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REPORT TO CONGRESS
SUBMITTED TO
THE COMMITTEE ON ENERGY AND COMMERCE
OF THE HOUSE OF REPRESENTATIVES
AND
THE COMMITTEE ON HEALTH, EDUCATION, LABOR,
AND PENSIONS OF THE SENATE
SECOND ANNUAL REPORT -- FEBRUARY 2005
DEPARTMENT OF HEALTH AND HUMAN SERVICES
U.S. FOOD
AND DRUG ADMINISTRATION
I. Introduction
II. Background
III. Accomplishments and Opportunities in Research on the Development of Tests and Sampling Methodologies
IV. Conclusion
Appendix A -- Statutory Language
Appendix B -- Research Projects
The Food and Drug Administration is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The Agency has long been a leader in research to improve the detection of adulterated food products, through the efforts of its cadre of top-notch scientists and public health experts and its partnerships with outside academic institutions, private companies, food consortia, and other government agencies.
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). Section 302(d) of the Bioterrorism Act directs FDA to provide for research on tests and sampling methodologies designed to test food to detect adulteration rapidly--particularly methodologies that detect intentional adulteration and tests that are suitable for inspections of food at ports of entry to the United States . Section 302(d) also requires the Agency to report annually to Congress on its progress in research on testing for rapid detection of food adulteration. This is the second annual report to Congress under section 302(d).
Since the Bioterrorism Act was enacted, FDA has initiated more than 100 intramural and extramural research projects to develop tests and sampling methodologies for detection of adulterated food. The Agency's research agenda is developed in coordination with other Federal agencies and is particularly focused on methods to detect high-priority biological agents (e.g., Clostridium botulinum neurotoxins), as well as chemical (e.g., ricin) and radiological threat agents that pose the greatest threats to the public and foods believed to be the most vulnerable or attractive to terrorists. Researchers also are exploring food testing protocols using the latest cutting edge technologies, such as the optical affinity biosensor technology and the quadruple time of flight mass spectrometer, to improve the timeliness and accuracy over existing available techniques.
Several research projects have been completed since the Agency's last report to Congress. Other projects, though still ongoing, have nevertheless produced significant accomplishments to enhance the security of the nation's food supply.
Among the Agency's accomplishments are the development, adaptation, or validation of rapid and field-deployable methods to detect various Category A agents in food and the establishment of testing protocols using the latest, cutting-edge technologies. These new data and technologies have been shared across the Federal government and with States and localities to equip them to perform food safety testing. Other research products have resulted in commercial production and publication in well-respected, peer-reviewed journals.
The events of September 11, 2001 , highlighted the need to enhance the security of the U.S. food supply and underscored the importance of FDA's food research activities. 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. This landmark legislation provided the FDA with significant new tools to protect the nation's food supply against the threat of intentional contamination and other food-related emergencies.
Section 302(d) of the Bioterrorism Act (see Appendix A) directs FDA to provide for research on test methods and sampling methodologies that allow for rapid detection of food adulteration and that offer significant improvements over available technology in terms of accuracy, timing, or costs. It instructs the Agency to give highest priority to research related to detection of intentional adulteration and to focus particularly on developing tests that are suitable for use in inspecting foods at ports of entry into the United States . Section 302(d) further requires FDA to prepare an annual report to Congress describing its progress in research on methods for rapid detection of adulterated food. The Agency submitted its first annual section 302(d) report in October 2003; this is FDA's second annual report under section 302(d).
FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.1
The Agency has long been a leader in research to improve the detection of traditional foodborne hazards. FDA now plays a central role in the nation's defense against terrorism, in part by safeguarding the food products it regulates from attack. The possibility of a biological, chemical, or radiological attack on the food supply is particularly worrisome because such an event could have significant public health consequences and could be especially dangerous for children, the elderly, and those who are immunocompromised. Therefore, the Agency is focusing on improving its capability to assess and respond to risks associated with threats to harm Americans through the food they eat.2 Research on tests for rapid detection of food adulteration is critical to this effort.
FDA's current food defense research agenda largely is directed toward foods believed to be most vulnerable or attractive to terrorists ("high priority foods"), based on the Agency's evaluation of the relative public-health consequences (i.e., the risk of morbidity and mortality) of a range of product-agent scenarios associated with potential tampering or criminal, malicious, or terrorist activity. Research also primarily targets agents that pose the greatest threats to the public, which include some biological agents that the Centers for Disease Control and Prevention (CDC) has classified as "Category A" or "Category B" agents due to their potential for adverse public health impact and large-scale dissemination, as well as priority chemical agents identified by CDC, and radiological agents.
Our key food defense research goals are the development of field-deployable analytical detection methods and the characterization of microbiological, chemical, and radiological agents in FDA-regulated foods. For some agents of concern, new microbiological, chemical, and radiological methods must be developed, validated, and used to detect, enumerate, and identify non-traditional agents that may threaten the food supply. In other instances, researchers are conducting "in-house" validation and performance testing of existing rapid screening kits for priority agents in high-priority foods, with the goal of having "portable" technologies that meet appropriate performance/validation standards. Characteristics research involves assessment of the abilities of non-traditional bacterial pathogens to survive and grow in food, as well as determination of the stability and activity of chemical agents while present in food. Researchers also are developing a transportable system for radionuclide analysis of FDA-regulated foods.
Intramural food defense research is conducted by the following components within FDA:
The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for oversight of the food supply and has an active research program to support its regulatory responsibilities, which include responding rapidly to newly emerging food safety threats to public health. CFSAN's counterterrorism research agenda is aimed at developing the tools essential to testing a broad array of food products for several biological and chemical agents.
The Center for Veterinary Medicine (CVM) has authority over feed and feed additives and drugs that will be given to animals, including food-producing animals. CVM's research projects are primarily designed to enhance the Agency's ability to detect particular substances (e.g., drug residues) in food.
The Office of Regulatory Affairs (ORA) is the lead office for FDA field activities, including inspections and examinations of food and other FDA-regulated products at ports of entry. ORA's food defense research efforts largely are directed toward developing tools to rapidly analyze large numbers of samples and to test foods for multiple substances simultaneously.
