Beware Diacetyl: the Next Legal Quagmire

REGULATORY REPORT

By Richard Fama, Esq.

With the specter of a continued law- Beware Diacetyl: The suits against flavor and food processors that make or use this chemical agent, companies all along the supply chain Next Legal Quagmire? will need to stay abreast of current regulations and potential legal ramifications in order to make informed choices about effective next steps. In order to understand the current level of concern by industry, regulators and consumers, let’s consider first the origins of diacetyl Move over asbestos, you may have met investigation in the U.S.

your match. For years, personal injury Studies Provide Evidence of Hazard lawyers have been searching for “the Concerns over occupational diacetyl M exposure were first documented in a next asbestos,” and although they study conducted by BASF in 1993. The BASF study involved the forced inhala- achieved significant successes against tion exposure of diacetyl to three groups of 10 rats over a four-hour peri- big tobacco, a new toxin with the staying od. The first group of rats was forced to inhale low concentrations of diacetyl power of asbestos has remained elusive. Recent court rulings and (2.25 mg/L) while the second and third groups were forced to inhale moderate years of civil lawsuit defeats have dulled the once shining star of so- (5.2 mg/L) and high levels (23.9 mg/L) of diacetyl, respectively. None of the called toxic mold. Personal injury lawyers may now be on the verge of rats exposed to low levels of diacetyl died during the study, while all of the striking gold—that is, the golden hue of diacetyl, a yellowish food fla- rats exposed to moderate and high levels died within seven days of exposure. voring agent that, when combined with other ingredients, produces a Notably, rats exposed to moderate and high levels resulted in an abundance of butter-like flavor. Approved for use by the U.S. Food and Drug symptoms indicative of respiratory tract injury. Administration (FDA), diacetyl is used in a variety of food products such In August 2000, the Missouri Department of Health and Senior as pastries, pancake syrup, candy, and most notably, microwave pop- Services requested assistance from the National Institute of Occupational corn. In its natural state, diacetyl is found in consumer products, such Safety and Health (NIOSH) to investi- gate severe obstructive lung disease in as butter, beer, coffee and chardonnay. former workers of the Gilster-Mary Lee popcorn plant in Jasper, Missouri. Five Over the past several years, however, increased attention has been given to other plants were also studied by diacetyl and its potential role in causing a rare lung disease, bronchiolitis obliter- NIOSH. ans, in hundreds of workers in microwave popcorn factories. Also called popcorn A NIOSH survey at the Gilster-Mary workers’ lung, bronchiolitis obliterans is a progressive disease of the lung’s smallest Lee plant in November 2000 showed airways. The disease is ordinarily associated with lung transplantation but may be that workers who prepared the butter triggered by adverse drug reactions, certain bacterial or viral infections, or inhala- mixture containing diacetyl had tion of airborne toxicants. Numerous lawsuits have been filed, cases argued and decreased lung capacities, and in some millions of dollars in damages awarded as a result of occupational exposure and cases, symptoms of bronchiolitis obliter- resulting injuries to these workers. ans in numbers exponentially higher

