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Disease is Swift, Response is Slow: Government Lets Flavoring Industry Police Itself, Despite Damage to Workers' Lungs

Posted on: Sunday, 23 April 2006, 06:00 CDT

By Andrew Schneider, The Baltimore Sun

Apr. 23--SANTA ANA, Calif. -- It took two years on the job and a chemical in something as ordinary as butter flavoring to turn a strapping factory worker into someone who sleeps tethered to an oxygen tank.

Francisco Herrera, 32, suffers from an aggressive disease that has destroyed 70 percent of his lungs and could kill him if he doesn't get a transplant. A physician diagnosed bronchiolitis obliterans after the flavoring plant worker became ill in 2003, concluding that the disease was caused by exposure to diacetyl.

This is the same chemical that federal scientists had determined the year before was toxic when vaporized and inhaled by workers in plants that produce microwave popcorn. Herrera's case is part of growing evidence, scientists say, of health hazards from diacetyl elsewhere in the food industry.

"Everyone knew that the diacetyl was harmful," said Herrera, a father of two who contends in a lawsuit that his employer never warned him of inhalation hazards. "But why didn't anyone tell the workers handling it?"

Diacetyl, which is found naturally in many foods, is artificially produced and widely used as a less expensive way to enhance flavor or impart the taste of butter. Thousands of workers in plants across the country make flavorings containing diacetyl and other chemicals or use flavorings to make products such as pastries, frozen foods and candies.

Consumers who prepare or eat them are not at risk, doctors say, because they are unlikely to experience the chemical concentration found in a workplace.

The National Institute of Occupational Safety and Health linked exposure to diacetyl and butter flavoring to lung disease that sickened nearly 200 workers at popcorn plants and killed at least three. Now investigators at NIOSH say the disease has been identified in more than two dozen workers from other parts of the food industry.

"Now we've got cases of bronchiolitis obliterans among workers in other plants that use flavorings and in plants that make the flavorings," said Dr. Kathleen Kreiss, chief of the field studies branch of NIOSH's division of respiratory disease studies.

"We need to get into some of these plants because we don't have confidence that the flavoring industry has taken steps to actually prevent this disease, and we need to determine how widespread the exposure may be."

Scientists at NIOSH and the Occupational Safety and Health Administration want to intensify investigations into illness caused by flavorings and issue federal regulations to protect workers. But top officials say they don't plan to act because in their view what is being done now is enough.

That response among agency heads is one example of how government has largely allowed the flavoring industry to police itself. The Food and Drug Administration has let flavoring producers and sellers decide which chemicals are safe, and California's occupational safety agency, Cal/OSHA, has delegated health examinations of flavoring workers to an industry-paid doctor.

Government physicians question the propriety of relinquishing the health evaluations to doctors paid by the plants.

"It needs to be made clear to everyone involved that accepted public health practices do not allow us to rely solely on medical conclusions obtained by industry or its paid consultants," said Dr. Robert Harrison, chief of occupational surveillance and epidemiology for California's Department of Health Services. "This practice would be unfair to the worker and contrary to the process under which we work."

The difficulty of assessing workplace illness is further complicated by employees who fear reprisal for complaining about hazards to anyone and by physicians who lack the training to recognize bronchiolitis obliterans and other occupational threats.

The safety of diacetyl, as well as many of the 2,000 chemicals blended to make flavorings, has never been tested by the government. The FDA classified them among substances "Generally Regarded As Safe." It took the word of a panel of scientists hired by the Flavor and Extract Manufacturing Association. Diacetyl was declared safe decades ago because the industry said it was safe, according to a spokesman for the FDA.

About 70 U.S. companies are involved in the making and sales of flavorings, according to the association, which is the largest trade group for the $3 billion-a-year industry. Of more than 8,000 employees, only about 3,000 are engaged in the actual production of flavorings. In the much larger food processing industry, tens of thousands of workers are estimated to work with flavorings.

Their wellbeing falls to physicians, scientists and industrial hygienists trained in occupational medicine, which is the study of workplace hazards - chemical and otherwise. They are the ones who have linked lung disease to exposure to flavorings.

And it is these specialists, both government and civilian, who are pressing OSHA and NIOSH to widen the investigation into worker safety in the flavoring industry.

