After years of internal review within the executive branch, on April 6, 2015, the US Environmental Protection Agency (EPA) finally published a proposed rule that would require reporting and recordkeeping for certain chemical substances when they are manufactured or processed at the nanoscale. If finalized, the rule could become the first federal environmental regulation to impose new reporting requirements that are specifically targeted at the category of nanoscale materials. EPA is using its authority under the Toxic Substances Control Act (TSCA) to issue the proposal.
Substances produced on a "nanoscale" are very, very small. A nanometer is one billionth of a meter. A carbon nanotube can be formed as small as one nanometer in diameter, smaller than a strand of DNA and about 100,000 times thinner than a human hair.1 The proposed rule would cover particles (or combinations of particles) with at least one dimension that is between 1 and 100 nanometers in size.
Often, substances that can be produced on a nanoscale exhibit commercially desirable properties that can be unique to their small size and shape. At the same time, concerns have been expressed that nanoscale substances might have health or environmental effects that differ from substances produced on a more conventional scale.
EPA's proposed rule is intended to facilitate the Agency's ability to gather data concerning the ways in which nanoscale substances are being produced and used in the US, as well as existing health and safety data that have not previously been provided to EPA. The proposed rule raises a number of important questions for the regulated community. For example:
- Will the information being collected expose the submitter to potential regulatory or enforcement consequences?
- What will EPA ultimately do with the information it collects?
Comments on the proposed rule are due by July 6, 2015.
Following is a summary of the proposed rule (available here),2 followed by a discussion of several of the questions the regulated community should be asking.
Who Will be Regulated?
Manufacturers (including importers) and processors of nanoscale forms of chemical substances3 that are currently listed on the TSCA Inventory4 could be affected by EPA's rulemaking. There are certain exemptions that would exclude small businesses and those who manufacture or process nanoscale materials in small quantities solely for research and development, or as part of articles, or as impurities.
What Will be Required?
Regulated entities will have both reporting and recordkeeping obligations. The reporting obligation will be one-time only, and reports will be submitted electronically to EPA. As envisioned, those who currentlymanufacture or process nanoscale materials would have to report certain data about those materials to EPA within six months after the final rule becomes effective. Those who intend to manufacture or process nanoscale materials in the future would be required to report the same data to EPA 135 days before commencing manufacture or processing.
Reporting entities would then be required to keep for three years copies of their reports, plus materials and documents sufficient to verify or reconstruct the values submitted in their report.
Companies that have already reported the same information to EPA-for example as part of EPA's Nanoscale Materials Stewardship Program-would not have to double report.
What Substances Will be Reportable?
Nanoscale materials (i.e., substances that measure between 1 and 100 nanometers in one dimension) that are solid at 25ºC and atmospheric pressure would be reportable in each discreet form that exhibits unique and novel characteristics or properties because of its size.
Whether a nanoscale substance is a discreet form will depend on three technical factors: (1) a change in process to affect a change in size or properties; (2) a change in mean particle size of 10% or more; and (3) a change in zeta potential,5 specific surface area, dispersion stability, or surface reactivity that is more than 7 times the standard deviation of the measure value. If a nanoscale particle has a different morphology or shape (e.g., spheres, rods, ellipsoids, cylinders, needles, wires, fibers, cages, shells, trees, flowers, rings, tori,6 cones, and sheets), it would also qualify as a discreet form of the substance for purposes of reporting.
There are a number of specified exceptions, including impurities (so as to keep the focus on intentionally manufactured substances), certain biological materials (e.g., DNA), and substances that dissociate completely in water to form ions that are less than 1 nanometer.
What Information Will be Reportable?
Regulated entities would be required to report several categories of data for each discrete form of a reportable chemical substance, including: (1) identifying information (i.e., the common trade name, the specific chemical name, and the molecular structure of each chemical); (2) material characteristics (i.e., particle size, morphology, and surface modifications); (3) physical and chemical properties; (4) information about impurities and byproducts resulting from manufacture, processing, and use; (5) production volumes; (6) information on how the substance can be used; (7) detailed methods of manufacturing or processing; (8) human exposure information; (9) environmental release information; (10) risk management practices (i.e., warnings, engineering controls, training, etc.); and (11) existing data about environmental and health effects.
What About Confidential Information?
EPA will permit reports (or a subset of the information included in a report) to be designated as Confidential Business Information (CBI), and will provide standard protections against the further disclosure of CBI.
Questions the Regulated Community Should Be Asking
Could These Reporting Requirements Expose Report Submitters To Enforcement Actions?
Will companies who report information in response to the reporting requirement fall into a potential trap, such that EPA will take the position that the information should have been reported earlier under TSCA Sections 5 or 8?
As described in the Agency's 2008 TSCA Inventory Status of Nanoscale Substances-General Approach, nanoscale materials are considered chemical substances as defined under TSCA section 3(2). Nanoscale forms of chemical substances that are not on the TSCA Inventory in any form are considered newchemical substances that require reporting to the Agency under Section 5 of TSCA at least 90 days beforemanufacture may commence in the US. EPA has assessed over 170 different "new" nanoscale substances under its Section 5 authority and has taken regulatory actions to control exposures and prevent potential unreasonable risks to human health or the environment from many nanoscale substances pending development of additional information (such as health and safety testing). Such actions are intended to generate data to allow EPA to more fully assess certain risks.
