Food Safety: Selected Issues and Bills in the 110th Congress
Food Safety: Selected Issues and Bills
th
in the 110 Congress
Updated January 2, 2008
Geoffrey S. Becker
Specialist in Agricultural Policy
Resources, Science, and Industry Division
Food Safety: Selected Issues and Bills
in the 110th Congress
Summary
A series of widely publicized incidents — from adulterated Chinese seafood
imports to bacteria-tainted spinach, meat, and poultry produced domestically — have
made food safety an issue in the 110th Congress. Numerous proposals were
introduced in 2007 that would alter aspects of the current U.S. food safety system;
some of these bills could receive consideration in 2008. This report provides an
overview of the current system, highlights major issues in the debate to improve it,
and describes the bills.
Reorganization of Food Safety Responsibilities. Critics believe that the
current system is fragmented and inefficient, threatening food safety; others believe
that, while improvements could be made, reorganization is not the most appropriate
response. The Senate-passed version of H.R. 2419, the omnibus farm bill, would
establish a commission to recommend changes.
Food Import Oversight. U.S. food imports have been increasing significantly,
raising questions about whether U.S. safeguards, generally established at a time when
most Americans obtained their foods domestically, sufficiently protect public health.
Pending proposals would variously require foreign countries and establishments to
seek U.S. certification before importing into the United States; expand oversight of
food imports; and/or charge fees on such imports to cover oversight costs.
Notification and Recall Authority; Traceability. Generally, neither the Food
and Drug Administration (FDA) nor USDA’s Food Safety and Inspection Service
(FSIS) has explicit statutory authority to order a recall of adulterated foods, to require
a company to notify them when it has distributed such foods, or to impose penalties
if recall requirements are violated. P.L. 110-85, which comprises wide-ranging FDA
amendments, includes a requirement that FDA establish a registry for reporting
potentially adulterated foods. The Senate-passed version of the farm bill contains a
similar requirement for FSIS-regulated foods. Still pending are numerous bills
containing provisions for mandatory recall authority. Several bills also would
require agencies to set up systems for tracing foods from their source of production
to final sale.
State-Inspected Meat and Poultry. Federally but not state-inspected meat and
poultry may be shipped across state lines. Both the Senate- and House-passed
versions of the pending farm bill would allow state-inspected products into interstate
commerce, but under very different approaches.
Other Proposals. Other pending food safety-related measures would curtail the
non-medical use of antibiotics in animal feeds; address the labeling of products from
cloned animals; and provide incentives aimed at improving the safety of fresh fruits
and vegetables.
Contents
In troduction ......................................................1
The Food Safety System........................................2
Food and Drug Administration (HHS).........................3
Food Safety and Inspection Service (USDA)....................4
Centers for Disease Control and Prevention (HHS)...............5
National Marine Fisheries Service (Department of Commerce)......5
Environmental Protection Agency.............................5
Other Federal Agencies with Food Safety Responsibilities..........6
Congressional Jurisdiction.......................................6
Administration Food Safety Strategy...................................6
Selected Issues....................................................8
Reorganize Food Safety Responsibilities...........................8
Issue ....................................................8
Legislation ...............................................8
Increase Funding and Staffing....................................9
Issue ....................................................9
Legislation ..............................................11
Improve Oversight of Food Imports..............................12
Issue ...................................................12
Legislation ..............................................13
Strengthen Authorities for Notification, Recall, and Product Tracing.....14
Issue ...................................................14
Legislation ..............................................15
Allow State-Inspected Meat and Poultry in Interstate Commerce........16
Issue ...................................................16
Legislation ..............................................16
Strengthen Produce Safety......................................17
Issue ...................................................17
Legislation ..............................................18
Restrict Antibiotic Use in Animals...............................18
Issue ...................................................18
Legislation ..............................................18
Increase Biotechnology Oversight................................19
Issue ...................................................19
Legislation ..............................................19
Appendix A: Overview of Selected Food Safety Bills....................20
Appendix B. Selected Food Safety Authorization Bills at a Glance..........27
Food Safety: Selected Issues and Bills
th
in the 110 Congress
Introduction
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, public health officials have estimated that each year in the United
States, 76 million people become sick, 325,000 are hospitalized, and 5,000 die from
foodborne illnesses caused by contamination from any one of a number of microbial1
pathogens.
Food safety-related incidents frequently heighten public and media scrutiny of
the U.S. food safety system in general, as a number of developments in 2006 and
2007 have illustrated. For example, more than 200 confirmed illnesses and three
deaths were linked in the autumn of 2006 to the consumption of bagged fresh spinach
grown in California and carrying the bacterium E. coli O157:H7. The incident raised
public concerns about the safety of all fresh leafy produce and stimulated a number
of industry and government initiatives to limit future contamination. Large recalls
of various meat and poultry products due to findings of E. coli O157:H7, Listeria,
and other problems occurred throughout 2007. In February of that year, the U.S.
Food and Drug Administration (FDA) announced a nationwide recall of Peter Pan
and Great Value brands peanut butter produced in a Georgia ConAgra plant due to
Salmonella contamination, after hundreds of illnesses, dating back to August 2006
and linked to the bacterium, were reported by public health officials.
At issue is whether the current food safety system has the resources, authority,
and structural organization to safeguard the health of American consumers, who2
spend more than $1 trillion on food each year. Also at issue is whether federal food
safety laws, first enacted in the early 1900s, have kept pace with the significant
changes that have occurred in the food production, processing, and marketing sectors
since then.
Attention shifted to the safety of food imports in early 2007 when pet food
ingredients imported from China sickened or killed an unknown number of dogs and
1 U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, “Foodborne Illness: Frequently Asked Questions,” accessed at
[http://www.cdc.gov/foodsafety/]. However, this estimate appears to be based primarily on
1997 and earlier data in a report by Paul S. Mead et al., “Food-related Illness and Death in
the United States,” Emerging Infectious Diseases, vol. 5, pp. 607-625, 1999.
2 Nearly half of U.S. food spending is now in restaurants and other places outside the home.
Roughly two-thirds of the $1 trillion is for domestically produced farm foods; imports and
seafood account for the balance. Data source: USDA, Economic Research Service.
cats and subsequently were found in some hog, chicken, and fish feed.3 In June 2007,
FDA announced that it was detaining all imports of certain types of farm-raised
seafood from China (specifically, shrimp, catfish, basa, dace, and eel) until the
shippers could confirm that they are free of unapproved drug residues.
These and other developments made food safety a top issue for a number of
lawmakers in the first session of the 110th Congress. Several of them called for
changes in the U.S. food safety system and/or funding increases that they assert are
needed to meet current obligations to protect consumers from unsafe food. Perceived
gaps in federal safeguards were explored at a number of congressional hearings in
2007. Several reports and studies released in 2007 by the Bush Administration also
called for changes or increased resources in the system.
Bills addressing various aspects of the issue have been introduced. Many appear
to focus on ensuring the safety of imported foods, and/or on strengthening the ability
of federal agencies to identify and recall contaminated products. Several call for a
more sweeping overhaul of existing statutes, including one that would combine
responsibility for all food safety under a single new agency. This report describes
many of these bills, both in tabular format (see Appendix A and Appendix B) and
in the text that follows. First, however, the report offers an overview of the current
system.
The Food Safety System
The Government Accountability Office (GAO) has identified 15 federal
agencies collectively administering at least 30 laws related to food safety. 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), together compose the majority
of both the total funding and the total staffing of the government’s food regulatory
system.4 FSIS’s annual budget is approximately $1 billion, at least 90% of it
appropriated funds and the balance industry-paid user fees. FDA’s annual budget for
human foods is less than $500 million. FDA oversight of animal drugs and feeds
totals another approximately $100 million, of which approximately 90% is
appropriated and the balance user fees.5
3 FDA requires the same general safety standards for human foods and animal feeds,
including pet food. A subsequent survey commissioned by the American Association of
Veterinary Laboratory Diagnosticians and conducted by Michigan State University counted
347 cases (235 cats and 112 dogs) of pets dying from contaminated pet food. Michigan
State University, “MSU survey determines that more than 300 pets may have died from
contaminated pet food; culprit may be lethal combination of contaminants,” news release,
November 29, 2007, accessed at [http://newsroom.msu.edu/site/indexer/3263/content.htm].
4 High Risk Series: An Update (GAO-07-310), January 2007.
5 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations for 2007, hearings before a Subcommittee of the Committee onthnd
Appropriations, House of Representatives, 109 Cong., 2 sess. Also, Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies Appropriations for
(continued...)
