Order Code IB10099
Issue Brief for Congress
Received through the CRS Web
Food Safety and Protection Issues
in the 107th Congress
Updated June 12, 2002
Donna U. Vogt
Domestic Social Policy Division
Jean Rawson
Resources, Science, and Industry Division
Congressional Research Service ˜ The Library of Congress

---

CONTENTS
SUMMARY
MOST RECENT DEVELOPMENTS
BACKGROUND AND ANALYSIS
Federal Agencies with Food Safety Responsibilities
Current Level of Preparedness for Food Safety and Security
DHHS/Centers for Disease Control and Prevention Surveillance Networks
DHHS/Food and Drug Administration
USDA/Food Safety and Inspection Service
USDA/Animal and Plant Health Inspection Service
USDA/Agricultural Research Service
State and Local Government Role in Food Safety
Funding
Appropriations for Food Safety and Bioterrorism
FY2003 Appropriations for Food Safety Activities
Proposed New Authorizations for Appropriations
Food Safety and Protection Measures in H.R. 3448 Conference Agreement
Registration of Food Processors
Record Keeping and Inspection
Detention Authority
Prior Notice, Marking, and Prohibition of “Port Shopping”
Debarment of “Bad Actor” Importers
Authority for Joint Agency Inspections and for Funding to States for Inspections
Research and Surveillance
Increased Inspection and Security Upgrades at Food Safety Facilities
Other Food Safety Issues
Recall Authority
Reorganization of the Federal Food Safety Regulatory Structure
Antimicrobial Resistance
Seafood Safety
LEGISLATION

---

IB10099
06-12-02
Food Safety and Protection Issues in the 107th Congress
SUMMARY
The Federal Food, Drug, and Cosmetic
In the weeks following the attacks, Con-
Act (FFDCA) gives the Food and Drug Ad-
gress added funds for anti-terrorism activities
ministration (FDA), in the Department of
to the law making FY2002 appropriations for
Health and Human Services (DHHS), author-
the USDA and the FDA (P.L. 107-76). In
ity to set and enforce standards for safety of all
addition, on January 10, 2002, the President
domestic and imported foods, except for meat,
signed a $20 billion Defense supplemental bill
poultry, and certain egg products, which are
into law that includes $328 million for USDA
under the authority of the U.S. Department of
and $151.1 million for FDA food protection
Agriculture (USDA). The FDA also ensures
activities.
that all animal drugs and feeds are safe, are
labeled properly, and produce no human
On June 12, 2002, the President is
health hazard when used in food-producing
expected to sign major counter-terrorism
animals. Also under FFDCA, the Environ-
legislation containing provisions related to
mental Protection Agency (EPA) sets legal
food safety and protection – the Public Health
limits (tolerances) on the amounts of pesticide
Security and Bioterrorism Preparedness and
residues that can be found in or on food. The
Response Act of 2002 (H.R. 3448/S. 1765).
Centers for Disease Control and Prevention
The bill authorizes $545 million for food
(CDC), also part of DHHS, tracks food-borne
protection (out of a total of $2.369 billion for
illness incidents and outbreaks, and provides
bioterrorism response). The bill contains
data and information to the other food safety
$130.25 million in appropriations for HHS
agencies.
and requires FDA to (1) register food proces-
sors and inspect their records, (2) detain adul-
Congress maintains close oversight of the
terated food, and (3) take a number of steps to
FDA’s food safety activities, particularly its
ensure the safety of imported foods (among
efforts to address the issue of microbiological
other provisions). The bill authorizes $415
contamination, which is responsible for an
million in appropriations for USDA, to be
estimated 76 million illnesses and 5,000
used for enhanced border inspection of im-
deaths in the United States each year. At issue
ports of plant and animal origin, lab biose-
for many years has been (1) whether the FDA
curity upgrades, and increased research.
has sufficient statutory authority over the food
industry to bring about continued improve-
To date, no further action has been taken
ments in food safety and to take enforcement
on other bills that would (1) give USDA
actions, and (2) whether the FDA has suffi-
authority to recall foods, and (2) consolidate
cient resources and personnel to inspect the
the activities of the 12 government agencies
volume of food it regulates.
with current food safety responsibilities into a
single independent federal entity. The Admin-
In addition to these ongoing concerns,
istration’s proposal for a Department of
the terrorist attacks and anthrax scares of fall
Homeland Security, and a similar Senate
2001 have raised worries about the FDA’s
proposal, S. 2452, would transfer some or all
(and USDA’s) readiness to prevent and re-
of USDA’s Animal and Plant Health Inspec-
spond to potential bioterrorist attacks on the
tion Agency to the new department, but would
nation’s food supply.
not make any changes in the organization of
federal food safety agencies.
Congressional Research Service ˜ The Library of Congress

