*. U.S. Environmental Protection Agency	12-P-0162
I JBL - Office of Inspector General	December 29, 2011
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At a Glance
Why We Did This Review
EPA Needs to Manage Nanomaterial Risks More Effectively
The purpose of this review was
to determine how effectively
the U.S. Environmental
Protection Agency (EPA) is
managing the human health and
environmental risks of
nanomaterials.
Background
Nanomaterials are currently
used in a wide variety of
applications, including
consumer products, health care,
transportation, energy, and
agriculture. The Agency
considers nanomaterials as
chemical substances that are
controlled at the scale of
approximately one-billionth of
a meter. EPA has the authority,
through several environmental
statutes, to regulate
nanomaterials. Although the
development of nanomaterials
and nanomaterial-enhanced
products is expanding rapidly,
the health implications of
nanomaterials have not yet
been determined.
What We Found
We found that EPA does not currently have sufficient information or processes to
effectively manage the human health and environmental risks of nanomaterials.
EPA has the statutory authority to regulate nanomaterials but currently lacks the
environmental and human health exposure and toxicological data to do so
effectively. The Agency proposed a policy under the Federal Insecticide,
Fungicide, and Rodenticide Act to identify new pesticides being registered with
nanoscale materials. After minimal industry participation in a voluntary data
collection program, the Agency has proposed mandatory reporting rules for
nanomaterials under the Federal Insecticide, Fungicide, and Rodenticide Act, and
is also developing proposed rules under the Toxic Substances Control Act.
However, even if mandatory reporting rules are approved, the effectiveness of
EPA's management of nanomaterials remains in question for a number of
reasons:
•	Program offices do not have a formal process to coordinate the
dissemination and utilization of the potentially mandated information.
•	EPA is not communicating an overall message to external stakeholders
regarding policy changes and the risks of nanomaterials.
•	EPA proposes to regulate nanomaterials as chemicals and its success in
managing nanomaterials will be linked to the existing limitations of those
applicable statutes.
•	EPA's management of nanomaterials is limited by lack of risk
information and reliance on industry-submitted data.
These issues present significant barriers to effective nanomaterial management
when combined with existing resource challenges. If EPA does not improve its
internal processes and develop a clear and consistent stakeholder communication
process, the Agency will not be able to assure that it is effectively managing
nanomaterial risks.
For further information, contact
our Office of Congressional and
Public Affairs at (202) 566-2391.
The full report is at:
www.epa.qov/oiq/reports/2012/
20121229-12-P-0162.pdf
What We Recommend
We recommend that the Assistant Administrator for Chemical Safety and
Pollution Prevention develop a process to assure effective dissemination and
coordination of nanomaterial information across relevant program offices. The
Agency agreed with our recommendation and provided a corrective action plan
with milestone dates. This recommendation is open with agreed-to actions
pending.

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