Top 5 Q&A on Nanotech Guidance From U.S. Government
June 29, 2011
And we thought micro-management was challenging: make way for nano-management. 
Regulation of nanotechnology is an emerging dimension of regulatory compliance in manufacturing. How do you regulate something whose size is one 100,000th the thickness of a piece of paper? Well, hang on -- here come the reg coats.
Earlier this month the European Commission or EC confirmed that it is not seeking to develop a new body of legislation to manage risks presented by nanomaterials. Instead, the EC is planning for nanomaterials to be managed under existing legislation, including REACH.
FDA regulates nanotech
The FDA, interestingly, released Draft Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, which is a first step towards FDA's firm regulation of nanotech. Here we'll take a look at the top 10 questions and answers about FDA's involvement with nano.
1. Why is FDA interested in nanotechnology? Nanotechnology has the potential to be used in an array of FDA-regulated products such as:
- medical products (e.g. to increase bioavailability of a drug)
- foods (e.g., to improve food packaging)
- cosmetics (e.g. to change reflectivity)
Materials at the nanoscale can have different chemical, physical, or biological properties compared to their conventionally-scaled counterparts.
2. What exactly is the new nanotechnology guidance? The agency is issuing this draft guidance on the subject of considering whether an FDA-regulated product contains nanomaterials or otherwise involves the use of nanotechnology. (Because you have to start somewhere..)
The issuance of this guidance is a first step toward providing regulatory clarity on FDA’s approach to nanotechnology, says the agency. Over time, they plan to issue more specific guidances tailored to particular products or classes of products.
3. Can the public comment on the nanotech draft guidance? Yes, for 60 days. The "Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology" is available at regulations.gov (search for docket number FDA-2010-D-0530). Comments will be accepted for 60 days after publication in the Federal Register of the notice announcing the availability of the draft guidance. The actual deadline for comments is August 9, 2011.
4. Is FDA announcing a regulatory definition of nanotechnology? No. The draft guidance does not establish a regulatory definition of the term "nanotechnology" or any related vocabulary. So we're still kind of talking about something unspecified. Which is frustrating to industry (recall IPC's response to EPA on Electronics Stewardship when EPA had failed to define the term.
5. What is FDA’s goal in terms of regulations for nanotechnology-enabled products and their uses? FDA’s goal is to develop "transparent and predictable regulatory pathways grounded in the best science."
Properties of a material may change as the size of the material enters or varies within the nanoscale range. It is critical for FDA to understand how such changes in physical, chemical, or biological properties affect the safety, effectiveness, performance or quality of a product.
The potential risks and benefits to human and animal health of the diverse array of nanotechnology applications are not yet completely identified or understood. The FDA will work with the EU and other nations to share information and findings. To get an idea of what has to happen for assured compliance with most substance-level regulations, see this list of functions for REACH regulation software.
Of particular importance to FDA are:
- the biological interactions of products containing nanomaterials
- understanding interactions of nanomaterials with biological systems
- the adequacy of testing approaches for assessing safety, effectiveness, and quality of products containing nanomaterials
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