Source: https://www.everycrsreport.com/reports/RS22600.html
Timestamp: 2018-05-27 13:57:37
Document Index: 750875086

Matched Legal Cases: ['art 1', '§1031', '§201', '§1621', '§136', '§301', '§1621', '§301', '§201', '§301', '§201', '§1031', '§141', '§1451', '§1365', '§1401', '§201', '§601', '§451', '§1031', '§1902', '§603', '§1365', '§1622', '§1751', '§1762', '§8301', '§7701', '§8401', '§1621', '§499', '§1551', '§1751', '§1762', '§71', '§1622', '§2201', '§1622', '§3371', '§742', '§301', '§136', '§346', '§349', '§300', '§2601', '§41', '§201', '§101', '§1202', '§103', '§202', '§303', '§105', '§11017', '§204', '§206', '§11016', '§11016', '§12106', '§11017', '§403']

The Federal Food Safety System: A Primer - EveryCRSReport.com
February 7, 2007 – December 16, 2016 RS22600
Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply. Federal responsibility for food safety rests primarily with the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). FDA, an agency of the Department of Health and Human Services, is responsible for ensuring the safety of all domestic and imported food products (except for most meats and poultry). FDA also has oversight of all seafood, fish, and shellfish products. USDA’s Food Safety and Inspection Service (FSIS) regulates most meat and poultry and some egg products. The Government Accountability Office (GAO) has identified as many as 15 federal agencies, including FDA and FSIS, as collectively administering at least 30 laws related to food safety. State and local food safety authorities collaborate with federal agencies for inspection and other food safety functions, and they regulate retail food establishments.
Over the years, GAO has published a series of reports highlighting how food safety oversight in the United States is fragmented and recommending broad restructuring of the nation’s food safety system. Similar observations are noted in a series of food safety studies by the National Research Council (NRC) and the Institute of Medicine (IOM) that recommend that the core federal food safety responsibilities should reside within a single entity/agency, with a unified administrative structure, a clear mandate, a dedicated budget, and full responsibility for oversight of the entire U.S. food supply.
The 111th Congress passed comprehensive food safety legislation with the FDA Food Safety Modernization Act (FSMA, P.L. 111-353). FSMA is the largest expansion of FDA’s food safety authorities since the 1930s. Although numerous agencies share responsibility for regulating food safety, FSMA focused on foods regulated by FDA, amended FDA’s existing structure and authorities, and did not directly address meat and poultry products under USDA’s jurisdiction. Beyond these changes, some in Congress continue to push for additional policy reforms to address other perceived concerns about the safety of the U.S. food supply.
December 16, 2016 (RS22600)
Funding and Staffing for Food Safety Programs
Figure 1. Selected Important Dates for Food Safety in the United States, 1862-2011
Table 2. FDA Employees and Food-Related Inspection Data, FY2004-FY2015
Table 3. FSIS Employees, Inspectors, and Establishments, FY2002-2015
Appendix A. Major Federal Food Safety Agencies and Selected Laws
Appendix B. Selected Comparison of FSIS and FDA Responsibilities
Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply. Federal responsibility for food safety rests primarily with the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). FDA, an agency of the Department of Health and Human Services, is responsible for ensuring the safety of all domestic and imported food products (except for most meats and poultry). FDA also has oversight of all seafood, fish, and shellfish products. USDA's Food Safety and Inspection Service (FSIS) regulates most meat and poultry and some egg products. The Government Accountability Office (GAO) has identified as many as 15 federal agencies, including FDA and FSIS, as collectively administering at least 30 laws related to food safety. State and local food safety authorities collaborate with federal agencies for inspection and other food safety functions, and they regulate retail food establishments.
Over the years, GAO has published a series of reports highlighting how food safety oversight in the United States is fragmented and recommending broad restructuring of the nation's food safety system. Similar observations are noted in a series of food safety studies by the National Research Council (NRC) and the Institute of Medicine (IOM) that recommend that the core federal food safety responsibilities should reside within a single entity/agency, with a unified administrative structure, a clear mandate, a dedicated budget, and full responsibility for oversight of the entire U.S. food supply.
The 111th Congress passed comprehensive food safety legislation with the FDA Food Safety Modernization Act (FSMA, P.L. 111-353). FSMA is the largest expansion of FDA's food safety authorities since the 1930s. Although numerous agencies share responsibility for regulating food safety, FSMA focused on foods regulated by FDA, amended FDA's existing structure and authorities, and did not directly address meat and poultry products under USDA's jurisdiction. Beyond these changes, some in Congress continue to push for additional policy reforms to address other perceived concerns about the safety of the U.S. food supply.
Americans spend more than $1 trillion on food each year, nearly half of it in restaurants, schools, and other places outside the home.1 Federal laws give food manufacturers, distributors, and retailers the basic responsibility for assuring that foods are wholesome, safe, and handled under sanitary conditions. A number of federal agencies, cooperating with state, local, and international entities, play a major role in regulating food quality and safety under these laws.
The combined efforts of the food industry and the regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, the Centers for Disease Control and Prevention (CDC) reports that each year an estimated one in six Americans—a total of 48 million people—becomes sick from contaminated food foodborne illnesses caused by contamination from any one of a number of microbial pathogens.2 Of these, an estimated 128,000 cases require hospitalization and 3,000 cases result in death. In addition, experts have cited numerous other hazards to health, including the use of unapproved veterinary drugs, pesticides, and other dangerous substances in food commodities, of particular concern at a time when a growing share of the U.S. food supply is from overseas sources. These concerns, combined with the ongoing recurrence of major food safety-related incidents, have heightened public and media scrutiny of the U.S. food safety system and magnified congressional interest in the issue.
Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply. Federal responsibility for food safety rests primarily with the Food and Drug Administration (FDA), which is part of the U.S. Department of Health and Human Services (HHS), and the Food Safety and Inspection Service (FSIS), which is part of the U.S. Department of Agriculture (USDA). FDA is responsible for ensuring that all domestic and imported food products—except for most meats and poultry—are safe, nutritious, wholesome, and accurately labeled. FDA also has oversight of all seafood, fish, and shellfish products. USDA's Food Safety and Inspection Service (FSIS) regulates most meat and poultry and some egg and fish products.
The Government Accountability Office (GAO) has identified as many as 15 federal agencies, including FDA and FSIS, as collectively administering at least 30 laws related to food safety.3 Appendix A and Appendix B provide a brief comparative look at each of these agencies and their responsibilities. State and local food safety authorities collaborate with federal agencies for inspection and other food safety functions, and they regulate retail food establishments. This organizational complexity, and trends in U.S. food markets—for example, increasing imports as a share of U.S. food consumption and increasing consumption of fresh, often unprocessed, foods—pose ongoing challenges to ensuring food safety.
The text box below provides a comparison of FDA and USDA and other federal agencies' responsibilities for food safety and related food quality and other requirements.
Comparison of Selected Agency Responsibilities for Food Safety and Quality
Food (but not meat)
Wild game ("exotic" meat)
Grading of raw fruit and vegetables
Eggs, processing and grading
Certifying organic production
Grading of fish and seafood
Front-line enforcement and referral
Source: CRS, as adapted by N. D. Fortin, Introduction to Food Regulation in the United States, Part 1, May 2008.
The division of food safety responsibility between FDA and USDA is rooted in the early history of U.S. food regulation. Congress created separate statutory frameworks when it enacted, in 1906, both the Pure Food and Drugs Act and the Meat Inspection Act. The former addressed the widespread marketing of intentionally adulterated foods, and its implementation was assigned to USDA's Bureau of Chemistry. The latter law addressed unsafe and unsanitary conditions in meat packing plants, and implementation was assigned to the USDA's Bureau of Animal Industry. This bifurcated system has been perpetuated and split further into additional food safety activities under additional agencies (for example, the Environmental Protection Agency, the National Marine Fisheries Service, and others) by a succession of statutes and executive directives. The separation of the two major food safety agencies was further reinforced when, in 1940, the President moved responsibilities for safe foods and drugs, other than meat and poultry, from USDA to the progenitor of HHS, the Federal Security Agency. Meat inspection remained in USDA. There has been discussion over time regarding whether this dispersal of food safety responsibilities has been problematic, or whether a reorganization would divert time and attention from other fundamental problems in the system.4 Figure 1 shows this history by providing a timeline of selected important dates for food safety in the United States.
Source: Compiled by CRS from various government and industry sources (see footnote 4).
Over the years, GAO has published a series of reports highlighting how food safety oversight in the United States is fragmented and recommending broad restructuring of the nation's food safety system.5 These GAO reports document examples where a number of federal agencies are responsible for some aspect of food safety or product quality, resulting in split agency jurisdiction for some foods. Limited coordination and sharing of information results in often overlapping and/or duplication of efforts. Similar observations are noted in a series of food safety studies by the National Research Council (NRC) and Institute of Medicine (IOM).6 The NRC/IOM studies further recommend that the core federal food safety responsibilities should reside within a single entity/agency; have a unified administrative structure, clear mandate, and dedicated budget; and maintain full responsibility for oversight of the entire U.S. food supply.
FDA has primary responsibility for the safety of most (about 80%-90%) of all U.S. domestic and imported foods.7 The FDA is responsible for ensuring that all domestic and imported food products—except for most meats and poultry—are safe, nutritious, wholesome, and accurately labeled. Examples of FDA-regulated foods are produce, dairy products, and processed foods. FDA also has oversight of all seafood and shellfish products, and most fish products (except for catfish).8 FDA has jurisdiction over meats from animals or birds that are not under the regulatory jurisdiction of FSIS. FDA shares some responsibility for the safety of eggs with FSIS. FDA has jurisdiction over establishments that sell or serve eggs or use them as an ingredient in their products.
As described in a memorandum of understanding between FDA and FSIS:9
FDA is responsible for implementing and enforcing the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), and parts of the Egg Products Inspection Act [21 U.S.C. §§1031 et seq.]. In carrying out its responsibilities under these acts, FDA conducts inspections of establishments that manufacture, process, pack, or hold foods, with the exception of certain establishments that are regulated exclusively by FSIS. FDA also inspects vehicles and other conveyances, such as boats, trains, and airplanes, in which foods are transported or held in interstate commerce.
In addition, the 111th Congress passed comprehensive food safety legislation with the FDA Food Safety Modernization Act (FSMA, P.L. 111-353), amending the Federal Food, Drug, and Cosmetic Act (FFDCA). FSMA was the largest expansion of FDA's food safety authorities since the 1930s.10 FSMA did not directly address meat and poultry products under USDA's jurisdiction. New rules governing FDA's food inspection regime of both domestic and imported foods under the agency's jurisdiction are now being implemented. For more information, see CRS Report R43724, Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353).
In the Washington, DC, area, two FDA offices are the focal point for food safety-related activities. The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for (1) conducting and supporting food safety research; (2) developing and overseeing enforcement of food safety and quality regulations; (3) coordinating and evaluating FDA's food surveillance and compliance programs; (4) coordinating and evaluating cooperating states' food safety activities; and (5) developing and disseminating food safety and regulatory information to consumers and industry. FDA's Center for Veterinary Medicine (CVM) is responsible for ensuring that all animal drugs, feeds (including pet foods), and veterinary devices are safe for animals, are properly labeled, and produce no human health hazards when used in food-producing animals.
The FDA also cooperates with over 400 state agencies across the nation to carry out a wide range of food safety regulatory activities. However, the state agencies are primarily responsible for actual inspection. FDA works with the states to set the safety standards for food establishments and commodities and evaluates the states' performance in upholding such standards as well as any federal standards that may apply. FDA also contracts with states to use their food safety agency personnel to carry out certain field inspections in support of FDA's own statutory responsibilities.
