Category: Environment

More New Interpretations of Federal Statutes: Pesticides

Posted Aug.15, 2010 under Chemicals, Environment, Governmental Interaction, Health, Regulation, Safety, Statutes
www.singularityhub.com

www.singularityhub.com

I previously discussed the recent efforts to expand and revise the interpretations of the Toxic Substances Control Act (TSCA) and the Food, Drug and Cosmetic Act (FDCA) to reach nanotechnology.  Simultaneously, efforts have been ongoing to expand and revise the interpretation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) – the federal pesticide statute – to similarly encompass nanotechnology.  In particular, the proposed interpretation would require any nanoscale material used in a pesticide to be considered a new substance, and subject to adverse effects determinations in place for new substances, even if a non-nanoscale form of the same material has already been in a product registered under the act.

 This proposed FIFRA interpretation is clearly part of the trend to bring nanotechnology under existing regulations and confirm the authority of existing agencies to make determinations about the safety of nanomaterials.  But is this a good idea?

 One bone of contention in the proposed FIFRA interpretation is the proposed application of Section 6(a)(2) to require pesticide manufacturers to report the deliberate inclusion of intentionally produced nanomaterials in their products.  Section 6(a)(2) is often referred to as the “adverse effects” section of FIFRA.  The implication, therefore, would be that nanomaterials would be presumed to have adverse effects.  EPA says otherwise, however, stating that the proposed interpretation would emphasize data collection, while also including adverse effects.  EPA also says that the proposed interpretation would reach substances other than nanomaterials.

 The nanotechnology-related industries have reacted with sharp criticism of the proposed interpretation, though they continue to recognize that regulation is inevitable.  Several industry groups, most notably the American Chemistry Council, have expressed concern that the proposed interpretation would “stigmatize” all uses of nanotechnology in pesticides, especially because it would use the “adverse effects” section of FIFRA as the primary means of regulation.  They say other sections of FIFRA would be more neutral and less stigmatizing.  This may be the case and deserves further consideration.  On the other hand, if those other sections do not permit EPA to conduct the kind of safety analyses permitted under Section 6(a)(2), there would be no advantage to the public in applying the other sections instead.

 Furthermore, industry groups have rallied around the general debate over the health and safety of nanomaterials.  FIFRA officials have cited existing studies tending to show risks to human health and the environment from nanomaterials.  An industry group, the Silver Nanotechnology Working Group, has claimed that concerns for health and the environment are overstated, insisting that long-term data show nanomaterials to be safe.  This debate seems to be premature.  It makes little sense at such an early juncture – when some data exists, but more is clearly warranted – to argue that minimal regulation is the best way to go.

 Another major concern of industry has been the costs of preparing and producing the data that would be required under the proposed interpretation.

 (The reactions of government officials and industry mentioned above were reported in:  Pat Rizzuto, EPA Developing New Interpretation, Policy on Pesticide Law for Nanoscale Ingredients, 121 Daily Env’t Rpt. (BNA) B-1 (June 25, 2010).)

 As I’ve said before, there are positives and negatives to the trend of broadening the interpretation of existing federal statutes to include nanotechnology.  Some may be:

 Positives:

●  No need to wait for Congress to act

●  Officials are already familiar with the statutes, so start-up would be minimal

●  Health and environmental concerns would start to be addressed without substantial delay

●  Nanotechnology’s discrete uses may best be regulated within statutes and by agencies that are more specialized, each dealing with different uses

 Negatives:

●  Is piecemeal regulation the best way to go, or is wholesale regulation a better approach?

●  Industry’s concerns may be ignored as the existing agencies go forward with the new interpretations

●  Potential conflicting decisions and interpretations among the various federal statutes

●  It is not at all clear that existing regulation, even if reinterpreted, reaches all of the unique issues presented by nanotechnology

 ***These concerns, and others, should be weighed in determining the best way to regulate nanotechnology.***

1 Comment

Following the TSCA Bill

Posted Aug.01, 2010 under Chemicals, Environment, Governmental Interaction, Health, Nanotubes, Regulation, Research, Safety, Statutes
www.h20technologies.com

www.h20technologies.com

I previously commented on the House bill that would amend the Toxic Substances Control Act (TSCA) by updating it to include more substances, more disclosure, and expedited review by EPA.  On July 29, 2010, the House Energy and Commerce Committee’s Subcommittee on Commerce, Trade, and Consumer Protection held a hearing on the bill (H.R. 5820).  Certain themes emerged from this hearing.

