Author Archives: ToxStrategies

ToxStrategies scientist Kara Franke presented a session on optimizing industrial hygiene data collection and management to inform the US EPA in the TSCA risk evaluation process at the 2021 AIHce EXP virtual conference. The presentation highlighted issues that included:

• Ensuring appropriate analytical limits of detection
• Best practices for record-keeping
• Collecting robust, high-quality data that represent not just high-risk workers but all workers with potential exposure.

The talk was titled “Updating your Exposure Assessment Strategy to Better Inform the TSCA Risk Reviews”. Contact Kara Franke with questions.

Cannabidiol (CBD) and other hemp-derived products continue to gain attention from the FDA and consumers. A ToxStrategies team led by Dr. Rayetta Henderson is continuing work on a systematic mapping of published literature related to CBD and safety. Studies will be categorized by CBD or related substance type, route of exposure, study model, and health outcome(s) (e.g., neurological, reproductive, etc.), and classified as beneficial or adverse. A preliminary analysis of the data was presented at the 2020 Society of Toxicology annual meeting; currently the team is updating that effort by mapping data published through the end of 2020. The resulting assessment will provide an overview of the current landscape of available CBD data, as well as identify outcomes or other sub-topics that may be suitable for further research and could support future work for systemic reviews, Generally Recognized as Safe (GRAS) assessments, and New Dietary Ingredient Notifications (NDINs).

Read more on CBD from ToxStrategies.

Dr. John M. Rogers, ToxStrategies Senior Consultant, has been awarded the 2021 Edward W. Carney Distinguished Service Award by the Society for Birth Defects Research and Prevention (BDRP, established in 1960 as the Teratology Society). This award honors Dr. Edward W. Carney, Past President of BDRP, for his exemplary dedication and service to the Society and the field of teratology. The Edward W. Carney Distinguished Service Award recognizes an individual who has provided distinguished service to BDRP. Dr. Rogers has served as BDRP’s President, Treasurer, and chair of several committees; was the Society’s inaugural Robert L. Brent Lecturer; and is Co-Editor of the Society’s journal, Birth Defects Research. He is the author of the chapter on Developmental Toxicology for Casarett and Doull’s Toxicology, the Basic Science of Poisons, has mentored many graduate students and postdoctoral fellows, is a frequent lecturer in BDRP’s Continuing Education Courses, and teaches developmental toxicology at the University of North Carolina, Chapel Hill. Dr. Rogers recently retired from the U.S. Environmental Protection Agency after 36 years as a scientist and director.

EpidStrategies, a division of ToxStrategies, Inc., is excited to be participating in the European Hematology Association Virtual Congress, which will be held virtually from June 9^th through 17^th, 2021.

Naushin Hooda, Xiaohui Jiang, and Gina Nicholson will present two virtual posters during the congress, on Friday, June 11, at 09:00 CEST. The posters are titled, “Healthcare resource utilization among patients with cold agglutinin disease in Denmark” and “Increased antidepressant use among newly diagnosed patients with cold agglutinin disease compared with other patients in a large US healthcare system.”

The abstracts will be published in the online Abstract Book, a supplement of HemaSphere (EHA’s official journal), the EHA Library, and the Virtual Congress platform. The abstracts are currently accessible on ehaweb.org, and will be available on the Virtual Congress platform at the time of the presentation. Registration is required to access the platform.

The EpidStrategies team, along with colleagues in industry and academia, have been deeply engaged in ongoing research on cold agglutinin disease (CAD), a rare, chronic type of autoimmune hemolytic anemia. In addition to the CAD work being presented at EHA 2021, our group has presented abstracts at the ISPOR Europe 2020 Virtual Conference (2020) and the Society of Thrombosis and Haemostasis Research Annual Meeting (2020), and has published our work in the peer-reviewed publications Journal of Medical Economics, Research and Practice in Thrombosis and Haemostasis, and Blood Advances.

EpidStrategies scientists are committed to assisting clients in developing therapies for rare diseases and have extensive experience supporting orphan product development and regulatory submissions by estimating target population size, characterizing rare patient populations, and identifying relevant clinical endpoints and potential safety concerns. For more information about our rare disease services, please see our website

ToxStrategies is pleased to announce that John M. Rogers, Ph.D., has joined our Health Sciences Practice, following a distinguished career with the U.S. EPA. Dr. Rogers brings more than 40 years of experience in the areas of developmental and reproductive toxicology, further strengthening the body of expertise that we offer our clients.

Dr. Rogers’ experience includes evaluating and advising on animal and in vitro toxicology research to support U.S. EPA decision-making. He also brings a wealth of teaching experience at Duke University, the University of North Carolina, North Carolina State University, and the University of Miami. In addition, he has held several positions with the Society of Toxicology, in their Reproductive and Developmental Toxicology Special Section, and the Teratology Society (now the Society for Birth Defects Research and Prevention).

