EU's "incrimental approach" in regulating nanomaterials

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

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.

Your Nanotechlaw Reading List

1. ITAR-TASS

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   MOSCOW, June 4 (Itar-Tass) -- A drat law authorising the creation of a nanotechnology corporation in Russia has been submitted to the State Duma.

   to nanotechnology+law russia ... on june 07

2. Meridian Institute Nanotechnology and Development News

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   A draft law has been submitted to the State Duma, Russia’s lower house of parliament, authorizing the creation of a state-run nanotechnology corporation that will “seek to implement scientific, technological and innovation policies, and facilitate the

   to nanotechnology+law russia ... on june 07

3. Nanotechnology Law Framework

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   to nanotechnology+law ... on june 02

4. Nanotechnology, Privacy and Shifting Social Conventions

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   Nanotechnology promises (or perhaps threatens) to change the way we live. Like other novel technologies, nanotechnology will allow us to do new things, and so will present us with new choices. Importantly, nanotechnology may also influence the very values

   to nanotechnology+law health+law custom ... on may 30

5. nanotechnology regulation

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   http://nanotechlaw.blogspot.com/2006/12/so-called-berkeley-nanotechnology.html (viewed 15/01/07). 44 DEFRA “Voluntary Reporting Scheme for engineered ...

   to nanotechnology+law ... on may 26

6. Workplace Exposure To Nanomaterials and The Question Of Will Nano Be The Next Asbestos

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   Workplace Exposure To Nanomaterials and The Question Of Will Nano Be The Next Asbestos Topics Covered Background Insurers Nanotechnology Safeguards Commercial Products Evidence Of Probable Harm Associated With Workplace Exposure To Nanomaterials Diseases

   to nanotoxicity workplace regulation nanotechnology+law environmental+law health ... on feb 28

7. Nanotoxicology at the University of Florida

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   Even those skilled in particle characterization face difficult challenges when faced with nanomaterials in the physiological environment. Schemes for dispersion such as changes in pH or the use of dispersion aids are difficult to implement in the body wi

   to nanotechnology+law nanotoxicity environmental+law ... saved by 1 other person ... on feb 07

8. Opinion on the ethical aspects of nanomedicine

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   What are the challenges for future laws and regulations? The challenges are primarily: - the risk evaluation for nanomedicine may not be adequate in all areas; - the implementation of risk evaluation measures should be carried out in a scientifically soun

   to nanotechnology medicine nanomedicine health eu+law law nanotechnology+law ... on feb 02

9. Growing nanotechnology problems: navigating the patent labyrinth

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   Nanowerk News) Carbon nanotubes (CNTs) belong to the most exciting nanomaterials discovered so far and the buzz associated with them has to do with their amazing properties. Depending on their structure, they can be metals or semiconductors. They exhibit

   to nanotechnology+law patent carbon+nanotube ... on jan 31

10. Scientific Technology Options Assessment - STOA (Important links for eu nanotech law)

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    The social and political relevance of nanotechnology and its applications are beginning to crystallise. Citizens will be confronted with nanotechnology applications at work, as consumers, or through the possible effects on the environment, public health a

    to eu eu+law nanotechnology+law nanotechnology+regulation parliament environmentregulation ... on jan 17

11. Nanotechnology and Regulation within the framework of the Precautionary Principle

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    Some elements of the Precautionary Principle exist in different regulation approaches. The regulation of Chemicals especially the proposal of the REACH regulation as well as the regulation of pharmaceuticals are examples for a precautionary approach with

    to eu nanotechnology+law nanotechnology+regulation environmental+lawprecautionary+principle ... on jan 17

12. Article on Intellectual Property - 12 JAN.pdf (application/pdf Object)

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    The challenges in the nanotechnology intellectual property arena are numerous. The battles have moved from

    to nanotechnology+law patent ipr toblog ... on jan 13

13. Search

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    Nanotechnology and the United States National Plan for Research and Development in Support of Critical Infrastructure Protection Lisa Campbell Canadian Journal of Law and Technology Volume 5, Number 3, November 2006 December 29, 2006 TOC Harmonization of

    to nanotechnology+law nanotechnology+regulation ... saved by 3 other people ... on dec 30

