Risk Limits Under New Toxics Law May Continue Past Practice

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By Steven Gibb

Dec. 7 — When the Environmental Protection Agency writes new chemical regulations under the amended toxics law it will need to apply conventional agency risk assessment norms or have to explain why it’s not doing so, former EPA officials said.

Under the law, the EPA must define what “unreasonable risk” means for chemicals as it crafts a risk evaluation rule to be finalized in June 2017.

Definitions set under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182), which amended the 1976 Toxic Chemicals Control Act, are critical to protecting the public, workers, children and the elderly from overexposure to toxic chemicals. They also are expected to affect the commercial viability of some compounds by controlling their uses.

Typically, the agency takes action on chemicals whose risks range between 1 in 10,000 excess cancer cases to 1 in 1 million excess cases.

“They’d have to explain why they’re moving out of that range if they did anything different,” former EPA toxics chief Jim Aidala told Bloomberg BNA.

No Dramatic Changes Expected

Other former EPA officials agree, saying that outside, expert input would be required for the EPA to adopt any alternative risk range for chemicals.

“I would not expect any dramatic changes at this point without the blessing of EPA science advisers or the National Academy of Sciences,” said former EPA risk assessor Oscar Hernandez, who, with Aidala is based in Washington D.C. with Bergeson and Campbell PC.

But other EPA veterans say the agency to date has been taking sensitive life stages into account.

Former EPA research official William Farland, with Colorado State University in Ft. Collins, said he did not expect much of a change.

“My thought is that they would continue with previous approaches [to risk assessment],” he said. “These standards have always been set to protect sensitive life stages or populations.”

Ensuring that the authority to set acceptable risk assessment standards remains with the EPA was a major recommendation of the Society for Toxicology during congressional negotiations on the legislation, which Farland participated in as a member of the society.

Science policy analysts say setting risk standards combines science and social values about what “acceptable risk” is for uniquely exposed groups and the general public. The EPA has been encouraged by its Science Advisory Board to add more social scientists to its ranks to help uncover social values surveys and other data to support acceptable risk determinations.

Risk Evaluation Rule

EPA toxics officials plan to propose a risk evaluation rule by the end of December and finalize it by June 2017.

The agency told Bloomberg BNA, “‘unreasonable risk’ under the new law is now a purely risk-based standard that will be profoundly more protective of human health and the environment. . . Further, in making an ‘unreasonable risk’ determination, EPA must now explicitly consider risks to vulnerable subpopulations who, due to either greater susceptibility or greater exposure, may be at greater risk from the chemicals.”

Unions and advocates for children and the elderly plan to pressure the agency for stricter risk limits to account for the susceptibility, vulnerability and unique exposures they focus on as the EPA crafts its risk evaluation rule for chemicals under the new law.

Nsedu Witherspoon, executive director of the Children’s Environmental Health Network, said she will urge the EPA to prioritize limits on chemicals that impact the developing brain and nervous system.

“To help reduce the unacceptably high prevalence of neurodevelopmental disorders in our children, we must eliminate or significantly reduce exposures to chemicals that contribute to these conditions,” she told Bloomberg BNA Nov. 10. These conditions include autism, attention deficit hyperactivity disorder, intellectual deficits, and other learning and behavioral disabilities.

Risk Provisions in the Details

Partly to account for these new challenges, the EPA’s toxics office has recruited Brenda Foos from the EPA Office of Children’s Health Protection to do a four-month detail in the chemicals program to support policymaking involving the amended toxics law.

Whether this means the EPA will trigger regulation at the 1 in 1 million excess cancer risk level for workers and children, or use a safety factor approach as applied under pesticide law, remains to be seen.

“EPA’s upcoming rules will address. . . health impacts in a meaningful way,” an agency spokeswoman said.

Environmental consultants, meanwhile, are playing down the impact of the EPA’s new authority to reduce chemical risks compared with the benefits of focusing on the public’s lifestyle choices—with the possible exception of workplace chemical exposures.

Dennis Paustenbach, president of the Cardno/Chemrisk consultancy in San Francisco, said, “I have some level of uncertainty about the benefits of continuing the ‘the less chemicals the better’ approach to how EPA regulates industrial chemicals. For years, this use of the precautionary principle was considered to always yield a safer environment. I want to believe that the scientific community accepts that there are safe doses of chemicals and that lower doses don’t necessarily improve public health.”

Lifestyle Contributes to Risk

Paustenbach takes a broad view of risks facing the public.

“I have come to believe that the risks associated with a less-than-ideal diet, exercise, and use of pharmaceuticals—over the counter and prescription—play a much bigger part in our healthfulness than industrial chemicals in our environment, but of course there are exceptions,” he said.

