E7-17962. Proposed Data Collections Submitted for Public Comment and Recommendations

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Proposed Project

Human Exposure to Cyanobacterial Toxins in Water (OMB No. 0920-0527)—Reinstatement—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

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.

During August 2006, we conducted our first study to assess exposure to microcystins in recreational waters with a bloom of Microcystis aeruginosa. We recruited 104 people who gave informed consent to participate. Ninety seven people did their recreational activities on Lake 1, which had a confirmed M. aeruginosa bloom, and 7 others did their activities on Lake 2, which had no bloom. Study participants completed a pre-activity questionnaire, a post-activity questionnaire, provided a 10-ml blood sample, and completed a telephone symptom survey 7-10 days after exposure. The concentrations of microcystins in Lake 1 ranged from 2 to 5 ug/L and in Lake 2 were all below the limit of detection (LOD). When we designed the study, we calculated that a person exposed to recreationally-generated aerosols from water containing 10 ug/L of microcystins should have levels of microcystins in their blood. However, the microcystin concentrations in Lake 2 were below the LOD and in Lake 1 were actually 2ug/L to 5ug/L, much lower than we anticipated based on data from the previous week. Thus, the recreational exposures were not likely high enough for us to quantify microcystins in blood and the serum samples were all below the LOD for microcystins.

For the new data collection, we will conduct two separate studies in different lakes. In total, we will recruit 200 study participants who are at risk for swallowing water or inhaling spray (i.e., water skiers, jet skiers, people sailing small boats) and who would normally be doing these activities, even in the presence of a bloom. We may recruit people who train for organized swimming events (e.g., triathlons) in lakes. In addition, we will recruit 50 study participants from lakes with no blooms as a comparison group to assess the health effects associated with recreational activities on “clean” lakes. Study participants will be asked to sign a consent form, complete a symptom survey before and after doing their recreational water activities, provide one 10-ml whole blood sample after their recreational activities, and complete a telephone symptom survey 8-10 days after doing study activities.

The purpose of the new data collection is to continue assessing the public health impact of exposure to the cyanobacterial toxins, microcystins, during recreational activities. We will examine the extent of human exposure to microcystins present in recreational waters and associated aerosols and whether serum levels of microcystins can be used as a biomarker of exposure.

There is no cost to the respondents other than their time. The total estimated annualized burden hours are 69.

Estimated Annualized Burden Hours

Forms	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Screening questionnaire	125	1	5/60
Consent and pre-exposure questionnaire	100	1	10/60
Post-exposure questionnaire	100	1	15/60
10-day post exposure questionnaire	100	1	10/60

Dated: September 6, 2007.

Maryam I. Daneshvar,

Reports Clearance Officer, Centers for Disease Control and Prevention.