U.S. EPA Design for the Environment Program

1. U.S. EPA Design for the Environment Program NEWMOA November 18, 2010 Clive Davies

2. Contents DfE Background Safer Product Labeling Program Enhancements Now Being Implemented Enhancements Being Considered, including ingredient communication Action Plans and Chemical Alternatives Assessments BPA in Thermal Paper DecaBDE

3. What DfE is About • Goals • Safer Products • Safer chemical ingredients is baseline • Life cycle impacts are considered • Protecting Consumers – Especially Children • Central Elements • OPPT technical tools and expertise • Multi-stakeholder participation • Results • Industry partners reduced more than 500 million pounds of chemicals of concern last year

4. I. Safer Product Labeling 1) Review every ingredient by functional use class To promote green chemistry To understand toxicity Lists Literature Analogous chemicals – SAR 2) Review formulation as a whole Synergistic effects pH Performance testing 3) Partnership Agreement Audits Logo Use

5. Steps to Earning the DfE Label

6. Component-Class Criteria • Master Criteria • Sets the Standard for Green Chemistry for all ingredients • Based on New Chemicals Program, OPP/OPPT Harmonized Guidelines, and Globally Harmonized System criteria • Tailored Criteria Differentiate Highly Functional Alternatives for key ingredient classes • Surfactants • Solvents • Chelants • Builders • Fragrances • Future Criteria would enhance transparency and promote Green Chemistry • Disinfectant Actives & Preservatives • Colorants • Polymers

7. Hazard Endpoints for Safer Chemicals • Every chemical is assessed against criteria • Authoritative government lists of chemicals of concern • Data from studies • Modeling to fill data gaps • Based on internationally agreed toxicological endpoints and thresholds • Acute mammalian toxicity • Aquatic toxicity • Bioaccumulation • Biodegradation • Carcinogenicity • Eutrophication • Genetic toxicity • Neurotoxicity • Repeated dose toxicity • Reproductive and developmental toxicity • Respiratory sensitization • Skin sensitization

8. Life Cycle Considerations • Program focuses on “hotspots” in the lifecycle • Requirements of DfE Standard: • Primary focus is on hazard for the chemical manufacturing, product manufacturing, use, and disposal phases (hazard reduction) • Packaging requirements reduce material use and make transportation phase more efficient (GHG reduction, resource conservation) • Performance requirements promote efficient product use (resource conservation) • Policy Goals: • Concentrates to reduce transportation needs. (GHG reduction) • Cold water detergents to reduce energy use. (GHG reduction) • Renewable raw materials and packaging (resource conservation)

9. Verification of Formulation • Partnership Agreement • Signed agreement between EPA and each manufacturer • 3 years in duration; will sunset unless renewed • Specifies • Chemicals in each formulation • Conditions of logo use • Audit procedures • Audits • Annual desk audits • Triennial on-site audit

10. Enhancements Now Being Implemented • Stakeholder group helped document DfE in the form of an ANSI Standard • Stakeholder group helped propose enhancements. • Audits • Continuous Delivery Systems for Consumer Products • Definitional Improvements

11. Now Being Implemented – Audits • Annual Desk Audits • Verify contents of recognized products and labels • Ensure safer chemistry status (continuous improvement) • Review production volumes, use of logo, etc. • On-site Audit • Once during 3-yr partnership period -- if more than one facility, two sites selected randomly will be audited • Confirms materials usage compared to Partnership Agreement (using batch tickets) • Ensures Good Manufacturing Practices (e.g., non-contamination of labeled products) • Reviews overall partnership compliance (e.g., documentation of end-user training, packaging)

12. Enhancements Now Being Considered • New Areas • Ingredient Disclosure • Dermal Contact Products • Enhancements to Existing Criteria • Performance: Pass/fail thresholds. • Packaging: Sustainable Packaging Coalition measures; 25% compliance and continuous improvement. • VOC : Adopt CARB or OTC levels. • Flammability: Clarify limits (140 F). • Enzymes: Allow low-dust granulated enzymes in dry formulations, if adequate engineering controls present.

13. Ingredient Disclosure • All must be listed • Non-confidential ingredients • On the bottle, or • An easily accessible location where ingredients can be found (e.g., a place on the formulator’s website). • Confidential ingredients, dyes and preservatives -- use a chemical descriptive name. • Scent ingredients • Can be listed on the label as “Fragrance, ” • more detailed information must be provided elsewhere • E.g., website list of the actual ingredients, or • reference to the IFRA list or a subset of chemicals on the IFRA list.

