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At least 19 recordsLinked to original sources

Chemical carcinogens: a review of the science and its associated principles. U.S. Interagency Staff Group on Carcinogens.

In order to articulate a view of chemical carcinogenesis that scientists generally hold in common today and to draw upon this understanding to compose guiding principles that can be used as a bases for the efforts of the regulatory agencies to establish guidelines for assessing carcinogenic risk to meet the specific requirements of the legislative acts they are charged to implement, the Office of Science and Technology Policy, Executive Office, the White House drew on the expertise of a number of regulatory agencies to elucidate present scientific views in critical areas of the major disciplines important to the process of risk assessment. The document is composed of two major sections, Principles and the State-of-the-Science. The latter consists of subsections on the mechanisms of carcinogenesis, short-term and long-term testing, and epidemiology, which are important components in the risk assessment step of hazard identification. These subsections are followed by one on exposure assessment, and a final section which includes analyses of dose-response (hazard) assessment and risk characterization. The principles are derived from considerations in each of the subsections. Because of present gaps in understanding, the principles contain judgmental (science policy) decisions on major unresolved issues as well as statements of what is generally accepted as fact. These judgments are basically assumptions which are responsible for much of the uncertainty in the process of risk assessment. There was an attempt to clearly distinguish policy and fact. The subsections of the State-of-the-Science portion provide the underlying support to the principles articulated, and to read the "Principles" section without a full appreciation of the State-of-the-Science section is to invite oversimplification and misinterpretation. Finally, suggestions are made for future research efforts which will improve the process of risk assessment.

Animals↗

D.A. Henderson: acting globally, thinking locally.

They had said that it couldn't be done-the worldwide eradication of smallpox. To hear D.A. Henderson tell it, the job of leading the World Health Organization's initiative to conquer the disease in the 1960s and 1970s rather fell into his lap. In fact, he describes each of the posts that he has held with great modesty, beginning with his military service at the Centers for Disease Control and Prevention all the way through his assignments as Dean of Public Health at Johns Hopkins, Associate Director of the Office of Science and Technology Policy in the Executive Office of the President, and more recently as Director of the Office of Public Health Preparedness under Secretary Thompson at the Department of Health and Human Services. Confronted with enormous challenges in terms of public health initiatives, Henderson describes each assignment as a matter of communicating with the people he works with and the people that he serves, and drawing on their insights to devise strategies for accomplishing the task at hand. With bioterrorism posing one of the major public health concerns to face the United States and the world, it's gratifying to know that someone with Henderson's track record and wide-ranging expertise is paying attention and making sure that medical and government officials are preparing to respond to the threat. Again and again, Henderson appears to have the knack for showing up in the right place at the right time with just the right idea.

Bioterrorism↗

Federal policy for the protection of human subjects. Final rule.

This document sets forth a common Federal Policy for the Protection of Human Subjects (Model Policy) accepted by the Office of Science and Technology Policy and promulgated in regulation by each of the listed Departments and Agencies. A Proposed Federal Policy for the Protection of Human Subjects published November 10, 1988 (53 FR 45661) has been revised in response to public comments. The Policy as revised is now set forth as a common final rule. For related documents, see other sections of this Federal Register part.

Behavioral Research↗

Public Health Service policies on research misconduct. Final rule.

This final rule removes 42 CFR part 50, subpart A, "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science," and replaces it with a new, more comprehensive part 93, "Public Health Service Policies on Research Misconduct." The proposed part 93 was published for public comment on April 16, 2004. The final rule reflects both substantive and non-substantive amendments in response to public comments and to correct errors and improve clarity, but the general approach of the NPRM is retained. The purpose of the final rule is to implement legislative and policy changes applicable to research misconduct that occurred over the last several years, including the common Federal policies and procedures on research misconduct issued by the Office of Science and Technology Policy on December 6, 2000.

Confidentiality↗

Nutrition Societies Presidents' Forum: future challenges and opportunities for nutrition societies in the 21st century.

The Chair introduced "Pasteur's Quadrant" as a potentially useful paradigm for modern science. Developed by Princeton's Donald E Stokes, the quadrant is two-by-two matrix that classifies knowledge as fundamental and/or applied. The Chair also noted the effect of competitive pressures, and the necessity for cooperation among nutrition societies. The Presidents of The American Society for Nutritional Sciences (ASNS), The American Society for Clinical Nutrition (ASCN), The American Society for Parenteral and Enteral Nutrition (ASPEN), and the Chair of the Institute of Food Technologist's (IFT) Nutrition Division presented their views on how societies can prepare to meet their members' upcoming needs. The Director of the Center for Food and Nutrition Policy discussed the future role of nutrition societies and how they might interact with various interest groups. The Forum, which included an opportunity for audience participation, took place soon after the February 1996 release of "Meeting the Challenge: A Research Agenda for America's Health, Safety, and Food." Published by the Executive Office of the President's Office of Science and Technology Policy, the report highlights the importance of nutrition to our nation's health.

Humans↗

The mouse in safety evaluation.

