Author Archives: ToxStrategies

The US Environmental Protection Agency (EPA) has released its draft Risk Evaluation for Trichloroethylene (TCE) for public comment. TCE is the eighth of the first ten chemicals to undergo risk evaluation under amended TSCA. The TCE draft risk evaluation and supporting documents can be found at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/draft-risk-evaluation-trichloroethylene.

The US Environmental Protection Agency (EPA) has finalized low-priority designations for 20 substances under the Toxic Substances Control Act (TSCA), and will not subject them to risk evaluations. “This final list of low-priority chemicals will allow EPA to focus its risk evaluation efforts on the chemicals that could significantly impact public health and the environment,” said the EPA. For more information, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemical-substances-undergoing-prioritization-low.

ToxStrategies scientists attended the 44^th Annual Winter Meeting of the Toxicology Forum January 27–29, where they presented on a wide range of topics, including the use of New Approach Methods (NAMs) in the risk characterization of PFAS; advances, opportunities, and challenges in using NAMs in toxicological evaluations; expanding the use and chemical space of the TTC; and challenges and opportunities in assessing the safety of sunscreen active ingredients. The following ToxStrategies scientists were participants at the meeting:

These scientists are all active in The Center of Excellence for 21^st Century Toxicology, a division of ToxStrategies.

For nearly six decades, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) have served as scientific advisory bodies to the Codex Alimentarius Commission. In light of the increasingly complex nature of chemical assessments in food since publication of the latest guidance in 2009, JECFA/JMPR have initiated multiple efforts to update subchapters in EHC 240 (Principles and methods for the risk assessment of chemicals in food, Environmental Health Criteria 240).

In particular, an updated Chapter 5 in EHC reflects new scientific developments and contributes to international harmonization in the application of dose-response modeling and derivation of acute and chronic health-based guidance values, considering toxicological, microbiological, and pharmacological effects. WHO has opened a public consultation on the updated chapter (and annex), to ensure its transparency and that it contains sufficient detail on the methods, assumptions, and scientific assessment.

Interested parties are invited to submit written comments by January 31, 2020.

Dr. Susan Borghoff, Director of ToxStrategies’ Center of Excellence for 21^st Century Toxicology, was invited to participate in the inaugural Conference on Reducing Animal Testing for Chemical Safety, convened on December 17, 2019, by EPA’s Office of Pesticide Programs. Approximately 60 scientists from government, academia, and industry were present at the full-day meeting, and were joined by more than 600 individuals in the morning session via teleconference. The gathered experts in environmental and chemical safety research discussed advancements in New Approach Methods (NAMs), to assess the current state of chemical safety research and discuss scientifically valid alternatives to animal testing. According to EPA, “This event, which will take place annually, is a major step in implementing [the Agency’s vision] to aggressively pursue reductions in animal testing.”

Dr. Borghoff brought her expertise in study design and managing research and regulatory-driven toxicology to the breakout group that discussed “Variability and Relevance of Current Animal Tests and Expectations of NAMs.” In her 30-year career, Dr. Borghoff has managed diverse research programs for both industry and government clients. Recent efforts have been focused on the development and implementation of a framework to evaluate both in vitro and in vivo mechanistic data into hazard characterization.

A recently published article by ToxStrategies scientists and others presents the systematic identification, appraisal, and integration of mechanistic data in an assessment of potential carcinogenicity of the non-nutritive sweetener sucralose. Based on the evaluation of over 700 measurements/assay endpoints related to one or more key characteristics of carcinogens (KCC) reported in the literature and via high-throughput screening data, the authors found a lack of evidence for activity across the mechanistic database. These results align with the overall lack of tumor response to sucralose in rodent cancer bioassays, corroborating previous reports of a lack of carcinogenicity related to sucralose exposure. The open-access article can be found here: https://www.sciencedirect.com/science/article/pii/S027869151930688X.

EpidStrategies, a division of ToxStrategies, is founded on rigorous scientific principles that guide our research on complex health conditions. We are scientists who provide consulting services to public and private sectors worldwide. With a focus on pharmaceuticals, medical devices, nutrition, and environmental chemicals, our scientists aid clients in the conduct, evaluation, and interpretation of epidemiologic studies. We are seeking an epidemiologist to join our team of epidemiologists and statisticians conducting systematic literature reviews and statistical analyses, and preparing manuscripts.  EpidStrategies offers a challenging and dynamic work environment, professional development opportunities, and competitive compensation and benefits.

Specific job responsibilities include:

• Perform systematic literature reviews following establishing guidelines such as PRISMA
• Conduct statistical analyses using SAS, STATA, or R
• Write project proposals and other technical documents
• Draft conference abstracts and manuscripts
• Develop new and maintain existing client relationships
• Project management including oversight of multiple project timelines, deliverables, and budgets

Ideal candidate will have:

• MPH, MS, or PhD in a relevant field such as epidemiology
• Approximately 3-5 years of work experience
• Strong writing and communication skills
• Experience conducting literature reviews
• Proficiency in at least one statistical computing package
• Familiarity with attending and presenting at professional conferences
• Existing authorization to work in the United States

Interested candidates should send a cover letter and CV to hr@toxstrategies.com.

ToxStrategies scientist Dr. Bill Rish is a co-author of a new article that demonstrates acceptably low doses of naturally occurring radiation (NORM) when using the waste from alumina production (APR, or alumina production residue) in producing and using cement. Putting APR to this beneficial use, instead of storing it indefinitely, has raised concerns about workers involved in cement production or use, or members of the public, being exposed to radiation. The findings of Dr. Rish and colleagues, however, demonstrate that workers or the public being exposed to radiation over the life cycle of APR reuse will not receive doses in excess of any current risk-based standards. The article is published in the Journal of Air & Waste Management Association.