niosh alert: preventing lung disease in workers who use or make
TRANSCRIPT
DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention
National Institute for Occupational Safety and Health
Preventing Lung Disease in WorkersWho Use or Make Flavorings
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Mention of any company or product does not constitute endorsementby the National Institute for Occupational Safety and Health (NIOSH). Inaddition, citations to Web sites do not constitute NIOSH endorsement ofthe sponsoring organizations or their programs or products. Furthermore,NIOSH is not responsible for the content of these Web sites.
ORDERING INFORMATION
To receive documents or other information about occupational safety andhealth topics, contact NIOSH at
NIOSH—Publications Dissemination4676 Columbia Parkway
Cincinnati, OH 45226–1998
Telephone: 1–800–35–NIOSH (1–800–356–4674)Fax: 513–533–8573
E-mail: [email protected]
or visit the NIOSH Web site at www.cdc.gov/niosh
DHHS (NIOSH) Publication Number 2004–110
December 2003
SAFER � HEALTHIER � PEOPLETM
This document is in the public domainand may be freely copied or reprinted.
Preventing Lung Disease in Workers
Who Use or Make Flavorings
Flavorings are complex mixtures of natural and
manmade ingredients that are added to many
food products in the production process. De-
pending on the flavoring and the process,
workers may be exposed to hazardous flavor-
ings or flavoring ingredients in the form of va-
pors, dusts, or sprays.
Workers who make, use, or work near fla-
vorings or flavoring ingredients should take
the following steps to protect their health:
• Ask your supervisor for training on the haz-
ards associated with the flavorings and
ingredients.
• Read labels on containers and material
safety data sheets (MSDSs) on the flavor-
ings and ingredients.
• Know and use the exposure control de-
vices and work practices that keep flavor-
ings and ingredients out of the air in your
workplace.
• Keep containers of flavorings and chemi-
cal ingredients tightly closed when not in
use so that their contents do not get into
the workplace air.
• Understand when and how to wear a res-
pirator (protective breathing mask) and
other personal protective equipment (such
as gloves and eye goggles) that your em-
ployer may provide.
• Participate in breathing tests provided by
your employer.
• Promptly report any persistent shortness
of breath or cough, or any problems with
your eyes, nose, throat, or skin to your su-
pervisor and your doctor. When you report
your symptoms, show them a copy of this
Alert.
Companies that use or make flavorings
should take the following steps to protect
the health of their workers:
• Limit hazardous worker exposures:
— Consider substitution of less hazard-
ous flavoring ingredients or formula-
tions where feasible.
— Use closed production processes (i.e.,
avoid handling of open containers of
flavorings and ingredients).
— Apply effective local exhaust ventila-
tion as well as general dilution ventila-
tion in places where flavorings or their
ingredients are handled.
— Isolate mixing and other high-exposure
processes from the rest of the work-
place and maintain these work areas
under negative air pressure.
— Use the lowest temperatures neces-
sary if heated processes are used.
— Establish and enforce work practices to
limit release of chemical vapors and
dust into the workplace air.
Please tear out and post. Distribute copies to workers. See back of sheet to order complete Alert.
WARNING!
Breathing certain flavoring chemicals in the workplace maylead to severe lung disease.
• Monitor air concentrations of flavoring in-
gredients to assure that control efforts are
limiting exposures.
• Train workers on the potential for lung dis-
ease and other health effects from expo-
sure to flavoring-related chemicals and on
waysexposurecan beavoidedorminimized.
• Assure appropriate labeling of containers
and posting of warnings.
• Provide workers with appropriate respira-
tory protection if they are at risk for hazard-
ous respiratory exposure to flavorings or
their ingredients
— while optimal exposure controls are be-
ing implemented,
— when controls are not working properly
because of a breakdown or mainte-
nance procedures, and
— when even the lowest exposures that
can be achieved are still associated
with potential risk.
• Provide workers with other appropriate per-
sonal protective equipment (e.g., gloves,
masks, and goggles) if they are at risk for
hazardous eye and skin exposure.
• Provide breathing tests (spirometry) be-
fore the first exposure, and on a regular
basis thereafter, to all workers at risk of
hazardous exposure to flavorings or their
ingredients. Refer workers for evaluation
by a physician if they have abnormal test
results, an accelerated drop in test results
over time, or persistent symptoms.
• Assess the patterns of reported symptoms
and lung function results among the entire
workforce to identify work areas, processes,
or exposures that may require more inten-
sive intervention to prevent further adverse
health effects.
For additional information, see NIOSH Alert: Preventing Lung Disease in Workers
Who Use or Make Flavorings [DHHS (NIOSH) Publication No. 2004–110]. Single cop-
ies of the Alert are available free from the following:
NIOSH—Publications Dissemination4676 Columbia Parkway
Cincinnati, OH 45226–1998
Telephone: 1–800–35–NIOSH (1–800–356–4676)Fax: 513–533–8573
E-mail: [email protected]
or visit the NIOSH Web site at www.cdc.gov/niosh
Department of Health and Human ServicesCenters for Disease Control and PreventionNational Institute for Occupational Safety and Health
Preventing Lung Disease in WorkersWho Use or Make Flavorings
The National Institute for OccupationalSafety and Health (NIOSH) requestsassistance in preventing lung diseaseand other health effects in workerswho use or make flavorings. The oc-currence of severe lung disease inworkers who make flavorings or usethem to produce microwave popcornhas revealed an unrecognized occupa-tional health risk. Flavorings are oftencomplex mixtures of many chemicals[Conning 2000]. The safety of thesechemicals is usually established forhumans consuming small amounts infood [Pollitt 2000], not for food indus-try workers inhaling them. Productionworkers employed by flavoring manu-facturers (or those who use flavoringsin the production process) often handlea large number of chemicals, many ofwhich can be highly irritating to breathein high concentrations.
