New Edition of NanoLawReport
Here is the Summer 2010 edition of NanoLawReport. Heading out to the beach for a few days to top off the summer. :)
H.R. 5786 "Safe Cosmetics Act of 2010" Introduced
Rep. Janice Schakowsky, with Reps. Ed Markey and Tammy Baldwin among the co-sponsors, introduced H.R. 5786, the "Safe Cosmetics Act of 2010" on 07/20/2010. The act would amend Chapter VI of the Federal Food, Drug & Cosmetic Act by adding new language regarding the marketing, labelling, testing and regulation of cosmetic manufacturers, packagers and distributors.
Two sections of the bill would affect the use of nanotechnology and nanoparticles in cosmetics:
`SEC. 614. COSMETIC AND INGREDIENT TESTING AND SAFETY.
`(d) Nanomaterials in Cosmetics- The Secretary shall--
`(1) monitor developments in the scientific understanding of any adverse health effects related to the use of nanotechnology in the formulation of cosmetics; and
`(2) consider scale specific hazard properties of ingredients when conducting or reviewing safety substantiation of cosmetic ingredients.
SEC. 618. COSMETIC AND INGREDIENT STATEMENTS.
`(e) Labeling of Nanomaterials in Cosmetics- The Secretary may require that--
`(1) minerals and other particulate ingredients be labeled as `nano-scale' on a cosmetic ingredient label or list if not less than 1 dimension is 100 nanometers or smaller for not less than 1 percent of the ingredient particles in the cosmetic; and
`(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.
Other sections of the bill would require:
Domestic manufacturers, packagers and distributors and foreign manufacturers, packagers and distributors who export to the United States to register annually with the Secretary of Health and Human Services (HHS); registration would include information about locations of facilities and trade names, numbers of employees at each location, gross receipts of sales and names and addresses of materials suppliers
Labels on each package of cosmetics would need to name each ingredient in descending order of dominance in the cosmetic. Internet vendors would need to post this information on their websites.
Within one year of the bill's enactment into law
manufacturers and distributors of cosmetics and ingredients shall submit to the Secretary (in an electronic format that the Secretary shall determine) all reasonably available information in the possession or control of the manufacturer or distributor that has not previously been submitted to the Secretary regarding the physical, chemical, and toxicological properties of single or multiple chemicals listed on the cosmetic labels under section 613, including--
`(i) functions and uses;
`(ii) exposure and fate information;
`(iii) tests of finished cosmetics; and
`(iv) any other information used to substantiate the safety of such cosmetics or ingredients.
The Secretary would, not later than 1 year following enactment, create a publicly accessible database of non-confidential information submitted by manufacturers and distributors.
Within two years of enactment, the Secretary would publish and periodically update lists of prohibited, restricted and safe ingredients
Manufacturers, packagers and distributors would be required to submit reports "containing information received concerning any serious adverse event associated with the use of the cosmetic". These reports would be available to the public via the HHS website.
Other provisions would require to the Secretary of Labor to
promulgate an occupational safety and health standard under section 6 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655) that requires the following:
(1) MANUFACTURERS AND IMPORTERS-
(A) IN GENERAL- Each manufacturer or importer selling any cosmetic for professional use shall--
(i) obtain or develop an expanded material safety data sheet described in subsection (b) for each such cosmetic or personal care product that--
(I) the manufacturer or importer produces or imports; and
(II) includes a hazardous chemical, or product ingredient associated with any chemical hazard, that has been indicated by authoritative bodies or scientific studies to be linked to health hazards including mutation, reproductive or developmental toxicity, neurotoxicity, endocrine disruption, asthma, or other immunological toxicity; and
(ii) make the expanded material safety data sheet available to distributors and employers, including salon owners, in English and, upon request, in other languages, including Spanish and Vietnamese.
(B) PROFESSIONAL USE DEFINED- In this paragraph, the term `professional use' has the meaning given such term in section 611 of the Federal Food, Drug, and Cosmetic Act.
(2) DISTRIBUTORS- Each distributor of a cosmetic or personal care product for professional use shall distribute and provide expanded material safety data sheets described in subsection (b) in the same manner as a distributor of a chemical hazard is required to distribute and provide material safety data sheets under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations.
(3) EMPLOYERS- Each employer, including any operator of a salon, shall--
(A) have an expanded material safety data sheet in the workplace for each cosmetic or personal care product for professional use that is used in the course of the employer's business;
(B) make such expanded material safety data sheet available to all employees of the employer who are exposed or use the product to the same extent and in the same manner as material safety data sheets are required to be made available under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations; and
(C) upon request, provide employees with translations of such expanded material safety data sheet in other languages, including Spanish and Vietnamese.
(b) Contents of Expanded Material Safety Data Sheet- An expanded material safety data sheet for a cosmetic or personal care product for professional use described in this section shall--
(1) contain the information required in a material safety data sheet under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations, for each hazardous chemical, or product ingredient associated with any chemical hazard, described in subsection (a)(1)(A)(i)(II); and
(2) include the following statement: `This expanded material safety data sheet is also available in multiple languages by contacting the manufacturer, using the contact information provided on this sheet.'.
