Backyard Talk

Putting the ‘Teeth’ into TSCA: A Tale of Two Bills

TSCA, the Toxic Substances Control Act, is meant to do as its name suggests – control the introduction of potentially toxic chemicals into personal care products and the environment. The law, introduced in 1976, has been left untouched for decades. The chemical market now contains over 85,000 chemicals, with about 1,000 new chemicals introduced every year – and TSCA’s rules have only resulted in bans on five of these substances. ‘TSCA has no teeth’ is a common refrain among environmentalists, and speaks to the Act’s general incompetence in protecting human and environmental health.

How does TSCA work, and what makes it so ineffective? Essentially, TSCA requires that the EPA maintain a list – the TSCA Inventory – of all chemical substances that are manufactured or processed in the U.S.  Though companies must let the EPA know they are starting to manufacture a chemical, they have no responsibility to provide safety data along with this notice. The EPA can only require testing once they have proven the chemical presents a “potential risk,” creating a massive loophole for untested but potentially hazardous chemicals to enter the market. Not only are new chemicals subject to no scrutiny, but in-use chemicals are given the benefit of the doubt. When TSCA was first introduced, it “grandfathered in” all existing chemicals with the assumption they were safe for use. It’s readily apparent that there are more loopholes than law in TSCA.

Luckily, TSCA reform is back on the table, with the introduction of two new chemical regulation bills to Congress just last week. On March 10, Senators David Vitter and Tom Udall introduced a new bill that builds incrementally on a previous reform attempt, the Chemical Safety Improvement Act. Though the Udall-Vitter bill gives the EPA more power to regulate and requires safety testing of current and new chemicals, it has drawn criticism from environmental groups. The coalition Safer Chemicals, Healthy Families released a letter critiquing the bill’s classification system for chemicals, which groups them as “High Priority” or “Low Priority” after an initial review. Chemicals deemed High Priority will be subject to further testing to determine their safety, while Low Priority chemicals will not, a distinction that may open a so-called ‘Low Priority Loophole’ with the potential for abuse by industry. Additionally, the bill curtails the ability of states to set their own more stringent regulations, a fact many environmental groups have criticized.

Senators Barbara Boxer and Ed Markey introduced their own bill, the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act, on Thursday. Named after two cancer survivors, the bill employs stricter standards for chemical safety evaluation, sets deadlines for determining safety, and also allows states to continue to employ stricter regulations than those at the federal level. The Environmental Working Group has praised the bill, including its changes to safety-standard language. Instead of requiring EPA to prove a chemical has “no unreasonable risk of harm,” the bill sets the standard as “reasonable certainty of no harm” – the same standard that is applied to food additives and pesticides. The bill requires that the EPA consider risks that might result from unintended chemical spills, not just intended exposure levels. It also fast-tracks the safety analysis of asbestos, a proven cancer-causing agent that TSCA has thus far failed to regulate.

The Boxer-Markey bill shifts the burden of proof for chemical safety determination in a significant way. Rather than requiring proof of a chemical’s ‘unreasonable’ harm before regulation, it requires ‘reasonable’ certainty of its safety. Of course, there are still nuances and uncertainties in the determination of what constitutes “reasonable” safety, just as “unreasonable” harm is a flexible concept. All things considered, the Boxer-Markey bill takes the furthest step toward precaution that we have yet seen in Congress.

May the best bill win!

Backyard Talk

Staying Safe (Probably): Risk, Hazard and Chemical Regulation

Risk’ and ‘hazard.’

These two words are often used interchangeably, but they have distinct meanings in the context of chemical safety assessment. When we say a particular chemical is ‘hazardous,’ we are noting its mere potential to cause negative health or environmental effects. On the other hand, ‘risk’ describes the probability that these negative effects will actually occur under specific circumstances. In order to generate a measurable risk, some exposure to the hazard in question must occur.

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Both a hazard and an exposure are necessary for a risk to exist.

If you have followed my last several posts, you’ve probably caught on to the idea that attempting to declare a chemical ‘safe’ or ‘unsafe’ is an exercise in futility. To comprehensively determine risk, we must know not only the detailed structure and function of a chemical, but also understand the intricacies of its interactions with the environment and the human body. Current chemical regulation in the United States operates within a risk-based framework. We establish standards and criteria for acceptable levels of hazardous compounds in products, in the environment and in our bodies; we enact bans and restrictions on chemicals in order to limit our exposures. These regulations are the product of risk assessments, which report not only the hazardous properties of chemicals but also the likelihood of human exposure.

My recent post on BPA illustrates the complexity of risk assessment. Though BPA has demonstrated hazardous potential, the levels to which humans are exposed to the compound, and therefore the actual risks of its use, are uncertain. Exposure may seem like a simple factor to evaluate, but our understanding of exposure is continually evolving, particularly with consideration for the special vulnerability of developing babies and children.  The ban on BPA in baby bottles reflects this emerging awareness of long-term effects of chemical exposures. However, the replacement of BPA with BPS illustrates the shortcomings of an approach that controls risk by limiting exposure to specific high-profile hazardous compounds.

The replacement of BPA, a known hazard, with BPS – an untested and unregulated compound with a nearly identical structure – may be considered an example of what scientists and regulators refer to as “regrettable substitution.” Regrettable substitution occurs when we eliminate one hazardous chemical from consumer products, only to replace it with a similar or even more hazardous alternative. Our risk-based chemical regulation enables us to remove demonstrably dangerous chemicals from consumer products, but also leaves profound loopholes for new chemicals, untested and unregulated, to enter the market in their stead, as long as risk assessments have not proven them dangerous. In a 2010 post on his Environmental Defense Fund blog, Dr. Richard Denison refers to this process as playing “whack-a-mole” with chemicals. No sooner have we knocked one hazardous chemical back into its hole, than a replacement rears its likely-hazardous head…until we generate evidence of its actual risk and seek to replace it with another unknown quantity.

Is this game of “whack-a-chemical” inevitable, or do more precautionary approaches exist? In Europe, regulators are striving for a balance between risk assessment and the more protective approach of hazard classification. While risk assessment relies on scientific studies to determine the risks of chemicals under different exposure scenarios, hazard classification groups chemicals based on their inherent hazard potential. It is this potential to cause harm that guides regulation, not demonstrated adverse effects.  A hazard classification regulatory scheme might have prevented BPS from entering the market, since its structural similarities to BPA make it a likely health hazard.

Hazard classification is essentially a more precautionary approach to chemical regulations. And when we operate in a framework of precaution rather than risk, the regulatory question itself changes. “A precautionary approach asks how much harm can be avoided rather than asking how much is acceptable,” write Dr. Ted Schettler and coauthors in a 2002 essay on the role of the Precautionary Principle in regulation and policymaking.

How can we better incorporate the Precautionary Principle into the chemical regulation process in the US? This question has been at the epicenter of the debate on reforming the Toxic Substances Control Act (TSCA), which I will cover next time on Backyard Talk.