A paragraph in an article April 23 on the hazards to workers who make or use flavorings with diacetyl implied that the government relied solely on industry-paid scientists in approving diacetyl as safe for consumption. In fact, in 1980 the Food and Drug Administration contracted with a scientific panel that reviewed existing literature about the chemical and found no reason to suspect risk. Previously, the FDA had based its safety assessment on information furnished by the flavoring industry.
The Sun regrets the errors.
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.
Another indicator of lung damage in the trade group's database goes back to 1977. In an experiment in which diacetyl was applied to the skin of rabbits by a research institute, scientists found the rabbits' lungs were destroyed. Hallagan said that, because the test was "dermal," the results had nothing to do with an inhalation threat.
Dr. David Egilman, a specialist in occupational medicine and an expert witness for workers in several of the early popcorn trials, faults the industry and its association for failing to inform "companies buying the flavoring and federal investigators trying to find the cause of an epidemic of lung disease among workers."
"The suffering of these workers, the deaths by suffocation, the young people debilitated to the point where they can't walk from their bed to the bathroom and back," he said, "all this pain could have been avoided if the flavoring industry didn't put profits before safety of the workers."
Hallagan said his group had released information on diacetyl as soon as it had it.
Regarding the dangers of respiratory hazards from flavorings, he noted that the group held workshops for its members and issued an August 2004 report on respiratory health and safety that remains on its Web site.
"I'm not sure what more we could have done to get the word out," he said.
Accounts differ on how much the industry was willing to work with medical investigators.
Kreiss says the trade group did little to cooperate. "We asked for a list of ... member companies, and we didn't get it. We asked for animal studies or other research, and we never got what we needed or all they had," she said.
"I don't understand how they could possibly say that," Hallagan said. "We gave them everything they asked for."
Signs of broader problem
On OSHA's Web site, the workplace regulator says that "138 plants manufacturing butter flavor popcorn employing some 3,400 employees may be at risk" of lung damage. But there is no mention of diacetyl's risk in the far larger number of other plants using it.
In 2002 and 2003, OSHA's own scientists studied diacetyl and urged their leaders to take broader action, according to OSHA sources who asked for anonymity because they fear retribution by superiors. The scientists listed scores of products using diacetyl and called on the agency to notify users other than popcorn makers.
NIOSH briefed OSHA on its findings in 2002 and at a conference of top OSHA officials and compliance officers in December 2004. OSHA, part of the Department of Labor, insists that it is doing, and has done, all that's needed.
"OSHA advises its inspectors that workers may be at risk of over-exposure to vapors of artificial flavorings in a variety of food processing work sites," said Al Belsky, a Labor Department spokesman. He listed targets such as food production sites using concentrated flavorings and sites that produce flavorings and fragrances.
But when The Sun questioned five OSHA compliance inspectors or their managers in different parts of the country, four said they had never heard of new inspection orders for flavoring plants from headquarters. One said he had heard of them but had not received the instructions. All asked that their names not be used.
"There is nothing to indicate that additional regulations are needed," Belsky said.
Asked to elaborate, OSHA spokeswoman Kate Dugan said: "We cannot regulate every hazard in every industry. That would be an impossible task." She said OSHA has a "general duty clause" that applies to hazards for which there aren't regulations.
However, this clause puts no responsibility on the employer other than to keep a plant safe.
David Michaels, an epidemiologist at George Washington University's School of Public Health who examined OSHA's handling of the popcorn workers' sickness, called its inaction "criminal."
Michaels, who heads the university's Project on Scientific Knowledge and Public Policy, said: "OSHA could have issued an emergency temporary standard, or at least ordered its inspectors to make sure no more workers are exposed to that hazard. NIOSH scientists proved the terrible damage caused by breathing those chemicals. OSHA did nothing.
"How many more workers like Francisco Herrera are going to lose their lungs before OSHA does its job?"
At NIOSH, scientists say they have learned of cases of lung disease from physicians, public health researchers and workers themselves. Privacy restrictions limit what physicians can discuss without patients' permission.
The cases, which have emerged during the past three years, include a man who worked at a small Baltimore-area flavoring company and workers from New Jersey, Georgia, Ohio and North Carolina.
The Maryland worker was in his mid-20s and had been on the job for less than two years when he was referred in 2003 by a pulmonologist at a suburban hospital to the University of Maryland Medical Center. Dr. Melissa McDiarmid, the head of UM's occupational medicine center, said she was amazed at the "very severe lung damage," given his short time on the job.
In North Carolina, Duke University physicians diagnosed the lung disease in a man, 43, who had worked for nine years in a potato chip plant, operating a misting device that sprayed spices onto hot chips.
The scientists have learned of three Midwestern cases treated by Dr. Allen Parmet, the occupational medicine specialist in Kansas City, Mo., who identified the outbreak among popcorn workers. Parmet said he evaluated a "really sick worker from a Chicago candy maker" last year. He diagnosed lung illness in two other men who worked for a Midwest company that makes machines to pop corn.
