Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

By Tim Cahill:

Yesterday the FDA's Nanotechnology Task Force released its report on the scientific and regulatory challenges related to the use of nanotechnology in products regulated by the FDA. As reported in our July 10, 2007 post, the Task Force's report did not call for additional FDA regulatory authority in this area. The Task Force concluded that the use of nanomaterials in products regulated by the FDA presents challenges similar to those products using existing technologies and other emerging technologies. Further, the Task Force determined that the current science on nanotechnology does not suggest that products using nanomaterials require additional labeling.

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By: Laurie N. Jacques:

I don’t know but I’ve been told,
Try nano-composites and you’ll be sold.

I’m sold on nano-composites after attending the National Composite Center’s Nano-Composite Bootcamp last week. Dr. Phillip S. Wilson, President of Inspired Innovations, LLC, outlined the many benefits of nano-composites that use nano-fillers such as nano-platelets instead of conventional fillers and reinforcements.

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It has been a little over a year since the American Bar Association published its "Innovative Regulatory Approaches” to Nanotechnology discussion paper in June 2006.  During the intervening  period, EPA published its White Paper and its TSCA voluntary framework.  Both provide some general idea of where EPA is heading with environmental regulation, and in this context it is useful to take a glimpse back at the ABA paper.

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Although it examined an uncommon nanomaterial (fluorescent food dye) of a size that is not truly nanoscale (320 nm), a recent paper looked into the ability of nanoparticles to penetrate into hair follicles for potential drug delivery purposes. 

The paper used in vitro porcine skin testing to compare the penetration abilities of nano food dye against the same substance in non-nano form.  The scientists found the nano food dye penetrated much deeper into hair follicles than its counterpart when a mechanical massage was applied to the porcine skin.   Penetration results without massage were essentially the same for the two materials.  The study concluded “movement of hairs may act as a pumping mechanism pushing the nanoparticles deep into the hair follicles.”

The scientists also conducted a second experiment -- in vivo human skin -- to determine how long the nano food dye was retained in hair follicles compared to its non-nano counterpart.  The scientists found the nano food dye was stored in hair follicles for 10 days, while its counterpart was stored for only 4 days.  As a result, the paper concludes “hair follicles represent an efficient reservoir for topically applied substances,” and noted this "reservoir" extends up to 200 nm into the underlying tissue. The scientists also explained the follicle "release" mechanism was natural sebum production. 

Combining both tests, the scientists believe hair follicles may be used as a successful reservoir for possible use in nanoscale dermal drug delivery applications.  The paper concludes particle size “plays an important role in follicular penetration," and “[p]enetration into the hair follicles is a fast process in comparison to the release of the nanoparticles our of the follicles, which continues for some days.” 

J. Loderman, et al., “Nanoparticles -- An efficient carrier for drug delivery into the hair follicles,” European Journal of Pharmaceuticals and Bio pharmaceutics,” Vol. 66, Issue 2, p. 159-164 (May 2007).  

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EPA published its long awaited draft Concept Paper for Nanoscale Materials Stewardship Program Under TSCA yesterday.  The paper contains a draft framework for EPA's voluntary reporting program.  Public comment is invited and a public meeting will be held on August 2 here in Washington, D.C.  EPA's framework is designed to collect data from manufacturers of nanoscale materials regarding the materials they make, encourage risk management practices, develop foundational scientific data for later EHS work, and promote a balance between nanotechnology's positive contributions and minimized possible EHS effects.

EPA suggests four primary categories of companies should participate in the program: manufacturers or importers of engineered nanoscale materials; companies that modify engineered nanoscale materials for subsequent use; companies that modify bulk materials producing engineered nanoscale materials; and companies that use engineered nanoscale materials in the manufacture of their products.

Participants will be asked to implement a nano-risk management program considering relevant input from EPA and to report back regarding its efficacy.  EPA intends to base its nano-risk management program on the results of its October 2006 scientific consultation on nano-risk management practices, and also is encouraging additional public submissions on this specific issue.

Participants will also be asked to provide information regarding their current use of engineered nanoscale materials under two plan levels.

The first "basic" level seeks information EPA believes is already in most companies' possession or should be easy for them to ascertain: materials characterization, hazard, use, potential exposure, and risk management practices.  These broad topics, of course, have numerous subtopics.  To give readers some idea of the extent of the information EPA is seeking, the draft questionnaire for this "basic" level is 25 pages long.