This Alert describes health effectsthat may occur because of workplaceexposure to some flavorings or theiringredients, gives examples of work-place settings in which illness has oc-curred, and recommends steps thatcompanies and workers should taketo prevent hazardous exposures.
BACKGROUND
NIOSH has investigated the occurrence ofsevere lung disease in workers at a micro-wave popcorn packaging plant. Eight for-mer workers at this plant developed illnesscharacterized by fixed airways obstructionon lung function tests [Akpinar-Elci et al.2002]. An evaluation of the current workforceat this plant showed an association be-tween exposure to vapors from flavoringsused in the production process and de-creased lung function [Kreiss et al. 2002a].Similar fixed obstructive lung disease hasalso occurred in workers at other plantsthat use or manufacture flavorings [NIOSH1986; Lockey et al. 2002]. In animal tests,inhaling vapors from a heated butter fla-voring used in microwave popcorn produc-tion caused severe injury to airways [Hubbset al. 2002a].
Medical test results in affected workers (in-cluding some lung biopsy results) are con-sistent with bronchiolitis obliterans, anuncommon lung disease characterized byfixed airways obstruction [Akpinar-Elci etal. 2002]. In bronchiolitis obliterans, inflam-mation and scarring occur in the smallest
1
WARNING!
Breathing certain flavoring chemicals in the workplace maylead to severe lung disease.
airways of the lung and can lead to severeand disabling shortness of breath. The dis-ease has many known causes such as in-halation of certain chemicals, certainbacterial and viral infections, organ trans-plantation, and reactions to certain medi-cations [King 2000]. Known causes ofbronchiolitis obliterans due to occupa-tional or other environmental exposuresinclude gases such as nitrogen oxides(e.g., silo gas), sulfur dioxide, chlorine,ammonia, phosgene, and other irritantgases [King 1998]. Recent NIOSH investi-gations strongly suggest that some flavor-ing chemicals can also cause bronchiolitisobliterans in the workplace. (Some work-ers exposed to flavorings in one of theseplants were also found to have occupa-tional asthma.)
HEALTH EFFECTS
The main respiratory symptoms experi-enced by workers affected by fixed air-ways obstruction include cough (usuallywithout phlegm) and shortness of breathon exertion. These symptoms typically donot improve when the worker goes homeat the end of the workday or on weekendsor vacations. The severity of the lungsymptoms can range from only a mildcough to severe cough and shortness ofbreath on exertion. Usually these symp-toms are gradual in onset and progressive,but severe symptoms can occur suddenly.Some workers may experience fever, nightsweats, and weight loss. Before arriving ata final diagnosis, doctors of affectedworkers initially thought that the symp-toms might be due to asthma, chronicbronchitis, emphysema, pneumonia, orsmoking. Severe cases may not respondto medical treatment. Affected workersgenerally notice a gradual reduction or
cessation of cough years after they are nolonger exposed to flavoring vapors, butshortness of breath on exertion persists.Several with very severe disease wereplaced on lung transplant waiting lists.Workers exposed to flavorings may also ex-perience eye, nose, throat, and skin irritation.In some cases, chemical eye burns have re-quired medical treatment.
Medical Evaluation
Medical testing may reveal several of thefollowing findings:
• Spirometry, a type of breathing test,
— most often shows fixed airways ob-struction (i.e., difficulty blowing airout fast and no improvement withasthma medications), and
— sometimes shows restriction (i.e.,decreased ability to fully expand thelungs).
• Lung volumes may show hyperinflation(i.e., too much air in the lungs due to airtrapping beyond obstructed airways).
• Diffusing capacity of the lung (DLCO)is generally normal, especially early inthe disease.
• Chest X-rays are usually normal butmay show hyperinflation.
• High-resolution computerized tomog-raphy scans of the chest at full inspira-tion and expiration may reveal hetero-geneous air trapping on the expiratoryview as well as haziness and thick-ened airway walls.
• Lung biopsies may reveal evidence ofconstrictive bronchiolitis obliterans (i.e.,
2 Flavorings
severe narrowing or complete obstruc-tion of the small airways). An open lungbiopsy, such as by thoracoscopy, ismore likely to be diagnostic than atransbronchial biopsy. Special pro-cessing, staining, and review of multi-ple tissue sections may be necessaryfor a diagnosis.
CURRENT EXPOSURELIMITS
Flavorings are composed of various natu-ral and manmade substances. They mayconsist of a single substance, but moreoften they are complex mixtures of severalsubstances. The Flavor and Extract Manu-facturers Association evaluates flavoringingredients to determine whether they are“generally recognized as safe” (GRAS)under the conditions of intended usethrough food consumption. Though con-sidered safe to eat, ingredients may beharmful to breathe in the forms and con-centrations to which food and chemicalindustry workers may be exposed.