"The men test the sprayer that shoots the butter-flavored oil into the center of the cooking kettle," he said. "No one else in their plant is sick, because no one else deals with the hot butter flavoring."
Dr. Nancy Sahakian, a member of the NIOSH field investigation team, is reviewing reports of injuries at a Cincinnati flavoring plant from the Ohio worker compensation agency. The Ohio agency said the workers were employed by the Swiss-owned Givaudan and its predecessor, Tastemaker.
"The cases occurred between 1988 and last year," she said, "and it looks like at least 15 of them involve respiratory injuries, including bronchiolitis obliterans." Sahakian has asked plant managers to meet with NIOSH "to explore how they might prevent respiratory health risks to their workers."
Earlier this month, NIOSH began looking into the case of a mother of three who worked for eight years at a small flavoring plant near Los Angeles.
There is concern that many workers with bronchiolitis obliterans are not being diagnosed with the disease because doctors could easily mistake their symptoms for more common respiratory diseases. This is especially true if they fail to consider workplace chemical exposure.
"It is a bit like looking at the children's puzzles with the hidden pictures," said Parmet, the Missouri physician. "If you don't know something is hidden, you have a great deal of trouble recognizing it is there. But if you know what might be there, you see it."
Authority to force entry
For NIOSH's investigators to accurately assess whether dangers exist in a workplace, they must get inside. Their regulations say that a request for help by three or more workers will give them access. But workers, fearing reprisals, often won't cooperate even after investigators learn about their illnesses.
"We promised them confidentiality," said Dr. Richard Kanwal, NIOSH medical officer and a leader of the flavoring investigations. "They were really frightened to talk to us, worried that they would lose their jobs if we showed up or questioned their management. These workers, and those who may have quit the companies, may not know what's causing their breathing problems."
The institute can also take the rare step of going before a federal judge to gain entry.
"The route of forced entry takes time, and the employer will probably fight it," said Fred Blosser, NIOSH's chief spokesman. "You've got to ask if the expenditure of time, effort and money to go the forced-entry route to get into a plant is going to result in actions that benefit the workers. The answer is probably not."
Dr. Richard Lemen, who spent 26 years working for NIOSH, including as its acting director, called that a "dangerous philosophy."
"If workers are sick in the workplace with an illness like bronchiolitis obliterans, which is a life-threatening disease, it is necessary to exercise the NIOSH right of entry and to get in and help these workers as soon as possible," said Lemen, a former assistant U.S. surgeon-general who now works as a public health consultant.
"Without exerting its right of entry, NIOSH is reverting to the days before Congress created it and OSHA, when scientific study of worker health depended on the willingness of employers and workers died needlessly."
Francisco Herrera, who said he has become too sick to play with his children, went to UCLA's medical school for a thoracic evaluation to qualify for worker's compensation.
Dr. Phillip Harber, chief of the school's Division of Occupational and Environmental Medicine, diagnosed bronchiolitis obliterans in Herrera.
"It's a preventable illness," Harber said, "if we can get to the flavoring plants and their workers quickly enough."
Cal/OSHA had learned that Herrera handled diacetyl at the plant at the corporate headquarters of Mission Flavors and Fragrances Inc. in Foothills Ranch, about 45 miles southeast of Los Angeles. Herrera used diacetyl two or three times a week while blending butter flavoring in batches up to 5,000 pounds, according to agency documents.
After inspecting the plant, Cal/OSHA fined Mission $45,575 for seven safety violations, including an inadequate respiratory protection program and a failure to notify the agency of a work-related illness.
"The employer did not report ... the serious illness of an employee who became seriously ill with a disease known as bronchiolitis obliterans," read one of the violations.
The company president, Patrick Imburgia, declined to comment beyond saying that the company had appealed its citation. Herrera has filed a civil suit for his injuries against Mission and two of its suppliers of diacetyl.
It looked as if Herrera's illness would give NIOSH the chance it wanted to get into some flavoring plants. The agency said that in late 2004 Cal/OSHA asked for federal investigators' help and promised to share the results of plant surveys, giving NIOSH a chance to learn whether its scientists' concerns were well founded.
"Our people have done enough research so we know that this issue has to be taken very seriously," Len Welsh, the head of Cal/OSHA, told The Sun last June. "And that's what we're going to do. We have between 16 and 20 plants that produce or mix butter flavoring, and we need to get our people into all of them."
Welsh described the expected collaboration as a fast-moving, intensive team effort that would also bring in the California Department of Health Services and NIOSH.
Months passed, and the federal investigators heard nothing.
Late last year, when Welsh was asked why the inspections of the flavoring plants hadn't progressed, he said that "the person I put in charge had to handle an outbreak of the heat-related illness last year."
But NIOSH was given a different explanation in late summer.
"We were told by staff members of the California health department that [the trade association] made it clear that it did not want NIOSH involved in any of the California flavoring plants," said Kreiss.
Welsh denied that.
"FEMA does not tell Cal/OSHA what to do and you know that," he told The Sun in an e-mail.
Hallagan, the trade association's top lawyer, said the group has "no power to stop anybody from going anywhere."
