5 Industry involvement is through the JIFSAN Advisory Council. The council provides advice, vision and support that is critical to advancing the Institute’s mission. Many multinational companies, including Kraft, Unilever, M&M Mars and Procter and Gamble are members of the Advisory Council.

Unique to JIFSAN is its focus on risk analysis. The Institute’s risk analysis effort promotes the development of risk-based, scientifically supportable food safety standards. In addition, JIFSAN maintains a Food Safety Risk Analysis Clearinghouse that collects available scientific data from governments, industry and academia6. The Clearinghouse is a centralised database for risk analysis information.

Benefits of collaboration

So, what value do these cooperative agreements have to industry? Should the global food industry encourage the formation of these types of programs with governments and academia? What advantages and benefits do these joint centres bring the food industry?

First and foremost, these collaborations should be mutually beneficial to the parties involved. In the United States, this involved the establishment of scientific competencies in areas pertinent to actual or potential issues and the development of relevant knowledge that can be used during emergencies. Cooperative research fosters innovation through the exchange of resources and expertise; provides training and professional development and fosters open dialogue among industry, academia and government based on an ongoing relationship. In addition to sharing information, the members of the collaboration are able to share the cost of research.

A significant benefit of collaboration is the ability to provide input into areas of research that are important to industry. For example, the Advisory Council at JIFSAN meets annually to participate in the review of research projects. At these meetings, industrial members provide their views to regulators and university participants concerning research needs and future directions. As a result of these discussions, research projects at JIFSAN include addressing antibiotic resistance in humans by exploring reasons why microbial pathogens in food animals develop resistance. This is important to industry, as it will provide a framework for the safe use of antibiotics in animal food production. Other examples of mutually beneficial projects include understanding the link between lycopene, an antioxidant found in tomatoes and the lowering of risk for certain diseases and how bacteria form protective ‘biofilms’ that currently cannot be penetrated by conventional detergents7.

At NCFST sustaining members participate on the Oversight Advisory Committee, which determines policy, goals and objectives of the centre’s programs. Current collaborative research programs that are of interest to food companies and have public health benefits cover technology assessments in the area of processing, such as the inactivation of Clostridium Botulinum spores by high pressure processing and the effects of cleaning on the removal of allergens from food contact surfaces. Projects in food packaging include the determination of seal integrity using ultrasound, on-line monitoring of electron beam radiation, the use of ultrasonic imaging to inspect package seal quality and an assessment of antimicrobial packaging materials for improved food safety8.

NCFST is playing a leading role in the development and commercialisation of high pressure processing and member companies can utilise commercial scale equipment for experimentation. High pressure processing provides a good example of cost leveraging – that is, pooling government dollars with food industry contributions to fund food safety research that benefits both. In this case, regulatory scientists and industry food technologists are learning about the food safety strengths and weaknesses of the process utilising real products. This is a cost effective way for companies to keep abreast of new technology developments and to effectively manage regulatory approval time.

The strongest argument for participation in cooperative agreements with government and academia is about communication and trust. The research centre or university setting provides a neutral, common ground for scientific dialogue and acts as the facilitator between government and industry on science-based issues. In this type of non-adversarial setting, scientists can mutually identify and prioritise research needs. By working together, companies can benefit from participating in research that will be used as the basis for regulation. These institutes are places that promote the exchange of scientific information that would not be communicated by other means.

Acrylamide is an example that I believe clearly demonstrates the value of industry participation in these types of collaborative agreements. The announcement by the Swedish National Food Administration of the discovery of acrylamide in food presented a significant regulatory challenge to governments and the global food industry. Remember that at the time of discovery, the issue presented numerous gaps in our scientific knowledge with no readily available solutions.

Acrylamide is classified as a probable human carcinogen by several global organisations (IARC, WHO, USEPA). While a safe dose is unknown, it may be as low as in the range of current food exposure. Due to this uncertainty, the presence of acrylamide in foods is perceived as a potential risk to humans. The significance of the human health risk is unknown due to uncertainty regarding bioavailability, metabolism and carcinogenicity of dietary acrylamide. At the time of discovery, dietary exposure was unknown as were the foods that contribute most to dietary exposure. Finally, the components required for formation, processes that favour formation and measures to reduce levels in food, had yet to be understood.

