1 Introduction

Purpose

The Design for the Environment (DfE) Master Criteria for Safer Ingredients (Master Criteria) are comprehensive, science-based criteria designed to ensure that the safest possible ingredients are used in DfE-labeled products. DfE evaluates each and every ingredient in a formulation within its functional class context (e.g., surfactants, solvents) and based on its key, distinguishing human health and environmental characteristics. In this way, potential product ingredients can be viewed as part of a continuum of improved or safer ingredient choices.

Development

The Master Criteria were developed by the Environmental Protection Agency’s DfE Program. The contents of these criteria, including definitions and toxicological preferences, were developed to facilitate use of safer chemistry under the DfE Program.

Scope

In DfE’s Safer Product Labeling Program, the Master Criteria serves as the primary tool to advance Green Chemistry in product formulation and to implement Informed Substitution, the reasoned transition from a chemical of particular concern to safer chemicals or non-chemical alternatives. DfE will use the Master Criteria to review all product ingredients (and their chemical components) for which a more customized set of criteria has not been developed. All chemicals in products designed for direct release to the environment (e.g. graffiti removers and marine cleaners) must also pass the DfE Criteria for Environmental Toxicity and Fate for Chemicals in Direct Release Products.

Implementation

The Master Criteria make it possible to draw a line demarcating the greener or “low-concern” end of the continuum. To define low-concern, DfE uses toxicological thresholds established by several highly respected health and environmental protection authorities; namely the United Nation’s Globally Harmonized System (GHS) for the Classification and Labeling of Hazard Substances and the U.S. EPA’s New Chemicals Program. For functional classes where no low-concern ingredients currently exist, DfE works with its stakeholders to carefully modify the Master Criteria in a way that allows for ingredient choices while ensuring the safest possible ingredients in that functional class. (Determinations made under these criteria are solely for use in distinguishing safer chemicals for the DfE Program. The Criteria are not a classification system.) 

The DfE product review is chemistry and toxicology intensive, calling on the extensive expertise of the EPA’s Office of Pollution Prevention and Toxics. This depth of expertise helps ensure that chemicals are fully and accurately characterized based on the best available information. Information will be drawn from peer-reviewed literature, primary source materials, hazardous chemical lists, and Agency databases, and by using predictive tools to estimate potential human health and environmental concerns based on a chemical’s structural and/or biological similarity to known chemicals of concern. EPA will consider all sources of developing information, including enhancements to estimation models such as EPI Suite^TM that occur over time, the Nanomaterials Stewardship Program, and the EPA Endocrine Disruptor Screening Program.

Reviews under these criteria will be conducted by qualified third parties. Reviewers will consult relevant source and supporting documents that describe the derivation and scope of the classification criteria for the different attributes to ensure consistent use of the information. Every subsection in section 3 includes references for data interpretation.  The third-party reviewer will proceed with the evaluation process as illustrated in Diagram 1 (not included here). The third-party reviewer will approach the review as follows:

1. 1. If the chemical has been evaluated under EPA or the OECD formal evaluation efforts, the resulting characterization(s) shall be the primary source of data for screening. Additional data will be reviewed as available. Effect levels will be compared to guidance thresholds in section 3.
   2. 2. If an EPA or OECD assessment is not available, the third-party reviewer will proceed with the chemical evaluation as described in this document.
   
   

   2 Terms and Preferences

    

   The following preferences and terms apply to all attributes and data requirements.

    

   2.1 A chemical is identified by its Chemical Abstract Service (CAS) number.

    

   2.2 An ingredient may be one chemical or a blend of multiple chemicals.

    

   2.3 Data collected from dermal and inhalation exposures are preferred over oral exposure data because the former two are more likely routes of exposure for cleaning products. Data for all relevant routes of exposure will be evaluated. Failure to pass an attribute by any relevant route of exposure results in failure to pass the Criteria.

    

   2.4 When data are developed for repeated dose toxicity, EPA requests that a functional observational battery, such as OPPTS 870.6200: Neurotoxicity Screening Battery [1], be added to the test method to provide neurotoxicity information.

    

   2.5 The GHS criteria and data evaluation approach and EPA risk assessment guidance will inform professional judgment in the review of both no observed adverse effect levels/concentrations (NOAEL/NOAEC) and lowest observed adverse effect levels/concentrations (LOAEL/LOAEC). NOAEL/NOAEC and LOAEL/LOAEC values are preferred to no observed effect levels/concentrations (NOEL/NOEC) and lowest observed effect levels/concentrations (LOEL/LOEC). In reviews that include conflicting data, a weight of evidence approach will determine a pass or fail.

    

   2.6 Data for the evaluation of chemicals under these criteria are preferred in the following order: 1) measured data on the specific chemical, 2) measured data from a suitable analog, 3) estimated data from appropriate models. Data requirements specific to each attribute are outlined in Section 4. The majority of measured data are expected to be from laboratory animal experiments. However, any available human data will be considered, e.g. Human Repeat Insult Patch Tests. Human data may require appropriate review for ethical treatment of the subjects.

    

   2.7 Use of existing data should follow the EPA HPV Challenge Program and OECD HPV Programme data adequacy guidelines: http://www.epa.gov/HPV/pubs/general/datadfin.htm.

    

   2.8 The links and references in this document are current as of the publication date of these Criteria. The reviewer must use the most recent version of each authoritative list, EPA data interpretation guidance, and test protocol when reviewing a chemical against these criteria. In the case where a GHS reference in this document is superseded by a more recent version, EPA may choose to update these Criteria to incorporate that newer version. In addition, EPA will consider all sources of developing information, including enhancements to estimation models such as EPI Suite^TM [2] that occur over time, the Nanomaterials Stewardship Program [3], and the EPA Endocrine Disruptor Screening Program [4].[1]

   2.9 EPA may choose to perform an in-depth review of a chemical under certain conditions. For example, in cases involving conflicting data, or where chemicals that are detected in bio- or environmental monitoring studies.