U.S. EPA Design for the Environment

Program

U.S. EPA Design for the Environment

Program

NEWMOANovember 18, 2010

Clive Davies

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ContentsContents

• 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

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• 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

What DfE is About What DfE is About

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I. Safer Product LabelingI. 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

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Steps to Earning the DfE LabelSteps to Earning the DfE Label

Submits its application for partnership to

qualified third-party reviewer.

Reviews all product ingredients

against DfE criteria, collects

performance information, and

develops chemical profiles.

Communicates findings to applicant.

Submit to DfE?

Performs QA on third-party

assessment and confirms that

ingredients meet DfE criteria for

human health and the environment.

Discusses its assessment with

applicant and third-party reviewer.

Improvements needed?

Partnership begins.

Yes

No

No

Yes

Applicant

Third-Party Reviewer

Third-Party Reviewer

DfE DfE

Applicant makes necessary improvements &

re-submits application

Applicant makes necessary improvements & re-submits application

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Component-Class CriteriaComponent-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

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Hazard Endpoints for Safer ChemicalsHazard 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

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Life Cycle ConsiderationsLife 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)

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Verification of FormulationVerification 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

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Enhancements Now Being ImplementedEnhancements 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

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Now Being Implemented – AuditsNow 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)

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Enhancements Now Being ConsideredEnhancements 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.

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Ingredient DisclosureIngredient 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.

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PackagingPackaging• 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)

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II. EPA Chemical Action PlansII. 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

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EPA Chemical Action PlansEPA 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

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What are Alternatives Assessments?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.

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Hazard Endpoints in the Assessment CriteriaHazard Endpoints in the Assessment CriteriaHuman 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

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Furniture Flame Retardancy Partnership Results: Data Presentation

EcotoxicityHazard Concern

Human HealthHazard Concern

EnvironmentalHazard Concern

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Endocrine Activity for Alternatives AssessmentEndocrine 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

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BPA Alternatives in Thermal Paper PartnershipBPA 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.

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Stakeholders for the BPA PartnershipStakeholders 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

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Partnership on FR Alternatives to decaBDE

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.

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Stakeholders for decaBDE PartnershipStakeholders for decaBDE Partnership• 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

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Thank you!Thank you!

For more information:

Clive Daviesdavies.clive@epa.gov

202-564-3821

For more information:DfE: epa.gov/dfe

facebook.com/epadfeAction Plans:

epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html