---

IB10099
06-12-02
MOST RECENT DEVELOPMENTS
On June 6, 2002, President Bush proposed the creation of a cabinet-level Department
of Homeland Security. Under this proposal, all of USDA’s Animal and Plant Health
Inspection Service (APHIS), which conducts border inspections of imports of plant and
animal origin (among other things), would be transferred to the new department. The Senate
Committee on Governmental Affairs reported out legislation similar to the Administration’s
proposal on May 22, 2002. The National Homeland Security and Combating Terrorism Act
of 2002 (S. 2452), would transfer only APHIS’s border inspection activities to a Department
of National Homeland Security.
On May 22 and 23, 2002, the House and Senate, respectively, passed the conference
agreement on major counter-terrorism legislation that includes provisions intended to
protect the nation’s food supply from acts of bioterrorism (H.R. 3448/S. 1765; H. Rept. 107-
481).
On May 13, 2002, President Bush signed into law a bill to direct U.S. farm and
agricultural policy through 2007 (P.L. 107-171, the 2002 farm bill). Within this far-ranging
law is a provision that would establish a 15-member Food Safety Commission charged with
preparing a report for the President and Congress that will make specific recommendations
on how the safety of the entire U.S. food supply could be improved. This law also authorizes
appropriations for (1) a competitive grants program to construct and upgrade the security
of facilities conducting anti-terrorism related research at public colleges and universities;
and (2) research and extension programs to improve bioterrorism prevention, preparedness,
and response.
On May 13, 2002, Senator Ted Kennedy introduced legislation that would require the
Food and Drug Administration to approve antimicrobial animal drugs only if the
manufacturer can demonstrate that there is a reasonable certainty that their use in animal
feeds at subtherapeutic levels does not contribute to the development of antibiotic resistance,
among other things (S. 2508). On February 27, 2002, Representative Sherrod Brown
introduced a similar bill that would also regulate antibiotics in animal feed. (H.R. 3804).
BACKGROUND AND ANALYSIS
Most of the food safety related legislative and regulatory changes over the past decade
have been aimed at protecting the nation’s food supply from microbiological, chemical, and
toxic hazards that occur either naturally or accidentally in the lengthy farm-to-table food
supply chain. The fall 2001 terrorist and anthrax attacks have forced Congress, federal food
safety officials, and food industry policymakers to consider the nation’s readiness to protect
against and respond to intentional acts of food adulteration or agricultural resource
contamination. There is widespread concern that naturally occurring pathogens such as E.
coli O157:H7, Salmonella, Shigella, and Cyclospora could spread easily through the multi-
link food chain and could be used as a bioterrorist weapon. These pathogens already cause
approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths each year in
the United States. Such an attack would be particularly lethal to children, the elderly, and
the immune-compromised. Government officials and food industry observers speculate that
CRS-1

---

IB10099
06-12-02
the foods most vulnerable to contamination would be those that are minimally processed at
a central location, and/or are ready-to-eat, such as milk and fresh produce.
Bioterrorism against the food supply would also directly harm the U.S. economy. U.S.
agriculture contributes $1 trillion to our gross domestic product (GDP) annually and provides
22% of all jobs. Food production exceeds $200 billion, with over $55 billion in exports each
year. The production and consumption of food is so extensive (coming from 500,000 farms
and handled by 57,000 food processors and 6,000 meat, poultry, and egg products
processors) that if even a small number of contaminants were intentionally introduced to
some part of the food chain, such an incident could seriously damage public confidence in
the food supply and could result in staggering economic losses.
Federal Agencies with Food Safety Responsibilities
Several federal agencies have regulatory responsibilities for food safety. The U.S.
Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) regulates
red meat, poultry, and certain egg products. The Animal Plant Health Inspection Service
(APHIS) inspects cargo and passengers at U.S. ports of entry for animal and plant pests, and
responds to animal disease outbreaks, among other duties. The Agricultural Research
Service (ARS) conducts research on animal diseases, food safety, and other subjects to
support FSIS’s regulatory activities.
The Federal Food, Drug, and Cosmetic Act (FFDCA) gives the Food and Drug
Administration (FDA) responsibility for the safety of all other foods. The FDA is an agency
of the Department of Health and Human Services (DHHS). Most of FDA’s activities lie
within two centers — the Center for Food Safety and Applied Nutrition (CFSAN), which
establishes guidance and regulatory requirements for assuring that food is safe and not
adulterated, and the Center for Veterinary Medicine (CVM), which ensures the safety and
efficacy of all drugs used in food animals and feeds. In addition, the Centers for Disease
Control and Prevention (CDC), also part of DHHS, tracks food-borne illness incidents and
outbreaks, and provides data and information to the other food safety agencies. State health
departments send CDC reports of confirmed food-borne problems for a national surveillance
database. Of the illnesses whose food source is known, 80% are associated with FDA-
regulated food products such as fish, shellfish, fruits, and vegetables; the remaining 20%
come from foods under FSIS’s jurisdiction.
Under the FFDCA, the FDA is required, through oversight and inspection, to ensure that
food manufacturers, producers, and distributors deliver into interstate commerce foods that
are free of contamination and free of unacceptable chemicals. The agency works with the
food industry to set manufacturing standards to minimize the opportunities where
contamination can occur. FDA monitors how well the food industry is meeting the standards
through occasional inspection, but largely takes regulatory action only when problems arise.
FDA maintains the same requirements for imported foods as for domestic foods. The agency
annually inspects roughly 1% of all imported foods over which it has jurisdiction. This level
of oversight over foods has been a recurrent issue among some Members of Congress.
Under the meat, poultry, and egg inspection statutes, USDA’s Food Safety and
Inspection Service (FSIS) has much more regulatory control over its products than the FDA
exercises over the rest of the food supply. Meat animals and poultry cannot be slaughtered
CRS-2

