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PubMed2002

Risk assessment at hazardous waste-contaminated sites with variability of population characteristics.

Risk assessment is considered to be an effective scientific tool which enables decisionmakers to manage hazardous waste-contaminated sites in a cost-effective manner while preserving public health. However, the current risk assessment framework proposed by the US Environmental Protection Agency (US EPA) has limitations in addressing the true variability of population characteristics. This study proposed a methodology that is different from the existing framework by accounting for the true variability of population characteristics. The key differences of the proposed methodology and the existing framework are the (1) use of the transient exposure concentration; (2) use of the entire population rather than a representative ideal individual; (3) use of age- and gender-based population subgroups to represent population characteristics; (4) use of a population growth model to represent growth dynamics; and (5) presentation of risk through a risk profile with risk summarized through a single indicator, potential cancer incidences (PCI). The proposed methodology was applied in a ground water contamination scenario due to benzene to determine its applicability. The results of the study showed that age-based variability of population characteristics is important in predicting the population risk while gender played a small role. The existing US EPA methodology and its variation using age-independent variability of population characteristics overestimate the risk given by PCI substantially, and therefore, the decisions can lead to costly cleanup goals. Population risk is not a single value but a distribution due to the contribution from ditferent individuals of the exposed population. Hence, the decision criterion proposed in this study, PCI, is found to be a useful indicator to describe population carcinogenic risk to the society under a variety of conditions and scenarios.

Demography↗
PubMed2006

Key issues in the role of peroxisome proliferator-activated receptor agonism and cell signaling in trichloroethylene toxicity.

Peroxisome proliferator-activated receptor alpha (PPARalpha) is thought to be involved in several different diseases, toxic responses, and receptor pathways. The U.S. Environmental Protection Agency 2001 draft trichloroethylene (TCE) risk assessment concluded that although PPAR may play a role in liver tumor induction, the role of its activation and the sequence of subsequent events important to tumorigenesis are not well defined, particularly because of uncertainties concerning the extraperoxisomal effects. In this article, which is part of a mini-monograph on key issues in the health risk assessment of TCE, we summarize some of the scientific literature published since that time on the effects and actions of PPARalpha that help inform and illustrate the key scientific questions relevant to TCE risk assessment. Recent analyses of the role of PPARalpha in gene expression changes caused by TCE and its metabolites provide only limited data for comparison with other PPARalpha agonists, particularly given the difficulties in interpreting results involving PPARalpha knockout mice. Moreover, the increase in data over the last 5 years from the broader literature on PPARalpha agonists presents a more complex array of extraperoxisomal effects and actions, suggesting the possibility that PPARalpha may be involved in modes of action (MOAs) not only for liver tumors but also for other effects of TCE and its metabolites. In summary, recent studies support the conclusion that determinations of the human relevance and susceptibility to PPARalpha-related MOA(s) of TCE-induced effects cannot rely on inferences regarding peroxisome proliferation per se and require a better understanding of the interplay of extraperoxisomal events after PPARalpha agonism.

Animals↗
PubMedDate not supplied

Basis for a proposed reference dose (RfD) for dioxin of 1-10 pg/kg-day: a weight of evidence evaluation of the human and animal studies.

The dioxins have been perhaps the most studied of all chemicals to which humans are routinely exposed. It has been reported that more than 5,000 scientific papers have been published that have evaluated the toxicology of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD). Although the cancer hazard posed by this chemical has probably received the bulk of attention over the past 20 years, the U.S. Environmental Protection Agency (EPA) and the recent U.S. EPA Science Advisory Board (SAB) that reviewed the "Reassessment" have suggested that the noncancer hazard may well be more important than the cancer hazard at current background doses to the general public. The World Health Organization (WHO) and U.K. Food Standards Agency (FAO) committee (JECFA) on dioxins has reached similar conclusions. This article reviews the published studies involving laboratory animals and humans that address the noncancer effects. Based on our review, developmental toxicity is the most sensitive effect of TCDD consistently seen in mice and rats. Specifically, of the various studies, a no-observed-adverse-effects level (NOAEL) of 13 ng/kg (maternal body burden) was identified as the most pertinent for deriving a reference dose (RfD) for humans. Although more than a dozen different adverse effects have been reported in various studies of humans over the past 25 years, the most consistent clinically important adverse effect of human exposure appears to be chloracne. Following a review of all published studies, we concluded that the best estimate of a LOAEL for production of chloracne is approximately 160 ng/kg (body burden). Based on our analysis, an RfD of between 1 and 10 pg/kg-d (TCDD TEQ) is consistent with the objectives of this risk criterion. Maintaining a lifetime average daily dose below this concentration, based on what is known today, should prevent noncancer effects in virtually all persons. This value is consistent with the JECFA recommendation of 70 pg/kg-mo.

