Quantitative Risk Analysis for N-Methyl Pyrrolidone using Physiologically Based Pharmacokinetic and Benchmark Dose Modeling
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New Study Finds PFOA Levels in Drinking Water Are Safe
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Derivation of a Drinking Water Equivalent Level (DWEL) Related to the Maximum Contaminant Level Goal for Perfluorooctanoic Acid (PFOA), a Persistent Water Soluble Compound.
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Magnetic Resonance Imaging and Computational Fluid
Dynamics (CFD) Simulations of Rabbit Nasal Airflows
for the Development of Hybrid CFD/PBPK Models.
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Estimates of Cancer Potency of 2,3,7,8-
Tetrachlorodibenzo(p)dioxin using Linear and Non-linear Dose-Response Modeling and Toxicokinetics.
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Acrylamide: Consideration of Species Differences and Nonlinear Processes in Estimating Risk and Safety for Human Ingestion.
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Derivation of Inhalation Toxicity Reference Values for Propylene Oxide Using Mode of Action Analysis: Example of a Threshold Carcinogen.
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Physiologically Based Pharmacokinetic Model Development and Simulations for Ethylene Dichloride (1,2-Dichloroethane) in Rats
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Derivation of Noncancer Reference Values for Acrylonitrile
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Physiologically Based Pharmacokinetic Modeling of Chloroethane Disposition in Mice, Rats and Women
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Propylene Oxide: Genotoxicity Profile of a Rodent Nasal Carcinogen
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Disposition of Styrene Acrylonitrile (SAN) Trimer in Female Rats: Single Dose Intravenous and Gavage Studies
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Bayesian Estimation of Pharmacokinetic and Pharmacodynamic Parameters in a Mode-of-Action-Based Cancer Risk Assessment for Chloroform. Risk Anal. 2007 Dec;27(6):1535-51
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The Sapphire Group Co-Sponsors Founders Fund Award for Society of Toxicology
The Sapphire Group is proud to announce its role in the creation of a new award for the Society of Toxicology - The Founders Fund. The Fund recognizes the uniquely valuable contribution of those professionals who organized, devoted their creative energies and time to establish the Society of Toxicology, and whose vision provided the foundation for vital contributions aimed at the protection of public health worldwide.
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Sweeney and Gargas Publish PBPK Model for 1,4-Dioxane
1,4-Dioxane (CAS No. 123-91-1) is used primarily as a solvent or as a solvent stabilizer. It can cause lung, liver and kidney damage at sufficiently high exposure levels. Two physiologically-based pharmacokinetic (PBPK) models of 1,4-dioxane and its major metabolite, hydroxyethoxyacetic acid (HEAA), were published in 1990. These models have uncertainties and deficiencies that could be addressed and the model strengthened for use in a contemporary cancer risk assessment for 1,4-dioxane. Studies were performed to fill data gaps and reduce uncertainties pertaining to the pharmacokinetics of 1,4-dioxane and HEAA in rats, mice, and humans. Three types of studies were performed: partition coefficient measurements, blood time course in mice, and in vitro pharmacokinetics using rat, mouse, and human hepatocytes. Updated PBPK models were developed based on these new data and previously available data.
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Sweeney and Gargas Publish PBPK Model for Ethylbenzene
A physiologically based pharmacokinetic (PBPK) model was developed for inhaled ethylbenzene (EB) in B6C3F1 mice. The mouse physiological parameters were obtained from the literature, but the blood:air and tissue:air partition coefficients were determined by vial equilibration technique. The maximal velocity for hepatic metabolism (Vmax) obtained from a previously published rat study was increased by a factor of approximately 3 to account for enzyme induction during repeated exposures. The Michaelis affinity constant (Km) for hepatic metabolism of EB, obtained from a previously published rat PBPK modeling study, was kept unchanged during single and repeated exposure scenarios. Hepatic metabolism alone could not adequately describe the clearance of EB from mouse blood. Additional metabolism was assumed to be localized in the lung. The parameters for pulmonary metabolism were obtained by optimization of PBPK model fits to kinetic data collected following exposures to 75-1000 ppm. The PBPK model successfully predicted all available blood and tissue concentration data in mice exposed to 75 or 750 ppm EB.
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The Sapphire Group Celebrates Medical Monitoring Milestone
Recently The Sapphire Group marked the six anniversary of an on-going medical monitoring program it is conducting for one of its leading clients. The monitoring program designed by The Sapphire Team is based on a very broad set of criteria to ensure the health of the employees and to prevent any false negatives.

