Category: Statutes

U.S. Supreme Court to Address an Issue Left Open in Bilski

Posted Jul.21, 2011 under Bionanotechnology, Litigation, Nanomedicine, Patents, Statutes, Supreme Court

supctIn 2010, the U.S. Supreme Court issued a closely-watched decision on patentable subject matter under § 101 of the Patent Act, Bilski v. Kappos, 130 S. Ct. 3218 (2010).  The Court has now granted cert in another case on patentable subject matter – Prometheus Laboratories, Inc. v. Mayo Collaborative Services, in which the Federal Circuit Court of Appeals held in 2010 that certain medical inventions met the requirements of patentable subject matter in § 101.  Prometheus was the sole and exclusive licensee of certain patents that claim methods for determining the optimal dosage of thiopurine drugs used to treat gastrointestinal and non-gastrointestinal autoimmune diseases.  When Prometheus sued Mayo for patent infringement, Mayo filed a motion for summary judgment of invalidity, arguing that the patents in question were invalid because they claimed subject matter unpatentable under the Patent Act, 35 U.S.C. § 101. Specifically, Mayo argued that the patents impermissibly claimed natural phenomena – i.e. the correlations between drug metabolite levels and efficacy and toxicity – and not patentable inventions.  In 2008, the district court granted Mayo’s motion for summary judgment of invalidity.

In 2009, the Federal Circuit reversed and upheld the patents under the “machine or transformation” test (the sole test at the time).  The U.S. Supreme Court then decided Bilski v. Kappos, which we discussed in this blog a year ago.  In Bilski, the Court rejected the “machine or transformation” test as the definitive test of patentability, relegating that test to one factor – “a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101.”  130 S. Ct. at 3227.  The Supreme Court then granted Mayo’s petition for certiorari in the Prometheus lawsuit, vacated the Federal Circuit’s 2009 decision, and remanded the case for further proceedings consistent with Bilski.  The Federal Circuit decided the case on briefs, without further oral argument, and held, in light of Bilski, that Prometheus had recited patentable subject matter under § 101.  628 F.3d 1347 (Fed. Cir. 2010).  Once again, the Supreme Court granted certiorari, and the Court will hear the case in the term that begins in October, 2011.

Although the Supreme Court has consistently construed § 101 broadly, the section does have limits.  The Federal Circuit described one limitation as follows:

The Supreme Court has . . . established that while a law of nature, natural phenomenon, or abstract idea cannot be patented, “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”

628 F.3d at 1354 (quoting Bilski, 130 S.Ct. at 3230) (emphasis added).  This is the core of the issue to be decided by the Supreme Court. 

As my co-blogger, Eric Laury, now J.D., stated in his earlier post about Bilski, “biotech and nanotech patents are not theoretically involved with . . . a machine nor do they transform matter.”  Bilski was good news for the bionanotech industry, but the case left loose ends.  Now it appears that the Supreme Court will take another step in the direction of defining patentable subject matter for the brave new world of modern inventions.  Nanotech firms, particularly those working in the area of biotechnology, should be closely watching the Supreme Court’s next move.

Mayo presented the following question in its cert petition:  “Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve ‘transformations’ of body chemistry.”

I suspect the fact that the Court granted cert a second time in Mayo v. Prometheus may not be a good sign for Prometheus.  It may mean that the Court had been expecting the Federal Circuit to reach the opposite result and wants to set the record straight.  On the other hand, the Court may further refine its definition of patentable subject matter under § 101 in a way that may achieve middle ground between innovation and patent protection.

