Catalogue Search | MBRL
Are you sure you want to remove the book from the shelf?
{{itemTitle}}
28
result(s) for
"Rodricks, Joseph V"
Sort by:
الأخطار المحسوبة : السمية وأخطار المواد الكيميائية على صحة البشر في بيئتنا
توطئة : الديك الرومي والفول السوداني والسرطان، .
Book
When Risk Assessment Came to Washington: A Look Back
Federal regulatory agencies had, by the 1970s, been charged with enforcing a host of new laws requiring that they establish controls on human exposures to chemicals necessary to protect health. The agencies relied upon a methodology introduced in the 1950s to identify safe levels of exposure to chemicals known to display toxicity. During the 2 decades prior to the 1970s, federal authorities had come to treat carcinogens as distinct from other toxic agents, and to regard them as unsafe at any level of exposure, and no systematic methods had been developed to deal with the rapidly increasing numbers of carcinogens. Beginning in the mid-1970s, some scientists and policy makers in regulatory agencies, including the present author, began to propose adopting emerging quantitative methods to evaluate the risks of carcinogens and introduced new notions of safety based on explicit consideration of risk. Quantitative risk assessment rose to prominence in the decade reviewed in this article (1974-1984) and began to replace the unsystematic approaches that provided no view of how well health would be protected under various regulatory controls. This article offers the author’s recollections of that important decade.
Journal Article
Respiratory effects of oral mitragynine and oxycodone in a rodent model
Abstract RationaleKratom derives from Mitragyna speciosa (Korth.), a tropical tree in the genus Mitragyna (Rubiaceae) that also includes the coffee tree. Kratom leaf powders, tea-like decoctions, and commercial extracts are taken orally, primarily for health and well-being by millions of people globally. Others take kratom to eliminate opioid use for analgesia and manage opioid withdrawal and use disorder. There is debate over the possible respiratory depressant overdose risk of the primary active alkaloid, mitragynine, a partial μ-opioid receptor agonist, that does not signal through ß-arrestin, the primary opioid respiratory depressant pathway.ObjectivesCompare the respiratory effects of oral mitragynine to oral oxycodone in rats with the study design previously published by US Food and Drug Administration (FDA) scientists for evaluating the respiratory effects of opioids (Xu et al., Toxicol Rep 7:188–197, 2020).MethodsBlood gases, observable signs, and mitragynine pharmacokinetics were assessed for 12 h after 20, 40, 80, 240, and 400 mg/kg oral mitragynine isolate and 6.75, 60, and 150 mg/kg oral oxycodone hydrochloride.FindingsOxycodone administration produced significant dose-related respiratory depressant effects and pronounced sedation with one death each at 60 and 150 mg/kg. Mitragynine did not yield significant dose-related respiratory depressant or life-threatening effects. Sedative-like effects, milder than produced by oxycodone, were evident at the highest mitragynine dose. Maximum oxycodone and mitragynine plasma concentrations were dose related.ConclusionsConsistent with mitragynine’s pharmacology that includes partial µ-opioid receptor agonism with little recruitment of the respiratory depressant activating β-arrestin pathway, mitragynine produced no evidence of respiratory depression at doses many times higher than known to be taken by humans.
Journal Article
What Happened to the Red Book's Second Most Important Recommendation?
Of the ten recommendations in the National Research Council's (NRC's) report Risk Assessment in the Federal Government: Managing the Process, commonly called the \"Red Book,\" three were highlighted in the report's Executive Summary. Two of the three have had wide influence on the conduct of risk assessment but the third has been virtually ignored. The Red Book Committee's proposal that Congress establish an independent Central Board on Risk Assessment Methods, if implemented, might have done much to improve the conduct of risk assessments by regulatory agencies, to ensure greater uniformity in approaches among agencies, and to enhance the scientific credibility of agency performance. Among the functions of the proposed Board was to be the development, for use by agencies, of guidelines for the conduct of risk assessment (including the selection of so-called inference options-or \"defaults\"-to deal with limits in scientific knowledge). Guideline development was seen by the Committee to represent a critical step in avoiding case-by-case manipulation of risk assessments by the insertion of arbitrary inference options, but Committee recommendations in this area have received significant attention only from the U.S. Environmental Protection Agency. Implementation of the several tasks proposed by the NRC Committee, including guideline development, by a truly independent Board of the type described in the Red Book, might still do much to strengthen the scientific basis of regulatory actions.
Journal Article
Reference manual on scientific evidence
The Reference Manual on Scientific Evidence, Third Edition, assists judges in managing cases involving complex scientific and technical evidence by describing the basic tenets of key scientific fields from which legal evidence is typically derived and by providing examples of cases in which that evidence has been used.First published in 1994 by the Federal Judicial Center, the Reference Manual on Scientific Evidence has been relied upon in the legal and academic communities and is often cited by various courts and others. Judges faced with disputes over the admissibility of scientific and technical evidence refer to the manual to help them better understand and evaluate the relevance, reliability and usefulness of the evidence being proffered. The manual is not intended to tell judges what is good science and what is not. Instead, it serves to help judges identify issues on which experts are likely to differ and to guide the inquiry of the court in seeking an informed resolution of the conflict.The core of the manual consists of a series of chapters (reference guides) on various scientific topics, each authored by an expert in that field. The topics have been chosen by an oversight committee because of their complexity and frequency in litigation. Each chapter is intended to provide a general overview of the topic in lay terms, identifying issues that will be useful to judges and others in the legal profession. They are written for a non-technical audience and are not intended as exhaustive presentations of the topic. Rather, the chapters seek to provide judges with the basic information in an area of science, to allow them to have an informed conversation with the experts and attorneys.
