Food Safety Magazine

COVER STORY | December 2000/January 2001

Food Safety Guide: Emerging Challenges, New Directions

By Julie Larson-Bricher

Food Safety Guide: Emerging Challenges, New Directions

This overview article serves as an introduction to the state of food safety challenges, regulatory developments and proposals, and science-based strategies, methods and practices that will likely impact the way in which food processors, food service operators and industry suppliers address emerging food protection concerns in the New Year.

In upcoming editions of
Food Safety Magazine, readers will find many of the issues mentioned in this overview detailed more thoroughly in full-length articles, case studies and interviews with food industry leaders, regulators and scientists. While the basic editorial foundation readers have come to expect in Food Testing & Analysis will not change, the publication’s new incarnation as Food Safety Magazine offers the opportunity for expanded coverage of emerging issues and science-based solutions for food safety and quality assurance professionals worldwide. As this article indicates, the trends and developments at the forefront of food safety and quality assurance efforts by industry, regulatory agencies, testing and analytical laboratories, consultants and technology suppliers in 2001 are truly “farm-to-fork” in scope.

Increase of Food Safety Measures and Programs in the Food Industry
Since the 1993 Jack-in-the-Box E. coli O157:H7 outbreak in the Pacific Northwest in which four children died and hundreds were made ill, the advent of new food safety regulatory mandates and the introduction of more science-based systems and innovative technologies for food safety and quality assurance/quality control (QA/QC) programs has increased dramatically. By the end of 2000, however, several heavily publicized food recalls—including a national recall of corn-based taco shells and baked goods containing genetically modified protein unapproved for human consumption, the Midwest-wide recall of ground beef for suspected E. coli contamination, and a nationwide recall for possible Clostridium botulinum contamination of soups imported from Canada—once again trained the spotlight on the importance of continuous improvements in food protection strategies.

The food and beverage industry’s advocacy of proactive food safety systems and principles has been one of the last decade’s strongest trends. With increased consumer demand for fresh, ready-to-eat (RTE), safe and high quality foods available year-round, the globalization of food distribution, and new regulatory compliance requirements, companies all along the food supply chain have adopted a variety of science-based measures, principles and practices to maintain a high level of food safety assurance and public confidence. The widespread adoption of Hazard Analysis & Critical Control Points (HACCP) systems by industry segments in which such systems are not mandated, as well as the industry’s active partnership with the U.S. Food and Drug Administration (FDA), Centers for Disease Prevention and Control (CDC), U.S. Department of Agriculture (USDA), states, academia and consumers in support of the President’s Food Safety Initiative are just two examples of industry’s commitment to identify and meet today’s food safety challenges.

And those challenges are wide-ranging. The identification, prevention, control and monitoring of foodborne pathogens and microbial parasites remains one of the food industry’s most pressing problems. In its most recent estimate, CDC stated that foodborne disease is responsible for approximately 76 million illnesses, 325,000 hospitalizations and 5,000 deaths annually in the U.S. Of those, known pathogens, such as Salmonella, E. coli O157:H7, Campylobacter and Listeria monocytogenes, account for 14 million illnesses, 60,000 hospitalizations and 1,800 deaths. Other microorganisms of concern include Shigella, Vibrio, Toxoplasma gondii, Yersinia enterocolitica and Staphylococcus aureus. Several leading food microbiologists predict that viruses will soon be added to the list of top microbial concerns for the food industry. In addition, continued emphasis on extending the shelf life of products to meet growing consumer demand and food distribution/ storage requirements will present new microbial safety challenges in 2001 in terms of pathogens, spoilage organisms and toxins. The trend toward developing improved methods for identifying bioengineered foods and increasing the effectiveness of environmental monitoring and sanitation programs are other active areas.

In 2001, food safety challenges with regard to chemical and physical contaminants will also remain priorities for the food industry. Many food processors have identified allergens, chemical contaminants and pesticide residues, packaging materials, nutraceuticais and vitamins A, D, E and K as areas to be considered for inclusion in company-wide food safety systems. Improvements in monitoring and verification for chemical hazards, such as pesticides, dioxin and dioxin-like compounds, heavy metals, and volatile organic compounds (VOCs) in imported raw materials and ingredients, as well as for sanitizers and chemicals used for plant or food service maintenance, will also impact food safety programs. Physical hazards, primarily foreign substances or adulterants inadvertently included in raw materials or ingredients, will also continue to be an important area of concern.

Outside of the established functions of food safety and QA/QC departments, the trend for designing food safety into new products falls under the purview of the research and development (R&D) department. Spurring this trend toward reducing and managing safety risks at the product formulation stage of development are food ingredient companies, many of which have been introducing and requesting regulatory approvals for a wide range of natural antimicrobials to help control known pathogens in at-risk food products.

While reducing the negative economic impact of a recall or product liability action and achieving regulatory compliance are certainly significant drivers for the trend toward food safety efforts, leading food companies have long promoted and will continue to promote food safety as just plain good business, maintaining that safety and quality are the most important issues for American consumers. In a 1998 company newsletter, for example, Nabisco CEO and President Jim Kilts made the case for implementing proactive food safety strategies to protect the reputation of company brands: Oreo, Lifesavers, Planter’s and A-1 are brands that stand for excellence, quality, and wholesomeness. Our brands are Nabisco. One hundred years in the making, Nabisco’s reputation is a precious thing. Everyone in the organization has a role in maintaining and protecting that reputation. The consumer today is more knowledgeable and aware of food safety issues than ever, and a safety incident in one country can affect brand loyalty globally. Once brand loyalty is eroded, it is extremely difficult to recover.