 Theme 1:  The Economy.

 ●  Jobs.  All agreed that a major goal should be to avoid the loss of more jobs.  This may mean that legislation updating TSCA may proceed more slowly than the current bill would require.  This, in turn, would stall regulation of nanotechnology through TSCA.

 ●  Expense and difficulty of compliance.  Cal Dooley, President and CEO for the American Chemistry Council, representing the large chemical manufacturers in the industry, expressed concern that the increased burden and costs on manufacturers, and the longer time frame for EPA to review submissions, would result in a delay in bringing new chemicals to market and would force manufacturers to other countries.  He stated:  “We would export innovation and jobs instead of products.”

 ●  Foreign competition.  This theme was especially emphasized by Beth D. Bosley on behalf of the Society of Chemical Manufacturers and Affiliates (SOCMA), representing small chemical manufacturers.  She argued that H.R. 5820 “poses overwhelming challenges for the industry,” including the loss of innovation and chemical manufacturing to foreign markets.  She feared that the “substantive loss of high-paying manufacturing jobs will result.”

 Theme Two:  Defining a Scientific Standard

 ●  The Hearing indicated that this is certain to be a sticking point in the debate to come over H.R. 5820.

 ●  Cal Dooley of the American Chemistry Council stated:  “[T]he safety standard as established in this bill sets such an impossibly high hurdle for all chemicals in commerce that it would produce technical, bureaucratic, and commercial barriers so significant they would be the law’s undoing.”

 ●  In contrast, Richard Denison, a Senior Scientist of the Environmental Defense Fund, praised H.R. 5820 for assuring that “the best and latest science” be used for risk-based safety determinations.

 Theme Three:  Impact on Industry Innovation

 ●  Some witnesses presented testimony that H.R. 5820 would spur industry innovation by raising U.S. chemical standards to a level that would allow American companies to compete in a global economy where disclosure of information has become important.

 ●  In contrast, as the representatives of the chemical industry argued, concerns exist that innovation in the chemical industry will be exported abroad and that proprietary information will be compromised.

 What about nanotechnology?

 Though not a pervasive theme, the Hearing had some mention of nanotechnology.  Richard Denison, a Senior Scientist with the Environmental Defense Fund, said the following about the current state of nanotechnology regulation:

 “EPA has had little choice but to resort to pleading with the emerging nanotechnology industry to provide, through a voluntary program, the most basic information EPA feels it needs to decide how best to regulate these materials – only to see a level of participation best described as paltry.  Such materials can by no means be assumed to be benign; for example, one class of nanomaterials – multi-walled carbon nanotubes – behaves in a manner that is ominously similar to asbestos.”

 http://energycommerce.house.gov/documents/20100729/Denison.Testimony.07.29.2010.pdf

 Regulation of nanotechnology is coming, one way or another.  It is time to have a full discussion and debate on how best to achieve that, for the interests of the public, workers, and industry.  Currently, it appears that debate on the bill will resume in earnest when the next Congress convenes.  Let’s hope that the debate addresses these critical questions.

 Transcripts and video from the hearing may be accessed at

 http://energycommerce.house.gov/index.php?option=com_content&view=article&id=2095:hearing-on-hr-5820-the-toxic-chemicals-safety-act-of-2010&catid=129:subcommittee-on-commerce-trade-and-consumer-protection&Itemid=70

2 Comments

A Tale of Two Bills – Nudging Toward Nanoregulation

Posted Jul.27, 2010 under Cosmetics, Environment, Governmental Interaction, Health, Products Liability, Regulation, Research, Safety, Statutes

prod liab imageIt’s fair to say that the United States has not yet tiptoed into the waters of regulating nanotechnology directly.  Rather, new efforts at regulation of chemicals and consumer products tend toward indirect regulation.  That is, these efforts would strengthen and expand existing federal regulation.  Two examples are recent bills introduced in the House of Representatives that would amend the Toxic Substances Control Act (TSCA) and the Food Drug and Cosmetic Act (FDCA) for substances and products that may or may not contain nanomaterials.  As discussed in a previous entry in this blog, placing nanomaterials under the same regulatory standards as non-nano substances is a subject that requires discussion on its own.

