Global Approach To Chemical Regulations A Worthy, But Difficult Goal

Implementing chemical regulations that protect human health and the environment is an expensive and complex exercise. Industry groups and regulators agree that sharing chemical safety data and software around the world would save hundreds of millions of dollars annually. They disagree, however, on what would be the best approach. Whereas the European Union says its chemical management program could be applied globally, the U.S. chemical industry’s main trade association, the American Chemistry Council (ACC), is strongly opposed to such a move.

The EU’s program for the Registration, Evaluation, Authorisation & Restriction of Chemical substances, called REACH, features risk assessment methods and data for thousands of commercial chemicals. According to the European Commission, so far it has cost more than $2 billion, paid mostly by industry, to implement. “Why should this work be duplicated outside of Europe?” asked Geert Dancet, executive director of the European Chemicals Agency (ECHA), as he made the case for REACH globalization at the Helsinki Chemicals Forum last month. The forum was sponsored by the city of Helsinki, Helsinki-based ECHA, and Finland’s Ministry of the Environment.

Benefits from unified chemical regulations would include sharing of product testing data, reduced animal testing, removal of some nontariff trade barriers, avoidance of data duplication, and promotion of a level playing field for industry by ensuring the same quality requirements for all, Rob Visser said at the forum. Visser is a consultant and former deputy director of environment at the Organisation for Economic Cooperation & Development (OECD).

“It’s very important to keep looking for convergence of chemical regulations; otherwise, chemical safety will be much more expensive,” Visser said. A global regulatory model would be particularly beneficial for people in developing countries, where resources for creating effective chemical legislation are scarce.

Although many experts at the forum agreed that some level of regulatory convergence makes sense, Michael P. Walls, vice president of regulatory and technical affairs for ACC and a panelist at the forum, made it clear that ACC strongly opposes the wholesale application of REACH beyond the EU.

“No one is settling on a process or a structure that is identical to REACH,” Walls said. ACC advocates an approach that uses risk-based evidence to minimize the burden on chemical companies. But compared with the U.S. Toxic Substances Control Act (TSCA), REACH places additional responsibility on manufacturers to manage chemical data.

“We want to encourage burden sharing and find ways to do that most efficiently and effectively­—not just for regulatory authorities but also for the industry,” Walls said. ACC also favors regulations that “promote innovation and protect proprietary interests,” he added.

Although the possibility of TSCA being adopted globally is unlikely given that it is set for modernization by Congress this year or next, Dancet said REACH is ready now. ECHA has already begun acting on its global ambitions, setting up formal agreements to share its chemical management approach with regulatory bodies in the U.S., Canada, Japan, and Australia. “We have an increasing number of requests to cooperate with us,” Dancet said. In particular, other countries want to learn more about ECHA’s software for managing chemical safety data.

“Fashionable subjects such as nanomaterials, endocrine disrupters, and the complicated effects of mixtures are attracting political attention,” Dancet added. If ECHA can stay at the forefront of adopting tests for such chemicals, then “we expect, as an agency, to become a hub, which facilitates international capacity building. We see this as an essential role for us.”

REACH has three key attributes that make it suitable for deployment beyond Europe, said Derek J. Knight, senior scientific adviser to ECHA, in a panel discussion at the forum. It ensures a high level of protection for human health and the environment, it makes industry responsible for establishing the safety of chemicals, and, although not perfect, it works, in part by using targeted activities to get the best effect.

Still, Jukka Malm, director of regulatory affairs at ECHA, tempered Dancet’s enthusiasm for exporting exact copies of REACH around the world. The more likely scenario is that countries will copy elements of REACH, including certain chemical data sets, risk assessment criteria, toxicity testing, and software for collecting and managing chemical data, he told C&EN.

Before considering how REACH—or any other system—should be applied, the first task for chemical industry stakeholders will be to undertake detailed discussions about the principles for global cooperation, Walls said. “There is, as yet, no formal system to facilitate this,” he cautioned.

Although Walls and Dancet don’t share a passion for the globalization of REACH, they agree that global cooperation on certain chemicals’ safety data and tests could yield significant cost savings. The cost of generating OECD-developed high-production-volume chemical data sets is between $500,000 and $2 million each, Walls said. REACH data sets can be more extensive and could be more expensive, “so minimizing duplication of those testing requirements can be very important.”

Potential savings from sharing chemical testing data for industrial chemicals over the next several years could total more than $1 billion. Although open to the sharing of such data, ACC remains “committed to be a full participant in the discussions around TSCA,” Walls said.

The debate over regulatory harmonization is occurring as new legislative challenges loom on the horizon. According to Visser, the consultant, these include nanomaterials, endocrine-disrupting chemicals, and the evaluation and regulation of chemical mixtures. Such issues will only add to the complexity and therefore expense of implementing future chemical legislation, he said.

Visser didn’t rule out using REACH as the starting point for a global chemical law. REACH “is an excellent body of legislation for risk management.” However, chemical safety is a moving target. New science is emerging, and REACH could be just the beginning, Visser said. OECD is not itself suited to becoming the global agency for chemical regulations because it is not a policy-focused organization, he added.

The United Nations’ Strategic Approach to International Chemicals Management (SAICM), a policy framework that promotes chemical safety around the world, could be a more suitable global hub for developing chemical policies, some conference attendees suggested. SAICM is already active in this field through its work with developing countries.

At its triennial summit meeting, set to take place in September in Nairobi, Ken­ya, the organization plans to introduce a program to enable developing countries to rapidly introduce chemical regulations. The program features tools and guidance materials for addressing chemical safety. Several international agencies are helping set up the program, which will have a total budget of $62 million.

SAICM is not a long-term option as a global hub for chemical regulations, however, because it runs only until 2020 and there are no plans to extend it or make it legally binding, said Kaj Madsen, senior program officer for chemicals at the UN Environment Programme. SAICM also is limited to developing countries. “There is no international mechanism for ensuring the exchange of chemical information,” Madsen acknowledged. “In future years we will need that.”

Dow Chemical also is backing regulatory convergence. “For multinational companies it would be really beneficial if there was acceptance of converged regulation,” Annamaria Frascaria, the firm’s associate regulatory director for environment, health, and safety, told C&EN. “It’s practical, obvious, and it makes sense. We don’t have to reinvent the wheel over and over again.” Although not advocating a global REACH system, Frascaria takes the view that some components of REACH could be used beyond Europe.

Manfred Marsmann, head of environmental affairs for Bayer, is another advocate of regulatory convergence. “It is an opportunity for synergies,” he said. “If you look at the architecture of regulations you see common principles such as the organization of the notification process, data requirements, and labeling systems.” A “library” of chemical systems would be of great benefit, although Marsmann warned that any successful approach must respect regulatory tradition at the national level.

Marsmann, along with regulators and other chemical sector stakeholders who gathered in Helsinki, agreed that the globalization of chemical safety regulations could generate significant savings. But with no agency appointed to lead the issue, no principles of action yet established, and disagreement over which regulatory model to follow, the path to securing those savings will be anything but quick and easy.