Tag Archives: Toxic Substances Control act

US chemists talk nano in a June 27, 2012 Washington, DC briefing

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The American Chemical Society (ACS) has a Science & the Congress Project where they provide information about various science and technology issues to policymakers. Their latest briefing will be on nanomaterials and the Toxic Substances Control Act.  From the June 21, 2012 news release on EurekAlert,

The American Chemical Society (ACS) Science & the Congress Project invites news media to attend a luncheon briefing on “Nanomaterial Safety: Do We Have the Right Tools?” It will be held Wednesday, June 27, 12-1:30 p.m., in the Russell Senate Office Building Room 325. To attend, register at http://tinyurl.com/ACSSciCongr-nanoEHS.

This briefing is hosted by the ACS Science & the Congress Project with honorary co-host the Congressional Nanotechnology Caucus.

With nanotechnology, scientists engineer materials on a molecular level; that is, they work with such basic factors as the size, shape and surface properties of substances, in addition to altering the chemical composition, to create materials that exhibit novel properties. While the science to engineer nanomaterials has been developed largely since the 1980s, public laws to regulate the safety of materials and chemicals, such as the Toxic Substances Control Act (TSCA), were crafted in the 1970s. Important questions for our times: Does our understanding of and information about nanotechnology adequately inform the policies designed to ensure safe product development? Likewise, do the current policies address both the possible problems and benefits associated with nanotechnology? This panel will discuss whether policymakers currently have the necessary tools, both scientific and policy mechanisms, to reap the potentials of nanotechnology.

The briefing will feature the following panelists and an open discussion:

Moderator: Kristen Kulinowski, Ph.D., Science and Technology Policy Institute, Institute for Defense Analyses

Panelists:

  • Lynn Bergeson, Bergeson & Campbell P.C.
  • Richard Denison, Ph.D., Environmental Defense Fund
  • Arturo Keller, Ph.D., University of California, Santa Barbara

For those of us who can’t attend, it is possible to find more information the Science &the Congress Project, from the About page (and if you keep reading you’ll find that you may still be able to access the briefing even if you can’t attend the real-time event),

Since 1995, the American Chemical Society (ACS) has operated the Science & the Congress Project to educate and inform Members of Congress and their staffs on the importance of science and technology to solving national challenges. The Science & the Congress Project has conducted well over 100 congressional briefings on important and timely policy topics, relying on panels of knowledgeable and diverse experts to provide comprehensive, balanced presentations about chosen topics, and to increase the level of scientific and technological literacy on Capitol Hill. The goals of the project include:

  • Highlighting the role of S&T in public policy.
  • Helping Members of Congress and their staffs gain a deeper knowledge of the science involved in policy issues.
  • Serving as a neutral and credible source of scientific information.
  • Promoting the responsible use of science in national policymaking.

Serving ACS and Its Members

The ACS Science & the Congress Project provides significant benefits for ACS and its members:

  • Balanced, nonpartisan briefings lend credibility to ACS policy efforts.
  • Initiation of briefings enhances ACS’s leadership role among peer organizations.
  • Collaborations with cosponsors enhance ACS’s ties and foster cooperation within the scientific community.
  • Online availability of briefing materials increases ACS members’ exposure to science policy topics.

Enhancing Relationships

During more than a decade of existence, the ACS Science & the Congress Project has conducted well over 100 briefings and built relationships with:

  • Congressional offices, committees, caucuses and staffers.
  • Experts in academia, non-governmental organizations and all levels of government.
  • Professional organizations with overlapping interests.

They also make their materials available after the briefing,

Serving as an Ongoing Source of Science Policy Information

Individual web pages for each Science & the Congress Project briefing provide a breadth of resources on the briefing’s topic, including:

  • The speakers’ presentations.
  • Speaker biographical and contact information.
  • Supplemental links, documents, and articles.

I checked and it is possible to access the briefings and other information without a subscription. I hope the nanomaterials briefing will be available soon on the website soon. Here’s the page you should check.

