[Federal Register: September 12, 2007 (Volume 72, Number 176)]
[Notices]
[Page 52132-52133]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se07-95]
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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 omb@cdc.gov. 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