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Tag Archives: safety

S. 3187, “Food and Drug Administration Safety and Innovation Act” passes in Senate

Prior to adjourning for the Memorial Say recess, the Senate, on 05/24/2012, by a vote of 96-1, passed  S. 3187, the "Food and Drug Administration Safety and Innovation Act", " To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes", after previously adopting an amendment in the nature of a substitute-  an amendment in the nature of a substitute strips all of the language of a bill following the enacting clause and replaces it with new language – offered by Senator Tom Harkin (D-Iowa). Included as part of the language of the amendment was Title XI – Other Provisions, Subtitle C- Misc. Provisions, Section 1133, "Nanotechnology Regulatory Science Program":

SEC. 1133. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

    (a) In General- Chapter X (21 U.S.C. 391 et seq.) is amended by adding at the end the following:

`SEC. 1013. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

    `(a) In General- Not later than 180 days after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary, in consultation as appropriate with the Secretary of Agriculture, shall establish within the Food and Drug Administration a Nanotechnology Regulatory Science Program (referred to in this section as the `program’) to enhance scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under this Act or other statutes administered by the Food and Drug Administration, to address

White House Issues Nanotechnology EHS Policy Statement

One June 9, the President’s Office of Budget and Management, United States Trade Representative, and Office of Science and Technology Policy issued a joint memorandum directed to all Executive branch departments and agencies entitled "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications ofNanotechnology and Nanomaterials."

The Policy Statement is important because it confirms a "best-science" approach to potential nano-EHS issues, rather than a reactionary approach.  While this has been the stated approach of various federal agencies in the past, it is nice to see it reaffirmed across the entire federal government at the highest levels. The memorandum also reaffirms the importance of nanotechnology to the US economy, and recognizes the potential adverse economic consequences that knee-jerk regulation might have. 

Perhaps most interesting is that the memorandum repeatedly refers to the sufficiency of existing regulations to deal with potential nano-related EHS risks.  Some advocacy groups may have been holding out hope that the Obama administration would enact new nano-specific regulations. That is very doubtful given the tenor of the memorandum, which should provide industry with a measure of reassurance in this regard.

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ABA Program on Nano Governance

Presenting what looks to be a very interesting line-up of top-rate speakers, the American Bar Association’s Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation, and Right-to-Know Committee) is presenting a webinar on January 27, 2011:

Nano Governance: The Current State of Federal, State, and International Regulation

Here is a summary of the webinar from ABA’s online announcement:

States, federal agencies, and foreign governments are challenged to address the risks and promote the benefits of evolving technologies, including nanotechnology. Companies globally are continuing to harness the properties of nanomaterials for use in products from airplanes to pharmaceuticals and from cosmetics to food packaging. Nano Governance: The Current State of Federal, State, and International Regulation will address these issues in a half-day program. This program will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential benefits of these materials. Panelists will report on new and emerging federal, State, and international nanomaterials regulations and governance strategies. Attendees will gain insight into potential public health and environmental impacts and the approaches various government agencies and industrial stakeholders are pursuing to address these issues while also promoting nanotechnology. The program is open to attorneys and other professionals with chemical regulatory compliance practices.

Educational Objectives:

  • Develop familiarity with new and emerging federal, State, and international nanomaterials regulations and governance strategies
  • Understand Potential Public Health and Environmental Impacts and the approaches various government

Massachusetts Issues Nano-EHS Guidance Document

This article originally appeared on the National Nanomanufacturing Network’s InterNano website on August 25, 2010.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Massachusetts’ Office of Technical Assistance and Technology (OTA) recently released its “OTA Technology Guidance Document: Nanotechnology – Considerations for Safe Development” which has been in development for the past couple of years. The document begins by noting the tremendous positive influence nanotechnology is predicted to have in the fields of biomedical devices, electronics, clean energy, and materials engineering, while at the same time acknowledging that “there are indications of potential harm from certain exposures and release of engineered nanoparticles.” OTA also believes that there “is little uncertainty” regarding available means to prevent potential workplace exposure to nanoscale materials. Simply put, despite unknown EHS risks, there is more than adequate knowledge to control potential exposure in OTA’s view.

