A Proposal for a Safe Exposure Level for Diacetyl

References

• Diacetyl (2,3-butanedione) CAS 431-03-8 [Internet]. Wake County (NC): Chemical Register; 1998 [cited 2010 Aug 25]. Available from: http://www.chemicalregister.com/Diacetyl_2_3-Butanedione/Suppliers/pid23004.htm..
   Google Scholar
• Kreiss K. Flavoring-related bronchiolitis obliterans. Curr Opin Allergy Clin Immunol. 2007; 7 (2): 162–167.
   PubMed Web of Science ®Google Scholar
• Rigler MW, Longo WE. Emission of Diacetyl (2,3 butanedione) from Natural Butter, Microwave Popcorn Butter Flavor Powder, Paste, and Liquid Products. Int J Occup Environ Health. 2010; 16 (3): 291–302.
   PubMed Web of Science ®Google Scholar
• Lawless HT, Antinone MJ, Ledford RA, Johnston M. Olfactory responsiveness to diacetyl. Journal of Sensory Studies. 1994; 9 (1): 47–56.
   Google Scholar
• Kanwal R, Kullman G, Fedan K, Kreiss K. Health hazard evaluadon report. Cincinnati (OH): National Institute for Occupa-tional Safety and Health (US); 2006 Jan. 175 p. Report No.: HETA2000-0401–2991.
   Google Scholar
• Fama R, Berger E. Consumer-driven diacetyl litigation: boom or bust. Mealey's Litigation Report: Food Liability. 2007;1(8).
   Google Scholar
• American Industrial Hygiene Association Diacetyl Workplace Environmental Exposure Limit Consortium. 2010. Produced by Mark Utell, M.D. in “Newkirk vs. ConAgra Foods, Inc., et al” Case 2:08-cv-00273-RMP. Available from: http://egilman.com/diacetyl_fiv/Diacetyl_Workplace_Environmental_Exposure_Limit_Consortium_contract_with_TERA.pdf.
   Google Scholar
• Maier A, Kohrman-Vincent M, Parker A, Haber LT. Evaluation of concentration-response options for diacetyl in support of occupational risk assessment. Regulatory Toxicology and Phar-macology. 2010; 58 (2): 285–296.
   PubMed Web of Science ®Google Scholar
• Morgan DL, Flake GP, Kirby PJ, Palmer SM. Respiratory toxicity of diacetyl in C57BL/6 mice. Toxicol Sci. 2008; 103 (1): 169–180.
   PubMed Web of Science ®Google Scholar
• Lockey JE, Hilbert TJ, Levin LP, Ryan PH, White XL, Borton EK, Rice CH, McKay RT, LeMaster GK. Airway obstruction related to diacetyl exposure at microwave popcorn production facili-ties. European Respiratory Journal. 2009;34(1 ):63–71.
   PubMed Web of Science ®Google Scholar
• ToxDx. Consumer safety estimate for inhalation of synthetic butter flavoring components of microwave-ready popcorn. Sub-mitted 4/21/2005 by Kendall B. Wallace, Ph.D., DABT. Pro-duced in “Newkirk vs. ConAgra Foods, Inc., et al” Case 2:08-cv-00273-RMP. Available from: http://egilman.com/diacetyl_fiv/ToxDx_LLC_Consumer_safety_estimate_for_inhalation_ofsynthetic_butter_flavoring_components_ofmicrowave_ready_popcorn.PDF.
   Google Scholar
• Lockey JE. Pulmonary function test results and occupational histories from the 27 quality control workers whose data was used to generate Lockey's ConAgra publication. 2010. Pro-duced in “Newkirk vs. ConAgra Foods, Inc., et al” Case 2:08-cv-00273-RMP. Available from: http://egilman.com/diacetyl_fiv/QA_worker_PFT_data_from_Lockey_et_al_2009_redacted.pdf.
   Google Scholar
• Casserly D. 2006. Threshold Limit Values for Chemical Substances (TLV®-CS): ACGIH [Internet]. Clear Lake (TX): ACGIH; 2006 [cited 2010 Aug 20]. Available from: http://www.acgih.org/t1v/03_TLV-CS-Update_AIHce06.pdf.
