Study Showed Chemical was Toxic
SARAH SHIPLEY St. Louis Post-Dispatch 28feb04
Former workers at a Missouri microwave popcorn plant are slowly suffocating from breathing a chemical that was known to be toxic long before most of them got sick, according to documents obtained by the Post-Dispatch.
At least 31 people who worked at a popcorn factory in Jasper County have been diagnosed with severe lung disease linked to breathing vapors from a butter flavoring. Eight are on waiting lists for lung transplants.
Doctors spent years figuring out what had caused the workers' lungs to scar and harden, their chests to tighten and wheeze, their skin to peel off in chunks.
A lawsuit filed in Jasper County Circuit Court claims that the butter flavoring manufacturer "knew or should have known" that its product was hazardous, and that the manufacturer failed to adequately warn those who worked with the chemical.
That manufacturer, International Flavors & Fragrances, has denied liability in the case, which is set for trial Monday. The company declined to comment for this report.
Did the company know that its butter flavoring could cause respiratory disease? That question is the foundation of the case.
What is clear, according to documents obtained by the Post-Dispatch, is that a key ingredient of the butter flavoring was known within the chemical industry to be highly toxic to rats in 1993, before the workers at the Gilster-Mary Lee plant in Jasper, Mo., fell ill.
Gilster-Mary Lee is not a defendant in the lawsuit. The company, based in Chester, Ill., bought the Jasper plant in 1999.
Similar lung problems have been detected among workers in at least six other plants nationwide, including a popcorn plant in Ridgway, Ill.
Chemical giant BASF studied the chemical, known as diacetyl [synonyms: 2,3-butanedione , Biacetyl , Dimethylglyoxal], in 1993. The buttery-smelling chemical can be made from a solvent. Diacetyl also occurs naturally in cheese, milk, coffee, vegetables and other foods.
After breathing diacetyl vapors for just four hours, some rats gagged and gasped for breath. Half the rats in the study died within a day.
The BASF study has never been published in the public domain. The flavoring industry had access to it, however, through a database kept by the Flavor and Extract Manufacturers Association, a trade group based in Washington.
The Post-Dispatch obtained a copy of the information from a federal health investigator familiar with the case.
The results are similar to those found in a rat study conducted in 2001 by the National Institute for Occupational Safety and Health, a federal workplace safety agency investigating what has come to be known as "popcorn workers' lung."
NIOSH's rat study was published in the journal Toxicology and Applied Pharmacology in 2002. [Abstract Below]
In the government study, 19 rats were exposed to heated butter flavor vapors for six hours. The vapors contained levels of diacetyl ranging from 203 to 371 parts per million, about two to four times the highest average level measured during a workday, but much lower than the concentration in holding tanks that workers might peek inside.
Dr. Ann Hubbs, a veterinary pathologist at NIOSH, examined tissue samples from the animals and found "the most dramatic case of cell death I've ever seen" in some of their airways.
The gentle carpet of cells containing fingerlike projections that normally sweep the airway clean had been destroyed in spots. Parts of the airway lining had disintegrated, exposing the tissue underneath, like the inside lining of a hose being pulled away from the wall.
Researchers theorize that such damage would scar the airways, crimping the tube that carries air into the lungs, Hubbs said.
"Airway injury can be a real concern, because it affects everything that goes on below the spot at which the injury occurs," she said.
BASF's study had similarly disturbing results. Thirty rats were divided into three groups and exposed to diacetyl vapors at much higher levels than in the NIOSH study. A summary of the results is included in the industry database, along with dozens of other studies and statements about the chemical.
All rats exposed to diacetyl rapidly showed signs of distress. Those exposed to medium and high levels died within seven days, according to the industry data. Of the 10 rats with highest exposure, nine died the first day.
Examination of their tissues after death showed that parts of their lungs had collapsed and filled with blood and fluid. Tissue swelled in the liver and cells in the kidney died.