To continue to grow the value of our brands and the confidence that our customers have in our ability to provide them with safe, wholesome, quality products, we have developed the Nabisco Food Safety Policy. This policy establishes standards that each of Nabisco’s operating companies must utilize in food safety strategies for their business, I endorse this policy because it provides a consistent framework of food safety principles across the entire business chain. Whether you’re a CEO or in operations, sales, marketing research and development, finance or any other function, we must recognize that Food Safety is the first ingredient in all Nabisco products. —The First Ingredient, Vol. 1, Issue 1

This commitment to systematic food protection, echoed by many others in the food supply and distribution chain over the years, has resulted in many scientific advancements in the latter half of the 1990s. As we enter a new era, identifying food safety hazards, controlling these hazards and reducing the incidence of foodborne illness will rest on how well the industry, in partnership with the scientific community and policymakers, can utilize these advances to meet the challenges ahead.

Regulatory Developments 2001
The nation’s commitment to reducing foodborne illness and improving food safety systems is indicated by increases at the two top federal food oversight agencies in Fiscal Year (FY) 2001 budgets targeting food safety initiatives. The U.S. Department of Health and Human Services (HHS) FY2001 budget includes $149 million directed toward the President’s Food Safety Initiative, an increase of $40 million over FY2000. This increase will provide CDC with $10 million toward an expansion of the PulseNet system for identifying disease-causing bacteria. FDA will receive an additional $30 million to improve inspection of all high-risk food establishments; to enhance laboratory analyses; to implement the Egg Safety Initiative, which includes improving test methods for Salmonella enteriditis; and to add more national and international data collection sites to the National Antimicrobial Resistance Monitoring System.

In December 2000, the FDA Center for Food Safety and Applied Nutrition (CFSAN) announced its annual “report card” on completed activities in 2000 in four program areas: food safety, food additives, dietary supplements and food biotechnology activities. CFSAN Director Joseph A. Levitt noted that the agency completed 78% of its 2000 goals with regard to “A list” priorities. Twenty-four goals in which substantial progress has been made will be carried over into FY2001 as high priority action items (Table 1. FDA CFSAN FY 2001 program priorities). Among the 84 goals met by CFSAN in 2000, several are food safety related, including:

• Increased by 90% the number of “high risk” domestic food inspections (3,000 inspections in FY 1999 compared to 5,700 in FY 2000).

• Nearly doubled the number of foreign on-site food inspections, conducting 165 inspections in FY2000 compared to 85 in FY 1999.

• Completed the collection and laboratory analysis of 1,000 samples of high- volume, imported produce, and initiated an assignment to collect 1,000 samples of domestic produce to determine incidence of microbial contamination. Also, reviewed and approved for use by field laboratories a number of rapid methods for detection of pathogens in imported produce.

• Conducted the third year of domestic seafood HACCP inspections, and completed first enforcement action against a purveyor of hot and cold smoked fish because the firm was not controlling the hazard of Clostridium botulinum. (The firm entered into a consent decree and agreed to stop processing until this hazard could be controlled.)

• Achieved adoption of the Food Code in 20 state agencies having jurisdiction over retail-level establishments. The Food Code is the guidance for food retail outlets such as restaurants and grocery stores on how to prevent foodborne illness. (Final decisions on controversial issues pertaining to the 1999 Food Code will be integrated into the 2001 Food Code.)

• Successfully launched new Food Contact Substances program, including publications of a proposed rule and companion guidance for premarket notifications.

• Streamlined, with USDA, process for reviewing food additives for meat and poultry products, and published a final rule for the simultaneous review of food ingredients and sources of radiation in meat and poultry.

• Published a final rule that defines the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body.

• Announced a strategy to strengthen FDA’s regulation of foods developed through biotechnology, including a proposed rule for premarket notifications, guidance for voluntary labeling and enhanced advisory committee expertise.

• Published draft guidance on three chemical contaminants: “Channels of Trade” policy for methyl parathion residues; adulteration level for patulin in apple juice products; and fumonisin levels in food and feeds.

• In collaboration with the National Conference of Interstate Milk Shippers, FDA initiated a Dairy Grade A HACCP Pilot Program in six dairy processing plants. These plants have implemented the voluntary HACCP Pilot and were listed in the Interstate Milk Shippers List under the HACCP alternative to the traditional PMO-based program.

• In April 2000, the agency issued a field assignment to visit 150 U.S. sprout growers to determine the extent to which the industry is adopting the sprout guidance. (A preliminary evaluation indicates mixed results, according to the agency. Added testing is identifying some contaminated sprouts before reaching consumers, and there were fewer outbreaks from sprouts in FY2000. However, nearly half of the sprout growers had not adopted effective preventive controls, in particular, microbial testing of spent irrigation water. A final report of the assignment will be issued in FY2001.)

• To measure adoption of the Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) guidance, FDA worked with USDA’s National Agricultural Statistical Service (NASS) to perform an extensive survey of production practices of fresh fruit and vegetable growers and packers in the U.S. This survey gathered data on the types of practices— agricultural water source, manure use, employee hygiene and facility sanitation— covered in the guide. A report of the survey results is expected to be available early 2001.

• In conjunction with USDA, FDA provided funding for a pilot project with eight federal, state and local laboratories to develop standards for sampling and testing methods for E. coli O157:H7. This program standardizes the E. coli 0l57:H7 food sample testing methods already ongoing at eight labs and it is working toward accreditation of the procedures used. The pilot will be completed in FY2001.

