Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad (2012) / Chapter Skim
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6 Domestic Action
6 Domestic Action
Pages 193-234
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Through the use of an enterprise risk management framework, the FDA can determine which risks are the most serious and have an objective way to rank its priorities.
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Enterprise-wide Risk Management Multinational food and medical product companies have been using enterprise risk management for some time (see Box 6-1)
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. The committee's recommendation is also consistent with the 2010 Institute of Medicine report Enhancing Food Safety that argued for consistency in applying a risk-based food safety system (IOM, 2010)
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The increasing number of foreign food facility inspections demanded by the Food Safety Modernization Act (about 19,200 by 2016) cannot be reasonably managed by an agency that, according to a 2007 GAO report, operates on about one-seventh of its required budget (GAO, 2007; McCain, 2011)
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SOURCE: McCain, 2011. Implementing Enterprise Risk Management at the FDA The committee recognizes that implementing an enterprise-wide risk management program is challenging for any large organization.
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Therefore, especially in the next 3 to 5 years, the committee sees promise in using enterprise-wide risk management to organize the FDA's foreign operations. Enterprise risk management depends on ongoing assessment of current and potential future risks.
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The Food Safety Modernization Act requires the FDA to inspect at least 600 foreign facilities in 2011 and double those inspections every year until 2016.2 The FDA will struggle to meet these requirements, especially if Congress does not increase its funding (Stewart and Gostin, 2011)
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In the next 3 to 5 years, the FDA should propose, in all its international harmoni zation activities, a standardized vocabulary, a minimum data set to be collected, and the frequency of data collection. This recommendation can be measured when the FDA releases a standardized vocabulary for data collection, a codebook of the minimum data required from all points on the supply chain, and a timetable explaining how often these data should be collected.
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Well-defined data architectures and topologies can allow the multiple agencies regulating food and medical products to coordinate their work and reduce redundancy. In addition to sharing across different agencies within a country, common data architectures and good systems for information sharing can also facilitate better international harmonization.
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For example, border rejection data, public safety breakout events, regulated product safety recall records, assessment reports of export and import companies, and product ingredient tracking information all need to be collected and linked. There is also room for misunderstanding when many people are responsible for data collection.
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The FDA's informatics strategy should aim to produce reports that will be compatible with reports produced by its counterpart agencies abroad. As Chapter 2 explains, the committee sees collaboration with the FDA's counterpart agencies abroad as fundamental to ensuring product safety.
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Collecting data from more sources and using a standard data format would improve PREDICT and allow inspectors to cross-reference disparate databases. BRIDGING TRAINING GAPS AT HOME AND ABROAD Training deficits are at the root of many product safety problems in emerging economies.
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However, revising the FDA staff college curriculum for a more international focus should happen in the next 3 to 5 years. Training of FDA Staff First of all, the committee recommends that the FDA staff college include more emphasis on the application of FDA regulations abroad.
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The Food Safety Modernization Act of 2011 and the road map outlined in the agency's Pathway to Global Product Safety and Quality will also require expensive changes to the status quo (FDA, 2011b)
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A Standing Regulatory Science College The committee recommends that the FDA use its authority to facilitate the creation of a standing international regulatory science college. Ideally, the costs of this college will be shared among many donor countries, foundations, and development banks.
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In these rotations the FDA staff would work closely with their counterparts in foreign agencies to identify product safety problems before they affect consumers. The FDA should consider basing this training program off the Field Epidemiology Training Program (FETP)
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The Joint Forces Staff College in Norfolk has trained 171 officers from 46 countries (Joint Forces Staff College, 2011)
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Involvement of Industry and Academia In developed countries, product safety depends on the regulatory authority, industry, and academia. In the weakest developing country regulatory systems, the regulatory authority works in isolation.
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Recommendation 6-4: U.S. policy makers should integrate food and medical product safety objectives into their international economic development, trade, harmonization, and public health work.
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The United States needs partners in this endeavor, including national regulators in emerging economies. The United States must use the broader global health and trade agenda to advance food and medical product safety.