A spokesman for BASF declined to comment on the study or whether any follow-ups were done. The company is not named in the lawsuit.
It's unclear exactly when the BASF study was added to the flavoring industry database, or when the members had access to it. The earliest hazard statement in the database is dated April 1989, when diacetyl vapor was pronounced to be "irritating to throat and lungs."
Entries dated January 2001 add that diacetyl carries a risk of serious damage to eyes, is harmful by inhalation, and is irritating to skin. The note, "wear face/eye protection" bears the same date.
The flavoring industry association, which is not named in the lawsuit, has previously issued statements saying that flavors are safe when handled properly. The association did not return calls for comment on the BASF study.
Waiting for transplants
For the sick workers, the dangers of diacetyl became public far too late. Linda Redman started working as a packer at the Jasper popcorn plant in 1995, two years after the original study. Within two years, her breathing was so bad that she had to quit.
Redman used to work 12 hours a day and then come home to garden, cook dinner, and do her family's laundry. Now, she lives alone in Joplin, relying on home health nurses four days a week to help with basic chores around the house.
Redman, 55, doesn't have the stamina to change her bedsheets or cook herself dinner, unless it's something out of a can.
Only 15 percent of her lung capacity remains. Redman bides her time while waiting for a lung transplant by taking breathing treatments every four hours. She is constantly tethered to an oxygen tank, but she still gets exhausted walking from the bedroom to the couch.
"There's no amount of money that can ever buy back what we've lost - our health," Redman said of herself and the other sick workers. "There's a couple of us I don't think can make it much longer."
Eric Peoples, 31, and the father of two small children, will be the first plaintiff to have his case heard. He started work at the plant in 1995 and now is on the waiting list for a double lung transplant.
Angela Nally, 51, started working at the plant in 1993 and quit eight months later. She has 20 percent of her lung capacity left.
Dustin Smith, 24, started at the plant in 1999 and didn't quit until NIOSH told him he had lost half his lung capacity.
One plaintiff still works at the plant, which has changed its procedures to comply with new federal safety recommendations.
"It's a shame we all had to end up this way," Redman said. "I feel like it's the flavoring people's fault that we ended up like this. They knew it was dangerous when they sold it. I'm angry at them, taking a chance on hurting so many people. They could have saved a lot of people's lungs."
No warnings to workers
Dr. David Egilman, an expert on occupational lung disease at Brown University, said that all of this misery could have been avoided if the chemical and flavoring industries responsibly followed up on the 1993 rat study.
The BASF study proved that the chemical was lethal to rats at a level similar to that which could be experienced by plant workers, Egilman said.
The middle exposure level in the rat study was 1,483 parts per million of diacetyl. A 2000 NIOSH study took a reading of 1,232 parts per million of diacetyl inside a butter flavor holding tank. That reading was taken after exhaust vents had been installed, so previous concentrations were probably higher, NIOSH studies said.
"That's why it's so sad," said Egilman, who is scheduled to testify as an expert witness for the plaintiffs. "It wasn't hard for (the flavor manufacturer) to prevent people from dying. They had enough information to prevent people from getting sick."
Instead of warning its customers appropriately, Egilman said, International Flavors & Fragrances led its customers to believe that the product wasn't dangerous.
The company distributed a safety sheet with its butter flavoring that read, "Respiratory protection: none generally required. If desired, use NIOSH-approved respirator." The Material Safety Data Sheet is dated 1992.
A safety sheet written in 1994 by flavoring manufacturer Bush Boake Allen, another defendant in the lawsuit, said that respirators were not normally required for its butter flavoring, unless vapor concentrations were "high." The company is now a subsidiary of International Flavors & Fragrances.
International Flavors & Fragrances said in a 2002 financial statement that it provided information on "appropriate engineering controls, such as adequate ventilation, proper handling procedures and respiratory protection for workers" to the popcorn plant in Jasper. The company said it believed that Gilster-Mary Lee failed to follow those instructions, and, as a result, any injuries employees suffered were due to "inadequate workplace conditions."
