REGULATION OF PRODUCTS CONTAINING NANOSCALE MATERIALS Mary Beth Deemer Jones Day, Pittsburgh ©copyright

INTRODUCTION Perceived Problem Enormous amounts of money have been spent on research and development of nanomaterials. Widespread integration of nanomaterials in consumer products. BUT relatively little is known about possible negative effects of nanomaterials on human health and the environment. 2

Reason For The Concern Nanoscale materials often behave quite differently than the larger sized version. Nanoparticles are able to penetrate cells and cross the blood-brain barrier causing damage in ways the larger version of the chemical cannot. 3

Questions for Regulatory Agencies Is regulation of nanomaterials appropriate? If yes, are existing regulatory regimes sufficient to protect consumers and workers from potential toxic effects? Or, is a new regulatory framework needed? 4

WHAT TO REGULATE? What is Nanomaterial? A definition based on size alone is insufficient. Current regulatory definitions (in the United States, EU and Australia) take into account attributes other than size, e.g., biopersistence or shape. Definition of Nanomaterial – Examples: “an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm [nanometers].” 2009 revised cosmetics regulation approved by the Council of the European Union. 5

Definition of Nanomaterial - Examples (Continued): “an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.” U.S. EPA Office of Pesticide Programs (2010) “In determining whether a nanoscale substance is a new or existing chemical, the Agency intends to continue to apply its current Inventory approaches based on molecular identity, rather than focus on physical attributes such as particle size.” U.S. EPA’s Office of Pollution Prevention and Toxics (January 2008 ) 6

Definition of Nanomaterial - Examples (Continued): “industrial materials intentionally produced, manufactured, or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 [nanometer] and 100 [nanometers], and is either a nano-object (i.e., that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e., having an internal or surface structure at the nanoscale.” Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (October 5, 2010) “where size distribution shows 10 percent or more of a substance (based on the number of particles) is at the nanoscale, NICNAS will consider this substance to be a nanomaterial for risk assessment purposes.” Notes to the NICNAS definition 7

Definition of Nanomaterial - Examples (Continued): “[A] material that meets at least one of the following criteria. it consists of particles with one or more external dimensions in the size range of 1 nanometer to 100 nanometers for more than 1 percent of their size distribution; it has internal or surface structures in one or more dimensions in the size range of 1 nanometer to 100 nanometers; or it has a specific surface area by volume greater than 60 square meters by per cubic centimeter, excluding materials consisting of particles with a size lower than 1 nanometer. European Commission (October 21, 2010) 8

Definition of Nanomaterial (Continued) On August 17, 2010, the International Organization for Standardization published a technical report Nanotechnologies – Methodology for the Classification and Categorization of Nanomaterials describing a way to classify nanomaterials according to their size, chemical nature, properties and characteristics. The classification system is called the “nano-tree.” One commenter called the various competing definitions of nanomaterials as “definitional disarray.” 9

WHO WILL REGULATE? In November 2007, the Office of Science and Technology Policy and the Council on Environmental Quality issued a memorandum Principles for Nanotechnology Environmental, Health, and Safety Oversight stating that federal agencies such as U.S. EPA, the Food and Drug Administration (FDA) and the Occupational Safety and Health Administration (OSHA) “must implement sound policies to protect public health and the environment” from risks related to nanotechnology. 10

Regulation by the FDA Least aggressive of the three Agencies. Stringent regulations exist for nanotechnology used in medicine and medical technology. No active regulations for nanotechnologies used in cosmetics, food and dietary supplements. Manufacturers are not required to notify either the FDA or their customers when nanotechnology is used in a product. 11

Regulation by FDA Instead, FDA maintains a voluntary disclosure list. In FDA’s view, existing regulations are sufficient to protect consumers from the potential dangers associated with nanotechnology. Manufacturers are required to ensure that the products are safe, but FDA does not investigate until it receives reports that a product is unsafe. Nothing unique to nanotechnology has convinced FDA that it needs to alter its traditional reactive style of regulation. 12

Regulation by OSHA The National Institute for Occupational Safety and Health (NIOSH) has published more than 170 peer-reviewed studies on the health effects of exposure to nanomaterials. Same manufacturers have used these studies to establish voluntary occupational exposure limits. In 2005, NIOSH proposed recommended exposure limits for fine and ultra fine nano-titanium dioxide. (NIOSH expects to finalize in 2011.) 13

