Recommendations for California’s future Toxics Clearinghouse

The European Chemicals Agency (ECHA) will publish on its website a vast amount of information on chemical substances from REACH Registration and the classification & labelling inventory that will be established under the CLP Regulation. This will cover in particular the hazard traits of all chemicals placed on the market in the EU, as well as exposure and use information for registered chemicals. Where a substance is not classified for a particular hazard, the classification & labelling inventory will specify whether this due to lack of data, inconclusive data, or data which are conclusive but do not lead to classification. It is reasonable to assume that this inventory will cover also all chemicals placed on the market or contained in products in California.

Furthermore, the ECHA will host the eChem Portal, which has been developed by the Organisation for Economic Co-operation and Development (OECD). It is a data base of data bases and will allow, in addition to ECHA’s own data from REACH and CLP, access to a range of other data bases from authoritative sources, such as the US-EPA’s IRIS and SRS data bases, data bases from Canada, Australia, and Japan, and others. In a joint project within the OECD it is foreseen to make the Portal fully searchable – initially by identifiers of chemicals, but eventually also by particular hazard traits or combinations thereof.

Strictly speaking, there is, therefore, no need for California to develop any additional database to create a Toxics Clearinghouse. Instead, authorities in California should ensure that there is a specific interface that is accessible to the public and redirects to the ECHA data bases and/or eChem Portal. This will obviously require full compatibility with ECHA’s IT system. If so desired, authorities in California could develop add-on modules that would make navigation easier for the general public and include some additional information, for example search possibilities for substances of concern that have been prioritised in California, where they are used in California and whether or not they have been replaced by alternatives. That additional information could be generated from the alternative analyses to be submitted to the Department of Toxic Substances Control (DTSC) and, conversely, DTSC could decide to join the eChem Portal and make the information generated in the alternative analyses available for inclusion into the Portal.

Recommendations for California’s future Green Chemistry Regulation

The post ‘Discussions at the Green Ribbon Science Panel – a reality check’ further down describes the rather critical reactions of the Panel members and other participants to the draft Straw Proposal of 1 October at the meeting of the Panel on 14 October.

The draft Regulation was also discussed with a broader range of stakeholders at a public workshop on 21 October 2009 in Sacramento and reactions were equally sceptical. In addition, more than 60 organisations, companies and individuals submitted written comments, which criticised the proposal in similar ways – some also included suggestions for a more appropriate Regulation.

The following recommendations for a more workable approach for the future Regulation in California have been developed against the background of these reactions and with a view of maximising synergies with the work that will be accomplished in the EU in the implementation of the REACH Regulation and the Regulation on Classification, Labelling and Packaging (CLP) that aligns the EU’s rules with the Globally Harmonised System for Classification and Labelling.

1. Identification of substances of concern

The Regulation should limit the hazard criteria to identify chemicals of concern to those hazards that are indeed so severe that they should trigger obligations to substitute the substances by safer alternatives. As a starting point, the Regulation should include the hazard criteria as contained in Article 57 of REACH to identify substances of very high concern (SVHC), which are also recognised in other third countries as of particular concern. These criteria include substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMRs), substances that are persistent, bioaccumulating and toxic (PBTs) or very persistent and very bioaccumulating (vPvBs), or others of equivalent concern, such as endocrine disruptors. If so desired, and even though the criterion of ‘equivalent concern’ as contained in Article 57 of REACH can  function as a ‘catch-all’ in case of need, California could add a limited set of further irreversible or chronic effects (e.g. respiratory sensitisation) and possibly also a consolidated ‘list of lists’ with names of substances from other authoritative sources. However, if too many chemicals are identified as ‘of concern’, limited resources are dispersed on too many chemicals rather than focusing on the most serious ones.

2. Scope of Products Covered

Likewise, the scope of products covered by an obligation to conduct alternative analyses should focus on those leading to highest exposures (i.e. substances by themselves, in mixtures, in articles where a release is intended, articles that are used by particularly vulnerable groups etc.). The Regulation should specify ‘de minimis’ concentrations of substances of concern in mixtures and articles so that the presence of trace impurities that are inadvertently present does not trigger the requirement for alternative analysis.