Occupational exposure guidelines havebeen developed for only a small number ofthe thousands of ingredients used in fla-vorings. For example, Occupational Safetyand Health Administration (OSHA) per-missible exposure limits (PELs) and/orNIOSH recommended exposure limits(RELs) have been established for only 46(<5%) of the 1,037 flavoring ingredientsconsidered by the flavorings industry torepresent potential respiratory hazardsdue to possible volatility and irritant prop-erties (alpha, beta-unsaturated aldehydesand ketones, aliphatic aldehydes, aliphaticcarboxylic acids, aliphatic amines, andaliphatic aromatic thiols and sulfides)[Hallagan 2002] (see Appendix). Materialsafety data sheets (MSDSs) contain
information about known occupationalhazards of specific chemicals, but theymay not be based on the most up-to-dateinformation in the case of newly recog-nized occupational health risks.
CASE CLUSTER REPORTS
Case Cluster 1
Four men and four women, aged 29 to 53,who had worked at a single microwavepopcorn packaging plant (popcorn plant A)developed fixed obstructive airways dis-ease. One of these former workers and an-other worker later identified at the sameplant had lung biopsy findings consistentwith bronchiolitis obliterans [Akpinar-Elciet al. 2002]. The cases occurred sporadi-cally over several years. Four had workedas mixers of a heated soybean oil, salt,and butter flavoring mixture; the butterflavoring was poured by hand from openbuckets into open mixing tanks (see Fig-ure 1). The other four had packaged micro-wave popcorn near the room where the oiland flavorings were mixed. Five had neversmoked or smoked very little. Initial symp-toms included cough, shortness of breathon exertion, and wheeze. Most had grad-ual onset of symptoms between 5 monthsand 5 years after starting work at the plant.Spirometry testing revealed severe air-ways obstruction in six workers. All eighthad normal chest X-rays; four of six testedhad normal DLCOs. Medical treatmentwith corticosteroid medication was not ef-fective. Most had severe disease by thetime they were referred to lung specialistsand four were placed on lung transplantlists. Their coughs diminished months toyears after leaving employment, but theirshortness of breath on exertion did not.
Flavorings 3
Spirometry tests of 117 of 135 currentworkers employed at this plant revealedthat the number of workers with airwaysobstruction was 3 times higher than ex-pected [Kreiss et al. 2002a]. Almost allchest X-rays and DLCOs in these workerswere normal. Workers with greater pastexposure to flavoring vapors were signifi-cantly more likely to have abnormalspirometry test results than those with lessexposure. Quality control workers, each ofwhom popped about 100 bags of micro-wave popcorn each shift in a small roomwith little ventilation, also had higher ratesof abnormal lung function. Many workersalso reported developing skin problems af-ter starting work at the plant.
Case Cluster 2
Five workers at a flavorings manufacturingcompany developed fixed airways ob-struction [Lockey et al. 2002]. All five
affected workers were relatively youngand none smoked. One was a 38-year-oldworker who became short of breath andstarted coughing within seconds after add-ing 30 gallons of acetaldehyde to a flavor-ing mixture. Her shortness of breath re-solved after a few minutes, but her coughpersisted. Two months later, she notedshortness of breath on exertion. Spirometrytests done after the onset of symptomsshowed fixed airways obstruction; spi-rometry test results before starting work atthe plant had been normal. She did not re-spond to treatment with medications. Simi-lar symptoms were experienced by theother four workers who developed fixedairways obstruction while working at theplant. No further lung function loss wasnoted over several years after removal fromexposure.
Case Cluster 3
Two young, nonsmoking, previouslyhealthy workers at a plant producing fla-vorings for the baking industry developedsevere fixed airways obstruction withinseveral months of starting to work at theplant [NIOSH 1986]. Both worked in aroom where liquid and powdered flavor-ings were combined with starch and flourin large mixers. Both developed shortnessof breath on exertion and persistentcough. Spirometry tests revealed severefixed airways obstruction. DLCOs andchest X-rays were normal. Neither workerhad a significant clinical improvement inresponse to bronchodilator and cortico-steroid medications. After being away fromthe workplace for several months, both af-fected workers had persistent severeshortness of breath on exertion. Two for-mer mixing room workers who weretested were also found to have mild tomoderate airways obstruction.
4 Flavorings
Figure 1. Mixing room, Case Cluster 1. The large
mixing tank holds heated oil and butter flavoring
mixture. Note loose-fitting lid, spillage on the out-
side of the tank, lack of local exhaust ventilation,
and open 5-gallon buckets used to manually trans-
fer concentrated butter flavoring from the smaller
heated tanks to the large mixing tank.
