Nanotechnology and the Consumer Product Safety Commission

Posted on September 24, 2008 by John C. Monica, Jr.

Late last month, the Woodrow Wilson International Center for Scholar's Project on Emerging Nanotechnologies (PEN) published a paper on the ability of the U.S. Consumer Product Safety Commission (CPSC) to deal with possible environmental, health, and safety risks potentially posed by the use of some nanoscale materials in certain consumer products.

 E. Marla Felcher, "The Consumer Product Safety Commission and Nanotechnology," Project on Emerging Nanotechnologies, PEN 14, August 2008.

 The article begins with an analysis of PEN’s online consumer nanoproduct inventory which is used to support the author’s claims that "nanotechnology-enabled products" have made their way into every category of product under the CPSC's jurisdiction. Of the 60 products on PEN’s website, the author claims that "all of them are available for purchase by consumers," and approximately "half of nanotechnology consumer products currently on the market would fall under CPSC's jurisdiction." She notes that "[e]very day, new nanoengineered products make their way into stores’ shelves, among them kids’ pants, teddy bears, baby bottles, pacifiers, teething rings, plastic food storage containers, socks, chopsticks, humidifiers, mobile phones, computer processors and tennis rackets."

In a loaded rhetorical follow-up question the author asks: "Is it safe for an infant to spend hours each day sucking on a nano-enhanced pacifier?" The question does more to cement the author’s predilection against the use of nanoscale materials in consumer products than it does to present readers with a true quandary. Moreover, while PEN’s online inventory is a great tool, the author fails to take into account that many of the products on the site have never been commercialized, or have long been taken off the market. Such an analysis would provide a helpful balance to the article’s "pending emergency" tone.

Getting beyond initial issues, the author’s key concerns appear to have less to do with potential nano-specific product risks than with CPSC foundational issues. The author’s primary complaint appears to be that the CPSC has no premarket testing authority. She also believes that there is "[a]mple evidence" that companies do not do premarket testing or self-report hazards and defects -- a conclusion many dispute.

In keeping with her general approach, the author lists "Five Generic Weaknesses in CPSC's Product Oversight Capacity:" 1. "CPSC's Data Collection System is Not Nano Ready;" 2. "CPSC has Limited Ability to Tell the Public About Health Hazards Associated with Nanoproducts;" 3. "CPSC Has Limited Ability to Get Recalled Nanoproducts Out of Use;" 4. "CPSC Lacks Sufficient Enforcement Staff to Identify Manufacturers That Fail to Report Nanoproduct Hazards;" and 5. "CPSC Does Not Have Sufficient Authority to Promulgate Mandatory Safety Standards for Nanoproducts."

While some of these points are valid, they are not nano-specific. In fact, this section of the article would suffer little if the prefix "nano" and the term "nanotechnology" were eliminated from the text. (Try it.) The same could be said for several of the prior papers published by PEN in which the authors’ complaints and cautions appear more related to broader governance issues than to nano-specific difficulties.

To get to the heart of the paper, most readers will want to flip to the last section where the author lists several recommendations to correct the problems she perceives with the CPSC.

The author recommends that the CPSC should: 1. "Build the agency’s nanotechnology base and expertise;" 2. Identify companies making "nanoproducts and request that they submit research studies, risk assessment data and any information they hold that will enable CPSC scientists to assess the safety of nanoproducts;" (Although she notes that the Consumer Product Safety Act provides sufficient authority to accomplish this recommendation); 3. "Coordinate with other health and safety agencies, and combine efforts to evaluate the risks associated with nanoproducts;" and 4. "Convene a CHAP to evaluate the health and safety risks associated with nanoproducts currently on the market that are intended for use by children."

The author’s second CPSC recommendation is the most interesting and could benefit from further development. If the Consumer Product Safety Act provides sufficient authority to allow the CPSC to ask companies making nanoproducts to submit safety and risk assessment data (as the author suggest), that should go a long way to satisfying the author’s nano-information gathering concerns. The potential civil liability facing companies marketing nanoproducts without first collecting such data after it has been specifically requested by the CPSC would act as a hefty deterrent to the potential misconduct she fears.

