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November 8, 2002 |
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FDA has issued a draft new destruction guidance that describes how FDA and U.S. Customs should handle imported foods that represent a significant risk to public health in the United States. The draft is titled, "Draft Guidance Concerning Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned." The guidance addresses the destruction, prior to refusal, of foods that represent a significant risk to public health and that have not been successfully reconditioned. It describes how FDA intends to collect information, analyze the public health risk, recommend seizure, and coordinate the destruction of violative imported food by Customs. These procedures will help prevent the possible re-entry of imported food that poses a significant public health risk. Once finalized, the new guidance will be included as a new subchapter of the Regulatory Procedures Manual -- Chapter 9 -- Imports.
Food products refused entry into the United States could be offered subsequently for re-importation, either by unscrupulous importers who choose to circumvent the import regulatory system, or by importers who simply are unaware of the previous refusal. The new guidance is intended to ensure that imported food posing a significant risk to public health is not distributed or exported and subsequently re-imported.
The scope of the guidance covers animal food and human food, including food-related items and dietary supplements. It does not cover cosmetics, or other FDA-regulated products (i.e., drugs, devices, and biologics). It also does not apply to any food that has been successfully reconditioned after detention.
The announcement of the release of the draft destruction guidance, and the 60-day public comment period, is posted in the Federal Register. It can be seen on the Web at http://www.fda.gov/OHRMS/DOCKETS/98fr/110502a.htm. The guidance itself can be seen on the Web at http://www.cfsan.fda.gov/~dms/impguid.html.
Further information can be obtained by contacting Joe McCallion, Division of Import Operations and Policy, Office of Regulatory Affairs (301) 443-6553.
FDA has awarded two contracts to assess the human health risk of two transmissible spongiform encephalopathies (TSEs), bovine spongiform encephalopathy (BSE) and chronic wasting disease (CWD), to help determine whether these TSEs are a threat to our food supply and how best to stop the spread of this disease in our deer and elk herds. The two contracts are with the Centers for Disease Control and Prevention (CDC) and the Institute of Food Technologists (IFT). IFT will be working with Harvard University's Center for Risk Analysis.
The IFT contract with the Harvard Center for Risk Analysis will support its extension of previous work on the BSE model. The new studies will identify the potential for FDA-regulated products to contain bovine brain, spinal cord, or distal ileum. It will also assess any potential human health risk from consuming products containing these bovine parts. The interagency contract with CDC will support research at Case Western University. The Case Western research aims to answer specific questions about CWD using cervidized and humanized transgenic mice and examine the susceptibility of these animals to CWD. The work from both of these efforts will provide valuable information.
TSEs are a group of fatal brain diseases, including BSE or "mad cow" disease in cattle, scrapie in sheep, and Creutzfeldt-Jakob disease in humans. The hallmark of TSE disease is accumulation in the brain of abnormal prion proteins that are misshapen versions of the normal prion proteins on the surface of brain cells.
Scientists do not know yet whether deer or elk with CWD might also transmit some form of TSE disease to people who eat or have close contact with them. With CWD beginning to spread over a wider geographical area in the United States, however, answering this question is of critical public health importance.
The two new contracts are part of a larger effort, supported by the Department of Health and Human Services and other Federal partners, to address concerns about CWD and BSE in the United States.
CFSAN awarded cooperative agreement research funds in September 2002 to augment its food safety research program. These awards were in three categories: Risk ranking and analysis; biosensors to detect bacterial, viral, and protozoan pathogens, toxins, and allergens in foods, food additives, and dietary supplements; and the assessment of the efficacy of multiple heat treatments used during the production of dairy products to inactivate bacterial spores. A single biotechnology category project to develop predictive algorithms and protein databases for identifying potential allergenicity of food proteins was independently funded; although, this category was included as part of this extramural food safety research solicitation.
In addition to these food safety research awards and as part of a separate solicitation, two awards were made to support ongoing efforts to avoid the threat of transmissible spongiform encephalopathies (TSE) in the nation's food supply.
Seven new grants totaling approximately $1,180,000 were funded.
Project Title: Dev & Implementation of Risk Ranking Framework
Organization: Institute of Food Technologists
Principal Investigator: Dr. Rosetta Newsome
First Year Award Amount: $191,917
Duration of Award: 2 years
No nationwide food system can deliver a risk free food supply. However a well-conceived strategic approach that quickly and accurately identifies hazards, ranks them by level of importance, and identifies approaches that have the greatest impact on reducing hazards would help support FDA's science-based policies that seek to maximize food safety and public health protection. The 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. A quantitative framework will be developed that includes one or more quantitative models to comparatively rank food safety threats and to evaluate the impact of control measures and practices. Use of the framework will help the Agency achieve its goals of ensuring the integrity of foods, reducing the incidence of foodborne illness, and prioritizing the commitment of Agency resources.
Project Title: Multi-Analyte Array Sensor for Foodborne Contaminants
Organization: Naval Research Laboratory
Principal Investigator: Dr. Chris Rowe Taitt
First Year Award Amount: $158,000
Duration of Award: 3 years
The goal of this project is development of multi-analyte assays for the simultaneous detection of bacterial, viral, and protozoan pathogens, toxins, and allergens in a variety of food matrices. The assays will initially be developed for use in association with the Naval Research Laboratory's Assay Biosensor. The three-stage approach planned for the research project includes: (1) Developing individual assays, (2) developing sample preparation techniques for selected food matrices and optimizing assays using spiked food samples, and (3) incorporating assays into the multi-analyte format and optimizing conditions of analysis for the analytes relative to appropriate food matrices.