---

IB10099
06-12-02
unless FSIS inspectors are present. Every plant that processes meat, poultry, and egg
products receives a daily visit from an inspector who checks operations and the plant’s
compliance with extensive record-keeping requirements. Meat and poultry imports can come
only from countries whose inspection systems FSIS has certified to be at least equal to the
U.S. system, and then only from plants that FSIS has approved. Imports receive various
levels of reinspection by FSIS before they are released into commerce.
Current Level of Preparedness for Food Safety and Security
Since the September 2001 attacks, federal food safety agencies have taken many steps
to increase their readiness in the event of a bioterrorist attack.
DHHS/Centers for Disease Control and Prevention Surveillance Networks.
In the last decade, the CDC established more than 10 surveillance systems to identify and
track the source of outbreaks of food-borne illnesses and to assist regulatory agencies in their
food safety activities. Consequently, the agency now has separate surveillance systems to
track botulism, Creutzfeldt-Jakob disease (the human form of “mad cow” disease),
Escherichia coli O157:H7, Giardia, Salmonella, and Salmonella enteritidis, viral hepatitis,
trichinellosis, typhoid fever, and Vibrio infections in foods. Since September 11, 2001, CDC
has been adapting these and other surveillance systems to track intentional acts of terrorism
directed towards the nation’s food supply. For example, FoodNet, established in 1995 by
USDA and FDA, is now on heightened alert to track the incidence rate of illnesses caused
by these same nine pathogens in nine different geographic areas. A different program,
PulseNet, which compares genetic patterns of bacteria isolated from patients and/or
contaminated food, is gearing up to identify any intentional hazards that may show up in
food.
Continued reforms in food safety activities and surveillance appear to be having a
positive effect. On April 19, 2002, CDC published preliminary numbers mentioning that
Pathogen Reduction/Hazard Analysis Critical Control Point (HACCP) systems regulations
in meat and poultry slaughter, egg processing, and seafood, better agricultural practices
(particularly for produce), new technologies to reduce food contamination, and increased
public education in food preparation practices, may be responsible for the reduction in food
borne illness reports.
CDC’s surveillance systems, for the most part, depend on the reporting capabilities of
local- and state-level health and agriculture officials. Since September 11, 2001, the agency
has been training these officials and laboratory technicians to recognize hazards in foods.
It has also begun to refurbish public health laboratories in most states to increase the capacity
of these facilities to quickly identify acts of terrorism.
CDC also is a participant in the intergovernmental Foodborne Outbreak Response
Coordinating Group (known as FORC-G), which was created in 1998 under the previous
administration’s Food Safety Initiative. The group is composed of representatives of FDA,
USDA, CDC, and EPA, as well as state and local food safety officials. Since FORC-G was
established by executive order, the Bush Administration would have to reactivate it in order
for it to reconvene. Currently, the group is not meeting.
CRS-3

---

IB10099
06-12-02
DHHS/Food and Drug Administration. Since the fall 2001 attacks, FDA has been
refocusing its attention and realigning its policy priorities and resources to try to prevent
potential terrorist attacks on the U.S. food supply. Its efforts have been concentrated on
immediate actions to deter or prevent terrorist activity by: (1) increasing inspection
capability; (2) improving surveillance programs for determining food hazards; (3)
strengthening assessments of threats to food; and (4) setting up a system to respond to
potential threats.
Working with the U.S. Customs Service, FDA by the end of September 2001 had placed
additional inspectors at ports of entry to create a presence designed to deter wrongdoers.
FDA also began inspecting and sampling more food imports and domestic plants that could
be processing vulnerable foods such as milk.
For the long term, the agency continued upgrading its computer surveillance data
systems, particularly its Operational and Administrative System for Import Support (OASIS),
a computerized screening system that uses a variety of risk-based criteria to target food
import shipments for further inspection. It is also developing an in-house surveillance
network system called eLEXNET that will improve the abilities of the agency’s laboratories
to diagnose infectious or toxic agents and to link food safety experts in federal, state, and
local food safety laboratories. FDA also has strengthened its ties to CDC’s surveillance
programs, particularly FoodNet and PulseNet.
On January 9, 2002, FDA published two sets of guidelines, one for the food industry
and the other for food importers. The guidelines, developed by the agency with industry
input, encourage operators to review sequentially controls where their food product might
be vulnerable to tampering, or criminal and terrorist attacks. FDA has identified a step-by-
step process for the food industry to determine hazards in foods that could pose the highest
risk to public health. It suggests categories where food manufacturers should examine
possible threats to avoid any potential tampering in raw material, packaging, and finished
products — for example, foods prepared in a central facility for distribution using unscreened
and transient field employees.
The agency has also begun to assess the gaps in the federal, state, and local safety nets
by determining whether rapid testing technology exists that is capable of identifying hazards
in foods, and whether there are sufficient numbers of trained laboratory personnel who can
identify various hazards. Also, the FDA is in contact with regulatory agencies abroad to
maximize coordination to protect food. International coordination will allow FDA to trace
back and respond quickly to any threats to the U.S. food supply.
According to agency officials, FDA is revising its existing emergency plan by
identifying its response team, providing the training and equipment needed to contain a
terrorist threat, revisiting its FORC-G emergency response plans, and developing a list of
contacts in other federal agencies, including the Environmental Protection Agency, the
Federal Bureau of Investigation, USDA, and 3,000 state and local offices with responsibility
for monitoring retail food establishments and their employees. In addition, the FDA has
communicated with consumers on its web page about the importance of vigilance as it
pertains to potential threats to the food supply.
CRS-4

---

IB10099
06-12-02
USDA/Food Safety and Inspection Service. On March 14, 2002, Under
Secretary for Food Safety Elsa Murano testified before the House Agriculture Appropriations
subcommittee on the steps FSIS and the Department currently are taking administratively to
address food biosecurity issues. At the Department level, the USDA Homeland Security
Council coordinates anti-terrorism activities across USDA and with other federal agencies.
The Protection of the Food Supply and Agriculture Production subcouncil coordinates
FSIS/APHIS preparedness and response activities. In the event of a food-related biosecurity
event, the Food Emergency Rapid Response and Evaluation Team (FERRET) authorized by
the Agricultural Research, Extension and Education Reform Act of 1998 (P.L. 105-185)
would join forces with the subcouncil. Within FSIS, the Food Biosecurity Action Team (F-
BAT) has placed the agency’s 7,600 inspectors on high alert to look for ante-mortem and
post-mortem irregularities in meat animals and poultry, has conducted mock exercises to
improve response time and communication in emergency situations, and is working with
slaughtering and processing operations to improve the security of both the physical plant and
the workforce. The Food Threat Preparedness Network (PrepNet) is a joint FSIS/FDA group
that works on threat prevention and emergency response.
The livestock industry also has launched a food-industry-wide effort (the Alliance for
Food Security) to develop bioterrorism risk management plans that coordinate with federal
preparedness and emergency response plans. Industry officials note that these activities build
upon efforts that began several years ago to forestall the introduction and spread of mad cow
disease, and more recently, foot-and-mouth disease.
USDA/Animal and Plant Health Inspection Service. APHIS, in cooperation
with other state and federal agencies, is charged with protecting against accidental
introductions of plant pests and animal diseases through inspection of craft, cargo, and
passengers at U.S. ports of entry. APHIS is also responsible for establishing quarantines,
controlling the interstate commerce of regulated articles, and directing and coordinating
eradication efforts with state and federal agencies inside areas of quarantine. While APHIS
has, in the past, successfully kept out or intercepted many foreign pests and diseases flowing
through commercial and trade channels, some concerns have been raised about its ability to
respond to deliberate, and perhaps domestically initiated, introductions of disease agents or
pests. These concerns were heightened recently by the USDA’s Office of the Inspector
General (OIG) report (available at [http://www.usda.gov/oig/auditrpt/50601-3-Ch.pdf])
stating that deficiencies in APHIS-FSIS coordination of meat cargo inspection procedures
could increase the possibility of the introduction of foot-and-mouth and mad cow diseases.
In response to the threats highlighted by last September’s attacks, APHIS officials have
announced that the agency is increasing the inspection staff at U.S. ports of entry by 350 and
is adding 20 veterinarians to imported and domestic disease surveillance and control
programs. APHIS also is stepping up the agency’s smuggling interdiction activities and
making $1.5 million in grants available to states specifically to help them plan their response
to potential foreign animal disease outbreaks.
Under the President’s June 6 proposal for a cabinet-level Department of Homeland
Security, all of APHIS would become part of the new department under its Border and
Transportation Security function. A similar Senate proposal for a new executive security
department, which the Senate Committee on Governmental Affairs reported out on May 22,
CRS-5

