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- Does your company supply an article going into the United States or manufacture an article there?
- Does your company understand what the “New TSCA” might mean for your article or otherwise regulated product going forward?
- Do you understand the substances in your article that have the potential to be harmful, if even at a parts per trillion dose when considered persistent in the body- bioaccumative or even toxic (PBT)?
- Does that same PBT substance(s) find its way into drinking water or the environment?
Now is the time article manufacturers should begin, if they haven’t already, collecting data on substances in their goods from their supply chain. This was made all too clear listening to Dr. Michal Freedhoff’s remarks on Tuesday, 28 September 2021 in Anaheim, CA at Product Stewardship Society's PSX 2021. You can read Dr. Freedhoff’s remarks here. Dr. Freedhoff is the Principal Deputy Assistant Administrator of the U.S. EPA in the Office of Chemical Safety and Pollution Prevention. She spent several years on Capitol Hill starting in 1996 before working at the EPA in January 2021. She is very familiar with the history of TSCA and its revisions.
TSCA was amended with the bipartisan Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016 and often referred to as the “New TSCA”. Prior to that, TSCA had not changed since 1976 when it was first enacted. There are not many exemptions for articles under the New TSCA. The EPA has been indicating this for a few years as they have rolled out the Top 20 substances.
And while articles have always been subject to TSCA, most of the individual sections of TSCA such as Substance New Use Restrictions (SNUR) exempt articles. Therefore article manufacturers have generally ignored TSCA because of the many exemptions. However, most of these general article exemptions say that articles are exempt unless a specific rule states that they are not exempt. Two recent examples of this include the recent revision of the Perfluoroalkyl Substances (PFAS) and Long-chain perfluorinated Chemicals (LCPFC) SNUR so that it applies to articles, and the recent Section 6 PBT rules. The proposed PFAS reporting rule will likely be finalized in 2022. It requires volume, exposure and release data for all imported PFAS between 2011 and 2021 so it will be very challenging for article manufacturers to collect the data and report.
Dr. Freedhoff expressed her frustration with industry for its lack of comment on proposed policy and for not being prepared to provide safety data when asked. She essentially made a plea to industry for more action or credible reasons for the need for more time.
Her remarks are putting article manufacturers on notice to pay attention to TSCA so that the EPA does not have to implement urgent rule revisions, like with PIB 3:1, that pull back final rules because the article manufactures, in this case the electronics industry, failed to pay attention to repeated calls for information and proposed rules at EPA.
It would appear that it is time for industry to step it up or face huge risk with potentially illegal and discontinued products with regulated substances in the future with no preparation for a non-regrettable substitute or a valid reason to ask for more time.
It is felt Dr. Freedhoff’s comments will stand since the previous administration did most of the work on the PFAS and Persistent Bioaccumlative and Toxic (PBT) rules and the previous Congress passed the legislation that required the PFAS reporting. Since the current administration is even more aggressive on the New TSCA it is likely to get even more difficult for article manufacturers.
It is nonetheless unlikely that EPA will generally include articles in most rulemaking. It is clear in the legislation that articles will only be included for chemicals where they have the potential to cause harm, but expected that it will now be up to the article manufacturers to know all the chemicals in their supply chain as well as demonstrate that the public is not exposed to any harmful chemicals in their articles found in the USA, regardless of where they are manufactured.
In closing, it is still unclear how the EPA plans to truly govern articles entirely. However, this trend points to the need for a new sense of urgency for article importers and manufactures to learn about their products so that they can effectively comment on the proposed roll out of the New TSCA. Article manufacturers will no doubt need help developing strategies to manage the collection of this data from their supply chain, including sampling strategies and exposure and risk assessments. Verisk 3E stands ready to help. Please contact Verisk 3E here to develop your plan today.