Diacetyl and Food Flavorings Regulatory Update - PowerPoint PPT Presentation

Diacetyl and Food FlavoringsRegulatory Update

Kelly Howard, CIH

Sr. Safety Engineer

Cal/OSHA Consultation Service

khoward@dir.ca.gov

• Flavors are widely used in processed foods
• Diacetyl (2,3-butanedione) a natural ingredient in beer, milk, bay oil, and other foods
• For California:
• Couple thousand food “processing” companies
• Employees working with diluted ingredients
• 28 food “flavoring” companies
• Approximately 750 employees
• Few ounces to 2000 lbs diacetyl per year
• Employees working with pure ingredients

• Break apart a strawberry and you get 400-500 base chemical ingredients
• Reverse engineer it with 20-30 to make up the core “strawberry” flavor, such as:

Formic acid

Ethyl acetate

Iso amyl acetate

Benzaldehyde

Butyl acetate

Etc.

Diacetyl

Acetic acid

Acetaldehyde

Acetoin

Proprionic acid

Methyl butyric acid

• Butter flavor
• Diacetyl is what imparts butter flavor, along with other ingredients such as acetoin
• “Creaminess”
• Cream strawberry flavor
• “Cheese cake”
• Butterscotch
• Chocolate

• Rare
• Devastating
• Part of continuum of fixed obstructive lung disease
• Irreversible
• Relative to food flavorings
• Short latency
• Young, non-smokers

• Irritant gases – Cl, H2S, nitrogen oxides, phosgene, ozone, SO2
• Sporadic associations with:
• nylon-flock workers
• workers who spray prints onto textiles (with polyamide-amine dyes)
• battery workers (exposure to thionyl  chloride fumes)
• Lung transplants

• 1985: NIOSH HHE in a California Bakery
• Two young non-smokers develop fixed obstructive lung disease
• Use of powdered flavors, including diacetyl are noted
• 2000: Missouri Microwave Popcorn
• Public Health Dept. contacted OSHA about 8 cases of respiratory disease in ex-workers of a popcorn plant
• NIOSH HHE conducted and identifies diacetyl as at least a “marker” for B.O. and respiratory effects
• NIOSH performs HHEs at 5 additional popcorn facilities with similar findings over the next five years

• 2003: first case of B.O. – liquid flavorings compounder
• By January 2004 could no longer work
• Almost missed as B.O.
• Cal/OSHA inspects and issues special order
• 2006: Second case of B.O. in another flavor manufacturing facility reported to CDPH. Cal/OSHA inspects and issues special order

• 7 more cases of severe lung problems
• Symptoms after 2-5 yrs exposure
• Non-smokers
• At least one more almost missed as B.O.
• One case with significant loss within 4 months
• Approximately 40 additional employees with “abnormal” lung functions

• FISHEP initiated in early 2006
• Approximately 28 companies identified as “formulators”
• No popcorn makers
• Consultation vs. Enforcement
• All formulators agreed to participate

• Characterize flavoring ingredient exposures
• FEMA “high priority” ingredients, especially
• Diacetyl
• Acetoin
• Acetic acid
• Benzaldehyde
• Acetaldehyde
• NIOSH
• Assess extent of disease and precursors
• Implement exposure controls

• Onsite evaluations at all 28
• IIPP
• HazCom
• Respirator Protection
• Annual ingredient use
• Employee ingredient exposure assessment
• Ventilation
• Medical screening
• Follow-up
• 3-month and 6-month

• “OSHA” method
• #2118 (partial valid)
• 2 silica gel tubes in series
• No cold storage, but still light sensitive
• Max 3 liters; 0.05 l/min
• 0.047 PPM min. DL

• “NIOSH” method
• #2557 (validated)
• Anasorb CMS tube
• Storage
• heat and light sensitive
• 7-day post-monitor window
• Max 10 L; 0.01-0.2 l/min
• 0.057 PPM min. DL

Diacetyl

• Direct-read: 100-700 PPM
• Process TWA: <0.017 – 8 PPM
• STEL: <0.13 - 38 PPM
• Areas: <0.017 – 1.4 PPM

Acetaldehyde

• 0.4 – 3.4 PPM (STEL)

Typical Exposure Levels

• 0.6-2.4 PPM (process TWA)
• 5-80PPM (C)

Acetoin

• <0.09 – 97 PPM (process TWA)

Benzaldehyde

• 0.05 – 5.7 PPM (process TWA)

• 0.65 kg of 100% diacetyl goes into a 161 kg ingredient mixture
• 2.5-4.4 PPM STEL; 0.28-0.45 PPM TWA
• Which is then mixed with ethanol and water to make up a 5500 kg batch of flavor concentrate
• <0.49 PPM 60-minute average
• Which is then packaged
• <0.042 PPM TWA

• 1.4 kg of 100% diacetyl (chilled) is weighted out and mixed into a key
• 0.56 PPM STEL
• Then added to a 1000 kg batch of powder
• 3.8 PPM STEL
• Then packaged (0.14% diacetyl)
• 1.12 PPM STEL

• Cal/OSHA
• Peter Scholz, CIH
• Gilbert Martinez
• Bob Middo
• Dan Leiner
• Mike Horowitz, CIH
• Steve Smith, CIH
• Deborah Gold, CIH

• NIOSH
• Lauralynn McKernan ScD, CIH
• Kevin Dunn MSEE, CIH
• CDPH
• Barbara Materna, PhD, CIH
• Janice Prudhomme, MD
• Thomas Kim, MD

• Scope
• Food products and flavors
• >1% diacetyl
• Work-related fixed obstructive lung disease (FOLD)
• Any diacetyl
• Any other artificial butter flavor