---

IB10099
06-12-02
2002, would transfer only APHIS’s border inspection function to the department (S. 2452,
the National Homeland Security and Combating Terrorism Act of 2002).
USDA/Agricultural Research Service. ARS is USDA’s in-house research agency,
and is responsible for supporting the regulatory missions of APHIS and FSIS with scientific
information. It operates animal disease bio-containment laboratories in Plum Island, NY,
and Ames, IA. In light of the events of fall 2001, ARS is increasing the security of its
pathogen culture collections used in disease diagnosis and treatment research. According to
USDA officials, laboratory security has been increased at several facilities involved in
research of animal pathogens such as foot-and-mouth disease and anthrax. Concerns about
a lack of adequate physical and biological security and about deteriorating facilities have
been raised since 1992, when an internal USDA review pointed out serious infrastructure
problems. Earmarks for improvements of sensitive facilities totaled $16 million in FY2001
appropriations (see Funding section for supplemental appropriations under more recent acts).
The President’s proposed Department of Homeland Security would become the new
home of two joint ARS/APHIS animal disease labs, one in Ames, Iowa, and one on Plum
Island off Greenport, New York. These labs perform research on the most dangerous animal
disease and pest organisms and are among those most in need of upgrading and security
enhancement. S. 2452, the Senate proposal for a Department of National Homeland
Security, does not contain this provision.
State and Local Government Role in Food Safety. State, county, and local
public health and agriculture departments, along with the CDC, play a major role in helping
FDA and USDA carry out their responsibilities. Even though federal law mandates the safety
of all food, more than 3,000 state and local regulatory agencies monitor over 1.2 million
retail food establishments to ensure that they are following procedures outlined in an FDA
guidance manual called the Food Code. CDC primarily assists state and local health
departments by investigating outbreaks of illness and by preparing and training state and
local officials in identifying the cause of the outbreak or intentional contamination.
Funding
Appropriations for Food Safety and Bioterrorism. On September 18, 2001, the
President signed P.L. 107-38 (H.R. 2888), the 2001 Emergency Supplemental Appropriations
Act for Recovery from and Response to Terrorist Attacks on the United States. The Act
appropriated $40 billion to be used by the President for relief efforts and anti-terrorism
activities. The Act divided the funds in half, giving the President immediate control over
disbursement of the first $20 billion, and requiring Congress to pass separate legislation to
allocate the remaining $20 billion. Out of the first $20 billion, FDA received $1.75 million
to secure the physical plants of the agency and its laboratories.
Congress included the legislation allocating the second $20 billion as an attachment to
the FY2002 Defense Appropriations Act, signed by the President on January 10, 2002 (H.R.
3338, P.L. 107-117). For USDA, P.L. 107-117 contains $328 million for a variety of
activities within ARS, APHIS, FSIS, and the Office of the Secretary to enhance security and
conduct counter-terrorism research. The Act allocates $151.1 million to FDA for a wide
range of counter-terrorism activities. The FY2002 FDA appropriation, which was signed in
December 2001, directs the agency to receive an additional $6.8 million, bringing the total
CRS-6

---

IB10099
06-12-02
for counter-terrorism activities to $157.9 million. FDA has stated its intention to hire 400
border personnel, including inspectors; 151 laboratory analysts; 84 compliance officers; and
38 risk assessors to improve its capacity to respond to terrorist threats.
The President’s FY2003 proposed budget requests $159.1 million to support ongoing
counter-terrorism activities for FDA. The request reflects an increase of $1.2 million over
FY2002 funding of $157.9 million. Of this $159 million, $98.1million is slated for counter
terrorism activities related to food safety, particularly the development of tests to detect
bioterrorist agents and to increase the safety of imported foods. The remaining $61 million
would be used for general counter-terrorism activity support.
FY2003 Appropriations for Food Safety Activities. For FY2003, the President
has requested $404.2 million for FDA’s food safety activities apart from those activities
designated under the counter-terrorism request. The funding request includes $91.5 million
to be used for microbiological food safety activities; $79 million for the testing of chemicals
and pesticide residues in foods; $22.1 million to continue BSE-related activities; $134.7
million for additional inspections; $44.1 million for what is called premarket analysis and
approval of food additives; $23.5 million for pay increases for the entire food safety program;
and $9.3 million for the testing of dietary supplements.
The FY2003 budget proposal requests a $905 million program level for USDA’s meat,
poultry and egg inspection programs. The request includes an increase of $14.5 million to
upgrade FSIS’s computerized inspection information system. (The proposal does not
designate any funds specifically for anti-bioterrorism activities.)
Proposed New Authorizations for Appropriations. The conference agreement
on the Public Health Security and Bioterrorism Preparedness and Response Act (H.R.
3448/S. 1765; H. Rept. 107-481), which the House passed on May 22 and the Senate on May
23, 2002, authorizes $545.25 million (out of a total of $2.369 billion in the bill) to be
appropriated for food safety counter-terrorism activities for FDA and USDA (see Table 1).
Of the $2.369 billion total appropriations authority in the Act, $545.25 million (or 23%) is
authorized for food protection and security related activities for the current fiscal year. For
subsequent fiscal years, the bill authorizes such sums as necessary to carry out the activities.
For FY2002, this bill provides for HHS and FDA together $130.25 million, or 5.5%, of the
bill’s total authorizations, and for USDA $415 million, or 17.5% of the total. The following
table summarizes the proposed distribution of funds.
Table 1. Proposed Authorizations for Food Protection for FY2002 in
the Public Health Security and Bioterrorism Preparedness and
Response Act of 2001
(H.Rept. 107-481 as passed by both chambers)
Section
Allocation
Proposed
Authorizations
301
HHS/Food Safety and Security Strategy
$.75 million
302
HHS/FDA Protection Against Adulteration of Food
$100 million
311
HHS/ Grants to States/Tribes For Inspections of Food
$10 million
Facilities
CRS-7