Project Title: Optical Biosensor Technology for Food Safety
Organization: University of Washington
Principal Investigator: to be named
First Year Award Amount: $199,052
Duration of Award: 3 years
The goal of this research is to develop novel optical affinity biosensor technology enabling fast, sensitive, specific detection and identification of foodborne pathogens and toxins in food samples. The research includes: (1) Development of novel optical multi-sensor hardware, (2) development of biomolecular coatings recognizing targeted foodborne pathogens and toxins, and (3) development of methodology for sensor-based detection of foodborne pathogens and toxins in complex food matrices. Development of a unique optical multi-sensor will be based on a combination of critical angle bulk refractometry and surface plasmon resonance (SPR). This approach should provide highly sensitive sensor technology with enhanced immunity to interfering environmental and matrix effects. Two types of biological coatings will be developed for each target analyte: One is a sensitive antibody based coating to bind pathogens, and the other is a reference coating insensitive to the analyte and capable of mimicking nonspecific response to the analyte-specific coating. Methodology for the extraction of liquid samples from food matrices and protocols for screening samples, for the presence of foodborne pathogens and toxins, by the biosensor will be developed.
Project Title: Heat Treatment of Bacterial Spores in Dairy Products
Organization: University of Wisconsin
Principal Investigator: Dr. Eric A. Johnson
First Year Award Amount: $132,756
Duration of Award: 3 years
The objective of this research is to characterize the risk from Clostridium botulinum or Bacillus anthracis in dairy products receiving more than one heat treatment. The sporicidal effect of multiple heat treatments on C. botulinum or B. anthracis will be determined in thermal death tube studies as well as during the production of dairy products under laboratory scale conditions using Bacillus cereus as the surrogate testing organism. Results of this research should provide valuable data regarding the potential risks of dairy products in the event of their contamination with pathogenic sporeformers.
Project Title: Database Approach for Prediction of Food Allergenicity
Organization: University of Texas - Medical Branch
Principal Investigator: Dr. Werner Braun
First Year Award Amount: $244,315
Duration of Award: 3 years
This project intends to validate the use of the applicant's web-based structural database of allergenic proteins (SDAP) to predict possible cross-reactions among food allergens, and establish a quantitative index to evaluate the potential allergenicity of novel proteins. The SDAP database allows statistical analysis and comparison of amino acid sequences, 3-D structures, and epitopes of known food allergens, and it is linked to other sequence and 3-D structural databases. An effort to collect all information in the current literature concerning the IgE epitopes of food allergens, to identify the physico-chemical properties that define an IgE epitope of a food allergen, and establish quantitative structure-activity relationships (QSAR) for predicting IgE epitopes will be made. The QSAR relationship will be tested against variants of 'Jun a 3' cedar pollen allergen for which there is considerable structure-epitope data. Correlations between allergenicity and the sequence-structure properties of these variants will be compared to the QSAR results from the general study, and validated software tools will be used to rank food proteins according to probable allergenicity.
Project Title: Degradation of Prions: Yeast Prion as a Surrogate Protein
Organization: North Carolina State University
Principal Investigator: Dr. Jason C. H. Shih
First Year Award Amount: $93,594
Duration of Award: 2 years
The objective of the project is the development of a nonpathogenic yeast prion protein as a surrogate TSE infectious agent. The surrogate will be used to facilitate a study of the enzymatic degradative process of disease-causing prion that has been observed in association with a bacterial keratinase produced by Bacillus licheniforms strain PWD-1. Yeast prion protein, Sup35p, is structurally similar to infectious self-propagating isoform of prion protein, PrPSc. It is comprised of a prion-determining NM region, and has been expressed and purified from Escherichia coli and shown to form amyloid structure in vitro. This yeast prion protein will be used as a surrogate for TSE infectious agent to study amyloid degradation by keratinase and to screen for other active proteases. Enzymatic processes will then be further tested with BSE tissues and prion to correlate enzymatic degradative performance against that observed with the Sup35p surrogate.
Project Title: Protein Markers for Verifying Inactivation of TSE Agents
Organization: Tennessee State University
Principal Investigator: Dr. Fur-Chi Chen
First Year Award Amount: $159,744
Duration of Award: 4 years
Surrogate agents for the prion protein associated with TSE diseases will be needed to facilitate research assessing the efficacy of inactivating TSE infectious agents during decontamination/deactivation procedures. The overall goals of this project are: (1) To identify heat- and protease-resistant protein markers that can be used as surrogate agents for prion proteins, and (2) to study denaturation of the protein markers as monitored by monoclonal antibody immunoassays for verifying the efficacy of manufacturing process to inactivate infectious TSE agents. Correlation between denaturation of protein markers and deactivation of prion proteins will be established, and reliability of the immunoassays for predicting deactivation of prion proteins will be evaluated using an in vitro amplification and cell culture model.
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Food Safety Initiative Staff E-mail: cwise@cfsan.fda.gov |
Office Number: (301) 436-2125 · FAX (301) 436-2605 CFSAN Web site: http://www.cfsan.fda.gov/ |