October 3, 2018
Navigating TSCA Reform: Evolving Chemical Hazard Evaluation Strategies for SMEs
You’re invited to a two-part webinar series.
Series summary: Recent regulations, such as the 2016 amended Toxic Substances Control Act (TSCA), and regulatory agencies, such as the European Union (EU), have begun to encourage alternatives to animal testing to assess chemical hazards. These efforts aim to replace animal tests with reliable and validated non-animal methods. This webinar series will highlight the regulatory landscape of toxicity testing requirements and the acceptance of animal testing alternatives for industrial chemicals, with a specific focus on the 2016 update to TSCA. It will showcase novel and emerging non-animal hazard evaluation strategies for compliance under regulations such as read-across, high-throughput assays, and quantitative structural-activity relationships (QSAR).
“Chemical Safety Evaluation Challenges of the Lautenberg Chemical Safety Act (LCsA)”
Thomas A. Lewandowski, Ph.D., DABT, ERT, ATS, Principal, Gradient
LCSA joins an array of regulatory schemes (and green chemistry initiatives) that may require substantial data on chemical health hazard. These new programs add substantially to the overall demand for chemical health hazard testing, but existing chemical testing approaches (e.g., traditional animal study toxicology) are limited in terms of the information they provide and are too slow and too expensive to meet the expanding need. We will highlight some of the latest approaches and tools available for chemical hazard evaluation and briefly establish the regulatory context for the presentations that follow.
“Strategies for Incorporating In Silico and In Vitro Approaches Into the Safety Evaluation of Existing and New Products”
Pamela J. Spencer, Ph.D., D.A.B.T. Senior director, Regulatory Affairs & Product Stewardship ANGUS Chemical Company
Under the new Lautenberg Chemical Safety Act (LCSA), unless EPA restricts a PMN substance, it is now required to make an affirmative finding that the substance is not likely to present an unreasonable risk of injury to health or the environment before non-exempt commercial manufacture can begin. As a small company with limited toxicology expertise, we have been able to create a modified stage-gate process to inform the information needs to improve successful outcome of a PMN under LCSA. The approach incorporates a well-defined, tiered use of new approach methodologies (NAMs) to provide early screening level safety information that can serve as a model for other small chemical companies.
“In silico Modeling as a Tool to Aid Design of Safer Preservatives for Consumer Products”
David Faulkner, M.P.H., Ph.D. Postdoctoral Fellow, Berkeley Center for Green Chemistry
Preservatives are crucial components of consumer products – from personal care products to building materials – but concerns about the human and environmental health impacts of these compounds has prompted research into safer compounds to fill this vital purpose. We investigated the antimicrobial properties of a series of phenolic compounds, conducted a hazard assessment using a range of computational tools to fill data gaps, compared our novel compounds to a suite of compounds currently in use, and developed safer compounds with comparable efficacy to extant preservatives.
“Generalized Read-across (GenRA), Research, Implementation, and Practical Application”
Grace Patlewicz, Ph.D., National Center for Computational Toxicology
Generalized read-across (GenRA) aims to facilitate systematic, objective and reproducible read-across predictions for in vivo toxicity endpoints and provide quantitative measures of uncertainty for the predictions derived. Dr. Patlewicz will present an overview of (GenRA), its implementation as a webtool within the EPA CompTox Chemicals Dashboard and ongoing research. This webinar does not necessarily represent U.S. EPA policy.
“Does One Size Fit All? Tailoring Read-across Methodology Based on Endpoint-specific Criteria”
James W. Rice, Ph.D., Senior Environmental Scientist, Gradient,
There are consumer product manufacturers for whom product evaluation and associated chemical safety fall outside the scope of large chemical registration programs (e.g., TSCA and REACH), but who are interested in specific health endpoints related to use of their products or proposed products. In response, we have developed and validated a read-across framework aimed specifically at filling dermal sensitization and irritation data gaps. The framework quantifies structural similarity between proposed surrogates and target chemicals and shows an expected common mode of action via structural alerts and relevant chemical properties.
“Use of Alternative Methods to Address Health and Environmental Hazards”,
Ann Tveit, Ph.D., D.A.B.T, Toxicology Manager, BASF Corporation,
Chemical regulations are increasing globally, some of which focus on reduction of number of animals used, refinement of methods, and replacement with non-animal approaches. Choosing appropriate alternative approaches requires a review of available information and expertise in toxicology, chemistry and analytics. No ‘one-size fits all” approach exists and consideration on a case by case basis by chemical and endpoint is needed. Depending on the complexity, alternative methods may not always result in lower cost or less time. When properly used and justified, alternative approaches may be useful to evaluate health and environmental hazards. Examples of alternative approaches used in selected REACH dossiers submitted to the European Chemicals Agency will be presented.