Showing posts with label nanosilver. Show all posts
Showing posts with label nanosilver. Show all posts
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Nanotech will affect every regulations within five years.

Sunday, December 17, 2006

I mean what I say and I say what I mean.

Do you know why EPA bothers regulating a washing machine? It's because it contains tiny beene silver nanoparticles that can kill germs. Hell, it may even be the most primitive form of nanotech but look at its impact, they are declaring washing machine as pesticide!

Do you know that silver nanoparticles has been used in underwear, shirts, paint, deodorant, mineral supplement, toothpaste, liquid condom, refrigerator, vaccuum cleaner, ink, porcellain, make up, soap, rubber gloves, dental LED, dishwashing liquid, baby milk bottle, door handle, handy coating and air conditioner? Of course, not all of them will be categorized as pesticide!

Not only that we are only talking about a primitive use of nanotechnology, we also "only" talk about silver nanoparticles. There are still plenty other nanoparticle which its usage is still unknown. That's not all, this has not include "passive" nanostructures such as carbon nanotube, which will be used in transistors, computer hardware and medical appliances.

Nanotech market is going to be bullish in the next two years. Some even predicted that within a decade, people will no longer use the word "nanotechnology" because "Today's 'nano materials' are tomorrow's 'materials.'

The good news is (I mean, for lawyers) the regulation is still unclear and the risks associated with it is also unclear. This means not only more lawsuit but also more deals. So, let's catch up...

 

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When nano turns washing machine into pesticide

Saturday, December 9, 2006

The EPA's nanosilver regulation still attracts me, as it reflects how a regulation that was initially intended to regulate pesticide can now be extended into device such as the samsung washing machine. As we have previously discussed, the EPA is investigating if the silver ions released by nanosilver appliances can kill friendly bacterias and harm human.

There has been news and post suggesting that the background of the regulation is unfounded since:
  1. People has been using silver appliances for ages (Yeah, for sure. But the problem with nanotoxicity is that, the behaviours and characteristics of nanoparticle of silver is different than its bulk form, right? Or is it the case that the old ages silver are already "nano" in essence?)
  2. The effect of silver in drinking water is cosmetic. (Does that apply to common silver or nanosilver?)
  3. Nanosilver ions bonds with chlorine and are inert.
  4. Other pharmaceutical that kills germs are flushed out of toilet every year, but they are not subjected to regulation
  5. There are so many nanomaterials out there, but why only regulate silver?
  6. Alternative anti-microbe such as Triclosan, which may be contained in Microban products is not regulated.
To Howard Lovy, nanosilver nay not be nanotech at all, it is simply "...nanoscale stuff being sprinkled into products". If we talk about jurisdiction, the EPA does have all the power to regulate anything that kills germs as "pesticide". The FIFRA seemed to take account only towards its effect. Whatever it is outside medicines, if it kills germs, its pesticide. The problem is, which one is more dangerous to the environment, triclosan from my toothpaste or some nanosilver coating?

Seeing the EPA revoked its previous decision, it is likely that they are of the opinion that the ions released by the nanosilver washing machines pose a threat to the environment and will therefore require a pesticide registration.

The moral message of the case:
  1. Effect-focus regulation can incorporate as many as nanotech product it deems necessary, so long as the effect is triggered (e.g. the effect is killing germs). The pros: broader preventive measure. The cons: overbroad interpretation, can include anything. On the other hand, some effect focused regulation constructed in bulk-scale chemicals paradigm (Referenced Dose, parts per million, etc) may be useless for nanotech.
  2. Interrelated and overlapped regulation may occur due to nanotech inventions. If today a washing machine is a pesticide, maybe some kind of lamps would be drugs tomorrow.
  3. Process-focused regulation is more precise, but not much can be constructed due to lack of nanotoxicology data.
  4. What you regulate today maybe obsolete in a few years. The tech progressed too fast, beyond our current capacity to legislate.

 

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Nanosilver under FIFRA

Thursday, December 7, 2006

The first time EPA said it will regulate Nanosilver, I thought it was going to be regulated in a specific legislation, independently of pesticide. Well, it didn't. All products containing nanoparticle of silver is to be regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

FIFRA defines "active ingridient" as (§ 136. Definitions):
(1) in the case of a pesticide other than a plant regulator, defoliant, desiccant, or nitrogen stabilizer, an ingredient which will prevent, destroy, repel, or mitigate any pest;
(2) in the case of a plant regulator, an ingredient which, through physiological action, will accelerate or retard the rate of growth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof;
(3) in the case of a defoliant, an ingredient which will cause the leaves or foliage to drop from a plant;
(4) in the case of a desiccant, an ingredient which will artificially accelerate the drying of plant tissue; and
(5) in the case of a nitrogen stabilizer, an ingredient which will prevent or hinder the process of nitrification, denitrification, ammonia volatilization, or urease production through action affecting soil bacteria.

