Showing posts with label nanoparticle. Show all posts
Showing posts with label nanoparticle. Show all posts
,

Inadequate regulation of nanotech in food and farming?

Thursday, July 19, 2007

ABC reported that nano-agrifood industry will be worth more than US$20 billion by 2010, with giant companies like Syngenta, Monsanto, Kraft Foods and Heinz probably investing.

There could be a significant market for "nanopesticide". The emulsion from Nano-sized versions of pesticide molecules are more stable, more toxic to pests and better absorbed into plants, however, at the same time could also pose new risks to humans or the environment.

The ability for nanoparticles to penetrate the surface of plants may mean they also penetrate into edible parts of the crop and their ability to dissolve may create new kinds of contamination in soils, waterways or the food chain.

 

, , , ,

EPA's Nano Program -- open for public comment

Saturday, July 14, 2007

EPA has issued Federal Register (FR) notices seeking public comment on a concept paper and other materials related to its Nanoscale Materials Stewardship Program.

The debate still hovers around the issue if nanomaterials are to be considered as a 'new' material under the TSCA. J.C. Davies said:
“The agency’s current practice is inadequate to deal with nanotechnology. It is essential that EPA move quickly to recognize the novel biological and ecological characteristics of nanoscale materials. It can do this only by using the ‘new uses’ provisions of TSCA, a subject not mentioned in the EPA’s inventory document. With the approach outlined by EPA and because of the weaknesses in the law, the agency is not even able to identify which substances are nanomaterials, much less determine whether they pose a hazard.”
EPA also issued papers for public comment on Nanoscale Materials Stewardship Program (NMSP)—in order to encourage industry to provide a voluntary scientific information about the risk management practices currently applied.

The EPA's official website on the program is here. Project on Emerging Nanotech website containing a March 2007 Report (titled Nanotech: Oversight for 21st Century) plus a webscast is available here. To get a glimpse on the application of TSCA to nanomaterials, read a March 2007 paper from Lynn L Bergeson here. You might also want to read Scott Deatherage's discussion in his blog on this issue here.

H.T: Gregor Wolbring

 

, , , ,

EU's "incrimental approach" in regulating nanomaterials

Thursday, June 28, 2007

We've had discussions on the Berkeley's regulation and I have posted some articles on EU's REACH. Here's an article explaining existing EU's regulatory infrastructure applicable to nanomaterials/nanoparticles and its weaknesses:
The European Commission has adopted a so-called ‘‘incremental approach’’, which focuses on adapting existing laws to regulate nanotechnologies, and therefore this paper aims to test the effectiveness of the ‘‘incremental approach’’. Three commercially available products containing fullerenes (C60 and carbon nanotubes) were analysed in a life cycle perspective in order to (1) map current applicable regulations, (2) analyse their applicability to nanomaterials, (3) identify their gaps, and (4) suggest proper solutions.
Read the full paper here.

My general observation: the paper still based itself on "emission" paradigm. Thus, the playing field is in the lowering of permissible emission. An important point here is that the paper suggested "free nanoparticles" to be exclusively categorized under the REACH and that it should be specifically registered. Interestingly, the paper recommends bottom-up nanoparticle to be regarded as "new substance".

 

, ,

Environmental Defense and Du Pont Launched Nano Risk Framework

Tuesday, June 26, 2007

Webcast of the Nano Risk Framework is available at the Woodrow Wilson International Center for Scholars here.

Here's a glimpse of the "Framework":

The Nano Risk Framework is designed to be a comprehensive, practical and flexible tool for documenting and communicating the steps a user has taken to evaluate and address potential risks of nanoscale materials. The Framework offers guidance on the key questions an organization should consider in developing applications of such materials, and on the critical information needed to make sound risk evaluations and risk management decisions.

 

, , , , ,

Precautionary Principle Urged (Again?)

Friday, June 15, 2007

A news from the EU (but it turned out to be not so new):
"Current scientific risk-assessment methods [for nanomaterials] are really not reliable. We don't have the knowledge. Nanomaterials are so small and reactive and we don't have natural defences in the body against them," said Eva Hellsten, from the Commission's DG Environment, Directorate Water, Chemicals and Cohesion.
EU are still debating as to whether nanomaterials/nanoparticles would be sufficiently regulated in its REACH directive. To sum up, their position on regulating engineered nanoparticles remans the same:
1. IS REACH enough or not?
2. We don't have "sufficent knowledge"
3. More money required for research
4. Precautionary Principle vs 'non' Precautionary Principle

So in this part of nanotech regulation, there is really nothing new in any part of the world. Boring!

