Nanotechnology Insurance Issues

For anyone who might be interested, I will be speaking on nano-related insurance issues at the opening plenary of the National Nanotechnology Initiative's upcoming Oct. 6 -7 conference and workshop on Nanomaterials and the Environment & Instrumentation.  The draft agenda for the conference can be found here, and the plenary is also supposed to be broadcast on the web.  I will post the information for the simulcast as we get closer to the conference date.  Cost, location, and registration info. is here.

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.  

Index to New Book -- "Nanotechnology Law"

For anyone interested, here is the index to my new book "Nanotechnology Law."  You can find the book on Amazon.

 

NanoBusiness 2009 Conference

 NanoBusiness 2009, the 8th Annual NanoBusiness Conference, will be held in Chicago, the city of big shoulders according to Carl Sandberg, September 8-10, 2009.

The conference offers a keynote address by Rep. Daniel Lipinski, (D- 3d District Illinois), Chairman of the Research and Education subcommittee of the House Committee on Science and Technology, along with such programs as "The Economy's Effect on Nanotech", "The Future of Nano Materials" and "Nanotechnology and the Obama Administration".

For more information and/or to register, please take a look at the NanoBusiness 2009 website.

 

EPA Retracts Carbon Nanotube SNURs

Today's issue of the Federal Register carries a notice from the EPA withdrawing two significant new use final rules. EPA is withdrawing these SNURs affecting multi-walled carbon nanotubes and single-walled carbon nanotubes after having received a notice of intent to submit adverse comments. The text of the notice is below and a link to the PDF version may be found here. The notice also refers to an earlier notice from EPA published in the Federal Register for June 24, 2009.

Federal Register: August 21, 2009 (Volume 74, Number 161)]
[Rules and Regulations]              
[Page 42177-42178]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au09-7]                        

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2008-0252; FRL-8433-9]
RIN 2070-AB27


Certain Chemical Substances; Withdrawal of Significant New Use
Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of final rules.

-----------------------------------------------------------------------

SUMMARY: EPA is withdrawing two significant new use rules (SNURs)
promulgated under section 5(a)(2) of the

[[Page 42178]]

Toxic Substances Control Act (TSCA) for chemical substances which were
the subject of premanufacture notices (PMNs), i.e., multi-walled carbon
nanotubes (PMN P-08-177) and single-walled carbon nanotubes (PMN P-08-
328). These chemical substances are subject to TSCA section 5(e)
consent orders issued by EPA. EPA published the SNURs using direct
final rulemaking procedures. EPA received a notice of intent to submit
adverse comments on these rules. Therefore, the Agency is withdrawing
these SNURs, as required under the expedited SNUR rulemaking process.
EPA also intends to publish in the Federal Register, under separate
notice and comment rulemaking procedures, proposed SNURS for these two
chemical substances.

DATES: This final rule is effective August 21, 2009.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov
.
    For technical information contact: Karen Chu, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8773; e-mail
address: chu.karen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    A list of potentially affected entities is provided in the Federal
Register of June 24, 2009 (74 FR 29982) (FRL-8417-6). If you have
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

II. What Rules are Being Withdrawn?

     In the Federal Register of June 24, 2009 (74 FR 29982), EPA issued
several direct final SNURs, including SNURs for the two chemical
substances that are the subject of this withdrawal. These direct final
rules were issued pursuant to the procedures in 40 CFR part 721,
subpart D. In accordance with 40 CFR 721.160(c)(3)(ii), EPA is
withdrawing the rules issued for multi-walled carbon nanotubes (PMN P-
08-177) and single-walled carbon nanotubes (PMN P-08-328) because the
Agency received a notice of intent to submit adverse comments. EPA
intends to propose SNURs for these two chemical substances via notice
and comment rulemaking in a future Federal Register document.
     For further information regarding EPA's expedited process for
issuing SNURs, interested parties are directed to 40 CFR part 721,
subpart D, and the Federal Register of July 27, 1989 (54 FR 31314). The
record for the direct final SNURs for these chemical substances which
are being withdrawn was established at EPA-HQ-OPPT-2008-0252. That
record includes information considered by the Agency in developing
these rules and the notice of intent to submit adverse comments.

III. How Do I Access the Docket?

     To access the electronic docket, please go to http://
www.regulations.gov
and follow the online instructions to access docket
ID no. EPA-HQ-OPPT-2008-0252. Additional information about the Docket
Facility is provided under ADDRESSES in the Federal Register document
of June 4, 2009 (74 FR 29982). If you have questions, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

IV. What Statutory and Executive Order Reviews Apply to this Action?

     This final rule revokes or eliminates an existing regulatory
requirement and does not contain any new or amended requirements. As
such, the Agency has determined that this withdrawal will not have any
adverse impacts, economic or otherwise. The statutory and executive
order review requirements applicable to the direct final rule were
discussed in the Federal Register document of June 24, 2009 (74 FR
29982). Those review requirements do not apply to this action because
it is a withdrawal and does not contain any new or amended
requirements.

