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I. Introduction
II. Summary Overview
III. Background
IV. Research on the Development of Tests and Sampling Methodologies
A. Center for Food Safety and Applied Nutrition
B. Center for Veterinary Medicine
C. Office of Regulatory Affairs
D. National Center for Toxicological Research
V. Conclusion
Appendix A
Appendix B
The events of September 11, 2001, highlighted the need to enhance the security of the U.S. food supply. As part of the nation’s response, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Public Law 107–188) which was signed into law on June 12, 2002. Title III of the Bioterrorism Act includes a number of provisions designed to improve the food safety efforts of the Food and Drug Administration (FDA or Agency), including new authority to utilize in protecting the food supply against terrorist acts and other threats.
Many of the Title III provisions are aimed at ensuring the safety of food imports. The ability to intercept adulterated food before it enters domestic commerce is a high priority and is reflected in the provisions that provide FDA increased authority to receive advance information on imports, examine imports, and temporarily hold food imports at a port of entry. Rapid detection of adulterated food was a particular emphasis.
Congress addressed the importance of research related to rapid detection of adulterated food in the Bioterrorism Act with the inclusion of section 302(d) (attached as Appendix A). This section directs the Secretary of the Department of Health and Human Services (HHS) to provide for research on test methods and sampling methodologies designed to test food in order to rapidly detect the adulteration of the food. The greatest priority is to be given to the detection of the intentional adulteration of food and in the development of tests that are suitable for inspections of foods at ports of entry into the U.S. Research efforts are to be aimed at improving existing technology in terms of accuracy, timing and costs. Section 302 provides for the Secretary, as appropriate, to coordinate such research with certain other federal officials. Section 302 also requires an annual report to Congress describing the progress on research. This report is the first annual report.
FDA currently has over 90 different active research projects involving the development of tests and sampling methodologies intended to increase the detection of adulteration of food. A complete list and description of these research projects is included in Appendix B. A number of the research projects are designed specifically with the goal of development of tests that will be suitable for inspections of food at ports of entry into the United States. For example, commercially available test kits are currently being analyzed for various food matrices to evaluate their suitability for field use at ports of entry. Another research project is validating methods of isolating, identifying and characterizing microbial agents so that the methods can be used in hand-held test kits. One project has already resulted in the development of a sample pretreatment procedure using a commercial test paper to detect a readily available highly toxic substance in various food matrices but the procedure needs additional development to be deployed for field use. FDA has significantly improved its capability to rapidly analyze a large number of samples and quickly and accurately identify toxic chemicals intentionally added to foods.
The various research projects detailed in Appendix B are at varying stages of development. Some projects are at an initial stage of “proof of concept.” At this stage, if the technology can be proved to work to detect a particular chemical or toxin, additional research will be planned to assess and refine the testing methods for several food matrices. Other projects have already produced results which are considered valuable in developing detection methods but may have technical barriers to using the methods on a wide scale. Further research may eliminate these technical barriers. Some results are promising and point to the ultimate use of a testing method.
Some projects focus primarily on the tools that will be valuable in developing the final assays and methodologies used in detection. The tools are not only the mechanical tools necessary for research and detection. The tools include better identification and characterization of organisms. These techniques not only detect adulteration but can identify common traits in adulterated foods which can aid in the investigation to track and identify a perpetrator of intentional adulteration.
Improving FDA’s food safety inspection, detection and monitoring capabilities is a top priority of HHS and was before the events of September 11. Although the U.S. food supply is among the world’s safest, the increase in the variety of foods and the items available has brought with it additional public health concerns. The complexity of the food industry, and the technologies used in food production and packaging, are increasing, requiring a comparable increase in oversight of the food supply. A growing proportion of food consumed in the U.S. is not produced domestically but is imported. The rise in imports raises the risk to the food supply because importing countries may not maintain the same high standards of production that exist in the U.S.
Sources of food contamination are almost as numerous and varied as the potential contaminants. These include everything from preharvest conditions to contamination introduced during processing, packaging, transportation, and preparation. The possibility of terrorist activity directed at the food supply has increased in the past two years based on various threat assessments which have been conducted and the state of world events. The concerns associated with intentional adulteration involve some of the same sources of contamination as unintentional adulteration. These include biological pathogens and toxins (e.g., bacteria, viruses, parasites), biologically-derived toxins (e.g., mycotoxins, ciguatera toxin, paralytic shellfish poison, ricin), pesticides, toxic metals, and TSE-type diseases (e.g., bovine spongiform encephalopathy).
FDA’s responsibility in the food area generally covers all domestic and imported food except meat products, poultry products, and egg products that are under the exclusive jurisdiction of the U.S. Department of Agriculture. This responsibility covers approximately 80% of the nation’s food supply. As noted, increasingly, food consumed in the U.S. is imported. Over the past few years, food imports have steadily risen and the trends shows no signs of abatement. FDA’s responsibility for oversight of food also extends to animal feed and animals intended for human consumption. Such a responsibility can only be carried out effectively through risk management principles which include the effort to uncover hazards before their introduction into the food supply. These principles are utilized throughout all of the FDA components that have responsibility for food safety so that there is an integrated system of addressing the safety of the food supply. Detection of adulterated foods, intentional or unintentional, is one critical means of uncovering such hazards. It is a critical component of FDA’s integrated system of assuring the public that the food supply remains protected and is safe.
FDA has been at the forefront of science based research efforts aimed at improving the detection of adulterated food products. FDA has a cadre of well-qualified and well-trained science and public health experts working cooperatively to ensure the safety of U.S. food. FDA also works in partnership with a myriad of outside academic institutions, private companies, food consortia and other government agencies to ensure the appropriate research is conducted and that the food supply remains safe. Scientists from outside government are routinely consulted regarding technical and scientific methods, processes, and analyses used by the agency.
Several FDA components are engaged in research to develop tests and sampling methodologies to use in food matrices. An overview of these research efforts is provided below. The specific research projects currently underway at all FDA components are listed in the table provided in Appendix B.
A. Center for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition (CFSAN) has an active research program that is a key component of its infrastructure for addressing its public health mission, including its responsibility for oversight of the food supply. CFSAN’s primary responsibilities and activities include:
The majority of the CFSAN offices have a laboratory component that supports critical research needs for the different regulatory programs. Two CFSAN research offices, the Office of Scientific Analysis and Support and the Office of Applied Research and Safety Assessment, have responsibility for the research and scientific analyses in support of the rest of the Center. In addition, the CFSAN Office of Science provides coordination among the different research components of the Center, and also is responsible for extramural programs and Center-wide research activities.
The research conducted by CFSAN supports its regulatory responsibilities which include responding rapidly to newly emerging food safety threats to public health. In current times, preparing for, and responding to, potential terrorist actions are a priority. CFSAN has developed a formal process for evaluating and determining its research priorities. This strategic planning process results in better management of research and laboratory resources and development of a consolidated research program that ensures that priority public health needs are addressed. CFSAN’s research program complements the efforts of other FDA components so that every effort is made to avoid duplication of effort and the best option for accomplishing the research goal is used. The “best option” often results in grants, contracts and cooperative agreements with outside academic institutions (e.g. the University of Washington, Harvard University, North Carolina University), food consortia (e.g. National Center for Food Safety and Technology (NCFST), Joint Institute for Food Safety and Nutrition (JFSAN)), other government agencies (e.g. Department of Defense (DOD), Centers for Disease Control and Prevention (CDC)) and private industry (e.g. Chem Sensing, Inc., Hawaii Biotech Group).
