The Frank R. Lautenberg Chemical Safety ifor the 21st Century Act, or the “Lautenberg Act,” was signed into law in June 2016, requiring the U.S. Environmental Protection Agency (EPA) to amend the Toxic Substance Control Act (TSCA) regulation with the overall goal of improving the nation's management of chemicals manufactured domestically, as well as those imported into the U.S. In June 2017, EPA Administrator Scott Pruitt signed three final rules meeting EPA's first-year obligations under the Act. Since then, many of the changes intended by the Act have been implemented. The following are three notable aspects of the Act that have been realized to date:
- Transparency for processing Premanufacture Notices (PMNs) has improved through online publishing of PMN statistics;
- Requirements to achieve EPA approval of new chemical manufacture under Section 5 of the rule have been updated; and
- Numerous manufacturers and importers have now submitted the details of chemical substances they manufactured during the “lookback period” of June 21, 2006 to June 21, 2016.
See Trinity's article in the Summer 2017 issue of Environmental Quarterly, EHS Manager's Guide to Toxic Substance Control Act Reform, for an overview of TSCA Reform.
TSCA Inventory Reset Status
The TSCA Inventory Notification (Active-Inactive) Requirements Rule requires manufacturers and importers to notify EPA regarding chemical substances manufactured or imported for non-exempt commercial purposes during the lookback period. This applies to chemical substances on the TSCA Inventory and provides exemptions from these requirements which align with those found in the PMN and Chemical Data Reporting (CDR) rules. Unlike the CDR rule, which has a minimum reporting threshold of 25,000 lbs per site for most chemicals, there is no minimum reporting threshold under the new inventory reset rule.
The manufacturers' deadline to submit a Notice of Activity (NOA) Form A to meet their reporting obligation was February 7, 2018. On April 20, EPA published an update to the non-confidential TSCA Inventory which included those chemical substances that were reported prior to the deadline. All of the chemical substances that were properly reported on a NOA Form A were added to the TSCA Inventory and given a status of “active,” indicating that the chemical substance is actively being used in commerce in the U.S. However, EPA has continued to accept manufacturing notifications from manufacturers and importers beyond the deadline. On the same date, EPA published a list of “Substances Reported in a NOA Form A from February 8, 2018 to March 30, 2018.” This second list is intended for informational purposes only and does not excuse manufacturers from reporting under the Inventory Reset Rule. EPA has also indicated its intent to update this list approximately once per month, implying that manufacturers may be able to continue to file NOA Form A into the foreseeable future.
Finally, the TSCA Inventory published in April 2018 included chemical substances referenced on the Interim List of Active Substances and those designated as Exempt from the Inventory Reset Rule-both of which were previously published by EPA.
TSCA Inventory Reset Implications for Processors
The TSCA Reform Rule differentiates processors from manufacturers. Whereas manufacturers produce unique chemical substances through chemical reactions or import unique chemical substances, a processor uses manufactured/imported chemical substances to prepare a chemical mixture or product for distribution in commerce. Similar to manufacturers, there is no minimum threshold quantity of a chemical substance that must be processed for a company to be considered a processor. To be a processor under TSCA, however, one must process a chemical substance for commercial purposes with the intent of obtaining commercial advantage.
As defined under TSCA, processors of chemical substances include a range of manufacturing operations from mixing and reformulating chemical substances for further industrial use, through producing consumer products such as paints, household cleaners, inks used in printers, and other similar applications. Although processors are not required to complete initial notification under TSCA New Chemical provisions in Section 5 or the Inventory Reset Rule, they are certainly affected by the TSCA Inventory Reset.