FDA's National Center for Toxicological Research (NCTR) conducts scientific research that supports and anticipates FDA's current and future needs, such as counterterrorism activities. NCTR's projects include both fundamental and applied research specifically designed to define biological mechanisms of action underlying the toxicity of FDA-regulated foods.
In addition to its intramural activities, the Agency's food defense research program draws upon its collaborative Centers of Excellence (e.g., the National Center for Food Safety and Technology (NCFST) and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN)) and extramural research programs that provide competitive research contracts and grants to other government agencies and academic institutions, among others. FDA has several extramural projects with Federal partners, including the CDC and the Department of Defense. The Agency also coordinates its food defense research agenda, as appropriate, with other Federal agencies, such as the CDC, the U.S. Department of Agriculture (USDA), the Environmental Protection Agency, and the National Institutes of Health, pursuant to section 302 of the Bioterrorism Act and Homeland Security Presidential Directive 9 ("Defense of United States Agriculture and Food").
An overview of the FDA's accomplishments and opportunities in intramural, extramural, and collaborative food defense research is provided below. Specific counterterrorism-related food research projects are listed in the table provided in Appendix B.
III. Accomplishments and Opportunities in Research on the Development of Tests and Sampling Methodologies
Since the Bioterrorism Act was enacted in June 2002, FDA has initiated more than 100 research projects to develop tests and sampling methodologies to increase detection of adulterated food. Several research projects have been completed since the Agency's last report to Congress, submitted in October 2003. Other projects, though still ongoing, have nevertheless produced significant accomplishments.
A key success in the food defense research area, relative to traditional foodborne pathogens, involves the establishment of a three-year ($1.6 million per year) Interagency Agreement (IAG) with the Department of Homeland Security (DHS), in collaboration with the Federal Bureau of Investigation, to support microbial forensics of Salmonella enterica, Shigella, and pathogenic Escherichia coli (and other enteric pathogens). The genomes of these bacteria are being studied and catalogued using bioinformatics to characterize the total genetic diversity within wild-type populations of these pathogenic groups. DNA microarray and other technologies are being developed to detect genetic alterations that could indicate and/or distinguish these natural evolutionary changes, as well as intentional genetic alterations. These studies, then, focus on distinguishing food contamination (and human infection) with normal circulating strains ("wild type") of these pathogens from strains that may be genetically manipulated and may have enhanced ability to cause human disease.
The Agency has initiated several promising food defense research projects, which include developing a method for identifying Y. pestis by microarray without the need for PCR. Other new projects focus on chemical agents and toxins.
Research to improve the testing and methodologies to detect food adulteration is essential to FDA's efforts to safeguard the food supply and thereby protect the American public. The Agency has made significant strides in developing and improving methods to rapidly detect food adulteration and in characterization of agents that might be used to contaminate food. Several significant studies continue, and others are just beginning. Continued support of FDA's food defense research is vital, because many of these projects require numerous steps and will not be able to be completed without multi-year support. We are confident that our commitment to this important research will lead to more rapid detection of food adulteration and, ultimately, to better protection for the American public.
(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).
The authority of the Secretary of Health and Human Services under section 302(d) is delegated to the FDA Commissioner.
Project / Accomplishments / Next Steps |
FDA Lead /Partners |
Status |
|---|---|---|
Detection of Monofluoroacetic Acid (MFA) in Foods Using Liquid Chromatography-Mass Spectrometry (LC-MS): Scientists developed and evaluated an LC-MS method for extraction and detection of various MFA concentrations in food matrices with possible interferences, including salt, fat, and sugar content. Also determined limit of detection and limit of quantitation of the method.
|
CFSAN / Chem Sensing, Inc. (See related CFSAN intramural project.) |
Completed |
Bovine Spongiform Encephalopathy (BSE) / Chronic Wasting Disease (CWD) Risk Assessment: Researchers modified the BSE model to track and report cases by animal age, type, and gender and reviewed data on dietary supplements and handling of bovine trimmings by packers/renderers. Work continues on assessing the potential human risk from CWD and to adapt the BSE model to assess the BSE risk from contaminated foods (e.g., dietary supplements) and cosmetics.
|
CFSAN / Institute for Food Technologists, Harvard Center for Risk Analysis |
Ongoing |
Validation of Detection Methods for Specific Microbiological Agents in High Priority Foods: Scientists developed and evaluated an immunocapture-polymerase chain reaction (PCR) method for isolating and identifying F. tularensis in foods. Currently evaluating an immunocapture-PCR method for isolating and identifying Y. pestis in foods. Also identified several methods for the detection of Brucella spp., three of which currently are being evaluated.
|
CFSAN / Midwest Research Institute |
Ongoing |
Support for the National Prion Disease Pathology Surveillance Center : Researchers conducted a preliminary test of species barrier of CWD for humans. Characterization of pathogenic deer and elk prion proteins continues, as does analysis of Creutzfeldt-Jacob disease (CJD) cases from CWD-endemic areas. Ongoing efforts to study the "species barrier" to human infection by CWD and CWD pathogenesis in mice inoculated with CWD prions.
|
CFSAN / Centers for Disease Control and Prevention |
Ongoing |
Production of Immunoassay Kits for Tetrodotoxin: Work with proprietary hybridoma has begun, with goal of producing immunoassay kits to detect tetrodotoxin. |
CFSAN / Hawaii Biotech Group, Inc. (See related CFSAN intramural project)
|
Ongoing |
Assessment and Validation of Immunoassay Methodology for Determination of Clostridium botulinum Toxin in Selected Food Matrices: Scientists determined that ORIGEN Analyzer FASTube assay can be performed in about one hour and is sufficiently sensitive in certain high-priority food matrices to be used as a rapid immunoassay method to screen for C. botulinum neurotoxins in food.
|
CFSAN / U.S. Army, Natick , MA |
Completed |
Verification of Biodetection Protocols for Agents Not Normally Associated with Foodborne Illness: With data on detection of B. anthracis in food, researchers continue to develop methods for detection of Y. pestis in food. Surge capacity by Edgewood Chemical Biological Center remains available to FDA, if needed.
