Establishment, maintenance, and availability of records: amendment to record availability requirements. Interim final rule; request for comments.
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The Food and Drug Administration (FDA) is amending its regulations on establishment, maintenance, and availability of records. FDA is issuing this interim final rule (IFR) to amend FDA's regulation on the record availability requirements to implement the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by the FDA Food Safety Modernization Act (FSMA). The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to records relating to any other article of food that the Secretary of Health and Human Services (the Secretary) reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which the Secretary believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This expanded records access authority will further help improve FDA's ability to respond to, and further contain threats of serious adverse health consequences or death to humans or animals. (+info)
Critical review of norovirus surrogates in food safety research: rationale for considering volunteer studies.
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Multidisciplinary and evidence-based method for prioritizing diseases of food-producing animals and zoonoses.
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To prioritize 100 animal diseases and zoonoses in Europe, we used a multicriteria decision-making procedure based on opinions of experts and evidence-based data. Forty international experts performed intracategory and intercategory weighting of 57 prioritization criteria. Two methods (deterministic with mean of each weight and probabilistic with distribution functions of weights by using Monte Carlo simulation) were used to calculate a score for each disease. Consecutive ranking was established. Few differences were observed between each method. Compared with previous prioritization methods, our procedure is evidence based, includes a range of fields and criteria while considering uncertainty, and will be useful for analyzing diseases that affect public health. (+info)
Tasman Spirit oil spill in Pakistan: research response and lessons learned.
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