FSIS regulates the safety, wholesomeness, and proper labeling of most domestic and imported meat and poultry and their products sold for human consumption, comprising roughly 10%-20% of the U.S. food supply.11 As described in a memorandum of understanding between FDA and FSIS, FSIS's jurisdiction is as follows:12
The Federal Meat Inspection Act (FMIA) of 1906, as amended, requires USDA to inspect all cattle, sheep, swine, goats, horses, mules, and other equines slaughtered and processed for human consumption. The Poultry Products Inspection Act (PPIA) of 1957, as amended, gives USDA the authority to inspect poultry meat. The PPIA mandates USDA inspection of any domesticated birds (chickens, turkeys, ducks, geese, guineas, ratites [ostrich, emu, and rhea], and squab (pigeons up to one month old]) intended for use as human food. The Egg Products Inspection Act, as amended, provides USDA authority to inspect liquid, frozen, and dried egg products. Each of these laws contains provisions governing USDA's authority to label food products under its jurisdiction.13
Under the authority of the Agricultural Marketing Act of 1946 as amended, USDA's FSIS may provide voluntary inspection for buffalo, antelope, reindeer, elk, migratory waterfowl, game birds, and rabbits. This type of inspection is performed by FSIS on a fee-for-service basis. However, these meat and poultry species are still within the purview of FDA under FFDCA, whether or not inspected under the voluntary FSIS program. FDA has jurisdiction over meat products from such species in interstate commerce, even if they bear the USDA inspection mark. FDA also has jurisdiction over shell eggs. In addition, the 2008 farm bill requires that FSIS inspect and grade farmed catfish products.14
Meat and poultry animals and products undergo continuous (i.e., 100%) inspection, which may in turn act as a deterrent to fraud in some cases. FSIS inspects all meat and poultry animals to look for signs of disease, contamination, and other abnormal conditions, both before and after slaughter ("antemortem" and "postmortem," respectively), on a continuous basis—meaning that no animal may be slaughtered and dressed unless an inspector has examined it. One or more federal inspectors are on the line during all hours the plant is operating. Processing plants visited once every day by an FSIS inspector are considered to be under continuous inspection in keeping with the laws. Inspectors monitor operations, check sanitary conditions, examine ingredient levels and packaging, review records, verify food safety plans,15 and conduct statistical sampling and testing of products for pathogens and residues during their inspections.16
FSIS is responsible for certifying that foreign meat and poultry plants are operating under an inspection system equivalent to the U.S. system before they can export their product to the United States.17 Meat and poultry imports are 100% visually inspected (process-based, documentation, labeling), although physical inspections of imports may be more random. FSIS conducts evaluations of foreign meat safety programs and visits establishments to determine whether they are providing a level of safety equivalent to that of U.S. safeguards. No foreign plant can ship meat or poultry to the United States unless its country has received such an FSIS determination.
Twenty-seven states operate their own meat and/or poultry inspection programs. FSIS is statutorily responsible for ensuring that the states' programs are at least equal to the federal program.18 Plants processing meat and poultry under state inspection can market their products only within the state. If a state chooses to discontinue its own inspection program, or if FSIS determines that it does not meet the agency's equivalency standards, FSIS must assume the responsibility for inspection if the formerly state-inspected plants are to remain in operation. FSIS also has cooperative agreements with more than two dozen states under which state inspection personnel are authorized to carry out federal inspection in meat and/or poultry plants. Products from these plants may travel in interstate commerce.19
CDC is responsible for (1) monitoring, identifying, and investigating foodborne disease problems to determine the contributing factors; (2) working with FDA, FSIS, National Marine Fisheries Service (NMFS), state and local public health departments, universities, and industry to develop control methods; and (3) evaluating the effect of control methods. CDC's "FoodNet" is a collaborative project with the FDA and USDA to improve data collection on foodborne illness outbreaks. FoodNet includes active surveillance of clinical microbiology laboratories to obtain a more accurate accounting of positive test results for foodborne illness; a physician survey to determine testing and laboratory practices; population surveys to identify illnesses not reported to doctors; and research studies to obtain new and more precise information about which food items or other exposures may cause diseases. FoodNet data allow CDC to have a clearer picture of the incidence and causes of foodborne illness and to establish baseline data against which to measure the success of changes in food safety programs. The Public Health Service Act (42 U.S.C. §§201, et seq.) provides legislative authority for CDC's food safety-related activities.
Although the FDA is the primary agency responsible for ensuring the safety, wholesomeness, and proper labeling of domestic and imported seafood products, the National Marine Fisheries Service (NMFS), which is part of the U.S. Department of Commerce, conducts, on a fee-for-service basis, a voluntary seafood inspection and grading program that focuses on marketing and quality attributes of U.S. fish and shellfish.20 The primary legislative authority for NMFS's inspection program is the Agricultural Marketing Act of 1946, as amended (7 U.S.C. §§1621 et seq.). NMFS has approximately 160 seafood safety and quality inspectors, and inspection services are funded with user fees. NMFS works with FDA, which helps provide training and other technical assistance to NMFS. Under the program, NMFS inspects a reported 20% of the seafood consumed in the United States.21
EPA has the statutory responsibility for ensuring that the chemicals used on food crops do not endanger public health. EPA's Office of Pesticide Programs is the part of the agency that (1) registers new pesticides and determines residue levels for regulatory purposes; (2) performs special reviews of pesticides of concern; (3) reviews and evaluates all the health data on pesticides; (4) reviews data on pesticides' effects on the environment and on other species; (5) analyzes the costs and benefits of pesticide use; and (6) interacts with EPA regional offices, state regulatory counterparts, other federal agencies involved in food safety, the public, and others to keep them informed of EPA regulatory actions. The Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. §§136 et seq.), and FFDCA, as amended (21 U.S.C. §§301 et seq.), are the primary authorities for EPA's activities in this area.