The program includes both objective and subjective criteria. The objective measures included a number of tests including cancer screenings, urine cytology, sonograms and others. The employees were also requested to fill out an in depth questionnaire to complete the subjective portion of the screening. The questionnaire asked the employees about various related symptoms, work history and other medical questions that would suggest other unrelated health issues such as high blood pressure. Any questionable health issue whether related specifically to the cancer of concern or not received for further evaluation.

After the initial round of screening, the findings were then compared to the National Cancer Institute, incident reports and statistical models which showed that the incident of cancer was not statistically significant.

Due to the findings of this initial screening and other health concerns such as over weight and smoking the company has taken on screening the employees every two years (which is considered extremely frequent for these types of cancer) and started an athletic program. In so doing, the client has achieved their main objective -- protecting the health of the employees.
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Christopher J. Bevan, Ph.D., DABT Joins The Sapphire Group
The Sapphire Group is pleased to announce that Christopher J. Bevan, Ph.D., DABT has joined its team of professionals as a Program Manager. Dr. Bevan is a toxicologist with more than twenty years expertise in providing assistance on issues relating to product safety and regulatory compliance, and risk assessment. He has assessed the potential hazards of commercial products; developed and coordinated toxicity testing programs; prepared summary reports of test results, and provided MSDS hazard communication recommendations; participated in industry trade association groups concerned with occupational and environmental health issues; interfaced with governmental regulatory agencies on issues involving toxicity testing and compliance, and risk assessment.
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The Sapphire Group Assists in a New Publication on Dioxin and Cancer
The Sapphire Group Assisted in the Publication of a New Study by J. A. Popp, et al. in Dioxin and Cancer to appear in Toxicological Science (Toxicol Sci 89 (2):361-369, 2006). To read the abstract for this paper, click below.
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Kirman and Gargas Publish New Cancer Dose-Response Assessment for Acrylonitrile
Chris Kirman and Michael Gargas, Scientists with The Sapphire Group, have recently published a paper on a cancer dose-response assessment conducted for acrylonitrile using updated information on mechanism of action, epidemiology, toxicity, and pharmacokinetics.
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The Sapphire Group Announces a Strategic Alliance with Crane Environmental
The Sapphire Group is delighted to announce its newest strategic alliance with Crane Environmental. Crane Environment, headquartered in Oxfordshire, United Kingdom, supplies the water, chemicals, retail and regulatory sectors with independent, high quality, and objective scientific advice on the environmental sources and pathways of chemicals, and their effects on human and ecological receptors.
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25 Years of Dioxin Cancer Risk Assessment
Thomas Long, MS of The Sapphire Group, in conjunction with Peter Wright and Lesa Aylward, recently published an article entitled "Twenty-Five Years of Dioxin Cancer Risk Assessment" in Natural Resources and Environment (Vol. 19, No. 4, Spring 2005). This comprehensive and authoritative article outlines the evolution of dioxin cancer assessment on all regulatory levels and serves as a helpful primer to both the novice as well as seasoned risk analysts. Mr. Long is a program manager with The Sapphire Group and may be reached at tfl@thesapphiregroup.com or at our Cleveland, OH office for more information or a reprint of this article.
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Ethyl Acrylate Risk Assessment with a Hybrid Computational Fluid Dynamics and Physiologically-based Nasal Dosimetry Model.
Cytotoxicity in the nasal epithelium is frequently observed in rodents exposed to volatile organic acids and esters by inhalation. An interspecies, hybrid computational fluid dynamics and physiologically based pharmacokinetic (CFD-PBPK) dosimetry model for inhaled ethyl acrylate (EA) is available for estimating internal dose measures for EA, its metabolite acrylic acid (AA), and EA-mediated reductions in tissue glutathione (GSH).
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Christopher R. Kirman, MS Wins Award for Outstanding Risk Assessment Paper