 

, , , , ,

Some good points on regulating the unknown

Saturday, February 24, 2007

This article from R.F.Wilson deserves a review:
This article examines our emerging knowledge base about the hazards of nano-sized particles (NSPs), focusing on risks posed by two types of exposure, inhalation of NSPs and topical application of products containing NSPs. It examines why the current regulatory framework is inadequate to respond to these risks and why regulators believe their hands are tied until new legislation is enacted. It then argues that this regulatory inaction leaves a significant role for the private insurance market, but that regulators should support this market in tangible ways, such as requiring federal grant recipients to carry commercial liability policies that would protect the public from potential adverse consequences
I still don't think that current research results on nanotoxicity is conclusive enough to start underwriting. A very limited underwriting agreement can be applied I guess. Swiss Re wrote a good report on the case, downloadable here.

 

, , , ,

Weak regulation on cosmetics a time bomb

Thursday, February 22, 2007

Voluntary regulatory system in US cosmetic industry can be a time bomb:
Now, new nanotechnologies are being widely deployed in cosmetics products, despite evidence of serious potential health risks. Moreover, the physical application of some of the nanotechnologies to the body in cosmetics makes these uses uniquely prone to skin penetration, inhalation and ingestion of the nanotech materials.

List of cosmetics using nano products:
  • Penetration enhancer - Encapsulating or suspending key ingredients in so-called nanospheres or nanoemulsions, increases their penetration into the skin
  • L’Oreal (which ranks No. 6 in nanotechnology patent holders in the U.S.) 75 has used polymer nanocapsules to deliver active ingredients, e.g. retinol or Vitamin A, into the deeper layers of skin. In 1998 the company unveiled Plentitude Revitalift, an anti-wrinkle cream using nanoparticles.
  • Freeze 24/7, a new anti-wrinkle skincare line is planning to incorporate nanotechnology in future products.
  • La Prairie’s product, the Dollars 500 Skin Caviar Intensive Ampoule Treatment, claims to minimize the look of uneven skin pigmentation, lines and wrinkles in six weeks using nanotechnology. La Prairie’s vice president of retail marketing and training, Holly Genovese, says the nanoemulsions in the product “optimize the delivery of functional ingredients into the skin and allow these materials to get to the site of action quicker”.
  • Procter & Gamble’s Olay brand was designed with nanoemulsion technology in 2005.
  • Other companies using nanotech in their skin products as of 2005 include: Mary Kay and Clinique from Lauder; Neutrogena, from Johnson & Johnson; Avon; and the
  • Estee Lauder brand.
  • Hair products – using nanoemulsions to encapsulate active ingredients and carry them deeper into hair shafts.
  • PureOlogy began experimenting with nanoemulsions in 2000 when the company’s founder set out to create a product line especially developed for color treated hair.Sunscreens – the zinc and titanium in sunscreens are “micronized”, making them transparent, less greasy, less smelly and more absorbable into the skin.
  • DDF planned more nanotech-enhanced anti-aging products as of 2004.
  • Colorescience markets a product named Sunforgettable, a powder which contains titanium dioxide nanoparticles.
  • Paris-based Caudalie launched its Vinosun Anti-Aging Suncare, a sunscreen and anti-aging treatment that relies on “nanomized” UV filters and antioxidants, in the US in 2003.
I guess although the heading is "cosmetic", when nanoproducts are used, examination mechanism shall not be voluntary. Download IEHN report here.

 

, , , , , ,

Update on Berkeley Nanotech Regulations

Friday, February 2, 2007

This is to update my analysis on Berkeley Nanotechnology Regulations in the previous post. On the December 2006 post, I suggested this interpretation:
  1. The duty is to report, no more, no less
  2. There are no exact standard as to the form of the report
  3. General minimum disclosure standards may apply. Producers shall disclose anything within the boundaries of their present knowledge. Non disclosure may arise civil liability
  4. It only applies to "manufactured" nanoparticles produced in the Jurisdiction of the city of Berkeley. That means, natural nanoparticle or nanoparticle resulting from side-reaction could be exempted from this regulation. This could also mean that nanoparticles being imported to Berkeley is outside the scope of this regulation
  5. The city cannot ban production and sale of nanoparticles by simply basing itself on the regulation. These are EPA's authority
  6. The regulation does not regulate nanotechnology as a whole! It only regulates nanoparticle. Obviously, nanostructures are exempted from this regulation
  7. There could be problems with regards to the definition of "nanoparticle"
With regards to point #2, I have obtained information that the standard reporting forms are currently being reviewed by industry and other stakeholders. So there might be a standard form of reporting. With regards to point #3, the report might need to be reviewed by an independent third party, a professional toxicologist or CIH, and this constitute a part of the reporting form. My interpretation is inaccurate with regards to point #4. Importation of nanoparticle to Berkeley will be subjected to the reporting obligation. With regards to point #6, nanostructures may be subjected to reporting obligation if one of their axis is 100 NM or smaller (fit the definition of "nanoparticle").