|
CFSAN / U.S. Army, Edgewood Chemical Biological Center |
Ongoing |
Develop/Validate Food Detection Systems: Scientists evaluated hand-held assays to detect C. botulinum neurotoxin E, Burkholderia pseudomallei, Shiga toxin, Staphylococcus aureus enterotoxin A, and V.cholerae. Delivered assays to FDA laboratories.
|
CFSAN / Naval Medical Research Center |
Ongoing |
Degradation of Prions: Yeast Prion as a Surrogate Protein: Researchers developed and used a yeast prion protein as a surrogate for TSE prions. Preliminary results indicate that the polymeric form of the yeast prion protein is resistant to, or partially digestible by, proteinase K and keratinase, depending on the enzyme concentration. Degradation study continues.
|
CFSAN / NC State University |
Ongoing |
Protein Markers for Verifying Inactivation of TSE Agents: Scientists identified heat- and protease-resistant protein markers from a gelatin model. Developed, purified, labeled, and mapped the epitopes of monoclonal antibodies to bovine tropomyosin and developed an immunoassay for bovine tropomyosin. Produced monoclonal antibodies for bovine type I collagen. Efforts continue on identifying heat- and protease-resistant protein markers as surrogates for TSE prion proteins and studying the denaturation of such markers using monoclonal antibody immunoassays.
|
CFSAN / TN State University |
Ongoing |
Optical Biosensor Technology for Food Safety: Researchers found secondary antibody amplification unnecessary for large-sized cell detection (e.g., detergent-lysed E. coli O157:H7) by surface plasmon resonance (SPR). Also improved sensitivity of SPR for domoic acid 20-fold. Found flow rate, cell thickness, and cell shape to affect adsorption or equilibrium of biomolecules in the SPR detector. Efforts continue on developing a novel optical affinity biosensor technology that will enable fast, sensitive, and specific detection and identification of foodborne pathogens and toxins in food samples.
|
CFSAN / University of WA |
Ongoing |
Develop Prototype of Food Pathogen Detector (MIPSTRIP): Work continues on developing a synthetic polymeric film (MIP) imprinted with a macromolecular external membrane component or components of E. coli O157:H7 as an initial capability. If successful and operationally suitable, the methods developed will be applied to certain select agents on foods.
|
CFSAN / Sensor Research and Development |
Ongoing |
Heat Treatment of Bacterial Spores in Dairy Products: Researchers enumerated spore mixtures to determine the effect of double heat treatments on spore inactivation. Analyzed survival to determine effect of fat level or hold time between treatments on heat sensitivity of spores. Determined survival of C. botulinum and B. cereus in pasteurized milk with spore germinants. Work continues on characterizing the risk from C. botulinum or B. anthracis in dairy products receiving more than one heat treatment.
|
CFSAN / University of WI |
Ongoing |
Multi-Analyte Array Sensor for Foodborne Contaminants: Scientists used the Naval Research Laboratory Array Biosensor to develop individual assays for C. botulinum neurotoxins, ovalbumin, ochratoxin, aflatoxin, E. coli O157:H7, S. aureus, Campylobacter jejuni, and Listeria monocytogenes. Will continue to optimize assays and develop a new assay for Vibrio vulnificus. Multiplexing of individual assays planned for FY05.
|
CFSAN / Naval Research Laboratory |
Ongoing |
Development of Cell- and Nanoparticle-Based Sensors for BSE: Researchers found, through preliminary testing, a G protein-based fluorescence assay to be successful at high concentrations to predict the ability of processing treatments to inactivate the infectivity and biological activity of prions. Detected prion in foods with sensor using gold nanoparticles with polyclonal antibodies to PrPSC. Also found a cell-based sensor using chromatophores was not sufficiently robust.
|
CFSAN / TX A&M University; (University of MD, collaborator) |
Completed |
Development and Implementation of a Risk-Ranking Framework to Evaluate Potential High Threat Microbiological Agents, Toxins and Chemicals in Food: Scientists evaluated and selected software as the information technology component to be used in developing the quantitative framework to evaluate the relative risks of contamination of FDA-regulated foods. Developed and revised questions for microbial and chemical hazards that can be used for ranking.
|
CFSAN / Institute of Food Technologists |
Ongoing |
Study of Nisin and Sublancin in a Strategy for Protection of the United States Food Supply from Pathogenic Bacterial Spores Introduced Through Bioterrorism: Researchers demonstrated the covalent incorporation of nisin into one or more targets in the Bacillus cell. Also demonstrated the effectiveness of nisin in various food models inoculated with B. cereus activated spores. Work continues on evaluating the effectiveness of nisin/sublancin mixtures in inhibiting bacterial spore outgrowth in food.
|
CFSAN / Joint Institute for Food Safety and Applied Nutrition (See related CFSAN intramural project) |
Ongoing |
Effects of Environmental Conditions, Phytochemicals, Modified Atmosphere Packaging, and Other Parameters on the Growth of Staphylococcus aureus on Mung Bean Sprouts: Scientists found chlorine solution to be effective in controlling growth of S. aureus in mung bean sprouts. Project continues to determine the effectiveness of disinfectant washes in reducing S. aureus on produce.
|
CFSAN |
Ongoing |
Improve Detection Methodologies for Microorganisms with Potential for Use in Terrorism : Researchers detected C. botulinum neurotoxins using two in vitro hand-held assays, suggesting possible use as a preliminary screening system. Data presented at scientific meeting; manuscript submitted for publication. Also found an FDA-developed ELISA kit effective for large-scale screening of food for C. botulinum neurotoxins. Collaborative study in planning stage; FDA seeking commercial source for bulk production. Developed and tested in dairy products an improved enrichment method for the detection of F. tularensis. Researchers continue to evaluate rapid methods for other priority agents.
|
CFSAN |
Ongoing |
Microarray Analysis of B. anthracis, C. botulinum, and S. aureus : Scientists developed a microarray for Staphylococcus spp. and demonstrated that multi-toxigenic strains may be common for S. aureus. Results will be published in a peer-reviewed journal. Also developed a microarray for B. anthracis, which will be reported in a peer-reviewed journal. In addition, scientists designed and fabricated a microarray for C. botulinum.
