Health Care

How the FDA and EPA’s failure to communicate could put patients in danger

Critically ill Americans’ access to life-saving medical treatment is in jeopardy as states’ regulators crack down on cancer-causing pollution.

FDA

For decades a chemical used to sterilize medical devices and surgery tools has been the only option to ensure safe devices for billions of critical health care procedures.

But the chemical, ethylene oxide, has been shown to cause cancer, and growing panic among people living near plants that sterilize medical devices has led to a major crackdown and the shutdown of the factories in several states.

Now the Food and Drug Administration is warning that closure of the facilities where ethylene oxide is used could threaten the lives of patients and limit their access to everything from pacemakers to equipment for hip replacements and feeding tubes that save the lives of premature babies.

The story of how American lives may be threatened over the use and production of this chemical is an example of what happens when two bureaucracies — the FDA and the Environmental Protection Agency — fail to work together. The situation raises questions about whether federal health authorities were too slow to connect the dots between the environmental concerns around the cancer-causing gas — which EPA first disclosed five years ago — and the potential consequences to the medical device industry, which uses the gas to clean roughly half of all sterile devices, or more than 20 billion products a year.

“We need to harmonize our federal agencies so they are in sync, so that one isn’t causing problems that the other has to try and fix,” said Diana Zuckerman, president of the National Center for Health Research, a watchdog group that conducts health research it can use to influence policymakers. The organization accepts no money from medical treatment companies.

Already, one sterilizing facility in Illinois has shuttered under pressure from state authorities to cut the emissions, and a second in Michigan has said it will end its sterilizing operations by the end of year. Meanwhile, the state of Georgia has temporarily closed two facilities and lawmakers there are pressing for the closure of a third.

“Without [this sterilizing technique] ... the sickest patients would be most at risk,” FDA wrote in briefing documents ahead of a two-day meeting that kicked off Wednesday to obtain expert recommendations about how to reduce or eliminate ethylene oxide emissions in medical device sterilization without compromising the availability of devices.

Caught flat-footed, FDA is now scrambling to find alternative sterilizing processes, as the Environmental Protection Agency and states consider tightening emissions standards for these facilities, potentially threatening the industry’s ability to continue operating. Experts say it is unclear if the technology even exists to reduce facilities’ emissions enough to protect nearby communities from elevated cancer risks, according to EPA’s calculations.

"Inadequate sterilization would threaten modern medicine as we know it,” said Kara Mascitti, an infectious disease specialist at St. Luke’s University Health Network, at Wednesday's FDA meeting.

As EPA takes its time to update national emissions standards for sterilizers, states are stepping in to use their authorities to crack down.

Even though EPA found in 2014 that ethylene oxide was linked with breast cancer, leukemia and other cancers at much lower exposure levels than previously thought, and finalized that conclusion in 2016, it wasn’t until EPA released new monitoring data in August 2018 that emissions from sterilizing facilities caught the attention of state and local regulators and the public.

An outcry arose in the Chicago suburb of Willowbrook in August 2018 after the Chicago Tribune used that EPA data to report that the community faced an elevated cancer risk, thanks to a Sterigenics sterilizing facility located in the neighborhood. The facility became a major issue in Illinois’ 2018 gubernatorial election, in part because the incumbent Republican Gov. Bruce Rauner’s former private equity firm owned Sterigenics.

But it wasn’t until the newly elected Democratic governor took office in Illinois in 2019 and banned the facility from using ethylene oxide that the issue hit FDA’s radar, said Suzanne Schwartz, the deputy director of the office of strategic partnerships and technology and acting office director in FDA’s Center for Devices and Radiological Health.

Outside experts say the situation represents the pitfalls that can occur when federal agencies do not properly communicate with each other.

“EPA has had this on their radar screen, they’ve known that there is a problem. They’ve been talking about it. And somehow as far as we know that information either did not get to the FDA or did not get to the FDA in a way that anyone at the FDA said, ‘Ah, if we don’t look into this we could end up with a shortage of devices that are lifesaving and important devices,'" Zuckerman said. "How could this have not been of concern to them years ago?”

FDA says it has proactively addressed the issue since it commenced working with EPA, states and the device industry following the Willowbrook plant closure in early 2019. The agency notes it helped prevent a shortage of critical breathing equipment by working with one device manufacturer to quickly find a new sterilization site. FDA also launched two contests to develop new sterilization techniques and figure out how to minimize pollution from ethylene oxide sterilization. FDA will work with contest winners to accelerate the availability of the technology. Those initiatives are already bearing fruit, and FDA told POLITICO it believes there may be new short-term mitigation strategies that it will be able to announce in the next few months.

FDA stressed that regulating air pollution falls outside of its jurisdiction and it told POLITICO the agency doesn’t get alerted if facilities that produce medical products it oversees are violating air regulations and posing a safety concern. Therefore, Schwartz said, there’s little it could have done to foresee this crisis sooner given that EPA never changed its standards for ethylene oxide emissions.

