EPA Embarks on First Major Rulemaking to Guide Regulation of Nanoscale Materials and Products

Kelley Drye Client Advisory

After almost a decade of study and input from stakeholders, the U.S. Environmental Protection Agency (“EPA”) has proposed first-time reporting requirements under the Toxic Substances Control Act (“TSCA”) for manufacturers, importers, and processors of nanoscale material.1  The agency’s action recognizes the inherent tension between the scientific and economic promise of nanotechnology and the uncertainty of potential hazards that may arise from the unique physical and chemical properties of nanoscale substances.  As EPA noted upon release of the proposed rule:

These chemical substances may have properties different than the same chemical substances with structures at a larger scale, such as greater strength, lighter weight, and greater chemical reactivity. These enhanced or different properties give nanoscale materials a range of potentially beneficial public and commercial applications; however, the same special properties may cause some of these chemical substances to behave differently than conventional chemicals under specific conditions.

The data collection effort is aimed at examining whether the physical and chemical properties of nanoscale materials have toxicological relevance.  EPA intends to use the information gathered through the reporting rule to determine if any further action under TSCA, including additional information collection, is needed.  In proposing the rule, the agency emphasizes that “[b]eing nanoscale is not itself an indication of, or criterion for, hazard or exposure potential.”

EPA proposes to use its authority under Section 8(a) of TSCA to require those who have manufactured, imported, or processed nanoscale materials within three years of the rule’s effective date to fulfill a one-time reporting obligation within six months of the final rule.  Persons who propose to manufacture, import, or process nanoscale materials would have to fulfill the reporting requirements 135 days prior to commencing manufacture, import, or processing.  The data to be reported include information that is known” or reasonably ascertainable” related to chemical identity, physical and chemical characteristics, production volume, use and function, methods of manufacture and processing, exposure and release, and environmental and health effects.  The proposed rule also includes a number of record keeping requirements.

Extending the reporting requirements to processors is not only rare under TSCA section 8(a), but may pose a challenge to companies.  In particular, it is unclear whether processors of nanoscale materials routinely receive from upstream manufacturers or otherwise have the information necessary to determine if they are processing a reportable chemical substance” (discussed below).  EPA does not further explain in the rule what information is known” or reasonably ascertainable” or what steps processors should be expected to take to obtain such information.

Reportable chemical substances under the rule must meet the following three conditions: (1) solid at 25º Celsius and atmospheric pressure; (2) the primary particles, aggregates, or agglomerates are in the size range of 1 to 100 nanometers in at least one dimension; and (3) the primary particles, aggregates, or agglomerates exhibit unique and novel characteristics or properties because of their size.  The proposed rule excludes substances that have only trace amounts of nanoscale particles, aggregates, or agglomerates such that the substances do not exhibit unique and novel characteristics or properties.  EPA makes the point that these size ranges should not be used to define the concept of nanoscale” material but should be used to determine whether the substance is reportable.  Chemical substances that are manufactured or processed in a nanoscale form solely as a component of a mixture, encapsulated material, or composite also would be subject to the reporting requirements.

EPA proposes to exclude several substances from the reporting rule, including nano-clays, zinc oxide, and nanoscale substances manufactured as part of a film on a surface, as well as proteins and RNA/DNA.  The agency requests comment on whether other substances should be excluded, specifically biological materials such as microorganisms, viral products, lipids, carbohydrates, enzymes, and peptides.  The proposed exclusions are based either on the agency’s belief that the chemical substances do not exhibit new properties when their size falls in the range of 1-100 nm, or that the information collected would be of limited value because the substance already is well-characterized or it presents little exposure potential.

The general exemptions to TSCA section 8(a) reporting would be applicable, including the exemption for small quantity research and development. EPA also proposes an alternate small manufacturer” exemption for companies having sales of less than $4 million regardless of manufactured quantities.  EPA posits that the typical small manufacturer exemption for companies having sales less than $40 million per year and manufacture quantities less than or equal to 100,000 pounds annually of an individual substance at any individual company site would not be an appropriate quantity threshold for nanoscale substances.

EPA identifies a non-exhaustive list of industry categories to which the proposed rule may apply, including Chemical Manufacturing or Processing (NAICS codes 325);  Synthetic Dye and Pigment Manufacturing (NAICS code 325130); Other Basic Inorganic Chemical Manufacturing (NAICS code 325180); Rolled Steel Shape Manufacturing (NAICS code 331221); Semiconductor and Related Device Manufacturing (NAICS code 334413); Carbon and Graphite Product Manufacturing (NAICS code 335991); Home Furnishing Merchant Wholesalers (NAICS code 423220); Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS code 423330); Metal Service Centers and Other Metal Merchant Wholesalers (NAICS code 423510); and Research and Development in the Physical, Engineering, and Life Sciences).  These are just examples of potentially affected industries; numerous other industry categories may fall within the scope of the proposed rule.  The above list likely reflects industries for which EPA has data related to small particulate size or the manufacture of powders and similar fine materials.

The proposed rule is the first major rulemaking effort aimed at collecting the data necessary to determine if novel nanoscale materials pose an unreasonable risk” that warrants further regulation.  Based on the information collected, EPA intends to evaluate nanoscale materials on a case-by-case basis,” recognizing that each nanoscale substance may have unique physical, chemical, and toxicological characteristics.  The proposal appears to be a reasonable effort in this regard, but raises numerous interpretative and technical issues for companies that may fall within its scope.  Comments on the proposed rule are due by July 6, 2015.

Kelley Drye’s Environmental Law Practice Group specializes in providing comprehensive solutions to complex problems. We provide both advice and representation for clients participating in rule-making and policy-making activities by federal regulatory agencies, including the U.S. Environmental Protection Agency and the Occupational Safety & Health Administration, and similar state agencies.

For more information about this Client Advisory, please contact:

Joseph J. Green
(202) 342-8849


[1] 65 Fed. Reg. 18,330 (Apr. 6, 2015).