How Does it Apply?
The amendments to the Toxic Substances Control Act (TSCA) require the EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce. To accomplish this, the Environmental Protection Agency (EPA) is proposing to require a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for non-exempt commercial purposes during the10-year time period ending on June 21, 2016. EPA would also accept such notices for chemical substances that were processed. EPA would use these notifications to distinguish active substances from inactive substances.
You may be affected by this action if you domestically manufactured, imported or processed chemical substances listed on the TSCA Chemical Substance Inventory for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016. You may also be affected by this action if you intend to domestically manufacture, import, or process chemical substances listed on the TSCA Chemical Substance Inventory in the future.
The following list of North American Industrial Classification System (NAICS) codes are not intended to be exhaustive, but rather provides a guide to help readers determine whether this action may apply to them:
- Chemical Manufacturing or Processing (NAICS code 325).
- Petroleum and Coal Products Manufacturing (NAICS code 324).
EPA makes the Inventory available to the public online, and it is a very useful tool. It is also important to recognize the tool's limitations, however, and that other review steps may be necessary in a particular situation. This article flags several of them.
Red Flags to Be Aware Of
The TSCA Inventory is a list of more than 80,000 chemicals in commercial production and use in the United States. If a chemical is not on it, a company generally must file a Pre-Manufacture Notice (PMN) with EPA 90 days prior to commercial production. In response to PMNs, EPA conducts a review to determine possible adverse human health and environmental effects of the “new” chemical. If that review shows acceptable results, and after the PMN submitter commences commercial manufacture and notifies EPA of that fact, EPA places the chemical on the Inventory
If the review shows concerns, however, the agency can place enforceable restrictions on the chemical. These may include workplace air exposure limits, mandatory worker use of respirators, or prohibitions on water releases, among many others. EPA also has the authority to completely prohibit production of a chemical, but this is unusual. Instead, companies may voluntarily decide against manufacturing a substance if the requirements of a 5(e) consent order are too onerous.
The same restrictions typically are applied to any subsequent manufacturers by the agency's promulgation of a Significant New Use Rule (SNUR). The restrictions imposed on the submitter typically are embodied in a consent order issued under authority of TSCA Section 5(e). Any TSCA rules applicable to a substance are indicated on the Inventory.
Looking at Publicly Available Information May Not Be Enough
The Inventory and Federal Register notices summarizing PMN submissions, notices of commencement, and SNURs are vital and useful indicators about competitors' activities and regulatory controls that may apply to one's own company if it produces the same or similar chemicals. But searching EPA's Chemical Substance Inventory is more complicated than one might guess.
There are two sections to the Inventory:
- The Public Inventory, in which a chemical's composition is fully disclosed (CAS number, complete chemical name, chemical formula)
- The Confidential Inventory, in which no CAS number is provided and only a generic name is included.
The exact chemical composition of the substance cannot be discerned from this generic name. Chemicals are placed on the Confidential Inventory when a company can justify to EPA that there is a valid need to hide the chemical identity from competitors and the public.
First, if EPA determines that the substance is not on the Confidential Inventory, the agency notifies the submitter of that fact and a PMN then must be filed and reviewed before commercial manufacture can commence.
Second, if the chemical falls into a listing on the Confidential Inventory, the agency notifies the submitter of that fact and of any SNUR restrictions that apply. The submitter then must either comply with the SNUR restrictions or file a Significant New Use Notice (SNUN) with EPA prior to manufacture. A SNUN essentially mimics the PMN notice and review process for the submitter.
Before filing for TSCA
EPA also has been considering issuing guidance to change the Inventory status of listed “statutory mixtures” for ceramics, cements and frits, likely to newly require PMNs to be filed for these complex substances.
EPA reached settlements on at least two PMN enforcement cases in 2012, with the larger penalty equaling $1.4 million. The best way for chemical producers and importers to avoid such penalties is to study the TSCA Inventory and PMN process, keep up with new developments and, if any doubt exists, consult experienced experts.
MMA Environmental has encountered multiple instances of this rule with clients who have received communication from chemical suppliers requesting confirmation of the reporting completion for TSCA. It is important to be sure that this report applies to your facility before responding to these types of inquiries. For specific questions regarding the rule, please contact your MMA Environmental representative.
Interested in learning more about how political change can affect regulatory bodies? Join us for an MMA Seminar, "Safety & Environmental Compliance Update" on March 29, 2018.