Document byJwmvy412JZVJzyeaEaoBng3

July 26, 2006 The Honorable Elaine L. Chao Secretary of Labor U.S. Department of Labor 200 Constitution Avenue, NW Room S-2018 Washington, DC 20210 Dear Secretary Chao: We are writing to express our strong support for the petition submitted by the United Food and Commercial Workers International Union and the International Brotherhood of Teamsters calling upon the Occupational Safety and Health Administration to issue an Emergency Temporary Standard (ETS) to protect workers exposed to the chemical diacetyl (2,3butanedione, CAS # 431-03-8), and to initiate formal rulemaking for permanent regulations to protect workers exposed to diacetyl and other harmful flavoring-related chemicals. Diacetyl is a commonly used food flavoring and is the primary constituent of artificial butter flavoring. There is compelling scientific evidence linking occupational exposure to diacetyl to bronchiolitis obliterans, a debilitating and sometimes fatal lung disease. In the general population, bronchiolitis obliterans is rare. In the last few years, however, numerous cases have been reported to or identified by the National Institute for Occupational Safety and Health (NIOSH) among workers employed in factories where flavorings containing diacetyl are produced or used.1 Dozens of workers employed at popcorn plants have developed occupational lung disease, and at least one has died. Several of these workers are on lung transplant lists.2,3,4 The sentinel case of the recent outbreak of bronchiolitis obliterans was a Missouri microwave popcorn plant worker diagnosed with the condition in 1999. The physician who diagnosed the case notified Missouri's health department, which in turn notified the Centers for Disease Control and Prevention (CDC), NIOSH's parent agency. In August 2000, NIOSH began an investigation at the Jasper, Missouri microwave popcorn plant where eight current or former workers had developed the disease.5 In this investigation, NIOSH scientists found that respiratory symptoms were linked with exposure to diacetyl and butter flavor. Workers at this plant had chronic cough and shortness of breath at a rate 2.6 times higher than what would be expected in the U.S. population. Twice as many workers than expected reported being told by their physicians that they had asthma or chronic bronchitis. Lung function testing revealed that three times as many workers as expected had obstruction to airflow. These results were reported first in the CDC's Morbidity and Mortality Weekly Report and then in the New England Journal of Medicine.6,7 In all, NIOSH has conducted six investigations at 10 microwave popcorn facilities, finding respiratory impairment among workers at a majority of the plants.3,8,9,10,11,12 Since the initial reports focused on individuals employed in microwave popcorn factories, the disease is often called "popcorn workers lung."13,14 It has become clear, however, that the disease has struck workers in other segments of the food and flavoring industry, and is not limited to microwave popcorn facilities.15 The California Department of Health Services has recently reported two cases among diacetyl-exposed workers employed at factories at which the flavorings are produced.16 To pursue their investigations, NIOSH has developed sampling and analytical methods for measuring exposure to flavoring-related chemicals.17 At the Jasper, Missouri plant, diacetyl was measured in concentrations ranging as high as 98 parts per million parts air by volume (ppm), with a mean of 8.1 ppm.18 In their evaluation of six microwave popcorn plants (five of which had workers with flavoring-associated lung disease), NIOSH scientists reported that the "lowest mean TWA [time weighted average] diacetyl air concentrations that we measured in mixing areas (0.02 ppm personal exposure and 0.2 ppm area air concentration) were at a plant with an affected mixer." On the basis of this finding, the NIOSH scientists concluded "it would seem prudent to maintain worker exposures to diacetyl below these levels."19 The role of diacetyl in the development of bronchiolitis obliterans has been confirmed in studies of laboratory animals. In 1993, a manufacturer of diacetyl conducted a study, which was never reported to the government or published in scientific literature, in which rats were exposed to pure diacetyl. The study found that one four-hour period of exposure to diacetyl resulted in an "abundance of symptoms indicative for respiratory tract injury."20 Following the recent outbreak of cases among humans, NIOSH scientists conducted a study in which rats were exposed to airborne concentrations of heated butter flavoring, of which diacetyl was the primary constituent. The rats were exposed for a single, six-hour period. The