The Federal Circuit’s 2010 decision may be accessed at

http://www.cafc.uscourts.gov/images/stories/opinions-orders/08-1403.pdf

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Supreme Court Rules in Favor of i4i Limited Partnership in Closely Watched Patent Case

Posted Jul.13, 2011 under Bionanotechnology, Litigation, Patents, Statutes, Supreme Court

supctEarlier I reported here on Microsoft Corp. v. i4i Limited Partnership, then subsequently on the oral argument before the U.S. Supreme Court.  The case arose from a patent infringement dispute relating to the method for editing computer documents, but generated wide-ranging interest in the business community, including developers of nanotechnology-based inventions, because of the broad legal issue addressed.  i4i sued Microsoft for patent infringement, and Microsoft defended on the ground that i4i’s patent was invalid.  The federal district court gave a jury instruction that the invalidity of a patent had to be proved by “clear and convincing” evidence.  Despite Microsoft’s arguments that it should be easier to prove invalidity of a patent (such as by applying a preponderance-of-the-evidence standard) in patent infringement litigation, the federal district court, Federal Circuit Court of Appeals, and the U.S. Supreme Court (in an 8-0 decision) all decided that the clear and convincing standard applied.

Justice Sotomayor, writing for the unanimous Court, 131 S. Ct. 2238 (2011), based the Court’s decision squarely on Section 282 of the Patent Act, 35 U.S.C. § 282, which provides a presumption of validity to patents, and on longstanding common-law doctrines.  The Court deferred to the judgment of Congress in the Patent Act, saying that “[w]here Congress has prescribed the governing standard of proof, its choice controls absent ‘countervailing constitutional constraints.”  (p. 2244)  No such constraints existed here.  Addressing Microsoft’s other argument – that a preponderance standard should apply where, as here, not all evidence in the case had been before the PTO during the patent examination process – the Court said that information could be a factor in the jury’s decision, but did not warrant a different standard of proof.  (p. 2250-51).

For nanotechnology firms with existing patents on inventions or in the R&D process, the Court’s decision is good news.  It provides a strong measure of certainty and economic stability to stakeholders investing in and promoting the patented technologies.  It also allows firms to bring patent infringement claims while maintaining some sense of security about their own patent’s validity.  Taken together with the 2010 Supreme Court case of Bilski v. Kappos, 129 S. Ct. 2735 (2010), which retained a broad definition for patentable subject matter, Microsoft v. i4i should provide nanotech patent holders with plenty of reason to be pleased.

 The decision is available at

http://www.supremecourt.gov/opinions/10pdf/10-290.pdf

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White House Takes a Science-Based Approach to the Study and Regulation of Nanotechnology

Posted Jun.15, 2011 under Cosmetics, Drugs, Environment, EPA, FDA, Food, Government Agencies, Governmental Interaction, Health, Pesticides, Regulation, Safety, Statutes, Workplace

white-house-south-2007-djIn a June 9, 2011, memorandum to the heads of U.S. executive departments and agencies, entitled Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, the White House confirmed its commitment to a “science-based” approach to health and safety matters related to nanotechnology.  The memorandum issued from the Office of Science and Technology Policy, the Office of Management and Budget, and the Office of the U.S. Trade Representative. The memorandum described its approach as

“generally applicable principles relevant to promoting a balanced, science-based approach to regulating nanomaterials and other applications of nanotechnology in a manner that protects human health, safety, and the environment without prejudging new technologies or creating unnecessary barriers to trade or hampering innovation.”

The memorandum went on to explain that the approach it establishes is inherent in the risk-based approach commonly used by federal agencies such as the FDA, but is grounded in best available, and evolving, science.

 This is a tall order.  It is important that the White House explicitly addressed nanotechnology and nanomaterials, rather than using the vague term “emerging technologies,” as it has done in the past.  But perhaps the most significant part of the memorandum is in its elevation of the science-based approach over other possible approaches (technology-based, economics-based, etc.) to the study and regulation of nanomaterials.

 Intending to provide guidance to existing federal agencies, the memorandum stated:  “Federal agencies should avoid making scientifically unfounded generalizations that categorically judge all applications of nanotechnology as intrinsically benign or harmful.”  Consumer trust, the memorandum went on to say, is important in encouraging technological innovation.

 On the one hand, the memorandum eased industry concerns that nanotechnology will be viewed as “bad” and all nanomaterials as “hazardous” because of the flurry of attention focused on the technologies and the concerns voiced by various groups.  But on the other hand, the message is clear that science will govern the study of nanomaterials and any decisions about whether or how to regulate.  And that is also a message to industry to come forward with the science that the agencies need.

