1. International Initiatives and the U.S. HPV Challenge Program Ken Geiser, PhD Lowell Center for Sustainable Production University of Massachusetts Lowell Ken Geiser, PhD Lowell Center for Sustainable Production University of Massachusetts Lowell

2. The International Drive to increase Industrial Chemical Hazard Data International discourse on chemical policy has long been hampered by inadequate hazard information on the large majority of industrial chemicals Since the mid 1990s there has been a serious international effort to generate, collect and present a base set of hazard data on industrial chemicals International discourse on chemical policy has long been hampered by inadequate hazard information on the large majority of industrial chemicals Since the mid 1990s there has been a serious international effort to generate, collect and present a base set of hazard data on industrial chemicals

3. Timeline 1976 – U.S. TSCA authorizes hazard data collection 1988 - OECD launches HPV Chemicals Program ……………… 1998 -- U.S. launches HPV Chemicals Challenge 1998 – OECD re-focuses its program 1999 – Canada CEPA requires full screening of DSL 2006 – European Union REACH sets framewprk for progressive data collection 1976 – U.S. TSCA authorizes hazard data collection 1988 - OECD launches HPV Chemicals Program ……………… 1998 -- U.S. launches HPV Chemicals Challenge 1998 – OECD re-focuses its program 1999 – Canada CEPA requires full screening of DSL 2006 – European Union REACH sets framewprk for progressive data collection

4. A. OECD HPV Chemicals Program In 1988 the Organization for Cooperation and Development, (OECD) Chemicals Division launched its High Production Volume (HPV) Chemicals Program (revamped in 1998) The HPV program seeks Member Countries to adopt chemicals for assessment from a list of priority substances manufactured or imported into at least one Member Country in quantities of 1000 tons or more per year. The 2004 OECD HPV list includes 4,843 chemicals In 1988 the Organization for Cooperation and Development, (OECD) Chemicals Division launched its High Production Volume (HPV) Chemicals Program (revamped in 1998) The HPV program seeks Member Countries to adopt chemicals for assessment from a list of priority substances manufactured or imported into at least one Member Country in quantities of 1000 tons or more per year. The 2004 OECD HPV list includes 4,843 chemicals

5. OECD HPV Chemicals Assessments Each Member Country “sponsors” a chemical for assessment based (roughly) on the proportion of that chemical produced by its internal industries Currently there are 1000 chemicals in the Program with assessments completed or in process Progressing at 100 per year Each Member Country “sponsors” a chemical for assessment based (roughly) on the proportion of that chemical produced by its internal industries Currently there are 1000 chemicals in the Program with assessments completed or in process Progressing at 100 per year

6. OECD SIDS Template OECD developed the Screening Information Data Set (SIDS) as a cross country harmonized, minimum data base template Template includes: General information Physical/chemical information Environmental fate and pathways (photodegradation, water stability, distribution, biodegradation) Ecotoxicity (aquatic, terrestrial ) Toxicity (acute, repeat dose, genetic, reproductive, developmental) OECD developed the Screening Information Data Set (SIDS) as a cross country harmonized, minimum data base template Template includes: General information Physical/chemical information Environmental fate and pathways (photodegradation, water stability, distribution, biodegradation) Ecotoxicity (aquatic, terrestrial ) Toxicity (acute, repeat dose, genetic, reproductive, developmental)

7. ICCA HPV Chemicals Program In 1998, the International Council of Chemical Associations (ICCA) established its own “working list” of substances for SIDS assessment Chemical manufacturers sponsored their chemicals for assessment identified from the ICCA’s list of 1000 priority chemicals Assessments conducted under ICCA’s program are submitted as “contributions” to the OECD Member Country’s HPV Program assessments ICCA has gone on to sponsor “extended HPV chemicals” not covered by the U.S. HPV Challenge In 1998, the International Council of Chemical Associations (ICCA) established its own “working list” of substances for SIDS assessment Chemical manufacturers sponsored their chemicals for assessment identified from the ICCA’s list of 1000 priority chemicals Assessments conducted under ICCA’s program are submitted as “contributions” to the OECD Member Country’s HPV Program assessments ICCA has gone on to sponsor “extended HPV chemicals” not covered by the U.S. HPV Challenge

