Screening Assessments

Screening Assessments Anticipation of the Pending PFOA Assessment, in Light of Learnings from Previous Assessments DuPont - Jack Soule- May 19 2005

Screening Assessments – re: PFOAConsiderations – Substance-specific • Extensive datasets exist for PFOA, with more studies underway. • EC & HC SLRA reports are expected later this year. • While several jurisdictions are conducting reviews, the interest is global. • No manufacture of PFOA occurs in Canada. • PFOA entry to Canadian environment may be via imported products as an impurity; or perhaps through the degradation of another substance; or via an environmental transport mechanism, yet to be defined. DuPont - Jack Soule- May 19 2005

Screening Assessments – re: PFOAConsiderations - General • Screening Assessments are intended to be*: - Streamlined assessments – efficiencies both through science tools and approaches and through administrative process - Build on information gathered from categorization, industry submissions, emerging science, international assessments/reviews and data collection, provincial or international decisions, etc. * EC Compliance Promotion Workshop 2005/01/27 DuPont - Jack Soule- May 19 2005

Screening Assessments – re: PFOAConsiderations - General • Screening Assessment Reports:* Brief text summary(2-5 pages) of critical information on: - Identity, Uses and Sources of Exposure - Exposure Assessment - Hazard Characterization - Risk Assessment Clear delineation of uncertainties/confidence in databases for exposure and effects. (Cut-off date for data identification specified.) * EC Compliance Promotion Workshop 2005/01/27 DuPont - Jack Soule- May 19 2005

Screening Assessments – re: PFOALearnings • Fluorinated substances do not conform to normal rules for substances – it is difficult, if not impossible, to model their properties • The scientific data on fluorinated substances is growing steadily • There are a variety of hypotheses on their environmental fate – containing significant differences • Assessment reports need to provide clear context for those decisions – i.e. the timeframe, the data considered, the data not considered, and why DuPont - Jack Soule- May 19 2005

Screening Assessments – re: PFOAConcerns • Due to brief format of SLRA’s, there could be a tendency to focus on the data that supports a particular conclusion, while leaving out data that supports a contrary view. • Uncertainties also need to be identified. • It is recognized that the SLRA reports will be studied by other jurisdictions, therefore the complete picture needs to be portrayed. • The complete basis for the decision will be important as time passes, and new data becomes available, in order to be able to fully understand the context and any limitations. DuPont - Jack Soule- May 19 2005

Screening Assessments – re: PFOA‘Precaution’ • We respect the precautionary approach in the assessment of chemicals • We respect the need for openness and transparency with stakeholders • We support the principles outlined in the Government of Canada’s publication: “A Framework for the Application of Precaution in Science-based Decision Making about Risk” • We believe that Risk Assessments need to adhere to this framework DuPont - Jack Soule- May 19 2005

Screening Assessments – re: PFOAKey Points on ‘Precaution’ • “Sufficiently sound” or credible scientific basis should be interpreted as a body of scientific information – whether empirical or theoretical – that can establish reasonable evidence of a theory’s validity, including its uncertainties and that indicates the potential for such a risk. (Sec.3.0 and Principle 4.3) • In order to capture the full diversity of scientific thought and opinion, the basis for decision makingshould be drawn from a variety of scientific sources and experts from many disciplines. Decision makers should give particular weight, however, to peer reviewed science and reasonableness in their judgments. (Sec. 3.0 and Principle 4.3) DuPont - Jack Soule- May 19 2005

Screening Assessments – re: PFOAKey Points on ‘Precaution’ • Availablescientific information must be evaluated with emphasis on securing high quality scientific evidence (not quantity). Reports should summarize the existing state of knowledge, provide scientific views on the reliability of the assessment and address remaining uncertainties and areas for further scientific research or monitoring. (Principle 4.3) • Two-way sharing of information and the inclusion of a range of perspectives in the decision-making process can become the cornerstone of openness and transparency for the decision-making process and enhance credibility of and trust in the decisions that the Government makes. (Principle 4.5) DuPont - Jack Soule- May 19 2005

Recommendations for SLRAsNeed for Consistency/Clarity regarding: - Incorporation of Government Framework on Precaution - Use of most relevant/justifiable hazard and exposure data - Appropriate/consistent use of safety factors - Peer review, review process and its function - Posting on web sites for comments - Publishing in the Canada Gazette and next steps - How best to handle substances with extensive data packages (PSL?) - Mechanism to deal with new data that could alter an earlier decision - How SLRA decisions are communicated - Canada’s role in the assessment of existing substances of global interest DuPont - Jack Soule- May 19 2005

Screening Assessments