Precautionary Principle

This principle is a regulatory concept designed to appeal to a natural desire for security and safety, something that the public health portfolio of environmental issues promises to deliver. When people hear of the concept, it appears to be a common-sense policy of “better safe than sorry.”

Opposing the principle is politically difficult as it makes policy makers appear callous and uncaring, even though the principle is technically impossible to meet. Once the precautionary principle is accepted as a matter of policy, it presses policy makers to make regulations as stringent as possible and even encourages lawmakers to ban certain technologies on the basis that they might pose safety risks. In essence, it grants regulators arbitrary power to regulate based on political rather than scientific or risk-based grounds.

The precautionary principle shifts regulation away from risk-based standards toward hazard-based ones. Risk standards require policy makers to determine an acceptable risk level for society, ideallybased on the best available, peer-reviewed science and a solid understanding of human exposure to the chemical. Often determinations include weighing those estimated risks against expected benefits that the substance may bring.

Hazard-based standards only consider whether something has the potential for harm at some level. A chemical may be dubbed “hazardous,” even if it poses little risk at existing exposure levels. For example, water can be considered hazardous because excessive consumption can produce fatal “water intoxification.”(1)

Hazard alone is not a good justification for regulation, yet advocates of precaution suggest it should be. Moreover, a hazard assessment is usually only one step in the risk assessment process whereby researchers consider risks associated with actual or estimated exposures.

It is worth noting, however, that even risk-based regulation can prove excessively precautionary. In fact, most of the highly precautionary laws and regulations currently on the books include some form of risk assessment. That is because regulators tend to error on the side of caution, building in a host of safety factors that substantially overestimate exposure to justify regulatory actions that may not be necessary.

Formalization of the precautionary principle as a policy tool began several decades ago.  Early versions of the precautionary principle appeared in several international documents, including the United Nations World Charter for Nature (1982), the Nordic Council’s International Conference on the Pollution of the Seas (1989), the United Nation’s Environment Program’s Rio Declaration of Environment, Development (1992), the United Nations Framework Convention on Climate Change (1992), and the Convention on Biodiversity.(2)

Environmental advocacy groups formalized the concept in 1998. That year, 31 activists from five countries met in Wingspread, Wisconsin, at the request of the North Dakota-based Science and Environment Health Network. The assembly produced the “Wingspread Statement,” which reads: “When an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause-and-effect relationships are not fully established scientifically.”(3)

Another version of this principle was essentially endorsed by 180 nations as a provision of the Cartagena Protocol on Biosafety in 2000. A section outlining the objective of the protocol notes that precaution—that is, regulation—should govern international movements of genetically modified (GM) products simply because they “may have adverse affects on the conservation and sustainable use of biological diversity taking also into account risks to human health.”(4) [Emphasis added] By getting policy makers to accept these definitions, environmentalists essentially declared that it is not necessary to scientifically demonstrate the need for an environmental health regulation.

Environmentalists have been able to use the precautionary principle to advance their agenda in a number of areas. Consider its impact on biotechnology.  Author Bonner Cohen notes that genetically modified (GM) crops have undergone extensive study by the world’s top scientific bodies—including the United Kingdom’s Royal Society, U.S. National Academy of Sciences, and World Health Organization—and they all report that GM foods pose no more risk than conventionally grown crops. Yet environmental groups have used the principle to claim that the public should not consume GM foods because the technology has not been proven safe.  As a result of their campaigns against these crops, GM foods are so unpopular in Europe that supermarkets do not carry any such crops.(5)

Such efforts have not worked as well in the United States, where GM foods are pretty common, but they have impacted developing nations. In 2002, Zambia and Zimbabwe’s governments locked up warehouses full of U.S. GM corn that was donated by the American government to help feed people during a famine in these two nations. The governments refused to distribute the food because leaders apparently did not want their citizens to eat GM foods because of concerns raised by environmentalists. Citizens in both nations eventually broke into the warehouses and seized the corn.(6)

The environmental movement’s precautionary principle was also used as the basis of an ambitious new regulatory program in Europe to regulate chemicals and other substances, which passed into law in December 2006. The European Union’s (EU) chemicals policy, called REACH—which stands for Registration, Evaluation, and Authorization of Chemicals—will employ the precautionary principle by requiring companies to prove their products are safe before they are introduced into commerce. Before REACH, government officials had to demonstrate that a product is not safe before removing it from the market. REACH reverses this burden, demanding that firms conduct extensive tests to demonstrate product safety.

