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Appendix C
Food Safety Systems in the United States and Other Countries

TABLE C-1 United States: Food and Drug Administration

1

Country population

307,446,061 (U.S. Census Bureau, 2009)

2

Name of organization

U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services

3

Year

created Although it was not known by its present name until 1930, the FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs (FDA, 2009a).

4

Legislation

The FDA is 1 of 15 agencies that collectively administer at least 30 laws related to food safety (GAO, 2008a). Its responsibilities are outlined primarily in the Federal Food, Drug, and Cosmetic Act of 1938 and its amendments, as well as (1) the Federal Food and Drugs Act of 1906, (2) the Federal Meat Inspection Act, (3) the Federal Trade Commission Act, (4) the Filled Milk Act, (5) the Import Milk Act, (6) the Reorganization Plan 1 of 1953, (7) the Poultry Products Inspection Act, (8) the Fair Packaging and Labeling Act, (9) the Controlled Substances Act, (10) the Egg Products Inspection Act, (11) the Sanitary Food Transportation Act, (12) the Bioterrorism Act of 2002, and (13) the Federal Anti-Tampering Act (FDA, 2009b,c,d).



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Appendix C Food Safety Systems in the United States and Other Countries TABLE C-1 United States: Food and Drug Administration 1 Country population 307,446,061 (U.S. Census Bureau, 2009) 2 Name of organization U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services 3 Year created Although it was not known by its present name until 1930, the FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs (FDA, 2009a). 4 Legislation The FDA is 1 of 15 agencies that collectively administer at least 30 laws related to food safety (GAO, 2008a). Its responsibilities are outlined primarily in the Federal Food, Drug, and Cosmetic Act of 1938 and its amendments, as well as (1) the Federal Food and Drugs Act of 1906, (2) the Federal Meat Inspection Act, (3) the Federal Trade Commission Act, (4) the Filled Milk Act, (5) the Import Milk Act, (6) the Reorganization Plan 1 of 1953, (7) the Poultry Products Inspection Act, (8) the Fair Packaging and Labeling Act, (9) the Controlled Substances Act, (10) the Egg Products Inspection Act, (11) the Sanitary Food Transportation Act, (12) the Bioterrorism Act of 2002, and (13) the Federal Anti- Tampering Act (FDA, 2009b,c,d). continued 

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 ENHANCING FOOD SAFETY TABLE C-1 Continued 5 Budget The FDA requests a total budget of $3.2 billion under the President’s fiscal year (FY) 2010 budget. This increase reflects an additional $259.3 million for Protecting America’s Food Supply; added to the $662 million for FY 2009, the proposed total for food safety at the FDA is $921.3 million in FY 2010. Within this initiative, the FDA proposes to collect a total of $94.4 million in new user fees to register food facilities and increase food inspections, issue food and feed export certifications, and reinspect food facilities that fail to meet its safety standards (FDA, 2009e). 6 Number of employees The estimated full-time equivalents (FTEs) for FY 2010 are for food • 947 FTEs in the Center for Food Safety and Applied Nutrition (CFSAN), • 456 FTEs in the Center for Veterinary Medicine (CVM), • 4,365 FTEs in the Office of Regulatory Affairs (ORA) (Of those 4,365, there is no specific number of FTEs dedicated to food safety [FDA, 2009f]. The FY 2010 budget stipulates 678 FTEs dedicated to Protecting America’s Food Supply [FDA, 2009e]), and • 1,062 FTEs inspecting food (Givens, 2009). 7 Definition of “food” The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article (21 U.S.C. 321, 1938, Federal Food, Drug, and Cosmetic Act, Section 201, Chapter II, “Definitions”). 8 Items regulated The agency as a whole regulates biologics, cosmetics, drugs, foods, medical devices, radiation-emitting electronic products, and veterinary products (FDA, 2009g). Recently, tobacco products were added to this list. As for food products, the FDA regulates all foods exchanged through interstate commerce or imported, with the exception of meat, poultry, and egg products, all of which are in the domain of the U.S. Department of Agriculture (USDA).

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 APPENDIX C TABLE C-1 Continued 9 Organization The FDA has three offices dedicated to food safety: CFSAN, which is responsible for the regulation of human food products; CVM, which is responsible for the regulation of animal food (feed) products; and ORA, which is the lead office for all FDA product-regulating offices: • CFSAN’s food responsibilities include the safety of foods, both domestic and imported, encompassing food and color additives; biotechnologically developed foods; regulations governing seafood and juice Hazard Analysis and Critical Control Points (HACCP), dietary supplements, infant formula, and food labels; industry and consumer education and outreach; postmarket surveillance; international food standards and safety harmonization efforts; and regulatory and research programs to address health risks associated with foodborne, chemical, and biological contaminants. • CVM regulates the manufacture and distribution of food additives and drugs to be given to animals, including animals from which human foods are derived and pet (or companion) animals. CVM is responsible for regulating drugs, devices, and food additives given to or used on more than 100 million companion animals, plus millions of poultry, cattle, swine, and minor animal species. • ORA supports the five FDA product centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement and executes the FDA’s Import Strategy and Food Protection Plans. ORA has offices across the United States and works with state, local, territorial, and tribal officials and sometimes funds grants and cooperative agreements with these officials (FDA, 2009b). 10 Regulation of on-farm The FDA has had minimal involvement in on-farm activity regulation. However, it appears that the FDA has the authority to regulate at least some on-farm activities related to other food products under the Federal Food, Drug, and Cosmetic Acta and the Public Health Service Act.b In 2004, the FDA issued a proposed rule governing safety procedures for shell eggs, which would be its first comprehensive on- farm regulation. Legislative proposals, including HR912, HR3624, HR5620, HR5904, HR6581, S2077, and S3385, also address the FDA’s role on farms (Burrows, 2008; Becker, 2009). continued