USDA's Agricultural Marketing Service (AMS) is responsible for establishing quality and marketing grades and standards for many foods (including dairy products, fruits and vegetables, livestock, meat, poultry, seafood, and shell eggs) and for certifying quality programs and conducting quality grading services. Accordingly, AMS is primarily responsible for ensuring product quality and not food safety. USDA programs establishing quality grade standards to encourage uniformity and consistency in commercial practices are provided for under the Agricultural Marketing Act of 1946 (7 U.S.C. §1621).
AMS also administers the Pesticide Data Program (PDP), a cooperative federal-state residue testing program through which it collects data on residual pesticides, herbicides, insecticides, fungicides, and growth regulators in over 50 different commodities.22 The pesticides and commodities to be tested each year are chosen based on EPA data needs and on information about the types and amounts foods consumed, in particular, by infants and children. Authorization for the program is under the Federal Food, Drug, and Cosmetic Act, as amended by the 1996 Food Quality Protection Act (21 U.S.C. §§301 et seq.).
Among the other agencies that play a role in food safety, USDA's Agricultural Research Service (ARS) performs food safety research in support of FSIS's inspection program. It has scientists working in animal disease bio-containment laboratories in Plum Island, NY, and Ames, IA. USDA's Animal and Plant Health Inspection Service (APHIS) indirectly protects the nation's food supply through programs to protect plant and animal resources from domestic and foreign pests and diseases, such as brucellosis and bovine spongiform encephalopathy (BSE, or "mad cow" disease). The Department of Homeland Security (DHS) is to coordinate many food security activities, including at U.S. borders.
Historically, federal funding and staffing levels between FDA and FSIS have been disproportionate to their respective responsibilities for addressing food safety activities. Although FSIS is responsible for roughly 10%-20% of the U.S. food supply, it has received about 60% of the two agencies' combined food safety budget. Although FDA has been responsible for 80%-90% of the U.S. food supply, a few years ago it received about 40% of the combined budget for federal food safety activities (Table 1). Staffing levels also have varied considerably among the two agencies: FSIS staff numbered around 9,400 FTEs in FY2010, while FDA staff working on food-related activities numbers about 3,400 FTEs.
In recent years, however, the balance of overall funding for food safety between FDA and USDA has started to shift. Congressional appropriators have increased funding for FDA food activities, which more than doubled from $435.5 million in FY2005 to $987.3 million in FY2016 (Table 1). Funding for FSIS remained mostly unchanged to slightly lower overall. The Food Safety Modernization Act (FSMA) also provided for additional limited funding through certain types of industry-paid user fees.
(FTEs as indicated and budget and appropriation figures in millions of dollars)
Federal Full-Time Equivalents (FTEs)a
Appropriationb
Total Program Level, Food Safety (incl. other funding and fees)
FY2013 Actualc
Sources: CRS, from annual agency budget justifications for FDA (http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetReports/default.htm) and FSIS (http://www.obpa.usda.gov/explan_notes.html). The "Appropriation" amount excludes all user fees. Estimated "Total Program Level, Food Safety" for FDA was provided by FDA budget staff (October-December, 2015).
c. Based on each agency's FY2013 sequestration operating plans and FY2014 operating plans. For more information see CRS Report R43110, Agriculture and Related Agencies: FY2014 and FY2013 (Post-Sequestration) Appropriations.
FSMA—comprehensive food safety legislation enacted in the 111th Congress—authorized additional appropriations and staff for FDA's future food safety activities.23 FSMA was the largest expansion of FDA's food safety authorities since the 1930s. Among its many provisions, FSMA authorized increased frequency of inspections at food facilities, tightened record-keeping requirements, extended oversight to certain farms, and mandated product recalls. It required food processing, manufacturing, shipping, and other facilities to conduct food safety plans of the most likely safety hazards and design and implement risk-based controls. It also mandated improvements to the nation's foodborne illness surveillance systems and increased scrutiny of food imports, among other provisions. FSMA did not directly address meat and poultry products under USDA's jurisdiction.
Although Congress authorized appropriations when it enacted FSMA, it did not provide the funding needed for FDA to perform these activities, and FDA funding for FSMA implementation and other food safety activities has been lower than what agency officials have said is needed to fully implement the law. Previously, FDA reported that an additional $400 million to $450 million per year above the FY2012 base is needed to fully implement FSMA.24 The enacted FY2016 Agriculture appropriation provided for a $104.5 million increase in budget authority for FDA's food safety activities, including FSMA implementation.25 For additional information, see CRS Report R44309, FY2016 Appropriations: Selected Federal Food Safety Agencies. Funding levels specific to food safety responsibilities at other federal and state agencies are not readily available.
Although FDA staff working on food-related activities has increased, actual staffing levels remain below that mandated in FSMA. Among its many provisions, FSMA mandated an increase in the number of food safety inspectors within FDA and expanded the agency's authority to increase inspection of domestic and foreign food facilities. FSMA states a "goal of not fewer than ... 5,000 staff members in fiscal year 2014."26 Instead, FDA reports actual staffing levels at 3,700 FTEs in FY2015 (Table 1). FSIS staff number about 8,900 FTEs, a reduction from that in previous years.
The discrepancy between the number of FDA and FSIS inspectors is, in part, attributable to differences in how each agency fulfills its respective inspection mandate. Whereas FDA inspection involves primarily review and sampling, FSIS personnel inspect all meat and poultry animals at slaughter on a continuous basis, requiring that at least one federal inspector is on the line during all hours the plant is operating. Processing inspection does not require an FSIS inspector to remain constantly on the production line or to inspect every item. Instead, inspectors are on site daily to monitor the plant's adherence to the standards for sanitary conditions, ingredient levels, and packaging and to conduct statistical sampling and testing of products. Because all plants are visited daily, processing inspection is also considered to be continuous.
