TSCA Stakeholder Meeting for Risk Assessment and Risk Prioritization- Will Your Business be Ready?

Posted on Behalf of  Michael Ierardi

TSCA Stakeholder Meeting for Risk Assessment and Risk Prioritization- Will Your Business be Ready?

The U.S. Environmental Protection Agency (EPA) held two public meetings to gather input that will inform a proposed rule to establish a risk-based process for chemical prioritization (August 10), in addition to its process for conducting risk evaluations to determine whether a chemical presents an unreasonable risk of injury to health or the environment under TSCA section 6(b) (August 9).

By June 2017, EPA must decide on a risk-based screening process for evaluating new and existing chemicals. The previous “unreasonable risk” standard will be replaced by the “safety standard” for regulating chemicals, which will consider both hazard and exposure in a risk-based approach that is protective of human health and the environment.

During these meetings, stakeholders from government, private industry, academia, non-governmental organizations, as well as medical professionals, offered feedback regarding their suggestions and concerns. Cardno ChemRisk scientists, Dr. Denise Hill and Ms. Claire McMenamy attended the meetings, and offer the following observations, as well as the selected comments, repeatedly offered by multiple stakeholders.

· It is essential to have transparency in the process of developing the guidelines that EPA will promulgate in the coming months.

· EPA must determine what data sources are acceptable, such as those from third parties.

·  Approaches to filling data gaps must be considered; strong support was offered by multiple stakeholders for alternative toxicological testing approaches that avoid the use of vertebrate animals, and for validated and appropriate computational modeling.

· EPA needs to improve and expand upon their current exposure assessment methodologies. For example, it’s important that low-exposure/low-risk uses be identified in the development of the Risk Evaluation.

· Exposure models should consider potentially exposed and susceptible populations, such as pregnant women and infants, workers, populations near facility fence-lines, and populations that may experience higher exposures due to their lifestyles, such as the diets of some American Indian and Alaska Native populations.


The agendas and EPA webinar slides are available here.

Will Your Business be Ready? Start preparing now.


Consider working with ChemRisk to develop comments for submittal to the EPA by August 24, 2016.


It is imperative that companies begin to review their product lines to identify chemicals that are critical to their business and prepare them for potential review. Is there a product or chemical that could really impact your bottom line if EPA pulled it off the market or restricted its use?

Our scientists are able to assist in:

· Reviewing product chemistries,

· Gathering and evaluating existing toxicity data, and

·  Identifying data gaps to be filled.

Please contact Dr. Denise Hill to learn more about ChemRisk’s capabilities in this area.