REGULATION & COMPLIANCE
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 it , 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 hazardbased 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 . 1
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
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
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