Regulatory DevelopmentsApril 6, 2015
On April 6, 2015, the U.S. Environmental Protection Agency (EPA) issued a Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects. EPA also proposes to require any persons who intend to manufacture or process chemical substances as discrete nanoscale materials after the effective date of the final rule to notify EPA of the same information at least 135 days before the intended date of commencement of manufacture or processing. Comments are due by July 6, 2015. EPA has posted a fact sheet on its website. EPA states that it anticipates holding a public meeting during the comment period, and it will announce the time and place of the meeting on its web page.
The proposed rule is long overdue and EPA's perseverance is laudable. EPA needs the information requested to conclude confidently that nanoscale versions of existing chemical substances pose no unreasonable risk, and to reassure the public what the nano community has been stating for years. That said, the proposal will almost certainly elicit a broad array of diverse comments from stakeholders along the value chain, and EPA can expect robust participation in the public meeting. EPA's thoughtful approach to defining what information is reportable, from which entities, and by when is plainly carefully calibrated to reflect the many issues unique to nanoscale chemical substances raised over the years. The proposal also breaks new ground in requiring reporting under Section 8(a) for processors (which are typically not subject to reporting under Section 8(a) rules, for example, the Chemical Data Reporting (CDR) rule), perhaps in recognition that different discrete nanoscale forms might be produced via processing. The criteria set forth in the proposal for defining what is subject to reporting, what is exempt, and a requirement for future reporting by entities that intend to manufacture or process a discrete form of a reportable chemical substance at least 135 days before commencement of manufacture or processing will be the subject of much debate. On the whole, the proposal is a thoughtful and useful step in gathering much needed information on existing chemical substances manufactured at the nanoscale.
Chemical Substances that Would Be Reportable
The proposed rule states:
This proposed rule would apply to chemical substances that are solids at 25ºC and atmospheric pressure and that are manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nanometers (nm) and exhibit unique and novel characteristics or properties because of their size. The proposed rule would apply to chemical substances containing primary particles, aggregates, or agglomerates in the size range of 1-100 nm in at least one dimension. This proposed rule would not apply to chemical substances that only have trace amounts of primary particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the unique and novel characteristics or properties because of particle size. EPA is proposing these parameters for purposes of identifying chemical substances that are subject to the rule, not to establish a definition of what is a nanoscale material.
Under the proposed rule, manufacturers and processors of multiple nanoscale forms of the same chemical substance would in some cases need to report separately for each discrete form of the reportable chemical substance. EPA proposes to distinguish the forms based on a combination of three factors: (1) a change in process to affect a change in size and/or a change in properties of the chemical substances manufactured at the nanoscale; (2) a change in mean particle size of ten percent or greater; and (3) the measured change in at least one of the following properties, zeta potential, specific surface area, dispersion stability, or surface reactivity, is greater than seven times the standard deviation of the measured values.
The proposed rule would also apply to chemical substances that are manufactured or processed in a nanoscale form "solely as a component of a mixture, encapsulated material, or composite." Chemical substances at the nanoscale that are manufactured but are then incorporated into mixtures, encapsulated materials, or composites by that manufacturer would not require separate reporting for their incorporation. EPA states that the person reporting the chemical substance would have to report each step of its manufacture, processing, and use to the extent it is known or reasonably ascertainable, however.
EPA notes that a chemical substance, as defined under TSCA Section 3(2), does not include any food, food additive, drug, cosmetic, medical device, pesticide, or other excluded materials. EPA states that such materials are not subject to this rule. EPA proposes to exclude certain biological materials (e.g., DNA, RNA, and proteins). EPA seeks comment to identify other specific biological materials that should be excluded from reporting and the reasons for excluding them, including microorganisms and viral-based products, lipids, carbohydrates, enzymes, and peptides. EPA proposes to exclude chemical substances that dissociate completely in water to form ions that are less than one nm. This exclusion would not apply to chemical substances manufactured at the nanoscale that release ions but do not dissociate in water to form those ions. EPA states that it believes that the chemical substances that would be excluded do not exhibit new properties when their size falls in the range of 1-100 nm and manufacturing or processing such substances at the nanoscale should therefore not be subject to the reporting requirements. EPA seeks comment to identify other water soluble compounds that should be excluded from reporting and the reasons for excluding them.