The second, "in depth" level asks select participants to essentially partner with EPA to collect additional data on a specific limited number of nanomaterials of greatest potential concern (tbd).  Participants will jointly review existing data, conduct preliminary assessments, identify any additional data needs, and then work on a joint action plan.  Joint research topics include: "characterizing the physical/chemical properties of the material; testing for health and environmental hazards; monitoring or estimating exposures and releases; determining fate and transport characteristics; evaluating the effectiveness of protective equipment or engineering controls; developing a model worker education program; and other evaluations agreed to under the plan of action."  EPA envisions some companies taking a direct/active role in this research, while others may chose to work in loosely formed coalitions.  After completing the research, there will be a final joint risk assessment for each material studied, and any additional actions/steps will be considered on a case-by-case basis.

EPA advises all of the information collected under both levels of the plan will be treated as being formally submitted under TSCA.  Companies will have the opportunity to designate certain information as "confidential business information" which will be subject to all existing TSCA protections.  EPA plans to use the collected information to determine "how and whether certain nanoscale materials or categories may present risks to human health and the environment," to identify any existing data gaps, prioritize nanomaterials for further research, and develop risk mitigation techniques (assuming the information warrants such measures).

EPA believes all nano-manufacturers and importers should participate in the program in order to encourage "responsible development of nanoscale materials" and to avail themselves of enhanced informed decision making, benefiting "all stakeholders."  EPA also believes the program will foster the openness and transparency many in the public and certain NGO's believe is crucial to the success of any regulatory program. 

Actual participation in the voluntary program, however, remains a concern.  EPA is asking the public for new ideas on providing incentives to companies to participate in the program.  At the same time EPA states that participation will not "relieve or replace" existing TSCA requirements that are otherwise applicable to each specific manufacturer and nanomaterial.

The paper also has several informative attachments.  Of particular interest are "Annex A" which contains a glossary of nanotechnology terms and notes substantial nomenclature gaps, and "Annex D" which identifies "issues and challenges" confronting the program.

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US EPA's long-awaited Nanoscale Materials Stewardship Program has finally been released for public comment and stakeholder involvement.  In fact, two Federal Register notices were issued today.  First, the notice on the Stewardship Program was issued.  Second, EPA issued a notice on the Information Collection Activities in Support of EPA's Stewardship Program for Nanoscale Materials.  Both notices and accompanying documents are available at EPA's website.

EPA will conduct a public meeting to discuss comments on this voluntary program on August 2, 2007 in Arlington, Virginia, and the comment period will run for 60 days from the date of the Federal Register notices, July 12, 2007.

Check back for more details as we review these materials.

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Under the Toxic Substances Control Act (TSCA) "new" chemical substances are subject to detailed premanufacturing notice and approval requirements.  This is unique because "traditional" environmental statutes such as the Clean Water Act and the Clean Air Act primarily regulate "end-of-pipe" or "end-of-stack" emissions.  Thus, some environmental lawyers herald TSCA as a proactive tool for EPA to regulate nanoscale materials before they are put in use, rather than simply monitoring and limiting eventual emissions/releases.

A core issue in this discussion has been whether -- because of their small size and sometimes unique properties -- EPA should treat all nanoscale materials as "new" chemicals under TSCA and subject them to the Act's premanufacturing notice and approval requirements.  Some argue this is the most conservative, precautionary approach given current EHS uncertainty surrounding some nanoscale materials in certain circumstances.

Earlier today EPA took a large step towards clarifying its approach by publishing a paper explaining its treatment of nanoscale substances under TSCA as "new" versus "existing" chemicals. "TSCA Inventory Status of Nanoscale Substances -- General Approach."  EPA's announced position is consistent with many predictions:  EPA does not intend to consider nanoscale materials "new" substances just because of their diminutive size -- they must have a distinct molecular identity that is not shared with any other chemical on TSCA's existing Chemical Substance Inventory before they are considered "new."

In reaching its position, EPA explains that term "chemical substance" is defined as “any organic or inorganic substance of a particular molecular identity," and that a "molecule" is defined as the smallest amount of matter retaining all of its same chemical properties.  Therefore, EPA reasons if a nanoscale material has the same molecular identity as its bulk counterpart, it is an "existing," not "new," chemical substance. 

However, EPA also indicates it is going to approach these determinations on a case-by-case basis, and “certain nanoscale substances that will be manufactured or imported for commercial purposes are expected to be new chemical substances and therefore subject to TSCA new chemical regulatory requirements. As are any other new chemical substances.”

Apparently realizing this issue may create uncertainty with nano-manufacturers, EPA encourages companies to consult EPA or submit a request for an inventory search to determine whether a particular nanoscale material in question should be treated as a "new" chemical under TSCA. 