As of February 2016, a reported more than 300,000 domestic and foreign food facilities were registered with the agency and are potentially subject to inspection FDA reports.27 Of these, about 88,000 facilities are domestic (U.S.) registrations, and 212,000 facilities are foreign registrations. Registration of domestic and foreign food facilities is required under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act," P.L. 107-188).28 Most recent available information for FY2012 indicate that FDA and the states under contract with FDA inspected 24,462 domestic food facilities and 1,342 foreign food facilities29 (Table 2).
Data compiled by FDA indicate that, on average, between 10% and 30% of all domestic facilities are inspected by FDA annually, most of which are considered "high-risk" facilities. Estimates of unannounced compliance inspections of domestic establishments by FDA officials range from once every five years to once every 10 years, on average, although the agency claims to visit about 6,000 so-called "high-risk" facilities on an annual basis. In general, FDA relies on notifications from within the industry or from other federal or state inspection personnel to alert it to situations calling for increased inspection.
FDA inspection rates of imported foods are much lower, with a reported roughly 2% of all food import lines being physically examined by FDA. Previously, GAO reported that FDA inspections covered only about 1% of the food imported under its jurisdiction.30 Although FDA is not able to physically inspect a large percentage of food entering the United States, FDA electronically screens all import entries using an automated system known as Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) information technology system.31 In addition, FDA can issue import bulletins to signal field inspectors to pay special attention to a particular product, or a range of products from a particular producer, shipper, or importer.32
- Field FTEsa
- HQ FTEs
All Registered Food Facilitiesb
Inspectionsc
% Inspectionsc
% Inspectionsd
Import Lines, millionsc (FDA Inspection)
Inspections, millionsc
% Inspectionse
Source: Compiled by CRS from various FDA sources or data provided by FDA. NA=not available.
a. FDA Budget Explanatory Notes for Committee on Appropriations, various years (http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetReports/default.htm).
b. Data from FY2004-FY2009 are from FDA Office of Legislation (September 22, 2010, and May 7, 2012, communication) and information in FDA, "Annual Report HHS OIG," FDA Inspections of Domestic Food Facilities (OEI-02-08-00080), Table 1, April 2010. Data for FY2010-FY2012 are from FDA, "Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices" (2011, 2012 and 2013), http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm271961.htm. Data for FY2013 and FY2015 are from FDA's website "Registration Statistics" (data as of February 2014 for FY2013, and data as of February 2016 for FY2015). Data reported for FY2010-FY2012 does not reflect corrections following the agency's 2012 Biennial Registration Renewal when the agency reported that previous statistics had been over reported.
c. Data for FY2010-FY2012 are from FDA, "Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices" (2011, 2012, and 2013), http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm271961.htm. These data are required pursuant to P.L. 111-353, §201(b), requiring that HHS report to Congress each year, information regarding domestic and foreign food facility inspections, food imports, and other data.
d. Calculated by CRS from available data.
e. As reported by FDA in its "Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices."
The number of regulated meat and poultry facilities under USDA's jurisdiction is much lower and has remained mostly stable over time (Table 3). Much of the agency's work is conducted in cooperation with federal, state, and municipal agencies, as well as private industry. FSIS currently conducts inspections in 6,389 establishments. This compares to 2002, when USDA reported that it conducted inspections in about 6,000 establishments. This total includes Talmadge-Aiken plants, wherein state inspectors perform inspections under federal inspectors' supervision. There were 350 Talmadge-Aiken plants in 2015, up from 235 in 2002.
Of the total number of meat, poultry, and egg establishments under FSIS jurisdiction, about 1,100 plants either slaughter or slaughter and process livestock or poultry.33 More than 4,000 facilities only process meat and poultry, and about 80 process egg products. FSIS also reinspects imported meat, poultry, and egg products at about 140 import reinspection facilities.34
Talmadge-Aiken
Source: USDA, Annual USDA Budget Explanatory Notes for Committee on Appropriations. Employees are permanent, full-time on September 30. FSIS also has part-time and temporary positions that have averaged nearly 500 employees in recent years.
Notes: A Talmadge-Aiken plant is a federal plant with state inspection program personnel operating under federal supervisors.
In the Senate, food safety issues are under the jurisdiction of the Committees on Agriculture, Nutrition, and Forestry; Homeland Security and Governmental Affairs; and Health, Education, Labor, and Pensions. In the House, various food safety activities fall under the jurisdiction of the Committees on Agriculture; Energy and Commerce; Oversight and Government Reform; and Science, Space, and Technology. Agriculture subcommittees of the House and Senate Appropriations Committees set funding and provide oversight of the major agencies that carry out food safety policies.
In general, the House and Senate Agriculture Committees maintain jurisdiction over USDA's meat and poultry inspection programs and also other food-safety-related programs administered by other USDA agencies (see text box below). One exception involves certain nutrition programs, such as the National School Lunch Program and certain other institutional food service programs administered by USDA's Food and Nutrition Service (FNS), where the committees of jurisdiction are the Senate Committee on Agriculture, Nutrition, and Forestry and the House Committee on Education and the Workforce. FDA-regulated foods and other products generally fall under the jurisdiction of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions. Under FSMA, the separate authorities between FDA and USDA for various foods were explicitly maintained in the enacted law.35
However, identifying committees of jurisdiction for specific laws, programs, and federal agencies is not straightforward36 and further complicated by split jurisdiction between FDA and USDA in the case of some foods due to documented fragmentation, overlap, and duplication among the agencies responsible for administering the laws and programs governing certain foods.37
Committee Jurisdiction for Key Food Safety Issues
House Authorizing Committees
The House Committee on Energy and Commerce has jurisdiction over all FDA-regulated products, including foods. The House Committee on Agriculture has jurisdiction over USDA's meat, poultry, egg products, and catfish inspection programs.
Senate Authorizing Committees
The Senate Committee on Health, Education, Labor, and Pensions has jurisdiction over all FDA-regulated products, including foods. The Senate Committee on Agriculture, Nutrition and Forestry has jurisdiction over USDA's meat, poultry, egg products, and catfish inspection programs.