The Sapphire Group acknowledges and congratulates our own Christopher R. Kirman, MS for winning the Outstanding Risk Assessment Paper "Addressing Nonlinearity in the Exposure-Response Relationship for a Genotoxic Carcinogen: Cancer Potency Estimates for Ethylene Oxide." (Risk Anal. 2004 Oct;24(5):1165-83), presented at the Society of Toxicology Annual Meeting, March 2005. Ethylene oxide (EO) has been identified as a carcinogen in laboratory animals. Although the precise mechanism of action is not known, tumors in animals exposed to EO are presumed to result from its genotoxicity. Together with what is known about human leukemia and EO at the molecular level, there is a body of evidence that supports a plausible mode of action for EO as a potential leukemogen. Based on a consideration of the mode of action, the events leading from EO exposure to the development of leukemia (and therefore risk) are expected to be proportional to the square of the dose. In support of this hypothesis, a quadratic dose-response model provided the best overall fit to the epidemiology data in the range of observation. Chris Kirman, a Senior Analyst and Scientist with of The Sapphire Group, is a toxicologist with nearly ten years expertise in regulatory toxicology, dose-response modeling, risk assessment and computer programming/database design. Job well done, Chris!
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Estimation of Inter-Individual Variation in Oxidative Metabolism of Dichloromethane in Human Volunteers.
A modified version of the original physiologically based pharmacokinetic (PBPK) model by Andersen et al. (1987) has been developed and used in conjunction with previously published human kinetic data for dichloromethane (DCM) metabolism and to assess interindividual variability in the rate of oxidative metabolism.
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A Chemical Engineer's Guide to Toxicology
Knowledge of the science of toxicology is a critical component to understanding current issues important in the professional, civic and personal lives of chemical engineers. Topics such as children's health, endocrine disrupters, development of new drugs, and the high-production-volume (HPV) chemical testing initiative are examples of such issues. This article discusses what toxicology is, the basic principles of toxicology, and its roles in public health and the pharmaceutical and chemical process industries.
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Using PBPK Modeling to Address Nonlinear Kinetics and Changes in Rodent Physiology and Metabolism Due to Aging and Adaptation in Deriving Reference Values for PGME and PGMEA.
Reference values, including an oral reference dose and an inhalation reference concentration, were derived for propylene glycol methyl ether, and an oral RfD was derived for its acetate (PGMEA). These values were based upon transient sedation observed in F344 rats and B6C3F1 mice during a two-year inhalation study. The dose-response relationship for sedation was characterized using internal dose measures as predicted by a physiologically based pharmacokinetic (PBPK) model for PGME and its acetate. PBPK modeling was used to account for changes in rodent physiology and metabolism due to aging and adaptation, based on data collected during weeks 1, 2, 26, 52, and 78 of a chronic inhalation study.
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Addressing Nonlinearity in the Exposure-Response Relationship for a Genotoxic Carcinogen: Cancer Potency Estimates for Ethylene Oxide.
Ethylene oxide (EO) has been identified as a carcinogen in laboratory animals. Although the precise mechanism of action is not known, tumors in animals exposed to EO are presumed to result from its genotoxicity. The overall weight of evidence for carcinogenicity from a large body of epidemiological data in the published literature remains limited. There is some evidence for an association between EO exposure and lympho/hematopoietic cancer mortality. Of these cancers, the evidence provided by two large cohorts with the longest follow-up is most consistent for leukemia. Together with what is known about human leukemia and EO at the molecular level, there is a body of evidence that supports a plausible mode of action for EO as a potential leukemogen. Based on a consideration of the mode of action, the events leading from EO exposure to the development of leukemia (and therefore risk) are expected to be proportional to the square of the dose. In support of this hypothesis, a quadratic dose-response model provided the best overall fit to the epidemiology data in the range of observation.
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The Sapphire Group assists Creosote Council II with FIFRA
The Sapphire Group is currently assisting the Creosote Council II with re-registration of creosote under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The Sapphire Group has more than 10 years of experience assisting clients with registration and re-registration of products under FIFRA. That experience has prepared its professionals well to address the complex scientific and regulatory challenges in the estimation of risks to workers presented by creosote. Some of the challenges stem from the product being a mixture and the nature of human exposure (largely skin contact). To address these, The Sapphire Group professionals are first advising the Council on the direction and content of EPA's own risk assessment. Next our professionals will assist the Council in reviewing EPA's assessment and in preparing comments to the Agency.