Acne Vulgaris↗
PubMedDate not supplied

Inhalation health risks of manganese: an EPA perspective.

In 1994, the U.S. Environmental Protection Agency (EPA) denied a petition by Ethyl Corporation to allow the use of methylcyclopentadienyl manganese tricarbonyl (MMT) in unleaded gasoline, because of health concerns related to the inhalation of manganese (Mn) particulate emissions from combusted MMT. Although Ethyl successfully challenged EPA's denial of the petition on legal grounds, issues raised in EPA's health risk assessment have not been resolved to date. This paper summarizes features of the EPA health risk characterization, which included the use of various statistical techniques to derive several estimates of inhalation reference concentration (RfC) values for Mn as alternatives to the established value of 0.05 microgram Mn/m3. An exposure assessment projected distributions of personal exposure levels to particulate Mn if MMT were used in all unleaded gasoline. It was estimated that exposure levels of 5-10% of the modeled population might exceed a possible alternative RfC value of 0.1 microgram Mn/m3. However, due to data limitations, the risk characterization for Mn/MMT could raise only qualitative concerns about potential public health impacts and was unable to provide a quantitative estimate of risk. To improve the risk characterization, better information on Mn/MMT population exposures and health effects is needed. Much of this information is expected to be obtained under provisions of Section 211 of the Clean Air Act. Among the specific issues that remain to be resolved are the form or forms of Mn emitted from the combustion of MMT in gasoline and the potentially different toxic properties of Mn in different forms.

Air Pollutants↗
PubMed2005

A comparative study of US EPA 1996 and 1999 emission inventories in the west Gulf of Mexico coast region, USA.

Emission inventory is one of the required inputs to air quality models. To assist in the urban and regional modeling efforts, United States Environmental Protection Agency (EPA) has compiled a National Emission Inventory (NEI) for criterion pollutants, and the precursors of ozone and particulate matter (PM). In December 2002, EPA released the 1999 NEI estimates (NEI99), which represent the most recent national emission data. However, the data sets are not in model-ready format for air quality simulations. This present work converts the NEI99 Final Version 2 data sets into Inventory Data Analyzer (IDA) format and processes the data using the Sparse Matrix Operator Kernel Emissions (SMOKE) modeling system to generate a gridded emission inventory in a domain covering the west Gulf Coast Region, USA. The spatial and diurnal emission characteristics of the gridded emission inventories are then assessed and compared with those of the National Emission Trend 1996 (NET96). The NEI99 database contains more complete emission records in both area and point sources. It is also found that NEI99 data exhibit greater emissions with respect to point and mobile sources but smaller emissions with respect to area sources when compared to the corresponding gridded NET96 data in the same study domain. The most distinct differences between the NEI99 and NET96 databases are CO emission of mobile sources, SO2 emissions of point sources, and VOC/PM/NH3/NOx emissions of area and non-road sources. The gridded NEI99 data show low VOC/NOx ratios (<2-5) in the urban areas of the study domain.

Air Pollutants↗
PubMed2002

Evaluation of the carcinogenicity of 1,1-dichloroethylene (vinylidene chloride).

