Inside OSHA
June 27, 2005


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

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

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

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.