The EPA slowdown on dangers of formaldehyde

There is a skirmish taking place in Washington over a draft report on the acceptable levels of formaldehyde that critics say illustrates how the Trump administration, through the Environmental Protection Agency (EPA), is bending long-established review procedures to benefit industry.

Formaldehyde is a colorless, flammable, strong smelling chemical. While best known for its use in embalming fluid and most widely used in industrial resins, it's commonly used as a precursor to other chemical compounds.

Formaldehyde is used in pressed-wood products, such as particleboard, plywood and fiberboard; glues and adhesives; permanent press fabrics; paper product coatings; and certain insulation materials. Additionally, it's commonly used as an industrial fungicide, germicide and disinfectant.

The chemical's unique and versatile properties also give it broad roles in the economy, supporting about 963,000 jobs and $433 billion in sales in the United States, according to the American Chemistry Council. Formaldehyde's use in housing applications and the automotive industry make it particularly valuable to Michigan's economy. Dow Chemical, a producer of formaldehyde, is located in Midland, Michigan.

A 1997 report by the U.S. Consumer Product Safety Commission found formaldehyde is normally present in both indoor and outdoor air at low levels, usually less than .03 parts per million of air. However, materials containing formaldehyde can release formaldehyde gas or vapor into the air. Formaldehyde is also a byproduct in combustion, including automobiles.

Industrial workers who produce formaldehyde or formaldehyde-containing products, laboratory technicians, certain health professions and mortuary employees may be exposed to higher levels of formaldehyde than the general public. Exposure occurs primarily by inhaling formaldehyde gas or vapor from the air or by absorbing liquids through the skin.

The American Chemistry Council, the industry's largest lobbying and trade organization, is taking issue with the most recent assessment of the dangers of formaldehyde, claiming “the U.S. Environmental Protection Agency's (EPA) 2010 draft Integrated Risk Information System (IRIS) assessment proposed risk value would set an acceptable air concentration that is thousands of times below levels that naturally occur in the environment."

The assessment, which was conducted by the EPA's Integrated Risk Information System (IRIS) and released in 2010, concluded formaldehyde causes respiratory cancers, leukemia and other health problems, including asthma.

"The truth is, formaldehyde is a natural part of our world and the illogical findings of IRIS are not," the 2018 publication goes on to state. "Formaldehyde is found in every living system – from plants to animals to humans – produced as part of our normal metabolic process. If a person inhales formaldehyde, the body breaks it down rapidly, just like when it is naturally produced in our bodies."

Health assessment conducted by the EPA's IRIS program are used to determine "acceptable levels" of exposure to specific chemicals. The assessments are simply findings, and don't serve as regulations themselves however, the assessments influence the EPA and other regulators to determine regulations.

But, according to some health and environmental groups, the response from the American Chemistry Council is more hot air in an effort to suppress the EPA's findings that could lead to tighter regulations on formaldehyde and open the industry up to expensive lawsuits.

Jennifer Sass, senior scientist with the Natural Resources Defense Council, said the EPA's draft assessment, which was released in 2010 and has since been re-assessed a second time, has already been reviewed a second time by the independent National Academy of Sciences but is being held up by the EPA due to industry pressure.

"Nancy Beck is holding it up," she said, referring to the EPA's deputy assistant administrator in the agency's Office of Chemical Safety and Pollution Prevention. "She's a political appointee that didn't go through a confirmation hearing, and she was a former lobbyist for the American Chemistry Council. She went right from there as a lobbyist to heading up the toxics process at the EPA. She had been working on these issues and TSCA (Toxic Substances Control Act), and her office is overseeing the process."

A request from Downtown Publications to the EPA for comment or interview with Beck was not granted.

An EPA spokesperson said the agency's Office of Research and Development is currently "Developing a new approach of soliciting program input on current and future IRIS assessments to ensure IRIS assessments are focused on the highest priority needs." The EPA said the formaldehyde assessment will be included in that activity.

Kimberly White, an environmental toxicologist and senior director at the American Chemistry Council said, "Separately, it's produced for industrial uses. It's a basic building block in a lot of chemistry in automobile products, it's used as a resin and you hear about it a lot in composite materials. That's a high level picture."

