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Food and Drug Administration
Food Safety and Inspection Service
Centers for Disease Control and Prevention
May 11, 2004
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Healthy People 2010 Focus Area Data
Progress Review
Focus Area 10: Food Safety
Challenges, Barriers, Strategies and
Opportunities
10-1 Reduce infections caused by key foodborne pathogens.
- Foodborne illness is recognized as a significant public health problem in the United States. A 1999 estimate from The Centers for Disease Control and Prevention (CDC) attributes 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths to foodborne pathogens annually(1).
- Data for objective 10.1 are from the Foodborne Diseases Active Surveillance Network (FoodNet), which was established in 1996. FoodNet is an active, population-based surveillance system designed to determine more precisely the burden and severity of foodborne illnesses, and to identify the sources of specific foodborne diseases. FoodNet is a collaborative activity of the CDC, the Food and Drug Administration (FDA), the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture, (USDA) and ten states (California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee).
- To achieve its objectives, FoodNet conducts active, laboratory-based surveillance of sporadic cases of foodborne diseases. FoodNet also conducts surveys in the FoodNet surveillance areas of microbiologic laboratories (to determine which pathogens are included in routine bacterial stool cultures and the specific techniques used to isolate pathogens, etc.); physicians (to obtain information on stool culturing practices); and the population (to obtain an estimate of those who seek medical care).
- CDC recently reported decreases in infections, from 1996-2003, caused by Yersinia (49% reduction), E. coli O157 (42% reduction), Campylobacter (28% reduction), and Salmonella (17% reduction). These declines are evidence of important progress towards the National Health Objectives and Healthy People 2010 objectives.
Challenges
and Barriers:
-
The burden of
foodborne illness is difficult to assess and finding ways to more precisely estimate the total burden
in the US population is a challenge. Active
surveillance only captures those individuals who were sufficiently ill to seek
medical care, whose physicians ordered testing of the correct pathogen on stool
culture, and where the pathogen was isolated.
- It is difficult
in individual cases to define a source (e.g., food, water, person-to-person
contact) of pathogens that cause gastrointestinal illness. Such determinations
are conducted in outbreak investigations.
- The FoodNet data
are largely limited to foodborne diseases cause by bacteria. Viruses are
considered to be the major cause of foodborne illness. Bacteria are the most
often confirmed cause of foodborne illness. A proportion of foodborne illness
is caused by parasites and by pathogens that have not yet been identified and
therefore cannot be diagnosed.
- The incidences
of some foodborne infections are increasing. A major challenge is finding ways
to reduce the incidence of infections caused by Vibrio species, Salmonella Newport, Salmonella Heidelberg, and Salmonella Javiana.
- Identification
of risk factors of foodborne illnesses in children, infants and the elderly is
needed to enable us to reduce the high incidence of these illnesses in these
populations.
Strategies/Opportunities:
Surveillance,
outbreak investigation, research, risk assessment, regulation, guidance,
enforcement, coordination, and education are the broad strategies Federal and
State agencies and others are using to focus efforts to decrease the number of
foodborne illnesses, including decreasing the number and size of foodborne
illness outbreaks.
In April 2003, the National Academy of Sciences (NAS) issued
a final report entitled "Scientific
Criteria to Ensure Safe Food", that concluded that performance standards are a
useful "score card" for measuring process control by food processors and
recommended that efforts be made to link such scientific criteria to
improvements in public health. NAS recommended, among others, development of a
comprehensive plan to harmonize disease surveillance and microbial prevalence
data, and the adoption of science-based strategies in developing food safety
criteria.
Surveillance:
Surveillance
systems, both passive and active, alert States, CDC, FDA, and FSIS to cases and
increases of foodborne illness. Disease surveillance and epidemiological
investigations provide information to use in outbreak investigation and in
tracebacks to food products, or to facilities, so that the remaining product
can be removed from the market and other corrections or interventions can be
made.
-
FoodNet
(described above) is
exploring statistical/epidemiologic methodologies to more precisely determine
the burden of foodborne illnesses in the U.S. population.
-
PulseNet is a national network of public health laboratories that
performs DNA "fingerprinting" on bacteria that may be foodborne. The network
permits rapid comparison of these "fingerprint" patterns through an electronic
database at CDC. The DNA "fingerprinting" method is called pulsed-field gel
electrophoresis (PFGE).
-
CaliciNet will help "fingerprint" strains of
Calicivirus (includes Noroviruses, previously named "Norwalk-like viruses")
that may cause foodborne outbreaks.
-
EHS-Net is a network of
environmental health specialists and epidemiologists who facilitate the exchange of
information about environmental causes of foodborne illness. This project is a
collaborative effort of CDC's National Center for Environmental Health
(Environmental Health Services Branch), FoodNet, and the Food and Drug
Administration (FDA). Eventually EHSNet will refine data on retail food
service-associated outbreaks that will help CDC/FDA/States evaluate Food
Code issues.
-
CAERS, the
CFSAN Adverse Events Reporting System, is a
new system for tracking and analyzing adverse event reports involving foods,
cosmetics and dietary supplements. CAERS will be used as a monitoring tool to
identify potential public health issues that may be associated with the use of
a particular product already in the marketplace.
-
EFORS, the Electronic Foodborne Outbreak Reporting
System, is CDC's new internet-based system designed for state health
departments to report foodborne disease outbreaks. EFORS is making the
reporting of data more timely and anticipates providing data more quickly on a
routine basis.
-
eLEXNET, the electronic Laboratory Exchange
Network, is a seamless, integrated, secure network that was developed by FDA to
provide access to critical food testing data from Federal (FDA, USDA, and DOD),
State, and local food safety laboratories. One
hundred laboratories representing all 50 states are participating eLEXNET, and
there is interest from international laboratories. eLEXNET allows health
officials engaged in food safety activities to compare, share, and coordinate
laboratory analysis findings on food products.
Regulation,
Guidance, Enforcement:
-
FDA and FSIS
implemented Hazard Analysis Critical Control Point (HACCP) systems regulations
for seafood (1997), meat and poultry (1998), and juice products (2002). HACCP is an internationally
recognized, scientific approach to producing safer food by anticipating how
biological, chemical, or physical hazards are most likely to occur and by
installing appropriate measures to prevent them from occurring.
- The Current Good
Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP)
regulations are general regulations that apply to all foods FDA regulates. In addition, there are specific CGMP
regulations that apply to specific food categories.
- FDA enforces
regulations through inspection and sampling.
- Surveillance
samples are samples collected when there is no prior knowledge or evidence that
a specific food shipment contains pathogens, illegal pesticides, or other
chemical residues.
- Compliance
samples are taken as follow-up to the finding of pathogens or illegal residues
or when other evidence, such as foodborne illness, indicates that a problem may
exist. Federal, State and local agencies cooperate in traceback investigations
and collect compliance samples following foodborne disease outbreaks.
- Regulatory
programsfor retail, milk, and shellfish involve a cooperative effort
among FDA, States, and the industry to regulate production or harvesting of
these foods.
- Guidance, such
as FDA's Guidance
for Industry: Guide to Minimize Microbial Food
Safety Hazards for Fresh Fruits and Vegetables (also known as "Good Agricultural
Practices" or "GAPs," http://www.foodsafety.gov/~dms/prodguid.html),
the FDA Food Code (for retail level establishments http://www.cfsan.fda.gov/~dms/foodcode.html ) as well as specific technical assistance have been provided to producers
(growers), processors, the States, and other countries.
- In 1999, 2373
federally inspected and 170 state inspected meat and poultry plants implemented
HACCP. In 2000, HACCP was implemented in over 3400 federally inspected and
2300 state inspected plants. FSIS recognized that both small and very small
plants would need additional guidance and assistance that the large plants that
implemented HACCP in 1998 did not require. To meet their needs, several
outreach programs have been established and implemented. All the information,
materials, guidance, and outreach efforts of FSIS are provided to federal and
state plants at no charge.
- FSIS recognized
early during HACCP implementation that both small and very small plants would
need guidance and assistance that the large plants did not require. The Small
and Very Small Plant Outreach Program was established in 1998 to provide
technical guidance, assistance and resource materials to small and very small
plants so they can meet their responsibilities for maintaining effective food
safety systems to produce safe products. The Small and Very Small Outreach
Program built and continues to maintain an infrastructure with university
extension agents, university professors, and state program directors that are
located in all 50 States; Washington, D.C.; Puerto Rico;
and the Virgin Islands. Small and very small plants can
utilize these contacts for guidance and assistance; information on
HACCP-related training classes; obtain HACCP and food safety resource
materials; and assistance in plan development. The outreach program provides
small and very small plants with the latest information on foodborne hazards,
information on up-to-date procedures and technologies and guidelines. All the
information, materials, guidance, and outreach efforts of FSIS are provided to
federal and state plants at no charge.
