[Federal Register Volume 59, Number 23 (Thursday, February 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2487]


[[Page Unknown]]

[Federal Register: February 3, 1994]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 50

[FRL-4832-8]

 

Review of National Ambient Air Quality Standards for Ozone

AGENCY: U.S. Environmental Protection Agency (USEPA).

ACTION: Notice of review.

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SUMMARY: This notice announces the EPA's plans to review and revise the 
Air Quality Criteria for Ozone and Other Photochemical Oxidants 
(Criteria Document) as rapidly as possible and to complete review of 
the national ambient air quality standards (NAAQS) for ozone (O3) 
as soon as possible thereafter.
    The Clean Air Act (Act) requires periodic review and, if 
appropriate, revision of the NAAQS and of the air quality criteria on 
which they are based. The EPA completed its last formal review of the 
air quality criteria for O3 in 1989. Based on that review, the EPA 
announced a final decision on March 9, 1993 not to revise the existing 
O3 NAAQS.
    Since early 1989, however, a substantial number of new studies on 
the health and environmental effects of O3 have appeared in the 
peer-reviewed literature. The EPA is moving as rapidly as possible to 
review them, consistent with assuring a sound, scientifically-
supportable decision.
    The review process includes: (1) Reviewing and revising the 
Criteria Document; (2) reviewing the NAAQS through development of a 
Staff Paper based on the revised Criteria Document; (3) external review 
of Criteria Document and Staff Paper drafts by the Clean Air Scientific 
Advisory Committee (CASAC) of the EPA's Science Advisory Board, an 
independent panel of scientific experts, and by the public; and (4) 
examining implementation ramifications of changes to the O3 NAAQS. 
The EPA intends to adhere to strict schedules for external review of 
Criteria Document and Staff Paper drafts consistent with a full 
opportunity for thorough scientific and public review, and to deny any 
requests for extensions of the public comment periods specified in this 
notice.
    During this NAAQS review, the EPA intends to continue implementing 
programs designed to meet the current standards and the requirements of 
the Clean Air Act Amendments of 1990 to ensure continued improvement in 
air quality. The EPA is also examining options for implementing 
alternative O3 NAAQS to ensure a smooth transition if a decision 
is made to revise the existing NAAQS.

FOR FURTHER INFORMATION CONTACT: Dr. Karen Martin, Air Quality 
Management Division (MD-12), U.S. Environmental Protection Agency, 
Research Triangle Park, N.C. 27711, telephone (919) 541-5274.

SUPPLEMENTARY INFORMATION:

