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). |
|
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 for food |
The estimated full-time equivalents (FTEs) for FY 2010 are |
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|
|
|
|
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). |
|
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: |
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|
|
|
|
10 |
Regulation of on-farm activity |
The FDA has had minimal involvement in on-farm 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). |
|
11 |
Risk-based policies, models, use of Hazard Analysis and Critical Control Points (HACCP), etc. |
HACCP is in place for juice and seafood. The FDA has some programs that it calls “risk-based.” See Chapters 1, 2, 3, and 4 for a full discussion of the FDA’s risk-based programs. |
|
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). |
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|
|
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). |
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|
|
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. |
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|
|
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). |
|
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). |
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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). |
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|
|
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 agencies with responsibilities for foods |
Customs and Border Protection, CDC, U.S. Department of Justice, Environmental Protection Agency, Federal Trade Commission, Library of Congress, National Library of 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 migration to a single food agency? |
Not applicable |
|
18 |
How is a single food agency working? |
Not applicable |
|
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. |
|
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. |
|
aFederal Food, Drug, and Cosmetic Act, Public Law 75-717, 75th Cong., 3rd sess. (June 24, 1938). Title 21 U.S. Code, Section 9. bPublic Health Service Act, Public Law 78-410, 78th Cong., 2nd sess. (July 1, 1944). c HR759, Food and Drug Administration Globalization Act of 2009, 11th Cong. |
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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 for food |
FSIS’s 9,500 employees include approximately 7,800 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. |
|
9 |
Organization |
Ten offices make up FSIS (FSIS, 2009a): |
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|
|
|
|
10 |
Regulation of on-farm activity |
FSIS officials have stated that the laws governing the agency provide no direct authority to regulate on-farm activity (Becker, 2009). |
|
11 |
Risk-based policies, models, use of Hazard Analysis and Critical Control Points (HACCP), etc. |
In order for a state to be approved for a Federal Grant of Inspection, it must provide a written hazard analysis and HACCP plan (FSIS, 2008b). USDA utilizes “public health–based inspection” (FSIS, 2008b) |
|
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 agencies with responsibilities for foods |
See Table C-1, row 16. |
|
17 |
Why was there a migration to a single food agency? |
Not applicable |
|
18 |
How is a single food agency working? |
Not applicable |
|
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: |
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|
|
|
|
|
|
This table focuses primarily on CFIA. |
|
3 |
Year created |
1996 (Bakvis, 1997) |
|
4 |
Legislation |
CFIA is responsible for the administration and enforcement of the following 14 acts (CFIA, 2009a): |
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|
|
|
|
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 for food |
There are a total of 7,053 CFIA staff—4,610 Inspection Staff 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). |
|
10 |
Regulation of on-farm activity |
The agricultural community has worked with CFIA and 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, models, use of Hazard Analysis and Critical Control Points (HACCP), etc. |
The Food Safety Enhancement Program is CFIA’s approach to encourage and support the development, implementation, and maintenance of HACCP systems in all federally registered establishments (CFIA, 2009g). |
|
12 |
Inspections (domestic) |
There are approximately 3,000 inspectors across all business lines (GAO, 2008b). |
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|
|