scientists reported significant lung damage among rats whose exposure was as low as 203 ppm, which according to the authors was "not extraordinary when compared with levels measured in the workplace."21 NIOSH scientists then conducted a study in which rats were exposed to pure diacetyl and found similar results.22 A toxicological study of guinea pigs exposed to diacetyl found exposure to the chemical caused adverse effects to respiratory tissue and structure.23 Although the precise number of workers already suffering respiratory effects from exposure to diacetyl is unknown, the potential magnitude of the problem is sizeable. NIOSH is currently investigating 15 cases of respiratory disease, including some workers with bronchiolitis obliterans, among the employees at a single Cincinnati, Ohio flavor manufacturing plant.3 Additional research will provide useful data on the mechanism through which flavoringrelated chemicals cause obstructive lung disease. However, NIOSH has already generated sufficient information for OSHA to issue rules to reduce exposure to these toxic chemicals. In their recent report, NIOSH scientists wrote that "(b)ecause entirely safe levels of occupational exposure to butter-flavoring chemicals are not known, it is important to limit 2 worker exposures as much as possible."19 It is the regulatory responsibility of OSHA to protect workers from exposure to workplace hazards. OSHA has issued permissible exposure limits (PELs) and/or NIOSH has recommended exposure limits (RELs) for only 46 of the 1,037 flavoring ingredients considered by the flavorings industry to represent potential respiratory hazards.1 This regulatory gap2 needs to be addressed; for this reason, we support the United Food and Commercial Workers (UFCW) and the International Brotherhood of Teamsters (IBT) petition to OSHA to initiate formal rulemaking to establish a permanent standard to protect workers from lung disease caused by flavoring-related chemicals. Until OSHA completes permanent rulemaking on flavoring-related chemicals, an ETS for diacetyl is essential. The data gathered by NIOSH indicate an appropriate emergency PEL would be below 0.2 ppm.19 In order to provide a sufficient margin of safety, the petition calls for an emergency temporary PEL of 0.05 ppm, averaged over an eight-hour day. Although other flavoring-related chemicals are likely to contribute to the adverse lung effects as well, controlling exposure to diacetyl, a known cause of bronchiolitis obliterans and a primary component of butter flavor, will also result in the reduction of exposure to other airborne contaminants in the workplace. In summary, there is compelling epidemiologic and toxicological evidence linking exposure to diacetyl to severe respiratory impairment and disease. It is more than thirty months since NIOSH issued an alert calling upon employers to "minimize occupational exposures to flavorings or flavoring ingredients."1 It is now time for OSHA to use the scientific evidence to protect American workers from debilitating lung disease. If you have any questions regarding this matter, please contact: David Michaels, PhD Professor and Associate Chairman Department of Environmental and Occupational Health George Washington University School of Public Health 2100 M Street NW, Suite 203 Washington, DC 20037 Phone: 202-994-2461 Email: eohdmm@gwumc.edu Respectfully submitted, (Affiliations listed for identification purpose only) 3 Nicholas A. Ashford, PhD, JD Professor of Technology and Policy, and Director MIT Technology and Law Program Massachusetts Institute of Technology Dean Baker, MD, MPH Professor and Chief Occupational and Environmental Medicine, and Director Center for Occupational and Environmental Health University of California, Irvine John M. Balbus, MD, MPH Director Health Program Environmental Defense John R. Balmes, MD Professor of Medicine University of California San Francisco, and Professor of Environmental Health Sciences University of California Berkeley School of Public Health Eula Bingham, PhD Professor Department of Environmental Health University of Cincinnati College of Medicine, and Assistant Secretary of Labor for Occupational Safety and Health, 1977-1981 David C. Christiani, MD, MPH, MS Professor of Occupational Medicine and Epidemiology Harvard School of Public Health, and Professor of Medicine Harvard Medical School Richard Clapp, DSc, MPH Professor Department of Environmental Health Boston University School of Public Health Mark R. Cullen, MD Professor of Medicine and Public Health Yale University School of Medicine Ellen A. Eisen, ScD Adjunct Professor of Environmental Health Harvard School of Public Health 4 Adam M. Finkel, ScD, CIH Professor of Environmental and Occupational Health UMDNJ School of Public Health, and