3. Prioritisation of Batches of Chemicals of Concern

As it is not feasible for companies to deal with all substances of concern at the same time, DTSC should periodically select batches of priority substances and trigger the analysis process – where necessary specifying also particular priority products. The specific substances and products for each batch should be identified through a public consultation process involving other government departments and all stakeholders. In selecting priority substances, DTSC should always include substances listed on Annex XIV of REACH, and possibly also those on the candidate list under REACH. In addition to the criteria as set out for ECHA for prioritising substances (substances that are PBTs or vPvBs, are in wide dispersive use or are used in high volume), DTSC could also include biomonitoring data as a reason for prioritising substances of concern, in particular substances found in umbilical cords. Substances included in the various batches of Canada’s Chemicals Management Plan could likewise be included. This would be a very effective way of proceeding – first because the processes under REACH will provide considerable information on the use of the substances and possible alternatives, which will help companies and DTSC to identify products where they do actually occur and to find feasible alternatives, and second because concerted action on these substances both in the EU and in California will have strong impacts on the global supply chains for the manufacturing of products containing the substances concerned, which will create synergies and efficiency gains for both authorities and industry. When deciding on the number of priority substances in the various batches, DTSC should be mindful of its own resources for oversight and control.

4. Realistic Time Periods and Available Data Sources

The time periods both for gathering data on the occurrence of substances in products and for conducting alternative analyses have to be realistic. Experience in both the EU and Canada has shown that replacing problematic substances in products by safer alternatives can take several years. From the date that a batch of priority substances of concern (and possibly also priority products) have been published, companies should have one year to investigate whether they are present in the priority products selected and report this to DTSC. Thereafter, the Regulation should foresee around 3 to 4 years for companies to conduct alternative analyses, where possible replace substances of concern by others, and report the results to DTSC. The first round of alternative analyses should not start before the end of 2011 as by then ECHA will have published on its website a significant amount of information on hazards, exposure and uses of substances from REACH Registration and the classification & labelling inventory that will be established under the CLP Regulation.

5.  Methodology for Alternative Analysis

In order to have a minimum of quality and provide some help to companies, DTSC should develop in the course of 2011 appropriate guidance in consultation with all stakeholders. The primary focus should be on health and safety aspects – i.e. comparing the hazards and exposures of the prioritised substances of concern and possible alternatives. One of the conditions for the alternatives analysis should be that none of the replacement substances can have the hazard traits identified under number (1) above, which would avoid the “replacing of one hazard with another hazard” problem. To maximise synergies with REACH, the Regulation should foresee that continuous use of a substance is only possible, if the same conditions are fulfilled as in REACH for granting authorisations: either ‘adequate control’ of all risks, or proof that the socio-economic benefits of continued use of a priority substance of concern outweigh the risks. A good starting point will be the guidance already developed by ECHA – in particular if the processes and criteria in California are aligned with those in the EU. Where necessary (e.g. to address broader aspects in the alternative analysis), DTSC should develop additional elements for guidance that are not addressed in the documents available from ECHA.

6. Oversight and Transparency

The process for the alternative analysis and monitoring the results has to be transparent and under oversight by DTSC. As a minimum, the results have to be reviewed by DTSC (or by an expert Committee nominated by DTSC – e.g. the Green Ribbon Science Panel, or by certified third parties) and preferably results should be submitted to public scrutiny, in particular in cases where companies conducting the analysis conclude that no alternatives to the prioritised substances of concern are available. Where similar claims have been refused in the EU (i.e. because alternatives are actually available) they should not be accepted in California. Necessary risk management measures identified in the alternative analysis for cases where no alternatives could be found or where adequate control could be demonstrated should be made general rules by DTSC. Where no alternatives have been found, the analysis should be repeated periodically. The draft Regulation needs to foresee clear rules on what cannot be considered confidential and/or find ways and means to allow disclosure to the public – for example in an anonymous form or by replacing very specific information (such as precise function of a chemical in a product) with somewhat broader, more generic information. The Regulation should also lay down that information on alternatives, exposures, or uses, which is easily available from the internet – including information that will be published on ECHA’s website – cannot be claimed to be confidential. Publication of the results of alternative analyses in California would provide interesting complementary information to REACH in the EU, where companies that successfully replace substances on Annex XIV do not have to report to ECHA. In order to handle the reporting and publication of the results of alternative analyses,  DTSC will have to develop an appropriate IT system, which should be compatible with REACH-IT and IUCLID used by ECHA to facilitate exchange of information.

7. No Duplication with Other Regulations

Some substances and products are already regulated extensively by other State or Federal law (e.g. ozone depleting substances, food contact material, cosmetics) – they should therefore not be regulated again by DTSC in the new Regulation.

