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Diacetyl and Food Flavorings Regulatory Update

Diacetyl and Food Flavorings Regulatory Update. Kelly Howard, CIH Sr. Safety Engineer Cal/OSHA Consultation Service khoward@dir.ca.gov. Food Flavoring. Flavors are widely used in processed foods Diacetyl (2,3-butanedione) a natural ingredient in beer, milk, bay oil, and other foods

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Diacetyl and Food Flavorings Regulatory Update

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  1. Diacetyl and Food FlavoringsRegulatory Update Kelly Howard, CIH Sr. Safety Engineer Cal/OSHA Consultation Service khoward@dir.ca.gov

  2. 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

  3. 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 Proprionic acid Methyl butyric acid

  4. 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

  5. Bronchiolitis Obliterans (BO) • Rare • Devastating • Part of continuum of fixed obstructive lung disease • Irreversible • Relative to food flavorings • Short latency • Young, non-smokers

  6. 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

  7. 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

  8. 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

  9. 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

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

  11. 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

  12. 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

  13. 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

  14. Typical Exposure Levels 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)

  15. Acetic Acid 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)

  16. 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 • <0.49 PPM 60-minute average • Which is then packaged • <0.042 PPM TWA

  17. 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

  18. 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

  19. Cal/OSHA Diacetyl Standard OverviewEffective 12/2/2010 • Scope • Food products and flavors • >1% diacetyl • Work-related fixed obstructive lung disease (FOLD) • Any diacetyl • Any other artificial butter flavor

  20. Definitions • 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

  21. 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

  22. 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 • >1% diacetyl

  23. 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 <RQL • Regulated Areas due to open process • Combination personal/area samples to verify if >RQL in regulated and surrounding areas

  24. 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 • >RQL could be expected, or • Powders are involved

  25. Full Standard Requirements • 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

  26. Full Standard Requirements • 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

  27. 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 < 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

  28. Full Standard Requirements • 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

  29. 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 >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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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.

  35. 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

  36. Resources • 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)

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