Food and Drug Administration (HHS). FDA is responsible for ensuring
that all domestic and imported food products — except for most meat and poultry
derived from the major animal species — are safe, nutritious, wholesome, and
accurately labeled.6 FDA shares 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 (FSIS generally is responsible for processed eggs). FDA
is also responsible for ensuring that seafood products, including those from
aquaculture, do not endanger public health. The primary statutes governing FDA’s
activities are the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21
U.S.C. 301 et seq.); the Public Health Service Act, as amended (42 U.S.C. 201 et
seq.); and the Egg Products Inspection Act, as amended (21 U.S.C. 1031 et seq.).
FDA’s food safety staff (FY2007) numbers approximately 1,900 in field offices
throughout the United States, plus more than 800 in its headquarters offices near
Washington, DC. FDA regulates food manufacturers’ safety practices by relying on
companies’ self-interest in producing safe products, by working with the industry to
improve production practices, and by making periodic (although infrequent)
inspections of the approximately 60,700 active food establishments subject to FDA
oversight. According to FDA, unannounced compliance inspections of individual
establishments by its officials now occur roughly once every five years. FDA relies
on notifications from within the industry or from other federal or state inspection
personnel, as well as other sources, to alert it to situations calling for increased
inspection.
The FDA headquarters 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.
FDA also cooperates with over 400 state agencies across the nation that carry
out a wide range of food safety regulatory activities. 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
5 (...continued)
Representatives, 110 Cong., 1st sess.
6 FDA does have jurisdiction over meats from animals or birds that are not under the
regulatory jurisdiction of FSIS. FSIS’s legislative mandate extends only to “amenable
species,” currently defined as cattle, sheep, goats, swine, equines, and the following poultry
species: chickens, turkeys, ducks, geese, ratites, and guineas.
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.
Food Safety and Inspection Service (USDA). FSIS regulates the safety,
wholesomeness, and proper labeling of most domestic and imported meat and poultry
and their products sold for human consumption. Under the Federal Meat Inspection
Act (FMIA) of 1906, as amended (21 U.S.C. 601 et seq.), FSIS inspects all cattle,
sheep, swine, goats, and equines both before and after they are slaughtered, and
maintains oversight during their processing into food products. Under the Poultry
Products Inspection Act (PPIA) of 1957, as amended (21 U.S.C. 451 et seq.), FSIS
is required to inspect “any domesticated bird” both before and after slaughter and
while being processed for human consumption. However, USDA regulations
implementing this law limit the definition of domesticated birds to chickens, turkeys,
ducks, geese, ratites (emus, ostriches, and rheas), and guineas. FDA has jurisdiction
over exotic and alternative meats not inspected by FSIS, and shares responsibility for
egg safety with FSIS. FSIS is responsible for the safety of liquid, frozen, and dried
egg products, domestic and imported, and for the safe use or disposition of damaged
and dirty eggs under the Egg Products Inspection Act, as amended (21 U.S.C. 1031
et seq.).
FSIS staff numbers around 9,400; roughly 8,000 of them, including about 1,000
veterinarians, are in about 6,300 meat and poultry slaughtering and/or processing
plants nationwide. FSIS personnel inspect all meat and poultry animals at slaughter
on a continuous basis, and at least one federal inspector is on the line during all hours
the slaughter plant is operating. During processing operations — that is, when meat
from animals is being transformed into cuts, ground products, and other consumable
items — an FSIS inspector may not be constantly on the production line or inspect
every item. Instead, the inspector visits the site on a daily basis 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 also is considered to be continuous.
FSIS also 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 products to the United States. FSIS inspectors located at U.S. ports of
entry carry out a statistically based sampling program to verify the safety of imported
meats from cattle, sheep, swine, goats, and equines and imported poultry meat from
chickens, turkeys, ducks, geese, quail, ratites, and guineas before they are released
into domestic commerce. FDA is responsible for ensuring the safety of imported
meat from any other species.
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. The approximately 2,100 plants that slaughter animals and/or
process meat and poultry under state supervision 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. Under a separate program, 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 so-called Talmadge-Aiken plants (named for the sponsors of the law that
created the program) may travel in interstate commerce.7
Centers for Disease Control and Prevention (HHS). CDC is
responsible for (1) monitoring, identifying, and investigating foodborne disease to
determine the contributing factors; (2) working with FDA, FSIS, and other federal
agencies, state and local public health departments, universities, and industry to
develop control methods; and (3) evaluating the effectiveness of control methods.
In 1995, CDC launched “FoodNet,” a collaborative project with FDA and USDA to
improve data collection on foodborne illnesses. 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 allows 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, as amended (42 U.S.C. 201 et seq.),
provides the legislative authority for CDC’s food safety related activities.
National Marine Fisheries Service (Department of Commerce).
Although 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) 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. 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.
Environmental Protection Agency. The Environmental Protection Agency
(EPA) has statutory responsibility for ensuring that the chemicals used in the
production and processing of food do not endanger public health. EPA’s Office of
Pesticide Programs (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 the Federal Food, Drug,
and Cosmetic Act, as amended (21 U.S.C. 301 et seq.), are the primary authorities
for EPA’s activities in this area.
7 A more extensive explanation of FSIS is available in CRS Report RL32922, Meat and
Poultry Inspection: Background and Selected Issues, by Geoffrey S. Becker.
Other Federal Agencies with Food Safety Responsibilities. 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. ARS 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), working with other
agencies, is responsible for coordinating federal preparedness for and response to a
terrorist attack, major disease outbreak, or other disaster affecting the national
agriculture or food infrastructure, and has additional routine food safety inspection8
responsibilities at U.S. borders.
Congressional Jurisdiction
Congressional oversight of the diverse federal food safety system is further
complicated because of the number of committees that have jurisdiction over one or
more aspects. For example, the congressional authorizing committees that direct
FDA activities are those with jurisdiction over public health issues: the Senate
Committee on Health, Education, Labor, and Pensions and the House Committee on
Energy and Commerce. Other committees that exercise oversight roles regarding
FDA include the House Committee on Oversight and Government Reform, and the
Senate committees on Aging, Homeland Security, and the Judiciary. With regard to
FSIS authorization and oversight, the House and Senate Agriculture Committees
have primary jurisdiction.
Annual funding decisions originate in the House and Senate appropriations
subcommittees on Agriculture, Rural Development, FDA, and Related Agencies,
which have jurisdiction not only over FSIS, a USDA agency, but also over FDA’s
appropriations. This latter arrangement reflects, in part, the agency’s origin within
the Department of Agriculture as the Bureau of Chemistry in 1862. Since 1940,
however, FDA has been administratively part of federal public health agencies,
specifically HHS and its predecessors.
Administration Food Safety Strategy
The Administration released, on November 6, 2007, two separate but related
reports with an impact on food safety. The broader of the two covers the safety of
most imports for consumers, including but not limited to food. This Action Plan for
Import Safety was prepared for the President by the Interagency Working Group on9
Import Safety. The other report is FDA’s Food Protection Plan, which focuses on
food, whether imported or domestically produced, and which contains
8 See also CRS Report RL32521, Agroterrorism: Threats and Preparedness, by Jim Monke.
9 Accessed at [http://www.importsafety.gov/report/actionplan.pdf].
recommendations for food imports that generally parallel those in the broader
report.10
Both plans are oriented toward assessing and prioritizing risks regardless of
where they occur (starting at a product’s point of origin), and preventing rather than
waiting for problems to occur. A number of the recommendations — such as
mandatory recall authority for FDA-regulated products (but not FSIS), electronic
certification of imports, and new user fees if products must be reinspected — would
require congressional authorization. Among other recommended statutory changes
are more explicit authority to require additional preventive (HACCP-like) controls
for high-risk foods (authority some believe FDA already has); and authority for FDA
accreditation of qualified third parties to conduct some types of inspections.
HACCP is the acronym for hazard analysis and critical control point, whereby
a production system is analyzed to determine its potential risks and hazards and
where they are most likely to occur. Preventive controls are then instituted at the
appropriate points, and continually monitored to ensure they are effective. Each meat
and poultry plant must have developed and must continue to follow its own HACCP
plan, which FSIS inspectors then review on an ongoing basis to ensure it is in place
and effective. Currently, only a few types of FDA-regulated food products must
follow HACCP rules.
Many other changes are to be implemented through administrative action, or
cooperative activities with foreign countries and industry stakeholders. Most cite
FDA as the lead agency; few would appear to involve FSIS-regulated products.