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 ENHANCING FOOD SAFETY TABLE C-1 Continued 11 Risk-based policies, HACCP is in place for juice and seafood. The FDA has some models, use of Hazard programs that it calls “risk-based.” See Chapters 1, 2, 3, and Analysis and Critical 4 for a full discussion of the FDA’s risk-based programs. Control Points (HACCP), etc. 12 Inspections (domestic) There are currently 1,062 FTEs who inspect food products. These FTEs are also responsible for inspection of other FDA-regulated products (Givens, 2009). CFSAN sets the food establishment inspection priorities on an annual basis. Districts give priority to an inspection based on local intelligence such as compliance follow-ups, complaint follow- ups, positive analytical results, and referrals from other federal and state stakeholders (Givens, 2009). The FDA contracts out many inspections to the states: 42 contracts, more than 10,500 inspections/year for food safety; 35 contracts, more than 5,000 inspections/year for feed and bovine spongiform encephalopathy; 18 contracts, 635 inspections/year for tissue residue. With a focus on public health outcomes, items are ranked into categories of “higher-,” “medium-,” or “lower-” risk based on the likelihood that a hazard in a product consumed/used will cause a health effect and the severity of that health effect (Solomon, 2009). A U.S. Government Accountability Office (GAO) report states that field-based staff responsible for carrying out inspection and enforcement activities for CFSAN-regulated products dropped by 255 staff years, or about 11.5 percent, from 2,217 in FY 2003 to 1,962 in FY 2006 (GAO, 2008a). 13 Imports All FDA-regulated products are subject to inspection when they are being imported into the United States. Formal equivalence, or a formal determination that the exporting country has a food safety program equal to that of the United States, is not in place. Procedures vary by product. From 2001 to 2007, foreign inspections declined: GAO analysis of FDA data shows that inspections of foreign food firms, which number almost 190,000, decreased from 211 in FY 2001 to fewer than 100 in FY 2007 (GAO, 2008a).

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 APPENDIX C TABLE C-1 Continued 14 Disease surveillance The U.S. Centers for Disease Control and Prevention (CDC) is responsible for tracking individual foodborne illnesses and investigating outbreaks of foodborne illness (CDC, 2009a). For a complete list of CDC’s food safety activities, see http:// www.cdc.gov/foodsafety/activities.html (accessed September 21, 2009). The FDA, USDA’s Food Safety and Inspection Service, CDC, and nine state health departments participate in FoodNet, which provides a network for responding to new and emerging foodborne illnesses of national importance, monitoring the burden of foodborne illnesses, and identifying the sources of such illnesses (CDC, 2009b). For a complete discussion, see Chapter 5. 15 Recall authority Currently, the FDA lacks mandatory recall authority and relies on voluntary recalls with the participation and cooperation of the manufacturer. The FDA’s Food Protection Plan and several billsc propose that the FDA be granted mandatory recall authority for foods (FDA, 2007; Hogan and Hartson, 2009). For a complete discussion, see Chapter 10. 16 Other U.S. regulatory Customs and Border Protection, CDC, U.S. Department of agencies with Justice, Environmental Protection Agency, Federal Trade responsibilities for Commission, Library of Congress, National Library of foods Medicine under the National Institutes of Health, National Oceanic and Atmospheric Administration/National Marine Fisheries Service under the U.S. Department of Commerce, state and local governments, USDA (see Table C-2), U.S. Department of Homeland Security, and U.S. Department of Treasury/Bureau of Alcohol, Tobacco, and Firearms. See Table 2-1 in Chapter 2 for a complete discussion of these agencies’ roles. 17 Why was there a Not applicable migration to a single food agency? 18 How is a single food Not applicable agency working? 19 Program evaluation GAO, FDA Performance Budget. See Chapters 1, 2, 3, and 4 for a complete discussion. 20 Research function See Chapter 6 for a complete discussion. continued

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 ENHANCING FOOD SAFETY TABLE C-1 Continued 21 Communication See Chapter 9 for a complete discussion. 22 Education The FightBAC! Program is a joint project of the FDA, USDA, EPA, and CDC funded by the contributions of industry trade and professional associations, grants, and technical assistance and in-kind support provided by government agencies and consumer organizations (PFSE, 2006). See Chapter 9 for a complete discussion. a Federal Food, Drug, and Cosmetic Act, Public Law 75-717, 75th Cong., 3rd sess. (June 24, 1938). Title 21 U.S. Code, Section 9. b Public Health Serice Act, Public Law 78-410, 78th Cong., 2nd sess. (July 1, 1944). c HR759, Food and Drug Administration Globalization Act of 00, 11th Cong. TABLE C-2 United States: Department of Agriculture/Food Safety and Inspection Service 1 Country population 307,446,061 (U.S. Census Bureau, 2009) 2 Name of organization U.S. Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) 3 Year created An 1884 act established the Bureau of Animal Industry, the true forerunner of FSIS. In 1977, the Food Safety and Quality Service (FSQS) was established and was assigned the responsibility for inspection of meat and poultry products from the Animal and Plant Health Inspection Service (APHIS). Finally, in 1981, FSQS was redesignated as FSIS (FSIS, 2007a). 4 Legislation FSIS operates under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, in addition to Executive Orders, small business protection laws, and other guidance applicable to all federal agencies (FSIS, 2007b). 5 Budget $972 million in fiscal year 2009 (Thompson, 2009). 6 Number of employees FSIS’s 9,500 employees include approximately 7,800 for food inspection program personnel, who are assigned to approximately 6,200 federal slaughter, food processing, and import establishments (FSIS, 2008a). 7 Definition of “food” See Table C-1, row 7. 8 Items regulated Meat, poultry, and egg products. Catfish is a recent addition.