The U.S. Environmental Protection Agency has classified 1,1-dichloroethylene (vinylidene chloride; VDC) as a "C" carcinogen and has developed an inhalation unit risk value and an oral cancer slope factor for this chemical. The development and use of these cancer potency estimates for risk assessment purposes are questionable. The inhalation unit risk value is based on increased kidney adenocarcinomas in Swiss mice from one study. This type of cancer was not increased in female mice or in rats or hamsters in the same study nor in male mice of a similar strain in another study with higher VDC exposures. The VDC oral cancer slope factor is based on a non-statistically significant increase in adrenal pheochromocytomas in male rats following oral exposure in a standard National Toxicology Program chronic bioassay. Both human and animal literature relevant to VDC carcinogenicity was reviewed according to the USEPA draft Guidelines for Carcinogen Risk Assessment with the objective of determining the weight-of-evidence for VDC carcinogenicity. We conclude that information currently available for VDC is most appropriately characterized in a weight-of-evidence narrative by the descriptor "inadequate for an assessment of human carcinogenic potential." For chemicals with this descriptor, dose-response assessment is not indicated. Under this guidance, quantitative estimates of cancer risks associated with VDC exposure are inappropriate until additional, more definitive evidence for human carcinogenicity becomes available.

Administration, Inhalation↗
PubMed2004

An operational assessment of the application of the relative reduction factors in the demonstration of attainment of the 8-hr ozone National Ambient Air Quality Standard.

The U.S. Environmental Protection Agency in 1997 revised the 1-hr ozone (O3) National Ambient Air Quality Standard (NAAQS) to one based on an 8-hr average, resulting in potential nonattainment status for substantial portions of the eastern United States. The regulatory process provides for the development of a state implementation plan that includes a demonstration that the projected future O3 concentrations will be at or below the NAAQS based on photochemical modeling and analytical techniques. In this study, four photochemical modeling systems, based on two photochemical models, Community Model for Air Quality and the Comprehensive Air Quality Model with extensions, and two emissions processing models, Sparse Matrix Optimization Kernel for Emissions and Emissions Modeling System, were applied to the eastern United States, with emphasis on the northeastern Ozone Transport Region in terms of their response to oxides of nitrogen and volatile organic carbon-focused controls on the estimated design values. With the 8-hr O3 NAAQS set as a bright-line test, it was found that a given area could be termed as being in or out of attainment of the NAAQS depending upon the modeling system. This suggests the need to provide an estimate of model-to-model uncertainty in the relative reduction factor (RRF) for a better understanding of the uncertainty in projecting the status of an area's attainment. Results indicate that the model-to-model differences considered in this study introduce

Air Pollutants↗
PubMed1985

Radiological sampling and analytical methods for National Primary Drinking Water Regulations.

Radiological sampling and analysis performed under the National Interim Primary Drinking Water Regulations were evaluated for the U.S. Environmental Protection Agency (EPA) Office of Drinking Water to consider whether any changes should be recommended. The authors reviewed the analytical screening scheme; sample collection, storage and analysis procedures; selection of analytical methods; reliability of results; and possible future needs. The main problem in the program has been dependence on a screening scheme of gross alpha-particle activity measurement and 226Ra analysis for predicting elevated 228Ra levels to determine compliance with the maximum contaminant level (MCL) for Ra. In some aquifers, 228Ra levels have been found to be unrelated to 226Ra levels. Several alternatives are discussed to eliminate this problem. A secondary problem is that the measurement for assuring compliance with the MCL for gross alpha-particle activity minus Ra, Rn and U uses chemical U analysis and assumes equilibrium of 238U and 234U. Because some ground waters are known to be at disequilibrium, radiometric U analysis is needed for those gross alpha-particle activities and chemical U values that could result in an erroneous conclusion relative to the MCL. In addition, studies were recommended for determining analytical uncertainties and assuring reliable sampling and sample maintenance; improvements in the system for accepting methods were suggested; and methods were identified for several radionuclides not currently in the analytical program that may be needed to assure absence of elevated radiation doses and could be useful for identifying trace contaminants.

Alpha Particles↗
PubMed2006

Science-policy in environmental and health risk assessment: if we cannot do without, can we do better?