A spokesman for Gilster-Mary Lee said he could not comment on what safety instructions the company received. "We view this as a very serious issue," said Tom Welge, vice president for technical sales. "We're committed to a safe workplace for our employees."
Dr. Richard Kanwal is a medical officer for NIOSH who is investigating the popcorn case. Kanwal said the agency has mailed a detailed warning to companies that may use butter flavor or similar preparations. The agency's recommendations include switching to safer flavorings, making the process a self-contained system to keep vapors down, and using respirators where needed.
So far, no "safe" level of workplace exposure to butter flavoring has been determined. The Food and Drug Administration has said that consumers are not at risk from preparing microwave popcorn at home.
"Even though there's limited data on which to base standards, there's plenty of information on how to be safe," Kanwal said.
Ken McClain, an attorney representing the plaintiffs, said that information was there all along, but it wasn't given to the workers.
"The only thing this group of people ever did wrong," he said of the plaintiffs, "was go to work."
source: http://www.stltoday.com/stltoday/emaf.nsf/Popup?ReadForm&db=stltoday%5Cnews%5Cstories.nsf&docid=CE8E1F567561BB0F86256E48003BDBF6 29feb04
Toxicology and Applied Pharmacology v.185, i.2 , 1dec02
A. F. Hubbsa, L. A. Battellia, W. T. Goldsmitha, D. W. Portera, D. Frazera, S. Frienda, D. Schwegler-Berrya, R. R. Mercera, J. S. Reynoldsa, A. Groteb, V. Castranovaa, G. Kullmanc, J. S. Fedana, J. Dowdya and W. G. Jonesc
a Health Effects Laboratory Division, National Institute for Occupational Safety and Health1, Centers for Disease Control and Prevention, 1095 Willowdale Road, Morgantown, West Virginia, 26505 b Division of Applied Research and Technology, National Institute for Occupational Safety and Health1, Centers for Disease Control and Prevention, 1095 Willowdale Road, Morgantown, West Virginia, 26505 c Division of Respiratory Disease Studies, National Institute for Occupational Safety and Health1, Centers for Disease Control and Prevention, 1095 Willowdale Road, Morgantown, West Virginia, 26505
Received 14 January 2002; accepted 11 September 2002. ; Available online 16 December 2002.
Abstract As the result of a high prevalence of fixed airways obstruction in workers at a microwave popcorn manufacturing plant, we examined the hypothesis that vapors of butter flavoring used in the manufacture of microwave popcorn and other foods can produce airway injury in rats. Rats were exposed to vapors liberated from heated butter flavoring. Rats were exposed for 6 h by inhalation and were necropsied 1 day after exposure. The exposure was found by GC–MS analysis to be a complex mixture of various organic gases with the major peaks consisting of diacetyl (2,3-butanedione), acetic acid, acetoin (3-hydroxy-2-butanone), butyric acid, acetoin dimers, 2-nonanone, and -alkyl lactones. Diacetyl was used as a marker of exposure concentration. In the lung, butter flavoring vapors containing 285–371 ppm diacetyl caused multifocal, necrotizing bronchitis, which was most consistently present in the mainstem bronchus. Alveoli were unaffected. Butter flavoring vapors containing 203–371 ppm diacetyl caused necrosuppurative rhinitis, which affected all four levels of the nose. Within the posterior two nasal levels (T3 and T4), necrosis and inflammation was principally localized to the nasopharyngeal duct. Control rats were unaffected. Therefore, concentrations of butter flavoring vapors that can occur during the manufacture of foods are associated with epithelial injury in the nasal passages and pulmonary airways of rats.
Author Keywords: flavoring; diacetyl; butter; popcorn; lung; nose; bronchitis; airway obstruction
1 Mention of company or product names does not constitute endorsement by the National Institute for Occupational Safety and Health.
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