NANOMATERIALS:
Risks and Regulatory Gaps
SEJ 2012, Lubbock TX
Jennifer Sass, Ph.D.
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Definition:
Nanotechnology is the understanding and control of matter at
dimensions between approximately 1 and 100 nanometers
(nm), where unique phenomena enable novel applications.
Encompassing nanoscale science, engineering, and
technology, nanotechnology involves imaging, measuring,
modeling, and manipulating matter at this length scale.
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NANO-ENABLED PRODUCTS
800+ consumer products using nanotechnologies, according to
manufacturer
Estimates predict 15% of goods globally, worth $2.6 trillion by
2014 will be nano-enabled
Every sector, and every Fortune 500 company is invested
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THE PROMISES
Clothing covered in nano-zinc oxide wires could power
devices. (Nature, Feb 2008)
Iron nanoparticles can decontaminate solvent-soaked soil up
to 1,000 times faster than a conventional iron mixture.
Improved hydrogen-fuel cells, lithium-ion batteries, and solar
cell
semiconductors
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THE PRODUCTS
Stain-resistant clothing (nano-perfluorinated compounds)
Clear sunscreen (TiO2)
The nanosolar utility panel carries 5-10 times more current
than typical panels
Nanosilver antibiotic clothing, food packaging, and teddy
bears
Carbon nanotube lighter stronger building materials
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NANOTOXICOLOGY: basic assumptions
Small size facilitates easier access to the lungs, passage
through cell membranes, and possibly skin penetrance.
Once inside the body, they seem to have access to all tissues
and organs, including the brain and fetal circulation.
Animal studies suggest that some nanomaterials cause
inflammation, damage brain cells and cause pre-cancerous
lesions.
Ultrafine (nano) air pollution, is associated with
size-dependent reduced lung function and
increased likelihood of asthma, respiratory
disease, and deaths from lung and heart disease.
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It is clear that inhaled nanomaterials can pass into the blood
stream, and from the blood through the blood-brain-barrier,
and the placental barrier.
Nano metal oxides in sunscreens may penetrate skin, though
most tests on intact skin have reported only limited
penetration.
Not much is known about whether ingested nanomaterials
can pass from the gut
into the blood stream.
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NANO TITANIUM DIOXIDE
When TiO2 nanoparticles were fed to mice in drinking
water (300-3,000 µg/day for five days), they showed
DNA damage. (Trouiller et al, 2009)
When pregnant mice were injected under the skin with
TiO2 (0.1 mg at 3, 7, 10, and 14 days postcoitum) the
nanoparticles were found in the offspring and caused
reduced sperm production and brain cell death in the
male offspring. (Takeda et al, 2008).
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NANO TITANIUM DIOXIDE
…Z-Cote (transparent zinc
oxide) and T-Cote
(transparent titanium
dioxide), that do not deposit
this chalky residue
“YOUR BOOBS HAVE A MIND OF THEIR OWN.
BUT WE KNOW WHAT THEY’RE THINKING”
…antibacterial and odorless through the application of
silver dioxide fiber technology, preserving garment
freshness. Finally, integrated titanium oxide fiber
technology protects against ultraviolet rays providing UPF
50+. http://cw-x.com/GearTechnology.aspx
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CARBON NANOTUBES: the new asbestos?
Both are long, rigid, fiber-like tubes.
Both have a diameter of about 100-200 nm.
Both cause cytotoxicity, DNA damage, mutation.
Both cause size-dependent inflammation, granulomas,
fibrosis
Review by Jaurand et al, 2009. http://www.biomedcentral.com/content/pdf/1743-8977-6-16.pdf
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FEDERAL INSECTICIDE, FUNGICIDE,
AND RODENTICIDE ACT
(FIFRA)
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NANOSILVER: ANTIMICROBIAL
Silver is a priority pollutant whose discharge is regulated by
EPA under the Clean Water Act
100’s of consumer products claim to use nanosilver;
Nanosilver, like silver, kills both harmful and beneficial
microbes. The nanoscale version is more toxic than
regular silver, and releases free ions.
In cultured mouse sperm stem cells, a 48 hr treatment of
nanosilver (15 nm diameter) was 45-fold more toxic than
silver carbonate (EC50 of 8.75 v 408 ug/ml).
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Silver is regulated as a contaminant under the Clean
Water Act
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Calls to regulate nanosilver as a pesticide from the National
Association of Clean Water Agencies (NACWA) and TriTAC
(Calif water treatment agencies) sent multiple letters to EPA
raising concern about nanosilver and nanomaterials
impacts on water treatment facilities (2011, 2010, 2008,
2006)
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EPA REGULATES THE WASHING MACHINE
… "ion generators that incorporate a substance (e.g., silver or
copper) ... for the purpose of preventing, destroying, repelling,
or mitigating a pest (e.g., bacteria or algae)...are considered
pesticides for purposes of FIFRA, and must be registered prior
to sale or distribution." (FR Notice, Sept 07)
All products must have applied to EPA for registration by
March 21, 2008, to continue to sell after that date.