The author also recommends two Congressional remedies:

1. "Amend the Consumer Product Safety Act to give CPSC the authority to require manufacturers to identify the presence of nanomaterials in their products;" and 2. "Adopt Section II of the Consumer Products Safety Act Bill recommended to Congress by the NCPS in its 1970 Field Report." This would give the CPSC the ability to promulgate "safety standards for any 'new' consumer products" . . . "where there exists a lack of information adequate to determine the safety of such product in use by consumers."

It is hard to argue against the author’s first Congressional recommendation. Collecting more information is a good thing as long as the requirements are not onerous and the CPSC actually has the ability to process and use the data productively. Although mentioned in the "Foreword," left out of the author’s Congressional "should do" list is more CPSC funding specifically dedicated to nanotechnology safety issues. Arguably, many of the author’s issues with the CPSC could be diminished with additional funding, staff, and resources to more fully address nanotechnology issues.

All in all, the paper is well worth reading as long as PEN’s and the author’s predispositions are kept in mind.

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New Report: Nanotechnologies for Energy and the Environment

Posted on June 11, 2007 by Michael E. Heintz

Research and Market recently announced the publication of a new report addressing environmental uses and applications of nanomaterials.  The report covers many applications, environmental media, and toxicology, and, "describes nanotechnologies, nanomaterials, nanotechnology companies, universities and research centers related to nanotechnologies for new environmental technologies.  Areas covered by are leading edge research in emission reduction, environmental remediation and monitoring, green manufacturing, water filtration and treatment, energy conversion and storage, alternative energy and toxicology. "

The table of contents of the report is available here, and the full report can be purchased for EUR 1,584 (approximately $2,100.00).
 

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Joint Risk Assessment Between DuPont and Environmental Defense

Posted on March 28, 2007 by Michael E. Heintz
Pesticide & Toxic Chemical News reports that chemical manufacturer DuPont and the nonprofit organization Environmental Defense are developing a joint framework for risk assessment of nanomaterials.  The framework itself is for "the responsible development, production, use and disposal of nano-scale materials that identifies, manages, and reduces potential risks across all lifecycle phases."

The partnership agreement outlines the relationship, and includes such areas as human health hazards, release and exposure potential, and occupational and environmental risk management.  The framework will primarily focus on the industrial, chemical, and manufacturing industries, and each partner will bear its own costs of research.  Further, the parties plan to involve additional stakeholders throughout the project in an effort to form a framework that will be widely accepted across all areas of nanotechnology.  Once the partnership is complete (following publication of the findings) all information will be released publicly for consideration.  A draft framework is available here, and is open for comment.

MEH:  This is exactly the type of partnership that will forward the research and understanding of nanotechnology impacts and how to address them.  By having two differing views involved, an understanding can be reached that can then be spread to the industry at-large.  The more stakeholders that get involved in the process, the better the resulting research and regulations will be.  This partnership is an excellent first step, and both DuPont and Environmental Defense should be commended for their initiative.
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Department of Defense is Watching "Nanomaterials"

Posted on December 14, 2006 by Michael E. Heintz
The United States Department of Defense's Materials of Evolving Regulatory Interest Team (MERIT) recently announced that it added "nanomaterials" to its emerging contaminants watch list.  The DoD defines "emerging contaminants" as those chemicals and materials with a "perceived or real threat to human health or environment," an "evolving regulatory interest," and "either no peer reviewed health standard or an evolving standard."  In addition, an emerging contaminant may have "insufficient human health data/science," or "new detection limits," or "new exposure pathways."

The watch list however, is different from the emerging contaminants action list.  The watch list includes those materials that DoD believes have a "probable mission or budge impact."  DoD then monitors events surrounding the listed material while conducting "rough impact analysis."  Other materials found on the watch list include: tungsten and its alloys, lead, beryllium, dichlorobenzenes, and dioxins, among others.  "DoD places materials on the Watch List when they are identified through the scanning phase as potentially affecting one or more DoD business areas. While the exact nature and magnitude of the potential impacts are unknown, the Department has identified these materials as having a potential to affect DoD functions. As a result, DoD is conducting Phase I assessments for each of these materials."

The difference between the watch list and action list is that under the watch list the DoD monitors developments concerning the listed material while expending minimal resources.  If the material is upgraded to the action list,  DoD has determined that the material is likely to impact the department, and it performs detailed analysis on the material while possibly expending "significant" resources on understanding the material.  Other activities performed once a material is upgraded to the action list include undertaking risk management actions and pollution prevention efforts by DoD.