Background

    Based on a Criteria Document issued by the Department of Health, 
Education and Welfare in 1970, the EPA promulgated the first NAAQS for 
photochemical oxidants under section 109 of the Act (36 FR 8186) in 
1971. The primary and secondary NAAQS were both set at an hourly 
average of 0.08 parts per million (ppm) total photochemical oxidants 
not to be exceeded more than 1 hour per year.
    In 1977, the EPA announced (42 FR 20493) the first review and 
updating of the 1970 Criteria Document in accordance with section 
109(d)(1) of the Act. The EPA published a Criteria Document in 1978. 
Based on the revised Criteria Document and taking into account public 
comments on revisions proposed to the primary and secondary NAAQS in 
1978 (43 FR 16962), the EPA announced revisions to the 1971 standards 
in 1979 (44 FR 8202). The primary standard was revised from 0.08 parts 
per million (ppm) to 0.12 ppm; the secondary standard was set identical 
to the primary standard; the chemical designation of the standards was 
changed from photochemical oxidants to O3; and the form of the 
standards was revised from a deterministic form to a statistical form, 
which defines attainment of the standards as occurring when the 
expected number of days per calendar year with maximum hourly average 
concentrations greater than 0.12 ppm is equal to or less than one.
    In 1982 (47 FR 11561), the EPA announced plans to revise the 1978 
Criteria Document. In 1983, the EPA announced (48 FR 38009) that review 
of primary and secondary standards for O3 had been initiated. The 
EPA subsequently provided a number of opportunities for public review 
and comment on drafts of the Criteria Document and associated Staff 
Paper (Review of the National Ambient Air Quality Standards for Ozone: 
Assessment of Scientific and Technical Information--Office of Air 
Quality Planning and Standards Staff Paper). After reviewing the draft 
Criteria Document in 1985 and 1986, the CASAC sent the Administrator a 
``closure letter'' outlining key issues and recommendations and 
indicating that it was satisfied with the final draft of the 1986 
Criteria Document.
    Following closure, a number of scientific articles and abstracts 
were published or accepted for publication that appeared to be of 
sufficient importance concerning potential health and welfare effects 
of O3 to warrant preparation of a supplement to the Criteria 
Document (Supplement). The CASAC, having already reviewed two drafts of 
the Staff Paper in 1986 and 1987, concluded that sufficient new 
information existed to recommend incorporation of relevant new 
information into a third draft of the Staff Paper.
    The CASAC held a public meeting in 1988 to review a draft 
Supplement and the third draft Staff Paper. Major issues included: The 
definition of adverse health effects of O3; the significance of 
health studies suggesting that exercising individuals exposed for 6 to 
8 hours to O3 levels at or below 0.12 ppm may experience lung 
inflammation and transient decreases in pulmonary function; the 
possibility that chronic irreversible effects may result from long-term 
exposures to elevated levels of O3; and, the importance of 
analyses indicating that agricultural crop damage may be better defined 
by a cumulative seasonal average than by a 1-hour peak level of 
O3. In its ``closure letter'' of 1989, the CASAC indicated that 
the draft Supplement and draft Staff Paper ``provide an adequate 
scientific basis for the EPA to retain or revise primary and secondary 
standards for ozone.''
    On October 22, 1991, the American Lung Association and other 
plaintiffs filed suit under section 304 of the Act to compel the EPA to 
complete its review of the criteria and standards for O3 under 
section 109(d)(1) of the Act [American Lung Association v. Reilly, No. 
91-cv-4114 (JRB) (E.D.N.Y.)]. The U.S. District Court for the Eastern 
District of New York subsequently issued an order requiring the EPA to 
sign a Federal Register notice announcing its proposed decision on 
whether to revise the standards for O3 by August 1, 1992 and to 
sign a Federal Register notice announcing its final decision by March 
1, 1993.
    On August 10, 1992 (57 FR 35542), the EPA published a proposed 
decision under section 109(d)(1) that revisions to the existing primary 
and secondary standards were not appropriate at that time. The notice 
explained in some detail (see 57 FR 35546) that the proposed decision 
would complete the EPA's review of information on health and welfare 
effects of O3 assembled over a 7-year period and contained in the 
1986 Criteria Document and the 1989 Supplement. The notice made clear 
that the Administrator did not take into account more recent studies on 
the health and welfare effects of O3 because these studies had not 
been assessed in the 1986-1989 Criteria Document/Supplement, nor had 
they collectively undergone the rigorous, integrative review process 
(including CASAC review) required to incorporate them into a new 
criteria document. The proposed decision, therefore, was based on an 
evaluation of key studies published through early 1989 as contained in 
the 1986-89 Criteria Document/Supplement, the 1989 Staff Paper 
assessment of the most relevant information in these documents, and the 
advice and recommendations of the CASAC as presented both in the 
discussion of these documents at public meetings and in the CASAC's 
1986 and 1989 ``closure letters.''
    In view of the large number of recent scientific papers and ongoing 
research on the health and welfare effects of O3, the August 10, 
1992 notice also announced the EPA's intention to proceed as rapidly as 
possible with the next review of the air quality criteria and standards 
for O3. On March 9, 1993 (58 FR 13008) the EPA published its final 
decision not to revise the current primary and secondary NAAQS for 
O3. Because of the scientific and technical complexity of such 
assessments, the EPA had estimated that 2 to 3 years would be necessary 
to rigorously assess more than 1,000 new studies and incorporate key 
information into a revised criteria document, to evaluate the 
significance of the key information for decision-making purposes, to 
develop staff recommendations for the Administrator, and to provide 
appropriate opportunities for CASAC review and public comment. Given 
the potential importance of the new studies and the EPA's continuing 
concern about the health and welfare effects of O3, the March 9, 
1993 notice also indicated the Administrator's intention to move the 
review process ahead as quickly as possible and, if appropriate, to 
propose revisions of the standards at the earliest possible date.

 Current Review Process/Schedule

    Following publication of the March 9, 1993 decision, the Agency, in 
consultation with the CASAC and the Science Advisory Board, undertook a 
rigorous examination of the NAAQS review process designed to identify 
all measures that could be taken to accelerate its review of the 
criteria and standards for O3 consistent with assuring a sound and 
scientifically-credible decision. As a result, the EPA has adopted a 
number of measures intended to accelerate the O3 NAAQS review. 
These measures include: (1) Conducting review and revision of the 
Criteria Document and development of the Staff Paper and associated 
analyses (e.g., exposure analysis and health risk assessments) in a 
more concurrent fashion than in the previous NAAQS reviews; (2) 
adhering to strict schedules for external review of Criteria Document 
and Staff Paper drafts consistent with a full opportunity for thorough 
scientific and public review; (3) establishing a highly-expedited 
Agency review process with senior level management oversight and 
involvement throughout the process, as well as early discussion of 
possible options with other Federal agencies, including the Office of 
Management and Budget; and (4) reducing the volume of information 
included in the revised Criteria Document by focusing on the most 
important new studies and setting a date beyond which new studies will 
not be included.
    The EPA's current O3 NAAQS review schedule incorporates the 
measures cited above. The Agency's target date for completion of the 
Criteria Document and Staff Paper is mid-1995, with proposal of changes 
to the O3 NAAQS, if appropriate, in mid-1996 and promulgation in 
mid-1997. Table 1 outlines key milestone dates for this accelerated 
schedule.
    As indicated in Table 1, there are a number of opportunities for 
public comment throughout the process. The EPA encourages involvement 
of interested parties and is providing this advance notice to alert 
potential participants in the review that adhering to the schedule will 
require some departures from past practices.