---

IB10099
06-12-02
312
HHS/Surveillance and Information Grants and Authorities
$19.5 million
331
USDA/APHIS Security
$30 million
332
USDA/FSIS Security
$15 million
333
USDA/ARS BioSecurity Upgrades
$180 million
Plum Island Research Center, Greenport, NY
($100 million)
ARS/APHIS Research Facility, Ames, Iowa
($80 million)
335
USDA/Research and Development
$190 million
Total HHS/FDA
$130.25 million
Total USDA
$415 million
TOTAL PROPOSED FUNDING
$545.25million
Food Safety and Protection Measures in H.R. 3448 Conference
Agreement
The food safety and protection measures included in the conference agreement on H.R.
3448 (H.Rept. 107-481) build upon long-standing concerns about the federal food safety
system. These concerns include (1) whether FDA has sufficient statutory authority to
oversee the food industry, and sufficient resources and personnel to carry out its mandate;
and (2) whether FSIS has sufficient authorities and resources to assure the safety of meat and
poultry. In this Act, Congress authorized the following extensions of FDA authority over
food, particularly imports, to ensure better the prevention and tracking of food adulteration.
Registration of Food Processors. The Act requires FDA to establish a one-time
registration system, within 18 months of enactment, for any domestic or foreign facility that
manufactures, processes, packs, and handles food in or for the United States. The Act gives
FDA authority to record all the identities (brand names) and the general food categories
under which business is conducted, and the addresses of the facilities. In return, the Act
requires each facility to be given a number so the list of registered facilities can be kept up
to date. It allows the use of electronic submissions to register as long as there are validating
protocols in place. Foreign facilities must name a U.S. agent in their registration.
Restaurants, certain retail stores, non profit food and feeding establishments, fishing vessels,
trucks and other motor carriers, and farms are exempt from registration requirements. The
conference managers point out that a registration system will permit FDA to obtain an
accurate inventory of its regulatory purview and will enhance its capability to trace back
contaminated food. Critics argue, however, that registration creates an enormous and
ineffective burden for FDA.
Record Keeping and Inspection. The Act authorizes the FDA to publish rules to
require that food manufacturing establishments keep 2 years of production and distribution
records. Under these rules FDA inspectors will have access to all processing, packing,
holding, importing, and distribution records in the event of a suspected food safety problem.
FDA is allowed to reduce the requirements for small businesses. The Act limits access to
records that may contain trade secrets and/or confidential information on recipes, and
financial, pricing, personnel, research, and sales data. The statutes governing meat and
CRS-8

---

IB10099
06-12-02
poultry inspection already allow FSIS access to records of this type. As with facility
registration, access to industry data will make it easier for the agency to determine the cause
and scope of distribution of an adulterated or misbranded food. Such authority also allows
the FDA to track and control better a food product suspected of being used in a biological
attack, particularly if the records show an “immediate previous source” and “immediate
subsequent source.” Opponents, however, are concerned that the standard permitting record
inspection is very high and that the agency may not have the freedom to act if they need to.
Detention Authority. The Act gives FDA the authority to detain food imports under
certain conditions. Currently, FDA must seek authorization from a judge to seize
contaminated food and/or get an injunction to prohibit the food from entering commerce. The
agency cannot require the owner of the product to hold it from further distribution. With new
authority under the Act, and if “credible evidence” indicates that a food presents a threat of
serious adverse health consequences or death to humans or animals, an FDA employee with
the approval of the Secretary of HHS, can detain a suspected food for 20 days and up to 30
days, if necessary. The Act requires FDA to promulgate procedures that will expedite the
processing of perishable foods so as not to unnecessarily ruin its marketability. An appeal
of the detention is possible. The conference managers see such detention authority as
helping prevent violative products from reaching consumers when a public health emergency
is declared. Critics claim, however, that the phrase “a threat of serious adverse health
consequences or death to humans or animals” is vague and therefore would be difficult to
implement.
Prior Notice, Marking, and Prohibition of “Port Shopping”. The Act gives
authority to FDA to prevent tampered or contaminated food from entering the country by
requiring importers to give prior notice of the intent to import food with enough time for the
Secretary to receive, review, and respond to the notice. If a notice is not given, the food will
be considered adulterated. Food imports that are refused entry are to be marked United
States: Refused Entry, and the Act makes the importer responsible for bringing the refused
food shipment into compliance with U.S. regulations. These new FDA authorities, according
to the conference managers, will protect U.S. consumers from unscrupulous importers and
will help FDA ensure that imports comply with U.S. regulations. They also put into statute
some of the requirements that FDA published as proposed rules, but never finalized, in the
last few years. Critics claim that the increased regulation will likely add to the cost of
imported products, and are not necessary because APHIS regulations already require
importers to notify U.S. Customs in advance of importing most food products.
Debarment of “Bad Actor” Importers. The Act prohibits any importer who is a
convicted felon related to the importation of food or has a pattern of importing adulterated
food from presenting any further shipments for entry into the United States. The Act does
protect an innocent purchaser of the food if that person can show the imported food is in
compliance with U.S. regulations. Critics say that FDA already has an import alert list of
importers who have violated U.S. laws and does not need what they say is a redundant
authority.
Authority for Joint Agency Inspections and for Funding to States for
Inspections. The Act authorizes the Secretary to commission officials of other federal
agencies to conduct examinations, inspections, investigations, and related activities at
facilities jointly regulated by HHS and the other agency. The Act also authorizes
CRS-9