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In May 2011, the FDA, in collaboration with the Office of the U.S. Trade Representative, signed a memorandum of understanding with the Asia Pacific Economic Cooperation's food safety forum and the World Bank to collaborate on food safety training programs (USTR, 2011c)
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trade and regulatory goals overlap. The committee acknowledges that trade and regulatory objectives will not always overlap, but the goal of better product safety will advance the cause of free trade.
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. Even where the FDA cannot adopt an international food safety standard, it should work with other industrialized countries to streamline the means by which low- and middle-income countries can demonstrate conformity or comparability (Horton and Wright, 2008)
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Planning for Recalls The ability to intervene quickly in an emergency is the essence of response to a product safety emergency. The faster the regulatory authority and companies move to remove an unsafe product from the market, the fewer the consumers harmed.
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.10 These records need to be available in the event that "FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse consequences or death to humans or animals."11 The Food Safety Modernization Act of 2011 further strengthened traceability by requiring the FDA to develop and implement enhanced tracking systems for high risk foods.12 Congress has established certain recordkeeping requirements: • "they must relate only to information that is reasonably available and appropriate; • they must be science-based; • they may not prescribe specific technologies to maintain records; • the public health benefits must outweigh the cost of complying with the requirements; • they must be practical for facilities of varying sizes and capabilities; • to the extent practical, they may not require a facility to change business systems to comply; • they must allow for the maintenance of records at a reasonably ac cessible location, provided that the records can be made available to FDA within 24 hours of a request; and • they may not require a full pedigree, or a record of the complete previous distribution history of the food from the point of origin" (FDA, 2011d)
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By demanding traceability in the medical products market, the FDA could improve supply chain management in developing countries. If all producers are required to maintain one-up, one-back traceability for their export products, economies of scale will make it attractive to extend the same standards to products for the domestic market.
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Without public-sector investment, research would suffer. It can be argued that food safety research is an impure public good because it has benefits that are both private (i.e., product liability)
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The FDA and the USDA should encourage private-sector participation in this research. In recent years, the financial crisis has constrained public-sector research, leading to greater collaboration in agricultural and food safety research under the CRADA system.
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Market incentives are a useful means to encourage adherence to standards and help control supply chains in developing countries. Economic incentives could also do much to increase political will for product safety in developing countries.
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regulators and their counterparts abroad to facilitate trade in safe foods. There are flaws in the Food Safety Modernization Act in that its mandates, however well-meaning, are largely unfunded (Ozersky, 2010)
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These are charges for APHIS' programs such as the export certification services and agricultural quarantine and inspection service (USDA, 2010b)
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. The Food Safety Modernization Act requires the traceability of the food supply chain and holds suppliers accountable for ensuring HACCP compliance.
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inspection procedures. Within a country, each producer wishing to export meat to the United States must undergo a similar certification.
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Product Liability in Developed Countries The U.S. legal system has two ways to ensure food and medical product safety.
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legal system ensures food and medical product safety in the United States is product liability. Entities involved in the manufacture, distribution, and marketing of a food or drug product to the public are obligated under U.S.
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In the next 3 to 5 years, the FDA should use enterprise risk management to inform its work abroad, but eventually the committee recommends that it use this tool to plan its domestic work as well. The committee recognizes that Congress might need to revise the laws governing FDA for this to happen.
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Similarly, the government can improve supply chain management by giving market incentives that reward supply chain management. The committee is especially impressed by the FDA's Secure Supply Chain pilot program.
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2011d. Product tracing: Information available related to product tracing under the Food Safety Modernization Act (FSMA)
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2008. Understanding developing country strategic responses to the enhancement of food safety standards.
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2010. Enhancing food safety: The role of the Food and Drug Administration.
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Washington, DC: International Food and Agricultural Trade Policy Council. Secure supply chain pilot program; notice of pilot program.
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2011c. USTR and FDA welcome collaboration by APEC and the World Bank to enhance food safety and faciliatate food trade.
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