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Under the Toxic Substances Control Act, non-exempt manufacturers and importers of new chemicals (those not yet in commerce) must comply with requirements under the New Chemicals Program before manufacturing can commence. This include submission of complicated Premanufacture Notices (PMNs) that provide the Environmental Protection Agency (EPA) information necessary to review the new chemical for unreasonable risks to human health or the environment. After the 90-day review period, and sometimes longer, EPA will decide whether it will restrict, regulate or allow the chemical to be manufactured or imported.
For the most part, PMNs are submitted after substantial time, energy and money have been spent in the development of a new chemical, so when a chemical is determined to present an unreasonable risk, it can be a costly waste of business resources. One proven way to mitigate this potential waste is through the EPA’s Sustainable Futures Initiative, a voluntary program that began in 2002. Sustainable Futures participants are trained to use the EPA’s own risk assessment tools and data to screen for risks early on in the chemical development process, rather than at the end, with the goal of creating new chemicals that are inherently cleaner and safer.
Learn an overview of the most relevant sections of the TSCA and its implementing regulations and much more during our in-depth webinar on March 4, 2014.
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As an added incentive, Sustainable Futures companies may receive regulatory relief, based on their participation, training and track record (at least five PMNs submitted for unregulated prescreened low hazard or low risk new chemicals). This relief is in the form of an expedited review of their PMNs, which is achieved by simultaneously submitting both the PMN and for a Test Marketing Exemption (TME). A TME is an exemption for the purpose of enabling a potential PMN submitter to assess commercial demand for a chemical product in the competitive market. TMEs are normally submitted prior to PMN submission, but when submitted simultaneously with a PMN, allow manufacturing to begin at day 45 of the review period, rather than having to wait the full 90-day PMN review period.
Another benefit to new chemical developers is the reduced regulatory uncertainty achieved by the prescreening process. New chemicals that consistently pass prescreening for risks and hazards result in savings in development costs, and may also increase competitive advantage through commercialization of safer chemicals, increased pollution prevention and innovation, focused testing, process efficiencies, and chemical waste reduction.
Join us on February 26 for an in-depth webinar about TSCA compliance. The event will be led by a seasoned EHS professional who has helped companies address environmental compliance and remediation issues.
Unlike many voluntary programs hosted by the EPA, Sustainable Futures requires that participants graduate from the program via a four step process:
Step One – Take Training which is provided on a fee-for-service basis by program partners using technical materials provided by the EPA. Training varies from half-day program overview sessions to intensive three-day sessions providing instruction in the use of EPA’s models and methods, including what each model does, what inputs are required, interpreting model results, and using results in assessments.
Step Two – Use Screening Models to develop new chemical notices. Although the models used are not restricted to EPA models, they should be applied to gain information related to hazards, exposure, and risk on alternative chemicals or processes under consideration during research and development prior to PMN submission.
Step Three – Submit Sustainable Futures PMNs. As noted earlier a minimum of five PMNs must be submitted prior to gaining regulatory relief under the Sustainable Futures program showing how modeling was used, a summary of modeling results and impressions of the usefulness of information gained through modeling.
Step Four – Notify EPA of Eligibility when Steps One through Three are complete. Written notification includes the date training was completed, a list of submitted PMNs and EPA’s review outcomes, a list of screening tools used for each PMN, and an overall assessment of the usefulness of those screening tools.
More information is available at http://www.cermonline.com/training/sustainable-futures-workshop.