---

IB10099
06-12-02
appropriations of (1) $10 million in FY 2002 for grants to states and specified Indian tribes
to conduct inspections; and (2) $19.5 million to states and Indian tribes to expand their
participation in food safety surveillance networks. The conference managers see these
delegations of authority as rationalizing manpower and resources to provide for more
inspections of food facilities. Opponents, however, are concerned about the risk of what they
term as “overzealous” state and local officials making judgments about manufacturing
procedures.
Research and Surveillance. The Act provides authorization for $19.5 million for
FY 2002 to be granted to states to expand their participation in PulseNet, FoodNet, and other
networks that support the foodborne disease surveillance programs run by the CDC. It also
requires that the Secretary coordinate surveillance for human and zoonotic diseases (the latter
are animal diseases that can be transmitted to humans) through FDA, CDC, and USDA. The
Act also will strengthen programs in the Agricultural Research Service and authorizes $190
for FY 2002 for state-level research, to enhance the scientific capacity for guarding against
and responding to bioterrorism threats, and to continue existing partnerships with institutions
of higher education, intelligence communities, and international organizations.
Increased Inspection and Security Upgrades at Food Safety Facilities. The
Act authorizes appropriations of additional funds to (1) expand both FDA and USDA
inspections; (2) plan for a bioterrorist response; (3) expand, upgrade, and secure their own
public food facilities to make them less vulnerable to potential terrorist acts; and (4)
collaborate with other federal and state agencies on these efforts. Critics of these provision
point out that FDA, together with the food industry, has developed and promoted the
adoption of “best practices” for the biosecurity of manufacturing facilities. Therefore, some
food industry representatives claim that the industry already has completed this type of
preparation and needs no further guidance or inspection.
The Act contains a separate subtitle that requires USDA to regulate hazardous
biological agents and toxins contained in its agricultural research facilities by inventorying
all such agents and restricting access to them. Finally, the Act creates new authority for civil
fines and criminal penalties for anyone who damages or disrupts an animal or agricultural
enterprise.
Other Food Safety Issues
Although Congress has addressed certain food safety related issues in the context of
bioterrorism legislation, there are many who still maintain that some other and larger reforms
are necessary to improve the overall performance of the nation’s food safety system.
Recall Authority. Some policy makers and consumer groups have argued for many
years in favor of giving both FDA and FSIS the direct authority to order recalls of suspected
contaminated foods. Currently, recalls are ordered by the manufacturer of the product on a
voluntary basis, usually after consultation with FDA or FSIS officials. Critics of mandatory
recall authority are concerned that it would give too much power to administrative officials
and could result in drastic financial losses from suspected contamination incidents that could
ultimately be proven false. Furthermore, opponents of mandatory recall say that the threat
of adverse publicity from a recall holds most companies in compliance, and that there have
CRS-10

---

IB10099
06-12-02
been few instances where companies have refused an FDA or USDA recommendation to
issue a recall.
Shortly after September 11, 2001, Representative Udall introduced legislation that
would amend the meat and poultry acts to authorize FSIS to recall suspected contaminated
meats directly (H.R. 3127). An August 2000 GAO study on FSIS and FDA recalls (Food
Safety — Actions Needed by USDA and FDA to Ensure That Companies Promptly Carry Out
Recalls) criticized the agencies’ efforts in making sure that companies carry out recalls
quickly and efficiently, particularly of products that may carry severe risk of illness. GAO
also stated that neither FDA nor FSIS compiles sufficient information on companies’ recall
schedules or methods, and that determining the need for mandatory recall authority could not
be done until such data were available. In addition to recall authority, civil penalty authority
for FSIS has been proposed several times in recent years. One such bill has been introduced
in the 107th Congress (H.R. 1276). Consumer groups and food safety advocacy groups have
testified in favor of obtaining these new enforcement tools. Interest in these authorities
could increase in light of the new awareness of the potential for bioterrorism.
Reorganization of the Federal Food Safety Regulatory Structure. For many
decades there has been a debate about the federal regulatory structure and whether it should
be changed. Some have proposed that the several different federal agencies having
responsibility for food safety be consolidated into a single entity. Two proposals (S. 1501,
the Safe Food Act of 2001, and an identical bill, H.R. 1671) would place USDA’s and FDA’s
food agencies (FSIS, CFSAN, and CVM) and the Department of Commerce’s National
Marine Fisheries Service into a single independent food safety agency. According to
proponents of the single agency concept, the current system is fragmented and ill-equipped
for meeting challenges from potential terrorist acts, as well as from emerging pathogens,
aging populations, and increasing level of food imports. Supporters say that a single agency
would result in a more consistent and efficient system for regulating food. Opponents
maintain that a reshuffling of bureaucracies would not necessarily provide safer food or the
additional resources needed for proper inspections. They also claim that food companies are
doing their job in producing and distributing safe food.
At an October 10, 2001 hearing on food protection post-September 11, the GAO
restated its long-standing criticism of the current food inspection system and reemphasized
the National Academy of Sciences’s (NAS’s) 1998 report calling for greater coordination and
statutory reform (see Ensuring Safe Food from Production to Consumption, available on the
GAO Web site at [http://www.gao.gov]). On March 15, 2002, Food and Drug
Administration Deputy Commissioner Lester Crawford said that he was taking calls for a
single food safety agency seriously. Crawford's remarks followed those of Homeland
Security Director Tom Ridge, who said at a recent food industry meeting that the Bush
Administration is examining whether the food safety system, as it has evolved over several
decades, is the best one for meeting future needs and threats. The Farm Security and Rural
Investment Act of 2002, which the President signed into law on May 13, 2002, (H.R. 2646/S.
1731, the 2002 farm bill), contains a provision creating a 15-member Food Safety
Commission that would review all the existing recommendations to improve food safety and
within 1 year deliver a report to the President and Congress making comprehensive
recommendations for enhancing the U.S. food safety system. Proposals to reorganize federal
food safety agencies are absent from the President’s Department of Homeland Security
CRS-11