Regulation by OSHA In August 2010, NIOSH and OSHA signed an interagency agreement to investigate and characterize the potential hazards of nanomaterials. OSHA and NIOSH will use the information collected to set up worker exposure databases, develop process descriptions and create guidance materials. The guidance materials will be designed for multiple applications and will be developed to indicate best practices in a rapidly progressing area where guidance is currently lacking. 14

Regulation by OSHA On December 2, 2010, NIOSH proposed a recommended exposure limit of 7 micrograms per cubic meter of air for carbon nano-tubes and nanofibers. The recommended limit is an 8-hour, time-weighted average. In animal studies, NIOSH reported observing pulmonary inflammation and fibrosis. Also, a scanning electron microscope captured the image of a carbon nanotube penetrating through the lungs to the pleura of a mouse. NIOSH selected the exposure limit of 7 micrograms per cubic meter because it is the lowest concentration that it can reliably measure. As such, NIOSH recognized that the recommended exposure limit may not be completely health protective. NIOSH expects to finalize the exposure limit in

Regulation by OSHA Until the toxicity of carbon nano-tubes and nanofibers is better understood and characterized, NIOSH recommends that employers implement occupational health surveillance programs and take additional steps to minimize risk, e.g.:  continuous sampling;  identify jobs where workers handle particles in bulk;  education;  provide hand washing facilities;  use light colored clothes and gloves to make dark nanotubes more visible;  engineering controls; and  PPE. 16

Regulation by U.S. EPA The Toxic Substances Control Act (TSCA) Mission: Preventing unreasonable risks posed by chemical substances to health and the environment without creating unnecessary economic barriers to technological innovation. Premanufacture Review (TSCA §5) Chemicals are subject to premanufacture review if they are “new.” Chemicals are “new” if they are not on U.S. EPA’s TSCA Inventory. Many nanomaterials are just smaller versions of chemicals already on the Inventory. 17

Regulation by U.S. EPA TSCA – Premanufacture Review (Continued) Ongoing debate between U.S. EPA, industry, consumer groups and academics as to whether nanomaterials are in fact “new” as defined in TSCA §3. Recognizing that the smaller size may change the properties of a substance, U.S. EPA has determined that some nano-versions of existing chemicals are in fact “new.” January 2008, U.S. EPA articulated its position. EPA classifies nanomaterials under TSCA based on their “chemical identities” rather than particle size or physical properties. 18

Regulation by U.S. EPA TSCA Premanufacture Review (Continued) Substances have different molecular identities under TSCA when they: 1.have different molecular formulas, atom connectivities or crystal lattices; 2.are different allotropes of the same element; or 3.have different isotopes of the same element. Allows U.S. EPA to make case-by-case determinations. In October 2008, U.S. EPA announced that carbon nanotubes are in fact “new” and subject to TSCA premanufacture notice (PMN) requirements for new chemicals.  U.S. EPA concluded that the chemical identity of carbon nanotubes differs from that of graphite or other allotropes of carbon already listed on the TSCA Inventory. 19

Regulation by U.S. EPA TSCA Premanufacture Review (Continued) Beginning in 2008, U.S. EPA entered into several TSCA § 5(e) ACOs with manufacturers of carbon nanotubes.  The ACOs did not prohibit manufacture or sales.  Under the ACOs, manufacturers were required to submit to U.S. EPA samples of the nanomaterial, MSDSs, and results of the 90- day inhalation toxicity study in rats.  The ACOs also required use of PPE for manufacturing employees. N.B. TSCA § 5(e) orders only bind the party submitting the PMN for a new chemical. 20

Regulation by U.S. EPA TSCA Significant New Use Rules (SNURs) Significant New Use Rules (SNURs) under TSCA § 5(a) bind other entities (e.g., manufacturers) to the same terms and conditions for that chemical. Unlike a § 5(e) PMN ACO, SNURs are subject to notice and comment. First carbon nanotube SNURs published in November  Because of subtle differences in nanostructures, manufacturers face uncertainty regarding whether they are subject to a SNUR.  Option - Manufacturers can submit a Notice of Bona Fide Intent to Manufacture requesting a U.S. EPA determination. 21

