Peer review of the earliest criteria documents
prepared by the EPA was carried out by various
committees of the agency’s Science Advisory
Board. The 1977 amendments to the CAA institutionalized the peer-review process for the
NAAQS [16]. The amendment requires the EPA
Administrator to appoint an independent scientific
committee, composed of seven members, including at least one member of the National Academy
of Sciences, one physician, and one person
representing state air pollution control agencies
to advise the Administrator on the science
informing the policy judgments made in setting
the NAAQS. The EPA has implemented this provision of the CAA by appointing a Committee,
which designated itself as the Clean Air Scientific
Advisory Committee (CASAC). The CASAC is
directly responsible to the EPA Administrator,
although it functions administratively as one of
the standing committees of the EPA Science Advisory Board. Traditionally, the requirement for one
CASAC member to be a member of the National
Academy of Sciences has been broadly
interpreted to also include membership in either
the National Academy of Engineering or the Institute of Medicine. To complement the expertise of
regular members of the CASAC, a number of
consultants, sometimes as many as a dozen, with
specialized expertise usually have been added to
the review panels for specific pollutants.
The CAA was amended again in 1990
[17]. Although major changes were made in the
CAA with these amendments, especially with
regard to the regulation of hazardous air pollutants, there were no changes in the fundamental
approach to dealing with the setting of NAAQS
for criteria pollutants. However, there were
changes in the CAA that have had major impact
on the regulation of emissions of PM and precursors especially from large power plants.
The pollutants originally designated as
“criteria pollutants” because of their ubiquitous
distribution and potential to endanger health
were photochemical oxidants (later regulated as
ozone), particulate matter (later regulated as Total
Suspended Particulates, then PM 10 , and PM 2.5 ),
carbon monoxide, sulfur oxides (regulated as sulfur dioxide), nitrogen oxides (regulated as NO 2 ),
and non-methane hydrocarbons (later dropped as
a criteria pollutant). The EPA [64] established
NAAQS for these pollutants soon after the
Agency was created using existing scientific documentation, that is, criteria. The original NAAQS
set in 1971 are shown in Table 3. As I will discuss
below, the EPA later added Lead as a criteria
pollutant with legal prodding from the National
Resources Defense Council [49, 72].
US Process for Setting National Ambient
Air Quality Standards
The process for developing and issuing NAAQS
after the initial NAAQS were set is quite complex
as discussed by Bachmann [7] and McClellan [36,
37, 39, 41]. Key elements of the process, as used
until quite recently, include preparation and
review of (a) criteria document, (b) staff paper,
(c) more recently a risk assessment, and (d) a
regulatory decision package leading to the
Administrator’s policy judgment decisions as to
the proposed and final NAAQS which are
published in the Federal Register. Traditionally,
CASAC focused its attention on reviewing the
Criteria Documents and Staff Papers and, more
recently, a formal Risk Assessment. As an aside,
the process was changed at the end of 2006 [51]
with an Integrated Science Assessment and Policy
Assessment Document replacing the Criteria Document and Staff Paper. Time will tell if these
changes really improve the overall process.
In addition to the documents noted above, the
Agency now prepares a Regulatory Impact Analysis which is required under Executive Order
12866 issued by President Clinton [18] that
applies to economically significant rules that
have “an annual effect on the economy of
$100 million or more or adversely effect in a
material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety or site, local, or tribal
governments or communities.” The results of the
Regulatory Impact Analysis are not considered
during the NAAQS rulemaking process given
the prohibition of consideration of cost in the
setting of the NAAQS [93].
Air Quality Guidelines and Standards
19
prepared by the EPA was carried out by various
committees of the agency’s Science Advisory
Board. The 1977 amendments to the CAA institutionalized the peer-review process for the
NAAQS [16]. The amendment requires the EPA
Administrator to appoint an independent scientific
committee, composed of seven members, including at least one member of the National Academy
of Sciences, one physician, and one person
representing state air pollution control agencies
to advise the Administrator on the science
informing the policy judgments made in setting
the NAAQS. The EPA has implemented this provision of the CAA by appointing a Committee,
which designated itself as the Clean Air Scientific
Advisory Committee (CASAC). The CASAC is
directly responsible to the EPA Administrator,
although it functions administratively as one of
the standing committees of the EPA Science Advisory Board. Traditionally, the requirement for one
CASAC member to be a member of the National
Academy of Sciences has been broadly
interpreted to also include membership in either
the National Academy of Engineering or the Institute of Medicine. To complement the expertise of
regular members of the CASAC, a number of
consultants, sometimes as many as a dozen, with
specialized expertise usually have been added to
the review panels for specific pollutants.
The CAA was amended again in 1990
[17]. Although major changes were made in the
CAA with these amendments, especially with
regard to the regulation of hazardous air pollutants, there were no changes in the fundamental
approach to dealing with the setting of NAAQS
for criteria pollutants. However, there were
changes in the CAA that have had major impact
on the regulation of emissions of PM and precursors especially from large power plants.
The pollutants originally designated as
“criteria pollutants” because of their ubiquitous
distribution and potential to endanger health
were photochemical oxidants (later regulated as
ozone), particulate matter (later regulated as Total
Suspended Particulates, then PM 10 , and PM 2.5 ),
carbon monoxide, sulfur oxides (regulated as sulfur dioxide), nitrogen oxides (regulated as NO 2 ),
and non-methane hydrocarbons (later dropped as
a criteria pollutant). The EPA [64] established
NAAQS for these pollutants soon after the
Agency was created using existing scientific documentation, that is, criteria. The original NAAQS
set in 1971 are shown in Table 3. As I will discuss
below, the EPA later added Lead as a criteria
pollutant with legal prodding from the National
Resources Defense Council [49, 72].
US Process for Setting National Ambient
Air Quality Standards
The process for developing and issuing NAAQS
after the initial NAAQS were set is quite complex
as discussed by Bachmann [7] and McClellan [36,
37, 39, 41]. Key elements of the process, as used
until quite recently, include preparation and
review of (a) criteria document, (b) staff paper,
(c) more recently a risk assessment, and (d) a
regulatory decision package leading to the
Administrator’s policy judgment decisions as to
the proposed and final NAAQS which are
published in the Federal Register. Traditionally,
CASAC focused its attention on reviewing the
Criteria Documents and Staff Papers and, more
recently, a formal Risk Assessment. As an aside,
the process was changed at the end of 2006 [51]
with an Integrated Science Assessment and Policy
Assessment Document replacing the Criteria Document and Staff Paper. Time will tell if these
changes really improve the overall process.
In addition to the documents noted above, the
Agency now prepares a Regulatory Impact Analysis which is required under Executive Order
12866 issued by President Clinton [18] that
applies to economically significant rules that
have “an annual effect on the economy of
$100 million or more or adversely effect in a
material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety or site, local, or tribal
governments or communities.” The results of the
Regulatory Impact Analysis are not considered
during the NAAQS rulemaking process given
the prohibition of consideration of cost in the
setting of the NAAQS [93].
Air Quality Guidelines and Standards
19