|
CFSAN (See related project) |
Completed |
Validation of Methods for the Isolation, Identification, and Characterization of Microbial Agents of Bioterrorism from Foods: Researchers developed a method for isolating and identifying B. anthracis in foods and methods for isolating and identifying F. tularencis and Y. pestis in foods using mouse enrichment procedures. Also raised antiserum to Y. pestis that is being evaluated for use in isolating Y. pestis and F. tularensis from food matrices. Efforts continue.
|
CFSAN |
Ongoing |
Investigation and Validation of Methods for Isolating Cryptosporidium parvum in Foods and Water: Scientists developed a viable protocol using absorption and filtration methodologies and FTA filter technology for PCR analysis for the detection of parasitic microorganisms in certain food matrices.
|
CFSAN |
Ongoing |
Detection of Enterohemorrhagic E. coli in Foods :Researchers developed an assay that showed adequate sensitivity in detecting E. coli O157:H7 in certain beverages and produce. Assay correctly identified the Shiga toxin gene types, including certain pathogenic strains that are not easily detected and identified. Will evaluate/validate revised protocol using seeded food samples.
|
CFSAN |
Ongoing |
Evaluation of an Enzyme-Linked Immunosorbent Assay (ELISA) for Detection of C. botulinum Neurotoxin in Foods : Scientists adapted the digoxigenin-labeled ELISA method to detect successfully C. botulinum neurotoxins in various food matrices, including high-priority foods.
|
CFSAN |
Ongoing |
Detection of Pathogenic V. parahaemolyticus in oyster enrichments by real time PCR : Researchers developed and optimized a multiplex PCR to detect and identify pathogenic Vibrioparahaemolyticus and are developing a CRADA with Cepheid Corporation to provide assay. Also developed a universal internal control system for assays to identify false positive reactions caused by PCR inhibitors and to aid in quantifying pathogens; provisional patent application submitted. Agency is receiving licensing inquiries from companies. In addition, researchers developed a real-time V. cholerae PCR assay that was presented at a scientific meeting. Continuing work on multiplexing assay to simultaneously identify V. vulnificus and V. parahaemolyticus and on optimizing Salmonella spp. assay.
|
CFSAN |
Ongoing |
Evaluation of Reliability and Sensitivity of Commercial Test Kits for Detection of Threat Agents in Food: Scientists demonstrated through testing that the efficacy of various commercial hand-held assays may be affected by a number of variables, including the purity and concentration of toxins, the specificity of the antibodies, and the nature of the food matrix. Problems included false negative results and poor performance in detecting toxin embedded in solids. Evaluations are progressing.
|
CFSAN |
Ongoing |
Cladistic Analysis of Microbial Threat Agents: Researchers completed sequencing for development of cladistic methodology to identify strains of E. coli, Shigella, and Salmonella. Testing and validation of PCR-based and microbiological methods for detection of E. coli O157:H7 strains is underway. Researchers continue to establish phenotypic markers for detection and identification of O157:H7 strains and microarray design for rapid screening of the O157:H7 genome.
|
CFSAN (partially supported by IAG with DHS) |
Ongoing |
Thermal resistance of Non-traditional Microbial Agents: Scientists measured thermal resistance of Yersinia enterocolitica 51871 and Y. enterocolitica 51872. Finalizing agreement to collaborate with University of Wisconsin at Madison on C. botulinum neurotoxin testing to quantify thermal resistance in various food matrices.
|
CFSAN; NCFST |
Ongoing |
Survival and Growth of Non-Traditional Pathogens in Foods: Researchers established overall growth and survival parameters of Y. enterocolitica using in vitro models of certain high-priority foods. Construction of BSL-3 laboratory necessary for Phase II work is underway. Work will continue on characterizing the ability of non-traditional vegetative pathogens (or surrogates) to survive and grow in various foods and to develop or extend models of survival and growth for these pathogens.
|
CFSAN; NCFST
|
Phase I completed; Phase II pending laboratory construction |
Detection of Picrotoxin in Foods Using High Performance Liquid Chromatography (HPLC): Scientists selectively determined analysis of picrotoxin standards using a modified version of the HPLC method, developed by FDA/ORA using a Mass Selective Detector. Efforts continue to evaluate and validate the HPLC means of analysis for picrotoxin using various means of detection.
|
CFSAN |
Ongoing |
Detection of Aconitine in Foods Using Liquid Chromatography: Researchers confirmed recovery of aconitine from spiked food matrices, including certain high-priority foods. Goal is to validate a HPLC method using UV detection to detect and quantify aconitine in foods.
|
CFSAN |
Ongoing |
Detection of Abrin in Foods: Scientists received from contract laboratory purified abrin isolates. Received from Department of Defense antibodies and an abrin extract and, from a private company, purified abrin C for comparison studies. Work continues on developing and validating rapid methods to detect abrin (select agent) and jequirity beans (source of abrin) in food.
|
CFSAN |
Ongoing |
Analysis of Foods for Amanitin: Researchers successfully analyzed amanitin in foods using ELISA kits designed for analysis in other media. Efforts continue on evaluating and validating these test kits.
|
CFSAN |
Ongoing |
Detection of Ricin in Foods: Scientists designed a two-tier screening process for detection and confirmation of ricin in food using lateral flow devices and ELISA technology and evaluated process with various food and cosmetic matrices. Work continues.
|
CFSAN |
Ongoing |
Methodologies and Analyses for T-2 Toxin in Selected Food Matrices: Researchers found one ELISA method to be useful in rapid detection of T-2 toxin in certain high-priority foods. Also found that second ELISA method may need confirmation due to risk of false positives and false negatives.
|
CFSAN |
Ongoing |
Rapid Tests for Tetrodotoxin (TTX) Intentionally Added to Food: Work continues on evaluating and optimizing the performance of the receptor binding assay, a commercially produced immunoassay kit, the mouse bioassay, and the HPLC method with mass selective detection for detecting TTX in various food matrices.