 Is the current trend toward indirect regulation a good idea?  It’s certainly easier and more efficient in the short run to promulgate broad regulations that encompass a variety of substances and uses, and to amend existing statutes.  And there is no doubt that these statutes needed updating to reflect scientific advancement and new risks.  But there is a danger that regulators – and the public – would be left with the impression that once these statutes have been updated, all substances are sufficiently regulated.  With the products of nanotechnology being so diverse, it is likely that many substances would slip through the cracks of the new legislation.

 Let’s look at the two recently introduced bills.  The Toxic Chemicals Safety Act of 2010 (H.R. 5820) would amend TSCA by requiring the chemical industry to provide EPA with minimum essential data on chemical characteristics, toxicity, exposure, and use, whereupon EPA would undertake an expedited process to reduce exposures to toxic substances in the population.  An important feature of the bill provides for public disclosure of non-confidential and otherwise non-exempt information.  The text of the bill may be found at

http://energycommerce.house.gov/documents/20100722/HR5820.pdf

The current text of TSCA is at 15 U.S.C. §§ 2601 et seq.

The other recently introduced bill is the Safe Cosmetics Act of 2010 (H.R. 5786), which contains provisions for protecting consumers from carcinogenic and other toxic ingredients in certain previously unregulated household products, such as perfumes, shaving creams, shampoos, and deodorants.  Like the proposed TSCA amendment, a major purpose of this bill is to update the existing FDCA and its regulations and to disclose the information regarding hazards to the public, in this case primarily through product labels.  Currently, the cosmetics industry is mostly self-regulated, and members of the industry have complained that this new bill lacks appropriate standards and would place an undue burden on the FDA.  Instead, the industry has proposed its own new requirements.

 H.R. 5786 also references nanoparticles, clearly indicating that nanotechnology was intended to be part of the amendment.  For example, Sec. 618(a)(5) requires that cosmetic manufacturers submit various information to the FDA, including “the ingredient list as it appears on the cosmetic label or insert, including the particle size of any nanoscale cosmetic ingredients.”  Sec. 618(e) goes on to authorize the Secretary of Health and Human Services to require that

 “(1) minerals and other particulate ingredients be labeled as ‘nano-scale’ on a cosmetic ingredient label or list if not less than 1 dimension is 100 nanometers or smaller for not less than 1 percent of the ingredient particles in the cosmetic; and

(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.”

 The text of this bill may be found at

http://www.govtrack.us/congress/billtext.xpd?bill=h111-5786

 Both bills seem to be a step in the right direction.  But in the context of nanotechnology, complicated questions persist.  For example:

●  Would these updated statutes reach the products of nanotechnology as effectively as they would reach substances and products that have no nano-contents?

 ●  Because benign substances may behave differently at the nanolevel, would such regulation miss potential toxic effects?

●  What science would be behind the decisions to disclose toxicity?

●  Should nanotechnology be regulated separate from chemicals and consumer products?

● Which alternative makes the most sense?

 These and others are the questions that Congress and regulators – and all those who may be potentially exposed – need fully discussed in the coming months and years.

2 Comments

A Digression Lesson: What Nanotechnology Can Learn from the Climate Change Litigation

Posted Jun.03, 2010 under Environment, Litigation, Toxic Torts
usalawyerstoday.com

usalawyerstoday.com

Law sometimes happens in peculiar ways.  And none so peculiar as the Fifth Circuit Court of Appeals’ recent dodging of the important issues raised by climate change litigation.  What happened (or rather, didn’t happen) is so important that it merits a digression here.  It also suggests ways that courts can make law without seeming to make law, especially when the cases involve new claims, new theories, and even new technologies.  The Fifth Circuit’s maneuver should serve as a warning – and a reminder of the clever traps of procedure – to those who attempt novel theories in the era of new technology.

 Here’s what happened.  Property owners and other residents along the Mississippi Gulf coast brought a tort action against oil companies, electrical companies, and utilities, claiming that the defendants caused massive emissions of greenhouse gases that contributed to global warming, which, among other things, added to the power of Hurricane Katrina.  They sought compensation for property damage from Katrina.  The lower court dismissed the action on a pretrial motion, and the plaintiffs appealed to the Fifth Circuit Court of Appeals.  The 3-judge Fifth Circuit panel (“the panel”) reversed and held that the action could go forward, Comer v. Murphy Oil USA, 585 F.3d 855 (5th Cir. 2009), but that decision was vacated when the Fifth Circuit accepted the case for a full-bench (“en banc”) rehearing.  A number of judges recused themselves from the rehearing, presumably because of potential conflicts of interest with the case.  Last week, the Fifth Circuit said that because the court no longer had a quorum of judges, it was not empowered to rehear the case, so it dismissed the appeal and reinstated the lower court’s dismissal of the action.

