Showing posts with label health. Show all posts
Showing posts with label health. Show all posts
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Indonesia: Turning Critics into Criminal (HRW 2010 Report)

Wednesday, May 19, 2010

 

The HRW 2010 report released earlier this May focused on Indonesia’s defamation law. According to the Human Rights Watch’s press release:

The 91-page report, "Turning Critics into Criminals: The Human Rights Consequences of Criminal Defamation Law in Indonesia," documents recent cases in which criminal libel, slander, and "insult" laws have been used to silence public criticism. Criminal defamation charges have been filed against individuals after they held public demonstrations protesting corruption, wrote letters to the editor complaining about fraud, registered formal complaints with the authorities, and published news reports about sensitive subjects.

In an SMH op-ed published today, the author of the report argue:

Not everyone in Indonesia who airs critical facts or opinions ends up accused of a criminal offence. But the arbitrary enforcement of such laws, and even the mere threat of enforcement, has a damaging chilling effect on civil society, the media, and private citizens' willingness to express critical thoughts or opinions, especially online.


The cover page of the report pictured Prita Mulyasari, the housewife sent to trial under the defamation law for complaining for a bad health service she had received from a hospital. In my earlier op-ed, I emphasize the need for an efficient and effective out of court settlement in health cases, such as that involving Prita’s:

In a market-based solution, the parties stay out of court. If the health service provider does something wrong, they pay the patient and the patient can agree not to sue at a price. If providers don't do anything wrong, they ask the patient to issue a public apology and a sum of money to the extent that they can pay. The cost expended in this mechanism is much lower compared to going to court. This mechanism requires the government to reduce information asymmetry in the market as parties can only negotiate when the evidence is available.

This report sends a very strong message to the international community and create pressures to the government that a reform is urgent. Click on the image below to download the full report:

 


Related posts:
Bringing patients to court may not be efficient
Housewife on trial for defamation



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The Bonn Charter for Safe Drinking Water

Friday, March 19, 2010

  According to the WHO website :

The IWA Bonn Charter for Safe Drinking Water sets out the principles of an effective drinking water quality management framework and the responsibilities of key parties. The Charter presents a framework for drinking water safety, which incorporates the development of water safety plans. The goal of the Charter is good safe drinking water that has the trust of consumers.

Click here to download International Water Association (IWA) Bonn Charter of 2004. The pfd links to this charter is broken in many websites, so the document is rather difficult to obtain online. Fortunately watsan.net kept a copy of it.

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Prita in New York Times

Thursday, December 10, 2009

Prita's story is now in New York Times:
PRITA MULYASARI became famous, as her lawyer put it, for going from “e-mail to jail.”
Her ordeal began when she sent an e-mail message complaining about the poor treatment she received at a hospital to 20 relatives, friends and co-workers. The message, forwarded from one mailing list to another, eventually fell into the hands of the hospital’s lawyers, who sued for defamation. In no time, Ms. Mulyasari, 32, a mother of two infants, found herself sharing a jail cell with murderers and facing six years in prison, seemingly yet another ordinary Indonesian caught up in one of the world’s most corrupt legal systems.

This will surely raises Omni Hospital's Public Relation budget. I have argued in my op-ed that bringing patients to court is not a good way of settling problems. The monetary damage caused by Prita's initial email to Omni's reputation is insignificant compared to the public relations disaster following her detention and trials. The public fund is used for trials and prosecution, Omni spent a lot of money (and time) to pay their lawyers and finance PR campaigns and the house of representative, the ministry of health and Tangerang mayor spent considerable time to act as a mediator to the case. In the end, nobody wins.

If only it had been settled out of court, we could have allocated these resources elsewhere.

Hat Tip to Rumi

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Calls for premarket registration of nanotech product

Sunday, October 11, 2009

EEB calls for premarket registration, stakeholders consultation and adequate legislative framework before a deeper entrance in nanotech market is made. In its brochure, it deems voluntary regulation as unsuccessful. I have yet to see where the failures are, but the EEB claims for lack of participation on the enactments of these codes.

It appears to me that the EEB stance are 'precautionary' in essence and relies more on command-and-control approach in nanotech regulation. The argument may have some merit provided that there are huge uncertainties surrounding nanotech products.

More regulatory framework of precautionary nature may reduce the risk of future market failure. But over-precautions will have implications on the growing market for nanotech.

Read more here.