- The
outreach program promotes the development of HACCP and food safety related
information, materials and education to small and very small plants by
providing support to educational institutions, including the 1890
Colleges, Land Grant Universities, Historically Black Colleges and Universities,
Tribal Colleges and Hispanic Universities, allowing them to offer low cost
educational classes and materials to plant owners and/or operators that
may not otherwise be able to afford such training. To help plant owners
and operators with new food safety regulations, the Small and Very Small
Plant Outreach Program offers workshops across the country on food safety
hazards such as Listeria monocytogenes, Bovine Spongiform
Encephalopathy (BSE) and E. coli O157:H7. The outreach program
also extends its outreach efforts to Native American populations and Alaska natives by coordinating
efforts to provide food safety seminars and workshops that include topics
such as HACCP, identification of foodborne illnesses, lamb slaughter in
Navajo or country settings, beef jerky and lamb operations, and safe food
handling from farm to table.
Education
and Training:
Safe food
preparation and storage education and training have been provided and
additional programs are being developed for regulators, industry (processors,
retail, and food service), consumers, and medical health professionals.
- In April 2004,
the FDA, CDC, FSIS, the American Medical Association, and the American Nurses
Association-American Nurses Foundation collaboratively produced and released Diagnosis
and Management of Foodborne Illnesses, A Primer for Physicians and Other
Healthcare Professionals as an educational resource to help primary care physicians and
other health professionals recognize, diagnose and treat foodborne illness. The Primer also provides patient
education handouts emphasizing the four key food safety behaviors. The Primer, initially
introduced in 2001, contains five new sections on new and re-emerging foodborne
illnesses and was written with an emphasis on living in the post 9-11
environment. http://www.fda.gov/bbs/topics/news/2004/NEW01047.html
Healthcare professionals can request free copies from the FDA ( or ), or
access it online. www.ama-assn.org/go/foodborne.
- The Foodborne
Pathogenic Microorganisms and Natural Toxins Handbook (also known as the
"Bad Bug Book") brings together in one place basic facts on foodborne agents,
from FDA, CDC, USDA/FSIS, and the National Institutes of Health. The material
has been updated with new
scientific information or links to foodborne outbreak reports. http://www.cfsan.fda.gov/~mow/intro.html
-
In 2003, FSIS
introduced a new educational campaign designed to reach millions of consumers
with food safety messages. The campaign's centerpiece is the Food Safety
Mobile, which travels the country delivering food safety education and
developing partnerships at the local level. For the communities the Mobile visits, representatives from the
national level are teamed with community leaders to provide answers for
consumers on national and local issues. Partners with the USDA Food Safety
Mobile come from all over the community: universities and cooperative
extension, state and local public health, agriculture, and other government
agencies, FSIS field offices, grocery stores, schools, and many others.
- The Center for
Food Safety and Applied Nutrition's Outreach and Information Center (O&IC) opened in September
1999. The O &IC enhances FDA's ability to
provide accurate and meaningful information to the public about food safety.
In addition to providing food safety information, the O&IC provides
assistance with other CFSAN issues including, nutrition, dietary supplements,
food labeling, cosmetics, food additives, and food biotechnology.
1-888-SAFEFOOD (1-888-723-3366)
- FSIS provides a
toll-free telephone service to prevent foodborne illness by answering consumer
questions in English or Spanish on safe storage, handling, and preparation of
meat, poultry, and egg products through the USDA Meat & Poultry Hotline
(1-800-256-7072). Another resource for consumers is "Ask Karen," a virtual
representative available on the FSIS home page for answering consumer questions
at: http://www.fsis.usda.gov/Home/index.asp
- Examples of
recent, ongoing, and planned education campaigns, including national, regional,
local, and school-based programs, are included in the "Strategies and
Opportunities" section of Objective 10-5 (page 20) and in the this section of
this Progress Review Briefing book.
Research
and Technology Transfer:
- FDA, FSIS and
others have developed microbiological risk assessments on particular organisms
(Salmonella spp., Listeria monocytogenes, Vibrio parahaemolyticus,
Vibrio vulnificus, Escherichia coli O157:H7, bovine spongiform
encephalopathy, and Clostridium perfringens) with the goal of
identifying and focusing prevention efforts on the riskiest products and
procedures or steps in the farm to fork continuum.
- FDA
conducts and participates in research to lower the incidence of and to detect
and identify foodborne pathogens.
- Since 1998,
FDA's Center for Food Safety and Applied Nutrition (CFSAN) has operated a
competitive extramural research program to augment its food safety research and
provide for critically needed research to characterize foodborne hazards more
rapidly and accurately, to provide the tools for regulatory enforcement, and to
develop effective interventions that can be used to prevent hazards at each step
from production to consumption.
- FDA
has awarded grants each year since 1999 to State and local regulators to fund
innovative programs designed to enhance food safety. These programs address specific objectives of Healthy
People 2010 to decrease risks of foodborne disease in
such diverse settings as animal feed plants, juice/cider operations, grocery
stores, and schools.
- USDA Cooperative
State Research, Education and Extension Service (CSREES) funds food safety
research in the area of food safety, particularly emphasizing the detection,
prevention and control of food-borne disease-causing microorganisms and
naturally occurring toxicants. Food safety grant programs include Ensuring
Food Safety and Epidemiological
Approaches for Food Safety.
- The USDA
Agricultural Research Service Food Safety Program addresses prevention and
control of food pathogens, the production, harvesting, processing,
transportation, handling, and storage of food (the farm to table continuum),
and the prevention of toxic chemical hazards in food through research programs
that benefit producers, processors, and the public. ARS coordinates its food
safety research to meet the needs of the Federal agencies, in particular the
USDA-Food Safety and Inspection Service, and the FDA-CFSAN. During 2002,
collaborative research programs were continued with the National Alliance for Food
Safety to specifically address issues relative to pathogen reduction including
robustness of predictive models for Listeria growth and inactivation in
ready-to-eat meat and poultry products and role of nematodes in preharvest
contamination of fresh fruit and vegetables. Collaborative postharvest research
programs were continued with the Institute for Genomic Research (TIGR) to
provide annotated genomic sequences of the bacterial pathogens Listeria
monocytogenes and Campylobacter jejuni. See http://www.jifsr.gov/ppd/ars010b.htm.
- FSIS is
implementing a broad, long-term, science-based, farm-to-table strategy to
improve the safety of meat, poultry, and egg products at each step in the food
production, processing, distribution, and marketing chain to better protect
public health. These steps are designed to focus attention on the risk of
microbial contamination. FSIS' goal is to build the principle of prevention
into the production and inspection processes and to foster the development and
use of new technology. FSIS
is seeking state, academic, and research institutions to work cooperatively in
identifying, developing, and validating new technologies that are economically
viable for small/very small meat, poultry, or egg product plants to help them
meet food safety requirements. See http://www.fsis.usda.gov/oa/topics/newtech.htm#Technology
-
FSIS release a
food safety vision document, "Enhancing Public Health: Strategies for the
Future" in July 2003, outlining several key initiatives the agency is
implementing to enhance meat and poultry safety and improve food inspection
systems. http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oa/programs/vision071003.htm
10-1a. Campylobacter
- The main route
of transmission of Campylobacter to humans is foodborne, via undercooked
meats and meat products, as well as unpasteurized and contaminated milk. The
ingestion of contaminated water is also a recognized source of infection.
Challenges and Barriers:
- Based on FoodNet
data, Campylobacter was identified as the most frequently isolated
bacterium from persons with diarrhea.
- The species
is widely distributed and occur in most warm-blooded animals. They are
prevalent in food animals such as poultry, cattle, pigs, sheep, ostriches and
shellfish, as well as in pets, including cats and dogs. The wide occurrence of
the organism hinders the development of strategies to control Campylobacter in the food supply from farm to table.
- FSIS baseline
testing conducted in 1994-1995 estimated the prevalence of Campylobacter on raw chicken carcasses to be 88%. (http://www.fsis.usda.gov/OPHS/baseline/contents.htm).
-
Campylobacter is a difficult organism to culture
and there is an ongoing search for optimal detection, enumeration and
identification methods.
Strategies/Opportunities:
- FoodNet is
conducting a case-control study of sporadic cases of Campylobacter in
young children to identify risk factors for infection, regional differences in
incidence of infection, and opportunities for prevention.
