Corporate Responsibility - A Consumer Goods Company Perspective

1. Corporate Responsibility -A Consumer Goods Company Perspective 7th November 2005 Brussels “Europe Goes Alternative” Randy Stolt – Procter & Gamble http://www.pg.com/science/animal_alt.jhtml

2. Our Commitments • We improve consumers lives with high quality products that clean homes, enhance personal wellbeing and contribute to family hygiene and health • Our products are safe for our consumers, employees and the environment • We meet or exceed all applicable regulations

3. The Dilemma Regulations Scientific Progress Animal Use Safety Consumer Confidence Innovation Stakeholder Concerns

4. Our Approach We want to ultimately eliminate animal use for consumer goods We employ the 3Rs and any animal use is a last resort The majority of our safety studies do not use animals We ensure high standards of care We have invested significantly in developing alternatives We actively share our discoveries We collaborate to promote acceptance of alternatives

5. Methods Researched, Developed, Pre-Validated or Validated with contributions by P&G scientists (status 2004) Regulatory Accepted Internal Safety Use Pre-validation Validation R&D Replacement Method þ Cytosensor Microphysiometer method Ex vivo Rabbit Enucleated Eye Irritation Test (Ex-RET) þ Bovine Ex vivo Corneal Opacification Permeability test (BCOP) þ Chicken Ex vivo Enucleated Eye Irritation test (CEET) þ In vitro Matrix Corrosivity assay (Corrositex) Partial Accept. þ Eye Human Tissue Equivalence assay (EpiOcular) Eye In silico Structure-Activity Relationship (SAR) model þ Skin Human Tissue Equivalence assay (EpiDerm) Partial Valid. Partial Accept. Skin Human Tissue Equivalence assay (EpiDerm + MTT, IL-1 ) þ In vitro Skin Penetration assay In silico Skin Penetration SAR model þ Proportionality (Calculation) Method for Acute Toxicity Partial Accept. In vitro Tissue Equivalence assay for Gastric Irritation Peptide Reactivity Screening Assay Skin Allergy Genomic Assay þ In silico Sensitization SAR model In vitro Guinea Pig Antibody Assay for Type I Anaphylaxis In silico SAR, coupled with in vitro Peptide Binding Estrogen Receptor Competitive Binding assay Androgen Receptor Competitive Binding assay Estrogen Transcriptional Activation Assay Chick Embryonic Retinal Cell assay þ Ames mutagenicity assay þ In vitro Chromosomal Aberration assay þ In vitro Micronucleus assay

6. (2) Regulatory Accepted Internal Safety Use Pre-validation (1) Validation R&D Replacement Method (cont.) þ SHE Cell Transformation Assay Chemical Assay for Hyaline Droplet Induction þ (3) In silico Genetox SAR model In vitro Fish Toxicity Assay Reduction Method þ Up-Down Procedure (UDP) þ Limit Dose Method þ Fixed-Dose Method þ Acute-Toxic-Class Procedure Partial Accept. þ Low-Volume Eye Test (LVET) þ Murine Local Lymph Node Assay (LLNA) þ Murine Intranasal Allergenicity Test (MINT) þ Rodent Whole Embryo Culture Assay þ Tg.AC Transgenic Mouse Model Partial Accept. þ P53+/- TS gene Knockout Mouse Model Partial Accept. þ In vivo Chromosomal Aberration assay þ In vivo Unscheduled DNA Synthesis (in vivo UDS) assay Refinement Method þ Murine Local Lymph Node Assay (LLNA) (4) (4) þ Murine Intranasal Allergenicity Test (MINT) 1: R&D; initial work to develop the method. Pre-validation, internal or external, informal assessment of the robustness of the method (sensitivity, specificity). Validation: formal, external validation process Regulatory: formal acceptance for regulatory decision making. 2: These methods are currently used in hazard assessment internally (occasionally externally). 3: Updated version in pre-validation (aromatic amines) 4: Noted above as a Reduction method also.

7. Challenge Thinking New Methods New Concepts Regulatory Acceptance Examples of Contributions

8. Data Sharing Exposure-based Waiving Decision Theory Thresholds of Toxicological Concern Read-Across & Chemical categories in vitro tests QSARs Optimised in vivo tests Which Concepts to Evaluate?

9. Importance of Dialogue, Cooperation & Collaboration • Across industry: • Sharing of resources • Common goals • Industry/Government: • Validation • Acceptance criteria • Industry/Academia: • Application of basic research • Support of research • Industry/Stakeholders: • Sharing concerns • Advocacy

10. What can Consumer Goods Companies bring to the Partnership? • A strong policy commitment to human and environmental safety • Experience in risk assessment • Operations in various regulatory environments from around the world • History of engagement on the 3Rs • Active cooperation within trade associations and with academia, regulators and stakeholders