EPA PMN Strategies, Filings, Representations
and Advocacy
Alternate Page Title: How to get a new chemical through the EPA in less time, with fewer dollars and without major headaches.
The Process:
The U.S. EPA requires that new chemicals being placed into commerce be notified to the EPA before any commercial use. The primary means of this notification is the Pre-manufacture Notification (PMN) process. In this process, the applicant must convince the EPA that the new substance does not present an unreasonable risk to man or the environment. The secondary means are the Low Volume Exemption (LVE) and Polymer Exemption; and less importantly, the Test Marketing and the Low Release and Exposure Exemptions. Most of these provide for limited commercial use but have more restrictions and have additional reporting and recordkeeping requirements.
There is no requirement that any toxicity data accompany a notification; however, if none is provided the EPA will use structural analogs to estimate the hazards of the new substance to man and the environment. For many classes of chemicals there is a de facto requirement for specific health effects or environmental data unless there is a good rationale why such data is not necessary to define the material’s hazard.
The Usual Problem:
A successful PMN application can be accomplished with only 90 days of Agency review, and an LVE with just 30. Unfortunately, many applicants fail to provide the information necessary for EPA to accept the notification and the EPA requests that the submission be suspended pending clarification of accumulation of additional data. This can be a very time consuming and expensive proposition with the EPA specifying and approving laboratory protocols and preliminary results – a process that can require one to five years (or longer). Needless to say, a delay of two or more years in a marketing plan can destroy a product’s profitability.
The Solution:
A more rationale and predictable approach is to understand what data the EPA needs to see in the application and provide it in the initial application. This can save money two ways. First, the required studies can often be conducted with less expensive, but adequate, protocols; second, the time savings can translate in an additional year or more of product sales.
TRA is highly experienced developing cost-effective strategies for successful EPA notifications and exemptions. TRA has an excellent reputation with EPA staff and can interact directly with the Agency on your behalf to accomplish successful and rapid notifications.