- FSIS conducted
baseline testing for Campylobacter in 1994-1995 and in 1999-2000 to
quantify Campylobacter on raw chicken carcasses. The baselines are
currently undergoing review by the National Advisory Committee on
Microbiological Criteria for Foods (NACMCF).
- Pasteurization
of milk and treatment of municipal water supplies eliminate another route of
transmission for Campylobacter and other bacteria.
- FDA assists
States in preventing disease transmitted through milk and helps to enforce
State milk regulations. It promotes and helps to ensure compliance with the
model Grade A Pasteurized Milk Ordinance (http://www.cfsan.fda.gov/~ear/pmo01toc.html ), a document similar to the Food Code.
10-1b. Escherichia coli O157:H7--Hemorrhagic colitis
-
Escherichia coli serotype O157:H7 is the fourth most
common cause of bacterial diarrhea in the United States. Each strain produces one or more related, potent Shiga
toxins that cause severe damage to the lining of the intestine. The toxins are
similar to the toxin produced by Shigella dysenteriae type 1.
- Illness is
characterized by diarrhea, often with large quantities of blood, so the illness
is sometimes called hemorrhagic colitis. About 10% of hemorrhagic colitis
victims, particularly the very young, may develop the hemolytic uremic syndrome
(HUS--see objective 10-1f). Adults with E. coli O157-associated HUS are
sometimes given the diagnosis of thrombotic thrombocytopenic purpura (TTP), a
disease with some similar features but of unknown etiology.
- Consumption of
undercooked or raw hamburger (ground beef) is the single most common cause of
illness. However, many other foods, including alfalfa sprouts, unpasteurized
fruit juices, dry-cured salami, lettuce, game meat, and raw milk and cheese
curds have been implicated in many of the documented E. coli O157:H7
outbreaks.
Challenges
and Barriers:
- Fewer than 60%
of U.S. clinical laboratories routinely test all stool samples submitted for
microbiologic culture for E. coli O157:H7; therefore, many infections
due to this pathogen that are severe enough to require medical attention go
undiagnosed and unreported.
Strategies/Opportunities:
- PulseNet, a
system of "fingerprinting" strains using pulsed-field gel electrophoresis
(PFGE), is enhancing detection of outbreaks of infections with E. coli O157,
and is refining case definitions for case-control studies to decrease
misclassification error.
- FSIS took
several actions in its effort to reduce the incidence of E. coli O157:H7
on products it regulates, including the following:
- Based on evidence of the higher
prevalence estimates of E. coli O157:H7 on ground beef, FSIS
required establishments that produce raw beef products to reassess their
HACCP plans in light of these data to determine whether E. coli O157:H7 is a
hazard reasonably likely to occur in their production of these products,
and, if so, whether their HACCP plans
appropriately address this hazard (67 FR 62325). See http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/00-022N.pdf and FSIS Directive
10.010.1 http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/10.010.1.pdf
- FSIS modified its sampling and
testing program for E. coli O157:H7 to eliminate existing exemptions, so that FSIS tests product at all
ground beef plants it inspects.
- FSIS conducted a risk assessment on E. coli O157:H7 in ground beef (See http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/00-023N/00-023NReport.pdf and presented it to the National Academy of Sciences (NAS) for review. The
risk assessment is currently being modified according to suggestions made
by NAS (http://www.nap.edu/books/0309086272/html/)
and to address additional questions generated by FSIS' policy office. FSIS also conducted a comparative risk assessment of intact
(non-tenderized) and non-intact (blade tenderized) steaks that was
reviewed by the National Advisory Committee on Microbiological Criteria
for Foods (NACMCF). NACMCF found that non-intact (tenderized) beef does
not pose a greater risk of illness than intact beef if it is oven broiled
and cooked to an internal temperature of 1400F (45.8°C)
or more. (http://www.fsis.usda.gov/OA/topics/o157.htm).
- FSIS has
prepared various guidance documents to help industry reduce the occurrence
of E. coli O157: H7 (http://www.fsis.usda.gov/OA/topics/o157.htm).
- Similarly, FDA
took several actions in its effort to reduce the incidence of E. coli O157:H7
on products it regulates, including the following:
- Following
multiple outbreaks of infections with Salmonella and E. coli O157:H7 linked to orange and apple juice consumption, FDA requires
(starting in 2002) the fresh juice industry to implement a HACCP plan.
FDA requires juice manufacturers to achieve a 100,000-fold (5-log)
reduction in the numbers of harmful pathogens in their finished products
compared to levels that may be present in the untreated product. The
juice processors are free to employ microbial reduction methods other than
pasteurization, including scrubbing, anti-microbial solutions, or
alternative technologies.
- In 2002
through 2004 FDA published draft and finalized guidance for the juice
industry:
- FDA
included in the Food Code additional safeguards for highly
susceptible populations on juice, eggs, and raw animal foods. See http://www.cfsan.fda.gov/~dms/fc-3.html
- E.
coli O157:H7
infections have also been associated with produce. FDA works with CDC and
States in produce outbreak investigations and performing follow-up
inspections.
10-1c.
Listeria monocytogenes
-
Foods associated
with sporadic listeriosis in the United States have included soft cheese, undercooked poultry, hotdogs not
thoroughly re-heated, and deli food. Listeriosis outbreaks in the United States have been associated with lettuce
(1979), contaminated milk (1983), Mexican-style soft cheese made with
unpasteurized milk (1985), ice cream or salami (1986-87), shrimp (1989),
hotdogs and cold cuts (1998-99), and sliced turkey deli meat (2002).
- The estimated
annual incidence of foodborne listeriosis in the United States is 2518 cases and 499 deaths, an approximate 20 % case
fatality rate(2). These
data confirm that, although foodborne listeriosis is rare, the associated
mortality rate is high among those who are most at-risk. Populations highly
susceptible to L. monocytogenes include fetuses and newborns, the
elderly, diabetics, and those with compromised immune systems (cancer, AIDS,
steroid use). Severe disease forms included meningitis and septicemia, and in
pregnant women, listeriosis may result in miscarriage or stillbirth, or
meningitis and septicemia in the newborn.
Challenges
and Barriers:
-
L.
monocytogenes is
found widely distributed in the environment and livestock, and is often found
in vegetables and uncooked meat. Contamination after thermal processing is the
major food safety concern for L. monocytogenes. Because L.
monocytogenes is often present in raw ingredients and is heat-resistant,
proper cooking is important to assure destruction of the organism.
-
L.
monocytogenes contamination most often occurs when a product or food contact surface is
contaminated between the cooking and packaging steps. L. monocytogenes can
also be introduced through employees, equipment, animals, environmental
reservoirs, or ingredients
- Unlike most
other bacterial pathogens, L. monocytogenes can grow at refrigeration
temperatures. The unusual growth and survival properties of the organism and
its ability to adhere to food contact surfaces contribute to the complexity of
eliminating it from the food-processing environment. Persistent strains may
develop due to physical adaptation such as surface attachment or biofilm
formation, as well as to a range of environmental conditions.
- Encouraging
physicians to request appropriate testing of stool specimens, particularly for Listeria
monocytogenes among pregnant women and among those with weakened immune
systems, would improve both treatment and data available.
Strategies/Opportunities:
- PulseNet, a
system of "fingerprinting" strains using pulsed-field gel electrophoresis
(PFGE) is enhancing detection of outbreaks of infections with L.
monocytogenes, and is refining case definitions for case-control studies to
decrease misclassification error.
- FDA and CDC enhanced disease surveillance and outbreak response
through listeriosis case control studies. Work is on-going in FoodNet to
develop a system that will facilitate prompt interviewing of all patients with
listeriosis and will rapidly link exposure data with PFGE results.
- FDA, FSIS, and CDC conducted an extensive risk assessment for L.
monocytogenes. The risk assessment was designed to predict the potential
relative risk of listeriosis among three age-based groups of people, perinatal,
elderly, and intermediate-age, from eating certain ready-to-eat foods. The agencies released a
draft report in 2001 and a final report in September 2003. This study
predicted the highest risk foods, on a yearly consumption basis, to be deli
meats, pasteurized fluid milk, high fat and other dairy products, and
un-reheated frankfurters. See http://www.foodsafety.gov/~dms/lmr2-toc.html
- The FDA/USDA
Listeria Joint Action Plan (2001) was designed to reduce the risk of illness
caused by L. monocytogenes by 50 percent by 2005, five years ahead of
the previously established Healthy People 2010 target. This plan included consideration of control measures for at-risk
foods; publication of guidance for processors, retailers, and food service
facilities; and consideration of enhanced labeling to provide additional
safeguards for consumers.