8. OECD and U.S. HPV Chemicals While the OECD HPV List is larger than the U.S. HPV List, the focus of the two programs in generally similar Both programs are based on the harmonized SIDS template Governments oversee chemical assessments under the OECD program, while corporations provide U.S. HPV data with minimum government review While the OECD HPV List is larger than the U.S. HPV List, the focus of the two programs in generally similar Both programs are based on the harmonized SIDS template Governments oversee chemical assessments under the OECD program, while corporations provide U.S. HPV data with minimum government review

9. B. Canadian DSL Chemicals Screening Domestic Substances List (DSL) of existing chemicals published in 1994 Contains 23,000 substances Enactment of the Canadian Environmental Protection Act (CEPA) in 1999 required that all DSL chemicals be screened and categorized The screening was jointly conducted by Health Canada and Environment Canada The screening and categorization project was completed in September, 2006 Domestic Substances List (DSL) of existing chemicals published in 1994 Contains 23,000 substances Enactment of the Canadian Environmental Protection Act (CEPA) in 1999 required that all DSL chemicals be screened and categorized The screening was jointly conducted by Health Canada and Environment Canada The screening and categorization project was completed in September, 2006

10. Criteria for DSL Categorization Environment Persistent Bioaccumulative Inherently Toxic to the Environment Human Health Greatest Potential for Exposure Inherently Toxic to Humans (cancer, birth defects, damage to genetic material, etc.) Environment Persistent Bioaccumulative Inherently Toxic to the Environment Human Health Greatest Potential for Exposure Inherently Toxic to Humans (cancer, birth defects, damage to genetic material, etc.)

11. DSL Categorization The screening relied primarily on existing data with QSARs and “read across” used for data gaps Final report lists some 4,000 substances categorized into high hazard tier These high hazard substances will be assessed for risk in future actions The screening relied primarily on existing data with QSARs and “read across” used for data gaps Final report lists some 4,000 substances categorized into high hazard tier These high hazard substances will be assessed for risk in future actions

12. Canadian DSL and U.S. HPV Chemicals The Canadian DSL screening covers significantly more chemicals than the U.S. HPV program The extent of DSL screening data is more limited than the SIDS template providing less data per substance than the HPV program The DSL has categorized substances, whereas the HPV program is planning this in the future The Canadian DSL screening covers significantly more chemicals than the U.S. HPV program The extent of DSL screening data is more limited than the SIDS template providing less data per substance than the HPV program The DSL has categorized substances, whereas the HPV program is planning this in the future

13. C. REACH European Union’s Registration, Evaluation and Authorization of Chemicals (REACH) provides a major redrafting of European chemicals policies Proposed by the European Commission in 2003 and enacted as a Regulation in December, 2006 As a EU Regulation all 27 Member States must adopt the language as written into national laws REACH drives the generation and collection of hazard data, while minimizing duplicate efforts and animal testing Came into force on June 1, 2007 European Union’s Registration, Evaluation and Authorization of Chemicals (REACH) provides a major redrafting of European chemicals policies Proposed by the European Commission in 2003 and enacted as a Regulation in December, 2006 As a EU Regulation all 27 Member States must adopt the language as written into national laws REACH drives the generation and collection of hazard data, while minimizing duplicate efforts and animal testing Came into force on June 1, 2007

14. REACH: Scope Covers some 30,000 substances manufactured or imported into any of the European Union countries in quantities of 1 ton or more per year Exemptions: medicinal products, food additives polymers pesticides and biocides ores, fuels, cements chemicals in research labs Covers some 30,000 substances manufactured or imported into any of the European Union countries in quantities of 1 ton or more per year Exemptions: medicinal products, food additives polymers pesticides and biocides ores, fuels, cements chemicals in research labs

15. REACH: Pre-registration By November 30, 2008 all manufacturers or importers of 1 ton or more per year must notify the new European Chemicals Agency in Helsinki Information: identification of registrant substance name annual volume deadline for registration By November 30, 2008 all manufacturers or importers of 1 ton or more per year must notify the new European Chemicals Agency in Helsinki Information: identification of registrant substance name annual volume deadline for registration