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 agencies with responsibilities for foods |
Health Canada (see row 2 above) |
|
17 |
Why was there a migration to a single food agency? |
To improve effectiveness (e.g., consistency of inspections, clarification of responsibilities), to improve efficiency by reducing duplication and overlap in food safety activities, and to reduce federal spending (GAO, 2005). |
|
18 |
How is a single food agency working? |
Financial savings, reduced overlap in inspections, and clearer responsibilities, better coordination, and reduced gaps in oversight have resulted (GAO, 2005). |
|
19 |
Program evaluation |
CFIA is required to produce a Corporate Business Plan at least once every 5 years. It also produces a Departmental Performance Report, which evaluates how well the agency’s Report on Plans and Priorities has been fulfilled (CFIA, 2009k). |
|
20 |
Research function |
Health Canada sets public health policy, conducts research and risk assessments, and sets limits on the amount of a substance that is allowed in a food product (GAO, 2005). |
|
21 |
Communication |
Canadian Consumer Information Gateway,a Canadian Partnership for Consumer Food Safety Education,b and Health Canadac |
|
22 |
Education |
Canadian Partnership for Consumer Food Safety Educationd |
|
a See http://consumerinformation.ca/ (accessed September 22, 2009). b See http://www.befoodsafe.ca (accessed September 22, 2009). c See http://www.hc-sc.gc.ca (accessed September 22, 2009). d See http://www.befoodsafe.ca (accessed September 22, 2009). |
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TABLE C-4 Australia
|
1 |
Country population |
21,779,000 (Australian Bureau of Statistics, 2009) |
|
2 |
Name of organization |
Food Standards Australia New Zealand (FSANZ) |
|
3 |
Year created |
1991 (FSANZ, 2009a) |
|
4 |
Legislation |
FSANZ Act of 1991 |
|
5 |
Budget |
During the 2007–2008 fiscal yea, operating revenue from the Australian and New Zealand governments was $22.113 million, and operating expenses were $22.098 million, resulting in an operating surplus of $0.015 million (FSANZ, 2008a). |
|
6 |
Number of employees for food |
158 (FSANZ, 2008a) |
|
7 |
Definition of “food” |
“Food” includes anything one eats or drinks, such as processed food, uncooked food, airline food, snacks, ingredients (e.g., herbs, spices), and food supplements (AQIS, 2009). |
|
8 |
Items regulated |
FSANZ is an independent binational organization responsible for developing food standards. In Australia, FSANZ works with Australian Commonwealth, state and territory, and nongovernmental organizations to protect the health and safety of Australians through the maintenance of a safe food supply. The agency itself is not responsible for enforcement (FSANZ, 2009b). |
|
9 |
Organization |
FSANZ is part of the Australian government’s Health and Ageing portfolio. It has offices in Australia and Wellington, New Zealand, and develops and maintains food standards (regulations) for Australia and New Zealand. In Australia, it is responsible for developing food safety measures for the handling of food, including food production and processing in the primary industries, and coordinating national surveillance activities and a national food recall scheme. The agency is governed by a board with a wide range of expertise and experience in food matters, with members drawn from both countries. In 2004, FSANZ was restructured to create separate risk assessment and risk management sections (FSANZ, 2009c). |
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|
|
Individuals and organizations can apply to amend a food standard if they can identify a regulatory problem and provide FSANZ with evidence supporting the inadequacy of existing standards or the need to create a new standard. Scientific justification for changing the Australia New Zealand Food Standards Code must be provided, including research data on consumer behavior. (FSANZ, 2008a). |
|
10 |
Regulation of on-farm activity |
FSANZ has developed food safety standards for Australia’s primary industries, including primary production and processing standards. This work extends existing food safety provisions in the Australia New Zealand Food Standards Code for the processing and retail sectors to food production, forming a whole-chain approach to food safety, from farm to consumer (FSANZ, 2008a). |
|
11 |
Risk-based policies, models, use of Hazard Analysis and Critical Control Points (HACCP), etc. |
