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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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