14. Packaging • Partners will be required to adopt sustainable packaging measures as a condition of partnership and show continuous improvement over time • At partnership initiation, must achieve at least 25% level in one of six sustainability measures (developed by Sustainable Packaging Coalition) • Report on packaging status will occur at partnership renewal • Materials must not contain heavy metals or other ingredients of concern (e.g., BPA or phthalates)

15. II. EPA Chemical Action Plans Chemicals for which action plans have been published: Benzidine dyes Bisphenol A (BPA) Hexabromocyclododecane (HBCD) Nonylphenol and nonylphenol ethoxylates (NP/NPE) Phthalates Perfluorinated chemicals (PFCs) Penta, octa, and decabromodiphenyl ethers (PBDEs) Short-chain chlorinated paraffins Chemicals in the action plan development process: Diisocyantes Siloxanes See: http://www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html

16. EPA Chemical Action Plans Of these action plan chemicals, DfE plans to conduct chemical alternatives assessments for the following: Bisphenol A (BPA) Decabromodiphenyl ether (decaBDE) Hexabromocyclododecane (HBCD) Nonylphenol and nonylphenol ethoxylates (NP/NPE) Phthalates Others

17. What are Alternatives Assessments? • Evaluates the impacts of a chemical and its alternatives. High, Moderate, or Low ratings are given for: • Human health effects • Environmental fate and effects • The goal is inform substitution to safer chemicals, and avoid simply switching to chemicals that are poorly understood. • Alternatives to the chemical of concern must provide the same function. • Life-cycle thinking ensures that other impacts are not overlooked.

18. Hazard Endpoints in the Assessment Criteria Human Health Toxicity Acute mammalian toxicity Carcinogenicity Mutagenicity/Genotoxicity Reproductive and Developmental Toxicity Neurotoxicity Repeated Dose Toxicity Respiratory and Skin Sensitization Eye and Skin Irritation/Corrosivity • Environmental Fate & Effects • Aquatic toxicity • Environmental persistence • Bioaccumulation

19. Furniture Flame Retardancy PartnershipResults: Data Presentation Ecotoxicity Hazard Concern Environmental Hazard Concern Human Health Hazard Concern

20. Endocrine Activity for Alternatives Assessment • This criterion would evaluate endocrine activity rather than characterize hazard in terms of “endocrine disruption”. • Including this endpoint in the alternatives assessment will provide information that could inform decision-making. • In consultation with EPA toxicologists and risk assessors, EPA will provide: • Summary statement of available data • Qualitative assessment of the level of evidence supporting designation • Presence of equivocal or conflicting data • Limitations • Level of confidence in the assessment

21. BPA Alternatives in Thermal Paper Partnership • Bisphenol A (BPA) is a high production volume chemical that is considered to be a reproductive, developmental and systemic toxicant, as well as weakly estrogenic. Aquatic toxicity is also of concern. • BPA is used in thermal paper as a developer that reacts with other chemicals in the presence of heat to create color and may be an important source of exposure and release to the environment. • The alternatives assessment will evaluate alternatives to BPA. • Timing: July 2010 – October 2011.

22. Stakeholders for the BPA Partnership • Thermal Paper Manufacturers • Thermal Paper Converters • Suppliers • POS OEM Manufacturers • Retailers • International • Green Chemistry Consultants • Chemical Manufacturers (Developers and Color-formers) • Trade Associations • Trade Unions • Government

23. Partnership on FR Alternatives to decaBDE • Based on concerns for human health and the environment, decabromodiphenyl ether (decaBDE) is being phased-out by manufacturers. • DecaBDE is used as a flame retardant in a variety of materials that have applications in electronics, wire and cable, construction, automotive, aviation, and textile industries, and is used in plastic shipping pallets. • The alternatives assessment will evaluate alternatives to decaBDE. • Timing: October 2010 to December 2011.

24. Stakeholders for decaBDEPartnership • Academics • Consultants • NGOs • Flame Retardant Manufacturers • Compounders and Resin • Manufacturers • Automotive Industry • Electronics Industry • Shipping Pallet Industry • Textile Industry • Recyclers • U.S. Federal Government • State and Local Governments • International

25. Thank you! For more information: Clive Davies davies.clive@epa.gov 202-564-3821 For more information: DfE: epa.gov/dfe facebook.com/epadfe Action Plans: epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html