Biomedical subjects

Jacqueline Patterson

Publications and source records attributed to Jacqueline Patterson.

4 recordsLinked to original sources

PubMed2006

VCCEP pilot: progress on evaluating children's risks and data needs.

The Voluntary Children's Chemical Evaluation Program (VCCEP) is designed to provide information to the public on children's potential health risks associated with chemical exposures. The key question of the VCCEP is whether the potential hazards, exposures, and risks to children have been adequately characterized, and, if not, what additional data are necessary. To answer this question, manufacturers or importers of 23 chemicals were asked by the U. S. Environmental Protection Agency (U.S. EPA) to sponsor their chemicals in the first tier of a pilot program. These chemicals were selected for evaluation because they have been found as contaminants in human tissue or fluids (adipose tissue, blood, breath, breast milk, or urine); food and water children may eat and drink; or air children may breathe (including residential or school air). Under the VCCEP framework, sponsoring companies agree to prepare Tier 1 hazard, exposure, and risk assessments on the individual chemicals, and identify the need for additional data. These assessment documents are submitted to the U.S. EPA and subsequently undergo review by experts in an independent peer consultation meeting that is open to the public. Following this peer consultation process, the U.S. EPA reviews each submission and makes a data-needs determination, which may include requesting further data collection or generation by the sponsor. Sponsoring companies then decide whether to volunteer for the next tier and collect or generate the requested data. The purpose of this article is to describe the VCCEP process and to review and present the key findings from the first set of chemicals that have been fully or partially evaluated under the pilot program (vinylidene chloride, decabromodiphenyl ether, pentabromodiphenyl ether, octabromodiphenyl ether, acetone, methyl ethyl ketone, decane, undecane, and dodecane). Specifically, we provide a brief summary of the sponsors' submissions, the peer consultation panels' discussions, and the U.S. EPA's data-needs decisions. Although we do not attempt to conduct independent analyses of the underlying data, we do identify a number of common themes that have emerged during implementation of the pilot program and discuss several key issues that could become important in the future. The information presented here should be useful for various parties interested in the progress of the VCCEP and the results of the initial (Tier 1) children's assessments.

Acetone↗

PubMed2003

Review of procedures for protecting human subjects in recent clinical studies of pesticides.

Arguments have been made for and against the regulatory use of data from human subjects on both scientific and ethical grounds. One argument against the use of data from human clinical studies involving pesticides asserts that such data are obtained from studies that do not follow the Common Rule (40 CFR 26), which provides procedures for protecting human subjects in studies funded by federal agencies, including the U.S. Environmental Protection Agency (U.S. EPA). Although privately conducted studies using human subjects are not legally subject to or required to comply with the Common Rule, the protections of the Declaration of Helsinki and the International Conference on Harmonisation (ICH) Good Clinical Practice are commonly followed. We sought to answer the question of whether recent human clinical studies with insecticides performed according to Good Clinical Practice provided volunteers with the same protections as the Common Rule. All three sets of guidance have in common the intent to protect volunteer human subjects by providing standards for the conduct of studies in which they participate. This analysis compares the elements of the Common Rule with comparable elements from the Declaration of Helsinki and Good Clinical Practice to evaluate similarities and differences in procedural requirements. It then evaluates the documentation from 15 recent human studies of twelve insecticides conducted at four clinical laboratories in order to determine whether the conduct of those studies is consistent with the protections of the Common Rule. There were some cases for which we could not verify compliance with certain Common Rule elements; however, based on our evaluation it is apparent that the studies we reviewed were conducted in a manner substantially consistent with the fundamental protections of the Common Rule-voluntary participation, informed consent, and review by an ethical committee or institutional review board.

Clinical Trials as Topic↗

PubMed2003

Weighing health benefit and health risk information when consuming sport-caught fish.

Fish consumers may incur benefits and risks from eating fish. Health advisories issued by states, tribes, and other entities typically include advice about how to limit fish consumption or change other behaviors (e.g., fish cleaning or cooking) to reduce health risks from exposure to contaminants. Eating fish, however, may provide health benefits. Risk communicators and fish consumers have suggested the importance of including risk comparison information, as well as health risk-benefit comparisons in health advisory communications. To improve understanding about how anglers fishing in waters affected by health advisories may respond to such risk-risk or risk-benefit information, we surveyed Lake Ontario (NY, USA) anglers. We interviewed by telephone 4,750 anglers, 2,593 of which had fished Lake Ontario in the past 12 months and were sent a detailed mail questionnaire (1,245 responded). We posed questions varying the magnitude of health risks and health benefits to be gained by fish consumption, and varied the population affected by these risks and benefits (anglers, children, women of childbearing age, and unborn children). Respondents were influenced by health benefit and health risk information. When risks were high, most respondents would eat less fish regardless of the benefit level. When risks were low, the magnitude of change in fish consumption was related to level of benefit. Responses differed depending on the question wording order, that is, whether "risks" were posed before "benefits." For a given risk-benefit level, respondents would give different advice to women of childbearing age versus children, with more conservative advice (eat less fish) provided to women of childbearing age. Respondents appeared to be influenced more strongly by risk-risk comparisons (e.g., risks from other foods vs. risks from fish) than by risk-benefit comparisons (e.g., risks from fish vs. benefits from fish). Risk analysts and risk communicators should improve efforts to include risk-risk and risk-benefit comparisons in communication efforts, and to clarify to whom the health risks and benefits from fish consumption may accrue.

Adult↗

PubMed2002

Human health risk assessment: selected Internet and world wide web resources.

The world wide web (WWW) has become a valuable source of 24 hour-a-day access to information needed by human health risk assessors. Various web sites and other Internet resources provide information needed for human hazard identification, dose-response evaluation, exposure assessment, risk characterization, and risk management. Information on risk communication is also available. Substantial collections of information on multiple aspects of risk assessment are found in sites sponsored by RiskWorld, the (US) EPA's National Center for Environmental Assessment (NCEA), the (US) National Library of Medicine's TOXNET, the (US) Agency for Toxic Substances and Disease Registry (ATSDR), and the International Programme on Chemical Safety (IPCS). Also valuable are various web sites providing information on the physical and chemical properties of chemicals, the environmental fate and transport of chemicals, government regulations, and guidance and training for performing risk assessments. Several professional societies and other organizations have web sites addressing risk assessment issues and information, and there are Internet mailing lists for online help and for sharing information and perspectives. We classify selected web sites according to user needs and provide the reader with a collection of selected sites that can serve as entry points to risk assessment-related web resources.

Databases as Topic↗