 The memorandum also announced the creation of an interagency working group to coordinate this basic framework across agency lines, promote coordination of regulatory activities, and share information.

 How is this policy likely to play out in the relevant departments and agencies?  Here are a couple of recent steps that illustrate the initial approach:

 ●  On June 10, 2011, the FDA issued a Draft Guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, to provide manufacturers, suppliers, importers, and other stakeholders with the FDA’s “current thinking” on the subject.  The Draft Guidance was issued in conjunction with the White House memorandum.  The document provided no definitions, nor did it provide any information on the regulatory status of any products.  Rather, the document stated that its purpose is “to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nano-technology in FDA-regulated products.”

 The FDA Draft Guidance is available at

http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm

 ●  A similar document was issued by EPA setting forth its proposed policy for obtaining data on nanoscale materials in pesticides, pursuant to its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Another important aspect of what EPA is considering is a case-by-case analysis of whether a nanoscale ingredient in a pesticide is considered “new” for the purpose of study and regulation.  This is a sharp departure from EPA’s earlier stance that it would consider all nanoscale ingredients as “new,” whether or not a non-nanoscale form of the ingredient was already registered under FIFRA.  The new approach is consistent with the urging of the White House memorandum that agencies avoid generalizations about nanomaterials and based all decision on the scientific evidence.

 The prepublication version of this notice is available at

http://www.epa.gov/pesticides/regulating/prepub-nanopest.pdf

 

The White House memo is available at

http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf

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Dipping Into the Regulatory Alphabet Soup Once Again: A Dilemma

Posted Jun.07, 2011 under Chemicals, Cosmetics, Drugs, Environment, EPA, Health, International Nanoregulation, Pesticides, Regulation, Safety, Statutes, Workplace
prod liab imageListening to the speakers at the American Bar Association section webinar on the subject of “Nano Governance:  The Current State of Federal, State, and International Regulation,” discussed in a recent blog post, I was struck by the proliferation of “alphabet soup” agencies and programs involved in deciding whether and how to regulate nanomaterials in the workplace, consumer products, and the environment.  The short list includes such well-known acronyms as FDA, EPA, OSHA, NIOSH, CPSC, NNI, TSCA, FIFRA, FHSA, REACH, and ISO (International Organization for Standardization), as well as many lesser known acronyms, such as SNUR (Significant New Use Rule), PPPA (Poison Prevention Packaging Act of 1970), CPSIA (Consumer Product Safety Improvement Act), OCSPP (EPA’s Office of Chemical Safety and Pollution Prevention), NMSP (Nanoscale Materials Stewardship Program), NICNAS (Australian National Industrial Chemicals Notification and Assessment Scheme), WPMN (international Working Party on Manufactured Nanomaterials), and many similar legislation and agencies on the state level.

The good news is that nanotechnology is receiving much attention across the board from regulatory agencies.  The less good news is that the work of determining the health and safety effects of nanomaterials on humans and the environment, including ecological systems, is fragmented and slow.

The U.S. federal government, by necessity, is comprised of a web of agencies and programs, each with many jobs.  With so much work to be done, smaller and smaller groups are focusing on specific research and problem solving initiatives.  As the federal government is accustomed to doing in many areas of concern, efforts to coordinate agencies and programs devoting a fraction of their time to nanotechnology health and safety issues are being utilized.  One clearinghouse for the efforts across the government is the National Nanotechnology Initiative (NNI).  Is that enough to prevent duplication of effort and resources and to encourage communication and progress?

The dilemma is not new.  It is at the foundation of all complex systems.  To get something done, the groundwork must be laid by a highly focused group.  As recommendations move along the regulatory channels, eventually (maybe) the work results in action by way of regulations or new/amended statutes.  Greater oversight and decision making at the top of the regulatory pyramid may sound more efficient, but the careful groundwork could be lost and the democratic principles on which our regulatory system is based (including publication and public comment) could be diminished.

