Results of Preliminary Assessment (the 3^rd Survey) of Environmental Risks of Chemical Substances

July 27, 2004

To prevent adverse impacts on human health and ecological system through the environmental pollution caused by chemical substances, Ministry of the Environment implemented preliminary assessment (the 3^rd Survey) of environmental risks. The result was summarized upon deliberation by Expert Committee on Chemical Substances in the Environmental Health Committee of the Central Environment Council.

The survey indicates that 3 substances including those finished carcinogenic risk assessment and 5 substances require further detailed assessment of health risk and ecological risk respectively.

In this preliminary assessment of environmental risk, various enhancement and improvement were made such as expansion of scope of chemical substances to be assessed, improvement of assessing methods, and trial carcinogenic assessment as a part of health risk assessment.

<Preliminary Assessment of Environmental Risks>

1.   Outline

The environmental risk assessment is conducted to determine the degree of risks based on the following steps for subjected chemical substances:

(i)	Specify toxicity to human health and ecosystem and find out correlation of quantity (concentration) and reaction (impacts)    [toxicity assessment]
(ii)	Estimate exposure of chemical substances to human and ecosystem through environment    [exposure assessment]
(iii)	Determine degree of risks by comparing the above two results

"Preliminary assessment of environmental risks" is conducted to screen chemical substances which may possess relatively high environmental risks out of numerous chemical substances, taking into consideration policies for environmental risk management. In this respect, it is essential to minimize the possibility of accidentally overlooking substances with high risks. Therefore, to make preliminary assessment safer, maximum detected concentration is applied for exposure assessment and information with higher sensitivity is applied for toxicity assessment.

Ministry of the Environment started preliminary assessment of environmental risks of chemical substances from FY 1997 and disclosed the results in the pilot project (January, 2001) and 2nd survey (January, 2002). The results were also compiled and disclosed as "Environmental Risk Assessment of Chemical Substances" (1^st and 2^nd volume). As for chemical substances which were determined as "requiring detailed assessment" by the survey, necessary administrative measures have been taken in collaboration with departments concerned.

2.   Chemical substances subjected for the assessment

Taking into consideration its purpose, preliminary assessment targets newly selected substances which are deemed as priority subjects and haven't been assessed or not under risk management yet. PRTR substances, designated chemical substances (currently 2^nd category for monitoring) under Law Concerning the Examination and Regulation of Manufactures, etc., of Chemical Substances, and substances which are suspected as endocrine disruptors are selected.

<Preliminary Assessment Conducted for This Survey>

Assessment mentioned below was implemented following the substances which were already assessed and disclosed to maintain an effective and systematic preliminary assessment of environmental risks.

• Assessment of health risk and ecological risk (21 substances) Following substances were determined as substances requiring detailed assessment due to relatively high risk;

  Human health risk:	acrolein and pyridine
  Ecological risk:	acrolein, ethylenediaminetetracetic acid, bisphenol A, pyridine

• Preliminary assessment of ecological risks conducted besides preliminary assessment of environmental risks (32 substances)
  Following was determined as a substance requiring detailed assessment due to relatively high risk;
  Nitrilotriacetic acid
  Quantitative carcinogenic risk assessment for substances which were subjected for qualitative carcinogenic risk assessment under 2^nd survey
  1, 2 dichloroethane

<Future Responses>

1.   Implementation of detailed assessment

For substances requiring detailed assessment, departments concerned shall collaborate each other to cope with them including implementation of further assessment.

(1)

Three substances determined by preliminary assessment of health risks For 1,2 dichloroethane, since it was detected from underground water, detailed assessment on oral exposure is deemed necessary. This substance is stipulated under environmental standards for water pollution. Water Pollution Control Law controls its discharge and underground infiltration and requires constant monitoring of water pollution. Information from regions with high concentration shall be carefully monitored for any changes. Acrolein and pyridine were estimated that exposure through food are high. Therefore, for these two substances, detailed assessment on oral exposure deemed necessary. Although their bioaccumulative and possibility of exposure through foods from environmental sources are considered to be low, certain information states these substances may be generated from food by heating. The information on possibilities of exposure through foods shall be collected.

(2)

Five substances determined by preliminary assessment of ecological risks Efforts to preferentially promote detailed assessment of ecological risks shall be made while deepening expertise in ecological toxicity. Concretely, results of preliminary assessment of ecological risks shall be reflected to the planning of additional environmental standards related to water pollution control for preservation of aquatic organism.

2.	Systematic implementation of environmental risk assessment and its wide application

(1)	Keeping close coordination between policies related to environmental risk management and survey of chemical substances, preliminary assessment of environmental risk will be implemented systematically.
(2)	Wide ranging scientific information collected and studied in the course of preliminary assessment of environmental risks, shall be utilized in many occasion as possible. (e.g., selecting substances requiring prompt chemical substance management from PRTR subjected substances, reviewing existing chemical substances, introducing GHS (Globally Harmonized System) for classification and indication of chemicals in Japan, etc.)
(3)	In order to extend application of results obtained from preliminary assessment of environmental risks, "profile" (provisional naming) summarizing assessment result for each substance shall be prepared. In addition, construction of data base for results shall be discussed.

3.   Future Tasks

(1)	It is needed to promote accumulation of material information required for preliminary assessment of environmental risks and to improve exposure assessment by utilizing PRTR data, etc.
(2)	Latest information on testing and assessment methods in OECD, etc., should be acquired and the new information must be reflected promptly to preliminary assessment of environmental risks. If any revision on assessment methods is made anywhere, prompt reassessment must be done for related substances though already assessed.
(3)	Preliminary assessment of human health risks including carcinogenic risks shall be evaluated comprehensively as a package of assessment.
(4)	For preliminary assessment of ecological risks, methods for impact assessment on organisms including benthic organism shall be studied to cover a wide range of organisms.
(5)	Necessary studies shall be done to include risk assessment of endocrine disruptors in preliminary assessment of environmental risks.