After years of debate and negotiation, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (The Lautenberg Act) on June 22, 2016, which marks the first comprehensive update to the Toxic Substance Control Act since the Congress enacted the law in 1976.
As the governing chemical management law in the U.S., the TSCA grants the Environmental Protection Agency (EPA) the authority to regulate a wide range of chemical substance and/or mixtures in commerce. However, it has long been criticized by NGOs, academics and some governmental agencies as being ineffective in limiting the use of chemicals that has serious impact on human health and the environment, such as the asbestos.
The new amendment significantly strengthened the old statute, by introducing new tools and concepts that are necessary for ensuring the safe use of chemicals – both new and those grandfathered in by the 1976 law. It establishes a strong domestic chemical regulatory system for businesses throughout the value chain, from raw material producers to retailers. Just as President Obama noted during the bill signing ceremony, the updated TSCA will be the first time in American history that “we will actually be able to regulate chemicals effectively.”
Key Reforms in The Lautenberg Act
Subjects all chemicals to EPA review
- When TSCA passed by the Congress in 1976, it grandfathered in some 62,000 chemicals already in commerce, without requiring the EPA to review the substance for safety. The amendment mandates EPA to conduct a risk-based review of all existing chemicals in commerce.
- Under the previous Act, the company is generally allowed to promote and sell new chemicals in the market unless EPA finds that the chemical “may present an unreasonable risk”. The amendment requires an affirmative finding on the safety of the new chemical from EPA before market entry.
Criteria for Chemical Review
- Under the “unreasonable risk” standard in previous Act, the EPA was required to conduct a cost-benefit analysis when addressing the risk posed by a chemical by taking into account cost or other non-risk factors and choosing the “least burdensome option”. The new amendment still allows the EPA to consider economic factors, but it redefines the “unreasonable risk” standard as one “based solely on considerations of risk to human health and the environment” and strikes out “least burdensome” provision.
- The amendment requires EPA to consider the risk of a chemical on “potentially exposed or susceptive subpopulations”, which may include (but are not limited to) infants, children, pregnant women, workers, the elderly.
- EPA will establish a transparent, risk-based process to identify high and low priority chemicals. It will require EPA to consider a chemical’s inherent hazards, uses, typical exposures to people (including vulnerable groups and the environment), proximity to drinking water sources, and other relevant information. Criteria and process for designating high- and low-priority chemicals must be developed by notice-and- comment rulemaking.
- EPA must designate as a high priority any chemical that EPA finds may present an unreasonable risk. A thorough risk evaluation will then be conducted on each chemical where EPA designated as “high-priority.”
- A chemical is to be designated low-priority only if EPA concludes based on sufficient information that it is not a high-priority substance. No further action is required for low-priority chemical, but it can move to high-priority once new information is obtained.
Restrictions on Chemicals That Pose Unreasonable risks
- For chemicals that pose unreasonable risks to human health or the environment, EPA will enforce any restrictions to the extent necessary to ensure that the chemical no longer present such unreasonable risk. The risk management measures may include labeling requirements, use restrictions, phase-outs, or bans of the chemical or specific uses.
Confidential Business Information (CBI)
- Under the previous act, the manufacturers of chemicals can keep certain information about chemical identity confidential by claiming it as confidential business information. The new law limits any presumption of protection from disclosure of chemical identities to the period before they enter the market, and require manufacturers to support their CBI claims for EPA review unless specifically excluded
Deadlines for Chemical Reviews
- By 6 months after the enactment, EPA must have risk evaluations underway on the first 10 high-priority drawn from its Work Plan.
- By 3.5 years after the enactment, EPA must have evaluations underway for at least 20 high priority chemicals, and EPA must have designated at least 20-low-priority chemicals.
- Risk evaluations must be complete in 3 years, with up to 6 month extension.
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