Regulatory DevelopmentsJanuary 12, 2017
After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. 82 Fed. Reg. 3641. Manufacturers and processers, or persons who intend to manufacture or process new discrete forms of certain existing chemical nanoscale materials not previously reported to EPA, must also report certain information to EPA prior to manufacture or processing. The information to be reported includes, insofar as “known to or reasonably ascertainable” by the person reporting, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects. Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the effective date of the final rule must report to EPA one year after the effective date of the final rule. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a new discrete form of a reportable existing chemical substance on or after the effective date of the rule. These persons are required to report to EPA at least 135 days before manufacture or processing of that discrete form with certain exceptions. The final rule will be effective on May 12, 2017.
As reported in our April 6, 2015, memorandum, “EPA Proposes Reporting and Recordkeeping Requirements for Nanoscale Materials,” EPA issued a proposed rule on April 6, 2015, that included a one-time reporting requirement, as well as a future reporting requirement for any person who intends to manufacture or process a reportable substance after the effective date of the final rule. With publication of the proposed rule in the Federal Register, EPA also opened the rulemaking docket. The docket includes 60 supporting documents, including an 85-page list of chemical substances that could be nanomaterials. More information regarding the materials posted in the docket is available in our April 8, 2015, memorandum, “EPA Opens Docket for Proposed TSCA Section 8(a) Rule for Nanomaterials.” EPA held a public meeting on June 11, 2015, on the proposed rule. Jeff Morris, Office of Pollution Prevention and Toxics (OPPT), and Jim Alwood, OPPT, provided further insight into EPA’s goals, directives, and expected results as related to the proposed rule. Concerns expressed by commenters included the proposed future reporting requirement, the definitions of novel and unique characteristics and trace amounts, the financial burden on industry; and the lack of coordination with other governments, such as Canada. More information regarding the meeting is available in our June 24, 2015, memorandum, “EPA Holds Public Meeting on TSCA Section 8(a) Proposed Rule.”
Chemical Substances that Would Be Reportable
The final rule applies to chemical substances, as defined in TSCA Section 3, that are solids at 25 ºC and standard atmospheric pressure; that are manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nanometers (nm) in at least one dimension; and that are manufactured or processed to exhibit one or more unique and novel properties. The final rule does not apply to chemical substances manufactured or processed in forms that contain less than one percent by weight of any particles, including aggregates and agglomerates, in the size range of 1-100 nm. EPA notes that these parameters “are for purposes of identifying chemical substances that are subject to the rule and do not establish a definition of nanoscale material.”
The final rule defines unique and novel properties as “any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance, and such properties are a reason that the chemical substance is manufactured or processed in that form or size.” Under the final rule, a reportable chemical substance is not just a substance containing particles in the size range of 1-100 nm; “it must also demonstrate a size-dependent property different from properties at sizes greater than 100 nm and is a reason the chemical is manufactured or processed in that form or size.” Reportable chemical substances do not include chemical substances manufactured or processed at the nanoscale that contain incidental amounts of particles in the size range of 1-100 nm, certain biological materials, chemicals that dissociate completely in water to form ions of less than 1 nm in size, and chemicals formed at the nanoscale as part of a film on a surface. While the proposed rule used “trace amounts” to define this concept, in response to public comments the final rule uses a numerical value of less than one percent of particles from 1-100 nm by weight to define those chemical substances that are not reportable.
EPA states that manufacturers and processors of multiple nanoscale forms of the same chemical substance will, in some cases, need to report separately for each discrete form of the reportable chemical substance. EPA notes that reporting of these discrete forms is not the same as new chemical reporting under TSCA Section 5. The final rule distinguishes between discrete forms in three different ways. The first is based on a combination of three factors:
- A change in process to effect a change in size, a change in properties of the chemical substances manufactured at the nanoscale, or both;
- A change in mean particle size greater than seven times the standard deviation of the measured values (+/- 7 times the standard deviation); and
- The 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 (+/- 7 times the standard deviation).
The second way of distinguishing a discrete nanoscale form of a particular chemical substance is a “specifically engineered change” in morphology or shape “to effect a change and form a unique and novel property” (the additional detail appears in the preamble but is not included in the codified text). EPA states that examples include spheres, rods, ellipsoids, cylinders, needles, wires, fibers, cages, hollow shells, trees, flowers, rings, tori, cones, and sheets. The third way is that forms of a reportable chemical substance that are coated with different chemical substances would be considered discrete forms for each chemical coating.
According to the final rule, chemical substances that are manufactured or processed in a nanoscale form for the purposes of being sold to others for use as a component of a mixture, encapsulated material, or composite are subject to reporting. EPA states that chemical substances at the nanoscale that are manufactured but are then incorporated into mixtures, encapsulated materials, or composites by that manufacturer do not require separate reporting for their incorporation. EPA notes that the person reporting as to the chemical substance must report the information required as to each step of its manufacture, processing, and use to the extent it is known or reasonably ascertainable, however.
