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Frequent Questions

Training & Graduation

Submissions

Submissions From Companies That Have Graduated

PBT Profiler

Training & Graduation

What qualifies as "taking training" for the purposes of graduation?
While EPA recognizes that there are many qualified groups which can offer training in these methods, we consider "taking training" as having taken Sustainable Futures hands-on training from EPA or one of the grantees who has worked closely with EPA on Sustainable Futures. An important component of the Sustainable Futures training is gaining an understanding of the concepts, goals, and benefits of the Sustainable Futures Initiative, and of the benefits prescreening chemicals at the research and development stage can provide.

Does an individual or company "graduate?"
A company "graduates." For example, if a trained individual moves to another company, "graduate" status does not travel with the person.

If my company contractor takes training does that count as my company taking training?
No, an individual from the company, not a contractor, must take training before the company will be considered as having taken training. EPA wants a company employee to attend so that the company will understand the scope, applicability, and limitations of the Sustainable Futures risk screening methods and understand the programmatic and administrative issues associated with Sustainable Futures.

If my company has a consultant do the prescreening on chemicals my company submits as PMNs, can those submissions count toward our total needed for graduation?
Yes, those submissions developed by a consultant or contractor can count towards graduation as long as the submissions meet other criteria for graduation. Remember that in order for a company to qualify for graduation a company employee must attend the training.

Do prescreened submissions count towards the five required PMN submissions if they were sent in before we took training?
Yes, prescreened submissions sent in prior to taking training will count towards graduation as long as the submission has been adequately screened and is not regulated.

Will Low Volume Exemptions (LVEs) count towards graduation from Sustainable Futures?
Yes, Low Volume Exemptions (LVEs) will count towards the total PMN submissions needed as long as they are prescreened and not regulated, and for a low volume exemption "not regulated" means it is granted by EPA.

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Submissions

Why is EPA asking for my company's impressions of the usefulness of the methods?
As explained in the Federal Register Notice announcing the Sustainable Futures Initiative, EPA is considering creating a new Pollution Prevention (P2)-based exemption to TSCA that would make the regulatory relief currently available only to graduates of the Sustainable Futures Initiative available also to any company that prescreens a low hazard, low risk new chemical notice. In order to do this EPA needs to provide evidence that risk screening at R&D results in health and environmental benefits.

What should I include in the summary of the usefulness of the methods?
The summary does not need to be detailed. The summary can be a table or brief text that could be included in the cover letter, in pollution prevention information on page 11 of the PMN form (PDF) (6 pp, 525KB, About PDF), or included as an attachment to the submission.

Do I need to run exposure models on a low hazard chemical?
No, you don't need to run exposure models if the chemical is low hazard. Remembering that risk equals hazard multiplied by exposure, if the analysis of human health and ecological effects indicate that no hazard is expected, exposure assessments are not needed because risk would not be anticipated. Please be aware that all hazard endpoints need to be addressed, i.e., ecological hazard as well as cancer and non-cancer hazard endpoints.

Will EPA review my prescreening assessment?
EPA considers all information submitted with every PMN; however, we do not have the resources to review in detail each Sustainable Futures prescreening assessment done by the submitting company. EPA will always conduct an independent review of each PMN.

Can I get a copy of EPA's review of my PMN?
EPA often uses previously submitted PMNs as analogs in the assessment of a new PMN, and as a result the EPA report is CBI and can not be made public, even to the submitter of the new PMN.  Unfortunately, we lack the resources necessary to create sanitized (i.e., non-CBI) summaries of EPA assessments.

Submissions From Companies That Have Graduated

Do we need to send in two copies of each submission?
No, you do not need to send in two copies of your submission. Your single submission will receive two case numbers, a PMN number and a Test Marketing Exemption (TME) application number. Remember that your submission must meet the requirements of a TME. Your cover letter should say that you are a graduate of Sustainable Futures and that your submission meets the requirements of a TME.

Can my company also get regulatory relief for Low Volume Exemptions (LVEs)?
The regulatory relief in the form of expedited (45-day) review applies to PMNs, which undergo a 90-day review, and not to LVEs, which undergo a 30-day review.

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PBT Profiler

Does EPA keep a record of the chemicals I evaluate using the PBT Profiler?
No user identification, chemical information, screening results, or any other electronic information entered into or generated by the PBT Profiler are intentionally tracked, stored, or collected. Information on user anonymity and security is provided on the PBT Profiler Web site Exit EPA Disclaimer.

Can I get a copy of the PBT Profiler as a stand-alone method like EPI Suite?
The PBT Profiler will not be available as a stand-alone method. The supporting modules and databases behind the PBT Profiler are routinely updated by Syracuse Research Corporation. If the model were a stand-alone there could eventually be multiple versions of the method in use, and this can create confusion. EPA prefers that the same version of the PBT Profiler be available to all users.

Will the PBT Profiler have a batch mode capability?
For an online method like the PBT Profiler to have a batch mode capacity would require that files be written to the server on which the method resides. Due to users' security concerns it was decided that the PBT Profiler would not have a batch mode capacity.

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