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 issues relevant to the regulation of those products, including the potential toxicology of such materials, the effects of such materials on biological systems, and interaction of such materials with biological systems.

    `(b) Program Purposes- The purposes of the program established under subsection (a) may include--

    `(1) assessing scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to the Food and Drug Administration;

    `(2) in cooperation with other Federal agencies, developing and organizing information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;

    `(3) promoting Food and Drug Administration programs and participate in collaborative efforts, to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;

    (4) promoting and participating in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;

    (5) collecting, synthesizing, interpreting, and disseminating scientific information and data related to the interactions of nanomaterials with biological systems;

    (6) building scientific expertise on nanomaterials within the Food and Drug Administration, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under this Act;

    (7) ensuring ongoing training, as well as dissemination of new information within the centers of the Food and Drug Administration, and more broadly across the Food and Drug Administration, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;

    (8) encouraging the Food and Drug Administration to participate in international and national consensus standards activities pertaining to nanomaterials; and

    (9) carrying out other activities that the Secretary determines are necessary and consistent with the purposes described in paragraphs (1) through (8).

    (c) Program Administration-

    (1) DESIGNATED INDIVIDUAL- In carrying out the program under this section, the Secretary, acting through the Commissioner of Food and Drugs, may designate an appropriately qualified individual who shall supervise the planning, management, and coordination of the program.

    (2) DUTIES- The duties of the individual designated under paragraph (1) may include--

    (A) developing a detailed strategic plan for achieving specific short- and long-term technical goals for the program;

    (B) coordinating and integrating the strategic plan with activities by the Food and Drug Administration and other departments and agencies participating in the National Nanotechnology Initiative; and

    (C) developing Food and Drug Administration programs, contracts, memoranda of agreement, joint funding agreements, and other cooperative arrangements necessary for meeting the long-term challenges and achieving the specific technical goals of the program.

    (d) Report- Not later than March 15, 2015, the Secretary shall publish on the Internet Web site of the Food and Drug Administration a report on the program carried out under this section. Such report shall include--

    (1) a review of the specific short- and long-term goals of the program;

    (2) an assessment of current and proposed funding levels for the program, including an assessment of the adequacy of such funding levels to support program activities; and

    (3) a review of the coordination of activities under the program with other departments and agencies participating in the National Nanotechnology Initiative.

    (e) Effect of Section- Nothing in this section shall affect the authority of the Secretary under any other provision of this Act or other statutes administered by the Food and Drug Administration.'.

    (b) Effective Date; Sunset- The Nanotechnology Regulatory Science Program authorized under section 1013 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) shall take effect on October 1, 2012, or the date of the enactment of this Act, whichever is later. Such Program shall cease to be effective October 1, 2017.

Except for some stylistic changes and the removal of a subparagraph on appropriations, Sect. 1133 is the language of S. 1662 , the "Nanotechnology Regulatory Science Act of 2011", introduced on 10/06/2011 by Senator Mark Pryor (D-Arkansas) andSenator Ben Cardin (D-Maryland) and subsequently assigned to the Senate Committee on Health, Education, Labor and Pensions . No hearings were ever held on the bill nor was it ever reported out of committee.

During floor debates on S. 3187, Senator Cardin urged his felllow Senators to support and pass S. 3187, focusing on the language of Sec. 1134:

Mr. CARDIN. Madam President, I rise to discuss the FDA Safety and Innovation Act, the bill now under consideration here in the Senate.. . .

I express my appreciation to Senator Pryor for his leadership on nanotechnology. I am pleased to join him in this effort and am hopeful that the language we have sponsored can be included in this bill.

   Nanotechnology has become increasingly indispensible in our daily lives--everything from cellphones and MP3 players, to packaging of our snack foods, to cancer treatments in development employ the use of nanotechnology.

   As this burgeoning technology continues to power more of our consumer products and drive job creation in America, it is essential that we fully assess, understand, and address any risks that it may pose to safety, public health and our environment.

