EPA Releases Final Guidance on TSCA Section 8(a) Nanomaterial Reporting Rule
The Environmental Protection Agency (EPA) released the Working Guidance on EPA’s Section 8(a) Information-Gathering Rule on Nanomaterials in Commerce (Guidance) on August 14, 2017. EPA developed the final Guidance based on draft guidance published for comments in May 2017 (see B&D Alert from May 23, 2017). Note that August 14, 2017, was also the effective date of the TSCA Section 8(a) Nanomaterial Reporting rule itself.
Review of the TSCA Section 8(a) Nanomaterial Reporting Rule
EPA promulgated a final rule (the Section 8(a) Rule or the Rule) to impose manufacturer and processor reporting obligations for certain nanomaterials under Section 8(a) of the Toxic Substances Control Act (TSCA). In short, the rule requires companies, unless exempt, to report to EPA a range of information related to “discrete forms” of nanoscale “reportable chemical substances.” Such reports for existing manufacturing or processing activities must generally be furnished within one year after the rule becomes effective (i.e., August 14, 2018, after the effective date was delayed as noted below). Prospectively, companies must report either at least 135 days before commencing future manufacturing or processing activities, or within 30 days of the formation of their intent to manufacture or process covered nanomaterials.
The Section 8(a) Rule was originally scheduled to become effective on May 12, 2017. EPA, however, received various questions and feedback after the rule was finalized. The Agency, therefore, postponed the effective date of the rule to August 14, 2017, noting that “the public interest is served by complete and accurate reporting under the rule, which would be greatly facilitated by the publication of the guidance.” EPA published a draft guidance document on May 16 to solicit comments. This latest release on August 14, 2017, is the finalized version of that guidance.
Key Messages from the final Guidance
With the draft guidance, the final Guidance takes the form of Frequently Asked Questions (FAQs). Below are a few important messages from the Guidance. Note that this summary does not include all questions and answers in the Guidance.
Roadmap for Compliance
The Guidance lays out three questions for companies to determine their reporting obligations under the Section 8(a) Rule:
- Is your chemical substance subject to the reporting rule?
- Are you a manufacturer (including importer) or processor who is required to report?
- What information must you report (FAQ 39)?
Unique and Novel Properties
The Guidance further clarifies the criteria for “unique and novel properties,” a key factor to determine reportability. Unique and novel properties are determined based on both the size-dependent factor and the intent factor, as designed under the Rule. The Guidance includes three examples - gold, carbon black, and titanium dioxide - to discuss what is and is not a unique and novel property (FAQ. 2).
Enhanced or Continuously Scaling Properties
Enhanced or continuously scaling properties, such as thermal conductivity or surface area, are not unique and novel properties by themselves (FAQ 3). Similarly, size is not per se unique and novel (FAQ 2). But some other intrinsic properties, whose changes are attributable to the change of, for example, surface area, can be unique and novel properties (FAQ 5).
Mixtures and Articles
Mixtures are not reportable, but the components within the mixture can be (FAQ 8). In a supply chain scenario for mixtures with a manufacturer and multiple processors, the reporting obligations for the contained nanomaterial attach to both the manufacturer and each processor (FAQ 9). The reporting obligations end after the substance is incorporated into an article (FAQs 17, 35).
Coating and Surface Treatments
Coating that results in a nanoscale material with different properties may render the coated substance a discrete substance and therefore reportable. Still, the reportable substance is the nanomaterial; so both coating and the nanoparticle should be reported (FAQ 13). On the other hand, some surface treatments, such as oxidation or neutralization, that are used as preparative or cleaning measures resulting in non-isolated particles do not create a separate reporting requirement (FAQ 12).
Reportability of Large Molecules
Certain large molecules, such as monomers, polymers, colloids, organic and inorganic pigments, and dyes, and polymer dispersions, are not automatically exempt. But they may not be reportable either, unless they meet the unique and novel properties criteria, including the intent, for reportable chemical substances (FAQ 14).