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 APPENDIX C TABLE C-2 Continued 9 Organization Ten offices make up FSIS (FSIS, 2009a): • Office of the Administrator—works closely with the rest of FSIS to achieve FSIS goals regarding food safety awareness and education. • Office of Data Integration and Food Protection (formerly the Office of Food Defense and Emergency Response)— coordinates and manages all homeland security activities within FSIS. It also houses the Data Analysis and Integration Group, which coordinates the agency’s data collection, analysis, and integration activities across all program areas. • Office of Field Operations—manages a nationwide program of inspection and enforcement activities regarding meat, poultry, and egg products. • Office of International Affairs—provides leadership in international food safety activities. • Office of Management—provides a full range of administrative and support services to FSIS. • Office of Outreach, Employee Education and Training— provides consolidated access, resources, and technical support for small and very small plants to better assist them in providing safe and wholesome meat, poultry, and processed egg products. • Office of Public Affairs and Consumer Education (formerly the Office of Public Affairs, Education, and Outreach)—is responsible for conducting public programs to inform, educate, and work with a variety of audiences. • Office of Program Evaluation, Enforcement and Review— is responsible for assessing program functions and operations under FSIS. • Office of Policy and Program Development (formerly the Office of Policy, Program and Employee Development)— develops and makes recommendations concerning all domestic and international policy for FSIS. • Office of Public Health Science—provides scientific analysis, advice, data, and recommendations regarding matters involving public health and science that are of concern to FSIS. 10 Regulation of on-farm FSIS officials have stated that the laws governing the agency activity provide no direct authority to regulate on-farm activity (Becker, 2009). 11 Risk-based policies, In order for a state to be approved for a Federal Grant models, use of Hazard of Inspection, it must provide a written hazard analysis Analysis and Critical and HACCP plan (FSIS, 2008b). USDA utilizes “public Control Points health−based inspection” (FSIS, 2008b). (HACCP), etc. continued

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 ENHANCING FOOD SAFETY TABLE C-2 Continued 12 Inspections (domestic) There are approximately 7,800 inspection program personnel, who are assigned to approximately 6,200 federal slaughter, food processing, and import establishments (FSIS, 2008a). FSIS inspects and monitors all meat, poultry, and egg products sold in interstate and foreign commerce to ensure compliance with mandatory U.S. food safety standards and inspection legislation. States can apply to operate under a cooperative agreement with FSIS; these programs must enforce requirements “at least equal to” those imposed under the Federal Meat and Poultry Products Inspection Acts (the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act), and their inspection is limited to products sold in intrastate commerce (FSIS, 2009b). Slaughter facilities and processing plants are inspected continuously and daily, respectively. FSIS also conducts a small number of in-commerce inspections (NRC, 2009). 13 Imports USDA enforces the concept of equivalence, whereby imported meat, poultry, and egg products must originate in countries eligible to export to the United States and establishments certified by the foreign government as eligible. Once eligibility is established, the APHIS animal health restrictions determine the specific types of products that can be imported from the country (FSIS, 2008c). 14 Disease surveillance See Table C-1, row 14. 15 Recall authority Currently, FSIS lacks mandatory recall authority and relies on voluntary recalls with the participation and cooperation of the manufacturer. If a company refuses to recall its products, FSIS has the legal authority to detain and seize those products in commerce (FSIS, 2009c). 16 Other regulatory See Table C-1, row 16. agencies with responsibilities for foods 17 Why was there a Not applicable migration to a single food agency? 18 How is a single food Not applicable agency working?

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 APPENDIX C TABLE C-2 Continued 19 Program evaluation FSIS is subject to U.S. Government Accountability Office reporting, and the agency itself has an Office of Program Evaluation and Improvement Staff, which formulates evaluation plans and conducts evaluations of existing and proposed programs, program components, inspection methods, and agency policies, directives, and regulations (FSIS, 2009d). 20 Research function FSIS has laboratories that support its food safety mission, but these appear to be mainly, if not entirely, intended to detect foodborne hazards and chemical contamination. The agency also conducts risk assessments on a variety of threats, including, for example, E. coli, bovine spongiform encephalopathy, and avian influenza (FSIS, 2009e). The agency also conducts research on consumer response to and effectiveness of FSIS food safety campaigns. The Agricultural Research Service (ARS), not FSIS, is the principal in-house scientific research agency of USDA. Recent ARS food safety projects include research on treating fresh produce with cold plasma (to protect the produce from potentially dangerous microbes such as Salmonella, Listeria, and E. coli O157:H7) and research on food irradiation (FSIS, 2009f). 21 Communication In 2008, FSIS launched a series of podcasts on food safety and education issues for consumers and stakeholders (FSIS, 2008d). 22 Education Programs (FSIS, 2009g, 2010) include Be Food Safe, Thermy™, Fight BAC!®, the USDA Food Safety Mobile, Is It Done Yet?, and National Food Safety Education Month®. Also see Table C-1, row 22. TABLE C-3 Canada 1 Country population 33,787,563 (Statistics Canada, 2009) 2 Name of organization There are two organizations in Canada that together are responsible for food safety: • Health Canada—establishes policies and standards related to the safety and nutritional quality of food sold in Canada. • Canadian Food Inspection Agency (CFIA)—provides all federal inspection services related to food, and enforces the food safety and nutritional quality standards established by Health Canada (Health Canada, 2009). This table focuses primarily on CFIA.

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0 ENHANCING FOOD SAFETY TABLE C-3 Continued 3 Year created 1996 (Bakvis, 1997) 4 Legislation CFIA is responsible for the administration and enforcement of the following 14 acts (CFIA, 2009a): • Agriculture and Agri-Food Administrative Monetary Penalties Act • Appropriation Acts • Canada Agricultural Products Act • Canadian Food Inspection Agency Act • Consumer Packaging and Labelling Act (as it relates to food) • Feeds Act • Fertilizers Act • Fish Inspection Act • Food and Drugs Act (as it relates to food) • Health of Animals Act • Meat Inspection Act • Plant Breeders’ Rights Act • Plant Protection Act • Seeds Act 5 Budget Food safety spending in fiscal year (FY) 2003 was $Canadian 360 million ($US 232 million). User fees for food inspections have been frozen at about $Canadian 40 million (about $US 26 million) since 1997 and in FY 2003 accounted for about 11 percent of CFIA’s food safety spending (GAO, 2005). 6 Number of employees There are a total of 7,053 CFIA staff—4,610 Inspection Staff for food and 3,228 Inspectors/Field Inspection Staff (CFIA, 2009b) 7 Definition of “food” Includes any article manufactured, sold, or represented for use as food or drink for human beings; chewing gum; and any ingredient that may be mixed with food for any purpose whatever (CFIA, 2009c). 8 Items regulated CFIA regulates all food products for humans and animals, veterinary biologics, plant seeds, fertilizers, and crops (CFIA, 2009d,e,f). 9 Organization CFIA is responsible for all food safety inspections and related activities, including inspections of imported and domestic products, export certifications, laboratory and diagnostic support, crisis management, and product recalls. CFIA is also responsible for food quality assurance inspections and animal health and plant disease control (GAO, 2005).

