Is EPA giving itself enough time to evaluate the safety of chemicals and protect health? Or is the Agency’s planned process to gather data for risk evaluations on chemicals under the Toxic Substances Control Act (TSCA), called the “Tiered Data Reporting Rule,” giving harmful substances a “pass” by running out the clock?
When TSCA was updated in 2016, it provided a process for EPA to sort through thousands of chemicals and identify the most dangerous as “High Priority Substances” for evaluation and possible regulation. Once a chemical is deemed “high priority,” TSCA allows the Agency up to 3.5 years to complete a risk evaluation to determine whether the chemical is hazardous enough to be regulated. (It should be noted that updated TSCA is now in its 6th year and only 33 chemicals – out of thousands – have been designated “high priority.”)
For most chemicals under evaluation, however, there are “data gaps” about how or whether a chemical affects health, such as how it may impact pregnancy or harm fetal development. While amended TSCA provides EPA with stronger authorities to gather the studies it needs to conduct risk evaluations when gaps in data exist, some studies to identify certain health effects can take 3 to 5 years to conduct – longer than the time allowed for the Agency to conduct a risk evaluation.
EPA could fix this problem by gathering data BEFORE it designates a chemical as “high priority,” including issuing orders for chemical manufacturers to conduct toxicity testing. But it hasn’t done this. Under EPA’s planned approach to data gathering, if the Agency is unable to gather and analyze the needed data in time for it to be included in a risk evaluation, the chemical can be determined as not risky (“does not pose an unreasonable risk,” in legal language) due to lack of data.
A recent example of this problem was EPA’s evaluation of Pigment Violet 29 (PV29), a chemical coloring used in paints, coatings, and plastics. Congress expressly named four health hazards in TSCA that they thought critical for EPA to prioritize when evaluating chemicals in commerce, including cancer, gene mutations, birth defects, and behavioral disorders, although that list does not fully capture the full spectrum of possible health harms from toxic chemicals, like diabetes and kidney and cardiovascular disease, to name a few. However, for PV29, EPA was missing critical data for all four health hazards expressly named by Congress and only had suitable data for 6 of 14 (43%) identified health hazards EPA identified linked to the chemical. Despite not having sufficient data, EPA conducted a risk evaluation of PV29 and concluded that the chemical did not harm reproductive or developmental health and was not a carcinogen, even though there was no data to decide whether this was true or not. While EPA concluded that PV29 poses an unreasonable risk to workers and occupational non-users from 10 conditions of use, meaning those uses will be subject to risk management rulemaking under TSCA, the Agency did not find unreasonable risks to consumers, bystanders, or the general population, which includes pregnant women and children, from any uses. But how does EPA know this when they don’t have the data?
Lack of data does not mean lack of harm. Further, TSCA states that EPA must ensure that chemicals do not harm certain populations, including pregnant women, children, workers, and marginalized communities. Letting the clock run out on its work fails the very people EPA is supposed to protect. The Agency can fix this problem easily by applying its statutory authorities to collect existing information and order new studies before it considers prioritization, thereby filling data gaps BEFORE the clock starts ticking.
In other words, if EPA proceeds with its planned Tiered Data Reporting Rule as it has been described to the public, the Agency will end up conducting chemical risk evaluations that will not include all the health effects data required to estimate the true risk of the chemical. This will mean EPA cannot do its job to identify and protect the public from harmful chemical exposures leaving us all exposed and at risk.