Defect Action Levels

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The Experts below are selected from a list of 21 Experts worldwide ranked by ideXlab platform

Martin J Hahn - One of the best experts on this subject based on the ideXlab platform.

  • FDA has the legal authority to adopt a threshold of toxicological concern (TTC) for substances in food at trace Levels.
    Food and Drug Law Journal, 2020
    Co-Authors: Martin J Hahn
    Abstract:

    : It now is possible to detect many substances in the parts per trillion and further advances will allow for even lower Levels of detection. Many of these substances may always have been present in the food supply, but escaped detection. Others may have been introduced through environmental contamination, changes in food processing, sourcing of ingredients from different manufacturers or countries, and a myriad of other reasons. The adulteration and various safety provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), principles of statutory construction, and case law, provide FDA with the legal authority to adopt the threshold concept. FDA and the courts have long recognized it is possible to establish safe Levels of poisonous or deleterious substances found in foods. FDA routinely conducts such an analysis under the general adulteration provisions of the FDCA and has identified safe Levels for numerous environmental contaminants found in food. The courts have recognized that through its exercise of enforcement discretion, FDA has the legal authority to establish non-binding Defect Action Levels for contaminants. FDA similarly could implement the Threshold of Toxicological Concern (TTC) through its exercise of enforcement discretion.

Linda Wang - One of the best experts on this subject based on the ideXlab platform.

  • FOOD IMPORT WOES WEIGH ON FDA: Requests by PRIVATE LABS to take on some of the agency's burden go unanswered
    Chemical & Engineering News, 2007
    Co-Authors: Linda Wang
    Abstract:

    DURING A TYPICAL WEEK, Alfredo Rodriguez, a senior microscopist at Anresco Laboratories, in San Francisco, analyzes roughly two dozen samples of imported foods, from Chinese dried mushrooms to Mexican hot sauce. He runs a variety of tests looking for insect fragments, rodent hairs, and other types of filth. "In general, every food has something," says Rodriguez. "It's really hard to have samples with zero insect fragments or rodent hairs. Even in the cleanest food, we find something." But when the degree of contamination or adulteration in a sample exceeds the "Defect Action Levels" permitted by the Food & Drug Administration, Rodriguez issues a positive report to the importer, who is then supposed to submit the lab results to FDA. The agency uses this information to determine whether a detained product meets FDA compliance and sanitation regulations to enter the marketplace. The problem is that positive reports generated by private laboratories often never reach FDA. ...

Andrew M. Welt - One of the best experts on this subject based on the ideXlab platform.

A. Gordon - One of the best experts on this subject based on the ideXlab platform.

  • Case study: FSQS in solving market access prohibition for a vegetable product—callaloo (Amaranthus sp.)
    Food Safety and Quality in Developing Countries, 2016
    Co-Authors: A. Gordon
    Abstract:

    Jamaican firms in 1993 were forced to deal with the prohibition of exports of canned callaloo (Amaranthus viridis and Amaranthus dubius), a traditional vegetable, to the US market for breach of FDA extraneous matter standards. In trying to get the import alert imposed removed, a task force had to address the ambiguity of the standard applied, the improvement in agronomic practices for the crop, upgrading of the process, and agree the specific standards to be applied with the US regulators. The process to regain access was successfully completed in 13 months and required implementing GAPs and monitoring the vegetable from farm to market to ensure the delivery of a product that complied with the Defect Action Levels for insects and insect parts and the maximum residue limit for MRL for pesticides approved for use by the EPA on the product.

John R. Pedersen - One of the best experts on this subject based on the ideXlab platform.

  • Analysis for Extraneous Matter
    Food Science Texts Series, 2010
    Co-Authors: Hulya Dogan, Bhadriraju Subramanyam, John R. Pedersen
    Abstract:

    Analysis for extraneous matter is an important element both in the selection of raw materials for food manufacturing and for monitoring the quality of processed foods. Defect Action Levels (DALs) of specific products are established for amounts of extraneous matter considered unavoidable and of no health hazard. However, the presence of extraneous material in a food product is unappealing, can pose a serious health hazard to the consumer, and represents lack of good manufacturing practices and sanitary conditions in production, storage, or distribution of food. This chapter provides an overview of basic official methods to isolate extraneous matter from foods, using a series of physical and chemical means to separate the extraneous material for identification and enumeration. Major concerns in the analysis of food products for extraneous matter by traditional methods are the subjectivity of methods and the availability of adequately trained analysts. The chapter also includes an overview of more sophisticated techniques to pinpoint the nature and source of contaminants (x-ray radiography, x-ray microtomography, electrical conductance, impact-acoustic emission, microscopy techniques, near-infrared spectroscopy, and enzyme-linked immunosorbent assays).