   By soundly assessing the safety of nanotechnology and developing best practices, the Nanotechnology Regulatory Science Act of 2011 will further job creation, public safety and growth in the industry.

   Our bill would establish a program within the FDA to assess the health and safety implications of using nanotechnology in everyday products, and develop best practices for companies using nanotechnology. This new program would bring more highly-skilled research jobs to Maryland.

   FDA's laboratories and research facilities at its consolidated headquarters are ideally suited to conduct the scientific studies required under the bill.

   The USDA's Beltsville Agricultural Research Center, BARC, is similarly equipped to provide innovative scientific technology, training, methods development, and technical expertise to improve public health.  . . . .

 I also will mention one other issue: nanotechnology. I congratulate Senator Pryor for his leadership in this area. Programs at FDA to access health safety facts and using nanotechnology in everyday products is something we need to do. This legislation advances that. I point out that I am proud that the lab facilities at the FDA are fully capable of dealing with the challenges presented by nanotechnology. This legislation acknowledges that.

   We also, in Maryland, are proud of the Beltsville Agricultural Research Center, which will advance nanotechnology and the impact it has on everyday products and safety. Those issues will be addressed also by the underlying bill. We very much appreciate the leadership of the committee.

On 05/30/2012, the House, under a suspension of the rules, passed H.R. 5651, the "Food and Drug Administration Reform Act of 2012". H.R. 5651 differs substantially from S. 3187; among these differences, H.R. 5651 contains no provisions regarding nanotechnology. These differences in language mean that a Conference Committee will be appointed to write a version of the two bills that should be adopted by both the Senate and the House. Although such a committee has not been appointed as of this date, one is expected to be formed soon. As with other legislation affecting nanotechnology we will monitor S.3187 and H.R. 5651 and update this site accordingly.  

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.

 

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 agencies are pursuing to promote nanotechnology while also addressing potential public health and environmental risks
  • Appreciate complexities of addressing potential risks with existing governance tools and strategies while also embracing new approaches to accommodate evolving technologies

I hope to attend by telephone and encourage any interested readers to do the same.  It should be a great conference.

 

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 nanoscale materials leave the manufacturing facility.

Second, evaluate potential worker exposure to nanoscale materials during the manufacturing process and then implement a hierarchy of exposure controls, including: substituting source materials with non-nano substances where appropriate, implementing engineering controls, using administrative controls, and requiring the use of personal protective equipment. This is all standard NIOSH-fare drawn from NIOSH’s excellent “Approaches to Safe Nanotechnology: Managing the Risks and Safety Concerns Associated with Engineered Nanoparticles.” OTA’s guidance document, however, does a good job of drawing out the most important “nuggets” of information from the NIOSH document in a few short pages.

Third, analyze whether unintentional release of nanoscale materials may occur with consumer use or disposal of the product. Along these lines, OTA recommends companies consider: labeling products as already suggested by BSI and the EU, warning potentially affected downstream users and others regarding potential EHS risks through the use of the Material Safety Data Sheets and other written warnings, complying with existing environmental laws such as the Toxic Substances Control Act, conducting an open and transparent risk and hazard testing regime for the product throughout its complete lifecycle, and recognizing that proactive prevention of EHS concerns is required for successful commercialization of nanotechnology.

In the end, OTA’s document is a helpful quick reference guide, but it does not cover any new ground or delve deeply into its existing source material. Businesses involved in nanomanufacturing should still consult the underlying source material cited in the document, as well as EHS and legal experts as necessary. Massachusetts should be commended, however, for putting out this basic guidance document and attempting to proactively address these issues.
 

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 be a lot of fun. Hope to see you there.

 

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 account that many of the products on the site have never been commercialized, or have long been taken off the market. Such an analysis would provide a helpful balance to the article’s "pending emergency" tone.

