Biomedical Engineering Reference
In-Depth Information
potential environmental risk: the actually released amounts must be known. To date, the assump-
tion has been that nanomaterials that are tightly embedded in a matrix pose no or only minimal
environmental risk. Nonetheless, only very few studies have examined the release of ENPs from
consumer products. The most likely entry pathways of nanomaterials into the environment are
sewage water and wastes. Wastes that contain nanomaterials can arise either during the production
of the raw materials, the manufacture of products with nanomaterials, as well as at the end of the
products' lifecycles.
*
The current domestic and international legal frameworks contain no specific
regulations for treating wastes containing nanomaterials. A release of ENPs into the environment
from wastes is possible, although virtually no studies have been conducted on this aspect. The
assumption is that ENPs are efficiently removed by filters during waste incineration. Given the
state of knowledge and the difficulty of extrapolating from studies involving naturally occurring
material to ENPs, regulators must exercise caution. As noted, there is little hard evidence that
ENPs pose a serious threat, but no real information to establish that they do not. So regulators have
embarked on accumulating the needed information, analyzing it, and taking steps to avoid being
blindsided by unanticipated problems.
In the following sections, the efforts of various national and international regulatory bodies in
addressing the dual issue of products containing nanomaterials and the consequences of their manu-
facture on the environment will be examined.
15.6 U.S. FOOD AND DRUG ADMINISTRATION
The U.S. Food and Drug Administration (FDA) within the Department of Health and Human
Services is the federal agency responsible for the implementation of regulations, guidances, and the
like for pharmaceuticals and medical products such as devices, biologics, and diagnostics, while
the U.S. Environmental Protection Agency (EPA) is responsible for addressing the environmental
effects of nanomaterials. The FDA must consider the risks from the use of nanomaterials. Its efforts
are made more difficult because various components within the agency are responsible for food and
food packaging, human and animal drugs, devices and diagnostic products, cosmetics, vaccines,
blood products and radiation emitting devices, and they do not act at the same speed or necessarily
according to the same script. In part, this difference is due to the fact that the statutory provisions
that the agency must administer for each group of products varies, with some products requiring
pre-market approval, others needing to comply with standards or monographs, and still others regu-
lated mainly by various guidance documents and voluntary submissions.
The criteria for marketing also varies, from requirements for proof of safety and effectiveness,
safety alone, FDA required proof of lack of safety, and so forth. The agency has been discussing
nanotechnology and how it might regulate products containing nanomaterials in earnest since its
internal task force published recommendations in a report issued in 2007.
†
The result has been a
variety of initiatives, depending on the class of products involved and the appropriate FDA center
taking action. Throughout, the agency has moved cautiously, repeatedly stating that the existing
regulatory framework should suffice, with some adjustments, and that the manufacturers intending
to market products using nanomaterials in one way or another should meet with the agency early in
the development cycle to come to agreement on the pathway to market and the data that should be
generated. As will be seen below, there has been no effort yet to label products as containing nano-
material, and no activity toward the mandated generation of an inventory of products employing
nanotechnology. The FDA has been candid in the description of its efforts and intent in the several
product areas it regulates, and since it is the dawning of regulation in the country with the most
advanced regulatory system, it is useful to quote from the materials the FDA has supplied.
*
Id.
at 4-13.
†
U.S. Food and Drug Administration. 2007. Nanotechnology Task Force Report. http://www.fda.gov/ScienceResearch/
SpecialTopics/Nanotechnology/UCM2006659.htm.