However, a sibling issue still remains undecided by EPA  -- whether the use of nanoscale materials constitutes a "significant new use" of an existing chemical substance which also triggers TSCA's  premanufacturing notice and approval requirements.  This is a much tougher issue to resolve.  Under the applicable statute, relevant factors in this consideration are:  (i) the projected volume of manufacturing and processing of a chemical substance, (ii) the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance, (iii) the extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance, and (iv) the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

How EPA will resolve this issue remains to be seen.  Stay tuned.

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Nanotechnology Now recently posted “Public Distrust of Science Made Cambridge the Biotech Capital of the World.”   The post summarizes an article on blog.wired.com which in turn comments on the City of Cambridge, Massachusetts’ efforts to deal with the emerging science surrounding recombinant DNA back in the 1970’s. The article intimates that Cambridge’s success in attracting biotechnology companies was due in part to the extensive public discussion regarding EHS issues the City fostered back when rDNA labs were first opening in Cambridge.

Although the Nanotechnology Now post does not mention it, the City eventually passed a moratorium on rDNA research and development, followed by its own unique rDNA ordinance in 1977 which essentially adopted NIH guidelines for working with rDNA.  (Both have since been amended/updated).  Other nearby communities soon followed Cambridge’s lead: Newton, Bedford, Worcester, Boston, Somerville, Waltham, Woburn, and Malden.  For those who are interested, Cambridge’s Director of Public Health published a helpful article outlining the history, intent, and possible implications of Cambridge’s rDNA ordinance which can be found here.

For those watching nanotechnology related events in Cambridge, the City’s Director of Public Health is also convening a six month advisory board process to provide guidance to the City regarding whether or not to regulate nanotechnology research and development within City limits.  While there are no current authoritative and comprehensive EHS guidelines for nanotechnology as there were with rDNA, it is a good possibility that Cambridge will attempt a similar approach with nanotechnology.

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By: Tim Cahill and Michael Heintz:

FDA Week reported on July 6, 2007 that the FDA's Internal Nanotechnology Task Force is close to issuing its first report and is going to recommend that the agency not create "regulatory policies" for nanomaterials.  Instead, the task force is likely recommending that FDA create guidelines for "best practices."  The Task Force report will also likely urge FDA to work with academia and the National Nanotechnology Initiative to gather more information about nanotechnology risks and benefits. 

FDA Week also observes that an agency official stated as early as 2005 that the agency would not regulate products containing nanotechnologies any different than conventional products, and "The agency does not regulate the technology as a separate entity so products such as drugs or medical devices that employ nanotechnology are scrutinized while cosmetics are not. "  The Task Force report will also likely urge FDA to work with academia and the National Nanotechnology Initiative to gather more information about nanotechnology risks and benefits.

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One downside to our focus on the safety of nanomaterials is that it can cause us to lose focus on the potential upsides of nanotechnology in the environmental, health and safety arena.  CORDIS is reporting on a study funded by the European Parliament's Scientific Technology Options Assessment ("STOA") committee which looked into whether nanomaterials could serve as substitutes for hazardous materials.

In particular, the study focused on two areas where nanotechnology is already making inroads --  coatings and catalysts:

Two areas where nanotechnology is already making inroads as a substitute for hazardous chemicals are coatings and catalysts. Coatings can create anti-adhesive surfaces which resist things sticking to them, such as dirt, or have biocidal properties to prevent living organisms from sticking to them.

Nanoparticles are also widely used in catalysts, although the authors point out that research in this field was already on the nanoscale, and so it is not clear to what extent future developments could be attributed to nanotechnologies.

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As reported by AzoNano.com, the EPA recently announced the award of two grants, collectively worth $600,000, to researchers at Oregon State University to study the human health impacts of nanomaterials.  The pair of studies look like the first step toward nanotechnology regulation.  According to the AzoNano article, the first study is a survey of common manufactured nanomaterials to understand their interaction with biological processes.  The second study looks specifically at how manufactured nanomaterials may "damage or kill cells:"

Dr. Alan Bakalinsky is studying the relationship between specific characteristics of nanoparticles, like shape and structure, and their effects on cells. The work is expected to lead to the development of safety guidelines for industrial and environmental exposure to nanomaterials. "We're trying to identify specific structures in manufactured nanoparticles that might cause damage to cells," said Bakalinsky. "If we can determine which shapes and structures are most dangerous to cell function, it should be possible to design the materials to avoid those shapes and minimize the risk of damage."

Both Oregon State researchers, Drs. Bakalinsky and Tanguay, look to be relatively new to the nanotechnology field.  Bakalinsky is a food science researcher and Tanguay is a molecular toxicologist. 

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