The counterterrorism research sponsored by CFSAN is aimed at developing the tools essential to testing a broad array of food products for a multiple number of biological and chemical agents. When imported food products are tested, often there is no expectation or knowledge of a particular agent, unless specific information has been received. In a potential terrorism event, such specific knowledge is unlikely; thus, the testing method has to be capable of identifying many agents to determine if there is adulteration. The research projects include a number of different toxins, contaminants and bacteria that are tested on food products, often utilizing testing methods that already exist. One of the goals is to identify the organism and contaminant in a food at the lowest level of sensitivity possible. The ability to detect these agents at an extremely low level and in the most rapid fashion possible is a research priority.
It is common for different foods to react differently to different agents and to different methods of testing. Since the spectrum of food is enormous, CFSAN works closely with FDA field and lab personnel to identify foods of concern or that represent unique analytical challenges. These foods figure in much of the research being conducted to develop better and more rapid testing methods. Some examples of the food matrices used in the research projects, or expected to be used, include milk, short-life dairy products, powdered infant formula, leafy vegetables, lettuce, grapes, fruit juice, soft-drinks, and chocolate.
One of the areas of research is the design of better means of detecting radiation in food. CFSAN is developing a transportable system for measuring gamma-, beta-, and alpha- radiation in foods. The goal is to have the system transportable to various locations so that the analyses can be performed by general analytical chemists with only minimal training using standard operating procedures. This transportable system will supplement FDA’s main radiological facility and provide for additional testing capability.
In addition to research on detection of adulterated food, efforts are also underway to identify organisms that might be capable of inhibiting or preventing the spread of certain toxins and contaminants in food once a particular bioagent has been detected.
Some examples of CFSAN research projects include:
A more comprehensive description of all the CFSAN research projects is contained in Appendix B.
B. Center for Veterinary Medicine
The Center for Veterinary Medicine (CVM) has authority over food additives and drugs that will be given to animals, including food-producing animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, millions of poultry, cattle, swine, and minor animal species. Animal feed and live animals for human consumption are food under the Federal Food, Drug, and Cosmetic Act.
CVM has an Office of Research which has a combination of staff expertise and animal and laboratory facilities to conduct food safety research. CVM often works with other organizations through Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Interagency Agreements, and Memoranda of Understanding.
CVM’s research group’s responsibilities include the following:
CVM is involved in various research projects to detect adulteration in food. These projects are primarily designed to enhance the Agency’s ability to detect particular substances in food. Many of the contaminants studied are drug residues. Methods are being developed using mass spectrometry to detect many different drugs in a single assay for shrimp, eggs, and meat. Milk is being studied for several different residues. A major concern has been the testing of feed and feed ingredients to detect bovine derived materials to avert diseases such as “Mad Cow Disease.” CVM successfully validated a method of analysis using PCR to detect bovine derived materials and is working to expand the number of species that the current PCR method is capable of detecting. CVM is studying the development of a test assay that is capable of discriminating between prohibited and permissible materials in grains and feeds at the needed sensitivities and in a more speedy manner. CVM also is involved in a project to determine the profile of antibiotic resistance in retail meats. This is done in cooperation with the CDC and public health laboratories in a number of states. The information is shared with PulseNet as part of the surveillance of the distribution of food borne pathogens within the U.S. There are also discussions currently underway with the U.S. Department of Agriculture to collaborate on additional research projects. A more comprehensive description of CVM research projects for test kits and methodologies for detection of adulteration is included in Appendix B.
C. Office of Regulatory Affairs
The Office of Regulatory Affairs (ORA) is the lead office for all FDA field activities, including ports of entry. Compliance and enforcement activities are handled by ORA. These activities require a high degree of technical scientific analysis in order to ensure compliance is based on sound scientific principles. ORA has two different components that handle scientific analysis and research. The Forensic Chemistry Center (FCC) is part of ORA and is a team of forensic science experts who provide expert advice and scientific evidence to FDA officials. The scientists work out of a high-tech laboratory facility. ORA/FCC works closely with CFSAN and other Centers to determine research priority needs and shares responsibility for developing new technology and procedures to rapidly detect toxic chemicals in food. ORA also collaborates with other entities such as DOD and New Mexico State University (NMSU) to conduct research on rapid test detection methods. There are also 13 field laboratories around the country that are part of ORA regional operations. The field laboratories are responsible for analyzing approximately 30,000 products each year including samples of imported foods.
FCC has been involved in ongoing efforts to improve FDA’s ability to prevent, detect and respond to an incident of chemical terrorism. One of the challenges in developing tests capable of detection of adulteration is that there are a potentially unlimited number of substances that may be used in an intentional adulteration. Different components need different screening techniques. In random testing of products obtained at a port of entry, samples will be collected in which the identity of the potential adulteration will most likely be unknown. The methodologies used for detection of adulteration may have to be for an unknown number of substances in order to determine if there is any adulteration. FCC’s efforts have been aimed at more rapid analysis of a large number of samples and at the ability to test for multiple substances simultaneously.
The existing analytical methodology has been improved and new procedures have been developed for this purpose. For example:
Efforts continue but may be limited by the availability of instrumentation needed to ensure complete lab capacity for all types of tests and screening methodologies.
FCC has transferred the technology described to detect toxic chemicals in foods to seven ORA laboratories located in New York City; Atlanta; Lenexa, Kansas; Jefferson, Arkansas; Denver; Los Angeles; and Seattle. These laboratories have been proficiency tested on the screening procedures and have demonstrated their competency in screening foods for toxic chemicals.
The laboratories which form the Food Emergency Response Network (FERN) (this includes FDA field laboratories, state food laboratories and other laboratories to accommodate the need for effective and efficient testing of food specimens to help public health officials deal with apparent or actual incidents of biological or chemical terrorism) have utilized the LC-MS, GC-MS, and ICP-MS procedures as well as GC-flame photometric detection and Enzyme Linked Immuno Sorbant Assay (ELISA) procedures developed by FCC and CFSAN during the Liberty Shield exercise. (Liberty Shield is a multi-department, multi-agency, national team effort to designed to increase protections for America’s citizens and infrastructure while maintaining the free flow of goods and people across the U.S. border with minimal disruption to the economy and way of life). In total, more than 600 samples of a wide variety of food products, with specific categories targeted, were analyzed in one month.
The testing procedures, described above, also will be used in mobile laboratories, currently being acquired. These particular mobile laboratories can be relocated at different ports of entry to permit rapid analyses and evaluation of imported food. The ability to use these mobile laboratories will reduce the time needed for analysis of adulterated food imports and expedite border entry of unadulterated food imports.
ORA has an Inter-Agency Agreement (IAG) with DOD that provides for research on test methodologies at NMSU. The IAG provides for the evaluation of various commercially available rapid test kits. There are a number of rapid tests kits that can be used for particular products. These commercially available rapid tests kits are evaluated by a private association, Association of Analytical Chemists (AOAC), and validated for a particular food product. Even if certified by the AOAC, the test kits need to be evaluated and validated for other food commodities. An ORA and CFSAN working group consulted with the field lab scientists to determine the areas of most concern. The rapid testing of perishable produce was concluded to be one of the top areas of concern. A number of rapid test kits are being evaluated by NMSU to determine if they can be validated for certain produce. A substantial amount of scientific data is available from the validation process conducted by the AOAC for the particular labeled product. This data is being used in the research conducted by NMSU to evaluate and validate the test kits for produce.
