EPA Exposed Human Test Subjects to Cancer-Causing Agents: Report

A new report indicates that federal environmental officials may have exposed human test subjects to cancer-causing pollutants without properly informing individuals about the potential health risks. 

The Office of Inspector General performed a review of five studies conducted by U.S. Environmental Protection Agency (EPA), compiling a report on the findings that was released this week.

The studies were conducted on human test subjects between 2010 and 2011, exposing participants to carcinogenic pollutants, diesel exhaust emissions and their airborne particulates.

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The Office of Inspector General (OIG) found that the EPA did not adequately inform the human test subjects of the potential harm the substances may cause, including the potential risk of developing cancer. The EPA also failed to obtain proper clearance from the biomedical Institutional Review Board (IRB) to conduct the studies, the report claims.

The EPA classifies diesel exhaust and its tiny particulates as “likely to be carcinogenic to humans by inhalation.” The agency also determined long-term inhalation is likely to pose a risk of developing lung cancer or to change the lungs permanently, even posing risk of death. However, during studies where more than 80 humans were exposed to high concentrations of diesel exhaust and particulates, none of the human test subjects were properly warned of the risks, the report concluded.

According to the OIG, the disclosure the EPA gave to participants went as far as playing down the risk of cancer, by stating cancer was a consequence during long-term, high concentration exposure, but not the short-term, low concentration exposure being conducted during the experiment.

During the studies, 20 to 40 people were placed in a chamber. Diesel exhaust was pumped into the chamber for two hours, exposing participants to pollution levels similar to those found in Los Angeles and New York City. Participants blood, heart and lung functions were monitored for 2 hours. Researchers said the exposure created an environment between high exposure, which could produce a biological response, and extreme exposure, which would produce clinical responses.

Considering the exposure situation, the disclosure did not adequately reflect the potential cancer risks participants faced, regardless of exposure levels and time, the OIG report states.

The OIG also found the EPA reported two of six adverse events that occurred during the studies much later than required. The agency also failed completely to report two other events to the governing body, the IRB, the report notes.

The OIG recommended the EPA establish procedures for obtaining approval for significant study modifications and updated guidance to include the EPA’s clinical followup responsibilities.

The EPA contends humans have been a part of critical studies for more than 40 years and help provide detailed biological information on how pollutants affect individuals,” calling their participation a step in “protecting the health of all Americans.”

The agency concurred with the recommendations of the OIG report and offered planned corrective actions, however critics say that is not enough.

The report comes at a time of heightened pushback against environmental regulations by Republicans, who leapt on the report as an example of EPA hypocrisy. Senator David Vitter called the agency’s environmental efforts “job-killing regulation” and said the agency’s failure to warn test subjects about cancer exposure does not match with its claimed desires to protect the population from harm from pollutants.

Vitter called for more transparency on the EPA’s process and used the incident as an opportunity to attack the agency’s push for Clean Air Act reforms to get particulate matter out of the air, saying the report puts the EPA’s science into question.

Vitter and GOP Senator Jeff Sessions called on the EPA to halt human testing.However, despite its criticism of the EPA, the OIG report rejected Republican demands to stop all studies conducted on human test subjects.

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