H.R. 5786 has been referred to the House Committee on Energy and Commerce and the House Committee on Education and Labor.
GAO Provides Recommendations Regarding EPA's Effort to Regulate Nanomaterials
On Friday, the United States Government Accountability Office issued its Report to the Chairman (Barbara Boxer) of the Committee on Environment and Public Works, US Senate, GAO-10-549:
Nanotechnology: Nanomaterials Are Widely used in Commerce, but EPA Faces Challenges in Regulating Risk.
Highlights from the report follow. The report confirms speculation that EPA intends to issue certain new rules pertaining to select nanomaterials by the end of 2010.
Background
"EPA has taken a mulitpronged approach to understanding and regulating the risks of nanomaterials, including conducting further research and implementing a voluntary data collection program. Furthermore, under its existing statutory framework, EPA has regulated some nanomaterials but not others. Although the EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering into the market without EPA review of all available information on their potential risk. Moreover, EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the statutes include volume based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials."
TSCA
"In the fall of 2009, EPA announced it would reconsider the policy described in its January 2008 document, TSCA Inventory Status of Nanoscale Substances -- General Approach, and subsequently announced it planned to develop a SNUR to regulate nanoscale versions of conventional scaled chemicals that are already on the TSCA inventory as a significant new use of that chemical. The agency intends to propose this rule in December 2010."
"TSCA also gives EPA authority to issue rules requiring companies to submit certain information about chemicals. EPA plans to issue one such rule for nanomaterials that would require manufacturers to provide information on production volume, methods of manufacture and processing, and exposure and release, as well as available health and safety studies. Evaluation of this information will provide EPA with an opportunity to consider appropriate action under TSCA to reduce unreasonable risks to human health or the environment, according to EPA. This rule may also help them collect information on nanomaterials not covered by the SNUR discussed above. EPA intends to propose this rule in December 2010."
"EPA officials told us they intend to propose a rule in December 2010 that would require companies to generate test data on the health effects of 15 to 20 different nanomaterials, including carbon nanotubes, nanoclays, and nano aluminum, and also on nanomaterials used in aerosol-applied products. This information will help EPA correlate the properties of these materials with specific health effects, manage or minimize risk and exposure, and help EPA determine the need for additional testing of these materials, according to EPA. EPA officials told us they will be working with the National Institute for Safety and Health Administration, and the Consumer Product Safety Commission on this effort."
FIFRA
"EPA officials told us that if a company replaces a conventionally sized active ingredient in a pesticide with a nanoscale version of that ingredient, it is mandatory for the company to amend its registration. Officials also noted, however, that the agency's position on this point needs to be made explicit to the regulated community and such a clarification could be made in EPA guidance. According to stakeholders, manufacturers of nanopesticides are required to obtain an amended registration in such a circumstance even without new EPA guidance explicitly requiring it since the registration requirement is based not only on questions of chemical identity, but also on claims made about the pesticide; its composition; and its chemistry, toxicology, and other information."
GAO's Recommendations
"We recommend that the Administrator of EPA, take the following three actions:
- Complete its plan to issue a Significant New Use rule for nanomaterials.
- Modify FIFRA pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.
- Complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.
In addition, the Administrator of EPA should make greater use of the agency's authorities to gather information under existing environmental statutes. Specifically, EPA should
- complete its plan to use data gathering and testing authorities under TSCA to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies; and
- use information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials.
Finally, the Administrator of EPA should consider revising the Inventory Update under TSCA so that it will capture information on the production and use of nanomaterials and so that the agency will receive periodic updates on this material."
EPA's May 4, 2010 Response to GAO
Finally, attached as an exhibit to the report was a written response from EPA in which the agency largely agreed with all of GAO's recommendations. Regarding GAO's Clean Water Act recommendation, EPA stated that its Office of Research and Development is currently developing methods to detect nanomaterials in water and predict levels of concern. Once able to detect and measure nanomaterials in water, EPA will then consider whether reporting requirements should be amended.
We will continue to monitor these issues and provide timely updates to our readers.
Cosmetics, Nanoparticles and FOE-AUS
Friends of the Earth - Australia (FOE-Aus) recently released a new report examining the presence of nanoparticles in cosmetics produced by such well known companies as Revlon, Max Factor, and The Body Shop.
In the press release accompanying the report, FOE-Aus noted that the labeling on cosmetics containers didn't reflect the presence of nanoparticles in the product:
“Of the ten products we surveyed, only one listed the use of nano-ingredients on the label. The government’s failure to require mandatory labeling of nano-ingredients denies women the capacity to make an informed choice about what they put on their skin.”