This listing of nanomaterials, without more information, is interesting for a number of reasons.  First, the DoD's watch and action lists are selective in nature. There are only eighteen materials on these lists in total, so the addition of nanomaterials is significant.  We therefore see this action as a step towards regulation of nanotechnology by DoD's recognition of nanomaterials as potentially impacting department operations and the environment.  Second, it is hard to know what DoD will be watching by posting "nanomaterials" on its watch list.  Given the different types and functions of nanomaterials and nanoparticles, a blanket listing is vague at best.  However, because the DoD elected to list nanomaterials at all is proof that federal agencies are increasing their focus on nanotechnology in general.

While this listing does not cause any regulatory actions to be taken by DoD, an upgrade to the action list could certainly mean a significant change in course as to how one of the country's largest agencies addresses nanotechnology.
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First EPA Regulation Of Nanotechnology?

Posted on November 24, 2006 by Patrick T. Lewis

Rick Weiss reported in yesterday's Washington Post that the EPA plans to regulate silver nanomaterials used in consumer products as "germ-killing" agents:

The decision -- which will affect the marketing of high-tech odor-destroying shoe liners, food-storage containers, air fresheners, washing machines and a wide range of other products that contain tiny bacteria-killing particles of silver -- marks a significant reversal in federal policy. * * *

Under the new determination, first reported on Tuesday by the Daily Environment Report, a Washington publication, and confirmed yesterday by the EPA, any company wishing to sell a product that it claims will kill germs by the release of nanotech silver or related technology will first have to provide scientific evidence that the product does not pose an environmental risk.

The EPA plans to regulate these materials under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA").  Howard Lovy from NanoBot questions whether the EPA is really breaking new ground in its regulation, since it already regulates the use of silver as an anti-microbial agent. 

As always, I imagine, the devil is in the details.  While EPA might already regulate silver under FIFRA, it probably will not apply the same regulatory standards to "nano-silver."  It will be interesting to see how much safety testing EPA requires "nano-silver" manufacturers to use, and whether those manufacturers will conduct the testing necessary to pass muster (or whether they will simply abandon the project).  I'm reminded of the issue of OSHA regulation of nanomaterials:   only a few years back, manufacturers of carbon nanotubes were submitting MSDSs that were essentially the same as for graphite (which is used to make the nanotubes). 

Jonathan Adler of Case Law School and the Volokh Conspiracy emphasizes that the new regulations will only apply to companies that make germ-killing claims in connection with the marketing of  nano silver-containing products.
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Report by Former FDA Official Urges Greater Regulation of Nanoindustry

Posted on November 21, 2006 by John C. Monica, Jr.
An October report authored by Michael R. Taylor, Esq., former FDA Deputy Commissioner for Policy (1991-1994) may not be warmly received by all nanomanufacturers. Taylor’s report focuses on what he sees as FDA’s three primary purposes in relation to nanotechnology: (1) ensure product safety; (2) foster innovation; and (3) maintain public confidence in nanoproducts.  Taylor analyzes existing FDA pre-market review and post-market monitoring powers over nanotechnology products and finds several insufficiencies.

The essence of Taylor's report is distilled in Table 2 on page 27 of the article, in a table entitled “Capacity of FDA’s Legal Authority to Achieve the Primary Goals of Regulatory Oversight for Nanotechnology Products.” The table provides a quick summary of how Taylor views the FDA’s current power to regulate the nanotechnology industry.

Specifically, Taylor identiies four FDA Pre-Market Oversight Goals:
1. Obtain information on new nanoproducts early in the development process;
2. “Define and enforce public safety standards for nano-materials, including the nature and extent of testing required to satisfy them;”
3. “Place the initial and continuing burden to demonstrate safety on the nanotechnology product’s sponsor;” and
4. “Review the nanotechnology product’s safety prior to marketing and improve conditions as needed to ensure safety.”

And four FDA Post-Market Oversight Goals:
1. “Require post-marketing monitoring and testing of nanotechnology products as needed to ensure safety;”
2. “Require timely adverse event reporting;”
3. “Inspect manufacturing establishments and examine records related to nanotechnology product safety;” and
4. “Remove from the market nanotechnology products that appear to pose a significant safety hazard and or no longer meet the applicable safety standard.” 