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The Social Cost of Cigarette (and its advertisement) in Indonesia

Thursday, September 10, 2009

Pramudya has been very kind in providing us a commentary on the recent Constitutional Court Decision on Cigarette Advertisement in his post. I agree with him that the negative externalities arising out of cigarette must be borne by the consumer and that -- given the explicit contribution to income -- dealing with tobacco industry in Indonesia would not be easy.

A research by Achadi et.al. quoting WHO suggests that around 10% of mortality in Indonesia annually (200,000 deaths) are caused by tobacco. 61% of other deaths are caused by non communicable diseases which may be related to active or passive cigarette consumption. Another shocking discovery quoted by Achadi's research is that more than one in two household in Indonesia has at least one smoker, and 98% of them smokes at home. What this means is that they pollute the air in their home and affects their children.

What are the health cost to children who are passive smoker? A research in the UK shows that at a worst case scenario where everybody smokes at home, the health cost per child would be 16.000 GBP per year. If broken down into the number of cigarettes (20 per day and remember that british cigarettes contained filters, non-cloved and are typically milder than Indonesian), the cost would be around 62 to 92 GBP per cigarette. What it means is that in order to offset the negative adverse effect of a cigarette to children, each will have to be priced around 62 Pounds (or at a current rate, around IDR 1.000.000,00). I think this figure still does not include the opportunity cost for getting sick.

The cost of a Dji Sam Soe cigar is around IDR 750. But that's not the true cost. It will raise health insurance premium, dental care, house insurance premium (cigarette butt is a little friend for the big fire), car insurance, cleaning costs, retirement fund and many other items I cannot list down since I am not an economist. And remember, smoking near babies may cost another 62-92 pounds per cigarette (excluding opportunity costs).

If smokers are unable to pay these costs, this will go to the state's expenditure. Which means, in the end of the day, non smokers will be paying for the true cost of every cigarette through their tax.

I don't smoke but occasionally I bring cigarettes as souvenirs. Makes me feel guilty :(
Okay, from now on, no more cigarette for souvenirs.

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Bringing patients to court may not be efficient

Friday, June 19, 2009

This is my recent op-ed piece in JP. I tried to argue that litigating is not always the best option, both for producer and consumer in cases where credence good is involved.

Unlike buying clothes in a department store, the quality of a particular health, legal and financial service is hard to ascertain. Even if consumers have experienced the service, the long-term effect of the service remains unknown. Is there any guarantee you will not be sued for following your lawyer's advice, or that you will not experience any side effects for taking medication? No.

Health, legal and financial services exploit the high degree of information asymmetry between seller and buyer. Put simply, the service is there because laypersons don't know what to do. Clients don't know the law and patients don't know their disease.

As such, consumers rely heavily on their service provider. Demands are created by the service provider and not by the consumer alone. So clients follow their lawyers on which transaction structure they should enter into and patients follow their doctors on which pills they should buy and swallow.

Hence, at the tip of the business is trust and reputation. Reputation may be worth more than the actual quality itself. As reputation is earned through sustainable efforts in performing high-quality, honest services and a good relationship with consumers, it is the Achilles' heel of this business.

Do courts resolve tarnished reputations through their verdicts? The news that a former patient has been victimized by a health service provider is more likely to be good news for the media than news that a hospital wins a lawsuit over its former patient.

People are naturally more interested in stories where they can be projected into the situation. Hospitals are impersonal institutions owned by corporations, therefore it is not in the interest of the layperson to hear a story of them winning a lawsuit.

Is criminal libel a good recourse to repair a damaged reputation? One thing about going to criminal proceedings is that external factors come into play in the process - namely the police and the prosecutors.

Once a case has been lodged with the police and transferred to the prosecutors, it is no longer in the full control of the "victim" or their lawyers. Unlike lawyers, the police and the prosecutors worked on behalf of the state in the pursuit of (bureaucratic) justice, not in the interests of both parties.

It is not within their consideration if the hospital is interested in maintaining reputation and the former patient just wants to go home. As such, criminal justice institutions may decide to proceed with imprisonment although it may not be in the best interests of any party.

Conventional wisdom suggests going to court in libel cases to get an injunction - that is, to get a court order for the defendant to stop defaming the client.

However, this is effective only in the age of the printing press, not in the Internet age. Court injunctions are meaningless, as the cost of distributing and multiplying information for every user is very low. Once an email is sent, there is no way to stop it from spreading.

