The U.S. Environmental Protection Agency (“EPA”) issued its Draft Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce ( “Draft Guidance”) on May 16, 2017. See 82 Fed. Reg. 22452 (May 16, 2017). EPA has requested public comment on the Draft Guidance, with public comments due on or before June 15, 2017.
The Draft Guidance addresses questions related to the final rule on nanomaterial reporting and recordkeeping recently issued by EPA under Section 8(a) of the Toxic Substances Control Act (“TSCA”). That rule, entitled the Chemical Substances When Manufactured or Processed as Nanoscale Materials: TSCA Reporting and Recordkeeping Requirements (“Final Nanoscale Rule”), was finalized by EPA on January 12, 2017, after years of development. See 82 Fed. Reg. 3641. EPA recently delayed the effective date of the Final Nanoscale Rule until August 14, 2017, likely to allow time issuance and public comment on the Draft Guidance. See 82 Fed. Reg. 22088 (May 12, 2017).
Background on the Nanoscale Rule
Historically, EPA primarily relied on TSCA Section 5 (along with certain other vehicles) to collect information and evaluate the risks related to nanoscale materials. The scope of Section 5 limited EPA from gathering information related to nanomaterials derived from chemical substances already in commerce. For over a decade, EPA has planned to develop additional regulatory mechanisms that would allow EPA to collect information and nanoscale materials not covered under Section 5 (See B&D Alerts from July 31, 2007 and October 13, 2014).
The Final Nanoscale Rule serves that purpose. EPA proposed the rule on April 6, 2015 (see B&D Alert from April 6, 2015). After nearly two years, the Rule was finalized on January 12, 2017. According to EPA, the Final Nanoscale Rule imposes a “one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials before those new forms are manufactured or processed.” EPA indicates that the Final Nanoscale Rule “will assist EPA in its continuing evaluation of chemical substances manufactured at the nanoscale . . . each nanoscale material derived from substances on the TSCA inventory would be evaluated on a case-by-case basis without a presumption of either harm or safety.”
The Final Nanoscale Rule applies when entities manufacture or process, or intend to manufacture or process, “reportable chemical substances” that: (1) are solids at 25 degrees Celsius and standard atmospheric pressure; (2) are manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1–100 nanometers (nm) in at least one dimension; and (3) are manufactured or processed to exhibit one or more “unique and novel properties.” The Final Nanoscale Rule requires separate reporting for each “discrete form” of such substance. Various exemptions exist, including those designed to exclude from coverage an otherwise reportable substance.
Depending on the status of manufacturing or processing activities, entities must submit reports to EPA either “within one year after the final effective date of the rule,” or “at least 135 days before commencing manufacture or processing,” or “within 30 days of the formation of . . . an intent” to manufacture or process a discrete form of the reportable chemical substance. These reports must contain a list of eleven categories of information that is “known to or reasonably ascertainable” by the entity, including the specific chemical identity, actual or anticipated production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety information.
The Final Nanoscale Rule differs from the proposed rule in several ways. The Final Nanoscale Rule, for example, uses a numeric threshold of 1 percent-by-weight to replace the previous “trace amount” concept for the purpose of exempting from coverage materials with incidental amounts of reportable substances. The Final Nanoscale Rule includes a new “element of intent” to clarify that materials must be intentionally manufactured or processed for their size-dependent “unique and novel properties” in order to be covered and reportable under the rule. The Final Nanoscale Rule also adjusts the substance exemption list by removing two substances and adding several biological materials while rejecting certain other exemptions requested by commenters. There are various other changes, such as adding a definition of “particles” and adjusting the threshold for small businesses.
Perhaps the most important set of changes from the proposed rule are several clarifications that the Final Nanoscale Rule is not a new chemical regulatory program for nanomaterials similar to Section 5 (including exempting substances not on the TSCA inventory when reporting would be required, and shortening the reporting window to 30 days before processing or manufacture, from 135, when a company lacks the “intent” to manufacture or process a discrete form of a reportable chemical substance). The preamble to the Final Nanoscale Rule states that these changes are designed to avoid the “unintended” situation when a company would be required to submit information to EPA under both Section 8(a) and Section 5. EPA emphasizes that companies should not be required to report under 8(a) if the Section 5 submissions will provide EPA information to evaluate the nanomaterials, and that the 135-day window “is not a formal review-period that prohibits manufacture before the end of the 135-day period.”
Delay of the Effective Date and the Draft Guidance
The Final Nanoscale Rule was initially scheduled to take effect on May 12, 2017. But following promulgation of the Final Nanoscale Rule in January, EPA received feedback and questions from various stakeholders. In addition, some manufacturers and users of nanomaterials have asked EPA to repeal or significantly modify the rule, asserting that it is burdensome and unclear. In response, EPA delayed the effective date of the Nanoscale Rule from May 12, 2017 to August 14, 2017, noting that “the public interest is served by complete and accurate reporting under the rule, which would be greatly facilitated by publication of the guidance.”
Four days later, EPA released the Draft Guidance. The Draft Guidance takes the form of a list of “frequently asked questions” and covers many aspects of the Final Nanoscale Rule, including the scope of covered chemical substances, potential regulated entities, reportable information, reporting timeframe, confidentiality claims, and other general concerns. EPA is seeking comments on the Draft Guidance for 30 days, with comments due on or before June 15, 2017. Note that EPA is seeking comments only on the Draft Guidance, and not the Final Nanoscale Rule itself.