US Environmental Protection Agency needs to do more about possible nanomaterial risks

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The US Environmental Protection Agency (EPA) has its own watchdog, the EPA Office of Inspector General. According to a Jan. 5, 2012 news item on Nanowerk that watchdog has published a report suggesting the EPA should do more to manage nanomaterials risks,

EPA has the statutory authority to regulate nanomaterials but currently lacks the environmental and human health exposure and toxicological data to do so effectively. The Agency proposed a policy under the Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA] to identify new pesticides being registered with nanoscale materials. After minimal industry participation in a voluntary data collection program, the Agency has proposed mandatory reporting rules for nanomaterials under the Federal Insecticide, Fungicide, and Rodenticide Act, and is also developing proposed rules under the Toxic Substances Control Act [TSCA]. However, even if mandatory reporting rules are approved, the effectiveness of EPA’s management of nanomaterials remains in question for a number of reasons:

  • Program offices do not have a formal process to coordinate the dissemination and utilization of the potentially mandated information.
  • EPA is not communicating an overall message to external stakeholders regarding policy changes and the risks of nanomaterials.
  • EPA proposes to regulate nanomaterials as chemicals and its success in managing nanomaterials will be linked to the existing limitations of those applicable statutes.
  • EPA’s management of nanomaterials is limited by lack of risk information and reliance on industry-submitted data.

The full report is titled EPA Needs to Manage Nanomaterial Risks More Effectively, Report No. 12-P-0162.

 

A few thoughts on business and nanotechnology

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In my response to a comment on yesterday’s posting I was not able to address the issue of  business’ role in nanotechnology safety efforts raised by this sentence,

Parents won’t leap for joy over the suggestion that their children must be exposed to these products, lest a company’s opportunity to move forward in marketing these products for profit be stymied.

As I don’t want to be misleading, it should be noted that the commenter is critical of my stance on risk and nanosunscreens and was using this comment to buttress a more comprehensive argument.

Reading the [July 7, 2011 corrected for grammar] comment earlier today was coincidental with my discovery yesterday of an article by a business owner (Scott Rickert, President and Chief Executive Officer of Nanofilm) about the proposed nanomaterials definitions in bills before the US House of Representatives and Senate (previously mentioned on this blog here).  From Taking the NanoPulse — Toxic Substance Meets Poison Thinking; New toxics legislation aims for safe. But is it sound? (Industry Week website) where Rickert discusses the Safe Chemicals bills and nanotechnology,

… for those of us in the nanotechnology field, there’s an additional wrinkle beyond the chemical formula of our products. Both the House and Senate version of the bill now include size, size distribution, shape and surface structure in the definition of a chemical’s “substance characteristic.” That means that over and above concerns about the chemical formula a nanotechnology company may be using, it may become suspect simply because of its nanoscale charactertics.

Am I worried? No. I know the people in this industry and I believe we have a track record that shows our care at policing ourselves. We’re not monsters. We have families, children and grandchildren, too. Make no mistake, we’re concerned about environmental health and safety in our industry. [emphasis mine] We have rules and programs in place. In addition, companies like mine have been working in special new voluntary reporting programs with the EPA. And, heaven knows, our whole industry has been educating scientists, governments, special interest groups and the general public about nanotechnology for a decade or more.

I think both the commenter and Rickert are right in entirely different ways and somewhat wrong in exactly the same way. Rickert goes on,

So what’s keeping me up at night? Not worries about toxicity and nanotechnology. We can handle that. I’m worried about toxicity in the law-making process. One of the Senate authors of the Bill says, “America’s system for regulating industrial chemicals is broken… Parents are afraid because hundreds of untested chemicals are found in their children’s bodies.”

Is that really where we want to start? Throwing open the door to panic — on both sides? I sat in on a nanotechnology industry conference call recently and the fear of a “witch hunt” was palpable.

If parents are terrified, they’re in the same boat as honest, responsible companies that are making products that improve lives and have long been committed to health and environmental causes. Do you think in this age of BP oil spills and late-night law-firm mesothelioma infomercials that businesses aren’t aware that preventing a problem is better than paying for it later?

To answer Rickert’s question, I think companies are quite aware of the risks and quite willing to pass them on to consumers and citizens in pursuit of an extra dollar.  With that, I’ve agreed with the commenter and now I’m going to agree with Rickert, there are honest responsible companies run by people who care about the environment and health.

Neither the commenter nor Rickert make a distinction I want to introduce about companies/businesses. A vast gulf exists between a small to medium-sized business and a multinational enterprise in terms of revenue and economic impact, perspective on responsibility, connections to their communities, and so on. Someone who’s built up their own business in their community is quite likely to have a different take on acceptable risks than someone who lives a continent away and has no direct ongoing contact with the community in which the business is operating.

Take for example,  Tony Hayward, Group Chief Executive, BP Oil. As I write this, BP Canada (BP Oil’s Canadian subsidiary) has started work on on a well for their coalbed methane project  in an area of British Columbia (Canada) that lies between the internationally famous Banff National Park and Waterton-Glacier International Peace Park which provides a corridor for mountain-dwelling wildlife who move between the two parks. From the news item on CBC (Canadian Broadcasting Corporation) News,

As oil continues to gush from a BP wellhead in the Gulf of Mexico, critics say the company has quietly broken ground on a controversial project in B.C.’s Rocky Mountains.

