The Centers for Disease Control and Prevention (CDC) recently announced final criteria for removing chemicals from the National Report on Human Exposure to Environmental Chemicals. Such removal can relieve industry of a burden, so chemicals professionals should become familiar with these criteria.
The importance of biomonitoring
Biomonitoring measures chemicals in blood, urine, or other human bodily fluids and tissue. Looking for chemicals in the body isn’t new, and finding them isn’t unexpected. What’s new is government agencies’ reliance on biomonitoring data. The U.S. Environmental Protection Agency, for example, relies on these data for chemical selection and prioritization among other reasons. Occupational safety and health regulatory agencies have used biomonitoring data for decades. Biological exposure indices exist for more than 40 industrial chemicals and are used to track occupational exposures by quantifying concentrations of chemicals in workers.
Vigorous and high-profile non-governmental organization (NGO) campaigns have recently taken the debate about the “harm” caused by chemical exposure to a new and emotional level. While it’s undeniable that the presence of chemicals in our bodies is compelling information, it’s less clear what it means, and what health and safety inferences, if any, can be drawn. Absence of clear regulatory guidelines to interpret these data adds to the confusion.
The report provides an ongoing assessment of the U.S. population’s exposure to environmental chemicals using biomonitoring. If a chemical is tracked in the report, business operations, government agencies and NGOs typically review the data to discern any detectable trends. Chemicals professionals will want to review the final criteria and assess whether they apply to chemicals of particular interest. The final criteria will become part of a combined process for nominating candidate chemicals for inclusion in or removal from the report, according to CDC (For more information see www.cdc.gov/exposurereport/).
A chemical will be removed from the report if it meets any one of the following final criteria and doesn’t meet either exception:
- A new replacement chemical (i.e., a metabolite or other chemical) is more representative of exposure than the one currently measured
- If after three survey periods (not less than six years), detection rates for all chemicals within a method-related group are less than 5% for all population subgroups (i.e., two sexes, three race/ethnicity groups, and the age groups used in the report)
- If after three survey periods, levels of chemicals within a method-related group are unchanged or declining in all the demographic subgroups in the report. Such evidence would be absence of a statistically significant (< 0.05) positive slope of mean (or geometric mean) levels over the time period.
A chemical meeting criterion 1 would be removed from future reports and replaced with the new chemical that better reflects actual exposure. One meeting criterion 2 or 3 would be removed from the report for two future survey periods (four years), then measured again in the following survey period (two years). If either criterion 2 or 3 is still satisfied for this 12-year period (three initial two-year survey periods, two intervening two-year survey periods, final two-year survey period), then the chemical would be removed from the report and not reinstated unless it once again met the inclusion criteria.
A chemical would continue to be measured and not removed if it met either of the following exceptions:
- It has an established federal biomonitoring health threshold (e.g., CDC’s level of concern for blood lead levels in children) or the CDC learns that a relevant federal agency considers it of sufficient priority to warrant continued monitoring
- It has a long half-life, requiring additional time to track changes reliably in population levels, or recent changes in exposure sources indicate that future levels are likely to increase.
The bottom line
Over the long haul, tracking biomonitoring data will continue to gather momentum and regulatory interest. The role of these data in toxic tort suits shouldn’t be overlooked. If the criteria can be satisfied, businesses need to consider strategies to remove chemicals from the report, and possibly prevent adverse regulatory actions and legal inferences to be drawn from them.
Lynn Bergeson, regulatory editor. She is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. Contact her at firstname.lastname@example.org. The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.