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3 Global Implication of Environmental Standards
Pages 44-64

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From page 44...
... BALANCING RISK ASSESSMENT WITH THE REALITIES OF UNCERTAINTY The challenges of risk and risk assessment in protecting public health through regulation of chemicals requires looking at the changes in Europe, according to Bernard Goldstein, Graduate School of Public Health, University of Pittsburgh. Central to the current debate about environmental control in the European Union is the precautionary principle.
From page 45...
... The European Union lost this World Trade Organization case primarily due to the lack of risk assessment, as well as an inconsistent application of the precautionary principle seemingly to form a trade barrier. Goldstein further noted that these types of cases are going to continue with genetically modified foods and with other health and safety issues for which the EU uses the precautionary principle to form trade barriers.
From page 46...
... Goldstein argued that one needs to build in an evaluation to determine if the precautionary approach is warranted. TABLE 3-1 Control of Hazardous Air Pollutants in the United States Before 1990 After 1990 Burden of proof To list chemical, EPA must To remove chemical from list, demonstrate that ambient levels industry must demonstrate that of pollutant produce risk chemical does not produce risk Regulatory control for Risk-based application of Maximum available control listed pollutant control technology technology Role of risk assessment Primary Secondary SOURCE: Goldstein and Carruth, 2003.
From page 47...
... A corporate more often that it is going to spend money, audit by Union Carbide Corporation resources, and social capital for the wrong 2.5 years prior to the Bhopal disaster reason. The precautionary principle, if had identified many of these prob- done well, is primary prevention, and risk lems (Ives, 1985)
From page 48...
... THE REACH INITIATIVE The European Union has the same issues as the United States but in a much more crowded situation, noted Robert Donkers of the delegation of the European Commission to the United States. The European Union has more than 450 million people in an area half the size of the United States.
From page 49...
... Donkers asserted that the European Union sees a need for REACH because the current system for chemical management is inefficient: · It is difficult to identify risks. · There is a lack of information about most substances on the market.
From page 50...
... If they choose not to share their use information with suppliers, downstream users have to perform chemical safety assessments for "unidentified uses," and inform the agency accordingly. Finally, Donkers noted that down stream users need to enter into dialogue with their supplies and consider taking part in consortia of providers and cost-sharing practices.
From page 51...
... It is reasonable to have a robust dialogue between the government agencies, affected parties, industry groups, and other stakeholders to ensure that, ultimately, there is a legislative outcome that achieves the purpose that was originally intended. Bus suggested that the need for reform is real, both in Europe and the United States -- where there is a distinction between new and existing chemicals.
From page 52...
... We live and interact in a global world. Thus any environment that is created in the European Union needs to achieve appropriate international integration and harmonization and, at the same time, also needs to be consistent with the expec tation of the World Trade Organization.
From page 53...
... This means that the assumptions could be refined with additional data, such as hazard date or other activities that could be undertaken. This additional screening might not require further testing, because one could decide that one could comply with those conservative risk evaluations simply by taking risk management decisions, concluded Bus.
From page 54...
... This will In the European Union, approximately result in a particular burden of cost on 75 percent of chemicals are not high the small to medium-sized enterprises volume productions, noted Bus. The that constitute approximately 90 perlow volume chemicals are produced by cent of the European Union industrial limited number of companies; thus forming sector.
From page 55...
... Broadly defined, environmental substances of concern under CEPA include both organic and inorganic matter, effectively spanning almost anything in the environment that could be harmful to human health. CEPA is CEPA is not intended to compete with not intended to compete with other other statutes, such as the Food and Drug statutes, such as the Food and Drug Act, the Hazardous Products Act, and the Act, the Hazardous Products Act, and Pest Control Products Act, but rather is the Pest Control Products Act, but an umbrella safety net piece of legislation rather comes into force where gaps where gaps exist in the statutes.
From page 56...
... containing 44 different substances was put forward, representing environmental agents of particular concern, as identified by an external multidisciplinary advi sory committee. A complete, detailed assessment of the chemicals on this list was required to be finished within five years, which included a full review of the scien tific literature on toxicity of the agent, leading to an assessment of the health risks associated with the substance.
From page 57...
... 1 2 3 1 N N GEA GEA GEA ST ST ST GEA GEA ST ST lic Pub nominations management Risk management of Risk other isdictions Decisions jur xicto phase) dr or phase)
From page 58...
... These recommendations may be accepted, declined or accepted with modifications to become the risk management strategy for address ing the substances that are identified as toxic under the statute, noted Krewski. Challenges of the Canadian Environmental Protection Act One of the challenges in implementing the Canadian Environmental Pro tection Act is to coordinate the activities of Health Canada and Environment Canada.
From page 59...
... For example, the 1996 Food Quality Protection Act for food sets the standard to be a "reasonable certainty of no harm"; however, for nonfood uses, the standard is to avoid "unreasonable risk to health or the environment," observed Goldman. For the TSCA for all chemicals, the standard is the unreasonable risk standard.
From page 60...
... Under TSCA, the -- LynnGoldman government needs to make a finding of unreasonable risk or exposure in order to have the chemical tested. In the absence of direct information about hazard and exposure data, the government has used production volume as a surrogate for potential exposure.
From page 61...
... INTERNATIONAL COOPERATION ON REGULATORY ISSUES: STRATEGIC APPROACH TO INTERNATIONAL CHEMICAL MANAGEMENT The public needs to recognize that almost all man-made products involve the use of intentionally produced chemicals. Every year tens of thousands of chemicals are produced and used in commercial activities, noted John Buccini of the United Nations Environmental Program.
From page 62...
... Policies for for the sound management of chemithe sound management of chemicals are cals are recognized as essential comrecognized as essential components of ponents of overall public policy in overall public policy in countries at all countries at all stages of developstages of development, and they should ment, and they should be reflected be reflected in national sustainable in national sustainable development development plans. plans.
From page 63...
... Whether it is to implement sound toxics policies or conventions, these countries need to have access to clean technologies, trained human resources, policies and legislation, and enforcement capacity. To help address the growing needs, the strategic approach to international chemicals management (SAICM)
From page 64...
... When REACH is enacted in the European Union, the United States, with a weaker chemical law, may become a dumping ground for chemicals that are no longer acceptable for use in Europe. Buccini noted that this has happened in the past.


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