Since 2004 is an election year, some for obvious reasons might think the U.S. Environmental Protection Agency (EPA) might not be as ambitious as it otherwise could be. However, there is little likelihood of a precipitous decline in rulemaking activities. This column summarizes key rulemaking and policy developments expected in 2004.
Biomonitoring. Several reports should be released in 2004 that will attract significant attention to the issue of chemical body burden (biomonitoring). The World Wildlife Fund, U.K. office, is scheduled to publish findings on contaminants found in people in Europe. The U.S. Centers for Disease Control and Prevention intends to release its "Third National Report on Human Exposure to Environmental Chemicals, perhaps as soon as late 2004. Also, the California Body Burden Campaign is lobbying for legislation to establish a state biomonitoring program; a key vote was expected in early 2004.
Chemical testing. EPA is expected to issue several Toxic Substances Control Act (TSCA) test rules, including the final dermal test rule, whose release was imminent at press time. This rule is likely to define "persons required to test" in a way that may have broad implications for chemical manufacturers, processors and others not typically affected. The definition has long been the subject of debate. The final rule may shed some light on EPA's current thinking.
Endocrine disruptors. EPA should take additional action on issuing final priority-setting criteria for its Endocrine Disruptor Screening Program and on proposing to implement the screening and testing phase. How EPA proceeds on both fronts should hold tremendous interest for the industrial and agricultural chemical communities.
Inerts. EPA must assess by August 2006 tolerances for inerts under the Food Quality Protection Act. Whether EPA jump-starts this program, how it evolves and who in the chemical community will take the lead in working with EPA to devise a sensible program are as unclear as they are important. While "inert" is a term officially relevant only in the pesticide area, EPA's review should also have significant implications for industrial applications of these chemicals.
Human testing. A report from the National Academy of Sciences at press time was due out in January, and may well generate some fallout. In addition, a proposed rule EPA intends to issue about its reliance on human test results may be out in late 2004 and likely will impact risk-assessment practices.
TSCA Inventory Update Rule (IUR) revisions. EPA is expected to issue revisions to the TSCA IUR in anticipation of the 2006 reporting cycle. Clarification of certain provisions, including the exemption for partial reporting, should be welcomed by the industry.
Persistent organic pollutants legislation. There is significant incentive for legislation to be enacted in 2004. The addition of new chemicals and "prior notice" (the process for adding new chemicals to the list of restricted chemicals) continue to be key issues. How these issues are resolved will have important implications for the chemical community.
Almost all of these issues will result in important policy developments. In particular, EPA's interpretation under TSCA of "persons required to test" may affect chemical producers and others not historically cited. Producers likely will welcome rulemaking that spreads the burden of testing to other entities.
How EPA comes down on the tolerance reassessment of inerts will have significant implications for both chemical producers and formulators who use these chemicals in pesticide products. Much will depend upon whom, if anyone, at EPA takes the lead on this project, and whether the private sector makes this a 2004-2005 priority.
EPA's position on human testing has huge implications for risk assessments. EPA will need to respond to the NAS report and move forward on defining its own policy on human testing. Final developments are unlikely in 2004, and this issue undoubtedly will be influenced by election-year politics.
The Registration, Evaluation and Authorization of Chemicals (REACH) legislation being considered this year by the European Union Parliament may put greater pressure on EPA to address some long-standing concerns expressed about TSCA's limited application to existing chemicals.
This year promises to be a busy and challenging one for the chemical community. Watch for these key developments and participate as much as possible to ensure EPA has the best and most relevant information.
Lynn Bergeson is a founding shareholder of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm. The views expressed herein are solely those of the author.