Design for the Environment Alternatives Assessments

Determine the feasibility of an alternatives assessment

To determine the need for and potential benefits of an alternatives assessment, DfE considers whether alternatives: are commercially available and cost effective; have the potential for an improved health and environmental profile; and are likely to result in lasting change. Stakeholder interest is also a key consideration.

Collect information on chemical alternatives

To develop a better understanding of the potentially problematic chemical and potential alternatives, DfE considers how well-characterized the possible alternatives are; the chemical manufacturing process; the range of functional uses that the chemical serves; and the feedstock or contaminants and residuals from the production process. DfE also considers the work of other organizations in exploring alternatives for the potentially problematic chemical, similar chemicals and functional uses. Based on analysis of this information and preliminary stakeholder consultation, DfE develops a proposed project scope and an approach for developing the alternatives assessment.

Convene stakeholders

DfE uses input from a diversity of perspectives to inform the project scope, identify alternatives, and facilitate manufacturer and user adoption of safer chemicals. Stakeholders are drawn from the entire supply chain and all life-cycle stages of the potentially problematic chemical. Involvement throughout the project helps to ensure that stakeholders contribute to, understand and support the outcome, enhancing credibility and promoting adoption of the safer alternatives. Typical stakeholders include: chemical manufacturers; product manufacturers; non-governmental organizations; government agencies; academics; retailers; consumers; and waste and recycling companies. Chemical and technology innovators are critical members of the group.

Identify viable alternatives

Through literature review and discussion with stakeholders, DfE collects information about viability on a range of potential alternatives. The focus is on finding alternatives that are functional with minimum disruption to the manufacturing process. To identify the most likely alternatives, DfE may also include viability demonstrations by chemical and product manufacturers.

Conduct the hazard assessment

Central to the Alternatives Assessment is evaluation of a robust set of hazard endpoints. Based on the best data that are available from the literature or can be modeled, DfE assigns a descriptor of hazard concern level-high, moderate or low-for each alternative across a range of endpoints, including acute and repeated dose toxicity, carcinogenicity and mutagenicity, reproductive and developmental toxicity, neurotoxicity, sensitization and irritation, acute and chronic aquatic toxicity, and persistence and bioaccumulation. In addition, we provide a qualitative description of potential endocrine activity.

Sources of information for assessment of hazard include:

1. Publicly available measured (experimental) data obtained from a literature review;
2. Measured data contained in confidential business information received by EPA;
3. Structure-Activity-Relationship (SAR)-based estimations from EPA's Pollution Prevention Framework and Sustainable Futures predictive methods;
4. Professional judgment of EPA science experts with decades of chemical review experience; and
5. Confidential data in experimental studies supplied by the chemical manufacturers.

When measured data are not available or adequate for an endpoint, DfE assigns a hazard concern level based on SAR and expert judgment. The DfE criteria for level of concern for hazard can be found in the Alternatives Assessment Criteria for Hazard Evaluation. This practice ensures that all endpoints are considered in the assessment and that alternatives are evaluated based on as complete an understanding of their human health and environmental characteristics as possible. DfE also designates a level of confidence associated with hazard assignments and notes decisions based on little or conflicting evidence.

The most instructive endpoints are those that reveal differences in toxicity among alternatives; these endpoints make it possible to distinguish the inherently safer chemicals from the less safe.

Apply economic and life cycle context

Once the hazard assessment has been completed, DfE prepares a report to inform stakeholders, the public and decision makers. The report provides contextual and supplemental information designed to aid in decision-making and may include descriptions of manufacturing processes, use patterns, and life-cycle stages that may pose special exposure concerns. The report may contain a description of the cost of use and the potential economic impacts associated with the selection of alternatives and may also contain information on alternative technologies that might result in safer chemicals, manufacturing processes and practices.

Apply the results in decision making for safer chemical substitutes

The DfE alternatives assessment combines: functionality (step 4), hazard assessment (step 5), economic and life cycle considerations (step 6) to facilitate decision-making by industry and others (step 7). One organization has developed tools for choosing safer chemicals based on the alternatives assessment methodology (Learn more about this project).