Case Cluster 4
A 54-year-old mixer of oil and butter flavor-ings at a microwave popcorn plant (pop-corn plant B) was referred for evaluationof a chronic cough [Parmet and Von Essen2002]. Spirometry tests indicated fixed air-ways obstruction. This worker reported hav-ing a chronic cough since beginning workat the plant 3 years earlier. His cough be-came noticeably worse when he used anew butter flavoring mixture. He experi-enced some improvement in respiratorysymptoms and lung function with cessationof exposure and treatment with corticosteroidmedication. Five of the six workers ex-posed to flavoring vapors in the plant de-veloped chemical eye burns after using thenew flavoring mixture. Their eye problemsresolved over several weeks with medicaltreatment and cessation of exposure [Kan-wal 2002a].
Case Cluster 5
A NIOSH investigation at a microwavepopcorn plant (popcorn plant C) found anobstructive pattern on lung function testingin 11 of 41 production workers—between 2and 3 times the number expected. The ob-struction was fixed (i.e., did not respond tobronchodilator medication), and DLCOwas normal in most of the affected workerswho underwent diffusing capacity testing.In this plant, the mixing and holding tanksfor heated oil and butter flavoring were lo-cated in a room where the packaging linesand all production workers were also lo-cated [Sahakian 2003].
Case Cluster 6
A 37 year-old mixer of heated soybean oiland flavorings at a microwave popcornplant (popcorn plant D) was found to have
severe fixed airways obstruction. He hadworked as mixer for 7 years. Spirometrytesting done during his first 3 years as amixer revealed that his lung function wasdeclining at a greater than expected rate.He developed progressive shortness ofbreath on exertion starting in his fourthyear as a mixer.
In this plant, the mixing and holding tanksfor heated soybean oil and flavorings havelocal exhaust ventilation and are locatedin a room that has separate ventilationfrom the rest of the plant. A NIOSH investi-gation found an excess of abnormalspirometry tests among current workerswho had worked as mixers (6 of 13; halfwith fixed obstruction). No significant ex-cess of spirometry abnormalities wasfound among packaging line workers.Respirators (protective breathing masks)were provided but not always used by mix-ers when exposed to flavorings [Kanwal2002b].
CONCLUSIONS
Case clusters of fixed obstructive lungdisease, one with biopsy evidence ofbronchiolitis obliterans, have been docu-mented among workers at several differ-ent plants where flavorings are used orwhere chemicals are handled in the pro-duction of flavorings. Recent attention hasbeen largely focused on workers exposedto volatile chemicals in butter flavorings atmicrowave popcorn plants, but other re-ports indicate that other flavoring and foodmanufacturing workers exposed to variousflavorings may also be at risk.
Little is currently known about whichchemicals used in flavorings have the po-tential to cause lung disease and other
Flavorings 5
health effects, and what workplace expo-sure concentrations are safe. As part ofongoing investigations into airways dis-ease in microwave popcorn workers,NIOSH has recently undertaken animalexperiments to evaluate individual butterflavoring chemicals. Results of an animalstudy indicate that exposure to vaporsfrom diacetyl, a chemical used to impartbutter-like flavor, causes airway injury,though perhaps to a smaller extent thanthat caused by exposure to vapors fromthe intact butter flavoring mixture itself[Kreiss et al. 2002b; Hubbs et al. 2002b].
Most chemicals used in flavorings have notbeen tested for respiratory toxicity via theinhalation route, and occupational expo-sure limits have been established for only arelatively small number of these chemicals.Although much remains unknown regard-ing the toxicity of flavoring-related chemi-cals, employers and workers can takesteps to address working conditions andwork practices that place workers at risk.
RECOMMENDATIONS
The following recommendations are pro-vided to reduce hazardous exposures as-sociated with the use or manufacture offlavorings. In general, NIOSH recommendsthat employers and workers implementcontrols to limit worker exposure. In orderof preference, the major types of controlsinclude the following:
1. Substitution
2. Engineering controls
3. Administrative controls
4. Education
5. Personal protective equipment
6. Exposure and worker health monitoring
Substitution
Substituting a less hazardous material caneffectively reduce an existing hazard. How-ever, substitution does not always repre-sent a feasible or definitive approach. Anadequate substitute may not exist; or, aswith flavoring mixtures, the exposures maybe complex and toxicities may be inade-quately understood. Therefore, do the fol-lowing when considering substitution:
• Exercise extreme care when selectingsubstitutes.
• Consider the possible adverse healtheffects of any candidate substitutes.
• Remember that as a general rule,flavoring formulations designed to re-lease less volatile chemicals or respira-ble powder into the air during handlingmay pose less risk to workers.
Engineering Controls
Engineering controls are the primary meth-ods for minimizing exposure associatedwith the use or manufacture of potentiallyhazardous flavorings. Examples includeclosed production systems (e.g., to elimi-nate handling open containers of fla-vorings or their chemical ingredients forplacement into mixing tanks), adequateventilation, and isolation.
• Whenever possible, use closed pro-cesses to transfer flavorings or theirchemical ingredients.
• Isolate the mixing room and other areaswhere flavorings and their ingredientsare openly handled. Maintain these workareas under negative air pressure rela-tive to the rest of the plant.
6 Flavorings
• Use local exhaust ventilation of tanksand other sources of potential expo-sure (e.g., places where flavorings areopenly weighed or measured) as wellas general dilution ventilation of thework area to eliminate or reduce possi-ble worker exposures. Obtain informa-tion about the design of appropriateventilation systems from a qualifiedventilation engineer or from IndustrialVentilation—A Manual of Recom-mended Practice [ACGIH 2001].
