Proposed Requirements for Designation of Reference and Equivalent Methods for PMINF2.5 and Ambient Air Quality Surveillance for Particulate Matter

SUMMARY: The EPA proposes to revise 40 CFR part 58 to establish ambient

air quality monitoring requirements for PM2.5 (particles with an

aerodynamic diameter less than or equal to a nominal 2.5 micrometers)

as measured by a new reference method being proposed in Appendix L to

40 CFR part 50 or by an equivalent method designated in accordance with

requirements being proposed in 40 CFR part 53. In addition, this

document also proposes certain revisions to existing ambient air

quality monitoring requirements for PM10 (particles with an

aerodynamic diameter less than or equal to a nominal 10 micrometers).

The changes proposed in this document address among other things,

network design and siting, quality assurance and quality control, and

monitoring methodology. The document also indicates EPA's intent to

explore opportunities to coordinate and integrate the existing

visibility monitoring requirements with the ambient air quality

monitoring requirements for particulate matter being proposed today to

accommodate a better regional haze program and to reduce burdens and

achieve multiple monitoring objectives.

DATES: Comments must be submitted on or before February 18, 1997.

ADDRESSES: Comments should be submitted (in duplicate, if possible) to:

Air Docket (LE-131), U.S. Environmental Protection Agency, Attn. Docket

No. A-96-51, 401 M Street, SW, Washington, DC 20460. The docket may be

inspected between 8:00 a.m. and 5:30 p.m. on weekdays. A reasonable fee

may be charged for copying.

Public hearing: The EPA will announce in a separate Federal

Register document the date, time, and address of the public hearing on

this proposed decision.

FOR FURTHER INFORMATION CONTACT: Mr. Neil Frank (MD-14), Monitoring and

Quality Assurance Group, Emissions, Monitoring, and Analysis Division,

U.S. Environmental Protection Agency, Research Triangle Park, North

Carolina 27711, telephone (919) 541-5560.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Authority

II. Introduction

III. Discussion of Proposed Revisions to Part 53

A. Designation of Reference and Equivalent Methods

B. Quality Assurance

IV. Discussion of Proposed Revisions to Part 58

A. Section 58.1 Definitions

B. Section 58.13 Operating schedule

C. Section 58.14 Special purpose monitors

D. Section 58.15 PM2.5 NAAQS eligible monitors

E. Section 58.20 Air quality surveillance: plan content

F. Section 58.23 Monitoring network completion

G. Section 58.25 System modification

H. Section 58.26 Annual SLAMS summary report

I. Section 58.30 NAMS network establishment

J. Section 58.31 NAMS network description

K. Section 58.34 NAMS network completion

L. Section 58.35 NAMS data submittal

M. Appendix A--Quality Assurance Requirements for State and

Local Air Monitoring Stations (SLAMS)

N. Appendix B--Quality Assurance Requirements for Prevention of

Significant Deterioration (PSD) Air Monitoring

O. Appendix C--Ambient Air Quality Monitoring Methodology

P. Appendix D--Network Design for State and Local Air Monitoring

Stations (SLAMS), National Air Monitoring Stations (NAMS), and

Photochemical Assessment Monitoring Stations (PAMS)

Q. Appendix E--Probe and Monitoring Path Siting Criteria for

Ambient Air Quality Monitoring

R. Cost Estimates for New PM Networks

S. Reference

V. Administrative Requirements

A. Regulatory Impact Analysis

B. Reporting and Record keeping Requirements

C. Impact on Small Entities

D. Unfunded Mandates Reform Act of 1995

I. Authority

Sections 110, 301(a), and 319 of the Clean Air Act as amended 42

U.S.C. 7410, 7601(a), 7619.

II. Introduction

A. Proposed Revision to the Particulate Matter NAAQS

Elsewhere in today's Federal Register, EPA announced proposed

revisions to the national ambient air quality standards for particulate

matter. In that notice, EPA proposes to amend the current suite of

PM10 standards by adding new PM2.5 standards and by revising

the form of the current 24-hour PM10 standard. Specifically, the

EPA proposes to add two new primary PM2.5 standards set at 15

g/m3, annual mean, and 50 g/m3, 24-hour

average. The proposed new annual PM2.5 standard would be met when

the 3-year average of the annual arithmetic mean PM2.5

concentrations, spatially averaged across an area, is less than or

equal to 15 g/m3. The proposed new 24-hour PM2.5

standard would be met when the 3-year average of the 98th percentile of

24-hour PM2.5 concentrations at each monitor within an area is

less than or equal to 50.

The EPA also proposes to retain the current annual PM10

standard at the level of 50 g/m3, which would be met when

the 3-year average of the annual arithmetic PM10 concentrations at

each monitor within an area is less than or equal to 50 g/

m3. Further, EPA proposes to retain the current 24-hour PM10

standard at the level of 150 g/m3, but to revise the form

such that the standard would be met when the 3-year average of the 98th

percentile of the monitored concentrations at the highest monitor in an

area is less than or equal to 150 g/m3.

In the part 50 notice, EPA also proposed to revise the current

secondary standards by making them identical to the suite of proposed

primary standards. The suite of PM2.5 and PM10 standards, in

conjunction with the establishment of a regional haze program under

section 169A of the Clean Air Act (Act), are intended to protect

against PM-related welfare effects including soiling and materials

damage and visibility impairment.

As discussed in the part 50 notice, the proposed new PM2.5

standards are intended to protect against exposures to fine particulate

pollution, while the new PM10 standards are intended to protect

against coarse fraction particles as measured by PM10.

For PM2.5, the annual standard is intended to protect against

both long- and short-term exposures to fine particle pollution. Under

this approach, the PM2.5 24-hour standard would serve as a ``back

stop'' to provide additional protection against days with high

PM2.5 concentrations, localized ``hot spots,'' and risks arising

from seasonal emissions that would not be well controlled by a national

annual standard.

In specifying that the calculation of the annual arithmetic mean

for an area (for purposes of comparison to level of PM2.5 annual

standard) should be

[[Page 65781]]

accomplished by averaging the annual arithmetic means derived from

multiple, population-oriented monitoring sites, EPA took into account

several factors. As discussed in the part 50 notice, many of the

community-based epidemiologic studies examined in this review used

spatial averages, when multiple monitoring sites were available, to

characterize area-wide PM exposure levels and associated public health

risk. Even in those studies that used only one monitoring location, the

selected site was chosen to represent community-wide exposures, not the

highest value likely to be experienced within the community. Because

the annual PM2.5 standard would be intended to reduce aggregate

population risk from both long- and short-term exposures by lowering

the broad distribution of PM concentrations across the community, an

annual standard based on spatially averaged concentrations from several

population-oriented monitoring sites would better reflect areawide PM

exposure levels and associated health risks than would a standard based

on concentrations from a single monitor with the highest measured

values in the area. The spatial average approach is not appropriate for

PM10 because the spatial distribution of coarse particles is

different and tends to be more localized in its behavior.

Finally, under the policy approach presented in the part 50 notice,

the 24-hour PM2.5 standard would be intended to supplement a

spatially-averaged annual PM2.5 standard by providing protection

against peak 24-hour concentrations arising from situations that would

not be well-controlled by an annual standard. Accordingly, the 24-hour

PM2.5 standard would be based on the single population-oriented

monitoring site within a monitoring planning area with the highest

measured values.

In EPA's judgment, an annual PM2.5 standard expressed as a

spatial average, established in conjunction with a 24-hour standard

based on the monitoring site with the highest measured values, would

provide the most appropriate target for reducing area-wide population

exposure to fine particle pollution and would be most consistent with

the underlying epidemiologic data base. On the other hand, EPA is

mindful that adoption of spatial averaging for a PM2.5 standard

would add a degree of complexity to the monitoring siting requirements

and to the specification of those areas across which spatial averaging

should be permitted. This approach may also require larger monitoring

networks in some areas. By proposing a spatial averaging approach, the

part 50 notice recognizes that some monitoring planning areas may have

to be subdivided into smaller subareas to reflect gradients in particle

levels (e.g., upwind suburban sites, central city sites, downwind

sites) as well as topographical barriers or other factors that may

result in a monitoring planning area having several distinct air

quality regimes.

Recognizing the complexities that spatial averaging may introduce

into risk management programs and that unforeseen issues may arise from

public comment on the requirements presented in this notice, the part

50 notice also requests comment on the alternative of basing the

PM2.5 annual standard on the population-oriented monitoring site

within the monitoring planning area with the highest 3-year average

annual mean. The part 50 notice indicates, based on comments received,

that EPA may choose either of these two approaches for specifying the

form of the annual PM2.5 standard at the time of promulgation of

any revisions to the PM standards.

In the part 50 notice, EPA also solicits comments on alternative

levels of both annual and 24-hour PM2.5 primary standards and on

revoking the current 24-hour primary PM10 standard.

B. Air Quality Monitoring Requirements

Section 110(a)(2)(C) of the Act requires ambient air quality

monitoring for purposes of the State implementation plans (SIP's) and

for reporting data quality to EPA. Uniform criteria to be followed when

measuring air quality and provisions for daily air pollution index

reporting are required by section 319 of the Act. To satisfy these

requirements, on May 10, 1979 (44 FR 27558), EPA established 40 CFR

part 58 which provided detailed requirements for air quality

monitoring, data reporting, and surveillance for all of the pollutants

for which national ambient air quality standards have been established

(criteria pollutants). Provisions were promulgated subsequently for

particulate matter (PM10) on July 1, 1987 (52 FR 24740).

The intent of the air quality surveillance requirement being

proposed today is to establish a revised particulate matter monitoring

network that would produce air quality data for the purpose of

comparison to the proposed primary and secondary PM NAAQS and to

facilitate implementation of a possible new regional haze program. In

developing a new particulate matter monitoring network and associated

requirements, consideration has been given to the indicators, forms,

and levels of the proposed primary and secondary PM NAAQS. As a result,

nationwide monitoring would be performed for two indicators of PM:

PM2.5 and PM10. To be reflective of the basis for and the

specification of the forms of the proposed new annual and 24-hour

primary and secondary PM2.5 NAAQS, new monitoring network design

and siting requirements are being proposed. For purposes of comparison

to the proposed PM2.5 annual standard, such sites would be

population-oriented and be representative of community-wide exposure

levels. The siting criteria for monitors to be used for comparison to

the proposed 24-hour PM2.5 standard would also be population-

oriented but reflective of the highest measured values within the

community. To ensure PM data of the highest possible quality, new

requirements for quality assurance and designation of new PM2.5

reference or equivalent samplers are also described.

With respect to NAAQS comparisons and visibility protection in more

rural areas, the new network design and siting requirements would

encourage the placement of PM2.5 monitors outside population

centers with two purposes in mind: (1) To provide air quality data

necessary to facilitate implementation of the proposed NAAQS, and (2)

augmentation of the existing visibility fine particle monitoring

network. The coordination of these two monitoring objectives would

facilitate implementation of a regional haze program and lead to an

integrated monitoring program for fine particles.

The network design and siting requirements for the annual and 24-

hour PM10 NAAQS would continue to emphasize identification of

locations at maximum concentrations. The PM10 network itself,

however, would be revised because the proposed PM2.5 standards

would likely be the controlling standards in most situations.