Opponents of the Mist Mountain project say they were surprised to find that BP Canada, an arm of the BP group of companies, began construction earlier this month on an exploratory well for its coalbed methane project near Fernie, B.C.

…

But Hejdi Feick, the director of communications for BP Canada, said British Columbians can be reassured that the company is a good corporate citizen.

“We are absolutely committed to doing this right,” she said Tuesday. “We have been very open and accessible over the last three years.”

That is little comfort for [Ryland] Nelson (from the group Wildsight), who said BP had promised to consult with the public every step of the way yet he only learned construction was underway when he went to the site Monday.

Nelson said the contractor on site told him they hope to bring in drilling equipment by the end of the month and start drilling this summer.

“Here they are, they’ve been working for nearly two weeks and nobody knew anything about it,” he said.

Remarkable here is how thoroughly tone deaf the company representative is to the reception this initiative is likely to enjoy. (By the way, I live in British Columbia.)

My point is that you can’t lump all businesses together as being thoroughly unethical in the pursuit of the almighty buck nor can you lump them together as honest, ethical entities being run by people who aren’t “monsters.” (Note: I believe that Rickert was using the word to make a point about business owners being people too. I have ruthlessly extracted that word from its natural placement to suggest that while  Hayward and his ilk may or may not be monsters, the consequences of their actions in the Gulf are monstrous.)

In the discussion about nanotechnology and safety I think we need to consider as many perspectives as possible without condemning everyone who represents business interests or being unduly naïve about competing interests. I do encourage you to read Ricket’s critique of the two Safe Chemicals bills as he brings up issues that would never have occurred to me and, I imagine, others who are not directly involved in the production of nanotechnology-enabled products.

Comparing nanomaterials definitions: US and Canada

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In light of yesterday’s (April 26, 2010) posting about Health Canada and their nanomaterials definition, Andrew Maynard’s April 23, 2010 post at 2020 Science (blog) is quite timely. Andrew has some details about new nanomaterials definitions being proposed in the both the US Senate and House of Representatives so that their Toxic Substances Control Act can be amended. From Andrew’s posting, an excerpt about the proposed House bill,

The House draft document is a little more explicit. It recommends amending section 3(2) of the original act with:

“(C) For purposes of this Act, such term may include more than 1 form of a substance with a particular molecular identity as described in sub-paragraph (A) if the Administrator has determined such forms to be different substances, based on variations in the substance characteristics. New forms of existing chemical substances so determined shall be considered new chemical substances.” (page 6)

with the clarification that

“The term ‘substance characteristic’ means, with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties of the chemical substance, including—

(A) chemical structure and composition

(B) size or size distribution

(C) shape

(D) surface structure

(E) reactivity; and

(F) other characteristics and properties that may bear on toxicological properties” (page 11)

Both the Senate bill and the House discussion document provide EPA with the authority to regulate any substance that presents a new or previously unrecognized risk to human health as a new substance. This is critical to ensuring the safety of engineered nanomaterials, where risk may depend on more than just the chemistry of the substance. But it also creates a framework for regulating any new material that presents a potential risk – whether it is a new chemical, a relatively simple nanomaterial, a more complex nanomaterial – possibly one that changes behavior in response to its environment, or a novel material that has yet to be invented. In other words, these provisions effectively future-proof the new regulation.

I prefer the definition in the draft House of Representatives bill to Health Canada’s because of its specificity and its future-oriented approach. Contrast their specificity with this from the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials:

Health Canada considers any manufactured product, material, substance, ingredient, device, system or structure to be nanomaterial if:

1. It is at or within the nanoscale in at least one spatial dimension, or;

2. It is smaller or larger than the nanoscale in all spatial dimensions and exhibits one or more nanoscale phenomena.

For the purposes of this definition:

* The term “nanoscale” means 1 to 100 nanometres, inclusive;

* The term “nanoscale phenomena” means properties of the product, material, substance, ingredient, device, system or structure which are attributable to its size [emphasis mine] and distinguishable from the chemical or physical properties of individual atoms, individual molecules and bulk material; and,

* The term “manufactured” includes engineering processes and control of matter and processes at the nanoscale.