   Google Scholar
• Brent RL. Utilization of animal studies to determine the effects and human risks of environmental toxicants (drugs, chemicals, and physical agents). Pediatrics. 2004;113(4)984–995.
   Google Scholar
• Gaylor DW, Kodell RL, Chen JJ, Krewski D. A unified approach to risk assessment for cancer and noncancer endpoints based on benchmark doses and uncertainty/safety factors. Regulatory Toxicology and Pharmacology. 1999; 29: 151–157.
   PubMed Web of Science ®Google Scholar
• Risk assessment guidance for superfund volume I: Human health evaluation manual (Part A). Office of Emergency and Remedial Response [Internet]. Washington D.C.: United States Environmental Protection Agency; 1989 [cited 2010 Aug 8]. Available from: http://www.epa.gov/oswer/riskassessment/ragsa/index.htm..
   Google Scholar
• Regulations (Preambles to final rules)-Air contaminants. Section 6 - VI. Health effects discussion and determination of final PEL [Internet]. Washington D.C.: Department of Labor, Occu-pational Safety and Health Administration Federal Register; 2008 [cited 2010 Aug 28]. Available from: http://www.osha.gov/p1s/oshaweb/owadisp.show_document?p_tablePREAMBLESp_id770.
   Google Scholar
• Redbook 2000, Section W: Guidelines for Toxicity Studies, Part C: Short-term, subchronic, and carcinogenicity studies with rodents [Internet]. College Park (MD): Food and Drug Admin-istration; 2000 [cited 2010 Aug 28]. Available from: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/ucm078311.htm.
   Google Scholar
• Toxicology/Carcinogenicity Standard Procedures: 14-day toxicity, 13-week toxicity, and 2-year studies [Internet]. Durham (NC): National Toxicology Program; 2010 [cited 2010 Aug 28]. Available from: http://ntp.niehs.nih.gov/?objectid72015DAF-BDB7-CEBA-F9A7F9CAA57DD7F5..
   Google Scholar
• Standing operating procedures for developing acute exposure guideline levels for hazardous chemicals [Internet]. Washing-ton D.C.: National Research Council, National Academy Press; 2001 [cited 2010 Aug 29]. Available from: http://www.nap.edu/openbook.php?isbn030907553X.
   Google Scholar
• Hayes AW. Principles and methods of toxicology. 4th ed. Philadelphia: Taylor & Francis; 2001.
   Google Scholar
• Klaassen CD, Watkins JB, Casarett U. Casarett & Doull's Essen-tials of Toxicology. 2nd ed. New York: McGraw-Hill Medical Pub-lishing Division; 2010.
   Google Scholar
• Guidance for benchmark dose (BMD) approach - Quantal data [Internet]. Sacramento, CA: DPR MT-1. Medical Toxicology Branch, Department of Pesticide Regulation, California Envi-ronmental Protection Agency; 2004 [cited 2010 Sept 10]. Avail-able from: http://www.cdpr.ca.gov/docs/risk/bmdquant.pdf..
   Google Scholar
• Wallace Kendall B. 2008. Review of TERA paper [Internet]. Message to: Steven Hermansky. 2008 July 10 [cited 2010 Oct 14]. Produced in “Newkirk vs. ConAgra Foods, Inc., et al” Case 2:08-cv-00273-RMP. Available from: http://egilman.com/diacetyl_fiv/Wallace_review_of.TERA_manuscript.pdf..
   Google Scholar
• Hubbs AF, Goldsmith WT, Kashon ML, Frazer D, Mercer RR, Battelli LA, Kullman GJ, Schwegler-Berry D, Friend S, Castra-nova V. Respiratory toxicologic pathology of inhaled diacetyl in sprague-dawley rats. Toxicol Pathol. 2008; 36 (2): 330–344.
   PubMed Web of Science ®Google Scholar
• Estenne M, Hertz MI. Bronchiolitis obliterans after human lung transplantation. Am J Respir Crit Care Med. 2002; 166: 440–444.
   PubMed Web of Science ®Google Scholar
• King TE. Bronchiolitis Obliterans. Lung. 1989; 167: 69-93.