FSANZ adheres to a risk analysis approach recommended by the Codex Alimentarius Commission, the recognized international agency for global food standards. This approach involves risk assessment (identifying hazards in food and likely risks to human health), risk management (developing control measures that minimize the risks), and risk communication (ensuring two-way exchange of information between all stakeholders in standards development) (FSANZ, 2008a). |
|
12 |
Inspections (domestic) |
State and territory agencies, the New Zealand Food Safety Authority, local government, and the Australian Quarantine and Inspection Service are responsible for the implementation of laws and enforcement actions (FSANZ, 2008a). |
|
13 |
Imports |
All food sold in Australia, including imports, must comply with state and territory food legislation and other legislative requirements. The Australian Quarantine and Inspection Service (AQIS) aims to ensure that imported foods are fit and safe for human consumption through a program of inspection for compliance with food standards. FSANZ provides advice to AQIS on the level of public health risk posed by specific foods, but AQIS has operational responsibility for inspection and sampling of imported foods to ensure that they are compliant with food standards (FSANZ, 2009d). |
|
14 |
Disease surveillance |
FSANZ acts as the central point for the collection of food surveillance data from public health units in Australia and New Zealand (FSANZ, 2009e). |
|
15 |
Recall authority |
The Commonwealth Minister responsible for consumer affairs and the state and territory governments have the legislative power to order a food product recall when a serious public health and safety risk exists. This is known as a mandatory recall (FSANZ, 2008b). |
|
16 |
Other regulatory agencies with responsibilities for foods |
Australian Competition and Consumer Commission, AQIS, Australian Pesticides and Veterinary Medicines Authority, Ministry of Health (New Zealand), National Health and Medical Research Council, National Measurement Institute, New Zealand Food Safety Authority, Office of Best Practice Regulation, Office of the Gene Technology Regulator, Standards Australia, Therapeutic Goods Administration (FSANZ, 2008a). |
|
17 |
Why was there a migration to a single food agency? |
The National Food Authority was formed in 1991 in an effort to effect economic reform and cooperation between the Commonwealth and the states and territories, with the aim of achieving uniformity in food standards across Australia (FSANZ, 2009a). |
|
18 |
How is a single food agency working? |
Some early issues, such as health claims and standards for special foods and sports foods, are still being addressed, but others, such as country-of-origin labeling, have been resolved (FSANZ, 2009a). |
|
19 |
Program evaluation |
An annual report is required in compliance with Section 69 of the Food Standards Australia New Zealand Act of 1991 and the Commonwealth Authorities and Companies Act of 1997. Annual surveys of consumers and stakeholders are also conducted (FSANZ, 2008a). |
|
20 |
Research function |
Research covers diverse topics, such as risk assessments, contamination in foods, nutritional claims, and consumer attitudes (FSANZ, 2008a). |
|
21 |
Communication |
Risk communication is one of the three elements of the risk analysis model used by FSANZ. Also, the agency regularly updates its consumer website, maintains a database and conducts gap analysis of consumer materials on pertinent topics, and maintains an advice line for consumers and industry (FSANZ, 2008a). |
|
22 |
Education |
FSANZ is a founding member of the Food Safety Information Council (FSIC), a not-for-profit group with members representing government, consumers, health professionals, and industry and with the role of educating consumers in food safety. FSIC organizes a National Food Safety Week each year (FSANZ, 2008a). |
TABLE C-5 New Zealand
|
1 |
Country population |
4,328,340 (Statistics New Zealand, 2009) |
|
2 |
Name of organization |
New Zealand Food Safety Authority (NZFSA) |
|
3 |
Year created |
2002 |
|
4 |
Legislation |
NZFSA enforces the following eight laws and their amendments (NZFSA, 2009a): |
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|
|
|
|
5 |
Budget |
Fiscal year ending June 2004: $NZ 78 million ($US 53 million). A portion of spending is financed by user fees assessed on industry for a range of regulator-provided services, including export certification, export audit arrangements, and market access efforts (GAO, 2005). |
|
6 |
Number of employees for food |
480 in 2004 (GAO, 2005) |
|
7 |
Definition of “food” |