The new network for PM10 would be derived from the existing

network of State and Local Air Monitoring Stations (SLAMS), National

Air Monitoring Stations (NAMS), and other monitors generically

classified as Special Purpose Monitors (SPM's) which include industrial

and special study monitors. Population-oriented NAMS will generally be

maintained, other key sampling locations in existing nonattainment

areas, and in areas whose concentrations are near the levels of the

proposed PM10 NAAQS will be continued. Currently approved

reference or equivalent PM10 samplers could continue to be

utilized. The revised network would ensure that analysis of national

trends in PM10 can

[[Page 65782]]

be continued, that air surveillance in areas with established PM

emission control programs can be maintained, and that the PM10

NAAQS will not be jeopardized by additional growth in PM10

emissions. PM10 sites should be collocated with new PM2.5

sites at key population-oriented monitoring stations so that better

definition of fine and coarse contributions to PM10 can be

determined to provide a better understanding of exposure, emission

controls, and atmospheric processes. PM10 sites not needed for

trends or for monitoring in areas with relatively high PM10

concentrations would likely be discontinued in a longer-term PM10

network. The sampling frequency at all PM10 sites would be reduced

to a minimum of once in 6 days, which would be sufficient to make

comparisons with proposed PM10 standards. The combination of fewer

PM10 sites and the reduction in required sampling frequency would

save significant resources that could be redirected to PM2.5

monitoring.

The new network for PM2.5 would consist of a ``core'' network

of population-oriented SLAMS monitors, ``core'' regional background and

regional transport SLAMS, a NAMS subset for long-term monitoring, other

SLAMS monitors, and supplementary network of SPM's. The core

population-oriented sites would be reflective of community-wide

exposure and would be required in all of the largest metropolitan areas

and must sample everyday. Frequent measurements are important to

understand episodic behavior of PM2.5, and to establish effective

emission control strategies to assure protection of the NAAQS. Many of

the new PM2.5 sites are expected to be located at existing

PM10 sites, and would be collocated with some PAMS sites.

Consistency with the proposed new PM2.5 NAAQS necessitates the

adoption of new concepts for identification and establishment of

monitoring stations for the PM2.5 ambient air monitoring network

as well as use of the data in relation to the proposed PM2.5

NAAQS. These concepts include: (1) The addition of specially coded

sites whose data would be used to compare to the levels of the annual

and 24-hour PM2.5 NAAQS, and (2) the inclusion of monitoring

planning areas and spatial averaging zones (SAZ) to correspond to the

population-oriented, spatial averaging approach. These concepts and

associated requirements are discussed in sections 58.15 and sections

2.8.1-2.8.3 of Appendix D below.

Although the major emphasis of the new PM networks is compliance

monitoring in support of the NAAQS, the network is also intended to

assist in reporting of data to the general public, especially during

air pollution episodes and to assist in the SIP planning process. To

these ends, additional monitoring and analysis requirements are

proposed concerning the location of nephelometers (or other continuous

particulate matter measuring devices) at some core monitoring sites and

the archiving of filters for possible subsequent analysis for subsets

of the PM2.5 SLAMS sites. Moreover, collection of meteorological

data at core SLAMS sites (including background and regional transport

sites) are suggested. The additional requirements should help to

further characterize the composition and trends in PM2.5 and

better understand the sources and processes leading to elevated

PM2.5 concentrations. Because these proposed revisions do not

specifically require the chemical analysis of collected PM2.5 or

PM10 filters, the Administrator would welcome comments on this

issue. In particular, comments are solicited on the need for

alternative PM2.5 monitoring methodologies and additional

monitoring requirements which might accompany the part 51

implementation rules to identify the causes of detected PM2.5

NAAQS violations and to assist in the development of PM2.5

emission control strategies.

While the proposed siting criteria and network designs are

appropriate for both the proposed revisions to the primary and

secondary NAAQS as a whole, additional consideration must be given to

air quality surveillance in more rural/remote areas to characterize

fine particle levels in order to protect against broader regional scale

visibility impairment. To achieve the appropriate level of air quality

surveillance in such areas, EPA believes it is important to coordinate

and integrate the background and transport monitoring sites specified

in this notice with the existing Interagency Monitoring of Protected

Visual Environments (IMPROVE) monitors that are in place in a number of

locations around the country to characterize fine particle levels and

visibility in mandatory Federal Class I areas (e.g., certain national

parks and wilderness areas). The need for coordination and integration

of visibility-oriented monitoring sites will increase when EPA proposes

rules under section 169A of the Act to supplement the secondary NAAQS

in addressing regional haze. More detailed guidance on monitoring and

assessment requirements will be provided when those rules are proposed.

This will include details on topics such as monitor placement,

monitoring methodology, duration of sampling and frequency of sampling.

It is anticipated, however, that the existing IMPROVE network, together

with sites established under this proposal, would be an integral part

of the network for determining reasonable progress under a regional

haze program.

In the meantime, EPA recommends that States, in conjunction with

EPA and Federal land managers, explore opportunities for expanding and

managing PM2.5 and visibility monitoring networks in most

efficient and effective ways to meet the collective goals of these

programs. To facilitate this, EPA has proposed changes in Appendix C

below, to allow use of existing or new IMPROVE monitoring sites to meet

the requirements for a transport and/or background site for the

proposed PM2.5 standards. States should consider the feasibility

of siting new transport/background and/or visibility monitoring

locations at or near mandatory Federal Class I areas currently without

an IMPROVE site so that such sites could provide data to characterize

both fine particle levels and visibility in or near Class I areas. It

is EPA's intent that monitoring conducted for purposes of the PM

primary and secondary NAAQS (including background and transport sites),

and for visibility protection be undertaken as one coordinated national

PM monitoring program, rather than as a number of independent networks.

It is recognized by EPA as well as many outside groups including

the Clean Air Act Advisory Committee's Subcommittee on Ozone,

Particulate Matter, Regional Haze Implementation Programs and the

National Research Council in its 1993 report ``Protecting Visibility in

National Parks and Wilderness Areas'' that chemical speciation of PM

data would permit development of more effective control strategies to

better target those sources of emissions that are causing or

contributing to elevated levels of PM2.5 and PM10. Speciation

of PM2.5 data can also be used to develop reliable estimates of

seasonal and annual average visibility conditions.

Because of the costs associated with conducting filter analysis on

a routine basis, this proposal only requires filters to be archived so

they are available for analysis on an as needed basis. The EPA requests

comment, however, on the extent to which chemical speciation should be

conducted. This would include: (1) Whether specific monitoring sites

should be designated for such analyses; (2) the criteria to be

[[Page 65783]]

used to select sites for speciated sampling and analysis; (3) the

extent and frequency to which speciation should be required by EPA for

at least some monitoring stations and (4) the need for monitoring

methodologies not described in this proposal which may be needed to

facilitate compositional analysis. The EPA recognizes that there is a

need for speciation and other specialized monitoring efforts which are

not specifically required by this proposed rule. Accordingly, EPA will

give these PM monitoring efforts high priority in its section 105

grants program. The Administrator solicits comment on the appropriate

portion of the nation's monitoring resources which should be dedicated

to speciation and collection of special study data relative to the

siting and collection of mass measurements for purposes of comparisons

to the NAAQS and visibility assessments at permanent and temporary

monitoring stations. The estimated cost for the new PM monitoring

program is discussed further in Section IV. R.

Finally, in anticipation of a new regional haze program and

associated additional monitoring requirements, EPA also requests

comment on ways that the future PM and IMPROVE networks can be

coordinated to conserve resources and serve the goals of both the PM

and regional haze implementation program.

This proposed rulemaking is taken in conjunction with the proposed

revisions to the PM NAAQS published elsewhere in today's Federal

Register and pertains to changes in the ambient air monitoring

requirements for particulate matter contained primarily in 40 CFR part

58. A new Federal Reference Method for PM2.5, and changes to the

definition of PM10 measurements are proposed in a new Appendix L

and revisions to Appendix J respectively in 40 CR part 50. The

effective date of these proposed monitoring regulations would be 6

months after the actual promulgation date. The EPA is soliciting

comment on all aspects of all of the proposed rules.

III. Proposed Revisions to Part 53

A. Designation of Reference Methods for PM2.5

The specifications for reference methods for PM2.5 are

described in Appendix L to part 50, proposed elsewhere in this issue of

the Federal Register. The performance-based specifications for the

operational aspects of a reference method sampler allow various sampler

manufacturers to design and fabricate different samplers that would

meet the specifications. Accordingly, multiple PM2.5 reference

methods are expected to become available from several manufacturers, as

is the case for reference methods for PM10 and most gaseous

criteria pollutants. Similarly, each reference method for PM2.5,

based on a particular sampler, would be formally designated as such by

the EPA under new provisions added to part 53.

These new provisions, primarily contained in a new subpart E, would

require that the applicant submit information and documentation to

demonstrate that a candidate reference method sampler meets the design

specifications set forth in Appendix L of part 50. The provisions would

also require that the applicant carry out specific tests to demonstrate

that the sampler meets all performance specifications. The nature of

these tests and the requirement that they be carried out by the

applicant rather than the EPA is consistent with the current

requirements in part 53 for designating reference methods for other

criteria pollutants.

Since the critical inlet and particle size separation components of

the sampler are specified by design, no wind tunnel or aerodynamic

performance tests of these components would be required. But

documentation would be required to demonstrate that samplers to be sold

as reference methods would be manufactured under an effective quality

control system, such as required in an International Organization for

Standardization (ISO) 1 9001-certified facility, or a quality

control system otherwise certified to meet similar requirements.

Specific tests would be required to verify that the critical PM2.5

impact or jet diameter was within the design specifications, and that

the surface finish of surfaces required to anodized meets the surface

finish specifications. Also, a checklist certifying that reference

method samplers are or will be manufactured under an acceptable quality

assurance system would have to be completed by an ISO-certified or

equivalent auditor and submitted initially and annually.

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\1\ The ISO certification ensures compliance to international

manufacturing standards from the design and engineering

specifications. An ISO certification, or its equivalence for the

manufacturing of the reference samplers is consistent with National

Technology Transfer and Advancement Act Section 12(d), 15 U.S.C.

Section 272 (1996).

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The performance tests for reference method samplers would focus on

testing of the sampler's operational performance parameters, the

accuracy of its measurement systems, its field precision, and various

other sampler control functions. A comprehensive test procedure is

proposed for testing a representative candidate sampler for correct

flow rate, flow rate regulation, flow rate measurement accuracy,

ambient air temperature and barometric pressure measurement accuracy,

filter temperature control and measurement accuracy, and sampling time

accuracy. This test procedure would require a temperature-controlled

environmental test chamber, a technique to simulate reduced barometric

pressure, and facilities to generate simulated solar radiation. Other

specific tests are proposed to test the sampler's post-sampling filter

temperature control, leak check procedure, flow rate cut off function,

and field operational precision. It should be noted that work to test

the feasibility of these proposed test procedures has not been

completed at this time; therefore, some technical changes to the

proposed test procedures may be necessary following the results of that

work.

B. Designation of Equivalent Methods for PM2.5

In keeping with the EPA's largely performance-based approach for

specification of measurement methods for environmental pollutants,

provision is also proposed for designating equivalent methods for

PM2.5. These provisions are contained in proposed additions to

subparts A and C and proposed new subparts E and F of part 53. To

minimize the number and extent of performance tests to which candidate

equivalent methods would be subjected, three classes of equivalent

method are proposed to be defined.