Many of the changes are expected to necessitate more spending, which neither report
quantified. The lack of specific funding requests was among the criticisms leveled
against the Administration strategy by some Members of Congress. Administration
officials stated that they would seek additional funds to help pay for these initiatives
as part of the upcoming FY2009 budget request.
Other perceived shortcomings in the strategy were cited by critics, including
some Members of Congress, consumer advocacy groups, and several food safety
experts. Several observed, for example, that the plan is not comprehensive because
it did not propose any specific food safety improvements on farms or at the retail
level, where problems often occur; that it relies too much on voluntary cooperation
with industry when stronger mandatory controls are called for; and that it fails to
emphasize badly needed improvements in information technology.11
10 Accessed at [http://www.fda.gov/oc/initiatives/advance/food/plan.html].
11 See, for example, the December 4, 2007, testimony of Michael R. Taylor, Research
Professor of Health Policy, The George Washington University, before the Senate
Committee on Health, Education, Labor, and Pensions hearing, “Developing a
Comprehensive Response to Food Safety.” Also, FDA Week, November 9, 2007.
Selected Issues
Reorganize Food Safety Responsibilities
Issue. Critics have argued for decades that U.S. food safety activities are
dispersed over too many agencies and are poorly coordinated. GAO has been among
these critics. In its annual (January 2007) report, GAO designated food safety
oversight as one of 29 “high risk” federal program areas. The report concluded that
the current federal safety system is “fragmented,” resulting in
inconsistent oversight, ineffective coordination, and inefficient use of resources.
GAO has recommended that Congress consider a fundamental reexamination of
the system and other improvements to help ensure the rapid detection of and
response to any accidental or deliberate contamination of food before public12
health and safety is compromised.
Opponents of major food safety system changes, including some in the food and
agricultural industries, assert that the system already is scientifically based, that the
statutes are adequate, and that food companies already produce and distribute safe
food, making the U.S. system a model for food safety around the world.
Legislation. The Senate-passed version of the omnibus farm bill (H.R. 2419)
would establish a Congressional Bipartisan Food Safety Commission to recommend
statutory changes to modernize the food safety system and ways to harmonize food
safety requirements across agencies. The language provides extensive guidance on
commission membership and on the programs to be examined, sets timelines for
completion, and provides $3 million annually in funding.13
If the commission language is maintained in the final farm bill (the House
version lacks it), this initiative could sideline further action in this Congress on
companion bills (H.R. 1148/S. 654) to reorganize the federal agencies responsible for
food safety, as well as to overhaul the safeguards themselves.
These two comprehensive companion bills would consolidate federal food
safety responsibilities under a new Food Safety Administration (FSA). The new FSA
would be responsible for administering all the major food safety laws. Agencies and
their functions to be transferred include FSIS and APHIS from USDA, as well as the
Department’s food safety research activities; the FDA’s Center for Food Safety and
Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM), as well as
portions of other FDA offices that support these centers; resources of the EPA that
regulate pesticide residues in food; NMFS seafood inspection; and any other offices
or services designated by the President.
12 High Risk Series: An Update.
13 The omnibus FY2008 appropriation measure (H.R. 2764), which the President signed into
law on December 26, 2007, also contains a number of directives to USDA and FDA to study
and recommend changes in the food safety system; see the next section of this report,
“Funding and Resources.”
H.R. 1148/S. 654 also would authorize a new food safety system to be based on
a comprehensive analysis of food hazards. They would require the registration and
regular inspections of all establishments (except farms, fishing vessels that do not
process food, and retail establishments), which would have to follow process controls
tied to science and health-based regulations, including performance standards.
Inspection fundamentals and frequencies also are spelled out in the bills. Among
other provisions, the bills specify prohibited acts; provide authority to detain, seize,
condemn, and/or recall foods suspected of being unsafe or misbranded (see page 14
for details), and include “whistleblower protection” for public and private employees
who report safety problems. They also include a certification system for imports, and
a mandatory national system for tracing food and food animals from their point of
origin to retail sale, which are described elsewhere in this CRS report.
Another comprehensive bill (H.R. 3624) proposes major changes in how the
current system is administered by the FDA — although it would not establish a new
single food agency. The bill would require establishment of a new “National Food
Safety Program” to be based on a comprehensive analysis of food safety hazards
throughout the production and marketing chain; the analysis would consider the
distinctive characteristics of food production and processing. The proposed bill
would mandate process control regulations, require quarterly inspections of
processors and importers, except those that have negligible risk or meet exceptional
standards, and spell out procedures for detaining and condemning adulterated or
misbranded products.
The bill also would require, among other things, tolerances for contaminants in
food tied to health-based standards, and a comprehensive public health assessment
system that includes active foodborne illness surveillance and sampling of food
products to test for contaminants. The bill’s import inspection and recall provisions
are described elsewhere in this CRS report.
Increase Funding and Staffing
Issue. Some critics argue that — irrespective of the need, if any, to reform
food safety statutes and organization — the primary problem is the lack of sufficient
funding and staff to carry out congressionally mandated responsibilities to ensure a
safe food supply. From time to time in the past, FSIS has had difficulty in adequately
staffing its service obligations to the meat and poultry industries. Usually a
combination of factors causes these shortages, such as new technologies that increase
plant production speeds and volume, or insufficient funds to hire additional
inspectors at times of unexpected increases in demand for inspections, for example.
According to a report released in early December 2007 by the FDA Science
Board, the FDA Commissioner’s expert advisory panel, a critical lack of resources
has seriously weakened the FDA’s scientific basis generally and its mission to protect
the food supply particularly, The report, prepared by a board subcommittee,
concluded in part, “... the Agency suffers from serious scientific deficiencies and is
not positioned to meet current or emerging regulatory responsibilities.” The
subcommittee report tied these deficiencies to two sources: (1) demands on FDA
have soared due in part to major advances in science and in the complexity of new
products, and to the globalization of the industries the agency regulates; and (2)
resources have not increased in proportion to the demands. Such demands include
an accumulation of unfunded legislative mandates imposed by Congress, the report
st at ed. 14
The report singled out the FDA’s two food safety centers, CFSAN and CVM,
where crisis management has “drawn attention and resources away from FDA’s
ability to develop the science base and infrastructure needed to efficiently support
innovation in the food industry, provide effective routine surveillance, and conduct
emergency outbreak investigation activities to protect the food supply.” Also, it noted
that “[a]n appallingly low inspection rate” leaves FDA unable to
sufficiently monitor either the tremendous volume of products manufactured
domestically or the exponential growth of imported products. During the past 35
years, the decrease in FDA funding for inspection of our food supply has forced
FDA to impose a 78 percent reduction in food inspections, at a time when the
food industry has been rapidly expanding and food importation has exponentially15
increased.
The FDA food safety budget has declined from almost half of the agency’s total
spending in 1971 to about one-fourth of the budget currently, partly because the drug
budget has expanded due to collection of drug approval user fees. FDA staffing in
programs not funded by user fees, including but not limited to food safety, has
decreased significantly, according to a former high-level official.16 This has occurred
at a time when FDA faces new challenges such as rising food imports due to
globalization of the U.S. food supply.
Although it requested modest increases for both FDA and FSIS in its FY2008
budget, the Administration stressed that it could meet these challenges by
strengthening the scientific basis of its programs, improving risk-based targeting of
inspection resources, and developing stronger partnerships with domestic and
international stakeholders. At 2007 hearings, some Members of Congress expressed
skepticism that these efforts could succeed without additional funds. More recently,
the HHS Secretary and FDA officials said that they had asked the White House to17
include significant increases as part of the President’s FY2009 budget request.
14 FDA Science and Mission at Risk, Report of the Subcommittee on Science and
Technology, prepared for the FDA Science Board, November 2007.
15 Ibid. The report cited an estimate by an advocacy group, the Coalition for a Stronger
FDA, that more than $130 million is needed to devise and implement a new food import
system alone.
16 Statement of William K. Hubbard, former FDA Associate Commissioner, before the
House Energy and Commerce Subcommittee on Oversight and Investigations, July 17, 2007.
17 See, for example, “House members grill FDA chief over produce safety, increased
inspections,” Food Chemical News, March 5, 2007; “FDA Chief Pressed on Below-Inflation
Budget Hike for Food Safety,” CQ Budget Tracker News, March 1, 2007. The more recent
HHS and FDA remarks were made at a December 4, 2007, hearing on imported food safety
before the Senate Committee on Health, Education, Labor, and Pensions.
