Joined: 16 Mar 2004
|Posted: Mon Dec 18, 2006 10:37 am Post subject: Nanotechnology regulatory oversight inadequate
|Nanotechnology regulatory oversight inadequate, study finds
by Ahmed ElAmin
The US Government needs to boost the Food and Drug Administration (FDA) resources so it can properly regulate nanotechnology products, according to a study by a Washington think-tank.
The call comes in a new report on the development and risks of the technology, released today by the Woodrow Wilson International Center for Scholars, and days before the FDA holds a public debate on the issue.
It raises fears that the lack of regulatory oversight of the technology could result in products begin put on the market that could potentially harm human health and the environment.
The report was written by Michael Taylor, a former FDA deputy commissioner for policy.
“The pressures of expanding regulatory responsibilities and the increasing cost of doing business, coupled with the failure of Congress and successive administrations to adequately fund even FDA's base operations, are a real threat to FDA's ability to effectively oversee nanotechnology,” Taylor stated in announcing his findings.
In relation to the food industry the Woodrow Wilson centre calls for more information to be passed on to the regulatory authority.
"In the absence of clear authority to access food industry data on pipeline products, FDA should attempt to access at least some of the food industry's safety related data by collaborating with industry, perhaps through a trade association, on a voluntary call for data on food uses of nanotechnology," Taylor stated.
Nanotechnology has been touted as the next revolution in many industries, including food manufacturing. It is a sector for which the topic has become a hot consumer issue due to fears over the unknown consequences of digesting nano-scale particles designed to behave in specific way in the body.
There is currently very little information available on the potential risks that these materials may pose to the environment and human health. This fact has spurred some governments such as the UK and Germany to begin studies and risks assessments into how to properly oversee the sector without killing off advances.
The Woodrow Wilson research center has strategically released the report days before FDA's first major public meeting on nanotechnology oversight, scheduled for October 10.
The FDA has also set up an internal task force to study how to regulate nanotechnology products.
In his report Taylor has identified about 300 nanotechnology consumer products being sold in the US. The Woodrow Wilson center called on the FDA should take some immediate steps to gather information about this first wave of nanotechnology products and to set the criteria for determining when a nanoscale material is ‘new' for legal, regulatory and safety purposes.
"By acting promptly, FDA will be in a better position to prevent regulatory and safety problems rather than having to react later, after the fact,” Taylor stated.
The report, commissioned by the related Project on Emerging Nanotechnologies, finds FDA's resource base severely eroded. It examines the FDA's capacity to properly regulate new products containing nanotechnology materials — including foods, packaging, drugs, medical devices, dietary supplements and cosmetics.
Taylor says important gaps in FDA's legal authority that hamper its ability to understand and manage nanotechnology's potential risks.
"This is particularly true in the area of cosmetics and dietary supplements, and in the oversight of products after they reach the marketplace,” he said.
David Rejeski, director of the Project on Emerging Nanotechnologies says nanotechnology is emerging rapidly as a technology across virtually every product category FDA regulates.
"Consumers rely on the FDA to judge what is safe and unsafe," he said. "Unless the FDA addresses potential nanotechnology risks now, public confidence in a host of valuable nanotechnology-based products could be undermined.”
Taylor called on Congress to give FDA the legal tools and resources it needs to do the job.
Some of his recommendations include giving FDA administrative authority to call for the submission of specified information on emerging technologies and products under its jurisdiction, including products in the development pipeline.
The FDA should also be provided with rule-making authority to establish interim pre-market notification mechanisms to address emerging and novel technologies. It should also have access to records by expanding its general inspection authority to include access to safety substantiation data and other information.
The FDA should have authority to require post-market monitoring and surveillance, if needed, to assure the long-term safety of the product, Taylor stated.
It should also be given broad authority to devise mandatory adverse event reporting systems that are appropriate for each product category, he stated.
Taylor finds that FDA's resource base and overall capacity have been eroded by the pressure of increasing demands and costs of doing business coupled with the failure of Congress and successive administrations to adequately fund even base operations.
He estimates that just to be able to do what it was doing in 1996 and continue the new activities mandated for it since then, FDA's 2006 budget would have to be 49 per cent greater than it is
Under the proposed 2007 budget for the FDA, the funding gap between responsibilities and capacity will grow to 56 per cent, he estimates.
Nanotechnology deals with the measurement, manipulation, and manufacture things at an atomic and molecular scale, usually between 1 and 100 nanometers. A nanometer is one billionth of a meter. A human hair is roughly 100,000 nanometers wide.
The market opportunity for nanotechnology is substantial, according to the report. Emerging nanotechnology was incorporated into about $30bn in manufactured goods in 2005—more than double the previous year.
By 2014, Lux Research projects that $2.6 trillion in global manufactured goods will incorporate nanotechnology, or about 15 per cent of total output.
A nanotechnology product reference database set up by the Project on Emerging Nanotechnologies lists 18 food and drink products, most of them supplements. Other products include a powdered chocolate drink and an oil made out of canola.
The US invests about $3bn annually in nanotechnology research and development, which accounts for approximately one-third of the total public and private sector investments worldwide.
Last September a House of Representatives science committee held a hearing to examine whether the federal government is adequately funding and coordinating research on the environmental and safety implications of nanotechnology.
The Project on Emerging Nanotechnologies was launched in 2005 by the Wilson Center and the Pew Charitable Trusts. It is designed as a resource for business, government and the public and aims to anticipate and manage the possible health and environmental risks posed by nanotechnology.
The Washington-based Woodrow Wilson International Center for Scholars is supported by public and private funds as an independent think-tank.
Source: Food Production Daily - USA
This story was first posted on 10th October 2006