|
CFSAN |
Ongoing |
Development of Mass Spectrometric (MS) Methods for Confirming the Presence of Bacterial Toxins in Foods: Custom software program completed to aid in rapid identification of protein toxins in foods. Existing LC-MS methods to analyze Staphylococcal enterotoxin B (SEB) and its enzyme digests found to lack sufficient sensitivity. Initial studies demonstrate that magnetic bead immunoextraction combined with digestions-LC-MS can be used to detect toxins from protein-rich matrices. Continuing evaluation of the efficacy of several analytical MS-based approaches for the detection and confirmation of bacterial toxins in complex food matrices and to demonstrate that detection limits can be further enhanced by immunoaffinity extraction.
|
CFSAN |
Ongoing |
Novel Application of Microarray Technology, Infrared (IR) Microspectroscopy, IR Imaging, and Multivariate Analysis to the Rapid Identification of Foodborne Bacteria and Spores: Researchers developed new sampling techniques and a novel IR procedure to measure cellular fatty acids. Successfully used these new protocols to classify bacteria and to identify bacteria by spectral comparison. Methodology published in two peer-reviewed journals.
|
CFSAN |
Ongoing |
Detection of Monofluoroacetic Acid (MFA) in Foods Using Liquid Chromatography-Mass Spectrometry (LC-MS): Scientists established the applicability of the LC-MS method for a variety of MFA concentrations spiked into foods.
|
CFSAN
(See related extramural project) |
Completed |
Development of Colorimetric Sensor Array for the Detection of Chemical Agents in Liquids (Water, Water/Ethanol): Feasibility Phase: Efforts were unsuccessful due to problems applying the array, which was developed for vapor phase work, to liquid samples. Arrays tested were not able to distinguish between the target compounds and interferences. Given the lack of sensitivity and specificity of the array, further project funding was not requested.
|
CFSAN (Intramural collaboration with Chem Sensing, Inc.) |
Completed |
Evaluation of z-Nose Technology for the Detection of Chemical Agents in Food: Evaluation of reference samples continues to illuminate relationship between method parameters and analyte response.
|
CFSAN |
Ongoing |
Development of a Transportable System for Radionuclide Analysis: Instrumentation for gamma-ray analysis is established and in a trial run, demonstrated excellent ease of use, accuracy and rate of analysis. Transport and additional testing are pending. Instrumentation for alpha- and beta-emitting analysis is fully functional and currently limited to trained personnel. Procedures are being developed for untrained analysts.
|
CFSAN |
Ongoing |
Study of Nisin and Sublancin in a Strategy for Protection of the U.S. Food Supply from Pathogenic Bacterial Spores Introduced Through Bioterrorism: Scientists made progress toward understanding the mechanism of nisin action, particularly in preventing the transformation of B. anthracis spores into the vegetative state in certain high-priority foods.
|
CFSAN (See related JIFSAN extramural project) |
Ongoing |
Identification of Pathogenic Spores Using Infrared Spectroscopy: Researchers developed new sampling techniques using a disposable infrared-transparent substrate that provided better precision and speed than existing techniques. Developed a novel internal reflection infrared procedure for measuring cellular fatty acids. Three articles published in peer-reviewed journals.
|
CFSAN |
Ongoing |
Development of an LC/MS Method for the Confirmation and Identification of TTX and Saxitoxin in Food Matrices: Research goal is to develop analytical methods capable of reliably detecting and confirming, through a single, multi-residue LC/MS method, individual saxitoxins and tetrodotoxin in food samples. An evaluation of specialty HPLC columns identified a suitable column and mobile phase that provided appropriate chromatographic resolution and speed of analysis. Work continues on optimization of the MS parameters and an analysis of the LC method in contaminated fish tissues.
|
CFSAN |
New |
Development of an LC-MS Negative Ion Screening Method for Identifying Adulterants in Foods: Research goal is to use the LC-MS method developed to detect MFA as the basis for developing a more generalized LC-MS method to analyze food samples for chemical adulterants that produce negative ions. Initial method development using MFA and other chemical adulterants is ongoing.
|
CFSAN |
New |
Decontamination of Food Processing Facilities and Equipment: Research goal is to determine if different sanitizing/decontamination techniques commonly used in food processing are effective against B. anthracis spores (or surrogates) and protein toxins (e.g., botulinum toxin and ricin). BL3 laboratory and pilot plant are under construction and researchers are being hired.
|
CFSAN; NCFST |
New |
Effect of Food Processing on the Inactivation of Protein Toxins and B. anthracis Spores: Research goal is to determine the effect of various processing parameters (i.e., shear stress, heat, and pressure) on the toxicity of C. botulinum toxin and ricin and on the survival of spores of B. anthracis (or a surrogate) and protein toxins (e.g., botulinum toxin and ricin). BL3 laboratory and pilot plant are under construction and researchers are being hired.
|
CFSAN; NCFST |
New |
Potential Interaction of Chemical and Foodborne Pathogen Toxins on Nervous, Immune, and Endocrine System Function in the Intact Rat: Research goal is to assess the hypothesis that potential synergistic toxicity to the nervous, immune, and endocrine systems from co-administration of a microbial toxin with a common toxic chemical. Preliminary results suggest that administration of LPS followed by exposure to DON enhances toxicity compared to either treatment administered alone. Subsequent experiments will focus on specific measures of neuroimmune toxicity.
|
CFSAN |
New |
Microarray Detection of Yersinia spp.: Research goal is to develop a method for identifying Y. pestis (using Y. enterocolitica as a surrogate) by microarray without the need for PCR. Preliminary experiments labeling DNA have been successful.
|
CFSAN |
New |
Using a PCR-Based Method for the Detection of Natural and Rendered Materials that May Potentially be Used in Animal Feedstuffs: Researchers are g athering final data from method validation study. Next steps include completing data analysis and preparation of final report. Scientists also developing method as confirmatory procedure for samples found positive by feed microscopy.
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CVM |
Ongoing |
Development of LC/MS Methods for Detection of Contaminants in Animal Feed: The objective of this research is to use liquid chromatography/tandem mass spectrometry for the detection of a broad array of possible feed contaminants: drugs, pesticides, natural toxins, and chemical threat agents. Initial research is focused on veterinary drugs.
