fifth annual nanotech commercialization conference of the union 2013.… · © 2013 bergeson &...

© 2013 Bergeson & Campbell, P.C. All Rights Reserved. © 2013 Bergeson & Campbell, P.C. All Rights Reserved.

Lynn L. BergesonBergeson & Campbell, P.C.Washington, D.C.www.lawbc.com

Fifth Annual Nanotech Commercialization Conference

NANO EHS

State of the Union 2013

Wake Forest Biotech PlaceWinston-Salem, North CarolinaApril 10, 2013

© 2013 Bergeson & Campbell, P.C. All Rights Reserved.

Topics to Be Covered Federal Legislative Initiatives

Federal Regulatory Initiatives

Key Stewardship Initiatives

International Nano Developments Are Outlined, But Will Not Be Discussed

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Federal Legislative Initiatives

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NANO Act Rep. Mike Honda (D-CA) reintroduced on January 13, 2013,

the Nanotechnology Advancement and New Opportunities (NANO) Act, H.R. 394

The bill includes recommendations from the Blue Ribbon Task Force: To promote the development and commercialization of

nanotechnology Requires the development of a nanotechnology research strategy

that establishes research priorities for the federal government and industry that will ensure the development and responsible stewardship of nanotechnology

Includes a number of provisions to create partnerships, raise awareness, and implement strategic policies to resolve obstacles and promote nanotechnology

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Nano Act (cont’d) Honda introduced similar legislation in the 112th (H.R.

2749), 111th (H.R. 820), and 110th (H.R. 3235) Congresses. None of the bills made it out of Subcommittee

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FDA Safety and Innovation Act

On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144), which includes a section concerning nanotechnology

The Act directs the Secretary of Health and Human Services to “intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act” or other statutes administered by FDA

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Federal Regulatory Initiatives

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FIFRA On December 1, 2011, EPA announced granting a

conditional registration for a nanosilver-based antimicrobial pesticide product that will be incorporated into textiles On January 26, 2012, the Natural Resources Defense Council

(NRDC) filed a lawsuit in the U.S. Court of Appeals for the 9th Circuit challenging the conditional registration

NRDC urges the court to set aside the authorization until the data EPA has requested are generated, submitted, and reviewed

January 16, 2013, Oral Argument

Decision expected any time

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TSCA SNURs -- February 25, 2013 -- EPA proposed Significant New Use

Rules (SNUR) for 14 generically identified carbon nanotubes (CNT) Names of chemicals subject to the rulings only in generic form and therefore

encourages importers, manufacturers, or processors of CNTs to contact the Agency if they are “unsure of whether [their] CNTs are subject to this proposed SNUR or any other SNUR”

EPA is using the specific structural characteristics for all CNTs submitted as new chemical substances under TSCA to help develop standard nomenclature for placing these chemical substances on the TSCA Inventory

EPA has compiled a generic list of those structural characteristics in a document entitled Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature

A deadline for comments on the ruling has been set for April 26, 2013

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TSCA (cont’d) EPA’s January 8, 2013, Regulatory Agenda

EPA is developing a SNUR under TSCA Section 5(a)(2) that would require persons who intend to manufacture, import, or process nanoscale materials for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity

EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a) that would require persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data

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United States -- FDA On April 20, 2012, FDA announced two draft guidance

documents Guidance for Industry: Assessing the Effects of Significant

Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives

Guidance for Industry: Safety of Nanomaterials in Cosmetic Products

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United States -- CPSC EPA and CPSC Collaboration

In December 2012, EPA and CPSC announced a worldwide research effort to assess any potential impacts of nanomaterials on people’s health and the environment

EPA’s collaborative research with CPSC is part of a larger international effort that focuses on: Identifying, characterizing, and quantifying the origins of nanomaterials

Studying biological processes affected by nanomaterials that could influence risk

Determining how nanomaterials interact with complex systems in humans and the environment

Involving industry to develop sustainable manufacturing processes

Sharing knowledge through innovative online applications that allow for rapid feedback and accelerated research progress