A 2017 one-page publication by the council notes humans produce about 1.5 ounces of formaldehyde each day and that it's a "natural by-product" from all combustion processes. The cartoonish infographic depicts everyday people exposed to formaldehyde. For instance, there is 3.95 mg/kg in coffee; 6 mg/kg in an apple; .0001 ppm in human breath; 11 mg/kg in fish; 10 ppm in car exhaust and other sources.

"Low levels of formaldehyde occur naturally in a variety of fruits and vegetables, including apples, carrots and bananas," the sheet states. "It does not accumulate in the environment or within plants and animals.”

"If you look at the EPA's 2010 draft, their value was set at .001part-per billion (ppb). If your body produces 1 (ppb), you're already three orders above that magnitude just by exhaling. That's not really reasonable," she said. "As a state regulator, say in Michigan, how do they adjust to levels that you find in the background every day.

"That's one of the things, that we want the agency to do, is do a reality check. If you're setting values that aren't realistic or make sense, then you need to re-evaluate the process for setting those values."

With the ubiquitous presence of formaldehyde everywhere we turn, one might be led to believe that formaldehyde poses no threat to human health at all. But just because a chemical can be naturally occurring or metabolized by the body in low amounts doesn't mean it can't be a threat. For instance, apple seeds contain a cyanide and sugar compound that degrades into hydrogen cyanide when metabolized. In World War II, hydrogen cyanide was used in gas chambers and called Zyklon B.

"Nobody is arguing whether it's a carcinogen. They are arguing on what kind of cancer," Sass said. "They are saying it wouldn't cause blood cancer because it doesn't get into blood. ... The industry argument is theoretical, but that fact is, you have half a dozen studies showing formaldehyde is linked to leukemia."

In reference to formaldehyde, White said the American Chemistry Council doesn't suggest that high levels of the chemical aren't harmful.

"Formaldehyde is considered a nasal carcinogen at very high doses," she said. "Those would be levels that you wouldn't find in the environment or in environmental exposures. At very high levels of exposure, scientific data supports that it is a nasal carcinogen."

An initial draft of the IRIS assessment on formaldehyde was released in 2010. The following year, the non-governmental, non-profit National Research Council of the National Academy of Sciences (NAS) reviewed the initial assessment and severely criticized the 1,000-plus page draft assessment. Among the NAS's criticisms was that the assessment failed to support its conclusions.

"Overall, the committee found that the EPA's draft assessment wasn't prepared in a logically consistent fashion, lacks clear links to underlying conceptual framework and doesn't sufficiently document methods and criteria used to identify evidence for selecting and evaluating studies."

While the NAS review said the initial assessment didn't support the findings linking formaldehyde to leukemia and some other health problems, it did support the findings that link it to nasal cancers. Still, the IRIS program withdrew its initial assessment. A second draft assessment has been completed, but has not yet been made available to the public, making the current assessment within the EPA nearly 40 years old.

Sass said part of the problem with the initial review was that it failed to focus on science used to reach its conclusions, instead adding hundreds of pages to address industry criticisms.

"The NAS didn't challenge their conclusion, but they did hit the IRIS staff hard on their science communication," she said. "They basically said the staff failed to justify the science used in the assessment... they basically said 'you need a prewritten rational or framework, and it can't be a rebutting and selecting process.'"

The EPA's IRIS program is located in the agency's National Center for Environmental Assessment in the Office of Research and Development. The placement of the program ensures IRIS can develop impartial toxicity information independent of its use by the EPA's program and regional offices to set national standards and clean up hazardous sites.

The criticism of the IRIS program applied not only to the formaldehyde assessment, but with what was viewed as longstanding problems in the program.

An EPA spokesperson said the agency has been responding to comments about the IRIS from the NAS and the Government Accountability Office (GAO) over the past year and a half. Changes include increased transparency and implementing review changes to create a clearer evaluation of underlying science. The EPA said those changes were deemed "substantial progress" by the NAS, and that the GAO noted significant improvements in their high-risk criteria ratings.