EPA proposes to exclude from the reporting requirements nanoclays, zinc oxide, and chemical substances manufactured at the nanoscale as part of a film on a surface. EPA states that it believes that information collected on these materials "would be of limited value because either they have been well-characterized or they present little exposure potential." EPA requests comment on these proposed exclusions and whether other chemical substances manufactured at the nanoscale should be excluded. Commenters should explain why they believe the chemical substances manufactured at the nanoscale should be excluded.
EPA notes that the general exemptions to TSCA Section 8(a) reporting would be applicable. Persons that manufacture or process, or intend to manufacture or process, these chemical substances as part of articles, as impurities, or in small quantities solely for research and development would not be subject to this action.
Importantly and perhaps appropriately, EPA proposes an alternate to the existing exemption for small manufacturers. Under TSCA Section 8(a) rules, a company qualifies as a small manufacturer by meeting either of the following two standards: (1) sales of the company are less than $40 million per year and the company does not manufacture more than 100,000 pounds annually of an individual substance at any individual site owned or controlled by the company; or (2) sales are less than $4 million regardless of the quantity manufactured. The proposed rule would define a small manufacturer or processor as any company with sales of less than $4 million, as the 100,000-pound threshold in the existing exemption "did not contemplate typical production volumes for chemical substances manufactured at the nanoscale." EPA requests comment on the proposed small manufacturer or processor exemption.
The proposed rule would not require manufacturers or processors to report certain information already submitted to EPA. EPA states that a person who submitted a TSCA chemical notice under Section 5 on or after January 1, 2005, would not be required to report regarding the same substance under this proposed TSCA Section 8(a) rule except where the person manufactured or processed a new discrete form of the reportable chemical substance. In addition, any person who has already reported under the Nanoscale Materials Stewardship Program (NMSP) part or all of the information that would be required under the proposed rule would not need to report that information again. EPA states that the purpose of these exemptions is to avoid duplicative reporting and, as an example, new chemical notices that have been reviewed as nanoscale materials would not be subject to reporting the same information under the proposed rule.
Timeline for Reporting
EPA proposes that persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the final effective date of the rule would report to EPA six months after the final effective date of the rule. EPA also proposes a continuing requirement that persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule would report to EPA at least 135 days before commencement of manufacture or processing.
EPA proposes one-time reporting of certain information, including specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety data. For this proposed rule, EPA modified an information reporting form developed for the NMSP. Any person required to report under the proposed rule would supply the information identified in the form to the extent it is known to or reasonably ascertainable by them. Once EPA publishes the proposed rule, it will place a draft of the proposed reporting form in the docket for public review. EPA requests comment on whether any information proposed to be collected is duplicative of information collected under other federal statutes and should thus be excluded.
Development of Additional Data
EPA notes that a TSCA Section 8(a) rule may not require persons to develop test data for submission to EPA. EPA encourages respondents to provide any relevant data on chemical substances manufactured at the nanoscale they decide to develop, however. EPA suggests that persons who intend to conduct testing consult with EPA before selecting a protocol for testing a chemical substance manufactured at the nanoscale. EPA also encourages persons that would be required to submit TSCA Section 8(a) data under the proposed rule to provide information on the potential benefits regarding the reportable chemical substance.
Request for Comments
EPA seeks public comment on all aspects of the proposed rule. In addition to specific requests noted above, EPA is interested in comments pertaining to the specific issues described below. EPA states that it anticipates conducting a public meeting during the comment period "to further discuss these and any other issues concerning the proposed rule."
