Vireo’s Analysis of Comments Submitted to the US EPA’s Proposed “Reporting and Recordkeeping Requirements for Nanoscale Chemical Substances in the Marketplace”

he EPA closed its public comment period on August 5th, 2015 for its initial proposal to 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.

Analysis of EPA

Sixty nine comments were received from industry, private individuals, business associations, academia, NGOs, and other organizations, including Vireo Advisors. More than forty of the 69 comments on EPA’s proposed TSCA Reporting and Recordkeeping Requirements rule for nanoscale materials were from industry, associations and industrial partners. Nine not-for-profit (NFP) organizations submitted comments on TSCA’s proposed rule, including six non-governmental organizations (NGOs) and two state government agenciesunanimously supporting reporting and recordkeeping requirements by the EPA for nanoscale materials.

Many commenters expressed concerns about the vague definition a ‘reportable chemical substance’ including definition of ‘unique and novel’ characteristics. EPA proposes defining a reportable chemical substance as ‘a chemical substance that is solid at 25 °C and atmospheric pressure that is 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.’ Some NGOs noted the possibility of manufacturers and processors taking advantage of the ambiguous definition to avoid reporting, and prefer the definition be based solely on size. More than half of industry comments addressed the definition of ‘reportable chemical substances’, and highlighted issues with the terms “unique and novel”, “particle”, “enhanced properties”, “trace amounts”, “film”, “coating”, and “aggregates and agglomerates”. NGOs would also like clarity or changes regarding the definition of ‘reportable substance’ – for example, explanation of the phrase ‘trace amounts’ and ‘release information’.

Industrial commenters sought EPA’s rationale for choosing ‘seven times the standard deviation of the mean’ approach of distinguishing discrete forms and further commented that no available methods are available to consistently and reliably measure the suggested properties. There were numerous calls for better and more specific guidance on the issue. Most NGOs would like to see the inclusion of a wider range of discrete forms and materials. Two NGOs suggested using a 10% change would be more sensitive than the proposed ‘seven times the standard deviation of the mean’ approach of distinguishing discrete forms. Several also suggested that a change in any of the 3 factors should trigger separate reporting.

One area of dissent between NFPs and industry was EPA’s proposal to exempt nanoclays, nanofilms, and nano ZnO. Whereas most NGOs did not support the exemptions, twenty-six industry/association comments supported exemptions for zinc oxides, nanoclays and films, and/or requested exemptions for other materials, including: color pigments, articles, naturally occurring materials, polymer substances, nanoscale substances incorporated into a polymer matrix, all biological materials, TiO2, and carbon black, among others. 

Similarly, while several NGOs specifically support the 135 day review period, many industrial commenters opposed it over concerns about competitive disadvantages, negative signals to the public and the marketplace that nanoscale materials pose more risk, and concerns raised about exceeding the EPA’s statutory authority.

Finally, industry expressed concerns about the burden of collecting and reporting, and requested EPA revisit the exemption threshold, not include period reporting, and harmonize data collection with recent Canadian reporting rules (hyperlink here) as well as ensure no overlap between other required reporting, and narrowing the required reported information. EPA responses are not anticipated before calendar year 2016.