Regulatory impact of the US Toxic Substances Control Act reformsBy Envigo - 6th July 2018
The experts at Envigo tell us how the TSCA reforms have created an acute need to carefully analyse and interpret all available data, to ensure regulatory compliance as well as consumer and environmental safety.
The updated Toxic Substances Control Act (TSCA), signed into Law on 22nd June 2016, allows the Environment Protection Agency (EPA) to assess chemical risks to human health and the environment, and to take action to control these risks. The Act authorizes the EPA to keep an ‘inventory’ of existing chemicals. Only chemicals on the inventory, which at present comprises around 83,000 products, can be manufactured or imported into the US.
TSCA provides the EPA with the power to regulate existing and new chemicals. All new chemicals are reviewed by the agency prior to being placed on the market. The EPA can ban the manufacturing or import of a chemical if it poses an unreasonable risk. The EPA issues restrictions on chemicals if it concludes that certain uses present an unreasonable risk and, if required, can demand additional data from manufacturers to determine risk levels.
The EPA gives all active substances either a high or low priority designation. High priority chemicals require a safety determination on whether they pose unreasonable risks of harm to human health or the environment. Low priority chemicals do not require further action, but can be elevated to high priority based on new information.
A safety assessment evaluates risk, whilst safety determination evaluates whether a chemical meets the safety standard risk. In this context, risk is based both on hazard and exposure. The EPA will evaluate both the hazard of the chemical and the extent to which humans or the environment are exposed to them. This assessment will be science-based and, if insufficient information is available, the authority can request manufacturers and processors to provide more data or testing using a tiered-testing approach.
Under the revised Act, the EPA is required to conduct risk evaluations for ten of the chemicals on the 2014 TSCA work plan. The agency is tasked with expediting review of those chemicals and, within three years, must propose a rule to manage the risk evaluation of these products and consequently all persistent, bioaccumulation or toxic (PBT) chemicals. Therefore, thousands of previously unregulated chemicals will now be regulated.
The EPA has 90 days following a pre-manufacture notification (PMN) to approve the manufacturing of a chemical, and must provide affirmative decisions on new chemicals or significant new use notifications (SNUNs) of existing chemicals before the product can enter the market. Depending on the outcome, the EPA will either place a ban on a chemical, request additional data or have it tested.
The chemicals industry will also be required to provide comprehensive information to substantiate confidential business information (CBI) claims. Companies must justify why they are entitled to confidentiality, the steps taken to keep the information secret, and how disclosure would cause competitive harm. They could be asked to supply information regarding chemical manufacture, process or distribution, marketing/sales, chemical identity/name and CAS number. All health and safety data will remain public. Unless renewed, all CBI claims expire after ten years.
As a first step, industry will need to review the TSCA work plan list and submit to the EPA information on ‘active’ chemicals (those manufactured or imported into the US), for them to be included on the ‘active’ list. Additionally, PMN and SNUN submissions need immediate submission. Industry should consider actions and decisions made under EU REACH regulation/ECHA and by Canadian regulatory authorities, be proactive in providing information to the EPA that defends their chemicals, and comment early on the scope of the assessments. Industry should also review the agency’s databases to identify any information gaps/studies that may be required to assess specific uses and exposure. The 2016 TSCA reforms implement new requirements on the use of animal alternatives and read-across approaches, i.e. quantitative structure activity relationships (QSAR’s). Companies must be prepared to provide detailed information to justify the need for confidentiality, and monitor the EPA’s requirements for new certification statements.
The TSCA reforms have created an acute need to carefully analyse and interpret all available data. In these circumstances, it is important for organizations to partner with a regulatory consultancy that understands the context of data against relevant regulations, and which can help identify any potential gaps to minimize the risk of rejection or the request for new data. A supplier with the capability and expertise in alternative testing methodologies (e.g. QSARs) could also be advantageous as this will be a key strategic area that the EPA will be developing from 2018 onwards.
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