August 2021 Chemical Safety and Regulatory News

EPA final rule sets reporting requirements for 50 chemicals

The EPA has issued a final rule that requires anyone who manufactures or imports 50 specified chemicals to report to the agency “certain lists and copies of unpublished health and safety studies” undertaken within the past decade.

This action is being taken, according to EPA, because the Interagency Testing Committee – established under the Toxic Substances Control Act of 1976 – has added the substances to its Priority Testing List.

The chemical substances subject to the rule include 20 chemicals EPA has designated as high-priority substances for risk evaluation under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The 20 high-priority chemicals are separate from the first 10 chemicals being evaluated for potential health and environmental risks under the Lautenberg Act. The 20 chemicals include:

• Seven chlorinated solvents
• Six phthalates, or hormone-disrupting substances, linked to several health issues
• Four flame retardants
• Formaldehyde
• One fragrance additive
• One polymer precursor

Also subject to the rule: 30 flame retardants the Consumer Product Safety Commission is evaluating for risks under the Federal Hazardous Substances Act of 1960.

Under the rule, published in the June 29 Federal Register and slated to go into effect July 29, manufacturers and importers must submit:

• Lists and copies of unpublished health and safety studies on health effects, such as toxicity studies on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, and endocrine effects
• All unpublished studies on environmental effects, environmental fate and physical chemical properties if performed as described in 40 CFR 716.50
• All unpublished studies on occupational (both users and nonusers), general population, consumer and environmental exposure
• Studies showing any measurable content of the specified chemical in the tested substance, whether single substances or a mixture; the composition and purity of test substances must be reported if included as part of the study.

New report finds chemical disaster risks from climate change

The Union of Concerned Scientists, Earthjustice, and the Center for Progressive Reform recently released a policy brief estimating the risks posed by natural disasters to Risk Management Program (RMP) facilities and the surrounding communities, according to the Equation, published by the Union of Concerned Scientists.

Thousands of industrial facilities in the United States store, transport, and use chemicals that have the potential to be lethal, carcinogenic, or generally harmful to human health. This new analysis finds that many of these facilities face risks from natural disasters projected to become more severe with climate change.

Using data from USGS, USDA FWS, FEMA, and a previous UCS analysis on future flooding due to climate change, the report estimates that 30% of RMP facilities are in areas prone to wildfires, inland flooding, coastal flooding, or storm surge from hurricanes.

To ensure hazardous facilities are prepared for the impending effects of climate change, and  communities that live nearby are protected, the report recommends the Biden administration take some of the following actions:

• Formally engage workers in facility preparedness and response planning
• Continue fenceline monitoring with public access to sampling data and timely community alerts
• Adopt RMP eligibility criteria to expand coverage to climate and natural disaster-vulnerable communities
• Prioritize enforcement resources to address heightened risks due to natural disasters and climate change.
• Bolster regulatory action with the administration’s broader investment in climate, equity, and infrastructure spending and policy-making.

EPA strengthens chemical risk evaluation under Lautenberg Chemical Safety Act

Responding to recent Executive Orders and directives from the Biden administration, EPA has announced changes to chemical risk evaluation policies under the Frank R. Lautenberg Chemical Safety for the 21st Century Act to “position EPA to move forward with actions to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law.”

According to an EPA press release, actions will include:

• Using a “whole substance” approach when determining unreasonable risk
• Expanding consideration of exposure pathways
• Establishing a “fenceline community exposure screening level” approach

The EPA said it plans to reopen and update the risk evaluation for 1,4-dioxane, soliciting feedback before any potential changes are finalized. In the cases of methylene chloride, trichloroethylene, carbon tetrachloride, perchloroethylene, n-methylpyrrolidone and 1-bromopropane, the agency said it intends to “further examine whether the policy decision to exclude certain exposure pathways from the risk evaluations will lead to a failure to identify and protect fenceline communities.”

Existing risk evaluations for asbestos, cyclic aliphatic bromide cluster and Pigment Violet 29 “are likely sufficient to inform the risk management approaches being considered and these approaches will be protective,” the agency determined.

“Fit for 55” – Delivering on the European Green Deal

The European Commission – the executive branch of the European Union (EU) – has adopted a package of proposals to deliver on the EU’s ambitious target of reducing greenhouse gas (GHG) emissions by at least 55% by 2030, according to the National Law Review. These proposals – collectively known as “Fit for 55” – are part of the suite of legislative tools, legal obligations, and policies to be rolled out under the European Green Deal, a broad non-binding action plan intended to make the EU’s economy more sustainable and help Europe become the world’s first climate-neutral continent by 2050. The comprehensive package of twelve policies proposed yesterday contains the following key initiatives:

The human cost of inaction on chemical waste

The Lancet Commission on Pollution and Health found in 2019 diseases caused by pollution and mismanagement of waste were responsible for nearly 11 million premature deaths, as reported in Chemistry World. That’s 16% of all global deaths.

The commission also found that deaths from environmental lead exposure (900,000) and occupational chemical exposure (870,000) were both higher than either malaria (643,000) or HIV (864,000). Total chemicals-related deaths (1.8 million) are many times greater than deaths from malnutrition, obesity, high-sodium diets and so many other societal issues and injustices – and do not include direct pollution, which accounts for another 9 million deaths.

Limited, fragmented science-policy interactions on chemical waste management are contributing to health and environmental damage across the world. German Chancellor Angela Merkel noted the UN Environment Programme (UNEP) projects are not going to hit these goals without better collaboration.

The Royal Society of Chemistry (RSC) advocates the global problem of chemical pollution and waste management is so critical and urgent that it needs proper global coordination and leadership from governments. The RSC calls for an intergovernmental panel, funded by UN member states, with access to world-class scientific and policy expertise in line with that of the Intergovernmental Panel on Climate Change.

The machinery of the UN is notoriously slow, but the RSC argues that when the agenda is drawn and the decisions are made, the UN Strategic Approach to International Chemicals Management must know the power of collective feeling in the chemistry community.