The final rule excludes certain biological materials including DNA, RNA, proteins, enzymes, lipids, carbohydrates, peptides, liposomes, antibodies, viruses, and microorganisms. Chemical substances that dissociate completely in water to form ions with a size of less than one nm are also excluded. EPA notes that this exclusion does not apply to chemical substances manufactured at the nanoscale that release ions but do not dissociate in water to form those ions. Chemical substances that dissociate completely in water to form ions with a size of less than one nm do not exhibit new size-dependent properties because the same properties would manifest in the dissociated form regardless of whether the substance is at the nanoscale before dissociation. Chemical substances formed at the nanoscale as part of a film on a surface are also excluded.
General Exemptions to TSCA Section 8(a) Reporting
The general exemptions to TSCA Section 8(a) reporting at 40 C.F.R. Section 704.5 are applicable to the final rule. These include the exemption for research and development (R&D), under which a person who manufactures or processes a chemical substance only in small quantities for R&D is exempt from the reporting requirements. According to EPA, examples of R&D activity are the analysis of the chemical or physical characteristics, the performance, or the production characteristics of a chemical substance. It can include production of a chemical substance for use by others in their R&D activities. EPA states that R&D activity generally includes specific monitored tests undertaken as part of a planned program of activity. There is also an exemption from reporting for TSCA Section 8(a) rules for small manufacturers and processors. Importantly, for purposes of this rule, EPA has defined and exempted any small manufacturer or processor as a company that has sales of less than $11 million per year.
Other Exceptions to Reporting
The rule does not require manufacturers or processors to report certain information that has already been submitted to EPA. A person who submitted a notice under TSCA Section 5 to EPA for a reportable chemical substance on or after January 1, 2005, is not required to report regarding the same substance under this 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 part of or all of the information that is required under the rule for the Nanoscale Materials Stewardship Program (NMSP) does not need to report that information again. EPA states that the purpose of these exemptions is to avoid duplicative reporting.
Timeline for Reporting
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 final rule must report electronically to EPA one year after the final effective date of the rule. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a new discrete form of a reportable existing chemical substance on or after the effective date of the rule. These persons are required to report to EPA at least 135 days before manufacture or processing of that discrete form, except where the person has not formed an intent to manufacture or process a discrete form of a reportable chemical substance 135 days before such manufacturing or processing. In those cases, the information must be filed within 30 days of the formation of such an intent. For example, according to EPA, if a person forms the intent on July 1 to manufacture a reportable chemical substance and intends to commence manufacture of the substance in less than 135 days, that person must report the required information as to the chemical substance no more than 30 days after forming the intent, which would be July 31.
The rule requires one-time reporting of certain information, including specific chemical identity, actual or anticipated production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety information. Any person required to report under the rule must supply the information identified in the form developed by EPA to the extent it is known to or reasonably ascertainable by them. EPA states that it intends to issue guidance for the final rule within six months, including guidance on the reasonably ascertainable standard, consolidating submissions, and generic chemical names.
Confidentiality and New TSCA
The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016, and became immediately effective. EPA states that the final rule contains “one minor change” to reflect the new statutory requirements for asserting confidentiality claims. TSCA Section 14(c)(1)(B) now requires a supporting statement for confidentiality claims, similar to the certification currently required in 40 C.F.R. Section 704.7, which EPA cross-referenced in the proposed rule. In the final rule, EPA substituted the wording of the Section 14(c)(1)(B) statement for the wording of the certification in Section 704.7(d) “so as to eliminate any possibility of doubt that the certification meets the statutory requirements.”
New TSCA also requires that companies provide a generic chemical identity when claiming a specific chemical identity as confidential. According to EPA, no conforming change is necessary for the final rule because companies reporting will be claiming chemical identities as confidential only when there is already a generic identity on the confidential portion of the TSCA Inventory. The Chemical Information Submission System (CISS), a web-based reporting tool, will automatically populate the submission with the generic chemical name associated with the Inventory listing. According to EPA, this process provides “the greatest degree of structural specificity that is practicable to afford at the current time.” EPA states that it will develop guidance regarding generic names as required by TSCA, and will determine appropriate procedures regarding their use and submission.
Response to Comments
The final rule summarizes EPA’s responses to comments on several general issues raised by multiple stakeholders. EPA prepared a separate document summarizing the comments relevant to the proposal and EPA’s responses to those comments. This document will be available in the docket for the rulemaking.
Several commenters stated that TSCA applies to chemical substances, not to different forms or sizes of chemical substances. EPA responded that Section 8(a) gives EPA discretion to require reporting as EPA “may reasonably require” and that this provides authority to require reporting pertaining to different forms.