Outbreak of rare illness In 2000, the outbreak of lung disease was identified in a popcorn factory in Jasper, Mo. Other cases surfaced in Iowa, Illinois, Nebraska and Indiana. By summer 2002, NIOSH had presented its findings to OSHA, state health departments and the flavoring industry. The information from NIOSH, an arm of the Centers for Disease Control and Prevention, was published in peer-reviewed journals.The industry's largest trade group released its own report on precautions in using diacetyl eight months after NIOSH sent a December 2003 alert to 4,000 businesses that might use or make butter flavoring and diacetyl.

The government alert suggested safeguards such as limiting release of vapors in production lines. Employers were asked to caution workers about the potential for lung disease. The employees who saw the alert were advised of symptoms that should prompt them to see a physician.

Bronchiolitis obliterans causes inflammation and obstruction of the small airways in the lung by rapid thickening or scarring. The irreversible condition is progressive and often fatal without a lung transplant. The disease results most frequently from industrial exposure to toxic substances such as chlorine and phosgene.

Occupational medicine specialists say there is an urgent need for early diagnosis partly because of the speed with which bronchiolitis obliterans destroys the lungs. For example, some popcorn workers had serious lung damage with five months or less on the job, and many were young, some in their 20s.

More than 150 former popcorn plant workers have sued companies supplying or making the butter flavoring, alleging that it destroyed their lungs even as the companies concealed their knowledge of the danger. To date, more than $100 million has been awarded in jury verdicts and paid in settlements.

At least 30 suits remain to be tried, those involved in the cases said.

In most of the suits, injured workers contended that product safety information failed to warn of actual hazards. Although the government sets guidelines for such information, the content of the message is left up to the makers and sellers of chemicals.

Three lawsuits have been filed in federal court in Iowa by popcorn workers naming not only flavoring companies but the trade association and the Roberts Group, a management group founded by the executive director of the association.

The latest suit, filed in February, charges that the Flavor and Extract Manufacturing Association "conspired with the other defendants to fraudulently conceal the true facts regarding the health consequences of the butter flavoring and/or their constituents from the scientific and medical communities, the government and the public."

John Hallagan, the trade association's lawyer and former science director, said the organization and the Roberts Group deny all allegations: "There is no conspiracy."

The trade association was slow to acknowledge the potential dangers of exposure to diacetyl, despite reports it had on file. In written comments to the government on the content of the planned NIOSH alert, in October 2002, the association maintained that "diacetyl has not previously been recognized as a respiratory hazard."

Yet, Hallagan said, the government had informed the association of hazards linked to the chemical and butter flavoring the year before, "when I got a call from NIOSH in" 2001.

He said Friday that there's no contradiction. Comments he made to NIOSH on behalf of the association "in 2002 reflected the state of our knowledge in 2001." He added, "I was not taking into account the information that NIOSH provided at that time."

The association's database on diacetyl grew in October 2001 when, he said, the group added an animal study that a German chemical company shared when news broke about problems in popcorn plants. The 1993 study subjecting rats to diacetyl showed that most of them suffered significant lung injury and many died, according to a copy of the results obtained by The Sun.

In 1985, consultants for the trade association produced a data sheet that says breathing diacetyl is harmful to the respiratory tract and is "capable of producing systemic toxicity."

Kreiss, who directs NIOSH's respiratory field studies unit, said "systemic toxicity is a serious condition. It means it can affect all organ systems via the lungs and has the potential to do far more damage than just an irritant."

Hallagan confirmed that the data sheet was made available to members in 1985. But, he said Friday, "Systemic toxicity does not necessarily refer to lung damage, and I don't know what systemic toxicity they were referring to."

He emphasized diacetyl's properties as an irritant, as he had previously in an e-mail response to a Sun question about the document's content.

"Liquid and vapor may be irritating to skin and eyes," he quoted from the sheet. "Vapor may be irritating to throat and lungs."

He did not cite the section on human health effects that warns of respiratory harm.

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Copyright (c) 2006, The Baltimore Sun

Distributed by Knight Ridder/Tribune Business News.

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Source: The Baltimore Sun, Maryland

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