• Arranged contracts with the National Academy of Science’s Institute of Medicine to establish a scientific framework for assessing the safety of dietary supplements, and to apply that framework to several specific dietary supplement products.

• Established the Dietary Supplement Strategic Plan goal to establish by the year 2010 a science-based regulatory program that fully implements the Dietary Supplement Health and Education Act of 1994, and that provides consumers with a high level of confidence in the safety, composition and labeling of dietary supplement products.

• Finalized safe handling labels and refrigeration requirements for marketing shell eggs as part of implementation of the Egg Safety Action Plan. The plan is a joint effort by FDA and USDA to reduce by 50% the number of Salmonella enteritidis (SE) illnesses attributed to contaminated eggs by 2005 and to eliminate SE illnesses by 2010.

According to FDA, there are two specific emerging areas of regulatory interest for 2001: biotechnology and food allergens. On May 3, 2000, the agency made a public announcement on three initiatives to strengthen the regulatory approach for bioengineered foods. First, the agency would initiate a proposed rule requiring that developers of bioengineered foods notify the agency before marketing such products. Second, FDA would seek the addition of scientists who have expertise in biotechnology to the Food Advisory Committee. Finally, the agency would aim to develop labeling guidance to assist manufacturers who wish to label their foods voluntarily as being made with or without the use of bioengineered ingredients. Addressing the issue of food allergens, the agency held 14 meetings in 2000 at different locations to raise consumer and industry awareness to the presence of allergens in foods and on labeling approaches to identify the presence of allergens.

The U.S. Department of Agriculture will have an additional $27.5 million earmarked for food safety initiatives and related research in FY2001. Activities funded in various agency program offices range from designing effective programs to control Salmonella enteritidis in and on shell eggs to developing programs to control animal-borne bacteria and pathogens that are transmitted to humans. USDA program offices will also commence research to develop effective pathogen control methods for fruits and vegetables, to develop intervention strategies used in HACCP plans to reduce pathogens in meat and poultry, and to improve pathogen, chemical and drug residue detection methods used during product processing and storage. Some specific food safety action items on the agendas of USDA program offices include:

Food Safety and Inspection Service (FSIS). With the full implementation of the Pathogen Reduction/HACCP Systems Rule as of January 2000, when all meat and poultry establishments came on line, the meat and poultry inspection system modernization efforts continue apace. The 2001 budget requests resources to ensure that demands for inspection services can be met while implementing HACCP based inspection procedures and continuing to make advances in reducing the risk of foodborne illness made under the President’s Food Safety Initiative. Action item highlights include:

• Implement HACCP-based inspection procedures. Currently, FSIS is examining how to redefine the functions of inspection personnel under a HACCP-based food safety system. By July 1, 2001, FSIS will begin to implement new slaughter inspection models in 100 poultry broiler establishments that shift the responsibility from FSIS to establishments for segregating animals suitable for food from those not suitable for food under HACCP and other process controls. In addition, FSIS will also implement daily unscheduled inspections in processing establishments by April 1, 2001, rather than conducting inspections during each shift.

• Enhance the implementation of the Pathogen Reduction/HACCP Systems Final Rule. In order to ensure that all establishments are meeting HACCP requirements, FSIS will increase the number and intensity of comprehensive reviews of state and foreign inspection programs to determine if they are equivalent with federal requirements. The implementation of HACCP and other regulatory reforms has placed increased demands on supervisors and inspectors for learning new processes that have increased the complexity of inspection activities. In order to ensure that these new functions are uniformly and effectively applied, meetings with inspectors are needed to address concerns and questions inspectors may have regarding verification of HACCP systems, process control systems and pathogen testing.

• Promote the adoption and enforcement by state agencies of uniform performance standards for commercial handling of inspected meat and poultry products from processing to consumers. (FSIS has several rules in the proposal stage for 2001, including performance standards for RTE and poultry products, bacon, and for the chilling or other processing of livestock carcasses and RTE poultry.)

• Promote the adoption of national uniform laboratory standards by federal, state and local governments for testing meat and poultry products.

• Implement the Shell Egg Action Plan.

• Conduct risk assessment studies of Listeria and Campylobacter.

• Provide training to state governments to facilitate the interstate shipment of state-inspected products. Agricultural Marketing Service (AMS). Some of the food safety related aims budgeted for FY 2001 include:

• $1.1 million to complete planning and begin implementing pesticide residue testing in support of the EPA’s water testing program.

• $6.2 million to broaden the scope of Pesticide Data Program (PDP) to include microbiological testing of fruits and vegetables as part of the President’s Food Safety Initiative.

• $0.7 million to establish market reporting of organic products and to finalize implementation of the National Organic Program, including development of an international certification program, accreditation of state departments of agriculture and private persons, establishment of a system to prevent fraudulent labeling and extensive customer outreach.

The Grain Inspection, Packers and Stockyards Administration (GIPSA). This program office, which expects to inspect 236 million metric tons of grain and four million metric tons of rice in 2001 has requested an increase of nearly $2 million to develop new biotechnology testing methods, analytical tests and greater quality assurance procedures for grain.

Food Safety Research and New Industry Programs for 2001
Another strong indicator of where food safety trends are headed in the New Year can be found in the types and areas of research funded for FY 2001 by a variety of government and trade organizations.

