Author Archives: ToxStrategies

We are pleased to announce that Mr. Donald F. Schmitt has joined ToxStrategies as a Senior Managing Scientist and will be based in the Chicago area. Mr. Schmitt has 30 years of corporate and consulting experience in toxicology, risk assessment, and regulatory affairs. He has significant experience in evaluating the safety of foods and food ingredients, additives and contaminants, feed additives, cosmetics, and environmental and occupational exposures. He has developed regulatory strategies for FDA-regulated products in support of regulatory compliance, product defense, product development and claims, and pre-market approval. Mr. Schmitt has conducted pre-clinical toxicity evaluations of drugs, medical devices, and biologics for both the government and private sectors. He has designed, contracted, and monitored pre-clinical safety studies required for regulatory clearance of new food additives, cosmetic ingredients, and human and veterinary drugs for clients. Additionally, he has provided technical support and assisted in the preparation of a variety of reports and submissions to regulatory authorities including Generally Recognized as Safe (GRAS) affirmation petitions/notifications, food contact notifications (FCNs), new dietary ingredient notification (NDIs), direct and indirect food additive petitions, health claims petitions, clinical study Investigator Brochures, and Investigational New Drug and New Drug Applications (INDs/ NDAs).

To read more about Mr. Don Schmitt and get his contact information, please visit his company web page.

ToxStrategies is pleased to announce the addition of two health scientists, Dr. Rayetta G. Henderson and Ann Holbrow Verwiel.

Dr. Henderson – Research Triangle Park, North Carolina
Dr. Rayetta Henderson joined our team as a senior health scientist and is located in the Research Triangle Park, North Carolina area. She has managed scientific programs for the EU’s Registration, Evaluation & Authorisation of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) Regulations and has experience supporting trade associations in the development of strategies for addressing metal-specific issues related to REACH and CLP. In this role, she served as a scientific representative on a number of technical working groups, including legal and financial subgroups. She is knowledgeable of the UN’s Globally Harmonized System (GHS) including hazard assessment and classification for jurisdictions worldwide. Dr. Henderson has substantial experience designing, monitoring, and interpreting scientific data from toxicity studies and alternative method studies in support hazard evaluations.

Dr. Henderson has studied and performed health effects assessments on various chemicals including perfluorinated compounds (PFCs), dioxin-like compounds, and metals, particularly nickel and nickel-containing substances. Dr. Henderson earned her Ph.D. in Toxicology from the University of North Carolina at Chapel Hill, where her research focused on understanding the mechanism of action leading to the developmental toxicity of perflurooctane sulfonate (PFOS).

To read more about Dr. Rayetta Henderson and get her contact information, please visit her company web page.

Ann Holbrow Verwiel – San Francisco Bay Area, California
Ann Holbrow Verwiel joined our team as a managing health scientist and is located in our new San Francisco Bay Area office. She has more than 20 years of experience in environmental consulting in the areas of human health risk assessment, site assessment, and environmental regulation. Over her career, she has focused on integrating risk assessment into an overall risk management approach to problem definition, investigation, and mitigation. She has successfully applied this approach in negotiations with regulatory agencies and public groups to significantly reduce the cost/extent of investigation, assessment, and mitigation. She has published and presented papers on a wide variety of topics, including Monte Carlo analysis of the conservatism in risk assessment, environmental fate and transport of contaminants, and environmental auditing.

Ms. Verwiel has managed and conducted numerous human health risk assessments that addressed a wide variety of chemicals in soil, soil vapor, air, and groundwater. She has evaluated the chemical signatures, fate and transport mechanisms, and likely current and future human exposures as key first steps in the health risk evaluation. In the area of air toxics, she has worked to develop investigation strategies and perform assessments of exposure to indoor and ambient air that included emission source evaluation; modeling; and soil vapor, indoor air, and ambient air measurements. She also has assisted several entities with air toxic analysis to meet the requirements of Proposition 65, AB2588 Toxic “Hot Spots” Act, and the California Environmental Quality Act (CEQA). She has worked with regulatory public participation specialists, public affairs officers, and others to develop written summaries and presentation materials that convey complex technical issues to the public. She has provided litigation support for several projects, involving disputes between property owners and facility operators, alleged air emissions exposures, and Proposition 65 litigation.

Austin, TX

Environmental Standards, Inc. and ToxStrategies are pleased to announce the beginning of a strategic alliance between the two environmental consulting firms. After working side by side with each other on numerous high-profile environmental projects throughout the years, the two companies have joined sales and marketing forces to offer their focused professional services to clients and prospects. Clients will benefit greatly from the “one-stop-shop” scientific consulting as Environmental Standards and ToxStrategies work together to offer solutions to address the scientific, technical, and regulatory challenges confronting our clients.

“We have the common interest of ensuring our clients receive the “best-in-class” of our respective services,” said Rock Vitale, CEO of Environmental Standards.

