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HPV Program

Synthetic chemicals play a vial role in the world today, providing a wide range of products and services which are essential to support the modern way of life. Many of these chemicals enter the environment via millions of consumer, agricultural and industrial products, where they may present health or environmental hazards.

In recent years there has emerged a consensus view about what tests should be conducted to evaluate both new and existing chemicals, particularly those which are manufactured in large quantities. Many of the existing major industrial chemicals have not yet been fully evaluated, and in 1989 the OECD countries initiated a voluntary testing program aimed at providing this data by conducting Screening Information Data Sets (SIDS) on High Production Volume (HPV) Chemicals.

Progress with testing under the OECD SIDS program has been slow, and increasing public concern over chemical safety prompted the US EPA, in collaboration with the CMA (now the American Chemical Council) and the Environmental Defence Fund, to launch the Chemical Right-to-Know initiative. A key element to this is the HPV challenge program, which is designed to obtain SIDS information on ca. 2800 HPV chemicals (ie supplied in the US at < 1 million pounds annually). Companies had until 1 December 1999 to volunteer chemicals for testing. EPA will enforce compulsory testing for unsupported HPV chemicals, and a proposed Test Rule for the first 37 chemicals was published on 26 December 2000. Testing was scheduled to be completed by the end of 2004.

A parallel scheme to evaluate HPV chemicals is the International Council of Chemical Associations (ICCA) HPV Program. This called for testing to assess 1000 high priority HPV chemicals by the end of 2004. These ICCA HPV chemicals are selected from the OECD HPV list of 4100 chemicals if produced at >1000 tonnes per annum in more than one region of the world or otherwise of special concern. The output of the ICCA scheme is fed into the OECD SIDS program.

It should be noted that there are other long-established HPV programs:
in Germany, Japan, Korea, Australia and within the UN.

The most notable is the EU Existing Chemicals Regulation, which covered all EINECS-listed existing substances manufactured or imported at >10 tonnes per annum. The available test data have already been reported for 1408 substances supplied at >1000 tonnes per annum. Of these, only 110 have so far been selected for full testing and risk assessment.

The slow progress with this EU HPV scheme has been one of the factors in the political initiative to revise fundamentally the EU chemical control scheme, under the EU strategy for a Future Chemicals Policy proposed in a much-discussed European Commission White Paper.

As one of the world’s leading laboratories for the safety evaluation of industrial chemicals, SafePharm has already undertaken testing and registration work for these various HPV programs. We believe that our experience in the whole area of chemical safety will be invaluable to those companies participating in the US and ICCA HPV programs, and moreover we are in a position to provide a complete service to enable companies to meet this challenge.

In particular we offer a 'turn-key' service comprising:

Identification of possible structure based category - using SAR if appropriate
Literature searches for existing data
Evaluation of available studies
Designing appropriate testing programs - where appropriate using the SIDS endpoints vs. category members matrix approach
Preparation of the EPA required Test Plan
Testing – SafePharm can undertake the complete set of SIDS studies required according to GLP
Compilation of the data summary form in appropriate electronic format

We firmly believe that the use of our considerable expertise will enable companies to save time and money in complying with this testing program. The key elements that SafePharm can bring to this process are:

Use of surrogate data where possible
Minimising tests costs – we offer discounts on our standard prices for testing packages involving multiple compounds
Effective project management to ensure testing programs are completed on time and within budget
Reduced workload of sponsor company

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