8. Direct restrictions for substances as already adopted in REACH

Annex XVII of REACH contains restrictions and/or prohibitions for a significant number of chemicals in all or some specific applications (including in consumer products) because of proven risks to human health or the environment. They are replaceable in these functions and DTSC might therefore consider adopting directly the same bans and restrictions. A similar alignment of  legislation in California with EU legislation has already been established for hazardous substances in electrical and electronic equipment and for phthalates in toys. The Regulation should also foresee a restriction mechanism that DTSC can use in case of urgency or in situations where clear risks are identified without the need to wait for the results of alternative analyses conducted by companies.

Teaching a graduate class at UC Berkeley

On 2 November 2009, I gave a lecture in the Course on “Health Risk Assessment, Regulation and Policy”, which is organised by the School of Public Health’s division on Environmental Health Sciences. The course is co-sponserd by the Indoor Air Department, which is part of the Environmental Energy Technologies Division of the Lawrence Berkeley National Laboratories.

The course introduces the basic scientific components of environmental and occupational health risk assessment and describes the policy context in which decisions to manage evnironmental health risks are made. The course presents the quantitative methods used to assess the human health risks associated with exposure to toxic chemicals, focusing on the four major components of risk assessment: hazard identification, dose-response assessment, exposure assessment, and risk characterisation. During the course students use these tools to develop their own risk assessment for an environmental health problem.

The course also provides a broad overview of occupational and environmental health regulations and consideration of how hazard, risk, cost and benefits are considered. It examines current political controversies about environmental policy.

The particular class was well attended with about 50 students from various departments. In my lecture, I presented the chemicals policy in the EU, its history and development from the first legislation in 1967 to the current regulatory framework (REACH), underlining in particular also the role of risk assessment and risk management, while comparing the situation in the EU to that in the US. I informed about the distribution of responsibilities within the various Directorates-General in the Commission and outlined the activities of my unit. The last part of the lecture dealt with the global implications of REACH, presented ongoing international activities related to global standards for chemicals, which have so far concentrated on hazard assessment, and explained why it would make sense to work towards more harmonisation also in risk management despite the challenges inherent to such international harmonisation activities. The students asked many interesting questions during and after the presentation.  

The slides that I used for my presentation are available here:

TSCA Workshop at Yale University

On 29 and 30 October, I participated at a workshop on the reform of the Federal Toxic Substances Control Act (TSCA), organised by the Center for Green Chemistry & Green Engineering at Yale University. The organisers had invited participants from academia, the chemicals industry, consulting companies, and some authorities to discuss whether and how a reform of TSCA could promote the principles of Green Chemistry.

Each participant had been asked to prepare replies to six questions:

1. What are the most effective and ineffective attributes of the current TSCA system? 
2. What are your top TWO overarching principles to guide TSCA reform?
3. For each of the two principles that you identified in question 2, what specific, operational elements are required for the sustainable and effective implementation of a reformed policy?
4. How can issues with conflicting science and/or stakeholder perspectives be resolved in a transparent, effective and timely manner?
5. Does TSCA in its current form promote or inhibit innovation in green chemistry and safer alternatives?
6. Should a reformed TSCA enhance the current efforts in innovation in green chemistry and safer alternatives?  If not, why not?  If so, how? 

Even though participants came from quite diverging backgrounds and different degrees of knowledge of the details of TSCA, there was a lot of agreement on the replies to the questions. The Center for Green Chemistry will prepare a detailed report with the outcome of the discussions that might lead to a publication in a scientific journal and could then also be used in the upcoming discussions in congress on TSCA reform.

Participants noted that overall there is a lot of ignorance about TSCA and its functioning among stakeholders, which is due to the fact that the legislation it had become somewhat ‘orphaned’ after its adoption in 1976 following elections of Congress that led to the departure of all those who had championed its adoption. Consequently, there had not been the same level of congressional oversight as for other legislation.