Could a submitter of a report that describes an ongoing activity concerning a nanoscale substance be determined by EPA to be in violation of TSCA Section 5 because EPA considers the substance to be "new" (i.e., because it is distinct or different from a conventional scale chemical substance), even though the submitter believed the substances already appeared on the TSCA Inventory? Is it possible that a health or environmental effects study that is submitted pursuant to a final Section 8(a) reporting rule could be interpreted by EPA to be "substantial risk" information which should have been previously reported to EPA pursuant to TSCA Section 8(e)?
What Will EPA Ultimately Do With The Information It Collects?
EPA recognizes the potential benefits of nanoscale technologies, but also is cognizant of concerns raised about potential harm. EPA has stated that it intends to use the information gathered to determine if any further regulatory action is needed. It remains unclear, however, how EPA can make the best use of information that is received 135 days in advance of an entity commencing manufacture or import of a nanoscale substance that it does not currently produce in the US.
Why Require Reporting 135 Days Before Manufacturing?
As noted, EPA already requires pursuant to its authority under Section 5 of TSCA that notification be provided to the Agency 90 days before any person may manufacture or import a new chemical substance (including one produced on a nanoscale). In the preamble to the proposed Section 8(a) rule, EPA spent several column inches explaining why 135 days was an appropriate number of days to require reporting before a nanoscale material which would be subject to the Section 8(a) rule will be manufactured or processed. But the proposed 8(a) rule is only pertinent to existing chemical substances, and EPA did not explain why reporting should be required before manufacturing or processing of an existing nanoscale substance is undertaken by a new manufacturer of a substance which presumably already appears on the TSCA Inventory. Moreover, it is unclear what EPA would hope to accomplish during those 135 days.
In a previous draft of the proposed rule that EPA submitted to the Office of Management and Budget (OMB), EPA was considering "developing a significant new use rule (SNUR) under TSCA section 5(a)(2) that would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent unreasonable risk to human health or the environment."7 Presumably, EPA would have defined manufacturing of an existing conventional scale substance on a nanoscale to have been a significant new use for which reporting would have been required. Persons who submit such notices pursuant to Section 5 of TSCA also can become subject to potential regulatory actions issued pursuant to Section 5(e) of TSCA if the Agency takes such an action before the 90-day notice review period has expired.
The SNUR was dropped from the proposed rule. Perhaps OMB objected to that aspect of the proposal because it would have been perceived as potentially stifling innovation. But the presence of the 135-day advance-notice requirement in the current proposed rule, without any explanation of why advance notice is required at all, leaves one wondering if EPA is nevertheless attempting to implement an approximation of the Agency's Section 5 "new chemical/new use" review program while still living within the terms of what may have been a compromise reached with OMB.
This begs the question, how does EPA intend to use the information it acquires if it wishes to develop timely restrictions on the manufacture, processing, or uses of a particular nanoscale substance to protect against the specific harms that may be identified before the 135-day period will have expired? EPA can take action reasonably swiftly using its Section 5(e) authority to prohibit or limit the production of a new nanoscale substance that is the subject of a premanufacture notification (PMN) (or to limit a significant new use of such a substance). The Agency acknowledges in the preamble to the proposed Section 8(a) rule that, before EPA can take a similar action on an existing nanoscale substance, EPA would need "a sound scientific basis for assessing and managing potential impacts resulting from the introduction of chemical substances manufactured at the nanoscale into commerce." Currently, it would seem the only option available to EPA in such circumstances would be to enter into some form of a voluntary, negotiated agreement, or a Section 6 rulemaking. It seems unlikely the Agency could undertake issuing even a proposed Section 6 rule within the 135-day window.
What Other Actions Is EPA Taking On Nanoscale Substances?
The Agency's TSCA proposal was the second announcement concerning nanoscale materials to emerge from EPA in rapid succession. Products that contain nanoscale elements that are marketed with "antimicrobial" claims are considered to be "pesticides" and are subject to EPA regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) rather than TSCA. In March, EPA issued its long-awaited response to a petition the Agency received in 2013 from certain environmental NGOs seeking to compel EPA action on virtually all products that contain nanoscale silver. EPA's March 2015 response (available here and discussed here) effectively settled a lawsuit that sought a court order compelling EPA to respond to the 2013 petition. The Agency's response restated EPA's position that the makers and marketers of products that contain nanoscale silver (and other active ingredients) are subject to EPA's registration requirements when they are sold with antimicrobial claims. Moreover, the EPA response also reemphasized the Agency's willingness and determination to take enforcement actions to block the sale (and penalize makers) of such products when they are distributed in a manner that violates EPA regulations.
Given that the long-standing log-jam on EPA actions to regulate nanoscale substances appears to have been broken, manufacturers, importers, and processors of substances produced on a nanoscale will need to pay attention to-and might be wise to provide their comments to EPA on-this most recent action.