2020-21735. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Understanding Long-term Respiratory Morbidity in Former Styrene-Exposed Workers: Medical Survey to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on February 28, 2020 to obtain comments from the public and affected agencies. CDC received one public comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone]. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Understanding Long-term Respiratory Morbidity in Former Styrene-Exposed Workers: Medical Survey—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Styrene is used in the production of automobile parts, boats, computer housings, food containers, wind energy components, and many other products. An estimated 90,000 U.S. workers are potentially exposed to styrene at more than 5,000 U.S. manufacturing plants. Occupational exposure to styrene has been associated with deleterious health effects, including changes in color vision, mucous membrane irritation, hearing loss, and neurocognitive impairment. Workplace exposure to styrene has also been associated with cases of non-malignant respiratory disease (NMRD), including COPD and obliterative bronchiolitis. However, little is understood about the long-term respiratory effects on styrene-exposed workers.

The goal of this project is to understand the prevalence of long-term respiratory morbidity in styrene-exposed workers. The objectives of the proposed study are: (1) To characterize work exposures by acquiring job histories and comparing with historical exposure levels obtained from a past industrial hygiene survey, (2) to examine prevalence of respiratory morbidity by duration and level of styrene exposure and other characteristics, (3) to apply research biomarkers of lung injury to a styrene-exposed workforce, and (4) to describe the prevalence of color vision impairment with the presence of respiratory morbidity. Our hypothesis is that workers previously exposed to high concentrations of styrene (≥5 ppm), even those with short tenure (<1 year), will have a higher prevalence of respiratory symptoms and lung function abnormalities compared with workers exposed to low concentration of styrene (<5ppm).

We will conduct face-to-face interviews with members of a cohort of workers from two reinforced plastic boatbuilding plants that closed in 1989 and 1993. The purpose of the interviews is to collect demographic information, detailed job history during and after the worker's tenure at the boatbuilding plant, upper and lower respiratory symptoms, physician diagnoses of respiratory diseases, cigarette smoking history, and medication use. A NIOSH employee will conduct the interviews. We will also conduct several lung function tests including: Exhaled nitric oxide, impulse oscillometry, multiple-breath washout, spirometry, and bronchodilator reversibility testing.

The purpose of the lung function testing is to identify small and large airway abnormalities that are consistent with NMRD. NIOSH technicians will perform the lung function testing. We will collect blood to analyze for biomarkers associated with lung injury caused by obliterative bronchiolitis. A NIOSH phlebotomist will collect the blood samples. Finally, we will assess cohort members for color vision abnormalities using the Lanthony D-15 Color Test. Color vision assessment will be completed by a NIOSH technician.

The only cost to boatbuilder cohort members is local travel to the medical survey site and their time. The total estimated burden hours are 712.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Boatbuilder Cohort Members	Questionnaire and medical survey consent form	676	1	15/60
Boatbuilder Cohort Members	Questionnaire	676	1	45/60
Boatbuilder Cohort Members	Exhaled Nitric Oxide—no form	676	1	5/60
Boatbuilder Cohort Members	Impulse Oscillometry—no form	676	1	10/60
Boatbuilder Cohort Members	Spirometry—no form	676	1	10/60
Boatbuilder Cohort Members	Bronchodilator Test—no form	50	1	20/60
Boatbuilder Cohort Members	Multiple-Breath Washout—no form	676	1	30/60
Boatbuilder Cohort Members	Color vision test—no form	676	1	5/60
Boatbuilder Cohort Members	Blood test—no form	676	1	5/60

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.