April 18, 2006Client Alert

Efforts to Regulate Metabolite Stalled

For several years, the Wisconsin Department of Natural Resources (“WDNR”) has been attempting to establish a regulatory standard in Chapter NR 140 of the Wisconsin Administrative Code (“WAC”) for a metabolite of Alachlor, known as Alachlor ESA. These efforts met a recent roadblock when a legislative oversight committee did its job and asked the agency to subject its proposed standard to a scientific peer review. WDNR has recently responded by seeking to withdraw the proposed standard from the rulemaking package so that the balance of the proposed revisions to NR 140 can proceed. The regulatory treatment of Alachlor ESA is certainly interesting in and of itself; however, the case study is more instructive as relates to future attempts to establish standards applicable to metabolites and other so-called “daughter compounds”.

Wisconsin’s landmark groundwater law was enacted in 1984. The law, contained in Chapter 160 of the Wisconsin Statutes, establishes the Legislature’s intent to minimize pollutants in groundwater through the use of numeric, compound-specific regulatory standards in all groundwater protection regulatory programs. The statute also sets forth the policies and procedures for enacting these regulatory standards.

Generally speaking, the groundwater law authorized the development of Chapter NR 140. NR 140 contains the groundwater standards, expressed as both preventive action limits (“PALs”) and enforcement standards (“ESs”), with which many of you are familiar in the context of agricultural chemical cleanups. Although the agchem cleanup program is housed within DATCP, the groundwater standards that DATCP uses as a regulatory tool are those adopted by WDNR in Chapter NR 140.

As noted, the groundwater law also establishes the process by which a new compound-specific standard in NR 140 is to be developed. The statute requires that WDNR adopt a numeric standard no more stringent than a federal standard for a given compound, to the extent such a federal standard exists. Where no federal standard exists—as is the case with Alachlor ESA—then the statute provides that WDNR is to rely on the methodology and science developed by the Wisconsin Department of Health and Family Services (DHFS) in developing a numeric standard.

WDNR and DHFS have been working on establishing a numeric standard for Alachlor ESA for more than a decade. An NR 140 standard already exists for Alachlor. When groundwater sampling showed the presence of the breakdown or “daughter” compound in certain wells, a well advisory was issued years ago and the effort to develop a regulatory standard began.

When WDNR and DHFS produced the data package and documentation it believed necessary to establish the standard, several interested parties in the industry responded. We helped coordinate and author voluminous written comments and public testimony was offered both at the public hearing stage and before the legislative oversight committee noting a series of serious scientific flaws in the agencies’ approach. We assisted our client in pointing out the flaws in the approach, the places where the agencies had departed from prior practice and from the mandates of the groundwater law and called for a scientific peer review to determine the fate of the proposed standard for Alachlor ESA.

The legislative oversight committee agreed, objected to the proposed standard and sent the rule package back to the agency with direction to pursue a peer review process funded by the manufacturer. This was a significant victory for the industry, and more importantly, for sound science. It will be looked to as efforts to regulate further breakdown products in groundwater will inevitably intensify.

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