SASSSASS 11

NANOMATERIALS: NANOMATERIALS:

Risks and Regulatory Gaps

SEJ 2012, Lubbock TX

Jennifer Sass, Ph.D.

SASSSASS 22

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.

 

SASSSASS 33

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

SASSSASS 44

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

SASSSASS 55

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

66

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.

SASSSASS 77

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.

88

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).

99

NANO TITANIUM DIOXIDE

“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

…Z-Cote (transparent zinc oxide) and T-Cote (transparent titanium dioxide), that do not deposit this chalky residue

1010

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

SASSSASS 1111

FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT

(FIFRA)

SASSSASS 1212

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).

SASSSASS 1313

Silver is regulated as a contaminant under the Clean Water Act

SASSSASS 1414

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)

SASSSASS 1515

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.

SASSSASS 1616

In March, 2008 US EPA fined a nanotech company, ATEN Technology $208,000 because its subsidiary, IOGEAR, was selling nanosilver as an unregistered pesticide.

SASSSASS 1717

SASSSASS 1818

SASSSASS 1919

TOXICS SUBSTANCES CONTROL ACT(TSCA)

SASSSASS 2020

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

New Chemicals Program 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

SASSSASS 2121

SASSSASS 2222

From a presentation by EPA’s Jim Allwood, Sept 22, 2010

SASSSASS 2323

SASSSASS 2424

SASSSASS 2525

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.

SASSSASS 2626

Comments were submitted by 6 major unions and 38 health and environmental groups (March 2012)

SASSSASS 2727

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

2828

NANOCHEMICALS IN MEDICINE

Emend ® (Merck, USA) approved by FDA in 2003 as an anti-nausea 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

2929

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 Nano-sized self assembled structured lipids, NSSL, to deliver insoluble vitamins through the cellular membrane

Nanotea (Shenzhen Become Industry&Trade Co., China)

3030

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.”

SASSSASS 3131

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

SASSSASS 3232

NNI FEDERAL BUDGET 2010-2011 (dollars in millions)

DOE 380HHS/NIH 456DOD 415EPA 17NIOSH 9FDA 7

CONCLUSION – E/OHS TESTING IS NOT KEEPING UP!

SASSSASS 3333

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

SASSSASS 3434

SASSSASS 3535

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/