Author Archives: ToxStrategies

The EPA just released a draft database of 1,173 hydraulic fracturing-related chemicals that were listed in the external review draft Assessment of the Potential Impacts of Hydraulic Fracturing for Oil and Gas on Drinking Water Resources (released June 4, 2015). The database provides physicochemical and toxicological information from a host of different sources, including: EPI Suite, LeadScope, QikiProp, Reaxys, IRIS, PPRTV, ATSDR, among others. The database also contains background information about how the list of chemicals was compiled.

The full draft database can be downloaded here.

On June 11, 2015, EPA released two technical guidance documents for evaluating vapor intrusion:

• OSWER Technical Guide for Assessing and Mitigating the Vapor Intrusion Pathway from Subsurface Vapor Sources to Indoor Air (VI Guidance)
• Technical Guide for Addressing Petroleum Vapor Intrusion at Leaking Underground Storage Tank Sites (Petroleum UST VI Guidance)

The VI Guidance provides a five-step process for evaluating whether the VI exposure pathway is complete and recommendations for completing a human health risk assessment, as well as mitigation measures, if necessary. The Petroleum UST VI Guidance considers the degradation of petroleum in the vadose zone and relies on separation distances to establish whether VI is a potentially complete exposure pathway.

ToxStrategies scientists and engineers have substantial experience addressing the vapor intrusion pathway. Example projects include modeling potential migration of vapors from the subsurface into building interiors, developing indoor air sampling plans, conducting indoor air sampling, developing applicable health-based screening levels, and assisting clients with community outreach.

Both documents can be found here.

The EPA has been conducting a 5-year, state-of-the-science assessment to determine the potential impacts of hydraulic fracturing activities on drinking water resources in the United States. On June 4^th, the EPA released an External Review Draft report, titled Assessment of the Potential Impacts of Hydraulic Fracturing for Oil and Gas on Drinking Water Resources.

The assessment found that “hydraulic fracturing activities have not led to widespread, systematic impacts to drinking water resources” but also “identifies important vulnerabilities to drinking water resources.”

ToxStrategies staff have been actively involved in assessing the potential human health impacts of natural gas exploration and production activities. Example projects include those involving conducting safety assessments for hydraulic fracturing fluids, assessing potential human health risks associated with impacts on ambient air, and assessing human health risks associated with accidental releases during drilling activities.

The full EPA report can be viewed here.

One of ToxStrategies’ Principal Scientists, Deb Proctor, attended, presented, and chaired at the 2015 ENV-Vision (Environmental Vision) Conference this week in Washington, DC.

The presentation, titled Cumulative Risk Assessment of Urban Air Toxics:  A Pilot Study in San Antonio, Texas, was held on Wednesday, May 13 at 1:00 pm in Crystal Ballroom Salon B during Session 4a:  Air Toxics Health & Risk Assessment.  We hope you were able to stop by and check out her talk.

ENV-Vision is an Electric Power Research Institute (EPRI) event hosted by the Air & Waste Management Association (AWMA).  This conference aims to exchange research results on current and emerging issues in the electricity sector, and to develop a shared vision to address the most critical environmental and sustainability challenges through engagement of electric industry leaders, regulators, NGOs, academics, and other stakeholders.

For more information on the conference, click here.

Alea Goodmanson and Camarie Perry will be at the annual TCEQ Environmental Trade Fair & Conference this week in Austin, TX.  They’re looking forward to seeing some familiar faces and meeting new people.  Stop by and visit them at booth #517!

We are pleased to announce that Dr. Andrea Weir has joined ToxStrategies, Inc. as a Senior Consultant and will be based in the Washington, DC area. Dr. Weir is a board certified toxicologist with 28 years of experience in toxicology, primarily in drug development. She has worked in both the contract research industry and at the U.S. Food and Drug Administration (USFDA).

Prior to joining ToxStrategies, Dr. Weir was a regulatory toxicologist at the USFDA for approximately 12 years, working primarily in the Center for Drug Evaluation and Research (CDER). During this time, Dr. Weir served as a pharmacology/toxicology reviewer and was responsible for critically reviewing the nonclinical sections of regulatory submissions such as INDs, NDAs, and BLAs. Dr. Weir actively participated in meetings (e.g., pre-IND meetings) advising pharmaceutical and biopharmaceutical companies regarding their nonclinical development plans, particularly the study design and data interpretation, as well as addressing toxicities and other challenges encountered in nonclinical studies. She was also actively involved in several internal FDA/CDER subcommittees. Following the USFDA, Dr. Weir was a Senior Scientific Advisor at Charles River Laboratories. She actively participated on numerous scientific advisory committees within the pharmaceutical and biopharmaceutical industry, which were held to obtain expert advice on various aspects of the nonclinical drug development process.

Dr. Weir has extensive experience with biopharmaceuticals such as monoclonal antibodies and fusion proteins, and with chemically-synthesized molecules. Her experience extends to a variety of clinical indications including rheumatoid arthritis, oncology and rare diseases, as well as multiple routes of administration including oral, intravenous, dermal, and ocular. Dr. Weir also has extensive experience in the design and interpretation of nonclinical toxicology studies (GLP and non-GLP) and in applying data from such studies to the overall drug development process. Dr. Weir has co-authored numerous journal articles and book chapters relating to drug development, and served as co-editor of a text titled Assessing Ocular Toxicology in Laboratory Animals.

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

ToxStrategies is pleased to announce the recent publication of Principles of Toxicology:  Environmental and Industrial Applications (3rd Edition), co-edited and co-authored by our Senior Science Advisor, Dr. Rob James. Dr. James co-authored three chapters, covering topics such as the general principles of toxicology, hepatotoxicity, and human health risk assessment. Dr. Janice Britt, a Senior Managing Scientist with ToxStrategies, also contributed to this publication by authoring a chapter on the properties and effects of pesticides xenical 120.

A copy of this publication is available for purchase here.

ToxStrategies’ experts prepared 2 presentations for the 2015 Battelle Eighth International Conference on Remediation and Management of Contaminated Sediments in New Orleans, Louisiana, January 12–15.

Senior Scientist Dr. Jon Urban was in attendance, presenting a poster entitled Lower Passaic River RMO-8: An Alternative Human Health Risk Assessment during the Tuesday evening session, “Ecological and Human-Health Risk Assessment.”

Principal Dr. Mark Harris was also in attendance, presenting ToxStrategies’ work entitled Lower Passaic River RMO-8: An Alternative Preliminary Remediation Goal during the Wednesday evening poster session, “Establishing Remediation Goals.”

Battelle 2015 is a forum for sharing research results, practical experiences and opportunities toward the goal of remediating, restoring and maintaining the environmental and economic vitality of waterways.

For more information on the conference, click here.