Course: BIS 105 Environmental Biology

Unit 9 Learning Module

Approaches to policy

Philosophical Approaches

There are two main approaches to determining how chemicals should be regulated. In the innocent-until-proven-guilty principle a substance is not considered harmful until scientific data can definitively link the harm due to a specific substance. The pace of development can be rapid, with economic benefits. However, this also means that a harmful substance may be widely used for a period of time before the harm it causes is identified.

In the precautionary principle if a substance may cause damage to the environment or human health, it must be shown to be non-harmful before it can be widely used. This limits the extent of the damage since only a small study group is exposed to the substance before the harm is identified. On the other hand, it slows down the pace of technological and economic advancement due to the time needed to prove a substance is safe. There is additional expense associated with the greater number of chemical screenings that need to be conducted as well.

An example of these different approaches can be seen with thalidomide. This drug was given to pregnant women to reduce the symptoms of morning sickness. At the time, many doctors didn't believe a drug taken by the mother would cross the placental barrier and, therefore, could not harm a fetus. Canada and over 20 European and African nations had already approved thalidomide for use by 1960. In the United States Dr. Frances Oldham Kelsey was the reviewer for thalidomide in the FDA. Citing insufficient data and questions about a report indicating nervous system side effects, she withheld approval of thalidomide even under heavy pressure from its manufacturer. By the early 1960s, over 10,000 children had been born with birth defects. Thalidomide was found to be a teratogen that caused deformed limbs.

Interestingly, after events such as this European nations have moved towards more of a precautionary approach. Meanwhile, other than pharmaceutical testing, the United States has adopted more of a innocent-until-proven-guilty approach.

International Efforts

In 2001, over 150 nations gathered in Stockholm, Sweden to negotiate an agreement on restricting the use certain harmful chemicals. This became known as the Stockholm Convention and it focused on 12 persistent organic pollutants (known as the dirty dozen). Nine of the chemicals were banned, DDT use was restricted, and the inadvertent production of dioxins and furans were limited. In 2009, an additional 9 chemicals were added to the list. As of February 2013, 178 nations are party to the Convention. Although the United States has signed the agreement, it has not yet ratified the Stockholm Convention.

In 2007, the 27 European Union nations established Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) program for addressing the use and production of chemicals. Substances produced or imported in quantities over 1 metric ton a year must be registered with the European Chemicals Agency. EU commissioned report estimated the costs to industry and users to be $3.8-7.0 billion over 11 years, while realizing benefits of $67 billion over 30 years.