The workshop agreed that among the main failures of TSCA is the lack of knowledge about the hazards and risks from the vast majority of chemicals on the market today, that the hurdles for EPA to adopt regulatory action to either require testing or restrict/ban the use of chemicals in certain or all applications are too high, and that this needs to be changed in the future. Among the successes, participants recognised the pre-manufacturing notices, which, if properly implemented and supplemented by adequate data requirements, are a useful tool to get information on ‘new’ chemicals. They should be changed to pre-marketing authorisations, though. There was also consensus that the EPA (or authorities in general) will not be able to evaluate and regulate all chemicals, and that any changes towards ‘greener’ chemicals will be driven by the market – in particular by downstream users and big retailers, such as Walmart. For that to happen in a meaningful way, information on hazards and risks of chemicals needs to be made publicly available, which clearly implies that the current rules on Confidential Business Information (CBI) - and in particular the way they are implemented – will have to be revised. Third Party certification (similar to what is now in place for organic food) might have its place in this user-driven selection process. Thus, EPA needs to become a sort of facilitator to require industry to generate information and then make it available. EPA will have to concentrate its own regulatory efforts on chemicals of highest priority and a renewed TSCA will have to foresee mechanisms and criteria for identifying these chemicals of highest priority. Whilst some participants held the view that TSCA prioritisaton and decision-making criteria should be strictly risk-based, others thought that for certain cases, hazard-based criteria are more appropriate. It was also agreed that it will be important to cover chemicals in finished articles, not just in substances and preparations, but that this will be quite complicated. Mechanisms for co-operation and burden-sharing with the States should be foreseen – more ‘advanced’ States such as California would not like to see their rights to act pre-empted by federal legislation.

With regard to ‘green innovation’, participants thought that a renewed TSCA will probably not be the driver for innovation as such (as this will have to come from demand from downstream users), but can certainly support a ‘greening’ of new chemicals by avoiding to put the requirements for new substances too high, requiring more information on existing substances and making this publicly available (so that users can ‘deselect’ the unwanted ones) and defining certain hazard / risk criteria that are considered as ‘undesirable’. Further incentives could be provided through reduced requirements for new benign substances that pass initial screening tests successfully (i.e. lower fees, faster procedures – similar to what is already in place for low-risk pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)). Actual financial support for ‘green innovation’ should rather be provided through other programmes.

In the discussions, I recalled that many of these issues had also been at the centre of the debate around REACH (from the early drafts, over the impact assessments to the finally adopted text) and also contended that a renewed TSCA should definitely foresee clear possibilities for international co-operation and using the results of the work conducted in other jurisdictions such as the EU or Canada. The European Chemicals Agency (ECHA) will make most of the information gathered under REACH publich available. At the end of the workshop, I had the impression that REACH does actually implement many of the principles and recommendations that had emerged from the discussions. One participant also clearly stated that currently legislative developments in the EU (such as RoHs and REACH) are the benchmarks for companies in the US when looking at which chemicals they want to use in their products. Ideally, a revised TSCA should indeed go into the same directions as REACH, be compatible and if possible supplement/complement what is foreseen in REACH.

Discussions at the Green Ribbon Science Panel – a reality check

The latest proposal for Regulation of the Department of Toxic Substances Control (DTSC) as described in the previous post (see further down) was discussed at a public meeting of the Green Ribbon Science Panel on 14 October 2009 in Sacramento. The agenda of the meeting, all relevant documents and a webcast / transcript are publicly available.

Following the introduction of the Panel members, the DTSC presented the draft Regulation in 3 sessions along the themes: identification and prioritisation of substances of concern, alternatives analysis, and regulatory responses. Each section contained a few specific questions for the Panel members.

Thereafter, the public present at the meeting had the possibility to give their views on the draft Regulation. I used the occasion to express concerns about the feasibility of the proposal in the light of the high number of substances and products covered, the difficulty to find the required data for the very demanding analyses, and the very short time frames foreseen. Most other speakers were also rather critical about the workability of the draft Regulation.

A represenative of the Office of Environmental Health Hazard Assessment (OEHHA) informed the meeting about progress with the development of the Online Toxics Clearinghouse, underlining that in the light of the existing large data gaps for many substances, the Office is very much interested in developing hazard indicators.

The afternoon session started with replies from DTSC to some questions for clarification raised by the Panel members, who then began their discussion. All members expressed frustration about the fact that they were expected to comment only on the very limited questions, whereas many had serious misgivings about the basic principle of the proposal. This led to a profound discussion about the principles. Practically all panel members considered the proposal unworkable and it was suggested that DTSC undertakes some ‘beta-testing’ to evaluate feasibility. Real-world examples were mentioned were the replacement of a given substance in specific products had required years of work and substantial financial resources. Many panelists were critical about the envisaged ’self-implementation’ by industry and the lack of oversight by the authorities, which could lead to diverging responses in similar situations. Others were worried about the availability of the required expertise in companies marketing finished products, and the absence of knowledge about product compositions along supply chains. This could lead to very high numbers of requests for waivers to DTSC, which could paralyse the entire system. Most considered the proposed ‘list of lists’ and hazard criteria for identifying substances of concern as too broad, a few others as too narrow. Questions were raised about how DTSC had determined the specific list of 16 substances that appeared to be rather arbitrary.

