Biomedical Engineering Reference
In-Depth Information
Finally, on September 5, 2012, the National Research Council released a pre-publication version of
a report titled
Science for Environmental Protection: The Road Ahead
.
*
The EPA asked NRC to assess
the EPA's overall capabilities “to develop, obtain, and use the best available scientific and technologic
information and tools to meet persistent, emerging, and future mission challenges and opportunities.”
The report discusses nanotechnology as an example of using emerging science to address regula-
tory issues and support decision making. The Committee states that to have the capacity to address
emerging tools, technologies, and challenges, the EPA “will need to have enough internal expertise to
identify and collaborate with the expertise of all of its stakeholders in order to ask the right questions;
determine what existing tools and strategies can be applied to answer those questions; determine the
needs for new tools and strategies; develop, apply, and refine the new tools and strategies; and use the
science to make recommendations based on hazards, exposures, and monitoring.” According to the
report, the example of engineered nanomaterials “illustrates some of the problems and pitfalls of cur-
rent approaches to emerging technologies.” While the EPA provided early funding regarding the use
of nanotechnology in remediation, the report states that it missed the opportunity to support research
addressing the environmental health and safety of nanomaterials, pollution prevention in the produc-
tion of nanomaterials, and the use of nanotechnology to prevent pollution. The reasons for the delay
in early intervention include “insufficient federal agency leadership, emphasis, and policy regarding
proactive
rather than
reactive
approaches to safer design.” If the EPA intends to promote and guide
early intervention in the design and production of emerging chemicals, materials, and products, the
report states, “it will need to commit to this effort beyond its regulatory role.”
15.9 THE EUROPEAN UNION
The EU and its member nations have been active in consideration of the same sorts of issues relat-
ing to nanomaterials, the environment, and the possible regulation of pharmaceuticals, foods, cos-
metics, and other medical products containing nanomaterials. There are a variety of reports and
descriptions of those activities readily available on the Internet. In this chapter, we will concentrate
on present activity and how it compares to efforts underway on the United States.
A significant step in EU regulation was the adoption in 2011 of a definition of nanomaterial. The
definition was adopted in the same year as the FDA acted, and the reasons for adoption were similar.
Nanomaterial was stated to mean:
… a natural, incidental or manufactured material containing particles, in an unbound state or as an
aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribu-
tion, one or more external dimensions is in the size range 1 nm-100 nm.
In specific cases and where warranted by concerns for the environment, health, safety or competitive-
ness the number size distribution threshold of 50% may be replaced by a threshold between 1 and 50%.
By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one
or more external dimensions below 1 nm should be considered as nanomaterials.
†
An accompanying explanation stated the case for the definition in much the same terms used by
the FDA:
Nanomaterials are currently governed by a variety of legislative instruments at EU and national level.
However, definitions have been developed on a case-by-case basis and vary across sectors, creating
unnecessary burdens for industry and hampering public debate about risks and benefits of these sub-
stances. This recommendation gives EU legislators a legal reference for nanomaterials, when adopting
new or implementing existing legislation.
*
National Research Council. 2012. Science for environmental protection: The road ahead. http://www.nap.edu/catalog.
php?record_id=13510.
†
Mantovani, E., A. Porcari, M.D. Morrison, and R.E. Geertsma. 2012. Developments in nanotechnologies regulations and
standards 2012—Report of the observatory nano at 8. www.observatorynano.eu.
