Regulatory toxicology and pharmacology : RTP
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Generally Recognized as Safe (GRAS) substances are exempt from premarket approval; however, the standard of "reasonable certainty of no harm" is the same. In 1997, the voluntary GRAS affirmation process was replaced with the voluntary U. S. ⋯ Only four raised questions about potential safety, of which three received a no questions letter upon providing more data. Of the 84 withdrawn notices, 22 received a no questions letter upon resubmission. In spite of criticisms, the FDA GRAS notice process is clearly defined, efficient, and cost-effective, and there have been no known public health issues following its implementation.
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Regul. Toxicol. Pharmacol. · Aug 2016
ReviewGRAS determination scientific procedures and possible alternatives.
The use of a food substance is Generally Recognized as Safe (GRAS) through scientific procedures or experience based on common use in food. The pivotal data used for GRAS determination must be of common knowledge and should include evidence for safety under the conditions of intended use of the substance. Such evidence includes data on the identity and specifications of the substance, its properties of absorption, distribution, metabolism and excretion, and depending on the level of concern, data on genotoxicity, acute and subchronic toxicity, reproductive and developmental toxicity and carcinogenicity. Several alternative procedures can be used as the replacement for standard scientific procedures in order to improve the GRAS process.
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The safety of food ingredients will be assessed in the 21st century by mixture of traditional methods, such as the "safe" dose concept, which is thought to be an accurate but imprecise estimation of dose below the population threshold for adverse effect, and contemporary methods, such as the Benchmark Dose (BMD), Chemical Specific Adjustment Factors (CSAF), physiologically-based pharmacokinetic models, and biologically-informed dose response modeling. New research on the horizon related to toxicology 21 may also improve these risk assessment methods, or suggest new ones. These traditional, contemporary and new methods and research will be briefly described.
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Regul. Toxicol. Pharmacol. · Aug 2016
ReviewThe relevance of international assessments to GRAS determinations.
A discussion of the risk assessment process as applied to the Generally Recognized As Safe (GRAS) determination of safety for new ingredients can benefit from an international perspective. When we think about how risk assessments are performed around the world it is critical to assess what can be learned. What are the similarities? What are the differences? What are the takeaways? It is important to talk about the similarities in processes, because it validates the approach taken by risk assessors who are charged with protecting the food supply. It is also instructive to evaluate the differences in order to determine where improvements can be made to our process.
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Regul. Toxicol. Pharmacol. · Aug 2016
Overview of the ISRTP October 2014 workshop on GRAS determinations.
On October 12-13, 2014 the ISRTP held a very successful Workshop on GRAS Determinations in Washington DC that was not only well-attended by seasoned public and private professionals from a wide swath of food safety disciplines but featured a series of very insightful and informative presentations from current and past officials from the US Food & Drug Administration (FDA). To stay true to our international nature as a Society, we had regulatory and industry representatives from Canada and Europe.