Several commenters stated that the reporting required under the rule is outside that allowed by Section 8(a); cited examples included particle size and morphology. EPA responded that it has broad authority to collect information under this section and explained that “material characterization including particle size and morphology is analogous to molecular structure of chemical substances manufactured and processed at the nanoscale.”
In response to comments that processors do not know about the particle size and other characteristics of formulations they process or use, and should not be required to report, EPA responded that reporting is required only to the extent the information is known or reasonably ascertainable, and includes information that the Administrator may reasonably require. According to EPA, if processors do not know about specific physical properties of chemical substances, they must still take “reasonable measures” to ascertain the information that would determine whether they are subject to the rule. If processors do not know about specific properties such as particle size and other properties that would allow them to know if they are processing a chemical substance subject to the rule, EPA states that “it would be within the reasonably ascertainable standard to ask their suppliers for information that would enable the processor to determine whether the supplier is selling them a nanoscale material subject to reporting and if so provide them with what reportable information they have.” The supplier is not required to provide any additional information to the processor but might provide other supporting information, such as whether the supplier reported or intends to report the chemical substance under the rule. If the supplier provides information indicating that the substance is not reportable or if the processor lacks any other means of reasonably ascertaining whether the substance is reportable, the processor does not need to perform tests to determine whether the substance is reportable. EPA states that processors “may want to document the steps they took to determine if reporting was required.” EPA notes that companies that purchase formulations but do not change or modify those formulations and only use them are not considered processors and are not required to report.
Several commenters asked if manufacturers and processors are required to report only available or reasonably ascertainable information, whether this means they need to develop information to comply with the rule. Other commenters asked EPA to clarify if manufacturers and processors need to develop information to comply with the rule. EPA responded that manufacturers and processors are not required to conduct testing or develop new information under this rule.
According to EPA, many commenters stated that the proposed rule would give too much discretion to interpret compliance obligations. Commenters suggested clarifying the definition of unique and novel properties, adopting an alternative, or not using it at all. Based on the comments, EPA states that it agrees that what is a reportable chemical substance should be better defined and clarified. EPA promulgated the final rule with further explanation of “unique and novel properties,” as described in the National Nanotechnology Initiative’s definition. According to EPA, a property is novel when it is different from the properties associated with other forms or sizes of the same chemical substance. For purposes of the rule, EPA defined unique and novel properties “to include an element of intent, meaning that those properties are the reason why the chemical substance is manufactured in that form or size.” EPA states:
Unique and novel properties means any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance, and such properties are a reason that the chemical substance is manufactured or processed in that form or size. In order to be reportable it’s not sufficient that a chemical substance contains particles in the size range of 1-100 nm; it must also have a size-dependent property different from properties at sizes greater than 100 nm and those properties are a reason that the chemical substance is manufactured or processed in that form or size. Intentionally manufacturing or processing nanoscale gold so that it exhibits a red or purple color instead of a yellow color would create a unique or novel optical property seen at the nanoscale. Such a change would likely result in changes of other properties, such as specific surface area which can result in different health and safety impacts. Unique and novel properties which impact performance generally cannot be isolated from concurrent changes in properties that impact biological systems …. EPA is exempting certain biological materials, in part, because they do not exhibit different size-dependent properties in the size range of 1-100 nm.
According to EPA, several commenters identified additional possible reporting exemptions for organic and inorganic pigments and dyes; polymers including polymer dispersions; and chemical substances used in adhesives, coatings, and sealants, and chemical substances when they are embedded in a polymer matrix or incorporated into a formulated product such as adhesives, cement, ink, coatings, glass, paint, plastic, and rubber because they are “well understood or characterized and present low risk and low potential for exposure.” Commenters suggested an exemption for polymers and polymer dispersions to be consistent with the polymer exemption under TSCA Section 5. Commenters also noted TSCA Section 5 regulations, such as significant new use rules (SNUR) that exempted requirements for carbon nanotubes, silica, and pigments when incorporated into polymer matrices. EPA responded that a reportable chemical substance is not just a substance containing particles in the size range of 1-100 nm; it must also have a size-dependent property different from properties at sizes greater than 100 nm. The chemical substances or activities identified by commenters could be manufactured in nanoscale forms that both exhibit unique and novel properties and in forms that do not. If a chemical substance does not exhibit unique and novel properties, then no reporting would be required. EPA states that it lacks information demonstrating minimal risk and exposure for nanoscale forms of the chemical substances or activities that commenters proposed for exemption. EPA notes that the polymer exemption under TSCA Section 5 is not based on any consideration of the potential for impacts from polymers with size dependent properties and does not include all polymers. According to EPA, most of the activities described by commenters for exemption would only require reporting for a reportable chemical substance before it is incorporated into a formulated product or polymer matrix. Reporting would not be required by persons who use the formulated product or polymer matrix.