Preliminary observation on the regulation will be based on this report (pdf).

I agree with Mr. Hadithy that these precautionary approaches are required to protect the society from unknown harm. There is really nothing unusual with respect to the regulation, it is no different than normal chemical legislation which also require disclosure. The only differences is that this one is applied to nanoparticles. As have been discussed in my other posts, there is inconclusive research result on the harmful effect of nanoparticles to human.

Cambridge is also planning to follow Berkely in regulating Nanotechnology:
COUNCILLOR DAVIS
WHEREAS: The use of subatomic materials as microscopic building blocks for thousands of consumer products has turned into a big business so quickly that few are monitoring nanotechnology’s effects on health and the environment; and
WHEREAS: The city of Berkeley, California, has amended the hazardous materials section of its Municipal Code in order to monitor those impacts; now therefore be it
ORDERED: That the City Manager be and hereby requested to examine the nanotechnology ordinance for Berkeley, California, and recommend an appropriate ordinance for Cambridge.
The document of the Cambridge Civic Council Meeting is available here. It has also been in the reported in the news:
Cambridge, Mass. is considering becoming the second city in the country to regulate nanotechnology-- the science of building devices at the molecular scale -- a month after Berkeley, Calif. became the first.
(Note: Boston Business Journal's definition of nanotech above appears to depict molecular manufacturing, this could be misleading with regards to the regulation of nanoparticles)

I have one more question. Supposed the City found that certain nanoparticle have a "med" or "high" risk, what will it attempt to do?

(Many Thanks to: Nabil A Al Hadithy, Secretary CEAC)

 

, , ,

REACH directive in force this June

Sunday, January 7, 2007

European Commission announced that the REACH Directive will be in force in June 2007. According to the Commission in its website "The new regulatory framework will improve the protection of human health and the environment by identifying the properties of chemical substances earlier and more accurately. Particular attention is given to the most toxic properties which cause cancer, infertility in men and women, genetic mutations and birth defects. The new approach is likely to improve the innovative capability and competitiveness of the EU chemicals industry."

REACH -- after some modification -- might be applied to Nanotechnology. However, to date there has been no official announcement from the EU that REACH will govern nanoparticles and nanomaterials.

The factbook on REACH is downloadable here, the summary of the legislation is available here.

 

, , ,

The so-called Berkeley Nanotechnology Regulation

Thursday, December 28, 2006

The famous first-in-the-world Nanotechnology Regulation of the City of Berkeley took effect last week. Curious on what the law actually contains? Take a peek:
15.12.040 Filing of disclosure information.
I. All facilities that manufacture or use manufactured nanoparticles shall submit a separate written disclosure of the current toxicology of the materials reported, to the extent known, and how the facility will safely handle, monitor, contain, dispose, track inventory, prevent releases and mitigate such materials.

15.12.050 Quantities requiring disclosure.
C. The following disclosure requirements shall apply in addition to those in subsections A and B of this section:
7. All manufactured nanoparticles, defined as a particle with one axis less than 100 nanometers in length, shall be reported in the disclosure plan.
That's it. Simple right? Nothing's special at all, the regulation only imposes a duty to report the toxicology features of nanoparticles being manufactured. Here's my analysis:
  1. The duty is to report, no more, no less
  2. There are no exact standard as to the form of the report
  3. General minimum disclosure standards may apply. Producers shall disclose anything within the boundaries of their present knowledge. Non disclosure may arise civil liability
  4. It only applies to "manufactured" nanoparticles produced in the Jurisdiction of the city of Berkeley. That means, natural nanoparticle or nanoparticle resulting from side-reaction could be exempted from this regulation. This could also mean that nanoparticles being imported to Berkeley is outside the scope of this regulation
  5. The city cannot ban production and sale of nanoparticles by simply basing itself on the regulation. These are EPA's authority
  6. The regulation does not regulate nanotechnology as a whole! It only regulates nanoparticle. Obviously, nanostructures are exempted from this regulation
  7. There could be problems with regards to the definition of "nanoparticle"
So, those are the analysis. Really-realy nothing special. I wonder why it had been such a big fuss. By the way, you can download the draft regulation yourself here. Let me know if your analysis are different than mine.


Any information contained herein is intended as a general discussion on legal and other corresponding issues. Tips and advices given on these issues do not constitute legal advice or a legal opinion. You shall seek independent counsel to act upon any laws discussed in this weblog.

ATTENTION: This post has been updated here.