Graduating from Sustainable Futures
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Sustainable Futures training materials and workshops can help the public gain insight into chemical screening and inform risk management decisions. Prescreening for hazard and risk concerns helps Sustainable Futures participants anticipate, avoid or control hazardous conditions related to use of their chemicals.
Additionally, companies that submit new chemical notices under section 5 of the Toxic Substances Control Act (TSCA) are eligible to become graduates in the Sustainable Futures program. Once companies graduate in the program by meeting the requirements outlined below, they become eligible for expedited review of subsequent prescreened low hazard and/or low risk new chemical notices.
Four-step process for graduation
Step 1: Take training
Take Sustainable Future training to become competent in the proper use of chemical risk screening models. Participants must take training to understand the Sustainable Futures Program and acquire an understanding of the scope, applicability, interpretation, and limitations of chemical hazard, exposure, and risk screening tools that can be used to conduct screening level assessments on chemicals based on an analysis of chemical structure or other considerations.
Step 2: Use screening models
Use chemical-risk screening models, such as the Sustainable Futures models, to develop new chemical notices. Participants must apply hazard and exposure screening models, where appropriate, to gain hazard-, exposure-, and risk-related information on alternative chemicals or processes under consideration in the research and development and product development stages (i.e., before submission of a premanufacture notice [PMN]). Use of chemical risk-screening models and methods other than the Sustainable Futures models is also acceptable.
Step 3: Submit Sustainable Futures PMNs
Submit five Sustainable Futures PMNs that have the information requested and that are not regulated by EPA. PMNs that are acceptable will count towards graduation. EPA has developed an example of a Sustainable Futures PMN to show the kinds of information that should be included in the submission that will indicate to EPA how the use of the screening models informed the submitter's judgment in development of the PMN. Submissions should include:
- A prescreened low hazard and/or low risk chemical substance that is not the subject of a regulation
- Evidence showing the chemical was prescreened and evaluated using chemical risk screening models
- Summaries of potential hazard, exposure, and risk associated with the PMN chemical
- Submitter's impressions of the usefulness of the information provided by the screening models in the development of the PMN chemical
See EPA's Sustainable Futures PMN example that uses the chemical isodecyl acrylate (CAS 1330-61-6) to illustrate the kinds of information to be included in a Sustainable Futures PMN. This example is for illustration only. Types of data and screening assessments included in notices submitted under Sustainable Futures will vary depending on the chemical class.
Step 4: Notify EPA of eligibility
Tell EPA you are ready to graduate and become eligible for expedited review of subsequent unregulated prescreened low hazard and/or low risk PMNs.
As explained in the Federal Register Notice announcing the Sustainable Futures Program, participants should write to the Director of the Chemical Control Division (address below) and provide the following non-confidential business information (non-Confidential Business Information) documentation:
- Date Sustainable Futures training was completed;
- List of the PMNs submitted and the outcome of EPA's review, e.g., the chemicals were not regulated;
- Summary listing of the hazard and exposure screening tools used to evaluate each PMN substance;
- Overall assessment of the value of the use of hazard and exposure screening tools to evaluate the PMN substances submitted.
Mail the information listed above to:
Director, Chemical Control Division (7405M)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., N.W.
Washington, D.C. 20460
Please also e-mail a PDF of the original documents to: Kelly Mayo, 202-564-7662.
Once Sustainable Futures participants have taken training and developed a track record by submitting at least five unregulated prescreened low hazard and/or low risk new chemical notices, they can take advantage of the expedited review of their subsequent Premanufacture Notices (PMNs).
As described in the Federal Register Notice announcing Sustainable Futures, the expedited review is achieved by allowing the graduate's submission to be considered both as a PMN and a Test Marketing Exemption (TME).
Under the electronic PMN system the Sustainable Futures graduate will need to create and submit two separate notices, the PMN and the TME, as the combined Sustainable Futures submission.
Using the electronic PMN submission system, the submitter can "create" the TME by doing the following:
- Copy the PMN file
- Rename the file
- Open the new file in the e-PMN software
- Make the changes needed to meet the requirements of a TME (Note in the cover letter that you are a graduate of Sustainable Futures and that your submission meets the requirements of a TME; PMN page 1, mark it as a TME, PMN page 7, change the production volume as needed, etc.)
- Finalize the submission and submit the TME.
The advantage of the simultaneous submission is that the case will be considered a TME and the submitter will be able to manufacture at day 45 instead of having to wait until the PMN 90-day review period ends. This in effect cuts the review time in half.
In addition to being able to manufacture sooner, Sustainable Futures participants can realize significant benefits by reducing regulatory uncertainty and anticipating or avoiding hazardous conditions related to their chemicals of concern.
Additional benefits to participants that increase competitive advantage include:
- Identification and commercialization of safer chemicals,
- Increased pollution prevention (P2) opportunities,
- Increased innovation,
- More focused testing,
- More efficient processes, and
- Reduced generation of chemical waste.
Avoiding problem chemicals and the potential high costs associated with those chemicals, sometimes called chemicals "left on the cutting room floor," may well be the source of the greatest cost savings to companies participating in Sustainable Futures. The ultimate identification and commercialization of safer chemicals benefits the participant as well as the general public and the environment.
Examples of benefits
Some examples from Sustainable Futures participants that are seeing significant cost savings associated with identifying problematic chemicals and processes early at research and development are offered below.
Eastman Kodak, under their Project XL, sponsored a cost-accounting study by the Tellus Institute that compared Kodak's operations both before and after using the P2 Framework models. Kodak's Tellus Report showed that by prescreening their chemicals at research and development (R&D), Kodak reduced product development costs between 13 percent and 100 percent, reduced time to market, and reduced generation of chemical waste.
Kodak told EPA, in their August 2003 Project XL Progress Report, "Kodak has reviewed materials that were possible candidates for commercialization using the P2 Framework. Of the materials that could have been commercialized, 24 percent were dropped early in the product development process."
Cytec Industries used the Sustainable Futures screening methods to evaluate three potential new materials as premanufacture notices and, according to Dr. Randy Deskin of Cytec, were able to stop development of one problematic material early on and refocus research efforts to look for a more environmentally friendly alternative. The Cytec Industries experience was published in Chemistry Business (December 2004/January 2005 issue) as: Cytec Industries Takes Stand on Sustainable Futures.
Read the reports:
- Study by the Tellus Institute
- August 2003 Project XL Progress Report
- Cytec Industries Takes Stand on Sustainable Futures.