• Check ventilation equipment regularlyfor adequate performance, especiallyin areas where flavorings and their in-gredients are handled (e.g., mixingroom) and in adjacent work areas.Also perform checks whenever a pro-cess change is made or a problem issuspected.
• For processes involving heating of fla-vorings, keep the temperature as lowas possible to minimize emissions ofvolatile chemicals into the air.
Administrative Controls
• Establish and enforce work practicesto limit release of chemicals and dustinto the workplace air when flavoringsor their ingredients are handled.
• Tightly seal containers with unused orresidual amounts of flavorings or theiringredients.
• Maintain good general housekeepingin any areas where flavorings or theiringredients are handled.
• Establish standard procedures forcleaning the workplace, tanks andother containers, and spills.
— Do not use compressed air forcleaning powdered flavorings or in-gredients, as this will increase con-centrations of airborne particulate.
— Use special caution when removingresidual chemicals from tanks andother containers with steam or hotwater, as this may increase expo-sure to volatile chemical vapors.
— Clean up spills of flavorings or their in-gredients promptly using proceduresand appropriate protective equipmentdesigned to limit exposure.
• Restrict access to all areas where fla-vorings are openly handled; only es-sential workers should enter theseareas and only when properly pro-tected (see section on personal pro-tective equipment).
Employer and Worker Education
Employer awareness of hazardous expo-sures in the production process and com-munication of this information to workersare vital elements in an optimal occupa-tional safety and health program.
• Inform workers about any materialsthat may contain flavoring agents andtell them the nature of the hazard.
• Provide general information and spe-cific hazard warnings through work-place postings, container labeling,MSDSs, and training.
• Train workers regarding the meansavailable at the facility to eliminate orlimit exposure and how they can takeaction to limit potential exposures forthemselves and fellow workers.
Flavorings 7
• Inform workers about symptoms thatmay indicate a flavoring-related healthproblem. Advise them to report thesesymptoms to their supervisors andphysicians.
Personal Protective Equipment
Whenever the substances and amountspresent in a plant or work area pose a po-tential hazard, provide personal protectiveequipment to protect workers from skin,eye, and respiratory tract irritation andother adverse health effects.
Skin and eye protection
• Enforce the use of chemical-resistantgloves and tight-fitting goggles forworkers with potential skin and eye ex-posure to irritant flavorings or theirchemical ingredients.
• Establish specific guidance about whento use the equipment for each job, basedon knowledge of the tasks performed,substances involved, and an assess-ment of potential exposures.
Respiratory protection
The use of respirators is the least pre-ferred method of controlling worker expo-sures to respiratory hazards.
• Do not use respirators as the primarycontrol for routine operations. However,they may be needed and used whileoptimal engineering controls and workpractices are being implemented, duringsome short-duration maintenance pro-cedures, and during emergencies.
• Use respirators for exposure situationsin which even the lowest concentrationsachievable with engineering controls
are still associated with risk (see sec-tion on worker health monitoring).
• The minimum protective respirator thatshould be used for workers exposedto flavorings or their chemical ingredi-ents is a NIOSH-certified half-mask,negative-pressure respirator with or-ganic vapor cartridges or canisters andparticulate filters.
• Use a full-facepiece respirator for eyeprotection as well as additional respi-ratory protection.
• Consider other respirators for workersexposed to flavorings or their chemicalingredients: powered, air-purifying res-pirators (with organic vapor cartridgesor canisters and particulate filters) and,for maximum respiratory protection,supplied-air respirators.
• Before using respirators, set up a writ-ten respiratory protection program thatmeets the requirements of the OSHArespiratory protection standard [29 CFR*1910.134].
• Designate a trained employee or super-visor to run the program and evaluateits effectiveness. Make sure that thedesignated person’s training or experi-ence is appropriate to the level of com-plexity of the program.
• Ensure that respirators selected foruse are certified by NIOSH accordingto 42 CFR 84.
*Code of Federal Regulations. See CFR in references.
8 Flavorings
• Implement a change schedule for can-isters and cartridges based on objec-tive information or data that will ensurethat canisters and cartridges arechanged before the end of their ser-vice lives.
• Include the following in the respiratoryprotection program:
— Procedures for selecting respirators
— Medical evaluations of workers re-quired to use respirators
— Fit-testing procedures for tight-fittingrespirators
— Procedures for proper use of respi-rators in routine and reasonablyforeseeable emergency situations
— Procedures and schedules forcleaning, disinfecting, storing, in-specting, repairing, discarding, andotherwise maintaining respirators
— Procedures to ensure adequatequality, quantity, and flow of breath-ing air for atmosphere-supplyingrespirators
— Training of workers in the respira-tory hazards to which they are po-tentially exposed during routine andemergency situations
— Training of workers in the properuse of respirators, including puttingthem on and removing them, anylimitations on their use, and theirmaintenance
— Procedures for regularly evaluatingthe effectiveness of the program
and worker compliance with pro-gram requirements
Exposure Monitoring
• Engage the services of a certified airsampling expert to identify the volatileflavoring chemicals that are present insignificant amounts in the air, and tomeasure the air concentrations of oneor more of these chemicals as indica-tors of exposure.