Rather than go to court, I would argue for a market-based solution. From the plaintiff's point of view, going to court means they have to pay litigation costs and legal fees. If they win in civil court, they may not be able to recover the costs as the defendant may not have enough money to pay. If it is the insurance company they are suing, the insurance company may decide to appeal, which means more costs and more publicity for the plaintiffs. If at all they finally win the case, it will not bring the damaged reputation back, so they will still need to pay a public relations company to repair the damage.

From the defendant's point of view, the judicial process is lethargic, cold, cumbersome, costly and often does not reflect their sense of justice. From the taxpayers' point of view, legal proceedings mean a burden for their tax money. Taxpayers pay every penny for electricity, water and other utilities spent by the police, the prosecutors and judges. Yet, like laypersons, judicial professionals do not know about medicine.

That is why judges need doctors to stand as expert witness. If there are two expert witnesses with conflicting views, one from the plaintiff and one from the defendant, judges will just have to choose the most convincing one and take the opinion into their decision. The end result could be far from we call "the truth".

In a market-based solution, the parties stay out of court. If the health service provider does something wrong, they pay the patient and the patient can agree not to sue at a price. If providers don't do anything wrong, they ask the patient to issue a public apology and a sum of money to the extent that they can pay. The cost expended in this mechanism is much lower compared to going to court.

This mechanism requires the government to reduce information asymmetry in the market as parties can only negotiate when the evidence is available.

In practice, this means medical records should be made available to the patient. Criminal, administrative and civil sanctions should be introduced for those who tamper with medical records or retain them from patients.

This setting will provide incentives for honest behavior. It will make information discovery cheaper for patients and insurance companies, and also prevent burdening taxpayers through complicated judicial proceedings.

The writer is the founder of the Center for Law Information.

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Bird flu strain: ownership or just profit?

Saturday, February 24, 2007

A colleague of mine wrote (in Bahasa) a nice piece in his blog, suggesting that the Indonesian government should create a material transfer agreement ("MTA") when handling the bird flu strain. To get an idea what a standard MTA looklike, you can click this link.

News however tend to suggest that Indonesia is claiming ownerhsip over the strain. But I agree with my colleague, it doesn't seemed like Indonesia is claiming ownership. It only wants a fair treatment. Health Minister said in an interview:
“WHO should have had walls to protect us as victims. It turned out to be that’s not the case and this is how it is in the world. Developing countries are always on the losing side like what happened to the AIDS and heart disease drugs,” she said.

Thus, there is indeed a case of securing it through the MTA. The non exclusive nature of the MoU is a good thing, as Indonesia still can make cooperation with other pharmaceutical companies.

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EU perspective on Nanomedicine

Friday, February 2, 2007

Olivier Van Droogenbroek referred me to the latest EGE (European Groups on Ethics in Science and New Technologies) activity: its adoption of the 21 st Opinion on the ethical aspects of Nanomedicine. The document is downloadable here.

Here's an excerpt on what they think, the hardest challenge to laws and regulations will be:
  1. the risk evaluation for nanomedicine may not be adequate in all areas;
  2. the implementation of risk evaluation measures should be carried out in a scientifically sound and transparent manner;
  3. there is a need for legal clarity in a number of areas especially where regulations and/or areas overlap;
  4. ethical dimensions must be taken into account in legal provisions
  5. on nanomedicine.
I have not look this document throughly. I found however, some interesting remarks on human enhancement, intellectual property and data protection as a result of the use of nanomedicine.

I will discuss the topics more detail in my later posts.

(H.T.
Olivier Van Droogenbroek)

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Update on Berkeley Nanotech Regulations

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)

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Regulating nanotech in food packaging

Wednesday, January 3, 2007

Nanologue has completed its interview research conducted at the sponsorship of the EU. This post will highlight the part of the research discussing regulaiton of nanotech in food packaging.

According to the research, nanotech in food packaging will bring benefits in the form of (i) Reduced usage of energy and raw materials (polymers) (ii) improvement of the mechanical properties of biodegradable polymers (iii) beneficial for reusable packaging due to improved mechanical strength and (iv) help to reduce the amount of packaging waste and save resources at the same time. There are however, risks associated with this. The first type of the risk deals with inconclusive research on impacts and lack of effects data: (i) Knoweldge about the effects of engineered nano-materials in the environment is still insufficient (ii) Risk of environmental pollution by nanoparticles (persistence and unknown catalytic effects) whereas the rests of the risks are common risks also found in normal chemicals which relates to pollution and waste: (a) Release of nano particles into the environment during the production and disposal phases of a product, (b) Uncontrolled incineration of nanocomposites could cause emissions of nanoparticles into environment and (c) Nanocomposite materials could disturb plastic recycling processes. Recyclers will have to deal with nanoparticular fillers, which eventually will be found in recycled materials.

