Chemical Regulation Alert

Steptoe & Johnson LLP's Chemical Regulation Alert, keeping you updated on recent developments in EU and US chemical regulation.

EU Environmental Liability Regime In Force
On April 30, the first ever EU-wide environmental liability regime came into force.  A broad range of activities and products already regulated by EU law will now become subject to strict liability.  This means that an operator will become liable without committing any fault or negligence.  The key test is whether the “operator” (a liable party) caused the damage in question.  An operator includes any person operating or controlling the activity in question and the holder of a permit or authorization for such an activity.  Not all of the environment is covered - the regime covers damage to protected species and natural habitats, water and land (or imminent threat of such damage).  It does not cover “traditional damages” (economic losses or personal injury claims).  Only very narrow defenses and exemptions will apply.  There will be no mandatory central fund, insurance or financial security requirements.  The new rules provide a common baseline for environmental liability across the EU but do not set a ceiling, so each of the 25 EU Member States will be able to adopt stricter standards (creating inevitable difficulties for multinational corporations). For more analysis and the full text, please click here.

BPD: An Important Milestone Passes
March 28th 2004 was an important day for the European biocides industry as it heralded the start of the full review programme for biocidal products under the Biocidal Products Directive (BPD).  For those companies with active substances in Product Type (PT) 8 timber preservatives and PT14 rodenticides, this day was the deadline for concluding a hectic period during which complete dossiers were prepared and submitted.  March 28th also saw the start of the concordant evaluation process, the outcome of which could lead to Annex 1 listing and continued supply into the markets of the EU, a decision to restrict supply, or more seriously, failure to gain approval and eventual removal of the active substance and products from the market. For more analysis and the full text, please click here.

Generics Thwarted and Basic Registrants’ Rights Upheld as California's Letter of Authorization Requirement Found Not to Frustrate the Purpose and Implementation of FIFRA
The California “exclusive use” rights of basic pesticide producers to their test data were upheld in a recent court decision.  In a May 12, 2004 order, a U.S. District Court ruled that Section 12811.5 of the California Food and Agricultural Code does not conflict with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and therefore is not preempted.  The decision upholds California’s “letter of access” system, and means that California registration is not likely to become any easier or less expensive for generic producers.  Follow-on registrants will require letters of authorization in order to rely upon certain types of data submitted to the Califronia Department of Pesticide Regulation (DPR) by previous registrants. If it is not overturned on appeal, the decision represents a substantial victory for DPR and basic registrants.  However, there is also activity underway that may lead to the repeal of Section 12811.5, so that the plaintiffs may achieve their goal by a different route. For more analysis and the full text, please click here.

Pesticide Scientific Advisory Panel Rejects EPA Effort to Use the Mouse Local Lymph Node Assay for Quantitative Assessment of Dermal Sensitization
EPA convened its FIFRA Scientific Advisory Panel (SAP) on May 4-6, to review a new approach to dermal sensitization risk assessment for pesticides.  The Agency’s Office of Pesticide Programs (OPP) developed and planned to use this approach to evaluate pending applications to register Acid Copper Chrome (ACC) wood preservative.  Hexavalent chromium is a known dermal sensitizer in humans, and EPA staff thought it best to apply this new technique, based upon the Mouse Local Lymph Node Assay (LLNA), to establish acceptable levels of chromium residues on the surface of treated wood.  The SAP did not accept EPA’s view that the LLNA provides an appropriate basis for quantitation of sensitization responses.  With respect to hexavalent chromium, the SAP suggested that EPA base its sensitization risk assessment on the unique body of human data on this material.  For more analysis and the full text, please click here.