[Federal Register Volume 84, Number 180 (Tuesday, September 17, 2019)]
[Notices]
[Pages 48929-48931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20083]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-19-BPL; Docket No. CDC-2019-0079]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
[[Page 48930]]
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Aerosols from cyanobacterial
blooms: Exposures and health effects in a highly exposed population.
CDC will conduct a study of 50 people highly exposed to cyanobacterial
harmful algal blooms (CyanoHABs) to assess exposure to CyanoHAB
aerosols and determine if exposure is associated with health symptoms
and/or outcomes.
DATES: CDC must receive written comments on or before November 18,
2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0079 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses.
5. Assess information collection costs.
Proposed Project
Aerosols from cyanobacterial blooms: exposures and health effects
in a highly exposed population--New--National Center for Environmental
Health, Centers for Disease Control and Prevention (CDC).
Background and Brief Description
CDC's National Center for Environmental Health (NCEH) has conducted
two studies to investigate the associations between exposure to
cyanoHAB toxins and health outcomes. In a 2006 study of recreational
microcystin (MC) exposure at a small lake, CDC recruited 104 study
participants from lake visitors planning recreational activities, such
as boating, that would generate aerosols. During data collection for
that study, MC concentrations within the bloom lake water were very low
(<2-5 mg/L). Study participants' plasma MC concentrations were all
below the limit of detection (0.147 mg/L) for the enzyme-linked
immunosorbent assay (ELISA).
In 2007 CDC/NCEH conducted a study of recreational MC exposure
among 81 children and adults planning recreational activities on either
of three California reservoirs--two with significant, ongoing blooms of
toxin-producing cyanobacteria, including Microcystis aeruginosa and one
without a toxin-producing algal bloom. Our findings indicated that
recreational activities in water bodies that experience toxin-producing
cyanobacterial blooms generate aerosolized cyanotoxins, making
inhalation a potential route of exposure.
It is likely that healthy people will not have adverse acute
effects from periodic exposures to MC in aerosols generated by water
based recreational activities in lakes with patches of toxin producing
blooms. However, microcystins are potent liver toxins, and exposure may
lead to more long-term effects. Other potent cyanotoxins, such as
anatoxin-a or cylindrospermopsin may be incorporated into aerosols and
inhaled and deposited in the body, presenting other, potentially
synergistic, health risks. In addition, it is possible that swimming
and other water-based activities that result in swallowing water
present a higher risk for adverse health effects from ingesting
cyanobacterial cells and extracellular toxins in the water.
CyanoHABs may present additional health risks as they senesce, or
die off. Previous work done in Wisconsin demonstrated low but
measurable concentrations of hydrogen sulfide and methane, both
respiratory irritants, in the air near dense and decomposing
cyanobacterial blooms.
The subpopulation to be studied comprises adults at least 18 years
of age, who have extensive occupational exposure to CyanoHABs on Lake
Okeechobee, Florida and connecting rivers. The study will be conducted
on Lake Okeechobee, Florida, U.S.A., which has a history of prolonged
CyanoHAB events.
CDC will notify potentially interested participants using posted
flyers with a phone number to call. CDC will recruit participants using
a phone-based screening survey to determine eligibility. Eligible study
participants will complete three appointments (at the beginning of the
study to provide baseline data and in the middle and end of the study
period). During the interviews, participants will complete a survey, do
a pulmonary function test, provide urine and nasal swabs for analysis
of cyanotoxins, and provide a blood specimen for analysis of liver
enzyme levels and creatinine. Before (pre-exposure) and after (post-
exposure) each of 12 boat trips, study participants will complete the
survey and provide urine and nasal swab specimens. Study participants
will donate one fish from each trip to be analyzed for cyanobacterial
toxins and the GPS
[[Page 48931]]
Exchange Format (GPX) file of the boat's travels.
Results from surveys, blood and urine specimens, nasal swabs,
pulmonary function test results, air, and fish samples will be analyzed
using univariate methods to summarize the data. CDC staff will compare
the following information to determine if there are correlations: (1)
Individual's pre-exposure results with post-exposure results, and (2)
biomonitoring results with cyanotoxin levels in air and water. CDC
staff will assess environmental and biomonitoring over time, and
overlay satellite photos provided by NOAA with GPX tracking files from
the boats to further assess exposure. The total annualized burden to
respondents is 784 hours.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Interested community members.. Screening survey 70 1 15/60 6
Eligible study participants... Survey.......... 50 27 15/60 113
Eligible study participants... Blood Specimen 50 3 15/60 13
Results.
Eligible study participants... Nasal Swab 50 27 10/60 75
Results.
Eligible study participants... Lung Function 50 27 45/60 338
Test Results.
Eligible study participants... Urine Specimen 50 27 10/60 75
Results.
Eligible study participants... GPX File of Trip 50 12 15/60 50
Eligible study participants... Record of fish 50 12 30/60 102
for Analysis by
EPA.
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Total..................... ................ .............. .............. .............. 784
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-20083 Filed 9-16-19; 8:45 am]
BILLING CODE 4163-18-P