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The other approach is to assume that substances are compounds in plastics. The act gives the agency power to
harmful until shown to be harmless. This approach follows the regulate these substances and ban them if they are found to
precautionary principle (p. 283). This more cautious approach pose excessive risk.
should enable us to identify troublesome toxicants before they However, many public health advocates view TSCA as
are released into the environment, but it may also impede the being far too weak. The 62,000 chemicals existing when
pace of technological and economic advance. TSCA became law were grandfathered in, and the num-
These two approaches are actually two ends of a con- ber has since swollen to 83,000, while just five have been
tinuum of possible approaches. The two endpoints differ restricted. Health advocates note that the screening required
mainly in where they lay the burden of proof—specifically, of industry is minimal and that to mandate more extensive
whether product manufacturers are required to prove safety and meaningful testing, the EPA must show proof of the
or whether government, scientists, or citizens are required to chemical’s toxicity. In other words, the agency is trapped
prove danger. in a Catch-22: To push for studies looking for toxicity,
it must have proof of toxicity already. The result is that
most synthetic chemicals are not thoroughly tested before
WEIGHING THE ISSUES being brought to market. Of those that fall under TSCA,
THE PRECAUTIONARY PRINCIPlE Industry’s critics say chemical only 10% have been thoroughly tested for toxicity; only
manufacturers should bear the burden of proof for the safety of 2% have been screened for carcinogenicity, mutagenicity,
their products before they hit the market. Industry’s supporters or teratogenicity; fewer than 1% are regulated; and almost
say that mandating more safety research will hamper the none have been tested for endocrine, nervous, or immune
introduction of products that consumers want, increase the price system damage, according to the U.S. National Academy
of products as research costs are passed on to consumers, of Sciences.
and cause companies to move to nations where standards In its regulation of pesticides under FIFRA, the EPA is
are more lax. What do you think? Should government follow charged with “registering” each new pesticide that manufac-
the precautionary principle and require proof of safety prior to a turers propose to bring to market. The registration process
chemical’s introduction into the market? involves risk assessment and risk management. The EPA
first asks the manufacturer to provide information, includ-
ing results of safety assessments the company has performed
Philosophical approaches according to EPA guidelines. The EPA examines the com-
pany’s research and all other relevant scientific research.
are reflected in policy It examines the product’s ingredients and how the product
will be used and tries to evaluate whether the chemical poses
This choice of philosophical approach has direct implica-
tions for policy, and nations vary in how they blend the risks to people, other organisms, or water or air quality. The
two approaches when it comes to regulating synthetic sub- EPA then approves, denies, or sets limits on the chemical’s
stances. European nations have recently embarked on a sale and use. It also must approve language used on the prod-
policy course that incorporates the precautionary principle, uct’s label.
whereas the United States largely follows an innocent-until- Because the registration process takes economic consid-
proven-guilty approach. For instance, compounds in cos- erations into account, critics say it allows hazardous chem-
metics require no FDA review or approval before being sold icals to be approved if the economic benefits are judged to
to the public. outweigh the hazards. Here the challenges of weighing intan-
In the United States, several federal agencies apportion gible risks involving human health and environmental quality
responsibility for tracking and regulating synthetic chemi- against the tangible and quantitative numbers of economics
cals. The FDA, under the Food, Drug, and Cosmetic Act become apparent.
of 1938 and its subsequent amendments, monitors foods
and food additives, cosmetics, drugs, and medical devices.
The EPA regulates pesticides under the Federal Insecti- Toxicants are regulated internationally CHAPTER 14 • Envi R onm E n TA l H EA lTH A nd T o xi C ology
cide, Fungicide, and Rodenticide Act of 1947 (FIFRA) The European Union is taking the world’s boldest step toward
and its amendments. The Occupational Safety and Health testing and regulating manufactured chemicals. In 2007, the
Administration (OSHA) regulates workplace hazards under EU’s REACH program went into effect (REACH stands for
a 1970 act. Several other agencies regulate other substances. Registration, Evaluation, Authorization, and Restriction
Synthetic chemicals not covered by other laws are regulated of Chemicals). REACH largely shifts the burden of proof
by the EPA under the 1976 Toxic Substances Control Act for testing chemical safety from national governments to
(TSCA). industry and requires that chemical substances produced or
imported in amounts of over 1 metric ton per year be regis-
EPA regulation is only partly effective tered with a new European Chemicals Agency. This agency
evaluates industry research and decides whether the chemical
The Toxic Substances Control Act directs the EPA to moni- seems safe and should be approved, whether it is unsafe and
tor thousands of industrial chemicals manufactured in or should be restricted, or whether more testing is needed. It is
imported into the United States, ranging from PCBs to expected that REACH will require the registration of about
lead to asbestos, and including bisphenol A and many other 30,000 substances. 401
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