INTRODUCTION
STUDY GOAL AND OBJECTIVES
Americans have the safest food supply in the world, yet the
Center for Disease Control (CDC) estimates that each year there are an estimated
76 million illnesses, 325,000 hospitalizations, and 5,000 deaths due to
foodborne illnesses. Foodborne illnesses are caused by pathogens, which include
bacteria, viruses, parasites, and toxins. Known pathogens account for 14 million
illnesses, 60,000 hospitalizations, and 1,800 deaths annually. Pathogens occur
naturally in plants and animals, but they can contaminate foods and make humans
who ingest them ill. These illnesses are typically short-lived, but chronic
medical complications, and even fatalities, can also occur.
Pesticides, on the other hand, are not natural; they are
manmade chemicals that are deliberately applied by farmers to protect crops.
These fungicides, insecticides, and herbicides protect crops against diseases,
insects, and weeds. The consequences of human ingestion of foods containing
pesticide residues are not as clear-cut because generalizations about health and
safety are drawn from studies with lab animals rather than human subjects.
GMOs (genetically modified organisms) are microorganisms,
plants, and animals that have had their genetic structure altered by artificial
means. Genetically modified (GM) products are such a new area of agriculture
biotechnology that there are presently only a few test makers. However, this
area is likely to grow as test makers identify the food industry's interest in
testing GM products.
While it is suspected that such medical complications as
birth defects and cancer can result in the long term, the consensus of health
professionals has been that pesticide residues in foods do not pose a serious
health risk. The view by regulators is telling: Governmental agencies track
outbreaks of foodborne illnesses according to specific types of pathogens, with
no mention made of pesticide residues; some residues are allowed to remain in
foods because tolerance limits are measured in above- or below-limit ranges, in
contrast to pathogens which are detected as either absent or present.
The increase in foodborne illnesses, in general, and in
specific types of pathogens, in particular, is due to various consumer,
manufacturing, and regulatory trends that may set the stage for contamination or
minimal screening methods. For example, there are changes in consumer
consumption habits and preferences for plant-based foods and minimally processed
convenience foods, as well as an increase in certain risk groups who are most
vulnerable to illnesses.
Then there are changes in food production, distribution, and
globalization of supply that expands the potential for imports tainted with
pathogens or pesticide residues. Compounding the problem are new types of
pathogens, as well as new strains of recognized pathogens, and both are
appearing in food products where they have never before been identified.
Food processors want to deliver a safe product to consumers,
and this can be achieved by testing the raw materials, the product during its
processing and production, and/or the finished products. Testing can be
conducted in the field or at inhouse/outside labs, and by growers, suppliers,
distributors, or processors. The processor's aim in testing a food sample is to
ensure its safety so that production can continue and move the product from the
warehouse through distribution channels that finally reach consumers. The food
processor selects a specific type of test according to various factors, such as
testing time required, specificity desired, and the price of the testing
process. For bacteria, which are the only pathogens routinely tested for in food
samples (viruses and parasites are typically tested in stool specimens of
infected persons as the first step), the food processor tests for specific types
of bacteria and can choose among culture tests, gene probes, manual
immunoassays, and instruments (automated immunoassays).
For other types of pathogens, such as toxins (including
mycotoxins and seafood toxins), there are manual immunoassays and instruments
(automated immunoassays, chromatography methods). For pesticide-residue
detection, there are manual immunoassays and instruments (automated
immunoassays) that test for a single type of residue and instruments
(chromatography methods) for screening multiple types of residues.
The goal of this report is to describe the various types of
tests that can detect pathogens, pesticides and GMOs in food samples, how food
processors are using them, and what market and regulatory forces are influencing
processors' choices of what pathogens to test for and what type of test is best.
REASONS FOR DOING THE STUDY
This report is designed to achieve the following objectives:
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To discuss the trends and developments taking place for
specific types of pathogens and pesticides, and to examine how they
influence the development and marketing of tests by test makers who aim to
help food processors deliver products that are free of pathogen
contamination and have pesticide residues below tolerance limits;
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To describe the trends and developments for each type of
test and for each type of test technology in terms of how each is meant to
satisfy the needs of processors as they, in turn, try to satisfy consumer
demands for minimally processed convenience foods and plant-based, healthful
foods;
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To analyze market and driving forces with particular
attention paid to regulatory forces that create certain programs for
specific industries, such as Hazard Analysis Critical Control Point (HACCP),
in order to suggest the market size for tests that screen for specific types
of pathogens and pesticides, as well as that for specific test technologies,
and to pinpoint target food-processing industries; and
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To examine the food-testing business in terms of types of
companies that are the most-active test makers and suppliers, and explore
the various ways they respond to the needs of food processors who want and
need reliable, sensitive, and cost-efficient tests.
CONTRIBUTION OF THE STUDY
BCC seeks to provide insight into one key question: Which
test technologies can best help food processors screen for pathogens and
pesticides as they seek to satisfy consumer demands for healthful and convenient
processed foods? This report presents the various types of pathogens (bacteria,
virus, parasites), toxins (mycotoxins, seafood), and pesticides that are tested
for, sources of contamination, and the food and beverage applications in which
they can be found as contaminants. The report also examines each testing
technology in terms of its pluses and minuses for the food processor.
The various market forces that shape consumer demand for
certain foods that have the potential to be contaminated will be discussed, as
well as the driving forces that influence food processors to test, either
because regulations mandate testing or because they want to, and how these
forces promote or hamper growth of specific tests.
The report analyzes specific test technologies that are
forecast to have fast growth and others that are projected to have slower
growth, taking into consideration such factors as ease-of-use performance,
whether results are indicated as qualitative or quantitative, long- or
short-term testing periods required, price, sensitivity and specificity,
accuracy, and reliability.
SCOPE AND FORMAT
The problem of foodborne illness is initially discussed,
followed by an examination of the need for testing. Each type of pathogen and
pesticide is described, as well as sources of contamination, food and beverage
applications in which they can be found, various types of tests and technologies
that screen for each, the market and driving forces influencing market size, and
the most-active test makers and their testing products. The market for GMOs is
introduced with an overall presentation of the GM products, along with the
testing-market size.
METHODOLOGIES
Business Communications Co., Inc. (BCC) makes sales estimates
and projections for testing products according to: specific types of bacteria,
toxins, and pesticides; by their specific testing technologies; and by the
industries that most commonly test their materials or finished products.
INFORMATION SOURCES
BCC first conducted an extensive review of the secondary
literature (print and electronic) consisting of materials gathered from trade
journals and magazines, company and product literature, trade and professional
associations, and government and industry sources. Subsequently, some 100
telephone interviews were conducted with personnel and technical sources in the
areas of quality assurance/control, marketing and sales departments of test
makers, independent labs, and researchers and academics at university and
governmental facilities.