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How Can a P2 Assessment Help Me With My PMN Submissions? There are several reasons why a P2 Assessment may be a good choice for your chemical.
The P2 Framework models and methodologies are based on, and in most cases the same as, the models the EPA employs to evaluate PMN substances. This means a P2 Framework assessment can give you a snapshot of how EPA is likely to view the submission, essentially taking it out of the black box. That’s why nearly 40% of the PMNs submitted to the EPA in 2006 were accompanied with Risk and Hazard Assessments! This allows the submitter to mitigate any potential hazards and risks that are identified prior to submitting the PMN. This can smooth the PMN review process and prevent problems during review that might hold up or prevent a successful PMN. We have found that when any potential areas of concern identified by the P2 Assessment are properly addressed, the corresponding PMN has a high likelihood of success. Additionally, in those instances where the P2 Assessment shows an area of concern that might not be able to be fully addressed, the forewarning provided by the assessment will allow you to anticipate potential regulatory action and be prepared, either with the necessary engineering controls and PPE or with alternative chemical(s) in extreme cases.
The P2 Framework assessment is not only useful to help with successful PMNs, it can be used to help select more environmentally friendly (GREEN) chemicals, thereby reducing the potential of product liability issues. Selecting for green alternatives is becoming an important part of the chemical industry and the P2 Framework tools provide one method to help with this. Using the P2 Assessment earlier in the R & D phase can help narrow down chemical choices to select the most environmentally friendly and cost effective options. Selected greener chemicals early on in the development phase can avoid costly engineering controls later and even make subsequent registration/notifications more straightforward.
As an added incentive to participate in the Sustainable Futurestm Initiative, (the voluntary EPA pilot program that focuses on use of the P2 Framework assessment) EPA is offering the ability to take your successful PMN chemicals to market faster. To qualify, a stakeholder needs to participate in a Sustainable Futurestm workshop and file between 5 – 10 successful PMNs accompanied by a P2 Assessment that indicates low risk. Once completed, the stakeholder can apply for regulatory relief and earn the ability to bring a new chemical to market in 45 days, rather than the standard 90. The savings in time and money can add up. Whether you want to make informed decisions about new chemical submissions or gain the ability to have a 45 day review of your chemicals, doing a P2 Assessment can help your company make greener chemicals all around. At CERM we have been trained by the EPA to run P2 Assessments as part of their outreach program for Sustainable Futurestm; training that included one on one work with the developers and users of the models and methodology to make us proficient in all aspects of their use. To date, we have completed assessments for about 100 chemicals and we have looked at discrete chemicals, mixtures, polymers, dyes and surfactants. CERM not only has assessed many chemicals, but has also helped formulate many of the guidance materials EPA uses in their Sustainable Futurestm Workshops and we regularly participate in those workshops as trainers in the US and abroad. We offer the expertise to assess your chemical by performing the P2 Assessment at nearly the cost of a single ecotoxicity study. Your company will gain short and long-term benefits by mitigating any potential hazards and risks that are identified, preventing problems during review that might hold up or prevent a successful PMN, and ultimately result in bringing your chemical to market faster. |
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