NAAQS Review Process Demystified, December 2004
The U.S. Environmental Protection Agency (EPA) is currently reviewing the National Ambient Air Quality Standards (NAAQS) for particulate matter and ozone, two common air pollutants that have been implicated in a wide range of health problems. The EPA review process offers the opportunity to make significant improvements in public health.
Background
The Clean Air Act requires EPA to review, and if necessary, revise the NAAQS for common air pollutants every five years. The Clean Air Act directs EPA to conduct a rigorous review of the latest scientific evidence, and to set standards at levels that will protect public health with an adequate margin of safety. Standards are supposed to protect the health of sensitive individuals and groups.
The NAAQS drive the nation’s air pollution control programs. The Clean Air Act requires the States and EPA to develop strategies for reducing pollution from cars, factories and power plants in order to meet the air quality standards.
On July 18, 1997, EPA revised its air quality standards for two key air pollutants, particulate matter and ozone. For the first time, EPA set specific standards for very fine particles known as PM2.5, those particles with a diameter of less than 2.5 microns. The standards were for 24-hour and annual average concentrations and supplemented earlier standards for inhalable particulate matter known as PM10.
The 24-hour PM2.5 standard was set at 65 mg/m3, with compliance determined based on the 3 year average of 98th percentile of 24-hour concentrations at each population-oriented monitor in area.
The annual average PM2.5 standard was set at 15 mg/m3, with compliance based on the 3 year average of annual arithmetic mean concentrations from single or multiple community oriented monitors in area.
Also for the first time, EPA set a new eight-hour standard for ozone. The pre-existing one-hour average ozone standard continues to apply in areas that violated the standard. The 8-hour average standard is set at a level of 0.08 ppm. The ozone standard is attained when the fourth highest eight hour concentration in a year, averaged over three years, is less than or equal to the standard.
This was a very significant step, because it recognized that the form and level of earlier NAAQS were not sufficient to protect public health.
When the new fine particle standards were announced in 1997, the President directed EPA to complete its next review of the PM NAAQS within five years, by July 2002. At the same time, EPA strengthened its PM research program, in coordination with other federal agencies, states, nonprofit organizations, and industry research institutions. This schedule would enable the Agency to consider the results of emerging scientific research before new control programs were slated to take effect.
Review Process
EPA follows a multi-step process for review of the NAAQS. Major steps in the process include:
· Development of a Criteria Document that synthesizes new research on health and environmental effects;
· Preparation of a Staff Paper that assesses the policy implications of the scientific information in the Criteria Document and discusses possible ranges for air quality standards;
· Preparation of a quantitative risk assessment that estimates health effects at various levels of the standards;
· Publication of proposed standards in the Federal Register; and
· Promulgation of final NAAQS.
The first four steps each entail the review of public comments.
In addition, an EPA advisory panel of outside experts, known as the Clean Air Scientific Advisory Committee (CASAC), convenes public meetings to review drafts of the Criteria Document, the Staff Paper, and the proposed standards. This influential panel typically must “reach closure” before EPA moves to the next step of the process. EPA staff make changes in the draft documents to satisfy the concerns raised by CASAC.
Clean Air Scientific Advisory Committee
The congressionally mandated CASAC panel has seven standing members, and about a dozen additional consultants added specifically for specific review of each standard. The members of CASAC are typically drawn from academia and from industry research organizations, and include a state air quality official. The expertise of the panel members ranges from toxicology to agricultural effects to air quality monitoring. The Committee has enormous influence on EPA’s standard-setting process.
Information on CASAC activities [www.epa.gov/sab] is available on an EPA website. This website also allows you to sign up for a listserv that provides notification of all upcoming meetings.
Requests to testify at CASAC meetings, or to distribute information to CASAC members are handled by:
Fred Butterfield
Designated Federal Officer
Science Advisory Board (1400A)
U.S. Environmental Protection Agency
1025 F St. NW 3rd Floor
Washington, DC 20460
Phone: 202-343-9994
Email: butterfield.fred@epa.gov
Criteria Document
The Criteria Document is a multi-volume compendium and synthesis of new scientific studies published since EPA’s last review of the PM standards. It is significant because any changes to the NAAQS must be based on the information in the Criteria Document. Chapters in the Criteria Document are drafted by staff scientists from EPA’s National Center for Environmental Assissment in the Office of Research and Development, assisted by outside consultants.
First, the draft chapters are subject to an external peer review process at public workshops. CASAC and members of the public review subsequent drafts.
Copies of the final CD are available online. To request a hard copy or CD-ROM version contact Emily Lee at EPA at: lee.emily@epa.gov or by phone at (919)541-4169, or by fax at (919)541-5078.
Comments on the PM or Ozone Criteria Documents may be sent to:
Dr. Lester Grant
National Center for Environmental Assessment
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Phone: (919) 541-4173
Email: grant.lester@epamail.epa.gov.
Staff Paper, Risk Assessment and Key Issues
The Staff Paper casts the technical information from the Criteria Document into terms relevant to policy makers. It provides a concise summary of the findings of new health studies and their policy significance. It tackles controversial issues such as the implications of the new epidemiological and toxicological studies on the assessment of causality, and the contribution of ambient air pollution to personal exposure.
The Staff Paper will go beyond the Criteria Document by analyzing new air quality monitoring information. It also includes a quantitative risk assessment of alternative levels of the standard.
Key issues in the NAAQS review are the definition of the regulated pollutant, the form and level of the standards, including averaging time, and how compliance will be measured. Each of these parameters affects the stringency of the standards. The Staff Paper will interpret new scientific information relevant to these policy choices.
For more information on policy issues in the review of the PM NAAQS click here.
The staff paper recommends ranges from which the EPA Administrator can select a particular level for a new PM standard.
EPA’s Office of Air Quality Planning and Standards drafts the Staff Paper. The contact person for PM is:
Dr. Mary Ross
Office of Air Quality Planning and Standards
U.S. Environmental Protection Agency (MD-15)
Research Triangle Park, NC 27711
Phone: (919) 541-5170
Email: Ross.Mary@epamail.epa.gov.
The draft Staff Paper and Risk Assessment for PM is available online.
For ozone, the EPA contact is:
Dr. Dave McKee
Office of Air Quality Planning and Standards
U.S. Environmental Protection Agency (MD-15)
Research Triangle Park, NC 27711
Phone: (919) 919-541-5288
Email: mckee.dave@epa.gov.
The risk assessment for both PM and ozone is prepared by:
Mr. Harvey Richmond
Office of Air Quality Planning and Standards
U.S. Environmental Protection Agency (MD-15)
Research Triangle Park, NC 27711
Phone: (919) 541- 919-5271
Email: Richmond.harvey@epa.gov.
Major Milestones
Important opportunities for public comment occur prior to and at the CASAC public meetings, and during the public comment period on the proposal.
Conclusion
The oil, automobile, electric utility, steel, and mining industries are heavily engaged in the NAAQS review process. These industries have a stable of technical consultants and lawyers to make the case against strong standards. The American Lung Association has launched a campaign to ensure that public health concerns are heard at every step of the process.