 Is it really so easy to circumvent our judicial processes?

 Why is this procedural maneuver important, and what does it have to do with nanotechnology?

The net effect was to reinstate a lower court ruling over the Fifth Circuit panel’s own decision.  That lower court ruling was a dismissal of the lawsuit.  What was unusual was that the Fifth Circuit did this without considering the issues raised on appeal.  In other words, the case was decided on a technicality.  In so ruling, the Fifth Circuit rejected a variety of measures that would have allowed the rehearing to go forward.  If the court had wanted to continue with the rehearing en banc, it could have found a way.

 Nanotechnology tort actions will arrive in the courts soon enough, raising unprecedented issues (and yes, some old issues as well).  It is important that those issues (new and old) received full consideration.  The law favors deciding cases on the merits, not dodging difficult controversial and new issues.  Moreover, nanotechnology litigation will involve many industries, enormous and small, so the notion that judges may have to recuse themselves is not far-fetched.

 Most judges have past connections with big industry in this country, whether it is oil and utility companies, pharmaceutical companies, nanomaterial firms, or anything else.  They had clients who either were those companies or who were engaged in business or litigation with or against those companies.  They had investments of their own.  Their legal practices, government service, or other pre-judicial professional obligations involved them with many law firms and attorneys.  It is important that judges recuse themselves when there is the potential for a conflict of interest or even just the appearance of a conflict of interest.  But if courts will decline to hear cases because too many of their judges must recuse themselves, then the parties, and all of us, will end up on the losing side.

 And that’s not justice.

2 Comments

Judicial Nano Standards?

Posted May.27, 2010 under Environment, Governmental Interaction, Litigation, Nanotoxicology, Regulation, Safety, Statutes
usalawyerstoday.com

usalawyerstoday.com

It is safe to say that the current state of nanotech litigation is embryonic.  There are only a handful of cases dealing with the validity of rules governing nanomaterials, and the results are
resoundingly similar – deference to the rule maker.  In Kennecott Greens Creek Mining Co. v. Mine Safety and Health Admin., 476 F.3d 94, 946 (D.C. Cir. 2007) (a three year old case that accurately represents the issue in the few cases brought before the courts), judicial review was sought regarding three regulations promulgated by MSHA. Specifically, the rules were implemented to require mining operations to utilize new engines that reduced the emission of diesel particulate matter, but it was argued that those same engines produced high levels of nanoparticle emissions  in the process.  On appeal, the court disagreed with the mine owners and took a complete deferential approach because the risks associated with nanoparticles, at this point, are speculative at best until further developments.

We should expect to see similar types of cases with the same results for some time or until there is solid proof of a substantial problem.

In June 2009, the EPA Nanomaterial Research Strategy released a list of eight questions that need to be considered to determine the risks involved with nanotechnology and quite possibly could become the nexus for non-deferential judicial opinions in the future.  Kristine L. Roberts, Nanotechnology and the Future of Litigation, LITIGATION NEWS,
Winter 2010, at 6, 8.  The list on page eight includes the following inquiries:

1) What advances in technology must occur to detect and quantify nanomaterials in the environment and biological material?
2) What are the major environmental impacts?
3) What are the exposure risks?
4) What are the effects on our health?
5) What are the ecological effects?
6) How many risk assessment approaches need to be amended/created?
7) Which nanomaterials have a high potential for release?
8)Can manufactured nanomaterials be utilized in a sustainable manner?

This list, at first glance, seems like a blunt tool when compared to the enormity of what it is attempting to procure.  However, this is one of the first proactive steps with regard to whom is going to be accountable for what in future ligation involving nanotechnology – litigation that should include more applicable standards based on
concrete information instead of automatic deference due to lack of knowledge.

1 Comment

The Exposure Chain

Posted May.19, 2010 under Environment, Governmental Interaction, Health, Nanobiotechnology, Research, Safety
www.singularityhub.com

www.singularityhub.com

 

 

 

The President’s Cancer Panel’s Report, referenced in my previous post, makes many important statements about cancer.  One summary statement stands out.  The PCP states:

“Single-gene inherited cancer syndromes are believed to account for less than 5 percent of malignancies in the United States.  An unknown percentage of cancers develop due to normal endogenous [internal] processes [such as aging]. . . . Other cancers develop as a result of exogenous [outside of the body] factors, some of which are controllable.”

