IFT comments to IOM NRC Workgroup on FDA’s Role in Ensuring Safe Food

March 24, 2009

IFT submitted comments to the Perspectives on FDA’s Role in Ensuring Safe Food Meeting, Institute of Medicine, National Research Council ;

Good afternoon, and thank you for the opportunity to address the Institute of Medicine and National Research Council about gaps in the food safety system under the purview of the FDA and the Agency’s November 2007 Food Protection Plan. My name is Dr. Frank Busta. I am representing the Institute of Food Technologists as its Senior Science Advisor and interim Vice President of Science and Policy Initiatives. I am also Director Emeritus and Senior Science Advisor of the National Center for Food Protection and Defense and Professor Emeritus of the University of Minnesota.

Founded in 1939, IFT is a not-for-profit international scientific and educational society of food scientists and technologists working in the government, academia, and the food industry. IFT is a diverse organization comprised of 20,000 individual members working in every aspect of the farm-to-table food chain. IFT exists to advance the science of food, and we share the long-range vision of a safe and abundant food supply that contributes to healthier people around the world.

IFT provided comments in July last year on the FDA’s Food Protection Plan, in which we expressed general agreement with the Plan’s core elements. My remarks this afternoon reflect some of our earlier comments and clarify others, particularly with regard to inspection.

IFT believes that the overarching goal of the Agency must be to protect the public from food-borne illness and food associated hazards. IFT believes that food safety must be built into food products from the beginning. To achieve this, food manufacturers must take responsibility for ensuring food safety through management systems that address facilities, processes, and products. It should have the commitment of top management and include adequate employee training in line with effective regulations.

IFT strongly supports risk-based approaches in efforts to ensure food safety, and we strongly believe in HACCP as a vital component of food safety management. IFT also believes in the critical nature of HACCP prerequisites (such as good agricultural practices [GAP] and good manufacturing practices [GMP] which are especially important in the control of hazards for which no critical control points [CCPs] exist). Manufacturers must be expected to implement HACCP prerequisites, conduct hazard analyses, and implement the internationally-recognized HACCP principles. The Agency is expected to verify that industry is fulfilling its responsibility. While recognizing the expense of testing and the fact that it is not possible to test all products or test safety into a product, testing is an important tool for verifying that process controls are in place and effective. IFT encourages smarter, risk-based approaches to sampling and testing.

Data and information available within FDA or other agencies, such as the State Department, Department of Defense, Department of Homeland Security, or Central Intelligence Agency, regarding countries, regions, and food safety programs of concern would be helpful to the food industry in implementing or enhancing food safety and defense management systems. These should include accidental contamination and intentional addition of materials for terrorist purposes or economic fraud. More specifically, an inventory of food protection programs by country, including main food exports and any particular concerns, would benefit food manufacturers and the Agency in better directing its resources.

FDA must complete its work in modernizing existing GMP regulations and adequately enforce industry compliance with GMPs. IFT believes that FDA should increase enforcement activities using the full range of legal tools available including imposition of penalties for failure and non-compliance.

Additionally, IFT believes that smarter, risk-based, prioritized approaches to inspection, which is unquestionably a deterrent to violation, must be considered. More efficient ways to inspect must be sought so that investigators can be in more establishments more frequently on the basis of highest risks. Thus, IFT recommends evaluation of how risk-based inspection might be done more wisely and efficiently for best use of resources.

With respect to third party audits, while we recognize that independent, third party certification has very real benefits, it also has inherent potential flaws without adequate checks and balances. In any certification system, there should be appropriate accreditation of any third party organizations by independent bodies that can ensure there are no conflicts of interest. And, ultimately consumers’ best interests must be paramount.

With regard to mandatory vs. voluntary recalls and records access, IFT would support mandatory recall authority if a company refuses to voluntarily recall a product “for which there is a reasonable probability that the use of or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.”

There are lapses within the food supply chain regarding ability to conduct one step forward and one step back track and trace requirements. We are pleased that the Agency recognizes the importance of improving traceability and we have the opportunity to work with FDA toward this.

All parties—industry, government, and consumers—will benefit from the development of unbiased equivalent audits and/or inspections applied to domestic and international manufacturers and their food ingredients and products based on internationally recognized standards such as those of the Codex Alimentarius Commission and International Standards Organization.

FDA has strong, valuable alliances and actively engages key organizations within the international regulatory, food standards, and food safety communities. We believe the Agency should continue to support international food safety activities, particularly with the World Health Organization and the Food and Agriculture Organization.

Food protection is defined as including food safety and food defense. The distinction between food safety and defense is ill-defined in the Plan; and, IFT found the plan lacking in measures that will increase food defense. While measures that increase food safety may also improve defense against intentional contamination, there are issues unique to food defense that cannot be addressed by food safety practices alone. These include continuing efforts in food defense awareness programs, such as those IFT conducted for the FDA, to alert food manufacturers to the vulnerabilities within the food and agriculture sectors, items not mentioned in the Plan. The use of CARVER+ Shock and similar methods for evaluating food systems vulnerability should be encouraged as tools to help companies assess the potential impact of an intentional contamination event.

To conclude, IFT recommends the following:

• focus on the overarching goal of protecting the public from foodborne illness and food associated hazards
• corporate responsibility for food safety management
• food safety built into food products
• modernization of GMP regulations and enforcement of industry compliance with GMPs
• FDA verification of industry implementation of food safety management systems that incorporate effective process controls
• appropriate independent accreditation of unbiased third party certification
• availability to industry of an inventory of food safety programs by country, including main food exports and any particular concerns
• maintenance of momentum in food defense along with food safety
• encouragement of companies to assess vulnerability to intentional contamination with tools such as CARVER+Shock.

On behalf of IFT and our 20,000 members, I thank you for the opportunity to provide input to this ad hoc committee of the IOM and NRC.

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