Cal/OSHA has the authority to enter any workplace, but Welsh chose to allow a trade association consultant to do the surveys.
"It is just better for everyone if we work cooperatively with the plants or industries we're investigating," Welsh said. "It's much better to go in [to the plants] with their permission rather than strong-arming our way in."
He said Dr. Cecile Rose, an occupational medicine specialist from the National Respiratory Center in Denver, is evaluating six plants that are paying her. She said she is "likely" to evaluate others.
Rose told The Sun she has been a consultant to the trade association for almost a decade.
Kreiss and Kanwal said they were surprised to find that Cal/OSHA was going to let an industry consultant do the surveys by herself.
"We pretty much got locked out of the discussions after we strongly made our case to Cal/OSHA that a completely legitimate study had to be done, where we could rely on the findings" without having to depend on information gathered by industry alone, Kanwal said.
Kreiss added: "That's just not how a regulatory or public health agency would handle a concern of this type. That's not the right way to do it."
Welsh said he saw no conflict of interest nor any other problem with Rose examining the workers even though he said his agency had never relied solely on a industry-paid physician before.
"If we could not trust her to [report honestly] as a trained physician, then we'd have to say that any physician that's under contract to a company can't be trusted to be a physician for employees."
Rose questioned why her involvement might be considered a conflict of interest. She said the flavoring companies should be commended for "their willingness to bear the cost of assuring the health and safety of their workers" by hiring her.
In a letter to The Sun, Rose said she had found no major health problems, just "mild abnormalities" in 16 workers.
For now, both Cal/OSHA and the state health department are awaiting results of the surveys being done by Rose. A health department official said Rose gave a preliminary briefing last month but declined to provide actual data, saying that it should come from the plants that paid for it.
Businesses that use flavoring with diacetyl appear to have a varying sense of the hazards, despite data provided by government and the trade group.
McCormick, a large seasonings maker based in Hunt Valley that belongs to the association, said it has "adopted and implemented applicable recommendations" of NIOSH and the trade group to minimize employee exposure to diacetyl. It declined to give specifics.
Parker Vanilla Products, in Essex, is one of thousands of small manufacturers that use diacetyl and, according to NIOSH, was on a list of those sent its 2003 alert. Tim Parker, president of the Baltimore County company, said he can't recall whether he got the alert in early 2004. Mainly, he remembers reading about the problem in newspapers, then trying to check it out.
"I called some of my suppliers, and they said it really wasn't a problem, that the popcorn plants were unventilated and that the sick workers had been exposed for years," Parker said.
"I thought that whatever was wrong with the diacetyl was resolved. ... I haven't heard anything" further, he said, "from OSHA, NIOSH, the flavoring associations or my suppliers, and that's wrong."
He said Parker Vanilla doesn't use a lot of diacetyl, and the dozen or so workers who handle it haven't had any health problems. "We try to be responsible," he said. "I looked into what I could use instead of diacetyl. Guess what? There's not any other choices for butter flavoring."
Physicians in and out of government say they're frustrated at the lack of action to protect workers. For UCLA's Harber, who diagnosed Herrera's illness, it's even more infuriating because he has just treated another worker from a second flavoring plant.
On Sunday, in an interview with The Sun, Irma Ortiz expressed more concern about the health of her former coworkers at the small Los Angeles-area plant than about her own difficulty breathing.
Ortiz, 43, said the chest specialist who referred her to Harber had been unsuccessfully treating her for asthma "until I showed him my little list with the chemicals that I worked with." Then, she said, the doctor was able to determine she had brochiolitis obliterans.
"We knew that diacetyl could kill and sicken workers. Although NIOSH proved it years ago, my patient continued working with the chemical without protection," Harber said. "She is a wonderful woman working for her children, and now she's tragically ill and might need a transplant to survive.
"The system is too slow to react, too slow to protect the workers from known hazards. "
Sun researchers Elizabeth Lukes, Paul McCardell and Carol Julian contributed to this article.
How to get help
NIOSH has a toll-free number for workers seeking a health hazard evaluation. Call 1-800-232-2114.
To read the agency's alert on diacetyl and flavorings, go to http:--www.cdc.gov/niosh/docs/2004-110/
REPORTS AND RESPONSE TO HEALTH CONCERNS FROM FLAVORING
August 2000 - NIOSH is called to Missouri popcorn plant to investigate workers' lung disease.
August 2002 - NIOSH scientists' findings on butter flavoring/diacetyl hazards appear in New England Journal of Medicine
October 2002 - Flavoring industry group downplays diacetyl hazard in comments to NIOSH.
December 2003 - NIOSH issues alert to be sent to 4,000 businesses that might use or make butter flavoring.
August 2004 - Flavor and Extract Manufacturing Association issues its report on precautions in use of flavorings.
December 2004 - As reports of health problems emerge in more plants, California officials seek NIOSH's help.
2005 - California officials reverse course, agreeing to let industry-paid consultant investigate workers' health. NIOSH is shut out.
February 2006 - Ohio workers' compensation agency tells NIOSH that at least 15 workers from a Cincinnati flavoring plant have respiratory disease.