Retailers May be Violating REACH Right-to-Know Provisions

One of the lesser-known provisions of the sprawling REACH law is the right of consumers to demand information on the chemical content of products they purchase. The Ecologist reports today that two major European retail chains are failing to meet these obligations.

Titles IV and V of the law require that sellers of products containing chemicals listed as substances of very high concern (SVHC) notify their customers of this (customers could be downstream producers utilizing a chemical in their own product, as well as retail consumers). Generally, the threshold for notification is the presence of an SVHC in a concentration of 0.1 percent. The reporting obligation can be triggered by the addition of a substance to the SVHC candidate list, which currently contains several dozen chemicals but is expected to grow exponentially in coming years.

Reporting duties can also be triggered by a customer request for such information. In this case, at least the name of the chemical and information allowing the safe use of the product must be provided to the customer within 45 days. In a recent investigation by the European Environmental Bureau (EEB), that NGO sent 158 information requests to 60 retailers and vendors in the EU. EEB contends that 50 percent of the requests were not answered at all, while 75 percent received legally insufficient responses. EEB goes on to recommend that companies selling into Europe establish electronic chemicals management systems, utilize third-party testing, and deliver certification manifests through the supply chain.

Compliance Challenges for Chemical Companies

An excellent article by James A. Kosch, partner at LeClairRyan, on the need for the chemical industry to adapt to a changing regulatory climate.

TSCA: Innovation Through Stronger Regulation?

The House Subcommittee on Commerce, Trade and Consumer Protection held a hearing on July 29, 2010 on H.R. 5820, recently-introduced legislation to revamp the Toxic Substances Control Act (TSCA). One recurring theme at the hearing was the contention that fuller information about chemicals and their potential health effects would encourage the development and commercialization of safer alternatives. It was suggested that this in turn would advance the innovation and competitiveness of U.S. chemical producers. In recent years, similar arguments have been made about the innovation and job-creation potential of carbon regulation and other environmental initiatives.

Let's not reflexively reject the notion that public policies can promote economic growth and competitiveness. Consider the Interstate Highway System. Is the nation’s economy healthier and its standard of living higher by virtue of the massive federal program to construct our network or highways, bridges, and roads? Economists across the political spectrum say “yes,” citing increased safety, workforce mobility, just-in-time delivery of industrial inputs, and the resulting growth of cities in the Sun Belt.

Turing our focus on chemicals policy, one can envision a regulatory framework that might help bring newer, safer products into the marketplace. It would require, on one hand, a fairly burdensome regimen of testing and reporting for existing chemicals (particularly those with indicia of hazard), and greater transparency into chemical formulations and other information now deemed proprietary. This would have to be coupled by more lenient treatment of new chemical formulations, including a comparatively expeditious path to market for those that are likely free of health and environmental concerns.

But is this type of framework embodied in H.R. 5820? Some proponents argue that it is. Dr. Richard Denison of the Environmental Defense Fund said at the hearing that the bill would allow “safer” chemicals to enter the market with less burdensome safety determinations. Stated that way, the argument appears internally inconsistent, because it is safety determinations that are chiefly relied upon to distinguish between good and bad chemical actors. Denison’s written testimony more explicitly defines what he means by “safer”: H.R. 5820 would allow new chemicals to enter the market without safety determinations if they are intrinsically low hazard, are safer for particular uses than chemicals already on the market, or serve critical uses.

What types of chemicals could be considered “intrinsically low hazard”? This category would include substances whose biological action is acknowledged to be benign and compounds with extremely low toxicity. However, most of the promising chemicals that have not yet been commercialized would fall outside of these relatively narrow classes. For these, structure-activity relationship (SAR) analysis would be needed to establish “intrinsically low hazard.” This type of analysis comes with its own complexities, and may not represent a significant decrease in burden as compared with traditional safety determinations. As such, it is not clear that chemicals in this category would benefit from an expedited route to market to the extent that the bill would promote innovation.

TSCA: Pre-Manufacture Notification and Review

TSCA reform promises to significantly alter the chemical marketplace. Contemplated changes will have a profound impact on all industries that manufacture, distribute, modify or utilize chemicals, articles or mixtures. Recognizing the magnitude of this potential impact, Science News & Views intends to provide substantive monitoring and analysis as the legislative process proceeds. Today, we will examine the current and proposed system of pre-manufacture notification and review of chemicals, a controversial aspect of the existing statute.

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Section 5 of existing TSCA prohibits the manufacture, processing, or import of a “new chemical substance” or “significant new use” of an existing substance unless a pre-manufacture notification (PMN) is submitted to EPA at least 90 days in advance.

Section 5 does not currently require a submitter to conduct testing before submitting a PMN, but merely to provide any information on health or environmental effects that are in its possession. During the 90-day review period, EPA is to utilize this and other information to determine whether the chemical “may present an unreasonable risk of injury to health or the environment,” and if so, to request more data, prohibit or limit manufacture, or halt the review process. In practice, the dearth of data accompanying submissions impairs the agency’s ability to make informed judgments about the safety of a given compound. Reform advocates cite this as a key weakness of the existing statute.

The proposed bills would toughen the Section 5 PMN and review process. Both the House and Senate would subject new chemicals and uses under Section 5 (as well as existing chemicals under Section 6) to the requirement of a “minimum data set.” This data set would consist of the chemical’s identity, physical characteristics, toxicological properties, hazard, exposure and use, along with other information that EPA establishes by rule. Indications are that the agency will require data on both traditional endpoints such as carcinogenesis and mutagenicity, and also emerging concerns such as bioaccumulation, environmental persistence and endocrine disruption.

The current presumption that a chemical is appropriate for the marketplace in the absence of an “unreasonable risk” or “insufficient data” finding will be inverted. Instead, a six-month to one-year review of the application will be triggered unless EPA affirmatively finds that the chemical is “reasonably anticipated” to meet safety standards.

Manufacturers and processers will have the responsibility of identifying or generating research needed to complete the data set for a new chemical or new chemical use, effectively shifting the “burden of proof” to them. They would also be responsible for updating data submissions to reflect new information. Both bills would give EPA the power to compel testing by administrative order and to specify appropriate methodologies. The House bill would allow the agency to to assess fines for non-compliance.

The PMN and minimum data set provisions will likely be the subject of debate and modification, particularly the timetables for implementation. Recent changes to chemical regulation in Europe help illustrate this point. The REACH law imposed similarly aggressive benchmarks for generation and submission of test data. This approach has proved to be impractical, time-consuming and expensive to implement.

Are we on a similar path with a new TSCA?

Clearly early engagement with legislators to help craft a smart and effective chemical regulation, one that protects human health and the environment in a cost-effective, rational manner, is critical.

Inaugural Post

Welcome to Science News & Views. This forum will explore how decisions concerning hazard, risk, human health and the environment shape modern life. We'll do this by highlighting news events, recent publications, and current trends in the scientific and policymaking communities. We believe this exercise will illustrate how business and consumers are impacted by good (and bad) policy and suggest how decision-making may be improved.

To kick things off, we'll take a look at a recent interview with Richard Hubner about product safety regulation. In this Q & A, Rich argues that elected officials and their staffs are ill-equipped to micro-manage regulatory decisions concerning risk. Instead, they should establish coherent legal frameworks and funding levels for regulatory agencies, put them to work developing risk-based performance standards, and hold them accountable. Rich also urges legislators to get back in the business of oversight, using hearings and subpoena power to monitor the work of regulators--in an ongoing fashion, not just when high profile events compel their attention and intervention.