Chemical manufacturers, importers, and processors must be prepared to identify current and/or foreseeable uses of in-commerce substances and may be required to perform further testing
The Risk Evaluation Rule, published in the Code of Federal Regulations (CFR), is a result of the Toxic Substances Control Act (TSCA) amendment, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA), which required the EPA to publish the process they will use to evaluate the risk of a chemical substances.
The publication of this rule is the third step of the general chemical evaluation process that resulted in the release of 3 major framework rules by the EPA: a rule updating the TSCA inventory (Inventory Reset Rule-see Intertek blog); a rule to establish a process and criteria for identifying high and low priority chemicals (Prioritization Rule-see Intertek blog); and a rule to establish a process for evaluating high priority chemicals (Risk Evaluation Rule). These rules are critical for EPA's implementation of the new TSCA program.
The Risk Evaluation rule codifies the process which the EPA will use to evaluate risks from chemical substances under TSCA Section 6. The process includes identifying the scope, assessing the hazards and exposures, characterizing the risk, and finally determining the risk. Chemical substances designated as high priority substances during the prioritization process and those for which EPA has initiated a risk evaluation in response to a manufacturer request, will be subject to this process.
Risk Evaluations will be based on the risk to health and the environment without consideration of costs. The EPA states it will conduct risk evaluations and define corresponding risk management by focusing on intended uses in commerce. The risk evaluations will focus on known or reasonably foreseen uses and the potential for exposure to the population from all uses. The EPA most likely will interpret the statutory definition of potentially exposed or susceptible subpopulations broadly and may include any subpopulation that may be at greater risk due to greater susceptibility or exposure. The EPA states it will consider the conditions of use on a case-by-case basis.
In response to public comments regarding the potential difficulties of tasking the EPA with identifying and regulating conditions of use within the statutory timeframe, the new rule indicates that the Agency will focus on the conditions of use that raise the greatest potential for risk, while still allowing for a timely and scientifically credible evaluation of the chemical substance.
EPA acknowledges that there may be circumstances where additional information may need to be developed within the risk evaluation process. The LCSA makes it easier for the EPA to request more testing when needed. The EPA may also make a voluntary call for information followed, as needed, by exercising EPA's authorities to require submission or generation of new data.
To make a risk determination, the EPA may weigh a variety of factors including, but not limited to:
The rule identifies the necessary components of the risk evaluation process as scope development (which will include a conceptual model and analysis plan), hazard assessment, exposure assessment, a risk characterization, and a risk determination. The draft scope, final scope, draft risk evaluation, final risk evaluation, and other designated information will be publicly available.
The EPA confirmed that it intends to ensure that the public has a full understanding of how risk evaluations will be conducted to provide transparency and predictability. It also indicated a need to allow the agency flexibility to adapt to changing science.
What can you do?
It is important for manufacturers and importers to work with the EPA, either on your own or as part of industry groups, to ensure that the EPA has all the information necessary to make informed decisions. This is especially true for the determination of uses.
Most importantly, manufactures and importers should develop a full understanding of their products. This investigation should include determining the ingredients in their products and understanding all intended uses.
How can we help?
Stay tuned as Intertek will be closely monitoring these key developments and we will be communicating important opportunities for stakeholder involvement in EPA's chemical inventory activities. Intertek offers a range of services to help you navigate the new chemical evaluation process including: working with your supply chain for the reset; interpreting risk evaluation data; and interpreting the results of EPA's risk evaluation. If you have questions about how the inventory reset, prioritization and risk evaluation rules may affect your business or for any other human and/or environmental health scientific and regulatory services, please contact us.
Today's expert blogger is Rose Passarella. Rose is a Senior Regulatory Manager within the Chemicals Group at Intertek Health, Environmental & Regulatory Services (HERS) with expertise in TSCA and LCSA implementation. Over the last year, she has delivered a series of webinars on the reformed TSCA. All the webinars are available for download and have been designed to provide a brief regulatory overview and provide a "To-Do-List" of actions needed to ensure your business is not negatively impacted. She is well-positioned to help with your chemical management needs due to the unique combination of having a Ph.D. in chemistry, and being a licensed lawyer with extensive experience in the chemical industry.