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.


    Dated: August 17, 2009.
Wendy C. Hamnett,
Acting Director, Office of Pollution Prevention and Toxics.

0
Therefore, 40 CFR part 721 is amended as follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).


Sec.  721.10155  [Removed]

0
2. By removing Sec.  721.10155.


Sec.  721.10156  [Removed]

0
3. By removing Sec.  721.10156.

[FR Doc. E9-20150 Filed 8-20-09; 8:45 am]

BILLING CODE 6560-50-S
 

Mapping Nano

It's almost a bit of a cliche now to say that nanotechnology is a growth field, ever expanding it's presence in government, academia and business.

With the release yesterday by the Project on Emerging Nanotechnologies (PEN) of an updated version of the Nano Metro Map, we can see that there is a good deal of truth to the cliche. The map shows the metro areas with the largest concentrations of nanoindustries,  universities, research institutes, organizations, and government agencies involved in various areas of nanotechnology.

While the map shows that California and the New England - New York region dominating, with the Research Triangle area of the Carolinas and Texas as 3rd and 4th in rank, what it also shows is the presence in all the continental states, (Alaska and Hawaii are not shown on the map), of at least one research facility, nanoindustry, etc. Nanotechnology has spread from the California and New England regions to become a national presence.

The map will be updated as PEN receives and analyzes more data. 

Fruit Flies And Carbon Nanotubes

Environmental Science And Technology recently published online an article, "Differential Toxicity of Carbon Nanotubes in Drosophila: Larval Dietary Uptake is Benign, but Adult Exposure Causes Locomotor Impairment and Mortality", by Xinyuan Liu and a team of scienticists from the Chemistry, Engineering, Ecology and Evolutionary Biology Departments and the Institute for Molecular and Nanoscale Innovation of Brown University, that examined reactions to exposure to carbon nanotubes (cnts) in the larval and adult stages of the common fruit fly.

The experiments showed that fruit fly larvae, exposed to cnts since the time of their hatching could absorb and sequester the cnts in their bodily tissues no no evident toxic side effects, even at concentrations of cnts that were four times greater than what they would have encountered in a "normal" environment.

Adult fruit flies, on the other hand, were not so fortunate when exposed to powdered forms of nanoparticles, with effects ranging from a loss of the ability to climb out of a test tube, due to the nanoparticles adhering to the fruit flies feet,  to death. At lower levels of concentration and exposure, nanoparticles were found to be transmitted to unexposed adult flies via fly-to-fly contact and grooming behaviors.

Noting that flies have acted as disease vectors throughout human history, the authors note that

In the environment, such transport and redeposition may bring nanoparticles into contract with humans or environmental receptors that would not otherwise be exposed.

As nanoindustries begin to expand and new factories built or old ones converted to new uses, it might be a good idea for corporations to pay close attention not only to their workers exposure to nanoparticles, but also to the potential exposure that insects, which will inevitably find their way into these facilities, may be subject to.

 

Flight of the Nanobees

In an earlier posting, we discussed the advances in the treatment of cancer by nanomedicine. A recent article by Neelesh R. Soman and other researchers at the Washington University School of Medicine in St. Louis and published online by the Journal of Clinical investigation describes and discusses what the authors refer to as

a new paradigm for targeted delivery . . . of problematic classes of cell-penetrating peptides to kill cancer cells both in vitro and in vivo.

The Article describes how the researchers created targeted nanostructures to deliver melittin, a toxin found in bees and usually transmitted to humans and other creatures via the stinger, leading to the nanostructures being dubbed "nanobees" in the university's press release.

As experiments with mice demonstrated, the nanobees had a dramatic effect on breast cancer cells, slowing growth by up to 25%, and on melanoma tumors, decreasing their size by up to 88%. Nanobees that never reached their targets accumulated in the spleen and liver, then passing harmlessly out of the body.

While the nanobees are effective in treating cancer, the usual side effects of chemotherapy or radiation therapy weren't noted:

. . . we observe a dramatic lack of toxicity with melittin-loaded nanoparticles in our mouse studies in terms of changes in serum electrolytes, serum enzymes, or body weights even after repeated injections (total 7) at doses 4 times the LD of free melittin.

As the authors note:

Perfluorocarbon nanoparticles thus represent the first in a class of unique lipid-based delivery vehicles for melittin and other cytolytic peptides with broad spectrum and multimodal antivascular and antitumor actions that could be exploited for anticancer therapy.

Nanotechnology: Here and Now

Late last year, Australia held a workshop on Nanotechnology and Social Inclusion. On April 23-24 of this year, New Zealand held it's version, sponsored by government ministries. An evaluation of the "Nanotechnology-Here and Now" workshop was published in May of this year.

