Size Matters: Regulating Nanotechnology

• Date: 01 August 2009

39 ELR 10806 ENVIRONMENTAL LAW REPORTER 8-2009

Size Matters: Regulating

Nanotechnology

by Albert C. Lin

Albert C. Lin is a Professor of Law at the University of California at Davis.

Nanomaterials and products containing nanomateri-

als are quickly being integrated into a wide range

of commercial and noncommercial applications.

As nanomaterials grow more commonplace, we are coming

in contact with these substances on an increasingly regular

basis, in products ranging from stain-resistant khaki pants

to sunscreens. Despite the expanding use of nanomaterials,

relatively little is known about the possible harm t hey could

pose. Current forms of government regulation are proving

inadequate in addressing t his potential harm. erefore, it

is imperative that new mecha nisms be developed to learn

more about these new substa nces, while protecting ag ainst

the unknown risks they present to society.

Nanotechnology is the term used to describe the bur-

geoning eld of manipulating matter at a nanometer scale.

Engineered nanomaterials are derived from conventional

chemical substances, but have unique characteristics and

surface coatings that often lead them to behave ver y dier-

ently. e small size and high surface-area-to-mass ratio of

nanosized particles enha nce the mechanical, electrical, opti-

cal, cata lytic, and/or biological activity of a substance. is

unusual behavior, however, along with k nown hazards pre-

sented by naturally occurring particles of somewhat simila r

size, has caused concern over the eects that nanomateri-

als could have on human health and the environment. Free

nanoparticles that may be released into the environment,

whether intentionally or incidentally as a product is used,

are of particular concern. ese substances are believed to be

the most likely to be able to enter the body, react with cells,

and cause tissue damage. ere is very little data on harm-

ful eect s from real world exposure to engineered nanopar-

ticles, but th is uncerta inty should not be used as an excuse

for regulatory inaction.

e existing statutes that might be used to regulate nano-

materials are inadequate. e Toxic Substances Control Act

(TSCA) is the main authority that could be used to regulate

nanomaterials, supplemented by media-based environmental

statutes, consumer safet y statutes, the Occupational Safety

and Health Act (OSHA), and statutes specic to drugs

and certain other products. TSCA’s purpose is to address

the concern t hat humans and the environment are exposed

to numerous chemical substances that pose unknown or

unreasonable risks. However, there is great diculty in the

implementation of this statute, especially as to nanomateri-

als. TSCA’s general approach is that no information on the

risk of a chemical means that there is no risk. is places

too heavy a burden on the EPA to demonstrate that a risk

is or may be unreasonable in order to require testing of a

substance or in order to regulate its manufacture or use. In

addition, chemical manufacturers sometimes take the posi-

tion that engineered nanomaterials should not be deemed a

new class for purposes of TSCA, and thus subject to more

regulation, because they are derived from conventional sub-

stances. Other potentially applicable statutes such as OSHA

only provide for protection and testing under limited cir-

cumstances. e government needs to become proactive and

establish a new regulatory approach for nanomaterials.

e government should engage and educate the public

about the relevant risks and benets of nanomaterials. is

means switching the regulatory paradigm of nanomaterials

from the harm principle, to a more appropriate precaution-

ary principle. Instead of regulating only when harm is dem-

onstrated, as under TSCA, we should develop a statute that

does not require conclusive evidence of risk as a prerequisite

for the adoption of mea sures to address potential risks. e

regulatory plan put in place needs to protect human health

and t he environment while facilitating planning and com-

mercialization eorts.

All products that contain nanomaterials should be subject

to a notication and labeling requirement. Promoting the

development of uniform nomenclature and metrology for

nanomaterials would help ensure eective notication and

labeling. Notication would help regulators to keep track

of nanotechnology developments and to identify regula-

tory needs, and labeling would assist the public in making

more informed choices. Because free nanomaterials pose

potentially greater risks, they should be required to u ndergo

a screening process to help minimize the exposure of work-

ers and consumers to nanomaterials with t he greatest like-

is Article is excerpted from  H. E. L. R.  ()

and is reprinted with permission.

H O N O R A B L E M E N T I O N

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