Taylor then evaluates what he perceives to be the effectiveness of FDA’s current authority to implement these goals across nine different product categories: Cosmetics, Whole Foods, Dietary Supplements, GRAS Food Ingredients, Food Additives, Food Packaging, Medical Devices, OTC Drugs, and New Drugs.

Medical Devices and New Drugs fare best under Taylor’s analysis, while Cosmetics, Whole Foods, and Dietary Supplements fall at the other end of his spectrum. Taylor’s analysis suggests, however, that virtually every product category could benefit from a strengthening of FDA’s existing regulatory authority.

Taylor further implies that FDA will not be able to reach the above-referenced goals unless Congress drastically increases its funding. To this end, Taylor asserts FDA’s 2007 budget falls 56% short of what it needs to perform the same tasks required of it in 1996.

The report concludes with helpful information concerning FDA’s existing nanotechnology activities, additional tools Taylor believes FDA needs to do its job, and several recommendations regarding how FDA should approach the significant gaps in the nano-regulatory picture he paints.

“Regulating the Products of Nanotechnology: Does FDA Have the Tools it Needs?,” Taylor, M., Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, October, 2006.

 
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Review: "Nanotechnology and the FDA," in Nanotechnology Law & Business

Posted on November 6, 2006 by John C. Monica, Jr.

In the September 2006 edition of Nanotechnology Law & Business, two (2) employees of FDA’s Center for Drug Evaluation and Research (“CDER”) -- Nakissa Sadrieh and Parvaneh Espandiari -- published “Nanotechnology and the FDA: What Are the Scientific and Regulatory Considerations for Products Containing Nanomaterials?”

The article begins with a disclaimer that the authors’ views and opinions are not necessarily those of FDA, and then narrows its specific focus to nano-products regulated by FDA’s Center for Drug Evaluation and Research (‘CDER’) – primarily new drugs and/or drug delivery systems.

To frame the discussion, the authors quote FDA’s informal three-pronged definition of “nanotechnology:”

[the] research and technology or development of products that involve all of the following: the existence of materials or products at the atomic, molecular or macromolecular levels, where at least one dimension that affects the functional behavior of the drug/device product is in the length scale range of approximately 1-100 nanometers; the creation and use of structures, devices and systems that have novel properties and functions because of their small size; and the ability to control or manipulate the product on the atomic scale.

The authors note the efficacy of this definition is currently under discussion within FDA’s CEDAR working group.

The article next addresses the likelihood of new nano-drugs and/or nano-drug delivery devices being treated by FDA as “combination products” (i.e., drug-device, drug-biologic, and device-biologic products), the development of which will be coordinated by FDA’s Office of Combination Products. The authors explain functionally how a nano-based “combination product” might be primarily assigned to one of three (3) FDA Agency Centers for premarket review and regulation based on a primary mode of action analysis (CDER, Center for Biologics Evaluation and Research, or Center for Devices and Radiological Health).

The highlight of the article is the authors’ opinion that existing FDA regulations adequately cover the types of nano-products currently being contemplated for submission as Investigational New Drugs to FDA. The authors note existing pharmaceutical testing includes the areas of pharmacology; safety pharmacology; absorption, distribution, metabolism and excretion; genotoxicity, developmental toxicity; irritation studies; immunotoxicology; carcinogenicity; and other product-specific tests. They conclude this existing preclinical testing is sufficient to detect any possible health risks posed by nano-drugs and/or nano-drug delivery devices.

In an effort to balance their conclusion, the authors then list eight (8) specific nanotechnology questions and eleven (11) safety considerations they believe need to be addressed by CDER. Notably, these considerations include whether ‘nanoparticles [will] gain access to tissues and cells that normally would be bypassed by larger particles,” and “[o]nce nanoparticles enter tissues, how long do they remain there and where do they concentrate.” The authors conclude that FDA may not currently have the ability to adequately address these issues, and propose “much of the currently ongoing research [may not be] focusing properly on the questions that may be most relevant to FDA as a regulatory agency.” The authors note that much of the current nano-testing is in vitro, and that in vivo studies should also be conducted in order to answer the most important questions presented.

The article concluded with the authors’ prediction that “we do not expect that the FDA will be issuing any new guidance to specifically focus on nanotechnology products, as these products will be covered by the existing guidance documents.” . . . and . . . “[i]n the meantime, and based on the available scientific knowledge, nanotechnology products will be handled on a case-by-case basis, as is the case for all other products submitted for review to the FDA.”




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