The outcomes of polymer PMN assessments conducted over the last year have indicated that the USEPA has significant concerns about the potential for inhalation exposure to polymer particulates and aerosols. While it has enunciated these concerns for quite some time, the results under “new” TSCA demonstrate an evolution in their approach to proposed actions and risk management options. The allowable conditions of use and other requirements of Consent Orders (CO) and subsequent Significant New Use Rules (SNUR) will vary depending on the concern identified for that particular PMN. However, for four categories of polymers the options are limited and have been defined in detail.
If you intend to manufacture or import a “new” polymer in the US unless the polymer is otherwise exempt you are obliged to file a PMN with the USEPA. Other than molecular weight data there are no statutory data requirements for polymer submissions. However, if the use specified in the PMN (or any “reasonably foreseeable” use) could involve inhalation exposure, the latest guidance from the Agency suggests that it is imperative to generate data that pre-emptively addresses Agency concerns to avoid lengthy delays.
The existing USEPA “Category” document already includes several polymer types, with definitions (scope of the category), the rationale for concern and suggested testing. There are four “new” categories where the definition, rationale for concern (hazard), and upfront “tiered” testing requirements have been defined.
knoell USA can help define options for new polymer submissions, including Inventory searches for alternative compositions using the 2% rule and the potential use of the Polymer Exemption. We can also provide analysis for global notification or exemption of new polymers in other jurisdictions. Contact us for an initial consultation.
Vice President, Industrial Chemicals and Business Administration
+1-610-558-3001, Extension 102
Director of Business Development
Industrial Chemicals, North America