While this may be a legitimate complaint for the Australian regulatory agencies to consider, FOE-Aus loses much of its credibility by suggesting that the "big cosmetics companies" and nanotechnologies companies view Australian women as "guinea pigs" and by calling for
a stop to sales of cosmetics that contain nano-ingredients, until the safety science catches up, and new laws are introduced to make companies test the safety of their products and to label all nano-ingredients,” said Ms Miller. “We are also calling for public participation in decision making about nanotechnology management”.
Considering the pace of legislation through any parliamentary body tends to be a slow process and that the issuance of regulations affecting labeling of products by the appropriate agencies would also be a long process, FOE-Aus is effectively calling for a moritorium on nano-based cosmetics for an unknown period of time.
It would be one thing if the report released by FOE-Aus supported these claims and demands. However, the report supports nothing at all.
As the report notes under the heading, "A General Note on the Study's Limitations":
This study was conducted with a limited budget and should be considered to be preliminary rather than comprehensive. Only a small number of observations of each sample were made. . . . While observations in this study of certain particle sizes does indicate that they were present in the cosmetics sampled, observations may not be statistically representative of the full sample. (Emphasis added.)
In another section of the report, we find this statement:
. . . the particulates shown are those observed via SEM [ Scanning Electron Microscopy] and may not be representative of the average particle in the analysis. Such statistical analyses are time consuming to perform . . . and furthermore require human assisted particle identification to insure correct results. (Emphasis added)
According to anarticle in the Sydney Morning Herald, the Australian Cosmetic Trade Association has dismissed the report. Considering the limited number of products that were tested - just walk into the "Beauty Aids" section of any CVS and there will be more cosmetics than anyone can count - and the limitations of the testing procedures that were done on them, the report that FOE-Aus presents is a weak base on which to make broad assertions about the safety of those products or to demand the shut down of an industry.
New Edition of Nanotechnology Law Report
New Edition of Nanotechnology Law Report
Inside you will find:
- EPA Considering New Approach to Nanoscale Materials Under TSCA
- EPA May Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA
- EPA Takes Aim at Antimicrobial Products Under FIFRA
- EPA Unveils New Principles for Chemical Management Reform
- EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
- EPA Withdraws Carbon Nanotube SNURs
- Press Release: New Contributing Editor for InterNano
- Virginia CLE presentation: “Insurance, Nanotechnology, and Risk”
- Nanoparticles and Deaths in the People’s Republic
- Sweating the Small Stuff
- Soil Association Cites China Deaths in Renewed Call for Moratorium on Nanotechnology Commercialization
- Nanotechnology Legislation in the 111th Congress
- Mapping Nano
- Flight of the Nanobees
Study of Chinese Print Workers Claims to Provide the First Human Evidence of the Clinical Toxicity of Long-term Nanoparticle Exposures
This article was originally published by the National Nanomanufacturing Network's "InterNano" project (www.internano.com). It is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.
A recent study published in the well-known medical journal, the European Respiratory Journal, has been receiving significant publicity as the authors have claimed their findings support an apparent linkage between workplace exposures to nanoparticles and severe respiratory disease. Specifically, in this study, investigators at China's Capital University of Medical Science related unusual and progressive lung disease in seven Chinese workers, two of whom died, to nanoparticle exposures in a print plant where a polyacrylic ester paste containing nanoparticles was used. This linkage was made by the study investigators despite a general lack of exposure data for the workers.
The complete review is after the jump . . .
Reviewed by Christopher M. Long, Sc.D., and Barbara D. Beck, Ph.D., DABT, FATS, Gradient
While there are cellular and laboratory animal studies that suggest the enhanced toxicity of some engineered nanoparticles (ENP) relative to larger sized particles of the same chemical composition (e.g., carbon nanotubes versus graphite, nano-sized titanium dioxide versus conventional titanium dioxide), there remains no direct human evidence of the health risks posed by ENP. The absence of any epidemiology or medical case studies examining potential ENP exposures and adverse health effects among either workers or consumers is likely a result of several factors. These factors include the fairly recent intensification in ENP manufacturing and commercial application, as well as the fact that relatively small amounts are typically manufactured and handled. The Song et al. (2009) study is a medical case report that claims to provide the first human evidence of "nanomaterial-related disease" following long-term nanoparticle exposure.
This study attributed unusual and progressive lung disease in seven Chinese workers, two of whom died of respiratory failure, to workplace nanoparticle exposures in a print plant where a polyacrylic ester paste containing nanoparticles was sprayed onto a polystyrene substrate, with subsequent heat-curing. For 5 to 13-month durations, all seven employees worked in the same department of the print plant, specifically, in a room with little to no ventilation due to the failure of the mechanical ventilation system. Lacking any measurement data of actual worker exposures, study investigators concluded, based on the detection of 30-nm nanoparticles in the paste material as well as in accumulated dust in the workplace, that these workers were exposed to polyacrylate nanoparticles. Reporting the presence of similarly-sized nanoparticles in the chest fluid and lung cells of the diseased workers, Song et al. highlighted the emerging body of nanotoxicological evidence from animal and in vitro studies to support their conclusion that the observed health effects were due to polyacrylate nanoparticle exposures.