The end of the report contains a bibliography of existing resources covering state-of-the-art workplace good practices for nanoscale materials. The bibliography includes the “usual suspect” documents and websites published by NIOSH, ICON, German government, British Standards Institute, ED/DuPont, NanoSafe, and ASTM. From these primary sources, OTA distills a basic set of good practices for entities working with nanoscale materials in Massachusetts.

First, establish a risk reduction plan for facilities working with nanoscale materials. Such a plan should have two levels. First, it should attempt to protect against direct and immediate worker exposure. Second, it should also attempt to protect against possible releases during transport, use, and disposal after the …

Wisconsin Legislature to Study Potential Regulation of Nanomaterials

Following California’s lead, Wisconsin’s legislature recently formed a special committee to study the potential regulation of nanomaterials from an environmental, health, and safety perspective.   Our readers will be interested in the committee’s membership and focus:

Special Committee on Nanotechnology Chair: Rep. Chuck Benedict Vice Chair: Sen. Mark Miller Legislative Council Staff: Mary Matthias, Pam Shannon, and Larry Konopacki Member List

The Special Committee is directed to examine the human health and environmental concerns related to the manufacture, use, and disposal of nanomaterials and develop legislation to address these concerns. In particular, the Special Committee shall consider the establishment of methods to monitor nanomaterials by use of a nanotechnology registry system or the imposition of other disclosure requirements. The Special Committee shall also develop strategies to facilitate the development of nanotechnology to create and retain jobs in Wisconsin, including ways in which government can help nanotechnology researchers, small firms, and start-ups address potential risks and meet regulatory requirements.  

You can find prior articles about Wisconsin’s prior efforts here and here.  The committee’s first meeting appears to be scheduled for September 2010.…

Nanotechnology Health and Safety Forum — Seattle, June 8 – 9, 2009

Battelle Memorial Institute, the University of Washington, and the University of Oregon are co-sponsoring the international Nanotechnology Health and Safety Forum (NHSF) in Seattle, Washington on June 8 – 9, 2009.  The NHSF is coinciding with the first world-wide meeting of the International Organization for Standardization (ISO) TC 229 — Nanotechnologies being held in the United States, and will take place at the Bell Harbor International Conference Center.

Topics covered at the NHSF will include:

  • The EHS Progress Report: today’s status and tomorrow’s next steps
  • International Standards: developing a timeline & milestones
  • Navigating Regulations: encouraging dialogue between Europe, Asia, and the U.S.
  • Safety Guidelines: state of the science and recommended occupational safety guidelines for working with nanomaterials
  • Managing Risk: the insurance industry perspective
  • What’s New: current activities of innovative nano-manufacturers

I have been invited to speak on the insurance/managing risk panel along with speakers from Riddell Williams, Hunton & Williams, Zurich North America, and Chubb Insurance:

The availability of insurance for entities using nanotechnology is critical to the further development and application of nanomaterials in industry. Yet the widening use of nanotechnology (while toxicology remains to be determined) is a central concern for the global insurance industry. Insurance, Nanotechnology, and Risk addresses the prospects for managing nano risk through the perspectives of a Silicon Valley loss control specialist, a major international underwriter, and liability / coverage counsel.

This should be a great conference with an international focus; plus Seattle in June is going to …

New Yale Study on Public Opinion

As a follow-up to last week’s post concerning The New York Times view of nanophobia, I also submit the following article.  Nanowerk is reporting on a new study released by Yale University concerning the public opinion as to the safety of nanotechnology after receiving various amounts of information.  The study is reported fully in Nature Nanotechnology (pay site).

The Yale study concludes that an individual’s view on how safe nanotechnology is, or isn’t, is based largely on their pre-existing cultural values.  As Dan Kahn, lead author, explains, and Nanowerk reports, "People who had more individualistic, pro-commerce values, tended to infer that nanotechnology is safe…while people who are more worried about economic inequality read the same information as implying that nanotechnology is likely to be dangerous."  Views on nanotechnology seems to correlate to views on other issues such as global warming.  The study goes on to conclude that communication with the public remains important, that perhaps the dialog should account for the existing predispositions of the audience.