How can empirical evidence of adverse effects from exposure to noxious agents, which is often incomplete and uncertain, be used most appropriately to protect human health? We examine several important questions on the best uses of empirical evidence in regulatory risk management decision-making raised by the US Environmental Protection Agency (EPA)'s science-policy concerning uncertainty and variability in human health risk assessment. In our view, the US EPA (and other agencies that have adopted similar views of risk management) can often improve decision-making by decreasing reliance on default values and assumptions, particularly when causation is uncertain. This can be achieved by more fully exploiting decision-theoretic methods and criteria that explicitly account for uncertain, possibly conflicting scientific beliefs and that can be fully studied by advocates and adversaries of a policy choice, in administrative decision-making involving risk assessment. The substitution of decision-theoretic frameworks for default assumption-driven policies also allows stakeholder attitudes toward risk to be incorporated into policy debates, so that the public and risk managers can more explicitly identify the roles of risk-aversion or other attitudes toward risk and uncertainty in policy recommendations. Decision theory provides a sound scientific way explicitly to account for new knowledge and its effects on eventual policy choices. Although these improvements can complicate regulatory analyses, simplifying default assumptions can create substantial costs to society and can prematurely cut off consideration of new scientific insights (e.g., possible beneficial health effects from exposure to sufficiently low 'hormetic' doses of some agents). In many cases, the administrative burden of applying decision-analytic methods is likely to be more than offset by improved effectiveness of regulations in achieving desired goals. Because many foreign jurisdictions adopt US EPA reasoning and methods of risk analysis, it may be especially valuable to incorporate decision-theoretic principles that transcend local differences among jurisdictions.

Decision Theory↗
PubMed2001

Estimates of the health risk reductions associated with attainment of alternative particulate matter standards in two U.S. cities.

As part of its periodic re-evaluation of particulate matter (PM) standards, the U.S. Environmental Protection Agency estimated the health risk reductions associated with attainment of alternative PM standards in two locations in the United States with relatively complete air quality data: Philadelphia and Los Angeles. PM standards at the time of the analysis were defined for particles of aerodynamic diameter less than or equal to 10 microm, denoted as PM-10. The risk analyses estimated the risk reductions that would be associated with changing from attainment of the PM-10 standards then in place to attainment of alternative standards using an indicator measuring fine particles, defined as those particles of aerodynamic diameter less than or equal to 2.5 microm and denoted as PM-2.5. Annual average PM-2.5 standards of 12.5, 15, and 20 microg/m3 were considered in various combinations with daily PM-2.5 standards of 50 and 65 microg/m3. Attainment of a standard or set of standards was simulated by a proportional rollback of "as is" daily PM concentrations to daily PM concentrations that would just meet the standard(s). The predicted reductions in the incidence of health effects varied from zero, for those alternative standards already being met, to substantial reductions of over 88% of all PM-associated incidence (e.g., in mortality associated with long-term exposures in Los Angeles, under attainment of an annual standard of 12.5 microg/m3). Sensitivity analyses and integrated uncertainty analyses assessed the multiple-source uncertainty surrounding estimates of risk reduction.

Air Pollutants↗
PubMed2000

Detection of astroviruses, enteroviruses, and adenovirus types 40 and 41 in surface waters collected and evaluated by the information collection rule and an integrated cell culture-nested PCR procedure.

We evaluated the use of an integrated cell culture-reverse transcription-PCR (ICC-RT-PCR) procedure coupled with nested PCR to detect human astroviruses, enteroviruses, and adenovirus types 40 and 41 in surface water samples that were collected and evaluated by using the Information Collection Rule (ICR) method. The results obtained with the ICC-RT-PCR-nested PCR method were compared to the results obtained with the total culturable virus assay-most-probable-number (TCVA-MPN) method, the method recommended by the U.S. Environmental Protection Agency for monitoring viruses in surface and finished waters. Twenty-nine ICR surface water samples were analyzed. Viruses were concentrated by using filter adsorption-beef extract elution and organic flocculation techniques, and then the preparations were evaluated for viruses by visualizing cytopathic effects in the Buffalo green monkey kidney (BGMK) cell line. In the ICC-RT-PCR-nested PCR technique we used Caco-2 cells to propagate astroviruses and enteroviruses (ICC step), and we used BGMK cells to propagate adenovirus types 40 and 41, as well as enteroviruses. Fifteen of the 29 samples (51.7%) were positive for astrovirus as determined by the ICC-RT-PCR-nested PCR method, and eight of these samples (27.5%) contained infectious astrovirus. Seventeen of the 29 samples (58.6%) were positive for enteroviruses when the BGMK cell line was used, and six (27.6%) of these samples were determined to be infectious. Fourteen of the 29 samples (48.3%) were positive for adenovirus types 40 and 41, and 11 (37.9%) of these samples were determined to be infectious. Twenty-seven of the 29 samples (93.1%) were positive for a virus, and 19 (68.9%) of the samples were positive for an infectious virus. Only 5 of the 29 samples (17.2%) were positive as determined by the TCVA-MPN method. The ICC-RT-PCR-nested PCR method provided increased sensitivity compared to the TCVA-MPN method.