14. 2006-12-05 Item 13 Manufactured Nanoparticle Health and Safety Disclosure.pdf (application/pdf Object)

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    AMENDING BERKELEY MUNICIPAL CODE (BMC) SECTION 15.12.040 TO ADD SUBSECTION I AND AMENDING BMC SECTION 15.12.050 TO ADD SUBSECTION C.7, REGARDING MANUFACTURED NANOPARTICLE HEALTH AND SAFETY DISCLOSURE BE IT ORDAINED by the Council of the City of Berkeley a

    to nanotechnology+law berkeley nanotechnology+regulation environmental+law ... on dec 28

15. Environmental Regulation of Nanotechnology : Some Preliminary ...

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    Environmental Regulation of Nanotechnology:. Some Preliminary Observations. by Glenn Harlan Reynolds. T. he relationship between new technologies and the en .

    to nanotechnology+law nanotechnology+regulation environmental+law ... on dec 28

16. Nanotechnology & Regulation

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    “Environmental Regulation of Nanotechnology: Some Preliminary ... conclusion, and a critical one, is that nanotechnology regulation is a process

    to nanotechnology+law nanotechnology+regulation ... on dec 28

17. REGULATORY CONSIDERATIONS FOR NANOTECHNOLOGY IN PUBLIC HEALTH

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    to nanotechnology+law health+law nanotechnology+regulation ... on dec 26

18. Regulations for Nanotechnology in Consumer Products

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    to eu+law consumer+protection nanotechnology+law nanotechnology+regulation ... on dec 26

19. globeandmail.com: The promise and perils of nanotechnology

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    to nanotechnology+law nanotechnology+regulation nanotoxicity, environmental+law ... on dec 23

20. Nanotech NIOSH to Issue Guidance for Employers

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    "The presence of an occupational health surveillance program – represented at the minimum level as a needs assessment – indicates that workplaces have taken appropriate steps in evaluating and preventing potential occupational exposures," Trout said l

    to niosh osha nanotechnology+law nanotechnology+regulation ... on dec 16

21. Nanotechnology Policy and Environmental Regulatory Issues

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    to nanotechnology+law environmental+law ... on dec 11

22. Reproductive Rights Blog: Liquid Condom Introduced in China

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    to nanosilver nanotechnology+law china condom health+law ... on dec 07

23. Chinese float liquid condom concept | The Register

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    to china design health product science sex toblog condom nanotechnology+law nanosilver ... saved by 23 other people ... on dec 07

24. The Volokh Conspiracy - Regulating Nanosilver:

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    to nanotechnology+law nanosilver environmental+law ... on dec 07

25. EPA Region 5: Federal Insecticide, Fungicide, and Rodenticide Act

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    to fifra pesticide environmental+law epa nanotechnology+law nanosilver ... on dec 07

26. Deciding the Future of Nanotechnologies: Legal Perspectives on ...

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    to nanotechnology+law nanotechnology+regulation ... on dec 07

27. Legal Lookout: Nanotechnology : EPA Considers How to Proceed

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    to epa nanotechnology+law nanotechnology+regulation environmental+law ... on dec 07

28. EUROPA - Rapid - Press Releases

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    to nanotechnology+law nanotechnology+regulation risk eu+law ... on dec 04

29. REACH is not enough, new labelling method might be required

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    to nanotechnology+law nanotechnology+regulation nanotechnology nanotoxicity eu+lawreach chemical ... on dec 04

30. Section Nanotechnology Project - Nanotechnology Law - ABA Section of Environment, Energy, and Resources Law

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    aba's briefing paper in nanotech

    to nanotechnology+law aba ... saved by 1 other person ... on dec 01

31. European Union Nanotechnology Law | Stanford Law School

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    to eu+law nanotechnology+law ... on nov 23