Getting beyond initial issues, the author’s key concerns appear to have less to do with potential nano-specific product risks than with CPSC foundational issues. The author’s primary complaint appears to be that the CPSC has no premarket testing authority. She also believes that there is "[a]mple evidence" that companies do not do premarket testing or self-report hazards and defects -- a conclusion many dispute.

In keeping with her general approach, the author lists "Five Generic Weaknesses in CPSC's Product Oversight Capacity:" 1. "CPSC's Data Collection System is Not Nano Ready;" 2. "CPSC has Limited Ability to Tell the Public About Health Hazards Associated with Nanoproducts;" 3. "CPSC Has Limited Ability to Get Recalled Nanoproducts Out of Use;" 4. "CPSC Lacks Sufficient Enforcement Staff to Identify Manufacturers That Fail to Report Nanoproduct Hazards;" and 5. "CPSC Does Not Have Sufficient Authority to Promulgate Mandatory Safety Standards for Nanoproducts."

While some of these points are valid, they are not nano-specific. In fact, this section of the article would suffer little if the prefix "nano" and the term "nanotechnology" were eliminated from the text. (Try it.) The same could be said for several of the prior papers published by PEN in which the authors’ complaints and cautions appear more related to broader governance issues than to nano-specific difficulties.

To get to the heart of the paper, most readers will want to flip to the last section where the author lists several recommendations to correct the problems she perceives with the CPSC.

The author recommends that the CPSC should: 1. "Build the agency’s nanotechnology base and expertise;" 2. Identify companies making "nanoproducts and request that they submit research studies, risk assessment data and any information they hold that will enable CPSC scientists to assess the safety of nanoproducts;" (Although she notes that the Consumer Product Safety Act provides sufficient authority to accomplish this recommendation); 3. "Coordinate with other health and safety agencies, and combine efforts to evaluate the risks associated with nanoproducts;" and 4. "Convene a CHAP to evaluate the health and safety risks associated with nanoproducts currently on the market that are intended for use by children."

The author’s second CPSC recommendation is the most interesting and could benefit from further development. If the Consumer Product Safety Act provides sufficient authority to allow the CPSC to ask companies making nanoproducts to submit safety and risk assessment data (as the author suggest), that should go a long way to satisfying the author’s nano-information gathering concerns. The potential civil liability facing companies marketing nanoproducts without first collecting such data after it has been specifically requested by the CPSC would act as a hefty deterrent to the potential misconduct she fears.

The author also recommends two Congressional remedies:

1. "Amend the Consumer Product Safety Act to give CPSC the authority to require manufacturers to identify the presence of nanomaterials in their products;" and 2. "Adopt Section II of the Consumer Products Safety Act Bill recommended to Congress by the NCPS in its 1970 Field Report." This would give the CPSC the ability to promulgate "safety standards for any 'new' consumer products" . . . "where there exists a lack of information adequate to determine the safety of such product in use by consumers."

It is hard to argue against the author’s first Congressional recommendation. Collecting more information is a good thing as long as the requirements are not onerous and the CPSC actually has the ability to process and use the data productively. Although mentioned in the "Foreword," left out of the author’s Congressional "should do" list is more CPSC funding specifically dedicated to nanotechnology safety issues. Arguably, many of the author’s issues with the CPSC could be diminished with additional funding, staff, and resources to more fully address nanotechnology issues.

All in all, the paper is well worth reading as long as PEN’s and the author’s predispositions are kept in mind.

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.

In June 2005, ISO formed a new Technical Committee to help focus the world’s attention on standards that would support the growth of nano-related industries. The scope of that committee, ISO/TC 229 – Nanotechnologies, includes standardization in the areas of terminology and nomenclature; measurement and instrumentation; material specifications; and health, safety and the environment. The standards that are being created by this Committee can be utilized by national bodies to support regulatory activity within nanotechnology development, which in turn supports workers that encounter nanotechnologies on the job.

