U.S. EPA issues TSCA Inventory Rest Rule: Substances are designated as 'active' and 'inactive'
Chemical manufacturers, importers, and processors must comply with upcoming reporting deadline or face loss of business
01 August 2017
This Inventory Reset Rule has been published as a result of the Toxic Substances Control Act (TSCA) amendment, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, requiring EPA to designate chemical substances as either "active" or "inactive".
The publication of this rule is the first step of the general chemical evaluation process that has resulted in the release of 3 major framework rules by the EPA: a rule updating the TSCA inventory (Inventory Reset Rule); 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 will be critical for EPA's implementation of the new TSCA program in the years to follow.
The Inventory Reset Rule is retrospective. For chemicals listed on the inventory, companies are required to file a Notice of Activity (NOA) for any U.S. activities (e.g., manufacturing, importing or processing) over the last 10 years, ending on June 21, 2016. This notice will ensure that a substance remains on the "active" inventory. The NOA must contain the chemical identity and indicate whether a company wants to maintain the Confidential Business Information (CBI), if applicable.
The EPA removed the proposed requirements to report commercial activity type and date range, as the EPA has determined these requirements are unnecessary to achieve the objective of designating substances as active or inactive on the Inventory. Forward-looking reporting includes: chemical identity information; the anticipated date of manufacturing or processing; and an indication of the need to maintain CBI. For all new claims other than for chemical identity, certification statements regarding the basis for the CBI claims must accompany the submission. EPA will review a subset of these claims.
Companies are exempt from reporting if:
- they reported their chemical in the 2012 and/or the 2016 CDR;
- their chemical was added to the inventory via a Notice of Commencement (NOC) filed between June 21, 2006 and June 21, 2016;
- their chemical was added to the Inventory on or after June 22, 2016;
- or they have evidence (a CDX receipt) that another manufacturer reported it (Note: if manufacturer withdraws, it is responsibility of the company that was relying on the reporting to ensure the substance is on the active list).
Once finalized manufacturers will have 6 months from the effective date of the rule to ensure their chemicals are listed on the inventory as active. Processors will have an additional 8 months. Joint submissions will be permitted.
What can you do?
Manufacturers and importers should pay careful attention to "exempt" substances (see above) to ensure nothing is missed. Processors should consult with their suppliers to ensure no business-critical chemicals are missed. Also, companies should pay special attention to infrequently made or purchased chemicals to ensure full coverage of your product line. Most importantly, please start now!
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 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.