The Australian and New Zealand workshops had similair goals, (raising the general level of knowledge about nanotechnology, identification of key issues, discussing current and future opportunities and challenges). But the New Zealand workshops took a different approach by presenting experts on health and safety, nanomedicine, nanobusiness etc via video linkups. Participants could question and discuss ideas and issues with the experts, followed by group discussions. In the evaluations of the workshop afterwards, participants considered the use of video conferencing as effective. Generally, they found the workshops to be useful but didnot lead to any greater understanding of nanotechnology than they had prior to participating in the workshops.  Since this was one the major goals of the workshops, it would seem to indicate that New Zealand's government may need to revise their presentation strategies. Unfortunately, there has been no indication that New Zealand will present more workshops in the future.

One can only hope that revised workshops such as this will be held in the future, so that accurate information can be given out and public responses gaged, if for no other reason than getting the public to understand what nanotechnology is and what it isn't.

Transatlantic Regulatory Co-operation: Securing the Promise of Nanotechnologies Update

In an earlier posting, we discussed this upcoming conference to be held in London September 10-11, 2009. At that time, the agenda was not yet available. A draft version of the agenda has now become available. Panel discussions include:

Chemicals regulation and nanomaterials

Food regulation and nanomaterials

Voluntary industry initiatives

This is a draft agenda, so panel discussions and speakers are still subject to change.

Tags:

Food, Glorious Food

Food, glorious food!
Hot sausage and mustard!
While we're in the mood --
Cold jelly and custard!
Pease pudding and saveloys!
What next is the question?
Rich gentlemen have it, boys --
In-di-gestion!
("Food, Glorious Food", OLIVER!, music and lyrics by Lionel Bart)

There are several things that all humans do, no matter their age, gender, location, etc. One commonly shared experience stands out from the rest:

We eat.

Oh boy, do we eat. Some of the most common events in all cultures revolve around eating, )wedding feasts, for example). Some of us eat too much, some not enough. Some regions can be easily identified by their regional cuisine as by name (for example, Tex-Mex brings up images of the Southwestern United States). Some foods have become so identified with particular regions that the mention of them brings up associations with that region - the cheesesteak with Philadelphia, gumbo with New Orleans, or crabcakes with my own hometown of Baltimore.

The Boston Globe published an article last week, " Food Scientists are Hoping for Big Things from Small Particles", which took a look at the potential for nanotechnology to make food healthier and preserve it longer without affecting the taste. As the article points out, this would be similar to when vitamin D and iodine were added to foods to combat diseases like rickets.

As Julia Child would have said, "Bon appetit".

Food, glorious food!
Eat right through the menu.
Just loosen your belt
Two inches and then you
Work up a new appetite.
In this interlude --
The food,
Once again, food
Fabulous food,
Glorious food.
 

 

EPA to Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA

Eight months after EPA's interim report on industry participation (or lack thereof) in its Nanoscale Materials Stewardship Program, EPA's Toxic Substances Control Act's ("TSCA") Interagency Testing Committee ("ITC") published a report in today's Federal Register mentioning that EPA intends to issue a new mandatory data collection rule for nanoscale materials under TSCA Section 8(a):

"EPA intends to develop a proposed TSCA section 8(a) rule to obtain information on the production, uses, and exposures of existing nanoscale materials.  EPA has indicated that it will ensure that the chemicals where there is ITC interest as described in this unit are either included in that action or are otherwise new chemical substances subject to premanufacture notifications (PMN) reporting under TSCA.  EPA also intends to develop a proposed TSCA section 4 rule to develop needed environmental, health, and safety data."

Among other things, TSCA section 8(a) allows EPA to issue a rule requiring the mandatory submission of data regarding:

(A) The common or trade name, the chemical identity, and the
molecular structure of each chemical substance or mixture for which
such a report is required.

(B) The categories or proposed categories of use of each such
substance or mixture.

(C) The total amount of each such substance and mixture
manufactured or processed, reasonable estimates of the total amount
to be manufactured or processed, the amount manufactured or
processed for each of its categories of use, and reasonable
estimates of the amount to be manufactured or processed for each of
its categories of use or proposed categories of use.

(D) A description of the byproducts resulting from the
manufacture, processing, use, or disposal of each such substance or
mixture.

(E) All existing data concerning the environmental and health
effects of such substance or mixture.

(F) The number of individuals exposed, and reasonable estimates
of the number who will be exposed, to such substance or mixture in
their places of employment and the duration of such exposure.

(G) . . . the manner or method of its disposal, and in any
subsequent report on such substance or mixture, any change in such
manner or method.
 

Some of the nanoscale materials prompting ITC's interest appear to be: fullerenes; titanium oxide nanowires; titanium oxide nanoparticles; nano zinc oxide; nanosilver; silica; quartz; cerium oxide; indium tin oxide; dendrimers; single-walled carbon nanotubes; multi-walled carbon nanotubes; carbon nanofibers; Se and Cd quantum dots; nanoceramic particles; and nanoclays.

 

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:

  1. Introduction
  2. Life Cycle Stages
  3. Fate and Transport
  4. Exposure - Dose Characterization
  5. 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."