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Page 1: Introduction to Risk Assessment and DINP

• DINP and the Plasticizer Debate

  • DINP (Diisononyl Phthalate) is a plasticizer used in manufacturing children's products.

  • Concerns arise due to a similar compound causing liver damage in lab rats.

  • The condemnation of DINP by Greenpeace and other groups led to calls for a ban on vinyl toys for children.

• Tension Between Safety and Industry

  • Major manufacturers like Mattel and Toys R Us defended plasticizers used in products, citing safety.

  • A major issue: no standard procedure exists for assessing how much DINP a child may absorb.

  • Variability in plasticizer content across toy components compounded the challenge.

  • Question of reliability of animal tests regarding the potential for liver damage in humans.

  • Uncertainty regarding how long it may take for health problems to manifest in children exposed to DINP.

• Industry Response and Changes

  • Mattel advised an elimination of DINP products, while still claiming their safety.

  • Transition to plant- and vegetable-based plastics emphasized during Barbie's redesign.

• Process of Risk Assessment

  • Involves research, risk assessment, risk management, and regulatory planning.

Page 2: Executive Order 12866 and Risk Assessment Process

• Elevated Importance of Risk Assessment

  • In 1993, Executive Order 12866 emphasized risk assessment across regulatory agencies, not just environmental ones.

  • Agencies must assess risks associated with substances and explain how regulations will mitigate these risks.

• Process Outline

  • Research: Gathering information about health/environmental effects of suspected hazards.

  • Risk Assessment: Determining levels of exposure and evaluating risk potential from findings.

  • Risk Management: Developing alternative regulatory strategies based on assessment results.

• Challenges Faced

  • Conflicts between scientific findings and political decisions due to delays in data.

  • Public officials often rely on incomplete and contested data, necessitating a compromise on policy decisions.

Page 3: Animal Testing and Data Gaps

• Controversy in Environmental Policy

  • Diverse expert opinions lead to contention during congressional and administrative hearings.

  • Often a lack of useful data about pollutants and environmental issues complicates decision-making.

• Requests for New Chemicals

  • EPA receives approximately 1500 petitions annually for new chemicals needing chemical testing.

  • Over 1400 chemicals deemed hazardous with less than 15% adequately studied regarding health risks.

• Causality and Extrapolation Difficulties

  • Difficulty establishing causality between exposure to substances and health issues due to latency and diffusion of effects.

  • Hazard assessment methodologies struggle due to reliance on extrapolated data from limited animal studies.

• Risk Criteria Challenges

  • A variety of risk criteria exists (health-based, technology-based, balancing), leading to confusion.

  • Health Based Criteria: Focused on human health risks without considering regulatory costs.

Page 4: Risk Assessment Criteria and Precautionary Principle

• Technology-based Criteria

  • Regulators ensure control technologies minimize residual public health risks post-regulation.

• Balancing Criteria

  • Agencies weigh regulatory costs against potential health threats in standard setting.

  • Complex regulations emerge from multiple risk determination criteria outlined in congressional mandates.

• Precautionary Principle

  • Advocates taking preventive measures when faced with potential harm from an activity, even without conclusive cause-and-effect proof.

  • Prominent in the European Union's climate change policies and global movements to curb emissions.

• Reflection and Influence

  • Examines how this principle shapes public perception of risks and influences policy decisions.

  • Discusses contexts where precautionary principles should or shouldn't apply.