The Final Rule
EPA Issues Final TSCA Reporting Rule for Nanoscale Materials
By Lynn L. Bergeson
The U.S. Environmental Protection Agency (EPA) issued on Jan. 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. This column summarizes the rule.
Reportable Chemical Substances
The final rule applies to chemical substances 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 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.
The 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.”
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. The final rule distinguishes between discrete forms in several ways as defined under the 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. 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.
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. 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 under the final rule, including the exemption for research and development. There is also an exemption from reporting for TSCA Section 8(a) rules for small manufacturers and processors. EPA has defined and exempted any small manufacturer or processor as a company that has sales of less than $11 million per year.
The rule does not require manufacturers or processors who submitted a notice under TSCA Section 5 to EPA for a reportable chemical substance on or after January 1, 2005, to report regarding the same substance under this rule, except when they manufactured or processed a new discrete form of the reportable chemical substance. 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 does not need to report that information again.
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 effective date of the final rule, which is May 12, 2017, must report electronically to EPA no later than one year after the final effective date of the rule, by May 12, 2018. 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.
The rule requires one-time reporting of specific chemical identity, actual or anticipated production volume, methods of manufacture and processing, use, exposure, and release information, and available health and safety information. Persons 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.
Confidentiality and New TSCA
New TSCA 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. EPA states that it will develop guidance regarding generic names as required by TSCA, and will determine appropriate procedures regarding their use and submission.
The final rule is clearer than the proposal in specifying reporting obligations. Clarity has been provided on key areas including exclusions, inclusion of an element of intent in obtaining unique and novel properties, and 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.
This last point is the big issue in the final rule. This is a controversial aspect and EPA has promulgated the requirement as proposed. Promulgating this requirement could become a target for consideration under the Congressional Review Act. 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.
Lynn L. Bergeson is Managing Partner of Bergeson & Campbell, P.C. (B&C®), a Washington, D.C. law firm focusing on conventional, nanoscale, and biobased industrial, agricultural, and specialty chemical product regulation and approval matters, environmental health and safety law, chemical product litigation, and associated business counseling and litigation issues. She is President of The Acta Group, with offices in Washington, D.C., Manchester, UK, and Beijing, China, and President of B&C® Consortia Management, L.L.C. (BCCM), with offices in Washington, D.C.