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

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Corporate responsibility a consumer goods company perspective l.jpg

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


Our commitments l.jpg
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


The dilemma l.jpg
The Dilemma

Regulations

Scientific

Progress

Animal

Use

Safety

Consumer

Confidence

Innovation

Stakeholder

Concerns


Our approach l.jpg
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


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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


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(2) with contributions by P&G scientists (status 2004)

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.


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Challenge Thinking with contributions by P&G scientists (status 2004)

New Methods

New Concepts

Regulatory Acceptance

Examples of Contributions


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Data Sharing with contributions by P&G scientists (status 2004)

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?


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Importance of Dialogue, Cooperation & Collaboration with contributions by P&G scientists (status 2004)

  • 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


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What can Consumer Goods Companies bring to the Partnership? with contributions by P&G scientists (status 2004)

  • 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


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