Biomedical Engineering Reference
In-Depth Information
work required to establish adequate governance, and the burden of proof of
nanomaterial toxicity, rests on the shoulders of administrations often under
unrealistic deadlines, without the considerable means in terms of budget,
manpower, and equipment such an endeavor would require (ibid).
In addition to these gaps in the regulatory framework, the United States
as well as other countries, use another exemption measure called GRAS
(Generally Recognized As Safe), which stipulates that “substances can be
marketed without FDA's approval or even its knowledge because such sub-
stances are generally recognized among qualified experts as having been
shown, through scientific procedures or experience based on common use, to
be safe” (GAO 2010). These substances are “hundreds of spices and artificial
flavors, emulsifiers and binders, vitamins and minerals, and preservatives—
to enhance a food's taste, texture, nutritional content, or shelf life” (ibid).
Despite the latest regulatory developments,* in the case of nanomaterials,
they “may escape pre-market review on the basis that they fit within certain
exceptions to the definition of 'food additive' in the FFDCA [Federal Food,
Drug, and Cosmetic Act]” (Duvall 2012).
This avoidance measure called GRAS, which served as the cornerstone for
the large-scale distribution of genetically modified organisms (GMOs), also
based on substantial equivalence (SRC 2001), in the fields and on plates all
over the Americas without any labeling, is a commercial postulate devoid of
any scientific foundation. According to this marketing assumption, trans-
genic products, nanoproducts, or any product resulting from such fabrica-
tion processes, are sufficiently different to require patents but not sufficiently
different to require a rigorous and complete social and scientific assessment.
If this portrait does paint a complex picture of the field of nanotechnol-
ogies, it also bears witness to the mechanisms that continue to “produce
ignorance,” which, while rooted in certain founding concepts of existing
regulatory frameworks, are also caused by the weaknesses in the budgets
dedicated to risk analysis.
†
As an indicator, the risk analysis budgets for the
National Nanotechnology Initiative in the United States have gone from
2.8% to 5.1% of the total budgets in 2006 and 2010 (Sargent 2011). It is there-
fore unsurprising that despite the downpour of money invested in this field,
large portions of the impact analyses for nanotechnologies are still missing
and that public policy regarding impact prevention is absent.
Notwithstanding the important hurdles that public authorities must tackle,
a number of national and international agencies as well as nongovernmen-
tal organizations have attempted to identify the various commercialized
*
“In the specific instance of nanotechnology, a food substance manufactured for the purpose
of creating very small particle sizes with new functional properties likely would not be cov-
ered by an existing GRAS determination for a related food substance manufactured without
using nanotechnology” (FDA 2012).
†
This concept of “ignorance production” is borrowed from the lawyer and politician Corinne
Lepage, Eurodeputy and member of the Committee on the Environment, Public Health and
Food Safety at the European Parliament.