For the risk assessment, the Group will address the application of data from one route of administration to another as well as the reliance on toxicity data from either the total mixture or the sum of individual components. A critical component in the success of this process is the Sapphire teams' competence in understanding how to effectively use the highly sophisticated exposure data the industry has collected.
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Ethyl Acrylate Risk Assessment with a Hybrid Computational Fluid Dynamics and Physiologically Based Nasal Dosimetry Model
Research conducted by scientists with The Sapphire Group on an interspecies, hybrid computational fluid dynamics and physiologically based pharmacokinetic dosimetry model for inhaled ethyl acrylate has been accepted for publication in Toxicological Sciences. Please contact The Sapphire Group should you wish to obtain a copy of this paper or to read the abstract for this publication, click below.
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The Sapphire Group Constructs Major Industrial Hygiene Program
The Sapphire Groups was recently retained to develop and set up an Industrial Hygiene (I.H.) program that spans 25 facilities in North America. The program will encompass the entire set of I.H. monitoring procedures. The Sapphire Group, lead by Bernard D. Silverstein, CIH, will construct the process to establish the current findings and help the management gain a full understanding of the substances represented in the workplace. This process includes the collection and critical evaluation of the historical database and development of an ongoing database of information.

The program includes all 25 facilities and will examine several major segments of information. It will review how much information exists, what that information shows and assess the nature and magnitude of the risks associated with the substances present in the workplace. In addition, appropriate measures for regulatory compliance will be established. The Sapphire Group will conclude the interpretation of their findings and recommendations in the next eight to ten months.
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The Sapphire Group Conducts Workshop on the Use of PBPK Modeling in Dose-Response Analysis
At the 2003 Toxicology and Risk Assessment Conference, the attendees were given the opportunity to gain hands-on experience in the use of physiologically-based pharmacokinetic (PBPK) modeling to calculate the relevant measure of dose. The Sapphire team of Drs. Mike Gargas and Lisa Sweeney and Mr. Chris Kirman presented case studies drawn from their cancer and non-cancer risk assessment work with the compounds methylene chloride, 1,3-butadiene and acrylonitrile.

The students conducted pharmacokinetic simulations with the PBPK computer models and were able to distinguish different internal measures of dose (e.g., peak blood concentrations of the compound or metabolite and amount metabolized), then compare these to responses to those observed in laboratory animals and occupationally exposed humans. The objective was to increase the students familiarity and comfort with PBPK modeling and the importance of an appropriate measure of dose as a component of risk assessment.

This is the second year that The Sapphire Group has conducted these workshops at the conference. The 2003 Toxicology and Risk Assessment Conference was sponsored by Tri-Service Toxicology; the U.S. EPA Office of Research and Development, National Center for Environmental Assessment; U.S. Army Center for Health Promotion and Preventive Medicine; Air Force Office of Scientific Research; Agency for Toxic Substances and Disease Registry, Division of Toxicology; the National Institute for Occupational Safety and Health with the cooperation of the National Research Council/National Academy of Sciences. Approximately 240 scientists from government, academia, non-profit organizations, and industry attended the meeting.
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The Sapphire Group Assesses Allometric Scaling in PBPK Modeling
Research conducted by scientists with The Sapphire Group assessing the dose-dependency of allometric scaling performance using physiologically based pharmacokinetic modeling has been accepted for publication in Regulatory Toxicology and Pharmacology. To read the abstract for this publication, click below.
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Lisa M. Sweeney, Ph.D., DABT Wins Award for Outstanding Risk Assessment Paper
The Sapphire Group acknowledges and congratulates our own Lisa Sweeney, Ph.D, DABT for Outstanding Published Paper "Demonstrating an Application of Risk Assessment" (July 2001-June 2002), presented at the Society of Toxicology Annual Meeting, March 2003. The paper developed an occupational exposure limit for three specific chemicals by making quantitative comparisons between the chemical disposition in animals and humans. This model can be used to calculate the variability among humans and is applicable to any chemical where there is a sufficient quantitative understanding. Lisa M. Sweeney, analyst and scientist, is a toxicologist with a broad range of experience. She has over eight years experience in risk assessment, pharmacokinetics, and biochemcial engineering. Job well done, Lisa!
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The Sapphire Group Examines the Association between Disinfection By-Products and Reproductive Toxicity
The Sapphire Group recently published a peer-reviewed paper investigating the association between disinfection by-products (DBP), a side effect of water chlorination, and reproductive and developmental effects. Headed by Dr. Carol Graves of The Sapphire Group, the study considered all toxicological and epidemiological evidence for the various effects. The study demonstrated that for more than a dozen reproductive and developmental outcomes the weight of evidence shows no association between DBP and concerns such as low and very low birth weight, preterm delivery, some specific congenital anomalies, and neonatal death.
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Dr. Tardiff Addresses Applying Biomarkers to Occupational Health Practice at NIOSH Conference
Dr. Robert Tardiff was the chairperson and keynote speaker on the topic of Applying Biomarkers to Occupational Health Practice at the NIOSH Exposure Assessment Workshop last month held in Sante Fe, New Mexico. Dr. Tardiff shared a broad vision of how biomarkers can be useful in assessing toxic risks in the workplace and offered guidance on how to sidestep some of the pitfalls in this promising field. Biomarkers of both exposure and toxic effects are fast becoming an important tool in determining the nature and magnitude of human exposure to chemicals in the environment and in identifying early indices of future clinical disease. The proceedings from the conference are expected to be published some time later this year.
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The Sapphire Group Demonstrates OCEs are Safe for Intended Purposes in Drinking Water
One of the most difficult things that society, scientists and regulatory agencies are confronted with is the estimation of how safe are chemical products in the marketplace when there are little or no relevant toxicity findings on that specific product. In particular, series of compounds in commerce today, polyurethanes made up in part of OCEs, important in the delivery of drinking water. These products include O rings and liners for storage tanks. The concern is over the chemicals that may leach at very low concentrations from these products even though the surface area has actually a relatively small percent of the contact with the water.