FSIS and FDA receive most of their funding through the annual Agriculture,
Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act. Some funds also are provided through user fees. In FY2007,
for example, more than 12% ($130 million) of the FSIS budget of approximately $1
billion was from user fees charged to establishments, mostly for inspections
conducted after regularly scheduled shifts. As noted, the $457 million FDA food
safety budget (FY2007) was virtually all from appropriated funds.
Proposed increases in program spending raise a variety of policy issues.
Requests for higher appropriations must compete with other priorities throughout the
federal discretionary budget (the programs do not operate, like farm support
programs, for example, as mandatory authorizations). Efforts to fill perceived
shortfalls through new user fees on the food industry always meet with resistance,
both from the companies that would have to absorb such costs, and from consumer
advocates, who have long argued that industry funds might “taint” programs that are
first and foremost public health programs. Nonetheless, a number of pending food
safety bills discussed in this report include proposed user fees to pay for such various
new activities as certification of food imports, re-inspection of products initially kept
out of commerce, and the auditing of private food testing laboratories.
Legislation. The first session of the 110th Congress did not clear a
freestanding Agriculture, Rural Development, Food and Drug Administration, and
Related Agencies Appropriations Act for FY2008 (H.R. 3161, S. 1859). Rather, the
programs operated for nearly the first three months of the fiscal year under a series
of continuing resolutions, and are now operating for the balance of FY2008 under the
Consolidated Appropriations Act, 2008 (H.R. 2764).
Division A of this omnibus measure provides new budget authority in FY2008
of $509.9 million for the FDA foods program area, or $52.8 million more than the
FY2007 enacted level of $457.1 million and the Administration FY2008 request of
$466.7 million. Of this, $28 million is to be spent from July 1, 2008, through
September 30, 2009, for implementation of a detailed plan for a comprehensive
overhaul of FDA’s food safety operations. Accompanying report language further
directs that nearly $327 million of the agency appropriation be spent for food-related
field activities; and that FDA make at least $18.3 million available immediately to
hire additional domestic and import inspectors, including $8 million “for the
deployment of inspectors with rapid response capabilities who will be responsible for
immediate attention to outbreaks of food-related disease as well as providing
technical assistance to states and others, as appropriate, to support overall practices
to increase the safety of food and food products.”
The report also states that FDA should contract with the National Academy of
Sciences for a comprehensive study of gaps in public health protection provided by
the food safety system, including a response to the recommendations of the FDA
Food Protection Plan released in November 2007. Moreover, both FDA and USDA
were separately directed to also submit their own plans addressing the weaknesses
that caused GAO to place food safety on its 2007 high-risk list.
The FY2008 measure provides new budget authority for FSIS of $930.1 million,
or nearly $38 million more than the enacted FY2007 level. (Currently authorized
user fees were expected to provide another $135 million for the year.) The increase
is in part to be used to hire additional inspectors in FY2008.
Table 1. Appropriated Funds for FSIS and FDA
(millions)
FY2007 EnactedFY2008 RequestFY2008 Enacted
FSIS $892.1 $930.1 $930.1
FDA $457.1 $466.7 $509.9
(food)
Source: House Appropriations Committee documents. FSIS total excludes user fees
(estimated to be approximately $135 million FY2008).
Improve Oversight of Food Imports
Issue. Concerns about perceived gaps in import safeguards, including what
many believe have been insufficient funds, are not new. However, they have gained
wider attention in recent years as U.S. food imports log significant increases, fueled
by the globalization of production and processing, and by consumers’ desire for a
wider variety of nutritious and inexpensive foods year-round. The value of total
imports of agricultural and seafood products increased from $39 billion in FY1996
to $83.7 billion in FY2007, a 115% increase. At issue is whether U.S. safeguards,
which generally were created at a time when most foods were supplied domestically,
can protect public health in a global marketplace.
The Bush Administration’s food safety and import safety strategies (see pages
6-7) assert that imported foods generally do not pose a greater food safety risk than
domestic foods. However, the increase in import volume, along with the changing
makeup — from largely unprocessed bulk ingredients for subsequent processing by
domestic establishments, to an increasing variety of ready-to-eat products, fresh
produce, and seafood — have taxed FDA’s ability to monitor them for safety, the
Administration reports said.
Among legislative changes recommended in the Administration food safety and
import strategies is the authority for FDA to require electronic import certificates for
shipments of products deemed to be of high risk. For such products, FDA would
have to negotiate and implement government-to-government agreements whereby an
importer would obtain certificates from either the appropriate foreign agency or an
accredited third party. This new certification system, which appears to be based at
least in part on the concept of the FSIS foreign equivalency determinations,
presumably would have to be consistent with international trade obligations, and
likely would be one of the initiatives requiring additional resources.18 The strategies
also entail new authority for FDA to block entry of foods imported from foreign
firms that impede entry by FDA inspectors to their facilities.
18 See also CRS Report RL34198, U.S. Food and Agricultural Imports: Safeguards and
Selected Issues, by Geoffrey S. Becker.
The imports issue was explored at a number of congressional hearings in 2007,
and several bills have been offered to change the current system. Those who oppose
major changes assert that imported foods already are subject to the same safety
standards as — and/or pose no greater hazards than — domestically produced foods.
They also contend that smarter allocation of existing resources, and the food
industry’s own controls, can and should be capable of addressing any problems that
ari s e. 19
Legislation. As of late 2007, at least a dozen food safety bills were pending
that contain provisions addressing some aspect of food import safety. About half of
them — H.R. 2997, H.R. 3100, H.R. 3610, H.R. 3937, H.R. 3967, S. 1776, and S.
A number of the bills would require that importing establishments, and/or the
foreign countries in which they are located, first receive formal certification from
U.S. authorities that their food safety systems demonstrably provide at least the same
level of safety assurances as the U.S. system. Some would direct that certifications
be denied or revoked if foreign safeguards are found to be insufficient, unsafe
imports are discovered, and/or foodborne illnesses are linked to such products. H.R.
2997 takes a somewhat different tack, by requiring that food imports (both FDA- and
FSIS-regulated) be certified by the government of their country of origin.
A number of the bills also propose the collection of user fees — for example,
up to $20 per shipment in one bill, up to $50 per shipment in another — from
importers to cover the costs of inspecting foreign products at the borders. Some of
the bills seek to require more physical inspections and testing by FDA at the border
or within other countries, to authorize more research into inspection and testing
technologies, or to restrict imports to specific ports.
A controversial provision in H.R. 3610 (introduced by House Energy and
Commerce Committee Chairman Dingell) would restrict imports of all FDA-
regulated foods to ports of entry located in metropolitan areas that have one of the 1320
FDA laboratories, although waivers could be granted under some circumstances.
At a July 17, 2007, hearing before the House Energy and Commerce Subcommittee
on Oversight and Investigations, the panel’s investigators testified that FDA border
inspectors currently had to cover 326 ports of entry, greatly straining the existing
workforce. Those opposed to the port restrictions in H.R 3610 argue that it would
result in severe economic dislocation and huge costs for industries and consumers.21
A separate provision in the Dingell bill would require the HHS Department to
establish a voluntary “Safe and Secure Food Importation Program” under which food
19 Ibid.
20 FDA had initially proposed to consolidate its 13 labs into six, but backed away from that
plan due in part to strong opposition by some key Members of Congress. The Consolidated
Appropriations Act, 2008, prohibits the agency from closing or consolidating these labs.
21 See, for example, the testimony on H.R. 3610 by the Food Marketing Institute and by the
American Association of Exporters and Importers, September 26, 2007, before the House
Energy and Commerce Committee, Subcommittee on Health.
importing companies could receive expedited movement of their products in
exchange for abiding by HHS-developed food safety and security guidelines.
Meanwhile, Title X of the Food and Drug Administration Amendments Act of
2007 (H.R. 3580; signed into law as P.L. 110-85), requires an annual report to
Congress on the number and amount of FDA-regulated food products imported by
country and by type of food, the number of inspectors and inspections performed, and
aggregated data on inspection findings, including violations and enforcement actions.