Frankly, accounting for the existing views of the audience hearing information on nanotechnology had not previously occurred to me, although it makes sense.  Its a matter of communication versus effective communication.  While I always try to research an audience before speaking, I’ll now be thinking more critically about how to account for that information in discussions and other presentations.…

Nanotechnology and the Consumer Product Safety Commission

Late last month, the Woodrow Wilson International Center for Scholar’s Project on Emerging Nanotechnologies (PEN) published a paper on the ability of the U.S. Consumer Product Safety Commission (CPSC) to deal with possible environmental, health, and safety risks potentially posed by the use of some nanoscale materials in certain consumer products.

 E. Marla Felcher, "The Consumer Product Safety Commission and Nanotechnology," Project on Emerging Nanotechnologies, PEN 14, August 2008.

 The article begins with an analysis of PEN’s online consumer nanoproduct inventory which is used to support the author’s claims that "nanotechnology-enabled products" have made their way into every category of product under the CPSC’s jurisdiction. Of the 60 products on PEN’s website, the author claims that "all of them are available for purchase by consumers," and approximately "half of nanotechnology consumer products currently on the market would fall under CPSC’s jurisdiction." She notes that "[e]very day, new nanoengineered products make their way into stores’ shelves, among them kids’ pants, teddy bears, baby bottles, pacifiers, teething rings, plastic food storage containers, socks, chopsticks, humidifiers, mobile phones, computer processors and tennis rackets."

In a loaded rhetorical follow-up question the author asks: "Is it safe for an infant to spend hours each day sucking on a nano-enhanced pacifier?" The question does more to cement the author’s predilection against the use of nanoscale materials in consumer products than it does to present readers with a true quandary. Moreover, while PEN’s online inventory is a great tool, the author fails to take into …

Nanotechnology Standards for Health, Safety, and Environmental Factors

This Article Was Authored and Contributed by the American National Standards Intititute

This second article in a series on nanotechnology standardization introduces the international working group that, under US leadership, is creating the standards needed to support the health, safety, and environmental aspects of nanotechnology.

In the post-war era of the late 1940s, global leaders of government and industry formed a central body to “facilitate the international coordination and unification of industrial standards.” Twenty-six member nations came together in 1947 to form the International Organization for Standardization (ISO). 

 

ISO and its national member bodies – including the American National Standards Institute (ANSI) – are constantly evolving to meet changing demands. Today, ISO is addressing issues such as industrialization, the advancement of information technologies, quality, the environment, and the health and safety of workers and consumers. Today, roughly one of every twenty ISO standards addresses issues pertaining to health, safety or the environment.…

New York Times Editorial On FDA

This morning’s New York Times features an editorial discussing Peter Barton Hutt’s before the House subcommittee responsible for FDA oversight.  Mr. Hutt warned that the FDA was "barely hanging on by its fingertips;"  others testifying before the subcommittee suggested the agency lacked funds and staffing to do its job:

In a hearing before a House Energy and Commerce subcommittee, members of the agency’s own scientific advisory board outlined the F.D.A.’s many weaknesses. It lacks scientists who understand rapidly emerging technologies — including genomics and nanotechnology — relevant to product safety. The agency is further hobbled by a high turnover rate of scientists, a decrepit information technology system, a weak organizational structure, and a shrinking inspection force.

That said, FDA has been researching nanotechnology issues for some time — it formed its Nanotechnology Task Force in August 2006.   Still, it’s interesting that nanotechnology safety issues have even found their way to the editorial page of the New York Times.…

Nanotechnology On The Agenda in Davos

Nanotechnology was among the many hot topics discussed at this year’s World Economic Forum in Davos, Switzerland.  Among the five conceptual pillars for this year’s Forum was the topic: "Exploring Nature’s New Frontiers," which is described here.  It’s a nice concept, I believe, because it highlights the diverse areas — everything from global climate change to disease eradication — in which nanotechnology and other emerging technologies may play a role. 