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CVM |
Ongoing |
Development of Multi-residue Multiple Species Methods to Screen for Drug Residues in Aquaculture Products: Scientists c ompleted qualitative procedure to screen for 18 veterinary drugs simultaneously. Work on quantitative method has begun. The methodology is now being extended to finfish species.
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CVM |
Ongoing |
Fingerprinting of Foodborne Pathogens by Pulsed-Field Gel Electrophoresis: All Salmonella and Campylobacter isolates recovered from National Animal Residue Monitoring System retail surveillance program are being subjected to PFGE analysis to determine genetic relatedness of recovered isolates. PFGE profiles are then submitted to PulseNet for comparison against those isolates that have been associated with human illness.
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CVM |
Ongoing |
Determination of Ceftiofur and Cephapirin in Incurred Milk Used for Test Kit Evaluations: Research goal is to test milk samples used in validating test kits to ensure sample stability. Project delayed due to resource constraints; planned for FY05.
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CVM |
Ongoing |
Antibiogram of Foodborne Pathogens Isolated from Retail Meats Marketed Throughout the United States: Researchers complete d preliminary studies, at University of Maryland, involving surveillance of retail meats of animal origin from the greater Washington, DC, area and the state of Iowa. The program has been expanded nationally to become a collaboration with CDC to survey animal-derived food products for the presence of foodborne bacterial pathogens and corresponding antimicrobial-resistance profiles.
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CVM / University of MD ; CDC |
UMD Component-Completed; CDC Collaboration-Ongoing |
Multi-class Method Development for Drug Residues in Tissue using LC-MS: Scientists c ompleted procedure to confirm residues of 9 aminoglycoside drugs at their tolerances in edible tissues of cattle, swine, horse, rabbit, and poultry.
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CVM |
Completed |
Determination of Nitrofuran Residues in Shrimp: Researchers successfully developed procedure to determine and confirm nitrofuran residues in shrimp. Method in use at FDA field laboratories.
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CVM |
Completed |
Method Development for Florfenicol in Bovine Milk: Scientists successfully d eveloped methods for the determination and confirmation of florfenicol in milk. Final report and manuscript in preparation.
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CVM |
Ongoing |
Development of a New Extraction and Detection System for Discriminating Between Prohibited and Exempt Feed Components: Researchers continue to work on PCR assay to detect prohibited proteins in animal feed processed under procedures used in the U.S. and those used in the European Union.
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CVM / Veterinary Laboratories Agency , UK Ministry of Fisheries and Food |
Ongoing |
Multilocus Sequence Typing (MLST) of Salmonella spp. : Scientists are performing MLST on 7 housekeeping genes of S. Newport . Sequencing is being performed in the forward and reverse orientation of each gene, in order to have 2 files of the same gene, from which a "consensus sequence" will be derived and used in Bionumerics for similarity clustering. Work with S. Heidelberg and S. Kentucky to follow.
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CVM |
Ongoing |
Characterization of Salmonella Isolated from the Veterinary Diagnostic Laboratories: Researchers continue to receive and analyze samples using antibiograms and PFGE and compare profiles to human clinical isolates through PulseNet to determine if there is a clonal spread of isolates between animals and humans or widespread dissemination of unrelated strains. Planned next step is to expand project to additional veterinary diagnostic laboratories.
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CVM / AZ Veterinary Diagnostic Lab.; MI State University; Rollins Animal Disease Diagnostic Lab.; State of MO Animal Health Div.; CE Kord Animal Lab.; University of MO |
Ongoing |
Characterization of S. typhimurium Isolates from the National Antimicrobial Resistance Monitoring System: Scientists found that integron-mediated antibiotic resistance is common among S. typhimurium isolates and that multi-drug resistant clones are widespread among isolates obtained from diagnostic and slaughter/processing samples. Manuscript and final report are in preparation.
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CVM |
Completed |
Analysis of Regulatory Samples for the Presence or Absence of Bovine-Derived Materials: Scientists continue to c onvert the standard method of PCR analysis of feed samples to a real-time PCR format that will be a field-deployable, robust method to determine the presence or absence of bovine-derived materials. Continued support to FDA field and state laboratories.
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CVM |
Ongoing |
Evaluation of Rapid Test Kits for Detection of Food Adulteration: Researchers continue to evaluate and validate various commercially available test kits for a range of food products. Project is focusing particularly on test kits for use at border locations.
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ORA / Department of Defense; NM State University |
Ongoing |
Evaluation of LC-MS, GC-MS, Ion Chromatography, ICP-MS, FTIR and ELISA Procedures for Detection of Toxic Chemicals: Progress made in evaluating various procedures to expand the scope of toxic chemical detection to additional food matrices.
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ORA |
Ongoing |
Evaluation of Quadruple Time of Flight Mass Spectrometer: Scientists continue to evaluate this relatively new, more selective technique for use in the detection of highly toxic proteins in food.
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ORA |
Ongoing |
Development of Liquid Chromatographic Procedures to Determine Sulfanomide Residues in Pasteurized Milk, Cheese, and Whey: Researchers are modifying existing methods for sulfonamide analysis in raw milk for use in the analysis of multiple sulfonamide residues in pasteurized milk, cheese, and whey.
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ORA |
Ongoing |
Modification of the Amplified ELISA for the Detection of Type A, B, E, and F Botulinal Toxins in Foods: Amplified ELISA system successfully identified C. botulinum toxin in a multistate foodborne illness outbreak linked to a commercial chili product. Results from the amplified ELISA were found to be comparable to the results from the standard mouse bioassay, which is a more time consuming and less specific method. Work continues on assessing the reproducibility of detection of several botulinum toxins in other foods.
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ORA |
Ongoing |
Validation Studies of Commercially Available Test Kits for Peanut Allergens and Other Allergenic Proteins: Scientists to continue evaluating the accuracy, sensitivity, repeatability, and precision of commercial ELISA test kits for screening for various protein antigens that act as allergens in certain individuals.