Strengthen Authorities for Notification, Recall,
and Product Tracing
Issue. Currently, neither FDA nor FSIS has explicit statutory authority to order
a recall of adulterated foods, require a company to notify them when it has distributed
such foods, or impose penalties if recall requirements are violated. (FDA can order
such recalls for one food, infant formula, and for unsafe medical devices, such as
pacemakers, as can other agencies for unsafe toys or automobiles.) These gaps
increase the possibility that unsafe food will not be recovered and will be consumed,
GAO has concluded.22
Defenders of the current system counter that the agencies already have sufficient
authorities to keep such products from reaching consumers. FSIS’s statutory
authority enables it to detain meat and poultry products of concern for up to 20 days,
and FDA’s authority enables it to detain the foods it regulates for up to 30 days. Both
agencies can, with a court’s permission, seize, condemn, and destroy unsafe food.23
Finally, private companies rarely if ever fail to order a voluntary recall when
problems arise; these are frequently announced by the government, and become
widely publicized, it is argued. Nonetheless, a number of Members of Congress
support GAO’s recommendation that legislation be considered to strengthen
notification and recall authorities.
Some argue that improved notification and traceability capabilities would enable
either FSIS (in the case of meat and poultry products) or FDA (in the case of other
foods) to determine more quickly a product’s source and whereabouts, to prevent or
contain foodborne illness outbreaks. The traceability issue has also been debated in
connection with protecting against agroterrorism, and for verifying the U.S. origin
of live animals and their products for marketing, trade, and/or animal health
purposes, for example.24
22 See, for example, Food Safety: USDA and FDA Need to Better Ensure Prompt and
Complete Recalls of Potentially Unsafe Food (GAO-05-51), October 2004. For additional
background, see CRS Report RL34167, The FDA’s Authority to Recall Products, by
Vanessa K. Burrows.
23 A court’s permission may not be needed in all cases; for example, the FFDCA
[§801(j)(1)] empowers officials to hold an import for up to 24 hours if there is “credible
evidence or information indicating that an article of food presents a threat of serious adverse
health consequences or death to humans or animals.”
24 See also CRS Report RS22653, Animal Identification: Overview and Issues, by Geoffrey
S. Becker.
The Administration’s November 2007 strategy for food safety calls for
mandatory recall authority in cases where firms (whether foreign or domestic) are
unwilling to do so voluntarily or expeditiously. FDA notes that it already has the
authority to seize adulterated or misbranded food, but this may not be practical once
a product is in wide distribution. The agency also is seeking authority to give it more
access to records in cases of food emergencies. Significantly, a major food industry
group, the Grocery Manufacturers Association (GMA), endorsed the proposal for
mandatory recall authority.25 The day after the Administration proposed it for FDA,
a USDA official asserted that FSIS does not need similar mandatory recall authority
for meat and poultry products. Responding to questions, the official stated that
USDA already has sufficient enforcement tools and that the voluntary approach now
in place works well.26
Legislation. Title X of P.L. 110-85, which was signed into law on September
Responsible parties and importers will be required to report to this registry detailed
information (outlined in the bill) about cases of actual or suspected food adulteration,
generally within 24 hours.27 The measure contains a number of explicit provisions
regarding the types of records that must be maintained and the specific data that must
be provided. Another recall-related provision, in Title VI of the bill, will require
FDA to work with companies, professional associations, and other organizations to
collect and communicate information about recalls of human or pet food and to post28
information regarding the products on an accessible FDA website.
Before passing its version of the omnibus farm bill (H.R. 2419) in December
2007, the Senate adopted a managers’ amendment that also establishes reportable
food registries for FSIS-regulated meat and poultry products. A House-Senate
conference committee, anticipated in early 2008, is likely to determine the outcome
of these registries, which are not in the House version.
Many pending food safety bills introduced during 2007 also contain provisions
dealing with notification, recall, and/or traceability: H.R. 1148/S. 654, H.R. 2108/S.
25 “GMA Applauds Bush Administration’s Focus on Prevention in Effort to Improve Safety
of Imported Food,” November 6, 2007, press release, at [http://www.gmaonline.org/news/
docs/NewsRelease.cfm? DocID=1806&].
26 Dr. Richard Raymond, Undersecretary for Food Safety, November 7, 2007, testimony
before the House Agriculture Subcommittee on Livestock, Dairy, and Poultry.
27 Responsible parties are defined to mean facilities that have to register with FDA under
Section 415 of the FFDCA, i.e., “any facility engaged in manufacturing, processing,
packing, or holding food for consumption in the United States ...” Exempted are farms,
restaurants, and other retail establishments.
28 Other food-related provisions in H.R. 3580, which primarily deals with FDA non-food
issues, include a required annual FDA report on the Administration’s Pesticide Residue
Monitoring Program; a required report on seafood safety risks, seafood inspection activities,
and the feasibility of a traceability system to trace the plant of origin for all domestic and
imported seafood products; and authority to partner with states to implement inspection
programs for imported seafood and aquaculture to ensure they meet federal standards.
S. 2418. Several of these would require any person to immediately notify authorities
if he or she has reason to believe that a food entering commerce is in violation of the
law; and would provide either FDA and/or FSIS with the authority to mandate recalls
if an establishment refused to do so voluntarily or sufficiently. Several bills also
would require establishment of a national system to trace food and food animals from
point of origin to retail sale.
One proposal would newly require all manufacturers of foods (and of other non-
food products like auto parts, drugs, and other consumer products) to have “recall
responsibility certificates” issued by U.S. Customs and Border Protection (CBP).
The document is to certify that the manufacturer, for a five-year period, has the
resources to cover the entire cost of any recall of its product, plus compensatory
damages and costs that may arise from product liability claims due to defects.
Allow State-Inspected Meat and Poultry
in Interstate Commerce
Issue. Federal law currently prohibits meat and poultry plants that operate
under one of the 27 state inspection programs from shipping their products across
state lines. Many of the states and small plants want to overturn that ban. Limiting
state-inspected products to intrastate commerce is unfair, these states and plants
argue, because their programs must be, and are, “at least equal” to the federal system.
Foreign plants operating under FSIS-approved foreign programs, which must be
“equivalent” to the U.S. program, can export meat and poultry products into and sell
them anywhere in the United States.
Those who oppose allowing state-inspected products into interstate commerce
argue that state programs are not required to have, and do not have, the same level
of safety oversight as the federal or even some foreign systems. For example,
foreign-processed products are subject to U.S. import reinspection at ports of entry.
These opponents of interstate shipment note that a recent FSIS review, which found
all but one of the state programs to be at least equal to the U.S. program, was based
largely on self-assessments.29
Legislation. Both the House- and Senate-passed versions of H.R. 2419, the
omnibus farm bill, would amend the meat and poultry inspection acts to permit
interstate shipment of state-inspected products — but under divergent approaches.
It would replace the current federal-state cooperative inspection program with a new
program that would enable meat and poultry that is not federally inspected to be
shipped across state lines, so long as the state programs adopt standards identical to
those of FSIS along with any additional changes FSIS required. Moreover, the bill
would enable many plants currently under federal inspection to apply for state
inspection and continue to ship interstate.
29 Until it ceded its inspection responsibilities to the federal government in August 2007
after USDA deferred a finding of “equal to” status, New Mexico had been the 28th state with
a program. See also CRS Report RL34202, State-Inspected Meat and Poultry: Issues for
Congress, by Geoffrey S. Becker; and FSIS Review of State Programs: Summary Report
(January 2007) at [http://www.fsis.usda.gov/PDF/Review_of_State_Programs.pdf].
The Senate version would supplement rather than replace the current
federal-state cooperative inspection program with an alternative whereby
state-inspected plants with 25 or fewer employees could opt into a new program that
subjects them to federally directed but state-operated inspection, thus allowing them
to ship interstate. The Senate version reportedly was developed as a compromise by
those on both sides of the issue, suggesting that it would more likely prevail in any
upcoming conference on the farm bill.
Strengthen Produce Safety
Issue. Increased consumption of fresh produce, particularly of leafy vegetables
such as spinach and lettuce, is viewed as a positive trend from a nutritional
perspective, but it has presented new challenges with regard to food safety. These
challenges have been underlined by reports, starting in September 2006, of foodborne
illnesses linked to California spinach and lettuce contaminated with the bacterium E.30
coli O157:H7, among other recent incidents. There is ongoing debate regarding the
extent to which FDA, which oversees the safety of all produce, has the authority to
regulate safety on the farm, one of the potential sources of such contamination.
The agency and other public officials have been encouraging the industry to
develop and follow voluntary guidelines for growing and packing safe products. A
a majority of California producers signed, in early 2007, a state Leafy Greens
Marketing Agreement. This binds them to implement and maintain safety standards
in growing and handling spinach, lettuce, and other leafy greens. Assessments of 2
cents per carton are to fund operations of the agreement, including periodic31
inspections.
