Formal Comments on Import Safety Formal Comments to Working Group on Import Safety

January 1, 0001

Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852

Re: Docket No. 2007N-0330 Presidential Interagency Working Group on Import Safety; Public Meeting

Dear Madame/Sir:

The Institute of Food Technologists (IFT) appreciates the opportunity to respond to the request of the Presidential Interagency Working Group on Import Safety with comments about the role of public and private sectors in promoting the safety of food products imported into the United States. The comments below explain that IFT is supportive of the risk-based, prevention-focused model described by the Presidential Interagency Working Group on Import Safety.

Founded in 1939, IFT is dedicated to advancing the science of food. Our long range vision is assurance of a safe and abundant food supply that contributes to healthier people everywhere. IFT is a not-for-profit international scientific and educational society comprised of individual food scientists and others working in related professions in the government, academia, and food industry. Of our 22,000 individual members, 17% live and work outside the United States in countries such as Australia, Canada, China, Germany, Japan, Korea, and Mexico.

IFT shares a common commitment with the Interagency Working Group on Import Safety, and we believe that food scientists and technologists play an essential role in protecting the consuming public. As a leader in the scientific community, IFT is particularly committed to advancing the safety of the global food supply. As demonstrated by IFT's contracts with the Food and Drug Administration and U.S. Academy for Educational Development and other activities with U.S. and international organizations, IFT seeks collaborative opportunities to achieve our vision.

IFT agrees with the Interagency Working Group that U.S. citizens would benefit from the continued availability of a variety of food purchase options regardless of the country in which the food product was produced. However, food safety must not be compromised in providing this benefit. Thus, we also agree with the Working Group that aspects of the present import system must be strengthened to promote food security, safety, and trade for the benefit of American consumers. Further, IFT agrees with the Working Group that the United States' import safety system must be a comprehensive, risk-based, preventive approach in which food manufacturers build food safety into their products. Indeed, the changing import environment for our increasingly global food supply demands a new approach to import safety.

Managing food safety is a very complex task for several reasons. First, hazards have become truly mobile, because of widespread global sourcing, food distribution, and human travel. As recognized by many in the international public health and scientific communities, a hazard, intentional contaminant or unsuspected adulterant, in a food or an ingredient in one country can be transported to human and animal populations in another country in a matter of hours. Further, we generally have less knowledge about food production, manufacturing, and distribution in countries exporting to the United States than we do for U.S. producers, manufacturers, and distributors. And, as pointed out by the Working Group, exporting countries often have less-developed regulatory systems than the United States. Nevertheless, we have had considerable success in enhancing food safety; but, current systems cannot ensure a risk-free food supply. Although the body of scientific knowledge continues to grow, we still do not have the scientific knowledge, technology, and equipment to eliminate all hazards from all foods. This complexity of continuing concern is addressed in one of IFT's Expert Reports-Emerging Microbiological Food Safety Issues: Implications for Control in the 21st Century (IFT, 2002). Though published five years ago, our report remains current and its recommendations timely because sufficient progress has not been realized due to limited resources and other factors.

The causes of the majority of foodborne illness are still unknown. More than 200 known diseases are transmitted through food, and more than half of all recognized foodborne disease outbreaks have unknown causes. As described in IFT's Expert Report, microbial hazards have the inherent capability of evolving. Bacteria can exchange genetic material among themselves, and they have highly sophisticated systems that allow them to respond at a genetic level to environmental conditions (i.e., stresses), triggering contingency plans for their survival in hostile environments. Such circumstances can lead to the development of a new pathogen, even from a commensal microorganism.

IFT is very supportive of the Working Group's recognition in its Strategic Framework that focusing on risks over the life cycle of a product is an important building block. IFT agrees with the Working Group that focusing on hazard analysis and risk management is an effective means for minimizing risks and maximizing quality by targeting resources on areas of greatest risk. We agree that a cost-effective, collaborative risk-based system that involves overseas manufacturers and the importing community to identify and mitigate risks at the most appropriate points of manufacture and distribution, rather than addressing issues at the border, is essential. We also agree that safety cannot be inspected into the system; food manufacturers, distributors, and others in the private sector have the responsibility to build safety into products and maintain control.