Sass, with the NRDC, said the issues have since been addressed, with the program being praised by the NAS in a 2014 assessment.

"That was a favorable review and the NAS said they were on the right track," Sass said.

While a second IRIS assessment of formaldehyde has apparently been completed, it has yet to be released for public review. Although the assessment hasn't been made public, the delay in its release suggests to some that the reassessment supports the findings of others in the scientific community that high exposure to formaldehyde may be linked to additional cancers.

"The reason industry cares about cancer classifications is because of liability of any litigation," Sass said. "If your workers have cancer associated with a specific site, it could lead to legal liability."

In August, U.S. Senator Edward Markey (D-Mass.) asked Acting EPA Administrator Andrew Wheeler about the release of IRIS assessment on formaldehyde and wasn't given a clear answer.

"(Former) Administrator Pruitt committed to release the EPA's scientific report on the carcinogen formaldehyde but never did so. Will you commit to releasing this report?" Markey asked.

"I've not been briefed specifically on the IRIS formaldehyde report, but I have sat down with our IRIS staff, and what I'm trying to do is provide more certainty to that process to make sure we know how the different assessments will be used in the regulatory programs, and it's my understanding that we still have a number of steps to complete on the formaldehyde assessment," Wheeler answered.

When pressed on when the assessment will be released, Wheeler didn't answer.

"The question I have put to our IRIS staff is 'what is the purpose of the assessment at this point, and whether or not that data they have used in the assessment is still current.' I know they started that before 2010," Wheeler said. "We will release it, but I need to make sure the science in the report is still accurate.

"What I've asked is for, not just that report, but everything we are doing on the IRIS program is to make sure we know the purpose of the assessment because we have a lot of chemicals that we should and could be assessing under the IRIS program, and I want to make sure that they are being used in our regulatory process because we have other chemicals that need to be assessed, as well. That is one of the questions that I've asked our program staff."

"Pruitt committed to releasing it, and I hope that you put it at the top of your list," Markey responded. "I expect you to, and to get it released so that the public can understand what those dangers are."

Markey followed up the exchange with a tweet on August 1: "EPA Admin Andrew Wheeler gave me an unacceptable answer today when I asked him if he would release the long-overdue study on the impacts of toxic #formaldehyde. The EPA should not continue to silence science that would protect public health and immediately release this report."

In May, Markey and senators Sheldon Whitehouse (D-RI) and Tom Carper (D-Del.) sent a letter to the EPA asking for the formaldehyde assessment to be released. The letter followed a statement by former administrator Pruitt in January in which he indicated the report was ready to be released.

"Unfortunately, it appears that the agency may be succumbing to the pressure from industry in its attempt to delay or block the publication of the formaldehyde health assessment," the senators said in the letter. "This is exceptionally disturbing, and lends further credence to the belief, already widely held, that the EPA has been captured by industry. We urge you to ensure there are not further efforts to delay or block the publication of this assessment that has serious implications for public health."

Nicholas Schroeck, director of clinical programs and associate law professor at University of Detroit Law School, and former director of the Transnational Law Clinic at Wayne State University Law School, said because formaldehyde is used for various industrial applications and is found in our air, water, foods, land and various consumer products, the EPA regulates it through the National Clean Water Act, Clean Air Act, and the Toxic Substances Control Act.

"If the EPA found that exposure at certain levels causes leukemia or nose and throat cancers, that's big," Schroeck said. "That would mean every state would potentially have to go back and look at all of their permitting, all the way down to manufacturing, and potentially homes and businesses that are off-gassing."

Schroeck said there's also likely to be litigation stemming from the assessment if it opens new classifications of cancer linked to formaldehyde, a move that has already been made by other agencies.

Research spanning decades has linked formaldehyde to nose and throat cancer, as well as respiratory problems. However, newer research suggests that it may be linked to leukemia.

A study by the National Cancer Institute (NCI), which is an arm of the National Institutes of Health, suggested professionals who are exposed to formaldehyde in their work, such as anatomists and embalmers, may have an increased risk of leukemia and brain cancer compared to the general population.

