ABSTRACT
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.
Subject(s)
Consumer Product Safety , Food Additives/adverse effects , Food Industry/methods , Food Safety/methods , Toxicity Tests/methods , Animals , Consumer Product Safety/legislation & jurisprudence , Consumer Product Safety/standards , Dose-Response Relationship, Drug , Food Additives/standards , Food Industry/legislation & jurisprudence , Food Industry/standards , Government Regulation , Health Policy , Humans , Nutritive Value , Policy Making , Recommended Dietary Allowances , Risk Assessment , United States , United States Food and Drug AdministrationABSTRACT
Toxicogenomics is the application of toxicology, genetics, molecular biology and environmental health to describe the response of organisms to environmental stimuli. The field of toxicogenomics has developed over the past 15 years mainly due to advances in toxicology, molecular genetics and cell biology. Its prospective use to resolve crucial data gaps and data inconsistencies could improve risk assessment by providing additional data to increase the understanding of mechanisms and modes of action (MOA) and enhance the reliability of dose-response extrapolation. Thus, toxicogenomics holds promise for advancing the scientific basis of risk assessments. However, one of the current issues is how genomic/transcriptional data is being used to further describe a MOA for oncogenicity and, in turn, its potential uses in cancer risk assessment. This commentary identifies how toxicogenomics could be used on a case by case basis to add information to a MOA addressing both the opportunities and challenges this technology holds. In addition, some pitfalls to avoid in the generation and interpretation of toxicogenomic data and validation issues that need to be addressed before toxicogenomics can be used in the risk assessment process and regulatory decisions are discussed.
Subject(s)
Genomics/methods , Toxicogenetics/methods , Toxicology/methods , Animals , Cell Transformation, Neoplastic/genetics , Dose-Response Relationship, Drug , Genomics/trends , Humans , Reproducibility of Results , Risk Assessment/methods , Risk Assessment/trends , Toxicogenetics/trends , Toxicology/trendsABSTRACT
OBJECTIVE: Environmental public health (EPH) practice is a vital component of the nation's public health system. Yet, a number of national reports have found that the disjointed structure of the EPH system hinders our ability to protect the public's health. This article examines the EPH organizational and workforce configurations in the US Northeast/Mid-Atlantic region and raises questions as to how to measure whether these varied configurations impact EPH performance. METHODS: A review of national reports and state-specific documents and 39 EPH practitioner interviews. RESULTS: Study findings revealed wide ranging organizational configurations and workforce challenges in the region. Although this study depicts just one region of the country, it provides insight into the complexity and variety of EPH structures and workforce throughout the nation. This diversity presents challenges in our ability to understand, measure, and evaluate EPH performance. CONCLUSIONS: This research has implications for the future of the national EPH system. As we move toward a more "outcomes focused" government, it is essential to the future of EPH to develop better ways to accurately assess, measure, and evaluate EPH performance. These study findings, along with a discussion on how to further advance EPH performance measures, helps facilitate this necessary shift to a more measurable, outcome-based EPH system.
