Training & Graduation
- What qualifies as "taking training" for the purposes of graduation?
- Does an individual or company graduate?
- Can contractors or consultants obtain Sustainable Futures graduate status?
- If my company contractor takes training does that count as my company taking training?
- 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?
- Do prescreened submissions count if theywere sent in before we took training?
- Does a PMN for a substance that was dropped from regulatory review, but for which EPA issued a TSCA non-section 5(e) SNUR, count towards graduation from the Sustainable Futures program?
- Will Low Volume Exemptions (LVEs) count towards graduation from Sustainable Futures?
- When a company graduates will they get something in writing from EPA?
- Why is EPA asking for my company's impressions of the usefulness of the methods?
- What should I include in the summary of the usefulness of the methods?
- Do I need to run exposure models on a low hazard chemical?
- Will EPA review my prescreening assessment?
- Can I get a copy of EPA's review of my PMN?
- If a company is sold, acquired or merged, what happens to the company’s graduation status?
Submissions From Companies That Have Graduated
- Once a company does graduate, how will EPA reduce the PMN review period from 90 days to 45 days?
- Do I still need to continue to prescreen my chemicals after I graduate in the program?
- Do we need to send in two copies of each submission?
- Can my company also get regulatory relief for Low Volume Exemptions (LVEs)?
- After a Graduate submits a combined PMN/TMEA and day 45 of the TMEA has been reached with no EPA objection/regulation will the company be notified that they will be able to commence commercial manufacture of their PMN substance?
- Does EPA keep a record of the chemicals I evaluate using the PBT Profiler?
- Can I get a copy of the PBT Profiler as a stand-alone method like EPI Suite?
- Will the PBT Profiler have a batch mode capability?
Training & Graduation
What qualifies as "taking training" for the purposes of graduation?
While EPA recognizes that there are many qualified groups that can offer training in these methods, we consider "taking training" as having attended one of the Sustainable Futures hands-on workshops given by, or cosponsored by the EPA Office of Pollution Prevention and Toxics. An important component of the Sustainable Futures training is gaining an understanding of the concepts, goals, and benefits of the Sustainable Futures Initiative, including the benefits of prescreening chemicals at the R&D stage.
Does an individual or company "graduate?"
The FR notice indicates that the Sustainable Futures Program is designed so “companies subject to… reporting requirements…. demonstrate experience and competence with the P2 Framework or other scientifically acceptable approaches to chemical risk screening…. Companies interested in participating in this pilot project must demonstrate an understanding of the scope, applicability, interpretation, and limitations of pollution prevention and chemical hazard and exposure screening tools...”. These excerpts emphasize that Sustainable Futures program graduation status is granted to the company, and not simply associated with intellectual property or select staff. In turn, if a trained individual moves to another company, "graduate" status remains with the company and does not travel with the person to his or her next company.
Can contractors or consultants obtain Sustainable Futures graduate status?
The FR notices emphasizes that Sustainable Futures program graduation status and associated regulatory incentives are given to companies who are subject to TSCA section 5 reporting requirements. Therefore, contractors and consultants who do not manufacture substances or are required to report under TSCA Section 5 are not able to “graduate” under the program. However, consultants and contractors can still derive a business benefit by attending training and understanding the graduation process since this information can be used to inform customers of the potential regulatory outcomes of their submissions and can be used to identify associated hazards and risks of particular chemistries along the development pathway.
If my company contractor takes training does that count as my company taking training?
No, a representative employed directly by 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. It is then assumed that the employee of the company will then circulate the information and insights gained during the training class with his/her colleagues within the company.
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, demonstrates an appropriate level of knowledge of the tools and assessment approaches, and is deemed “successful” by EPA.
Does a PMN for a substance that was dropped from regulatory review, but for which EPA issued a TSCA non-section 5(e) SNUR, count towards graduation from the Sustainable Futures program?
EPA may consider a submission regulated with a non section 5(e) SNUR as “successful” and count that submission towards graduation on a case-by-case basis pending the review of cases after EPA receives the company’s graduation request. For notifications concerning substances regulated by a TSCA non-section 5(e) SNUR, the review must indicate EPA did not find that the submitter’s use may present an unreasonable risk to human health or the environment. It is important to note that EPA’s non-section 5(e) SNUR actions apply to potential new uses that are different from those uses identified in the original PMN submission. A non-section 5(e) SNUR indicates that an additional evaluation would be required of any new uses of the chemical to determine whether exposures to, or releases of, that substance from the new use may result in an unreasonable risk to health or the environment.