Scope of Inquiry/“Known or Reasonably Ascertainable” Information
The Section 8(a) Rule only requires that “known or reasonably ascertainable” information be reported. The Guidance refers to the 2011 Chemical Data Reporting (CDR) regulation on what sources should be considered as in a person’s possession or control or expected so for a similarly situated reasonable person (FAQs 17, 25). Beyond that, EPA expects that the companies do not confine their inquiry to “what is known to managerial and supervisory employees” (FAQ 17). In addition, the inquiry should extend both upstream and downstream to the extent that any information is known or reasonably ascertainable: Companies should review information that the manufacturers, importers, or processors of the chemicals, including the processor submitter’s suppliers, may have in possession; they should also review known or ascertainable information on subsequent industrial users and processors, and on commercial and consumer uses (FAQs 17, 27). Not known or reasonably ascertainable information may be reported as “NKRA” or “not known or reasonably ascertainable.” (FAQ 27).
With respect to data gaps, the Guidance instructs companies to focus on the “known or reasonably ascertainable” standard. The Section 8(a) Rule does not require new testing, chemical analysis, or development of information for the purpose of Section 8(a) compliance (FAQs 19, 24, 40). Also specifically, companies are not required to contact a new survey of their customers with “a comprehensive set of identical questions to multiple customers” just to meet the Section 8(a) requirement (FAQs 17, 19). EPA, however, notes that existing customer surveys are likely deemed as “reasonably ascertainable” to the companies; and the Rule may require a company to send out “limited inquiries,” such as “contacting a major customer or examining that customer’s public website,” when the company’s current knowledge is below the known or reasonably ascertainable standard (FAQs 19, 26).
Applicability to Import/Export Activities
Importers are covered under the Section 8(a) Rule because TSCA includes import under the definition of “manufacture” (FAQ 22). Companies that manufacture or process reportable chemical substances solely for export are also covered under the Rule for their domestic activities because the exemptions under TSCA’s export provision do not apply to Section 8(a) (FAQ 21).
Timeframe for Prospective Reporting
The Guidance reemphasizes that the 135-day period (applicable if a company has formed the intent long before the manufacturing or processing activity) is not a formal review period and that the rule does not prohibit manufacturing or processing activities before the 135-day period ends. The Guidance clarifies that any follow-up action would be a separate action under TSCA (FAQ 28).
Update Information/Additional Reporting
The Guidance confirms that the Section 8(a) Rule generally requires one-time reporting. The key trigger for additional reporting is a new discrete form of a reportable chemical substance. Updating with new information is not required unless a new discrete form is created (FAQ 29). For new processing methods, the intent and effect of a process change are the key criteria to determine whether a new report is needed (FAQ 31). Similarly, while sometimes certain new uses of reportable chemical substances will be exempt from reporting under the Section 8(a) Rule, in other situations the Rule can be triggered because, for that new use, the company manufactures or processes a new discrete form of the reportable chemical substance. However, the company is also advised that a new use by itself may be subject to the Significant New Use Rule (SNUR) notification requirement under TSCA Section 5 (FAQ 7).
Substances exempted under TSCA Section 3(2)(B), such as pesticides and food, food additives, drugs, cosmetics, and devices, as well as others, are not subject to the reporting obligations under the Rule (FAQ 42). But a pesticide intermediate is subject to the Rule (FAQ 43). When a substance may have both TSCA and non-TSCA uses, the Guidance directs the company to only report the quantity intended for TSCA use, but not the quantity exempt from TSCA (FAQ. 44).
Electronic Reporting Tool
The Guidance states that the reporting tool will be available when the Rule becomes effective, which was August 14, 2017. There will be user guidance for the reporting module (FAQ 47). Joint submission between manufacturers and processors will not be available in the current system, but EPA will work on adding functionality if companies are interested. Consolidated submissions are allowed, but companies should contact EPA before they submit consolidated submissions (FAQ 48).
Companies should follow the confidentiality section under the Rule, as well as EPA’s latest guidance, on asserting and substantiating confidentiality (FAQs 51, 52). For information known to the submitter, but belonging to a different entity and provided under a non-disclosure agreement or another arrangement, EPA considers such third-party confidentiality claims to be within the ambit of the required statement under the Rule regarding disclosure causing “substantial harm to the competitive position of the person” reporting (FAQ 53).
EPA notes that companies may have questions that are not covered under the Guidance, and asks the companies to contact EPA for case-by-case inquires. It also represents that it may add or revise questions and answers to the Guidance. Therefore, interested parties may want to participate in the process to have their concerns heard and addressed.
More generally, as the Rule became effective on August 14, 2017, affected companies must start compliance with the Rule. Data collection may present challenges under the rule. Companies that have both historical (or ongoing) and future manufacturing or processing activities need to have strategies for both retrospective and prospective reporting.