   PubMed Web of Science ®Google Scholar
• Mannino DM. Chronic obstructive pulmonary disease: definition and epidemiology. Respiratory Care. 2003; 48 (12): 1185–1193.
   PubMedGoogle Scholar
• Bello D, Woskie SR, Streicher RP, Liu Y, Stowe Mil, Eisen EA, Ellenbecker MJ, Sparer J, Youngs F, Cullen MR, Redlich CA. Polyisocyanates in occupational environments: a critical review of exposure limits and metrics. Am J Ind Med. 2004; 46: 480–491.
   PubMed Web of Science ®Google Scholar
• Allen BC, Kavlock RJ, Kimmel CA, Faustman EM. Dose-response assessment for developmental toxicity. Fundamental and Applied Toxicology. 1994; 23 (4): 487–495.
   PubMedGoogle Scholar
• Rothman KJ, Greenland S, Lash TL. Modern Epidemiology. 3rd ed. Philadelphia: Wolters Kluwer Health; 2008.
   Google Scholar
• Cox-Ganser J, Ganser G, Saito R, Hobbs G, Boylstein R, Hendricks W, Simmons M, Eide M, Kullman G, Piacitelli C. Correct-ing diacetyl concentrations from air samples collected with NIOSH Method 2557. J Occup Environ Hyg. 2011; 8 (2): 59–70.
   PubMed Web of Science ®Google Scholar
• Kanwal R, Kullman G. Health hazard evaluation report. Cincinnati (OH): National Institute for Occupational Safety and Health (US); 2004 Dec. 63 p. Report No.: HETA2003-0112–2949.
   Google Scholar
• Kullman G, Sahakian N. Health hazard evaluation report. Cincinnati (OH): National Institute for Occupational Safety and Health (US); 2007 Apr. 50 p. Report No.: HETA2006-0195–3044.
   Google Scholar
• Rosati JA, Krebs KA, Liu X. Emissions from cooking microwave popcorn. Grit Rev Food Sci Nutr. 2007; 47 (8): 701–709.
   Google Scholar
• Plopper C, Have-Opbroek A. Diseases of the Bronchioles. Epler GR, Series Ed. New York: Raven Press; 1994.
   Google Scholar
• Galbraith D, Weill D. Popcorn lung and bronchiolitis obliterans: a critical appraisal. Int Arch Occup Environ Health. 2009; 82 (3): 407–416.
   PubMed Web of Science ®Google Scholar
• van Rooy FG, Rooyackers JM, Prokop M, Houba R, Smit LA, Heederik DJ. Bronchiolitis obliterans syndrome in chemical workers producing diacetyl for food flavorings. Am J Respir Crit Care Med. 2007; 176 (5): 498–504.
   PubMed Web of Science ®Google Scholar
• Kreiss K, Hubbs A. Letter to the editor: RE: Galbraith D and Weill D (2009), popcorn lung and bronchiolitis obliterans: a critical appraisal 82(3)407-416. Int Arch Occup Environ Health. 2009; 83 (4): 467–469.
   PubMedGoogle Scholar
• Israel L, Kim T, Prudhomme J, Bailey R, Harber P. Workplace Spirometry: Early Detection Benefits Individuals, Worker Groups and Employers [Internet]. Case Ed.: Jeremy Falk, reviewed by Environmental & Occupational Health Assembly. New York (NY): American Thoracic Society; 2010 [cited 2010 July 23]. Available from: http://www.thoracic.org/clinical/ats-clinical-cases/pages/workplace-spirometry-early-detection-ben-efits-individuals,-worker-groups-and-employers.php
   Google Scholar
• Akpinar-Elci M, Travis WD, Lynch DA, Kreiss K. Bronchiolitis obliterans syndrome in popcorn production plant workers. Eur Respir J. 2004; 24: 298–302.
   PubMed Web of Science ®Google Scholar
• Kanwal R, Kullman G, Piacitelli C, Boylstein R, Sahakian N, Martin S, Fedan K, Kreiss K. Evaluation of flavorings-related lung disease risk at six microwave popcorn plants. J Occup Env-iron Med. 2006; 48 (2): 149–157.
