Around the 3rd century B.C., the island of Kos was home to one of the greatest collections of written medical works ever known. This Hippocratic Corpus included about 70 pieces, attributed to Hippocrates, known as the “Father of Modern Medicine” and the man behind today’s Hippocratic Oath, taken by professionals in the medical fields. These lists remain foundational and include terms and practices that changed the course of medicine in the ancient world. But although the spirit of some of these practices remain, most terms, instruction, methodology and treatments have changed over time.
Time changes things.
In 1978, the Environmental Protection Agency (EPA), under the Toxic Substances Control Act (TSCA), called for the submission of lists of chemical substances manufactured or processed, including imports, used in commerce. The first comprehensive list of about 62,000 chemicals was published in 1979 and since that time, about 22,000 substances have been added to this list, called the TSCA Inventory. Like a corpus of chemical names, this list has increased over time, and legislation was required to change the current inventory list and remove substances that are no longer in commerce.. Therefore, the EPA has set out to strengthen the management of this list with the TSCA Inventory (Active-Inactive) Rule.
What is the reason and purpose of the reform?
The TSCA Inventory is a list of all existing non-exempt chemical substances manufactured, processed or imported into the United States. Like any regulation, a few exemptions exist regarding what chemical substances are subject to TSCA. Basically, businesses can’t sell, manufacture, import or process a chemical substance if it is not on this list, and new substances are added to the list as they are introduced in commerce. Since there was no mechanism to indicate when a substance was no longer in commerce, over time, the TSCA Inventory did not provide a completely accurate list of chemicals used in commerce in the United States.
The Inventory Notification (Active-Inactive) Rule was published as a mandate by statute, set out in the Lautenberg Chemical Safety Act. The purpose of the rule is to get a more accurate picture of the chemicals that are currently being used in an effort to evaluate chemical safety to provide the most impact to protect people and the environment. The result? A better-defined list of active chemicals.
To accomplish this reset, the EPA began with identifying substances designated as Active (based on other activities required under TSCA). For substances on the existing TSCA Inventory, manufacturers and importers of chemical substances must submit a notification for each substance that they have manufactured or imported from June 21, 2006 to June 21,2016. Manufacturers and importers for substances that are listed as confidential on the inventory will also need to submit additional notification to justify their confidentiality claim if they want the information for a substance to remain proprietary on the inventory. Processors can also submit a notification as well but this is not required. The completion of the notification period will result in a comprehensive TSCA Inventory list with substances designated as either Active or Inactive. Active substances will be present in commerce, and Inactive substances although not present in commerce can be “re-activated” with the submission of a notification to the EPA.
What is required by Manufacturers, Importers and Processors?
Manufacturers and importers of (non-exempt) substances are required to provide a notification to the EPA for substances manufactured (or imported) for non-exempt purposes from June 21, 2006 to June 21, 2016. This notification must be submitted electronically using the EPA’s CDX system. There are two types notice forms:
- Notice of Activity Form A – used for retrospective reporting or to list a substance as active at the end of the initial notification period.
- Notice of Activity Form B – used for forward-looking reporting or to move a substance from inactive to active.
Processors aren’t required to act. Their participation is completely voluntary. However, processors may want particular chemicals or particular substitutes on the active list to protect continuity of business, promote sustainability and reduce operational risk (fines, etc.). If a processor chooses to participate the notification for processor is the same as for a manufacturer (or importer).
Are there any exemptions from reporting?
Any business that is manufacturing, processing, distributing or using a substance that is not listed as Active once the reset is complete would be in violation of this part of TSCA. Violations could result in fines between $25,000 and $50,000 per day and disruptions in business continuity across the entire supply chain. However, exemptions exist for some substances:
Yes, the exemptions from reporting are below:
- Excluded Chemical Substances – any chemical substance not covered by the terms chemical substance subject to commercial activity designation and reportable chemical substance as defined at 40 CFR 710.23.
- Manufacturing or processing for an exempt commercial purpose – see 40 CFR 710.27.
- Chemical substances for which EPA already has an equivalent notice – this includes the following 3 scenarios: – see TSCA Inventory Notification (Active-Inactive) Requirements Fed Reg Vol. 82, No. 154 (August 11, 2017) Federal Register: The Daily Journal of the United States. Web. 11 August 2017.
- Chemical substance that are on the list of interim active substances published on the EPA website.
- Substances that were added to the Inventory between June 12, 2006 and June 21, 2016.
- Substances for which the manufacturer has evidence in the form of a CDX receipt documenting that the EPA has received a NOA Form A from another manufacturer. (The Summary of the Final Rule section of the copy published in the Federal Register does note some important considerations when relying on this exemption that should be reviewed before making an informed decision to rely on this particular exemption.)
If a manufacturer (or importer) has a substance that is on the confidential portion of the inventory but this substance falls under an exemption, a notification must be completed if the manufacturer (or importer) wishes to maintain the confidentiality of the listing.
What can we expect moving forward?
The period to submit notifications began on August 11, 2017. Since that time, the EPA has provided the following information that we assembled into a timeline.
The EPA is also undertaking efforts to prioritize substances for risk evaluation and will also be conducting risk evaluations. Input from industry for these activities will be essential as the EHS industry looks forward to pursuing safer, smarter workplaces and communities.
About the Author
Erika Scrimpshire is the Senior Product Marketing Manager at SiteHawk. A resident of Nashville, TN, Erika helps the SiteHawk Product and Marketing teams in their vision to deliver innovative compliance solutions and drive safer, smarter workplaces.