On April 27, 2020, the US Environmental Protection Agency (EPA) released the draft risk evaluation of perchloroethylene for public review and comment. Perchloroethylene is the last of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).
The US Environmental Protection Agency (EPA) released the second set of Scope Documents for chemicals undergoing risk evaluation under TSCA and is soliciting public comment. Those seven chemicals include: Butyl benzyl phthalate, Dibutyl phthalate, Dicyclohexyl phthalate, Di-ethylhexyl phthalate, Di-isobutyl phthalate, Formaldehyde, Phthalic anhydride. Links to these chemicals can be found at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemicals-undergoing-risk-evaluation-under-tsca.
ToxStrategies’ scientists have proposed potential expansions of the use cases for the threshold of toxicological concern (TTC) in human health risk assessment applications. Analyses indicate that conservative TTC values for chemicals are, on average, approximately six-fold lower than IRIS derived reference dose (RfD) values for noncancer effects. The findings have three potential applications: (1) serve as provisional toxicity values estimated from TTC Cramer Classifications in data-poor or emergency situations, (2) serve as a comparator for toxicity criteria derived by multiple agencies or stakeholders, and (3) identify RfD values that might warrant reanalysis when they are substantially lower than their corresponding TTC value. Importantly, the findings reaffirm the health protective nature of TTC values, with the majority of TTC values being lower than their corresponding RfD values.
The open-access article was published in Regulatory Toxicology and Pharmacology.
ToxStrategies scientists have the following e-posters available for viewing via the SOT Virtual Meeting Program. Please click on the poster to view abstract and full poster.
Dr. Ali Chesney, lead author on The Process and Challenges of Deriving Exposure-Based Limits for Toxicological Risk Assessment for Components and Impurities Present in Cell Therapy Products with Case Studies
Dr. Allison Franzen, lead author on An Adverse Outcome Pathway for Renal Tumors in Male Rats through Chemical induction of α2u-globulin (α2u) Nephropathy (α2u-N)
Deborah Proctor, lead author on Risk Assessment of Manganese Exposure for Pica Child: Application of PBPK Modeling
Dr. Rayetta Henderson, lead author on Creating a Literature Database for Cannabidiol (CBD): Systematic Evidence Mapping
Dr. Caroline Ring, lead author on Quantitative integration of dose-response data for relative potency estimates of dioxin-like chemicals
Mina Suh, lead author on Oral and Inhalation Bioaccessibility of Cobalt and Nickel in Metal Alloys: A Critical Consideration for Site-Specific Human Health Risk Assessments and Read Across
Dr. Chad Thompson, lead author on Exposure to Environmentally Relevant Concentrations of Hexavalent Chromium Do Not Induce Ovarian Dysfunction in Mice
Dr. Daniele Wikoff, lead author on Systematic Characterization of Hexavalent Chromium and Potential Female Reproductive Outcomes – Application of US EPA Critical Appraisal Tools and Stepwise Inclusion of Mechanistic Data
Please follow us on Twitter and LinkedIn for our upcoming featured poster of the week.
Over the next several months, the Society of Toxicology will host live webinars of sessions and courses originally scheduled for the 2020 SOT Annual Meeting.
Information on confirmed webinars and registration details can be found here.
Due to concerns over COVID-19 (Coronavirus), the Texas Commission on Environmental Quality has canceled the 2020 Environmental Trade Fair & Conference.
Next’s years Trade Fair & Conference is tentatively scheduled for May 11-12, 2021.
This week, the US Food and Drug Administration (FDA) released guidance for sponsors conducting clinical trials on how to manage ongoing and planned activities. This guidance emphasizes patient safety and communication. FDA noted that the decisions about continuing with patient recruitment and treatment, implementing alternative options for patient monitoring or visits, or discontinuing a trial may depend on specific, individual circumstances. Changes or missing information with regard to COVID-19 should be well documented, and the clinical study report should describe contingency measures, a list of all participants affected, and the analyses and corresponding discussions that address the impact.
The complete guidance document can be found here.
ToxStrategies is seeking an experienced toxicologist/pharmacologist (minimum of 3 years in biopharmaceutical/pharmaceutical experience, in industry, government [FDA], or Contract Research Organizations [CROs]), to join our expanding Biopharmaceutical/Pharmaceutical consulting practice. ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. Scientists in our Biopharmaceutical/Pharmaceutical Practice provide consulting services to pharmaceutical companies in all phases of the drug development process. This includes providing clients with scientific, strategic, and regulatory expertise in the nonclinical safety assessment of biopharmaceutical/pharmaceutical products. This position requires understanding the scientific and regulatory process for the development of biopharmaceutical/pharmaceutical products for a variety of therapeutic indications. The candidate must be familiar with current ICH and regulatory guidelines for drug development, as well as industry trends and new techniques and methods used in safety assessment studies.
This position will involve designing and overseeing nonclinical safety assessment programs for drug candidates, developing study protocols and reports, and interpreting data from various studies for the client and regulatory authorities. The candidate will be responsible for writing various regulatory documents (e.g., pre-IND packages, INDs/CTAs, BLAs/NDAs, Investigator Brochures), as well as risk assessments/monographs for drug components (e.g., impurities, solvents). Within ToxStrategies you will work alongside toxicologists, epidemiologists, engineers, and biostatisticians who are recognized as leaders in their respective fields. This position offers a stimulating and challenging work environment, opportunities for professional development and leadership, and competitive compensation and benefits.
For more information on ToxStrategies’ practice areas and team, please visit www.toxstrategies.com. To apply, please submit a cover letter and resume to hr@toxstrategies.com.
ToxStrategies is an Equal Opportunity Employer and a Woman-Owned Business.