• Diacetyl
• 2,3-butanedione (CAS#431-03-8)
• Proprietary formulations containing diacetyl
• E.g. diacetyl starter distillate CAS#977019-27-4
• Other Artificial Butter Flavor
• Diacetyl trimer
• Acetoin
• 2,3-pentanedione
• 2,3-hexanedione
• 2,3-heptanedione

• Program Reviewer
• a certified industrial hygienist or licensed professional engineer who is knowledgeable in both industrial ventilation design and the control of hazardous exposures, and who is responsible for certifying the effectiveness of the employer's diacetyl control program
• OSHA Reliable Quantitation Limit (RQL)
• the airborne concentration published as the reliable quantitation limit of the OSHA Method. This is 0.012 ppm (0.041 mg/m3) as a 180-minute Time-Weighted Average (TWA) or 0.035 ppm (0.12 mg/m3) as a 15-minute short term average

• Partial standard requirements
• Fixed obstructive lung disease (FOLD) and any
• Diacetyl, or
• Other artificial butter flavoring
• Medical Surveillance; PLHCP written opinion; Removal; Report to CalOSHA
• Full standard requirements
• >1% diacetyl

• Exposure Assessment
• OSHA Method #1013 or equivalent
• Full-shift + worst case 15-minute averages
• Initial
• Enclosed Process Verification – “program reviewer” determines process is enclosed based on its design and construction, and
• Inspect for visible emissions
• Combination personal/area samples to verify <RQL
• Regulated Areas due to open process
• Combination personal/area samples to verify if >RQL in regulated and surrounding areas

• Exposure Assessment (continued)
• Periodic
• At least annually
• As needed due to process change
• Employee notification
• Regulated Areas
• Established unless process is enclosed
• Temporary
• Enclosed process is opened
• Spills, leaks, etc where
• >RQL could be expected, or
• Powders are involved

• Regulated Area (continued)
• Demarcation+limited access+Supervision
• The name/employee identifier recorded on a daily log
• Each person trained
• Each person utilizes required PPE for that area
• Employer's control measures are followed

• Engineering and Work Practice Controls
• <RQL or lowest feasible
• Exhaust control or enclosure
• Minimize heat application
• Process isolation and chilling
• No compressed air, opening of pressurized vessels, dry sweeping
• Uncontrolled release procedures

• Engineering and Work Practice Controls (continued)
• Written exposure control program
• Exposure control program evaluation
• Validated by a “program reviewer”
• Diacetyl exposures are < RQL or as low as feasible
• Prohibit airborne contamination outside the regulated area
• Enclosed processes are indeed enclosed
• <RQL and no powders where respirator protection not required in the regulated area
• Respirator use compliant with 5144

• Respiratory Protection
• Regulated areas, unless
• No diacetyl-containing powders, and
• <RQL, and
• “Program Reviewer” validation
• Until exposures assessed or for uncontrolled releases
• An employees working adjacent to a regulated area or an enclosed process requests one
• Respiratory Protection Selection Table

• Medical Surveillance
• Supervised by an occupational or pulmonary medicine physician
• Administered by a PLHCP
• Language barriers accommodated
• Any employee who:
• Reports diacetyl-related signs/symptoms
• Been in a regulated area or exposure >RQL >14 days/12 months
• Initial
• Training prior to initial medical and preferably prior to assignment
• No more than 14 days post-assignment
• Within 10 days where symptoms reported or in uncontrolled release and no prior medical

• Follow-up
• Every 6 months
• Uncontrolled release or report of symptoms
• Within 10 days
• Uncontrolled release = 6 month follow-up for at least 12 months
• Termination and reassignment
• Follow-up medical evaluation unless previous within 30 days
• Continue at least 12 months post-reassignment
• Information provided to the PLHCP

• PLHCP Written Opinion
• Initial, follow-up, termination or re-assignment
• Any limitations on respirator use
• Any limitations on exposure to diacetyl or other flavoring substances, use of PPE or on performance of tasks
• Conclusion on whether medical condition may be diacetyl or food flavoring related and whether there is need for further evaluation
• Whether employee should be removed from a job assignment or any needed job modifications

• Medical Removal
• Per PLHCP recommendations with no loss of earnings, etc
• Maintain current earnings, seniority, etc until
• PLHCP recommends return to original job status
• PLHCP determines permanent removal
• Six months elapse since the beginning of the medical removal period

• Information, Training and Labeling
• Awareness training – all employees
• Additional training
• Before assignment
• Annual
• In-house labeling beyond 5194/FDA
• Diacetyl
• Other Artificial Butter Flavors
• Recordkeeping
• Per 3204
• Entry logs, etc
• Training – 3 years
• Ventilation – per 5143

• WARNING: This product contains diacetyl which can be a severe respiratory hazard. Breathing dust, powder, mist or vapor from this product could result in irritation of the eyes and respiratory tract and in permanent lung damage.
• WARNING: This product contains an artificial butter flavoring other than diacetyl. The health effects of these materials selected as substitutes for diacetyl are currently being studied for potential respiratory hazards. Avoid eye contact or breathing dust, powder, mist or vapor from this product as irritation of the eyes or respiratory tract may result.

• Reporting
• Within 24 hours for flavor-related FOLD
• Use of diacetyl
• Within 60 calendar days of 12/2/2010
• 15 calendar days of new use
• Posted in affected area(s) until no longer used

• California Health Department
• cdph.ca.gov/HealthInfo/discond/Pages/FlavoringLungDisease
• HESIS Fact Sheet
• NIOSH
• cdc.gov/niosh/topics/flavorings
• "Preventing Lung Disease in Workers Who Use or Make Flavorings.“ (2004)