The US Environmental Protection Agency (EPA) has announced its one-time reporting requirement for  nanomaterials. From a Jan. 12, 2017 news item on Nanowerk,

The U.S. Environmental Protection Agency (EPA) is requiring one-time reporting and recordkeeping requirements on nanoscale chemical substances in the marketplace. These substances are nano-sized versions of chemicals that are already in the marketplace.
EPA seeks to facilitate innovation while ensuring safety of the substances. EPA currently reviews new chemical substances manufactured or processed as nanomaterials prior to introduction into the marketplace to ensure that they are safe.

For the first time, EPA is using [the] TSCA [Toxic Substances Control Act] to collect existing exposure and health and safety information on chemicals currently in the marketplace when manufactured or processed as nanoscale materials.

The companies will notify EPA of certain information:
– specific chemical identity;
– production volume;
– methods of manufacture; processing, use, exposure, and release information; and,available health and safety data.

Reactions

David Stegon writes about the requirement in a Jan. 12, 2017 posting on Chemical Watch,

The US EPA has finalised its nanoscale materials reporting rule, completing a process that began more than 11 years ago.

…

The US position contrasts with that of the European Commission, which has rejected the idea of a specific mandatory reporting obligation for nanomaterials. Instead it insists such data can be collected under REACH’s registration rules for substances in general. It has told Echa [ECHA {European Chemicals Agency}] to develop ‘nano observatory’ pages on its website with existing nanomaterial information. Meanwhile, Canada set its reporting requirements in 2015.

The US rule, which comes under section 8(a) of TSCA, will take effect 120 days after publication in the Federal Register.

It defines nanomaterials as chemical substances that are:

• solids at 25 degrees Celsius at standard atmospheric pressure;
• manufactured or processed in a form where any particles, including aggregates and agglomerates, are between 1 and 100 nanometers (nm) in at least one dimension; and
• manufactured or processed to exhibit one or more unique and novel property.

The rule does not apply to chemical substances manufactured or processed in forms that contain less than 1% by weight of any particles between 1 and 100nm.

Taking account of comments received on the rulemaking, the EPA made three changes to the proposed definition:

• it added the definition of unique and novel properties to help identify substances that act differently at nano sizes;
• it clarified that a substance is not a nanomaterial if it fits the specified size range, but does not have a size-dependent property that differs from the same chemical at sizes greater than 100nm; and
• it eliminated part of the nanomaterial definition that had said a reportable chemical may not include a substance that only has trace amounts of primary particles, aggregates, or agglomerates in the size range of 1 to 100nm.

…

The EPA has added the new information gathering rule (scroll down about 50% of the way) on its Control of Nanoscale Materials under the Toxic Substances Control Act webpage.

There’s also this Jan. 17, 2017 article by Meagan Parrish for the ChemInfo which provides an alternative perspective and includes what appears to be some misinformation (Note: A link has been removed),

It was several years in the making, but in the final stages of its rule-making process for nanomaterial reporting, the Environmental Protection Agency declined to consider feedback from the industry.

Now, with the final language published and the rule set to go into effect in May, some in the industry are concerned that the agency is requiring an unnecessary amount of costly reporting that isn’t likely to reveal potential hazards. The heightened regulations could also hamper the pace of innovation underway in the industry.

…

“The poster child for nanotechnology is carbon nanotubes,” says James Votaw, a partner with Manatt, Phelps & Phillips, of the form of carbon that is 10,000 smaller than human hair but stronger than steel. “It can be used to make very strong materials and as an additive in plastics to make them electrically conductive or stiffer.”

The EPA has been attempting to define nanomaterials since 2004 and assess the potential for environmental or human health risks associated with their use. In 2008, the EPA launched an effort to collect voluntarily submitted information from key players in the industry, but after a few years, the agency wasn’t happy with amount of responses. The effort to create a mandatory reporting requirement was launched in 2010.

Yet, according to Votaw, after a 2015 proposal of the rule was extensively criticized by the industry for being overly ambiguous and overly inclusive of its coverage, the industry asked the EPA to reopen a dialogue on the rule. The EPA declined.

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The new reporting requirement is expected to cost companies about $27.79 million during the first year and $3.09 million in subsequent years. [emphasis mine]

As far as I’m aware, this is a one-time reporting requirement. Although I’m sure many would like to see that change.

As for the Canadian situation, I mentioned the nanomaterials mandatory survey noted in Stegon’s piece in a July 29, 2015 posting. It was one of a series of mandatory surveys (currently, a survey on asbestos is underway) issued as part of Canada’s Chemicals Management Plan. You can find more information about the nanomaterials notice and approach to the survey although there doesn’t appear to have been a report made public but perhaps it’s too soon. From the Nanomaterials Mandatory Survey page,

The Government of Canada is undertaking a stepwise approach to address nanoscale forms of substances on the DSL. The proposed approach consists of three phases:

• Establishment of a list of existing nanomaterials in Canada (this includes the section 71 Notice);
• Prioritization of existing nanomaterials for action; and
• Action on substances identified for further work.

The overall approach was first described in a consultation document entitled Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List, published on March 18, 2015. This consultation document was open for a 60-day public comment period to solicit feedback from stakeholders, particularly on the first phase of the approach.

A second consultation document entitled Proposed Prioritization Approach for Nanoscale Forms of Substances on the Domestic Substances List was published on July 27, 2016. In this document, the approach proposed for prioritization of existing nanomaterials on the DSL is described, taking into consideration the results of the section 71 Notice.  Comments on this consultation document may be submitted prior to September 25, 2016 …

I look forward to discovering a report on the Canadian nanomaterials survey should one be made public.