Each of the thirteen ORA field laboratory directors has been authorized to set the research priorities for each field laboratory. The research priorities for the field laboratories are set in consultation with the Centers and, for most labs, with Science Advisors from academic institutions. The various labs are conducting a number of research projects (and have plans for others to start within this fiscal year) that are aimed at improving the detection of adulterated foods through test assays and improved methodologies. Improvement in the timing and accuracy of detection is a high priority. A few examples of these research projects include:
ORA research projects are described in more comprehensive detail in the table provided in Appendix B.
D. National Center for Toxicological Research
FDA’s National Center for Toxicological Research (NCTR) is the fourth FDA component that is involved in research for rapid detection of adulterated food. NCTR has a breadth of toxicological expertise and provides a strong base of knowledge and experience for research on a broad level. The mission of NCTR is to conduct peer-reviewed scientific research that supports and anticipates FDA’s current and future regulatory needs. This involves fundamental and applied research specifically designed to define biological mechanisms of action underlying the toxicity of products regulated by the FDA. This research is aimed at understanding critical biological events in the expression of toxicity and at developing methods to improve assessment of human exposure, susceptibility and risk.
In addition to research specific to detection of adulteration and improvement in the rapidity of detection, NCTR supports the research efforts of other FDA components through its laboratory facilities as well as provide for the use of these facilities for other government entities. NCTR is building a Biosafety Level-3 laboratory and is converting two rooms of its animal quarantine facility to be full Biosafety Level-3. These laboratories will provide facilities to conduct bioterrorism research and analytical studies to develop methods to support the rapid detection and identification of biological warfare agents and other foodborne contaminants. The Biosafety Level 3 laboratory also will provide surge capacity for the State of Arkansas Department of Health. NCTR has a Memorandum of Understanding with the Arkansas Department of Health to share both the laboratory space and scientific expertise in preparation for and/or in response to acts of terrorism.
NCTR researchers have developed a novel approach to rapidly identify biomarkers of toxicity using a mass spectrometry-based method for detection of microorganisms. This spectrometry-based procedure is designed to identify and detect biomarkers for the presence of specific genes that identify biological agents or those that could be introduced into otherwise harmless organisms. This effort is in collaboration with DOD. After identification of the biomarker-proteins using mass spectrometry, it should be feasible to develop field diagnostic kits to identify these biomarkers. Molecular biology studies associated with food safety are also applicable to the bioterrorism initiative. Scientists at NCTR have used PCR technology to identify and classify twelve foodborne pathogens, information that also assists in developing methodologies to identify food adulteration.
The research projects currently underway at NCTR that deal with detection of adulteration in food are described in more detail in Appendix B.
Research to improve the testing and methodologies to detect food adulteration is a high priority for FDA. With continued support, current research activities are expected to continue. Many of the research projects require numerous steps and will not be able to be completed without multi-year support. Additional research is often possible only with the purchase of additional technical and mechanical tools – usually expensive and difficult to obtain.
There is progress in developing new tests and sampling methodologies. All of the intermediate results offer significant improvement over available technology in terms of accuracy, timing and costs. Improvements in accuracy and timing of test methods usually ensures that the costs associated with the testing for adulteration will be reduced. Wide-scale deployment of new test methods has been limited and actual availability of tests kits for port of entry testing will not occur until additional progress has been made in the research.
More food matrices need to be examined to develop a wide array of detection methodologies. For some foods there are no current means, or very limited means, of detecting adulteration. In this instance, any research that develops new methodologies to detect adulteration, even if not “rapid” in the traditional sense of understanding the term, provides improvements in terms of speed, accuracy and costs. Initial development is required before consideration can begin on a more “rapid” method. With additional support, this can be pursued.
FDA is committed to continuing the current research efforts on detection of adulteration. The efforts already have resulted in improvements. We are confident that the research will lead to additional improvements and more rapid detection of adulteration particularly in detecting intentional adulteration.
(d) TESTING FOR RAPID DETECTION OF ADULTERATION OF FOOD.—Section
801 of the Federal Food, Drug, and Cosmetic Act, as amended by subsection
(a) of this section, is amended by adding at the end the following:
"
(i)(1) For use in inspections of food under this section, the Secretary
shall provide for research on the development of tests and sampling
methodologies—
"
(A) whose purpose is to test food in order to rapidly detect the
adulteration of the food, with the greatest priority given to detect
the intentional adulteration of food; and
"
(B) whose results offer significant improvements over the available
technology in terms of accuracy, timing, or costs.
"
(2) In providing for research under paragraph (1), the Secretary
shall give priority to conducting research on the development of
tests that are suitable for inspections of food at ports of entry
into the United States.
"
(3) In providing for research under paragraph (1), the Secretary
shall as appropriate coordinate with the Director of the Centers
for Disease Control and Prevention, the Director of the National
Institutes of Health, the Administrator of the Environmental Protection
Agency, and the Secretary of Agriculture.
"
(4) The Secretary shall annually submit to the Committee on Energy
and Commerce of the House of Representatives, and the Committee
on Health, Education, Labor, and Pensions of the Senate, a report
describing the progress made in research under
paragraph (1), including progress regarding paragraph (2).
| Project/Title/Description | Project Lead/Partners |
|---|---|
| Detection of Monofluoric Acid (MFA) in Foods Using Liquid Chromatography-Mass Spectrometry - The method originally listed for detection was cumbersome and did not have adequate sensitivity.Develop a procedure which offers a straightforward, rapid method for the extraction and detection of MFA in complex matrices.Assessment as to whether the technology can work. |
FDA/CFSAN External: Chem Sensing, Inc. |
| BSE/CWD Risk Assessment - Provide for assessment of the potential human risk from chronic wasting disease (CWD), if CWD is determined to be transmissible to humans.Harvard will adapt the BSE model for CFSAN's use in assessing BSE risk from contaminated foods (including dietary supplements), cosmetics, and certain OTC drugs. | CFSAN/FDA External: Harvard University |
| Validation of Detection Methods for Specific Microbiological Agents in High Priority Foods - Assist CFSAN in developing validated methods for the detection of Francisella tularensis in food.Validate methods in specified food matrices. | FDA/CFSAN
External: Midwest Research Institute, Kansas City, Missouri |
| CDC - Support for National Prion Disease Pathology Surveillance Center - The National Prion Disease Pathology Surveillance Center (NPDPSC) (supported by a cooperative agreement with the CDC) will characterize cases of prion disease in persons who may have been exposed to deer or elk that were affected with CWD, and will further FDA's understanding of the potential for CWD to cause human diseases through exposure to contaminated materials from deer and elk. | FDA/CFSAN
External: CDC |
| Production of Immunoassay Kits for Tetrodotoxin -Using antibodies from a proprietary hybridoma that they have in storage from past work, Hawaii Biotech Group, Inc. will supply immunoassay kits to CFSAN.The goal is to produce the kits and supply them to CFSAN. | FDA/CFSAN
External: Hawaii Biotech Group, Inc. |
