Global Cooperation on Data Exchange on Hazardous Properties of Chemicals for GHS Classification

Transcription

1 Global Cooperation on Data Exchange on Hazardous Properties of Chemicals for GHS Classification Ms. Elena Zhurba CISCenter Russia Federation Mr. Derek D. Swick, MPP Senior Policy Advisor, API United States of America 7 September

2 What is Data? Data - factual information, especially information organized for analysis or used to reason or make decisions. The American Heritage Dictionary 2

3 Data Quality Data quality requirements depend on user needs! Data acceptable for one purpose may not be suitable for another Different types of data sets on chemicals may be needed for: Safety Data Sheets compilation Technical Specifications (Russia) Chemical Assessment for REACH Registration Dossier SIDS GHS Classification 3

4 Safety Data Sheet Example The SDS contains different types of data (heterogeneous data): 1. Identification 2. Hazard(s) identification 3. Composition/information on ingredients 4. First-aid measures 5. Fire-fighting measures 6. Accidental release measures 7. Handling and Storage 8. Exposure controls/personal protection 9. Physical and chemical properties 10. Stability and reactivity 11. Toxicological information 12. Ecological information 13. Disposal considerations 14. Transport information 15. Regulatory information 16. Other information 4

5 GHS Classification Various hazards to consider, different types of data needed 5

6 Data for GHS Classifications (4 rev) Physical Hazards Health and Environmental Hazards Specified test methods Test methods neutral as long as they are scientifically sound and validated according to international procedures and criteria already referred to in existing systems for the hazard class of concern and produce mutually acceptable data Example: Methods for drug testing (WHO) 6

7 Approach to Data Quality Assessment Heterogeneous Data Structuring the data into homogeneous data elements Homogeneous Data element Data element quality criteria Homogeneous Data element Data element quality criteria Homogeneous Data element Data element quality criteria Quality assessment criteria identification for every element General Data Quality Criteria 7

8 Use of Data for Different Regulatory Purposes May data generated for purposes of compliance with one regulation be used to comply with other regulations? YES, if: Requirements for the homogeneous data elements are identical for their Content & Data Quality 8

9 OECD Harmonized Template (OHT) OECD Harmonized Templates - standard data formats for reporting studies on any type of a chemical (e.g., pesticides, biocides, industrial chemicals) to determine their properties or effects on human health and the environment Designed for data reporting, storage and exchange Aimed at developers of database systems, as they prescribe the formats by which information can be entered into and maintained in database. Governments and industry will be able to electronically exchange test study summary information. Examples of use: IUCLID 5, echemportal, 9

10 Role of Data Quality in Chemical Assessment Chemical assessments attempt to rely upon the best data, but deciding which data are best can be complicated Are the data well suited for the assessment being conducted? Do the data come from a reliable source and were they generated in a transparent and reproducible manner? Are there consistent results to support the outcome? Are data being evaluated and utilized in a consistent and unbiased manner? 10

11 Klimisch Approach for Evaluating Studies Presented in Klimisch et al Numerical system for quantifying the quality of a study (toxicology, ecotoxicology, physico-chemical properties, etc.) 1 and 2 Klimisch are general used for assessments Consider variety of aspects GLP, use of guideline, etc. Adopted for use in OECD SIDS program, the U.S. HPV program, and EU REACH 11

12 Klimisch Scale 1. Reliable without restriction Study uses appropriate guideline (OECD, national standard) GLP conditions at lab 2. Reliable with restrictions Study was appropriately conducted but has limitations (e.g. insufficient detail, documentation, not using current guideline) 3. Not reliable Study was not well conducted, missing details Generally not used for hazard/risk assessment 4. Not assignable Insufficient detail to determine reliability May be used as supporting study in an assessment, especially if 1 or 2 reliability studies are available as key studies 12

13 Good Laboratory Practice (GLP) GLP are standard practices and procedures that laboratories follow in order to ensure consistency in operations, documentation, etc. Government agencies (EU, U.S. FDA, U.S. EPA) inspect facilities for compliance with standards GLP does not necessarily mean a study was well designed for the outcome of interest nor does it mean that the results of study have been properly interpreted 13