- The FDA/CDC 2003
Update of the Listeria Action Plan is to provide guidance for processors that manufacture or prepare
ready-to-eat foods and for retail and food service and institutional
establishments; provide training and technical assistance for industry and food
safety regulatory employees; enhance consumer and health care provider
information and education efforts; review, redirect, and revise enforcement and
regulatory strategies, including microbial product sampling; enhance disease
surveillance and outbreak response; coordinate research activities to refine
the Risk Assessment, enhance preventive controls, and support regulatory,
enforcement, and educational activities. See http://www.cfsan.fda.gov/~dms/lmr2plan.html
- In recent years,
FSIS has been involved in a number of activities to address contamination of
products with Listeria including the following:
- Requiring
companies in 1999 to reassess HACCP plans to address Listeria in the
hazard analysis (http://www.fsis.usda.gov/FOIA/notices/23-99.htm);
- Releasing Directive
10,240.3, "Microbial Sampling of RTE Products for the FSIS Verification Testing
Program," effective December 9, 2002, that specifies that FSIS will conduct
intensified multiple product and environmental sampling to test for Listeria in establishments that produce products at the most
risk of contamination and that either do not have an evaluated
environmental testing regime as part of a control program or choose not to
share data from existing programs on an ongoing basis;
- Releasing a risk
assessment addressing contamination of ready-to-eat meat and poultry products
in February 2003 http://www.fsis.usda.gov/OPHS/lmrisk/DraftLm22603.pdf and releasing a draft risk
assessment addressing L. monocytogenes contamination of deli meats in
May 2003 http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/97-013F/ListeriaReport.pdf
-
Publishing
an interim final rule June 6, 2003, in the Federal Register requiring official
establishments that produce certain ready-to-eat meat and poultry products to
take steps to further reduce the incidence of L. monocytogenes). The
rule was implemented in October 2003;
- Releasing
Directive 10, 240.4, "Verification Procedures for the Listeria monocytogenes
Regulation and Microbial Sampling of Ready-to-Eat (RTE) Products for the
FSIS Verification Testing Program," October 2003, that provides instructions
for FSIS inspection personnel for verifying whether establishments are
complying with the regulations, including those for ready-to-eat products; and
- Conducting
five interactive workshops in September/October 2003 for small/very mall plants
to prepare them to implement FSIS Directive 10.240.4.
- CDC, FDA, and
FSIS have cooperatively produced education materials and programs for retail
delicatessens and for consumers to help reduce the incidence of listeriosis,
and some of these materials are available in Spanish.
- In 2001, the
Association of Women s Health, Obstetric and Neonatal Nurses (AWHONN), the
International Food information Council (IFIC) Foundation, USDA/FSIS and DHHS
(FDA and CDC) issued an advisory (available in English and Spanish) designed
specifically for pregnant women, describing their risk from listeriosis and how
to avoid it. See http://www.fsis.usda.gov/OA/pubs/lm_tearsheet.htm , http://www.cfsan.fda.gov/~dms/adlister.html , http://www.fda.gov/bbs/topics/NEWS/2002/NEW00836.html
10-1d. Salmonella
spp.
-
An estimated 1.4
million cases of salmonellosis occur annually in the United States, with more than 500 fatal cases
each year. Approximately 2000 serotypes are known to cause disease in humans.
Salmonella Enteritidis and Salmonella Typhimurium, combined, cause half of all
Salmonella infections in the U.S.
Challenges
and Barriers:
- Non-typhoidal
Salmonella is the third most commonly reported cause of foodborne illness
in the United States. A comprehensive farm-to-table
approach to food safety is necessary for control. Farmers, industry, food
inspectors, retailers, food service workers, and consumers are each critical
links in the food safety chain.
- The incidences
of foodborne infections caused by some strains of Salmonella are
increasing. A major challenge is finding ways to reduce the incidence of
infections caused by Salmonella Newport, Salmonella Heidelberg, and Salmonella Javiana.
Strategies/Opportunities:
- In addition to
FoodNet surveillance, the National Salmonella Surveillance System
collects reports of isolates of Salmonella from human sources from every
state in the United
States. State Public
Health Laboratory Directors and State and Territorial Epidemiologists report
this information to CDC through the Public Health Laboratory Information
System (PHLIS).
- FSIS began
implementing the HACCP system in 1998 for meat and poultry and it was fully implemented
in 2000. Included in HACCP were performance standards for Salmonella that establishments must meet for FSIS to verify that they are within
regulatory compliance. The proportion of samples positive for Salmonella collected
through Salmonella HACCP compliance testing has been well below the
established performance standards and has generally tended to decrease each
year (which correlates with drops in foodborne illness reported by the CDC). See http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5115a3.htm
-
FSIS issued new
procedures through FSIS Directive 5000, May 21, 2003 http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/5000.1Rev1.pdf
for responding to establishments that fail Salmonella performance
standard testing for raw products. These procedures constitute a more
scientific and systematic approach to food safety and to the enforcement of
current regulations. The procedures accelerate the review of a plant's HACCP
plan and involve higher level supervisors at an earlier stage than previous
procedures and emphasize coordination between personnel at various levels in
the field to address inspection failures.
- FSIS received
recommendations from the NACMCF for improving FSIS' use of performance
standards in evaluating microbiological contamination of food products, which
included gathering quantitative data and designing statistically valid studies
to determine prevalence estimates for proper risk assessments. See http://www.fsis.usda.gov/OPHS/nacmcf/2002/rep_stand2.pdf
- FDA enforces the
seafood HACCP regulation to reduce infections from food pathogens including Salmonella spp. Since the Healthy People 2010 Food Safety objectives were developed and
published, FDA has published and implemented HACCP regulations for juice, as
well as guidance to industry for achieving 5-log reduction of pathogens,
including Salmonella spp., in juice. FDA developed and provided Good
Agricultural Practices guidance and training, and other technical assistance,
both domestically and abroad to decrease infection associated with produce. See http://www.foodsafety.gov/~dms/prodguid.html
FDA developed specific guidance for processors such as sprout growers. See http://www.cfsan.fda.gov/~lrd/hhsprout.html
- See also
strategies for E. coli O157:H7 under 10-1b and see other FDA
surveillance, regulatory and educational efforts for Salmonella spp.
under 10-2b.
10-1e.
Cyclospora cayetanensis
-
Cyclospora
cayetanensis (previously termed "cyanobacterium-like body") is a recently characterized
coccidian parasite. The first known cases of infection in humans were
diagnosed in 1977. Before 1996, only three outbreaks of Cyclospora infection
had been reported in the United
States.
- In 1997, CDC
received reports of outbreaks of cyclosporiasis from eight states in the United
States and one province in Canada that were associated with events that
occurred during March -May and comprised approximately 140 laboratory-confirmed
and 370 clinically defined cases of cyclosporiasis. CDC coordinated
epidemiological investigations into the outbreaks with State and FDA
cooperation. Fresh, spring-grown raspberries from Guatemala were identified as the probable
vehicle of infection for most of these outbreaks of cyclosporiasis. Guatemalan
berry growers voluntarily suspended shipment of fresh raspberries to the United States.
Challenges and Barriers:
-
The United States continues to have a very low incidence of
cyclosporiasis (0.1 cases per 100,000 population in 2002). Because of its very
low incidence, the Food Safety Working Group has chosen to drop this
developmental objective from the focus area and to focus on higher incidence
pathogens.
-
Reporting of cyclosporiasis, as for other pathogens, is dependent
on isolation of the organism (oocyst), requiring special analytical methods. Few labs test for this pathogen and few physicians order the test.
- The Cyclospora oocysts have been difficult to detect in
food matrices.
Strategies/Opportunities:
- Following the
1997 cyclosporiasis outbreaks, FDA implemented a number of measures to prevent
future occurrences in berries from Guatemala and other countries:
- FDA worked with
the CDC, the Guatemalan government and the Guatemalan Berries Commission in
1997 and succeeding years to determine when the country might resume shipment
of fresh raspberries to the United States. FDA provided follow-up inspection and guidance to the growers in Guatemala.
- FDA developed a
method for concentration
and preparation of Cyclospora from berries for the polymerase chain
reaction (pcr) and for microscopy and made this available through the FDA's
Bacteriological Analytical Manual, Online in 2001: http://www.cfsan.fda.gov/~ebam/bam-19a.html
- FDA continues to
provide technical assistance to other governments and growers in the forms of
guidance and training on preventing Cyclospora contamination of produce
and analytical methods for isolating and identifying the organism. In November
2002, FDA completed a farm investigation and training course in Chile as follow-up to a cyclosporiasis
outbreak implicating raspberries from Chile.
