Hazard: A new danger
The US Toxic Substances Control Act (TSCA) sets forth a risk-based approach to chemical evaluation and potential regulation. In 2022, however, the Environmental Protection Agency (EPA) announced a ‘whole chemical’ approach to chemical evaluation, which jettisons the prior, entirely risk-based approach.
EU REACH, meanwhile, has always been based on a whole chemical approach, combining hazard and risk. However, the upcoming revision of REACH, as well as of surrounding EU legislation, will further strengthen the hazard element.
In 2016, 40 years since its original passage in 1976, Congress dramatically amended TSCA through the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. These amendments set in motion an unprecedented and sustained scientific scrutiny of chemicals in commerce by the EPA.
The agency, these stated, must “prioritize chemicals for a multi-year intensive risk evaluation process to determine whether a chemical substance presents an unreasonable risk […] under the conditions of use”. In promulgating the risk evaluation regulations in 2017, the EPA interpreted this specific statutory provision as requiring it to make an unreasonable risk determination for each condition of use assessed in the risk evaluation, rather than make a single one for the chemical.
If unreasonable risk is identified, the EPA must then promulgate risk management regulations to eliminate the unreasonable risk, which may include banning or severely restricting the use of the chemical. For each of the initial ten risk evaluations, the agency relied on a ‘conditions of use’ approach to make unreasonable risk determinations. Scores of conditions of use were deemed to present unreasonable risk, triggering TSCA’s risk management provisions.
In 2022, the EPA jettisoned the conditions of use approach to unreasonable risk determination for a whole chemical approach, in which it would make a single determination that is comprehensive for the chemical substance. It is now revising the unreasonable risk determinations for eight of the ten initial risk evaluations to reflect the whole chemical approach.
Surprisingly and in many stakeholders’ opinion, illegally, the EPA made these significant changes without amending the regulation governing unreasonable risk determinations. This was in direct contravention of TSCA and the Administrative Procedure Act, both of which require that any change in approach be accomplished through notice and comment rulemaking.
The EPA bypassed rulemaking by asserting that the 2017 regulations are subject to interpretation and support both the whole chemical and the conditions of use approaches to unreasonable risk determinations. Thus, according to this expansive view, it can issue risk evaluations based on a whole chemical approach without any further rulemaking. Moreover, the agency is convinced that it will be better positioned to achieve TSCA’s objectives through a whole chemical approach.
By embracing a whole chemical approach to assessing chemicals, the EPA has pivoted toward hazard-based chemical evaluations. Under such an approach, all the conditions of use assessed in a TSCA risk evaluation would be lumped together into a single unreasonable risk determination for the whole chemical, irrespective of the potential risks associated with individual conditions of use.
Under this approach, an unreasonable risk determination for the whole chemical draws no distinction between uses that present negligible risk and those conditions of use that present more significant risk, warranting risk management. Including conditions of use that essentially present no risk is akin to a hazard-based approach that ignores risk altogether. Even more concerning, the EPA has indicated that it can impose risk management on any uses that do not drive unreasonable risk.
As noted by the EPA in the final version of the HBCD risk evaluation, it “is not limited to regulating the specific activities found to drive unreasonable risk and may select from among a suite of risk management options related to manufacture, processing, distribution in commerce, commercial use, and disposal in order to address the unreasonable risk. For instance, the agency may regulate upstream activities (e.g., processing, distribution in commerce) in order to address downstream activities driving unreasonable risk (e.g., use) even if the upstream activities are not unreasonable risk drivers.
To date, however, the EPA has not yet proposed a risk management rule on a chemical for which it has rendered an unreasonable risk determination based on the whole chemical approach. Although industry has not chosen to challenge the whole chemical approach in court, litigation may ensue after risk management rules are finalised. Time will tell.
REACH is moving in a similar direction. While it is already hazard-centred, for example, with respect to gathering and evaluating hazard data for the purposes of REACH registration and evaluation, as well as identifying substances of very high concern (SVHCs), the upcoming revision of REACH will further emphasize the hazard element.
By way of example, the revised REACH will change the current approach to the restriction of chemicals. Currently, a substance can be restricted under REACH if it poses an ‘unacceptable risk’.
In addition, the regulation also sets out generic restrictions that apply irrespective of the risk. However, such generic restrictions currently only apply to substances that have a harmonized classification as carcinogenic, mutagenic, and reprotoxic (CMR), and exclusively to consumer uses.
The revised REACH will extend the scope of the generic restrictions to professional uses, as well as to additional hazard classes: endocrine disruptors (EDs), substances that are persistent, bioaccumulative, and toxic (PBTs) or very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT) or very persistent and very mobile (vPvM).
There will be another significant change to REACH restrictions: under the current regime, exemptions from restrictions can be granted based on a risk assessment and a socio-economic analysis. After the revision, exemptions will only be granted for ‘essential uses’, which are yet to be defined by the European Commission (EC), irrespective of the level of risk.
The EC also intends to increase the number of substances identified as SVHCs significantly, from the current number of 224 to more than 10,000. The focus will again be on EDs, PBT/vPvB and PMT/vPvM substances. Such SVHCs will likely be further prioritized for restrictions.
Currently, not many substances have been identified by their REACH registrants as EDs, PBT/vPvB, or PMT/vPvM. By way of example, only 101 have been identified as PBT/vPvB substances. To reverse this trend, the revised REACH will probably introduce an obligation for REACH registrants to generate new hazard data related to the ED endpoint.
In addition, the EU is in the process of adopting an amendment to the EU Classification, Labelling & Packaging Regulation (CLP) that implements the GHS rules. The amended CLP revision will introduce ED, PBT/vPvB, and PMT/vPvM as new hazard classes. This will lead to the need for the operators to carry out a hazard evaluation and potentially generate new data if necessary.
Finally, the REACH revision intends to stop the current practice whereby different types of products are risk assessed by separate EU bodies. Such practice, according to the EU, is inconsistent and often brings contradictory results.
To break this status quo, the EU wants to introduce a ‘one substance, one assessment’ approach, whereby the risk assessment would be carried out primarily by the European Chemicals Agency (ECHA). There is a concern that such risk assessment will probably focus on hazard data because ECHA mainly manages this type of data.
Food packaging will probably continue to be assessed by the European Food Safety Authority (EFSA). However, the European Commission has already announced that its ongoing revision of food contact materials legislation will focus on the risk management of EDs and PBT/vPvB substances, potentially leading to their being banned.
Regarding the timing of the REACH revision, the EC is currently working on a legislative proposal that should be published by the end of 2023. After the publication, the proposal will move to the European Parliament and to the European Council for the full legislative procedure. The final regulation amending REACH is expected in 2026.
This article was originally published in Speciality Chemicals Magazine's January/February 2023 issue.