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.
When a company graduates will they get something in writing from EPA?
Yes, once a company graduates they will receive correspondence from EPA indicating that, by virtue of their participation in Sustainable Futures, and their use of risk screening tools, they can now submit a simultaneous TMEA and PMN. When the company submits a combined PMN/TMEA they should add to the submission cover letter that they have graduated from Sustainable Futures and are allowed to submit a combined PMN/TMEA.
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 the pollution prevention information on page 11 of the PMN form, or included as an attachment to the submission.
Do I need to run exposure models on a low hazard chemical?
During the period when a submitter is demonstrating their knowledge of the P2 Framework methods while working on their 5-10 successful submissions, the submitter needs to evaluate the full suite of risk assessment sections including exposure to gain experience in using the tools and characterizing the endpoints. Creating this exposure section may or may not require actually running the modeling tools. After a submitter has achieved graduation status and is completing the prescreening for the purposes of the dual TMEA/PMN submissions they may choose not to run the exposure tools on low hazard substances. However, the EPA would encourage submitters to take the time to understand their engineering processes and environmental releases even for chemicals they deem as low hazard, in the event the EPA characterizes the submitted chemical with a higher hazard concern and requires follow-up on your operations.
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. If you have specific questions on your assessment, please contact OPPT with your questions and we will do our best to provide you feedback.
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. You may contact your program manager for the case to inquire about receiving a sanitized copy.
If a company is sold, acquired or merged, what happens to the company’s graduation status?
The Sustainable Future program graduation status is attached to specific companies and not simply associated with intellectual property or select staff as a result of asset acquisition. Experience, understanding and competence obtained by graduate companies can not necessarily be transferred through asset acquisition of another company. Therefore, if intellectual property assets of a company (Company A) have been acquired by another company (Company B) rather than taking place via merger of two companies and, Company A, a Sustainable Futures Program graduate no longer controls the assets associated with the Sustainable Futures Program, then, Company B may not maintain an existing graduation status under the Sustainable Futures Program by relying on acquisition of assets from Company A. Instead, Company B must satisfy the requirements for Sustainable Futures graduation and work through the process to obtain their own graduate status. The EPA will not be involved in evaluating whether the above discussion directly relates to any particular situation, instead the EPA will leave that determination up to a company’s legal counsel and will expect that appropriate steps are taken based on the above discussion.
Submissions From Companies That Have Graduated
Once a company does graduate, how will EPA reduce the PMN review period from 90 days to 45 days?
EPA is not reducing the review period for a PMN from 90 to 45 days. There will be two concurrent review periods - a 90-day Premanufacture Notice (PMN) review period and a 45-day Test Marketing Exemption Application (TMEA) review period. Once a company graduates, they will be permitted to send in a PMN and a TMEA for the same substance at the same time, i.e., a simultaneous or combined submission of the PMN and TMEA. PMNs and TMEAs have different review periods - 90 days for a PMN and 45 days for a TMEA. When a Graduate submits a combined PMN/TMEA, and if the TMEA is granted, the company is free to begin test marketing manufacture at day 45 under the provisions of the TMEA. Manufacture under a TMEA does not mean the substance would go on the TSCA inventory. When the PMN reaches day 90 and if EPA has not regulated the PMN, the company is free to begin commercial manufacture under the terms of the PMN. If the company made several batches of the substance under test marketing manufacture (between day 45 and day 90), they would be permitted to sell or use the material from those batches until the amount made under test marketing manufacture is gone. Commercial manufacture that may begin after the PMN review period closes on day 90 must take place before a company can submit a notice of commencement (NOC). A company may not use leftover material made under the TMEA in submitting an NOC. With the submission of the NOC, the substance that is the subject of the PMN then would be added to the TSCA inventory. The substance won't be added to the Inventory until EPA receives the NOC.
The TMEA component of the combined submission must be a legitimate TME. When the TMEA is submitted, the company must specify (1) the amount of material to be produced and distributed, (2) the number of potential customers to whom it is distributed, and (3) the time period of the test marketing must be specified to EPA in advance of distribution (see http://www.epa.gov/oppt/newchems/pubs/tmeranddbulletin.pdf). EPA does not require a production volume or use limit regarding the TMEA, but the company will be held to the production volume they stated in the TMEA. Therefore, if you need to manufacture 1,000 pounds during the TMEA period for a specialty use, state this in the TMEA. Likewise, if you need to manufacture 1,000,000 pounds for a variety of specific consumer product uses, state that in the TMEA.
