international initiatives and the u.s. hpv challenge program
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International Initiatives and the U.S. HPV Challenge Program. Ken Geiser, PhD Lowell Center for Sustainable Production University of Massachusetts Lowell. The International Drive to increase Industrial Chemical Hazard Data. - PowerPoint PPT PresentationTRANSCRIPT
International Initiatives and the U.S. HPV Challenge Program
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
The International Drive to increase Industrial Chemical Hazard DataThe 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
TimelineTimeline
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
A. OECD HPV Chemicals ProgramA. 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
OECD HPV Chemicals AssessmentsOECD 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
OECD SIDS TemplateOECD 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)
ICCA HPV Chemicals ProgramICCA 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
OECD and U.S. HPV ChemicalsOECD 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
B. Canadian DSL Chemicals ScreeningB. 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
Criteria for DSL CategorizationCriteria 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.)
DSL CategorizationDSL 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
Canadian DSL and U.S. HPV ChemicalsCanadian 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
C. REACHC. 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
REACH: ScopeREACH: 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
REACH: Pre-registrationREACH: 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
REACH: RegistrationREACH: Registration
Phased in by annual volume category over 11 years
Phased in by annual volume category over 11 years
Tons/year >1000 tons, CMRs, vPvBs, PBTs
100-1000 tons 10-100 tons 1-10 tons
Deadline 3-1/2 years 6 years 11 years 11 years
Est. Number of firms
2,600 2,800 4,600 20,000
Chemical Safety Report
Yes Yes Yes No
REACH: Registration InformationREACH: 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”
REACH: Registration Chemical Safety ReportREACH: 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
REACH: EvaluationREACH: 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
REACH and U.S. HPV ChemicalsREACH 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
ConclusionsConclusions
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
ConclusionsConclusions
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