Biomedical Engineering Reference
In-Depth Information
The other guidance document posted by the CFSAN relates to food and food packaging.
*
The CFSAN identifies the purpose of the document “to describe the factors you should con-
sider when determining whether a significant change in manufacturing process for a food substance
already in the market:
•
Affects the identity of the food substance
•
Affects the safety of the use of the food substance
•
Affects the regulatory status of the use of the food substance
•
Warrants a regulatory submission to FDA”
As with all food substances, this guidance also is intended to recommend that manufacturers
consult with FDA regarding a significant change in manufacturing process for a food substance
already in the market, irrespective of any conclusion about whether that change affects the safety or
regulatory status of the food substance.
†
Over the past several years, the agency has engaged in a dialog with the regulated industry, opt-
ing to encourage contact prior to the submissions for products where one issue may be the presence
of nanomaterials and providing forms of guidance for the generation of data where no submission
is required. It has emphasized its expertise in dealing with small molecules, and declined to push
too hard in the absence of hard information on product problems. There has been no concerted
effort to mandate inventory information or require notification before marketing a product solely
because it employs nanomaterials. There are no nanomaterial product registration requirements
and no mandated report of adverse effects. The lynchpin has been to encourage dialogue with the
centers, and it is an open question whether the FDA is acquiring information relating to regulatory
aspects of nanotechnology quickly enough to be in a position to address issues developing in the
foreseeable future.
15.7 U.S. ENVIRONMENTAL PROTECTION AGENCY
The FDA's strategy of the EPA, on the other hand, is somewhat more directed to implementing
specific regulations based on two major statutes it administers. The law of broader application is
the Toxic Substances Control Act (TSCA) that gives the EPA authority over “chemical substances,”
including nanoscale materials. To ensure that nanoscale materials are manufactured and used in a
manner that protects against unreasonable risks to human health and the environment, the EPA is
pursuing a comprehensive four-prong regulatory approach under TSCA. This approach includes:
the Premanufacture Notifications (PMN), Significant New Use Rule (SNUR), information gather-
ing authority, and test authority.
‡
These tools facilitate both the acquisition of information needed
to make regulatory decisions and actions to attempt to prevent risk in the interim. Regarding the
Premanufacture Notifications (PMN), TSCA requires manufacturers of new chemical substances to
provide specific information to the EPA for review prior to manufacturing chemicals or introducing
them into commerce. The EPA can take action to ensure that chemicals that pose a risk to human
health or the environment are effectively controlled. Since 2005, the EPA has received and reviewed
over 130 new chemical notices under TSCA for nanoscale materials, including CNTs. The agency
has taken a number of actions to control and limit exposures to these chemicals, including:
*
U.S. Food and Drug Administration. 2012. Draft guidance for industry: Assessing the effects of significant manufactur-
ing process changes, including emerging technologies, on the safety and regulatory status of food ingredients and food
contact substances, including food ingredients that are color additives. http://www.fda.gov/Food/GuidanceRegulation/
GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm300661.htm.
†
Id.
at 4.
‡
U.S. Environmental Protection Agency. 2010. Control of nanoscale materials under toxic substances control act. http://
www.epa.gov/oppt/nano/.