“Food” includes any thing or article, whether processed, semiprocessed, or raw, that is intended for human consumption. This includes drink, chewing gum, and any substance that enters into or is used in the composition, manufacture, preparation, and preservation of any food or drink but does not include cosmetics or tobacco or substances used only as medicines and drugs. It includes bottled water, primary produce (e.g., live shellfish, fruit on a tree), water used in the manufacture of a food, and by-products of animals if they go into food. It may include live animals and plants (depending on intent). It excludes cookware and related products (e.g., pie dishes, packaging [except for edible packaging]) (NZFSA, 2009b). |
|
8 |
Items regulated |
All foods and food products (domestically produced and imported and exported), animal products, agricultural compounds (GAO, 2005). |
|
9 |
Organization |
NZFSA is New Zealand’s controlling authority for domestic food safety; imports and exports of food and food-related products (including plant products); administration of legislation covering food sales on the domestic market; primary processing of animal products; and regulation of agricultural compounds (pesticides, fertilizers, and veterinary medicines). It also has farm-to-table responsibilities, from primary production through processing to retailers and consumer education. NZFSA’s organization includes a verification agency, which audits animal product facilities to verify that exporters are following agreed-upon processes (GAO, 2005). |
|
10 |
Regulation of on-farm activity |
NZFSA is responsible for developing and implementing food regulations for primary production. |
|
11 |
Risk-based policies, models, use of Hazard Analysis and Critical Control Points (HACCP), etc. |
NZFSA applies a generic risk management framework (RMF) to systematically address all food safety issues. Systematic application of an RMF ensures that all aspects of risk analysis (risk assessment, risk management, and risk communication) work together. The system takes into account uncertainty and the need for continuous updates, and has consumer health goals (NZFSA, 2009c). |
|
12 |
Inspections (domestic) |
NZFSA investigates breaches of the legislation it administers, carries out compliance audits, and assists with overseas audits of New Zealand’s food processing systems. The Compliance and Investigation group ensures that standards are enforced, undertakes investigations, and manages corrective actions. The group complements regulatory controls undertaken by health protection units and local authorities in the domestic arena and develops/coordinates implementation of systems and processes for response to events and emergencies. The NZFSA Verification Agency audits the food safety programs of food processors and provides export certification. Its veterinarians inspect live animals (NZFSA, 2009d). |
|
13 |
Imports |
Food imported into New Zealand for sale must comply with New Zealand standards. It is the importers’ responsibility to ensure that all requirements are met. Prescribed foods, which present a risk to consumers, are monitored for specific hazards and must meet certain clearance procedures (NZFSA, 2009e,f). |
|
14 |
Disease surveillance |
NZFSA and FSANZ are jointly responsible for shared information on food emergencies and surveillance (NZFSA, 2009d). |
|
15 |
Recall authority |
NZFSA, or the Minister for Food Safety, has the ability to initiate a recall, and this ability is not limited to matters of food safety. The wording in the Food Act of 1981 specifies “for the purpose of protecting the public,” allowing considerable scope for recall, including matters relating to food safety, fraud, and noncompliance with food standards. In most circumstances, the need to exercise this legal power will result from the failure of a business to act responsibly and will be used primarily with respect to matters of food safety (NZFSA, 2009g). |
|
16 |
Other regulatory agencies with responsibilities for foods |
Food Standards Australia New Zealand, Officials Committee on Food Safety (creates the “whole of government food policy”), territorial authorities, and public health units (FSANZ/NZFSA, 2008). |
|
17 |
Why was there a migration to a single food agency? |
New Zealand wanted to address inconsistencies between the methods used in the Ministry of Agriculture and Forestry’s export food safety program and the Ministry of Health’s domestic food safety program (GAO, 2005). |
|
18 |
How is a single food agency working? |
The public, consumer organizations, and industry are more confident in the single agency (GAO, 2005). |
|
19 |
Program evaluation |
