Regulating Nanotechnology A Legal Primer. Ralph F. Hall University of Minnesota Law School Baker & Daniels

Transcription

1 Regulating Nanotechnology A Legal Primer Ralph F. Hall University of Minnesota Law School Baker & Daniels

2 Why care about Ethical, Legal and Social Implications (ELSI) of Nanotechnology Technology issues are multidimensional It s more than science Avoid Gelsinger situation Patient death Delayed gene therapy by 15+ years Identify and mitigate risks for societal benefit Maximize nanotechnology benefits Scientific input needed to appropriately regulate nanotechnology Public expects it and they are right

3 Laws Relating to Nanotechnology Express a Public Consensus Blending: Ethics Value of Innovation Views of Risks and Benefits Trust in Science and Scientists View of Industry Autonomy values

4 Intersection of Law and Nanotechnology Intellectual property Research regulation Basic research Clinical Studies Product testing Product approval and marketing Product manufacturing Product use Experts (MDs, academics) Consumers Advertising, promotion and labeling International trade Investor interactions Worker exposure Information requirements Environmental disposal Illegal uses Homeland security 4

5 New Therapies or Uses (Faster approvals = less research) Patient and Consumer Rights (Access) Policy Balance Safety (More research = slower approval) Cost 5

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7 Key Legal/Regulatory Issues Is nanotechnology just another new technology? Can nanotechnology be regulated using existing systems? Is nanotechnology even new? Are there unique risks and benefits from nanotechnology? What testing is needed? Do subsets of nanotechnology need separate regulation? How do we balance the risks and benefits Risk of over regulation and under regulation Benefit of innovation What role should stakeholders play? Global v. national v. local control Berkeley, Cambridge and others Issues of democracy Nanoparticles have existed since the dawn of time Do we differentiate old and new nanoparticles?

8 Steps to Regulation Decide need to provide oversight What s the risk or need to regulate? Why regulate? Define activity or item to be regulated Determine information and testing needs Determine method of regulation Balance certainty and flexibility 8

9 Regulatory Requirements In order to regulate, one must: Define the item or activity to be regulated Must define nanotechnology or nonmaterial Scientific definitions might not meet legal needs Decide who will regulate Federal, state or local Which existing or new agency Central or decent sized Determine regulatory approach Soft to hard regulation Premarket v. postmarket Role of consumer/ user autonomy Role of compensation systems Tort liability 9

10 Differing Regulatory Approaches Information Disclosure Regulate Activity (bans or limitations) Regulate Use (who, when and why) Regulate Exposure Levels Regulate Marketing MSDS Labeling Research Disposal Drugs and medical devices Workers exposure Water levels Premarket requirements Promotional activity 10

11 Dynamic Oversight A New Regulatory Approach Spectrum of Oversight Softer Approaches Voluntary datasharing Codes of conduct Voluntary consultation with agency review Guidelines Agency Implementation Coordinating Entity or Process* Public Engagement and Input Harder Approaches Ban, moratorium Standards Stringent premarket testing Enforceable fines * with citizen, governmental, academic, industry, tribal, and NGO representation Courtesy of work done under a NIRT grant to the University of Minnesota Wolf, Kuzma, Ramachandran, Kokoli, Jordan & Hall

12 Key Features Integrates soft and hard approaches to oversight, moving between these two dynamically as data become available and attitudes and analyses evolve. Provides strong coordination among various regulatory agencies, the various stakeholders and the public. Provides oversight throughout the life-cycle of the technology or product. General public heavily involved in the oversight framework. Engagement and inputs from other stakeholders

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14 No Agreed Legal Definition of Nanotechnology Nanotechnology is the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications [N]anotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale. NNI the manipulation, precision placement, measurement, modeling or manufacture of sub-100 nanometer scale matter European Commission, 2001 Sub 300 nm scale Friends of the Earth 14

15 Problems with the NNI Definition as a Legal Definition Nanotechnology is the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications [N]anotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale.

16 Importance of Particle Size Distribution 100 nm Adapted from R. Hall, % <100 nm 50% <100 nm 10% <100 nm A B C Percent 1 nm Particle Size in nm 1000 nm 2009 Burdock Group All rights reserved. Do not copy without written permission from Burdock Group.