While highly tragic and certain to create a stir among regulators, the media, and the general public, it is important to recognize that this study does more to highlight the critical need to follow well-established industrial hygiene practices than to provide direct evidence in humans of any unique health risks posed by ENPs. This study has several key limitations, including a general lack of information on the exposures experienced by the workers. Given the spraying of a chemical paste and the heating of a plastic material in an enclosed space lacking any mechanical ventilation, it is clear that these workers were exposed to a complex cocktail of chemicals and fumes, in addition to any nanoparticle exposures.
Based on the identification of nanoparticles in the paste, in accumulated dust in the workplace, and in lung tissues and cells of the workers, it is likely that these workers were exposed to nanoparticles in their workplace. However, Song et al. do not provide the necessary materials characterization data to demonstrate that the observed nanoparticles are indeed engineered nanoparticles (i.e., nanoscale particles intentionally created to have nano properties) and to confirm that the nanoparticles observed in the paint paste are the same nanoparticles identified in the workplace dust and in biological samples. Incidental nanoparticles are ubiquitous in indoor and outdoor air from a variety of anthropogenic and natural sources (engine exhaust, metal fumes, secondary organic aerosols), and characterization data are thus needed to confirm that the nanoparticles observed in the dust and in biological samples are indeed polyacrylate nanoparticles.
Given the lack of chemical analysis of the nanoparticles and the workers’ co-exposures to a variety of other toxic substances, it remains highly uncertain to what extent workplace nanoparticle exposures, compared to other workplace exposures, may have contributed to the observed health effects. Further, toxicological evidence cited by the investigators as linking ENP such as carbon nanotubes and zinc oxide with toxic responses in animals and cell cultures is of dubious relevance to polyacrylate nanoparticles, which are unlikely to exhibit similar biological activity due to important differences in toxicologically-relevant properties, in particular chemical composition. Scientific evidence is quite clear that toxicological properties differ greatly among different nanoparticles.
Regardless of the actual role of nanoparticles in the observed health effects, there are important lessons that can be learned from this study. In particular, given the limited knowledge regarding the health and safety risks posed by ENPs, it is imperative that best management practices for workplace exposures be followed to control and minimize potential exposures. It is clear that occasional use of cotton gauze masks, as reported by Song et al. for the Chinese workers, is not an adequate practice for controlling workplace exposures. Fortunately, a number of good resources are available for identifying state-of-the-art nano practices, including the ICON GoodNanoGuide . This study also highlights the critical need for robust exposure assessments to support health effects studies, providing data to characterize key nanoparticle properties and to differentiate ENPs from incidental nanoparticles.
In summary, this study highlights the importance of continued vigilance for any signs of ENP-related illnesses in exposed human populations. However, it lacks the essential materials characterization, exposure, and toxicity data for both the ENP and the other chemicals to which the workers were exposed. Thus, the study is not supportive of the authors' conclusions that ENP exposures underlie the observed health effects among the Chinese workers and that these findings are of relevance to all commercially available ENPs.
New Article: Examples of Recent EPA Regulation of Nanoscale Materials Under the Toxic Substances Control Act
Nanotechnology Law & Business just published our new article on the EPA's recent treatment of nanoscale materials under the Toxic Substances Control Act. An abstract for the article is below and you can find a copy of the article itself here.
Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.
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Nanoparticles and Deaths in the People's Republic
By now, I think that most readers of this blog have either read "Exposure to Nanoparticles is Related to Pleural Effusion, Pulmonary Fibrosis, and Granuloma" by Yuguo Song, Xue Li, and Xuqin Du, recently published in the European Respiratory Journal or any of the news articles based on it, such as this one from Reuters. The paper makes for very sobering reading.
For anyone who hasn't read the article,a brief synopsis is in order:
From January 2007 to April 2008, seven female patients were admitted to Chaoyang Hospital in Beijing. All seven worked in the same department of a printing plant and all seven were suffering from the same symptom - shortness of breath, pleural effusion and pericardial effusion, and were treated with antibiotics and surgery and placed on oxygen to assist their breathing. Five of the women stabilized; two, ages 29 and 19, died of respiratory failure. Further investigations revealed accumulations of nanoparticles in their lungs, nanoparticles that the women had been exposed to for various lengths of time in their workplace.
The authors reached the following conclusion:
. . . it is the nano materials containing nano-sized particles that appear to produce the toxicities seen in the exposed workers.
Therefore, we have more evidence to show that the nano particles contained in the polyacrylate emulsion had possibly caused the disease. There is an indication from this report that shows the possible dangerous nature of nano particles. Nano particles can penetrate the membrane of pulmonary epithelial cells and lodge in the cytoplasm and caryoplasm, as well as aggregate around the membrane of red blood cells and exert toxicity. Patients may develop clinically serious conditions associated with damaged respiratory function including a progressive pulmonary fibrosis that is resistant to several methods of treatment.