Director, Directorate of Health Standards Programs, OSHA, 1995-99, and Regional Administrator, Region VIII, OSHA, 2000-2003 Arthur L. Frank MD, PhD Professor of Public Health and Chair Department of Environmental and Occupational Medicine Drexel University School of Public Health Laurence Fuortes, MD Professor of Occupational and Environmental Health College of Public Health University of Iowa Michael Gochfeld, MD, PhD Professor and Director Occupational & Environmental Residency Program Environmental and Occupational Health Sciences Institute UMDNJ-Robert Wood Johnson Medical School Lynn R. Goldman, MD, MPH Professor Bloomberg School of Public Health Johns Hopkins University, and Assistant Administrator for Toxic Substances, Environmental Protection Agency, 1993-1998 Philip Harber, MD MPH Professor and Chief Division of Occupational and Environmental Medicine David Geffen School of Medicine at UCLA Peter F. Infante, DDS, DrPH Professorial Lecturer Department of Environmental and Occupational Health George Washington University School of Public Health, and Director, Office of Standards Review, OSHA, 1982-2002 Leslie M. Israel, DO, MPH Associate Clinical Professor Center for Occupational and Environmental Health University of California Irvine Joel Kaufman, MD, MPH Professor Departments of Environmental & Occupational Health Sciences and Medicine, and Director of the Occupational and Environmental Medicine Program University of Washington 5 Matthew Keifer, MD, MPH Associate Professor of Medicine and Environmental and Occupational Health University of Washington Joel N. Kline, MD Professor and Director University of Iowa Asthma Center Division of Pulmonary, Critical Care, and Occupational Medicine Roy J. and Lucille A. Carver College of Medicine University of Iowa David Kriebel, ScD Professor Department of Work Environment University of Massachusetts Lowell Sheldon Krimsky, PhD Professor of Urban & Environmental Policy & Planning School of Arts and Sciences Tufts University, and Adjunct Professor Department of Public Health and Family Medicine Tufts School of Medicine Stephen M. Levin, MD Medical Director IJ Selikoff Center for Occupational and Environmental Medicine Mount Sinai School of Medicine Peter Lurie, MD, MPH Deputy Director Public Citizen's Health Research Group Steven Markowitz, MD Professor and Director Center for the Biology of Natural Systems Queens College, The City University of New York Robert McConnell, MD Professor of Preventive Medicine Keck School of Medicine University of Southern California David Michaels, PhD, MPH Professor and Associate Chairman Department of Environmental and Occupational Health George Washington University School of Public Health, and Director, Project on Scientific Knowledge and Public Policy (SKAPP) Assistant Secretary of Energy for Environment, Safety and Health, 1998-2001 6 Rafael Moure-Eraso, PhD, CIH Professor and Chair Department of Work Environment University of Massachusetts Lowell Karen B. Mulloy, DO, MSCH Co-Director Program in Occupational & Environmental Health University of New Mexico Health Sciences Center L. Christine Oliver, MD, MPH, MS Assistant Clinical Professor of Medicine Harvard Medical School, and Associate Physician, Massachusetts General Hospital David Ozonoff, MD, MPH Professor and Chair Emeritus Department of Environmental Health Boston University School of Public Health Allen J. Parmet, MD, MPH, FACPM Colonel, United States Air Force (Retired) Anthony Robbins, MD, MPA Professor Tufts University School of Medicine, and Assistant Surgeon General and Director National Institute for Occupational Safety and Health, 1978-1981 Kenneth Rosenman, MD Professor of Medicine and Chief Division of Occupational and Environmental Medicine Department of Medicine College of Human Medicine Michigan State University Marc Schenker, MD, MPH Professor and Chair Department of Public Health Sciences University of California at Davis School of Medicine Brian S. Schwartz, MD, MS Professor of Environmental Health Sciences, Epidemiology, and Medicine Bloomberg School of Public Health Johns Hopkins University Joel Schwartz, PhD Professor Environmental Epidemiology, Exposure, Epidemiology, and Risk Program Harvard School of Public Health 7 Michael A. Silverstein, MD, MPH Clinical Professor University of Washington School of Public Health and Community Medicine, and Director of Policy, OSHA, 1993-1995 Rosemary K. Sokas, MD, MOH Director and Professor Environmental & Occupational Health Sciences University of Illinois at Chicago Leslie Stayner, PhD Professor and Director Division of Epidemiology and Biostatistics University of Illinois at Chicago School of Public Health Kyle Steenland, PhD Professor Department of Environmental and Occupational Health Rollins School of Public Health, Emory