-
DPDx, Identification and Diagnosis of
Parasites of Public Health Concern, with emphasis on Intestinal and Foodborne
Parasites, uses the Internet to strengthen diagnosis of parasitic diseases both
in the United States and abroad and will enhance
CDC's capacity to address the global problem of parasitic diseases.
10-1f. (Developmental) Hemolytic uremic syndrome,
postdiarrheal
-
Postdiarrheal
hemolytic uremic syndrome (HUS) is a life-threatening illness characterized by
hemolytic anemia, thrombocytopenia, and renal injury. Because there are no
diagnostic tests specifically designed for HUS, surveillance efforts rely on
recognition of the syndrome by physicians.
- HUS can occur in
persons of any age. The syndrome of HUS is fairly distinctive in children, and
HUS is the major cause of acute renal failure in this age group. In adults,
HUS may be confused with thrombotic thrombocytopenic purpura (TTP), a disease
of unknown etiology.
- HUS typically
develops about a week after a diarrheal illness caused by Shiga toxin-producing E. coli. Current data suggest that 80% or more cases of postdiarrheal
HUS are due to E. coli O157:H7 and the remainder are largely due to
non-O157 Shiga-toxin-producing E. coli.
-
HUS can lead to
permanent loss of kidney function and other severe complications. Death occurs
in 5% of children and a larger proportion of the elderly.
Challenges
and Barriers:
See information under objective 10.1b, E. coli O157:H7.
Strategies/Opportunities:
-
Sufficient, nationally representative data from FoodNet are now
available to move this objective from "developmental" status to "measurable,"
and the available data are provided in the data tables and charts. The Food
Safety Work Group is proposing this status change to the Healthy People
Steering Committee for consideration during the June 2004 meeting.
-
The proposed objective is: Reduce cases of postdiarrheal
hemolytic uremic syndrome (HUS) in children less than 5 years of age. The 1997
baseline is 1.36 cases per 100,000 children under age five and the 2010 goal
will be a 50% reduction to 0.7 cases per 100,000.
- Crude incidence rates are presented for HUS. This analysis is restricted to HUS-diagnosed patients who reside in the FoodNet catchment area and are less than five years of age.
- See information under objective 10.1 b, E. coli O157:H7.
10-1g. Congenital Toxoplasma gondii
-
Toxoplasma
gondii, cause of
the disease toxoplasmosis, is a single-celled, microscopic parasite found
throughout the world. The cat is the definitive host in the reproductive cycle
of this parasite. The infective stage (oocyst) develops in the gut of the cat.
The oocysts are then shed into the environment with cat feces.
- People get
toxoplasmosis the following ways:
- By consuming
foods (such as raw or undercooked meats, especially pork, lamb, or wild game)
or drinking untreated water (from rivers or ponds) that may contain the
parasite.
- Fecal-oral:
Touching hands to mouth after gardening, handling cats, cleaning a cat's litter
box, or anything that has come into contact with cat feces.
- Mother-to-fetus
(if mother is pregnant when first infected with T. gondii).
- Through organ
transplants or blood transfusions, although these modes are rare.
Challenges
and Barriers:
- Challenges in preventing toxoplasmosis include educating pregnant
women (or women of childbearing age) in all racial/ethnic groups about the
importance of avoiding ingestion of undercooked or raw meat; washing hands,
cutting boards, counters, knives and utensils after preparing raw or
undercooked meat; and thoroughly washing the soil off all fruits and vegetables
that are eaten raw.
- Toxoplasmosis Incidence data are not collected through FoodNet.
Although it has been proposed for inclusion on the list of nationally
notifiable diseases, toxoplasmosis was not added. A database of cases is not
available for determining a baseline or setting a target. Thus, the Food
Safety Work Group is recommending that this developmental objective be dropped
during the Midcourse Review.
Strategies/Opportunities:
-
Easy to read fact sheets about toxoplasmosis-related prevention
are now available on the CDC Web site. The Division of Parasitic Diseases is
also developing a new pamphlet about preventing congenital toxoplasmosis that
will be available on the CDC Web site. It is important that CDC, State, and
local health departments make these prevention materials available in multiple
languages (appropriate for each State) so that prevention messages can reach
all racial/ethnic groups.
-
A recent survey of pregnant women in the U.S. conducted by the American
College of Obstetricians and Gynecologists indicated that pregnant women were
most likely to hear about toxoplasmosis from "magazines or books on pregnancy
and childbirth." These media are likely to be very helpful for targeting
preventive messages.
- In addition, the government and meat industry should continue
efforts to reduce Toxoplasma gondii in meat.
10-2.
Reduce outbreaks of infections
caused by key foodborne bacteria
10-2a. Escherichia coli O157:H7 Outbreaks
- PulseNet is
enhancing detection of outbreaks of infections with E. coli O157:H7 and Listeria
monocytogenes, and is refining case definitions for case-control studies to
decrease misclassification error.
-
EFORS, the Electronic Foodborne Outbreak Reporting
System, is CDC's new internet-based system designed for State health
departments to report foodborne disease outbreaks.
- For Challenges
and Strategies, see objective 10-1b.
10-2b. Salmonella serotype
Enteritidis Outbreaks
-
Salmonella serotype Enteritidis (SE) isolations
from humans emerged in the United States
in the 1980's. SE continues to cause sporadic illnesses and outbreaks.
Challenges
and Barriers:
-
Control
of SE is complicated by the presence of the organism inside the yolk of the
egg. Vertical transmission, that is, deposition of the organism in the yolk by
an infected layer hen prior to shell deposition, is thought to be the primary
method of spread of the organism, with shell eggs identified as the most common
vehicle. Foods other than eggs have also caused outbreaks of SE disease.
Strategies/Opportunities:
- In addition to
FoodNet surveillance and EFORS for outbreak reporting from each state, the
National Salmonella Surveillance System collects reports of isolates of Salmonella from human sources from every state in the United States. State Public Health Laboratory Directors and State and
Territorial Epidemiologists report this information to CDC through the Public
Health Laboratory Information System (PHLIS).
- The President's
Council on Food Safety identified egg safety as one component of the nation's
food safety program that warranted immediate federal, interagency action. The
Council developed an Egg Safety Action Plan to address the presence of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach.
The Action Plan offers industry the flexibility to choose from two SE reduction
strategies, each equivalent to meet the Action Plan's interim goal of a 50%
reduction in egg-associated SE illnesses by 2005. http://www.cfsan.fda.gov/~dms/fs-toc.html
- FDA
has implemented several measures, including the following:
- FDA
included guidance on egg safety in labeling guidelines and in two FDA draft
guidelines for HACCP at retail. The first, Managing Food Safety: A Guide
for the Voluntary Use of HACCP Principles for Operators of Food Service and
Retail Establishments, is targeted to operators of retail food
establishments, with attention to CDC-identified risk factors and active
managerial control of risks within a food service establishment. The draft
guide was developed in 1998 and is available. The second guide will be
available soon. http://www.cfsan.fda.gov/~dms/eggsguid.html http://www.cfsan.fda.gov/~dms/hret-toc.html
- In
December 2000, FDA published a final rule requiring that all shell eggs (except
those treated to destroy Salmonella), both in interstate and intrastate
commerce, bear safe handling instructions and be stored and displayed at a
temperature of 45 °F or less. FDA provided industry guidance and continued to
work with States and processors to implement this rule in FY 2002. FDA is predicting
a 33% reduction in illnesses from SE in eggs from this rule. This builds upon
the labeling and refrigeration rules which also contribute about 15% towards
the risk reduction goal. http://www.cfsan.fda.gov/~lrd/hhseggs2.html
- In
2001 FDA developed egg safety information for consumers and guidance for food
service and retail operations http://www.cfsan.fda.gov/~dms/fs-eggs.html
-
FSIS signed 11 new State partnership cooperative
agreements in 2003 to fund food safety education projects for animal and egg
producers The cooperative agreements focus on preventive measures that can be
taken on the farm and cover a variety of topics including SE. The agreements
are designed to provide guidance and funding to the many stakeholders, such as
food animal producers, veterinarians and public health personnel, who all play
a role in ensuring food safety at the production level.
- FSIS is
completing an egg baseline study to establish
lethality performance standards for pasteurized egg products. Data will be
used in an FSIS Salmonella Enteritidis risk assessment. FSIS anticipates
completion of the risk assessment in 2004.
10.3
Prevent an
increase in the proportion of isolates of Salmonella species from humans
and from animals at slaughter, that are resistant to antimicrobial drugs.