R EPRINTED FROM F OOD S AFETY M AGAZINE, OCTOBER/NOVEMBER 2007, WITH PERMISSION OF THE PUBLISHERS. © 2007 BY T HE TARGET G ROUP • www.foodsafetymagazine.com than that of the general public. Indeed, plant employees had 3.3 times the rate “California, however, may be the first state to of pulmonary obstruction on NIOSH spirometry tests as compared to national take action against diacetyl use.” rates. Medical findings on the affected workers were consistent with constrictive bronchiolitis obliterans. Significantly, diagnosed with bronchiolitis obliterans lung disease in production workers.” five of six quality control workers who was received. Neither of these workers NIOSH further noted, however, that it repeatedly popped bags of popcorn in was employed in the microwave pop- is unknown if other chemicals may have microwave ovens—100 bags per worker corn industry but both were involved in also contributed to the development of per shift—in a poorly ventilated environ- the manufacturing of artificial butter fla- disease. ment were found to have obstruction vorings and handled pure diacetyl dur- on spirometry. None of the other five ing the course of their employment. Current Standards and microwave popcorn plants evaluated by As a result of these two cases, Regulations NIOSH had similar evidence of risk. Cal/OSHA conducted investigations of FDA has given diacetyl “Generally Only three of the five plants, however, the two companies in August 2004 and Regarded as Safe” (GRAS) status and popped many dozens of bags of August 2006, respectively. One of the there are currently no limits or stan- microwave popcorn per shift. companies investigated was Carmi dards governing the use of diacetyl in NIOSH also conducted animal stud- Flavor and Fragrance Co. (Carmi) in the workplace. California, however, may ies. In one study, rats forced to inhale Commerce, CA. Since April 2006, five be the first state to take action against vapors from heated butter flavoring additional flavor manufacturing workers diacetyl use in the workplace. In used at the Gilster-Mary Lee plant have been diagnosed with severe fixed response to pressure from labor unions developed severe injury to their airway obstructive lung disease. Thus, a total of and advocacy groups, the California leg- epithelial lining after a six-hour expo- seven workers from four flavoring man- islature proposed a bill that, if enacted, sure. In another animal study, diacetyl ufacturers in California have been diag- would ban the manufacturing, packag- alone produced similar effects. nosed with some degree of severe fixed ing, mixing or blending of diacetyl or NIOSH’s evaluation of the work- obstructive lung disease. Six of the products that contain diacetyl in the force at the Gilster-Mary Lee plant workers handled diacetyl and other workplace on or after Jan. 1, 2009. showed an association between exposure chemicals, and the seventh was a pro- Under the proposed bill, naturally to vapors from flavorings used in the duction worker who packaged powdered occurring diacetyl in food or beverages popcorn production process and flavorings. or processes that result in the natural decreased lung function. Similar fixed On June 11, 2006, CDHS and production of diacetyl would be exclud- obstructive lung disease has also Cal/OSHA requested NIOSH’s techni- ed from this prohibition. occurred in workers at other plants that cal assistance with industrial hygiene Further, in April 2007, the U.S. use or manufacture flavorings. Thus, assessment and medical screening for Department of Labor’s Occupational NIOSH concluded that inhalation occupational lung disease at the Carmi Safety and Health Administration exposure to butter flavoring chemicals is plant. In August 2006, NIOSH staff (OSHA) announced that it is initiating a risk for occupational lung disease. conducted air sampling in all areas of an OSHA National Emphasis Program While the medically-established link the plant. NIOSH staff also conducted to address hazards and control measures between diacetyl exposure (as opposed follow-up spirometry tests on produc- associated with working in the to exposure to butter flavoring chemi- tion and laboratory workers. The aver- microwave popcorn industry where but- cals generally) and bronchiolitis obliter- age and peak air concentrations of ter flavorings containing diacetyl are ans remains inconclusive, diacetyl diacetyl at the Carmi plant were found used. OSHA will provide direction on remains at the epicenter of controversy to be similar to concentrations meas- inspection targeting and procedures, among those concerned with workplace ured at popcorn plants where workers methods of controlling the hazard and and consumer safety. exposed to butter flavoring chemicals compliance assistance. The 24 states and developed similar severe fixed obstruc- two U.S. territories operating their own Carmi Plant Investigation tive lung disease. Thus, it was no sur- OSHA programs are encouraged, but In August 2004, the California prise that the rate of Carmi plant work- not required, to adopt similar programs. Department of Health Services (CDHS) ers diagnosed with fixed obstructive Additionally, several advocacy groups and Division of Occupational Safety lung disease far exceeded what would be and politicians have petitioned FDA to and Health (Cal/OSHA) received the expected in the general population. remove diacetyl’s GRAS designation. first report of bronchiolitis obliterans in NIOSH concluded the report of its Recently, U.S. Congresswoman Rosa L. a worker at a food flavoring manufactur- investigation of the Carmi plant by not- DeLauro called on Andrew von ing plant in California. In April 2006, a ing that “it is highly likely that expo- Eschenbach, FDA Commissioner, to report of another worker from a differ- sures to diacetyl contributed to the reexamine the GRAS designation for ent flavoring manufacturing company occurrence of severe fixed obstructive diacetyl. Dr. David Michaels, Director

