A voluntary scheme launched by the US Environmental Protection Agency (EPA) in 1998 to publish hazard data on high production volume (HPV) chemicals by 2005 has yet to deliver on its key aims, NGO Environmental Defense Fund (EDF) has concluded in its final assessment of the programme.
According to EDF’s analysis:
10% of the 2,782 HPV chemicals on EPA’s core list are designated “orphans” - not sponsored by any company and data have therefore not been submitted;
Of the 1,900 qualifying substances that have been sponsored, more than one-fifth lack finalised initial data submissions and a third still lack final data sets;
For 734 of the sponsored substances, companies chose an alternative route to submit more detailed screening information data sets (SIDS) as defined by the OECD under a parallel scheme coordinated by the International Council of Chemical Associations (ICCA);
Companies relied heavily on alternative testing methods such as grouping and estimation methods to fill data gaps. More than 80% of chemicals were grouped.
EPA is only just beginning to carry out quality and completeness reviews and hazard assessments based on the data submitted. This process is not now expected to be completed until the end of 2009.
Since the launch of the HPV programme, a further 700 substances have reached HPV status. Of 574 of these covered by an American Chemistry Council (ACC)-backed “extended HPV program (EHPV)”, only 231 have been sponsored. All health and safety information under the EHPV program, which includes use and exposure as well as hazard data, is to be published by the end of 2009.
EDF characterises the programme as “limping” as it approaches the finish line given the objectives that have yet to be achieved.
However, in response the ACC claims the EDF “sorely misses the mark by downgrading the chemical industry’s efforts.” More than 300 firms have worked intensively on their own or in consortia to provide data under the scheme, it points out.
The HPV program, it concludes, has produced “more information on more chemicals in less time under any initiative than before”.
● The ICCA set a challenge for its members worldwide to submit SIDS dossiers for 1,000 HPV chemicals by the end of 2004. Its latest available progress report suggests such dossier have been approved under the OECD system for 386 substances, with a further 68 draft dossiers having been sent to sponsor OECD countries for forwarding. Although it failed to achieve its target, the ICCA says the initiative has been welcomed by the OECD for accelerating progress under its scheme.
Participation in the ICCA initiative has given HPV chemical producers and importers in the EU a head start in their preparations to comply with the REACH Regulation both in terms of data collection and also in gaining experience of working in consortia to generate data.