©2015 reid and riege, p.c. john r. bashaw, esq. mary m. miller, esq. march 26, 2015 unseen...

©2015 Reid and Riege, P.C.

John R. Bashaw, Esq.Mary M. Miller, Esq.March 26, 2015

UNSEEN CHALLENGES IN

REGULATING NANOMATERIALS


Nanotechnology 101

What is nanotechnology?

Where do we find engineerednanomaterials?

Why should we be concerned?


What is Nanotechnology?

• The control of matter at dimensions of 1 to 100 nanometers which, at the nanoscale, can exhibit unusual physical, chemical, and biological properties

• At the nano level, certain particles may become:• Better heat or electricity conductors• Stronger• Better light reflectors• More magnetic• Capable of changing color


What are Engineered Nanomaterials and Where Do

You Find Them Today?• Carbon nanotubes, metal oxides, zero-valent metals,

quantum dots, dendrimers, and nanosilver are common types of nanomaterials

• Over 1,800 inventoried consumer products with nanomaterials

• Technology, e.g. high-capacity computer drives and automobile catalytic converters

• Sunscreens, clothing, electronics, sporting equipment; cosmetics; fuel additives; medical equipment; textiles; plastics; and more


EPA Statement on Nanomaterials

“Currently, knowledge of the unique features of nanomaterials that influence their behavior in environmental and biological systems is inadequate for predicting potential impacts across the materials’ lifecycle. We need new models and data to support the development of more efficient and comprehensive engineered nanomaterials (ENM) testing procedures.”


So Why Be Concerned About Nanomaterials?

• Rate of production outpaces toxicity studies.

• Some evidence that carbon nanotubes have properties similar to asbestos.

• Lack of information regarding best measurement techniques.

• Common measures for protecting against inhalation and dermal exposure may not be adequate

• At this time, very limited government oversight.


U.S. “Regulation” of Nanomaterials

• Occupational Safety and Health Act (“OSHA”)

• EPA and Toxic Substances Control Act (“TSCA”)

• Food and Drug Administration (“FDA”)

• Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”)

• Other regulations may include the Endangered Species Act, Clean Water Act, Resource Conservation and Recovery Act (“RCRA”), and the Clean Air Act


Nanomaterials Being Studied by EPA

• Nanosilver – antibacterial, antifungal and antiviral properties; used in medical product and clothing

• Nanotubes – most abundant class of nanomaterials• Cerium dioxide – fuel borne catalyst in diesel engines• Titanium dioxide – sunscreens and cosmetics• Iron – used to catalyze breakdown of chlorinated

hydrocarbons• Micronized Copper – preservative in wood products,

paints and coatings


What Do We Know About Nanomaterial Exposure in the

Workplace?• Workplace settings considered to have greatest

exposure potential

• Potential mainly for inhalation, dermal contact, and possibly some ingestion exposures


OSHA Standards

• Section 5(a)(1) of OSHA, often referred to as the General Duty Clause, requires an employer to “furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.”

• Section 5(a)(2) of OSHA requires employers to “comply with occupational safety and health standards” promulgated under OSHA.

• Potentially applicable standards range from occupational injury reporting standards, to eye, face, hand and respiratory protection.


How Workplace Nanomaterial Exposure May Occur

Tasks with Potential Nanomaterial Inhalation Exposure

•Generating nanomaterials in non-enclosed systems•Handling (e.g., weighing, blending, spraying) nanomaterial powders•Maintenance of production equipment•Cleaning of dust collection systems used to capture nanomaterials•Machining, sanding, drilling, or other mechanical disruptions of materials containing nanomaterials


How Workplace Nanomaterial Exposure May Occur

Tasks with Potential Nanomaterial Dermal Exposure

•Working with nanomaterials in liquid media without adequate protection (e.g., gloves)•Working with nanomaterials in liquid media during pouring or mixing operations, or where a high degree of agitation is involved•Maintenance of production equipment•Cleanup of spills and waste material


Training and Gathering Information

As a rule of thumb, training and gather information should include:•Identification of nanomaterials the employer uses and the processes in which they are used; •Results from any exposure assessments conducted at the work site; •Identification of engineering and administrative controls and personal protective equipment to reduce exposure to nanomaterials;•The use and limitations of such equipment; and•Emergency measures to take in the event of a nanomaterial spill or release.


Potential Hazards

• Nanomaterials (e.g., carbon nanotubes) may be deposited in the respiratory tract and cause inflammation and damage to lung cells and tissues, resulting in pulmonary inflammation and fibrosis

• The inhalation of nanoscale titanium dioxide particles (which may be used in paint, paper, cosmetics, food, etc.), is considered a potential occupational carcinogen by NIOSH

• Nanomaterials may penetrate cell membranes and may cause damage to intracellular structures and cellular functions.