R EPRINTED FROM F OOD S AFETY M AGAZINE, OCTOBER/NOVEMBER 2007, WITH PERMISSION OF THE PUBLISHERS. © 2007 BY T HE TARGET G ROUP • www.foodsafetymagazine.com of Project on Scientific Knowledge and “Federal regulators were informed that Public Policy of the George Washington University has also weighed in on the brewing controversy surrounding the physicians may have identified the first FDA’s GRAS designation of diacetyl. “[T]here is compelling evidence of dis- non-industrial occupational case of ease caused by breathing diacetyl vapors, and there is no evidence that there is a safe exposure level below bronchiolitis obliterans.” which exposure does not cause lung disease,” said Michaels. effects,” Rosati said. “Obviously, we are Following publication of Rose’s letter looking at diacetyl because it is a known on a public health blog, the Flavor and A Hotbed of Litigation compound that will come off this pop- Extract Manufacturers Association Although diacetyl has been used in corn. But we’re not looking at that (FEMA) issued a statement recommend- artificial butter flavoring for more than alone.” ing that its members reduce “to the 50 years, significant numbers of While the risk to consumers is gener- extent possible” the amount of diacetyl microwave popcorn manufacturing ally considered low, the results of EPA’s in butter flavorings they make. “This workers diagnosed with severe fixed study, which was to have been complet- new information suggests a possible obstructive lung disease were not seen ed years ago, have yet to be published. association between inhaling the fumes until the early 1990s. It was about that Even without such a study, evidence from the preparation of several bags of time that diacetyl concentrations in arti- is beginning to surface anecdotally that heavily butter-flavored microwave pop- ficial butter flavorings increased due to diacetyl may in fact have a significant— corn each day when the butter flavor formula changes. Consequently, hun- and adverse—health impact on con- contains diacetyl and the development dreds of lawsuits involving occupational sumers. In early September, the of the patient’s severe respiratory ill- diacetyl exposure have been filed against Associated Press (AP) newswire reported ness,” the FEMA statement said. microwave popcorn and food flavoring that a pulmonary specialist from the In addition, both CDC and FDA manufacturers, and hundreds of mil- National Jewish Medical and Research stated that they are actively reviewing lions of dollars have already been paid Center in Denver, CO, had informed the potentially broader health implica- out in settlements and jury awards. federal regulators that physicians may tions posed by the use of diacetyl in Millions more have been spent on attor- have identified the first non-industrial non-industrial settings as raised by the neys’ fees defending those suits. occupational case of bronchiolitis oblit- Denver report. Two of the nation’s In fact, two new lawsuits on behalf erans. The single case involves a con- largest microwave popcorn product of 44 more plaintiffs have recently been sumer whose exposure to fumes from makers, ConAgra Foods and Pop filed in Jasper County, MO, against the preparing butter-flavored microwave Weaver, also announced that they will makers of a butter flavoring used at a popcorn several times a day over a num- begin to phase out and/or remove local microwave popcorn plant. The ber of years is the only plausible expla- diacetyl from their products due to plaintiffs in those lawsuits involve 43 nation at this time for the patient’s ill- worker safety and potential consumer current and former workers at the plant ness, stated Dr. Cecile Rose, in a written health concerns and plan to develop and a man who lived near the facility. statement to FDA, the Centers for alternative formulations to attain the Disease Control and Prevention (CDC), desired buttery flavor profile. Impact on Consumers and other public health agencies. Despite the debate surrounding the Although one case does not constitute Future Implications safety of diacetyl in the workplace, no incontrovertible evidence that One of the primary impediments to scientific study results have been microwaving popcorn at home increases diacetyl becoming the “next asbestos” is released examining its effects on con- consumers’ risk of developing lung dis- the relatively limited number of individ- sumers. In the fall of 2003, the U.S. ease, Rose indicated that levels of air- uals exposed to it in the workplace. The Environmental Protection Agency (EPA) borne diacetyl measured at the patient’s flood of recent reports of tainted food began a study to examine the type and home near the microwave area were products imported from China, howev- amount of chemicals emitted from “similar to those reported in the er, has heightened the public’s fears popped microwave popcorn bags. microwave oven exhaust area” at one about the safety of the foods they con- “Further research would be needed to microwave popcorn processing plant sume. Seasoned trial attorneys will sure- determine the health effects of those where employees developed severe fixed ly attempt to prey upon these fears by chemicals and whether consumers are at obstructive lung disease believed to have attempting to establish a casual link risk,” said Jacky Rosati, an EPA scientist been caused by diacetyl exposure. The between diacetyl exposure at the con- involved in the study. “Once we know doctor also said that the patient’s respi- sumer level and respiratory disease. If what chemicals are and the amounts, ratory difficulties appeared to stabilize successful, every person who suffers or somebody else can look at the health after he quit using microwave popcorn. has suffered from respiratory disease is a

R EPRINTED FROM F OOD S AFETY M AGAZINE, OCTOBER/NOVEMBER 2007, WITH PERMISSION OF THE PUBLISHERS. © 2007 BY T HE TARGET G ROUP • www.foodsafetymagazine.com potential plaintiff. The costs associated ease, food manufacturers should give tive flavoring compounds to remove it with defending such claims would be serious consideration to eliminating entirely from production processes and staggering. diacetyl from their products whenever finished products. n A groundswell of consumer-driven possible. Recent legislative efforts on the diacetyl litigation is not merely a federal and state levels to regulate Richard Fama is a member of Cozen pipedream of trial lawyers. Much of the diacetyl use in the workplace are clearly O’Connor and is actively involved in the scientific research conducted to date, intensifying and may result in an out- firm’s food liability practice group. He rep- including the NIOSH rat study, clearly right ban of the product in California. resents major food processors, manufac- provides the foundation for the theory Other states’ legislatures are sure to fol- turers and distributors (including Fortune that diacetyl vapors can cause respirato- low California’s lead. 100 companies) in products liability mat- ry injury to consumers of food prod- In light of this trend, food manufac- ters, including diacetyl-related claims and ucts. Bolstered by a potentially larger turers are well advised to eliminate lawsuits arising from tainted food products. pool of litigants from the consumer sec- diacetyl from their products before they He also provides counsel to manufacturers tor—especially if medical cases linked to are required to do so by legislative or and distributors regarding country of origin the chemical flavoring agent such as that regulatory efforts. Continuing to use labeling issues. He can be reached at reported in Denver rise in number—and diacetyl in food products—irrespective of [email protected]. teamed with advocates such as Dr. whether it is capable of causing respira- Michaels and legislators like Rosa L. tory disease—may become too costly, DeLauro, trial lawyers are likely to suc- both from a monetary and public rela- ceed in expanding diacetyl litigation far tions standpoint, for microwave pop- beyond that which we know today in corn and food flavoring manufacturers, the industrial occupational environ- and even food distributors and retailers. ment. The potential legal quagmire that Despite the lack of a concrete, med- diacetyl, the food industry’s “asbestos,” ically-established link between diacetyl poses is one that can be largely mitigat- inhalation exposure and respiratory dis- ed by a commitment to finding alterna-