Regulation by U.S. EPA TSCA SNURs (Continued) In June 2009, U.S. EPA issued two more SNURs for public notice and comment. In July 2009, U.S. EPA clarified that the SNURs did not apply to all variants of nanotubes – only those subject to the PMN. The SNURs were withdrawn in August The withdrawn SNURs would have required employees handling carbon nanotubes to use gloves impervious to nanoscale particles, to wear chemical protective clothing and to wear NIOSH-approved full face respirators with N-100 cartridges. Also, manufacturers, importers and processors would have been required to notify U.S. EPA at least 90 days before beginning an activity designated as a significant new use. 22

Regulation by U.S. EPA TSCA SNURs (Continued) The carbon nanotube SNURs have garnered significant attention. New SNURs were proposed on November 6, Final SNURs were promulgated as Final Rules on September 17, Effective October 18,

Regulation by U.S. EPA – TSCA 2011 Agenda TSCA § 4 In Spring 2009, U.S. EPA announced that “[a] TSCA section 4(a) test rule may be needed to determine the health effects of multiwall carbon nanotubes.” Proposed rule may extend to nanoscale materials already in commerce and not already tested by other federal and international organizations. Nanomaterials likely to be targeted by the rule include multiwalled carbon nanotubes, nanoscale clays and alumina, and spray-applied nanomaterials. Under TSCA § 4(a), U.S. EPA may require entities to develop and submit data on health and environmental effects of a substance. Persons subject to a test rule must submit a notice of intent to conduct the required testing or apply for an exemption. U.S. EPA is expected to propose this rule in April

Regulation by U.S. EPA – TSCA 2011 Agenda TSCA § 8 In September 2009, U.S. EPA stated its intention to propose TSCA § 8(a) rules to obtain information on the production volumes, methods of manufacture, uses, and exposures of nanoscale materials already in commerce. TSCA § 8 allows U.S. EPA to issue rules requiring mandatory submission of data “necessary for the effective enforcement of this chapter.” U.S. EPA submitted the proposed rule to the White House Office of Management and Budget (OMB) in November 2010 and indicated that it intends to publish the proposed rule in February

Regulation by U.S. EPA – TSCA 2011 Agenda U.S. EPA is developing a SNUR under Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process new nanoscale materials based on chemical substances listed on the TSCA Inventory to submit a Significant New Use Notice (SNUN) to U.S. EPA at least 90 days before commencing the activity. The SNUR would identify existing uses of nanoscale materials based on information submitted under U.S. EPA’s Voluntary Nanoscale Materials Stewardship Program and other information. U.S. EPA anticipates proposing the SNUR by the end of

Regulation by U.S. EPA The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) U.S. EPA has taken a close look at regulating nanosilver as a pesticide. A “pesticide” is “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest. A “pest” includes not only insects, rodents, fungi and weeds, but also any virus, bacteria, or micoorganism that U.S. EPA declares to be a pest. Silver is a registered antimicrobial pesticide under FIFRA used for water purification purposes. Nanosilver is used in numerous commercial products, including food storage containers, clothing, toys and electronics. 27

Regulation by U.S. EPA FIFRA (Continued) In 2007, U.S. EPA determined that a silver-ion-generating washing machine should be regulated as a pesticide.  Products that release silver ions as disinfectants have been targeted by U.S. EPA for data collection and regulatory control. In February 2008, U.S. EPA Region 9 settled a FIFRA enforcement action against a company for selling unregistered pesticides in its nanosilver-coated computer keyboards and making unsubstantiated claims concerning the pesticides’ effectiveness. In December 2010, U.S. EPA instituted a FIFRA enforcement action against a California company for marketing unregistered and misbranded pesticides and making false claims about an air filter containing nanoparticles. 28

Regulation by U.S. EPA FIFRA (Continued) In 2008, U.S. EPA sought comments on a petition from NGOs requesting that U.S. EPA classify nanosilver as a new pesticide and require registration under FIFRA. FIFRA requirements include registration, approval, labeling, and data submission. U.S. EPA’s Proposed New Interpretation of FIFRA Proposed Policy submitted to OMB on July 30, Under the new interpretation, the deliberate presence of an intentionally produced nanoscale material in a pesticide product would be reportable under § 6(a)(2) of FIFRA. 29

Regulation by U.S. EPA U.S. EPA’s New Interpretation of FIFRA (Continued) Section 6(a)(2) is commonly referred to as the “adverse effects” reporting provision of FIFRA. [i]f at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant shall submit such information to the administrator. 30