Following the invitation from the chair for constructive proposals, the Panel then converged somewhat towards recommendations that the criteria for identifying substances of concern can be broad, but that DTSC must determine prioritisation and actually list substances for which the process of analysis and regulatory response then has to be conducted. This should be repeated periodically. Substance that are found in biomonitoring studies in California and in particular in umbilical cords should get very high priority. The alternative analysis should give higher weight to health and safety issues rather than the very broad range of other parameters and the process needs to be transparent, providing possibilities for third Party input and guranteeing some minimum quality (e.g. through independent certification and the development of appropriate guidance by DTSC). The relation between the necessary transparency and the legislation on confidential business information have to be clarified. Information from other authoritative bodies should be used – in this context it was noted that a lot of hazard and use infomration will become publicly available from the implementation of REACH in the EU or through Canada’s Chemicals Management Plan. In case of conflicting information from such bodies, DTSC or OEHHA should decide, which information should be used.

The acting Director of the DTSC then drew the Panel’s attention to a thoughtstarter on private/public partnerships to contribute to the successful implementation of the Green Chemistry Initiative, and invited all to reflect about the ideas raised in the paper.

The next meeting of the Green Ribbon Panel will take place towards the end of January 2010 and will focus mainly on the Online Toxics Clearing House. The draft Regulation will be discussed with a broader range of stakeholders at a public workshop on 21 October in Sacramento.

An ambitious new proposal in California – but is it realistic?

The Department for Toxic Substances Control (DTSC) in California released on 1 October a new ’straw proposal’ for a Regulation to implement Assembly Bill 1879 of the Green Chemistry Initiative (see earlier post ‘Initial Findings’ for further context). The proposal and additional explanatory documents are available on DTSC’s Green Chemistry website. In summary, the proposal intends the following:

A. It designates ‘priority consumer products’ which will be subject to the subsequent requirements, including for example: products designed for children, cosmetics, clothing, lines and textiles, furnishings (including kitchen appliances), cleaning products and detergents, air fresheners, food contact materials, any product designed or reasonably anticipated to release chemicals during use and disposal. 

Nota bene: the definition of ‘consumer product’ includes all substances, mixtures and articles placed on the market in California, including also those sold to professionals.

B. It defines the criteria for identifying chemicals of concern. This is achieved via:

1. a list of 16 specific chemicals (or groups of chemicals) of concern and a “list of lists” (with reference to the list of substances classified for certain hazards on Annex VI of the EU Regulation on Classification and Labelling of Dangerous Substances (CLP), PBTs, vPvBs, endocrine disruptors, various US EPA lists, substances classified in Canada as inherently toxic to the aquatic environment or as high priority for human health, the Japanese list of mutagenic substances, the OSPAR list etc.), or
2. a comparison to hazard criteria that are much wider than the criteria for substances of very high concern (SVHC) in Article 57 of REACH. Further to the criteria for SVHC in REACH, there is for example acute toxicity (cat. 1 and 2), CMR’s Category 2 (in the GHS System), eye damage, resipiratory sensitisation, skin sensitiation, single target organ toxicity, toxicity to the aquatic environment Category 1 and 2, bioaccumulation with BCF > 500, hazards to the ozone layer….

Consequently, the number of potential chemicals of concern is multiple times higher than what will ever be considered as SVHC in the EU. This could lead to a situation that because everything is of concern nothing is of particular concern anymore and there are no real priorities. Astonishingly, the list of 16 named chemicals includes di-isodecyl-phthalate (DIDP), which is not classified for any hazard, and for which a comprehensive risk assessment conducted in the EU concluded in 2003 that there are no risks that need to be reduced.

C. Manufacturers (including importers – and hence retailers) who make a product available on the market in California have to screen ALL chemicals that occur in the products mentioned under Number A (no minimum threshold concentration !) to see whether they are on any of the lists in B(1) or meet the hazard criteria under B(2). If need be – i.e. no data available – they have to conduct testing in accordance with ‘any applicable, standardized test method’ (i.e. no reference to OECD test methods or Good Laboratory Practice – GLP), and companies ‘may’ share data (no mandatory data sharing). Furthemore, ALL products have to be screened for the presence of chemicals listed in any of the lists under point B(1). Manufacturers then have to enter all the hazard information for all the chemicals into the so-called Toxics Clearing House (which does not yet exist – see earlier post ‘Initial findings’ for further context).  And all of this has to be accomplished within 1 year from adoption of the new Regulation.