14 OECD Manual for Investigation of HPV Chemicals Covers how OECD chemical assessments are developed Chapter 3: Data Evaluation - The process of determining the quality of existing data takes into consideration three aspects - adequacy, reliability and relevance of the available information to describe a given SIDS element. Approach generally based on Klimisch cals/ pdf 14

15 Reliability, Relevance, Adequacy Reliability - evaluating the inherent quality of a test report or publication relating to preferably standardized methodology and the way the experimental procedure and results are described to give evidence of the clarity and plausibility of the findings Relevance - covering the extent to which data and tests are appropriate for a particular hazard identification or risk characterisation Adequacy - defining the usefulness of data for hazard/risk assessment purposes When there is more than one study for each SIDS element, the greatest weight is attached to the study that is the most reliable and relevant 15

16 Ensuring Suitability of Data Key step in reviewing data is evaluating whether the data are sufficient for the task at hand Examples: Mammalian data for evaluating human health effects Aquatic data for evaluating environment effects Acute studies for short-term exposure/effects Repeat-dose studies for longer-term exposure Study/data quality are irrelevant if the data are not appropriate for the subject of the review 16

17 Application of Data Quality OECD and REACH require studies of sufficient reliability for all key endpoints Klimisch code 1 or 2 data for each endpoint U.S. EPA Integrated Risk Information System (IRIS) considers the quality of the database when setting risk values (e.g. RfD, RfC) for chemicals. An uncertainty factor is applied to the risk value depending on the quality of the database: 1 (no adjustment) for very robust database, 3 or 10 for databases that are not as good Result is lower risk values for databases that are determined to be of lower quality 17

18 Application of Data Quality Deficiencies in a certain investigation of a chemical DO NOT preclude the use of this information, but may reduce the confidence in use of this data o WOE approach (REACH, OECD recommendations) In many cases, available information is not sufficient to assess how well a study was conducted. Comparing studies similar in design may help assess the quality of the data 18

19 Global Initiatives Aimed to Avoid Duplication of Efforts Development of a UN GHS Global List of Classified Chemicals Parallel Process of OECD Clearing House on New Chemicals APEC Chemical Dialogue Virtual Working Group on Harmonisation of Data on the Hazardous Properties of Substances 19

20 A Global Chemical GHS Classification List? GHS hazard classification is technical and requires knowledge and expertise to accurately classify chemicals To assist stakeholders and companies in implementing the GHS, several countries, regions, and organizations have developed for common and high production volume chemicals lists of specific chemicals classified according to the GHS criteria These GHS chemical classification lists have come to different conclusions on the hazard classifications for some chemicals 20

21 A Global Chemical GHS Classification List? The differences in hazard classification can be significant and result in different hazard communication The proliferation of lists is creating disharmony and problems concerning the hazard classification for chemicals which are distributed internationally It is in the spirit of the GHS to minimize these classification discrepancies and help with lowering trade barriers It is legitimate for national and intergovernmental agencies to explore they can do to aid industry in providing accurate and useful information about their substances 21

22 UNSCEGHS Global Lists Informal Correspondence Group For the current biennium, this working group was charged with considering the following three items (Mandate/Terms of Reference: ST/SG/AC.10/C.4/2010/20 paragraph 12): a) The principles to guide the development of a global list of GHS classified chemicals, including how priorities should be established b) What chemicals should be the focus of work for classification according to the GHS, considering those chemicals possessing hazards of serious health, physical and/or environmental concern; those most commonly used and transported worldwide; and which end-points should be covered; and c) The interim steps such as the development of a proposal on functionalities that would increase the efficacy of the OECD echemportal regarding the current GHS classification of chemicals in existing lists 22

23 UNSCEGHS Proposed Guiding Principles for Developing a Global List of Classified Chemicals* (a) The development of a global list is compatible with the GHS principle of self-classification since the list will be non-binding (see (f) below). The process for developing and maintaining a global list must be clear, transparent and follow the principles of the GHS. Opportunities should be provided for stakeholders, including stakeholders without UN status, to provide input electronically, as well as a mechanism for expert review, conflict resolution and updating the list when new data becomes available. (b) All GHS hazard categories and classes must be included in the global list of classified chemicals. (Development of the global list needs to involve priority setting and proceeding in a stepwise fashion. While the ultimate goal is to include all GHS classes/categories, an interim step may include a phased-in approach. The pilot program being proposed for the next biennium will not require that substances be selected in order to have all hazard classes/categories covered.) *See UN/SCEGHS/23/INF.34 23