Adenoviruses, Human↗
PubMed2003

Do reports on drinking water quality affect customers' concerns? Experiments in report content.

The Safe Drinking Water Act Amendments of 1996 required U.S. utilities to report on drinking water quality to their customers annually, beginning in fall 1999, on the assumption that such reports would alert them to quality problems and perhaps mobilize pressure for improvement. A random sample of New Jersey customers read alternative versions of a water quality report, in an experiment on reactions to water quality information under U.S. Environmental Protection Agency (USEPA) rules. Experiment design was 2 x 3 + 1: two versions each--one with, one without, a violation of a health standard--of a report that was (1) Qualitative (without water quality numbers, thus not meeting USEPA rules); (2) Basic, with minimal information meeting the rules; or (3) Extended, adding reading aids and utility performance information; plus a control instrument without any hypothetical report. Results of ANOVA suggest the reports will have less effect than hoped or feared. These manipulations were successful: people reading the Qualitative versions were less likely to say that the report gave the amounts of substances found in the water, and those reading Violation versions were more likely to report a violation of a health standard. The main differences in responses to the report involved the judged adequacy of the information, and to a lesser extent responses on a Concern scale (constructed from measures of concern, judged risk, clean-up intentions, distrust of utility information, and doubt that the utility was doing all it could to improve water quality). Overall judgments of water quality and utility performance did not change, either relative to the controls or in before versus after responses. Qualitative reports performed worse than others, confirming the decision to have utilities report actual contaminant levels. Extended reports did only slightly better than the Basic versions on these measures. Many respondents had trouble identifying the presence or absence of substance amounts or violations, despite their seeming obviousness (e.g., in a "bottom line" summary on the front page of each report), suggesting many were not processing this information carefully. However, the pattern of responses for those who accurately identified the presence or absence of substance amounts or violations did not differ substantially from that for the group as a whole. Generic risk beliefs (serious local environmental problems; lack of control over risks to one's health) dominated demographic variables, attitudes toward utility water quality or trustworthiness, and the content and format of water quality reports in influencing concern about drinking water quality. Previous empirical and theoretical evidence for lack of change in public risk attitudes due to one-time or infrequent communications--e.g., role of personal experience, perseverance of prior trust or distrust--seems to be confirmed for annual water quality reports.

Attitude↗
PubMed2005

Mortgaging the future: dumping ethics with nuclear waste.

On August 22, 2005 the U.S. Environmental Protection Agency issued proposed new regulations for radiation releases from the planned permanent U.S. nuclear-waste repository in Yucca Mountain, Nevada. The goal of the new standards is to provide public-health protection for the next million years - even though everyone admits that the radioactive wastes will leak. Regulations now guarantee individual and equal protection against all radiation exposures above the legal limit. Instead E.P.A. recommended different radiation exposure-limits for different time periods. It also recommended using only the arithmetic mean of the dose distribution, to assess regulatory compliance during one time period, but using only the median dose to assess compliance during another period. This piece argues that these two changes - in exposure-limits and in methods of assessing regulatory compliance - have at least four disturbing consequences. The changes would threaten equal protection, ignore the needs of the most vulnerable, allow many fatal exposures, and sanction scientifically flawed dose calculations.

