James VotawIt 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 Back Story
Nanotechnology has been heralded as a next big frontier in science and technology innovation. In the chemicals industry nanomaterials are used in a range of applications — from clothing and agrochemicals to consumer goods and pigments.
“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.
In the final language released last week, the EPA addressed some of the concerns, but also created new ones.
Expect Delays
According to the rule, any company that manufacturers, processes or imports nanomaterials has to submit reports 135 days before they begin working with the materials.
“Imagine that you want to buy something and then you have to spend months filling out information about it and then you have to wait some more,” Votaw explains.
The one loophole is if you’re in a plant startup phase, during which time you can report within 30 days of forming the intent to manufacture. There’s just one problem: The EPA estimates that it will take about 164 hours to prepare the reports, which shakes out to about 5.5 hours of work each day in that period to submit on time.
This is exactly the kind of issue Votaw says would have been brought up if the EPA had included more time for public feedback.
Worth The Costs?
The new reporting requirement is expected to cost companies about $27.79 million during the first year and $3.09 million in subsequent years.
One worry about how the rule is designed is that it creates a standing requirement for reporting, which could result in unnecessary and duplicate reporting among different companies.
“In the future, manufacturers, processers and importers are still subject to reporting,” Votaw says. “So even if the EPA already has a report about a nanomaterial and it includes reasonable information about how it’s used and what its properties are…if someone else wants to start using that same material, now they have to report the same information to the EPA.”
It’s also unclear that there is a high hazard risk associated with nanomaterials. So far, Votaw says he has yet to hear of research or any instance where the types of nanomaterials being targeted by this EPA regulation have turned out to be harmful.
“There is not any kind of hazard associated with particle size,” Votaw says. ”Just being small is not an indication of hazard.”
Moving Forward
According to the EPA, the agency is attempting to gather information and so far it isn’t imposing any limits on the use of nanomaterials. But Votaw points out the new reporting requirements could also create a stigma around working with nanomaterials that could slow research.
Because of these issues, the EPA could face legal challenges to parts of the rule — either to the 135-day stipulation or perhaps to how the rule defines nanomaterials:
- 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.
“A more reasonable approach might be to say that all the nanoscale materials we’re interested in are the ones that are relevant to human health risks,” Votaw says.
Votaw says the rule could also potentially have wider industry implications.
“There are concerns that it could set up the EPA to take a similar approach to classifying other groups of materials,” Votaw says.