On Nov. 30, 2000, Agriculture Secretary Dan Glickman named 29 food safety- related research, surveillance and education projects as recipients of$ 14.2 million in competitive grants for 2001. Among those funded, Cornell University will receive nearly $600,000 to develop a comprehensive food safety training program for farm workers, and Colorado State University will receive $479,223 to develop ways to reduce the risk of Listeria monocytogenes and other pathogens in dried foods.

FDA recently awarded more than $530,000 in one-year grants tol3 state and local regulatory agencies’ food safety projects as part of President Clinton’s Food Safety Initiative. Funded projects include the Jefferson County, MO, Health Center “Study of Baseline Microbiological Contaminate Levels,” which aims to establish level baselines for food service and retailers using ATP/enzyme bioluminescence and rapid pathogen testing, and the Delaware Health & Social Services project, “Innovative Inspection Methodologies,” in which researchers will develop an inspection method using a traceback technique.

FDA CFSAN also released a list of priority research needs for 2001, which illustrates the range of food safety issues identified by the agency as areas which require science-based answers (See box on pages 30-31).

Many leading food industry trade and scientific organizations are offering new food safety programs slated to begin in the 2001. The American Meat Institute Foundation (AMIF) recently unveiled its new Microbiological Benchmarking Program, which will help plants compare their microbiological profiles against other industry companies. Under the program, each participating plant will submit by overnight delivery a randomly selected sample of product each week using an anonymous identification number. Each sample will be tested for total aerobic plate count, generic E. coli plate count and incidence of Salmonella. Other organisms, such as Campylobacter and Listeria, may be added later, based on agreement among participating plants.

Under the new AMIF program, samples will be collected and analyzed according to USDA methods. Chilled carcasses will be sampled one day after slaughter. Trimmings will be sampled at the time of fabrication or when received at the grinding operation. Ground product will be sampled at the time of production. Product categories that will be sampled under the program include: steer/heifer beef carcasses; cow/bull beef carcasses; barrow/gilt carcasses; sow/boar carcasses; 50% beef trimmings; 90% beef trimmings; 72% pork trimmings; ground beef and ground pork. Participating plants will receive individual sample results on an ongoing basis. A quarterly report will be provided that shows the results of each sample analyzed in the product categories in which the plant is participating. Results will be shown by plant with mean and standard deviation calculated for each.

The National Food Processors Association (NFPA) is offering a new Food Safety and Quality Systems Supplier Audit Program for 2001. For nearly two years, NFPA investigated the feasibility of coordinating third-party audits of suppliers to food processors and learned that some suppliers may experience as much as 20 or more audits for each of their facilities, each with different forms, different standards and much duplication. One processor reported earlier this year that three separate auditors showed up on the same day. The new program is designed to benefit all segments of the food industry: suppliers to processors, through fewer and less disruptive audits; processors, through greater confidence in third-party audits; and independent auditors and firms, through a partnership with the food industry to administer a high quality audit that will enhance food safety standards. The new program will be launched in a pilot phase in 2001.

AOAC International introduced several proficiency testing programs in the past few years for food testing and analytical laboratories, including standard microbiology, pathogen-free microbiology, meat microbiology, HACCP compliance and nutritional labeling. The association’s newest programs are the Combination Pathogen Program in Meat Matrix and the Pesticide Residue in Fruits and Vegetables.

Advances in Method and Technology Innovations
The introduction of innovative and improved food safety and quality assurance technologies, sampling, testing and analytical methods and instrumentation, and hazard reduction or control strategies will continue to advance the cause of industry, government and other organizations to ensure that the U.S. food supply remains one of the safest in the world. In 2001, science-based methods and technologies that assist in the monitoring and verification of food safety systems will continue to be of prime interest to the industry.

Common Food Safety Systems. Growers and raw material suppliers rely on Good Agricultural Practice guidelines and third-party auditing and testing programs that are commodity-specific. Ingredient and raw material suppliers have experienced an increased demand by food processors to operate under the HACCP model and to provide certificates of analysis, for example, to ensure that raw materials have been evaluated prior to receipt at the plant. The most commonly used programs in food processing facilities include HACCP systems, Good Manufacturing Practices (GMPs), prerequisite programs and sanitation standard operating procedures (SSOPs), and in-house or third-party testing or auditing. At the retail end, more than one million restaurants, grocery stores and institutions follow the FDA Food Code, the reference that provides information on food safety rules and measures pertaining to areas such as worker hygiene, sanitation and holding times and temperatures to prevent foodborne illness. Some food retail operations also utilize a modified form of HACCP as a food safety system.

Many leading food producers and suppliers integrate food safety with quality management systems, such as the International Organization of Standards (ISO) 9000 guidance and conformance series of standards. In December 2000, ISO released a revision to the series, which replaces several previous standards with a single quality management system, now known as ISO 9001:2000.

Microbiology Innovations. Improving prevention, reduction, control and verification measures for foodborne pathogens, spoilage organisms and toxins will remain a top concern for many food producers. Specificity, accuracy and speed are among the most important factors demanded by industry in terms of technological advances.

Many of the top scientific technologies for the rapid detection, identification and enumeration of potentially harmful microorganisms continue to be improved upon as industry demands more real-time results about potential hazards in the food supply. Advances that will continue to have an impact on food safety management decisions include:
• Culture-based tests such as enzyme-linked immunosorbent assay (ELISA) and enzyme immunoassay (EIA) methods and diagnostic test kits for bacterial pathogens and mycotoxins have dramatically reduced the time to result of conventional enrichment and plating techniques. Commercially available ELISA methods for E. coli O157:H7 provide 24-hour results, while such tests for Salmonella and Listeria range from 24 to 48 hours to result. An ELI SA-based method for the rapid detection of Campylobacter was recently introduced, and kits for the detection of Shiga toxin as well as for Staphylococcus aureus and Enterobacteriacrae counts are also on the market. Other culture-based tools that have been used widely with good results in the food industry include specialized selective culture media that encourages rapid growth of target organisms and screening kits, which offer results in just a few minutes and have proven popular for use as HACCP verification tests.

