Document ID: EPA-HQ-OAR-2008-0503-0021
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-01-16T05:00Z

Decision VIII/10.  Actions by Parties not operating under Article 5 to
promote industry's participation on a smooth and efficient transition
away from CFC-based MDIs

1.	That Parties not operating under Article 5 will request companies
applying for MDI essential-use exemptions to demonstrate ongoing
research and development of alternatives to CFC MDIs with all due
diligence and/or collaborate with other companies in such efforts and,
with each future request, to report in confidence to the nominating
Party whether and to what extent resources are deployed to this end and
progress is being made on such research and development, and what
licence applications if any have been submitted to health authorities
for non-CFC alternatives;

2.	That Parties not operating under Article 5 will request companies
applying for MDI essential-use exemptions to demonstrate that they are
undertaking individual or collaborative industry efforts, in
consultation with the medical community, to educate health-care
professionals and patients about other treatment options and the
transition to non-CFC alternatives;

3.	That Parties not operating under Article 5 will request companies
applying for MDI essential-use exemptions to demonstrate that they, or
companies distributing or selling their product, are differentiating the
packaging of the company's non-CFC MDIs from its CFC MDIs and are
applying other appropriate marketing strategies, in consultation with
the medical community, to encourage doctor and patient acceptance of the
company's non-CFC alternatives subject to health and product-safety
considerations;

4.	That Parties not operating under Article 5 will request companies
manufacturing, distributing or selling CFC MDIs and non-CFC alternatives
not to engage in false or misleading advertising targeted at non-CFC
alternatives or CFC MDIs;

5.	That Parties not operating under Article 5 will request companies
applying for MDI essential-use exemptions to ensure that participation
in regulatory proceedings is conducted with a view toward legitimate
environmental, health and safety concerns;

6.	That Parties not operating under Article 5 will request companies
manufacturing CFC MDIs to take all economically feasible steps to
minimize CFC emissions during the manufacture of MDIs;

7.	That Parties not operating under Article 5 will request companies
manufacturing, distributing or selling CFC MDIs to dispose of expired,
defective, and returned MDIs containing CFCs in a manner that minimizes
CFC emissions;

8.	That Parties not operating under Article 5 will request companies
manufacturing CFC MDIs to review annually CFC requirements and current
MDI market forecasts, and notify national regulatory authorities if such
forecasts will result in surplus CFCs obtained under essential-use
exemptions;

9.	That Parties not operating under Article 5 will request companies
applying for MDI essential-use exemptions to provide information on the
steps that are being taken to provide a continuity of supply of asthma
and chronic obstructive pulmonary disease (COPD) treatments (including
CFC MDIs) to importing countries;

10.	That Parties not operating under Article 5 will request companies
applying for MDI essential-use exemptions to provide information that
demonstrates the steps being taken to assist the company's MDI
manufacturing facilities in Parties operating under Article 5 and
countries with economies in transition in upgrading the technology and
capital equipment needed for manufacturing non-CFC asthma and chronic
obstructive pulmonary disease (COPD) treatments;

11.	To request the Technology and Economic Assessment Panel to reflect
paragraphs 1 through 10 above in a revised version of the Handbook on
Essential-Use Nominations;