Now, let's compare this with FDA's institutional capacity as has been discussed in my previous post. Taylor divided supervision mechanisms (on food packaging and other products) into pre marketing and post marketing.

Pre marketing. He reported that FDA's authority to inspect product on the pipeline is 'weak'. However, it has the strong capacity to (i) enforce safety and testing requirements, (ii) place burden to prove safety to sponsor and (ii) review safety prior to marketing. Post marketing. FDA has only moderate capacity to inspect facilities and safety records and it has 'no' capacity to requiry timely adverse event reporting or in requiring producers to conduct post market monitoring and testing. It has however, strong authority to remove unsafe products from the market -- of course!

The Nanologue's concerns with regards to "food packaging" is more toward its environmental risks (I suppose it means the use of nano-bags in replace of paper bags) while Taylor's report concerns more to its health impact. I think the nanologue should have also highlighted more on the implications of nano-food packaging to human, although food packaging undeniably have important side-effect towards the environment. When it comes to Taylor's proposal, then the recommendation is relatively simple: move the gradation of FDA's authority from 'none' or 'moderate' to 'strong'. This can provide a good balancing when a weaker precautionary approach is selected.

In my next post, I will try to highlight the regulation of nano-food packaging in the European Union. Meanwhile, you can read Nanologue's report here.

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Environmental, Health and Safety Policy Recommendation

Tuesday, December 12, 2006

ICF International, a consulting services company for technology solutions in the energy, environment, transportation, social programs, defense, and homeland security markets had released its recommendation on Environmental, Health and Safety Policy recommendation for the US Government, in a 36 page document.

One thing I like from the document is the way it explains and analyse inter-departemental competence in US Government in handling Nanotechnology's Environmental, Health and Safety (EHS) issues. On the other hand, I am quite pessimistic that this report can encompass all of Nanotech's EHS issue.

The Reason? They focus mainly on the toxicity of nanomaterials (See: Part I, Framing the issue). The whole set of assumption which forms the rest of the report is based on this. It is not that this issue is not important, it is important and it reflects the most "current" nanotech EHS issue. However, it may not be that current in one or two years. Thus, I don't think that the rest of the recommendation can cover Nanotech EHS issue, other than the relationship between nanomaterials to human and the environment.

EHS issue on the second and third generation nanotechnology which covers active nanostructure will also need to be addressed. So far, I have not discover any research focusing on this.

You can download ICF International report here.

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Unwise Nanotechnology Regulation

Monday, December 11, 2006

Neil Lane's statement is compelling:

"In my view, given what's at stake, this situation is unacceptable. I fear that nanotechnology may be heading for a fall. A major environmental, medical or safety problem -- real or bogus -- with a product or application that's labeled 'nanotechnology' -- whether it actually is nanotechnology or not -- could dampen public confidence and financial investment in nanotechnology's future, and could even lead to unwise regulation. We should not let this happen," stated Dr. Lane.

As stated by NSF, Nanotechnology development will occur in these stages:



1st Generation: Passive nanostructures

2nd Generation: Active nanostructures
3rd Generation: Systems of nanosystems
4th Generation: Molecular nanosystems

Each generation of nanotechnology will bring different effects and entails different risks. First generation Nanotech will carry environmental risks. The question is always about nanotoxicity. It will therefore require (i) sufficient testing methods and (ii) development of (iii) pre-market testing for health and environmental impact, (iv) life cycle assessment (v) methods for reducing exposure.

Coping method: Reform and adaptation of environmental and health laws

Second and third generation nanotech carries a different risk in the form of system instabilities: "your biosensors is malfunction", "the nanodynamo isn't working", "how come my drug is directly excreted out of body"?

Coping method: Consumer law oriented. Reform on product liability/service liability rules.

The last generation of nanotechnology -- molecular manufacturing -- will be the most complicated and bring enermous affect. First generation oriented legislations will be absolutely obsolete. Some second generation laws can probably inspire the fourth generation nanotechnology regulation, but gaps are unavoidable. CRN is the only organisation that focuses specifically on fourth generation nanotechnologies. All of these risks must be dealt from now on as even early studies on the fourth generation nanotechnology may not be sufficient to mitigate the risk.