32. P6_TA-PROV(2006)0392

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    european parliament action plan on nanotech

    to eu+law nanotechnology+law ... saved by 1 other person ... on nov 21

33. Nanotech the IP issues

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    For example, a paper from Lawrence Letham which highlights general legal issues relating to nanotech, a general IP trend on nanotech from Chemical and Engineering magazine, Nanotech patent application in Japan from D. Kanama, Nanotech patent trends by Kal

    to nanotechnology nanotechnology+law patent ipr ... on nov 20

34. Berube on Michael Taylor's analysis

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    Everyone knows the FDA is missing tools for regulating cosmetics like it does drugs. And everyone knows the FDA needs a bigger budget if we are going to ask it to treat all nanoproducts it regulates as "new" rejecting the bio-equivalence fast lane. We kno

    to nanohype fda drugs nanotechnology+law ... on nov 15

35. Nanotechnology under the Toxic Substances Control Act | Prevention, Pesticides and Toxics (OPPTS) | US EPA

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    to epa tsca environmental nanotechnology+law ... on oct 29

36. Connotea: msredsonyas's bookmarks for http://www.epa.gov/oppt/nano/index.htm

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    to nanotechnology+law tsca epa environment ... on oct 29

37. FDA needs industry support on nanotechnology

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    to fda health+law nanotechnology+law ... on oct 10

38. Let practicality guide nanotechnology regulation

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    to nanotechnology+law nanotechnology+regulation ... on sept 15

39. Nanotech-Regulation.pdf (application/pdf-Objekt)

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    to nanotechnology+law ... on sept 15

40. Patenting Nanotechnology - an Overview of the Current Climate and Explanation of Classification 977

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    to nanotechnology ipr patent nanotechnology+law ... on sept 12

41. The Journal of Philosophy, Science & Law - Nano-Conceptions

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    to nanotechnology+law ... saved by 1 other person ... on sept 10

42. OnPoint -- 03/01/2006 -- Nanotech: RFF's J. Clarence Davies explains the need for new nanotechnology law

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    to nanotechnology+law ... on sept 10

43. SSRN Electronic Library

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    ssrn page on nanotech

    to nanotechnology regulation nanotechnology+law ... saved by 26 other people ... on sept 08

44. SSRN-International Regulatory Regimes for Nanotechnology by Kenneth Abbott, Sandeep Gopalan, Gary Marchant, Douglas Sylvester

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    to nanotechnology+law ... on sept 06

45. Blawg Republic News Search: nanotechnology

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    to be reviewed and discussed on the blog

    to nanotechnology+law ... on sept 06

46. WorldChanging: Tools, Models and Ideas for Building a Bright Green Future: Nanotechnology and the Developing World: The Regulatory Gap

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    regulatory gap

    to nanotechnology+law ... saved by 2 other people ... on aug 18

47. SciDev.Net

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    regulatory gap in nanotech

    to nanotechnology+law ... on aug 18

Precautionary Principle Urged (Again?)

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!

Synthia's Patent Application at the USPTO

For those of you who are curious, here's a link to Venter Institute's "synthetic life" patent application at the USPTO:

The present invention relates, e.g., to a minimal set of protein-coding genes which provides the information required for replication of a free-living organism in a rich bacterial culture medium, wherein (1) the gene set does not comprise the 101 genes listed in Table 2; and/or wherein (2) the gene set comprises the 381 protein-coding genes listed in Table 3 and, optionally, one of more of: a set of three genes encoding ABC transporters for phosphate import (genes MG410, MG411 and MG412; or genes MG289, MG290 and MG291); the lipoprotein-encoding gene MG185 or MG260; and/or the glycerophosphoryl diester phosphodiesterase gene MG293 or MG385.