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United States -- CPSC (cont’d) CPSC, in working with other federal agencies, ensures that

common public health concerns are met and will use research findings to inform:

Protocol development to assess the potential release of nanomaterials from consumer products

Credible rules for consumer product testing to evaluate exposure

Determination of the potential public health impacts of nanomaterials used in consumer products

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Key Stewardship Initiatives

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United States -- NanoRelease Project The NanoRelease Project is organized by the ILSI

Research Foundation, and is supported by EPA, Environment Canada, Health Canada, the American Chemistry Council, the Society of Chemical Manufacturers & Affiliates, the National Institute of Standards and Technology, the Adhesive and Sealant Council, and the American Cleaning Institute

The NanoRelease Project is intended to support the development of methods to understand the release of nanomaterials used in products

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United States -- NanoRelease Project (cont’d) The NanoRelease Project completed Phase 1 in 2011,

selecting multi-walled CNTs in polymers for evaluation

In Phase 2, three Task Groups are evaluating: Measurement methods;

The effect of materials selected on release rates; and

Identifying the key exposure/release scenarios

Phase 3 began in late 2012, with a “round robin” approach to inter-laboratory testing using a reference nanomaterial-matrix and positive controls for the study of multi-walled CNTs released from selected polymers

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European Union Nanomaterials as defined in the EU 2011

recommendations are subject to REACH

Although there are no explicit requirements for nanomaterials under REACH or CLP, they meet the regulations’ substance definition and therefore their provisions apply

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ECHA’s Activities Since REACH and CLP cover nanomaterials, ECHA has

gradually increased its activities in this area since 2011

In October 2012, ECHA established a nanomaterials working group (ECHA-NMWG) to discuss scientific and technical questions relevant to REACH and CLP processes and to provide recommendations on strategic issues. It is an informal advisory group consisting of experts from member States, the European Commission, ECHA, and accredited stakeholders organizations, with the mandate to “[p]rovide informal advice on any scientific and technical issues regarding implementation of REACH and COP legislation in relation to nanomaterials”

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Canada Environment Canada proposed in 2008 a Section 71

notice

In October 2011, Health Canada published a “Policy Statement on Health Canada’s Working Definition for Nanomaterials” It is at or within the nanoscale (1-100 nm) in at least one external

dimension, or has internal or surface structure at the nanoscale

It is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena

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Canada (cont’d) Industrial or commercial chemicals:

Substances listed on the Domestic Substances List (DSL) whose nanoscale forms do not have unique structures or molecular arrangements are considered existing and do not require notification

Nanomaterials manufactured in or imported into Canada that are not listed on the DSL are considered new. The nanoscale form of a substance on the DSL is considered a "new" substance if it has unique structures or molecular arrangements. New nanomaterials are subject to notification

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Canada (cont’d) Pharmaceuticals: A number of nanotechnology-based

products in the areas of medical devices and drugs are currently under review

Food-related applications: Six notifications received Two letters of no objection issued

Other four are under review

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Australia National Industrial Chemicals Notification and Assessment

Scheme (NICNAS) introduced the first regulatory program for “industrial nanomaterials” as of January 1, 2011 Working definition: “[I]ndustrial materials intentionally produced,

manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, 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)”

Included are: Aggregates/agglomerates as nanostructured substances

Materials where size distribution shows 10% or more of a substance (based on number of particles) are at the nanoscale

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Australia (cont’d) The Department of Innovation, Industry, Science and

Research, as part of the National Enabling Technologies Strategy, is assessing the feasibility of a nanotechnology product registry The December 2011 report by the Centre for International

Economics concludes that the challenge presented by nanotechnology can be met through existing regulatory frameworks, making it difficult to see a nanoproducts registery delivering a net benefit to the community

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Australia (cont’d) Safe Work Australia (SWA) is implementing the

Nanotechnology Work Health and Safety Program, which is supported by: Nanotechnology Work Health and Safety Advisory Group

Nanotechnology Work Health and Safety Measurement Reference Group

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Australia (cont’d) On October 22, 2012, SWA announced the availability of