• Nanoscale dust particles may be combustible and require less energy to ignite than larger dust particles, creating a risk of explosions and fires

• Nanomaterials may act as chemical catalysts and produce unanticipated reactions, also creating a risk of explosions and fires


Occupational Exposure Limits

• Very few limits currently exist and testing can be difficult

• Worker exposure to carbon nanotubes and nanofibers should not exceed 1 microgram/m3 (8-hour weighted average)

• Worker exposure to nanoscale titanium dioxide should not exceed 0.3 milligrams/m3


Methods of Reducing Exposure

• Work with nanomaterials in ventilated enclosures equipped with high-efficiency particulate air filters (HEPA filters may effectively remove nanomaterials, according to NIOSH)

• Lacking that, provide local exhaust ventilation equipped with HEPA filters designed to capture the nanomaterials at the point of generation or release

• Establish logical spill cleanup procedures (e.g., do not dry sweep nanoscale dust, use wet wiping or vacuums with HEPA filters)

• Provide workers with respirators, gloves and protective clothing

• Provide hand washing facilities• Make available medical screening and surveillance for

exposed workers


EPA Regulation of Nanomaterials

A Brief History . . .• January 2008 – The “soft” approach

- Voluntary submittals via Nanoscale Materials Stewardship Program

- Only 4 companies willing to join and provide complete data

- Program discontinued December 2009


. . . More History

• Time to get tougher

- Use Secs. 5 and 8(a) of TSCA to mandate information disclosure

- Significant New Use Rules (SNURs) for Carbon Nanotubes (CNTs) and other nanomaterials

• See 75 Fed. Reg. 56,880 (9/17/10)

- Since 2005, 120 nanomaterials reviewed by EPA under the Premanufacture Notice review, or SNURs


SNURs

• Significant New Use Rules Under Sec. 5(a) of Toxic Substances Control Act (TSCA)

• Apply only to specific chemicals – specific carbon nanotubes and a few other nanomaterials

• If you manufacture, import or process the carbon nanotube for a “significant new use” that is defined in the SNUR, you have to give EPA 90 days advance notice and you may have restrictions on use.

• Gives EPA a chance to collect more information.


SNUR Example

• Multi-walled CNT (PMN P-08-177)

- Significant New Uses are

• Protection in the workplace – NIOSH approved, air-purifying, tight-fitting full face respirators required

• Industrial, commercial and consumer activities

• Releases to water

• Exemptions for MWCNT that are cured, embedded or incorporated fully into a matrix

• For any proposed processing, manufacturing or importing of this MWCNT for these uses, you must submit a Significant New Use Notice to EPA


Proposed Approach - TSCA

• Expand SNURs to wider universe of nanomaterials. Proposal submitted to OMB in October, 2010.

• Use TSCA Sec. 8(a) Data Call-In Information Gathering Authority – persons who manufacture nanomaterials already in commerce and new nanomaterials must provide EPA with information concerning production volume, methods of use, exposure and release information, and available health and safety data. Some exemptions for small quantity manufacturers. (March 25, 2015).

• Reduce availability of Confidential Bus. Info.


Problems with TSCA

• TSCA does not require upfront testing by the manufacturer (unless obligated by Consent Order or SNUR for a particular nanomaterial)

• TSCA relies on modeling instead of specific toxicity testing and environmental fate data

• TSCA protects Confidential Business Information


Technological Limitations

• Technology not able to detect all nanomaterials in the ambient environment

• And, technology to remove the nanomaterials, when detected, is limited


Prevalence of Nanomaterials in Food, Cosmetic and Drug

Products• By one estimate, an average of three to four new

nano food and food-related products are being introduced into the market per week

- Foods of all varieties - Food Contact Substances (FCS), including packaging

• Nanotechnology in Cosmetics - Sunscreens

• Nanotechnology in Drugs - Drug delivery


History of FDA Regulationof Nanomaterials

• FDA Nanotechnology Task Force formed in August 2006

- Task Force Releases Report in 2007

• FDA issued Draft Guideline in June 2011 - declined to adopt a formal definition of “nanoproduct” or

“nanotechnology” - in determining whether an FDA regulated product

incorporates nanotechnology, FDA will consider: (1) whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100nm); or (2) whether an engineered material or end product exhibits properties that are attributable to its dimension(s), even if these dimensions fall outside the aforementioned nanoscale range, up to one micrometer.


Current State of FDA Regulation

• Two more Draft Guidances were issued in April, 2012 dealing with Food and Cosmetics

• Like the earlier June 2011 Guidance, neither create legally enforceable responsibilities and do not change existing law or regulations

• Both are likely areas of FDA focus going forward

• Both make clear that the onus of putting out a commercially safe product has been, and will continue to be, on the manufacturer


Guidance on Cosmetics

• “Safety for Nanomaterials in Cosmetic Products”

- FDA acknowledged that existing product testing paradigms may need to be modified to address newly arising concerns

- Some factors for manufacturers to consider:

• properly characterizing the nanomaterial used, including its size, distribution and aggregation and agglomeration characteristics

• nanoscale impurities that may result when manufacturing nanomaterials – tests should be tailored to detecting the presence, and evaluating the effects, of any such impurities.

