Years in the Making

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EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) made available on May 16, 2017, and requested comment on a draft guidance document, “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” This column discusses the draft guidance.

The draft guidance provides answers to questions EPA has received from manufacturers, including importers and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the Jan. 12, 2017, final Toxic Substances Control Act (TSCA) Section 8(a) rule. The final rule requires one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials. The rule was years in the making, and is believed by many to be somewhat confusing and difficult to apply to real world settings. The guidance is both a step in the right direction and much needed, but comment upon it will be essential to make the guidance more serviceable.

The draft guidance reiterates that under TSCA, the definition of “manufacture” includes import. In the case of a company importing a chemical substance as part of a formulation, such as ink/toner products, the chemicals in the formulation are subject to TSCA reporting requirements, including the final rule for nanoscale materials. If the chemical substance is imported in a form that meets the definition of a reportable chemical substance, the importer of the toner must report. Processors that do not know about the particle size and other characteristics of formulations they process or use must take reasonable measures to ascertain the information that would determine whether they are subject to the rule. The supplier is not required to provide any additional information to the processor but might provide other supporting information, such as whether the supplier has reported or intends to report the chemical substance under this rule. Companies that purchase formulations but do not change or modify those formulations and only use them, are not considered processors and thus are not required to report under the rule.

Each manufacturer and processor in the supply chain must report “reasonably ascertainable” information on the reportable chemical substance. The draft guidance clarifies the scope of what would be required under the “known to or reasonably ascertainable by” reporting standard. As defined by 40 C.F.R. Section 704.3, the standard means “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.”  A submitter must ascertain what they know about the manufacturing, processing, and use of a chemical substance it manufactures (including imports) or processes, without confining its inquiry to what is known to managerial and supervisory employees. According to the draft guidance, a submitter would also be expected to review other information that the manufacturer (including importer) or processor may have in its possession. This standard requires that submitters conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees).

Because the final rule requires only one-time reporting, a change in manufacture, processing or use will not require updating EPA with new information, unless the change creates a new discrete form of a reportable chemical substance. EPA notes that the type of process change is not the criterion for distinguishing new processing methods from existing methods. EPA states that any manufacturing or processing change that is intended to change particle size and properties would be a process change that could require new reporting.

EPA states that the purpose of the final rule is not to create an inventory of nanoscale material chemical substances in commerce, but rather to collect information on the manufacture (including importation), processing, and industrial, commercial and consumer uses of certain chemical substances that are nanoscale materials. EPA notes that it will use information gathered through the rule to inform its understanding about the manufacture, processing, and use of nanoscale substances and to determine if any further action under TSCA is needed.

Information under the rule may be claimed as confidential at the time it is submitted. Submitters must provide upfront substantiation of confidentiality claims for processing and use information, and for confidentiality claims for site or chemical identity.

Discussion

While the publication of the draft guidance within four months of issuance of the final rule is laudable, the draft guidance does not significantly expand upon that which is already known, nor does it make the rule clearer or easier with which to comply in all respects. Companies subject to the reporting requirements of the final rule can expect to continue to struggle in sorting out what discrete forms are required to be reported.

The draft guidance is helpful in responding to questions regarding what the final rule means by “coating” and why coated nanomaterials are defined separately from mixtures, given that there is no discussion of what is meant by coating in the proposed or final rule. The draft guidance is also helpful in more clearly articulating the scope of the 135-day reporting period in connection with forming an intent to manufacture or process a reportable material. EPA notes that the 135-day period is not a formal review period that prohibits manufacture before the end of the 135-day period. Rather, based on EPA’s experience with premanufacture notice reviews in the new chemicals program, EPA believes that in most cases companies have the requisite intent to manufacture or process a reportable chemical substance at least 135 days before manufacturing or processing will begin, and the rule requires reporting based upon this presumed intent. If a company does not form the requisite intent 135 days ahead of time, the guidance clarifies that the company must report within 30 days of the formation of such an intent. If a company desires to begin manufacture or processing less than 135 days after the submission is made, EPA notes that the company is free to do so. There is no obligation upon the company to wait 135 days after reporting to manufacture or process.

The draft guidance also clarifies that for each reportable chemical substance, each processor of that substance is required to report. EPA is casting a wide net to ensure that all methods and instances of processing are covered, even though EPA may receive a substantial amount of duplicative information from processors that use standard industry practices. EPA does not reconcile this fact with the requirement in Section 8(a)(5)(A) to avoid requiring “reporting which is unnecessary or duplicative.”

On the whole, EPA’s significant efforts to prepare and issue guidance quickly are appreciated. Questions undoubtedly will remain, however. Comments were due by June 15, 2017.

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.

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