17 Definitional Issues Why 100 nm? Many experts say that line is stupid or silly Should it be a risk based line? What does approximately, unique or novel mean? Should imaging and measuring be viewed the same as manipulating? 17

18 Effect of Particle Size on Surface Area As cube dimension decreases, surface area increases exponentially 1. The greater the surface area: 2. The greater the percentage of molecules are present at the surface and; 3. The greater the influence of individual atoms 2009 Burdock Group All rights reserved. Do not copy without written permission from Burdock Group. 18

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20 Key Regulatory Systems OSHA / NIOSH EPA TSCA FIFRA FDA CPSC Gene Therapy Work place safety Disposal Environmental concentrations Use of new chemicals Pesticides and related products Drugs, devices and biologics Food and Cosmetics Consumer products (toys, clothes, etc.) RACand related structures 20

21 OSHA, NIOSH and the Work Place Three Core Regulatory Approaches General Duty Clause Obligation to provide a safe work environment Specific Standards, Requirements Or Work Processes Safety Systems Exposure Levels Information Disclosure MSDS 21

22 OSHA and NIOSH Worker exposure levels set before understanding of nanotechnology Some exposure already to nanoparticles Little data on specific risks Can or must new exposure levels be set? Differentiate between nano size and nonnanosized material? Definition of nanoparticle Worker protection systems created for larger particle sizes Legal basis for size based regulation?

23 TSCA and New Chemicals TSCA requires prior notification of new chemical substances Potential testing requirements Chemical controls Chemical substance is defined as any organic or inorganic substance of a particular molecular identity Does a nano version of an existing article have a new molecular identity? Carbon is well know and is not a new chemical Are carbon nanotubes a new chemical substance?

24 Carbon Nanotubes Some concern that carbon nanotubes of a particular size might act like asbestos Can and should TSCA regulations apply? Carbon nanotubes have same molecular identity as any carbon product (e.g. charcoal) Nano carbon exists in nature EPA has said TSCA applies to carbon nanotubes Is that supportable? Does this approach apply to all nano products?

25 FDA Overview Nanotechnology is not new to FDA (Maybe the word is) Numerous nanotechnology products have already been approved by FDA Silver nanoparticles Engineered calcium phosphate Liposomes Microemulsions Albumin bound nanoparticles No unique safety issues have emerged Nanotechnology cuts across drugs, food, cosmetics, devices and food additives FDA task force concluded that current systems are adequate More scientific knowledge needed 25

26 FDA s View

27 FDA Regulatory Overview Definitions within FDA determine regulatory pathway Intended use, source or function based definitions Food and cosmetics Post hoc regulation Illegal to sell an adulterated or misbranded product Food additives Premarket approval needed Testing and approval requirements Food contact substance premarket notification When is something a food additive v. a food?

28 FDA Regulatory Overview New drugs NDA required Extensive testing Devices fall into three classes High require premarket testing and approval Medium risk (class II or 510(k) products) must show substantial equivalence Is a nano version of a 510(k) product still substantially equivalent? When is something a drug or a device?

29 Impact of Definitions Product Time Cost Clinical Trial Drug PMA Device 510(k) Device Biologic (biotech) Cosmetic 8-10 years 5 years 3 years 8-10years 2 years $750 MM+ 5-30,000 $50 MM 1,000 $10 MM -0- $750 MM+ 5-30,000 $5 MM -0-

30 Do Nanoparticles Act Chemically Under FDA law, drugs work chemically, devices mechanically or physically At the nano level, the distinction between chemistry and physics blurs A compound blocks a cell receptor preventing serotonin reuptake is that physical or chemical? Mouthwash as a device Does the regulatory pathway for the same article for the same purpose vary with size?

31 Normal Receptor Binding (Neuro Transmitter Drugs)

32 Transmitter Binding Using a Nanoparticle

33 Drug Approval Process *

34 Drug Approval Process *

35 EPA Environmental laws cover handling, disposal and exposure levels Technology, concentration and exposure based regulation Clean Air Act, RCRA, Clean Water Act, etc. Numerous existing standards and technology requirements Are they applicable to nanomaterials? Do standards need to vary based on the nano characteristics of the article? Different standards based on size and shape?

36 Consumer Product Safety Commission (CPSC) Regulates consumer products including toys and clothes via standards, general duty and information systems Substantially strengthened in 2007 Authority to require: Testing Labeling Recalls Open issues regarding identification, testing and labeling of products that might contain nano materials

37 Nanosilver Example Regular silver is inert Nanosilver is biologically very active Nanosilver already used in products Antimicrobial cleaning systems Consumer products (washing machines) Medical devices Bandages Human exposure issues Nanosilver may pose an environmental risk in aquatic settings

38 Nanosilver Multiple involved agencies and regulations Clean Water Act Safe Drinking Water Act FIFRA NEPA FDA CPSC FDA has a categorical exception for environmental impact assessments for almost all drugs and devices FDA doesn t address environmental impact of medical products with nanosilver Which system(s) should regulate nanosilver? Should these regulations be consistent? How do we assess nanosilver risk? How do we regulate it?

39 Conclusion Legal or regulatory oversight is the end result of nanotechnology policy debate Improper regulation can permit harm or strangle innovation Scientists need to play a role is developing regulatory approaches Key Issues for regulatory decisions Definitions Testing needs Labeling Risk identification Use and benefit