• When applicable, measure air concen-trations of total respirable dust and theair concentration of any flavoring chemi-cal with an OSHAPEL or a NIOSH REL.
• Use repeated monitoring to determinewhether new engineering controls orchanges in work practices are effec-tively reducing exposures.
• Continue routine monitoring on a regu-lar basis to ensure the continuing ef-fectiveness of controls.
• If monitoring indicates that exposureconcentrations have increased, thor-oughly investigate engineering controlsto identify problems and guide remedialactions.
Worker Health Monitoring
• Implement preplacement and regularlyscheduled ascertainment of symptomsand spirometry testing of lung functionfor all workers with potentially hazard-ous exposure to flavorings or flavoringingredients.
Flavorings 9
• Follow the latest American Thoracic Soci-ety guidelines [ATS 1995] for spirometrytesting.
• Perform testing at least annually, sinceexisting information makes it difficultto specify the interval between testing.The relatively rapid onset of severe air-ways obstruction in some affectedworkers suggests that more frequentintervals (perhaps every 3 months)may be appropriate in some situations.
• Conduct more frequent testing if ab-normalities related to flavoring expo-sure are detected in a particularworkforce. Regardless, workers shouldnot wait for regularly scheduled testingto report symptoms.
• Promptly refer workers for further med-ical evaluation if they have persistentcough; persistent shortness of breathon exertion; frequent or persistentsymptoms of eye, nose, throat, or skinirritation; abnormal lung function onspirometry testing; or accelerated de-cline in lung function. Provide the eval-uating physician with a copy of thisAlert. The intent is to identify and pre-vent progression of work-related medi-cal conditions. The physician shouldadvise the worker about any sus-pected or confirmed medical conditionthat may be caused or aggravated bywork exposures, about recommenda-tions for further evaluation and treat-ment, and specifically about any recom-mended restriction of the worker’sexposure (including removal from theworkplace) or use of personal protec-tive equipment. The physician shouldprovide the employer with informationabout recommended restrictions of the
worker’s exposure or use of personalprotective equipment.
• Do not rely on the absence of respira-tory symptoms that occur in relation towork exposures to indicate that expo-sures are adequately controlled. Incontrast to workers with work-relatedasthma, few if any workers with fixedairways obstruction from exposure toflavorings report improvement ondays off work or during vacations.Also, flavoring-exposed workers whodevelop fixed airways obstruction maynot have symptoms early in the courseof their illness. Regularly scheduledspirometry is currently the best avail-able test for early recognition of de-creasing or abnormal lung functionfrom occupational exposure to flavor-ings or their ingredients.
Surveillance and DiseaseReporting
• Assess the patterns of reported symp-toms, abnormal spirometry, physician-advised exposure restrictions, and otheravailable information about health ef-fects within the workforce to identify ar-eas, processes, and exposures thatmay require more intensive interven-tion to control exposures and preventfurther adverse health effects.
Physicians, workers, and employers shouldreport to the NIOSH Division of RespiratoryDisease Studies (800–232–2114) and theirState health department any cases of lungdisease with fixed airways obstruction orany other significant work-related lung dis-ease in workers exposed to flavorings orflavoring ingredients. The information fromsuch reports can help identify high-risk
10 Flavorings
work settings and guide efforts to preventadditional cases.
ACKNOWLEDGMENTS
The principle contributors to this Alert wereRichard Kanwal, Greg Kullman, KathleenKreiss, Robert Castellan, Joe Burkhart,Kenneth Hilsbos, Muge Akpinar-Elci, ChrisPiacitelli, and Randy Boylstein. The Flavorand Extract Manufacturers Association ofthe United States reviewed a draft of thisdocument and provided helpful commentsand suggestions. Please direct comments,questions, or requests for additional infor-mation to the following:
DirectorDivision of Respiratory Disease StudiesNational Institute for Occupational Safetyand Health
1095 Willowdale Road, Suite 2900Morgantown, WV 26505
Telephone: (304) 285–5705; or call1–800–35–NIOSH.
We greatly appreciate your assistance inprotecting the health of U.S. workers.
John Howard, M.D., DirectorNational Institute for OccupationalSafety and Health
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ATS [1995]. Standardization of spirometry.Am Rev Respir Crit Care Med 152:1107–1136.
CFR. Code of Federal regulations. Wash-ington, DC: U.S. Government Printing Of-fice, Office of the Federal Register.
Conning DM [2000]. Toxicology of foodand food additives. In: Ballantyne B, MarrsTC, Syversen T, eds. General and appliedtoxicology. 2nd ed. London: MacmillanReference Ltd., pp. 1977–1992.
Hallagan JB [2002]. Letter of November26, 2002, from J.B. Hallagan, Flavor andExtract Manufacturers Association of theUnited States, to R. Kanwal, Division ofRespiratory Disease Studies, National In-stitute for Occupational Safety and Health,Centers for Disease Control and Preven-tion, Department of Health and HumanServices.
Hubbs AF, Battelli LA, Goldsmith WT, PorterDW, Frazer D, Friend S, Schwegler-BerryD, Mercer RR, Reynolds JS, Grote A,Castranova V, Kullman G, Fedan JS,Dowdy J, Jones WG [2002a]. Necrosis ofnasal and airway epithelium in rats inhal-ing vapors of artificial butter flavoring.Toxicol Appl Pharmacol 185:128–135.