The task for the industry for continued product approval for these polyurethanes was to estimate the safe levels of these OCEs by using surrogate compounds which have large amounts of data. Critical to this process was to demonstrate the confidence in these extrapolations for safe levels. The Sapphire Group designed a study in which they began with the evaluation of candidates to choose the appropriate surrogate compound on which they would be able to confidently extrapolate the data. The criteria was developed by the team to select the right surrogate. Once the appropriate surrogate was selected, the team established what would be considered safe levels of the surrogate compound then extrapolated the findings to identify the safe levels of OCEs.

The team of experts at The Sapphire Group was able to demonstrate to the National Sanitation Foundation, the governing regulatory body, that OCEs are safe for their intended purposes. A significant outcome of this study is this process can be used to determine safety levels regarding a number of other products in the marketplace where little or no toxicity data is available.
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Dr. Robert Clark joins The Sapphire Group's Team of Experts
The Sapphire Group is pleased to announce that Robert Clark, PhD, DEE, PE is joining The Sapphire Group's team of scientists. Recently retired from the USEPA, Dr. Clark brings a particularly high level of expertise in the area of chlorination by-products in drinking water, an area where The Sapphire Group is already acknowledged as one of the leading firms. Dr. Clark, working with the water industry and others, has been engaged in this highly complex and difficult subject for many years and has assisted in determining in precise terms the extent to which chlorinated by-products are formed.

Dr. Clark has served as a member on a number of internationally recognized organizations and held national level office for the American Society of Civil Engineers and the American Water Works Association (AWWA). In 1993, he received the A.P. Black Award from the AWWA for lifetime accomplishments in drinking water research. In 2002, Dr. Clark received a Distinguished Service Career Award from the EPA. Dr. Clark has published more than 340 papers and five books.

Dr. Clark is also currently working on projects related to homeland security including reworking the risk assessment methodologies for water system vulnerability with Sandia National Laboratories and with Rutgers University's Center for Information Management, Integration and Connectivity to assist in the development of an early warning system for drinking water utilities.
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Sapphire Milestone, 6th Anniversary
At the beginning of this year, The Sapphire Group passed a significant milestone of completing six years in business. We are delighted by our company’s growth and success.

Two significant factors stand out in measuring our success, the steady increases in our client portfolio and the new and increased scope of many of our client projects. This clearly demonstrates their satisfaction in the results of our work. We thank them for their contribution and trust.

We believe our commitment to sound science, and our abilities to forge new scientific ground, strategic thinking and rapid response provide advancement in the area of health science risk assessment for the chemical and consumer products industries.
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Mead and Westvaco Merge
The Sapphire Group is pleased to announce that it will be expanding its client case as a result of the Mead and Westvaco merger. The Sapphire Group has had a long-standing relationship in providing services to the Mead Corporation, and is pleased that they will not only continue that relationship but also be providing services to Mead’s new business ally, Westvaco.
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Super-Chlorination of Swimming Pools — What Level is Safe for Swimmers?
Sometimes closer examination coupled with a sound scientific approach is the best pathway to challenge a regulatory policy about health risks. This is the case with the use of super-chlorination and in understanding what is a safe level for people of all ages to re-enter a swimming pool. Super-chlorination is a process that is used periodically, more frequently in hot climates and seasons, to control disease-causing organisms. The Sapphire Group has presented data to the EPA to show that the current standard of 3 ppm, which the EPA is considering moving to 4 ppm, could actually be set as high as 10 ppm while still providing an ample margin of safety.