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 APPENDIX C TABLE C-3 Continued 10 Regulation of on-farm The agricultural community has worked with CFIA and activity Agriculture and Agri-Food Canada to develop on-farm food safety programs and to establish a process through which these programs can be officially recognized by CFIA for technical soundness and administrative effectiveness (COFFS Working Group, 2009). 11 Risk-based policies, The Food Safety Enhancement Program is CFIA’s approach models, use of Hazard to encourage and support the development, implementation, Analysis and Critical and maintenance of HACCP systems in all federally Control Points registered establishments (CFIA, 2009g). (HACCP), etc. 12 Inspections (domestic) There are approximately 3,000 inspectors across all business lines (GAO, 2008b). Restaurant and food service inspection across Canada is generally carried out by provincial governments, municipalities, or regional health authorities (CFIA, 2009h). 13 Imports All food products imported into Canada must meet Canadian food safety requirements. Importers are responsible for the safety of foods they import into Canada. There are additional provisions for certain products (for example, meat and fish) that have been assessed as potentially presenting higher levels of risk because of the hazards commonly associated with those products (e.g., microbial concerns, veterinary drugs), combined with high volumes of consumption and trade. Other products (eggs, dairy products, and processed fruits and vegetables) must meet equivalence requirements. Inspection frequencies are adjusted to reflect the history of compliance associated with importers and products (CFIA, 2009i). 14 Disease surveillance Public Health Agency of Canada and Health Canada are responsible for disease surveillance (GAO, 2008b). 15 Recall authority When the Minister of Agriculture and Agri-Food believes that an item poses a risk to public, animal, or plant health, he/she can, under the Canadian Food Inspection Agency Act, order a company to recall a product (CFIA, 2009j). 16 Other regulatory Health Canada (see row 2 above) agencies with responsibilities for foods continued

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 ENHANCING FOOD SAFETY TABLE C-7 Denmark 1 Country population 5,519,441 (Statistics Denmark, 2009) 2 Name of organization Danish Veterinary and Food Administration (DVFA) under the Ministry of Family and Consumer Affairs. The Danish Institute for Food and Veterinary Research, a separate institute within DVFA, is responsible for research and risk assessment (GAO, 2005). 3 Year created 2000 4 Legislation The Danish Food Act, adopted in 1998, reformed Danish food safety law by replacing seven existing food laws with this single law (GAO, 2005). 5 Budget DVFA’s budget for 2004 was 856 million Danish kroner (about $US 142 million) (GAO, 2005). 6 Number of employees Approximately 1860 employees (DVFA, 2009b) for food 7 Definition of “food” See European Union (Table C-6), row 7. 8 Items regulated All food products from farm to fork (DVFA, 2009b) 9 Organization DVFA is responsible for almost all food safety matters. Exceptions are the Plant Directorate, which is responsible for animal feed inspections, and the Directorate for Fisheries, which is responsible for inspection of fish on ships. These two agencies are in the Ministry of Food, Agriculture, and Fisheries (GAO, 2005). 10 Regulation of on-farm DVFA is responsible for safe food production, including from activity field to table. Plant production falls under the Danish Plant Directorate (DVFA, 2009c). 11 Risk-based policies, Companies must impose self-inspection programs that must models, use of Hazard be organized in accordance with the principles embodied Analysis and Critical in the HACCP system. Self-inspection programs must also Control Points ensure that companies adhere to food-related legislation (HACCP), etc. (DVFA, 2009d).

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 APPENDIX C TABLE C-7 Continued 12 Inspections (domestic) Inspection is the cornerstone of the control process with respect to companies and primary producers. Food control and veterinary inspections are handled by three regional veterinary and food control centers. Companies and producers must have so-called self-inspection programs with systematic action plans to ensure that regulations are observed in the handling of food products and livestock. Government food authorities conduct inspections to ensure that the relevant regulations are observed, and results are posted in a place visible to consumers (DVFA, 2009d). Under the new system, municipal inspectors are part of DVFA (GAO, 2005). 13 Imports The International Trade Division of DVFA is responsible for imports (DVFA, 2009e). See also European Union (Table C-6), row 13. 14 Disease surveillance Statens Serum Institut, the DVFA, the Danish Plant Directorate, the Danish Institute for Food and Veterinary Research, the National Board of Health, the Danish Environmental Protection Agency, and the Royal Veterinary and Agricultural University (Lo Fo Wong et al., 2004) 15 Recall authority See European Union (Table C-6), row 15. 16 Other regulatory Danish Food Industry Agency, Danish Plant Directorate, agencies with Danish Directorate for Fisheries responsibilities for foods 17 Why was there a Improve effectiveness (e.g., communications with consumers, migration to a single consistency of inspections) and improve efficiency (e.g., move food agency? resources to high-risk areas, reduce overlaps in responsibility) (GAO, 2005). 18 How is a single food Reduced overlap in inspections, risk-based inspections that agency working? put resources where they are most needed, more consistent and timely enforcement action, and reduced spending, most notably in microbiological laboratories, have resulted (GAO, 2005). 19 Program evaluation DVFA must be able to demonstrate the probability that—all other things being equal—it has made a difference in the population’s benefit from foodstuffs and helped stop the spread of livestock diseases and infections. One of the ways this probability is demonstrated is by examining the incidence of specific diseases where intervention has occurred. continued

