On January 12, 2017, the EPA finalized a rule on nanomaterial reporting and record keeping under Section 8(a) of the Toxic Substances Control Act (TSCA). See 82 Fed. Reg. 3641. The rule, called Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements (Final Rule), was in development for years and was set to go into effect on May 12, 2017. Id.
The Final Rule establishes reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. Specifically, the rule requires persons that manufacture or process, or intend to manufacture or process these chemical substances to electronically report to EPA certain information, which includes insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects. The rule involves 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.
At the nanoscale, the physical, chemical, electrical and biological properties of matter differ in fundamental ways from the properties of the same matter in its macro or bulk form. These other properties provide a wide range of environmental, commercial, industrial, and health benefits and new applications for use of nanomaterials are discovered daily. However, there is also increasing scientific evidence showing that nanomaterials may present hazards to the environment and human health. The EPA is careful to explain that the Final Rule does not conclude that nanoscale materials do, or are likely to, cause harm to the environment or humans. The EPA claims that the information gathered will assist the EPA in determining if any further action under TSCA is necessary.
However, instead of the Final Rule going into effect on May 12, the EPA delayed the effective date until August 14, 2017. See 82 Fed. Reg. 22088. After issuing the Final Rule the EPA received feedback and questions and the EPA determined it would issue draft guidance on the rule and delayed the effective date noting that “the public interest is served by complete and accurate reporting under the rule, which would be greatly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.” A few days later, the EPA issued the Draft Guidance and requested public comment on the same. See 82 Fed. Reg. 22452. The Draft Guidance is styled as a question and answer or frequently asked questions document. Curiously, the EPA sought comments on the Draft Guidance and not on the Final Rule itself. Comments were due by June 15, 2017. It remains to be seen how the EPA will respond to any comments it receives on the Draft Guidance, but for now the effective date of the Final Rule remains August 14, 2017.