• The advances made in the past few years in fully automated instrumental methods, such as spiral platers, colony counters and readers and rapid microbe identification systems have been well-received by the food industry. Today’s automated systems are used in a variety of applications, including food safety and quality testing for total count coliforms, yeasts and molds, environmental hygiene, spoilage organisms and specific pathogens.

• The advent of genetic-based fingerprinting technologies has raised the scientific bar and will continue to become more sophisticated in 2001. Automated polymerase chain reaction (PCR)-based technology is one of the fastest developing genetic-based analytical tools used in the battle against harmful microorganisms, particularly in sensitive industry categories such as RTE meat and poultry, refrigerated foods and minimally processed produce. PCR, which offers high specificity and extremely rapid analytical turnaround times, may become more popular as inexpensive test methods and instruments are introduced for commercial use. The continued improvements in PCR and other DNA fingerprinting technologies, including probes, ribotyping and pulsed field gel electrophoresis, will assist industry in identifying significant foodborne hazards and establishing where these hazards exist or where they have been introduced into the food production process.

• The screening and detection of pathogens in process/ingredient water and online continuous monitoring equipment are in demand as water quality issues move to the forefront of public and international concern. Further developments in water control systems, such as ozone cleaning equipment, dry cleanup and anaerobic digestion systems will also aid in eliminating pathogens to ensure water safety and quality in food and beverage operations.

• Rapid response biosensor technologies are now becoming more available to the food industry, both for laboratory use and for in-plant continuous monitoring applications. Biosensors installed in processing equipment which are able to detect specified microorganisms during processing are also expected to become increasingly used by the food industry in the next few years.

Chemistry Innovations. Technological advances for prevention, control, detection and monitoring of chemical contaminants will continue to be in demand in 2001. As with microbiological innovations, the more rapid or near real-time these technological advances are, the better. Leading the list of current concerns in this area:
• Since the passage of the 1996 Food Quality Protection Act (FQPA), the government-mandated effort to determine safe pesticide residue levels in foods, the criteria for risk assessment have shifted from determining individual pesticide residues in foods to assessing the accumulative effect of all residues consumed by an individual. As EPA continues its efforts to reassess and reregister pesticides in accordance with FQPA, organohalogenated, organophosphorus and nitrogenous pesticides have received particular focus. As a result, many new rapid, multiresidue analytical instruments and methods based on chlorine, sulfur, phosphorus and nitrogen have been developed in the past few years, to the benefit of the industry. Rapid extraction techniques such as pressurized solvent extraction, supercritical fluid extraction and solid-phase micro- extraction, followed by gas chromatography or liquid chromatography analysis have simplified the task of analyzing entire groups of pesticide residues in a rapid sequence.

• Nutraceuticals, botanicals, vitamins and dietary supplements are part of one of the biggest growth areas in the food industry, and emerging food safety assurance issues associated with these products will necessitate new advances in testing and technology. New and improved extraction techniques to enhance removal of potential organic solvent contamination while still maintaining a maximum amount of active ingredient will be a priority for companies in this field. Other expected improvements in technology include simplified high-performance liquid chromatography and liquid chromatography/mass spectrometry systems for botanicals and aflatoxin analyses, ELISA techniques developed specifically for more difficult assays such as in process control for B vitamins and bioassay techniques for chemical constituents in herbal and nutraceutical analysis to ensure the product is correctly characterized, free of contaminants and nontoxic.

• Again, water quality and safety issues are emerging as significant issues on the world stage. On-site water quality testing capabilities in the form of test strips, portable meters and automated analyzers have improved in the past few years. Such instruments identify potential contaminants and measure process control efficacy. Tests are available for measuring aluminum, arsenic, chloride, lead, pH, nitrate, phosphate and other chemicals.

• Controlling chemical residue contamination presents another food safety challenge to the food industry, primarily because these substances can be difficult to detect and eliminate from the production process. Chemical residues can be introduced into production from a range of sources, from ingredients, food and color additives, flavor compounds and vitamins, to sanitizers and maintenance chemicals, lubricants, oxidizing agents and other process aids. Because the hazards posed by these contaminants are so wide- ranging, technologies that enable in-plant detection and control of a variety of chemical residues will be in high demand in the new year.

Physical Hazards Detection Innovations. Foreign material detection and monitoring has long been a staple of food safety programs. In-line metal detectors, on-line visual inspection systems, X-ray technology and other systems that aid in the detection of physical hazards ranging from pits and seeds to nuts and bolts have evolved into highly automated, continuous monitoring systems. Technologies based on laser imaging and ultrasound are making advances in detecting foreign substances on packaging materials.

Focus Areas in Food Safety Assurance
The emerging food protection challenges poised to have an impact on industry safety and quality management programs in 2001 range from shelf life extension, packaging, and environmental monitoring and sanitation, to mycotoxins, allergens, biotech foods, and pathogen destruction.