Every year, NZFSA releases an annual report that reviews the performance and operations for the previous financial year (1 July to 30 June). It includes financial statements for the year (NZFSA, 2009h). |
|
20 |
Research function |
The Food Safety Programme within NZFSA conducts research on food safety issues, including risk assessments, and investigates food safety incidents. |
|
21 |
Communication |
The Communications and Infrastructure group ensures that NZFSA communicates and consults effectively with all stakeholders and meets their needs for timely, accurate, and relevant information. |
|
22 |
Education |
NZFSA and FSANZ are jointly responsible for consumer and industry education on food standards issues (NZFSA, 2009d). |
TABLE C-6 European Union
|
1 |
Country population |
Approximately 495 million (European Commission, 2007a) |
|
2 |
Name of organization |
European Food Safety Authority (EFSA) Food and Veterinary Office (FVO) |
|
3 |
Year created |
EFSA: 2002 |
|
|
|
FVO: 1997 |
|
4 |
Legislation |
Council Directive (EC) 97/78 General Food Law of 2002 Hygiene I (Regulation [EC] 852/2004) Hygiene II (Regulation [EC] 853/2004) Hygiene III (Regulation [EC] 854/2004) Hygiene IV Directive (EC) 2002/99 Regulation (EC) 882/2004 (GAO, 2008b) |
|
5 |
Budget |
€73million (EFSA, 2008) |
|
6 |
Number of employees for food |
EFSA: not applicable |
|
|
|
FVO: 163 total; of these, 81 are inspectors (FVO, 2009) |
|
7 |
Definition of “food” |
“Food” (or “foodstuff”) means any substance or product, whether processed, partially processed, or unprocessed, intended to be or reasonably expected to be ingested by humans. “Food” includes drink, chewing gum, and any substance, including water, intentionally incorporated into the food during its manufacture, preparation, or treatment (EFIC, 2002). |
|
8 |
Items regulated |
Food and feed safety, nutrition, animal health and welfare, plant protection and health (EFSA, 2009a) |
|
9 |
Organization |
EFSA is an European Union (EU)–funded agency. It is governed by a Management Board whose members are appointed to act in the public interest and do not represent any government, organization, or sector (EFSA, 2009b). |
|
|
|
FVO staff are organized in six units with different responsibilities within the office (FVO, 2009). |
|
10 |
Regulation of on-farm activity |
Food and feed laws cover all stages of production, processing, and distribution (GAO, 2008b). |
|
11 |
Risk-based policies, models, use of Hazard Analysis and Critical Control Points (HACCP), etc. |
In the European food safety system, risk assessment is done independently from risk management. As the risk assessor, EFSA produces scientific opinions and advice to provide a sound foundation for European policies and legislation and to support the European Commission, European Parliament, and EU Member States in taking effective and timely risk management decisions (EFSA, 2009a). Good Hygiene and Manufacturing Practices and HACCP principles are applied (EFSA, 2009c). |
|
12 |
Inspections (domestic) |
FVO is responsible for ensuring that European Community legislation on food safety, animal and plant health, and animal welfare is properly implemented and enforced. Each year, FVO develops an inspection program, identifying priority areas and countries for inspection. To ensure that the program remains up to date and relevant, it is reviewed midyear (FVO, 2009). |
|
13 |
Imports |
In most cases, an on-the-spot inspection by Directorate F of FVO is required before import approval can be considered. This inspection is designed to evaluate whether the animal and public health situation, the official services, the legal provisions, the control systems, the production standards, etc., meet EU requirements (European Commission, 2007b). |
|
14 |
Disease surveillance |
The European Centre for Disease Prevention and Control is responsible for surveillance of disease, including foodborne infection, across the EU (GAO, 2008b). |
|
|
|
Each country’s epidemiologist is responsible for the national surveillance of Salmonella, E. coli, and other human gastrointestinal infections (GAO, 2008b). |
|
15 |
Recall authority |
The EU distinguishes between withdrawals and recalls and has authority for both. Withdrawals occur when the product is still under the control of the producer and are intended to prevent the distribution or display of a product that is dangerous. Recalls occur when the product is already available to consumers, and they are intended to achieve the return of an unsafe product (GAO, 2008b). |
|
16 |
Other regulatory agencies with responsibilities for foods |