You’ll notice the House of Representatives’ draft bill offers five elements to the description (chemical composition, size or size distribution [emphasis mine], shape, surface structure, reactivity, and other characteristics and properties that may bear on toxicological properties). So in the US they include elements that have been identified as possibly being a problem and leave the door open for future discovery.

The proposed legislation has another feature, Andrew notes that,

Both the Senate bill and the House discussion document provide EPA with the authority [emphasis mine] to regulate any substance that presents a new or previously unrecognized risk to human health as a new substance. This is critical to ensuring the safety of engineered nanomaterials, where risk may depend on more than just the chemistry of the substance. But it also creates a framework for regulating any new material that presents a potential risk – whether it is a new chemical, a relatively simple nanomaterial, a more complex nanomaterial – possibly one that changes behavior in response to its environment, or a novel material that has yet to be invented. In other words, these provisions effectively future-proof the new regulation.

As far as I can recall, Peter Julian’s (MP – NDP) tabled draft bill for nanotechnology regulation in Canada does not offer this kind of ‘future-proofing’ although it could be added if it is ever brought forward for debate in the House of Commons. Given the quantity of public and political discussion on nanotechnology (and science, in general) in Canada, I doubt any politician could offer those kinds of amendments to Julian’s proposed bill.

As for Canada’s proposed nanomaterials reporting plan/inventory/scheme, Health Canada’s proposed definition’s vagueness makes compliance difficult. Let me illustrate what I mean while I explain why I highlighted ‘size distribution’ in the House of Representatives draft bill by first discussing Michael Berger’s article on Nanowerk about environment, health and safety (EHS) research into the toxicological properties of nanomaterials. From Berger’s article,

” What we found in our work is that nanomaterials purchased from commercial sources may not be as well characterized as indicated by the manufacturer,” Vicki H. Grassian, a professor in the Department of Chemistry at the University of Iowa, tells Nanowerk. “For example, it might be stated that a certain nanoparticle is being sold as 30 nm in diameter and, although ’30 nm’ might be close to the average diameter, there is usually a range of particle sizes that can extend from as much as small as 5 nm to as large as 300 nm. [emphases mine]”

That’s size distribution and it reveals two problems with a reporting plan/inventory/scheme that uses a definition that sets the size within a set range. (Julian’s bill has the same problem although his range is 1 to 1000 nm.) First, what happens if you have something that’s 1001 nm? This inflexible and unswerving focus on size will frustrate the intent both of the reporting plan and of Julian’s proposed legislation. Second, how can a business supply the information being requested when manufacturers offer such a wide distribution of sizes in  products where a uniform size is claimed? Are businesses going to be asked to measure the nanomaterials? Two or three years or more after they received the products? [Aug.4.10 Note: Some grammatical changes made to this paragraph so it conveys my message more clearly.]

Then Berger’s article moves onto another issue,

Reporting their findings in a recent paper in Environmental Toxicology and Chemistry (“Commercially manufactured engineered nanomaterials for environmental and health studies: Important insights provided by independent characterization”), among other problems Grassian and first author Heaweon Park also discuss the issue of batch-to-batch variability during the production of nanoparticles and that some nanomaterials which were being sold as having spherical morphology could contain mixed morphologies such as spheres and rods [emphases mine].

That’s right, you may not be getting the same shape of nanoparticle in your batch. This variability should not pose a problem for the proposed reporting plan/inventory/scheme since shape is not mentioned in Health Canada’s definition but it could bear on toxicology issues which is why a plan/inventory/scheme is being proposed in the first place.

Interestingly, the only ‘public consultation’ meeting that Health Canada/Environment Canada has held appears to have taken place in 2007 with none since and none planned for the future (see my April 26, 2010 posting).

Apparently, 3000 stakeholders have been contacted and asked for responses. I do wonder if an organization like Nano Quebec has been contacted and counted not as a single stakeholder but as representing its membership numbers (e.g. 500 members = 500 stakeholders?) whatever they may be. There is, of course, a specific Health Canada website for this interim definition where anyone can offer comments. It takes time to write a submission and I’m not sure how much time anyone has to devote to it which is why meetings can be very effective for information gathering especially in a field like nanotechnology where the thinking changes so quickly. 2007 seems like a long time ago.

Finally, Dexter Johnson on his Nanoclast blog is offering more perspective on the recent Andrew Schneider/National Nanotechnology Initiative dust up. Yes, he gave me a shout out (and I’m chuffed) and he puts the issues together to provide a different perspective on journalistic reporting environment, health and safety issues as they relate to nanotechnology along with some of the issues associated with toxicology research.