A key conclusion of IFT's Expert Report focuses on the value of Food Safety Objectives (FSOs). As defined by the International Commission on Microbiological Specifications for Food (ICMSF, 1997, 2002), a Food Safety Objective is a statement of the maximum frequency and/or concentration of a microbiological hazard in a food at the time of consumption that provides the appropriate level of protection. A relatively new concept, FSOs enable food manufacturers to design processes that provide the appropriate level of control that can be monitored to verify effectiveness. The FSO approach to risk management can integrate risk assessment and hazard management practices, including Good Manufacturing Practices and Hazard Analysis and Critical Control Point systems, into a framework that achieves public health goals in a science based, flexible manner. IFT's Expert Report recommended that regulatory agencies work with other public health officials and interested parties, including industry and consumers, to establish FSOs.

Another challenge is the fact that public health, foodborne illness, and hazard surveillance systems are too limited and disparate to enable control of pathogens to the extent desired. IFT's Expert Report notes that effective surveillance for food safety requires the coherent assembly of information from different sources. We stated that integrating animal and environmental surveillance systems into established human surveillance systems will greatly increase understanding of the epidemiology and sources of foodborne disease. We agree with the Working Group that a forward-looking approach to import safety will require new ways to gather, aggregate, integrate, analyze, communicate, and act upon information about imports from across the import life cycle. Thus, as the Working Group's Strategic Framework is moved forward and interoperable systems built, IFT recommends the integration of surveillance systems on a global scale. Additional information emanating from expanded and integrated surveillance systems would provide a broader vision of the flow of pathogens and potential pathogens throughout the food chain, and would fill in data gaps needed for risk assessment.

IFT agrees with the Working Group that technological innovation and new science need to be promoted. We agree that research into the causes of risk, such as the conditions that lead to contamination of foods with certain pathogens, can help government and industry identify vulnerable points in the life cycle of specific products. The development of innovative technologies to identify and subsequently mitigate risks would be helpful for regulatory agencies and food manufacturers alike in detecting specific contaminants and taking appropriate steps to control hazards at particularly vulnerable points in the life cycle. IFT's Expert Report pointed out that new scientific tools can provide ways to assess risk and thereby enable informed, intelligent decisions based on data and facts.

Recognizing that nanoscale science, engineering, and technology, for example, have great potential to impact the food industry, IFT is supporting research and development in this emerging technology. We have convened forums that have attracted and involved representatives from Canada, the United Kingdom, The Netherlands, Japan, Taiwan, Brazil, and India. With these initiatives and other events, IFT is leveraging its capacity to galvanize international cooperation, scientific information exchange, technology transfer, and institution-building activities in countries and nations around the world.

IFT supports international harmonization of food standards. Recognizing the importance of the Codex Alimentarius Commission, IFT has actively participated as a non-government organization in the work of the Commission and several of its subsidiary bodies. For example, IFT member experts contributed to the development within the Codex Committee on Food Hygiene guidelines on risk assessment and HACCP. More recently, IFT is developing a three part training program on quality control and assurance concepts, incorporating Codex approaches to food safety management, which we anticipate delivering to food industry and government audiences in China. This is one of a number of activities stemming from our strategic focus on collaborative and capacity-building efforts in China and Latin America.

In summary, IFT is supportive of the risk-based, prevention-focused model described by the Presidential Interagency Working Group on Import Safety. Because freedom from risk cannot be ensured nor can safety be inspected into products, we agree that the private sector has a leading role in strengthening the safety of imports by building safety into food products. Toward this end, as more resources become available, IFT recommends allocation of additional funding for food safety research, and for industry training programs on risk-based food safety management systems. Additional resources are also needed in regulatory agencies for oversight and regulation of the food system.

IFT appreciates the opportunity to provide this input to the Presidential Interagency Working Group on Import Safety.

Sincerely,

John D. Floros, Ph.D.
IFT President, 2007 - 2008

References

ICMSF. 1997. Establishment of microbiological safety criteria for foods in international trade. International Commission on Microbiological Specifications for Food. Blackie Academic and Professional, an imprint of Chapman and Hall, New York, N.Y.

ICMSF. 2002. "Microorganisms in Foods 7. Microbiological Testing in Food Safety Management." International Commission on Microbiological Specifications for Food. Kluwer Academic, N.Y.

IFT. 2002. Emerging Microbiological Food Safety Issues: Implications for Control in the 21st Century. An Expert Report of the Institute of Food Technologists, Chicago, Ill.

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