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Justices Consider Many Options in Microsoft v. i4i Patent Case Oral Arguments

Posted May.10, 2011 under Litigation, Patents, Statutes, Supreme Court

supctOn April 18, 2011, the U.S. Supreme Court heard oral arguments in Microsoft v. i4i Limited Partnership, a patent case I previously addressed in this blog.  The central issue before the Court involved the standard of proof used to determine the validity of a patent in patent infringement litigation.  The court below had held that a party sued for patent infringement who raises invalidity of the patent as a defense must prove invalidity by clear and convincing evidence.  Microsoft, the petitioner, argued that because Section 282 of the Patent Act, 35 U.S.C. § 282 – which provides a presumption of validity for a patent – does not specify a heightened standard, the standard should be a preponderance of the evidence, thereby making it easier to challenge the validity of a patent.  i4i argued that the clear and convincing evidence standard, which has been followed for decades, should continue to apply.  Chief Justice Roberts has recused himself from the case because of investments he holds in Microsoft.

Early in the argument, Justice Kagan noted that the early cases addressing the subject contained broad language suggesting a heavy burden of persuasion.  Justice Ginsberg further noted the absence of any attempt by Congress to clarify the standard in the Act.  Absent statutory language to the contrary, Justice Kagan suggested simply following precedent and applying the clear and convincing evidence standard.

Justice Breyer acknowledged that the Supreme Court could make a change to the procedural way this issue is resolved.  He framed the problem as an economic one, a need to achieve balance between providing legal protection for inventions that warrant it and preventing undeserving inventions from taking advantage of the protections of patent law.  One approach to the central issue in the case, he suggested, would be to ask the Patent Office for reconsideration.  Another would be to let the jury apply the clear and convincing standard to the “brute facts,” then allow the judge to make the ultimate decision about validity.

Much of the questioning involved Microsoft’s argument that a clear and convincing standard is not appropriate in a case in which the PTO did not previously consider the  prior art evidence introduced by the defendant in the infringement litigation.  The justices considered whether accepting that argument would mean that two different standards should apply, depending on whether the evidence had been considered by the PTO.  i4i countered with several justifications for applying the clear and convincing standard across the board.  One point was the unfairness of a lower standard, which would make it easier for a single non-expert jury to invalidate a patent when so many parties (inventor, investors, licensees) relied upon the patent at the time it was issued.  Along this vein, another approach considered by the Court during the argument was to instruct the jury to apply the clear and convincing evidence standard, but include a further instruction that the jury could consider, in appropriate circumstances, that the PTO had not considered the prior art.

The variety of suggestions discussed in the oral arguments make prediction of the ultimate result difficult.  It is still possible that the Court will find a clear answer in the language of Section 282.  Firms with patents on nanotechnology applications could be disappointed to find that the Court rejects an across-the-board use of the clear and convincing evidence standard.  If that happens, infringers will have an advantage over original inventors, and more patents will be held invalid in court.  The effect could be significant, perhaps having a chilling effect on advances in science and on investment in original inventions.

The transcript of the oral argument may be found at

http://www.supremecourt.gov/oral_arguments/argument_transcripts/10-290.pdf

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Patent Case Before U.S. Supreme Court Will Impact Nanotech Firms

Posted Apr.09, 2011 under Litigation, Patents, Statutes, Supreme Court

supctOn April 18, 2011, the U.S. Supreme Court will hear oral arguments in Microsoft Corp. v. i4i Limited Partnership, in which i4i accused Microsoft of patent infringement.  i4i won a verdict in the 2009 case, but Microsoft has pursued the matter on appeal, claiming, among other things, that i4i’s patent was not valid.  The Supreme Court is now being asked to address the standard of proof required to establish whether a patent is invalid in patent litigation.