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 ENHANCING FOOD SAFETY TABLE C-7 Continued 20 Research function The Danish Institute for Food and Veterinary Research, a separate institute within DVFA, is responsible for research and risk assessment (GAO, 2005). 21 Communication Evaluation of each firm is published in the form of Figure C-1 (DVFA, 2009f). 22 Education One of the main aims of DVFA is to promote better food and a healthy diet (DVFA, 2009g). had no r emarks, has emphasised that certain rules must be obeyed, issued an injunc tion order or a prohibition, issued an administrative fine, reported the enterprise to the police or w ithdrew an approval. Elite-smiley The elite-smiley is awarded to enterprises w ith the best inspec tion history. FIGURE C-1 Evaluation scheme for Danish firms. SOURCE: DVFA, 2010. Figure C-1 vectors TABLE C-8 United Kingdom 1 Country population 61.4 million (National Statistics, 2009) 2 Name of organization Food Standards Agency (FSA) 3 Year created 2000 (FSA, 2009a) 4 Legislation Codex Alimentarius; European Union legislation; Food Safety Acts of 1990; Food Standards Act of 1999; Hygiene Legislation of 2006; Individual laws of Scotland, Wales, and Northern Ireland (FSA, 2009a). 5 Budget £160.4 million in fiscal year 2008–2009 (FSA, 2009b) 6 Number of employees The agency employs about 2,350 staff, including 1,600 for food inspectors in the Meat Hygiene Service (GAO, 2008b). 7 Definition of “food” See European Union (Table C-6), row 7. 8 Items regulated See European Union (Table C-6), row 8.

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 APPENDIX C TABLE C-8 Continued 9 Organization Several advisory committees, with members of an overarching FSA Board appointed by individual countries’ ministers and the Secretary of State for Health. Several subcommittees operate under the FSA Board, including the Meat Hygiene Service (MHS) subcommittee. The MHS subcommittee itself is responsible for safeguarding public health and animal welfare at slaughter through the effective enforcement of legislation (FSA, 2009b). 10 Regulation of on-farm Farmers are to employ Hazard Analysis and Critical Control activity Points (HACCP) (GAO, 2008b). 11 Risk-based policies, FSA is the main United Kingdom (UK) body in charge models, use of Hazard of assessing food risks and focuses on processes, such as Analysis and Critical HACCP (GAO, 2008b). The agency recognizes that there is Control Points a degree of scientific uncertainty in risk assessments (FSA, (HACCP), etc. 2000). See also European Union (Table C-6), row 11. 12 Inspections (domestic) FSA works closely with local food law enforcement officers to ensure that food law is applied throughout the food chain. FSA advises and trains on enforcement issues and provides grants to local programs. The agency also ensures that local authorities’ monitoring of food businesses is functioning correctly by performing audits and collating data on local authorities’ enforcement activities. Additional authorities work on specific commodities, such as horticultural products, dairy, and eggs. Food outlets are given a score based on inspection findings, and these scores are posted on the door of the firm and online (FSA, 2009c). 13 Imports FSA is responsible for the public health aspects of food imported into the United Kingdom. This means ensuring that imported food is safe for people to eat. Local and port health authorities are responsible for the enforcement of food safety and standard controls on food products. FSA’s Imported Food Division helps improve the effectiveness of enforcement of imported food controls. FSA has particular responsibility for imports of fresh, dried, cooked, cured, and smoked fish and fishery products, such as canned tuna, fish sauces, and prawns. Also see European Union (Table C-6), row 13. continued

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 ENHANCING FOOD SAFETY TABLE C-8 Continued 14 Disease surveillance FSA monitors the effectiveness of programs to control microbiological hazards through microbiological surveys. These surveys are carried out on a regular basis, focus either on particular foods or food processes, and are undertaken in response to microbiological food hazards, outbreaks of foodborne disease, or recommendations made by the independent Advisory Committee on the Microbiological Safety of Food (FSA, 2009d). The Health Protection Agency is responsible for managing infectious diseases, disease outbreaks, radiological health, and emergency planning. If a foodborne illness outbreak covers a wide area, the Health Protection Agency initiates investigations to determine the contaminant and identify its source, and provides information to FSA so it can manage the risk (GAO, 2008b). 15 Recall authority FSA has mandatory recall authority (GAO, 2008b). 16 Other regulatory Department for Environment, Food, and Rural Affairs, agencies with Veterinary Laboratories Agency, Animal Health, Her responsibilities for Majesty’s Revenue and Customs, local authorities, private- foods sector industry organizations (GAO, 2008b). 17 Why was there a FSA was founded in response to (1) the loss of public migration to a single confidence in the government’s handling of food safety food agency? issues, such as bovine spongiform encephalopathy (BSE) and Salmonella in egg products, and (2) perceived conflict of interest in the Ministry of Agriculture, Fisheries, and Food, which also promoted UK agriculture (GAO, 2008b). 18 How is a single food The UK audit office found that FSA had improved public agency working? confidence, a stated objective (GAO, 2008b). 19 Program evaluation A strategic plan is outlined every year, and group progress reports form the basis of a report to the Executive Management Board at the end of each quarter (FSA, 2009b). 20 Research function The agency carries out and commissions extensive scientific research and survey work to ensure that its advice to the public is based on the best and most up-to-date science. The agency is advised in its work by independent scientific committees. Studies focus on nutrition, BSE, chemical and microbial contamination, and food safety (FSA, 2009e). 21 Communication Communication programs are in place, including blogs, YouTube videos, and podcasts (FSA, 2009a). 22 Education Education programs are in place, including training modules, phone applications, and YouTube videos (FSA, 2009a).