Regulation by U.S. EPA U.S. EPA’s New Interpretation of FIFRA (Continued) EPA claims that the new interpretation is geared at obtaining data in general, not just data on adverse effects. Trade Associations and others have objected stating that the use of Section 6(a)(2) reporting would stigmatize all use of nanotechnology in pesticides. U.S. EPA has stated that it intends to make it clear that there is no connection between adverse effect and the presence of a nanoscale ingredient. Rather the goal of the new interpretation and policy is to obtain information U.S. EPA needs to ensure pesticides meet FIFRA’s safety standards. 31

Regulation by U.S. EPA TSCA vs. FIFRA – Is Either Effective to Regulate Nanoscale Materials? According to the ABA, FIFRA offers U.S. EPA ample authority to regulate nano pesticides. FIFRA, unlike TSCA, allows U.S. EPA to regulate research and development. The registration requirement is FIFRA’s most powerful tool. Under this authority, U.S. EPA can prohibit, condition or allow the manufacture and use of nano pesticides. 32

Regulation by U.S. EPA – What’s Next? May 2010 Government Accountability Office (GAO) Report Regarding U.S. EPA Regulation of Nanomaterials. Recommendations: 1.Promulgate regulations under TSCA and FIFRA to prevent products from entering the market without U.S. EPA review of their potential risks. Actions recommended: Issue TSCA SNURs for nanomaterials. Promulgate regulations requiring submission of data on nanomaterials under TSCA §§ 4 and 8. Modify FIFRA pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides. Clarify that nanomaterials in both registered and new pesticides must be reported. 2.Explore regulation of nanomaterials under CAA, CWA, RCRA and CERCLA. Challenge – Adequately measuring nanomaterials. Recommended First Step – Use information gathering powers under the CWA to require entities to submit data regarding nanomaterial discharges. 33

Other Voices Some consumer advocate groups and at least one former U.S. EPA official has called for an entirely new, comprehensive regulatory framework that focuses on products rather than materials. 34

35 MANAGING NANOPHOBIA Charles H. Moellenberg, Jr. Jones Day, Pittsburgh © copyright

36 Expect the Unexpected “The first lesson learned is to expect the unexpected when you are dealing with technology, particularly one that has the potential of being life-threatening and ecologically disastrous.” Dick Thornburgh (commenting on 30 th anniversary of Three Mile Island)

37 Product Lifetime IP: patent, trademark, licensing Regulatory approval and reporting Workplace safety: OSHA, NIOSH Product liability Environmental discharges and disposal International regulation Advancing knowledge in science and risk

38 Report Card No lawsuits No reports to FDA of adverse events Few proposals for specific laws and regulations Perception of risk – fear of unknown

39 Litigation risk Broad legal duties to design safe products, to test and to warn Lends itself to junk science experts

Litigation risk Fear leads to medical monitoring without injury Evolution and change in knowledge creates risk of second-guessing foreseeability, reasonableness and failure to test or disclose 40

41 Advocacy Groups ETC Group – monitoring power, tracking technology, strengthening diversity COMPETITION ANNOUNCEMENT: Design a Nano-Hazard Symbol ETC Group announces International Graphic Design Competition THE COMPETITION IS NOW CLOSED Biotechnology, nuclear power, toxic chemicals, electromagnetic radiation -- each of these technological hazards has a universally recognized warning symbol associated with it. So why not nanotechnology -- the world's most powerful (and potentially dangerous) technology?

42 Insurance Check policies Products coverage for BI and PD Watch for new exclusions Recall coverage? Environmental pollution exclusion?

43 Be Part of the Discussion Legislation and regulation Research targets and funding PR and media Industry standards and guidelines

44 Preventing Litigation Moellenberg and Juni, “A Practical Guide to Product Liability Risk for Nanotechnology,” BNA Toxics Law Reporter, March 5, 2009 On Jones Day website –

45 Preventing Litigation Literature search Monitoring and testing for safety Cooperative research with government, university, or trade group

46 Preventing Litigation Compliance with regulations and industry standards, including agency reporting Monitor competitors’ products Quality control and field experience

Preventing Litigation Watch warranties Review advertising and marketing 47

48 Preventing Litigation Document control and retention to show careful approach

Questions?? 49

CLE Code 0803 Thank you for participating! 50