"As part of the processes that occur with manufacturing, there are various toxins that are emitted. The key here is for the EPA to be establishing what are those standards that are allowable so that the manufacturers that are responsible for producing these products and have emissions can then be compliant with the emissions [regulations]," said FDA’s Schwartz. "Otherwise it's outside FDA authority."

The device industry offers a similar defense for the industry’s failure to adjust its manufacturing processes, saying the 2016 conclusions from EPA's Integrated Risk Information System program were never meant to create a new limit that policymakers would use to regulate pollution. No sterilization facility has violated any federal or state air standards, medical device lobby AdvaMed said.

"I would challenge the premise of any of the questions that say because there is a new [EPA] number [on ethylene oxide] that somehow behavior should have changed,” Crist said on a Tuesday press call.

State regulators sued Sterigenics’ Willowbrook facility for public nuisance, but the state did not argue that Sterigenics exceeded the limits of ethylene oxide allowed by the state EPA’s permit. Meanwhile, Sterigenics in August voluntarily shut down its Smyrna, Georgia plant to upgrade its emissions technology as state pressure grew. Another plant in Georgia operated by Becton Dickinson temporarily closed down last month after legal battles with the state attorney general.

Illinois is moving to change its state standards. Gov. J.B. Pritzker has promised to sign a bill recently advanced by the House that would phase out ethylene oxide use in the state entirely in the next few years.

Now, EPA is preparing to review the hazardous air pollutant regulations governing more than 100 sterilizers around the country.

As part of that review, the agency can consider the importance of sterilizers to public health, said Janet McCabe, who led EPA’s air office under the Obama administration.

“The [Clean Air] Act allows EPA to consider issues in addition to air quality impacts of regulatory requirements,” she said. “It’s a reasonable thing for EPA to consider what are the implications for the medical sterilization needs if new regulations are put on the sterilizing companies.”

The agency had initially planned to update the emissions rules for sterilizers by the end of the year, but significantly slowed that process down in September and now says only that it plans to issue a proposed rule “in the coming months.”

Instead, EPA says it plans in the coming weeks to issue an advance notice laying out potential approaches to new regulations, and to use a formal mechanism under the Clean Air Act to collect data from sterilizers about their facilities, emissions controls and procedures and how much it would cost to tighten emissions controls. It will also convene a Small Business Advocacy Review Panel before taking any regulatory action.

Air experts say the delay may be coming, in part, from open questions about other sources of ethylene oxide. Data released by EPA on Wednesday showed high background levels of the gas, even where there aren’t major sources like sterilizers or chemical manufacturing plants.

But the regulatory decision is particularly fraught for the Trump administration, and sterilizers have a powerful ally in their effort to avoid tougher requirements. Chemicals manufacturers — who emit vastly more ethylene oxide — also strongly disagree with the finding from EPA's IRIS program that the chemical poses health hazards at very low levels of exposure. The American Chemistry Council, the chemicals industry’s primary lobbying group, has asked EPA to change that finding.

EPA proposed new air regulations for certain chemicals manufacturers on Wednesday, but in doing so raised doubts about whether the agency should rely on its own IRIS assessment when regulating ethylene oxide. The regulatory proposal would require chemical manufacturing facilities to upgrade vents, storage tanks and other equipment associated with the chemical, but would still allow cancer risks that are 200 to 300 times higher than the level the agency typically considers acceptable, according to the IRIS assessment.

AdvaMed argued that fears over pollution has led to a wave of misinformation and decisions driven by emotion rather than scientific expertise.

“In the absence of the fact-finding and information-seeking and the appeal to the rigors of science, what supplants that unfortunately are emotionally charged decisions and none of us wants that. No lawmaker, no policymaker. We want that appeal to the academic world. And to the authority that FDA and EPA hold in this space,” AdvaMed’s Crist said Tuesday.

These industry groups have found support from the state of Texas, which this summer issued a risk value for ethylene oxide that concludes people do not experience increased cancer risks unless they are exposed to levels 3,500 higher than EPA said in its IRIS assessment.

The Trump administration, which has been skeptical of the independent scientists who do risk assessments like the one for ethylene oxide, has hinted that it may not tie its regulatory decisions to that number. In a statement to POLITICO, EPA noted that the division that issued that risk assessment “is not a regulatory program.” And in a proposal for an unrelated rulemaking, the agency asked for comment on whether to use its own risk assessment when crafting regulations — a move that raised alarm among environmental groups and communities.

While EPA slowly marches along, HHS’ department for protecting critical health infrastructure, the Assistant Secretary for Preparedness and Response, has stepped in to help agencies coordinate on potential shortages, said Laura Kwinn Wolf, director of ASPR’s Division of Critical Infrastructure Protection. Wolf said the agency will soon convene an interagency disaster leadership group to ensure device access.

But this work may come too late for the brewing public health crisis caused by device plant closures.

The impact resulting for the plants that have already closed and the specter that more could come “will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care,” FDA’s recently departed acting commissioner Ned Sharpless warned in late October.