January 11, 2008
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January 11, 2008
HEADLINE
ATS Tells EPA Administrator to Tighten Ozone Standard
In January, ATS Executive Director Stephen Crane PhD, MPH and William Rom MD, Chair of the ATS Environmental Health Policy Committee, joined representatives of the America Lung Association and other scientific and public health groups in a meeting with EPA Administrator Stephen Johnson urging him to issue a significantly tighter standard for ozone pollution in pending final rule. The ATS is supporting a standard of 0.060 ppm/8-hours. By court order, EPA is required to issue a revised national air pollution standard for ozone by March 2008.
The focus of the meeting was scientific evidence supporting the need for a stricter standard. A number of studies have shown adverse morbidity and mortality effects with exposures at and below the current standard of 0.08 ppm/8-hours. Dr. Rom summarized the key studies supporting the need for a stricter standard and countered industry arguments that the science on ozone was too "uncertain" for the EPA to issue a tighter standard.
EPA Administrator Johnson has held a series of meetings with concerned industry, scientific/medical, public health and state air quality controllers to collect input on the forthcoming ozone standard. In their proposal rule, EPA suggested lowering the standard from the current level 0.08 ppm to a level between 0.070 and 0.075 ppm. The final rule will be issued by March 12, 2008.RESEARCH
ATS Comments on Research Involving Decisionally-Impaired Patients
The ATS and several sister organizations submitted joint comments to the Office for Human Research Protection (OHRP) in response to their request for public comment on the rules protecting patients with "decision making" impairments participating in research protocols. Existing OHRP rules focus primarily on patients with permanent mental impairments. The focus of the request for comments was how to protect the interests of patients with temporary decision-making impairments - like critically ill patients - in clinical research.
The comments submitted by the ATS focused on research in critically ill patients and described the need for and challenges associated with conducting clinical research in the critical care unit. The key themes developed in the comments included:
- Ethical Clinical Research in the ICU Must be Preserved and Enhanced with National Standards
- The Unique Needs of Critically Ill Patients Participating in Clinical Research Must be Recognized
- Surrogate Consent Must be Preserved
- Cross Institution Procedural Consistency and Simplification should be Enhanced
- Waiver of Informed Consent Requirement in Certain Emergency Research
The following organizations joined the ATS in submitting these comments to OHRP: American College of Chest Physicians, Society for Critical Care Medicine, Canadian Clinical Trials Group, Canadian Critical Care Society, National Association for the Medical Direction of Respiratory Care and the American Society for Critical Care Anethesiologists.
Points of Contact
| Gary Ewart | Senior Director, Government Relations |
| Nuala Moore | Senior Legislative Representative |
| Joe Kirby | DC Office Administrator |