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 APPENDIX C REFERENCES AQIS (Australian Quarantine and Inspection Service). 2009. Frequently Asked Questions: What Is Classified as Food? http://www.daff.gov.au/aqis/faqs (accessed October 7, 2009). Australian Bureau of Statistics. 2009. 0.0—Australian Demographic Statistics. http://www. abs.gov.au/ausstats/abs@.nsf/mf/3101.0 (accessed October 7, 2009). Bakvis, H. 1997. Creating the Canadian Food Inspection Agency: The Role of Central Agen­ cies as Facilitators and Guardians. http://www.tbs-sct.gc.ca/asd-dmps/db/ccfa_s-eng.asp (accessed September 22, 2009). Becker, G. S. 2009. Food Safety on the Farm: Federal Programs and Selected Proposals. Report No. RL34612. Washington, DC: Congressional Research Service. Burrows, V. K. 2008. FDA Authority to Regulate On­Farm Actiity. Washington, DC: Con- gressional Research Service. CDC (U.S. Centers for Disease Control and Prevention). 2009a. Food Safety Office. http:// www.cdc.gov/foodsafety/ (accessed September 21, 2009). CDC. 2009b. Food Safety Office: Oeriew of CDC Food Safety Actiities and Programs. http://www.cdc.gov/foodsafety/activities.html (accessed September 21, 2009). CFIA (Canadian Food Inspection Agency). 2009a. Acts and Regulations. http://www.inspection. gc.ca/english/reg/rege.shtml (accessed September 22, 2009). CFIA. 2009b. Inspectors and Inspection Staff, from Agency Inception to March 00. http:// www.inspection.gc.ca/english/agen/inspece.shtml (accessed September 22, 2009). CFIA. 2009c. Glossary: “Food.” http://www.inspection.gc.ca/english/fssa/fssae.shtml (accessed September 22, 2009). CFIA. 2009d. Animals. http://www.inspection.gc.ca/english/anima/animae.shtml (accessed Sep- tember 22, 2009). CFIA. 2009e. Food. http://www.inspection.gc.ca/english/fssa/fssae.shtml (accessed Septem- ber 22, 2009). CFIA. 2009f. Plants. http://www.inspection.gc.ca/english/plaveg/plavege.shtml (accessed Sep- tember 22, 2009). CFIA. 2009g. Hazard Analysis Critical Control Points/Food Safety Enhancement Program. http://www.inspection.gc.ca/english/fssa/polstrat/haccp/haccpe.shtml (accessed Septem - ber 22, 2009). CFIA. 2009h. Information for Restauranteurs and Food Serice Operators. http://www. inspection.gc.ca/english/fssa/labeti/retdet/rest1e.shtml (accessed September 23, 2009). CFIA. 2009i. Canada Has a Robust Risk­Based Import Control System. http://www.inspection. gc.ca/english/fssa/concen/specif/vegprofse.shtml (accessed September 23, 2009). CFIA. 2009j. The Canadian Food Safety System—Food Recall. http://www.inspection.gc.ca/ english/fssa/recarapp/systeme.shtml (accessed September 22, 2009). CFIA. 2009k. Reports to Parliament. http://www.inspection.gc.ca/english/corpaffr/ar/artoce. shtml (accessed March 11, 2010). COFFS Working Group (Canadian On-Farm Food Safety Working Group). 2009. The Canadian Approach. http://www.coffs-safc.ca/canadian-approach.html (accessed Sep- tember 22, 2009). DVFA (Danish Veterinary and Food Administration). 2009a. About the Danish Veterinary and Food Administration. http://www.uk.foedevarestyrelsen.dk/Aboutus/forside.htm (accessed October 2, 2009). DVFA. 2009b. From Farm to Fork. http://www.uk.foedevarestyrelsen.dk/forside.htm (accessed October 2, 2009). DVFA. 2009c. Mission and Vision. http://www.uk.foedevarestyrelsen.dk/Aboutus/Mission_ and_vision/forside.htm (accessed October 2, 2009).

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 ENHANCING FOOD SAFETY DVFA. 2009d. Inspection Principles. http://www.uk.foedevarestyrelsen.dk/Inspection/Inspection_ principles/forside.htm (accessed March 11, 2010). DVFA. 2009e. Legislation on Import of Food of Animal Origin from Third Countries. http:// www.uk.foedevarestyrelsen.dk/ImportExport/Legislation_on_import_of_food/Forside.htm (accessed October 2, 2009). DVFA. 2009f. Danish Smileys Get a Broader Smile. http://www.fvm.dk/News_display.aspx?I D=18488&PID=169628&year=2009&NewsID=5570 (accessed March 11, 2010). DVFA. 2009g. Nutrition. http://www.uk.foedevarestyrelsen.dk/Nutrition/forside.htm (accessed October 2, 2009). DVFA. 2010. Smileys Keep Food Safety High in Denmark. http://www.findsmiley.dk/en-US/ Forside.htm (accessed April 20, 2010). EFIC (European Food Information Council). 2002. FAQ: Is There a Legal Definition of Food and Processed Food? http://www.eufic.org/page/en/faqid/food-processed-food/ (accessed September 30, 2009). EFSA (European Food Safety Authority). 2008. EFSA’s Management Board Adopts Stra­ tegic Plan 00−0. http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_ 1211902231849.htm (accessed September 30, 2009). EFSA. 2009a. About EFSA. http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_ AboutEfsa.htm (accessed September 29, 2009). EFSA. 2009b. The European Food Safety Authority at a Glance. Parma, Italy: EFSA. EFSA. 2009c. Topics A–Z: Foodborne Diseases. http://www.efsa.europa.eu/EFSA/efsa_locale- 1178620753812_1211902031795.htm (accessed September 30, 2009). EFSA. 2009d. Networks. http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_ PartnersNetworks.htm (accessed September 30, 2009). EFSA. 2009e. EU Agencies and Institutions. http://www.efsa.europa.eu/EFSA/Partners Networks/efsa_locale-1178620753812_1178698951636.htm (accessed September 30, 2009). EFSA. 2009f. How We Work. http://www.efsa.europa.eu/EFSA/AboutEfsa/efsa_locale- 1178620753812_HowWeWork.htm (accessed September 30, 2009). European Commission. 2007a. Key Facts and Figures About Europe and the Europeans. Luxembourg, Germany: Office for Official Publications of the European Communities. http://europa.eu/abc/keyfigures/sizeandpopulation/index_en.htm (accessed September 29, 2009). European Commission. 2007b. General Guidance on EU Import and Transit Rules for Lie Animals and Animal Products from Third Countries. Brussels, Belgium: European Commission. FDA (U.S. Food and Drug Administration). 2007. Food Protection Plan: An Integrated Strat­ egy for Protecting the Nation’s Food Supply. Rockville, MD: FDA. FDA. 2009a. History. http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm (accessed March 11, 2010). FDA. 2009b. Centers and Offices. http://www.fda.gov/AboutFDA/CentersOffices/default.htm (accessed September 15, 2009). FDA. 2009c. Legislation. http://www.fda.gov/RegulatoryInformation/Legislation/default.htm (accessed September 14, 2009). FDA. 2009d. Other Laws Affecting FDA. http://www.fda.gov/RegulatoryInformation/ Legislation/ucm153119.htm (September 14, 2009). FDA. 2009e. Summary of the FDA’s FY 00 Budget. http://www.fda.gov/ (accessed Septem- ber 14, 2009). FDA. 2009f. Food and Drug Administration Detail of Full­Time Equialent (FTE) Employ­ ment Program Leel. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/ Reports/BudgetReports/UCM153892.pdf (accessed September 14, 2009).