As new materials, structures, devices and systems are developed that derive their properties and function due to their nanoscale dimensions, standards act to enhance the development of these technologies by encouraging cooperation and collaboration in the industry. Bringing experts together for the purpose of standardization promotes the best uses and highest functioning of nanotechnology across the wide range of industries that it affects.

“Standards are important for supporting research aimed to safely develop and apply nanotechnology for societal benefit and economic growth,” said Clayton Teague, director of the National Nanotechnology Coordination Office, Executive Office to the President of the United States. “Standards are equally important for research aimed to better protect public health and the environment, and for facilitating the review and regulation of nanotechnology-based materials and products. They are therefore one of the foundational components that enable effective assessment of products created with nanomaterials, as well as development of associated policies and best practices to protect the people who manufacture, work with, and use those materials.”

Work in Progress for Health and Safety Standards

ISO TC 229’s standard-setting activities are assigned to four Working Groups (WGs). Responsibility for the development of science-based standards for the safe development and use of nanotechnologies falls to WG 3, Health, Safety and Environment. Operating under the leadership of Steven Brown of Intel Corporation (USA), the group has become a focal point for nanotechnology safety experts.

Representatives from seventeen of TC 229’s thirty participating national bodies are active in the work of the WG. Several other internationally-recognized bodies participate as liaisons to the committee, including: the European Committee for Standardization (CEN) TC 352, Nanotechnologies; the European Commission Joint Research Centre (EC-JRC); and the Organisation for Economic Co-Operation and Development Working Party on Manufactured Nanomaterials (OECD WPMN).

Its workload is heavy, with five active projects and a proposed sixth work item now under consideration.

As announced in last month’s article, the WG’s most mature document, a guidance document that provides critical information on occupational safety for those involved in the manufacture and use of nanomaterials in the workplace, was recently finalized.

Publication of the report, entitled Health and safety practices in occupational settings relevant to nanotechnologies, is anticipated by year-end 2008.

“This technical report will serve as a foundation for responsible national nanotechnology occupational safety and health programs worldwide,” said Vladimir Murashov, special assistant on nanotechnology to the director of the National Institute for Occupational Safety and Health (NIOSH), and the project leader for this initiative.

The report builds on guidance originally provided by NIOSH, the federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness.

Japan and South Korea have also stepped forward in leadership roles, serving as project leaders for three of the WG’s other active projects:

Endotoxin test on nanomaterial samples for in vitro systems;
Generation of nanoparticles for inhalation toxicity texting; and
Monitoring nanoparticles in inhalation exposure chambers for inhalation toxicity testing.
The fifth – and newest – WG 3 work item, Guidance on physico-chemical characterization of engineered nano-objects for toxicologic assessment, will serve as a reference for characterizing nano-objects for toxicology testing. The United States, under the leadership of Dr. Richard C. Pleus (Intertox) is spearheading this effort.

How to Participate

For each ISO Technical Committee or Subcommittee where the U.S. is a participating member, ANSI accredits a Technical Advisory Group (TAG) to develop and transmit our national positions on standards proposals and related activities. In the case of nanotechnology activities within ISO, one U.S. TAG, supported by multiple working groups, determines U.S. positions and advocates those positions at ISO

Dr. Laurie Locascio of the National Institute of Standards and Technology (NIST) chairs the U.S. ISO/TC 229 TAG Working Group on Health, Safety and Environment. Members of the TAG WG include representatives of academia, government, standards developing organizations, and industry. With this expert input, the TAG WG prepares the U.S. position for WG 3 issues, recommends future work items, and considers proposals from other national bodies.

“With Steve Brown’s leadership of the WG, and the active participation of our TAG members, the U.S. has the ability to help set the pace of nanotechnology standardization for health, safety, and the environment,” said Dr. Locascio. “Developing standards in this area will have a powerful impact on our ability to move this technology platform forward in a responsible manner.”