Patenting new lifeforms: more than just Harvard Mouse Part II

"For the first time, God has competition," adds Pat Mooney of ETC Group. "Venter and his colleagues have breached a societal boundary, and the public hasn't even had a chance to debate the far-reaching social, ethical and environmental implications of synthetic life," said Mooney

Harvard Mouse Part one was a collaboration between Harvard and Du Pont to create a gene that can make mouses susceptible to cancer. USTPO granted the patent application but both Canada and Europe rejected it as they deem it contrary to the the public ordre.

Now we have another patent application from the Venter Institute. A new bacteria not previously existed on the nature. So this is more than just the Harvard Mouse, I suppose there is a new set of 'novelty' being offered here.

The problem is, if we patent the lifeform, the descendant and its variant may be subjected to ownership of the patent owner, I mean, the genetic information. ANother problem entangled with this patent application, the ETC said, is its environmental concerns:

Action Needed: Before syns are allowed to go forward, society must debate whether they are socially acceptable or desirable: How could their accidental release into the environment be prevented or the effects of their intentional release be evaluated? Who will control them, and how? How will research be regulated? In 2006 a coalition of 38 civil society organizations called on synthetic biologists to withdraw proposals for self-governance of the technology.

ETC group is trying to block this patent application for public ordre reasons:

ETC is also writing to WIPO and the U.S. PTO, asking them to reject the patent on the grounds that it is contrary to ordre public (public morality and safety). Later this month ETC Group will attend Synthetic Biology 3.0 (an international conference of synthetic biologists) in Zuerich, Switzerland June 24-26 where it will call upon scientists to join in a global dialogue on synthetic biology. ETC will organize meetings with governments and civil society during the upcoming scientific subcommittee meetings of the UN Convention on Biological Diversity (CBD) in Paris, July 2-6, in order to discuss the implications of the creation of synthetic life forms for the Biodiversity Convention and for its protocol on biosafety. ETC Group will convene a global meeting of civil society actors on this and related issues within the next year.

Compliance towards Berkeley's Nano Regulation

From the Berkeley Daily Planet:

By the June 1 reporting date the only business following the formal reporting procedure was Bayer Laboratories, according to Toxics Manager Nabil Al-Hadithy. The other two local users of the technology, UC Berkeley and the Lawrence Berkeley National Laboratory (LBNL) responded, but did not include the specific data required by the ordinance.

“I am especially disappointed because LBLN has been engaged in the process [of writing the reporting procedures] for two years and has failed to implement it,” Al-Hadithy said.

The policy requires companies working with engineered nanoparticles—materials one of whose axes is 100 nanometers or less (a nanometer is one-trillionth of a meter)—to submit a report disclosing the toxicology of the nanoparticles used and “how the facility will safely handle, monitor, contain, dispose, track inventory, prevent releases and mitigate such materials,” says the city ordinance.

For my previous post on this issue and my discussion with N. Hadithy with regards to the content of the Berkely regulation, click here and here.

Copyright on the 21st Century: Brussel Copyright Summit 2007

Larry Lessig gave a talk at Brussel's 2007 Copyright Summit. He explained the "sharing" characteristic of the 21st Century internet economy. The video quality is not so good, but in general it is OK.

Nanotechnology shifts social convention

That was explained by Chris Mac Donald in his Health Law Review paper. Here's a quote:

Cheap, high-quality, unobtrusive surveillance equipment of the kind promised by nanotechnology is likely to lower the costs, and increase the benefits, of invading other people’s privacy. We can reasonably expect that the availability of such technology will make it harder to maintain current privacy conventions. You and your neighbours may thus become tempted to shift from a pattern of behaviour under which you both respect each other’s privacy to a pattern under which you both invade each other’s privacy. After all, you’re both likely at least to be tempted to eavesdrop or sneak a peek, once in a while; and besides (or so you may reason), if your neighbour is likely snooping, why shouldn’t you too? Nanotechnology, then, may work to corrode extant social conventions – ethically useful social standards – associated with privacy.

Read the full paper yourself here.