Last month, the U.S. Environmental Protection Agency (EPA) released an update of the Toxic Substances Control Act (TSCA) Inventory to add, for the first time, commercial activity status data according to new reporting requirements. It’s the first update in almost 40 years.
In spite of its name, the TSCA Inventory is not a “toxics” list. Rather, it’s a list of substances that are allowed to be in U.S. commerce, either because they were in commerce at the time TSCA was enacted in 1976 and added to the original Inventory (under TSCA section 8), or because they entered U.S. commerce after being reviewed as a new chemical substance (under TSCA section 5).
Substances that are not on the Inventory are considered “new” chemical substances and are subject to TSCA section 5 new chemical review.
Determining if a chemical is on the Inventory is a critical step before manufacturing a product using that chemical. Section 5 of TSCA requires anyone who plans to manufacture a new chemical substance for a non-exempt commercial purpose to provide EPA with a Premanufacture Notice (PMN) at least 90 days before initiating the activity.
There are exceptions to this, however. TSCA section 5 exemption applications have a 30-day review period for low volume exemption applications, low environmental release and low human exposure exemption applications; and 45 days for test marketing exemption applications.
If your product is imported into the U.S., there may be differences in reporting requirements for domestically manufactured substances versus imported substances, e.g., less information may be required in a TSCA section 5 notice for an imported substance compared to a domestically manufactured one.
If a substance is subject to regulation under TSCA, it can be commercialized in the U.S. as long as the commercial activity adheres to the requirements and/or restrictions of the regulation. If a company that manufactures, imports, processes, or distributes a substance in U.S. commerce obtains new information that reasonably supports the conclusion that such substance presents a substantial risk of harm to health or the environment, the company is required to notify EPA of such information under TSCA section 8(e). A risk evaluation may be initiated by EPA to determine if a chemical substance presents an unreasonable risk to health or the environment.
Active vs. Inactive
Until this update, it was not known which of the chemicals on the TSCA Inventory were actually in commerce.
Currently, the list identifies more than 86,000 chemicals.
The update indicates that 47% of these chemicals are “active,” which means they have been manufactured, processed, or imported for a nonexempt commercial purpose during the 10-year “lookback” period ending on June 21, 2016.
Under the Active-Inactive rule, a substance is not designated as an “inactive substance” until 90 days after EPA publishes the initial version of the Inventory with all listings identified as active or inactive. The rule provides time for manufacturers and processors to react to an inactive substance identification and to file an Notice of Activity (NOA) Form B prior to the effective date of the inactive designation 90 days later.
Manufacturers and processors should be aware that if there is a substance that is listed as “inactive” that is currently being manufactured or processed, they have 90 days (i.e. until May 20, 2019) to file an NOA Form B so that they can continue their current activity. Manufacturers and processors that intend to manufacture or process an “inactive” substance in the future must submit an NOA Form B before they start their activity.
Also, almost 20% of the chemicals in commerce are considered Confidential Business Information (CBI). EPA is currently developing a rule outlining how the Agency will review and substantiate these chemicals going forward.
What Is a Chemical Substance?
TSCA defines a “chemical substance” (including mixtures) as: “any organic or inorganic substance of a particular molecular identity, including any combination of these substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any element or uncombined radical.”
Chemicals substances on the Inventory include:
- Polymers, and
- Chemical substances of unknown or variable composition, complex reaction products, and biological materials (UVCBs).
Chemical substances not on the Inventory are those with uses not regulated under TSCA. These chemical substances may be governed by other U.S. statutes, for example:
- Foods and food additives,
- Tobacco and tobacco products,
- Nuclear materials, or
With more than 2,000 chemicals introduced annually, the TSCA Inventory is updated almost daily. It will pay to check it often when manufacturing new products. The process can be greatly facilitated through a chemical management system powered by regulatory content from leading providers. Contact Enablon for more information.
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