Prevention of Increase in
Proportion of Salmonella
Species Resistant to
Antimicrobial Drugs
Objective |
Salmonella source |
Antimicrobial Drug |
Percent of Isolates that are Resistant |
1997 Baseline |
2010 Target |
10-3a. |
Humans |
Fluoroquinolones |
0 |
0 |
10-3b. |
Third-generation cephalosporins |
0 |
0 |
10-3c. |
Gentamicin |
3 |
3 |
10-3d. |
Ampicillin |
18 |
18 |
10-3e. |
Cattle at slaughter |
Fluoroquinolones |
Developmental |
10-3f. |
Third-generation cephalosporins |
Developmental |
10-3g. |
Gentamicin |
Developmental |
10-3h. |
Ampicillin |
Developmental |
10-3i. |
Broilers at slaughter |
Fluoroquinolones |
Developmental |
10-3j. |
Third-generation cephalosporins |
Developmental |
10-3k. |
Gentamicin |
Developmental |
10-3l. |
Ampicillin |
Developmental |
10-3m. |
Swine at slaughter |
Fluoroquinolones |
Developmental |
10-3n. |
Third-generation cephalosporins |
Developmental |
10-3o. |
Gentamicin |
Developmental |
10-3p. |
Ampicillin |
Developmental |
-
Although some
foodborne diseases reported to FoodNet are decreasing, the potential for
serious illness increases when the bacterial pathogen is resistant to the
antibiotics that are normally used to treat it. Concerns regarding the global
increase in antimicrobial drug resistance have been expressed by expert
scientific organizations such as the Institute of Medicine, World Health Organization and the
American Society for Microbiology.
- An increasing
number of infections from Salmonella species have been shown to be
resistant to multiple antimicrobial agents.
- Data for
objective 10.3 are obtained from the National Antimicrobial Resistance
Monitoring System (NARMS). NARMS was established in 1996 in response to the
concerns regarding increased antimicrobial resistance. NARMS is a collaborative
program between FDA, CDC, FSIS, the Agricultural Research Service (ARS), and
the Animal and Plant Health Inspection Service (APHIS) to prospectively monitor
trends over time in antimicrobial susceptibilities of foodborne enteric
organisms. The program is administered by the FDA Center for Veterinary Medicine (CVM).
- Funds were
provided in May 1997 to increase the national surveillance for antimicrobial
resistance of foodborne pathogens. The program has continued to expand to
include additional sites and sources of enteric bacteria. In 2003, the sources
of human isolates for NARMS have expanded to include all 50 states.
Challenges and Barriers:
-
It has been
demonstrated that the use of antibiotics in humans, animals, and the
environment contributes to resistance development. Due to the complexity of
antimicrobial drug resistance, collaboration between many diverse groups,
including agriculture experts, public health experts, and regulatory agencies
is required to successfully address the issue.
-
NARMS began with
minimal funding and has expanded over time. Due to the changes over time,
there are limitations to the use and interpretation of the data, particularly
for HP2010 objectives that require nationally representative prevalence data. NARMS data are descriptive in nature and are intended to identify trends that
can be targeted for further scientific investigation.
- FSIS has
contributed Salmonella isolates from animals to the NARMS program since
1997. However, the bulk of FSIS data are from the Salmonella HACCP
compliance testing program, a regulatory program which is not statistically
designed to estimate prevalence. Therefore, these data cannot be used to
establish valid baselines. Although the Agency will likely conduct baseline
testing of animals at slaughter in the future, neither bacterial isolates nor
antimicrobial resistance data will be available in 2004 for use in the
Midcourse review to establish measurable objectives for 2010. For that reason,
the Food Safety Work Group has recommended that objectives 10-3e through 10-3p
be dropped during the Midcourse Review.
Strategies/Opportunities:
Surveillance data
-
A proposed
initiative that may provide valuable data for forming future Healthy People
objectives is the Collaboration for Animal Health, Food Safety, and
Epidemiology (CAHFSE) program. Through this initiative, FSIS, ARS and APHIS,
with cooperation from industry, will coordinate their efforts to measure
antimicrobial resistance from the farm to the table. The CAHFSE program may be
a valuable way to measure prevalence of antimicrobial-resistant organisms in
animals over time.
Strategies/Opportunities: Preventing an increase in antimicrobial
resistance
Education:
-
The CDC, in
collaboration with the American Medical Association and medical specialties has
developed and published guidelines for the prudent and judicious use of
antimicrobial drugs in humans. They have also worked with Medical Schools to
implement curricula for medical students on the appropriate use of
antimicrobial drugs.
- A program is
also being developed in conjunction with the Michigan State School of
Veterinary Medicine to produce similar curricula for veterinary medical
students.
- FDA/CVM has
developed educational media to educate veterinarians and food animal producers
regarding prudent use. These include individual pamphlets describing the
judicious use of antimicrobials specifically for swine, poultry, pork, dairy
cattle, and beef cattle veterinarians, as well as dairy, beef, poultry, and
pork producers. In addition, a NARMS pamphlet was published that describes the
problem of antimicrobial resistance and how the NARMS program works.
- CVM has worked
with the American Veterinary Medical Association (AVMA) to encourage
development of general veterinary antimicrobial drug use guidelines and
specific guidelines by each food animal producer group.
- The FDA/CVM also
worked with the AVMA and the National Pork Board to produce two videos,
"Keeping Up Our Guard," for
veterinarians and "Safeguarding America's Health," for livestock producers. The videos incorporate the
AVMA's set of fifteen judicious use principles designed to reduce the potential threat to human health from resistant bacteria
developed from the use of antimicrobial drugs
in food animals. The video, "Keeping up our Guard" has been
distributed to veterinary schools. It is available through the AVMA free loan
video library. The video "Safeguarding America's Health" is available
from CVM.
Research:
-
The FDA/CVM is
supporting research at Iowa State University to develop a software program for
veterinarians that will guide them in the prudent and appropriate use of
antimicrobial drugs in animals.
- Through NARMS
funding, the CDC has supported research at the University of California and Michigan State University on the prudent use of antimicrobial drugs in dairy cattle.
The University of Michigan study compared "organic" dairies that did not use
antimicrobial drugs with those dairies that routinely used antimicrobial
drugs. The results indicated that there was no difference in the cost to the
dairy producer when no antimicrobial drugs were used. These results have been
presented at veterinary and dairy producer meetings and published in
peer-reviewed journals.
- Two studies on
the prudent use of antimicrobial drugs in swine are ongoing at the Ohio State and Tufts Universities. 2003 was the final funding year and the studies are in
the final stages. Preliminary results were presented at the NARMS Scientific
Meeting held March 4-5 in Atlanta, GA.
- The three
participating NARMS laboratories are conducting research into the genetic
determinants of resistance. USDA Agricultural Research Service (ARS) has
developed microarray technology to identify resistance determinants in Enterococcus spp. USDA ARS has also developed the PulseVet program in collaboration with
CDC's PulseNet. PulseVet will conduct genetic fingerprinting of animal enteric
bacterial isolates for comparison to human isolates in PulseNet. The isolates
are collected as part of NARMS and other monitoring programs.
Regulatory Action:
-
The FDA/CVM is
currently in a regulatory action to withdraw the approval for the use of
fluoroquinolones in poultry. The FDA Administrative Law Judge reviewed the
proceedings and ruled that the approval should be withdrawn. The industry
sponsor of enrofloxacin for use in poultry may appeal this ruling to the FDA
Commissioner. This action is the result of a risk assessment conducted by
FDA/CVM that determined a risk to human health from the consumption of
antimicrobial resistant Campylobacter organisms found in poultry.
10-4 (Developmental) Reduce deaths from anaphylaxis
caused by food allergies.
-
For certain
individuals, the presence of allergens in food can be life threatening. In the
U.S. allergenic proteins found in the
following eight foods cause an estimated 90% of allergic reactions from foods:
milk, eggs, fish, wheat, tree nuts, peanuts, soybeans, and crustaceans.
Currently, there is no cure for food allergy. The only successful method to
manage food allergy is to avoid foods containing the allergen. Formulated
foods present a separate challenge. In such cases, the individual relies on
accurate ingredient labeling.(3)
-
The
International Classification of Diseases-10 (ICD-10) contains new codes for
reporting deaths from food-induced anaphylaxis (T78.0 and T78.1). The developmental objective for
anaphylactic deaths from food allergies is based on the ICD-10 classification
reports through the national vital statistics system (CDC/NCHS).