Report, Sec. 1, at 1.  The PCP then goes on to point out that the existing studies of the relationship of environmental exposures to cancer are out of date, but that even newer studies cannot take into account the many synergistic effects of multiple exposures in the environment that could lead to cancer.

Part of this problem is due to the complex chain of exposures.  The PCP summarizes the chain as follows:

Use of chemicals or other substances in industry and agriculture:  exposure of workers

Dispersal of  contaminants through:

Soil

Air

Water

Consumer products

Entry of the contaminants into the human body through various routes, which may impact both somatic cells and germ cells (egg and sperm)

Occurrence of higher levels of toxic and hormone-disrupting substances in women, including maternal blood, placental tissue, and breast milk

Transference of the substances from the mother to the next generation can occur to the fetus in utero or to a breast-feeding infant

Because the substances may interfere with the genes of the parents, without directly causing disease in the parents, these genes may predispose future generations to cancer.  This transference of the propensity to cause cancer may go from the parents’ genes to the next generation and beyond.

 In one of only a few references to nanotechnology in the Report, the PCP said:  “Limited research to date on unintended health effects of nanomarterials, for example, suggests that unanticipated environmental hazards may emerge from the push for progress.”  Report, Exec. Summary, at iii.

Where does nanotechnology fit into the chain?  At least theoretically, at every stage.  But nanotechnology is a complicating factor in an already complex scientific task.  As a kind of facilitating system – or delivery system, for lack of a more accurate description – nanotechnology may change the characteristics of the substances the technology interfaces with.  This may occur at the earliest stages of developing a use for nanomaterials, but its ultimate impact may not be seen or even measurable for years or generations.  Very little is known about this process.  At the nanolevel, some substances may be absorbed into the human body in unanticipated ways.  Now place this into the exposure chain, and the problems of characterizing and measuring risk increase exponentially.

 I will continue to sort through the Report and its relevance to nanotechnology in future posts.

http://www.cdc.gov/exposurereport/pdf/FourthReport.pdf

Leave a Comment

Report of the President’s Cancer Panel – What’s Nano Got To Do With It?

Posted May.07, 2010 under Environment, Governmental Interaction, Health, Regulation, Research, Safety

prod liab imageRecently, the President’s Cancer Panel released its report, “Reducing Environmental Cancer Risk: What We Can Do Now,” which made the bold and distressing statement that “the true burden of environmentally induced cancer has been grossly underestimated.”  Currently, there are approximately 80,000 chemicals on the market in the United States many of which are likely carcinogens that are used by most Americans on a regular basis in their daily lives.  The risks of these carcinogenic substances have a significantly greater impact on children than adults.  The Panel observed that most of these chemicals are “un- or understudied and largely unregulated.”  Among other things, the Panel concluded that research on the environmental causes of cancer has taken a back seat to research on the genetic and molecular mechanisms that cause cancer.  Research into the environmental causes of cancer has been given low priority and insufficient funding, they say.

 What does this report on chemicals and cancer have to do with nanotechnology?  The long-term health risks of nanotechnology are currently unknown.  If, as the Panel states, only a few hundred of those existing 80,000 chemicals have been tested for safety to date, where does that put emerging technologies such as nanotechnology?  Right now, at the bottom of the list.  And if the Panel’s recommendations are implemented, it is likely that available resources will be consumed by studying a fraction of those 80,000 chemicals.

 The Panel identified the following barriers to effective regulation of environmental contaminants:

 “(1) inadequate funding and insufficient staffing,

(2)   fragmented and overlapping authorities coupled with uneven and decentralized enforcement,

(3)   excessive regulatory complexity,

(4)   weak laws and regulations, and

(5)   undue industry influence.”

 It is worth considering the degree to which each one of these barriers to effective regulation may apply to nanotechnology, either now or in the coming months and years.

 Given this state of affairs, what is to be done?  One might reasonably ask:  Why should the public bear the burden of proving that an environmental exposure is harmful?  Would it make more sense to have industry – those developing the substances and placing them on the market – conduct the studies on the human environmental impacts in the first instance?  When it comes to consumer products, it seems that it is only after the fact – after harm has come to persons exposed – that the requisite depth of study is conducted.

 This is an ongoing discussion.  I will be examining other aspects of the Panel’s report in relation to nanotechnology in future posts.

