E7-8075. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Joan Karr, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

Long-Term Efficacy of a Program to Prevent Beryllium Disease—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Beryllium is a lightweight metal with many applications. Exposed workers may be found in the primary production, nuclear power and weapons, aerospace, scrap metal reclamation, specialty ceramics, and electronics industries, among others. The size of the USA workforce at risk of chronic beryllium disease (CBD), from either current or past work-related exposure to the metal, may be as high as one million. Demand for beryllium is growing worldwide, which means that increasing numbers of workers are likely to be exposed.

Exposure to beryllium can lead to sensitization and cause an immunologic granulomatous lung disease. Sensitization is a cell-mediated allergic-type response that may be detected in the peripheral blood with the beryllium lymphocyte proliferation test (BeLPT), which is used by the industry as a surveillance tool. Workers found to be sensitized may be clinically evaluated for CBD with tests including bronchoalveolar lavage and transbronchial biopsy. Cross-sectional studies in various beryllium workplace populations have identified sensitization in the range of less than 1% to 14% of workers. The proportion of sensitized workers who have beryllium disease at initial clinical evaluation has varied from 10 to 100% in different workplaces. Sensitized workers not initially diagnosed with CBD are often diagnosed with the disease upon follow-up, but whether all sensitized workers will eventually develop beryllium disease is unknown. Industry screening programs have enabled the identification of CBD in persons without apparent symptoms, often early in disease progression (often referred to as “subclinical disease”). Progression from sensitization to subclinical disease to clinical impairment, while difficult to predict for any one individual, is not uncommon.

Currently, there are no preventive programs that have been demonstrated to have long-term effectiveness in preventing beryllium sensitization and CBD among beryllium-exposed workers. In the United States, recent short-term evidence (i.e., average work tenure 16 months, maximum four years) at one facility suggests that the comprehensive preventive program that was implemented by company management beginning in 2000 has successfully reduced the incidence of beryllium sensitization, as defined by the occurrence of confirmed abnormal BeLPTs. However, the follow-up has thus far been limited to current workers, the duration has been too short to document a reduced incidence of CBD, and it is possible that sensitization has been delayed, rather than prevented. Evaluation of this program's effectiveness would therefore be more complete by including individuals who have left employment and documenting whether: (1) The program was effective at two other facilities at which it was implemented, (2) the program prevented beryllium sensitization over a longer period of time (i.e., up to eight years); and (3) the program prevented CBD, which generally takes longer to develop.

Study Design

This proposed study is designed to evaluate the effectiveness of a comprehensive preventive program at three beryllium plants. Eligible workers for this survey include those hired between implementation of a comprehensive program (2000-01) and December 31, 2008, including any already known to be sensitized. NIOSH will offer all eligible current and former workers the BeLPT to identify sensitization and administer a work and medical history questionnaire.

There are no costs to former worker respondents except their time to participate in the interview. Current workers will participate during work hours, and will thus be compensated for their time by their employer. Former workers will participate during their own time.

Estimate of Annualized Burden Hours

Respondents	Number of respondents	Number of responses/respondent	Avg. burden/response (in hours)	Total burden (in hours)
Current Workers	239	1	45/60	179
Former Workers	340	1	45/60	255
Total	579			434

Dated: April 23, 2007.

Joan F. Karr,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.