The first class (Class I) would include PM2.5 methods based on

samplers that are very similar to a reference method sampler as

specified in appendix L to part 50. Class I would primarily include

methods based on samplers whose primary difference from reference

method samplers is one or more modifications necessary to provide

capability for collection of several sequential samples automatically

without intermediate operator service. Samplers capable of collecting

multiple sequential samples are important because the sampling

schedules proposed in Sec. 58.13 of part 58 call for daily sampling for

certain SLAMS. With such a requirement, there is an expected need for

samplers that will permit the collection of the required daily samples

without the need for an operator to visit the site on a daily basis or

for installing multiple samplers at the site. (Since the samplers would

need to sample from midnight to midnight, a minimum of two single day

samplers would be

[[Page 65784]]

required for full daily sampling; however, as a practical matter,

additional single day samplers would generally be needed at a daily

monitoring site to cover weekends, holidays, and personnel and

scheduling logistics.) A sampler capable of automatically collecting

five sequential samples would permit twice-weekly servicing of a

monitoring site (assuming sample filters can be retrieved and reloaded

on the inactive channels without affecting the actively sampling

channel).

Since the design of sequential samplers is not specified

explicitly, sampler manufacturers would be able to design and develop

their own techniques to provide for this capability. Where the

sequential sample technique consists of relatively minor or simple

modifications of the reference method sampler, the sampler would be

classified as a Class I candidate equivalent method. (Sequential

samplers would also be possible as Class II or III equivalent methods.)

Class I equivalent method sequential samplers would have to be

tested to make sure that the modifications required to provide for

sequential sampling do not significantly compromise sampler

performance. However, because of their similarity to the reference

method sampler, the only additional test requirement for most Class I

candidate equivalent methods--in addition to the tests and performance

requirements applicable to reference method samplers--would be a test

for possible loss of PM in any new or modified components in the

sampler inlet upstream of the sample filter. This additional test for

Class I samplers is set forth in the proposed new Subpart E, along with

the tests for reference method samplers.

Class II equivalent methods would include all other PM2.5

methods that are based on a 24-hour integrated filter sample which is

subjected to subsequent moisture equilibration and gravimetric mass

analysis, but with an associated sampler having substantial deviations

from the design or performance specifications for reference method

samplers. These samplers may have a different inlet, a different

particle size separator, a different volumetric flow rate, a different

filter or filter face velocity, or other significant differences. More

extensive performance testing would be required for designation of

Class II candidate equivalent methods, with various tests required

depending on the nature and extent of the differences between the

candidate sampler and specified reference method samplers. These tests

include a full wind tunnel evaluation, a wind tunnel inlet aspiration

test, a static fractionator test, a fractionator loading test, and a

volatility test. The tests and their specific applicability to various

types of candidate Class II equivalent method samplers are set forth in

proposed new subpart F.

Finally, Class III equivalent methods would include any candidate

PM2.5 methods that could not qualify as Class I or Class II. This

class would include any filter-based integrated sampling method having

other than a 24-hour PM2.5 sample collection interval followed by

moisture equilibration and gravimetric mass. More importantly, class

III would also include filter-based continuous or semi-continuous

methods, such as beta attenuation instruments, harmonic oscillating

element instruments, and other complete in situ monitor types, as well

as non-filter-based methods such as nephelometry or other optical

instruments.

The testing requirements for designation of Class III candidate

methods would be the most stringent, since quantitative comparability

to the reference method would have to be shown under various potential

particle size distributions and aerosol composition. However, because

of the variety of measurement principles and types of methods possible

for Class III candidate equivalent methods, the test requirements would

have to be individually selected or specifically designed or adapted

for each such type of method. Therefore, the EPA believes that it is

not practical to attempt to develop and explicitly describe the test

procedures and performance requirements for all of these potential

Class III methods a priori. Rather, it is proposed that the test

procedures and performance requirements applicable to specific Class

III candidate methods would be determined by the EPA on a case-by-case

basis upon request, in connection with each proposed or anticipated

application for a Class III equivalent method determination. In this

regard, the EPA is interested in receiving comments pertinent to the

nature and extent of tests that would be appropriate and effectual in

determining the performance of various types of Class III candidate

equivalent methods relative to the performance of reference methods for

PM2.5.

All classes of candidate equivalent methods would have to be field-

tested to determine their comparability to measurements obtained with

collocated reference methods. For Classes I and II, these collocated

field test requirements are specified explicitly in Subpart C, which is

proposed to be revised to include the specific requirements for

PM2.5 candidate equivalent methods. The proposed requirements for

PM2.5 methods are generally patterned after the existing

requirements for PM10 candidate methods.

However, because of the need for greater measurement precision for

PM2.5, the comparability specifications, summarized in Table C-4,

are somewhat more stringent than those previously established for

PM10. Also, for Class II candidate equivalent methods--where two

different test sites are required--more definitive specifications are

proposed for the tests sites in terms of the PM2.5 to PM10

measurement ratio for the test samples. This is necessary because

experience with PM10 measurements has indicated that PM

measurements made with dissimilar samplers are often considerably

affected by differences in the ``character'' of the PM at different

monitoring sites, as represented by differences in particle size

distribution, composition, density, humidity, and other factors. For

purposes of the comparability test, the character of the PM at each

test site is represented by the measured PM2.5 to PM10 ratio,

which must be greater than 0.75 for one site and less than 0.40 at the

other site. (More definitive tests of PM character at the test site are

deemed too difficult or costly to carry out for purposes of the

comparability test.) Insuring comparability to reference method

measurements at sites having profoundly different character of PM is

critically important for Class II (and Class III) candidate equivalent

methods. Note, however, that the PM2.5 to PM10 ratio

requirement does not apply to testing of Class I candidate methods,

where only one test site is required.

C. Quality Assurance

Accurate measurement of ambient particulate matter concentrations

is severely hampered by the impracticality of providing PM

concentration standards for field (or even laboratory) testing of

ambient samplers or monitors. Therefore, it is necessary to rely on a

specific, well-defined reference method, uniformity of reference method

devices and procedures, and continual assessment of bias and operating

precision. For the purposes of this regulation, PM2.5

concentration measurements would be referenced to measurements made

with a reference method sampler in accordance with the reference method

as specified in Appendix L of part 50 of this chapter. Monitoring for

PM2.5 requires greater attention to achieving data of high

quality, with minimal imprecision and

[[Page 65785]]

relative error. These higher quality monitoring data are essential to

reduce the chance that PM2.5 measurements would potentially cause

unjustified health risk to the population, when measurements

underestimate true concentrations, or unnecessary control requirements,

when measurements overestimate the true concentrations.

To meet a data quality objective of 15% precision for

ambient PM2.5 attainment measurements, enhanced quality assurance

would be required in all areas relating to sampler performance

including sampler manufacturing and sampler operation. This is

especially important because a reference method sampler is proposed to

be used to audit other field monitors, as described later.

Designated reference and equivalent method samplers and monitors

would be required to be manufactured in a manufacturing facility that

is either (1) an ISO 9001-registered manufacturing facility, with

registration maintained continuously, or (2) a facility that can be

demonstrated, on the basis of information submitted to the EPA, to be

operated according to an EPA-approved and periodically audited quality

system which meets, to the extent appropriate, the same general

requirements as for an ISO-registered facility. (This requirement is

referred to in this document as an ISO-registered facility, regardless

of the procedure taken for EPA approval.)

In addition to the ISO registration (or equivalent) requirement, a

quality assurance manufacturing checklist would have to be submitted

annually attesting that the appropriate quality assurance procedures

are routinely implemented in the manufacturing of samplers sold as

reference or equivalent method samplers. This check list would have to

be signed by an ISO-certified auditor or by an auditor who, based on

information submitted to the EPA, meets the same general requirements

as provided for ISO-certified auditors. (Similarly, an auditor approved

by EPA through either mechanism is referred to in this document as an

ISO-certified auditor.) This requirement allows for the demonstration

of consistency in production and sustained uniformity in design and

operation. Further, all testing related to an application for a

reference or equivalent method determination under part 53 would have

to be carried out in accordance with ISO 9001 and ANSI/ASQC E4

standards.

It is believed that these requirements are necessary to insure that

all samplers or analyzers sold as reference or equivalent methods are

manufactured to the high standard required to achieve the needed data

quality. These procedures are in keeping with the developing

international standards for manufacturing in this and other industries.

However, comments on the appropriateness and impact of these proposed

requirements are solicited. While these requirements are currently

proposed to apply only to the manufacture of PM2.5 monitors,

extending these requirements to the manufacture of PM10 monitors

and possibly other types of SLAMS monitors will likely be considered at

a later time.

A new operational requirement would also have to be met by each

PM2.5 sampler or monitor to retain its designation as a reference

or equivalent method. Each user agency operating a SLAMS site would be

required to obtain at least 6 collocated measurements (audits) per year

with a reference method ``audit'' sampler for each routinely operating

PM2.5 monitor. The data obtained from these collocated audits

would be used to determine a national network integrated operating

precision and relative accuracy performance indicator for each

designated method. A PM2.5 monitoring method that fails to meet

the specified limits for this performance indicator would be subject to

possible cancellation of its reference or equivalent method designation

under the provisions of Sec. 53.11. For more information on this

provision, see section 6 of proposed revisions to Appendix A of part 58

and its associated preamble, set forth elsewhere in this Federal

Register.

D. Other Changes

A number of other relatively minor technical changes are proposed

to Appendix A, some of which affect designation of reference or

equivalent methods for other criteria pollutants as well as for

PM2.5. These changes include new definitions and clarifications of

existing definitions in Sec. 53.1; clarifications of the reference and

equivalent method designation requirements for methods for all

pollutants, including the new classes of equivalent methods for

PM2.5 and a new table summarizing all the designation

requirements; and updating of the name of the EPA laboratory to which

applications are to be sent. Additional changes include proposed

clarifications of the content of information required in submitted

applications regarding the candidate method test data, manufacturing

quality assurance system, and product warranty, and the content

required in the operation or instruction manual associated with a

candidate method sampler or analyzer.

Also, because of the increasing complexity of anticipated candidate

methods for all criteria pollutants, an increase in the EPA's time

limit for processing applications for reference and equivalent methods,

from 75 to 120 days, is proposed. Finally, it is proposed (under

Sec. 53.4) that applicants for a PM2.5 reference or equivalent

method determination be required to provide a sampler or analyzer that

is representative of the one associated with the candidate method for

inspection and possible testing by the EPA in connection with

processing of the application.

IV. Discussion of Proposed Revisions to Part 58

A. Section 58.1--Definitions

The revisions proposed today would revise the definition of the

term traceable and add definitions of the terms Consolidated

Metropolitan Statistical Area (CMSA), core SLAMS, equivalent methods,

Metropolitan Statistical Area (MSA), monitoring planning area (MPA),

monitoring plan, PM2.5, Primary Metropolitan Statistical Area

(PMSA), population-oriented, reference method, SAZ (SAZ), SPM fine

monitors, and Annual State Monitoring Report.

B. Section 58.13--Operating Schedule

1. PM10 Sampling. The current operating schedule for PM10

is based primarily on an analysis of the ratio of measured PM10

concentrations to the controlling PM10 standard. Depending upon

the ratio, the sampling frequency is either every day, every other day,

or every sixth day. The proposed operating schedule would reduce the

sampling frequency at all PM10 sites to once every sixth day.