 The report may be found at

 http://deainfo.nci.nih.gov/advisory/pcp/pcp08-09rpt/PCP_08-09_508.pdf

1 Comment

Nanotechnology and Government Alphabet Soup

Posted May.01, 2010 under Environment, Governmental Interaction, Health, Regulation, Safety, Statutes
www.inoxpa.com

www.inoxpa.com

As I’m reading some material on the federal National Nanotechnology Initiative (NNI) web site, I am struck by the breathtakingly broad scope of nanotechnology and its incorporation into useful products that reach into every facet of life.  The NNI coordinates funding for nanotechnology R & D across 25 federal departments and agencies.  NNI promotes the development and use of the technologies through NNCO (the National Nanotechnology Coordination Office) and the NSET Subcommittee (the Nanoscale Science, Engineering, and Technology Subcommittee), and of course those 25 federal departments and agencies.  NNI also is involved in coordinating research strategies for studying the effects of nanotechnology on the environment and on the public’s health and safety.  But so far it has not taken any specific position on regulation.

 

To demonstrate what regulation could look like, it’s useful to think about the many departments, agencies, and federal acts or regulatory measures that could come within the jurisdictional scope of nanotechnology and nanosubstances.  To name just a few:

 

Department of Agriculture

Department of Labor

Department of Homeland Security

Department of the Interior

Health and Human Services

Department of Energy

Etc.

 

FDA (Food and Drug Administration)

FDCA (Food, Drug, and Cosmetic Act)

EPA (Environmental Protection Agency)

CWA (Clean Water Act)

CAA (Clean Air Act)

OSHA (Occupational Safety and Health Administration)

PEL (Permissible Exposure Limits)

NIOSH (National Institute of Occupational Safety and Health)

NSF (National Science Foundation)

FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act)

NEPA (National Environmental Protection Act)

TSCA  (Toxic Substances Control Act)

CPSC (Consumer Product Safety Commission)

FHSA (Federal Hazardous Substances Act)

SDWA (Safe Drinking Water Act)

To name only a few . . .

 

The point of this alphabet soup exercise is that nanotechnology impacts so many facets of society that developing an approach to regulation will be difficult at best.  Leaving regulation to individual agencies will by its nature be narrow, thereby missing many issues.  But broad regulation – such as a new department along the lines of Homeland Security – may lack coherence and control.  As nanoproducts proliferate and nanotechnology becomes more pervasive, regulation will come, and it must strike a balance between these two poles.

1 Comment

Risk and State of the Art

Posted Apr.13, 2010 under Cosmetics, Environment, Governmental Interaction, Health, Litigation, Products Liability, Safety, Toxic Torts
usalawyerstoday.com

usalawyerstoday.com

In product liability litigation, product sellers often rely on the so-called state-of-the-art defense.  By raising this defense, the seller – usually the product manufacturer – argues  that the risks or hazards of the product complained of in the current litigation were not known to it at the time the product was designed, marketed, and sold to the user or consumer.  As with everything in the law, arguments abound as to how to define the state of the art.  For example, manufacturers have argued that the state of the art should be defined as the industry standard at the time.  This was essentially the argument made by asbestos insulation products manufacturers in the seminal case of Borel v. Fibreboard  Paper Products Corp., 493 F.2d 1076 (5th Cir. 1973).  The court had a very different view, however.   Reflecting concerns that using the industry standard to define the state of the art at any point in time would encourage entire industries to be lax in conducting research on the hazards of their products and/or disseminating information about known hazards to the public, the court held the manufacturers to the standards of experts in the industry.  The court defined this as follows:

The manufacturer’s status as an expert means that at a minimum he must keep abreast of scientific knowledge, discoveries, and advances and is presumed to know what is imparted thereby.  But even more importantly, the manufacturer has a duty to test and inspect his product.  The extent of research and experiment must be commensurate with the dangers involved.

Id. at 1089-90.

Plaintiffs, on the other hand, prefer to define the state of the art to reflect technology on the cutting edge of scientific knowledge at the relevant time.  This concept would limit use of the state-of-the-art defense to a much smaller group of cases and result in broad liability for product sellers.  This view completely ignores whether making the product safer was feasible at the time or whether the utility of the product was greater than the possibility of any dangers it might create.  At the extreme, sellers could be absolutely liable for any and all injuries from their products.  Thus, in Beshada v. Johns-Manville Products Corp., 447 A.2d 539 (N.J. 1982) – another asbestos failure-to-warn case – the court refused to recognize the state-of-the-art defense on policy grounds because the manufacturers were in a better position to bear the losses associated with their products, and spread those costs, than the injured victims.

