On April 6, 2015, the Environmental Protection Agency published a proposed rule under Section 8(a) of the Toxic Substances Control Act, which would impose certain reporting and recordkeeping requirements on manufacturers and processors of specified nanoscale substances. The deadline for comments on this proposed rule is July 6, 2015.
TSCA Section 8(a) authorizes EPA to promulgate rules imposing reporting and recordkeeping requirements, as EPA may “reasonably require,” on manufacturers and processors of chemical substances. The agency uses the information to set priorities for Section 4 testing and other regulatory actions. Typically, EPA promulgates Section 8(a) for specific chemicals, although EPA previously has promulgated “model” rules applicable to multiple chemicals, e.g., the Preliminary Assessment Information Rule promulgated in 1982.
Under EPA’s current proposal, persons who manufacture and process “discrete” forms of reportable nanoscale substances any time in the three years prior to the rule’s effective date of the rule would report to EPA within six months after rule’s effective date. Similarly, persons intending to manufacture or process a discrete form of a reportable nanoscale substance would have to report to EPA at least 135 days before the commencement of such manufacture or processing. Entities would have to report information such as chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety data.
Small companies would be exempt from this rule, although EPA is proposing a new definition of “small manufacturer and processor” to account for the typical scale of nanoscale material manufacture. Under the proposed rule, a small manufacturer or processor is a company with sales of less than $4 million. The general exemptions from Section 8(a) reporting, such as the research and development exemption, also would apply.
Reportable nanoscale substances are solids at 25 degrees celsius and atmospheric pressure, which are manufactured or processed in a form where the primary particles, aggregates or agglomerates are in the 1-100 nanometer (nm) size range (in at least one dimension) and exhibit unique and novel characteristics due to their size. Significantly, EPA states that this description is not intended to define what is a nanoscale material, an issue that has plagued regulators across jurisdictions, but only is intended to define what substances are subject to the rule.
In addition, the rule would not apply to chemical substances that only have trace amounts of such primary particles, aggregates or agglomerates in the 1-100 nm size range, such that no unique and novel characteristics are exhibited due to particle size. Also excluded from reporting are certain biological materials, chemical substances which dissociate completely in water to form ions less than 1 nm, nanoclays, zinc oxide and substances manufactured at the nanoscale as part of a film on a surface.
“Discrete” nanoscale forms of the same chemical substances would separately be subject to the rule’s requirements. According to the proposed rule,
[a] discrete form of a reportable chemical substance differs from another form of the same reportable chemical substance in that either:
(1) The change in the reportable chemical substance is due to all of the following:
(i) There is a change in process to affect a change in size and/or
a change in one or more of the properties of the reportable chemical
substances identified in (iii);
(ii) There is a size variation in the mean particle size that is
greater than 7 times the standard deviation of the mean particle size
(+/- 7 times the standard deviation); and
(iii) There is a measured change in at least one of the following
properties, zeta potential, specific surface area, dispersion
stability, or surface reactivity, [that] is greater than 7 times the standard
deviation of the measured value (+/- 7 times the standard deviation);
(2) The reportable chemical substance has a different morphology.
Examples of morphologies include but are not limited to sphere, rod,
ellipsoid, cylinder, needle, wire, fiber, cage, hollow shell, tree,
flower, ring, torus, cone, and sheet; or
(3) A reportable chemical substance that is coated with another
chemical substance or mixture at the end of manufacturing or processing
has a coating that consists of a different chemical substance or
Although EPA previously has promulgated TSCA rules for specific nanoscale materials (e.g., significant new use rules for specified carbon nanotubes), this proposed rule is EPA’s first attempt to regulate nanoscale materials broadly in a non-chemical specific way. The information provided through this rule, if it is promulgated, likely will lead to further regulation. The scope of such regulation could include Section 4 test rules, a particular challenge for nanoscale materials insofar as there is no formally accepted methodologies for testing such materials.