Chemical Watch Global Business Briefing (May 2014; Issue 67) has published an article authored by Anthesis's Paul Ashford (Managing Director of Anthesis-Caleb) on California's emerging chemicals/consumer product legislation.

How do California’s new rules on assessing alternatives to certain chemical/consumer product combinations differ from other regulatory regimes?

In March this year, California’s Department of Toxic Substances Control (DTSC) revealed the identity of the first three of its priority products under its Safer Consumer Products (SCP) Regulation (CW 17 March 2014).  The DTSC’s announcement was the culmination of a laborious process which had begun seven years earlier as the flagship of the state’s green chemistry programme. The Regulation, which passed into law last October, is designed to highlight the use of hazardous substances in consumer products and, by doing so, to encourage – indeed, to require – the assessment of alternatives that would offer less hazard while fulfilling the same function.

The general thrust to “de-toxicify” consumer products is at the heart of the green chemistry movement, and there is no question that the regulation seeks to achieve this through the selection of consumer-facing cases where the hazards are clear and palpable. Indeed, only the most hardened sceptic would challenge the assertion that the most effective way of controlling risk is to reduce hazard at source. However, the question is: can it and will it work? This article seeks to address some of the challenges the regulation faces, and draws from other alternative assessment experiences to identify the areas where approaches differ.

Nothing new

Early experiences of industrial chemical use in the consumer realm are littered with cases where uncontrolled hazards resulted in unacceptable risks. Inevitably, this resulted in the hunt for alternatives. The use of ammonia as a refrigerant, for example, was prevalent in the early part of the twentieth century when Thomas Midgley, a DuPont researcher at the time, became responsible for the introduction of a most remarkable substitute which had thermodynamic properties absolutely suited to the application and yet was so inert that it posed no obvious threat to human health. The substitute was chlorofluorocarbons, or CFCs as they became widely known, and the rest, as they say, is history. We shall return to this example later to draw further lessons.

For those uses of industrial chemicals that appeared benign (ie there was no evidence of acute human health effects), the belief was that there were no hazards and no resulting risks. The use was said to be “grandfathered” by the fact that the history of previous generations indicated no effect that could be linked to the chemical. However, this assumed that researchers were looking in the right place for such effects. As research began to shift from the acute to the chronic, more linkages emerged, especially in the areas of carcinogenicity and repro-toxicity. This has since led to the emergence of a series of toxicological end-points requiring systematic evaluation. However, for a long while, the burden of proof lay with society – as represented through its regulators.

Shift in burden of proof

The EU REACH Regulation was among the first to formally shift the burden of proof to those placing a chemical on the market. Its goal is that all suppliers to the market must develop a common set of data to address a set of prescribed toxicological endpoints. Most importantly, this applies to all existing substances, irrespective of their perceived level of hazard. Therefore, previously grandfathered chemicals have not been exempt from registration under REACH.

The ongoing development of such a comprehensive hazard dataset has naturally attracted the attention of regulators in other jurisdictions and this, in turn, has spawned a number of REACH-like regulations around the world to help capture the same datasets. The regulators also wanted to acknowledge those chemical companies which had been proactive in their development of such data, and so they created a framework within which access to data would need to be purchased (typically via a letter of access). Whilst this is an important principle to establish, it has made the use of the same data in multiple jurisdictions harder, especially if data-holders do not have interests in those jurisdictions.

How California selected its chemicals of concern

In preparing its list of chemicals of concern, the DTSC drew on the work of a number of other agencies around the world. This work has included some of that carried out by the US EPA under the Toxic Substances Control Act (TSCA). REACH has also been a prime source of priority substances, since those which have been identified as having real issues have already found themselves on the candidate list (151 substances in total at this time). However, the regulatory process is always some years behind the curve when it comes to the science. If the science is unambiguous, then this is not so much of a problem because there may already be consensus about the need to act. However, in many cases the science is contested, and this can lead to dilemmas about how and when to act. In some cases, the market takes matters into its own hands. The issue becomes one of philosophy, with the more precautionary approach being to act sooner rather than later. However, if we were to apply that principle to everything in our lives, we wouldn’t drive or fly, because the precautionary approach would be to avoid the hazard. Instead, we take the risk because the benefits of travel are seen to outweigh the risk. Similarly, when a hazardous substance is used, we need to have the ability to assess the risk alongside the benefit.

The judgement of hazard and risk becomes even more important when the hazard data is second-hand. Again, REACH requires a disclosure of all uses and the inclusion of an exposure scenario for each of them, in order to produce a risk assessment – the chemical safety report – for that substance. Therefore, if a particular chemical is chosen for substance evaluation under the community rolling action plan, there is primary data available within the dossiers for each substance registered.