---

IB10099
06-12-02
proposal and from S. 2452, the National Homeland Security and Combating Terrorism Act
of 2002.
Antimicrobial Resistance. Antimicrobials, a set of agents that include among
others, antibiotics and disinfectants, have benefitted the public health by treating diseases
that were un-treatable earlier. Antibiotics are also fed to farm animals to speed their growth,
to promote the efficient use of the feed, and they are sprayed on crops similar to pesticides.
Their widespread use may be causing some of these drugs to lose their ability to control
disease, and some to become resistant to a number of antibiotics that are crucial for treatment
of certain diseases. Although resistance to antibiotics has been noticed since they were
introduced in the 1940's, more tracking (surveillance) and publicity has recently raised
concern among some Members of Congress over this public health issue, particularly the use
of antibiotics in food animals to promote growth. Some experts expect resistance problems
to worsen in the future. (See CRS Report RL30814, Antimicrobial Resistance: An Emerging
Public Health Problem.)
Defining appropriate legislative responses is particularly difficult given the complexity
of the antimicrobial resistance problem, the lack of data to assess the problem, and the
disagreement over the seriousness of the extent of the health threat of resistance. Use of
antimicrobials in human medicine, for example, is thought to be the primary source of
resistance. In addition, the uses of antibiotics in the agricultural sector have raised questions.
The conflict there is over how much antibiotic use, both for treating disease and promoting
growth, in food-producing animals contributes to resistant strains of bacteria.
On January 18, 2001, an Interagency Task Force on Antimicrobial Resistance, co-
chaired by CDC, FDA, and NIH, released a “Public Health Action Plan to Combat
Antimicrobial Resistance.” The Plan reflects a broad-based consensus of federal agencies1
on what actions the government should take to combat antimicrobial resistance. The Plan
contains goals and 84 action items–13 of which are considered “top priority”:surveillance,
prevention and control, research, and product development. Each action item specifies the
coordinator, participating agencies, and timelines. It asks all federal agencies to standardize
detection methods, design and implement a national surveillance plan, and develop
procedures to monitor patterns of antimicrobial drug use in human medicine, agriculture, and
consumer products.
The Plan also calls for a public health education campaign to promote prudent
antimicrobial drug use. It advocates the use of vaccinations to prevent infections from
occurring in patients residing in nursing homes, among other places. It calls for the
implementation of the FDA framework for antibiotics in food animal production. It supports
research on resistance genes by public and private groups. Such research would develop
rapid diagnostic tests and novel therapies to better control resistance. It recommends the
creation of an interagency antimicrobial resistance product development working group to
identify and publicize public health needs for new products. It also calls upon the federal
1 Members include: Agency for Healthcare Research and Quality (AHRQ), CDC, FDA, Health Care
Financing Administration (HCFA), NIH, and the Health Resources and Services Administration
(HRSA), several agencies of USDA, the Department of Defense (DoD), the Department of Veterans
Affairs (DVA), and the Environmental Protection Agency (EPA).
CRS-12

---

IB10099
06-12-02
government to identify incentives that can be used to promote the development of new
human and animal drugs and their judicious use. A second plan will consider the
implications of resistance internationally.
On February 27, 2002, the Preservation of Antibiotics for Human Treatment Act of
2002 (H.R. 3804) was introduced. The measure would prohibit approvals of new
antimicrobial animal drugs unless the manufacturer could demonstrate that subtherapeutic
use of the drug in animal feeds would not contribute to the development of antimicrobial
resistance. The bill also would rescind existing approvals and exemptions concerning the
nontherapeutic use of certain antimicrobial drugs until the same standard of lack of harm to
human health is met. On May 13, 2002, Senator Ted Kennedy introduced a bill, the
Preservation of Antibiotics for Human Treatment Act of 2002 (S. 2508 ) that is similar but
not identical to H.R. 3804. It would prohibit the use of any antibiotic of the fluoroquinolone
class to be used in poultry, and require that any new antimicrobial that would be used
nontherapeutically would have to show that there was a lack of harm to human health. The
conference report on H.R. 3448 authorizes $25 million for FY2002 and FY2003 and such
sums as may be necessary for FY2004-FY2006 for research and development initiatives for
detection of antimicrobial resistance in priority pathogens.
Seafood Safety. The issue of risk of mercury exposure from fish consumption is
receiving renewed attention. News media have been covering an environmental group’s
charge that the FDA does not adequately protect pregnant women and children from
consuming too much mercury-containing fish, particularly canned tuna. Critics also claim
that FDA has abandoned an ongoing mercury testing program that it ran in the 1990s. FDA
officials state that the testing program revealed that mercury levels have remained stable over
time, which is why the agency diverted resources to other purposes. They say furthermore
that the agency’s routine surveillance of the food supply consistently shows that mercury
levels of popular seafoods remain below the FDA action level of 1 part per million. On
March 6, 2002, Representative Pallone introduced legislation (H.R. 3885) that would require
FDA to treat mercury as a food additive under the FFDCA and set a tolerance level for it that
would guarantee “a reasonable certainty of no harm” from aggregate dietary exposure
(among other things). S. 555 is a similar bill.
LEGISLATION
The bills are listed under their primary topic. The categories are not mutually exclusive.
Proposals Receiving Recent Action
H.R. 3448 (Tauzin/Dingell)
Public Health Security and Bioterrorism Preparedness and Response Act as introduced.
As reported to the Senate, Bioterrorism Preparedness Act of 2001. Improves the ability of
the United States to prevent, prepare for, and respond to bioterrorism and other public health
emergencies. Introduced December 11, 2001; passed the House on December 12, 2001
under a suspension of the rules. On December 20, 2001, the Senate passed S. 1765 in toto
in the nature of a substitute to H.R. 3448. Conference report (H. Rept. 107-481) filed in the
CRS-13

