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U.S. Food and Drug Administration perspective of the inclusion of effects of low-level exposures in safety and risk assessment.
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MedLine Citation:
PMID:  9539036     Owner:  NLM     Status:  MEDLINE    
A brief overview is provided of some of the general safety and risk assessment procedures used by the different centers of the U.S. Food and Drug Administration (U.S. FDA) to evaluate low-level exposures. The U.S. FDA protects public health by regulating a wide variety of consumer products including foods, human and animal drugs, biologics, and medical devices under the federal Food, Drug, and Cosmetic Act. The diverse legal and regulatory standards in the act allow for the consideration of benefits for some products (e.g., drugs) but preclude them from others (e.g., food additives). When not precluded by statutory mandates (e.g., Delaney prohibition), the U.S. FDA considers both physiologic adaptive responses and beneficial effects. For the basic safety assessment paradigm as presently used, for example in the premarket approval of food additives, the emphasis is on the identification of adverse effects and no observed adverse effect level(s) (NOAEL). Generally, the NOAEL is divided by safety factors to establish an acceptable exposure level. This safety assessment paradigm does not preclude the consideration of effects whether they are biologically adaptive or beneficial at lower dose levels. The flexibility to consider issues such as mechanisms of action and adaptive and beneficial responses depends on the product under consideration. For carcinogenic contaminants and radiation from medical devices, the U.S. FDA considers the potential cancer risk at low exposure levels. This generally involves downward extrapolation from the observed dose-response range. The consideration of adverse effects of other toxicologic end points (e.g., reproductive, immunologic, neurologic, developmental) associated with low exposure levels is also becoming more of a reality (e.g., endocrine disrupters). The evaluation of the biologic effects of low-level exposures to toxic substances must include whether the effect is adverse or a normal physiologic adaptive response and also determine the resiliency of a physiologic system. The public health mandate of the U.S. FDA includes an active research program at the National Center for Toxicological Research and the other U.S. FDA centers to support the regulatory mission of the U.S. FDA. This includes the development of knowledge bases, predictive strategies, and toxicologic studies to investigate effects at the lower end of the dose-response range. Because of the wide diversity of legal and regulatory standards for various products regulated by the U.S. FDA agency-wide safety and risk assessment procedures and policies generally do not exist.
D W Gaylor; P M Bolger; B A Schwetz
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Environmental health perspectives     Volume:  106 Suppl 1     ISSN:  0091-6765     ISO Abbreviation:  Environ. Health Perspect.     Publication Date:  1998 Feb 
Date Detail:
Created Date:  1998-04-23     Completed Date:  1998-04-23     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  0330411     Medline TA:  Environ Health Perspect     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  391-4     Citation Subset:  IM    
National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079-9502, USA.
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MeSH Terms
Consumer Product Safety*
Risk Assessment*
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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Journal Information
Journal ID (nlm-ta): Environ Health Perspect
ISSN: 0091-6765
Article Information
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Print publication date: Month: 2 Year: 1998
Volume: 106 Issue: Suppl 1
First Page: 391 Last Page: 394
ID: 1533277
PubMed Id: 9539036

U.S. Food and Drug Administration perspective of the inclusion of effects of low-level exposures in safety and risk assessment.
D W Gaylor
P M Bolger
B A Schwetz
National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR 72079-9502, USA.

Article Categories:
  • Research Article

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