• in addition to exposure of the nanomaterial cosmetic products through its intended route of intake (orally, dermal application, etc.), they may be absorbed elsewhere or even systemically.


Guidance on Foods

• “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”

- certain nano substances can exhibit vastly different characteristics than their macro counterparts

- Additionally, alterations in particle size distribution on the nanometer scale which alter the properties of food and FCS may require new regulatory filings and may also affect the regulatory status of the food


FIFRA: Current Approach

• EPA has considerable authority under FIFRA to prohibit, condition or allow the manufacture and use of nanopesticides

• Aspects of this authority include: experimental use permits; requirements for preregistration testing; registration (prior to sale or distribution); post-registration effects and testing; etc.

• The key question is whether a nanomaterial is present in a pesticide, and if so, whether it creates an unreasonable adverse environmental effect (which has a definition that considers the economic, social and environmental costs and benefits of use)

• Nanosilver is the current primary focus under FIFRA


FIFRA: Proposed Regulation

• June 17, 2011 Fed. Reg. Notice seeking comments on how EPA can use secs. 6(a)(2) and 3(c)(2)(B) of FIFRA to get information on what nanoscale materials are in pesticides

• Information will be used to determine if registration of such materials is required

• Current registration application for a nanosilver product used to disinfect tiles has taken over four years in the EPA approval process


EPA Inspector General’s Report

• Dec. 29, 2011 – EPA Needs to Manage Nanomaterial Risks More Effectively.– “EPA does not currently have sufficient information or

processes to effectively manage the human health and environmental risks of nanomaterials.”

– “EPA has the statutory authority to regulate nanomaterialsbut currently lacks the environmental and human healthexposure and toxicological data to do so effectively.”


More Quotes . . .

• “even if mandatory reporting rules are approved, the effectiveness of EPA’s management of nanomaterials remains in question . . .”– No internal formal process to disseminate and utilize

mandated information

– No effective communication with external stakeholders

– Limitations inherent in existing statutes


EPA Staffing Issues

• Office of Chemical Safety and Pollution Prevention (OCSPP) has overall responsibility for regulation of chemicals, including nanomaterials– 5 full-time people work on nanomaterials

– No formal process for distributing data collected under TSCA and FIFRA outside of OCSPP


Other Influences on Nanomaterial Regulation

• President’s June 9, 2011 Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials– Existing statutes provide a firm foundation for

regulation and oversight of nanomaterials

– An evolution is anticipated

– Essential to gather information

– Use science-based approaches that take into account risks


Free Market Influences

• Investment in least-risky nanotechnologies to avoid mass toxic torts, future restrictive regulation, and bad publicity.

• Insurance coverage for manufacturers of nanomaterials


Patent Issues

• The USPTO approved a series of expansive patents in the late 1990s and early 2000s that created a monopoly over the building blocks of nanomaterials and this has hindered subsequent development as obtaining licenses has proved difficult and expensive

• Nanomaterials were not classified separately by the USPTO until 2001

• This is especially true for four fundamental structures: dendrimers, carbon nanotubes, iron oxide particles and quantum dots

• IBM possessed a patent, now expired, that essentially encompassed all single-walled carbon nanotubes, regardless of specific application

• Chances to do it right: gold nanoshells and carbon-based fullerenes


Web Resources

• http://www.cdc.gov/niosh/topics/nanotech/

• http://www.nano.gov/• http://www.nanowerk.com/• https://nanohub.org/groups/gng• http://www.nanotechproject.org/• http://www.epa.gov/oppt/nano/• http://www.epa.gov/nanoscience/• https://www.osha.gov


Disclaimer

This PowerPoint presentation is for informational purposes only and should notbe construed as legal advice on any subject matter. You should not act upon anything contained in the presentation without consulting legal counsel as individual situations and facts vary. To ensure compliance with certain U.S. Treasury Regulations, please be advised that any statements in the

presentation relating to any Federal tax issue are not intended or written to be used, and cannot be used, by any person for the purpose of avoiding any Federal tax penalties. Transmission or receipt of the presentation materials are not

intended to create an attorney-client relationship nor will the act of sending e-mail to the presenter in the webinar create an attorney-client relationship. Certain

portions may constitute attorney advertising and do not constitute legal advice.


One Financial PlazaHartford, CT 06103(860)278-1150

234 Church StreetNew Haven, CT 06510(203)777-8008

65 LaSalle RoadWest Hartford, CT 06107(860) 232-6565

John R. Bashaw, Esq.Mary M. Miller, Esq.One Financial PlazaHartford, CT 06103

(860) [email protected]@rrlawpc.com

©2015 reid and riege, p.c. john r. bashaw, esq. mary m. miller, esq. march 26, 2015 unseen...

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