- Identifying the chemical substances that would be
subject to reporting. EPA has developed the proposed
approach based on the approximate size range of 1-100
nm as used by the National Nanotechnology Initiative
(NNI) for defining nanotechnology, experience in
conducting assessments of new chemicals manufactured at
the nanoscale by EPA under TSCA, and data submitted to
EPA under the NMSP. EPA solicits comment on each
aspect of the proposed approach to identifying the
chemical substances that would be subject to the
reporting requirements of the rule.
- Distinguishing between nanoscale forms of a
reportable chemical substance. EPA states that it
considered several different approaches to distinguish
between nanoscale forms of a reportable chemical
substance, including a percentage or numerical change
in measured properties. EPA seeks comment on an
approach based solely on the behavior of the reportable
chemical substance. For example, if a manufacturer or
processor knows about or engineers a reportable
chemical substance with multiple nanoscale forms with
different performance characteristics, then each
nanoscale form would be reported. If multiple
nanoscale forms of a reportable chemical substance do
not perform differently, then only a single report of
the entire range would be reported. EPA states that it
is especially interested in comments on whether these
approaches would require reporting of sufficiently
distinct nanoscale forms of a chemical substance so
that reporting would be focused on those nanoscale
forms with potential for significantly different
physical or chemical characteristics or properties.
EPA also seeks comment on each aspect of its proposed
reporting such as size increments, the number of
standard deviations, morphology, the specific
physical-chemical properties identified, exclusions to
reporting, and whether companies have the analytical
tools to make such distinctions.
- Reporting discrete forms at least 135 days before
commencement of manufacture or processing. EPA
proposed the 135-day period based on EPA's experience
with premanufacture notice (PMN) submissions, and the
determination that the intent to manufacture was formed
at least 135 days before commercialization (i.e., the
90-day PMN review period plus 45 days). EPA
specifically seeks comment on whether this time-period
should be 135 days as proposed, 90 days to be similar
to the PMN review period, or some other time period.
According to EPA, it would be most helpful if
commenters explain why the time period they suggest is
- Considerations for EPA's economic analysis. EPA
states that it has evaluated the potential costs for
manufacturers and processors of reportable chemical
substances for the proposed rule. EPA specifically
seeks additional information and data that EPA could
consider in developing the final economic analysis. In
particular, data that could facilitate EPA's further
evaluation of the potentially affected industry and
firms, including data related to potential impacts for
those small businesses that would be subject to
reporting. EPA is especially interested in available
data or other measures of the number of and potential
growth in the number of commercial nanoscale materials
or firms that might manufacture or process such
- Electronic reporting. In proposing to require
electronic reporting under this rule that is similar to
those established in 2013 for other TSCA reporting, EPA
states that it "intends to save time, improve data
quality and increase efficiencies for both the
submitters and the Agency." EPA is specifically
interested in comments related to the adoption of the
existing mechanisms and related procedures for use in
transmitting the reports proposed in this rule,
including comments related to the extent to which
potentially reporting entities are already familiar
with those mechanisms given their existing use for
other TSCA reporting. EPA is also interested in
feedback on how electronic reporting mechanisms affect
reporting entities in terms of reporting time, added
efficiencies, and potential burden associated with
training to use the electronic systems (i.e., Central
Data Exchange (CDX) and Chemical Information Submission
- Consideration of potential future rulemaking regarding periodic reporting. EPA seeks comment on the possibility of a future rule that would require periodic reporting of chemical substances manufactured at the nanoscale, similar to reporting that occurs under the Chemical Data Reporting (CDR) rule. EPA states that such a rule could require manufacturers and processors of chemical substances manufactured at the nanoscale to report the type of information collected under the CDR rule to EPA at the same reporting interval as currently required by CDR reporting (every four years). The reporting could occur at lower thresholds for criteria such as production volume. EPA notes that the CDR "is a program designed to collect screening-level, exposure-related information on chemical substances and to make that information available for use by EPA and to the public consistent with confidentiality under TSCA Section 14 and EPA regulations in 40 CFR Part 2." EPA uses CDR rule data to support risk screening, assessment, priority setting, and management activities, and the CDR rule data "constitute the most comprehensive source of basic screening-level, exposure-related information on chemicals available to EPA."