Outer Continental Shelf Air Regulations

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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