Many critics of nanotechnology and nanoindustry may use this study as a basis for calls to end the use of nanoparticles in manufacturing processes or to call for the shutdown of nanoindustries altogether. That is unlikely to happen. Too much time, money and effort has been invested for a shutdown to become a reality. The genie has left the bottle and it's not going back.
Further, as the authors state throughout their article, the women's workplace contributed as much, if not more, to the women's illnesses as the nanoparticles did:
A survey of the patients' workplace was conducted. It measures about 70 square meters. . . has one door, no windows, and one machine used to air spray materials, heat and dry boards. This machine has three atomizing spray nozzles, and one gas exhauster (a ventilation unit) that broke 5 months before the occurrence of the disease.
Accumulated dust particles were found at the intake of the gas exhauster. During the five months preceding illness the door of the workspace was kept closed due to cold outdoor temperatures. The workers . . . had no knowledge of industrial hygiene and possible toxicity from the materials they worked with. The only personal protective equipment (PPE) used on an occasional basis was cotton gauze masks. According to the patients, there were often some flocculi produced during air spraying, which caused itching on their faces and arms. It is estimated that the airflow or turnover rates of indoor air would be very slow, or quiescent due to the lack of windows and the closed door.
In their conclusions, the authors note that
. . . more studies on the possible mechanisms, diagnosis, treatment and prevention of the nano material related disease are needed.
. . . these cases arouse concerns that long term exposure to some nanoparticles without protective measures my be related to serious damage to human beings. . . . Effective protective methods appear to be important in terms of protecting exposed workers from illness caused by nano particles. (emphasis added).
Such future studies as the authors call for may be used as the basis for new and more effective regulation of the nanoindustrial environment, to prevent tragedies such as the deaths of the two young women in this study.
EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
Last Friday, EPA's Office of Research and Development announced in the Federal Register a 45 day comment period for its new draft case study on the use of nanoscale TiO2 in water and sunscreens:
"Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen"
FR 74,146 at 38188 (July 31, 2009). The report focuses on two specific applications of nanoscale titanium dioxide (nano-TiO2): (i) as an agent for removing arsenic from drinking water, and (ii) as an active ingredient in topical sunscreen. The draft report is divided into five chapters:
- Introduction
- Life Cycle Stages
- Fate and Transport
- Exposure - Dose Characterization
- Characterization of Effects
The report is formidable in length, scope, and detail. For those looking for some quick highlights, the report provides a great series of summaries of the existing TiO2 environmental, health, and safety literature. For example:
- Table 4-4 presents an overview of approximately 25 existing TiO2 skin absorption/penetration studies dating back to 1997;
- Table 5-3 provides a summary of nano-TiO2 ecological effects; and
- Tables 5-4 through 5-6 provide a summary of health effects of nano-TiO2 particles in mammalian animal models via dermal, oral, and respiratory exposure routes.
EPA notes that the "document is not intended to serve as a basis for risk management decision in the near term on these specific uses of nano-TiO2." Rather, its focus is on developing necessary data for "future assessment efforts." Specifically, the "document is a starting point to determine what is known and what needs to be known about selected nanomaterials as part of a process to identify and prioritize research to inform future assessments of the potential ecological and health implications of these materials."
Zurich Insurance Unveils New Nanotechnology Exposure Protocol
Zurich North America recently published the June 2009 edition of its Industry Insight online magazine which focuses exclusively on nanotechnology issues. The magazine contains four informative articles which are well worth reading:
- "At the leading edge: Zurich's thought leadership on nanotechnology;"
- "No small thing: The enormous potential of nano;"
- "The kings of small things: The regulatory environment for nanotechnology development;" and
- "Large risks from small things? Myth and reality of nano-risks."
Our readers may be particularly interested in the "leading edge" article in which Zurich describes its nanotechnology emerging risk activities dating back to 2006. The article discusses Zurich's involvement in ANSI's TAG to ISO/TC 229 Nanotechnologies standards and nomenclature group; its ongoing efforts to make sure its voice is heard in the ongoing regulatory debate surrounding certain nanoscale materials; and the formation of a new Zurich Nanotechnology Exposure Protocol™ (ZNEP™).
As Zurich explains, its new ZNEP™ is a risk assessment protocol designed to understand potential nano-related insurance risks:
"By working closely with corporate customers, collecting data on the specific nano-particles they were using, learning about the specific applications where they're employed, and then combining this information, Zurich could form a global overview of nanotechnology and its various facets of risk. Such an activity would not only be a very good way to protect is business, but it could form a basis for providing risk management advice to its customers going forward."
Zurich is working with Seattle-based Intertox to implement its ZNEP™, which it also hopes will dramatically shorten the lag time between discovery of new nanotechnology-based inventions and their insurability. Readers may also recall that Zurich's Director of Emerging Issues recently spoke on insurance issues at the very well-attended Nanotechnology Health and Safety Forum in Seattle, Washington.
New Edition of Nanotechnology Law Report
Here is the Summer 2009 edition of Nanotechnology Law Report. The newsletter contains the below-listed articles (and more):
- EPA Issues Significant New Use Rules for Carbon Nanotubes
- Are Nanoparticles Released by Cutting or Compounding Nano-Composites?