Shelf Life. Extending the shelf life of food products to meet consumer demand and to ensure the safety of products that now travel increased distances to retail outlets is an emerging focus area for food safety technological development. The ability to determine whether shelf life problems are being caused by pathogen or spoilage organism contamination, by interactions with packaging materials or barrier protection failures by packaging materials, by oxidation reactions, or by time-temperature abuse during distribution or storage are among the most significant concerns. As a result, advances in microbiological, chemical and physical measurement technologies associated with both the quality assurance and safety of the product will be of prime interest to food companies in search of lengthier shelf lives.

Assessing the microbiological, chemical and physical reactions or changes of a product during processing, distribution and storage offers important information about what will most affect the product’s safety and overall quality. Many new and improved instruments have been introduced that assist in the prediction of shelf life and storage stability, including electronic nose technology, texture analyzers, thermal analyzers, colorimeters, portable water activity devices and automated rheological instruments. On the microbiological side, pathogens, spoilage microorganisms and toxins - particularly bacteria that can grow in refrigerated temperatures - are of primary concern in determining shelf life and maintaining product safety. Rapid microbiological detection methods, kits and automated systems have proved useful for this application; these include ELISAs, DNA probes, impedance and conductance systems, ATP-based tests, PCR and bacteriophage technologies, and automated plate counting methods that measure the state of decomposition of a food.

Among the most promising shelf life technologies developed to ensure food safety during distribution are time-temperature integrator (TTI) devices, which act as “tell the truth” tags with regard to the temperature exposure history of the product as it travels from place of manufacture, through various distribution channels to the consumer. By recording and visually showing changes in mechanical, chemical, enzymatic or microbiological systems, TTIs can be used to monitor the temperature exposure of individual food packages, cartons or pallet loads, and the data gathered from each stage of distribution could be used to identify food safety problems and implement corrective actions at the appropriate stages. In addition to the TTIs currently on the market, a variety of other improved portable temperature recording devices have become essential tools in food safety applications.

Food Packaging and Packaging Interaction. As the demand for conveniently packaged, ready-to-eat and heat-and-eat foods with longer shelf lives continues to increase, the development and use of innovative packaging materials is an important trend in the industry. A number of potential food safety issues have been raised with regard to packaging, including the possibility of chemical or microbiological interaction between the food and the packaging, which may present a health risk. Residual solvents or other contaminants that have migrated into the package during processing or preparation also may pose a food safety hazard. Developments in oxygen and carbon dioxide analyzers, which enable the user to obtain data very rapidly about the level of oxygen concentration and/or carbon dioxide in food and beverage packages; advances in highly automated package integrity/leak detectors and on-line vision, X-ray, gamma ray, laser imaging and ultrasound technology systems; and more rapid response, portable water activity devices have been useful to ensure product and packaging safety and quality.

Environmental Monitoring and Sanitation. During the past decade, ATP bioluminescence for rapid sanitation validation and for HACCP monitoring has been the tool of choice for food companies. ATP bioluminescence-based technologies allow very rapid preoperational swabbing and sanitation assessments for SSOP and environmental monitoring programs. Rapid test kits that detect generic E. coli and coliforms are also useful in sanitation programs. A variety of other environmental monitoring aids, such as microbial air samplers, automatic handwashing systems and chemical sanitizers, and time-and-temperature recording and monitoring devices, have also enjoyed widespread use in food safety programs.

Mycotoxins, Naturally Occurring Toxins and Environmental Contaminants. In early 2000, Codex Alimentarius identified several contaminants and naturally occurring toxins as high priority items for international risk assessment review. These include ochratoxin A, cadmium, dioxins and dioxin-like compounds, fumonisins, chloropropanols, tin, trichothecenes, ethyl carbamate, nitrate, phenylhydrazines, glycyrrhizic acid and polycyclic aromatic hydrocarbons. Although useful rapid tests exist for many mycotoxins and naturally occurring toxins such as aflatoxin, histamine, and saxitoxin, much information on several of the environmental contaminants is still being gathered for further risk assessment and test development.

Allergens. Allergen control and verification testing has rapidly become a significant area of interest for the food industry. Peanuts, eggs and milk top the list of identified allergen hazards, and rapid ELISA-based test kits for these are available commercially. Food safety systems will continue to institute allergen controls as part of corporate GMPs and HACCP plans to ensure that the hazard is being properly managed, and the demand for technologies that identify and reduce the risk of cross-contamination is expected to increase as a result.

Irradiation/Pathogen Destruction and Control Technologies. In the last several years, FDA has approved the use of irradiation technology to control disease-causing microorganisms in a number of foods, including fresh and frozen red meats and poultry, to control pathogens such as Salmonella and E. coli O157:H7 and spoilage organisms; pork, to control the trichina parasite; fruits, vegetables and grains, to control insects; and seasonings, spices and dry enzymes used in food processing, to control microorganisms. While the technology has been embraced by many food ingredient suppliers and processors, the primary challenge in 2001 will continue to revolve around gaining consumer acceptance of these products. Developments in other pathogen destruction and sterilization technologies, such as those based on ultrasonic thermal processing, aseptic processing and pasteurization techniques, and verification systems to check whether pathogens have in fact been destroyed, will also be a growth area. The benefits of new processing technologies that incorporate irradiation and ultrasonic, for example, not only include the prevention of harmful bacteria or pathogen growth in food products, but also help to preserve processed food against pest infestation, spoilage and chemical contamination.

