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 404-498-1210 or send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-E11, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov.

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

Human Exposure to Cyanobacterial (blue-green algal) Toxins in Drinking Water: Risk of Exposure to Microcystin from Public Water Systems (OMB No. 0920-0527) “ Revision—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).

Cyanobacteria (blue-green algae) can be found in terrestrial, fresh, brackish, or marine water environments. Some species of cyanobacteria produce toxins that may cause acute or chronic illnesses (including neurotoxicity, hepatotoxicity, and skin irritation) in humans and animals (including other mammals, fish, and birds). A number of human health effects, including gastroenteritis, respiratory effects, skin irritations, allergic responses, and liver damage, are associated with the ingestion of or contact with water containing cyanobacterial blooms. Although the balance of evidence, in conjunction with data from laboratory animal research, suggests that cyanobacterial toxins are responsible for a range of human health effects, there have been few epidemiologic studies of this association.

CDC originally planned to conduct a study of human exposure to microcystins in drinking water from a source with a cyanobacterial bloom. However, regional weather patterns over the last 2 years (since the original OMB application was approved) have not supported blooms in the lake that is the source of drinking water for our cooperating utility. Therefore, we have decided to redirect our activities to assess recreational exposures. Anecdotal evidence suggests that exposure to cyanobacterial toxins in recreational waters may be an important public health issue.

CDC, National Center for Environmental Health plans to recruit 2,000 people (2,500 contacts, 80% agreeing to participate) as they arrive to participate in recreational activities on fresh water bodies with cyanobacteria blooms. Questionnaires will be administered to all study participants while they are on the beach and again when they leave the beach for the day. CDC plans to contact them by phone 7 days after their beach exposure to administer a final questionnaire. Water samples for levels of cyanobacterial toxins and water quality indicators, including microorganisms will also be examined. Blood samples will be collected from a subset of study participants who are exposed to recreational waters with blooms of Microcystis aeruginosa. Blood samples will be analyzed using a newly developed molecular assay for levels of microcystin L-R-one of the hepatotoxins produced by this organism. CDC will evaluate the probability of detecting (1) increases in symptoms after people engage in recreational activities in water bodies during cyanobacteria blooms, and (2) low levels of microcystins (<10 ng/ml of blood) in the blood of people who are exposed to very low levels of this toxin while engaged in recreational activities. There are no costs to respondents except their time to participate in the survey.