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 APPENDIX C FDA. 2009g. What FDA Regulates. http://www.fda.gov/AboutFDA/WhatWeDo/ WhatFDARegulates/default.htm (accessed March 11, 2010). FSA (Food Standards Agency). 2000. Statement of General Objecties and Practices: Put­ ting the Consumer First. http://www.food.gov.uk/aboutus/how_we_work/sgop (accessed October 7, 2009). FSA. 2009a. The History of the Food Standards Agency. http://www.food.gov.uk/aboutus/ how_we_work/historyfsa/ (accessed October 7, 2009). FSA. 2009b. A Year at the Food Standards Agency 00/0: Annual Report and Consolidated Resource Accounts. England, UK: FSA. FSA. 2009c. Enforcement. http://www.food.gov.uk/enforcement/ (accessed March 11, 2010). FSA. 2009d. Microbiological Sureillance. http://www.food.gov.uk/science/surveillance/ microsurv/ (accessed October 7, 2009). FSA. 2009e. Science and Research. http://www.food.gov.uk/science/ (accessed October 7, 2009). FSA. 2009f. Agency on the Web. http://www.food.gov.uk/aboutus/aboutsite/fsainteractive (accessed October 7, 2009). FSANZ (Food Standards Australia New Zealand). 2008a. Food Standards Australia New Zealand Annual Report: 00–00. Canberra BC, Australia: FSANZ. FSANZ. 2008b. Food Standards Australia New Zealand Food Industry Recall Protocol: A Guide to Conducting a Food Recall and Writing a Food Recall Plan, th Edition. Canberra BC, Australia: FSANZ. FSANZ. 2009a. A Short History of NFA/ANZFA/FSANZ. http://www.foodstandards.gov. au/aboutfsanz/historyoffsanz.cfm (accessed October 7, 2009). FSANZ. 2009b. FSANZ Feedback and Complaints. http://www.foodstandards.gov.au/ aboutfsanz/feedbackandcomplaint113.cfm (accessed October 7, 2009). FSANZ. 2009c. About Us. http://www.foodstandards.gov.au/aboutfsanz/index.cfm (accessed October 7, 2009). FSANZ. 2009d. Imported Food Inspection Scheme. http://www.foodstandards.gov.au/ consumerinformation/importedfoods.cfm (accessed March 11, 2010). FSANZ. 2009e. Food Sureillance Monitoring the Food Supply. http://www.foodstandards. gov.au/monitoringandsurveillance/foodsurveillance.cfm (accessed October 7, 2009). FSANZ/NZFSA (New Zealand Food Safety Authority). 2008. The New Zealand Food Regula­ tory Enironment. Wellington, New Zealand: FSANZ/NZFSA. http://www.nzfsa.govt. nz/labelling-composition/publications/food-regulation-booklet/index.htm (accessed March 11, 2010). FSIS (Food Safety and Inspection Service). 2007a. About FSIS: Agency History. http://www. fsis.usda.gov/About_FSIS/Agency_History/index.asp (accessed September 21, 2009). FSIS. 2007b. Acts & Authorizing Statutes. http://www.fsis.usda.gov/regulations_&_policies/ Acts_&_Authorizing_Statutes/index.asp (accessed September 21, 2009). FSIS. 2008a. Strategic Plan FY00–0. Washington, DC: USDA FSIS. FSIS. 2008b. Regulations & Policies: Federal Inspection Programs. http://www.fsis.usda.gov/ regulations_&_policies/federal_inspection_programs/index.asp (accessed September 22, 2009). FSIS. 2008c. Regulations & Policies: Import Information. http://www.fsis.usda.gov/regulations_ &_policies/index_of_certified_countries/index.asp (accessed September 22, 2009). FSIS. 2008d. News & Eents. http://www.fsis.usda.gov/News_&_Events/NR_042308_01/in- dex.asp (accessed September 22, 2009). FSIS. 2009a. About FSIS: Structure & Organization. http://www.fsis.usda.gov/About_FSIS/ Structure_&_Organization/index.asp (accessed September 21, 2009). FSIS. 2009b. Regulations & Policies: State Inspection Programs. http://www.fsis.usda. gov/regulations_&_policies/state_inspection_programs/index.asp (accessed March 11, 2010).