In contrast with the split in jurisdictions among the authorizing committees, within each of the House and Senate Appropriations Committees, one subcommittee (Agriculture) is responsible for funding and oversight of both FDA and USDA.
Food and Drug Administration (FDA)a
Ensures that all domestic and imported foods, except processed egg products and major types of meat and poultry, are safe, wholesome, and properly labeled, by setting safety and sanitation standards, periodically inspecting manufacturing facilities, reviewing records of and spot-checking imports. Also oversees the safety of animal drugs and feeds, including those used in food-producing animals.
Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§301-399a) as amended; Public Health Service Act (42 U.S.C. §201), Egg Products Inspection Act (21 U.S.C. §1031); Federal Import Milk Act (21 U.S.C. §§141-149); Fair Packaging and Labeling Act (15 U.S.C. §§1451-1461); Federal Anti-Tampering Act (18 U.S.C. §1365); Pesticide Monitoring Improvements Act of 1988 (21 U.S.C. §1401)
Monitors, identifies, and investigates foodborne diseases; develops and evaluates improved epidemiological and laboratory methods.
Public Health Service Act (42 U.S.C. §201)
Food Safety Inspection Service (FSIS)a
Regulates the safety, wholesomeness and proper labeling of most commercial types of both domestic and imported meat and poultry, catfish products, and processed egg products, by approving establishment designs, safety plans; inspecting every animal and carcass in slaughtering plants and daily inspecting all meat and poultry processing plants; determining the equivalency of importing countries' meat and poultry safety systems.
Federal Meat Inspection Act (21 U.S.C. §§601-695); Poultry Products Inspection Act (21 U.S.C. §§451-472); Egg Products Inspection Act (21 U.S.C. §§1031-1056); Humane Methods of Slaughter Act of 1978 (7 U.S.C. §§1902, 1904, 21 U.S.C. §§603, 610, 620); Federal Anti-Tampering Act (18 U.S.C. §1365); Agricultural Marketing Act of 1946 (7 U.S.C. §1622); Richard B. Russell National School Lunch Act (42 U.S.C. §§1751-1770), as amended by Child Nutrition and WIC Reauthorization Acts (42 U.S.C. §1762a(h))
Oversees animal and plant health, including the prevention of foreign diseases and pests, and eradication and containment of such problems domestically (including those that threaten public health).
Animal Health Protection Act (7 U.S.C. §§8301-8322); Plant Health Protection Act (7 U.S.C. §§7701-7721); Agricultural Bioterrorism Act of 2002 (7 U.S.C. §8401)
Establishes quality and marketing grades and standards for dairy products, fruits and vegetables, livestock, meat, poultry, seafoods, and shell eggs; certifies quality programs; conducts quality grading services, generally user fee-funded.
Agricultural Marketing Act of 1946 (7 U.S.C. §§1621-1638d), Perishable Agricultural Commodities Act, 1930 (7 U.S.C. §§499a- 499s); Federal Seed Act (7 U.S.C. §§1551-1611)
Encourages and coordinates efforts to ensure the safety of foods in school lunch and other domestic programs.
Program subsidies authorized by Richard B. Russell National School Lunch Act (42 U.S.C. §§1751-1770), as amended by Child Nutrition and WIC Reauthorization Acts (42 U.S.C. §1762a(h))
Sets quality standards for and tests grains and related commodities, primarily for marketing purposes.
U.S. Grain Standards Act (7 U.S.C. §§71-87k), Agricultural Marketing Act of 1946 (7 U.S.C. §§1622, 1624)
Conducts in-house USDA research on agricultural and food topics, of which food safety is one of many.
Numerous laws dating to the Department of Agriculture Organic Act of 1862 (7 U.S.C. §2201 note), up through and including recent omnibus farm laws
National Institute of Food and Agriculture (NIFA) (formerly Cooperative State Research, Education, and Extension Service)
Coordinates and administers federal funding of land grant and other institutions to conduct agricultural and food research, education and extension activities; food safety is one of many subject areas.
Numerous laws dating to the Department of Agriculture Organic Act of 1862, up through and including recent omnibus farm laws
Offers a variety of voluntary seafood safety and quality inspection services on a fee-for-service basis.
Agricultural Marketing Act of 1946 (7 U.S.C. §§1622, 1624); Lacey Act (16 U.S.C. §3371); Fish and Wildlife Act of 1956 (16 U.S.C. §742)
Regulates the use of certain chemicals and substances that present an unreasonable risk of injury to health or the environment. Regulates pesticide products; sets maximum allowable tolerances for residue levels on food commodities and animal feeds. Sets national drinking water standards and consults with FDA. Sets scientific water quality criteria for rivers, lakes, and streams that are protective of human health and wildlife.
Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§301-399a), as amended; Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. §§136-136y), as amended by the Food Quality Protection Act of 1996 (21 U.S.C. §346a); Clean Water Act (33 U.S.C. 1251-1387); Safe Drinking Water Act of 1974 (21 U.S.C. §349 and 42 U.S.C. §§300f-300j-26); Toxic Substance Control Act (15 U.S.C. §§2601-2697)
Enforces federal prohibitions against unfair or deceptive acts or practices in trade, including consumer deception regarding foods.
Federal Trade Commission Act (15 U.S.C. §§41-58)
Alcohol and Tobacco Tax and Trade Bureau (ATF)
Administers and enforces laws on the production, safety, distribution and use of alcoholic beverages.
Federal Alcohol Administration Act (27 U.S.C. §§201-219a); Internal Revenue Code (26 U.S.C. Ch. 51)
Coordinates many food security activities, including inspecting imports of food, plants, and animals at the border. Conducts agricultural border inspection activities formerly done by APHIS.
