Vireo’s Updates on the EPA’s Proposed Reporting Rule for Nanoscale Materials under the Toxic Substances Control Act

The US Environmental Protection Agency (EPA) is proposing reporting and recordkeeping requirements for nanoscale chemical substances in the marketplace under the Toxic Substances Control Act (TSCA). This initial proposal would require one-time reporting and recordkeeping information from manufacturers of nanoscale materials including specific chemical identity, production volume, manufacturing and processing methods, exposure and release information, and existing data on environmental and health effects. The EPA has extended the public comment period for 30 days until August 5th, 2015.

Shatkin co-authored an article about the Proposed Reporting Rule for Nanoscale Materials that was picked up by the National Law Review. EPA held a public meeting on the rule in June 2015. Shatkin’s co-authored summary of the meeting is here. The proposed rule and instructions for submitting comments are in the docket folder.

During a Panelist Discussion in the Symposium on Sustainability and Commercialization at TechConnect/Nanotech15, it was suggested that EPA may not finalize the rule until after the 2016 elections, with reporting required at least 6 months later, in 2017. The proposed rule and instructions for submitting comments are in the docket folder.

KEY COMMENTS on the rule by Shatkin/Vireo:

1.     Definitions: the definition of a Reportable chemical substance

1.     “.. manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nm and…” “…exhibit unique and novel characteristics or properties because of their size” and “…does not include substances with “trace amounts” of nanoscale particles”

2.     These definitions do not allow potential submitters to determine whether they have a reportable chemical substance. EPA needs to provide definitions of these terms that relate to measureable properties.

2.     Further, the definition of a “Discrete form of a reportable chemical substance” is problematic because some properties are more accurately measured than others, which means there may be greater or lesser ability to discern materials for certain types of substances, including polydisperse mixtures, and high aspect ratio substances. The ability to accurately measure size versus say, surface reactivity, is not uniform and the selection of model assumptions affects the resultant measurements, including the ability to discern seven times the standard deviation of the mean. I recommended EPA provide guidance on measurement methods, and consider whether to uniformly apply the 7X standard deviation to all properties.

3.     Third, EPA included a section in the Proposed Reporting Form on the product Life-cycle. I raised the issue of the lack of understanding of this issue among many industry professionals, and suggested EPA provide guidance on the topic.

Other key industry comments:

- The 135 day review period was noted as raising concern about economic impacts, in that it exceeds the standard 90 day review period for new substances.

- Potential burden on industry, especially smaller companies without internal resources to prepare the required information.

- The minimum size criteria for reporting. At $4 million, some expressed concern that even non-profitable companies will have to report.

July Industry Webinar Summary and Q&A with US EPA Staff

On July 29th a webinar featuring Jim Alwood of US EPA was hosted by SEMI, the Nano Business Commercialization Association, the Semiconductor Industry Association (SIA) and SESHA, aiming to clarify TSCA Section 8(a) proposed rule for chemical substances manufactured or processed as nanoscale materials, and answer pertinent questions from various industry stakeholders.

In the Q&A, questions sought clarification and guidance on the definition of a reportable chemical substance. Vague terminology such as “unique”, “novel” and “trace” used by the EPA in its proposed ruling was highlighted as needing clarification. Additional questions focused on how industry should identify nanoscale materials, including recommendations for tests for non-uniform materials, EPA didn’t offer much guidance beyond what is set forth in the proposed rule and called on industry to comment for clarification.

Other industry questions centered around whether specific forms of nanostructures would be included under the new ruling such as bound versus unbound nanoscale materials, nano-structured integrated circuits, or nanoscale materials incorporated into articles. Of note, the EPA suggested that generally, film, nano-structured integrated circuits, and nanoscale materials incorporated into articles are likely not chemical substances that would be reportable under the new rule; however, companies should seek clarification by commenting on the proposed ruling.

Clarification was also sought from the EPA on distinguishing between processor activities and user activities of nanostructures and if any guidance will be provided. Broadly, the EPA stated that processors change materials formulations, either chemical or form; if there is no change in the starting material formulation, a company may be considered a user and exempt from reporting under TSCA Section 8(a).

Jim Alwood reiterated that now is the chance for stakeholders to have the EPA address and clarify issues by commenting on the proposed ruling. The proposed rule and instructions for submitting comments are in the docket folder with a deadline set of August 5th, 2015.