Inside OSHA June 27, 2005 INDUSTRY, ENVIRONMENTALISTS OFFER PLAN FOR POSSIBLE NANOTECH RULES The chemical industry and a major environmental group are jointly calling for the Environmental Protection Agency (EPA) to conduct more research and develop a regulatory plan for nanoparticles as the agency examines the risks posed by the emerging field of nanotechnology. Any EPA regulation might speed up OSHA's efforts to compile information needed to consider an occupational exposure standard on nanoparticles. The joint proposal by Environmental Defense and the American Chemistry Council, the first by industry and environmentalist on this topic, calls for broad negotiations on possible changes to regulations under the Toxic Substances Control Act (TSCA). While EPA has authority under TSCA to regulate "new" chemicals, the unique composition of nanoparticles is raising questions over how the law applies to existing chemicals. Section 5 of TSCA requires manufacturers of new chemicals to submit premanufacture notification (PMN) that includes data on toxicity before manufacturing is permitted. Chemicals are considered new under TSCA if the are not already listed on the TSCA inventory. But it is unclear whether chemicals already in the inventory that contain nanoparticles are considered new or are exempt from PMN requirements as existing chemicals. Because the chemicals contain vastly different properties, environmentalists -- including Environmental Defense -- have called on EPA to clarify that such substances are considered new under TSCA and trigger PMN notification. Nanotechnology refers to chemicals that are manipulated at the molecular levels, resulting in unique properties that are expected to have widespread industrial and medical uses. EPA has received at least one request for a low-volume exemption of a single-wall carbon nanotube under TSCA Section 5, raising questions on whether the carbon-based particle can be considered a "new" chemical and whether EPA can use traditional review models for bulk materials. EPA has not made a decision on either issue, a source said. Similar questions were raised in another case before EPA, where DuPont Haskell Laboratory for Health and Environmental Sciences of Newark, DE, in April 2003 submitted information on another carbon nanotube (available on InsideHealthPolicy.com). EPA proposed in a May 10 Federal Register notice its intention to obtain industry nanoparticle data through a voluntary reporting pilot project. EPA sources have said the information could help guide the agency on whether to develop new regulations for the chemicals. Charles Auer, the director of the agency's Office of Pollution Prevention and Toxics, raised the possibility at the meeting of "parallel" tracks where an existing agency advisory committee would address the issue of whether the nanoparticles are "new," while industry, environmentalists and other groups would participate in developing a voluntary reporting pilot project. Environmental Defense and the American Chemistry Council made the joint proposal at a June 23 EPA public meeting on nanotechnology, which calls for international efforts to standardize testing and risk assessment protocols for nanotechnology development, and the drafting of measures to protect human health and the environment while regulators, industry and the scientific community continue to research and develop the technology. A number of other environmental groups, environmental consultants and technology companies made presentations at the EPA meeting in Washington, DC. The joint plan, which sources say was developed in recent weeks, also calls for an increase in government research on the health and environmental implications of nanotechnology and "timely and responsible development and regulation of nanomaterials." "A government program should address intentionally produced nanoscale materials produced in or imported into the U.S. and characterize hazard and exposure sufficiently to assess any risks of these materials," the plan says. "It should also assess the appropriateness of or need for modification of existing regulatory frameworks." Environmental Defense also distributed its own comments at the meeting, which go beyond the joint plan by outlining the types of risk-related data the agency should review, including information on the acute and chronic toxicity of nanoparticles. OSHA Office of Chemical Hazards Director Bill Perry attended the meeting. "We're thinking regulation, but we're [now] thinking information," he had said at the June 12-15 American Society of Safety Engineers (ASSE) annual conference in New Orleans, LA. OSHA is involved with several interagency work groups that are currently reviewing research in order to make recommendations for possible standards. Until OSHA addresses nano particles in a new standard, its Hazard Communication Act and standards on respiratory protection, protective equipment, laboratories and toxic and hazardous substances apply, Perry said.