Some Current Initiatives to Increased Relevant Toxicological Information
OECD member countries and their
chemical industries are working together to investigate all chemicals produced
or imported into their countries in quantities greater than 1000 tonnes per
year. There are over 5000 HPV chemicals that fall into this category. The
outcome of the screening includes a public chemical hazard assessment document.
The U.S. High Production Volume Information System (HPVIS)[i]
developed by EPA contributes to the OECD programme and will provide access to
basic health and environmental effects on 1400 HPV chemicals sponsored under
the HPV Challenge Program.[ii] Within the European Union, a new proposal for
the Registration, Evaluation and Authorization of Chemicals (REACH) was
initiated in October 2003, with a view to address improved human health and
environmental protection from chemicals.[iii] Under this program, chemicals sold and used
in Europe in quantities greater than one tonne
per manufacturer per year are to be registered on a central database. Information required for registration
increases with tonnage, including the compilation of life stage-specific
toxicological data for HPV chemicals. Use
of chemicals identified on the basis of their hazardous properties as being of
‘very high concern’ will require specific authorization.
To facilitate access to these
and other sources of information, an OECD Global HPV Chemicals Portal is being
developed to allow web based simultaneous search and query of multiple sources
of information on health and environmental effects data free of charge.
A
second U.S. HPV program, EPA’s Voluntary Children’s Chemical Evaluation Program
(VCCEP), was developed to obtain toxicity, exposure, and risk information to
understand the effects on children from chemicals to which they were likely to
be exposed. In addition to collecting
SIDS screening level data, EPA identified two tiers of advanced toxicity tests
and exposure information which it considered necessary to more fully understand
and characterize the risk of childhood exposure to certain chemicals. Chemicals which had been found in human
tissues and the environment were selected for a pilot of VCCEP. EPA had decided at the initiation of VCCEP to
run a pilot of the program to determine what efficiencies could be identified
which could benefit the implementation of a larger program. In December 2000, EPA requested chemical
manufacturers to sponsor the chemicals selected for the VCCEP pilot. Chemical manufacturers responded by
volunteering to sponsor the development and collection of information on 20
pilot VCCEP chemicals. To date information has been submitted and reviewed on
12 of the 20 pilot chemicals. The information collected by the chemical
sponsors has been made available to the public on the VCCEP website.[iv] The pilot program is currently under
evaluation.
In the United States, EPA is sponsoring a
study with the National Academy of Sciences[v] (BEST-U-03-08-A)
to assess and advance current approaches to toxicity testing and
assessment to meet regulatory data needs.
The NAS has been tasked with developing a long-range vision and
strategic plan for advancing the practices of toxicity testing and human health
assessment for environmental contaminants. In developing the vision and
strategic plan, the committee is considering evolving regulatory data needs;
current toxicity testing guidelines and standards used by EPA and other federal
agencies; the use of emerging science and tools (e.g., genomics, proteomics,
transgenics, bioinformatics, computational toxicology, in vitro testing, and
other alternatives to animal testing); and the challenges of incorporating more
complex understanding of toxicity (e.g., toxicokinetics, mechanisms of action,
systems biology) into human health risk assessment. The NAS has been asked to consider how any
new system might lead to the collection of new data relevant to better
assessing children’s risks.
[i] US EPA. High Production Volume Information
System. Available at www.epa.gov/hpvis Accessed 15 June 2006
[ii] US EPA High Production Volume
(HPV) Challenge Program. Available at
www/epa.gov/hpv Accessed 15 June
2006
[iii] EU. The New EU Chemicals
Legislation REACH. Available at http://ec.europa.eu/enterprise/reach/index_en.htm
Accessed 15 June 2006
[iv]US EPA. Voluntary Children's Chemical Evaluation
Program. Available at www.epa.gov/chemrtk/vccep Accessed 15 June 2006
[v] National Academy
of Sciences. Toxicity Testing and
Assessment of Environmental Agents.
Available at http://www8.nationalacademies.org/cp/projectview.aspx?key=74 Accessed 15 June 2006
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