The Second Joint Working Group to Review the CSCL
Summary
The Second Joint Working Group to review the CSCL (hereinafter referred to as the CSCL WG) was held on March 27, 2008. CSCL WG comprises 18 members such as scientists, chemical and downstream industry organization representatives, consumers, and NPOs. The theme of the second CSCL WG was how to conduct risk assessment under CSCL effectively and efficiently, especially for substances that were already placed on the market.
All distributed documents are available on the following website (Japanese only)
http://www.meti.go.jp/committee/gizi_1/17.html
A summary of the handout document showing the discussion points in the second CSCL WG follows:
1. The basic principles and purpose of the risk assessment conducted under CSCL
- Is it an appropriate direction and procedure under CSCL to collect basic exposure data on substances already placed on the market such as manufactured/imported volume and identified use of them at the first step, and to collect hazard information gradually based on manufactured/imported volume after collection of these kinds of exposure data, while taking into account the WSSD 2020 goal?
2. Collection of exposure information for appropriate risk assessment
- What is the appropriate procedure to collect manufactured/imported volume information on substances already placed on the market, as basic exposure information, in order to conduct appropriate risk assessment of them under CSCL?
- What is the best way to collect use information?
- How can PRTR data and actually measured values of concentration in the environment be used for risk assessment under CSCL?
3. Collection of hazard information for appropriate risk assessment
- Is it appropriate for the government to collect hazard information on substances already placed on the market gradually based on manufactured/imported volume, making SIDS as a basic data set, in order to conduct appropriate risk assessment under CSCL?
- Can the government use GHS classification when it conducts risk assessment, if it is available?
4. How to conduct risk assessment under CSCL and division of role between the government and the industries
- Is it appropriate for the government to keep playing a role in conducting risk assessment from mainly a regional perspective under CSCL?
- What is the best way and system to conduct risk assessment efficiently and effectively including prioritization of risk assessment substances?
- What is the best way to collect information that industries own from the point of view of role-sharing?
- What is the role of industries in order to promote voluntary chemical management measures?
5. How to deal with confidential business information (CBI) in the collected data
- Is it necessary to protect CBI from collected data by the government under CSCL through operating the information publication law appropriately?
- Is there anything else to take note of when it comes to CBI in collected data under CSCL?
The next CSCL WG is scheduled for May 29, 2008. The theme of the 3rd CSCL WG is how to conduct hazard/risk assessment of new chemicals. The CSCL WG will probably be held four times before this summer.
Comments of Members in the Meeting
1. The basic principles and purpose of the risk assessment conducted under CSCL
- It’s reasonable to collect hazard information based on the exposure volume. However, the way to control high-hazard chemicals should be maintained under CSCL.
- Strict regulatory measures such as prohibition of chemicals under CSCL should not be taken based on the result of screening level risk assessment.
- Risk Assessment can not be finished once, but reiterated several times with collection of information. It is important to discuss the way to send monitoring substances to specified substances.
- It is efficient to collect and analyze hazard information after analysis of exposure information.
2. Collection of exposure information for appropriate risk assessment
- Manufacture/import volume and identified use information are necessary at the minimum because exposure information can not be assumed. Meanwhile, it is useful to use PRTR information and the concentration in the environment if they exist.
- If a specified statistic has a problem with the collection rate, it should be a mandatory base collection.
- Detailed information on use is CBI, but it is possible for industries to provide categorized use information.
3. Collection of hazard information for appropriate risk assessment
- SIDS is the dataset for screening assessment. Another framework is necessary to collect chronic toxicity information.
- Exposure through water is mainly assessed at this moment, but inhalation toxicity should be considered in order to conduct detailed risk assessment.
- GHS information is just the result of classification and is different from the study report in terms of the quality of data. GHS information should be used with care.
- QSAR result should be utilized when risk assessment is conducted.
4. How to conduct risk assessment under CSCL and the division of roles between the government and industry
- It’s all right for the government to play a central role in conducting risk assessment and industry cooperates with it. We should discuss what kinds of information industry should provide the government.
- It’s not realistic for the government to conduct risk assessment of all substances. It’s important to prioritize substances for risk assessment based on exposure volume, as with Canada’s categorization approach.
- If the government can get detailed exposure information, it can conduct more precise risk assessment. That means the government can use a low uncertainty coefficient, which may give industry the advantage because it does not have to conduct risk assessment in a conservative manner. Additional testing causes costs for industry, but industry already has exposure information. Industry should provide information while considering this situation.
5. How to deal with confidential business information (CBI) in the collected data
- Safety information is a kind of property that society should share. Data in each endpoint such as NOAEL and testing conditions should be made publicly available.
- QSAR is a cost effective method. If the quality of QSAR improves, a lot of people can benefit from using it. In order to improve QSAR quality, safety information should be made publicly available without hesitation.
- I have concerns about the publication of precise manufacture volumes in terms of the Monopoly Prohibition Law.
- According to Information-disclosure Law, information that has the potential to undermine the legitimate interests of business such as competition position does not have to be disclosed, so we should think about information disclosure based on this provision.