Biotechnology. Public reaction to the November 2000 recalls of food products containing Starlink corn, the variety containing a genetically altered protein unapproved for human consumption, has firmly placed the issue of biotech foods on the U.S. food safety agenda for 2001. Following the recalls, Agriculture Secretary Dan Glickman remarked that, with regard to biotech foods, “The fact is, no issue facing USDA has developed further and faster during my tenure. Consider that, since I became Secretary, biotech crops have mushroomed from under 4 million acres planted to over 70 million today and growing. This is a rapidly developing technology, and we have done our best to navigate a steady course. What we do today regarding this young science will have tremendous impact in the future. If we blindly reject this technology out of fear, then we will never know what could have been. Similarly, we must recognize that the application of this technology does pose potential risks and real challenges to the food chain and to our environment.”

While no single, rapid test or technology is currently available to substantiate whether a crop, food or food ingredient has been genetically modified, present regulations require quantitative detection systems, such as quantitative competitive PCR or real-time PCR for DNA detection. ELISA systems using immunochemical approaches are currently used to identify target proteins.

As detection methods improve to meet food safety assurance and export testing requirements and new labeling requirements throughout the world, the need for verification of those systems for use by the food industry will increase. The USDA Grain Inspection Packers and Stockyards Administration, for example, recently opened a biotechnology accreditation lab in Kansas City, MO. The facility is expected to review laboratories testing grains for the presence of biotechnology-derived grains and will accredit laboratories that meet performance standards. The lab will also evaluate test kits against the manufacturer’s performance specifications for determining the presence of biotechnology-derived grains in bulk grain to ensure that these tests are accurate and reliable. In addition to government programs like GIPSA’s, many industry trade organizations and international standard- setting bodies are developing programs to address the need for science-based risk assessment, policies, methods and technologies with regard to biotech foods.

Sound Science In a New World
When the World Health Assembly, under the auspices of the World Health Organization (WHO), adopted a resolution on food safety by consensus of all countries last year, it called upon WHO to significantly strengthen its leadership role in food protection activities worldwide. The resolve highlighted the need to control foodborne diseases associated with microbial pathogens, as well as food safety hazards presented by chemical, physical, sanitary and water contaminants. To address this array of emerging food safety challenges, all of the players in the food manufacturing and distribution chain will have to remain vigilant in establishing effective policies, protocols and strategies to identify and reduce the incidence of foodborne illness-causing hazards.

The food industry has long understood the benefits to the business of a comprehensive, science-based food safety program. As food safety management practices and systems become more refined and tailored to each specific link in the food production and distribution chain, the demand for science-based technologies will increase in a variety of areas. As we enter 2001, the continued commitment to partnering between industry, the scientific community and policymakers, will enhance the use of these advances to meet the challenges ahead.

FDA CFSAN Announces Priority Research Needs for FY2001
As part of the Center for Food Safety and Applied Nutrition’s research planning process, we have developed a list of priority research needs for the new fiscal year. CFSAN is mindful that as a leader in food safety, communicating these needs to other agencies and to its partners in academia and industry is critical to the achievement of its goals.
    The scope of the research needs outlined in this document extends beyond the available resources in CFSAN.
Nevertheless, through interaction and collaboration between our sister agencies and our partners in industry and academia, our hope is that these critical food safety research areas will be addressed.
    We will be happy to provide you with more information on any or all of the research areas identified. Likewise, we are always pleased to meet with representatives from our sister agencies and our partners in industry and academia.
    Thank you in advance for your consideration.
—Robert L. Buchanan, Ph.D. Senior Science Advisor

• Providing FDA’s field investigators and laboratories with more sensitive, reliable, and cost-effective tools, particularly sampling methodologies, for analyzing food and environmental samples (e.g., high priority commodities include produce, eggs, and seafood) for microbial pathogens, where frequency and extent of contamination are expected to be low.

• Developing a general RT-PCR based detection method for all foodborne pathogenic viruses from a single food sample, utilizing the essential elements of Differential Display Technology and identification by hybridization to a DNA array, or “chip” technology). Further refinement to genotype viral strains would facilitate molecular epidemiological analysis (i.e., VirusNET) in outbreak situations.

• Providing commodity specific data to enhance science-based guidance to industry on Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) that will help assure the safety of fresh and fresh-cut produce. Information on the efficacy of innovative on-farm prevention strategies under commercial conditions is of particular interest.

• Developing quantitative models for the survival and inactivation of foodborne pathogens in manure used for crop fertilization.

• Developing parameters for effective use of different technologies in reducing pathogenic microorganisms in or on produce, sprouts, juice, and seafood, used as standalone methods or in combination schemes. These data will allow FDA to develop improved industry guidance, set performance standards, and effectively evaluate industry’s HACCP plans.

• Identifying indicator organisms, quality attributes, and other product characteristics that could be used as markers of increased contamination by microbial and viral pathogens, including protozoan parasites. These data will allow FDA to provide guidance on cost-effective monitoring schemes to its field investigators and to industry.

• Identifying the natural environmental parameters that affect incidence and prevalence of microbial pathogens in seafood harvested in the wild.

• Providing scientific information needed to develop and implement more effective egg safety risk management programs for Salmonella enteritidis control, surveillance, and education.

• Providing a clear physiological and molecular (evolutionary) understanding and assessment of the impact and significance of mechanisms of microbial antibiotic resistance (AR) emergence, acquisition, spread, persistence and decline, as it relates to the ecology! production/processing/handling of FDA regulated foods (e.g., produce) and the emergence of new foodborne pathogens (e.g., Salmonella typhimurium DT1 04, E. coli O157:H7).

• Acquisition of specific data to support assessment of public health risks posed by a variety of toxins (e.g., algal, fungal, and bacterial toxins) that occur in seafood, produce, grain, and other food products.