Hubbs A, Castranova V, Jones W, PorterD, Goldsmith W, Kullman G, Battelli L,Friend S, Mercer RR, Schwegler-Berry D,Kreiss K [2002b]. Workplace safety andfood ingredients: the example of butter fla-voring. In: Abstracts of papers, 224th ACS
Flavorings 11
National Meeting, Boston, MA, August18–22, 2002. Washington, DC: AmericanChemical Society, AGFD–148.
Kanwal R [2002a]. Letter of April 19, 2002,from R. Kanwal and S. Martin, Division ofRespiratory Disease Studies, NationalInstitute for Occupational Safety andHealth, Centers for Disease Control andPrevention, Department of Health andHuman Services, to Keith Heuermann,B. K. Heuermann Popcorn, Inc., Phillips,Nebraska.
Kanwal R [2002b]. Letter of November 18,2002, from R. Kanwal, Division of Respira-tory Disease Studies, National Institute forOccupational Safety and Health, Centersfor Disease Control and Prevention, De-partment of Health and Human Services,to Greg Hoffman, American Pop CornCompany, Sioux City, Iowa.
King TE [1998]. Bronchiolitis. In: FishmanAE, ed. Pulmonary diseases and disorders.New York: McGraw-Hill, pp. 825–847.
King TE [2000]. Bronchiolitis. Eur RespirMon 14:244–266.
Kreiss K, Gomaa A, Kullman G, Fedan K,Simoes EJ, Enright PL [2002a]. Clinicalbronchiolitis obliterans in workers at amicrowave-popcorn plant. N Engl J Med347:330–338.
Kreiss K, Hubbs A, Kullman G [2002b]. Cor-respondence: bronchiolitis in popcorn-fac-tory workers. N Engl J Med 347:1981–1982.
Lockey J, McKay R, Barth E, Dahlsten J,Baughman R [2002]. Bronchiolitis obliteransin the food flavoring manufacturing indus-try. Am J Respir Crit Care Med 165:A461.
NIOSH [1986]. Hazard evaluation and tech-nical assistance report: International BakersServices, Inc., South Bend, IN. Cincinnati,OH: U.S. Department of Health and HumanServices, Public Health Service, Centers forDisease Control, National Institute for Occu-pational Safety and Health, NIOSH ReportNo. HETA 85–171–1710.
Parmet AJ, Von Essen S [2002]. Rapidlyprogressive, fixed airway obstructive dis-ease in popcorn workers: a new occupa-tional pulmonary illness? J Occup EnvironMed 44:216–218.
Pollitt FD [2000]. Regulation of food addi-tives and food contact materials. In:Ballantyne B, Marrs TC, Syversen T, eds.General and applied toxicology. 2nd ed.London: Macmillan Reference Ltd.,pp. 1653–1660.
Sahakian N [2003]. Letter of January 13,2003, from N. Sahakian, Division of Respi-ratory Disease Studies, National Institutefor Occupational Safety and Health, Cen-ters for Disease Control and Prevention,Department of Health and Human Serv-ices, to Gary Sanders, Agrilink Foods,Ridgeway, Illinois.
12 Flavorings
APPENDIX
Flavoring substances with OSHA PELs and/or NIOSH RELs
FEMA No.FEMA No. CAS No.CAS No. Substance Synonyms*
2003 75-07-0 Acetaldehyde Acetic aldehyde; ethanal; ethyl aldehyde
2006 64-19-7 Acetic acid Acetic acid (aqueous); glacial acetic acid
(pure compound); ethanoic acid; methane-
carboxylic acid
2055 123-92-2 Isoamyl acetate Banana oil; isopentyl acetate; 3-methyl-1-butanol
acetate; 3-methylbutyl ester of acetic acid; 3-methyl-
butyl ethanoate
2057 123-51-3 Isoamyl alcohol Primary isoamyl alcohol; fermentation amyl alcohol;
fusel oil; isobutyl carbinol; isopentyl alcohol;
3-methyl-1-butanol
2170 78-93-3 2-Butanone Ethyl methyl ketone; MEK; methyl acetone; methyl
ethyl ketone
2174 123-86-4 Butyl acetate n-Butyl acetate; n-butyl ester of acetic acid; butyl
ethanoate
2175 110-19-0 Isobutyl acetate Isobutyl ester of acetic acid; 2-methylpropyl acetate;
2-methylpropyl ester of acetic acid; β-methylpropyl
ethanoate
2178 71-36-3 Butyl alcohol n-Butyl alcohol; 1-butanol; n-butanol; 1-hydroxy-
butane; n-propyl carbinol
2179 78-83-1 Isobutyl alcohol IBA; isobutanol; isopropylcarbinol; 2-methyl-1-
propanol
2184 128-37-0 Butylated BHT; dibutylated hydroxytoluene; 4-methyl-2,6-