We have developed draft language demonstrating the submission is a legitimate TMEA and you are free to model your cover letter after this note. You may modify the language in any way you think is appropriate. A number of companies have used this, or similar, language and the Agency determined that this language demonstrates the application is in fact a legitimate TMEA. The central argument made in the draft language is that because the new substance was developed using risk screening tools at R&D, the substance is unique because risk reduction and/or pollution prevention were considered at R&D, resulting in a potentially unique product that warrants test marketing. The draft language refers to the "P2 Framework" which is the computerized chemical screening models. Sustainable Futures is the programmatic structure EPA uses to deliver the P2 Framework risk screening tools to industry together with training and regulatory relief for qualifying low hazard/low risk PMN submissions.Submit the customary PMN and add to the cover letter a statement that says you have graduated from Sustainable Futures and that this is a simultaneous PMN/TMEA submission under Sustainable Futures. Your submission will then receive both a PMN and TMEA number.
Do I still need to continue to prescreen my chemicals after I graduate in the program?
Yes, your graduation status reflects the companies commitment to prescreening activities which help inform the decision making process. Therefore, the subsequent TMEA/PMN submissions should still contain a prescreening review. After a submitter has achieved graduation status and is submitting the dual TMEA/PMN submissions, they may choose not to run the exposure tools on low hazard substances. However, the EPA would encourage submitters to take the time to understand their engineering processes and environmental releases even for chemicals they deem as low hazard, in the event the EPA characterizes the submitted chemical with a higher hazard concern and requires follow-up on your operations.
Do we need to send in two copies of each submission?
Yes, under the electronic PMN system you will need to create and submit two separate notices as the combined Sustainable Futures submission. The electronic PMN system requires each submission to be a unique submission. This means that for Sustainable Futures submissions, the submitter will need to send to EPA two different notices - the PMN and the TMEA. Each submission will have a Submission Report Number (SRN) which EPA uses for tracking. Using the electronic PMN submission system, the submitter can "create" the TMEA by doing the following: (1) copy the PMN file; (2) renaming the file; (3) open the new file in the e-PMN software; (4) make the changes needed to meet the requirements of a TMEA (note in the cover letter that you are a graduate of Sustainable Futures and that your submission meets the requirements of a TMEA; PMN page 1 mark it as a TMEA submission, PMN page 7 change the production volume as needed, etc); (5) finalize the submission and submit the TMEA.
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. No one is allowed to submit a LVE (Low Volume Exemption) and a PMN at the same time and only Sustainable Futures Graduates may submit a simultaneous Test Marketing Exemption Application (TMEA) and a PMN for the same chemical at the same time, but not a combined LVE/PMN.
After a Graduate submits a combined PMN/TMEA and day 45 of the TMEA has been reached with no EPA objection/regulation will the company be notified that they will be able to commence commercial manufacture of their PMN substance?
If and when the TMEA portion of the combined PMN/TMEA is granted and the PMN is dropped during the first 30 days of review, you will be notified by EPA's Sustainable Futures staff and/or staff in the OPPT Chemical Control Division. The email or phone call from the SF staff will most likely be from Maggie Johnson or Kelly Mayo. You will be contacted by EPA staff in the OPPT Chemical Control Division if either the TMEA is not granted or the PMN is not dropped during the first 30 days of review. When you submit your combined PMN/TMEA, please email Maggie Johnson (email@example.com) or Kelly Mayo (firstname.lastname@example.org) to let the SF staff know it is coming and tell them who should be contacted if and when the TMEA is granted and the PMN is dropped during review.
When the TMEA portion (of a PMN/TMEA submission) is approved the SF Graduate will be able to commence manufacture for test marketing purposes as stipulated by the TMEA, but will not be able to commence manufacture for commercial purposes until day 90, as long as the Agency takes no action on the PMN portion of a combined PMN/TMEA. The PMN component of the simultaneous submission will still receive the normal 90-day PMN review period just like all other PMNs. If EPA grants the TMEA, but does not drop the PMN during the first 30 days of review, the submitter will be notified that they must choose, by letter within 15 days of being notified of the Agency's decision, to continue only one of the two notification procedures (i.e., withdraw the TMEA and continue with the PMN, or continue with the TMEA and withdraw the PMN).
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 .
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.