But the prevailing view allows product sellers to rely on state of the art as a defense to claims for defective products.  The Third Restatement of Torts:  Products Liability (1998) refers to “the foreseeable risks of harm” as a basis of liability for defective design and failure to warn of the hazards of a product.  But what is foreseeable?  All lawyers know the answer to that question is unclear and very fact specific.

Which brings us to the risks of nanotechnology.  What should we demand of sellers of nanotechnology and the products making use of the technologies?   Should the burdens of research into the risks be greater or less because the technology is developing?  Whether or not regulation occurs, personal injury litigation will arise at some point.  It seems inevitable, given the course of other consumer and workplace products.

One thing is clear:  It will not suffice for defendants to argue that they were not aware of the potential hazards of their products if they did not conduct research into the health and safety impacts and apprise themselves of all other available and pertinent research results.  If concerns arise from initial research (as they have in some studies of nanoparticles), their obligation is to conduct further research and to use the information in product design decisions or to provide sufficient warnings.  The words of the Court of Appeals in Borel resonate here:  “But even more importantly, the manufacturer has a duty to test and inspect his product.  The extent of research and experiment must be commensurate with the dangers involved.”

Leave a Comment

Initial Thoughts on Regulation

Posted Apr.09, 2010 under Environment, Governmental Interaction, Health, Regulation, Toxic Torts
www.h20technologies.com

www.h20technologies.com

We are seeing an explosion of interest in and information about nanotechnology, its uses and its risks.  The law has yet to develop in this field.  I am pleased to start the conversation in this blog on the legal issues that are beginning to emerge about nanotechnology.  My entries will focus on efforts to determine what risks the new technologies may pose to consumers and the population in general.  My expertise in the area of toxic tort law is uniquely suited to examining the emerging health concerns from the viewpoint of anticipated litigation.  My co-blogger, Eric Laury, Widener Law ’11, will focus on the legal issues involving the development and use of the technologies, including intellectual property matters.  This blog is not intended to be a news source, though it will provide some links to stories in the news that bear upon our commentary.  Rather, we intend to analyze and question the developments as they emerge, and to place them in a legal context that will be useful for attorneys, regulators, and other legal observers.  We hope that our observations will begin the discussion and debate over the legal ramifications of nanotechnology.

Every week, numerous developments are reported in the media, but I will give my attention here to just one of them.  On March 25, 2010, the President’s Council of Advisors on Science and Technology (P-CAST) issued its report on the Third Assessment of the National Nanotechnology Initiative.  Among many other things, P-CAST calls for “clear principles” for identifying the environmental, health, and safety risks of nanotechnology.  To implement this, the report recommends further development of the existing cross-agency strategic plan to link research activities and information sharing and suggests that “member agencies increase coordinated efforts to overcome barriers to effective, sustainable, and responsible commercialization of nanotechnology.”

This is vague, suitably so for the first steps toward regulation.  One might question, however, the laissez-faire approach that it supports.  To start the discussion on examining the risks of nanotechnology, it is worthwhile to consider how the Government might regulate the products of these technologies.  What would regulation of the health and environmental impacts of nanotechnology look like?  One possibility is the current P-CAST proposal – interagency exchange of information with an individual directing interagency coordination efforts.  Another model would be the creation of an umbrella agency to manage nanotechnology, including the health, environmental, and safety risks of products using the technology.  This concept would take all nanotechnology-related matters away from other agencies – which, presumably, have at least some experience with handling new technologies – and place them within the authority of the new agency.  Another model might be creating a Department of Science and Technology along the lines of the Department of Homeland Security, though determining which agencies – or which parts of which agencies – would fall within the authority of a new Department would be problematic.  Finally, we could leave well enough alone and let existing agencies regulate individual uses of nanotechnology as they arise.  Under this incremental approach, for example, the FDA could regulate medical uses of nanotechnology on a use-by-use basis.

We need to think now about regulating nanotechnology and about what structure that regulation should take.  The history of toxic tort litigation is strewn with products that were allowed on the market with little or no health and safety regulation.  The result was massive health risks, seemingly endless litigation, and studies done too long after the fact.  Just consider the course of asbestos litigation.

www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-nano-report.pdf

2 Comments