| Assessment and Validation of Immunoassay Methodology for Determination of C. botulinum Toxin in Selected Food Matrices - Validate detection of Clostridium botulinum toxin and Bacillus anthracis in fresh fruits and vegetables using the ORIGEN M1.5 immunoassay analyzer, a rugged and portable rapid detection system suitable for field-testing of foods.Determine (1) operational limitations of key parameters; (2) optimize sampling protocols; and (3) optimize reagents for detection of specified biological agents in selected foods. | FDA/CFSAN
External: U.S. Army Natick, Massachusetts |
| The Verification of Biodetection Protocols for Agents not Normally Associated with Foodborne Illness - Methods to investigate and detect the deliberate introduction of pathogens not historically associated with foodborne illness into the food supply.Objective is to validate methods currently available to the ECBC Microbiology Team for the detection of B. anthracis and Y. pestis in food matrices specified by CFSAN. | FDA/CFSAN
External: IAG w/ Edgewood Chemical Biological Center (ECBC), Aberdeen Proving Ground, Maryland |
| Develop/Validate Food Detection Systems - CFSAN needs to enhance its rapid detection and identification capabilities with respect to specific microbial pathogens that are not typically considered foodborne pathogens.Naval Research Center–Maryland is to assist CFSAN in obtaining rapid hand held detection assays and to develop and validate methods by which these assays for the detection of pathogens in food. |
FDA/CFSAN
External: Naval Research Center, Silver Spring, Maryland |
| Degradation of Prions: Yeast Prion as a Surrogate Protein - The project is to produce and use a yeast prion-like protein as a surrogate for TSE prions and to develop techniques, using this surrogate, to predict the ability of treatments or manufacturing process to inactivate TSE prions. |
FDA/CFSAN
External: North Carolina State University |
| Protein Markers for Verifying Inactivation of TSE Agents - Project focuses on the development of surrogate agents for the prion proteins associated with TSE diseases and related measuring techniques to facilitate studies in assessing the efficacy of the inactivation of TSE infectious agents. | FDA/CFSAN
External: Tennessee State University |
| Optical Biosensor Technology for Food Safety - Main goal of research is to develop novel optical affinity biosensor technology that will enable fast, sensitive, and specific detection and identification of foodborne pathogens and toxins in food samples. | FDA/CFSAN
External: of Washington, Seattle Institute of Radio Engineering and Electronics, Prague, Czech Republic |
| Develop Prototype of Food Pathogen Detector (MIPSTRIP)- The goal of the MIPSTRIP project is to develop a synthetic polymeric film (MIP) imprinted with a macromolecular external membrane component or components of Escherichia coli O157:H7 as an initial capability.The pathogen will recognize the imprint and bind to the film.If successful and operationally suitable, the methods developed will be applied to certain select agents on foods. | FDA/CFSAN
External: Sensor Research and Development, Maine |
| Heat Treatment of Bacterial Spores in Dairy Products - Objective of research is to characterize the risk from C. botulinum or B. anthrasis in dairy products receiving more than one heat treatment.Because of the potential aerosol hazard involved with handling B. anthracis under food processing conditions, the closely related species Bacillus cereus would be used as a surrogate-testing organism for B. anthracis. | FDA/CFSAN
External: University of Wisconsin – Madison |
| Multi-Analyte Array Sensor for Food-borne Contaminants - Research will involve development of multi-analyte assays for detection of nine different foodborne contaminants in a variety of foodstuffs.This two-dimensional format allows for multiple tests to be performed in parallel, with the each sample analyzed for multiple analytes.Thus, controls and standards can be analyzed at the same time as the sample, allowing direct quantification and comparison between different samples.Results are typically available in 15-20 minutes, although lengthened assay times can be used to increase assay sensitivity. | FDA/CFSAN
External: Naval Research Laboratory, Washington DC |
| Development of Cell- and Nanoparticle-Based Sensors for BSE - Aim of research is to develop a method that can be used to predict the ability of processing treatments to inactivate the infectivity and biological activity of prions. | FDA/CFSAN
- External:UMBC, Baltimore, MD and Texas A&M University, College Station, TX |
| Development and Implementation of a Risk-Ranking Framework to Evaluate Potential High Threat Microbiological Agents, Toxins and Chemicals in Food - Objective of this project is to develop a risk-ranking framework that assists in evaluating microbiological, toxicological, and chemical threats that occur intentionally or unintentionally to FDA regulated foods.Framework will assist in directing the research needed to develop new assays and methodologies. | FDA/CFSAN
External: Institute of Food Technologists |
| Study of Nisin and Sublancin in a Strategy for Protection of the United States Food Supply from Pathogenic Bacterial Spores Introduced Through Bioterrorism - Study the inhibitory properties of the two antimicrobial peptides, nisin and sublancin (different ratios) on the germination of spores of the bacterium Bacillus cereus.The experiments performed with the laboratory media will be repeated using the model food system, to establish whether the presence of food components substantially alters the inhibitory effectiveness of the nisin/sublancin mixtures. |
FDA/CFSAN
External: Funded by the Joint Institute for Food Safety |
| Effects of Environmental Conditions, Phytochemicals, Modified Atmosphere Packaging, and Other Parameters on the Growth of Staphylococcus aureus on Mung Bean Sprouts - Staphylococcus aureus toxins are a select agent as at relatively low amounts they can debilitate individuals.While the organism can be commonly found in food, it is not in itself a select agent.However, the organism could be applied to food with the intent that it will generate the toxin within the food.The project seeks to investigate the means of eliminating or inhibiting the organism in foods. | FDA/CFSAN |
| Improve Detection Methodologies for Microorganisms with Potential for Use in Terrorism - Current microbiological techniques used for regulatory purposes are typically slow (2 to 5 days) and labor intensive, completely inadequate for CT use.This project will evaluate rapid methods that have recently been developed for clinical and environmental samples.Hand held kits (lateral flow kits) for C. botulinum, B. anthracis, and F. tularencis will be evaluated for their use in foods.The ability of hand held kits, ELISA and PCR methods for B. anthracis and F. tularencis will be evaluated and modified when necessary for specific foods.New methods will be developed that are faster, more selective and suitable to field labs. | FDA/CFSAN |
| Microarray Analysis of B. anthrasis, C. botulinum, and S. aureus - To develop an oligonucleotide microarray for detection and analysis of select agents including B. anthrasis, C. botulinum, and S. aureus.Project to study a platform based, rapid, computerized PCR detection | FDA/CFSAN |
| Validation of Methods for the Isolation, Identification, and Characterization of Microbial Agents of Bioterrorism from Foods - Focus of project is to develop methods for isolating and identifying B. anthracis, Y. pestis, F. tularencis, and Brucella spp. from food matrices using microbial culture methods and mouse enrichment procedures.Hand-held kits obtained from the Department of Defense will be evaluated as a presumptive test for the presence of these organisms in food. | FDA/CFSAN |
| Investigation and Validation of Methods for Isolating Cryptosporidium parvum in Foods and Water - C. parvum is not generally considered a lethal bioterrorism threat.However, it does have great potential as a biological weapon as it fits most of the criteria used to define an effective biological weapon.Because C. parvum shares many attributes with other parasitic foodborne pathogens such as Cyclosporidium, Giardia, and Microsporidia spp., information from this proposed study can be transferred to the isolation and detection of these pathogenic parasites from food matrixes.The project will assess the utility of FTA filter methodologies for parasite detection and direct comparisons will be made to commercially available kits. | FDA/CFSAN |
| Detection of Enterohemorrhagic Escherichia coli (EHEC) in Foods - A real-time PCR assay for EHEC in foods has been developed.The assay detects and differentiates between the stx and eae genes via melting curve analysis, however, it will not determine the specific toxin types.Project is aimed at modifying the assay in order to improve differentiation. | FDA/CFSAN |