   PubMed Web of Science ®Google Scholar
• Kreiss K, Gomaa A, Kullman G, Fedan K, Simoes EJ, Enright PL. Clinical bronchiolitis obliterans in workers at a microwave-pop-corn plant. N Engl J Med. 2002; 347 (5): 330–338.
   PubMed Web of Science ®Google Scholar
• Wang M-L, Petsonk EL. Repeated measures of FEV1 over six to twelve months: what change is abnormal? J Occup Environ Med. 2004; 46: 591–595.
   Google Scholar
• Kreiss K, Kullman G. 2002. Health hazard evaluation interim letter report. Cincinnati (OH): National Institute for Occupa-tional Safety and Health (US); 2002 Dec 13.17 p. Report No.: HETA20000401.
   Google Scholar
• Kerstjens H, Rijcken B, Scouten J, Postma D. Decline of FEV1 by age and smoking status: facts, figures, and fallacies. Thorax. 1997; 52: 820–827.
   PubMed Web of Science ®Google Scholar
• Chaisson N, Kreiss K, Hnizdo E, Hakobyan A, Enright P. Evaluation of methods to determine excessive decline of forced expi-ratory volume in one second in workers exposed to diacetyl-con-taining flavorings. J Occup Environ Med. 2010; 52 (11): 1119–1123.
   PubMed Web of Science ®Google Scholar
• Rantanen J, Barnhart S, Dement JM, Hillerdal G, Huuskonen MS, Kivisaari L, Kusaka Y, Lahdensuo A, Langard S, Mowe G, Okubo T, Parker JE, Roggli VL, Rodelsperger K, Roger J, Tossavainen A, Woitowitz HJ. Asbestos, asbestosis, and cancer: the Helsinki criteria for diagnosis and attribution. Scandinavian J Work Environ Health. 1997; 23 (4): 311–316.
   PubMed Web of Science ®Google Scholar
• Cal-OSHA Reporter. Cal/OSHA Diacetyl Regulation Finally Published [Internet]. Granite Bay (CA): Providence Publications, LLC.; 2010 [cited 2010 Nov 1]. Available from: http://www.cal-osha.com/Cal-OSHA-Diacetyl-Regulation-Finally-Published.aspx..
   Google Scholar
• Neely W, Hall T. Vapor pressure of diacetyl. J Chem Eng Data. 1972; 17 (3): 294–295.
   Google Scholar
• Hubbs AF, Battelli LA, Goldsmith WT, Porter DW, Frazer D, Friend S, Schwegler-Berry D, Mercer RR, Reynolds JS, Grote A, Castranova V, Kullman G, Fedan JS, Dowdy J, Jones WG. Necro-sis of nasal and airway epithelium in rats inhaling vapors of arti-ficial butter flavoring. Toxicol Appl Pharmacol. 2002;185 (2): 128–135.
   PubMed Web of Science ®Google Scholar
• Sumpter TL, Wilkes DS. Role of autoimmunity in organ allograft rejection: a focus on immunity to type V collagen in the pathogenesis of lung transplant rejection. Am J Physiol Lung Cell Mol Physiol. 2004;286(6)11129–1139.
   Google Scholar
• Epler GR, Colby TV. The spectrum of bronchiolitis obliterans. Chest. 1983; 83 (2): 161–162.
   PubMed Web of Science ®Google Scholar
• Fowler EH, Dodd DE. Acute inhalation studies with methyl iso-cyanate vapor. II. Respiratory tract changes in guinea pigs, rats, and mice. Fundam Appl Toxicol. 1986; 6 (4): 756–771.
   Google Scholar
• Kilgour JD, Rattray NJ, Foster J, Soames A, Hext PM. Pulmonary responses and recovery following single and repeated inhalation exposure of rats to polymeric methylene diphenyl diiso-cyanate aerosols. J Appl Toxicol. 2002; 22 (6): 371–385.
   PubMed Web of Science ®Google Scholar
• Burge P, Robertson A, Cullinan P, Howell T. Obliterative Bron-chiolitis in Boatbuilders Exposed to Styrene and Isocyanates. Am J Respir Crit Care Med. 2008; 177: a157.
   Google Scholar