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Medical Surveillance for Flavorings-Related Lung Disease in Flavor Manufacturing Workers: The CA Department of Medical Surveillance for Flavorings-Related Lung Disease in Flavor Manufacturing Workers: The CA Department of Public Health Experience Thomas J. Kim, MD, MPH Epidemic Intelligence Service Officer California Department of Public Health Occupational Health Branch www. dhs. ca. gov/ohb/flavorings. htm

Identification of Bronchiolitis Obliterans (BO) in California • • • 29 y/o Male in Identification of Bronchiolitis Obliterans (BO) in California • • • 29 y/o Male in August 2004 40 y/o Female in April 2007 Powder-flavor mixers Non-smokers, no prior chemical exposure Symptoms after 2 – 5 yrs exposure BO diagnosis based on history, fixed airways obstruction and high resolution CT (HRCT) findings

The California Response • • Cal/OSHA citations and special order Diacetyl hazard factsheet Identification The California Response • • Cal/OSHA citations and special order Diacetyl hazard factsheet Identification of diacetyl users in CA Collaboration among – Cal/OSHA – Industry and medical consultant – CA Department of Public Health – Technical assistance from NIOSH

CA Response: Industry Special Emphasis Program • Companies agreed to – Undergo IH assessment CA Response: Industry Special Emphasis Program • Companies agreed to – Undergo IH assessment – Start a medical surveillance program – Implement exposure controls – Otherwise be subject to compliance inspections • Data obtained from 21 companies – Approximately 530 workers

Goals of Medical Surveillance • Primary – Identify BO at earliest onset – Industry-wide Goals of Medical Surveillance • Primary – Identify BO at earliest onset – Industry-wide analysis to identify risk factors to guide prevention measures • Secondary – Identify other occupational lung disease related to flavor manufacturing – Improve longitudinal surveillance and spirometry quality in CA occupational health clinics

Surveillance Description • Role of companies • Role of providers • Role of the Surveillance Description • Role of companies • Role of providers • Role of the CA Department of Public Health

Role of Companies • Appropriately identify workers at potential risk and enroll in surveillance Role of Companies • Appropriately identify workers at potential risk and enroll in surveillance • Contract with qualified clinical services • Ensure surveillance occurs at recommended intervals • Train workers • Communicate with health provider, IH, and Cal/OSHA on necessary interventions

Role of Providers • • • Implement recommended guidelines Administer questionnaire and spirometry Educate Role of Providers • • • Implement recommended guidelines Administer questionnaire and spirometry Educate workers at each visit Maintain good spirometry quality Initiate further evaluation in workers with abnormal screening • Protect workers through duty modifications or removal • Workplace visits and ensure good communication with companies

Role of CDPH • Serve as a consultant to local providers • Develop surveillance Role of CDPH • Serve as a consultant to local providers • Develop surveillance guidelines • Provide central review of spirometry quality • Analyze industry wide surveillance data • Work with Cal/OSHA and NIOSH to prevent disease via control measures

Surveillance Overview Questionnaire Spirometry Occupational Health Provider Worker status determination Feedback & consultation to Surveillance Overview Questionnaire Spirometry Occupational Health Provider Worker status determination Feedback & consultation to provider CDPH: Spirometry quality review; surveillance data interpreted Further medical evaluation; Duty modification; Cal/OSHA evaluation; Workplace intervention

Abnormal Spirometry Evaluation Spirometry & Questionnaire Abnormal spirometry Normal Complete PFTs Fixed obstruction Non-fixed Abnormal Spirometry Evaluation Spirometry & Questionnaire Abnormal spirometry Normal Complete PFTs Fixed obstruction Non-fixed Obstruction Post-hire or worsening control asthma HRCT Asthma: stable Restriction

Abnormal Spirometry Evaluation Spirometry & Questionnaire Abnormal spirometry Normal Complete PFTs Fixed obstruction Non-fixed Abnormal Spirometry Evaluation Spirometry & Questionnaire Abnormal spirometry Normal Complete PFTs Fixed obstruction Non-fixed Obstruction Post-hire or worsening control asthma HRCT Asthma: stable Restriction

FEV 1 and FEV 1/FVC • Obstructive pattern: – FEV 1/FVC ≤ LLN – FEV 1 and FEV 1/FVC • Obstructive pattern: – FEV 1/FVC ≤ LLN – Interval FEV 1 decline > 15% from baseline • FEV 1/FVC alone – Provides increased sensitivity • For the elderly • And young healthy males • FEV 1/FVC – >70% – LLN (90% NHANES predicted) per ATS

Advantage of Using Longitudinal Decline in FEV 1 6 Month Interval >15 % decline Advantage of Using Longitudinal Decline in FEV 1 6 Month Interval >15 % decline Predicted FEV 1

Abnormal Spirometry Evaluation Spirometry & Questionnaire Abnormal spirometry Normal Complete PFTs Fixed obstruction Non-fixed Abnormal Spirometry Evaluation Spirometry & Questionnaire Abnormal spirometry Normal Complete PFTs Fixed obstruction Non-fixed Obstruction Post-hire or worsening control asthma HRCT Asthma: stable Restriction

Bronchiolitis Obliterans Case • Obstructive pattern on spirometry • Fixed obstruction on pre/post bronchodilation Bronchiolitis Obliterans Case • Obstructive pattern on spirometry • Fixed obstruction on pre/post bronchodilation spirometry • On High Resolution Chest CT (HRCT) – Mosaic pattern of attenuation – Air trapping on expiratory views – Cylindrical bronchiectasis – others

Abnormal Spirometry Evaluation: Asthma Spirometry & Questionnaire Abnormal spirometry Normal Complete PFTs Fixed obstruction Abnormal Spirometry Evaluation: Asthma Spirometry & Questionnaire Abnormal spirometry Normal Complete PFTs Fixed obstruction Non-fixed Obstruction Post-hire or worsening control asthma HRCT Asthma: stable Restriction

Concurrent Lung Conditions: Asthma • • Communicate with PMD Workplace hazard education Higher threshold Concurrent Lung Conditions: Asthma • • Communicate with PMD Workplace hazard education Higher threshold for suspicion Further evaluation warranted – Newly diagnosed through surveillance – Any post-hire onset – Worsening medical control

The Reality of Surveillance from the Public Health Perspective • Non-uniform data collection of The Reality of Surveillance from the Public Health Perspective • Non-uniform data collection of symptoms, work information and exposures • Poor timeliness of medical records • Until recently, lack of recommended guidelines • Spirometry quality • Unacceptable curves • Poor repeatability • Improper instrument set up for result printout

Continuing Efforts • Finalize database and analyze questionnaire and spirometry data – Cross-sectional analysis Continuing Efforts • Finalize database and analyze questionnaire and spirometry data – Cross-sectional analysis – Longitudinal analysis • Work with providers on improving spirometry quality • Continue to serve in consulting role

Acknowledgements • CA Dept of Public Health – Barbara Materna – Janice Prudhomme – Acknowledgements • CA Dept of Public Health – Barbara Materna – Janice Prudhomme – Egils Kronlins • NIOSH – – – Kay Kreiss Nancy Sahakian Kathy Fedan Brian Tift Eva Hzindo Lee Petsonk • Consulting Experts – – – Cecile Rose Leslie Israel Paul Enright Phil Harber John Balmes • Cal/OSHA – Dan Leiner – Kelly Howard and other HIs • EIS Field Assignments Branch – Sheryl Lyss The findings and conclusions in this presentation have not been formally disseminated by the CDC and should not be construed to represent any agency determination or policy