 Section 282 of the Patent Act, 35 U.S.C. § 282, provides that “[a] patent shall be presumed valid” and imposes the burden of proving the invalidity of a patent on the party claiming that the patent is invalid.  But the Act does not indicate the strength of that presumption.  In 1984, the Federal Circuit Court of Appeals, in American Hoist & Derrick Co. v. Sowa & Sons Inc., 725 F.2d 1350 (Fed. Cir. 1984), held that invalidity must be proved by clear and convincing evidence.  This means that sometimes invalid patents will benefit from the gloss of validity because the standard of proving invalidity is so high.  Although the U.S. Supreme Court has not yet addressed this issue, Microsoft has pointed to the Court’s language in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), in support of its challenge to the clear and convincing language.  In KSR, the Court stated that at least under the circumstances of that case “the rationale underlying the presumption . . . seems much diminished.”

 If the Supreme Court were to reject the clear and convincing standard and impose one based upon, for example, a preponderance of the evidence, alleged infringers would have an easier time challenging the validity of the holder’s patent.  All participants in patent litigation would feel the impact, including patent holders, challengers, and judges.

 How will the Microsoft v. i4i decision impact nanotech firms?

 Patents incorporating nanotechnology often involve newer innovations, with the patent holders seeking to establish a place in commerce.  If a party challenging the patent’s validity must prove invalidity by clear and convincing evidence, the holder of the patent may have an advantage in litigation. And this litigation advantage could translate into a commercial advantage.  By contrast, if the Supreme Court lowers the threshold for the presumption of validity, holders of newer and more innovative patents could lose their competitive edge.  The impact in the nanotechnology field would be felt most strongly by smaller, upstart firms.

 I will report again on this matter after the oral arguments on April 18.

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TSCA Regulation Moves Forward – Slowly

Posted Nov.29, 2010 under Bionanotechnology, Chemicals, Cosmetics, Environment, EPA, European Union, Governmental Interaction, Health, Nanosilver, Nanotubes, Pesticides, Regulation, Safety, Statutes

nano 3On November 22, 2010, EPA submitted a proposed rule under Section 8(a) of TSCA to the Office of Management and Budget for its review.  The proposed rule includes reporting requirements for manufacturers of nanoscale materials and could be published in the Federal Register for public comment in December.

 The first of three proposed rules expected in 2011, this proposed rule would require disclosure of information on manufacturing and processing, as well as on exposure and release of nanomaterials.  This is merely a prelude to any actual regulation of the industries and processes making use of nanotechnology.  It is a critical step toward reducing risks to human health and the environment.  But it also highlights the fact that regulation of nanomaterials is a long, slow process that may not yield satisfactory results for many years.

 In September, an EPA representative told members of the nanomaterials industry, “We are at the stage where we really don’t have a clear idea of how to manage risk. . . . The more information we can collect through regulation—on what is being manufactured, toxicity data, and the development of the proper protocols for measuring toxic effects of the nanomaterial—the better off we will be to manage the risk and demonstrate to the American people we have a handle on the issue.”

 The current proposal can be seen as early steps in risk assessment, but far from the risk management eventually envisioned by EPA.

The European Union may be further ahead.  On November 24, 2010, the European Parliament voted to extend its restriction on many hazardous substances to most electrical and electronic products, but stopped short of imposing a restriction on nanosilver and carbon nanotubes.  Observers say that it is likely that these substances will be incorporated into the law when the law comes up for review in three years.  Thus, the EU may be heading toward management of the risks of nanotechnology more quickly than the U.S.

 Even so, why so slow?  Regulators should get moving on resolving obstacles such as the scope of nanoscale definitions, deciding how much data is enough before effective regulation may be accomplished, and whether small businesses warrant an exception to regulation.

 

Sources (all by BNA subscription):

225 BNA Daily Env’t Rptr. A-6 (Nov. 24, 2010)

34 BNA Chemical Reg. Rptr. 1149 (Nov. 24, 2010)

34 BNA Chemical Reg. Rptr 960 (Oct. 4, 2010)

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Patents on Genes and the Future of Personalized Nanomedicine

Posted Sep.18, 2010 under Bionanotechnology, DNA Nanotechnology, Health, Litigation, Nanobiotechnology, Nanomedicine, Patents, Statutes
Wikimedia

Wikimedia

The nexus of a large number of nanotech inventions, specifically related to personalized medicine, is biological material and other naturally occurring materials.  In order to obtain a patent, the inventor is essentially required to create a new composition of matter from that which occurs naturally.  Until recently, scientists and inventors alike have been able to satisfy this requirement, but change might be on its way.