Human Health Hazard Assessment and Classification of Carbon Nanotubes, which recommends that multi-walled CNTs should be classified as hazardous unless toxicological or other data for specific types imply otherwise The report recommends classification as hazardous for repeated

or prolonged inhalation exposure and for carcinogenicity

For all other endpoints, NICNAS found that CNTs either were not classified as hazardous, or cannot be classified as insufficient data are available

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Australia (cont’d) SWA recommends the following label statements for

products containing nanomaterials when the hazards are not fully characterized: Contains engineered/manufactured nanomaterials. Caution:

Hazards unknown

Contains engineered/manufactured nanomaterials. Caution: Hazards not fully characterized

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Denmark The Danish EPA published on March 20, 2013, a proposal for

technical information requirements for nanomaterials The Danish EPA states that its proposal may be used in

legislation concerning nanomaterials, such as the REACH regulation

The proposed information requirement scheme is based on the REACH methodology, i.e., a stepwise approach requiring more information at higher tonnage levels

The proposal “should not necessarily be seen as a proposal for updating REACH, as it could also be put forward as a stand-alone scheme for nanomaterials and used in relation to adapting other existing legislation, or it could be used for guiding”

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France France published a February 17, 2012, “Decree

regarding the annual mandatory reporting of nanoparticulate substances placed on the market” Companies that manufacture, import, and/or distribute a

“substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with substance identity, quantity, and use information

The report will be due by May 1 for information about nanoparticle substances produced/imported/distributed during the prior year

The Decree is effective January 1, 2013, so a report containing 2012 data will be due by May 1, 2013

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France (cont’d) An August 10, 2012, order establishes the information to be

provided to determine the identity of the declarant, the identity of the nanoparticle substance, its uses, and the quantities of the nanoparticle substance produced, distributed, or imported

On September 6, 2012, Carl Schlyter, a Swedish Green member of the European Parliament, filed a challenge in the EU General Court against the European Commission for its refusal to disclose an opinion on the French law on nanomaterials Schlyter said he filed the case because regulation of nanomaterials is

“highly political” and it should be clear what objections the European Commission raised and how the French law was subsequently modified

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Japan Japan’s Ministry of Economy, Trade and Industry (METI)

established a Committee on Safety Management for Nanomaterials The Committee will focus on risks caused by nanomaterials, and

study appropriate management procedures for nanomaterials considering the actual usage and life cycles

The Committee held its first meeting on December 2, 2011

The Committee intended to compile an interim report “around spring to summer in 2012,” but has not released anything to date

METI calls on industry to report voluntarily their safety data and management activities

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Korea National Nano-safety Master Plan (2012-2016) covers

nanomaterials, nanotechnology, nanoproducts, and occupational safety

The Ministry of Knowledge and Economy prepared a “Guidance on Safe Management of Nanotechnology-Based Product”

The Ministry of Environment developed a guidance on the occupational safety management of nanomaterials

The Ministry of Environment began a voluntary survey on the production, use, import, and export volumes and use patterns of manufactured nanomaterials

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Norway On January 9, 2013, the Norwegian Climate and

Pollution Agency (Klif) posted a notice concerning the annual update of information and mandatory reporting of quantities for chemicals for 2012 to the Norwegian Product Register The Product Register is the central register for chemical products

in Norway, and there are currently approximately 25,000 products registered

According to Klif’s notice, changes include adding a “NANO box” that registrants should mark if the chemical contains nanomaterials

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Switzerland On April 25, 2012, the Federal Council continued the

action plan for synthetic nanomaterials through the end of 2015 The primary focus is on developing a methodical basis for nano-

specific provisions

By the end of 2014, a new report will provide an update on the situation

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Switzerland (cont’d) On February 22, 2013, Empa released Human and

Ecotoxicity of Synthetic Nanomaterials: Initial Insights for Major Accident Prevention The study is intended to address whether new criteria for the

determination of the quantity thresholds in the Ordinance on Protection against Major Accidents may result from the accident potential or possible new hypothetical accident scenarios related to the human and ecotoxicity of synthetic nanomaterials