---

IB10099
06-12-02
House on May 21; passed in the House on May 22; and passed in the Senate on May 23,
2002.
S. 1765 (Frist)
Bioterrorism Preparedness Act of 2001. Improves the ability of the United States to
prepare for and respond to a biological threat or attack. Introduced December 4, 2001; passed
the Senate, December 20, 2001, as a substitute in the form of an amendment to H.R. 3448.
H.R. 2646/S. 1731 (Combest/Daschle)
Farm Security and Rural Investment Act of 2002. Provides for the continuation of
agricultural programs through FY2011. Contains provisions on bioterrorism preparedness,
country-of-origin labeling of meats, irradiation labeling, and humane treatment of livestock,
among other things. Conference agreement passed by the House on May 2 and by the Senate
on May 8, 2002. Signed into law by the President on May 13, 2002 (P.L. 107-171).
S. 2452 (Lieberman)
The Department of National Homeland Security and Combating Terrorism Act of 2002.
Provides for transferring functions from various regulatory and emergency response agencies
to create a Department of National Homeland Security and creates a National Office for
Combating Terrorism. Introduced on May 2, 2002; reported out of the Committee on
Government Affairs with amendments on May 22, 2002.
Proposals Addressing USDA and FDA Enforcement Authorities
H.R. 1276 (Lowey)
Expands enforcement options under the Federal Meat Inspection Act and Poultry
Products Inspection Act to include the imposition of civil money penalties against violators.
Introduced March 28, 2001, and referred to the Committee on Agriculture.
H.R. 3075 (Dingell)
Imported Food Safety Act of 2001. Amends the FFDCA to improve border inspections,
increases the number of inspections and tests of imported food, requires that imported food
have country-of-origin labeling, establishes criminal penalties for adulterating imported food,
establishes user fees to pay for additional inspections, and provides FDA with new authority
and resources to inspect and detain food. Introduced October 10, 2001; referred to the
Committee on Energy and Commerce, October 10, 2001.
H.R. 3127 (Udall)
Unsafe Meat and Poultry Recall Act of 2001. Amends the Federal Meat Inspection Act
and the Poultry Products Inspection Act to authorize the Secretary of Agriculture to order the
recall of meat and poultry that is adulterated, misbranded, or otherwise unsafe. Introduced
October 12, 2001, and referred to the Committee on Agriculture.
H.R. 3804 (Brown)
Preservation of Antibiotics for Human Treatment Act of 2002. Amends the FFDCA to
ensure that use of certain antibiotic drugs in animal agriculture do not compromise human
health by contributing to the development of antibiotic resistance. Introduced February 27,
2002; referred to the Committee on Energy and Commerce, Subcommittee on Health, March
13, 2002.
CRS-14

---

IB10099
06-12-02
H.R. 3885 (Pallone)
Seafood Safety and Mercury Screening Act of 2002. Amends the FFDCA to require the
Secretary of Health and Human Services to establish a tolerance for the presence of methyl
mercury in seafood, and for other purposes. Introduced March 6, 2002; referred to the
Committee on Energy and Commerce, Subcommittee on Health, March 26, 2002.
S. 555 (Leahy)
Mercury-Safe Seafood Act of 2001. Similar to H.R. 3885, it amends the FFDCA to
require the Secretary of Health and Human Services to establish a tolerance for the presence
of methyl mercury in seafood. Introduced March 15, 2001; referred to the Senate Committee
on Health, Education, Labor, and Pensions.
Proposals Addressing Consolidation of Food Safety Agencies
H.R. 1671 (DeLauro)
To consolidate into a single independent agency within the executive branch
responsibilities regarding food safety, labeling, and inspection currently divided among
several federal agencies. Introduced May 1, 2001; referred to Committee on Agriculture,
Subcommittee on Department Operations, Oversight, Nutrition, and Forestry, and
Subcommittee on Livestock and Horticulture, May 14, 2001. Referred to Committee on
Energy and Commerce, May 1, 2001, and referred to Subcommittee on Health, May 15,
2001.
S. 1501 (Durbin)
Safe Food Act of 2001. To consolidate in a single independent executive branch agency
the responsibilities regarding food safety, labeling, and inspection currently divided among
several Federal agencies. Introduced October 4, 2001; referred to the Committee on
Governmental Affairs. Hearing held on related issue of bioterrorism preparedness, including
restructuring of the federal food safety system on October 10, 2001, before the Subcommittee
on Oversight of Government Management, Restructuring, and the District of Columbia.
Proposals Addressing Antimicrobial Resistance
H.R. 3804 (Brown)
Preservation of Antibiotics for Human Treatment Act of 2002. Amends the FFDCA
to ensure that use of certain antibiotic drugs in animal agriculture does not compromise
human health by contributing to the development of antibiotic resistance. Introduced
February 27, 2002; referred to the House Committee on Energy and Commerce, and on
March 13, 2002, was referred to the Subcommittee on Health.
S. 2508 (Kennedy)
Preservation of Antibiotics for Human Treatment Act of 2002. Amends the FFDCA to
preserve the effectiveness of medically important antibiotics by restricting their use as
additives to animal feed. Introduced May 13, 2002; referred to Senate Committee on Health,
Education, Labor, and Pensions.
CRS-15

---