In May 2009, the American Civil Liberties Union and the Association for Molecular Pathology filed suit, in the United States District Court for the Southern District of New York, against the United States Patent and Trademark Office and Myriad Genetics. The complaint pertained to patents that were granted on the BRCA1 and BRCA2 human genes that are mutations correlated to the increased risk of breast or ovarian cancer.  Myriad Genetics designed a procedure to test for these mutations to indicate the likelihood of a woman developing either or both of the diseases.  The complaint asserted that patents on genes should not be allowed because they are violative of § 101, patentable subject matter, of the Patent Act, namely all three of the judicially recognized exceptions to patentability:  natural phenomena, laws of nature, and abstract ideas. Subsequently, the American Civil Liberties Union and the Public Patent Foundation filed a motion for summary judgment, in August 2009.  On March 29, 2010, the District Court found that the isolated segments of DNA utilized for the diagnostic tests were “not markedly different from native DNA as it exists in nature” and held the patents granted to Myriad were not valid.  Ass’n. for Molecular Pathology v. U.S.P.T.O., 702 F. Supp. 2d 181 (S.D.N.Y. 2010) available at http://www.aclu.org/files/assets/2010-3-29-AMPvUSPTO-Opinion.pdf.

This particular case involved the nature of medical tests utilized to screen women for the specific types of cancer.   Myriad holds (held) patents on the two genes that indicate the likelihood of the woman developing cancer.  Two main issues precipitated the litigation.  First was the fact that Myriad charges more than three thousand dollars for its exclusive Comprehensive BRACAnalysis test.  This exorbitant cost prohibited many women from being able to have the test, placing them at an increased risk of developing cancer.  It was asserted that if Myriad would license the test, the cost would become more reasonable and allow for more women to benefit from the technology.  This is the specific goal of personalized medicine; however that goal is more often thwarted by the exclusionary nature of patents (absent licensing and/or collaboration).

The second concern arose from those women who actually undergo testing and are delivered a positive diagnosis for possible development of cancer.  Because Myriad held the patent on the test, the women were prevented from obtaining a second opinion to confirm the results prior to deciding to undergo preventative surgery. Examples of such prevention include radical mastectomies and ovarian removal surgery.  The combination of these concerns cuts directly to the heart of the ongoing debate:

Should patents on biological material be allowed, and if so, what does that mean for the future of scientific research and the development of personalized medicine?

The precursor to this debate harkens back to the California Supreme Court case of Moore v. Regents of the Univ. of Calif., 793 P.2d 479 (1990), where the court was asked to decide if a cancer patient had any property rights in a commercially viable invention created from his particular cancer cells.  The court ultimately decided that the plaintiff did not have any property rights in his biological materials because they considered the material discarded.  The same debate takes place today with regard to human DNA, but no specific human has a specific property right to a specific segment of the human genome.  As a result, scientists are able to use raw DNA and patents on genes are issued if the inventor/scientist has isolated a particular gene from its naturally occurring form, essentially creating a new composition of matter.  However, in light of the decision in Myriad, the fate of thousands of patents (issued and pending) might be uncertain.

Of course, I will bring the focus back to the challenges awaiting nanotechnology in the fields of personalized medicine, molecular biology, etc.  As I stated in the beginning of this post, the nexus of a large number of nanotech inventions is biological material and other naturally occurring materials.  We know from the patentable subject matter paradigm, now including Bilski, that there still exists a broad spectrum of possibilities of what is considered a “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof . . . .”  35 U.S.C. § 101.  But, is there restriction on the horizon as a result of the Myriad decision?  Only time will tell.    

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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.***

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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

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