Given the apparent significance and potential negative impact on the global food industry of finding acrylamide in food, several JIFSAN industry advisory members requested the assistance of Dr. David Lineback (University of Maryland), JIFSAN Director. Immediately, JIFSAN became part of a flurry of worldwide activities to understand and define the issue. In the early stages, much of the communication and information flow between global regulators and the food industry passed through the JIFSAN ‘bridge’. Shortly after the WHO meeting on acrylamide in June 2002, the food industry coalition led by the Grocery Manufacturers of America (GMA) and JIFSAN joined to convene a scientific workshop. The goal of the workshop was to develop conclusions on how efforts of industry, government and academia can be coordinated to effectively use available resources to address the scientific issues raised by the presence of acrylamide in foods. Scientists from around the world attended the workshop to discuss data gaps in scientific knowledge. A second workshop was held in April 2004 – the goal of which was to provide a venue for sharing the results of research conducted around the world since the first workshop. Again, the focus was on gaps in science and the identification of projects to address these gaps for funding by governments and industry. Both workshops were successful in identifying a number of projects for development and funding. There are more than 180 research projects underway, many as a result of these meetings. Four projects, including one in the UK, have been funded by the Industry Acrylamide Alliance (an informal designation for funding contributed by some of the food companies involved in the acrylamide issue) and JIFSAN. In addition, a global network Web site (Acrylamide Infonet) was establishedby FAO/WHO/JIFSAN as an inventory of ongoing global research on acrylamide. It includes information for formal research, surveillance information and industry data. The network also serves as a discussion forum for active researchers.

The acrylamide example clearly demonstrates the benefits to food companies of being a part of government-university cooperative research agreements. The workshops, Web site, and ongoing issue participation by JIFSAN have fostered worldwide trust, cooperation and communication. These meetings attracted leading scientists from around the world. Government scientists were able to discuss various scientific questions with university and industry scientists in the neutral forum created by the workshops. Industry and university scientists reviewed mitigation strategies and ongoing projects related to the practical reduction of acrylamide in commercial products. In turn, exposure data generated by government has helped direct company efforts in key product categories. Breakout groups of scientists enabled the agreement to support new research projects. Industry participants were exposed to new technologies and potential innovations and government scientists were able to review potential industry product and process solutions.

Summary

Cooperative research programs, as exemplified by JIFSAN and NCFST in the United States, are providing significant benefits to all parties. First, these agreements have dramatically expanded the external network of scientists and knowledge beyond the core competencies of government and industry. Second, participation in these programs has given food companies ‘a seat at the table’, enabling open dialogue and communication in a neutral environment. The benefits are better coordination, resource utilisation, issue resolution and improved readiness to deal with future issues.

Ultimately, for all parties, the value of government and university cooperative research agreements involving industry participation is found in the measure of success of these agreements. That is, will the scientific knowledge generated impact national regulatory policy? Will it ensure that regulatory policy continues to be based on sound science? Will it help develop scientific knowledge ahead of the next issue? In the case of acrylamide the answer seems to be ‘yes’.

References

  1. Miller, Sanford A., Rainey, Nannie H., and Shank, Fred R., 1987. FDA and food research: keeping pace with technological change. Food Technology 41(5): 89, 91, 93, 95-97, 99, 101-102 and 315
  2. IBID
  3. IBID
  4. Kurtzweil, Paula. 1991. Taste of the future. FDA Consumer 25(10): 24-27
  5. Annual Report (2000-2001). The Joint Institute for Food Safety and Applied Nutrition (JIFSAN).
  6. IBID
  7. Kurtzweil, Paula. 2000. Joint program pools food research resources. FDA Consumer 34 (1) Jan-Feb 2000
  8. Annual Report (2003). National Center for Food Safety and Technology, Illinois Institute of Technology Food Chemical News (May 16, 1994). FDA intends to award NCFST agreement with IIT Shank, Fred R. (August, 1998). Welcoming Remarks at JIFSAN Meeting

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