Nearly All New Nanoengineered Chemicals Are Regulated by EPA Due to Potential Risks

By Pat Rizzuto

Oct. 16 — The Environmental Protection Agency has regulated nearly all nanoengineered chemicals that it has reviewed under its new chemicals program, an EPA program manager who reviews such chemicals said Oct. 16.

By contrast, the EPA's new chemicals program typically regulates only 10 percent to 15 percent of the traditional compounds it reviews, said Jim Alwood, a program manager in the EPA's Chemical Control Division who coordinates nanotechnology issues under the Toxic Substances Control Act.

During a webinar offered by the Air & Waste Management Association, Alwood described how the EPA's New Chemicals Program has dealt with nanoengineered chemicals, challenges it faces and future directions the agency— in cooperation with regulatory authorities in other countries—is taking toward such compounds.

Under TSCA, any chemical that is on the inventory of compounds that has been or is being made in or imported into the U.S. is classified as an existing chemical.

Any chemical not on that inventory is considered new. If a company wants to make or import a new chemical, it must notify the EPA 90 days before doing so.

It does this by filing a premanufacture notice (PMN), which contains basic information such as chemical identity, anticipated use, projected production volume, exposure and release information and existing toxicity or other test data.

More Than 160 PMNs Received

The EPA has received more than 160 PMNs for nanoengineered chemicals since 2005, Alwood said. By 2005, nanotechnologies had developed to the point that chemical manufacturers began to submit PMNs.

Types of nanoengineered chemicals the agency has reviewed include primarily carbon nanotubes and nanofibers as well as fullerenes, quantum dots, silica derivatives, titania derivatives and compounds that are so unique Alwood said he couldn't describe them without potentially violating confidential business information.

Nanoengineered chemicals have been used for purposes such as purifying drinking water, harnessing solar power, constructing windmills and making cars lighter and thus more fuel efficient, he said.

The agency has allowed most of the 160-plus new nanoengineered chemicals to enter commerce, Alwood said.

Due to uncertainties about nanomaterials, however, the EPA's consent to manufacture the chemicals has come with requirements, he said.

The EPA often requires workers to be protected, prohibits any release of the chemical to water and requires the manufacturer to provide new toxicity, fate or other data, Alwood said.

Six Months to Two Years Needed for Review

It also takes the agency longer, typically, to review a PMN for a nanoengineered chemical than for a traditional compound, he said.

Under TSCA, the agency has 90 days to review a PMN. If the new chemical doesn't appear to pose an unreasonable risk and the agency takes no action, the manufacturer can begin to make or import the chemical after the 90-day review period is over.

It is taking the agency about six months to two years to review PMNs for nanoengineered chemicals and decide how to regulate them, Alwood said.

A benefit of the agency's thorough reviews of new nanoengineered chemicals is that some compounds with problematic characteristics have never reached the marketplace, Alwood said. The companies that designed these chemicals recognized the EPA's concerns and voluntarily decided to not make them, he said

The review can, however, delay the marketplace entry of chemicals with beneficial uses, he said.

Beneficial Use Recognized

Lynn Bergeson, managing partner of Bergeson & Campbell P.C., who participated in the A&WMA's webinar, pointed to an example of a beneficial use of a nanoengineered chemical.

The day of the webinar, the EPA announced the winners of the 19th Annual Presidential Green Chemistry Challenge Awards, she said.

These included quantum dots used by QD Vision Inc.

The company uses the quantum dots to make LED lighting and displays for televisions and mobile devices with few environmental impacts and waste, the EPA said in announcing the award.

Using the technology in just 10 percent of flat-screen TVs can save 600 million kilowatt-hours worldwide every year, the EPA said, adding that would provide electricity for 50,000 homes for one year.

Absent Data, EPA Presumes Risks

Alwood said the reason the EPA takes more time to review PMNs for nanoengineered chemicals is that it has far less information about them. It therefore needs to be protective and presume they may cause health or ecological problems when they may not, he said.

The agency can't require data be submitted with the PMN, but information that would be useful includes toxicity data and information about how the nanoengineered chemical moves through the environment and whether it bioaccumulates, Alwood said.

“If you submit a PMN without data, we estimate risk, and we tend to estimate it [the chemical] will pose a risk,” he said.

The agency recently submitted a proposed data collection rule to the Office of Management and Budget.

Alwood declined to speculate how long it may take for the agency to issue a final rule—if the OMB approves the proposed regulation.

Would Help New Chemicals Program

Information about existing nanoengineered chemicals would help the agency's new chemicals program because it would help the agency understand which chemicals are being made in volumes of greater concern, he said.

Meanwhile the EPA is working with other countries through the Organization for Economic Cooperation and Development to develop categories into which similar nanoengineered chemicals could be combined for risk assessment and management, he said. The OECD Expert Meeting on Categorization of Manufactured Nanomaterials discussed categories of nanomaterials during a Sept. 17-19 meeting.

To contact the reporter on this story: Pat Rizzuto in Washington at

To contact the editor responsible for this story: Larry Pearl at