16. REACH: Registration Phased in by annual volume category over 11 years Tons/year>1000 tons, CMRs, vPvBs, PBTs 100-1000 tons 10-100 tons1-10 tons Deadline3-1/2 years6 years11 years Est. Number of firms 2,6002,8004,60020,000 Chemical Safety Report Yes No

17. REACH: Registration Information Technical Dossier Substance identity Chemical-physical characterization Existing human and ecological toxicology data Information on potential uses New Chemical “Safety Data Sheets” based on 16 elements of the Globally Harmonized System of Labeling and Classification of Hazards “Chemical Safety Report” Technical Dossier Substance identity Chemical-physical characterization Existing human and ecological toxicology data Information on potential uses New Chemical “Safety Data Sheets” based on 16 elements of the Globally Harmonized System of Labeling and Classification of Hazards “Chemical Safety Report”

18. REACH: Registration Chemical Safety Report Manufacturers or importers of substances with quantities on 10 tons or more per year must prepare a Chemical Safety report which includes a Chemical Safety Assessment Chemical Safety Assessments must include: human health hazard assessments environmental hazard assessments PBT and vPvB assessments and, if the substance is high hazard, then exposure assessment risk characterization Manufacturers or importers of substances with quantities on 10 tons or more per year must prepare a Chemical Safety report which includes a Chemical Safety Assessment Chemical Safety Assessments must include: human health hazard assessments environmental hazard assessments PBT and vPvB assessments and, if the substance is high hazard, then exposure assessment risk characterization

19. REACH: Evaluation Evaluations are conducted by the Member States Based on a “rolling plan” informed by substances of concern with a quota of 5% of Registrations per year There are 2 types of Evaluation Dossier Evaluation a compliance check on the data a review of testing protocols Substance Evaluation a check on validity of findings a request for additional information or testing Evaluations are conducted by the Member States Based on a “rolling plan” informed by substances of concern with a quota of 5% of Registrations per year There are 2 types of Evaluation Dossier Evaluation a compliance check on the data a review of testing protocols Substance Evaluation a check on validity of findings a request for additional information or testing

20. REACH and U.S. HPV Chemicals All U.S. HPV chemicals will be covered under the REACH registrations REACH will generate new data on lower volume substances, whereas the HPV Challenge does not cover lower volume chemicals REACH Registration data includes all SIDS data non-SIDS data, use data and exposure data REACH Registration data will be reviewed for quality when chemicals are selected for Evaluation while HPV data quality checks are planned for during Tier II reviews All U.S. HPV chemicals will be covered under the REACH registrations REACH will generate new data on lower volume substances, whereas the HPV Challenge does not cover lower volume chemicals REACH Registration data includes all SIDS data non-SIDS data, use data and exposure data REACH Registration data will be reviewed for quality when chemicals are selected for Evaluation while HPV data quality checks are planned for during Tier II reviews

21. Conclusions The U.S. HPV Challenge contributes new hazard information on the largest volume production chemicals REACH Registration data will corroborate the HPV data and add more data on high volume production chemicals The OECD, DSL and REACH Evaluation data provide a means of checking and validating industry submitted data such as the data submitted under the HPV Challenge The U.S. HPV Challenge contributes new hazard information on the largest volume production chemicals REACH Registration data will corroborate the HPV data and add more data on high volume production chemicals The OECD, DSL and REACH Evaluation data provide a means of checking and validating industry submitted data such as the data submitted under the HPV Challenge

22. Conclusions The OECD HPV Program, the U.S. HPV Challenge, and the ICCA Extended HPV Program offer new and more accessible data for a majority of HPV chemicals The Canadian DSL Program offers new and accessible data on lower volume chemicals REACH will offer even more data on all chemicals The Canadian DSL Program has categorized chemicals by level of hazard: the U.S. HPV Program and REACH plan to do this in the future The OECD HPV Program, the U.S. HPV Challenge, and the ICCA Extended HPV Program offer new and more accessible data for a majority of HPV chemicals The Canadian DSL Program offers new and accessible data on lower volume chemicals REACH will offer even more data on all chemicals The Canadian DSL Program has categorized chemicals by level of hazard: the U.S. HPV Program and REACH plan to do this in the future