FDA Needs to Re-examine Diacetyl's Designation as "Generally Regarded as Safe"

Press Release

FDA Needs to Re-examine Diacetyl's Designation as "Generally Regarded as Safe"

Congresswoman Rosa L. DeLauro (Conn.-3) called on Andrew von Eschenbach, Commissioner of the Food and Drug Administration to re-examine the designation "generally regarded as safe" (GRAS) for diacetyl - the food flavoring chemical more commonly used in popcorn, but also found in pastries, frozen foods and candies. Its use in plants across the country has resulted in a number of workers becoming extremely ill, including some who are now awaiting lung transplants and three who have died.

"In light of overwhelming scientific evidence, the possibility of harm to people who regularly prepare popcorn products containing diacetyl in a microwave oven can no longer be disregarded. For this reason, I am urging the FDA to consider revoking the generally safe designation for diacetyl and removing it from the market until further testing is completed. This chemical poses a real threat to the workers exposed to it. The FDA needs to take action on this issue and employ its regulatory mandate to protect the public."

Below is the text of the letter.

May 7, 2007

Andrew C. von Eschenbach, MD
Commissioner
U.S. Food and Drug Administration
5630 Fishers Lane

Rockville , MD 20852

Dear Commissioner,

I write to urge to you re-examine the designation "generally regarded as safe" (GRAS) for diacetyl - the food flavoring chemical more commonly used in popcorn, but also found in pastries, frozen foods and candies.

When FDA codified diacetyl as GRAS in 1983, the Select Committee of GRAS Substances (SCOGS) concluded: "There is no evidence in the available information on diacetyl or starter distillate that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future." However, I believe that recent developments call into question such findings

Seven years ago this month, the Missouri Department of Health and Senior Services was contacted by physician to report eight cases of fixed obstructive lung diseases, bronchiolitis obliterans, also known as "popcorn lung," in workers in a Missouri microwave popcorn plant. Follow-up investigations by the National Institute for Occupational Safety and Health (NIOSH) found diacetyl to have caused the lung disease. Since that time, cases of bronchiolitis obliterans have been identified in microwave-popcorn workers in several states, including Missouri , Iowa , Ohio , New Jersey , and Illinois .

In all, NIOSH has conducted six investigations at 10 microwave popcorn facilities, finding respiratory impairment among workers at a majority of the plants. However, it has become clear that the disease has struck workers in other segments of the food and flavoring industry, and is not limited to popcorn facilities. The disease in flavor-manufacturing workers has been identified in Ohio , California , Maryland , and New Jersey where diacetyl is used.

It is my understanding that many of these workers were made so ill that they are currently awaiting lung transplants. Scientists have called the effect of diacetyl on workers' lungs "astonishingly grotesque" and likened it to "inhaling acid." Three workers have died so far.

Five years ago last month, CDC, in its Morbidity and Mortality Weekly Report (MMWR), called for health care providers to report additional suspected cases of respiratory disease in workers exposed to food flavoring chemicals.

Last month, in MMWR, CDC recommended that employers implement safety measures to minimize worker exposure to flavoring chemicals, such as diacetyl.

Furthermore, the role of diacetyl in the causing harm to airway epithelium was suggested in studies of laboratory animals. NIOSH scientists have conducted several studies in which rats and guinea pigs exposed to diacetyl suffered adverse effects to their respiratory tissue and structure.

According to the New York Times, evidence suggesting the possibility of a link between diacetyl and lung disease was raised as long ago as 1993 in a study by a German company. The New York Times also reported that an industry trade association was made aware of the possible risk in 1996.

Certainly, in light of all this evidence, the possibility of harm to persons who regularly prepare popcorn products containing diacetyl in a microwave oven cannot be disregarded.

For all these reasons, I would urge you to re-consider that designation of diacetyl as generally safe with a view to its removal until further testing is completed. There seems to be compelling scientific evidence that this chemical poses a real threat to the workers exposed to it. It is critical that the FDA take action on this issue and employ its regulatory mandate to protect the public.

Thank you for your consideration of this request. I look forward to your response.

Sincerely,

ROSA L. DeLAURO

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