24 UNSCEGHS Proposed Guiding Principles for Developing a Global List of Classified Chemicals (c) Only substances, as defined by the GHS, will be included on the global list of classified chemicals. (d) All substances must be accurately identifiable and described for each entry (e.g. including Chemical Abstracts Service Registry Numbers (CAS numbers) and relevant impurities). (e) The data sets forming the basis for the chemical classification must be referenced with the classification. The source of the information must also be electronic, readily available, and publicly accessible. The data used for the classification should be based on sound scientific principles. (f) The global list of chemical classifications will be non-binding. As with the GHS itself, countries will have the option to make the list binding if they adopt it through their legislative and/or regulatory process. 24

25 UNSCEGHS Global Lists Informal Correspondence Group Next Steps A pilot program will be used to determine what issues may be encountered in the development of a global list of classified chemicals A potential outline of work for the pilot program in the next biennium ( ) includes: (a) Review and choose potential chemicals for the pilot program (b) Gather available information on the selected chemicals (c) Review information according to GHS classification criteria and seek consensus on harmonized classifications (d) Develop an initial process for stakeholder participation (e) Identify and assess issues/resource requirements (f) Consider the relationship between the GHS global list and the TDG classification list Implementation of the pilot program will lay the groundwork for developing a future program of work 25

26 UNSCEGHS Global Lists Informal Correspondence Group Next Steps Selection of chemicals for the pilot program should be based on the following proposed criteria: (a) Chemicals that are data rich and data poor (b) Consideration of chemicals that have impurities (c) Chemicals with harmonized and un-harmonized GHS classifications in existing systems (d) Chemicals that raise serious health, physical, and/or environmental concerns. (e) Chemicals most commonly used and transported worldwide The revised guiding principles and a paper on the next steps and proposed work (including transparency, development of criteria for source data, and a mechanism for expert review) are expected to be submitted to the 24 th session of the Sub-Committee in December

27 Global Lists Benefits An international list of chemicals classified in terms of the GHS or a similar database has the most value when it is accepted by all countries implementing the GHS The benefits include Supporting/promoting cost-effective GHS implementation Avoiding duplication of effort Applying expert systems to maximize resources and minimize costs Promoting harmonization/consistency in classification Facilitating international trade Improving safety for workers and others through consistent and harmonized communications on chemical hazards and practices to follow for safe handling and use Improving the credibility of industry 27

28 Database and GHS List Considerations There are a number of technical issues to be addressed with regard to lists that can also apply to databases/information exchange: Contain the data to support the classifications or a section explaining the rationale behind the classifications Have provisions for stakeholder input/data Provide a conflict resolution mechanism Include mechanisms for updating as new evidence-based science becomes available Have defined criteria for source data Allow for self-classification/flexibility Be voluntary 28

29 OECD Clearing House on New Chemicals OECD CHNC envisions a sustainable world where: Countries can see, understand and accept each others assessment results aimed at protecting human health and the environment Companies can submit one new chemical notification and then market globally Countries and companies are more efficient and effective in their activities related to new chemicals 29

30 OECD Clearing House on New Chemicals Parallel Process = Single Notification for a new chemical Identify target jurisdictions & nominate Lead and Secondary Countries Submit a proposal for a Predetermined Set of Information (PSI) to a panel of those target jurisdictions for discussion in a Pre-Notice Consultation (PNC) Agreed PSI is collected by the notifier and submitted to the Lead Country in their notification format Consensus on the hazard assessment Draft hazard assessment is prepared by the Lead Country, and shared with the Secondary Countries and the notifier Data assessment, proceeding per the Lead Country s standard regulatory process Notifier submits the country-specific information to each of the Secondary Countries 30

31 Proposals for Future Work What are the requirements to the quality of data in different Regulations and voluntary initiatives? REACH OECD HPV UN GHS GPS etc 31

32 Data Exchange on the Hazardous Properties of Chemicals UNSCEGHS U.S. NLM OECD ECHA APEC CD The challenge will be to include all appropriate players, to not duplicate efforts, to identify the strengths of the various players, to delegate the appropriate activities to the right players, and to coordinate all the activities. 32

33 The End... Questions? 33