Homeland Security Act of 2002 (6 U.S.C. §101); Tariff Act of 1930 (19 U.S.C. §§1202-1654)
Source: Prepared by CRS based in part on various reports by the Government Accountability Office, including GAO, Federal Food Safety Oversight, GAO-11-289, March 2011. Does not include two USDA agencies included by GAO (Research, Education, and Economics [REE] agencies: National Economic Research Service [ERS] and National Agricultural Statistics Service [NASS]).
a. These agencies have the leading food safety regulatory authorities.
(Foods Program only)
Federal Meat Inspection Act (21 U.S.C. 601), Poultry Products Inspection Act (21 U.S.C. 451), Egg Products Inspection Act (21 U.S.C. 1031)
As may be amended by the FDA Food Safety Modernization Act (FSMA): Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. 301; Public Health Service Act (42 U.S.C. 201); Egg Products Inspection Act (21 U.S.C. 1031); Public Health Security and Bioterrorism Preparedness and Response Act (21 U.S.C. 341)
Major types of domestic and imported meat and poultry and their products; catfish products; processed (dried, frozen, liquid) egg products (20% of at-home U.S. food spending)
All other domestic and imported foods, also animal drugs and feeds including those used in food-producing animals (80% of at-home U.S. food spending)
Funding (FY2016)
Appropriated: $1.015 billion for FY2016. Expected user fees are estimated to include another $150 million.
Appropriated: $887.3 million for FDA's Foods Program for FY2016. Expected user fees are estimated to include another roughly $18 million.
About 9,600 FTEs
About 3,700 FTEs
6,400 slaughter and/or processing establishments
88,400 subject to inspection
Ante- and post-mortem inspection of every animal, carcass and part; traditionally organoleptic (but see "Food safety plans" below); only USDA-inspected and passed products may enter commerce
Prohibits adulteration or misbranding; relies on facilities that manufacture, process, pack, or hold food for humans or animals to meet prescribed standards (e.g., regarding additives, contaminants, etc.); all facilities must register, report changes in timely manner.
Slaughter plants: all times of operation; processing plants: at least once daily
FSMA requires increased inspection rates for any registered facility, particularly those identified as "high-risk." Domestic high-risk facilities are to be inspected not less than once in the five-year period after enactment, and not less than once every three years thereafter. Domestic non-high-risk facilities are to be inspected not less than once in the seven-year period after enactment, and not less than once every five years thereafter.
Requires all establishments to prepare and have preapproved "HACCP" (hazard analysis and critical control point) plans determining risks, controlling them (with documentation)
Prior to FSMA, facilities followed general regulations on good manufacturing practices (GMPs) to address safe handling and plant sanitation—except a form of HACCP required for seafood, low-acid canned foods, juices. FSMA §103 created new requirements for facilities to evaluate hazards, implement preventive controls, monitor controls, and maintain records. FDA rulemaking is clarifying requirements under new written HACCP-type and/or broader written food safety plans as part of its so-called Hazard Analysis and Risk-Based Preventive Controls.
Specified products only from countries where FSIS has determined "equivalence" of foreign safety system, with annual verification; imports exempt from prior notice but subject to reinspection at 150 import establishments (est. 10% reinspected)
Prior to FSMA, food safety system equivalence was not determined beforehand; reliance on inspections was at 300 ports (est. 1% of notified entries inspected). FSMA provides for tighter controls and use certification or verification systems for imported foods (to be determined by FDA rulemaking). At least 600 foreign facilities must be inspected the year following enactment, and in each of the subsequent five years the number of foreign facilities inspected is to double.
Private labs accredited for chemical testing of meat and poultry (for imports, see above)
Prior to FSMA, there was no accreditation for food testing labs or use of third parties for import oversight. FSMA §202 requires FDA to establish a program for testing of food by accredited labs and to recognize accreditation bodies to accredit labs. FSMA §303 creates a system of accreditation of third-party auditors and audit agents to certify importing entities. FDA's rulemaking is ongoing.
On-farm oversight
FSIS inspection authority begins at slaughter plant
Prior to FSMA, those engaged solely in harvesting, storing, or distributing raw agricultural commodities were generally exempt from registration, GMP regulations, and record-keeping. FSMA §105 created new farm-level requirements, particularly for fresh produce determined to be higher-risk (FDA rulemaking is ongoing). Some small farm businesses are exempt from regulation.
Review and preapproval required for all labels
All foods must adhere to food labeling requirements such as statement of identity, declaration of net contents, nutrition labeling; labels cannot be false or misleading.
P.L. 110-246 §11017 amended meat and poultry laws to require an establishment to notify USDA if it has reason to believe that an adulterated or misbranded product has entered commerce
P.L. 110-85 (amended by FSMA) requires FDA to maintain a reportable food registry for industry to report food safety cases in order to help FDA better track patterns and target inspections. FSMA §204 provided for an enhanced tracing system for foods that FDA determines to pose a higher food safety risk. As part of the ongoing rulemaking process, FDA has launched product tracing pilots.
No authority to mandate recalls; relies on voluntary efforts
Prior to FSMA, FDA had no authority to mandate recalls (except infant formula). FSMA §206 provides for mandatory recall authority where there is a reasonable probability that a food is adulterated or misbranded, and its use or exposure to it will cause serious adverse health consequences or death. Civil/criminal penalties apply for failure to comply with a recall order.
USDA, Economic Research Service (ERS) food sales data.
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, "Estimates of Foodborne Illness in the United States," February 2011.
GAO, Federal Food Safety Oversight, GAO-11-289, March 2011.
For a discussion of the history of federal food safety organization and of efforts to change it, see R. A. Merrill and J. K. Francer, "Organizing Federal Food Safety Regulation," Seton Hall Law Review, vol. 31, no. 61 (2000). See also National Research Council, Ensuring Safe Food from Production to Consumption, National Academy Press, 1998.