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ORA |
Ongoing |
Specific Detection and Speciation of Shigella spp. from PCR Inhibitor-rich Produce Using a Modified Enrichment Protocol: Researchers found that the modified cultural enrichment protocol can significantly improve the sensitivity of methods for detecting and determining the species of Shigella in cilantro, as a proxy for PCR inhibitor-rich produce. Research continues on other options for differential and selective isolation of Shigella spp. in produce.
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ORA |
Ongoing |
Rapid Evaluation of Food Samples for B. anthracis Contamination Using Time Resolved Dissociation Enhanced Lanthanide FluoroImmunoAssay (DELFIA) Analysis: Researchers have validated the proprietary DELFIA reagents for screening for B. anthracis in foods. Efforts continue on evaluating the application of this method for confirmatory testing of B. anthracis in foods.
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ORA |
Ongoing |
Final Testing of a DNA Probe for the Detection and Speciation of Shigella: After testing several agars for recovery of Shigella spp. in PCR inhibitor-rich foods, two agars were selected. Using a chemiluminescent, digoxigenic-labeled, PCR-generated non-radioactive DNA probe, researchers successfully detected low levels of Shigella spp. in artificially contaminated produce samples. Next steps will be to further test the efficacy of the probe to determine whether the medium and method used would react with a panel of Gram negative organisms (e.g., S. arizonae, E. coli, E. aerogenes, S.flexneri, S. boydii, S.sonnei, and S.dysenteriae ), followed by screening of food products.
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ORA |
Ongoing |
Detection of Shiga Toxins in Foods: Efforts are ongoing to evaluate various methods to identify the Shiga toxin in food and to evaluate currently available Shiga toxin test kits. Once an acceptable technique is developed, food spiked with the toxin will be tested to determine the sensitivity of the method for various food matrices. If certain matrices interfere with toxin detection, methods to remove the interference will be evaluated
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ORA |
Ongoing |
Matrix Solid Phase Dispersion (MSPD) Extraction and LC Determination of Aflatoxins in Peanut Butter: Work proceeds on developing a rapid, sensitive, and cost-effective methodology for analyzing aflatoxins in peanut butter using MSPD. |
ORA |
Ongoing |
Rapid HPLC Determination of Nitrate/Nitrite in Baby Foods: Researchers continue to evaluate methods for extraction and detection of nitrate/nitrite in baby foods containing meat and poultry.
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ORA |
Ongoing |
Isolation and Detection of Shigella in Foods Using Real-Time PCR:Scientists have completed sensitivity and specificity experiments and comparison of two sample preparation methods. Work continues on testing recovery of Shigella in spiked food samples, with the goal of developing a method to detect and quantify Shigella in food in less than one hour.
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ORA |
Ongoing |
Primer and Probe Design for Real-Time PCR Isolation and Detection of Listeria monocytogenes: Researchers have completed sensitivity and specificity experiments. Efforts continue on testing recovery of L. monocytogenes in spiked food samples, with the goal of developing a method to detect and quantify L. monocytogenes in food in less than one day. Ultimately, this assay will be combined with a multiplex assay for real-time PCR detection of Salmonella spp., L. monocytogenes and Campylobacter spp.
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ORA |
Ongoing |
Development of Reagents Standards for the Rapid Detection of Norwalk-like Viruses (NLV) in Foods: With the goal of developing reliable, traceable standards for detecting NLV in food matrices, samples have been received and verified by real-time PCR. Scientists will validate method by cloning and sequencing the genetic codes detected and amplified by this method.
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ORA |
Ongoing |
Usefulness and Application of the Nitron Portable X-Ray Fluorescence (XRF) Device in Foods: Scientists used the XRF device to successfully identify--in 60 seconds or less--six test compounds of toxic elements (i.e., arsenic, lead, mercury, cadmium, thallium, and chromium) in food. Next steps will be to define the detection limits for the device and to test the device under field-type conditions.
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ORA |
Ongoing |
Improving the Sensitivity of the CFSAN PCR Method for Shigella in Fresh Produce and Other Food Samples: Using a real-time PCR method, researchers have achieved high specificity (100%), higher sensitivity, and a shorter reporting time (less than 24 hours) than existing methods. Research continues.
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ORA |
Ongoing |
Validation Study of a Highly Sensitive and Specific 24-hour PCR Method for Rapid Screening of Salmonella: Researchers successfully demonstrated that this PCR method was more sensitive than the commercially available VIDAS test kit. In a survey of 167 produce samples, Salmonella was successfully identified in one sample by the 24-hour PCR method and confirmed by BAM methodology. A concurrently run VIDAS screen test was negative, even though the sample was shown to be positive for Salmonella by PCR and BAM. Incorporated research projects on development of a real-time PCR assay and a microarray-based method for detecting Salmonella in food.
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ORA |
Ongoing |
Use of Real-Time PCR for Rapid Detection of Shigatoxin Producing E. coli in Foods After a Short Enrichment: Work continues on enhancing the sensitivity of methods to isolate and detect Shigatoxin producing E. coli by using a short enrichment period prior to the real-time PCR.
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ORA |
Ongoing |
Improved Method for Detection of Enterotoxigenic E. coli (ETEC): Scientists continue to develop a rapid, effective procedure for enumeration of ETEC in food.
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ORA |
Ongoing |
Analysis of Paralytic Shellfish Poisoning (PSP) Toxins Using Cell Bioassay, HPLC, and LC/MS: Researchers continue to compare three methodologies for the rapid identification and confirmation of the presence of toxins linked to PSP. |
ORA |
Ongoing |
Discovery of Unrecognized and Uncharacterized Viral Agents: Researchers are developing a new method of genomic subtraction capable of rapidly identifying previously unrecognized viral agents.
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ORA |
Ongoing |
Comparison of Three Methods for Okadaic Acid Detection and Modification of Cytoxicity Assay for Diarrheic Shellfish Poisoning: Work continues to compare sensitivity, selectivity, and ruggedness of methods for okadaic acid detection.