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00 ENHANCING FOOD SAFETY FSIS. 2009c. Fact Sheets: Production & Inspection—FSIS Food Recalls. http://www.fsis.usda. gov/Fact_Sheets/FSIS_Food_Recalls/index.asp (accessed September 21, 2009). FSIS. 2009d. About FSIS: Office of Program Ealuation, Enforcement, and Reiew— Program Ealuation and Improement. http://www.fsis.usda.gov/About_FSIS/Program_ Evaluation_&_Improvement/index.asp (accessed September 22, 2009). FSIS. 2009e. Science: Risk Assessments. http://www.fsis.usda.gov/Science/Risk_Assessments/ index.asp (accessed September 22, 2009). FSIS. 2009f. Home: Food Safety Interention Technologies Research Unit. http://www.ars. usda.gov/main/site_main.htm?modecode=19-35-75-00 (accessed September 22, 2009). FSIS. 2009g. Educational Materials & Campaigns. http://www.fsis.usda.gov/Food_Safety_ Education/food_safety_education_programs/index.asp?src_location=content&src_ page=FSEd (accessed April 20, 2010). FSIS. 2010. Food Safety Education. http://www.fsis.usda.gov/Food_Safety_Education/index. asp (accessed April 20, 2010). FVO (Food and Veterinary Office). 2009. The Food and Veterinary Office—Contributions. http://ec.europa.eu/food/fvo/how_en.htm (accessed September 30, 2009). GAO (U.S. Government Accountability Office). 2005. Food Safety: Experiences of Seen Countries in Consolidating Their Food Safety Systems. Washington, DC: GAO. GAO. 2008a. Federal Oersight of Food Safety: FDA Has Proided Few Details on the Resources and Strategies Needed to Implement Its Food Protection Plan. Report number: GAO-08-909T. Washington, DC: GAO. GAO. 2008b. Food Safety: Selected Countries’ Systems Can Offer Insights into Ensuring Import Safety and Responding to Foodborne Illness. Washington, DC: GAO. Givens, J. M. 2009. Reiew of FDA’s Role in Ensuring Safe Food (FDA’s Approach to Risk Based Inspections—A Field Perspectie). PowerPoint Presentation at Workshop on Per- spectives on FDA’s Role in Ensuring Safe Food, Washington, DC. Health Canada. 2009. Food and Nutrition: What Is Health Canada Doing? http://www.hc-sc.gc. ca/fn-an/index-eng.php (accessed September 22, 2009). Hogan and Hartson, LLP. 2009. Key Proisions in Select Food Safety Legislation (The Durbin, Dingell, and Costa Bills; and Current Law). Washington, DC: Hogan and Hartson, LLP. Lo Fo Wong, D. M. A., J. K. Andersen, B. Nørrung, and H. C. Wegener. 2004. Food Contami­ nation Monitoring and Foodborne Disease Sureillance at National Leel. Paper delivered to Second Food and Agriculture Organization/World Health Organization Global Forum for Food Safety Regulators, Bangkok, Thailand, October 12–14, 2004. http://www.fao. org/docrep/meeting/008/j3140e/j3140e00.htm (accessed October 2, 2009). National Statistics. 2009. Population Estimates: UK Population Grows to . Million. http:// www.statistics.gov.uk/cci/nugget.asp?ID=6 (accessed October 7, 2009). NRC (National Research Council). 2009. Reiew of the Methodology Proposed by the Food Safety and Inspection Serice for Followup Sureillance of In­Commerce Businesses: A Letter Report. Washington, DC: The National Academies Press. NZFSA (New Zealand Food Safety Authority). 2009a. Legislation: Policy & Law. http://www. nzfsa.govt.nz/policy-law/legislation/index.htm (accessed September 24, 2009). NZFSA. 2009b. Glossary and Acronym Definitions: “Food.” http://www.nzfsa.govt.nz/ publications/glossary/index.htm? (accessed September 25, 2009). NZFSA. 2009c. Food Safety in New Zealand: Application of a Risk Management Framework. http://www.nzfsa.govt.nz/about-us/risk-management-framework/index.htm (accessed September 29, 2009). NZFSA. 2009d. NZFSA Profile—December 00. http://www.nzfsa.govt.nz/about-us/profile/ december-2007/index.htm (accessed September 29, 2009).

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0 APPENDIX C NZFSA. 2009e. Import Clearance Procedure. http://www.nzfsa.govt.nz/importing/import- clearance-procedure/page.htm#TopOfPage (accessed September 29, 2009). NZFSA. 2009f. Importing—Oeriew. http://www.nzfsa.govt.nz/importing/overview/ (accessed September 29, 2009). NZFSA. 2009g. NZFSA Recall Quick Reference Guide. http://www.nzfsa.govt.nz/processed- food-retail-sale/recalls/quick-reference/index.htm (accessed September 29, 2009). NZFSA. 2009h. NZFSA Accountability Documents. http://www.nzfsa.govt.nz/about-us/ accountability-documents/index.htm (accessed September 25, 2009). PFSE (Partnership for Food Safety Education). 2006. About PFSE. http://www.fightbac.org/ (accessed September 21, 2009). Solomon, S. 2009. Regulating in the Global Enironment. PowerPoint Presentation at Work- shop on Perspectives on FDA’s Role in Ensuring Safe Food, Washington, DC. Statistics Canada. 2009. Canada’s Population Clock. http://www.statcan.gc.ca (accessed Sep- tember 22, 2009). Statistics Denmark. 2009. Quarterly Population (Ultimo). http://www.dst.dk/HomeUK/ Statistics/Key_indicators/Population/pop_quarterly.aspx (accessed October 2, 2009). Statistics New Zealand. 2009. Estimated Resident Population of New Zealand. http://www.stats. govt.nz/methods_and_services/population_clock.aspx (accessed September 24, 2009). Thompson, A. 2009. Food Safety & Inspection Serice. http://cod.nfc.usda.gov/FMT/ 2009FMT/2-C%20FSIS.ppt (accessed September 21, 2009). U.S. Census Bureau. 2009. U.S. Census Bureau. http://www.census.gov/ (accessed September 14, 2009).

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