GAO, High-Risk Series: An Update, GAO-15-290, February 11, 2015. See also GAO, Federal Food Safety Oversight: Additional Actions Needed to Improve Planning and Collaboration, GAO-15-180, December 18, 2014; GAO, Opportunities to Reduce Potential Duplication in Government Programs, Save Tax Dollars, and Enhance Revenue, GAO-11-318SP, March 2011; GAO, Federal Food Safety and Security System: Fundamental Restructuring Is Needed to Address Fragmentation and Overlap, GAO-04-588T, March 2004; GAO, Food Safety and Security: Fundamental Changes Needed to Ensure Safe Food, GAO-02-47T, October 2001; and GAO's reports on Federal Food Safety Oversight (2011, 2008, and 2005).
NRC/IOM, Enhancing Food Safety: The Role of the Food and Drug Administration, 2010 (National Academy of Sciences); NRC/IOM, Ensuring Safe Food from Production to Consumption, 1998; and NRC/IOM, Scientific Criteria for Safe Food, 2003.
FDA's share of the U.S. food supply is approximated by backing out the reported 10%-20% of foods under USDA's jurisdiction. The 20% estimate is based on information reported by GAO in "Revamping Oversight of Food Safety," prepared for the 2009 Congressional and Presidential Transition, and appears to represent proportions of total spending for food consumed at home. The 10% estimate is based on data from USDA-ERS on U.S. per capita food consumption. See also Department of Homeland Security (DHS), "National Infrastructure Protection Plan: Agriculture and Food Sector Snapshot," http://www.dhs.gov/food-and-agriculture-sector.
FSIS was authorized to inspect farmed catfish products under a 2008 farm bill provision (P.L. 110-246, §11016).
MOU 225-99-2001 (between USDA's FSIS and FDA), http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/domesticmous/ucm117094.htm.
For more information, see CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-353). FSMA does not directly address meat and poultry products under USDA's jurisdiction.
"A Guide to Federal Food Labeling Requirements for Meat, Poultry, and Egg Products," prepared for USDA Food Safety and Inspection Service by Hogan & Hartson, LLP, August, 2007.
FSIS was authorized to inspect farmed catfish products under a 2008 farm bill provision (P.L. 110-246, §11016). The 2014 farm bill (P.L. 113-79, §12106) reconfirmed this provision and also mandated that USDA and FDA enter into an agreement to improve interagency cooperation and prevent duplication. See MOU 225-14-0009 (http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/domesticmous/ucm396294.htm). FSIS promulgated final regulations in December 2015 (80 Federal Register 231: 75590-75630, December 2, 2015) and started implementing the rule in March 2016.
In a Hazard Analysis and Critical Control Point (HACCP) plan a facility must identify each point in its processes where contamination could occur ("critical control point") and have a plan to control it, as well as document and maintain records.
For information, see FSIS, "FSIS Import Procedures for Meat, Poultry & Egg Products," http://www.fsis.usda.gov/.
USDA, "States Operating their Own MPI Programs," https://www.fsis.usda.gov/wps/portal/fsis/topics/inspection/state-inspection-programs/state-inspection-and-cooperative-agreements/states-operating-their-own-mpi-programs.
The 2008 farm bill (P.L. 110-246, §11017) contained new provisions intended to enable more interstate shipment of state-inspected products.
National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program, http://www.seafood.nmfs.noaa.gov/. See also CRS Report RS22797, Seafood Safety: Background and Issues.
NOAA, "Inspecting Seafood—A Highly Trained Nose Knows," Fishwatch.gov, October 2012.
For more information, see AMS's website, https://www.ams.usda.gov/datasets/pdp.
P.L. 114-113 explanatory text (Division A, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016, p. 29). For information on FSMA implementation, see CRS Report R43724, Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353).
FDA, "Registration Statistics," http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm236512.htm. Previously FDA had reported a much greater number of registered facilities, totaling 450,000 facilities (see Table 2). Following the agency's 2012 Biennial Registration Renewal, FDA reports "there was a significant decrease in the number of registered facilities as a result of facilities failing to renew their registration." Prior to 2012 there was no reregistration requirement. Although some facilities that should have reregistered may have failed to reregister, in some cases facility registrations had remained registered over the years even though the facility had ceased operations.
The Bioterrorism Act directed FDA to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. Under the act, domestic and foreign facilities must be registered with FDA and must give advance notice to FDA of imported food shipments. Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States were required to register with FDA by December 12, 2003. Domestic facilities must register whether or not food from the facility enters interstate commerce. Foreign facilities that manufacture/process, pack, or hold food also must register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. See FDA's website (http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.htm).
FDA, "2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices," November 2013, http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm376478.htm.
GAO, Fundamental Changes Needed to Ensure Safe Food (GAO-02-47T), October 10, 2001.
According to FDA, PREDICT "uses data analytics from the entire life cycle of a product to better identify and target high-risk products before they enter the country" and "helps field inspectors determine which products pose the greatest risk and, therefore, should be physically examined" (http://www.fda.gov/forindustry/importprogram/ucm172743.htm).
An import alert is a notification from FDA to its field staff that all future shipments of an imported product may be refused admission without physically examining the product in each shipment. FDA's import alert database is at http://www.accessdata.fda.gov/cms_ia/default.html.
FSIS's inspection directory, http://www.fsis.usda.gov/wps/portal/fsis/topics/inspection/mpi-directory.
After an incoming shipment has met U.S. Customs and Border Protection and APHIS requirements, the shipment must be reinspected by FSIS at an approved import inspection facility. For more information, see https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/port-of-entry-procedures/fsis-import-reinspection/ct_index9.
See FSMA §403. Past congressional debates involving food safety have examined proposals to combine all federal food safety agencies and authorities under a single (possibly Cabinet-level) agency.
For more background information, see CRS Report 98-175, House Committee Jurisdiction and Referral: Rules and Practice and CRS Report 98-242, Committee Jurisdiction and Referral in the Senate.
For a listing of GAO reports documenting such cases, see footnote 5.