However, it seems hardly feasible to conduct the required analysis and information gathering for practically all chemicals in all products within such a short time. If necessary in the absence of data, the testing for certain hazards will already take longer than 1 year. Also, animal welfare considerations would plead for mandatory data sharing to avoid multiple testing of the same chemicals.

D. Manufacturers then have to prioritise the substances of concern in their products in three categories: 1. those reasonably anticipated to be released or those found in the California Environmental Contaminant Biomonitoring Programme or any other biomonitoring programme, 2. those encapsulated and without release during normal intended use, but which may be released to the environment during reclamation or disposal, 3. as number 2, but also no release during reclamation or disposal.

Despite this prioritization, the follow-up obligations remain largely the same.

E. Manufacturers have to supply to all downstream users and even to private consumers documentation on the chemicals of concern in the products, including all the hazard information, exposure information, and an indication that an alternative analysis will be conducted

F. Within one year, manufactures then have to conduct an alternative analysis which identifies for each chemical of concern alternatives (or for the entire product) and then analyzes an extremely broad range of parameters:

• comparison of the hazards for each of the categories in B(2) and exposure
• functional equivalence
• environmental impacts: raw material use, energy consumption, water consumption, air emissions, solid waste, wastewater releases, liquid waste, end of life options, reusability and recyclability, land use change etc.
• economic information: capital investment, operations and maintenance cost, cost for resources and energy, corporate image and brand value, consumer acceptance, insurance costs, worker wellness and moral, societal health costs and many more
• impacts on global warming, acidification, smog, ozone depletion, eutrophication and many more

All of this to be done iteratively until reaching a stable result and then to be documented and posted ‘on a public website’ and to be submitted to the DTSC. The analysis has to be completed for ALL chemicals of concern in all the products within one year following their identification. Where no alternative is found or implemented, the analysis has to be repeated within two years.

It is questionable whether such a demanding analysis for which most of the data will not be easily available – if at all – can be performed in such a short time. The ‘publication obligation’ – which is very welcome to increase transparency – seems difficult to reconcile with the general rules on Confidential Business Information in California, which are extremely broad.

G. Manufacturers then have to implement a ‘regulatory response’ ranging from substitution wherever possible, via bans after X years (even when no alternative is identified), to specific notification and labelling obligations, end-of-life management obligations, requirements to generate more data or to provide funding for research and development of alternatives. The criteria for when which response applies are not self-evident.

It is not clear, whether DTSC has conducted any feasibility study, or an assessment of how many companies, products, or substances will be concerned by the very demanding requirements of the draft Regulation. It seems that it is also not foreseen to develop any guidance or support for the work to be accomplished, due to lack of resources.

Most of the importers in California will probably not have the capacity nor the knowledge to conduct the required tasks and they will then turn to their suppliers who, more often than not, will be in third countries, in particular China, but also in the EU. So obviously, the draft Regulation can have massive trade implications.

The new draft will be discussed at a meeting of the Green Ribbon Science Panel on 14 October in Sacramento and in a public workshop on 21 October. Further written comments can be submitted until 4 November 2009. It will be interesting to see the reactions from the technical experts of the Panel and from other stakeholders.

Movements at Federal Level

On 29 September 2009, I attended a speech given by Lisa Jackson, the Administrator of the United States Environmental Protection Agency (EPA), where she announced core principles of the Obama Administration’s goals for legislative reform of the main legislation governing chemicals in the US, the 1976 Toxic Substances Control Act, TSCA.

A large audience (probably around 400 persons) was present with a strong participation from the NGO Community. The event was broadcast live on radio and there were film cameras present. Ms Jackson was welcomed and celebrated almost like a pop-star: huge rounds of applause and standing ovations – quite unlike any event of this kind in Europe.

Ms Jackson peppered her speech with rather strong remarks on the former Bush administration. Example: ‘Environmentalism is not, in fact, dead. It has been sick. But thanks to President Obama we’re going to be able to get it health care’ or ‘We have done more in 8 months than the Bush administration in 8 years’. A copy of her speech as prepared for delivery can be found online on the EPA’s website.

Although she said she did not like speaking about her personal history, a good part of her speech was just about that: her growing up in New Orleans in the 9th Ward, inspiration to serve the Community by her father’s example, who also worked for the Postal Service and that eventually inspired her to join EPA, her experience as a mother of a son who is suffering from asthma etc. (Again, unlike in Europe, many of the public speeches and presentations that I have attended so far in the US tended to be rather personal).