Challenges
and Barriers:
-
1999 is the
first year ICD-10 was used and data were available. Reports from 1999 and 2000
show a significantly lower number of reports of deaths from anaphylaxis caused
by food allergies than expected.
- Death
certificate data do not necessarily reflect all allergen-related deaths.
- The
under-reporting may be associated with unfamiliarity of medical practitioners
with the use of the ICD-10 classification system and the availability of the
new codes.
- Morbidity from
non-fatal allergic reactions is not captured using data for deaths from
anaphylaxis.
- Foods can be
cross contaminated with allergens when non-dedicated equipment or production
lines are used to produce both allergen-containing foods and foods that are not
supposed to contain allergens.
- Manufacturers may
be using labeling statements such as, "may contain" rather than improving
prevention of cross contact of products.
- Avoidance of
specific allergy-causing food is the only way to avoid an allergic reaction.
Reading ingredient labels for all foods is the key to maintaining control over
the allergy. Consumers
may not understand all terms that designate the food to which they are
allergic.
Strategies/Opportunities:
- FDA/CFSAN
and the HP2010 Food Safety Work Group have used information from the 2001
FDA/FSIS Consumer Food Safety Survey to develop an additional sub-objective on
food allergens for consideration during the Healthy People Steering Committee
meeting in June 2004.
-
The
proposed objective is 10.4b "Reduce severe allergic
reactions to food among adults who have a food allergy diagnosis." The 2001
baseline is 27% and the 2010 goal will be a 22% reduction to 21%.
- Prevention
of reactions of allergic individuals to allergens in foods requires a many-
pronged approach including processing without cross-contact, appropriate
ingredient labeling, inspection efforts, and specific education or training of
food workers, medical professionals and consumers.
Enforcement and inspection:
- FDA's
Current Good Manufacturing Practices (CGMPs) regulations are requirements for
protecting foods from conditions that may render the food injurious to health
and cause the food product to be adulterated, including cross-contamination
with food allergens in products not labeled as containing these foods or food
ingredients.
- FDA
developed guidance for regulators on how to perform allergen inspections and
has provided training and train-the-trainer courses, as well as video courses
in 2001. http://www.cfsan.fda.gov/~dms/wh-alrgy.html
-
In
2003, FDA and the Association of Official Analytical Chemists -
International (AOAC) collaboratively validated the performance of test kits to
detect peanut proteins in breakfast cereal, cookies, ice cream
and milk chocolate. FDA drafted guidance on use of these test kits. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01258.html
-
FDA
initiated targeted inspections of establishments for allergen/cross
contamination with a pilot in 2001. In 2002 FDA performed 1653 targeted
allergen inspections. Because FDA is reviewing its allergen enforcement
authority allergen inspections were scaled back to 960 in 2003.
- In
1998, the FDA formed a partnership with the Minnesota Department of Agriculture
and the Wisconsin Department of Agriculture, Trade and Consumer Protection in
response to an increase of allergen-related recalls and concerns of controls of
cross contamination of undeclared allergen residue. The goals of the
Partnership were to eliminate duplicate inspection and sample collections,
ensure uniform enforcement, obtain current information on allergen awareness
and provide feedback on useful allergy control information and training to the
food industry.
Labeling:
-
FDA
regulations include ingredient-labeling requirements. Advisory labeling ("may
contain") cannot be used in lieu of food manufacturing practices.
- FDA
has put forward guidance concerning processing food
to combat undeclared allergens. A Dear Colleague letter was released and
a notice of availability of FDA's Compliance Policy Guide (CPG) on Allergens,
entitled "Statement of Policy for Labeling and Preventing Cross-contact of
Common Food Allergens," was published in the Federal Register on May 3, 2001. The Dear
Colleague letter is available on the Internet at http://www.cfsan.fda.gov/~dms/alrgltr2.html . The Allergen CPG is available on the Internet at http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm
-
Congress
is preparing to reintroduce an allergen-labeling bill. FDA has provided
technical assistance as requested on this issue. The bill is entitled The Food
Allergen Labeling and Consumer Protection Act (FALCPA). The Senate version of
the bill, Title II of S. 741, was passed by the Senate, introduced in the
House, and referred to the House Subcommittee on Health. The House version of
the bill, HR 3684, was introduced in the House and referred to the same House
Subcommittee.
- FSIS
advocates the use of voluntary labeling statements by industry to alert people
who have sensitivities or intolerances to the presence of specific ingredients.
http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/oppde/larc/ingredients/allergens.htm
- FDA
held a public meeting in 2001 to assist FDA to determine what additional
actions may be necessary to provide consumers with adequate information on
product labels
- FDA
hosted a public workshop in 2002 on the labeling of foods containing
allergens. The workshop was held to provide information about FDA food
labeling regulations, allergen declaration and other related matters to the
regulated industry, particularly small businesses and startups.
Education:
-
CDC-Division of
Adolescent and School Health is providing food allergen information through the
School Action Plan.
- The
Food Allergy and Anaphylaxis Network provides information for consumers and
food service on food allergens.
- FDA
has developed educational materials and activities for those with food
allergies, for processors, retailers, preparers, and those who care for school
children with allergies, i.e., parents, teachers, caregivers, child care
workers, as well as for medical professionals. http://www.cfsan.fda.gov/~dms/wh-alrgy.html
-
FDA/CFSAN
is developing an educational program to provide information to emphasize food
allergy issues with physicians and other health professionals. This program
will focus on:
- Providing
information on an ongoing basis regarding FDA/CFSAN food allergy activities to
physicians, other health professionals and their organizations.
- Developing
mechanisms to enhance surveillance of food allergy associated anaphylaxis and
death.
10-5. Increase the proportion of consumers who
follow key food safety practices.
-
The key food
safety practices are based on the four Fight BAC!® messages developed by the
public-private Partnership for Food Safety Education in cooperation with FSIS,
CDC and FDA: clean--wash hands, utensils and surfaces often; separate--don't
cross-contaminate; cook--cook to proper temperatures; and, chill--refrigerate
promptly.
- Estimates based
on the FDA/FSIS 2001 Consumer Food Safety Survey suggest that 75.4% of
consumers report food handling practices that are consistent with the four
basic food safety messages, up from 73.1% in 1998. In particular, consumers
reported using improved food-handling practices that reduce cross-contamination
after contact with raw fish, meat, or chicken. Consumers reported an increase
in thermometer use. The number of consumers eating pink hamburger, steak
tartare, and raw eggs stayed relatively level. However, more people reported
eating raw clams, oysters, or fish in 2001 than in 1998.
Challenges
and Barriers--Data:
-
The Food Safety
Survey data available to measure progress toward this objective require
self-reports of average behaviors across multiple and varied instances.
Therefore, the measured percentage of consumers who engage in safe behavior is
likely to be an overestimate. However, the change in safe practices, because
they are measured in the same way over time, is likely to be realistic.
- The data
collection method used to obtain data for measuring progress toward this goal,
telephone surveys, has suffered from declining response rates across all types
of surveys. Extraordinary efforts are required to achieve minimally acceptable
response rates. This increases the field time and the cost of each data collection.
- A large sample
of at least 4,500 is needed to produce statistical analysis of small
demographic subgroups. This increases the cost of each data collection.
Challenges
and Barriers--Consumer Practices:
-
Changing
people's behavior is generally difficult. In situations where most people
believe they already follow the recommended behaviors, as is the case with home
food safety practices, increasing compliance is especially difficult because
those not in compliance are likely to be resistant to the recommended
practices.
Strategies/Opportunities--Data
-
Planning
began in 2003 for the next Food Safety Survey data collection, planned for
2005.
Strategies/Opportunities--Consumer
Practices:
10-6
Improve food employee behaviors
and food preparation practices that directly relate to foodborne illnesses in retail
food and food service establishments.
- This objective
is based on assessments of the occurrence of CDC-identified foodborne disease
risk factors(4) in
retail food and food service establishments. Information gathered during data
collection efforts may identify beginning patterns in compliance with specific Food
Code requirements related to food preparation practices and food employee
behaviors at institutional food service establishments, restaurants, and retail
food stores. The 2010 goal is to reduce by 25% the occurrences of
CDC-identified risk factors that cause foodborne illness in retail food and
food service establishments.
- The nine types
of retail food and food service establishments are: institutional food
services (hospitals, nursing homes, elementary schools), restaurants (fast
food, full-service), and retail food store departments (deli, meat and poultry,
produce, seafood).
