CHALLENGING BOUNDARIES

Forming EDSP Screening Consortia

GLENN S. SIMON, PH.D., DABTDirector of Toxicology

September 10, 2009

CHALLENGING BOUNDARIES2

Forming EDSP Screening Consortia

•Why Form/Join Consortium?

•Why Not?

•Who Should/Can Join?

•Manager/Support - Internal vs. External?

•Cost Sharing Formula?• (THE SECRET REVEALED!!)

OUTLINE

CHALLENGING BOUNDARIES3

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

CHALLENGING BOUNDARIES4

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

CHALLENGING BOUNDARIES5

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

CHALLENGING BOUNDARIES6

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?

CHALLENGING BOUNDARIES7

Forming EDSP Screening Consortia

BEST COST-SHARING FORMULA?

EASY ANSWER…………

CHALLENGING BOUNDARIES8

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

CHALLENGING BOUNDARIES9

Forming EDSP Screening Consortia

BEST COST-SHARING FORMULA?

EASY ANSWER…………

CHALLENGING BOUNDARIES10

Forming EDSP Screening Consortia

BEST COST-SHARING FORMULA?

THE ONE EVERYONE AGREES TO