HOW CAN A P2 ASSESSMENT HELP YOUR PMN SUBMISSION?

 

The Pollution Prevention Framework (“P2 Framework”) is a collection of the US EPA’s computer-based methods for predicting physical/fate properties, toxicity hazard, exposure and risk when data for a chemical are insufficient. The P2 Framework has been developed and refined by the US EPA and other groups over the past 30+ years. Most of the models have been peer reviewed and are widely accepted screening-level methods for assessing chemical substances in the absence of chemical-specific data. For more information, you can visit the EPA's Sustainable Futures site. (By clicking this link you are leaving the CERM website.)

 

The P2 framework is part of the Sustainable Futures Initiative, a voluntary EPA program that focuses on use of the P2 Framework assessment to evaluate the potential environmental risks of new chemicals prior to PMN submission or earlier on in the development process. Participation in the Sustainable Futures Initiative can not only reduce development costs, but can also help submitters understand the US EPA PMN review process and potentially qualify for expedited review of PMN submissions.

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TAKE YOUR CHEMICAL OUT OF THE BLACK BOX AND HELP ENSURE A SUCCESSFUL PMN.

 

The P2 Framework models and methodologies are based on, and in most cases the same as, the models the US EPA employs to evaluate PMN substances. A P2 Framework assessment can give you a snapshot of how the EPA is likely to view the submission, essentially taking it out of the black box. Nearly 40% of the PMNs submitted to the EPA in 2006 were accompanied with Risk and Hazard Assessments.

 

KEEP THE PMN CLOCK MOVING

 

Not only can identifying any potential hazards and risks prior to the PMN submission smooth the review process in general, it can also prevent delays. If the EPA decides that the information is inadequate or needs further clarification, the back and forth can take considerable time.  Once outside of the original 90-day (or other relevant) time period, the Agency is no longer bound by to a time-frame.  This can lead to submissions being potentially held up for years. Sometimes a simple upfront piece of data can prevent costly and time consuming testing required by the agency; small changes in the chemical manufacturing process can sometimes reduce estimated exposures by an order of magnitude. Use of these modeling tools can help pinpoint where to target additional information gathering and can help ensure a higher likelihood of success.

 

HELP SELECT MORE ENVIRONMENTALLY FRIENDLY CHEMICALS.

 

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.

 

CUT YOUR PMN REVIEW TIME IN HALF.

 

As an added incentive to participate in the Sustainable Futurestm Initiative, EPA allows participating companies to take their successful PMN chemicals to market faster. To qualify, a stakeholder needs to participate in a Sustainable Futures 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.

 

WHY CHOOSE TO CERM FOR YOUR P2 ASSESSMENT?

 

Our staff has been trained by the EPA to run P2 Assessments as part of the Sustainable Futures® program. This training includes one-on-one work with the developers and users of the models and methodology, making us proficient in all aspects of their use. To date, we have completed assessments for about 100 chemicals ranging from discrete chemicals to complex mixtures, as well as polymers, dyes and surfactants. See what our clients say about our services.

 

CERM not only has assessed many chemicals, but has also helped formulate many of the guidance materials EPA uses in their Sustainable Futurestm Workshops. In addtion, CERM has taken the lead in planning and presenting at most of the recent SF workshops provided in the US and abroad.

We offer the expertise to assess your chemical by performing the P2 Assessment at a cost similar to 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 bring your chemical to market faster.