The Administrator has proposed a new 24-hr PM10 standard based

on the 98th percentile which offers a more stable statistical form. She

has also solicited comment on the need to retain any 24-hour PM10

standard. Unlike the current 24-hr PM10 standard, the proposed

standard, if adopted, would not place emphasis on the most extreme 24-

hr concentrations, especially in areas influenced by fugitive dust.

Furthermore, more emphasis for control requirements is anticipated to

be placed on annual average concentrations and fewer nonattainment

areas (i.e. violation areas) are expected to be based on peak daily

concentrations. Consequently, 1 in 6 day sampling should be sufficient

to support the new PM10 NAAQS and a less dense monitoring network

would also be needed. Comments are solicited on the appropriate

sampling schedules

[[Page 65786]]

for PM10 sites if the 24-hour NAAQS for PM10 is retained.

2. PM2.5 Sampling. Core PM2.5 SLAMS (including NAMS and

Core SLAMS collocated at PAMS sites) would be required to sample every

day, unless an exception is approved by EPA during established seasons

of low PM pollution during which time a minimum of once in 6 days

sampling would be permitted. Non-core SLAMS sites would generally be

required to sample a minimum of once every sixth day, although episodic

or seasonal sampling could also be possible (e.g., in areas where

significant violations of the 24-hour NAAQS are expected or at sites

heavily influenced by regional transport or episodic conditions).

Special purpose monitors, however, may sample on any sampling schedule.

There is currently very little PM2.5 measurement data. New

networks must be established as expeditiously as possible to help

characterize the nature and extent of PM2.5 ambient air quality

nationwide. Daily sampling for PM2.5 is especially important

during the first few years of the new PM2.5 monitoring program to

allow for the collection of complete sets of data in order to help with

identifying temporal patterns and to understand the episodic behavior

of fine particles.

Although daily sampling with manual methods is labor intensive due

to site visits and filter equilibration and weighing, semi-automatic

sequential samplers are anticipated to be approvable as class I

equivalent samplers (under the provisions of Part 53) which will

simplify the data collection process. The EPA solicits comments on the

need to extend the start date for a requirement to perform everyday

sampling until the time when Class I equivalent samplers have been

approved by the Agency.

In addition, alternative PM2.5 operating schedules which

combine intermittent sampling with the use of acceptable continuous

fine particle samplers are approvable at some core sites. This

alternative is intended to give the States additional flexibility in

designing their PM2.5 monitoring networks and to permit data from

continuous instruments to be telemetered. This would facilitate public

reporting of fine particle concentrations, allow air pollution alerts

to be issued and episodic controls to be implemented (as currently done

in woodburning areas for PM10). Furthermore, this would permit

monitoring agencies to take advantage of new and improved monitoring

technologies that should become available during the first few years

following the promulgation. As proposed, applicability of the

alternative depends on population size of the monitoring area and

PM2.5 air quality status.

After the initial 3 years of PM2.5 data collection and after

characterization of PM2.5 levels, determination of violation areas

and development of State Implementation Plans), reductions in the

frequency of PM2.5 sampling may be appropriate. The EPA welcomes

comments on the need for continued long-term monitoring with reference

or equivalent samplers on an every day schedule at some or all

monitoring stations and on the appropriateness of the criteria for

allowing alternative schedules.

C. Section 58.14--Special Purpose Monitors

Special purpose monitoring is needed to help identify potential

problems, to help define boundaries of problem areas, to better define

temporal (e.g., diurnal) patterns, to determine the spatial scale of

high concentration areas, and to help characterize the chemical

composition of PM (using alternative samplers and supplemental

analyzers), especially on high concentration days or during special

studies. Special purpose monitors are an important part of the overall

PM monitoring program, and sufficient EPA and State resources must be

allocated for their use.

Today's revisions propose that special purpose PM2.5 and

PM10 monitors may sample with any measurement method on any

sampling schedule. However, the data from SPM's would not be used for

attainment/nonattainment designations if the monitoring method is not a

reference or equivalent method or does not meet the requirements of

Section 2.4 of Appendix C of Part 58. Moreover, in order to encourage

the deployment of SPM's, today's revisions propose that nonattainment

designations will not be based on data produced at an SPM site with any

monitoring method for a period of 3 years following the promulgation

date of the NAAQS.

The rationale for this concept is based on the need for to

encourage building from ``ground zero'' a monitoring infrastructure.

Such an infrastructure is needed because of the complexity of the

PM2.5 problem and the relative paucity of PM2.5 data to

determine where problem areas lie, and the lack of information about

sources and formation of aerosols in particular areas. The requirements

for the NAMS, minimum core SLAMS, and minimum additional SLAMS sites,

described in this notice, are designed to provide much of the

information needed to merely define the location of problem areas.

There is a need, however, to look beyond this minimal network to

create an ``optimal'' network that would gather air quality data over a

wider geographic area. The optimal network would consist of SLAMS

monitors in addition to the required minimums and also SPM's. There are

several reasons for a moratorium on regulatory use of data from the

during the first 3 years following promulgation of the NAAQS:

(1) SPM data have historically supplemented the SLAMS network to

provide the States with a flexible monitoring program. Although the SPM

monitoring does not have to use reference or equivalent monitors, the

States tend to use these monitors for data collection. And although SPM

data are not required to be submitted to EPA, the States tend to enter

all such data into the AIRS data base. Because of the paucity of

PM2.5 data, we want to encourage both the collection--with

reference or equivalent monitors--and the reporting of as much new

PM2.5 data as possible. This includes SPM data.

(2) There is a general reluctance among State and local governments

and businesses to monitor ambient air quality beyond those minimum

requirements contained in regulations promulgated by the Environmental

Protection Agency (EPA) in the Code of Federal Regulations at Part 58.

The reluctance is based in part on the fact that areas have

historically been designated to nonattainment where monitoring shows

violations of the NAAQS and then classified according to the

seriousness of the air pollution problem. Currently, such a

nonattainment designation and classification automatically trigger the

State implementation attainment planning and demonstration

requirements, potential stationary and mobile source emission controls,

nonattainment new source review for sources wanting to locate or expand

in the new nonattainment area, and possibly additional requirements

relating to nonattainment of the NAAQS. Thus, to many affected parties,

the current regulatory system results in a disincentive for detecting

violations.

(3) The EPA is evaluating a concept involving the identification of

areas that have measured or modeled violations and subsequent

identification of other areas whose emissions contribute to those

violations. The new required PM2.5 monitoring network, however,

may be insufficient to determine all such violation areas and

contributing areas, and therefore additional monitors may be desirable.

Ambient air

[[Page 65787]]

monitoring will play an important and expanded role in defining

violating and contributing areas; with a moratorium on the regulatory

use of SPM data, States and businesses would have an additional

incentive to monitor for data to more accurately determine the extent

of these areas.

(4) During the initial stages of development of a new PM2.5

network, there is a greater need for experimental sampling--to move

samplers around, to sample for short periods of time, and to utilize

different methods. Incomplete data sets may not be fully representative

of local air quality. For these and other similar reasons, there is a

need for a pilot network that would not be subjected to the same rules

as the full SLAMS network.

(5) Finally, collecting data at a number of sites beyond either the

minimum or optimal number proposed in these regulations would support

modeling studies to better define pollution problems, identification of

potential pollution problems for enhanced air management programs, the

design and implementation of episodic control plans to encourage quick

response actions for voluntary emission reduction measures to lower

pollution and thereby possibly avoiding nonattainment or ``bump-ups'',

and to measure progress toward attainment by relating air quality to

population.

The system of SPM's would at first not be part of the full required

or even the ``optimal'' network. To provide the best kind of

information, EPA believes that properly sited Federal Reference or

Equivalent Methods be used for these SPM efforts in order to collect

technically credible data. The EPA also believes that data from those

efforts be reported to AIRS so that they are generally available to the

public at large and to those who need them for understanding the nature

of the problem and for developing solutions and control strategies.

In proposing a 3-year moratorium on the regulatory use of SPM data,

EPA is trying to establish an incentive for States to engage in this

additional SPM monitoring using properly sited Federal Reference or

Equivalent Monitors. The data from these SPM's would supplement the

data collected by SLAMS sites. Although the SPM data would be exempt

from regulatory use during the 3-year moratorium, they would

nevertheless be evaluated by the State during its annual SLAMS network

review. A notice of NAAQS violations resulting from PM SPM``s should be

reported to EPA, such high concentrations should be evaluated by the

State in the design of its overall SLAMS network and considered by EPA

in its review and approval of the State''s monitoring plan. Therefore,

during the first 3 years, the SPM data would still play an important

role in the regulatory process. After the proposed 3-year exemption

period, SPM locations should be considered as potential SLAMS in the

State's development and subsequent EPA reviewal process of their

monitoring plan network, if the sites record high concentrations which

indicate potential violations of the PM NAAQS (for either PM10 or

PM2.5) and have been operating for at least 6 months.

The EPA could have taken a different approach to this problem and

not propose a moratorium on the regulatory use of data from the SPM

sites. States would still be able to deploy SPM monitors in ways to

avoid legal consequences if an exceedance of the NAAQS were found. For

instance, any State may use non-reference or non-equivalent methods,

which do not meet EPA specifications. Any State could site monitors so

that they do not meet EPA siting criteria. Such monitoring would avoid

the above-described legal entanglements associated with any NAAQS

exceedances, because the data collected would not, under current EPA

regulations, be valid for use in comparison to the NAAQS. Moreover, any

State could simply not submit the SPM data to EPA.

The approach described in the above paragraph, however, does have

major disadvantages. For instance, an approach that uses unacceptable

monitors or siting would result in data that--even if close to being

representative of the area or what a properly sited acceptable monitor

would measure, would still be clouded with questions regarding its

accuracy or precision, which would limit their value in the kinds of

analyses mentioned above. In the case of data simply not submitted to

EPA, data would not be available to either other States that would be

working on development of a solution to the PM-fine problem, or, more

important, to the public at large so that they could be aware if there

really are problems detected by the monitor.

In light of these concerns, EPA's proposal is an attempt to take a

more straightforward approach, which will encourage collection of

additional data that is technically credible and publicly available,

and therefore address the Act's mandate for EPA to take the lead in

this matter, as found in section 103(c).

D. Section 58.15--PM2.5 NAAQS Eligible Monitors

This new section is proposed to define the PM2.5 monitors

eligible for use in determining compliance with the PM2.5 annual

and 24-hour NAAQS. The EPA proposes that States identify on EPA's AIRS

monitoring site file, all PM2.5 sites eligible for both annual

NAAQS comparisons and 24-hour comparisons and those only eligible for

24-hour (daily) comparisons. The former sites are intended to be

population oriented spatial averaging sites and the latter are intended

to represent population-oriented ``hot spot'' locations. The reasons

for the different types of monitors are discussed in the preamble to 40

CFR part 50.

