Nanoscale Material Reporting is in Effect
By Lynn L. Bergeson
After a decade of trying, the U.S. Environmental Protection Agency (EPA) now has in effect a final Toxic Substances Control Act (TSCA) Section 8(a) information gathering rule focusing on nanoscale materials. This article explains the final rule, what stakeholders are required to do, and by when.
EPA has for years tried to obtain information on chemicals deemed “existing” under TSCA, yet manufactured at the nanoscale. As has been noted many times, some chemical substances and materials exhibit “size dependent” properties and/or functionalities at the nanoscale (1-100 nanometers) that are dissimilar to properties and/or functionalities exhibited by the same substances and materials at the bulk (conventional) scale. EPA has stated, correctly, that it needs information on these existing nanoscale materials to ensure that the products that contain them, and the conditions of their manufacture and/or processing, are safe and unlikely to pose workplace risks or risks to others in the value chain and to users of these materials.
Most would agree with EPA that it needs more information. The tricky part has been identifying with precision the kind of information EPA needs to ensure its regulatory judgment is sufficiently informed so that it can make risk assessment determinations. Years ago, EPA encouraged companies that manufacture, import, or process nanoscale materials voluntarily to report certain information to EPA. As EPA was unable to obtain the quality or quantity of information it needed, it opted to deploy its authority under TSCA Section 8(a) to obtain such information. EPA issued a proposed nanoscale materials reporting rule on April 6, 2015, that included a one-time reporting requirement, as well as a future reporting requirement for any person who intends to manufacture or process a reportable substance after the effective date of the final rule. EPA opened a rulemaking docket, and convened a public meeting on June 11, 2015. Concerns expressed by commenters included the proposed future reporting requirement, the vagueness of definitions of “novel” and “unique” characteristics, “trace” amounts, the financial burden on industry, and the lack of coordination with other governments, such as Canada.
On Jan. 12, 2017, EPA issued a final rule. The rule imposes a one-time reporting obligation and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. Manufacturers (including importers) and processers, or persons who intend to manufacture or process new discrete forms of certain existing chemical nanoscale materials not previously reported to EPA, must also report certain information to EPA prior to manufacture or processing.
What Must Be Reported
The information to be reported includes, insofar as “known to or reasonably ascertainable” by the person reporting, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects. Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the effective date of the final rule must report to EPA one year after the effective date of the final rule. This means that for companies that have manufactured, imported, or processed reportable nanoscale materials at any time between Aug. 14, 2014, and Aug. 14, 2017, must submit reports for these substances to EPA no later than Aug. 14, 2018.
There is also a standing one-time reporting requirement for persons who intend to manufacture or process a new discrete form of a reportable existing chemical substance on or after the Aug. 14, 2017, effective date. These persons are required to report to EPA either at least 135 days before commencing manufacture, import, or processing reportable nanoscale materials or, if they have formed an intent less than 135 days before such manufacture, import, or processing, then within 30 days after forming such an intent.
Chemical Substances That Would Be Reportable
The final rule applies to chemical substances, as defined in TSCA Section 3, that are solids at 25 ºC, and that 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 that are manufactured or processed intentionally to exhibit one or more “unique and novel” properties. The final rule does not apply to chemical substances manufactured or processed in forms that contain less than one percent by weight of any particles, including aggregates and agglomerates, in the size range of 1-100 nm. “Unique and novel” properties means “any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance, and such properties are a reason that the chemical substance is manufactured or processed in that form or size.” Reportable chemical substances do not include chemical substances manufactured or processed at the nanoscale that contain incidental amounts of particles in the size range of 1-100 nm, certain biological materials, chemicals that dissociate completely in water to form ions of less than 1 nm in size, and chemicals formed at the nanoscale as part of a film on a surface.
The final rule excludes certain biological materials including DNA, RNA, proteins, enzymes, lipids, carbohydrates, peptides, liposomes, antibodies, viruses, and microorganisms. Chemical substances that dissociate completely in water to form ions with a size of less than one nm are also excluded, as are chemical substances formed at the nanoscale as part of a film on a surface. The general exemptions to TSCA Section 8(a) reporting are applicable to the final rule. Importantly, for purposes of this rule, EPA has defined and exempted any small manufacturer or processor as a company that has sales of less than $11 million per year.
The rule requires reporting of information including chemical identity, actual or anticipated production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety information. Any person required to report under the rule must supply the information identified in the form developed by EPA to the extent it is known to or reasonably ascertainable by them. EPA issued guidance on August 14, 2017, on the reporting rule which stakeholders are urged to review.
EPA is to be commended for crafting a final rule that is clearer than the proposal and more likely to elicit useful information. Complying will remain challenging, and the guidance notes that it “will not provide answers to all of the potential questions that will arise as manufacturers and processors seek to comply with the rule.” EPA states that it will answer questions on a case-by-case basis, and fortunately intends to add further questions/answers and revisions to the guidance based on questions identified by persons who may be subject to the rule.
More information is available on EPA’s website here.
Lynn L. Bergeson is Managing Partner of Bergeson & Campbell, P.C. (B&C®), a Washington, D.C., law firm focusing on conventional, nanoscale and biobased industrial, agricultural and specialty chemical product regulation and approval matters, environmental health and safety law, chemical product litigation and associated business counseling and litigation issues. She is President of The Acta Group, with offices in Washington, D.C., Manchester, UK, and Beijing, China, and President of B&C® Consortia Management LLC (BCCM), with offices in Washington, D.C.