Home > Nanotechnology Columns > Barg Coffin Lewis & Trapp LLP > Far-Reaching Information Request on Nanoscale Chemical Substances Proposed by EPA
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Joshua A. Bloom Partner Barg Coffin Lewis & Trapp LLP |
Abstract:
For the first time, and after multi-year negotiations with, and review by, the Office of Management and Budget, the U.S. Environmental Protection Agency is proposing to use its authority under the federal Toxic Substances Control Act (TSCA) to require companies to provide information on existing nanoscale materials, in addition to reporting for new discrete nanoscale materials before they are manufactured or processed.
April 16th, 2015
Far-Reaching Information Request on Nanoscale Chemical Substances Proposed by EPA
For the first time, and after multi-year negotiations with, and review by, the Office of Management and Budget, the U.S. Environmental Protection Agency is proposing to use its authority under the federal Toxic Substances Control Act (TSCA) to require companies to provide information on existing nanoscale materials, in addition to reporting for new discrete nanoscale materials before they are manufactured or processed. This proposal, which was published in the April 6, 2015 Federal Register, and for which comments may be submitted until July 6, 2015, represents yet one more step in the direction of greater regulatory scrutiny of all chemicals and substances used in the United States.
Under TSCA, EPA may, among other authorities, require information regarding chemicals, including nanoscale materials, before a chemical is manufactured and otherwise regulate chemicals that pose certain risks. However, in practice, EPA has regulated only a small sliver of chemicals placed in the market in the course of the almost 40 years that TSCA has been in force. In response to TSCA's limitations, various state initiatives, such as California's Safer Consumer Products regulations, have attempted to fill the gap. More recently, there have been serious efforts in Congress to reform TSCA, first in 2013, and now with two competing bills being considered that would significantly amend TSCA in ways that would lead to far greater regulation of chemical usage. Those efforts, in concert with EPA's proposed nanoscale information-gathering regulation and hints of broader information submission requirements, suggest that increasing scrutiny and regulation of both existing and new nanoscale materials can be expected.
According to EPA, the proposed information-gathering rule is required because more information is needed to understand potential environmental and health effects that may result from use of nanoscale materials. The Agency attempted to obtain similar information in 2008 and 2009 through its voluntary Nanoscale Materials Stewardship Program to "complement and support its regulatory activities on chemical substances manufactured at the nanoscale." Notwithstanding that effort, EPA estimates that it received information on only about ten percent of nanoscale substances that were manufactured during that time period. As a result, EPA now seeks to mandate submission of that information through its broad TSCA Section 8(a) authority, which directs the Agency to develop rules that require companies that manufacture or process chemical substances to submit to EPA "such reports as [EPA] may require."
The proposed rule, which EPA describes as a "one-time" requirement, would apply to any chemical substance that is solid at 25°C and atmospheric pressure, is processed in a form where the primary particles, aggregates, or agglomerates are within a size range of 1-100 nanometers, and exhibits unique and novel characteristics because of its size. In some instances, manufacturers and processors of multiple nanoscale forms of the same chemical substance would need to report separately for each discrete form, and chemical substances that are manufactured or processed in a nanoscale form solely as a component of a mixture, encapsulated material, or composite would also need to be reported.
Excluded from reporting requirements would be certain biological materials (e.g., DNA, RNA, and proteins). In addition, EPA is seeking comment on excluding other biological materials, such as microorganisms and viral-based products, lipids, carbohydrates, enzymes, and peptides. Also excluded would be chemical substances that dissociate completely from water to form ions that are less than one nanometer. EPA further proposes excluding nanoclays, zinc oxide, and chemical substances manufactured on a nanoscale as part of a film on a surface.
In addition, the general TSCA exemptions, such as, for example, the exemption for research and development in which only small quantities of a chemical substance are manufactured or processed, for pesticides (which are regulated under the Federal Insecticide, Fungicide and Rodenticide Act), and for materials regulated under the federal Food, Drug, and Cosmetics Act, would continue to apply. Further, to the extent information on a chemical substance has already been provided to EPA under Section 5 of TSCA (as long as the information was provided after January 1, 2005 and the chemical substance now being processed or manufactured is not a new discrete form of the prior-reported chemical), or if the information was already provided under the Nanoscale Materials Stewardship Program, information on that substance would not be required under the proposed reporting rule.
Any information required to be reported under the proposed rule with respect to any discrete form of a reportable chemical substance that was manufactured or processed within three years prior to the final effective date of the rule would need to be submitted within six months after the final effective date of the rule. With respect to discrete forms of reportable chemical substances that would be manufactured or processed on or after the effective date of the final rule, reporting to EPA would be required no less than 135 days before commencement of manufacture or processing.
The type of information that EPA would require to be submitted under the proposed rule would be similar to that requested under the Nanoscale Materials Stewardship Program—specific chemical identity, material characterization, physical chemical properties, production volume, use, methods of manufacturing, exposure and release information, and existing data concerning environmental and health effects. Such information would need to be submitted "to the extent it is known to or reasonably ascertainable by" the manufacturer or processor.
Also noteworthy is that EPA is seeking comment on consideration of potential future rulemaking regarding periodic reporting. That rule would require reporting similar to that required under the Chemical Data Reporting (CDR) rule (40 CFR part 711), and would require manufacturers and processors of nanoscale chemical substances to report every four years, but at thresholds lower than those established under the CDR rule. EPA contemplates that it would seek information that would "constitute the most comprehensive source of basic screening-level, exposure-related information on chemicals available to EPA."
The proposed reporting and recordkeeping requirement proposal, in concert with the competing TSCA reform bills being debated in Congress and EPA's signaling that it will seek to broadly exercise its information-gathering authority with respect to chemical substances manufactured or processed at the nanoscale level, portends increasing scrutiny and regulation as the use of nanoscale materials becomes more widespread. Manufacturers and processors will need to stay engaged in those regulatory efforts to ensure that regulations remain workable and do not chill future development or application of nanoscale substances.
Joshua A. Bloom is a partner at Barg, Coffin, Lewis & Trapp, LLP, a San Francisco-based environmental law firm. He can be reached at or via the firm's website - http://www.bcltlaw.com .
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