| Evaluation of an Enzyme-Linked Immunosorbent Assay (ELISA) for Detection of C. botulinum Neurotoxin in Foods - Project will evaluate a variety of foods that presently and/or historically represent likely candidates for outbreaks of botulism as well as those products that might be used as vehicles of terrorism.The Project will determine if a digoxigenin-labled Enzyme-linked Immunosorbent Assay (DIG-ELISA) method for detection of C. botulinum toxin in media can be adopted to effectively detect botulinal toxin in foods. | FDA/CFSAN |
| Detection of Pathogenic Vibrio parahaemolyticus in oyster enrichments by real time PCR - Study demonstrated that real time PCR is a rapid and reliable technique for detecting V. parahaemolyticus possessing the tdh gene in pure cultures and in oyster enrichments. | FDA/CFSAN |
| Evaluation of Reliability and Sensitivity of Commercial Test Kits for Detection of Threat Agents in Food - Project is designed to evaluate the efficacy, reliability, and limitations of using hand-held assay systems, which were developed by the Naval Medical Research Center for use with environmental samples, to detect Staphylococcal enterotoxins (SE) A, B and C in various food matrices contaminated with these toxins.Each assay system will: determine its sensitivity; and determine the feasibility and limitations of using it to detect SE in food matrices. | FDA/CFSAN |
| Cladistic Analysis of Microbial Threat Agents - In order to develop a method for the rapid identification and differentiation of suspect bioterrorist agents, project is examining the DNA sequence diversity among Escherichia coli, Shigella spp., and Salmonella enterica pathogens and related strains and then analyzing the associated sequence changes by using bioinformatics and phylogenic techniques.Project aims to sequence limited portions of particular regions of these bacterial genomes to develop methods for the rapid identification and differentiation of suspect bioterrorist agents.Genotypic differences among strains revealed by these analyses will be exploited to develop rapid DNA-based screening and surveillance methods to detect and identify these strains in the food supply. | FDA/CFSAN |
| Thermal resistance of Non-traditional Microbial Agents - Quantify the thermal resistance of non-traditional microbial agents in a variety of food matrices under various conditions. | FDA/CFSAN, NCTR |
| Survival and Growth of Non-Traditional Pathogens in Foods - Data obtained will be used to develop or extend models of survival and growth for these pathogens that can be used to support risk assessments under a variety of scenarios and to identify any significant data gaps and conditions where more detailed data are needed. | FDA/CFSAN |
| Detection of Picrotoxin in Foods Using HPLC - Determine a method of analysis for Picrotoxin.Select chemical agent. | FDA/CFSAN |
| Detection of Aconitine in Foods Using Liquid Chromatopography - Develop the reliable and simple HPLC-UV method to detect and quantify Aconitine (select chemical agent) in various food matrices for the potential of terrorism. | FDA/CFSAN |
| Detection of Abrin in Foods - Determine the feasibility of detecting abrin using commercially available diagnostic assays for ricin.If this is not feasible, develop ELISA, HPLC, and LC/MS methodologies for the detection of abrin in food. | FDA/CFSAN |
| Analysis of Foods for Amanitin - To ascertain if a test kit developed for analysis of amanitin in urine is applicable to the analysis of amanitin in foods. | FDA/CFSAN |
| Detection of Ricin in Foods - Development of rapid, field deployable, methods for the detection of ricin in food. | FDA/CFSAN |
| Methodologies and Analyses for T-2 Toxin in Selected Food Matrices - Kits will be moderately useful for rapid survey of samples once an analyst has become proficient in the procedure. | FDA/CFSAN |
| Rapid Tests for Tetrodotoxin Intentionally Added to Food - Mouse bioassay, a commercially produced immunoassay kit, a receptor assay method, and methods using LC/MS will be evaluated and optimized for detection of tetrodotoxin in various food matrices.Goals are to provide rapid, practical tests that can be used to screen food for contamination with tetrodotoxin and confirm its identity. | FDA/CFSAN |
| Development of Mass Spectrometric Methods for Confirming the Presence of Bacterial Toxins in Foods - Three major objectives: 1.) Evaluate the efficacy of several analytical MS-based approaches for the detection of bacterial toxins.2.) Evaluate the efficacy of these analytical approaches when toxins are to be detected in complex food matrices.3.) Demonstrate that detection limits for toxins in foods can be further enhanced by immunoaffinity approaches.ELISA kits will be obtained and immunoaffinity columns containing antibodies for staph enterotoxins will be prepared in order to extract toxins from complex matrices. | FDA/CFSAN |
| Novel Application of Microarray Technology, Infrared Micropectroscopy, Infrared Imaging, and Multivariate Analysis to the Rapid Identification of Foodborne Bacteria and Spores - Identification of foodborne bacteria and their respective endospores in food matrices by combining methodologies in microbiology, chemistry, IR microspectroscopy and imaging, and chemometrics.Speed and high throughput are among the many requirements for the development of a successful methodology for the identification of foodborne bacteria.The high throughput requirement may be accomplished by combining microarray technology and IR microspectroscopy and IR imaging spectroscopy.These procedures should allow the measurements of large numbers of test samples on a single microscopic slide. | FDA/CFSAN |
| Detection of Monofluoroacetic Acid (MFA) in Foods Using Liquid Chromatography-Mass Spectrometry - The method originally listed for detection of fluoroacetic acid was cumbersome and did not have adequate sensitivity.This method is based on liquid chromatography-mass spectrometry technology and has been shown to detect MFA at low mg/kg (ppm) in a limited number of food matrices.Objectives of the study were to develop a procedure which offers a straightforward, rapid method for the extraction and detection of MFA in complex matrices. | FDA/CFSAN |
| Development of Colorimetric Sensor Array for the Detection of Chemical Agents in Liquids (Water, Water/Ethanol): Feasibility Phase - ChemSensing has demonstrated and patented the use of SmellSeeing™ and TasteSeeing™ dye arrays to identify and quantify a variety of analytes.ChemSensing has demonstrated the applicability of the technology to detecting a wide range of compounds, including strongly complexing (alcohols, amines) and weakly complexing (halocarbons, ketones) analytes.Objectives of the study were to determine the feasibility of using metalloporphyrin arrays in detecting CT chemical agents in food. | FDA/CFSAN |
| Evaluation of z-Nose Technology for the Detection of Chemical Agents in Food - Evaluate the z-Nose instrument for the necessary selectivity and sensitivity to detect chemical agents in food.Additionally, to develop methods to test for chemical agents in food.The z-Nose may offer the selectivity and sensitivity of a laboratory gas chromatograph, but with much shorter analysis times. | FDA/CFSAN |
| Development of a Transportable System for Radionuclide Analysis - A transportable radionuclide analytical system is being developed for measuring gamma-, beta-, and alpha- radiation in foods.The system will be transportable and SOPs will be written so analyses can be performed by general analytical chemists with only minimal training.The system will increase the testing capacity for sample analysis. | FDA/CFSAN |
| Using a PCR-Based Method for the Detection of Natural and Rendered Materials that May Potentially be Used in Animal Feedstuffs –Purpose is to extend the number of species that the current PCR method is capable of detecting. Previous work at CVM (Office of Research) demonstrated and validated a PCR-based method for detection of bovine derived materials in complete animal feed.Bovine derived materials represent only one possible source of added protein.Other sources include, but are not limited to, deer, sheep, elk, goats, and swine.Current methods do not permit their detection.The test articles in this study are animal blood rendered animal byproducts, and animal feed. | FDA/CVM |
| Development of Multi-residue Multiple Species Methods to Screen for Drug Residues in Aquaculture Products: Shrimp – Purpose is to develop a method using mass spectrometry to screen imported shrimp for residues of most drugs commonly used in aquaculture. | FDA/CVM |