E. Section 58.20--Air Quality Surveillance: Plan Content

The revisions proposed today would require States to submit a PM

monitoring plan to the Regional Administrator within 6 months of the

effective date promulgation. The monitoring plan would describe the PM

monitoring strategy based on the use of SLAMS (including NAMS and PAMS)

and SPM's for PM10 and PM2.5; describe the phase-in of

PM2.5 monitors and changes in the existing PM10 monitoring

program; describe monitoring objectives and scales of

representativeness to facilitate subsequent interpretation of data;

define sampling schedules; denote sites intended for comparison to the

PM NAAQS; and define the monitoring planning areas (MPA's) and SAZ's

(SAZ's) within the State. It should also reference the revised quality

assurance plan which is required by Appendix A to Part 58. In regard to

the use of air quality data for making comparisons to the NAAQS and

other SIP related purposes, the monitoring plan shall also describe the

SPM's whose data the State intends to use for SIP purposes. The

monitoring plan must also provide for an annual review for termination,

relocations, or establishment of new SLAMS or core SLAMS.

F. Section 58.23--Monitoring Network Completion

Under the revisions proposed today, the PM networks would be

expected to be completed within 3 years of the effective date of

promulgation. While new PM2.5 networks are developed, existing

PM10 networks should be considered for reductions consistent with

the goals stated in the background section earlier. For PM2.5, a

3-year phase-in would be used. The proposed schedule for deployment of

new required PM2.5 monitors is described

[[Page 65788]]

here. During the first year, a minimum of one monitoring planning area

per State would be required to have core PM2.5 SLAMS. This area

would be selected by the State according to the likelihood of observing

high PM2.5 concentrations and according to the size of the

affected population. In addition, one PM2.5 site would be

collocated at one site in each of the PAMS areas. During the second

year, all other core population-oriented PM2.5 SLAMS, and all core

background and transport sites, must be fully operational. During the

third year, any additional required PM2.5 (non-core) SLAMS must be

fully deployed and all NAMS sites must be selected from core SLAMS and

proposed to EPA for approval.

G. Section 58.25--System Modification

No changes to the regulatory language are proposed to Sec. 58.25;

however, under the revisions proposed today, the annual system

modifications review must include changes to PM2.5 site

designations (e.g., NAAQS comparison sites), the number or boundaries

of monitoring planning areas and/or SAZ's.

H. Section 58.26--Annual State Monitoring Report

Under the current regulations, States are required to submit an

annual SLAMS data summary report. Under today's proposed revisions,

this report shall be expanded to include additional information. First,

the new State Monitoring report shall describe the proposed changes to

the State's Monitoring Plan, as defined in Sec. 58.20. It shall include

a new brief narrative report to describe the findings of the annual

SLAMS network review, reflecting within year and proposed changes to

the State air quality surveillance system, and to provide information

on PM SPM's and other PM sites described in the monitoring plan

regardless of whether data from the stations are submitted to EPA

(including number of monitoring stations; general locations; monitoring

objective; scale of measurement; and appropriate concentration

statistics to characterize PM air quality such as number of

measurements, averaging time, and maximum, minimum, and average

concentration). The latter is needed for EPA to ensure that a proper

mix of permanent and temporary monitoring locations are used, that

populated areas throughout the nation are monitored, and to provide

needed flexibility in the State monitoring program. The content of this

brief report shall be in accordance with EPA guidance, and will be

available at the time of promulgation of the final Part 58 rule.

Next, States would be required to describe the proposed changes to

existing PM networks. Proposed changes to the existing networks may

include modifications to the number, size, or boundaries of Monitoring

Planning Areas or SAZ's, number and location of PM SLAMS; number or

location of core PM2.5 SLAMS; alternative sampling frequencies

proposed for PM2.5 SLAMS (including core PM2.5 SLAMS and

PM2.5 NAMS); core PM2.5 SLAMS to be designated PM2.5

NAMS; and PM SLAMS to be designated PM NAMS. SLAMS with NAAQS

violations should be considered to become new or replacement core

sites, and SPM's with NAAQS violations could become part of the SLAMS

network. The proposed changes should be developed in close consultation

with the appropriate EPA Regional Office and submitted to the

appropriate Regional Office for approval. The portion of the plan

pertaining to NAMS would be submitted to the Administrator (through the

appropriate Regional Office).

Finally, as a continuation of current regulations, the States shall

be required to submit the Annual SLAMS summary report and to certify to

the Administrator that the SLAMS data submitted are accurate and in

conformance with applicable Part 58 requirements. Under the revisions

proposed today, States would also be required to submit annual

summaries of SPM data to the Regional Administrator for sites included

in their Monitoring Plan and to certify that such data are similarly

accurate and likewise in conformance with applicable Part 58

requirements or other requirements approved by the Regional

Administrator, if these data are intended to be used for SIP purposes.

During the first 3 years following promulgation, the monitoring

plan and any modifications of it must be submitted to EPA by July 1

(starting on the year following promulgation) or by alternate annual

date to be negotiated between the State and Regional Administrator,

with review and approval/disapproval by the Regional Administrator

within 45 days. After the initial 3-year period or once a SAZ has been

determined to be violating any PM2.5 NAAQS, then changes to a

monitoring planning area will require public review and notification to

ensure that the appropriate monitoring locations and site types are

included. Specific comment on or suggestions for alternate procedures

that are not unduly time consuming or burdensome to allow public review

and comment on changes in MPA's, SAZ's, or other elements of a

monitoring plan developed by a State or local air pollution control

agency are especially welcome.

I. Section 58.30--NAMS Network Establishment

The revision proposed today would designate 6 months after the

effective date of promulgation as the date by which the NAMS network

portion (to be derived from core PM2.5 SLAMS) of each State's

SLAMS network must be fully described and documented in a submittal to

the Administrator (through the appropriate EPA Regional Office). At

this time, a State's NAMS PM10 network must be reaffirmed if no

changes are made to the existing network and if changed must also be

fully described and documented in a submittal to the Administrator

(through the appropriate EPA Regional Office).

J. Section 58.31--NAMS Network Description

Today's proposed revision would require that the NAMS network

description also include for PM2.5 the monitoring planning area,

SAZ, and the site code designation to identify which site will be used

to determine violation of the appropriate NAAQS (annual or 24-hour).

K. Section 58.34--NAMS Network Completion

The revision proposed today would designate 3 years after the

effective date of promulgation as the date by which the State must have

all PM2.5 NAMS in operation, and 1 year after the effective date

of promulgation as the date by which the State must have made all

changes to the existing PM10 NAMS.

L. Section 58.35--NAMS Data Submittal

This section defines the data submittal requirements for NAMS and

SLAMS. Consistent with current requirements, only the total mass

derived from PM10 and PM2.5 SLAMS would be required to be

submitted to EPA. However, EPA encourages reporting all data from

monitors proposed in the State monitoring plan. These optional data

would include data from SPM's and compositional data from all monitors.

M. Appendix A--Quality Assurance Requirements for SLAMS

Meeting the more stringent data quality objectives for ambient

PM2.5 monitoring will require considerably enhanced quality

assurance in the areas of sampler operation, filter handling, data

quality assessment, and other

[[Page 65789]]

operator-related aspects of the PM2.5 measurement process.

Most operational quality control aspects are specified in Appendix

A in general terms. For PM2.5, however, explicit, more stringent,

requirements are proposed for sample filter treatment--including the

moisture equilibration protocol, weighing procedures, temperature

limits for collected samples, and time limits for prompt analysis of

samples. These requirements, which are specified in the reference

method set forth in proposed new Appendix L to part 50, will help to

control measurement precision. Additional or supplemental detailed

quality assurance procedures and guidance for all operator-related

aspects of the PM2.5 monitoring process will be developed and

published as a new Section 2.12 of the EPA's, Quality Assurance

Handbook for Air Pollution Measurement Systems series to assist

monitoring personnel in maintaining high standards of data quality.

Procedures for continually assessing the operational quality of the

SLAMS monitoring data are specified explicitly in Appendix A of part

58. Perhaps the most significant new data quality assessment

requirement proposed for PM2.5 monitoring is the requirement that

each routinely operating PM2.5 ``compliance'' monitor must be

``audited'' at least 6 times per year. A compliance monitor is a

monitor at a site which is included in the PM monitoring plan and whose

data is intended for comparison to the NAAQS as described in Appendix

D. This is the first time a requirement has been proposed to assess the

relative accuracy of the mass concentration measured by a SLAMS PM

monitor.

Each of these 6 ``audits'' would be performed by the monitoring

agency and would consist of concurrent operation of a collocated

reference method audit sampler along with the routinely operated

compliance sampler or monitor. The data from these collocated audits

would be pooled by the EPA to assess the performance of PM2.5

monitoring methods on a national basis and for each reporting

organization. These data would also be used in a screening test of the

performance of individual monitors at each monitoring location. Six has

been determined to be the minimum number of audit data points needed to

yield a reasonable assessment of individual monitor operational

performance on an annual basis. This number is analagous to the data

requirements for the precision and accuracy assessments for PM10,

PM2.5 and other pollutants described in Section 5.

The integrated operating precision and relative accuracy, evaluated

annually, would have to meet a limit of 15 percent. A

monitoring method that fails this requirement nationally would be

placed in a probationary status pending resolution of the inadequate

performance or possible cancellation of its reference or equivalent

method designation under the provisions of Sec. 53.11 of part 53 of

this chapter. While this action would not result in immediate

cancellation of the designation, it would require the method applicant

(e.g., the manufacturer) to correct the method performance problems or

to submit alternative evidence or arguments (possibly in collaboration

with other affected entities) that the method's designation should not

be canceled.

Reporting organizations whose monitoring data failed to meet this

requirement (or are significantly worse than the national norm) would

be notified that its quality assurance plan or procedures need

improvement. Similarly, monitoring data from individual sites that fail

the screening test would require remedial action or replacement of the

monitoring method. Note, however, that failure of either of these tests

or the national test would not automatically cause the associated

monitoring data to be invalid.

Comments are solicited on these method operating performance audits

and particularly on the potential use of the audit data by EPA to: (1)

Determine a national network operating precision and accuracy

performance indicator for each type of designated method, (2) determine

the operational performance of methods used by reporting organizations

relative to the national norm, and (3) consider cancellation of the

reference or equivalent method designation of methods failing to meet

the 15 percent operational performance specification.

Other data assessment requirements proposed in Appendix A for

PM2.5 monitoring networks are patterned after the current

requirements for PM10 networks and are intended to supplement the

audit procedure. PM2.5 network monitors would be subject to

precision and accuracy assessments for both manual and automated

methods, using procedures similar or identical to the current

procedures required for PM10 monitoring networks. Results of these

field tests performed by the monitoring agencies (along with the

results of the field audits) would be sent to the EPA, which then would

carry out the specified calculations. These calculated statistics would

become part of the annual assessment of the quality of the monitoring

data.

For automated methods, the additional assessment of the precision

would consist of a one-point precision check performed at least once

every 2 weeks on each automated analyzer used to measure PM2.5.

This precision check would be made by checking the operational flow

rate of the analyzer. A standard precision flow rate check procedure

similar to that currently used for PM10 network assessments is

proposed. Also proposed is an alternative procedure where, under

certain specific conditions, it would be permissible to obtain the

precision check flow rate data from the analyzer's internal flow meter

without the use of an external flow rate transfer standard. (This

alternative procedure would also be made applicable to PM10

methods.)

The additional accuracy assessment procedure proposed for

PM2.5 automated methods is also similar to that used for PM10

networks, although each PM2.5 analyzer would have to be audited

quarterly rather than annually, as is the current requirement for

PM10 analyzers. The assessment would be performed on the

analyzer's operational flow rate using a flow rate transfer standard,

with the accuracy calculated from the percent difference between the

actual flow rate and the corresponding flow rate indicated by the

analyzer.