In addition, as reported by Nanowerk, the World Economic Forum-founded "Global Risk Network" released its 2008 annual report [1.6mb pdf] that described nanotechnology risk as a "Core Risk."  Unsurprisingly, the driver for characterizing nanotechnology as a "Core Risk" appeared to be the still-preliminary state of the research into nanotechnology safety:

The report notes that studies reveal health impairment due to exposure to widely used nanoparticles (paint, cosmetics, healthcare). The primary impacts of a potential problem would be on public health, with secondary impacts on investment in a range of nanotechnologies.

It also states that increasing human exposure to nanotechnology will increase severity should an event occur, but this has to be balanced against the multiple opportunities created by nanotechnology. …

The Economist on Nano Safety

The November 22, 2007 issue of The Economist contains a story on nanotechnology safety entitled "A little risky business."   The article focuses on Andrew Maynard’s presentation before the House Science Commitee in October, an event we covered here, and also covers the ongoing debate over the use of silver nanoparticles as an antimicrobial agent in consumer products.  …

New Study On Detecting Carbon Nanotubes In Living Organisms

Researchers at Rice University successfully utilized a near-infrared flourescent imaging technique to detect individual carbon nanotubes in fruit flies.  The study, reported here and here, involved an experiment where the researchers fed fruit fly larvae a diet that contained carbon nanotubes.  The flies were then shot with a laser, which excited the nanotubes and allowed them to be viewed using a flourescent technique.   The good news is that the fruit flies apparently survived to adulthood just as well as fruit flies in the control group, and apparently weighed the same as the controls, too.  The study’s conclusions about the bioaccumulation of the nanotubes in the fruit flies are interesting:

When the researchers removed and examined tissues from the flies, they found the near-infrared microscope allowed them to see and identify individual nanotubes inside the tissue specimens. The highest concentration of nanotubes was found in the dorsal vessel, which is analogous to a main blood vessel in a mammal. Lesser concentrations were found in the brain, ventral nerve cord, salivary glands, trachea and fat. Based on their assays, the team estimates that only about one in 100 million nanotubes passed through the gut wall and became incorporated into the flies’ organs. 

I don’t know enough about the anatomy of a fruit fly to fully grasp the significance of these findings, but I find it hopeful that only a tiny fraction of the nanotubes accumulated in the flies’ organs, and also find it hopeful that the flies were apparently not harmed by the nanotubes’ presence.  One of the …

Nanomaterials as replacements for hazardous chemicals?

One downside to our focus on the safety of nanomaterials is that it can cause us to lose focus on the potential upsides of nanotechnology in the environmental, health and safety arena.  CORDIS is reporting on a study funded by the European Parliament’s Scientific Technology Options Assessment ("STOA") committee which looked into whether nanomaterials could serve as substitutes for hazardous materials.

In particular, the study focused on two areas where nanotechnology is already making inroads —  coatings and catalysts:

Two areas where nanotechnology is already making inroads as a substitute for hazardous chemicals are coatings and catalysts. Coatings can create anti-adhesive surfaces which resist things sticking to them, such as dirt, or have biocidal properties to prevent living organisms from sticking to them.

Nanoparticles are also widely used in catalysts, although the authors point out that research in this field was already on the nanoscale, and so it is not clear to what extent future developments could be attributed to nanotechnologies.

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EPA Announces Nanotechnology Safety Research Grants

As reported by AzoNano.com, the EPA recently announced the award of two grants, collectively worth $600,000, to researchers at Oregon State University to study the human health impacts of nanomaterials.  The pair of studies look like the first step toward nanotechnology regulation.  According to the AzoNano article, the first study is a survey of common manufactured nanomaterials to understand their interaction with biological processes.  The second study looks specifically at how manufactured nanomaterials may "damage or kill cells:"

Dr. Alan Bakalinsky is studying the relationship between specific characteristics of nanoparticles, like shape and structure, and their effects on cells. The work is expected to lead to the development of safety guidelines for industrial and environmental exposure to nanomaterials. "We’re trying to identify specific structures in manufactured nanoparticles that might cause damage to cells," said Bakalinsky. "If we can determine which shapes and structures are most dangerous to cell function, it should be possible to design the materials to avoid those shapes and minimize the risk of damage."