Chief veterinary officers and national food safety authorities of all 27 EU Member States (EFSA, 2009d), the European Chemicals Agency, the European Centre for Disease Prevention and Control, the European Commission’s Joint Research Centre (EFSA, 2009e). |
|
17 |
Why was there a migration to a single food agency? |
The EU aimed to harmonize and simplify its food safety legislation and to create a single, transparent set of food safety rules that is applicable to all EU member countries (GAO, 2005). |
|
18 |
How is a single food agency working? |
An estimated 38 percent of people in the EU stated that, overall, food safety has improved, 29 percent that it has stayed about the same, 28 percent that it has worsened, and 5 percent said they did not know. In addition, an estimated 59 percent of people in the EU agreed that food produced in the EU is safer than food imported from elsewhere, 27 percent disagreed, and 13 percent did not know. However, some problems remain: despite regulatory improvements, there is still potential for fraud in the system; resources are sometimes mismatched with problems; and the large and growing size of the food supply makes it more difficult to control (GAO, 2008b). |
|
19 |
Program Evaluation |
EFSA releases annual reports on trends in foodborne illness (GAO, 2008b). |
|
|
|
FVO publishes an annual report on its activities, which reviews the progress of its inspection program and presents the global results (FVO, 2009). |
|
20 |
Research function |
EFSA follows a workflow that extends from the moment EFSA receives a request for scientific advice or initiates its own activity to the moment it publishes and communicates its scientific findings (EFSA, 2009f). |
|
21 |
Communication |
Aside from risk assessment, EFSA’s other main purpose is communication on risks associated with the food chain (EFSA, 2009a). |
|
22 |
Education |
Not applicable |
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 for food |
Approximately 1860 employees (DVFA, 2009b) |
|
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 activity |
DVFA is responsible for safe food production, including from field to table. Plant production falls under the Danish Plant Directorate (DVFA, 2009c). |
|
11 |
Risk-based policies, models, use of Hazard Analysis and Critical Control Points (HACCP), etc. |
Companies must impose self-inspection programs that must be organized in accordance with the principles embodied in the HACCP system. Self-inspection programs must also ensure that companies adhere to food-related legislation (DVFA, 2009d). |
|
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 agencies with responsibilities for foods |
Danish Food Industry Agency, Danish Plant Directorate, Danish Directorate for Fisheries |
|
17 |
Why was there a migration to a single food agency? |
Improve effectiveness (e.g., communications with consumers, consistency of inspections) and improve efficiency (e.g., move resources to high-risk areas, reduce overlaps in responsibility) (GAO, 2005). |
|
18 |
How is a single food agency working? |
Reduced overlap in inspections, risk-based inspections that 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. |
|
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). |
FIGURE C-1 Evaluation scheme for Danish firms.
SOURCE: DVFA, 2010.
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 for food |
The agency employs about 2,350 staff, including 1,600 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. |
|
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 activity |
Farmers are to employ Hazard Analysis and Critical Control Points (HACCP) (GAO, 2008b). |
|
11 |
Risk-based policies, models, use of Hazard Analysis and Critical Control Points (HACCP), etc. |
FSA is the main United Kingdom (UK) body in charge of assessing food risks and focuses on processes, such as HACCP (GAO, 2008b). The agency recognizes that there is a degree of scientific uncertainty in risk assessments (FSA, 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. |
|
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 agencies with responsibilities for foods |
Department for Environment, Food, and Rural Affairs, Veterinary Laboratories Agency, Animal Health, Her Majesty’s Revenue and Customs, local authorities, private-sector industry organizations (GAO, 2008b). |
|
17 |
Why was there a migration to a single food agency? |
FSA was founded in response to (1) the loss of public confidence in the government’s handling of food safety 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 agency working? |
The UK audit office found that FSA had improved public 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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