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ORA |
Ongoing |
Development of a Real-Time Reverse Transcription PCR Assay for Hepatitis A Virus (HAV): Researchers proceed on developing a rapid and reproducible PCR method to detect HAV in foods within 1-2 hours. |
ORA |
Ongoing |
Bioassay Detection of Non-O157 Shiga Toxins via Translation Arrest: Efforts continue on developing a bioassay to detect Shiga toxins from non-O157:H7 E. coli.
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ORA |
Ongoing |
Development of Specific Methodologies for Herbal and Dietary Supplements' Main Active Ingredients: Researchers are developing an assay, using nuclear magnetic resonance, to detect and identify active ingredient(s) and any adulteration of herbal and dietary supplements. Project also will lead to methods to test the stability of such active ingredient(s).
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ORA |
Ongoing |
Upgrade of Field Pesticide Analytical Capability with Gas Chromatograph Mass Selective Detection System : Researchers have successfully developed methods to detect specific classes of pesticides in food. Next steps of research will be to modify the procedure using the ion trap LC/MS instrumentation to detect several common pesticides that are not amenable to detection by gas chromatograph.
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ORA |
Ongoing |
Development of Methods for Detection and Culture of Caliciviruses : Efforts continue on developing an immune capture technique to recover caliciviruses from spiked food samples and to develop a tissue culture system to support the growth of caliciviruses.
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ORA |
Ongoing |
Development of Liquid Scintillation Counting Method for Determination of Gross Alpha and Beta Radioactivity in Food and Food Packaging: Researchers successfully detected gross alpha and beta radioactivity in water. Next steps will be to establish a rapid and reliable screening method to detect gross alpha/beta radioactivity in water and radionuclide-specific alpha/beta radioactivity in food and food packaging.
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ORA |
Ongoing |
Development of Methods for Radioactive Contamination in Food Using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Alpha Spectrometry: Researchers optimized a set of tuning parameters for accurate and precise measurements of radionuclides such as plutonium-238, plutonium-239, and americium-241. Next steps will be to develop and evaluate ICP-MS and alpha spectrometry methods with sufficient sensitivity to detect micro levels of radioactive elements in foods.
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ORA |
Ongoing |
Rapid Assay of Food Samples for Americium-241 via Gamma Ray Spectroscopy: The High-Purity Germanium well detector, in conjunction with a computerized gamma-ray spectrometer, was installed and tuned. Efforts continue to optimize sample preparation methods and gamma ray spectrometric techniques to optimize the detection and analysis of low levels of americium-241 in foods.
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ORA |
Ongoing |
Development of Radiochemical Procedures for Determination of Strontium-89 and Strontium-90 in Food Using Strontium-Specific Extraction Chromatography: Scientists tested pre-concentration levels of yttrium in sample food matrices. Next steps will be to develop and optimize radiochemical procedures for yttrium-90/strontium-90 and total strontium analysis and evaluating column performance for the DGA resin.
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ORA |
Ongoing |
Development of Methods for the Identification of Y. pestis in Produce and Bottled Water: Researchers have developed a medium that appears to be more effective than a commercially available medium for selection and differentiation of avirulent Y. pestis.
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ORA |
Ongoing |
Development of a Real Time PCR Method for the Detection of Y. enterocolitica in Green Leafy Vegetables: Work proceeds on improving the assay sensitivity and developing a multiplex nucleic acid procedure for the detection of virulent Y. enterocolitica.
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ORA |
Ongoing |
Developing and Evaluating Risk Assessment Models for Key Waterborne and Foodborne Pathogens and Chemicals: Researchers are collaborating with scientists from the Environmental Protection Agency in broad research on risk assessment associated with waterborne and foodborne pathogens and chemicals to support further development of assays and methods.
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NCTR |
Ongoing |
Rapid Screening Test for Food Quality: Researchers successfully developed rapid chemical sensors to assess food quality. These Food Quality Indicators (FQIs) were shown, through testing by the Canadian Center for Fisheries Innovation, to be sensitive, rugged, and simple enough that multiple analysts can obtain results of equal quality. A CRADA has been developed with Litmus for a commercial outlet and partial support for extension of the FQI technology. |
NCTR |
Ongoing |
Development of Multiresidue Methods to Determine and Confirm Sulfonamides in Edible Tissues of Aquacultured Species: NCTR researchers provided guidance to CVM for inter-laboratory method trials for multi-sulfonamide methods.
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NCTR
(See related CVM project) |
Completed |
Combining Pyrolysis Metastable Atom Bombardment/ Mass Spectrometry (PyMAB/MS) with Pattern Recognition to Sub-type Bacteria: Work progresses on demonstrating the validity of the combination of PyMAB/MS with computerized pattern recognition for bacterial sub-typing of novel strains and those previously incapable of being distinguished using molecular technology. Researchers expect to produce a scientifically and technologically validated basis for commercial licensing of an NCTR-patented process for assembling coherent spectral databases for use in rapid chemotaxonomy at the strain and sub-strain level.
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NCTR |
Ongoing |
Evaluation of PyrMAB/MS and Matrix-Assisted Laser Desorption/Ionization Time-of-Flight (MALDI-TOF) MS for Rapid Characterization of Presumptive Bioterror Agent Samples: Researchers have successfully used MALD-TOF MS and PyMAB-TOF MS to produce unique mass spectra of pathogenic Vibrio spp. and Salmonella spp. Efforts continue on refining mass spectral data methods for rapidly identifying microorganisms from contaminated samples and for differentiating tainted samples from hoax samples.
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NCTR |
Ongoing |
Development of Dynamic Mass Spectral/Pattern Recognition Based Methods for the Rapid Identification of Bioterrorist Agents: Scientists invented a computational method to improve the quality of MALDI spectral methods for certain biological pathogens and to correctly identify bioterror agents and hoax materials.
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NCTR |
Ongoing |
1FDA is responsible for safeguarding approximately 80% of the nation's food supply--all domestic and imported food except meat products, poultry products, and processed egg products that are under the U.S. Department of Agriculture's jurisdiction.
2FDA's plan, "Protecting and Advancing America's Health: A Strategic Action Plan for the 21st Century," outlines various steps the Agency is taking to respond to new food defense challenges.