- Annual Nano TiO2 Production Estimated at 44,000 Metric Tons
- Are Nano Consumer Products Headed Underground?
- Oversight of Next Generation Nanotechnology
- Regulating Nanotechnologies
- More Interesting Nano-Regulatory Developments
- Nano Tug of War
- Pumpkins & Nanoparticles
- Green Nano
- NanoBiotech 2009
- Take two silver nanoparticles and call me in the morning
- International Approaches to the Regulatory Governance of Nanotechnology
- ETUC Resolution on Nanotechnologies and Nanomaterials
- Private Spending on Nano Exceeds Government Spending
- EMERGNANO Released
Are Nanoparticles Released by Compounding or the Cutting of Nano-Composites?
Perhaps the most overlooked issue when examining potential nano-related environmental, health, and safety concerns is whether there is any true likelihood of exposure in reasonably foreseeable use scenarios. While there should continue to be extensive toxicity testing for certain nanoscale materials, the most interesting research (from my perspective) relates to potential workplace and/or condumer exposure in realistic settings. We examine two studies along these lines below.
C. Su-Jung et al., "Control of Airborne Nanoparticles Releases During Compounding of Polymer Nanocomposites," 3 Nano: Brief Reports and Reviews 4, 301 - 309 (2008).
This study was conducted by researchers at the National Science Foundation-funded Center for High-Rate Nanomanufacturing at the University of Massachusetts at Lowell. The scientists examined potential nanoparticle release related to the twin-screw extruder compounding of polymer nanocomposites. The test was conducted because "commercial compounding (mixing) of nanocomposites is typically achieved by feeding the nanoparticles and polymer into a twin-screw extruder, the airborne particles associated with nanoparticles reinforcing agents are of particular concern, as they can readily enter the body through inhalation."
The nanoparticles in question were nano aluminum oxide particles acquired from Nanophase Technologies in commercially available form. The particles were spherical in shape and ranged from 27 to 53 nm in diameter. They were also specifically "engineered to form agglomerates with a nominal size of 200 nm."
Regarding the test itself, the scientists fed 2.3kg of polymer pellets and 0.16 kg of nano-alumina particles into a twin-screw extruder for processing and then measured potential nanoparticle release through two measurement techniques: (i) TSI Fast Mobility Particle Spectrometer for real time measurement; and (ii) personal air sampling using a special filter media designed to catch nanoparticles.
The study concluded that "[t]he twin-screw extrusion process for compounding polymer nanocomposites tends to break up nanoparticle aggregates and mechanically disperse particles thoroughly during the extrusion process." The study also found that "[nano]particle diffusion was enhanced by . . . poorly-performing local and general exhaust systems."
Interestingly, for part of the test the scientists applied a nominal engineering control by covering the open top of the extruder feeding tube throat with aluminum foil which they found "dramatically reduced" nanoparticle measurements. They also found that consistently cleaning the lab after each use "reduced laboratory background nanoparticle concentration."
D. Bello et al., "Exposure to nanoscale particles and fibres during machining of hybrid advanced composite containing carbon nanotubes," 11 J. Nanopart Res 231 - 249 (2009).
The researchers in this study investigated whether and to what extent airborne nanoparticles were generated by wet and dry cutting of two hybrid carbon nanotube composites. The dry cutting method employed a diamond coated band saw. The wet cutting was performed using a diamond grit rotary cutting wheel with water lubricating the cutting surfaces during the process. Because the scientists were interested in potential "worst case" scenarios, no vacuum or emission controls were used in tests.
The researchers found that wet cutting did not produce airborne nanoparticle emissions above background levels, but that dry cutting "generated statistically significant quantities of nanoscale and fine particles as compared to background (p<0.05), regardless of the composite type, . . . as expected."
Interestingly, the study also found that "CNTs, either individual or in bundles, were not observed in extensive microscopy of collected samples" for either wet or dry tests.
We will continue to track down and summarize these types of potential exposure studies. Right now, they are few and far between.
Pumpkins & Nanoparticles
Much of the funding and research in nanobiotechnology has been directed at applying nanotechnology toward treating human illnesses and injuries. Dr. Edward Corredor and his collegues looked at something else: plants.
The possibility of targeting the movement of nanoparticles to specific sites of an organism paves the way for the use of nanobiotechnology in the treatment of plant diseases that affect specific parts of a plant. . . .
Recently, our group has applied carbon-coated iron nanoparticles to pumpkin plants in order to develop tools for the directed release of chemicals into plant organs susceptible to infection by pathogens that spefically attack them. . . .
The aim of this work was to analyse the penetration and movement of nanoparticles into plant cells, and the capacity of a magnetic field to retain them in spefic part of the plant.
