E6-7395. Proposed Criteria for Removing Chemicals From Future Editions of CDC's National Report on Human Exposure to Environmental Chemicals

AGENCY:

Centers for Disease Control and Prevention (CDC), Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

On Monday, October 7, 2002, CDC published final criteria for consideration of chemicals or categories of chemicals for possible inclusion in future releases of CDC's “National Report on Human Exposure to Environmental Chemicals (the “Report”) and also solicited chemicals for possible inclusion in future editions of the “Report” (See Federal Register, 67 FR 62477). The final selection criteria have remained the same since the issuance of the 2002 notice. They are as follows: (1) Independent scientific data which suggest that the potential for exposure of the U.S. population to a particular chemical is changing (i.e., increasing or decreasing) or persisting; (2) seriousness of health effects known or suspected to result from exposure to the chemical (for example, cancer, birth defects, or other serious health effects); (3) proportion of the U.S. population likely to be exposed to levels of chemicals of known or potential health significance; (4) need to assess the efficacy of public health actions to reduce exposure to a chemical in the U.S. population or a large component of the U.S. population (for example, among children, women of childbearing age, the elderly); (5) existence of an analytical method that can measure the chemical or its metabolite in blood or urine with adequate accuracy, precision, sensitivity, and speed; and (6) incremental analytical cost (in dollars and personnel) to perform the analyses (preference is given to chemicals that can be added readily to existing analytical methods).

On Tuesday, September 30, 2003, CDC published a record of the nominated chemicals of interest that were scored by a panel of experts in accordance with the published selection criteria. (See Federal Register, 68 FR 56296.) All of this information is available on CDC's Web site at http://www.cdc.gov/​exposurereport/​chemical_​nominations.htm. Past and future nominations do not result in obligatory laboratory analysis or inclusion of nominated chemicals in the “Report,” but rather serve to better inform CDC about which chemicals are of concern to the public.

CDC now requests public comment on proposed criteria for removing chemicals from future editions of the “Report.” These removal criteria (given below) will become part of a combined process of nominating chemicals for inclusion in or removal from the “Report.” This process will include (a) nominations from the public of chemicals to include or remove from the “Report,”(b) an external scoring of nominations in accord with the published nomination and removal criteria, and (c) assistance from the Board of Scientific Counselors of CDC's National Center for Environmental Health/Agency for Toxic Substances and Disease Registry in reviewing plans for including or removing chemicals and identifying alternatives for monitoring specific at-risk population subgroups. This combined process for nomination and removal would occur periodically (e.g., every six years). The criteria for selecting and removing chemicals apply only to those chemicals published in the “Report,” not those merely nominated.

The proposed removal criteria are as follows: A chemical may be removed from the “Report”: (1) If a new replacement chemical (i.e., a metabolite) is more representative of exposure than the chemical currently being measured or; (2) if after three survey periods (or not less than six years), detection rates for all chemicals within a methodological and chemically-related group* are less than 5 percent for all population subgroups (two sexes, three race/ethnicity, and three age groups) or; (3) if after three survey periods (or not less than six years), levels of chemicals within a methodological and chemically-related group are unchanged or declining in all the specific subgroups as documented in the “Report.”

A chemical would continue to be measured and not be removed from the “Report” if it met either of two proposed exceptions to these criteria: (a) It is a chemical for which there is an established biomonitoring health threshold (e.g., CDC's level of concern for blood lead levels in children) or any chemical for which there is widespread public health concern (e.g., mercury) or (b) three survey periods (or not less than six years) have passed, which constitute the minimum time before a chemical could be removed; a longer period may be necessary to account for the half-life of a particular chemical or to account for a recent change (e.g., the removal of a chemical from commerce) that would necessitate monitoring of the population.

Note that the criteria for removing a chemical from the “Report” are not the corollaries of the criteria for adding chemicals to the “Report.” After reviewing and incorporating public comments from this announcement, CDC will publish the criteria in their final form in the Federal Register.

*Chemicals within a methodological and chemically related group are those which are detected and identified by a single test or analytic procedure, such that individual chemicals in the group cannot easily be dropped from analysis while others in the group continue to be monitored.

DATES:

Submit comments on or before May 31, 2006, to the below address.

ADDRESSES:

Address all comments concerning this notice to Dorothy Sussman, Centers for Disease Control and Prevention, National Center for Environmental Health, Division of Laboratory Sciences, Mail Stop F-20, 4770 Buford Highway, Atlanta, Georgia 30341.

FOR FURTHER INFORMATION CONTACT:

Dorothy Sussman, Telephone [phone].

SUPPLEMENTARY INFORMATION:

CDC publishes the “Report” under the authorities 42 U.S.C. 241 and 42 U.S.C. 242k. The “Report” provides ongoing assessment using biomonitoring of the exposure of the noninstitutionalized, civilian population to environmental chemicals. Biomonitoring assesses human exposure to chemicals by measuring the chemicals or their metabolites in human specimens such as blood or urine. For the “Report,” an environmental chemical means a chemical compound or chemical element present in air, water, soil, dust, food, or other environmental medium. The “Report” provides exposure information about participants in an ongoing national survey known as the National Health and Nutrition Examination Survey (NHANES). This survey is conducted by CDC's National Center for Health Statistics; measurements are conducted by CDC's National Center for Environmental Health. The first “Report,” published in March 2001, gave information about levels of 27 chemicals found in the U.S. population; the second “Report,” published in January 2003, contained exposure information on 116 chemicals, including the 27 chemicals in the first “Report.” The third “Report,” published in July 2005, contained exposure information on 148 chemicals, including data on the chemicals published in the second “Report.” This “Report” can be obtained in the following ways: access http://www.cdc.gov/​exposurereport;​; e-mail ncehdls @cdc.gov; or telephone [phone]. Over time, CDC will be able to track trends in exposure levels. The “Report” is published every 2 years; the fourth “Report” is slated for publication in 2007.

James D. Seligman,

Chief Information Officer, Centers for Disease Control and Prevention (CDC).