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Iranian Study Shows Staggering Carcinogenic Risk in Hospital Laboratories from Occupational Exposure to Deadly Chemicals

Study found highest incidences of occupational carcinogenesis among clinical laboratory and histology technicians, followed by pathologists

It has been known for years that formalin (a form of formaldehyde used as a disinfectant and preservative in the handling of tissues samples in anatomy, pathology, and microbiology labs), as well as xylene and toluene, are dangerous to clinical laboratory workers. Nations around the world have taken steps to minimize exposure to these dangerous chemicals. However, a recent study in Iran found that those measures may not have gone far enough to protect histology and clinical laboratory technicians, pathologists, and medical laboratory scientists.

The study conducted by researchers in the Department of Occupational Health Engineering, School of Public Health, at Tehran University of Medical Sciences, showed that levels of exposure to these chemicals is still significantly higher than recommended, resulting in a higher risk for cancer among lab workers in Iran’s hospitals.

The scientists published their findings in the journal Nature Scientific Reports titled, “Occupational Exposure, Carcinogenic and Non-Carcinogenic Risk Assessment of Formaldehyde in the Pathology Labs of Hospitals in Iran.”

“Employing risk assessment techniques as a complementary tool in monitoring programs for respiratory exposure in the different work setting should be considered to protect the staffs against both non-cancerous and cancer-related hazards,” the study authors wrote.

Lessons learned from the Iranian hospital lab study could benefit clinical laboratory workers in US hospitals and help those who work with formaldehyde, toluene, and xylene worldwide to reduce their chances of developing a vascular condition known as Raynaud’s phenomenon (shown above) which can lead to necrosis and gangrene, as well as other dangerous health conditions affecting the lungs, brain, and other systems and organs in the body. (Photo copyright: Wikipedia.)

Study Details

The Iranian study considered the carcinogenic and non-carcinogenic impact of occupational exposure to formaldehyde in the pathology laboratories of four Tehran hospitals. The researchers “used a quantitative risk assessment method proposed by the United States Environmental Protection Agency (EPA), along with its provided database known as the Integrated Risk Information System (IRIS). Respiratory symptoms were assessed using the American Thoracic Society (ATS) questionnaire,” the study authors wrote in Nature Scientific Reports.

The scientists found that “91.23% of exposure levels in occupational groups exceed the NIOSH [National Institute for Occupational Safety and Health] standard of 0.016 ppm.” They determined that “41.03% of all the studied subjects were in the definite carcinogenic risk range (LCR > 10−4), 23.08% were in the possible carcinogenic risk range (10−5 < LCR < 10−4), and 35.90% were in the negligible risk range (LCR < 10−6),” they wrote.

“The highest index of occupational carcinogenesis was observed in the group of lab technicians with a risk number of 3.7 × 10-4, followed by pathologists with a risk number of 1.7 × 10-4,” the scientists wrote. “Furthermore, 23.08% of the studied subjects were within the permitted health risk range (HQ < 1.0), while 76.92% were within the unhealthy risk range (HQ > 1.0),” they added.

“Formaldehyde exhibits high solubility in water and is rapidly absorbed by the nasal cavity, sinuses, throat, and mucous membrane of the upper respiratory tract upon exposure,” the study authors wrote. “Consequently, due to the elevated potential for both carcinogenic and non-carcinogenic formaldehyde exposure among pathology staff—particularly laboratory technicians—the implementation of management measures … becomes imperative to lower the exposure levels of all employees below permissible limits.”

Those management measures include:

  • “Strict guideline adherence and safe work protocols,
  • “Increasing staff numbers to decrease exposure duration,
  • “Adoption of engineering solutions such as localized ventilation systems, and
  • “Use of respiratory protective equipment during sample handling and tissue processing.”

Previous Reports on Exposure Risk to Clinical Lab Workers

The knowledge of the danger behind these chemicals isn’t new.

In “National Academy of Sciences Confirms That Formaldehyde Can Cause Cancer in a Finding That Has Implications for Anatomic Pathology and Histology Laboratories,” Dark Daily covered how, in 2011, the US Department of Health and Human Services (HHS) National Toxicology Program’s (NTP) “Report on Carcinogens” was the first instance where formaldehyde was upgraded to “known to be a human carcinogen.”

In 2017, a pathology lab in Auckland, New Zealand, lost its accreditation because formaldehyde levels were so high the lab had to be evacuated nearly every day, The New Zealand Herald reported.

And in “Health of Pathology Laboratory Technicians at Risk from Common Solvents like Xylene and Toluene,” we reported on a 2011 study conducted in Wellington, New Zealand, that linked exposure to these chemicals with increased auto immune connective tissue diseases, notably doubling likelihood of developing Raynaud’s phenomenon.

“In epidemiological studies on industrial workers, pathologists and anatomists, the relationship between exposure to formaldehyde and an increased risk of various types of cancer including nasal cavity, nasopharynx, lung, brain, pancreas, prostate, colon and atopic lymphoma system has been determined,” the Iranian scientists wrote in Nature Scientific Reports.

Call for Stronger Regulations

“The Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Environmental Protection Agency have expressed serious concern about the carcinogenicity of formaldehyde,” the Iranian scientists noted, adding that “the potential carcinogenic risk to humans has been studied in a number of cohort and case-control studies.”

There is room for more studies looking at the health effects of exposure to these chemicals among lab workers, as well as continued evaluation of the risks and preventative measures that could be taken. Perhaps tightened regulations will make its way to US labs, echoing more stringent ones of the European Union.

