Friday, April 9, 2010
Former EPA Chemicals Chief Gives Recommendations for a "Workable and Effective" Chemical Regulatory System
A few days ago I mentioned that advocacy groups highlighted their differences with industry on TSCA reform at a recent chemical industry trade show called GlobalChem. Also presenting at that conference was the former head of the EPA Office responsible for chemicals management, Charlie Auer, now a private consultant. He offered the following "approach elements" on how to move towards a "workable and effective chemical regulatory system in the US."
1) Improved hazard and exposure/use database: a requirement for regular periodic reporting from companies throughout the chemicals value chain to ensure that EPA's understanding of uses/exposures remains current. Auer noted that this should include an Inventory Reset component. He also suggested that there is a need for tiered datasets, i.e., basic data requirements triggered at each level, the ability for EPA to modify basic requirements based on hazard screening results, and a role for SARs, read-across, and other non-animal testing methods.
2) Staged process for risk assessment and risk management: Auer noted that there must be an "open, measured and timely" process in which there must be risk management following risk assessment, a role for periodic reassessment based on new information, consideration of the life-cycle of chemicals, and decisions based on the best available scientific data.
3) Broad risk management authority providing more flexible and effective tools: To include "rule plus order authority" and the ability to require development of enforceable pollution prevention and green chemistry plans.
4) Control actions: To be based on scientifically sound risk assessments, identification of mitigation or prevention measures to ensure safety, and "a determination by EPA that it is reasonable to require such measures."
Auer also suggested that there needed to be better balancing of confidential business information protection and disclosure, legislation that encourages innovation, and greater responsibility by industry throughout the chemicals value chain. He noted that EPA should be directed to regularly update test guidelines to meet current standards and work to achieve by 2020 the NAS "Toxicity Testing in the 21st Century." EPA should also be able to recognize or apply the work done by other governments.
And he, like just about everyone else, noted that EPA must be given adequate resources to do its job. For Auer, that includes adequate funding but also the institution of some sort of chemical registration fee system.
Thursday, April 8, 2010
According to Geert Dancet, the Executive Director of the European Chemicals Agency (ECHA), the agency will soon publish a list of thousands of high volume and high hazard chemicals it expects to be registered by the November 30 deadline for doing so under the EU's Registration, Evaluation, and Authorization of CHemicals (REACH) regulation.
Dancet encouraged companies that purchase chemicals used in the European market to review the list to be sure the substances they need and ways they use them will be registered. A newly established "Directors' Contact Group" will review the list and is expected to "identify issues of concern and describe feasible, prioritized solutions" by June 1.
ECHA says it has "a general idea of the number of chemicals" it expects to be registered by the deadline, which it anticipates to be around 9,200 chemicals. The big question is the actual number of registrations since a single chemical may be registered by more than one company. ECHA is expecting the number of registrations to range somewhere between 25,000 and 75,000.
All of this has ramifications for TSCA reform in the US as any major problems, or lack thereof, in this first of three REACH registration deadlines will give some indication of the workability of a general data call-in for all chemicals in the US. As noted yesterday, NGOs are strongly in favor of industry providing at least basic data on all chemicals while industry is stongly in favor of EPA first prioritizing to a short list of chemicals for which specific data requests will then be made to industry.
Wednesday, April 7, 2010
[NOTE: See the Update at the end]
Two of the largest chemical trade associations recently sponsored the chemical industry trade show called GlobalChem. Among the many industry, consultant, and government speakers was Dr. Richard Denison of the Environmental Defense Fund (EDF). Dr. Denison took the opportunity in his talk to highlight where the EDF-sponsored advocacy coalition, Safer Chemicals Healthy Families, differs from industry in the nuts and bolts of TSCA reform.
Denison first noted that 5 years after the deadline for completion of the voluntary HPV Challenge there are still only 60% of chemicals with final submissions. Not a great track record for self-policing in his opinion. He then listed three major differences between what the SCHF Coalition wants and what he characterizes industry to want.
1) SCHF wants data on all chemicals, while industry wants only to provide data on the small subset of chemicals that are of high priority. Industry believes that a REACH-like data call-in for all of the 85,000 chemicals on the current TSCA Inventory is overly burdensome, impossible to manage, and not very productive. Denison believes that data on all chemicals must be obtained so that safe chemicals can be identified for use as substitutes, otherwise you could identify a problem chemical that needs to be banned but have no data on the safety of potential replacements.
2) SCHF wants prompt action on the "most dangerous" chemicals such as those with high hazard, high exposure, PBTs, and those that have already been identified as of higher concern through other programs, while industry wants a long, costly risk assessment process that prolongs study before taking action.
3) SCHF wants to consider multiple sources of exposure, consistent with the recent NAS recommendations, while industry wants to assume that humans and the environment are only exposed to one chemical at a time. Here there is the logistical problem of just how one might go about determining hazard of mixtures but also of determining exposure not only of one chemical from multiple sources but many similar-acting chemicals from multiple sources.
I suppose one could take exception to whether Denison accurately characterized the industry positions, but at the very least it seems he is close enough for argument. There are very real concerns from industry of the burden of a REACH-like program that requires vast resources, both from industry and EPA (REACH created an entirely new 400-person and growing Agency to deal with the data review). There are also very real concerns that without having data for alternative chemicals there is no way of knowing that they are actually "safer" substitutes for obviously hazardous materials. And if there is no exposure, there is no risk, no matter how hazardous a chemical might inherently be. So an accurate assessment is no easy task.
Clearly there is still a lot of work to be done. Hopefully the expected introduction of the Kid Safe Act will give a concrete proposal on which all stakeholders can then base a dialogue. I think that without an actual bill we will simply be dancing around the edges and not getting into the vast differences in the details.
Update: Note that Richard Denison, the subject of this post, has provided additional information in the comment below, including what he calls “the democratization of chemicals management.” Please click on the Comments link below.