She briefly set out her four top priorities for her tenure at EPA: climate change and clean energy, clean air / clean water, toxic chemicals, renewed dialogue on environmentalism.

She then spent the major part of her speech presenting Essential Principles for Reform of Chemicals Management Legislation, which in a nutshell are:

• Chemicals should be reviewed against safety standards that are based on sound science and reflect risk-based criteria protective of human health and the environment
• Manufacturers should provide EPA with the necessary information to conclude that new and existing chemicals are safe and do not endanger public health or the environment
• Risk management decisions should take into account sensitive subpopulations, cost, availability of substitutes and other relevant considerations
• Manufacturers and EPA should assess and act on priority chemicals, both existing and new, in a timely manner
• Green Chemistry should be encouraged and provisions assuring transparency and public access to information should be strengthened
• EPA should be given a sustained source of funding for implementation including through fees from industry.

When introducing the first principle, she specifically said that economic considerations should play NO role. But later responding to a question from the audience about the role of cost/benefit analysis, she backtracked a bit saying that cost/benefit analysis will certainly play a role “somehow”. The terms ’hazard’ or ‘hazard based decision making’ were not mentioned once.

The audience was asked to hand in written questions during her speech. In the question section, strangely enough, the moderator put forward mostly questions dealing with climate change, clean water/air and superfund issues. He only took up two questions on the new chemicals strategy: one on cost/benefit analysis as mentioned before, and the second one on whether the ‘new TSCA’ will include provisions like clean air/clean water acts that citizens can enforce the legislation through Court action, which she considered a good idea. She also mentioned that the American Chemistry Council, which represents the American chemicals industry, had changed its position and was now no longer fighting change but supported a ’switch’.

Overall, whilst this announcement represents a significant departure from the current legislation, if the new legislation would be based strictly on these new principles, it would still fall significantly short of REACH. However, obviously, this is only a beginning and the legislative process can lead to a very different outcome – and, as they like to say here often: the devil will be in the detail.

Initial findings

The Final Report on the California Green Chemistry Initiative was adopted in December 2008. In parallel to the drafting of the report, the California State Assembly and Senate adopted already two bills that were approved by the Governor in September 2008, to lay down legal requirements with regard to recommendations 4 and 5 of the Green Chemistry Initiative. The two bills (Assembly Bill No. 1879 and Senate Bill No. 509) amend the Health and Safety Code of California and require the Department of Toxic Substances Control (DTSC) to achieve by 1 January 2011 the following:

• adopt regulations to establish a process to identify and prioritise chemicals of concern in consumer products
• adopt regulations to establish a process by which chemicals of concerns in consumer products and their potential alternatives are evaluated to limit risks. The evaluation shall include life-cycle assessment tools
• adopt regulations to establish regulatory responses that the DTSC may take following the completion of the alternative analyses
• to identify the hazard traits and other relevant data that are to be included into the online Toxics Information Clearinghouse. In so doing, the DTSC shall consult with other states, the federal government and other nations, as well as with international bodies.

To be noted: the definition of consumer product in the Health and Safety Code is actually very broad and does include all substances/mixtures and articles (with few specified exceptions) used, bought or leased for use in California, regardless of whether they are intended for use by professionals or the general public. The bills did not introduce any date by which the entire process of alternative analyses would have to be completed.

In order to comply with these obligations, the DTSC organised a series of workshops with a broad range of stakeholders throughout spring 2009 and released on 23 April a so-called first Draft Straw Proposal in plain English to set out the basic concepts of the future Regulation. The straw proposal foresaw the following steps:

• criteria for the identification of chemicals of concern
• criteria for the prioritisation of the chemicals of concern in view of evaluation
• a process for conducting an alternative analsyis over the entirely life-cycle of substances and transmission of the analysis to the Toxics Information Clearinghouse
• regulatory responses to be complied with in the light of the outcome of the alternative analysis

This  proposal and more general policy considerations was thoroughly discussed at a meeting of the Green Ribbon Science Panel on 29 and 30 April 2009 (background documents, presentations, videos and the transcript of the meeting are available online). Further written submissions from a range of stakeholders have been published on the DTSC website.

During my meeting with the DTSC on 16 September 2009, I learned that following the round of consultations, DTSC will most likely change quite drastically the approach outlined in the first draft Straw Proposal. A new draft Straw Proposal should become available in the near future for discussion at the next meeting of the Green Ribbon Panel, which is tentatively scheduled for 14 October 2009 and a further public workshop at the end of October (date not yet determined – was originally planned for August 2009).

