1. 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

2. 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

3. 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

4. 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

5. 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

6. Surveillance Description Role of companies Role of providers Role of the CA Department of Public Health

7. 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

8. 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

9. 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

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

11. Abnormal Spirometry Evaluation Spirometry & Questionnaire Abnormal spirometry Complete PFTs Normal Fixed obstructionNon-fixed ObstructionRestriction HRCT Asthma: stable Post-hire or worsening control asthma

12. Abnormal Spirometry Evaluation Spirometry & Questionnaire Abnormal spirometry Complete PFTs Normal Fixed obstructionNon-fixed ObstructionRestriction HRCT Asthma: stable Post-hire or worsening control asthma

13. 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

14. Advantage of Using Longitudinal Decline in FEV1 >15 % decline 6 Month Interval Predicted FEV1

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

16. 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

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

18. 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

19. 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

20. 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

21. 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