For manual methods, an additional precision assessment would be

calculated from the data collected from collocated samplers, as is

currently required for manual PM10 methods. The number of

collocated samplers within each PM2.5 network is proposed to be

based upon the total number of samplers within the reporting

organization's network. For 1 to 10 total sites, 1 site would be

selected for collocation; for 11 to 20 total sites, 2 sites would be

selected for collocation; and if a reporting organization has over 20

total sites, then 3 sites would be selected for collocation. As for

PM10, one sampler of the collocated pair would be designated as

the primary sampler whose samples would be used to report air quality

for the site, and the other would be designated as the duplicate

sampler. The percent differences in measured concentration between the

two collocated samplers would be used to calculate this additional

network precision.

The accuracy of the flow rate system of manual methods for

PM2.5 would be determined, as for automated methods, by auditing

each sampler each calendar quarter. Using a flow rate transfer

standard, each sampler would be audited at its normal operating flow

[[Page 65790]]

rate. The percent differences between these flow rates would be used to

calculate an additional indicator of accuracy.

Although the new quality assurance requirements for PM2.5

would result in an increase in the quality of the PM monitoring data,

the additional QA/QC checks would entail additional cost to the

monitoring agency. Some of the new QA/QC assessment requirements may

somewhat overlap the similar information provided by other checks, such

as the periodic flow rate checks and the use of collocated samplers in

monitoring networks. Consequently, the EPA solicits comments on the

need to maintain all of these QA requirements and also on the adequacy

of the proposed QA data assessments to ensure the defined quality for

PM2.5 measurements.

Table A-1, which summarizes the minimum data quality assessment

requirements, would be updated to include the new requirements for

PM2.5 methods, and other minor, mostly editorial changes are

proposed to Appendix A to update and clarify the language and specific

requirements.

A change to section 2.5 of Appendix A is also being proposed to

provide for technical system audits to be performed by EPA at least

every three years rather than every year. This change to a less

frequent system audit schedule recognizes the fact that for many well

established agencies, an extensive system audit and rigorous inspection

may not be necessary every year. The determination of the extent and

frequency of system audits at an even lower frequency than the proposed

three year interval is being left to the discretion of the appropriate

Regional Office, based on an evaluation of the Agency's data quality

measures. This change would afford both the EPA and the air monitoring

agencies flexibility to manage their air monitoring resources to better

address the most critical data quality issues.

N. Appendix C--Monitoring Methodology

Section 2.2 of Appendix C is proposed to be amended to allow the

use of PM10 monitors as surrogates for PM2.5 monitors for

purposes of demonstrating compliance with the NAAQS. However, following

the measurement of a PM10 concentration higher than the 24-hour

PM2.5 standard or an annual average concentration higher than the

annual average PM2.5 standard, the PM10 monitor would have to

be replaced with a PM2.5 monitor. In addition, for NAMS that are

converted to PM2.5 monitoring from PM10 monitoring, the

PM10 monitoring must continue concurrently with the PM10

monitoring for 1 year following the beginning of the PM2.5

monitoring.

Appendix C would also be amended to add a new section 2.4

containing provisions that would allow the use at a SLAMS of a

PM2.5 method that had not been designated as a reference or

equivalent method under part 53. Such a method would be allowed to be

used at a particular SLAMS site to make comparisons to the NAAQS if it

met the basic requirements of the test for comparability to a reference

method sampler for PM2.5, as specified in Subpart C of part 53 of

this chapter, in each of the four seasons of the year at the site at

which it is intended to be used. A method that meets this test would

then be further subjected to the operating precision and accuracy

requirements specified in section 6 of Appendix A of this part, at

twice the normal evaluation interval (6 audits in 6 months instead of 6

audits in 12 months). A method that meets these requirements would not

become an equivalent method, but the method could be used at that

particular SLAMS site for any regulatory purpose. The method would be

assigned a special method code, and monitoring data obtained with the

method would be accepted into AIRS as if they had been obtained with a

reference or equivalent method. This provision could thus allow the use

of non-conventional PM2.5 methods, such as optical or open path

measurement methods, which would be difficult to test under the

equivalent method test procedures proposed for part 53.

In addition, Appendix C would also be amended to add two new

sections. A proposed new section 2.5 would clarify that correlated

acceptable continuous (CAC) methods for PM2.5 approved for use in

a SLAMS under proposed new provisions in Sec. 58.13(f) would not become

de facto equivalent methods. This applies to methods that have not been

designated equivalent and do not satisfy the requirement of Section 2.4

described above. The new section would further clarify that the

monitoring data obtained with CAC methods would be restricted to use

for the purposes of Sec. 58.13(f) and would not be used for making

comparisons to the NAAQS. Proposed new section 2.9 would define so-

called ``IMPROVE'' samplers for fine particulate matter and clarify

that IMPROVE samplers, although not designated as equivalent methods,

could be used in SLAMS for monitoring regional background

concentrations of fine particulate matter.

Finally, minor changes are proposed to section 2.7.1 to update the

address to which requests for approval for the use of methods under the

various provisions of Appendix C should be sent, and section 5 to add

additional references.

O. Appendix D

The revisions to Appendix D proposed today would revise Sections 1,

2, 2.8, 3, 3.7, and 5 to incorporate changes made necessary by the

proposed new PM2.5 NAAQS. Section 1 is revised to add criteria for

core PM2.5 stations. Two additional SLAMS monitoring objectives

are added: the first is to determine the extent of regional pollutant

transport among populated areas, which may originate from distant

pollutant sources; the second is in support of secondary NAAQS, to

determine the welfare-related impacts in more rural and remote areas

(such as visibility impairment and effects on vegetation). Section 2 is

revised to include information that would be useful in designing

regulatory networks. Section 2.8 and 3.7 are revised to apply to

PM2.5 as well as PM10. Section 2.8.1 is added to discuss

monitoring planning areas and SAZ's. Section 2.8.2 is added to address

the PM2.5 monitoring sites and other requirements to be discussed

in the State PM monitoring plan. Finally, section 2.8.3 is added to

describe the selection of monitoring locations and SAZ's within the

monitoring planning area. A series of diagrams are used to illustrate

the basic principles.

The PM2.5 NAMS shall be selected from the core PM2.5

SLAMS. This network will focus on population-oriented surveillance and

is intended to provide a national trends network to study the impact of

PM2.5 emission sources including regional transport. A new Table

5, which lists the goals for the number of PM2.5 NAMS by EPA

Region, is added to Section 3.7. Table 5 in Section 5 is redesignated

as Table 6 and revised to include PM2.5.

In Section 2.8.1, in particular, MPA's and SAZ's are introduced to

conform to the population-oriented, spatial averaging approach taken in

the proposed new PM2.5 NAAQS under 40 CFR Part 50. This approach

is more directly related to the epidemiological studies used as the

basis for the proposed revisions to the particulate matter NAAQS. This

proposal recognizes that the use of MPA's and SAZ's introduces greater

complexity into the network design process and the assessment of

violations of the NAAQS. Thus, the Administrator would specifically

welcome comments on the

[[Page 65791]]

network design approach described in Section 2.8.1 through Section

2.8.3.

Previous requirements for number of monitors in this appendix have

been related to the urbanized area populations. The boundaries for the

urbanized populations to do not follow political or geographical

boundaries. Hence, it is difficult at times to determine the component

populations, emissions, or location of monitoring sites. A new concept

is being introduced with this proposal to change from urbanized area

population to MSA/PMSA populations for PM10 and PM2.5. This

will make it easier to track monitors for the above reasons, and to

more accurately relate measured concentrations to population exposures.

1. NAAQS Comparison Sites and New Site Codes

Through its monitoring plan, which is reviewed and approved by the

Regional Administrator, a State would select the population-oriented

2 sites eligible for NAAQS comparisons which are included in each

monitoring planning area and its SAZ's. Comparisons with the annual

primary PM2.5 NAAQS would be based on population oriented SLAMS

sites as well as other sites representative of area-wide concentrations

in SAZ's. Comparisons to the 24-hour primary PM2.5 NAAQS would be

based on these sites as well as all other sites which are population-

oriented. To encourage PM2.5 monitoring initially, for the first 3

years after effective date of promulgation a moratorium is proposed on

using data from all eligible SPM's to determine violations of the

NAAQS. After this time, any operating SPM site which records a

violation of the NAAQS would become eligible for NAAQS comparisons,

should be included in the State monitoring plan, and should be

considered during the State's review and development of their

monitoring network.

---------------------------------------------------------------------------

\2\ As currently used in Part 58, population-oriented monitoring

or sites applies to residential areas, commercial areas,

recreational areas, industrial areas where workers from more than

one company are located, and other areas where a substantial number

of people may spend a significant fraction of their day.

---------------------------------------------------------------------------

Figure 1 in Appendix D shows a conceptual Venn diagram that

illustrates which PM2.5 sites in a MPA would be eligible for

comparison to the 24-hour and annual PM2.5 NAAQS. To be eligible

for NAAQS comparisons, sites must meet all three of the following

requirements: (1) Are NAMS/SLAMS or other population oriented sites,

(2) are included in the monitoring plan, and (3) meet the requirements

of 58.13 and Appendices A, C, and E. Sites that meet the additional

requirement of generally representing areawide concentrations in the

SAZ are also eligible for comparison to the annual PM2.5 NAAQS

using the spatial averaging procedure specified in Part 50 Appendix K.

Such sites are designated ``B''. All core monitoring sites and NAMS

sites, which are a subset of the core sites, are B sites as are many

other SLAMS and some non-SLAMS sites. Other population-oriented sites

which are more representative of localized hot spots are only eligible

for comparison on a site-by-site basis to the 24-hour PM2.5 NAAQS

and are designated ``D''. These may include population-oriented

industrial monitors which meet the applicable Part 58 requirements and

are also included in the PM monitoring plan. The figure shows that all

PM2.5 SLAMS sites are designated ``B'' or ``D''. Sites not

designated as ``B'' or ``D'' sites would be designated as ``O'' sites.

These codes would become new pollutant specific codes on the AIRS

monitoring site file. In addition, core SLAMS PM2.5 sites will

receive a new AIRS site type code. These data reporting changes will be

described more fully in future AIRS guidance.

A network design issue that relates to the spatial averaging form

of the annual standard is the selection of the first (and/or only) site

in a prospective SAZ. Because the intent of the spatial average form of

the PM2.5 NAAQS is to estimate community, area-wide air pollution,

the emphasis on the first selected SLAMS sites (including core SLAMS)

would be ``typical population exposure.''

2. Monitoring Planning Areas and SAZ's

In order to acquire population-oriented, spatially averaged

monitoring data that correspond more closely to the data that are the

basis for the proposed PM2.5 NAAQS, the concepts of monitoring

planning areas and SAZ's are used in Section 2.8.1. As part of its

monitoring plan, a State will propose monitoring planning areas and

also propose non-overlapping SAZ's for each monitoring planning area.

The number of monitoring planning areas is determined by the State.