Dr. Rogers has served on the editorial boards of The Journal of Toxicology and Environmental Health, Mutation Research – Reviews and The Journal of Developmental Origins of Health and Disease, and also served as an Associate Editor for Environmental Health Research and Birth Defects Research (BDR). He is currently Co-Editor of BDR. He is a recognized expert in developmental and reproductive toxicology, with more than 100 peer-reviewed publications and 40 book chapters, including  writing the chapter “Developmental Toxicology” in Casarett and Doull’s Toxicology (now in it’s ninth edition).

During his distinguished career, Dr. Rogers has won fourteen Scientific and Technical Achievement Awards and three Bronze Medals for his research at EPA, including research on the developmental toxicity of per- and polyfluoroalkyl substances (PFOA) and methanol, maternal toxicity and adverse outcome pathways.

Learn more about Dr. Rogers here .

ToxStrategies Information Specialist Ms. Seneca Fitch is among a group of scientists from the regulatory community, academia, the pharmaceutical industry, and consulting who have published an article in Scientific Reports (an open-access publication of the journal Nature). The paper investigates why some new drugs, having survived the rigorous process of animal and human testing necessary to bring them to market, end up causing unexpected, and sometimes severe, adverse drug reactions in the wider patient population (killing more than 10,000 patients annually in the United States). The authors point out that a battery of new tests and techniques have emerged in the last few decades (referred to as new approach methods [NAMs]) to study the mechanisms of toxicity of chemicals and identify endpoints of concern. Pursuing three separate evidence streams for specific drugs associated with drug-induced liver injury, they propose a “paired-compound approach” to comparing various tests, to reach a systematic, transparent, and evidence-based approach to drug development. 

ToxStrategies is pleased to announce the additions of Dr. LeeAnn Racz as a Senior Engineer and Ms. Jennifer Bare as a Scientist III.  

Dr. Racz comes to the Exposure Sciences Practice with a diverse background in environmental assessment, human health risk assessment, and industrial hygiene, gained in large part from her 23-year career in the U.S. Air Force. She is a Board-Certified Environmental Engineer and Certified Industrial Hygienist, with expertise in environmental health and workplace exposure assessment and environmental engineering and has led teams involved in compliance education, emergency response readiness, and response and recovery at aircraft crash and other accident sites. She has also directed radiation safety programs and managed radiation surveys. As a consultant, Dr. Racz recently worked with a global manufacturing company to develop and implement pandemic protective measures. 

 Ms. Bare is an environmental engineer specializing in quantitative exposure modeling and reconstruction, human health risk assessment, chemical transport analysis, and data management. She designs and applies chemical exposure models for volatile and semi-volatile organic compounds, particulates, and metals, and also reconstructs and predicts community exposures to industrial emissions. Her experience also includes assessing products and chemicals that are regulated under California’s Proposition 65 and USEPA’s Toxic Substances Control Act (TSCA). 

The Biden Administration has directed the Environmental Protection Agency (EPA) to evaluate policies under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure their compliance with statutory requirements.  This evaluation has resulted in significant changes, announced by EPA on March 29, 2021 as to how EPA will assess and manage the risks associated with new chemicals, including changes to:

• The introduction of significant new use rules (SNURs),
• Assumptions about protections afforded by OSHA’s standards as part of New Chemical risk evaluations

SNURs: EPA announced that the agency will no longer exclude conditions of use of a new chemical from their review based on the existence of proposed SNURs. Instead, EPA will review all reasonably foreseen conditions of use. Where a use may present an unreasonable risk, or where there is insufficient information to make a safety determination, EPA will issue an order to address those potential risks, whether or not it is the applicant’s intended or planned use. This new practice will require more information and extend the level of effort and time for EPA New Chemical reviews.

Worker Protection Through Existing OSHA Standards: EPA will no longer assume that workers are adequately protected under OSHA’s worker protection standards and Safety Data Sheets (SDSs) when evaluating the risks of a new chemical. Instead, EPA will identify the absence of worker safeguards as a reasonably foreseeable conditions of use. Under this approach, if potentially unreasonable risks are identified, then necessary worker protections will be mandated through a TSCA order. Thus, reliance on OSHA standards, personal protective equipment, and knowledge provided by hazard communication programs will no longer be incorporated into New Chemical risk evaluations or the resulting risk management actions. EPA has not clarified whether this policy might result in replacement of OSHA occupational exposure limits (OELs) that could be deemed to not meet EPA risk acceptance criteria. It seems likely that this approach will be also be adopted in EPA high-priority existing chemical risk evaluations. A previous article on the ToxStrategies website discussed the significant differences between EPA TSCA worker risk assessments and OSHA assessments used to establish OELs.