Participation in the U.S. ISO/TC 229 TAG Working Group is open to all nationally interested stakeholders, and the TAG actively seeks participants who have expert knowledge in all aspects of nanotechnology as it relates to health, safety, and the environment. To join the U.S. TAG for ISO/TC 229 or any of its WGs, contact Heather Benko (hbenko@ansi.org; 212.642.4912).

For more information on the U.S. TAG for ISO/TC 229, visit www.ansi.org/iscotc229tag.

Stay Tuned: The next article in this series will introduce ISO/TC 229/WG 1, Terminology and nomenclature.

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. 

All in all, the Economist article I think provides a useful synopsis of the current dilemma surrounding nanotechnology safety.   Its safety discussion begins with a discussion of the distinction between naturally occurring nanoparticles and engineered nanoparticles:

All that sounds alarming, but assessing the risks calls for perspective. Humans are already surrounded by nanoparticles of one sort or another. Much of the food people eat is made of naturally occurring nanoscaled components. Each person breathes in at least 10m nanoparticles a minute. Most of them do no harm.

That said, I am a little disappointed that the article did not sufficiently emphasize the inconclusive nature of the animal studies on nano safety.  The article only alludes to studies that show the potential for toxicity:

[s]tudies show there is the potential for such materials to cause pulmonary inflammation; to move from the lungs to other organs; to have surprising biological toxicity; to move from within the skin to the lymphatic system; and possibly to move across cell membranes.

However, we also know that there are a number of studies that suggest that nanomaterials may not have significant toxic effects -- see, e.g., Nano Law Report's coverage of the buckyball study and the study looking at SWNTs in fruit flies

With all of that said, the article's bottom line strikes me as reasonable -- that we need to do a better job learning what the risks of nanomaterials are so that we can responsibly regulate their use and manufacture and not lose the "baby with the bathwater" in the process.

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 researchers quoted in the report, Dr. Bruce Weisman, is a well-known nanotechnology researcher at Rice.

Update:

Thanks to Youtube, we can see a six second video of the carbon nanotubes "lit up" inside the fruit flies here

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.

 

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

 

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.

Doug Trout, Associate Director for Science for the Division of Surveillance, Hazard Evaluations and Field Studies discussed this issue at the International Conference on Nanotechnology Occupational and Environmental Health and Safety last week. According to the article, NIOSH will recommend that all nanotechnology employers implement an occupational health surveillance program designed to help employers evaluate the risks and necessary protections resulting from nanotechnology's use. The necessity for such guidance is apparent, considering "the growth of nanotechnology in the workplace, the unique physical and chemical properties of nanomaterials and early evidence suggesting that 'nanoparticles may have toxic effects greater than larger-size particles and at lower doses.'"

For those unaccustomed to the field of occupational health, the article explains that an occupational health surveillance program includes hazard surveillance and/or medical surveillance. These two components are designed to identify and monitor workplace hazards and occupational health problems.

The first step in any health surveillance program is a needs assessment. NIOSH intends to provide a needs assessment framework for employers, including recommendations for the evaluation of various risk factors. We know, however, that the needs assessment will contain a hazard assessment and an exposure assessment. The article quotes Trout as stating "The purpose of this needs assessment in an occupational setting is to determine – by performing hazard and exposure assessments – whether a health risk due to occupational exposure [to nanomaterials] exists in the workplace."

As most employers already realize, the research on the risks and effects of nanotechnology is still evolving. Trout is quoted as acknowledging that "information may not be available to make a well-informed determination of risk." For that reason, "periodic reassessment" will be of vital importance in the workplace.

Even NIOSH cannot provide definitive answers to nanotechnology employers- at least not yet. Everyone agrees, however, that the use of nanotechnology may pose a significant risk to employees. The NIOSH guidance will provide some welcome relief to employers struggling to understand what the dangers of nanotechnology are and how to avoid them.

For the full article, see here.

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 in the journal Nature Nanotechnology.  You can access the full article here (subscription required). 

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.