Diacetyl and Food Flavorings Regulatory Update

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Diacetyl and Food FlavoringsRegulatory Update

• Kelly Howard, CIH
• Sr. Safety Engineer
• Cal/OSHA Consultation Service
• khoward_at_dir.ca.gov

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Food Flavoring

• 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

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What is a flavor?

• 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 Proprion
ic acid Methyl butyric acid
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Where does diacetyl come in?

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

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Bronchiolitis Obliterans (BO)

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

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Other possible causes

• 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

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A Brief History

• 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

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Events in CA

• 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

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Additional Concerns in 2006-2007

• 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

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FISHEP

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

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FISHEP Objectives

• 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

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FISHEP Focus

• 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

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Diacetyl Sampling Protocols

• 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

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Typical Exposure Levels
Diacetyl

• Direct-read 100-700 PPM
• Process TWA lt0.017 8 PPM
• STEL lt0.13 - 38 PPM
• Areas lt0.017 1.4 PPM

Acetaldehyde

• 0.4 3.4 PPM (STEL)

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Acetic Acid
Typical Exposure Levels

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

Acetoin

• lt0.09 97 PPM (process TWA)

Benzaldehyde

• 0.05 5.7 PPM (process TWA)

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A perspective - concentrate intended to flavor
bottled water

• 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
• lt0.49 PPM 60-minute average
• Which is then packaged
• lt0.042 PPM TWA

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Another perspective chocolate flavored powder
mix

• 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

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FISHEP Acknowledgements

• 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

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Cal/OSHA Diacetyl Standard OverviewEffective
12/2/2010

• Scope
• Food products and flavors
• gt1 diacetyl
• Work-related fixed obstructive lung disease
  (FOLD)
• Any diacetyl
• Any other artificial butter flavor

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Definitions

• Diacetyl
• 2,3-butanedione (CAS431-03-8)
• Proprietary formulations containing diacetyl
• E.g. diacetyl starter distillate CAS977019-27-4
• Other Artificial Butter Flavor
• Diacetyl trimer
• Acetoin
• 2,3-pentanedione
• 2,3-hexanedione
• 2,3-heptanedione

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Definitions

• 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

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Application

• 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
• gt1 diacetyl

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Full Standard Requirements

• 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 ltRQL
• Regulated Areas due to open process
• Combination personal/area samples to verify if
  gtRQL in regulated and surrounding areas

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Full Standard Requirements

• 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
• gtRQL could be expected, or
• Powders are involved

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Full Standard Requirements

• Regulated Area (continued)
• Demarcationlimited accessSupervision
• 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

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Full Standard Requirements

• Engineering and Work Practice Controls
• ltRQL 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

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Full Standard Requirements

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

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Full Standard Requirements

• Respiratory Protection
• Regulated areas, unless
• No diacetyl-containing powders, and
• ltRQL, 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

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Full Standard Requirements

• 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 gtRQL gt14
  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

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Full Standard Requirements

• 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

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Full Standard Requirements

• 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

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Full Standard Requirements

• 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

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Full Standard Requirements

• 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

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In-house Labeling

• 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.

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Full Standard Requirements

• 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

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Resources

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