hydroxytoluene di-tert-butyl phenol; 6-di-tert-butyl-p-cresol
2205 138-22-7 Butyl lactate n-Butyl lactate; butyl ester of 2-hydroxypropanoic
acid; butyl ester of lactic acid
2414 141-78-6 Ethyl acetate Acetic ester; acetic ether; ethyl ester of acetic acid;
ethyl ethanoate
2418 140-88-5 Ethyl acrylate Ethyl acrylate (inhibited); ethyl ester of acrylic acid;
ethyl propenoate
2419 64-17-5 Ethyl alcohol Alcohol; ethanol; EtOH; grain alcohol; cologne
spirit
2434 109-94-4 Ethyl formate Ethyl ester of formic acid; ethyl methanoate
See footnotes at end of table. (Continued)
Flavorings 13
Flavoring substances with OSHA PELs and/or NIOSH RELs (Continued)
FEMA No.FEMA No. CAS No.CAS No. Substance Synonyms*
2487 64-18-6 Formic acid Formic acid (85%–95% in aqueous solution);
hydrogen carboxylic acid; methanoic acid
2489 98-01-1 Furfural Fural; 2-furancarboxaldehyde; furfuraldehyde;
2-furfuraldehyde
2491 98-00-0 Furfuryl alcohol 2-Furylmethanol; 2-hydroxymethylfuran
2525 56-81-5 Glycerol Glycerin (anhydrous); glycyl alcohol;
1,2,3-propanetriol; trihydroxypropane
2544 110-43-0 2-Heptanone Amyl methyl ketone; n-amyl methyl ketone; methyl
(n-amyl) ketone
2546 123-19-3 4-Heptanone Dipropyl ketone; butyrone; DPK; heptan-4-one;
propyl ketone
2676 79-20-9 Methyl acetate Methyl ester of acetic acid; methyl ethanoate
2716 74-93-1 Methyl mercaptan Mercaptomethane; methanethiol; methyl sulfhydrate
2731 108-10-1 4-Methyl-2- Isobutyl methyl ketone; methyl isobutyl ketone;
pentanone MIBK; hexone
2842 107-87-9 2-Pentanone Ethyl acetone; methyl propyl ketone; MPK
2924 79-09-4 Propionic acid Carboxyethane; ethane carboxylic acid; ethyl-
formic acid; metacetonic acid; methyl acetic acid;
propanoic acid
2925 109-60-4 Propyl acetate n-Propyl acetate; n-propyl ester of acetic acid
2926 108-21-4 Isopropyl acetate Isopropyl ester of acetic acid; 1-methylethyl ester of
acetic acid; 2-propyl acetate
2928 71-23-8 Propyl alcohol n-Propyl alcohol; ethyl carbinol; 1-propanol;
n-propanol
2929 67-63-0 Isopropyl alcohol Dimethyl carbinol; IPA; isopropanol; 2-propanol;
sec-propyl alcohol; rubbing alcohol
2966 110-86-1 Pyridine Azabenzene; azine
3098 110-62-3 Valeraldehyde n-Valeraldehyde; amyl aldehyde; pentanal;
valeral; valeric aldehyde
3223 108-95-2 Phenol Carbolic acid; hydroxybenzene; monohydroxy-
benzene; phenyl alcohol; phenyl hydroxide
See footnotes at end of table. (Continued)
14 Flavorings
Flavoring substances with OSHA PELs and/or NIOSH RELs (Continued)
FEMA No.FEMA No. CAS No.CAS No. Substance Synonyms*
3233 100-42-5 Styrene Ethenyl benzene; phenylethylene; styrene
monomer; styrol; vinyl benzene
3241 75-50-3 Trimethylamine N,N-Dimethylmethanamine; TMA
3326 67-64-1 Acetone Dimethyl ketone; ketone propane; 2-propanone
3368 141-79-7 4-Methyl-3-penten- Isobutenyl methyl ketone; isopropylideneacetone;
2-one methyl isobutenyl ketone; mesityl oxide
3478 109-79-5 1-Butanethiol Butanethiol; n-butanethiol; 1-mercaptobutane;
n-butyl mercaptan
3537 108-83-8 2,6-Dimethyl-4- Diisobutyl ketone; DIBK; sym-diisopropyl acetone;
heptanone isovalerone; valerone
3589 108-46-3 Resorcinol 1,3-Benzenediol; m-benzenediol; 1,3-dihydroxy-
enzene; m-dihydroxybenzene; 3-hydroxyphenol;
m-hydroxyphenol
3553 78-59-1 Isophorone Isoacetophorone; 3,5,5-trimethyl-2-cyclohexenone;
3,5,5-trimethyl-2-cyclohexen-1-one
3616 108-98-5 Benzenethiol Mercaptobenzene; phenyl mercaptan; thiophenol
3667 101-84-8 Diphenyl ether Diphenyl oxide; phenoxy benzene; phenyl oxide;
phenyl ether
3779 7783-06-4 Hydrogen sulfide Hydrosulfuric acid; sewer gas; sulfuretted hydrogen
3909 108-94-1 Cyclohexanone Anone; cyclohexyl ketone; pimelic ketone
3946 583-60-8 2-Methylcyclo- o-Methylcyclohexanone
hexanone
Adapted from Hallagan [2002].*Synonyms from Online NIOSH Pocket Guide to Chemical Hazards (www.cdc.gov/niosh/npg/npgd0297.html).
Flavorings 15
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