The Same Old TSCA Is New
In the U.S., some chemicals are regulated by specific agencies. The rest are regulated by the EPA, in accordance with the Toxic Substances Control Act (TSCA). First passed in 1976, TSCA has undergone a rewrite that’s still working its way through Congress (as of 6/26/16).
“You need to worry about TSCA if your chemical isn’t regulated by other agencies,” said Imogene Treble, PhD, managing scientist at Exponent Inc., during The ‘New’ Old TSCA: How is Implementation of Existing TSCA Rules Changing, a presentation at Stewardship 2015.
Although the law creates a high bar for the prohibition of chemicals, the EPA can require chemical testing, reporting and recordkeeping, and import/export regulations, said Treble. Within that framework, how the EPA implements its rules has evolved.
In general, TSCA regulates individual components, not mixtures. Because companies track products rather than chemicals, this sometimes presents a challenge. Through TSCA, the EPA conducts extensive data gathering, with the goal of making the information it gathers publicly available. On this front, the agency has developed an online portal that gives access to TSCA data that it gathers.
When companies submit a new chemical, the EPA has 90 days to review the submission. If the chemical isn’t on the inventory, you will have to prepare and submit a premanufacture notice form (PMN), said Treble. The outcomes of the review could be a ban (unlikely), restrictions on manufacture and distribution, or no action.
After manufacturing the first commercial batch, companies submit notice to have the chemical added to the inventory. “There’s a large number of PMNs that are submitted that are never commercialized,” said Treble.
To submit a PMN, companies need to provide:
- The chemical identity and use
- Manufacturing site, process description, worker exposure, and environmental releases
- Annual volume
- Number of locations.
- All known health and safety data
Treble noted that most chemicals previously went through review without concerns, but that number has dropped. Recently, a larger share of chemicals have been approved but with restrictions. “This is how they are using their toolbox to regulate new chemicals,” said Treble. Companies may also have a harder time getting new chemicals approved and to market, even if they have the same properties as an existing chemical.
Rise of the SNURs
EPA uses Significant New Use Rules (SNURs) to regulate chemicals. “All SNURs are not created equal,” said Treble. They may range from requiring personal protection equipment to setting release-to-water limits to meeting specific testing requirements. SNURs can also trigger export notification, chemical data reporting and recordkeeping, said Treble. “EPA has done a much better of job of trying to get SNURs out and in a timely fashion,” she added, though there can be times when years pass before the SNURs come out.
The CDR Report
TSCA also requires companies to submit a CDR Report every four years. The next submission to EPA is due in 2016 between June and September, and will include data from 2012 to 2015.
Companies regulated by the EPA must include the following in their report:
- Volume data for 2012 to 2014
- For 2015 data, a full dataset of information, including the physical form, concentration, number of workers exposed, processing and use information
“They’re asking…how is this product being used downstream,” said Treble. “This information gets used by them to determine which chemicals they want to do risk assessments on, so it’s really important that you get it right.”
TSCA and Existing Chemicals
TSCA allows the EPA to regulate hazard and exposure information, create SNURs and create a list of chemical substances that present an unreasonable risk of injury. When the EPA tried to do the latter, it didn’t work. “The point of this talk is what EPA is trying to do and to use all aspects of TSCA and see what works and what’s not,” said Elaine Freeman, MS, DABT, managing scientist at Exponent Inc.
Regarding SNURs, the EPA is using them to limit the use of existing chemicals in new ways. Before a company can use the chemical in a new application, EPA wants to assess the use. “It’s not the same old TSCA. What you did five or ten years ago won’t work now or not as well,” said Freeman.