05-11371. Proposed Data Collections Submitted for Public Comment and Recommendations

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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).

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:

Type or respondents	Number of respondents	Number of responses per respondent	Average burden per response (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.