The proposed rule would have exempted nanoclays and zinc oxide from the reporting requirements. Based on those proposed exemptions, several commenters proposed limited or no reporting for nanoscale materials such as carbon black, silica, titanium dioxide, nanosilver, and nanocellulose. The commenters asked EPA to define better the criteria it used to exempt nanoclays and zinc oxide as “well-characterized,” so that the criteria could be applied to these chemical substances. The final rule no longer exempts nanoclays and zinc oxide from reporting. EPA states that, when considering the comments to exempt other chemical substances, it “realized that it had given too much weight to the available information on zinc oxide and nanoclays.” According to EPA, even for nanoscale materials that could be described as a group as “well-characterized or demonstrating low hazard based on data not relating to nanoscale forms in particular,” EPA lacks information on how much and what type of specific nanoscale materials are in commerce and what kind of information is available to assess the properties that can impact health and safety and, thus, potential risks of those nanoscale materials.
EPA received numerous comments regarding the 135-day reporting requirement for new discrete forms, which several commenters characterized as de facto new chemical reporting. EPA states that several commenters supported the 135-day reporting requirement because it would provide EPA with more time to identify potential concerns and initiate appropriate action to address them. EPA states that it “did not intend to create de facto new chemical reporting for new discrete forms of nanoscale materials, because the 135-day period is not a formal review-period that prohibits manufacture before the end of the 135-day period.” According to EPA, there is no obligation upon the company to wait 135 days after reporting to manufacture or process. EPA states that if the company changes its schedule or does not form the intent until a later time, “it may wish to document supporting facts,” however. Further, EPA states, the comments made it realize that the proposed regulatory text created an unintended result (and not commented upon). Because (1) the default period of 135 days is greater than the advance of periods required for various TSCA Section 5 submissions, and (2) the reporting exemption for TSCA Section 5 submissions in the proposed rule would apply only where the company had already filed a TSCA Section 5 submission, a company proposing to manufacture a discrete form of a reportable substance for which a TSCA Section 5 submission had not been filed might conceivably be required to first file a TSCA Section 8(a) report, followed by a Section 5 submission. EPA states that in such cases, it needs only the Section 5 submission. The final rule includes a new subcategory of non-reportable chemical substances for chemical substances that are not on the TSCA Inventory at the time reporting would otherwise be required. The inclusion of this new subcategory helps to clarify EPA’s original intent that if a reportable chemical substance is not on the TSCA Inventory, a manufacturer only needs to submit a new chemical notification under TSCA Section 5.
The final rule has been years in the making, and EPA’s perseverance is laudable. EPA is also to be commended for its careful and deliberate revisions to the proposed rule and for crafting a final rule that is clearer and more likely to elicit useful information. As EPA acknowledges in the rule, EPA needs the specified information 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.
Given that reporting must be made one year from the effective date of the final rule, it is critical that EPA provides the guidance it notes it intends to issue by June of this year, including guidance on the reasonably ascertainable standard, consolidating submissions, and generic chemical names as soon as possible, and no longer than the six months that EPA intends. This is particularly important given that the final rule applies to both manufacturers and processors, recognizing that the latter have not generally been subject to previous TSCA Section 8(a) reporting requirements.
The final rule is clearer than the proposal in laying out reporting obligations and requirements. In particular, we appreciate the relative clarity provided by the:
- Exclusion from reporting for chemicals that contain less than 1 percent by weight of nanoscale particles (1-100 nm), although it is not clear that a level applied to U.S. Occupational Safety and Health Administration (OSHA) carcinogens is appropriate as a cutoff value for chemicals that, according to the notice, are being reviewed “without a presumption of either harm or safety.”
- Inclusion of an element of intent in obtaining unique and novel properties (“meaning that those properties are the reason why the chemical substance is manufactured in that form or size”) is helpful and companies may want to consider how this aspect applies in relevant cases.
- Clarification that a company need not wait 135 days after reporting before manufacturing or processing a new nanoscale form of an existing chemical will be valued in a commercial setting, in that it provides a measure of both flexibility and certainty. Whether this blunts the significant concerns expressed with such reporting requirements is less clear.
This last point, with its focus on the requirement for upfront reporting on new forms of existing chemical nanoscale materials, is the big issue in the final rule. As indicated in our earlier memo on the proposed rule and in our January 4, 2017, memorandum, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2017,” this is a controversial aspect and EPA has essentially promulgated the requirement as proposed. In the Predictions memo, we speculated that promulgating this requirement could become a target for consideration under the Congressional Review Act given its potential for significant adverse effects on competition and innovation. Similarly, the Trump Administration could decide not to enforce the requirement pending amendment or withdrawal of the rule. It could also be the target of a legal challenge. EPA may have shored up its legal arguments in the final rule, but whether they suffice to preclude or to prevail in the face of a challenge remains to be seen.