This may be one area to cover a small State like Rhode Island or be as

many as 25 to correspond to existing air pollution control districts in

a State like California. Information to be considered includes

topography, PM emissions, number and type of significant PM sources as

well as population density and distribution. Monitoring planning areas

are required to include all metropolitan statistical areas (MSA's) and

Primary Metropolitan Statistical areas (PMSA's) with population greater

than 500,000, and generally recommended to include MSA's/PMSA's with

population greater than 250,000 and high pollution (defined as

producing measurements greater than or equal to 0.8 times the level of

the PM2.5 NAAQS) as well as other areas determined to be likely to

have high concentration of PM2.5. In addition, optional MPA's may

include other designated parts of a State. An MPA should not include

different areas separated by topographical barriers. Each MPA can have

one or more SAZ's representing the area. The SAZ define the area within

which all eligible monitoring data (from ``B'' sites) will be averaged

for comparisons with the annual PM2.5 NAAQS. The MPA's and SAZ's

would be reviewed and approved annually by the Regional Administrator.

Until the monitoring plan is approved, EPA intends to have the SLAMS

and sites eligible for NAAQS comparisons default to the SLAMS

previously approved. Sites which have discontinued monitoring would

continue to be used for comparisons to the NAAQS until their monitoring

type status changes.

Multiple zones within an MPA are most appropriate for large

metropolitan areas, large geographical monitoring regions and areas in

which concentrated source regions are in low population portions of an

MPA. All MPA's and SAZ's must be defined on the basis of some existing

delineated mapping data such as county boundaries, zip codes, census

blocks or groups of census blocks. This will assist in the proper

characterization of the spatial representativeness of air monitoring

sites and facilitate better presentations of air monitoring data on

national, regional, and local maps.

All areas in the ambient air may become a SAZ based on

considerations of population density, pollution concentration gradients

and or the physical size of the area. Generally, a SAZ should

characterize an area of relatively homogeneous air quality (i.e., the

annual average concentration of the individual monitoring locations

within the area should be within 20 percent of the spatial

average) and be affected by the same major source categories of

particulate matter. In MSA's, the SAZ's must completely cover the

entire MPA. In other MPA's, the SAZ's might not completely cover the

entire MPA. For example, small networks consisting of say one or two

monitoring sites may not adequately characterize the air quality in a

large geographic area or in large areas of relatively low population or

pollution density. In another situation,

[[Page 65792]]

population centers and pollution regions represented by monitoring

sites may be geographically disjoint. In these cases, the spatial

representativeness of the monitoring site should be considered in

defining the SAZ boundaries. Until more monitoring sites are

established, the monitored air quality in areas outside of SAZ's is not

known. Although ideally all areas of a State should be included in a

SAZ, monitoring density may be insufficient to completely characterize

a specific MPA and more monitors would be needed. Nonetheless, in some

circumstances a SAZ can be represented by a single monitoring location

and this may be sufficient to properly characterize an MPA. The SAZ's

should generally include a minimum population of 250,000 and not more

than 2 million. Deviations from this criteria should be based on the

area's physical size and population density.

The Administrator recognizes that the designation of SAZ's within

Monitoring Planning Areas introduces a certain degree of complexity

into the monitoring network planning and data usage process. Comments

are therefore solicited on the use of a simpler approach to satisfy the

requirements for spatial averaging which are proposed in Part 50. In

particular, comments are solicited on a approach wherein there is only

one SAZ in each MPA which has the same boundaries as the MPA.

3. Core Monitoring Sites

To provide a minimal PM2.5 network in all high population

areas for protection of the annual and 24-hour PM NAAQS, each required

monitoring planning area must have at least two core monitors. The new

core monitoring locations would be an important part of the basic PM-

fine SLAMS regulatory network. These sites are intended to primarily

reflect community-wide air pollution, which would reflect monitoring

locations in residential areas or where people spend a substantial part

of the day take. In addition to the population-oriented monitoring

sites, core monitors would also be established for background and

transport monitoring. States should work cooperatively in establishing

their State networks in order to maximize the value of monitoring data

to best understand the regional behavior of PM2.5.

To permit interface with measurements of ozone precursors which are

also contributors to PM2.5, an additional core monitor collocated

at a PAMS site is required in those MSA's where both PAMS and

PM2.5 monitoring are required. The core monitor to be collocated

at a PAMS site is considered part of the MPA PM2.5 SLAMS network

and is not considered as a part of the PAMS network as described in

Section 4 of Appendix D.

The new core population-oriented PM-fine network is conceptually

similar to the existing NAMS for other pollutants, but would allow for

some year to year changes in site location to ensure that the typical

areas of high pollution, high population areas are always monitored.

Core sites will be the key sampling locations designated for initial

monitoring, and a subset would be selected for longer-term monitoring.

The latter would become the NAMS.

The core sites will also produce the most complete data in the PM-

fine network. Daily sampling would be required, except during low

pollution seasons or other periods as exempted by EPA. As such, a

subset of these sites should be considered as candidate locations for

adding state-of-the-art research monitoring devices whose data might

need to be considered in future reviews of the PM NAAQS. This will

ensure continuity and comparability of past, present and future PM data

bases.

Finally, because the core sites would produce the most data, many

would be the most likely locations for determining violations of a

short-term NAAQS. The core locations would become critical for judging

future attainment in an area that has been determined to violate the

NAAQS, again putting emphasis on areas with the largest population

impact. Complete data at background and transport core sites will also

provide the needed data base to better understand the source-receptor

relationships and assist the implementation program.

Each SAZ in a required MPA must have at least one core monitor; the

SAZ's in optional MPA's should have at least one core monitor; and it

is also suggested that SAZ's should have at least one core site for

every four SLAMS. Exemptions are allowed for required core stations in

MSA's with population greater than 500,000, if measured or modeled

concentrations of PM2.5 are less than 80 percent of the NAAQS for

PM2.5. Specific comments on the required and suggested number of

core monitoring locations are requested.

4. Examples of MPA's, SAZ's and NAAQS Eligible Monitors

Some examples may better illustrate how the concepts of monitoring

planning areas and SAZ's may be realized in practice. The San Joaquin

Valley air basin in California could be an MPA. If emission sources are

distributed throughout this region, then the entire MPA could also be

the SAZ. For large counties, such as California's San Bernardino

County, which have non-uniform emission sources and population density,

there could be at least two SAZ's, such as an eastern SAZ and a western

SAZ which is part of the South Coast Air Basin. For an MSA, such as the

Philadelphia MSA, or MSA/MPA which crosses State boundaries, separate

SAZ's are suggested for each State portion, with substantial population

(e.g. greater than 250,000). For the Philadelphia PA-NJ MSA, this could

mean at least separate zones for the Philadelphia, PA and NJ portions.

In this manner, each State would be responsible for the networks in its

SAZ portion of the MPA. (Each of these SAZ's must have at least one

core monitor for a total of two for the MPA). Furthermore, for MSA's

and large geographic areas with concentrated source regions or

industrial areas, such as Philadelphia, separate SAZ's are suggested

for the residential/city center and the industrial area to better

characterize the gradients in PM2.5 concentrations. Downtown

street canyons may be appropriate SAZ's if they also include

residential areas, such as is the case in mid-town Manhattan, NY or if

they include commercial areas which have higher PM2.5

concentrations within the MPA and where significant numbers of people

work during the day. Comments are solicited on criteria for defining

SAZ's.

A series of figures is presented to illustrate the concept of MPA's

and SAZ's. A hypothetical MPA representing an Eastern urban area is

given in Figure 2 of appendix D and illustrates how monitors can be

located in relation to population and areas of poor quality. Figure 3

in Appendix D shows the same MPA as Figure 2, but includes three SAZ's:

an industrial zone, a downtown central business district, and

residential areas. Figure 4 in Appendix D shows the same MPA

illustrated in Figures 2 and 3. However, sites are denoted by whether

they are eligible for comparison with the 24-hour PM2.5 NAAQS or

both the 24-hour and the annual PM2.5 NAAQS. Figure 5 in Appendix

D shows potential SAZ's in a hypothetical Western State. Figure 6 in

Appendix D illustrates State coverage by SAZ's both within and outside

MPA's. More detailed guidance for network design for PM2.5 using

the concepts of core monitoring stations, MPA's, and SAZ's will be

available shortly in an EPA guidance document which is in preparation.

[[Page 65793]]

5. Substitute PM Samplers

Appendix C (Section 2.2) to Part 58 describes conditions under

which TSP samplers may be used as substitutes for PM10 samplers

and when such TSP samplers must be replaced with PM10 samplers.

The proposed rule will describe similar language regarding PM10

samplers which may be used as substitutes for PM2.5 and provide

clarification to ensure that only the appropriate TSP or PM10

sites are required to be converted to PM10 and PM2.5,

respectively. This provision is intended to be used when PM

concentrations are low and substitute samplers can be used to satisfy

the minimum number of PM samplers needed for an adequate PM network.

This may be most appropriate when sufficient resources to purchase new

PM samplers may not exist and existing samplers can be temporarily used

to serve a new PM network.

6. NAMS Network Design

In Section 3.7, the PM10 design criteria for NAMS, namely

monitoring objectives, spatial representativeness, the category ``a''

maximum concentration site, number of sites, etc., remains in effect.

In addition, the traditional concept of NAMS as long-term monitoring

stations to assess trends and to support national assessments and

decisions is reiterated. However, concerning PM2.5 network design,

a more flexible approach is proposed. First, the PM2.5 NAMS will

be concentrated in metropolitan areas in keeping with the risk

management approach of the proposed new PM2.5 NAAQS. Next, a

numeric range of prospective PM2.5 NAMS by EPA Region are

identified. These are based on consideration of a number of factors set

by Regions to provide maximum flexibility for State and local agencies,

but should represent the range of conditions occurring in the Regions

taking into consideration such factors as the total number and types of

sources, ambient characteristics of particulate matter, regional

transport, geographic area, and affected population. The goals for

Regions varies from a low of 10 to 15 for Regions VII, VIII and X to a

high of 35 to 50 for Regions IV and V while the total ranges from 205

to 295 with an expected national target of 250. In particular, comments

are requested about the general approach of goals by Region and the

numbers estimated.

P. Appendix E

Today's revision to Appendix E consists of relatively minor changes

to Section 8 which currently provides the sampler siting criteria for

PM10. The modifications basically expand the siting requirements

to include PM2.5 as well as PM10 by selectively replacing the

term PM10 with PM which would be defined as applying to PM10

and PM2.5. This will permit existing PM10 sites to continue

to be used and, when appropriate, to serve as platforms for new

PM2.5 sampling.

Q. Appendix F

A new section has been added for the annual summary statistics for

PM2.5 in Appendix F. It should be noted that the current

procedures for reporting and certifying the air quality data may be

changed later, since the AIRS system is undergoing reengineering.

R. Cost Estimates for New PM Networks

The costs associated with the start-up of a PM2.5 network and

the phase-down of the existing PM10 sampling network depend on the

3-year phase-in of the new proposed requirements and the number of PM

monitors that the Administrator believes are necessary in a mature

network.

Table 1. PM-2.5 Network Costs

[Thousands of dollars]

----------------------------------------------------------------------------------------------------------------

Number of Number of Capital Sampling Filter Special Total

Year sites samplers cost & QA analysis studies cost

------------------------------------------------\1\--------------------------------\2\--------------------------

1997........................... 0 0 $4,095 ......... ........... ......... $4,095

1998........................... 216 318 7,908 $4,382 $1,558 $2,600 16,478

1999........................... 714 1,004 6,850 11,514 926 1,300 20,590

2000........................... 1,200 1,490 ......... 17,833 926 1,300 20,059

----------------------------------------------------------------------------------------------------------------

\1\ The PM-2.5 Network includes 160 collocated monitors for QA purposes, and 130 collocated monitors to avoid

weekend site visits.