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In March, 2008 US EPA fined a nanotech company,
ATEN Technology $208,000 because its subsidiary,
IOGEAR, was selling nanosilver as an unregistered
pesticide.
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TOXICS SUBSTANCES CONTROL ACT
(TSCA)
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TSCA provides broad authority to:
•Gather information on new and existing
chemical substances and mixtures
•Require testing of chemicals
•Screen and control unreasonable risks of new
and existing chemicals
•Coordinate with other Federal agencies
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New Chemicals Program
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Pre-manufacture Notices (PMNs)
Low Release/Exposure Exemption (LoREX)
Significant New Use Rules (SNURs)
Consent Orders
Existing-chemical based nanomaterials
 SNURs for Existing NMs
 Section 4 test rule
 Section 8(a) – report existing data
 Section 8(e) – notices of substantial risk
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From a presentation by EPA’s Jim Allwood, Sept 22, 2010
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EPA Publishes Proposed SNURs for 17 Chemicals,
Including CNTs and Fullerenes – December 28, 2011
Under TSCA Section 5(e) - required to notify EPA at least 90
days before commencing manufacturing, producing,
importing.
EPA determined that nano SNURs may present and
unreasonable risk of injury to human health. EPA requiring
PPE – gloves, chemical protective clothing, respirators - and
some workplace monitoring.
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Comments were submitted by 6 major unions and 38
health and environmental groups (March 2012)
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FOOD AND DRUG ADMINISTRATION
(FDA)
•FDA does not have authority to require cosmetic
companies to submit safety data
•FDA does not have authority to obtain post-market
health and safety data for any products
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NANOCHEMICALS IN MEDICINE
Emend ® (Merck, USA) approved by FDA in 2003 as an antinausea drug for chemotherapy patients. Nanocrystals.
Doxil® (ALZA Corp, USA) approved by FDA in 2005 to treat
ovarian cancer and Kaposi’s sarcoma. Lipid nanoparticles.
Estrasorb™ (Novavax, Inc, USA) approved by FDA in 2003 as
topical estradiol lotion to treat menopause. Micellar
nanoparticles.
Rapamune ® (Wyeth, USA) approved by FDA in 2000 as an
immunesuppresant for renal transplant patients. Nanocrystal
form.
Zirconium Oxide ® (Altair Nanotechnologies, Inc, USA)
commercially available since 2003 for dental fillings
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NANOCHEMICALS IN FOOD AND BEVERAGES
Nanoceuticals ™ Slim Shake Chocolate (RBC Life
Sciences, USA). Pure cocoa is added to a nano-cluster
Canola Active Oil (Shemen Industries, Israel). Uses Nanosized self assembled structured lipids, NSSL, to deliver
insoluble vitamins through the cellular membrane
Nanotea (Shenzhen Become Industry&Trade Co., China)
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NANOCHEMICALS IN FOOD CONTACT MATERIALS
Kitchen cutting board (S Korea) nanosilver
Home and garden spray (ABL, USA) nanosilver
Aluminum foil (Melitta, Germany). With non-stick coating. “Put simply, is
that the black coating material to carbon, in a glass matrix is embedded.
The black area reached up to 100 degrees Celsius higher surface
temperatures when cooking … the food is prepared quickly.”
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CONSUMER PRODUCT SAFETY COMMISSION
•CPSAct prohibits the agency from imposing mandatory
safety standards if the industry agrees to write its own
standards
•CPSAct prohibits the agency from informing the public
about a product without pre-approval of the manufacturer
•CPSC has no authority to require pre-market testing; only
has authority to implement post-market product recalls
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NNI FEDERAL BUDGET 2010-2011
(dollars in millions)
DOE
HHS/NIH
DOD
EPA
NIOSH
FDA
380
456
415
17
9
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CONCLUSION – E/OHS TESTING IS NOT
KEEPING UP!
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Allocation of EPA/ORD EHS budget, $20M:
50%
Sources, Fate, Transport, and Exposure
30%
Human Health and Ecological Effects
10% Risk Assessment Methods and Case Studies
10%
Preventing and Mitigating Risks
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The Solution:
We need reform of our nation’s chemical regulatory act,
TSCA.
Support Senator Lautenberg’s SAFE CHEMICALS ACT,
which would require all new chemicals, including
nanomaterials, to be tox tested before they are
commercialized.
The Safe Chemicals Act is supported by a coalition of over
11 million individuals, including parents, health
professionals, advocates for people with learning and
developmental disabilities, reproductive health advocates,
environmentalists and businesses from across the nation.
http://www.saferchemicals.org/safe-chemicals-act/
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