Nationally, USDA’s Agricultural Marketing Service (AMS) published in the
October 4, 2007, Federal Register an advance notice of proposed rulemaking on
whether to establish a “marketing program to address the handling of fresh and
fresh-cut leafy green vegetables. The program would allow packers, processors,
shippers, and marketers (collectively referred to as handlers) to maintain the quality
of their products by reducing the risk of pathogenic contamination during the32
production and handling of leafy greens.” Consumer advocates criticized the
proposal because it might deter FDA from taking a more aggressive regulatory
approach to protecting consumers from unsafe produce, despite AMS assertions that
it was not intended to do so.
30 See also archived CRS Report RL33722, Food Safety: Federal and State Response to the
Spinach E. coli Outbreak, by Donna V. Porter.
31 The agreeement can be accessed at [http://www.caleafygreens.ca.gov/].
32 72 Federal Register, pp. 56678-56680. The Agricultural Marketing Agreement Act of
1937 as amended (7 U.S.C. 601-674) authorizes AMS to implement federal marketing
orders and agreements, which are designed to establish and maintain orderly marketing
conditions for the regulated commodities. Both orders (which are mandatory for affected
parties) and agreements (which, like the one discussed in this Federal Register, are
voluntary) can be used for such purposes as setting grade, size, or other quality attributes
of a commodity, for determining marketing conditions, and for providing research and
promotional activities, among other things.
Legislation. Bills taking a variety of approaches to improving fresh produce
safety have been offered in the 110th Congress. One of the more comprehensive (S.
2077), introduced by Senate Agriculture Committee Chairman Harkin, would require
HHS-FDA to promulgate rules on good manufacturing practices (GMPs) for
“minimally processed produce” (i.e., fresh-cut produce). The bill also would require
FDA, in consultation with USDA, to issue rules on good agricultural practices for
growers of fresh produce. Both processing establishments and growers would have
to implement written plans detailing controls for limiting contaminants, and submit
to periodic FDA inspections. Among other provisions, the bill provides for research
and public education on produce safety, and for equivalency procedures for countries
exporting produce to the United States.
Elsewhere, a provision in Title X of P.L. 110-85 directs FDA to work with
states on programs and activities to improve food safety, including the safety of fresh
and processed produce with the goal of strengthening state programs.
Restrict Antibiotic Use in Animals
Issue. Public health experts have expressed concern about increasing
antibiotic resistance among sick patients. Such antimicrobial resistance has been
linked to a number of causes such as overuse by medical professionals and their
patients, and the wide use of antibiotics for nontherapeutic (essentially nonmedical)
purposes in food animals. Farmers administer antibiotics in feed for some types of
food-producing animals not only to treat and prevent diseases but also to encourage
growth and efficient use of feed rations. Some argue that nontherapeutic uses should
be severely constrained and/or limited to drugs not associated with human medical
treatments. Others oppose this approach, arguing that many animal production
operations would not be commercially viable without the drugs’ routine use and/or
that the linkage between such use and antimicrobial resistance lacks a strong33
scientific basis.
Legislation. As of late 2007, one major proposal had been offered affecting
agricultural use of antibiotics. Companion bills H.R. 962/S. 549 would amend the
food and drug act to define a nontherapeutic use of a critical antimicrobial animal
drug (i.e., a drug that is important in treating human illnesses) as “any use of the drug
as a feed or water additive for an animal in the absence of any clinical sign of disease
in the animal for growth promotion, feed efficiency, weight gain, routine disease
prevention, or other routine purpose.” Within two years, FDA would have to
withdraw approval of such nontherapeutic drug use unless the drug application holder
can demonstrate there is “reasonable certainty that no harm to human health” will
occur. The bills also contain data collection and reporting requirements for drug
manufacturers.
33 This discussion is based largely on a section in archived CRS Report RL31853, Food
Safety Issues in the 109th Congress. Also see the FDA website “New Guidance for Industry
on Antimicrobial Drugs for Food Animals: Questions and Answers,” accessed at
[ h t t p : / / www.f d a . go v/ oc / a nt i mi c r obi a l / que s t i ons .ht ml ] .
Increase Biotechnology Oversight
Issue. Since genetically engineered (GE, sometimes called genetically
modified, or GM) crop varieties first became commercially available in the
mid-1990s, U.S. soybean, cotton, and corn farmers have rapidly adopted them to
lower production costs and raise crop yields. A number of animal biotechnologies
(including cloning) also are becoming available. Members of Congress, particularly
from agricultural areas, generally favor the adoption of such technologies, along with
publicly supported research and other activities aimed at gaining their acceptance in
foreign and domestic markets. Others question the food safety impacts of GE crops
and animals, and whether the current U.S. regulatory framework, which is based
primarily upon statutory authorities enacted before the rise of agricultural
biotechnology, is still adequate.
Legislation. The Senate-passed omnibus farm bill (H.R. 2419) would prohibit
FDA from issuing a final risk assessment and from lifting the voluntary moratorium
on marketing products of cloned animals until completion of newly mandated studies
on the safety and on the market impacts of introducing such products. The outcome
of this language could depend upon decisions in a House-Senate conference
committee in early 2008. Meanwhile, language accompanying the omnibus
appropriation for 2008 (H.R. 2764) also calls on the FDA to continue the voluntary
moratorium until more studies can be completed.
S. 414/H.R. 992 would amend the food and drug act and the meat inspection act
(but not the poultry inspection act) to require that products from cloned animals or
their progeny be so labeled. FSIS and FDA would have to require that anyone who
“handles, or distributes a cloned product for retail sale maintain a verifiable
recordkeeping audit trail” to verify compliance. A separate proposal (H.R. 1396/S.
536) would amend the Organic Foods Production Act of 1990 (7 U.S.C. 6504) to
prohibit the use of the “organic” label on food products from cloned livestock or their
progeny.
Appendix A: Overview of Selected Food Safety Bills
Bill Conten ts Status
H.R. 912 (Farr)Authorizes new appropriations for produce safetyIntroduced 2/8/07;
Spinach Researchresearch; provides for payments for spinach industry lossesreferred to Agriculture
and Recovery Act ofafter the FDA September 2006 health advisory on fresh
H.R. 962/S. 549Requires FDA to withdraw approval of nontherapeuticH.R. 962 introduced
(Slaughter/Kennedy)uses in food animals of drugs used to treat human diseases,2/8/07; referred to
Preservation ofunless manufacturer can reasonably demonstrate no harmEnergy and Commerce
Antibiotics forto human health due to antimicrobial resistance.Committee
Medical Treatment
Act of 2007S. 549 introduced
2/12/07; referred to
Health, Education,
Labor, and Pensions
H.R. 992/S. 414Amends the food and drug act and the meat inspection actH.R. 992 introduced
(DeLauro/Mikulski)to deem as misbranded a food or meat food product2/12/07; referred to
Cloned Foodderived from a cloned animal if it does not bear aAgriculture and to
Labeling Actconspicuous label stating this fact; requires verifiableEnergy and Commerce
recordkeeping.
S. 414 introduced
1/26/07 and referred to
Health, Education,
Labor, and Pensions
H.R. 1148/S. 654Establishes a new independent Food Safety AdministrationH.R. 1148 introduced
(DeLauro/Durbin)to administer and enforce all federal food safety laws. 2/16/07; referred to
Safe Food Act ofRequires: (1) a national food safety program based on anEnergy and Commerce
2007analysis of the food hazards; (2) standards for processorsand to Agriculture
of food and food establishments; (3) a certification system
for foreign governments or food establishments seeking toS. 654 introduced
import food; (4) a system for tracing food and food-2/15/07; referred to
producing animals from point of origin to retail sale; (5)Agriculture
maintaining an active surveillance system of food, food
products, and epidemiological evidence; (6) a sampling
program to monitor contaminants in food; (7) an analysis
of hazards in the food supply; (8) a national public
education campaign on food safety; and (9) research
relating to food safety. Sets forth provisions regarding
prohibited acts, administrative detention, condemnation,
recall, penalties for violations of food safety laws, whistle
blower protection.