• Identification and evaluation of relevant characteristics of different forms of product packing and handling on the safety of a variety of foods, especially those whose processing does not include a terminal inactivation step (e.g., modified atmosphere packing of minimally processed and “sous vide” products).

• Developing modeling techniques to assess microbial behavior in various foods, human exposure and dose-response relations to certain foodborne pathogens (e.g., enumerative detection methods for pathogens), potential risk of those pathogens causing human illness, and the setting of safety performance standards to regulate microbial content of food.

• Establishing standards related to techniques for assessing the safety of foods (and feeds) developed using biotechnology at the pre-market level. FDA needs to understand the underlying basis of allergic mechanisms in humans and have the means to assess the potential allergenicity of new proteins introduced into foods. Additionally, FDA must be able to assess the risk potential for “unexpected effects” in bioengineered foods, such as the lowering of nutrient levels important for human health or the raising of endogenous toxicants and anti-nutrients.

• Developing advanced analytical methods and enhanced sampling protocols for use in the surveillance for pesticide residues of both domestic and imported foods. With the passage of the Food Quality Protection Act, which mandated that EPA review all existing tolerances as well as institute measures to provide additional protection to children, it is likely that tolerances for many pesticides will be reset at lower levels. FDA must have the capability to monitor the food supply for pesticide residues at these lower levels.

• Developing rapid, sensitive, and cost-effective analytical methods for determining dioxins in foods.

• Developing analytical methods to exclude from the marketplace those dietary supplements and dietary supplement ingredients that contain adulterants, poisons, mycotoxins, pesticides, heavy metals (e.g., lead, arsenic) and/or substances that may render the product unsafe.

• Conducting analyses of infant formula and developing methods needed for selected essential and nonessential ingredients, including new ingredients (e.g., bio-engineered fat sources, fructo-oligosaccharides [fiber-like”]), to support compliance and enforcement activities and to assess the safety of new formulas within 90 days.

• Developing methods for medical foods to substantiate product safety, validate label claims, facilitate reviews of premarket notifications, and assist in the development of GMPs.

• Developing conventional foods-related analytical methods to determine soy protein in soy health claim-bearing products, trans fatty acids in foods bearing trans-fat free claims, inulin and fructo-oligosaccharides in “dietary fiber”-containing health claims, and isomers of vitamin K for which Regular Daily intakes (RDIs) are under consideration.

• Developing methods to assess the safety of bacteria used as probiotics (i.e., viable microorganisms that are beneficial to human health). Such studies should include the evaluation of health effects, mechanism of action, and stability characteristics of the specific strain (or strain combinations), the definition of physiologically relevant consumption levels, and the definition of the active principle (whole cell, viable/nonviable cell, cell components) of a probiotic product.

• Determining the population trends with respect to food safety knowledge, attitudes, and practices, especially behaviors that may be significant risk factors for foodborne illness (e.g., food consumption, in-1ome food preparation and handling). Moreover, FDA needs information on consumer practices as a result of various food safety labeling and education initiatives (e.g., FDA warning statements on unpasteurized juices, the FightBac education campaign, USDA labels for safe handling instructions on shell eggs).

• Developing and validating accurate, rapid, and cost-effective analytical methods for determining sulfites in the various food types in which sulfites are used. Additionally, available or new methods should be assessed / developed for the capability of distinguishing between added sulfite and sulfur compounds naturally present in some foods (e.g., garlic, onion). Particular emphasis is needed on the concerns related to sulfiting agents, such as determining what reversibly bound forms of sulfite are present in food and, of these forms, which ones produce reactions in sensitive individuals.

• Estimating the dietary intake of food contact substances to support premarket safety review, by obtaining analytical data from migration tests on actual finished materials or on substances that maximize migration of additives / components used in finished materials. These data should be used in developing experimental or computational models of “worst-case” migration scenarios.

• Determining the types of recycled plastic materials suitable for use in food packaging, including any necessary limitations on material source(s), physical property parameters and levels of residual contaminants, or on the application of barrier layers of virgin grade resin to the recycled plastic. Additionally, FDA needs analytical methods to determine the levels of the metals (e.g., Pb, Cr, Cd, Hg, and As) ubiquitous in packaging from both virgin and recycled paper/paperboard pulp.

• Extending existing computational toxicology models for structure-based prediction of likely toxic effects of chemicals in animal and microbial testing to predict dose-response behavior. For example, developing structure activity analyses for estimating carcinogenic potency and predicting toxicity of dietary supplement components that are structurally similar to drugs. Further expansion and validation of computational models would support efficient FDA decision making and resource allocation.

• Estimating exposure to hormonally active agents (HAAs)—tor example, estrogens— through analytical methods development and modeling, in a wide variety of foods and food packaging materials obtained from market surveys (i.e., legal grocery stores) and packages collected from FDA’s Total Diet Study. FDA needs to accurately determine estimated daily intakes of HAAs as part of its food additive safety review.

• Development of nutritional testing schemes that are based on the nature and predicted consumption pattern of macro-ingredient food additives. By definition, a macro-ingredient may constitute a significant portion of the diet; hence, traditional application of a safety factor to a “no effect level (NOEL)” in animal studies for safety assessments in food additive petitions (and their review) is not feasible. FDA must give guidance regarding the appropriateness of such testing.

(Further information on these priority research areas can be obtained at


Categories: Process Control: Best Practices; Regulatory: FDA, Guidelines, HACCP, USDA; Sanitation: Environmental Monitoring, SSOPs; Testing and Analysis: Methods