[Federal Register Volume 72, Number 176 (Wednesday, September 12, 2007)]
[Notices]
[Pages 52132-52133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-17962]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-07-0527]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

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).

[[Page 52133]]

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
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                                                                                     Number of    Average burden
                              Forms                                  Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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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
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    Dated: September 6, 2007.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E7-17962 Filed 9-11-07; 8:45 am]
BILLING CODE 4163-18-P