Both Oregon State researchers, Drs. Bakalinsky and Tanguay, look to be relatively new to the nanotechnology field.  Bakalinsky is a food science researcher and Tanguay is a molecular toxicologist.  …

Congressional leaders urge nanotech safety research

According to a December 21, 2006 press release, both outgoing House Science Committee Chairman Sherwood Boehlert (R-NY) and incoming Chairman Bart Gordon (D-NT) urged the Bush administration "to establish a research agenda with clear priorities to ensure a greater understanding of the potential environmental, health, and safety risks associated with nanotechnology."  

I suspect that in 2007, the new Congress may well push a nanotechnology safety initiative.  Nanotechnology safety issues are increasingly being publicly discussed, especially given Berkeley’s new regulations and NIOSH’s recent interest in occupational nanotechnology safety.  Andrew Maynard’s proposal, discussed in Nature in connection with the National Nanotechnology Initiative, so far looks to be the most comprehensive public proposal — the press release expressly references it.   We previously reported on Maynard’s proposal here and here

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NIOSH Guidance For Nanotechnology Employers

By, Jaime T. Landrum:

As the impact of nanotechnology grows, more companies are considering the utilization of nanotech products and processes in the workplace. Questions regarding nanotechnology’s effect on the American worker, however, come side-by-side with these business decisions. As reported at Occupational Hazards, The National Institute for Occupational Safety and Health (NIOSH) is expected to issue guidance for employers facing these problems.…

Consumer Survey: U.S. Consumers Willing To Use Nanotechnology, But Have Reservations

Rice University’s Center for Biological and Environmental Nanotechnology, together with researchers from University College London and the London Business School, released the results of a major consumer research study that sought to measure public perceptions of the risks & benefits of nanotechnology.  As reported in PhysOrg,

The largest and most comprehensive survey of public perceptions of nanotechnology products finds that U.S. consumers are willing to use specific nano-containing products – even if there are health and safety risks – when the potential benefits are high. The study also finds that U.S. consumers rate nanotechnology as less risky than everyday technologies like herbicides, chemical disinfectants, handguns and food preservatives.

The study also found that American consumers did take nanotechnology’s possible health risks into consideration when evaluating whether they would purchase products containing nanotechnology:

One survey polled consumers about how likely they would be to use four specific, nano-containing products: a drug, skin lotion, automobile tires and refrigerator gas coolant. This is the first large-scale study to experimentally gauge the public’s reaction to specific, nano-containing products, and [Professor Steven] Currall said the use of scenarios about plausible, specific products yielded results that challenge the assumption that the public focuses narrowly on risk.

"It was clear that people were thinking about more than risk," he said. "The average consumer is pretty shrewd when it comes to balancing risks against benefits, and we found that the greater the potential benefits, the more risks people are willing to tolerate."

Their findings were published …

Christian Science Monitor Endorses Maynard Proposal

The Christian Science Monitor dedicated its editorial yesterday to the issue of nanotechnology safety, and endorsed the proposal set forth in November’s Nature by fourteen scholars to discuss what lead author, Professor Andrew Maynard, termed the five "grand challenges" of nanotechnology safety.

Citing a Lux Research study, the CSM editorial indicated that by 2014, manufacturers will sell $2.6 trillion dollars’ worth of products that use nanotechnology.   After praising EPA’s decision to regulate "nanosilver," a decision that we have reported on at length here, CSM endorsed the Maynard proposal:

They include developing ways to detect nanomaterials in the air and water, learning how the shape of nanomaterials affects their toxicity, creating accurate models for predicting how nanomaterials act in the human body and the environment, and finding ways to engineer nanomaterials so that they are safe by design.

Both the chairman and ranking minority member of the House Science Committee have endorsed the paper and urged the White House and federal agencies to put together a plan to fund the scientists’ recommendations in the fiscal 2008 budget.

The need to act is urgent. Otherwise the enormous benefits of nanotech risk falling victim to safety issues that could – and should – have been confronted already.

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