In order for a chemical substance to be procured or produced in the U.S., it must be listed on the TSCA Inventory or be exempt from TSCA new chemical requirements. Through the TSCA Inventory Reset, EPA may redesignate chemical compounds that are currently approved for use as inactive. Once EPA has identified a substance for inactive designation and published the updated inventory, a 90-day grace period will be in effect before any further processing of the chemical substance (including use of existing on-site inventory) will be prohibited by TSCA. For manufacturers or processors of a chemical that has an inactive designation, a notification of intent to use the chemical substance (i.e., NOA Form B) must be submitted to EPA during this window. The final designations of active and inactive status are expected to be published by EPA in early 2019. Essentially, if a chemical supplier that manufactures or imports a chemical did not properly report a chemical substance, that substance cannot be used by downstream processors until EPA has been notified.
Chemical substances that are not required to be on the TSCA Inventory are not subject to the TSCA Inventory Reset rule and will not be designated as active or inactive. This includes non-commercial uses of chemical substances used in small quantities for research and development, chemical substances manufactured under low-volume or low-risk related exemptions, pharmaceuticals, certain polymers, and other specific classes of chemical substances. Naturally occurring materials are also not regulated by TSCA. Incorporation of chemical substances into articles is also not within the scope of TSCA, unless the chemical substance is intended to be released from the article during use (e.g., in an ink jet cartridge).
Chemical processors utilizing chemicals listed on the TSCA Inventory that are not yet marked active have until October 5, 2018, to notify EPA that the chemical substance(s) is still in active use in commerce. To determine if this notification is required for chemical substances processed, the April 2018 version of the TSCA Inventory-or more recent if one is published before October 5-should be evaluated to determine if each chemical substance (by CAS number) used by the processor is listed on the Inventory as active. The most recent list of substances reported under the TSCA Inventory Notification (Active-Inactive) Rule should also be consulted for clarification on the potential determination.
If a chemical compound is listed on the TSCA Inventory but is not designated as active, the processor can elect to file the required NOA Form A directly. A processor choosing to make this notification must report the chemical identities and indicate whether it seeks to maintain an existing confidential business information (CBI) claim for confidential chemical identities. Similar to CDR, these forms will be submitted via EPA's Central Data Exchange (CDX) website.
If the chemical substance of interest is not found on these lists, a processor may choose to contact the supplier or manufacturer of the chemical and inquire about the TSCA status of the chemical substance. In certain instances, information may be held by the manufacturer or importer as CBI and it will not be accessible on the TSCA Inventory. In these cases, the chemical supplier may be able to provide a certification of TSCA compliance or the chemical processor may file a joint submission of a NOA Form A with the supplier to ensure that the reporting obligations are met and that the identity of the chemical remains confidential. Both manufacturers and processors must take necessary precautions to ensure that product information designated as CBI is not inadvertently made public through TSCA Inventory Reset reporting.
From Lookback to “Lookahead”
In addition to the retrospective reporting requirements for the lookback period, the rule provides forward-looking reporting requirements for substances identified as inactive after EPA's finalization of the active and inactive designations but that are subsequently expected to be reintroduced. Manufacturers and processors that intend to reintroduce into commerce an inactive chemical for nonexempt purposes once the final designations are complete must submit a report not more than 90 days before the anticipated manufacture or processing of the chemical. This must be completed on NOA Form B and must include the anticipated date by which the inactive substance is intended to be domestically manufactured, imported, or processed. These forms will be submitted via EPA's CDX.
The Inventory Reset requirements of TSCA regulations are intended to streamline and modernize the TSCA Inventory. The updates to the TSCA Inventory inherent in the Inventory Reset process have the potential to affect manufacturers and processors of chemical substances alike. Chemical processors that may not have been subject to TSCA requirements or reporting in the past may now be impacted by the outcome of this reset and are encouraged to evaluate the current status of chemical substances critical to their processes to ensure business continuity. Trinity is monitoring TSCA Reform rulemaking and will continue to work with our clients to ensure compliance with these changes. If you have any questions, please contact your local Trinity office at (800) 229-6655, Ellen Hewitt at 614-433-0733, or Brian Noel at (518) 205-9000.