The text of REACH highlights the precautionary principle as the focus of the program. Article 1 notes that the provisions of REACH are “underpinned by the precautionary principle.”(7) (The use of the precautionary principle in European legislation is not surprising as the Treaty of the European Union also known as the Treaty of Maastricht,(8) demands that EU regulatory bodies employ the precautionary principle in environmental legislation) (9). To achieve its goals, REACH demands a massive amount of data submission and testing from companies.(10) It covers more than 100,000 chemicals, for which companies must submit data in an attempt to prove safety.(11) The more than 600 page legislation is expected to cost billions of dollars in direct compliance costs (€3.6 to €5.2 billion),(12) substantially impact and potentially impede global trade,(13) and produce unmeasured indirect costs.(14)

REACH is precautionary, but it is not purely hazard-based. All covered chemicals are brought into the system based on the assumption of hazard, but the law’s data submission and testing provisions attempt to set risk-based priorities. Chemicals dubbed “of concern” are assessed further. At that point, companies must show that, “risks associated with uses of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks,”(15) or be subject to regulation. Still, REACH remains precautionary in nature and may lead to unnecessary product removals. Unfortunately, the bureaucracy and other associated costs associated with REACH pose significant roadblocks to technological development and entrepreneurship, preempting economic growth in a way that cannot be measured.

Shortly after REACH was enacted in 2006, several American states—starting with California—began looking into enacting their own versions of this law. California passed a similar law, the Green Chemistry Initiative, and several other states have passed chemical regulation laws.(16) In the United States Senate, Sen. Frank Lautenberg began working in tandem with environmental groups to build momentum for a U.S. version of REACH. To that end, he commissioned the Government Accountability Office to assess the need for revisions to the Toxics Substances Control Act—amendments that could transform that program into a REACH-styled law.(17) Sen. Lautenberg followed that report with the introduction of legislation designed to get the process moving in the direction of a U.S. REACH law. The first of these was the Child, Worker and Consumer Safe Chemicals Act; Rep. Henry Waxman (D-Calif.) introduced a companion bill in the House of Representatives.(18) Since then, Lautenberg and Waxman have introduced TSCA reform bills in the 110^th, 111^th and 112^th Congresses.(19)

Currently, U.S. environmental law does not overtly list the precautionary principle as a governing standard, yet precaution is the hallmark of many environmental policies. Federal pesticide regulations provide a perfect example of very precautionary—yet still risk-based—law. The 1996 Food Quality Protection Act (FQPA) was designed to replace an old standard called the Delany Clause, which regulated pesticide residues on processed food. It prohibited the addition to food of any substance that had been shown to cause cancer in laboratory animals. That was such a precautionary standard that many lawmakers and agricultural interests feared it would eliminate many valuable agrochemical products. Passed by a Republican Congress seeking to curb regulatory excesses, FQPA adopted a risk-based standard that limited residues on all foods—both processed and unprocessed—to a level that ensured “a reasonable certainty that no harm will result from aggregate exposure.”(2) Despite contentions by supporters that the standard would be less stringent, the new law in fact proved more stringent than its predecessor. One observer commented: “No, you may not gain peace of mind when discovering that the new standard is stricter than Delaney, at least the way EPA and FDA was interpreting it.”(21)

“No harm” suggests a zero-risk standard, and aggregate exposure considerations added a new level of precaution. The new law also demanded that regulators apply an additional 10-fold safety factor for any product to which children might be exposed, in addition to safety factors they already employed. Shortly after the FQPA was passed, University of Texas professor Frank Cross pointed out in a law review article that EPA’s conservative risk estimates were already excessively cautious, overstating pesticide exposure thousands and even hundreds of thousands of times beyond the most likely actual exposure levels.(22) And the FQPA has added factors of caution beyond even that, leading to the removal of many products from the market.

For example, during the first 10 years of the FQPA’s life, the EPA completed a 10-year study of 230 organophosphates and carbonates pesticides. It concluded that the Act demands that the agency ban 3,200 uses of pesticide products in these categories and place restrictions on 1,200 other uses. It deemed 5,237 uses as “safe” under the Act.(23) That is 46 percent of the uses of the 230 chemicals—a substantial increase of regulations using FQPA’s risk-based standard.

Attempts to curb such regulatory excesses have taken the form of regulatory oversight laws that focus on the regulatory process in general, rather than reforms to the underlying basis of these laws. By and large, these efforts have not proven particularly effective either in curbing precautionary environmental policy or in promoting rigorous risk-assessment and cost-benefit considerations as criteria for environmental regulation.(24)