Dr. Corredo et al's recent article in BMC Plant Biology, "Nanoparticle Penetration and Transport in Living Pumpkin Plants: In situ Subcellular Identification", presents the results of their experiments with pumpkin plants. What the experiments showed was
Only the cells containing the nanoparticle agglomerates exhibited more dense cytoplasms. . . .This fact suggested that the penetration of nanoparticles through the tissues did not damage them.
The presence of nanoparticles in epidermal cells after the application by spraying is of special interest. As stated before, one of the main drawbacks of other methods is that they cannot be employed for agronomic purposes. The method used in this work resembles the procedures which would be used by breeders and coordinators of phytosanitary control, employing both large scale and hand-on spraying to leaf surfaces. The fact that nanoparticles passed through the epidermal cell walls opens up the possible application of these nanotechnology tools for agronomical purposes.
In short, carbon coated nanoparticles could be used to target plant diseases and treat specific areas of the plant, much as the last entry on this site discussed using targeted nanoparticles to treat tumours in the human body. Similarily, magets would be used to guide the nanoparticles to where the diseased area is. It's easy to see how this would benefit farmers: less of their crop would be lost to plant diseases, yielding a higher return on their investment in the form of larger harvests of healthier crops.
Large scale use of targeted nanoparticles is probably a long way down the road, for reasons presented in this article
. . . in order to make the system suitable for agronomical purposes, methodological improvements would need to be made.
And for reasons that are not discussed in the article: (1) the regulatory process, (2) the opposition to wide spread use that would come from various social-political groups, such as Friends of the Earth, which would play out in the media and could create a climate of fear and rejection, such as happened here and in Europe with genetically modified foods, and (3) more testing that would need to be done to see if the nanoparticles would remain in the plants when they are harvested and how such accumulations might affect human or animal health.
Granted, those do lie outside the focus of this article, but they are factors that will need to be considered if the articles results are to become part of the future commericalization of nanobiotechnology.
EPA Issues Significant New Use Rules for Two Nanomaterials
This article, which appeared in the Nov. 17, 2008 issue of Pesticide & Toxic Chemical News, Volume 37, No. 3, was reproduced with permission from Agra Informa. Further use of this article is prohibited without the express written permission of the publisher. For more information about Pesticide & Toxic Chemical News, Food Chemical News or other Agra Informa publications, go to: www.foodregulation.com .
EPA earlier this month announced it is promulgating significant new use rules (SNURs) under TSCA for two nanomaterials — siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles — that were subject to premanufacture notices (PMNs). Some stakeholders view the move as a further sign that EPA is willing to use its authority to regulate nanomaterials, although to what extent remains uncertain.
The rules take effect on Jan. 5, 2009 unless the agency receives critical comments before Dec. 5.
The SNURs are the latest action from EPA on the nanotechnology front. The agency recently issued a consent order for carbon nanotubes (see PTCN, Oct. 20, Page 1). In addition, EPA provided clarification of TSCA requirements for carbon nanotubes last month (see PTCN, Nov. 3, Page 23).
Fewer than 10 SNURs for nanomaterials have been promulgated, according to EPA spokesperson Enesta Jones, but she could not name the materials or when the SNURs had been promulgated because of confidential business information protections.
With the most recent SNURs, anyone who intends to manufacture, import or process either siloxane modified silica nanoparticles or siloxane modified alumina nanoparticles for a significant new use, which includes using either substance without gloves or a respirator and using either substance as a powder, is required to notify EPA at least 90 days before beginning to do so. "The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs," the agency said in a Nov. 5 Federal Register notice.
According to their PMNs, siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles will be used as additives. Based on data from tests of unidentified analogous material and the substances' physical properties, EPA has determined that there are concerns for lung effects from inhalation and systemic effects from dermal exposure. However, the PMNs indicate worker inhalation exposure to the alumina nanoparticles is expected to be minimal, inhalation exposure to the silica nanoparticles is not expected, and dermal exposure to both materials is also not expected.
"Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance[s] may present an unreasonable risk," the agency said in the FR notice. "EPA has determined, however, that use without impervious gloves or a NIOSH-approved respirator with an [Assigned Protection Factor] of at least 10; the manufacture, process, or use of the substance[s] as a powder; or uses of the substance[s] other than as described in the PMN[s] may cause serious health effects."
EPA would have to be notified at least 90 days before anyone began to manufacture, process or use the nanomaterials in such ways.
The agency has also determined that the results of a 90-day inhalation toxicity test would help characterize the human health effects of the two nanomaterials, although the test isn't required.
"Manufacture can occur as long as the manufacturer does not engage in the significant new uses," Jones told Pesticide & Toxic Chemical News via e-mail.
"[The 90-day inhalation toxicity test] is the test EPA recommends to be conducted to address health concerns cited in the SNUR. In other words, if a manufacturer wants to engage in the new uses or have EPA modify or revoke the SNUR, then conducting these tests could help EPA change its original findings."
The 90-day inhalation study is the same study that is required under the recently issued carbon nanotube consent order. But the study is not designed for determining chronic effects or for nanomaterials, according to John Monica, head of the nanotechnology practice group at the law firm of Porter Wright Morris & Arthur.