Several recent publications have reviewed the history, rationale and experience concerning the use of mice as a test species in oncogenicity bioassay programs. Conclusions from three of these publications will be discussed: The Report of the International Expert Advisory Committee on the Relevance of Mouse Liver Hepatoma to Human Carcinogenic Risk (from the Nutrition Foundation), the Report of the NTP Ad Hoc Panel of Chemical Carcinogenesis Testing and Evaluation (from the Board of Scientific Counselors of the National Toxicology Program), and Chemical Carcinogens: Review of the Science and its Associated Principles (from the Office of Science and Technology Policy). Using the recommendations from these and other groups regarding modification of the current testing protocols and alternative approaches to evaluating the adverse health effects of long-term, low-level exposure to environmental chemicals, an effort will be made to predict some future developments in this area of toxicology.

Animals↗

Global information infrastructure.

The High Performance Computing and Communications Program (HPCC) is a multiagency federal initiative under the leadership of the White House Office of Science and Technology Policy, established by the High Performance Computing Act of 1991. It has been assigned a critical role in supporting the international collaboration essential to science and to health care. Goals of the HPCC are to extend USA leadership in high performance computing and networking technologies; to improve technology transfer for economic competitiveness, education, and national security; and to provide a key part of the foundation for the National Information Infrastructure. The first component of the National Institutes of Health to participate in the HPCC, the National Library of Medicine (NLM), recently issued a solicitation for proposals to address a range of issues, from privacy to 'testbed' networks, 'virtual reality,' and more. These efforts will build upon the NLM's extensive outreach program and other initiatives, including the Unified Medical Language System (UMLS), MEDLARS, and Grateful Med. New Internet search tools are emerging, such as Gopher and 'Knowbots'. Medicine will succeed in developing future intelligent agents to assist in utilizing computer networks. Our ability to serve patients is so often restricted by lack of information and knowledge at the time and place of medical decision-making. The new technologies, properly employed, will also greatly enhance our ability to serve the patient.

Computer Communication Networks↗

Carcinogenic risk assessment in proper perspective.

The evidence that human cancers result in large measure from factors related to life style, working conditions, or other extrinsic variables--and are thus, in principle, preventable (Doll and Peto, 1981)--and the hypothesis that there is no threshold for the carcinogenic effects of many cancer-causing agents (Office of Science and Technology Policy, 1985) have spurred efforts to minimize human exposure to carcinogens. In pursuit of this goal, attempts have been made to identify airborne and other extrinsic carcinogens and to assess the extent to which they contribute to the occurrence of cancer. The status of such endeavors is summarized in the following, without any attempt at a comprehensive review, which would be beyond the scope of this report.

Carcinogens, Environmental↗

Key scientific issues in the health risk assessment of trichloroethylene.

Trichloroethylene (TCE) is a common environmental contaminant at hazardous waste sites and in ambient and indoor air. Assessing the human health risks of TCE is challenging because of its inherently complex metabolism and toxicity and the widely varying perspectives on a number of critical scientific issues. Because of this complexity, the U.S. Environmental Protection Agency (EPA) drew upon scientific input and expertise from a wide range of groups and individuals in developing its 2001 draft health risk assessment of TCE. This scientific outreach, which was aimed at engaging a diversity of perspectives rather than developing consensus, culminated in 2000 with 16 state-of-the-science articles published together as an Environmental Health Perspectives supplement. Since that time, a substantial amount of new scientific research has been published that is relevant to assessing TCE health risks. Moreover, a number of difficult or controversial scientific issues remain unresolved and are the subject of a scientific consultation with the National Academy of Sciences coordinated by the White House Office of Science and Technology Policy and co-sponsored by a number of federal agencies, including the U.S. EPA. The articles included in this mini-monograph provide a scientific update on the most prominent of these issues: the pharmacokinetics of TCE and its metabolites, mode(s) of action and effects of TCE metabolites, the role of peroxisome proliferator-activated receptor in TCE toxicity, and TCE cancer epidemiology.

Dose-Response Relationship, Drug↗

Priority list of research areas for radiological nuclear threat countermeasures.

To help the nation prepare for the possibility of a terrorist attack using radiological and nuclear devices, the Office of Science and Technology Policy and the Homeland Security Council established an interagency working group. The working group deliberated on the research needs for radiological/ nuclear threat countermeasures and identified and prioritized 18 areas for further attention. The highest priorities were given to research on (1) radioprotectors for use prior to exposure; (2) therapeutic agents for postexposure treatment; (3) antimicrobial therapy for infections associated with radiation exposure; (4) cytokines and growth factors; (5) mechanisms of radiation injury at the molecular, cellular, tissue and organism levels; and (6) automation of biodosimetric assays. High priority was given to (1) developing biomarkers for biodosimetry; (2) enhancing training in the radiation sciences; (3) exploring the consequences of combined injury; (4) establishing a repository of information regarding investigational countermeasures; and (5) following the health of an exposed population to better prepare for subsequent events. The research areas that the committee felt required the attention of the radiation research community are described in this report in an effort to inform this community about the needs of the nation and to encourage researchers to address these critical issues.

Guidelines as Topic↗