[Federal Register: February 12, 2007 (Volume 72, Number 28)]
[Notices]
[Page 6570-6571]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe07-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-07-0527]
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 or
send comments to Joan F. Karr, CDC Reports Clearance Officer, 1600
Clifton Road, MS-D74, Atlanta, GA 30333 or send an email 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 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
[[Page 6571]]
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 recruit 100 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.
Estimate of Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Forms respondents responses per response (in hours
respondent hours)
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Screening Questionnaire......................... 188 1 10/60 31
Pre-exposure Questionnaire...................... 150 1 10/60 25
Post-exposure Questionnaire..................... 150 1 10/60 25
10-day post exposure Questionnaire.............. 150 1 10/60 25
Total....................................... .............. .............. .............. 106
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Dated: February 6, 2007.
Joan F. Karr,
Acting Reports Clearance Officer. Centers for Disease Control and
Prevention.
[FR Doc. E7-2309 Filed 2-9-07; 8:45 am]
BILLING CODE 4163-18-P