Paustenbach pointed to the progress made over the past 50 years with respect to cleaning up air, water, soil and foods. His company also supports industry clients where workplace chemical exposures are an issue that may be addressed by future TSCA rules.

“It is true that we are allowing exposures in the workplace, for some chemicals, that deserve to be addressed in the next few years,” Paustenbach said. “I believe it is likely that the new toxicology and epidemiology information that will be collected in the coming years will have a ‘trickle down’ effect on occupational exposure limits.”

Paustenbach said that he sometimes recommends stricter occupational exposure limits for chemicals than government standards to his client companies after reviewing their worker data.

Costs Paid by Someone

When asked about the increases in costs on industry for chemical rules that employ stricter risk standards due to susceptible subpopulations, Tracey Woodruff with the University of California, San Francisco said “the costs of not regulating are borne by the public.”

Woodruff directs the UCSF Program on Reproductive Health and the Environment and is advocating for stricter controls of chemicals that may affect vulnerable subpopulations such as children and pregnant mothers. The center addresses both individual chemicals and EPA science policies. It is closely tracking EPA’s approach to “unreasonable risk” under the amended toxics law to see how EPA accounts for these subpopulations in its risk evaluation and chemical control rules.

Woodruff recently answered some questions about this subject posed by Bloomberg BNA. The questions and answers were edited for length and clarity.

BBNA: Do you have more impact focusing on individual chemicals or on EPA science policy?

Woodruff: We’re surrounded by toxic environmental chemicals from the moment of conception, through infancy, childhood, and up to our deaths, and yet we have devoted only a small fraction of our national resources and effort to identify and prevent harmful exposures.

To address our goal of improving health by reducing toxic chemical exposures we start with the question “what are the chemicals we need to focus on from a health and policy perspective and where do we have data gaps?”

We also think about what the most efficient ways are to address exposures. It turns out that identifying and preventing exposures during pregnancy is highly efficient because if we protect that developmental period, the whole population, and future generations, benefit.

So one of our earliest studies was to document exposure to toxic chemicals among pregnant women in the U.S. by leveraging biomonitoring data collected by the U.S. Centers for Disease Control and Prevention. This research resulted in one of our well-cited findings that at least 43 chemicals are found in 99-100 percent of moms across the US. So that’s the data/science piece.

Then we ask—what does the science say about EPA’s methods of chemical hazard and risk assessment?

For example, it is quite common to conduct risk assessments for one chemical at a time—but does this make scientific sense? Let’s think about phthalates, a group of chemicals, many of which are a health concern, but which have not been addressed in combination. If you only consider exposures to phthalates one at a time without taking into account that people are simultaneously exposed to phthalates and many other chemicals, then the science shows that you are systematically underestimating risk.

That is essentially what the National Academy of Sciences said in 2008 in their report Phthalates and Cumulative Risk Assessment: The Task Ahead. This matters a lot as these risk estimates inform policy decisions, and the EPA will have to state whether they considered aggregate exposures for all conditions of use for a chemical under the amended toxics law.

Another broad challenge that undermines science policy is that “no information” has often been likened to “no risk.” Historically this false equation has been the default approach in environmental decision-making.

But absence of information is not absence of risk—it just means we don’t know. We need to make decisions based on the available information in a timely way. Under our current approach—people continue to be exposed until or even after there is strong evidence that a chemical is harmful, a policy that does not address potential health effects and is not health protective.

What’s our goal? To improve health by preventing harmful environmental chemical exposures. Then you ask what do we know and where are we lacking information? So this is where a review of the evidence comes in and where we have been pioneering “systematic review” methods—a systematic and transparent approach for identifying, evaluating and synthesizing the available evidence. It also identifies where we have and do not have data. The beauty of systematic review methods is that we can learn from the clinical sciences that have been developing systematic review methods for over 20 years. Systematic review methods are receiving a lot of attention as there is a great need to improve our evidence synthesis methods to make judgments about protecting public health in a more timely manner.

BBNA: What one change in EPA science policy would you make if you could?

Woodruff: There is more than one change needed. But an important one would be EPA’s default assumption that there is a “safe” level of exposure to chemicals that can have health effects other than cancer.

This does not mean EPA would ban or remove all chemicals; it simply means that EPA should fairly evaluate the scientific evidence and recognize that people vary in their susceptibility, due to age, genetics and disease status and that they are exposed to multiple chemicals at the same time.

The EPA needs to evaluate the hazards and risks of environmental chemicals for the entire spectrum of exposures and vulnerabilities and to value those risks in its cost-benefit analyses.

This need to throw out the assumption of “safe levels” of environmental chemicals agrees with what the National Academy of Sciences said in its report “ Science and Decisions.” This would then provide a more scientific basis for decision-making.

To contact the reporter on this story: Steven Gibb in Washington at sgibb@bna.com

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com

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