The activities of the DTSC to implement the Green Chemistry Initiative, including also for the other 4 policy recommedations, which are less advanced, are described in a Status Report on the Implementation of the Green Chemistry Initiative of June 2009.

Meanwhile, pressure to review the chemicals legislation also at Federal Level in the US is growing.  Whilst various bills to fundamentally change the current Toxic Substances Control Act (TSCA) – the existing main legislation for industrial chemicals - are prepared or under discusssion in Congress, the EPA-Administrator Lisa Jackson will give a speech on 29 September 2009 in San Francisco, where among other topics she will set out ideas on how to reinvigorate TSCA.

First steps

After completing all initial  – at times somewhat bureaucratic – steps with the administration of UC Berkeley, I have an office at the Institute of European Studies.  The Institute seeks to increase understanding of Europe – its people, developments and challenges – in the US through the generation and dissemination of scholarship. The Institute also hosts the EU Center of Excellence at UC Berkeley, which is funded by a grant from the European Commission, and intends to promote a deeper understanding of the European Union and raise the level of dialogue and discourse on transatlantic relations throughout California. I have offered to contribute to the programme of the Institute with presentations on the history and content of the EU chemicals policy (REACH) and the gobal implications of REACH.

I have spent the first weeks of my fellowship to learn about California’s Green Chemistry Initiative, which comprises 6 main actions:

1. Expand pollution prevention and product stewardship programmes to more business sectors to refocus additional resources on prevention rather than clean-up.
2. Develop Green Chemistry workforce education and training, research and development and technology transfer through new and existing educational programmes and partnerships.
3. Create an online Product Ingredient Network to disclose chemical ingredients for products sold in California, while protecting trade secrets.
4. Create an online Toxics Clearinghouse, an online database of chemical toxicity and hazards to help prioritize chemicals of concern and data needs.
5. Accelerate the Quest for Safer Products, creating a systematic, science-based process to evaluate chemicals of concern and alternatives to ensure product safety.
6. Move towards a Cradle-to-Cradle Economy to leverage market forces to produce products that are ‘benign-by-design’.

At UC Berkeley, the Center for Green Chemistry has been created as a focal point for cooperation between the Colleges of Chemistry, Natural Resources, and the Schools of Business, Law and Public Health, in developing the technical tools, policy strategies, curricula and the informed public interest voice needed to advance the policies and science of green chemistry. Among others, students organise a seminar series on Green Chemistry and Sustainable Design as a venue for the discussion and dissemination of information among students and faculty from diverse fields. 

My work will concentrate mainly on actions 4 and 5 of California’s Green Chemistry Initiative. Both involve the development of new Regulations, which are currently under discussion with a broad range of stakeholders. A specific advisory board, the Green Ribbon Panel, has been set up to advise the government. I will soon meet two members of the Panel, who work at UC Berkeley’s School of Public Health: Megan Schwarzmann and Mike Wilson. On 16 September 2009, I will have a meeting at the Department of Toxic Substances Control of the California Environmental Protection Agency in Sacramento, who is leading the process to draw up the new Regulations. On 23 September 2009, I will have a meeting with the Office of Enviromental Health Hazard Assessment of the California EPA in Oakland, who is contributing to the process. The next post on the blog will contain a description of the current status of the work here in California.

Project Description

The key topic that I want to pursue during my fellowship in Berkeley is an investigation on how to move forward with a meaningful co-operation between California, possibly other US States and even the Federal level, and the European Union in legislating dangerous chemicals.

The project will start with a comparative analysis of how legislation on chemicals is being developed in California and the EU – including the main principles and process by which legislation is adopted and which objectives are pursued. The analysis will identify the main actors in the various jurisdictions and their interactions, as well as their limitations of powers.

Earlier research conducted at the University of Berkeley – in particular the Center for Institutions and Governance - has already led to general recommendations that a co-operation between California and the EU should be established. Building on this research and my own experience to work towards regulatory convergence and common goals in multilateral and bilateral contexts, the project should result in recommendations for ways and procedures of practical co-operation between the main actors, rather than to formalise legal co-operation agreements. The project intends to identify in particular:

• key actors and institutions in California and in the EU
• ways to establish networks of contacts and other practical means for co-operation that do not require formalised Treaties or Agreements
• creation of direct contacts between the main actors in the EU – in particular the European Chemicals Agency (ECHA) - and in California to allow for direct co-operation in the work on individual chemicals, such as prioritisation and evaluation, risk assessment outcomes and risk reduction measures
• ways and means in which actions in California can influence further reform of chemicals legislation at US Federal level.