| Fingerprinting of Foodborne Pathogens by Pulsed-Field Gel Electrophoresis – This research will provide background data on DNA fingerprinting performance on E.coli, Salmonella, and Campylobacter.The research will be used to establish the analytical technique and its validation for use in future research and to support CVM’s technical qualifications for inclusion in CDC’s PulseNet national database. | FDA/CVM |
| Determination of Ceftiofur and Cephapirin in Incurred Milk Used for Test Kit Evaluations – Purpose is to test milk for ceftiofur and cephapirin to determine the concentration of the drugs in the milk. This is part of the test kit evaluation program, which maintains incurred milk samples of a known concentration for use in validating test kits.The stability of the drug in the milk samples is not known.It has been over two years since the concentration of existing milk was last tested. | FDA/CVM |
| Antibiogram of Food Borne Pathogens Isolated from Retail Meats Marketed Throughout the United States. The project determines the antimicrobial susceptibility profiles on specific food-borne pathogens and develops a profile of antibiotic resistance in retail meats.The information generated from these studies are shared with PulseNet as part of their surveillance of the distribution of food borne pathogens within the United States. | FDA/CVM External: CDC, Public Health Laboratories from California, Colorado, Connecticut, Georgia, Maryland, Minnesota New York, Oregon, and Tennessee. |
| Multi-class Method Development for Drug Residues in Tissue using LC-MS – Purpose is to develop a method to confirm the presence of aminoglycoside drug residues in liver and kidney samples from multiple animal species using mass spectrometry. | FDA/CVM |
| Determination of Nitrofuran Residues in Shrimp – Purpose is to develop an analytical method for determination of nitrofuran residues in shrimp. | FDA/CVM |
| Method Development for Florfenicol in Bovine Milk – Purpose is to develop and/or validate a regulatory method for the determination and confirmation of residues of florfenicol in milk at the target level.A confirmatory procedure is needed to complete the regulatory method.Most of the study will be devoted to developing and conducting a validation of a mass spectrometric confirmatory procedure. | FDA/CVM |
| Development of a New Extraction and Detection System for Discriminating Between Prohibited and Exempt Feed Components – Purpose is to produce a new ELISA test capable of discriminating between prohibited and exempt materials, which will be coupled with a simplified extraction procedure.The assays currently available for detection of materials of bovine origin are not capable of discriminating between prohibited and exempt materials at the needed sensitivities.Feed microscopy can do this task, but lacks the sensitivity as well as speed for analysis of multiple samples.This study will test animal feed. | FDA/CVM External: Veterinary Laboratories Agency, Ministry of Fisheries and UK: |
| Multilocus Sequence Typing of Salmonella - To better characterize the potential of resistant organisms to spread from food animals to humans, will apply a new genotypic method known as Mulitlocus Sequence Typing (MLST).This study will be the first attempt to apply this method to a large number of non-typhoid Salmonella isolates from both animals and humans.It may help distinguish strains pathogenic for humans from virulent strains in the food supply. | FDA/CVM |
| Characterization of Salmonella Isolated from the Veterinary Diagnostic Laboratories - Research will establish a DNA fingerprinting database for Salmonella isolates obtained from veterinary diagnostic laboratories from six different states.The isolates will be sent to CVM/OR who will perform PFGE and share their DNA fingerprints with PulseNet. | FDA; Arizona Vet. Diag. Lab., AZ; Michigan State University; Rollins Animal Dis. Diagn. Lab, NC; State of MO Animal Health Division, MO; Animal Lab, TN Dept of Agriculture, TN; Univ. of MO- MO |
| Broad Scan Analysis for Drug Residues in Eggs – Purpose is to develop a method to allow most classes of animal drugs to be detected and confirmed in eggs using mass spectrometry and a few generic sample extractions. | FDA/CVM |
| Characterization of Salmonella typhimurium Isolates from the National Antimicrobial Resistance Monitoring System (NARMS) - Research will establish a DNA fingerprinting database for Salmonella typhimurium from NARMS (animal origin) in CVM/OR, which will be shared with PulseNet. | FDA/CVM |
| Analysis of Regulatory Samples for the Presence or Absence of Bovine-Derived Materials - Analyze feed samples to determine the presence or absence of bovine derived materials by PCR. The project is to develop standard methods of analysis. | FDA/CVM |
| Evaluation of Rapid Test Kits for Detection of Food Adulteration - Commercially available test kits are only validated fora given number of food commodities.The project will evaluate and validate the kits for a range of food products, particularly for use at border locations | FDA/ORA IAG w/DOD/New Mexico State University |
| Evaluation of LC-MS, GC-MS, Ion Chromatography, ICP-MS, FTIR and ELISA Procedures - These procedures will continued to be evaluated to expand the scope of toxic chemical detection in more food matrices. | FDA/ORA |
| Evaluation of Quadruple Time of Flight Mass Spectrometer -The relatively new equipment will be investigated for the detection of highly toxic proteins. | FDA/ORA |
| Continued Evaluation of Existing and New Technologies - These technologies will continually evaluated for suitability for field use. | FDA/ORA |
| Evaluate Existing Screening Procedure and Develop New Analytical Procedures for Chemical Warfare Agents - Methods of detection for traditional chemical warfare agents have not been established for many food matrices.Research will be conducted to develop these procedures and to evaluate existing screening procedures for the ability to detect the agents in food matrices. | FDA/ORA |
| The Investigation of QeEChERS Method for Use in Regulatory Pesticide Analysis - The regulatory pesticide procedures for low fat items listed in the Pesticide Analytical Manual consist of several steps, including polar solvent extraction, removal of water, concentration, then various cleanup procedures followed by further concentration steps.The QeEChERS (Quick, Easy, Cheap, Effective, Rugged, Safe) method simplifies the pesticide extraction and cleanup process, reducing the use of solvents, time and equipment.Research will investigate the applicability of this procedure (or a modification) for use in regulatory pesticide analyses. | FDA/ORA |
| Development of Liquid Chromatographic Procedures to Determine Residues in Pasteurized Milk, Cheese and Whey - Adaptation of Charm II Screening Tests for Beta-Lactams, Sulfonamides - FDA regulates pasteurized milk, cheese, and whey, but, in general, no residue testing has been performed on these products and no methodology exists.The project will research modification of existing methods to be used in the analysis of multiple sulfonamide residues in pasteurized milk, cheese, and whey.Modification of available methods will maximize the cost and time savings for the analysis of these three matrices.Three methods for sulfonamide analysis in raw milk will be evaluated for rapidness, detection limits, and ruggedness and adaptability to cheese and whey analysis. | FDA/ORA |
| Modification of the Amplified ELISA for the Detection of Type A, B, E, and F Botulinal Toxins in Foods - A rapid test is needed for laboratories that do not have animal facilities. Purified antibodies could be used in a modification of the existing amplified ELISA method that has been used to detect botulinal toxins in culture media. | FDA/ORA |
| Validation Studies of Commercially Available Peanut Allergen Test Kits - Immunoassay based test kits are frequently used by regulatory labs because they have allowed for the screening of various foods, such as peanuts, for protein antigens acting as allergens in certain individuals.The effectiveness and accuracy of these test kits needs to be evaluated.Using available commercial test kits to test a common standard an also a variety of food matrices with naturally occurring allergens would validate their efficiency.Commercial ELISA kits will be evaluated for accuracy, sensitivity, repeatability and precision. | FDA/ORA |
| Specific Detection of Shigella spp. from PCR Inhibitor-rich Produce Using a Modified Enrichment Protocol - The objective of this research is to develop a sensitive, rapid method for detection of Shigella spp. in PCR inhibitor-rich produce.Work was needed to determine if the method was equally sensitive for other types of sprouts and other types of PCR inhibitor-rich produce. | FDA/ORA |
