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GLIN==> Persistent Pollutants in Pregnant Women
- Subject: GLIN==> Persistent Pollutants in Pregnant Women
- From: "Alex J. Sagady & Associates" <ajs@sagady.com>
- Date: Wed, 08 Jun 2005 13:05:17 -0400
- Delivered-to: glin-announce-archive@glc.org
- Delivered-to: glin-announce@great-lakes.net
- List-name: GLIN-Announce
This should be of interest to those interested in Great Lakes toxicants....
Today's Federal register
[Federal Register: June 8, 2005 (Volume 70, Number 109)]
[Notices]
[Page 33498-33499]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn05-109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-05-0445X]
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) 371-5983 or send an e-mail
to <A HREF="mailto:omb@cdc.gov";>omb@cdc.gov</A>. Send written comments to CDC Desk Officer, Human
Resources and Housing Branch, New Executive Office Building, Room
10235, Washington, DC 20503 or by fax to (202) 395-6974. Written
comments should be received within 30 days of this notice.
Proposed Project
A Multi-Center Study to Assess Exposure to Environmental Pollutants
Among Primiparous Women in North America--New--National Center for
Environmental Health (NCEH), Centers for Disease Control and Prevention
(CDC).
[[Page 33499]]
Background and Brief Description
Persistent organic pollutants (POPs) are a group of man-made
chemicals that can stay in the environment for long periods of time and
can be transported long distances in the environment. Heavy metals such
as lead and mercury are naturally found substances that can also be
released into the environment as a result of human activities (e.g.,
smelting). Exposure to these contaminants, even at low levels, may lead
to adverse health effects, particularly in high-risk groups such as the
unborn child. However, before we attempt to determine if these
contaminants are associated with health effects, we have to find out if
these contaminants are present in our blood and in what amounts. The
Arctic Monitoring and Assessment Program (AMAP), established in 1991
under the Arctic Environmental Protection Strategy (AEPS), has the
responsibility to monitor levels and assess effects of selected
pollutants (i.e., POPs and heavy metals) in all Arctic locations. To
our knowledge, a similar integrated program for monitoring exposure to
POPs and metals does not exist in North America.
The proposed program will monitor levels of POPs and heavy metals
in first-time pregnant (Primiparous) women. The program will help
determine geographical and temporal trends of these exposures in
selected cities within the United States, Canada, and Mexico. CDC will
be responsible for the investigation in the United States; Canada and
Mexico will be responsible for the investigation in their countries.
The findings will inform first-time pregnant women in the vicinity of
the study sites of their exposure to selected POPs and heavy metals.
This program will also provide unique information regarding
accumulation of POPs and heavy metals in relation to dietary patterns,
and will allow assessment of trends in diet, which is critical public
health information. Biomonitoring for POPs and metals will enhance
awareness among this vulnerable population of the risks posed by these
chemicals in various regions of North America and help identify ways to
reduce exposure. The program will enroll 25 pregnant women (20-25 years
of age) per site (United States: 5 sites; Canada: 5 sites; Mexico: 10
sites). The current protocol only describes and seeks approval for
enrollment of 75 pregnant women from three of the five U.S. sites. Two
U.S. sites have ongoing studies, in collaboration with CDC, where they
are testing maternal blood for POPs and metals; these two sites are
non-federal, academic institutions, and CDC does not have a formal
funding agreement with these institutions. Data from previous projects
in the United States and Canada will be used for comparing results of
the current project. As there has been little national or regional
monitoring in Mexico, more sites will be selected in Mexico than in the
United States and Canada.
In collaboration with obstetricians at the local sites, study
participants will be recruited during their prenatal clinic visit,
after their 36th week of pregnancy but prior to delivery. One person
from the study team will approach the mother during a routine prenatal
visit, explain the project, and obtain signed consent if the mother is
willing to participate. The study will involve administering an
exposure questionnaire and collection of blood and urine samples during
the 3rd trimester of the pregnancy. This is only a one-time study;
blood collection and administration of the questionnaire will only be
done once. All samples will be analyzed at a single laboratory in each
country, and the results will be distributed to the study participants
and their physicians prior to publication. There are no costs to
respondents other than their time. The estimated total annualized
burden hours are 53 hours.
Estimate of Annualized Burden Table:
----------------------------------------------------------------------------------------------
Number of Average burden
Type or respondents Number of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------
Screening First-time Pregnant Women............ 106 1 5/60
Demographic and Health History Questionnaire... 75 1 10/60
Food Frequency Questionnaire................... 75 1 25/60
----------------------------------------------------------------------------------------------
Dated: May 31, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 05-11371 Filed 6-7-05; 8:45 am]
BILLING CODE 4163-18-P
------------------------------------------
==========================================
Alex J. Sagady & Associates http://www.sagady.com
Environmental Enforcement, Permit/Technical Review, Public Policy,
Evidence Review and Litigation Investigation on Air, Water and
Waste/Community Environmental and Resource Protection
Prospectus at: http://www.sagady.com/sagady.pdf
PO Box 39, East Lansing, MI 48826-0039
(517) 332-6971; (517) 332-8987 (fax); ajs@sagady.com
==========================================
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