“Our plans for increased sharing of technical insight and professional knowledge between ToxStrategies’ 20-plus toxicologists and engineers and the 100-plus chemists, geoscientists, and information technologies professionals of Environmental Standards will strengthen the value-proposition we have for our clients,” commented Mark Harris, President of ToxStrategies.

Environmental Standards’ core services are environmental chemistry quality assurance, consulting geosciences and site remediation, and information technologies/environmental data management buy xenical online. ToxStrategies specializes in analyses of toxicological and epidemiological data, human health risk assessment, assistance with REACH (Registration, Evaluation, Authorization and Restriction of Chemical Substances) compliance, computational analyses and modeling, exposure assessment, food and supplement safety, product safety, and scientific and strategic expertise in the nonclinical safety assessment of pharmaceuticals and biopharmaceuticals.

About Environmental Standards, Inc.
Environmental Standards was founded in 1987 and is headquartered in Valley Forge, Pennsylvania. The company has regional offices in Charlottesville, Virginia; Kingston, Tennessee; and Houston, Texas. The Inc. 5000 List of America’s Fastest Growing Private Companies has listed Environmental Standards from 2007 to 2011. Environmental Standards employs over 100 full-time professionals.

For more information about Environmental Standards, contact Kevin Renninger, Director of Business Development/Principal, at 610.935.5577 or at krenninger@envstd.com or visit their website at www.envstd.com.

About ToxStrategies
ToxStrategies was founded in 2008 and is headquartered in Houston, Texas. The company has regional offices throughout the country. ToxStrategies employs over 20 full-time professionals.

For more information about ToxStrategies, email info@toxstrategies.com or visit their website at www.toxstrategies.com.

Tallahassee, FL

We are pleased to announce that Dr. Robert James and Dr. Janice Britt have joined ToxStrategies, and will open a ToxStrategies office in Tallahassee, Florida.

Dr. James, a Senior Principal, has more than 35 years of experience in basic human and animal toxicological research and environmental consulting. He has worked with the departments of pharmacology, toxicology, and medicine at the University of Utah, Vanderbilt University, Georgia Institute of Technology, University of Arkansas for Medical Science, University of Florida, Florida State University, and Medical College of Wisconsin. His basic and applied research has resulted in 75 scientific publications and he is an editor of a toxicology textbook.

In addition to his academic career, Dr. James has served as a consulting environmental toxicologist since 1979. He has provided toxicological expertise, safety/risk assessment or staff training to Fortune 500 companies, state environmental and public health departments, and various federal agencies. As a toxicological consultant he has authored hundreds of scientific evaluations in the areas of: exposure-pathway and site-specific risk assessments, safety/risk evaluations for chemicals present in soil, water, air, foods and medicines; attached to indoor and outdoor surfaces; and in consumer products or construction materials. The chemicals of potential concern included, but are not limited to: heavy metals, radionuclides, industrially important chemicals and components of commercial products, petroleum products, organic solvents (BTEX, formaldehyde), chlorinated solvents, pesticides/fumigants, pharmaceuticals, food chemicals (e.g., acrylamide, diacetyl), and environmentally persistent chemicals (e.g., brominated ethers, PFOA, PCBs, PCDD/Fs).

Dr. James’ experience in occupational and environmental exposures of consumer/commercial products, drugs, and industrial chemicals ultimately has led to legal work both as a consultant and expert witness. He has worked on a variety of legal issues including site clean-up apportionment; in limine, Lone Pine, Kelly-Frye, and Daubert motions; issues of general and specific causation; and cases involving class certification, product safety, dose-reconstruction, liability, and toxic tort remedies such as medical surveillance.

Dr. Janice Britt, a Senior Managing Scientist, has over 20 years experience as a toxicologist with extensive experience evaluating the potential human health impact of exposure to chemicals as well as experience in conducting risk assessments. She has conducted in-depth critical analyses of the toxicological literature for numerous chemicals, developed briefing books on particular scientific issues, written toxicological reviews and profiles, performed site-specific risk assessments, assisted in writing Daubert and Lone Pine motions, and evaluated the appropriateness of specific regulatory toxicity criteria (e.g., reference doses, cancer slope factors) and occupational exposure guidelines (e.g., ACGIH TLVs, OSHA PELs). Dr. Britt has evaluated a wide variety of compounds, including chlorinated solvents, BTEX, insecticides, herbicides, heavy metals, PCBs, perchlorate, PFOA, pharmaceuticals, and food additives.

Examples of recently completed projects by Dr. Britt include an evidence-based evaluation of the irritancy effects of formaldehyde. As part of this project, she conducted a comprehensive review of the toxicity of formaldehyde and background exposures to formaldehyde by humans. Dr. Britt recently completed an evidence-based review on the occupation of painting as it relates to leukemia, particularly acute myelogenous leukemia (AML). As part of this review, she evaluated the background incidence and risk factors for AML. She is currently working on an evidence-based analysis of benzene and multiple myeloma.