“It is imperative to implement control measures across various hospital departments to mitigate occupational formaldehyde exposure levels proactively. These findings can be valuable for policymakers in the health sector, aiding in the elimination or reduction of airborne formaldehyde exposure in work environments,” the Iranian scientists wrote.

Managers of histology and clinical laboratories may find useful advice in hospital laboratory studies like that coming out of Iran. Protecting the health of lab workers worldwide starts with reducing their exposure to deadly chemicals.

—Kristin Althea O’Connor

Related Information:

Occupational Exposure, Carcinogenic and Non-Carcinogenic Risk Assessment of Formaldehyde in the Pathology Labs of Hospitals in Iran

National Academy of Sciences Confirms That Formaldehyde Can Cause Cancer in a Finding That Has Implications for Anatomic Pathology and Histology Laboratories

Pathology Lab Loses Accreditation Because of High Levels of Formaldehyde

Health of Pathology Laboratory Technicians at Risk from Common Solvents like Xylene and Toluene

NTRL Report on Carcinogens. Twelfth Edition, 2011

Efforts to Allow FDA Oversight of Clinical Laboratory-Developed Tests Continue in New Congress

The VALID Act has been refiled and the FDA has declared its intent to issue a proposed rule to enable it to oversee LDTs

Should the federal Food and Drug Administration (FDA) have the authority to regulate laboratory-developed tests (LDT)? Advocates in favor of this outcome are working to make FDA oversight of LDTs a reality.

On March 29, HR.2369—the Verifying Accurate Leading-edge IVCT Development Act of 2023 (VALID Act)—was refiled in the US House of Representatives by Representatives Larry Bucshon, MD, (R-IN) and Diana DeGette (D-CO). The 273-page proposal would move LDT oversight to the FDA.

Prior to that, however, the FDA had already announced its intention to issue a proposed rule giving the agency regulatory oversight of LDTs.

“The FDA has continually supported the passage of the VALID Act by Congress,” attorney Charles Dunham IV, a Shareholder at Greenberg Traurig LLP in Houston, told Dark Daily. “In fact, there is speculation that the VALID Act will be attached to the Pandemic and All Hazards Preparedness Act as it moves through Congress.”

Dunham is moderating a legal panel at next week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, which takes place April 28-26 in New Orleans. The VALID Act and other lab-related legal topics will be discussed by attorneys on the panel.

Charles Dunham IV

“The FDA may not actually proceed with promulgating rules to regulate LDTs if it is concerned it will not be successful in court if the rules are challenged, which would happen,” said attorney Charles Dunham IV (above), a Shareholder at Greenberg Traurig, LLP. Clinical laboratory leaders can learn more from Dunham during a panel discussion at next week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans. (Photo copyright: Greenberg Traurig LLP.)

Arguments For and Against FDA LDT Regulation of LDTs

Supporters of the VALID Act contend that putting LDTs under FDA regulation will lead to improved patient safety and less review for low-risk tests. Their argument is that LDTs should undergo the same FDA review and approval process as other medical devices.

Hospital laboratory managers and pathologists—particularly in academic medical center laboratories—have largely opposed FDA regulation of LDTs. They prefer to keep the current setup under which lab-developed tests are validated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). They argue that FDA intervention will slow down development of new tests.

In fact, it was academic medical center pathologists who led the fight against the VALID Act in the last session of Congress, as Dark Daily reported in “Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests.” Lawmakers eventually chose not to include the VALID Act in the 2022 year-end spending bill.

In response, an FDA official indicated during the American Clinical Laboratory Association’s (ACLA) annual meeting on March 1 that the federal agency plans to issue a proposed rule to regulate LDTs, BioWorld reported. That rulemaking has not yet emerged. It’s possible the FDA will wait and see what happens in Congress with the VALID Act.

Attorney David Gee, JD, a partner at Davis Wright Tremaine LLP in Seattle, told Dark Daily that a US Supreme Court decision last year concerning the Environmental Protection Agency (EPA) casts doubt on the FDA’s ability to regulate LDTs.

“Some legal experts have suggested that one significant new legal challenge FDA may face is the Supreme Court’s West Virginia v. EPA decision last summer that limited the ability of the EPA to cap power plant emissions by regulation due to the EPA’s lack of explicit congressional authority to do so,” said Gee, who also will appear on the Executive War College legal panel next week.

“The West Virginia v. EPA ruling provides support for those in the clinical lab industry who point to the FDA’s lack of clear statutory authority to regulate LDTs and therefore fundamentally disagree with FDA’s longstanding position that LDTs are medical devices subject to FDA’s authority to regulate,” he added.

Actions Clinical Laboratory Managers Can Take

Clinical laboratory managers who want to share their thoughts about the future of LDT regulation may want to take one or both of the following actions:

  • Contact their representatives in Congress.
  • Find out whether any trade associations they belong to have taken a position on the VALID Act.

Clinical laboratory professionals should monitor the VALID Act’s progress while also paying attention to industry groups and manufacturers that support or oppose the bill.

Doing so will provide a clearer indication of who has the most to gain or lose should the legislation be passed. Pathologists and medical laboratory managers should also remain alert for further efforts by the FDA to issue proposed rulemaking to regulate LDTs. 

Scott Wallask

Related Information:

H.R. 2369 Verifying Accurate Leading-edge IVCT Development Act of 2023

2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management

Clinical Laboratory Improvement Amendments of 1988

Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests

Hillebrenner Says FDA No Longer Waiting on Congress for LDT Regulation

West Virginia v. EPA Decision

Looming Government Shutdown Opens Door for Congress to Possibly Pass Clinical Laboratory Bills

Theranos Whistleblower Tyler Shultz Publicly Denounces LDT ‘Loophole’ that the Disgraced Blood-testing Company Exploited

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