H.R. 1396/S. 536Amends the Organic Foods Production Act of 1990 toH.R. 1396 introduced
(Woolsey/Kohl)prohibit the labeling of cloned livestock and products3/7/07; referred to
(no title)derived from cloned livestock as organic.Agriculture
S. 536 introduced
2/8/07; referred to
Agriculture
Bill Conten ts Status
H.R. 1760/S. 1149Amends the meat inspection act and the poultry productsH.R. 1760 introduced
(Kind/Kohl)inspection act to authorize the interstate distribution of3/29/07; referred to
(no title)state inspected meat and poultry if the Secretary ofAgriculture
Agriculture determines that state inspection requirements
are at least equal to federal inspection requirements;S. 1149 introduced
provides for partial reimbursement for inspection costs.4/18/07; referred to
Agriculture
H.R. 2108/S. 1274Amends the food and drug act to require a person who hasH.R. 2108 introduced
(DeLauro/Durbin)reason to believe that any food (including pet food)5/2/07; referred to
Human and Pet Foodintroduced into interstate commerce may be in violation ofEnergy and Commerce
Safety Act of 2007the act to immediately notify FDA of its identity and
location. If a food may pose a threat to public health,S. 1274 introduced
authorizes and requires FDA to implement a series of5/2/07; referred to
specific notification, detention, and recall procedures. Health, Education,
Sets forth certification and inspection requirements forLabor, and Pensions
foreign governments and foreign firms seeking to import
food into the United States. Also requires new FDASome provisions
measures to prevent contamination of pet food.included in P.L. 110-85
(see below)
H.R. 2315/S. 1150Directs USDA to review each state’s meat and poultryH.R. 2315 introduced
(Pomeroy/Hatch)inspection program for effectiveness and steps needed to5/15/07; referred to
New Markets forconvert to program described as follows. Amends theAgriculture
State-Inspected MeatFMIA and PPIA to authorize USDA to approve a
and Poultry Act ofqualifying state meat and/or poultry inspection programS. 1150 introduced
2007and allow the shipment in commerce (including interstate)4/18/07; referred to
of meat and poultry products so inspected (replaces currentAgriculture
federal-state inspection program). Also provides ability
for federally inspected plants to convert to the new stateLike provisions
inspection program.incorporated by House
Agriculture Committee
Provides for annual FSIS reviews of state plans; federal-into H.R. 2419, the
state cooperative agreements and partial reimbursementomnibus farm bill (see
for costs of meeting federal requirements; and limitationsbelow)
on size of plants permitted to enter the new program.
Prohibits from state inspection plan participation
establishments with more than 50 employees, with some
exceptions.
H.R. 2419 (Peterson)House version of omnibus farm bill includes provisions onH.R. 2419 introduced
Farm, Nutrition, andstate inspection like those in H.R. 2315/S. 1150 (see5/22/07; referred to
Bioenergy Act ofabove).Agriculture, which
2007reported it as amended
Senate version supplements current rules with programon 7/23/07 (H.Rept.
enabling products inspected by state personnel who are110-256). Passed by
under federal supervision to be shipped in interstatefull House on 7/27/07
commerce. Limits eligible establishments to those with 25
or fewer employees; state-inspected establishments withFull Senate considered
more than 25 employees could shift to regular federalH.R. 2419 beginning
inspection. Current federal establishments ineligible for11/5/07, substantially
the new state program. Contains 60% federal cost shareamended it, and passed
and 100% in states with high level of pathogen testing;the bill 12/14/07;
provides for new training and outreach programs.House-Senate
conference pending
Bill Conten ts Status
Senate version also establishes new Bipartisan Food
Safety Commission (see S. 2245); extends mandatory FSIS
inspection to farm-raised domestic catfish; establishes
reportable (i.e., adulterated) food registries for meat and
poultry; prohibits FDA from issuing a final risk
assessment and lifting the voluntary moratorium on
marketing products of cloned animals until completion of
new studies on the safety and on the market impacts of
introducing such products.
H.R. 2997 (Kaptur)Directs USDA and FDA to jointly establish a mandatoryIntroduced 7/11/07;
Assured Food Safetycertification program required for all food imports, to bereferred to Energy and
Act of 2007issued by the country of origin. Directs USDA and FDACommerce, to
to prohibit importation of a product that fails safetyAgriculture, and to
standards until the foreign production facilities can beWays and Means
inspected to determine that sufficient corrections have
been made, to be followed by more rigorous inspections
for three years. Establishes user fees on food imports of
up to $20 per line item imported, to pay for inspections.
H.R. 3100 (Kirk)Amends the food and drug act to authorize additionalIntroduced 7/19/07;
Import Safety Act ofappropriations for FDA of $20 million for each of FY2008referred to Energy and
2007through FY2012 for import inspections of processed foodCommerce
(and toothpaste). Significantly increases civil penalties for
food-safety related violations.
H.R. 3161, S. 1859Makes FY2008 appropriations for the: (1) USDA; (2)H.R. 3161 introduced
(DeLauro/Kohl)FDA; (3) Commodity Futures Trading Commission; andand reported as an
Agriculture, Rural(4) Farm Credit Administration. Specifies certain usesoriginal measure
Development, Foodand limits on or prohibitions against the use of funds7/24/07 by
and Drugappropriated by this act. (See text of this CRS report forAppropriations
Administration, anddetails on food safety-related funding for FDA and USDA)(H.Rept. 110-258)
Related AgenciesPassed by House 8/2/07
Appropriations Act,
2008S. 1859 introduced and
reported 7/24/07 by
Appropriations (S.Rept.
FY2008 funding for
these agencies
incorporated into H.R.
Signed into law
December 26, 2007
H.R. 3484 (DeGette)Establishes new notification and recall authorities forIntroduced 9/6/07;
Safe and Fairmeat, poultry, and other foods, including a requirementreferred to Agriculture
Enforcement andthat USDA or FDA be notified any time there is reason toand to Energy and
Recall (SAFER) forbelieve that a food is adulterated or misbranded. ProvidesCommerce
Meat, Poultry, andUSDA and FDA with mandatory recall authorities if
Food Act of 2007specified voluntary actions are not undertaken.
Bill Conten ts Status
Other provisions make it easier for FSIS to refuse to
provide or to withdraw inspection from meat or poultry
establishments; and provide new monetary penalties for
violations of food safety laws.
H.R. 3485 (DeGette)Requires, within one year of enactment, the establishmentIntroduced 9/6/07;
Tracing andof new traceability systems for both FDA and USDAreferred to Agriculture
Recallingregulated food products, through all stages of production,and to Energy and
Agriculturalprocessing, and marketing; includes record keeping andCommerce
Contaminationaccess requirements for producers, processors and others.
Everywhere (TRACE)
Act of 2007
H.R. 3580 (Dingell);Title X requires regulations on processing and ingredientIntroduced 9/19/07;
P.L. 110- 85standards for pet food, and on updated standards for petreferred to Energy and
Food and Drugfood labeling; also requires an early warning andCommerce. Bill
Administrationsurveillance system to identify pet food adulteration andreflects compromise
Amendments Act ofassociated disease outbreaks. Requires FDA to collect,between House and
2007 aggregate, and disseminate information on recalls of eitherSenate versions of FDA
human or pet foods; to coordinate activities, providebills (H.R. 2900; S.
assistance and support staff training for states to improve1082); only Senate
food safety programs, including for fresh and processedversion contained food
produce, and including at retail food establishments.safety provisions
Title X also amends the food and drug act to require aPassed House under
registry on potentially contaminated human and animalsuspension 9/19/07;
foods, and spells out notification and recordkeepingpassed Senate by
requirements, including standards and data elements forunanimous consent on
reporting instances of suspected food adulteration,9/20/07 and cleared for
including notification within 24 hours by processors. AlsoWhite House; signed
requires the preparation of various food safety-relatedinto law 9/27/07 (P.L.
reports; and provides for enhanced FDA inspection of110-85)
aquaculture and seafood through partnerships.
H.R. 3610 (Dingell)Reiterates that all FDA-regulated imported foods mustIntroduced 9/20/07;
Food and Drugmeet the same standards as U.S.-produced foods; entryreferred to Energy and
Import Safety Act ofwould be denied to foods that do not. All food importsCommerce
2007must originate from facilities or countries that have been
certified by FDA as having safety standards that provide
the same level of safety as U.S. standards. Failure to do so
could result in revocation of the certificate. Charges FDA
with enforcing the provision through random inspections,
sampling and testing. Requires user fees on imported
foods, beginning in FY2008, of up to $50 per recorded
import load. At least 90% of the fee revenue must be used
to carry out import and overseas inspections, with priority
on inspections at ports of entry and on detection of
intentionally adulterated food. Not more than 10% of the
revenue may be used for newly authorized research into
testing techniques for use on import inspections.
Bill Conten ts Status
Requires FDA to restrict imports of all foods to ports of
entry located in a metropolitan area that has an FDA
laboratory capable of testing such foods, although waivers
could be granted in limited circumstances. Prohibits
closing any of the current FDA laboratories, or any of the
20 FDA district offices. Requires the labeling of all foods
to identify the country of origin. Requires establishment
of a voluntary “Safe and Secure Food Importation
Program” under which food importing companies could
receive expedited movement of their products.