Monica told PTCN that EPA can recommend alterations to a study to make it more relevant for a specific material, and in fact did so for the inhalation studies requested in some of the other non-nanomaterial SNURs also announced in the Nov. 5 FR notice.
The SNURs and consent order are a "great opportunity" to get testing done on nanomaterials, but EPA needs to sit a group of experts down to determine how chemical test guidelines need to be modified for nanomaterials, Monica said. "During the request for comments [on the SNURs], someone will raise or should raise the issue."
Monica added he would expect someone to ask EPA to identify the analagous materials and test data it used to determine there are concerns for certain effects.
The SNURs, consent order, and carbon nanotube notice indicate what EPA has maintained all along — that EPA has the authority to regulate nanomaterials under TSCA and is willing to use it, Monica said.
Betsy Mason, an associate in the law firm Goodwin Procter's Environmental and Energy Practices, echoed Monica, telling PTCN that EPA's recent actions show "the agency is willing — perhaps more now than previously — to use the different legal tools available to it under TSCA Section 5 to regulate nanomaterials."
But Mason also noted that it isn't yet clear whether the agency is shifting away from relying on voluntary industry efforts like the Nanoscale Materials Stewardship Program to "bona fide regulation and enforcement" or if it's using the SNURs and consent order as a supplement to encourage more volunteers to participate in such initiatives.
"In either case, I think it's reasonable to expect that EPA will issue more nano-related consent orders and more nano-related SNURs in the future," she said.
U.K. commission urges testing
While EPA is starting to use some of its regulatory powers to address the potential risks of nanomaterials, the United Kingdom's Royal Commission on Environmental Pollution is urging quick action on testing and regulating nanomaterials in a report published Nov. 12.
The commission, which is appointed by the Queen and funded by the government, publishes in-depth reports on critical environmental issues. In its current report, "Novel Materials in the Environment: The Case of Nanotechnology," the commission finds no evidence of harm to human health or the environment from nanomaterials.
"However, it is very early in the development of this technology, and the amount of testing has been relatively limited," the commission said in a statement. "We are aware that laboratory tests on some nanomaterials suggest that they have properties which could cause concern. This strengthens our case for an increase in the amount and type of testing to assess whether these theoretical risks are real, and to monitor their behavior in the environment."
Furthermore, this research has to be done "on a more systematic and strategic" basis, which includes evaluating methods for predicting the fate and effects of nanomaterials, better understanding of the principles that determine nanomaterial toxicity, and enhancing nanomaterial monitoring and surveillance methods, the commission says in its report.
As for the U.K. government, the commission recommends that any revisions to existing regulations should be focused on the properties of nanomaterials, not their size. "Since these properties and functionalities will often differ substantially from those of the bulk material, strict chemical equivalence does not preclude the need for a separate risk assessment," the report says. Furthermore, the government should prioritize testing, starting with those materials with properties suggesting they pose a risk to human health or the environment. The government should also require companies to report any "reasonable suspicion" that a nanomaterial poses a risk "at the earliest opportunity."
The commission's report is available at www.rcep.org.uk/novelmaterials.htm.
— Liz Buckley elizabeth.buckley@informa.com
Existing Respirator Materials Prove Effective For Certain Nanoparticles
At this morning's session of the International Conference on Nanotechnology Occupational & Environmental Health & Safety in Cincinnati, Ohio, Daniel Japuntich, Division Scientist at 3M, presented "Filtration and Respirators: Current Knowledge." Japuntich shared 3M's research findings indicating HEPA respirator materials are effective in filtering nanoparticles down to three (3) nanometers in size.
The 3M research found nanoparticles act as solids, "obey the laws of physics," and fit nicely within existing filtration models. Thus, Japuntich concluded existing NIOSH respirator standards under 42 CFR 84 should be sufficient for many nanorelated uses. Japuntich noted the efficacy of filter materials must be evaluated in the context of a complete workplace respirator program including hazard measurement and assessment, face-piece choice, face fit testing, and worker training programs.
Another conference presentation by Michele Ostraat, a Research Engineer at DuPont, discussed similar findings by the Nanoparticle Occupational Safety and Health Consortium. Ostraat spoke regarding the Consortium's recent aerosol chamber research studies on a variety of respirator material using six different types of nanoparticles. Ostraat posed that, while existing respirator material proved effective for nanomaterials, filter efficacy for nano-aerosols decreases as exposure time increases in certain instances. The Consortium intends to publish several papers in 2007 setting forth its research findings in detail. Ostraat also explained the Consortium's parallel goals of making consistent nano-aerosols for research purposes (which it has already accomplished), and creating a reliable, inexpensive, portable, nanoparticle measuring device (which it hopes to unveil by mid-2007).
First EPA Regulation Of Nanotechnology?
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.
Report by Former FDA Official Urges Greater Regulation of Nanoindustry
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.
Review: "Nanotechnology and the FDA," in Nanotechnology Law & Business
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.
[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.”
