Legislation - Reach is just the tip of the iceberg. Albeit the European Union has set the pace for strengthening chemical legislation there is a lot of regulatory progress in the U.S., too. The agenda is driven by both politicians and public pressure groups determined to put UN's Strategic Approach to International Chemical Management (SAICM) into practice. While the far- reaching reform of the Toxic Substance Control Act (TSCA) is still pending, federal states have taken the lead: In the last eight years, 18 states have passed 71 chemical safety laws according to a report published in November by a Washington-based coalition of 250 environmental and health advocacy groups. The report also found that the pace of state policymaking on chemicals has more than tripled in eight years.

At the federal level, California's Green Chemistry Initiative is widely seen as the lighthouse project. Representing the eighth largest economy in the world, the Golden State is expected to provide the blueprint for collaborating with manufacturers, importers and retailers to increase the safety of use of chemicals.

"Our regulatory proposals are intended to prevent California from becoming a toxic dumping ground," said Maziar Movassaghi, Acting Director of the California Department of Toxic Substances Control, in a recent Bloomberg Businessweek article. Although the statement might sound somewhat harsh for European observers, his sentiments reflect the current situation in which the federal players see the need to act on their own, especially since Congress appears to take an indefinite amount of time to pass the reform of TSCA.

Pending TSCA reform

Even though the legislative procedure carries the name "TSCA Reform 2010," it was obvious that decisions would not be made before 2011. Despite growing public resentment over the delay, the outcome of the recently held mid-term elections is not likely to refuel the process. Political observers expect both houses to adjust the pending proposals to the new majorities. On top of this, a serious number of co-introducers of the bills have lost their mandate in the election. On the other hand, there still is broad consensus in both the Senate and the House of Representatives on the need of making the existing law fit for the requirements of the global market, particularly in light of Europe's Reach regulation. Furthermore, the regulatory developments on federal level, especially the commencement of the California Green Chemistry Initiative, will have a strong impact on Washington, too.

As the reform's passage is inevitable, global players should prepare both their enterprises and value chains for the upcoming changes. The U.S. Environmental Protection Agency (EPA) is determined to place a much harder workload on industries.

"More than 30 years after Congress enacted TSCA, it is clear that we are not doing an adequate job of assessing and managing the risks of chemicals in consumer products, the workplace and the environment," stated Lisa Jackson after taking over her new role as EPA Administrator in 2009. "It is now time to revise and strengthen EPA's chemicals management and risk assessment programs."

Following the example of the EU, the U.S. will shift the burden of demonstrating the safety of chemicals to importers, manufactures and processors. All market participants will have to provide the agency with sufficient information showing that new and existing chemicals are safe. In connection with these goals, TSCA will focus more strongly on the risks of sensitive subpopulations like children. For this purpose, the EPA will define a minimum data set that is to be submitted. The set will include data on chemical identity, substance characteristics, biological and environmental fate, transport, toxicological properties, volume manufactured, process or import status, intended uses and exposures from all stages of lifecycle. Any "failure" - a term which has not yet been defined by the EPA - to submit the required data might limit or even stop the market access of a substance.

Health And Consumer Protection

The overall goal of the reform is to establish a framework to ensure that all chemical substances to which people are exposed will be reviewed for safety and restricted where necessary to protect public health and the environment. Although TSCA will take into consideration already existing test data from regulations like Reach, enterprises have to be prepared to deliver additional data regarding the uses of a substance. As it stands, there are no plans for data sharing or establishing organizations similar to Substance Information Exchange Forums (SIEFs). However, it is likely that consortia structures will be revived, at least for funding the costs associated with testing.

TSCA has asked EPA to reduce the use of chemicals of highest concern. To promote the development of safer alternatives, the EPA will issue a priority list that comprises at least 300 new and existing substances and mixtures. The required data must be submitted 18 months after the publishing of the list. Risk management decisions should take into account sensitive subpopulations, cost and availability of substitutes, etc.
According to the pending Senate bill, all other substances have to be addressed within 30 months of addition to safety determination or within 14 years after enactment of TSCA 2010, whichever comes first. In contrast to this, the House bill encompasses three timelines - ranging from three to five years - depending on production volumes.

California Green Chemistry Initiative

As TSCA reform 2010 is still waiting to be passed, the California Green Chemistry Initiative is attracting increasing attention. The initiative is a broad public policy striving for safer products, the expansion of pollution prevention and product stewardship programs as well as the move toward a cradle-to cradle economy. Due to its wide focus the initiative is expected to significantly increase the compliance management burden of any company whose products are sold in California.

The Initiative comprises of two laws coming into force in January 2011. One of them, AB 1879, will establish a safer alternatives regulatory regime for consumer products. At press time, the law was expected to concentrate until 2016 on children's products, including toys, personal care products and household cleaners, as well as on the associated components of these products. From 2016 on the law is going to cover the full range of consumer products. In contrast to European law there will be only a few exemptions like food, pesticides, prescription drugs and medical devices. Another law, AB 289, provides an important means for DTSC to obtain information regarding chemical manufacture, use, and fate in California.

While TCSA regulates the substance sector, the California Green Chemistry Initiative operates at product level. Because of, manufacturers, distributors and retailers will have to analyse the chemical composition of the products they deal with. In June 2011, the Department of Toxic Substances Control (DTSC) will release a list of Chemicals under Concern, from which a list of Priority Products will be generated, later on. Apart from EPA defined chemicals, the list is expected to encompass substances according to Reach Annex XIV, Canada Schedule 1 and CA Prop 65.

If companies use Priority Chemicals in their products, they are requested to show all effects that are connected with the uses of the product. Although details on the scope of examination have not yet been published, it is expected that DTSC is going to demand more data than the European Chemicals Agency (ECHA). Nonetheless the DTSC will also accept dossiers submitted under Reach. If the proportion of a Chemical of Concern is below 0.1% w/w or below the thresholds established for hazardous waste companies only have to submit a corresponding notification.

On top of their reporting duties, companies will have to perform assessments for each Priority Chemical they are using in order to explore safer alternatives. After successfully replacing Chemicals of Concern, companies are obliged to report the corresponding product composition changes to DTSC.

Proactive R&D

In order to avoid regrettable substitutions, companies should not entirely concentrate on valid substance lists but also look for chemicals discussed by regulatory stakeholders and influencers. Regarding both listed and discussed chemicals, R&D, portfolio, sales and procurement managers have to find viable answers to questions like: In what way does a substance have a regulatory impact on which product? Does the substance add an essential value to this product? If not, how can a substitution process be organized? If the substance is indispensable, what is to be done to provide all required data on safe uses?

To minimize both the costs and the risks of compliance management, any R&D project should start with a comprehensive definition of target markets. Product stewards depend on this knowledge to find synergies from organizing the necessary compliance processes holistically. European companies, for instance, should structure the management of Reach regulation in a way that allows them to reuse the data in the U.S. and vice versa.