Manufacturers, importers, and processors of specified nanoscale materials are required to submit reports to the U.S. Environmental Protection Agency. The deadline for reporting is August 14, 2018.
On January 12, 2017, the EPA published its final rule on reporting and recordkeeping requirements for nanoscale materials under Section 8 of the federal Toxic Substances Control Act (TSCA). The rule is codified at 40 CFR section 704.20. Although it initially established May 12, 2018 as the deadline for reporting, the EPA extended the deadline to August 14, 2018 in a subsequent notice.
According to the EPA, the rule’s requirements “will assist [the agency] in its continuing evaluation of chemical substances manufactured at the nanoscale, informed by available scientific, technical and economic evidence.” Information received by the required reporting will assist the EPA in determining what, if any, additional actions under TSCA may be required to address unreasonable risks to human health and the environment.
What substances are reportable under the rule?
The rule applies to chemicals substances meeting all of the following criteria:
- Are solids at 25°C and standard atmospheric pressure;
- 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
- Are manufactured or processed to exhibit one or more unique and novel properties.
The rule does not apply to chemical substances that are manufactured or processed in forms that contain less than 1% by weight of any particles, including aggregates and agglomerates, in the size range 1-100 nm. Section 740.20(c) describes other chemical substances that are not subject to reporting.
Who must report?
Entities that imported or processed discrete forms of reportable chemical substances from August 14, 2014 to August 14, 2017 must report by August 14, 2018. There is a separate requirement for entities that intend to manufacture, import or process such substances after August 14, 2017. Such entities must report to the EPA at least 135 days before such activities. As a result of concerns from industry, during the rulemaking process, that such an extended time period could impede innovation, the EPA qualified this requirement: if the entity did not form the intent to conduct such activities with reportable substances 135 days before such activities begin, then the report must be submitted within 30 days of forming such intent.
What must be reported?
Required information includes: specific chemical identity; actual or anticipated production volume; methods of manufacture and processing; use, exposure and release information; and available health information. Reports must be made electronically via the EPA CDX portal using a form specific for this reporting obligation.
What happens next?
TSCA Section 5 requires manufacturers and importers to notify the EPA before first manufacturing or importing a “new” chemical substance, i.e., a substance that is not already identified on the TSCA Inventory list. Although the EPA encourages manufacturers and importers to advise it if a new chemical is nanoscale, Section 5 and its implementing regulations do not call out specific submission obligations for nanoscale substances.
In fact, a 2008 EPA guidance document states that a nanoscale chemical substance will be considered the same as a chemical on the TSCA Inventory if has the same “molecular identity.” That means that no new chemical notification need be submitted under TSCA Section 5 for nanoscale materials having the same molecular identity as its “regular-sized” counterparts on the TSCA Inventory. Some non-governmental organizations have criticized this approach, citing concerns that novel characteristics of nanoscale materials warrant the closer examination provided by the Section 5 evaluation process.
The 2016 TSCA amendments conferred on the EPA more expansive authority to regulate new and existing chemicals. Information received under this nanoscale material reporting obligation may trigger the EPA’s enhanced regulatory authority in any number of ways, from new Section 4 test rules to Section 6 regulations to additional Section 8 reporting requirements – and perhaps, even rescission of the EPA’s 2008 guidance document.
Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your Prop 65 compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].
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