Ethics↗
PubMed2003

Drawing the battle lines: tracing the "Science War" in the construction of the chloroform and human health risks debate.

The United States Environmental Protection Agency (US EPA) and the Chlorine Chemistry Council, the Chemical Manufacturers Association, and others have been embroiled in a legal challenge concerning the US EPA's "reversal" regarding the scientific assessment of chloroform's carcinogenicity. This issue arose during the US EPA's November 1998 promulgation of a Maximum Contaminant Level Goal for chloroform in the Stage 1 Final Rules for Disinfectants and Disinfection Byproducts in drinking water. In this paper we adopt a claimsmaking approach: to trace the development and outcome of the chloroform court challenge in the USA, to examine the construction of scientific knowledge claims concerning chloroform risk assessments, and to investigate how different interpretations of scientific uncertainties regarding the evidence are contested when such uncertainties are brought into a regulatory and judicial arena. This "science war" (Chlorine Chemistry Council and others v. US EPA and others) took place in the US Court of Appeals for the District of Columbia Circuit. The scientific "authority" in the construction of scientific claims in this dispute is based on the International Life Sciences Institute expert panel report on chloroform. Examining these science wars is important because they signal critical shifts in science policy agendas. The regulatory outcome of the chloroform science war in the United States can have profound implications for the construction and acceptance of scientific claims regarding drinking water in other jurisdictions (e.g., Canada). In this challenge, we argue that the actors involved in the dispute constructed "boundaries" around accepted and credible scientific claims.

Carcinogens↗
PubMed2001

An empirical Bayes approach to estimating the relation of mortality to exposure to particulate matter.

As part of its assessment of the health risks associated with exposure to particulate matter (PM), the U.S. Environmental Protection Agency analyzed the risks associated with current levels, and the risk reductions that might be achieved by attainment of alternative PM standards, in two locations in the United States, Philadelphia, and Los Angeles. The concentration-response function describing the relation between a health endpoint and ambient PM concentrations is an important component, and a source of substantial uncertainty, in such risk analyses. In the absence of location-specific estimates, the concentration-response functions necessary for risk assessments in Philadelphia and Los Angeles must be inferred from the available information in other locations. Although the functional form of the concentration-response relations is assumed to be the same everywhere, the value of the PM coefficient in that function may vary from one location to another. Under this model, a distribution describes the probability that the PM coefficient in a randomly selected location will lie in any range of interest. An empirical Bayes estimation technique was used to improve the estimation of location-specific concentration-response functions relating mortality to short-term exposure to particles of aerodynamic diameter less than or equal to 2.5 microm (PM-2.5), for which functions have previously been estimated in several locations. The empirical Bayes-adjusted parameter values and their SEs were used to derive an estimate of the distribution of PM-2.5 coefficients for mortality associated with short-term exposures. From this distribution, distributions of relative risks corresponding to different specified changes in PM-2.5 concentrations could be derived.

Air Pollutants↗
PubMed1996

Urinary chromium concentrations in humans following ingestion of safe doses of hexavalent and trivalent chromium: implications for biomonitoring.

In this study, we evaluate the significance of increased urinary chromium concentrations as a marker of chromium exposure and potential health risk. Six human volunteers ingested trivalent chromium [Cr(III)] and hexavalent chromium [Cr(VI)] at doses that are known to be safe but are much higher than typical dietary levels. The following dosing regimen was used: d 1-7, 200 micrograms/d chromium picolinate (a dietary supplement); d 8-10, Cr(VI) ingestion at the U.S. Environmental Protection Agency (EPA) reference dose (RfD) of 0.005 mg/kg/d; d 11-13, no dose; d 14-16, Cr(III) ingestion at the U.S. EPA RfD of 1.0 mg/ kg/d; and d 17-18, postdose. Urine voids were collected throughout the dosing periods and analyzed for chromium. Our findings are as follows: (1) ingestion of 200 micrograms/d of chromium picolinate yielded significantly elevated urine concentrations such that each participant routinely exceeded background, (2) ingestion of the Cr(VI) RfD (0.005 mg/kg/d) yielded individual mean urinary chromium levels (1.2-23 micrograms/L) and a pooled mean urinary chromium level (2.4 micrograms/L) that significantly exceeded background, and (3) ingestion of the Cr(III) RfD yielded no significant increase in urinary chromium concentrations, indicating that little, if any, absorption occurred. Our work identified three critical issues that need to be accounted for in any future studies that will use urinary chromium as a marker of exposure. First, a minimum urinary chromium concentration of approximately 2 micrograms/L should be used as a screening level to critically identify individuals who may have experienced elevated exposures to chromium. Second, if Cr(III) levels in soils are known to be less than 80,000 ppm and the Cr(III) is insoluble, urinary chromium concentrations are not an appropriate marker of exposure. Third, newer forms of chromium supplements that contain organic forms of Cr(III) must be considered potential confounders and their contribution to residential chromium uptake must be carefully evaluated.