eBook
Review and Update of Leukemia Risk Potentially Associated with Occupational Exposure to Benzene
Since the 1980 U.S. Supreme Court decision on the Occupational Safety and Health Administration's (OSHA) proposal to lower the occupational benzene standard from 10 ppm to 1 ppm, numerous quantitative assessments of the leukemia risk of benzene exposure have been prepared. The primary difference between these risk assessments has been in the way in which benzene exposure has been estimated and in the models applied to describe the dose-response relationship. The more recent assessments, in attempting to estimate benzene exposures on an individual basis, and in applying models which make maximal use of the available data points, represent a substantial improvement over earlier assessments. In this paper, we will review the available risk assessments and the data upon which they are based and will present our own assessment, which builds on prior efforts. Our reevaluation of the underlying data on the cohort that we judged to be most suitable for quantitative risk analysis suggested that past assessments may have overestimated risk by a factor of 3 to 24. In addition, we will present some recently made available data of relevance to the benzene exposure histories of cohort of concern. These data provide additional suggestion that the total benzene exposure of certain members of this cohort has likely been seriously underestimated, the extent to which remains to be determined. Further analysis of these data and pursuit of additional sources to improve the characterization of the benzene exposure of this cohort appear to be warranted in order to define more precisely the benzene-leukemia dose-response relationship.
Journal Article
Assessment of the Potential Risk to Workers from Exposure to 1,3-Butadiene
The available epidemiologic data provide equivocal evidence that 1,3-butadiene is carcinogenic in humans; some available studies suggest that the lymphopoietic system is a target, but there are inconsistencies among studies in the types of tumors associated with 1,3-butadiene exposure, and there is no evidence of a relationship between length of exposure and cancer risk, as one might expect if there was a true causal relationship between 1,3-butadiene exposure and cancer risk. The available chronic animal studies, however, show an increase in tumor incidence associated with exposure to high concentrations of 1,3-butadiene. In addition to the general uncertainty of the relevance of animal data to humans, there are several additional reasons why the National Toxicology Program's mouse study may not be appropriate for assessing possible human risks. These include: a) the possible involvement of a species-specific tumor virus (MuLV) in the response in mice; b) apparent differences between mice and humans in the rate of metabolism of 1,3-butadiene to reactive epoxides that may be proximate carcinogens; c) use of high dose levels that caused excess early mortality; and d) exposure of animals to 1,3-butadiene for only about half their lifetime. While recognizing the uncertainty in using the available animal data for risk assessment, we have performed low-dose extrapolation of the data to examine the implications of the data if humans were as sensitive as rats or mice to 1,3-butadiene, and to examine how the predictions of the animal data compare to that observed in the epidemiologic studies. With the mouse data, because the study was of less than lifetime duration, we have used the Hartley-Sielken time-to-tumor model to permit estimation of lifetime risk from the less than lifetime exposure of the study. With the rat data, we have used three plausible models for assessing low-dose risk: the multistage model, the Weibull model, and the Mantel-Bryan probit model. With both the rat and mouse data, we used information on how much 1,3-butadiene is retained by animals exposed to various concentrations of the chemical. This improves the accuracy of the low-dose extrapolation. When extrapolated to low-dose levels, mice appear to be at greater risk (by a factor of 5-fold to 40-fold) than rats. Some of this difference (a factor 3-fold to 5-fold) may be due to the faster rate of metabolism of 1,3-butadiene to, and higher blood levels of, epoxide derivatives in mice than in rats. If humans, rats, and mice were at equal risk from equal average lifetime daily doses of retained 1,3-butadiene, the mouse and rat data would predict risks to occupationally exposed humans that are statistically inconsistent at the 95% level with the results of the available human data, unless human exposure in the past was very much lower than is believed to have been the case.
Journal Article
Strategies to Protect the Health of Deployed U.S. Forces: Assessing Health Risks to Deployed U.S. Forces -- Workshop Proceedings
Risk management is especially important for military forces deployed in hostile and/or chemically contaminated environments, and on-line or rapid turn-around capabilities for assessing exposures can create viable options for preventing or minimizing incapaciting exposures or latent disease or disability in the years after the deployment. With military support for the development, testing, and validation of state-of-the-art personal and area sensors, telecommunications, and data management resources, the DOD can enhance its capabilities for meeting its novel and challenging tasks and create technologies that will find widespread civilian uses.Strategies to Protect the Health of Deployed U.S. Forces assesses currently available options and technologies for productive pre-deployment environmental surveillance, exposure surveillance during deployments, and retrospective exposure surveillance post-deployment. This report also considers some opportunities for technological and operational advancements in technology for more effective exposure surveillance and effects management options for force deployments in future years.
eBook
FDA's Ban of DES in Meat Production
Protection of the public from health hazards due to chemicals added to foods is provided for in the food safety sections of several laws. Because absolute safety is unattainable, the FDA applies a science based operational definition of the term. Accordingly, it becomes periodically necessary to review and change past decisions about the safe uses of substances. The need arises because of changes, with time, in the quantity and nature of the pertinent scientific information. This phenomenon is examined using FDA's ban of DES in meat production as an example.
Journal Article