Read more about Dr. Britt here.

San Francisco, CA

ToxStrategies’ scientists will be presenting short papers across mulitple sessions at the Society of Toxicology’s 51st Annual Meeting, from March 11-15, 2012, in San Francisco, CA. We are also excited to announce that ToxStrategies will be exhibiting at the ToxExpo. Please visit us in Booth #938 to learn more about our services and meet members of our staff. Click here for a complete list of our SOT 2012 presentations.

Cincinnati Area, Ohio

We are pleased to announce that Dr. Candace Doepker has joined ToxStrategies as the Food & Product Safety Practice Leader, and will be based in the Cincinnati, Ohio area. She was trained in the field of cytogenetic toxicology and has 16 years experience providing toxicological and scientific issues management support for many different multi-billion dollar food, health, beauty and oral care brands. Relevant to the food industry, Dr. Doepker has spent the last six years helping to ensure consumer safety, worker safety and general product stewardship in all of the following categories: coffee, snack foods, jams, jellies, baking mixes, juices, peanut butter, flavors and oils. Recently, she has developed a strong working knowledge of the Food Safety Modernization Act and is experienced in facilitating discussions with multi-disciplinary teams to prepare for its implementation. Additionally, she has helped to evaluate risk and guide the strategic direction of companies involved with topics such as actives in drug products, caffeine, Proposition 65 regulations, heat formed toxicants, nuisance dusts, workplace allergens and carbon monoxide. In all of these topic areas she gained significant experience in taking complex technical documents and issues and simplifying them in easy to understand language.

Dr. Doepker is recognized in the food industry for her strong working knowledge of diacetyl and workplace flavor safety. Dr. Doepker has served multiple years as the Chairwoman of the Caffeine and Food Ingredients committee at the International Food Information Council, as well as serving on the Council’s Board of Directors. She has been on the Scientific Advisory Board of the National Coffee Association for 5 years and has been an active member of both the Grocery Manufacturers Association and International Life Science Institute’s science and regulatory committees.

To read more about Dr. Doepker, or to obtain her new contact information, please click here.

San Francisco Bay Area, California

We are pleased to announce that Mr. Gregory P. Brorby has joined ToxStrategies as a Senior Managing Scientist. Mr. Brorby will be based in the San Francisco Bay Area, and greatly enhances our exposure assessment capabilities. He is a board-certified toxicologist with more than 25 years of experience in the fields of human health risk assessment, exposure simulation and dose reconstruction, and toxicology. Mr. Brorby has directed or participated in studies to estimate exposure to chemicals such as lead and phthalates from use of consumer products, particularly with regard to potential exposure via incidental hand-to-mouth contact, to assess compliance with CPSC, FDA, and California Proposition 65 requirements. He has also directed or participated in studies to reconstruct historic exposures to chemicals, including asbestos, in occupational settings. Mr. Brorby also conducts independent review of risk assessment-related work performed by others, and has significant experience communicating complicated technical information to a non-technical audience.

To read more about Mr. Brorby, or to obtain his new contact information, please click here.

Brussels, Belgium

ToxStrategies scientists will travel to Brussels, Belgium, this summer to present several short papers at the 31st International Symposium on Halogenated Persistent Organic Pollutants – Dioxin 2011.

Diliberto, J.J., Sirinek, L., Burkhalter, B., Wikoff, D.S., Hixon, G., Becker, J., Patterson, D.G., Turner, W., Tachovsky, J.A., Birnbaum, L.S., Haws, L.C. Endometriosis in a cohort of women living in the Kanawha River Valley in West Virginia: Blood levels of non-dioxin-like PCBs and relationship with BMI and age.

Haws, L.C., DeVito, M.J., Walker, N.J., Harris, M.A., Tachovsky, J.A., Birnbaum, L.S., Farland, W.H., Wikoff, D.S.Development of a consensus-based weighting framework for evaluating estimates of relative potency for dioxin-like compounds that includes consideration of data from human cells.

Haws, L.C., Fitzgerald, L., Burkhalter, B., Harris, M., Wikoff, D.S. Assessment of the US EPA’s proposed toxicological values for TCDD for regulation of dioxin-like compounds in foods: bridging the science divide in a global market.

Rowlands, J.C., Urban, J., Wikoff, D.S., Budinsky, R. The presence and estimated functional effect of single nucleotide polymorphisms at the AIP, ARNT, HSP90AA1, AND HSP90AB1 loci in the human population.

Thomas, R.S., Rowlands, J.C., Budinsky, R.A., Thompson, C.M., Urban, J.D., Dombkowski, A. Genomic approaches for relative potency assessment.

Wikoff, D.S., Thompson, C., Walker, N., DeVito, M., Harris, M., Birnbaum, L. Haws, L. Derivation of relative potency estimates using benchmark dose modeling: a case study with TCDF.

For a list of previous conference presentations, please see our Abstracts and Presentations.