With the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA Reform), there are many important changes to the Toxic Substances Control Act. Section 5 of TSCA addresses Premanufacture Notification (PMN) requirements for new chemicals. While the general process for the submission of a PMN remains comparable, there have been some major changes that will have an impact on manufacturers and importers of new chemicals.
Effective immediately, the EPA must make an affirmative finding that 1) the new chemical presents an unreasonable risk (an “A” determination), 2) that the information provided is insufficient to permit a reasoned evaluation (a “B” determination), or 3) the new chemical is not likely to present an unreasonable risk (a “C” determination).
If an “A” determination is made, the EPA must use Section 5(f) and either limit the amount or impose other restrictions on the chemical substance through a new rule or the agency may completely prohibit the chemical substance by issuing a new rule.
If a “B” determination is made, the EPA must use a 5(e) consent order. Under a consent order, the agency can determine that a chemical substance used under certain conditions and with appropriate precautions would not pose an unreasonable risk but that use under other conditions may pose an unreasonable risk.
If a “C” determination is made and the agency determines that the chemical substance is not likely to present an unreasonable risk, then the manufacturer or importer may commence production. Unlike in the past, the manufacturer or importer need not wait for the 90 day review period to expire once notified by the EPA that the chemical substance is not likely to present an unreasonable risk.
Prior to the enactment of TSCA Reform, a manufacturer or importer could begin making and selling a new chemical at the end of the 90 day review period as long as the EPA did not find that the new chemical “may present an unreasonable risk”.
If your company recently submitted a PMN prior to the enactment of this new law, the 90 day review period has been reset. The agency has said that it will make every effort to complete the review of the new chemical within the remaining time under the original 90-day review period.
When submitting a PMN to the EPA, it is most desirable to provide the EPA with actual exposure data. This should include: occupational exposures in the workplace; exposures to the general population from chemicals in the air and drinking water; consumer exposure through the use of household products; and ecological environmental exposures. Measured data under real-life conditions is preferred and is more accurate than modeled data.
In the absence of measured data, the EPA method for doing risk assessments for new chemical substances utilizes predictive methods for hazard and exposure analysis. The EPA has computerized these predictive models and has made the models available to the public as their Sustainable Futures program. In using these models, the agency will use conservative assumptions and “worst-case” scenarios which could result in an “A” or “B” determination in their findings.
Use of the Sustainable Futures models by chemical manufacturers can serve as an early screening method to identify potential risks early in the new chemical notification process.
Critical Path Services can help you to navigate through the new chemical notification process. We have people on our team that are highly experienced with TSCA regulations and specifically, with the EPA’s New Chemicals Program. In addition, there are members of our Industrial Chemicals team that have experience in both running the Sustainable Futures models and in interpreting the output of the models.