On August 14, 2017, EPA released the Working Guidance for the Nanoscale Material Reporting Rule. The Working Guidance considerably narrowed the scope of “reportable chemical substance” from the draft Guidance. EPA considers the Guidance a “working” document because it intends to update the Guidance based on questions the Agency receives.
The Working Guidance also discusses other aspects of what makes a chemical a “reportable chemical substance” and a number of other issues. It is divided into the following sections:
- What Chemicals are Reportable?
- Who is Required to Report?
- What Information is to be Reported?
- When is Reporting Required?
- General Questions.
The most helpful information is found under “What Chemicals are Reportable?” and “Who is Required to Report?”
What Chemicals are Reportable. A reportable chemical substance is one that it solid at 25º C, 1 – 100 nanometers in size in at least one dimension, and intentionally manufactured or processed to exhibit unique or novel properties because of its size. The draft Guidance had raised a number of unanswered questions regarding what comprised unique and novel properties.
In the Working Guidance, EPA explicitly states that “size is not considered to be a unique and novel property.” The Working Guidance differentiates between unique and novel properties and enhanced or continuously scaling properties. The later are those which do not intrinsically change on the nanoscale and instead scale proportionately with size. Chemicals that have different functionality at the nanoscale than the form greater than 100 nanometers would be considered substances demonstrating unique and novel properties.
Additional points about “reportable chemical substances” include discussion of discrete chemical substances and coatings. The Working Guidance notes that some nanoscale materials are engineered to give all the particles a certain morphology or shape. The change in shape needs to be a specifically engineered change in the shape of particles to be a discrete form of a reportable chemical substances. EPA explains that coating a nanoscale material results in a nanoscale material with different properties; in other words, by coating a nanoscale material, one has created a reportable chemical substance.
Who is Required to Report. According to the Working Guidance, each manufacturer and processor in the supply chain must report on the reportable chemical substance. EPA notes that processors should document the steps they took to determine whether reporting is required. If processors do not know about specific properties that would allow them to know if they are processing a chemical substance subject to the rule, EPA believes that it would be within the reasonably ascertainable standard to ask their suppliers.