Administration, Oral↗
PubMedDate not supplied

Quality assurance responsibilities as defined by the EPA Good Automated Laboratory Practices (GALPs).

In December 1990, the Environmental Protection Agency's (EPA) Office of Information Resources Management (OIRM) issued a draft of the Good Automated Laboratory Practices (GALP). The GALPs developed from a union of existing Federal and EPA regulations and policies, including: the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) & Toxic Substance Control Act (TSCA), Good Laboratory Practices (GLP), the EPA Information Resources Management Policy (IRMP), and the Computer Security Act of 1987. The GALPs consolidate the regulations and policies to provide a single source of reference, and sever as an extension of the GLP standards (40 CFR 160 & 792). Whereas the GLPs describe acceptable laboratory management practices, the GALPs describe acceptable automated data management practices, and give guidance for standardizing and implementing procedures to ensure the quality and integrity of automated data collection and storage. The GALPs have been formatted to parallel the structure of the GLPs. Just as the GLPs define the responsibilities of the Quality Assurance Unit (QAU) in maintaining good laboratory practices, the GALPs define the responsibilities of the QAU in maintaining good automated data practices. The QAU is charged with (i) maintaining copies of written procedures for the automated data collection system, (ii) performing inspections of laboratory operations utilizing the automated data collection system and reporting findings, (iii) ensuring authorization and documentation of deviations from written procedures, (iv) auditing data and reports from the automated data collection system to ensure they accurately represent the raw data, and (v) maintaining records of the above-defined QAU functions.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Laboratory Information Systems↗
PubMedDate not supplied

A review of US EPA and FDA requirements for electronic records, electronic signatures, and electronic submissions.

Both the United States Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have issued regulatory documents that address the issues and requirements concerning electronic reporting to the Agencies. EPA has published two comprehensive and useful electronic data interchange (EDI) guidelines: 1) the EPA Electronic Data Interchange (EDI) Implementation Guideline, Draft of September 23, 1994 and October 18, 1994 that is available at the following EPA web site address: www.epa.gov/oppeedi1/guidelines/general.pdf and 2) the Interim Final Notice, Filing of Electronic Reports via Electronic Data Interchange, September 4, 1996, Federal Register Notice [FRL-5601-4, Volume 61, Number 172, page 46684], also available at: www.epa.gov/oppeedi1/edipoli.htm. The FDA has published a guidance document titled, "Guidance for Industry, Computerized Systems Used in Clinical Trials, April 1999" that is available at FDA's web site: www.fda.gov/ora/compliance_ref/bimo/ffinalcct.++ +htm. FDA's guidance document addresses a number of issues for electronic records that are applicable to all areas of GLP compliance. Another FDA document presently under development is titled, "Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway." The ESTRI document defines strategic plans for electronic submissions to FDA. FDA has published a guidance document in this area titled, "Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations, January 1999." This guidance document is available at: www.fda.gov/cder/guidance/index.htm. FDA has also published an important final rule applicable to all electronic records and signatures that is part of the U.S. Title 21 Code of Federal Regulations (CFR), Part 11, titled, "FDA's Final Rule, Electronic Records; Electronic Signatures, effective August 20, 1997." This FDA ruling is discussed below and is available at: www.fda.gov/cder/esig/index.htm.

Authorship↗