| Rapid Evaluation of Food Samples for Bacillus Anthracis Contamination Using Time Resolved DELFIA Analysis - Time-Resolved Fluorescence (TRF) is one of the most sensitive and reliable means for the unequivocal detection of bioterrorist related pathogens.TRF Dissociation Enhanced Lanthanide FluoroImmunoAssay (DELFIA) is one of the confirmatory evaluations performed by the CDC for the detection of Bacillus anthracis, Yersina pestis, Francisella tularensis, ricin, and Staphylococcal enterotoxin B.This technology was extensively used by CDC during the evaluation of clinical and environmental samples in the fall of 2001.ORA must determine the effectiveness of this technique for rapid screening of high risk food samples.Of particular importance, is the development of rapid detection methods for Bacillus anthracis in food samples.Despite the use of rapid and sensitive techniques involving Real-Time PCR and Time-Resolved Fluorescence (TRF) for the identification of bioterrorist pathogens in clinical samples, no current method exists for direct application to food products.The proposed research project will be limited to the analysis of B. anthracis. | FDA/ORA |
| Final Testing of a DNA Probe for the Detection of Shigella - The Bacteriological Analytical method is relatively insensitive for the detection of low numbers of Shigella in the presence of large numbers of other microorganisms.The research is to develop a chemiluminescent, digoxigenic-labeled, PCR-generated non-radioactive DNA probe for the detection of and/or enumeration of Shigella from foods or cultures.Chemiluminescence would allow for increased sensitivity of the probe.The research will examine other antibodies, or mixes of antibodies, in an attempt to find and IMS system that could be used for all Shigella. | FDA/ORA |
| Detection of Shiga Toxins in Foods - There are several methods available to purify large amounts of Shiga toxin, including column chromatopography, plasmid expression vectors, and receptor-medicated affinity chromatopography.These toxins are biologically active, and could be used to contaminate food.Assays (ELISA) would allow for rapid and sensitive detection of the toxins, but these assays have not been used to detect Shiga in food.However, the assays should be utilized to evaluate the ability to detect Shiga toxins in spiked food matrices.The research should lead to development of a rapid assay for the detection of Shiga toxins in foods.The combination of IMS with a sensitive assay should allow detection of low levels of Shiga toxin. | FDA/ORA |
| Matrix Solid Phase Dispersion Extraction and LC Determination of Aflatoxins in Peanut Butter - Aflatoxins are toxic metabolites produced by fungi of the genus Aspergillus.They have been associated with various diseases in livestock, domesticated animals and humans worldwide.Matrix solid-phase dispersion (MSPD) is a technique that is being used extensively for isolating drugs and pesticides from milk and tissue.Purpose of the study is to couple an MSPD extraction with an IAC clean-up, for the analysis of alfatoxins in peanut butter.Substitution would result in large reductions of solvent consumption, waste production and time.The modified MSPD-Alfatest methodology will first provide FDA with a rapid, sensitive, and cost effective regulatory method for the mycotoxins studied.With the knowledge gained from this research, other compounds of regulatory concern could be studied with this methodology. | FDA/ORA |
| Rapid HPLC Determination of Nitrate/Nitrite in Baby Foods – Research will apply some previously collaborated official European extraction methods (perhaps with some modification) and evaluate both ion chromatopographic performance as well as the ability of the system to selectively detect these compounds in more complicated food matrices.Project will evaluate methods for the extraction of NOx in baby foods containing chicken, beef and other meat products using the ion chromatopographic post-column detection system developed in ORA’s laboratory. | FDA/ORA |
| Development of a Real Time PCR Assay for the Detection of Salmonella in Food Samples Using Molecular Beacons - Rapid detection methods utilizing molecular biology techniques such as quantitative real-time PCR using molecular beacons can greatly improve and expedite the detection and isolation of bacterial pathogens such as Salmonella. A highly sensitive and specific real-time PCR assay combined the speed and specificity of PCR with the specificity and high sensitivity of molecular beacons.Continuation of further testing is needed in order to determine the suitability of this assay for the detection of Salmonella in foods. The objective of the project is to develop and optimize the assay by adding a second set of primers and probe (multiplex PCR) in order to improve the specificity and sensitivity. | FDA/ORA |
| Detection of Shigella in Foods Using Real-Time PCR - FDA conventional method for Shigella is dependent upon traditional enrichment and biochemical identification.The purpose of the project is to develop amethod using real-time PCR or 5'-nuclease assay to detect and quantify Shigella in less than 1 hour time span. | FDA/ORA |
| Primer and Probe Design for Real-Time PCR Detection of Listeria monocytogenes - Currently, the FDA method requires a minimum of five days for analysis and a maximum of two weeks for confirmation.Recent technology in molecular biology involving the 5' -nuclease assay or real-time PCR can shorten the detection of pathogens to hours instead of days.Development of a rapid method that can detect Listeria monocytogenes in less than a day will expedite regulatory actions and thus protect the consumer from adulterated products. | FDA/ORA |
| Development of Reagents Standards for the Rapid Detection of Norwalk-like Viruses in Foods - There is a current effort underway to compare two methodologies to determine the optimal method for recovering Norwalk-like viruses (NLV) in food matrices. An easier, safer, and more convenient method for training the new analysts in RT-PCR would be the use of cloned DNA of viral genes in expression vectors of the polymerase and capsid regions of Norwalk, Hawaii and Sapporo viruses.Cloning and sequencing of the polymerase and capsid regions in a field lab would provide the documentation needed for the tractability of the standards, providing ORA field labs with reliable, traceable standards for regulatory sample analysis and for proficiency testing of the analysis. | FDA/ORA |
| Usefulness and Application of the Nitron Portable X-Ray Fluorescence (XRF) Device to the Food, Drug and Device Programs and Counterterrorism in Foods - The effectiveness of a portable XRF device to detect and/or quantify "metals" in foods (including dietary supplements, housewares, herbal products, food cans, and raw foods), and surgical stainless steel instruments will be determined.To determine the effectiveness of the Nitron XRF in accomplishing counterterrorism objectives in foods in a rapid fashion, in a field setting.There is a need to be able to rapidly identify products that may pose potential exposure hazards regarding toxic elements, ones that may be leached from ceramicware, present in foods, or present in drugs.There is also a need to rapidly detect and quantify those elements that are required to meet standards.Objective is to evaluate the effectiveness of the device in detecting a mixture of toxic elements added to a variety of foods, at a variety of levels and determine the analytical threshold for the detection of individual elements. | FDA/ORA |
| Microarray-Based, New Method for Detection/Identification of Salmonellas, Listerias and other Foodbourne Pathogens in Food Samples - Certain species of Salmonella and Listeria and other foodborne pathogens such as Campyrobacter, E. coli 0157:H7, Shigella and Vibrio are the most frequently encountered bacterial pathogens in field labs.Current methods of detection/identification of each of these pathogens are laborious and time consuming.Proposed research aims at the development of a Microarray-based, new, rapid, one-step method.Based on the unique gene sequences in microbial genomic DNA, the microarray method involves the use of the pathogen-specific, oligonucleotides linked to the surface of activated glass.In comparison with the current detection schemes, the new method would represent a leap of improvement in the analytical activity. | FDA/ORA |
| Improving the Sensitivity of the CFSAN PCR Method for Shigella in Fresh Produce and Other Food Samples - The current PCR method for Shigella has limited sensitivity.The sensitivity could be improved by modifying the method's current cell concentration procedure and the addition of a Shigella specific enrichment step.By increasing the sensitivity of the current Shigella PCR method, the Agency improves its chances of detecting this pathogen in fresh produce prior to it reaching the public. | FDA/ORA |