                                Table 1                                 
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          Major milestones                     Tentative dates          
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CASAC Subcommittee Meeting on        December 1993.                     
 Exposure Assessment Methods.                                           
CASAC and Public Comment Period for  February to May 1994.\1\           
 Criteria Document (CD) (90 days).                                      
CASAC Subcommittee Meeting on Risk   March 1994.                        
 Assessment Methods.                                                    
CASAC Meeting on CD................  July 1994.                         
Comment Period on Staff Paper (SP)   September to October 1994.         
 (60 days).                                                             
CASAC Meeting on SP................  October 1994.                      
Public Comment Period on Revised CD  Early 1995.                        
 and SP (90 days).                                                      
CASAC Meeting on Revised CD and SP.  Mid-1995.                          
Agency Development of Regulatory     Mid-1995 to late 1995.             
 Decision/Proposal Package Draft.                                       
Office of Management and Budget      Early 1996.                        
 Review of Proposal Package.                                            
Publication of Proposal in Federal   Mid-1996.                          
 Register.                                                              
Public Comment Period on Proposal    Mid-1996.                          
 (90 days).                                                             
CASAC Meeting to Review Proposal...  Late 1996.                         
Regulatory Decisions and Final       Early 1997.                        
 Package Draft Completed.                                               
Office of Management and Budget      Early 1997 to mid-1997.            
 Review of Promulgation Package.                                        
Publication of Promulgation Notice   Mid-1997.                          
 in Federal Register.                                                   
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\1\For a notice of availability of external review draft, see 59 FR     
  4278, January 31, 1994.                                               

    In particular, the EPA has often granted requests for extensions of 
public comment periods in previous reviews; in order to meet the 
accelerated schedule for the O3 NAAQS review, however, the EPA 
intends not to grant such extensions during this review. Accordingly, 
potential participants in the review should take note of the process 
outlined in this notice and be prepared to respond promptly when 
opportunities to comment are offered.
    Given the scientific and technical complexity of the issues likely 
to be involved in the O3 review, the diversity of scientific 
opinion that has characterized previous reviews of the criteria and 
standards for O3, and the need to ensure that its ultimate 
decision is soundly based, the EPA cannot, of course, provide any 
absolute assurance that it will meet all of the interim milestone dates 
indicated in Table 1. Completion of the necessary steps in a timely 
manner is also predicated upon the availability of adequate resources 
during the review process. However, the Administrator has emphasized a 
high priority on meeting the accelerated schedule outlined in this 
notice.
    To that end, the review process is well under way. The EPA 
initiated action to update the air quality criteria for O3 in 
August 1992 (57 FR 38832). It held two peer-review workshops on draft 
health effects chapters of a revised Criteria Document (58 FR 35454) in 
July 1993. Additional workshops on draft air quality and ecological 
effects chapters (58 FR 48063) were held in September 1993. Since then, 
the EPA has discussed the schedule and process outlined in this notice 
with the CASAC (58 FR 59034). The EPA is also conducting exposure and 
risk analyses. A subcommittee of the CASAC met on December 16, 1993 to 
review methodologies (58 FR 63345). A further subcommittee meeting on 
risk analysis is planned for spring 1994.

Implementation

    It is important to stress that while conducting this review, the 
EPA remains committed to implementing the existing O3 NAAQS in 
accordance with the Clean Air Act Amendments of 1990 (CAAA). During the 
review, the EPA will continue to work with States to implement emission 
control strategies required by the CAAA to meet the existing O3 
NAAQS. These efforts include State and Federal actions to reduce 
emissions of volatile organic compounds and nitrogen oxides, which act 
as precursors to O3 formation in the troposphere. The EPA will 
make every effort to maintain implementation schedules consistent with 
requirements of the CAAA to ensure continued improvement in air 
quality.
    As part of the review, the EPA is examining the ramifications of 
any changes to the NAAQS on current implementation efforts. If 
appropriate, new implementation rules and guidelines will be considered 
for alternative NAAQS. The EPA also is reviewing options to ensure a 
smooth transition for implementation of any new O3 NAAQS in the 
event a decision is made to revise the current O3 NAAQS.

List of Subjects in 40 CFR Part 50

    Environmental protection, Air pollution control, Carbon monoxide, 
Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.

    Dated: January 27, 1994.
Carol M. Browner,
Administrator.
[FR Doc. 94-2487 Filed 2-2-94; 8:45 am]
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