Possible coping method: (i) Informational law oriented, major overhaul on information
management laws. (ii) Application of legal futurism studies




(Many Thanks to: Mike Treder/CRN)

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REACH is not enough, new labelling method might be required

Monday, December 4, 2006

Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) is one of the three independent scientific committes managed by the EU's directorate general of health and consumer protection. Its task is in giving considerations and insights into "where amendments are needed to procedures for assessing risk of the products of nanotechnologies, and identifies areas where major gaps in knowledge exist."

The EU Comission launched a public consultation in December 2005 and published its recommendations based on the consultation:

With regards to Hazard Evaluation, "The SCENIHR opinion highlights that the paradigm for nanotoxicology does not exist and there is a need for a case-by-case assessment of environmental and health impacts of nanotechnology products" and consider it beneficial to "bench mark studies, including reference materials with very well understood toxicology in man, such as quartz and asbestos."

In its report, it acknowledges that "Due to the lack of available data on the risk characterisation of different nanoparticle-based products, no generic conclusions are possible at this stage.
Consequently, each product and process that involves nanoparticles must be considered
separately.."

The SCENIHR listed a few type of risks associated with certain circumstances:
  • Worker safety during the manufacture of nanoparticles.
  • Safety of consumers using products that contain nanoparticles.
  • Safety of local populations due to chronic or acute release of nanoparticles from manufacturing and /or processing facilities.
  • The impact on the various environmental compartments per se resulting from production, formulation and use, and on the potential for human re-exposure through the environment.
  • The environmental and human health risks involved in the disposal or recycling of nanoparticle dependant products.
These characterisation by the SCENIHR reflects the possibility of regulating nanotechnology in each economic chains, from production, to consumption, to dumping, to the re-usage. If this is adopted, then the future EU regulation will comprise of a process-focus regulation, product-focused regulation and sectoral regulations.

The SCENIHR also suggest a precautionary approach with respect to "nanoparticles which are likely to be highly biopersistent in humans and/or in environmental species." It also stresses that "there is no reliable information on the effect of the simultaneous exposure to multiple forms of nanoparticles, where it would be appropriate to assume the effects are additive, or on the interaction between nanoparticles and other stressors (either physical, chemical or biological), which should be considered on a case-by-case basis."

Nanoparticle as stressor is particularly important as it means that a hazardous effect may not be resulted not from the nanoparticle itself but due to its surroundings. This means that each producer of nanoproduct will have the obligation to dilligently provide information on how consumer should treat their product. Possible allergic reaction should also be provided and this may not be an easy task. In my opinion, this will carry several legal consequences:
  1. There has to be a regulation on the storage and transportation of nanoproducts which contain hazardous nanoparticle
  2. Some nanoproducts shall not be sold for free
  3. Producer can be exempted from liability if they can prove that they have provided adequate information on how a product should be treated
It is interesting to note that the SCENIHR regards the current REACH proposal may be inadequate:
The regulation of products containing nanoparticles based on tonnage, as proposed for existing chemicals under REACH, needs to be considered further because there are many more nanoparticles to the tonne than is the case for larger particles, and their behaviour in the body and in the environment may be different. If the nanoparticle form of a chemical does have distinctly different properties in biological systems from other physical forms of the same chemical, it will be necessary to readily identify the nanoparticle form of each chemical for the purposes of hazard warning labels etc. One approach to ensure that the effects of the nanoparticle form of a chemical is properly assessed would be to have a unique identification for it, either assigning different CAS numbers to the nanoparticle form, or adding a code (CAS-NP50) to existing CAS numbers leaving the CAS number for identifying similar chemical compounds . It is also inappropriate to assume that current workplace exposure standards for dusts can be applied directly to the nanoparticle form of the dust component. New standards will therefore need to be considered. Similarly, classification and labelling for human health and the environment may need to be reconsidered.
This point is especially important. This suggest that nanoproduct shall not and cannot be treated as chemicals, because their properties are different from chemical bulk. A legal consequences of this is that, producers cannot rely merely on REACH in conducting their safety standard as their duty to care with regards to nanoproduct is different than those established under the REACH. Another important thing is: there is going to be another classification/labelling method for nanoparticles that is different from normal chemical classifications.

You can download the complete report here, and the summary here.

Email me for suggestions, or leave a comment.