| Validation Study of a Highly Sensitive and Specific 24-hour PCR Method for Rapid Screening of Salmonella - Developed highly sensitive and specific PCR method for rapid screening of Salmonella in Foods.Recent study in fresh produce and shrimp samples further showed that by combining our PCR method with shortened pre-enrichment time the presumptive results could be obtained in a time frame of 24 hours.This system will reduce the reporting time of Salmonella analysis in the ORA labs and improve the throughput of the import sample analysis by FDA.Validation of the new system in all food matrixes targeted by the FDA will ensure the broad applicability of the system in the regulatory samples. | FDA/ORA |
| Use of Real-Time PCR for Rapid Detection of Shigatoxin Producing Escherichia coli in Foods After a Short Enrichment - Rapid and sensitive methods for detecting contamination of food with enteric pathogens is important to public health and essential to detecting and limiting possible bioterrorism events.Molecular-based technologies show great promise to provide solutions to these analytical problems.The purpose of this project is to enhance the sensitivity of this rapid assay in order to detect 0.1 CFU/g in foods by use of a short enrichment period prior to real-time PCR.This work will be coordinated with another project to improve template preparation techniques for this assay. | FDA/ORA |
| Improved Method for Detection of Enterotoxigenic E. coli (ETEC) - Considerable effort has been devoted to improved detection of enterohemorrhagic E. coli in recent years.However, less work has been conducted to improve methods for detection of the various groups of diarrheagenic E. coli.An example of the complexity of the current approach: a regulatory cheese sample in PRLNW was recently found to contain enough E. coli to warrant ETEC analysis by radioactive probe.This process required 173 hours for analytical time, and also generated initially confusing results when a strain of Hafnia alvei was found to give false probe results.These lab procedures consume a tremendous amount of analytical time in FDA labs and make it more difficult to fulfill mandates to increase the percentage of the U.S. food supply tested annually for microbiological quality.A rapid, effective, procedure is needed for enumeration of ETEC in food. | FDA/ORA |
| Analysis of PSP Toxins; Cell Bioassay, HPLC and LC/MS - This project will be directed to the comparison of three methodologies for the rapid identification and confirmation of paralytic shellfish poisons (PSPs); N2A cell bioassay, pre-column oxidation/derivation HPLC with fluorescence detection, and Electrospray LC/MS. | FDA/ORA |
| Discovery of Unrecognized and Uncharacterized Viral Agents- For epidemic control and for defense against bioterrorism attacks, rapid identification and characterization of the responsible unknown agent are crucial.The most recent technologies for detecting and identifying previously unrecognizable pathogens are differential display (DD), representational difference analysis (RDA), subtractive hybridization, expression library screening, broad-range polymerase chain reaction and analysis of gene expression (SAGE).They are all time consuming and not very reproducible approaches.ORA will develop a new subtraction hybridization method to suite its need.This new genomic subtraction method, in theory, will be suited to rapidly identify any previously unrecognized viral agents. | FDA/ORA |
| Comparison of Three Methods for Okadaic Acid Detection and Modification of Cytoxicity Assay for DSP - Project will compare sensitivity, selectivity, and ruggedness. | FDA/ORA |
| Development of a Real-Time Reverse Transcription Polymerase Chain Reaction Assay for HAV - Currently, the detection of isolated hepatitis A virus (HAV) takes 12-15 hours.The goal of this study is to develop a real time polymerase chain reaction (PCR) protocol to detect and possibly quantitate HAV in 1-2 hours.The projected method should be faster for detection and quantitation of HAV and its reproducibility should be instrumental for its application throughout FDA labs.The field labs still lack a rapid and reproducible method to detect HAV in foods.For these reasons a reproducible, rapid method is needed to detect and quantitate HAV isolated from foods.The application of the real-time PCR using the Smart Cycler ™should shorten the detection steps used with the traditional PCR, eliminate post amplification steps and increase reproducibility.The proposed methods should be a fast and reproducible detection and quantitation tool to screen foods for the presence of HAV. | FDA/ORA |
| Bioassay Detection of Non-O157 Shiga Toxins via Translation Arrest - Continuation of a project focused on the development of a novel bioassay to detect Shiga toxins from non-O157 H7 Escherichia coli | FDA/ORA |
| Development of Specific Methodologies for Herbal and Dietary Supplements' Main Active Ingredients - Methods for quality assurance must be able to specifically determine the active ingredient, and any possible degradation products.In this project, a specific stability-indicating NMR spectroscopic assay for the active ingredient in herbal and dietary supplements will be developed. | FDA/ORA |
| Upgrade of Field Pesticide Analytical Capability with Gas Chromatograph Mass Selective Detection System - Project is to develop better analytical methods for pesticide detection. | FDA/ORA |
| Development of Methods for Detection and Culture of Caliciviruses - Detection of caliciviruses has been a challenge because no susceptible lab animal or cell culture system is available.Labs are faced with two problems regarding control and distribution of foods that may be contaminated with viruses capable of causing gastroenteritis.The first of these is that the field labs are not equipped with a validated method for testing food either pro- or retro- actively.Secondly, there is no known source from which to obtain such viruses for detailed characterization.Research is to develop an immune capture technique to recover caliciviruses from spiked deli salads.Present proposal is to continue with this work as well as to develop a tissue culture system aimed at providing the environment necessary for the growth of caliciviruses. | FDA/ORA |
| Developing and Evaluating Risk Assessment Models for Key Waterborne and Foodborne Pathogens and Chemicals – Purpose is to develop and evaluate risk assessment models and chemical risk assessments for food and water.The model will be useful in further development of assays and methodologies. | FDA/NCTR |
| Rapid Screening Test for Food Quality – Purpose is to develop simple, field-compatible methods to test for food quality. | FDA/NCTR |
| Development of Multiresidue Methods to Determine and Confirm Sulfonamides in Edible Tissues of Aquacultured Species – Purpose is to develop analytical chemical methods to determine, detect, and confirm sulfonamide residues in edible tissues of aquacultured species. | FDA/NCTR |
| Combining MAB/MS with Pattern Recognition to Sub-type Bacteria – The development of a rugged, rational, and flexible PyMAB/MS-based method capable of differentiating strains would provide an option to molecular methods for the rapid chemotaxonomy not only of novel strains but also of others that cannot be presently distinguished using molecular technology.Such a capability is useful not only in relation to clinical needs and epidemiological studies, but also in relation to the agency's food safety assurance mandate.This project will demonstrate the validity of the combination of pyrolysis/metastable atom bombardment (MAB)/mass spectrometry (PyMAB/MS) with computerized pattern recognition for bacterial sub-typing.The work should produce a scientifically and technologically validated basis for commercial licensing of an NCTR-patented process: a method for assembling coherent spectral databases for use in rapid chemotaxonomy at the strain and sub-strain level.Effort is to produce a quicker method of analysis at greater sensitivity. | FDA/NCTR |
| Evaluation of Pyrolysis MAB/Tof MS and MALDI/Tof MS for Rapid Characterization of Presumptive Bio-terror Agent Samples - Evaluate the suitability of mass spectral data obtained from both pyrolysis metastable atom bombardment MS and matrix-assisted laser desorption/ionization time-of-flight MS techniques for identifying microorganisms from contaminated samples and differentiating contaminated samples from hoax samples. | FDA/NCTR |
| Development of Dynamic Mass Spectral/Pattern Recognition Based Methods for the Rapid Identification of Bioterrorist Agents - Develop the necessary computational capability to enable the rapid identification of pathogen/non-pathogen microorganisms and non-biological hoax materials. | FDA/NCTR |