- The 17,477
observations collected in 1999 baseline study (Report of the FDA Retail Food
Program Database of Foodborne Illness Risk Factors http://www.cfsan.fda.gov/~dms/retrsk.html ) found five practices and behaviors needing priority attention within retail
food establishments. The following practices and behaviors exceeded a 40% OUT
OF COMPLIANCE observation rate:
- Cold holding of
potentially hazardous food at 41°F (5°C) or below;
- Cold holding of
ready-to-eat, potentially hazardous food at 41°F (5°C) or below;
- Date marking of
commercially processed ready-to-eat, potentially hazardous food;
- Cleaning/sanitization
of surfaces/utensils; and
- Proper, adequate
hand washing.
Challenges/Barriers
in assessing the occurrence of foodborne illness (FBI) risk factors and
tracking trends:
-
Maintaining a
study design that results in comparability between FDA 1999 baseline data and
data from subsequent data collection efforts. Data collection in 2003 and 2008
will result in data that begin to show patterns of change in behaviors or
practices. Additional data collection beyond 2008 is needed to begin to
identify and track trends. In essence, maintaining a measurement tool that we
could repeat on a cyclical basis to see what changes have occurred;
- Recognizing
limitations associated with data derived from observations made at a single
inspection of each food establishment.
Challenges/Barriers in improving food employee behaviors and
food preparation practices (reducing the occurrences of foodborne
illness (FBI) risk factors) within retail food establishments:
-
Training this
high-turnover job force is a major challenge. The retail level food and food
service workforce is diverse, multi-lingual, and has various cultural
practices.
- Another
challenge is in applying the knowledge obtained through food worker training
courses to achieving real behavior change in the retail food and food service
establishment. Changing people's behavior is generally difficult.
- Responsibility
for establishing and enforcing retail food safety regulations is splintered
across thousands of regulatory agencies with differing priorities.
Strategies/Opportunities
(Assessment):
-
The
FDA, National Retail Food Program Team collected data in 2003 and plans data
collections by FDA personnel in 2008. Data collected in 2003 are being analyzed
now with a report to be released in September 2004 and a satellite broadcast
scheduled for October 14, 2004.
Strategies/Opportunities
(Behaviors and Practices):
-
Strategy chosen
- to track trends in the occurrence of FBI risk factors rather than illnesses -
Although identifying the level of foodborne illnesses would be the ideal, the
occurrence of foodborne illness is grossly underreported, making it an
unreliable program measurement. As an alternative, the occurrence of FBI risk
factors was selected as the performance indicator.
- Encourage State
and local regulatory agencies to focus on Food Code interventions and
strategies under the Draft National Voluntary Retail Food Regulatory Program
Standards(5). State
and local regulatory jurisdictions use of the Program Standards allows
for the development of community-based baselines by States and local
jurisdictions under Standard #9. Regulatory agencies may wish to use the FDA
model or customize their baselines to address specific needs or concerns within
their jurisdictions.
- Follow the FDA
Retail Food Program Operational Plan for long term goals for the national
program as well as GPRA measurement of the successful implementation of program
objectives.
- Enhance industry
focus on Food Code interventions and attention to active managerial control
of key risk factors through broad application of the Program Standards improved training materials and courses, and public educational campaigns.
- The Food Safety
Training and Education Alliance for Retail, Food Service, Vending,
Institutions, and Regulators (FSTEA) is a partnership of industry, consumer,
trade, Federal, State and local food protection agencies to improve and promote
food safety education for food service personnel and food safety regulators and
increase implementation of the Food Code. See www.fstea.org
-
To reduce the
incidence of foodborne illness associated with eggs, FDA prepared a brochure
and poster on safe handling of eggs and egg-containing menu items, which has
been distributed widely to State regulatory and health agencies and mailed
directly to more than 70,000 food service managers. Spanish and Chinese
versions of the brochure and poster are available.
- The FSIS Thermy™
campaign expanded to food service (institutional settings) in 2002. Thermy™ is
the messenger of a national consumer education campaign designed to promote the
use of food thermometers. The time/temperature recommendations are based on the FDA Food Code
2001. Thermy™ magnets and posters were developed and distributed. Thermy™ campaign products are
available in English and Spanish versions. See http://www.fsis.usda.gov/thermy/index.htm.
- FSIS, FDA and
CDC have been part of a task force with the International Association for Food
Protection's Retail Food Safety and Quality Professional Development Group
(IAFP) to develop10 international food safety icons. These icons or symbols
depict ten different food safety concepts for use as communication and
education/training tools in the culturally diverse workforce in the foodservice
industry and are now available. (See Exhibits section of this Briefing Book.)
10-7. (Developmental)
Reduce human exposure to organophosphate pesticides from food.
-
The Food Quality
Protection Act of 1996 mandated that the Environmental Protection Agency (EPA)
reassess existing standards for pesticides used on food crops.
0rganophosphates, a group of approximately 40 closely related pesticides, have
been designated as first priority in the standards reassessment. These
pesticides are used on fruits and vegetables important in the diets of
children.
Challenges
and Barriers:
- Organophosphates were used on many food crops and
accounted for about half the amount of insecticides used in the US at the time Food Quality
Protection Act (FQPA) was implemented.
Strategies/Opportunities:
- The EPA
reassessment of organophosphates resulted in cancellation of a number of uses
of these pesticides.
-
Levels of
pesticide residues in foods are monitored annually through FDA's Total Diet
Study (TDS). It was expected that results of the TDS would demonstrate a
gradual decrease in the number and levels of organophosphate pesticides in
foods over the period relevant to the Healthy People 2010 (1997-2010).
-
A recent review
of the TDS results for organophosphates for the period 1997-99 indicated very
few detectable levels of organophosphate residues in foods. In addition, the
levels detected in these samples were extremely low.
-
It is expected
that the TDS will demonstrate even fewer findings in subsequent years. With
such low levels and so few findings each year, it would not be possible to
demonstrate a decreasing trend in the presence of organophosphate residues in
TDS samples. For this reason, the working group will recommend during the
Midcourse Review that this objective be excluded.
- The proposed
measure was to be based on a calculation of human exposure from food
consumption data and pesticide residue data (TDS). The CDC/National Center for
Environmental Health Second National Report on Human Exposure to
Environmental Chemicals, released on January 31, 2003, will
provide a more direct measure of exposure/body burden through biomonitoring. Biomonitoring is the assessment of human exposure to
chemicals by measuring the chemicals or their metabolites in human specimens
such as blood or urine.
- Refer to related
objectives 8-24a-d in the Environmental Health Focus Area for data on exposure
to four pesticides. (These data are included in the Data Tables section of the
briefing materials.)
Related
Objectives from Other Focus Areas
- 8.
Environmental Health
- 8-5.
Safe
drinking water
- 8-6.
Waterborne
disease outbreaks
- 8-8.
Surface
water health risks
- 8-10.
Fish
contamination
- 8-24.
Exposure
to pesticides
- 8-25.
Exposure
to heavy metals and other toxic chemicals
- 8-29.
Global
burden of disease
- 8-30.
Water
quality in the U.S.-Mexico border region
- 14.
Immunization and Infectious Diseases
- 14-21.
Antimicrobial
use in intensive care units
- 20.
Occupational Safety and Health
- 20-8.
Occupational
skin diseases or disorders
- 23.
Public Health Infrastructure
- 23-2.
Public
access to information and surveillance data
Notes:
(1)
Mead, P.S., L. Slutsker, V. Dietz, L.F. McCaig,
J.S. Bresee, C. Shapiro, P. M. Griffin, and R.V. Tauxe. 1999. Food-Related
Illness and Death in the United States. Emerging Infectious Diseases 5(5):607-625. See
Exhibit section.
(2)
Mead, P.S., L. Slutsker, V. Dietz, L.F. McCaig,
J.S. Bresee, C. Shapiro, P. M. Griffin, and R.V. Tauxe. 1999. Food-Related
Illness and Death in the United States. Emerging Infectious Diseases 5(5):607-625. See
Exhibit section.
(3) Falci, K.J.,
K.G.Gombas and E.L. Elliot. 2001 Food Allergen Awareness: An FDA Priority
New initiatives focus on allergens
in 2001. Food Safety Magazine 2:
(4) Based on the Centers for Disease Control and
Prevention (CDC) Surveillance Report for 1988 - 1992, five broad categories of
risk factors contributing to foodborne illness were identified. The identified
risk factors include: Food from Unsafe Sources; Inadequate Cooking; Improper
Holding Temperatures; Contaminated Equipment; and Poor Personal Hygiene.
(5) These 9 standards constitute a framework for measuring a regulatory food
program's effectiveness and provide a process for continuous improvement via a focus
on the reduction of foodborne illness risk factors as well as the promotion of
active managerial control of these risk factors.
Hypertext updated by ear June 9, 2004