H.R. 3624 (Pallone)Requires new “National Food Safety Program” that mustIntroduced 9/20/07;
Consumer Foodbe based on a comprehensive analysis of food safetyreferred to Energy and
Safety Act of 2007hazards throughout the production and marketing chain. Commerce
Mandates process control regulations; requires quarterly
inspections of processors and importers, except those that
have negligible risk or meet exceptional standards.
Creates system involving routine FDA inspections of
foreign processing facilities and of imports at ports of
entry. Authorizes (but does not appear to require) FDA to
enter into an agreement with any foreign country desiring
to export food to the United States. FDA must certify the
specific types of food products covered by the foreign
safety system, and review each foreign certification at least
once every three years.
Includes import inspection provisions and requirements for
notification and mandatory recall. Permits FDA to impose
traceability requirements on any type or class of food
product if necessary to protect public health.
H.R. 3937 (DeLauro)Requires all FDA-regulated food imports from a foreignIntroduced 10/23/2007;
Food Import Safetyfacility or country that has been certified by HHS asreferred to Committee
Act of 2007having at least the same level of safety as U.S. standards,on Energy and
to be periodically reviewed by HHS. Permits HHS toCommerce
revoke certification if a foreign facility or country is linked
to illness or no longer meeting requirements. Provides for
mandatory notification of problem foods, and for
mandatory recall of such foods if voluntary actions to do
so are not sufficient. Sets forth civil and criminal
penalties.
H.R. 3967 (Burgess)Authorizes FDA to refuse any food from any country,Introduced 10/23/07;
Imported Food Safetygrowing area, producer, manufacturer or shipper due eitherreferred to Energy and
Improvement Act ofto repeated foodborne disease outbreaks or repeatedCommerce
2007adulteration, and if there is a reasonable probability of
significant adverse health consequences, and systemic
intervention is needed. A lower threshold could be used to
refuse an import in an emergency situation.
Bill Conten ts Status
S. 1292 (Schumer)Amends the meat and poultry inspection acts to requireIntroduced 5/3/07;
Meat and PoultryFSIS to establish a traceability system for all stages ofreferred to Agriculture
Products Traceabilityproduction, processing, and distribution of meat and meat
and Safety Act offood products and poultry and poultry food products. The
2007system must be able to trace each animal or group of
animals to any location the animal was held before
slaughter; and each carcass, carcass part and food product
forward from slaughter through processing and
distribution to the ultimate consumer. Also authorizes
recordkeeping requirements.
S. 1776 (Durbin)Amends the food and drug act to require FDA to establishIntroduced 7/12/07;
Imported Food Safetywithin two years a certification system for foreignreferred to Agriculture
Act of 2007governments and establishments seeking to import food
into the United States. Requires FDA to review, audit, and
certify a foreign government before certifying its program
as at least equivalent to the U.S. system; additionally
requires an onsite inspection of foreign establishments
before certifying equivalency. Requires audits at least
every five years to determine continued compliance, and
provides for decertification if a food import is linked to
human illness outbreaks. Establishes user fees of up to
$20 per recorded import load, with no less than 50% of
revenues to be used for border inspections and no more
than 50% for research on testing and sampling techniques.
S. 2077 (Harkin)Requires adoption of good manufacturing practicesIntroduced 9/20/07;
Fresh Produce Safety(GMPs) for processors of “fresh cut” produce, coveringreferred to Agriculture
Actsanitation procedures and water standards, including
testing, and based on a scientific risk assessment; has
similar good agricultural practices for growers. Provides
for FDA inspections of processors and producers. Other
provisions of the bill provide for research and public
education on produce safety, and for equivalency
agreements with countries exporting produce to the United
States.
S. 2081 (Brown)Provides new recall and notification authorities for FDAIntroduced 9/20/07;
Food and Productand FSIS generally similar to those in H.R. 2108/S. 1274,referred to Agriculture
Responsibility Act ofH.R. 3484 and H.R. 3624 (see above). Also, all
2007manufacturers of foods (and of other non-food products
like auto parts, drugs and other consumer products) must
obtain “recall responsibility certificates” which certify that
they have the resources to cover the entire cost of any
recalls, plus compensatory damages and costs that may
arise from product liability claims.
S. 2192 (Feingold)Requires FDA to collect user fees from a manufacturer ofIntroduced 10/18/07;
Food and Producta food (or other FDA-regulated product) if it must bereferred to Health,
Responsibility Act ofreinspected to ensure the correction of a violation found inEducation, Labor, and
Bill Conten ts Status
S. 2245 (Durbin)Establishes a Congressional Bipartisan Food SafetyIntroduced 10/25/07;
Food Safety AuthorityCommission to recommend statutory changes to modernizereferred to Homeland
Modernization Actthe food safety system and ways to harmonize food safetySecurity and to
requirements across agencies.Governmental Affairs;
added to Senate version
of farm bill (H.R. 2419)
S. 2418 (Casey)Requires public notification regarding any prohibitedIntroduced 12/5/07;
Ending Agriculturalimported food products; spells out civil penalties forreferred to Agriculture
Threats:importing such products; requires certification standards
Safeguardingfor accrediting imported food safety laboratories; provides
America’s Foodfor data sharing, public notification regarding recalled
Supply for Everyonefood products; authorizes appropriations for foodborne
(EAT SAFE) Act ofillness education, and for food safety personnel hiring and
Appendix B. Selected Food Safety Authorization Bills at a Glance
i n
sk 654n 536h
(Where boxes areS. 549KennedyS. 414kul S.urbi.ohlS. 1149S. 1274urbiS. 1150Hatc
ty, bills contain noer/MiDy/ Kohl D
icable provision.). 912. 962/. 992/. 1148/. 1396 Sse. 1760/K. 2108/. 2315/. 2419. 2997ur. 3100. 3484. 3485. 3580
rlaughteLauro/eLauro/oolind/eLauro/omeroy/apt.L. 110-85
H.R Far H.R S H.R D H.R D H.R W H.R K H.R D H.R P H.R H.R K H.R Kirk H.R DeGette H.R DeGette H.R P
Bill Focus:produceantibiotics(ag use)cloningsingleagencyanimalcloningstatemeat &pet/humanfoodstate meat& poultryimportsimportsrecalltrace-abiltyFDA
poultry
stem reorganizationyesstudy
(S en at e)
oblem notificationyesyesyesyes
(S en at e)
iki/CRS-RL34152datory recallyesyesyes
g/wacing/recordkeeping ye s ye s
s.or
leakfo r cement/p enalties ye s ye s ye s ye s
://wikirformance stndrds.yes
http process controlsyes
spection frequencyyes
d. testing/samplingyes
reign certificationyesyesyes
pedite import entry
user fees (for)(imports)
b e ling organic
search; educationyesyes
er selectedindustrylimits onrequirewhistle-“organic”interstatepet foodinterstateaddtl.state
isionslosspaymts.uselabelingblowerprotect.noteligibleshipmentpermittedrulesrequiredshipmentpermittedapprops.authorityasst.;misc. on
seafo o d s
here boxes are empty,losd
bills contain no. 3610. 3624. 3937r. 3967esininniny
applicable provision.)ingelallonerg. 1292chumer. 1776rb. 2077. 2081ow. 2192eingol. 2245rb. 2418se
H.R DH.RPH.RDeLauH.RBuSSSDuSHarkSBrSFSDuSCa
Bill Focus:importsnewprogramimportsimportstraceabilityimportsproducerecallsuser feesstudysmuggledimports
stem reorganizationyesyes (study)
oblem notificationyesyesyesyes
datory recallyesyesyesyes
acing/recordkeeping au t h o r i zed meat / p o u l t r y
fo r cement/p enalties ye s ye s ye s
rformance stndrds.yesProducegrowers &
iki/CRS-RL34152
g/wprocessors process controlsyes
s.orspection frequencyyesyes
leak
yesyeslab certif.
://wikid. testing/sampling
httpreign certificationyesyesyesyes
pedite import entryyes
user fees (for)(imports)(imports)(reinspection)
b e ling COOL
search; educationyesyesyesyesyes
er selected provisionslimit portswhistle-newcertifyCommissionaddtl.
of entry;blowerauthorityfirms’to study &approps.
no labprotectionto refuseability torecommendauthorized;
closuresunsafepay forchangesmore
importsrecalls training