While still skeptical of the merits of this proposed increase of the re-entry standard beyond 4 ppm, the EPA has asked for additional data on the decay rates of chlorine and the formation rate of chloroform under conditions of super-chlorination. Such an undertaking may not be feasible because of the many variables that exist among chlorinated pools. In its counter proposal to the EPA, The Sapphire Group is offering an alternative the modification and use of computer models that have proven useful for chlorinated drinking water for application to chlorinated swimming pools. The Sapphire Group is confident in their use of these models, and believes the tool is ripe to provide highly accurate and applicable data to answer the EPA’s questions and justify raising the safe levels of re-entry of swimmers into super-chlorinated swimming pools.
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Greetings for the Season!
From all of our colleagues and their families, The Sapphire Group wishes you joy in this holiday season.

It is our privilege and mission to serve the health of people around the world and the health of our planet.

It is in this time that we are also reminded of a greater mission of Peace on Earth and Good Will toward Men.

To you and your families the best of times now and in the New Year ahead. Happy Holidays.
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Dr. Robert Tardiff is Named to National Research Council Subcommittee
Dr. Robert Tardiff, president and CEO of The Sapphire Group was recently named to serve on a subcommittee of the National Research Council on Assessing Toxicological Risks to Deployed Military Personnel. The mission of the subcommittee is to review the Army's Technical Guide and its supporting documents on assessing and managing risks from exposures to hazardous chemicals during military operations, and to evaluate the documents for their scientific validity, completeness, and conformance to the current understanding of risk assessment practices. The subcommittee will identify deficiencies in the documents and make recommendations for improvement. This project is particularly timely in light of the ongoing international missions of our Armed Forces.
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Chapter in New Book on Brownfields by Sapphire Team
The Sapphire Group contributes a key chapter in the most up-to-date and comprehensive book on Brownfields. The chapter entitled "The Role of Risk Assessment in Redeveloping Brownfield Sites" was coauthored by Thomas F. Long, Michael L.Gargas, Richard P. Hubner and Robert G. Tardiff. The book is published by the American Bar Association is entitled Brownfields, A Comprehensive Guide to Redeveloping Contaminated Property. The book was written as both a guide and a resource manual of authoritative sources for stakeholders to address how to most cost effectively deal with sites contaminated with chemicals. The Sapphire Group's chapter provides guidance and insight to the risk assessment process surrounding brownfields.
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The Sapphire Group Joins Forces with DuPont's Haskell Laboratory
The Sapphire Group is pleased to announce that it has formed a joint business alliance with DuPont's Haskell Laboratory. Founded in 1935, DuPont's Haskell Laboratory is one of the world's premiere laboratories for toxicology and industrial medicine. The strength of this relationship allows The Sapphire Group to offer its clients the performance benefits of the full range of toxicological studies, both mammalian and ecological.

One of the major attributes of the scientists at DuPont's Haskell Laboratory is their ability to successfully conduct mode of action and metabolism studies. These types of studies are vital to the demonstration of a product's chemical safety in the workplace and the marketplace. "The quality of DuPont's Haskell Laboratory is unsurpassed," says Dr. Robert Tardiff, president of The Sapphire Group.

The advantage for clients in extending these types of services is that it offers an enormous difference in the robustness of a risk assessment. The scientists at The Sapphire Group are experts in their ability to interpret the findings of this type of work, merge it with their epidemiological studies and the works of other investigators to provide defensible and insightful conclusions and business recommendations.
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Dr. David W. Gaylor Now Affiliated with The Sapphire Group
The Sapphire Group is pleased to announce that David W. Gaylor, Ph.D., has joined its team of professionals. Dr. Gaylor's expertise in food risk assessments and food safety brings a tremendous amount of experience to our clients. Dr. Gaylor, along with Dr. Lawrence Fishbein and Dr. Joseph F. Borzelleca, represent an important nucleus in food safety assessment at our firm.

Dr. Gaylor previously served as the principal advisor to the National Center for Toxicological Research at the FDA. His tenure at the FDA included policy development through implementation in a wide range of areas. Additionally, he developed experimental protocols and provided statistical analyses of experiments in carcinogensis, teratogenesis, mutagenesis and neurotoxicity. He also developed techniques to advance the science of quantitative health risk assessment. His statistical expertise will be a superb complement to that of Dr. Carol Graves.