Global environmental regulations• Regulations prohibiting or restricting uses of toxicsubstances• EU RoHS• Lead• Hexavalent chromium• Cadmium• Mercury• Brominated flame retardants• EU REACH, currently regulating a list of 46 Substances of Very HighConcern• Copycat Legislation –EU accession candidates, Asia, US states, etc.• Certain defense exemptions, but this has not prevented substances fromlargely disappearing from the market for commercial off-the-shelfapplications• Qualifying alternatives to MIL specifications often not possible
Global environmental regulations : Examples from EU RoHS - Lead• Lead-free solders performance unknown in harsh operating environments• Thermal cycling• Vibration• Mechanical shock• Combinations of• Dust• Humidity• Salt Spray• Other environmental threats• Critical system failure possible• Tin whiskering• Short circuits• Connectivity issues
Global environmental regulations : Examples from EU RoHS - Others• Hexavalent Chromium• Corrosion protection• Cadmium• Used mainly as plating on fasteners for corrosion• Mercuryprotection• Used in polyurethane elastomers, excellent catalyst formolding• Brominated Flame Retardants• Used mainly in textiles, electronic housings, aircraftinterior plastics to slow down rate of incineration andallow time to escape fire
Global environmental regulations : Examples from EU REACH• EU REACH -- currently 46 SVHCs• N-methyl-2-pyrrolidine• Leather finish, conductive epoxy, hardener, PI, PAI, PVAC• DIHP• Adhesives, sealers, PVC• Hydrazine• Rocket fuel, process material for adhesives• Strontium Chromate• Coating, protection element for battery, support element for pipes• 1,2 Benzenedicarbolic acid, di-C7-11-branched and linear alkylesters• Rubber, NBR, PE, CR• 4-(1,1,3,3-tetramethylbutyl)phenol• Rubber
Assessing and Managing Risk: Program Elements• Assessment of products, processes, supply chains,regions of import/export, materials/performancespecification requirements and program launch dates toidentify highest risks.• Supplier risk mitigation strategy to ensure mechanismsare in place to prevent disruptions in production.• Qualification of alternatives meeting militaryspecifications, leveraging existing studies and databases.• Incorporation of materials selection and designsoftware into the engineering process, avoiding materialsavailability risks.
Assessing and Managing Risk: Program Objectives• Senior Management must lead and shape the thoughtprocess• Mandate evaluation of business risk• Go beyond clerical task of tracking substance lists--Move your EHS team beyond 20 th Century mentality• There are too many substances, too manyjurisdictions and change is too frequent!• Enforce risk-based decision-making• Contractually define liabilities• The contract is the battlefield for compliance risk
Assessing and Managing Risk: Organizational Approach• This will require a cross-functional effort• Do not allow decisions to be made within silos• EHS Manager – is this material hazardous?• Legal – is this material compliant with the law?• Sales – will the customer buy this material?• Purchasing – is this material the cheapest?• Engineering/Design – will this material work?
Assessing and Managing Risk: EHS Manager• GOAL: Incorporate the concept of risk andprioritize conformance resources• Compliance with the law is mandatory• However, nonconformance risks must be prioritized• Financial: fines, penalties, loss of market• Strategic: mission-critical components, key customers, keymarkets• Cost of conformance must be considered; conformance is aninvestment in a product/program/customer/market
Assessing and Managing Risk: Sales• GOAL: Meet customer needs• Clearly understand customer needs• Negotiate and educate when appropriate• Forward Terms and Conditions on for reviewand approval• If out of scope, ask for additionalcompensation
Assessing and Managing Risk: Sales• Example: Customer request• “Send me certification that your products are REACH-registered”• Registration does not apply for articles without intentional release• This can be evaluated by your compliance point-of-contact• Come back to customer with proposal – a statement that “ourproducts shipped to you in the EU comply with the REACHRegulation”• Ensure that level of conformance is commensurate with Terms andConditions
Assessing and Managing Risk: Purchasing• GOAL: Define a “cost of noncompliance”• Grade suppliers by risk• Enforce Terms and Conditions! This is the front lineof the battle• Avoid request for change orders• Mechanism to prevent risky purchases• Approved vendor lists• Use your leverage when others escalateproblem suppliers to you• Strategic stockpiling
Assessing and Managing Risk: Purchasing• Example: Two suppliers• Supplier 1• Annual revenues < $10 million• Incorporated in non-NATO member state• No designated RoHS-compliance individual (salesperson fieldingcompliance questions)• Supplier 2• Annual revenues > $10 billion• Large DoD contracts• Quick check of website reveals robust compliance activities• All else being equal, Supplier 2 poses a lower risk of noncompliance
Assessing and Managing Risk: Engineering/Design• GOAL: Life cycle design, incorporating supplychain risk as a critical element of design• Provide rules of thumb for design engineers• Need competency, not expertise• Use “checklist” approach• Analysis of alternatives at front-end• Cost• Availability, including lead time• MIL-specs• Hazards• Use customized database for reference and informationmanagement
Assessing and Managing Risk: Engineering/Design• Example: Core metals (steel, aluminum, etc)• There will almost never be a concern; trace amounts of hazards pose no risk• Example: Surface coatings• How does the corrosion protection work?• What is the usage environment?• Example: Plasticizers, softeners• Low Phthalates bad• DEHP (DOP), BBP, DBP, DIBP• High Phthalates OK• DINP, DIDP, DPDHP, DIUP, DTDP• Substitutes better long term• DINCH, Adipates, Benzoates
Assessing and Managing Risk: Summary• Given these higher numbers of new substances subject to obsolescence,systems, customized tools and processes must be employed to ensurethe use of critical materials is not threatened• These systems, tools and processes must:• Track use of all restricted and hazardous substances inaerospace/defense applications• Prioritize by risk to the organization• Accommodate the transfer of information through the supply chainwith sufficient speed to enable design and sourcing changes in atimely manner• Allow for the ability to flow new terms and conditions up and down thesupply chain so the procurement process can keep up with theregulatory changes
Thank YouA.J. GuikemaTetra Tech, Inc.firstname.lastname@example.org