One study looked at funeral industry workers who died between 1960 and 1986, with researching comparing those who died from hematopoietic and lymphatic cancers and brain tumors with those who died from other causes. (Hematopoietic or hematologic cancers such as leukemia develop in the blood or bone marrow. Lymphatic cancers develop in tissues and organs that produce, store and carry white blood cells that fight infections and other diseases, according to the NCI.)

The NCI analysis showed that those who performed the most embalming and those with the highest estimated formaldehyde exposure had the greatest risk of myeloid leukemia. There were no association with other cancers of the hematopoietic and lymphatic systems or with brain cancer.

Information provided by the NCI included another study that looked at 25,619 workers in industries with the potential for occupational formaldehyde exposure and estimated each worker's exposure to the chemical while at work. The results showed an increased risk of death due to leukemia, particularly myeloid leukemia, among workers exposed to formaldehyde.

The risk was associated with increasing peak and average levels of exposure, as well as with the duration of exposure, but it was not associated with cumulative exposure, according to the NCI.

An additional 10-years of data on the same workers were used in a follow-up study published in 2009. That analysis continued to show a possible link between formaldehyde exposure and cancers of the hematopoietic and lymphatic systems, particularly myeloid leukemia.

As in the initial study, the NCI said the risk was highest earlier in the follow-up period. Risks declined steadily over time, such the cumulative excess risk of myeloid leukemia was no longer statistically significant at the end of the follow-up period. The researchers noted that similar patterns of risk over time had been seen for other agents known to cause leukemia.

A study of 11,039 textile workers conducted by the National Institute for Occupational Safety and Health (NIOSH) found an association between the duration of exposure to formaldehyde and leukemia deaths. However, the evidence remains mixed, as a similar study of 14,014 British industry workers found no association between formaldehyde exposure and leukemia deaths, the NCI said.

According to the National Institutes of Health, formaldehyde undergoes rapid chemical changes immediately after absorption. Therefore, some scientist think that form is unlikely to have effects at sites other than the respiratory tract. However, some laboratory studies suggest that formaldehyde may affect the lymphatic and hematopoietic systems.

"Based on both the epidemiological data from cohort and case-control studies, and the experimental data from laboratory research, NCI investigators have concluded that exposure to formaldehyde may cause leukemia, particularly myeloid leukemia, in humans," the NCI said.

In 2011, the National Toxicology Program Report on Carcinogens changed the listing status of formaldehyde from "reasonably anticipated to be a human carcinogen" to "known to be a human carcinogen."

The current EPA IRIS assessment of formaldehyde was completed in 1990. That assessment identified formaldehyde as "a probable human carcinogen," based on incidences of nasal squamous cell carcinomas. As the EPA continues to contemplate its own assessment of formaldehyde risks, several protective measures are already in place.

In 1987, OSHA established a federal standard that reduced the amount of formaldehyde workers can be exposed to over an eight-hour workday, from 3 ppm to 1 ppm. That standard was reduced to .75 ppm in 1992.

Some private companies have also taken measures to reduce formaldehyde products for sale. For instance, in 2017, CVS Health announced it would phase the removal of the most prevalent formaldehyde-containing products from its CVS Health, Beauty 360, Essence of Beauty and Blade product lines. The phase out, which includes more than 600 products and will be complete by the end of 2019, also includes products containing parabens and phthalates.

Most recently, federal legislation was passed in 2010 and went into effect this year that regulates use of formaldehyde in hardwood plywood, particle board, fiberboard and other wood products. The Formaldehyde Standards for Composite Wood Products Act limits amount of formaldehyde emissions in those products.

Restrictions from the finalized rule of the act went into effect earlier this year, following a lawsuit against the EPA that claimed it had illegally delayed the rule. Under the finalized rule in 2016, wood products had to comply with the limits by December of 2017. However, the EPA had set out to extend the compliance deadline until December of 2018.

New Orleans-based A Community Voice, The Sierra Club and Earth Justice filed suit against the EPA, challenging the delay in US District Court in Oakland, California. In February, the federal court ruled the delay was beyond the scope of the EPA's authority and not in accordance with the act.