University Laura S. Welch, MD Center to Protect Workers' Rights, and Professorial Lecturer Department of Environmental and Occupational Health George Washington University School of Public Health 8 REFERENCES 1 National Institute for Occupational Safety and Health. Preventing lung disease in workers who use or make flavorings. NIOSH Publication No. 2004-110, 2004. Available at: http://www.cdc.gov/niosh/docs/2004-110/ 2 Michaels D, Monforton C. Scientific evidence in the regulatory system: Manufacturing uncertainty and the demise of the formal regulatory system. J Law Policy 2005;13(1): 17-41. Available at: http://www.defendingscience.org/upload/Scientific-Evidence-in-the-Regulatory-SystemManufacturing-Uncertainty-and-the-Demise-of-the-Formal-Regulatory-System.pdf 3 Schneider A. Disease is swift, response is slow. Baltimore Sun. April 23, 2006. Available at: http://www.baltimoresun.com/news/health/bal-te.flavoring23apr23,0,2684871.story?coll=balnationworld-utility 4 Akpinar-Elci M, Travis WD, Lynch DA, Kreiss K . Bronchiolitis obliterans syndrome in popcorn plant workers. Eur Resp J 2004;24: 298-302. 5 NIOSH Health Hazard Evaluation Report. HETA-2000-0401-2991: Gilster-Mary Lee Corporation, Jasper, Missouri. (January 2006). Available at: http://www.cdc.gov/niosh/hhe/reports/pdfs/2000-04012991.pdf 6 Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. Fixed obstructive lung disease in a microwave popcorn factory-Missouri, 2000-2002. 51:345-347 (Apr. 26, 2002). Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5116a2.htm 7 Kreiss K, et al. Clinical bronchiolitis obliterans in workers at a microwave-popcorn plant. N Engl J Med. 2002;347(5):330-338. 8 NIOSH Health Hazard Evaluation Report. HETA 2003-0112-2949: ConAgra Snack Foods, Marion, Ohio. (December 2004) Available at: http://www.cdc.gov/niosh/hhe/reports/pdfs/2003-0112-2949.pdf 9 NIOSH. Letter to Frank Morrison, Nebraska Popcorn, regarding HETA 2002-0089: Nebraska Popcorn, Clearwater, Nebraska. (July 2, 2003). Available at: http://www.cdc.gov/niosh/hhe/reports/pdfs/2002-0089-letter.pdf 10 NIOSH. Letter to Keith Heuermann, B.K. Heuermann Popcorn, regarding HETA 2001-0517, B.K. Heuermann Popcorn Inc., Phillips, Nebraska. (May 13, 2003) Available at: http://www.cdc.gov/niosh/hhe/reports/pdfs/2001-0517-letter.pdf 11NIOSH Heath Hazard Evaluation Report. HETA 2001-0474-2943: American Pop Corn Company, Sioux City, Iowa. (July 2004). Available at: http://www.cdc.gov/niosh/hhe/reports/pdfs/2001-04742943.pdf 12 NIOSH Health Hazard Evaluation Report. HETA-2002-0408-2915: Agrilink Foods Popcorn Plant, Ridgeway, Illinois. (October 2003). Available at: http://www.cdc.gov/niosh/hhe/reports/pdfs/20020408-2915.pdf 13 Schachter EN. Popcorn workers lung. N Engl J Med. 2002;347(5):360-361. 9 14 Parmet AJ, Von Essen S. Rapidly progressive, fixed airway obstructive disease in popcorn workers: a new occupational pulmonary illness? J Occup Environ Med. 2002;44:216-218. 15 Lockey J.E. et al. Bronchiolitis obliterans in the food flavoring manufacturing industry. Abstract presented at the Annual Meeting of The American Thoracic Society, 20 May 2002. Available at: http://www.abstracts2view.com/atsall/ 16 Harrison R, Gelb A, Harber P. Department of Health Services, State of California. Food flavoring workers with bronchiolitis obliterans following exposure to diacetyl, California, May 15, 2006. Available at: http://www.capanet.org/pdfs/BO_cases_%20final_5_16_06.pdf 17 Pendergrass SM. Method development for the determination of diacetyl and acetoin at a microwave popcorn plant. Environ Sci Technol. 2004;38(3):858-861. 18 Kullman G, et al. Characterization of respiratory exposures at a microwave popcorn plant with cases of bronchiolitis obliterans. J Occup Environ Hyg. 2005;2:169-178. 19 Kanwal R, et al. Evaluation of flavorings-related lung disease risk at six microwave popcorn plants. J Occup Environ Med. 2006;48(2):149-157. 20 BASF. Report: study on the acute inhalation toxicity LC50 of diacetyl FCC as a vapor in rats 4hour exposure. Project No. 1310247/927010, June 8, 1993. Available at: http://www.defendingscience.org/ 21 Hubbs AF, et al. Necrosis of nasal and airway epithelium in rats inhaling vapors of artificial butter flavoring. Toxicol Appl Pharmacol. 2002;185:128-135. 22 Hubbs AF, et al. Inhalation toxicity of the flavoring agent, diacetyl (2,3-butanedione), in the upper respiratory tract of rats. Toxicologist. 2004 ;78(S-1):438-439. Available at: http://www.toxicology.org/AI/Pub/tox/2004Tox.pdf 23 Fedan JS, Dowdy JA, Fedan KB, Hubbs AF. Popcorn worker's lung: In vitro exposure to diacetyl, an ingredient in microwave popcorn butter flavoring, increases reactivity to methacholine. Toxicol Appl Pharmacol (in press). Abstract: Proc Am Thorac Soc 2005 May; 2(Abstracts):A814. 10