1. Preparing an Essential-Use Nomination for CFC MDIs: The U.S. Experience Consultative Meeting on Essential Use Nominations Bangkok, Thailand 6 July 2008

2. Overview Language of Decision IV/25 Questions to Address in Nomination Activities to Undertake to Prepare U.S. and Other Major Developed Country Results in Managing Essential Uses Summary

3. Decision IV/25 For the Parties to deem them essential, uses must be: –“necessary for the health, safety or is critical for the functioning of society… and –there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.”

4. Decision IV/25 “that production and consumption…should be permitted only if:” –“all economically feasible steps have been taken to minimize the essential use and any associated emission…” “and” –“the ODS is not available in sufficient quantity and quality from existing stocks of banked or recycled ODS”

5. Broad Questions to Answer in a Nomination Why is continued production of the ODS essential? How much is required? Why can’t the need be met in another way (through alternatives)? What has been done to find alternatives? Why can’t other sources of ODS be used (stocks or recycled/reclaimed)? How are ODS emissions being minimized?

6. U.S. EPA Steps to Prepare EUE Nomination Lead Agency: develop informal plan Coordinate with companies & associations –gather specific data about products, historical production volumes, market information Seek strong partnership with health ministry –essentiality definition rests on protection of patient health Numbers and types of patients Alternatives treatments already approved & being considered Prices of treatment options Understand care delivery approaches of domestic health industry –characterize domestic medical industry providing treatment Develop, vet and submit national EUE nomination

7. Overview of U.S. Essential Use Experience Formally request applications for exemptions Create regulatory framework to govern exemptions Analyze & review company applications Develop & vet EUE nomination for submission to Parties Interact with MATOC to clarify data, improve understanding Implement regulatory exemption to phaseout Report to OzSec in Accounting Framework

8. Requesting Exemption Applications Started 3 years before the phaseout –1 year to prepare nomination –1 year for Parties to review and authorize –1 year to establish domestic regulations for the exemption Published a notice requesting applications –Defined the types of information to be submitted to demonstrate that the ODS is “necessary for the health, safety or is critical for the functioning of society” and “no available technically and economically feasible alternatives” Set a deadline for submission of applications

9. Timing of EUE Nomination Process In U.S., we start early: –Takes approx 1 year to complete domestic regulation exempting new production from ban –Must have Parties’ authorization 1 year prior to the year that exemption is needed: Prepare nomination in 2007, for 2010 Submit nomination in January 2008, for 2010 Need Parties’ decision at end 2008, for 2010 Start regulatory process in 2009, for 2010

10. 3 Processes At 1 Time Exemption for Year X Exemption for Year X+1 Exemption for Year X+2 Exemption for Year X+3

11. Changing Domestic Regulations Amend domestic regulations for exemption: –Defined conditions for essential use exemption to phaseout –Permitted production/consumption beyond the phaseout –Created new reporting and recordkeeping requirements

12. Analyze & Review Applications from Companies & Associations In 1993, received applications for many uses of ODSs For some, held sector meetings –Companies shared information on technically and economically feasible alternatives –Companies withdrew applications For others, met to describe why couldn’t be nominated For final group, developed nominations –Now clear guidelines to nominate CFCs for MDIs

13. Interact with MATOC Provide additional information to TOC –Interact with companies to get information –Internal government coordination, too Develop additional clarification, support for why ODS is essential –Decision IV/25 is basis –Many other Decisions, especially regarding CFCs for MDIs

14. Implement EUE Exemption Allocate “allowances” to exempt production & import of specific amounts of ODS Define specific uses for which exempt production & import permitted Develop and communicate clear reporting requirements –To gather data for Accounting Framework

17. Summary: U.S. Lessons Learned Requires substantial effort to collect information to justify EUE nomination Demands high level of coordination with “new” domestic stakeholders Requires much planning for effective management of overlapping multi-year processes