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Forming EDSP Screening Consortia

Forming EDSP Screening Consortia. GLENN S. SIMON, PH.D., DABT Director of Toxicology September 10, 2009. Forming EDSP Screening Consortia. OUTLINE. Why Form/Join Consortium? Why Not? Who Should/Can Join? Manager/Support - Internal vs. External? Cost Sharing Formula?

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Forming EDSP Screening Consortia

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  1. Forming EDSP Screening Consortia GLENN S. SIMON, PH.D., DABT Director of Toxicology September 10, 2009

  2. Forming EDSP Screening Consortia OUTLINE • Why Form/Join Consortium? • Why Not? • Who Should/Can Join? • Manager/Support - Internal vs. External? • Cost Sharing Formula? • (THE SECRET REVEALED!!)

  3. Forming EDSP Screening Consortia WHY FORM/JOIN A CONSORTIUM? • Share the $$ cost (evenly or not) • May be able to leverage lab study costs • Share the sweat equity • Share the risk • Industry has one voice in front of EPA • EPA perceives this as advantageous • Ensure data utility for other purposes • REACH, others

  4. Forming EDSP Screening Consortia WHY NOT FORM A CONSORTIUM? • Additional Costs (but shared costs) • Time required to get started and with testing • Adminstrative Fees, Consultants Experts • Legal Fees • Helps avoid anticompetitive claims • Accounting/bookkeeping fees • Travel time and costs for meetings • Unequal sharing of sweat equity • Discontent with consortium’s decisions • Must provide for data preservation

  5. Forming EDSP Screening Consortia WHO WOULD JOIN CONSORTIUM? • Any company covered by rule • Any other interested companies • More companies, more $$ sharing • Must avoid anti-competitive behaviors • All members will own data

  6. Forming EDSP Screening Consortia WHO TO MANAGE CONSORTIUM? • Internal management • Unequal distribution of sweat equity • Issues/appearance of preferential/anticompetitive treatment • External management • Legal Firm • Consulting/Management Firm • Administrative only? • Technical expertise? • Bookkeeping/accounting?

  7. Forming EDSP Screening Consortia BEST COST-SHARING FORMULA? EASY ANSWER…………

  8. Forming EDSP Screening Consortia COST-SHARING CONSIDERATIONS • Equal shares or classes of costs • Arbitrary shares for consortia of <3 companies • Producers vs. Others – different costs • Cost based on: • Production volume* • Sales* • Production capacity* • Hybrid of above *May require sharing of confidential info, necessitating external management

  9. Forming EDSP Screening Consortia BEST COST-SHARING FORMULA? EASY ANSWER…………

  10. Forming EDSP Screening Consortia BEST COST-SHARING FORMULA? THE ONE EVERYONE AGREES TO

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