US EPA publishes the TSCA Prioritization Rule: Substances are to be designated as high-priority or low-priority
Chemical manufacturers, importers, and processors must be prepared to work with the EPA for high-priority substances under new rules.
22 August 2017
The Prioritization Rule has been published in the Code of Federal Regulations (CFR) as a result of the Toxic Substances Control Act (TSCA) amendment, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which required EPA to publish the process they will be using to designate chemical substances as either High- or Low-Priority for the next step of risk evaluation.
The publication of this rule is the second step of the general chemical evaluation process that has resulted in the release of 3 major framework rules by EPA: a rule updating the TSCA inventory (Inventory Reset Rule-see Intertek blog); a rule to establish a process and criteria for identifying high priority chemicals and low priority chemicals (Prioritization Rule); and a rule to establish a process for evaluating high priority chemicals (Risk Evaluation Rule). These proposed rules are critical for EPA's implementation of the new TSCA program.
The Prioritization Rule makes transparent the guidelines that EPA will use in identifying substances believed to have the greatest hazard and exposure potential (High-Priority chemicals) that must be evaluated before those substances believed to present less risk. It is not an exact scoring or ranking system. Designations are based on the chemical substance, and are not limited to a specific use. However, EPA may identify the "circumstances" that constitute the "conditions of use" for each chemical substance. EPA will seek to identify candidates for the Low-Priority designation if the information on the potential for harm or adverse effects is sufficient to establish that a risk evaluation is not warranted.
The prioritization process begins when EPA publishes the identity of a substance, along with the reasons behind the selection for prioritization, in the CFR. EPA will require all related information, including hazards, health effects, exposure and common uses, to be submitted within the 90-day comment period.
There is no formal part of the Prioritization Rule that offers a warning to industry about a given substance, (i.e. no "pre-prioritization" process). However, EPA will begin a stakeholder engagement process to collect comments addressing pre-prioritization activities as early as Fall of 2017, in order to ensure industry has sufficient information prior to selection and the start of the process.
Please remember, a prioritization designation does not determine if a chemical presents an unreasonable risk— as it is not a risk evaluation. The high priority label means that EPA will require a full risk evaluation on this substance. Following the risk evaluation, if warranted, EPA may regulate that substance.
Some of the criteria EPA will use to screen the proposed candidates include:
- hazard and exposure potential;
- persistence and bioaccumulation;
- potentially exposed or susceptible subpopulations;
- storage near significant sources of drinking water;
- production volume/changes in production volume;
- other risk based criteria relevant to EPA's priority designation.
EPA may consider inactive substances, as they are still chemical substances on the TSCA inventory. They may also consider substances newly added to TSCA inventory following Pre-Manufacture Notification (PMN) review. However, both scenarios are not likely. Most likely, high-priority candidates will be selected from the substances listed in the "2014 Update of the TSCA Work Plan for Chemical Assessments" that have been established as having high persistence and bioaccumulation scores, are known human carcinogens, and have high acute and chronic toxicity.
What can you do?
It is important for manufacturers and importers to work with EPA, either on your own or as part of industry groups, to ensure EPA has all the information necessary to make informed decisions. If information, such as toxicological data or use or exposure information, on a substance that has been designated a high-priority substance is available, it should be provided during the comment period.
Most importantly, manufacturers and importers should develop a full understanding of their products. This investigation should include determining the ingredients in their products and understanding whether any of these ingredients are included in the 2014 TSCA Work Plan. If their products do include these substances, companies should ask themselves whether they have looked for any substitutes and whether they know their downstream users, releases and disposal, etc.
How can we help?
Stay tuned, Intertek will be closely monitoring these key developments, and 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.