FIFRA applies to all types of pesticides, including insecticides, herbicides, fungicides, rodenticides and antimicrobials. Some minimum risk pesticides (green pesticides included) are exempted.

Thus, EPA Regulation can have a wide scope of various indoor use consumer goods and products used in health care. Antimicrobial pesticides are defined as "substances or mixtures of substances used to destroy or limit the growth of microorganisms, whether bacteria, viruses, or fungi -- many of which are harmful-on inanimate objects and surfaces". So, anyone that claims that its product can kill germs, they are subjected to inspection. It is to be noted that EPA's regulation on antimicrobes differs slightly from general pesticide regulation, in that it obligates special efficacy test.

Anti decay coatings may be exempted as a "treated article":
An article or a substance treated with or containing a pesticide to protect the article or substance itself (for example, paint treated with a pesticide to protect the paint coating, or wood products treated to protect the wood against insects or fungus infestation), if the pesticide is registered for such use.
(Note the "registered for such use" condition). However, if they claim to kill E.coli, S.aureus, Salmonella sp. or Streptococcus sp. they must be registered as a pesticide as "it make a public health claim that goes beyond the preservation of the treated article itself". This means that some deodorant/absorpent might be required to register themselves under FIFRA. Those used for human and animal (antibiotics) may not be regulated under FIFRA but are subjected to FDA review.

Some of nanosilver products (such as the Samsung Washing Machine) are actually used for coating. Some other however are clear anti-microbes. Nanosilver has been presumed to be able to kill viruses such as HIV and Avian Flu and is currently under intensive research.

If used as merely as coating, Nanosilver may enjoy exemption. However, if producer claims that the coating kill germs (such as used in advertisement of washing machines) then they are subjected to review. If used as drugs, then it is the FDA's jurisdiction. The EU has yet to regulate nanosilver, but you can always checkout the EU's pesticide homepage here.

Nano-silver has been used in a wide range of product, either as coating or as anti-microbes, as used in liquid condoms, soaps, dishwashing liquid. Some of these "food and drug" type nanosilver product has been manufactured in China and Korea. I think they might have difficulty if produced in USA. You can see them here.

 

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Behind the nanosilver regulation

Scott E. Rickert wrote an article explaining the background of EPA's nanosilver regulation:
Various U.S water authorities became concerned that discharged nanosilver might accumulate in the water system, particularly in wastewater treatment plants where beneficial bacteria are used to purify water of its toxins. This opinion means that nanosilver could be viewed as an environmental pesticide, requiring the product to be registered and tested under the Federal Insecticide, Fungicide and Rodenticide Act. In the words of EPA spokesperson Jennifer Wood, "The release of silver ions in the washing machines is a pesticide, because it is a substance released into the laundry for the purpose of killing pests.
Further, he argued that a heavy regulation may impede research and development. This is not good as current nanotech products as used in solar cells would certainly be beneficial to the environment. Let's not forget its application in biosensors: early cancer detection.

We do need a balanced regulation.

 

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EPA's first nanoproduct-focused regulation

Thursday, November 23, 2006

The press and the blogosphere have been echoing EPA's new nanoproduct-focused regulation. Yes, EPA has decided to "regulate" silver nanoparticles used in various consumer products such as high-tech odor-destroying shoe liners, food-storage containers and air fresheners. The silver nanomaterials are used to kill germs. However, there are worries that they will harm beneficial bacterias:
Until now, new products made with tiny germ-fighting particles of silver did not have to pass muster with regulators. That has concerned environmentalists and others who think that the growing amount of nanosilver washed down drains may be killing beneficial bacteria and aquatic organisms and may also pose risks to human health.
Companies using silver nanoproducts will have to prove to the EPA that their product is safe. According to WP:
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. "We will be able to evaluate them and ensure that these products are not going to do damage to the aquatic environment," said Jim Jones, director of the EPA's Office of Pesticide Programs.
I have not really seen the so-called "regulation" so I am not able to give my analysis here. However, there are several questions that can be asked:
  1. What will happen to products already on the market? Does this apply retroactively? Do they need to be suspended pending the scientific findings?
  2. Does this mean that it shifts the burden of proof from EPA to producers? Supposed EPA declared that a product is OK, but then someday something happens to the product (i.e. it turn out to be harmful for the environment) to what extent would the producer be liable for the product, either under environmental, health or consumer law?
  3. Since it deals with nanosilver, is it OK to cover similar products in a single exam? Scientific assessment may raise the burden of cost for the industry, if there is a product that is more or less similar, it could be economical to cover them in one assessment, rather than doing multiple assessment. To what extent will this be regulated?
  4. What are the relationship between this regulation and other regimes?