"They are in effect, as of June 1," said Patti Goldman, managing attorney for Earth Justice. "They were adopted, and the Trump administration was delaying the compliance deadline. That's the pattern they use: delay, then try to change it and keep them from going into effect."

The new limits change how much formaldehyde can off-gas from wood products. Goldman said the act stems from off-gassing products used in trailers constructed for the Federal Emergency Management Agency (FEMA) following Hurricane Katrina.

"People were housed in trailers and were sickened from formaldehyde," she said. "They were built so quickly, some described them as 'oozing' formaldehyde."

Following the Hurricane Katrina disaster, FEMA provided thousands of manufactured homes for displaced residents, both for hurricanes Katrina and Rita. Soon after victims took residence, complaints of headaches, nosebleeds and difficulty breathing were made in relation to formaldehyde resins used in the homes.

According to FEMA, the Centers for Disease Control and Prevention (CDC) in 2008 tested FEMA supplied trailers and mobile homes in Louisiana and Mississippi. The CDC found potentially hazardous levels of formaldehyde, with an average of .077 ppm, which the CDC said could be linked to increased risk of cancer for longterm exposure. The minimal risk level is .008, as prescribed by the Agency for Toxic Substances Disease Registry, a division of the CDC. Levels in FEMA trailers tested ranged from .003ppm to .59 ppm.

The lack of a federal legal limit of formaldehyde in wood products then led federal lawmakers to create the new act.

"There were some really weak limits before Katrina," she said. "There's a lot of controversy over formaldehyde. But it's an air irritant and causes a lot of cancers, and as a contributor to asthma, it has been documented more recently."

The new standard as it relates to wood products, she said, is among the strongest in the world.

Goldman said the new limits are based on those already in place in California. She said the tactic to delay compliance deadlines isn't new to the Trump administration.

The first time it happened was when Reagan came in," she said. "His chief of staff did a memo that said to the Federal Registry that if a law wasn't in effect, then freeze it and you have to review it. That's happened with every administration change, particularly when you have a different political party coming in.

"What was different this time was that it went a lot further. Bush had done some without a comment period and it was invalidated. Trump almost uniformly was extending deadlines and kept extending. Then they got caught on that. It was almost a cottage industry to keep the rules from going into effect."

White, with the American Chemistry Council, said the council is supportive of the new rules regarding wood products.

"They basically mirror what has been in place in California for a number of years," she said. "The ACC is a proponent of getting those standards nationalized, and realistically, here in the United States, those standards have ben the de-facto standards."

White said the lack of quality assurances when FEMA trailers were constructed led to the changes, as formaldehyde is a nasal carcinogen at high doses. She said it's with new classifications of cancer that the ACC doesn't believe science supports changes.

She said there are new "systematic review" changes to how the EPA conducts assessments for chemicals under the Toxic Substances Control Act (TSCA), which don't immediately apply to the formaldehyde assessment, and are a positive step forward for the EPA.

Those proposed changes in August were still out for public comment under the Federal Registry. However, the comment period was scheduled to be closed prior to publication of this article. White said the ACC was planning to submit comments before the deadline.

Meanwhile, Sass, with the NRDC, said the new review rules for TSCA chemicals are another effort to limit scientific evidence that can be considered in chemical reviews at the EPA. Specifically, she said the changes call for giving extra weight to good laboratory practices," or GLP standards, which she labels a code for industry-sponsored studies. At the same time, she said the proposed changes would solidify efforts to discount certain epidemioglocial studies, playing on an unformalized "Scientific Transparency Rule" that sought to limit certain studies from being included in reviews.

Reviews conducted under TSCA are chemical reviews used specifically by the EPA to regulate a variety of chemicals, including pesticides, PFAS and other toxic compounds.

"Beck has come up with her own systematic review, and it hasn't gone through any peer review. It's at odds with the updated IRIS systematic review process, but it has been praised," Sass said. "Every chemical under TSCA will go through the new process, if she gets her way. We will fight it.

"This is a systematic review that nobody has written about. It's really under the wire." ­