According to the study, data available at the present time are very limited and are inadequate to allow general conclusions to be drawn

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Taiwan In January 2013, the Institute of Occupational Health and

Safety (IOHS) published guidelines for the safe use of nanomaterials, including protection methods and ways to reduce exposure

IOHS intends the guidelines to help employers manage risks associated with the use of nanomaterials in the workplace

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United Kingdom (UK) The UK’s Health and Safety Executive (HSE) posted a 2013

guidance document describing how to control occupational exposure to manufactured nanomaterials in the workplace

HSE intends the guidance to assist in compliance with the Control of Substances Hazardous to Health Regulations 2002 (COSHH) (as amended)

The guidance is specifically about the manufacture and manipulation of all manufactured nanomaterials, CNTs, and other bio-persistent high aspect ratio nanomaterials (HARN)

According to HSE, the control principles described in the guidance can be applied to all nanomaterials used in the workplace

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Other International Initiatives

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United Nations United Nations Subcommittee of Experts on the GHS

During its December 13-14, 2012, meeting, the Subcommittee accepted a proposal submitted by France concerning how harmonized guidance in the GHS should ensure harmonized hazard communication of nanomaterials

An informal correspondence group, led by France, will address the issue, taking into account existing work in this area

It will then report back at the Subcommittee’s next session

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OECD Organization for Economic Co-operation and

Development (OECD): Two Working Parties:

Working Party on Manufactured Nanomaterials (WPMN) (Chemicals Committee)

Working Party on Nanotechnology (WPN) (Committee for Scientific and Technological Policy)

Approximately 100 countries engaged (member or “active” relationship)

Forum for intergovernmental cooperation on environment

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ISO International Organization for Standardization (ISO)

Technical Committee 229 -- Nanotechnologies

Four Working Groups

JWG1 -- Terminology & Nomenclature (Canada)

JWG2 -- Measurement & Characterization (Japan)

WG3 -- Health, Safety & Environment (U.S.)

WG4 -- Material Specification (China)

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ISO (cont’d) Key ISO Activities: ISO Core Terms (80004-1)

Nanomaterial: Material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale. Term includes:

Nano-object: Material with 1, 2, or 3 external dimensions in the nanoscale

Nanostructured material: Material having internal or surface nanostructure

Nanostructure: A composition of inter-related constituent parts in which one or more is a nanoscale region

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SAICM Global Plan of Action of the Strategic Approach to International

Chemicals Management (SAICM) Switzerland proposed that the sound management of nanotechnologies and

manufactured nanomaterials be added to the Global Plan of Action

During the third International Conference on Chemicals Management, held September 17-21, 2012, participants agreed to add measures to:

Explore the development of registers/inventories and/or market assessment activities of manufactured nanomaterials;

Promote the availability of information on the presence of manufactured nanomaterials within the product supply chain and throughout the life cycle, which could include possible labeling, consistent with relevant international obligations, and/or other forms of guidance relating to consumer products containing manufactured nanomaterials;

Continue work on manufactured nanomaterials as an “emerging policy issue” under SAICM, and to develop international technical and regulatory guidance and training materials for their sound management

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Resources U.S. Environmental Protection Agency --

www.epa.gov/ncer/nano/questions/index.html National Nanotechnology Initiative -- www.nano.gov American Bar Association -- Nanotechnology Program -- http://www.americanbar.org/groups/environment_energy

resources/projects_awards/nanotech.html Bergeson & Campbell, P.C. -- Website and Nano and Other

Emerging Chemical Technology Blog -- www.lawbc.com; www.nanotech.lawbc.com

National Institute for Occupational Safety and Health --http://www.cdc.gov/niosh/topics/nanotech

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Thank You

Lynn L. BergesonBergeson & Campbell, P.C.

2200 Pennsylvania Avenue, N.W.Suite 100W

Washington, D.C. [email protected]

www.lawbc.comhttp://nanotech.lawbc.com/

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