Evaluation is the purview of the regulator…

It is unsurprising that regulators around the world have decided that evaluating the data is their prerogative. Whilst they rely on co-operation with the industries producing and using a chemical for much of the information, they understandably wish to keep the ultimate evaluation step in-house. This is fine when the evaluation is limited to hazard, but when it extends to risk, as the selection of priority products does, the extent to which the precautionary principle influences the assessment will have a substantial bearing on the outcome, especially where reliable exposure data is limited. In this context, it is noteworthy that the DTSC has selected as one of its first priority products the use of methylene diphenyl diisocyanate (MDI) in sprayed polyurethane foam (SPF) - something for which exposure and monitoring data is already being collected by the US EPA because MDI is one of substances it chose as a work plan chemical. This is particularly frustrating for industry, because a more measured approach would have been for the DTSC to wait for the work plan to be completed before drawing its conclusions on whether SPF should qualify as a priority product. Indeed, this is one of the challenges being mounted by industry as we move into the public consultation period.

There is an additional issue about the linkage of specific chemicals with specific uses. It appears that some of the data in the priority product profile for SPF issued in March 2014 relates to chemicals that are not used in the products in question. However, without access to something equivalent to a REACH chemical safety report, there is no reason why the DTSC would have known this in advance.

…but what about the alternatives?

As has already become clear, it is only possible to evaluate an alternative at the “use” level. This explains why the SCP Regulation focuses on products and why Authorisations under REACH (exemptions from what would otherwise be a ban) are only granted for well defined, and often narrow, uses.

There are inherent challenges in evaluating alternatives. Firstly, the evaluation of alternatives from a hazard and risk perspective may be less well advanced than for the chemical of concern because it hasn’t received the same regulatory priority. Secondly, it may be that the hazards are in different areas, which may be less well understood or defined. This is particularly the case for endocrine disruptors, for which, as yet, there are no agreed criteria for regulatory classification. It is little surprise that the answer concluded from an alternative assessment depends on the scope of that assessment. It is no criticism of Thomas Midgley that he did not consider ozone depletion in his initial assessment, but he would be interested to note that, 80 years on, CFCs are being replaced by ammonia because the hazard can be better defined and managed.

Who should do the alternative assessment?

Bearing in mind the interest of the regulators in being in control of the evaluation step, it is fascinating to realise that, both in REACH and the SCP Regulation, the responsibility for alternative assessment has been handed back to industry. This is possibly because the respective regulators believe that industry will understand the technical and economic factors more clearly. Whilst this is the case, the view will vary, depending where in the supply chain the alternatives are being assessed. Picking up the prospect of an alternative assessment for SPF, a building owner might look at alternative insulation materials and make trade-offs in thermal performance. However, this will be of greater concern to the climate scientist, who would see poorer energy efficiency as an outcome. The alternative supplier might argue for greater thicknesses to compensate, but this would be less resource efficient. Therefore, alternative assessment is inevitably an outcome of balancing a number of potentially conflicting factors. The DTSC has made it clear that there will be 13 factors considered in the case of the SCP Regulation (the so-called A-M List) – but it has not said how they showed be weighted. It is very difficult to see how industry can be left to prioritise 13 different criteria in a meaningful and self-consistent way. Early pilots have suggested that the field needs to be narrowed down quickly to make the process manageable. One way of doing so is to make hazard a subset of risk, but this may not be acceptable to green chemistry purists. Equally, if different jurisdictions apply different criteria and priorities, the outcomes will be many and varied and lead to greater disaggregation in markets.

Is there an alternative way?

The replacement of CFCs, and of HCFCs and other ozone-depleting substances, has been brought about by a willingness to assess the situation at a global level and seek appropriate alternative solutions that meet technical, economic, hazard and risk criteria. The UN Montreal Protocol on ozone-depleting substances has not always been successful, and substitutes such as n-propyl bromide serve as a painful reminder of what can happen when the dataset is either incomplete, or contested – resulting in this instance in a failure to identify significant neurotoxic effects on workers. Nevertheless, carrying out the evaluation once within an expert body (in this case, the Montreal Protocol’s Technology and Economic Assessment Panel), including access to various stakeholders, provides the best chance of reaching a successful outcome on both the desirability of a substitution and the selection of an appropriate alternative.

The DTSC appear to have bitten off a massive amount to chew and, in the absence of access to primary data, and with a myriad of criteria to prioritise (including a very narrow definition of economic factors), it seems unlikely that an industry-led, localised alternative assessment process will reach a satisfactory outcome, even if the priority products survive the consultation process.

There is, perhaps, a case for stepping back and focusing our efforts on “doing it once and doing it right”, either as a global assessment or as parallel assessments using a standardised approach. Either of these would not only need the co-operation of industry, but also co-operation between jurisdictions. They would also need careful co-ordination of stakeholder interests. Ironically, the lack of consistency in methodologies could prove to be the biggest barrier to the successful de-toxicification of the supply chain that so many crave.