\2\ Three different types of filter analyses are anticipated (exceedances analyses, screening analyses, and

detailed analyses).

Table 2.--Cost for PM2.5 Filter Analyses

------------------------------------------------------------------------

Estimated

Type of filter analysis cost per

sample

------------------------------------------------------------------------

Exceedance Analysis: $200

High PM2.5 concentration events are optically analyzed

for particle size and composition utilizing electron

microscopy..............................................

Screening Analysis:

X-Ray Fluorescence (XRF) for elemental composition

(crustal material, sulfur, and heavy metals)............ 50

Thermo-optical analysis for elemental/organic/total

carbon.................................................. 50

Detailed Analysis:

Inductively Coupled Argon Plasma (ICAP) Analysis for

elemental composition................................... 100

Analysis for speciated organic composition............... 400

Analysis for sulfate, aerosol acidity.................... 100

------------------------------------------------------------------------

Table 3 presents the change in PM10 network costs. The costs

are shown for a current network of 1,650 sites and the phase down to a

future projected network of 600 sites. PM10 costs have been

calculated for the continued operation on a one in 6-day schedule, and

for the relocation or discontinuance of monitoring sites. Table 4 shows

the cost of PM monitoring according to sampling frequency and the type

of PM monitor. Details of this information can be found in the

``Information Collection Request'' for these proposed requirements.

[[Page 65794]]

Table3.--PM-10 Network Costs

[Thousands of dollars]

----------------------------------------------------------------------------------------------------------------

Capital

Number of Number of cost to Operation & Total

Year sites samplers\1\ remove maintenance cost

sites cost

----------------------------------------------------------------------------------------------------------------

1997................................................. 1,650 1,810 ......... $15,474 $15,473

1998................................................. 1,374 1,544 $110 12,181 12,291

1999................................................. 972 1,132 174 8,914 9,088

2000................................................. 600 760 161 5,966 6,127

----------------------------------------------------------------------------------------------------------------

\1\ The PM10 network includes 160 collocated monitors for QA purposes.

Table 4.--Costs for Particulate Monitoring

------------------------------------------------------------------------

PM monitor and sampling One-time capital Annual operation &

frequency cost maintenance cost

------------------------------------------------------------------------

PM-10 1-in-6 day sampling $14,500............ $8,700.

schedule.

PM-2.5 1-in-6 day sampling $9,600 to $16,900.. $11,200.

schedule.

PM-2.5 every day sampling...... $14,600 to $21,900. $18,900.

Nephelometer (continuous)...... $20,100 to $26,300. $16,700 to

$17,500.

------------------------------------------------------------------------

S. Reference

1. Information Collection Request, 40 CFR 58 Ambient Air Quality

Surveillance, OMB #2060-0084, EPA ICR #0940.14, U.S. Environmental

Protection Agency, Office of Air Quality Planning and Standards,

Research Triangle Park, NC 27711 (October 23, 1996).

V. Administrative Requirements

A. Regulatory Impact Analysis

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the

Agency must determine whether the regulatory action is ``significant''

and therefore subject to Office of Management and Budget (OMB) review

and to the requirements of the Executive Order. The Order defines

``significant regulatory action'' as one that is likely to result in a

rule that may:

(1) Have an annual effect on the economy of $100 million or more or

adversely affect in a material way the economy, a sector of the

economy, productivity, competition, jobs, the environment, public

health or safety, or State, local, or governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an

action taken or planned by another Agency;

(3) Materially alter the budgetary impact of entitlements, grants,

user fees, or loan programs or the rights and obligations or recipients

thereof; or

(4) Raise novel legal or policy issues arising out of legal

mandates, the President's priorities, or the principles set forth in

the Executive Order.

It has been determined that this rule is not a ``significant

regulatory action'' under the terms of the Executive Order 12866 and is

therefore not subject to formal OMB review. However, this rule is being

reviewed by OMB under Reporting and Record keeping Requirements (see

below).

B. Paperwork Reduction Act

The information collection requirements contained in this proposed

rule have been submitted for approval to OMB under the Paperwork

Reduction Act, 44 U.S.C. 3501 et seq. An Information Collection Request

document has been prepared by the EPA (ICR No. 0940.14) and a copy may

be obtained from Sandy Farmer, Information Policy Branch, EPA, 401 M

Street SW, Mail Code 2137, Washington, DC 20460; or by calling (202)

260-2740.

1. Need and Use of the Collection

The main use for the collection of the data is to support the PM

NAAQS revisions. The various parameters reported as part of this ICR

are necessary to ensure that the information and data collected by

State and local agencies to assess the nation's air quality are

defensible, of known quality, and meet the EPA's data quality goals of

completeness, precision, and accuracy.

The need and authority for this information collection is contained

in Section 110(a)(2)(C) of the Act, which requires ambient air quality

monitoring for purposes of the SIP and reporting of the data to EPA,

and Section 319, which requires the reporting of a daily air pollution

index. The legal authority for this requirement is the Ambient Air

Quality Surveillance Regulations, 40 CFR 58.20, 58.21, 58.25, 58.26,

58.28, 58.30, 58.31, 58.35, and 58.36.

The EPA's Office of Air Quality Planning and Standards uses ambient

air monitoring data for a wide variety of purposes, including making

NAAQS attainment/nonattainment decisions; determining the effectiveness

of air pollution control programs; evaluating the effects of air

pollution levels on public health; tracking the progress of SIP's;

providing dispersion modeling support; developing responsible, cost-

effective control strategies; reconciling emission inventories; and

developing air quality trends. The collection of PM2.5 data is

necessary to support the PM2.5 NAAQS, and the information

collected will have practical utility as a data analysis tool.

The State and local agencies with responsibility for reporting

ambient air quality data and information as requested by these proposed

regulations will submit these data electronically to the U.S. EPA's

Aerometric Information Retrieval System, Air Quality Subsystem (AIRS-

AQS). Quality assurance/quality control records and monitoring network

documentation are also maintained by each State/local agency, in AIRS-

AQS electronic format where possible.

2. Reporting and Recordkeeping Burden

The total annual collection and reporting burden associated with

this proposal is estimated to be 490,526 hours. Of this total, 484,545

hours are estimated to be for data reporting, or an average of 3,327

hours for the estimated 130 respondents. The remainder of 5,981 hours

for recordkeeping burden averages 46 hours for the estimated 130

respondents. The capital O/M costs associated with this proposal are

estimated to be $19,714,453. These estimates include time for reviewing

instructions, searching existing data sources, gathering and

maintaining the data needed, and completing and reviewing the

collection of information.

The frequency of data reporting for the NAMS and the SLAMS air

quality data as well as the associated precision and accuracy data are

submitted to EPA according to the schedule defined in 40 CFR part 58.

This regulation currently requires that State and local air quality

[[Page 65795]]

management agencies report their data within 90 days after the end of

the quarter during which the data were collected. The annual SLAMS

report is submitted by July 1 of each year for data collected from

January 1 through December 31 of the previous year in accordance with

40 CFR 58.26. This certification also implies that all SPM data to be

used for regulatory purposes by the affected State or local air quality

management agency have been submitted by July 1.

3. Burden

Burden means the total time, effort, or financial resources

expended by persons to generate, maintain, retain, or disclose or

provide information to or for a Federal agency. This includes the time

needed to review instructions; develop, acquire, install, and utilize

technology and systems for the purpose of collecting, validating, and

verifying information, processing and maintaining information, and

disclosing and providing information; adjust the existing ways to

comply with any previously applicable instructions and requirements;

train personnel to be able to respond to a collection of information;

search data sources; complete and review the collection of information;

and transmit or otherwise disclose the information.

An Agency may not conduct or sponsor, and a person is not required

to respond to a collection of information unless it displays a

currently valid OMB control number. The OMB control numbers for EPA's

regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Comments are requested on the Agency's need for this information,

the accuracy of the provided burden estimates, and any suggested

methods for minimizing respondent burden, including through the use of

automated collection techniques. Send comments on the ICR to the

Director, OPPE Regulatory Information Division; U.S. Environmental

Protection Agency (2137); 401 M St., SW.; Washington, DC 20460; and to

the Office of Information and Regulatory Affairs, Office of Management

and Budget, 725 17th St., NW., Washington, DC 20503, marked

``Attention: Desk Officer for EPA.'' Include the ICR number in any

correspondence. Since OMB is required to make a decision concerning the

ICR between 30 and 60 days after December 13, 1996, a comment to OMB is

best assured of having its full effect if OMB receives it by January

13, 1997. The final rule will respond to any OMB or public comments on

the information collection requirements contained in this proposal.

C. Impact on Small Entities

Pursuant to section 605(b) of the Regulatory Flexibility Act, 5

U.S.C. 605(b), the Administrator certifies that this rule will not have

a significant economic impact on a substantial number of small

entities. This rulemaking package does not impose any additional

requirements on small entities because it applies to governments whose

jurisdictions cover more than 200,000 population. Under the Regulatory

Flexibility Act, governments are small entities only if they have

jurisdictions of less than 50,000 people. In addition, this rule

imposes no enforceable duties on small businesses.

D. Unfunded Mandates Reform Act of 1995

Under sections 202, 203 and 205 of the Unfunded Mandates Reform Act

of 1995 (``Unfunded Mandates Act''), signed into law on March 22, 1995,

the EPA must undertake various actions in association with proposed or

final rules that include a Federal mandate that may result in estimated

costs of $100 million or more to the private sector, or to State or

local governments in the aggregate.

The EPA has determined that this rule does not contain a Federal

mandate that may result in expenditures of $100 million or more for

State, and local governments, in the aggregate, or the private sector

in any one year. Our economic analysis indicates that the total

implementation cost will be approximately $88,728,000 in 1996 dollars

for the 3 years to phase in the network, or an average of $29,576,000

for the 3-year implementation. The table below shows how this 3-year

average was derived for the various cost elements of monitoring. While

this table represents the 3-year period 1998-2000, the total cost for

PM2.5 monitoring include the initial capital costs anticipated in

1997. In addition, this rule imposes no enforceable duties on small

businesses.

Cost Based on 3-Year Average

[Thousands of dollars]

------------------------------------------------------------------------

3 year

Cost/Element PM10 PM2.5 totals

------------------------------------------------------------------------

Network design......................... $0 $571 $571

Site installation...................... 311 5,013 5,324

Sampling & analysis.................... 2,647 6,758 9,405

Maintenance............................ 1,233 1,928 3,161

Data management........................ 1,245 1,574 2,819

Quality assurance...................... 1,745 3,373 5,118

Supervision............................ 1,988 1,189 3,177

--------------------------------

Summary \1\........................ 9,169 20,407 29,576

------------------------------------------------------------------------

\1\ Totals are rounded.

List of Subjects

40 CFR Part 53

Environmental protection, Administrative practice and procedure,

Air pollution control, Reporting and recordkeeping requirements.

40 CFR Part 58

Air pollution control, Intergovernmental relations, Reporting and

recordkeeping requirements.

Dated: November 27, 1996.

Carol M. Browner,

Administrator.

For the reasons set forth in the preamble, title 40, chapter I,

part 53 and part 58 of the Code of Federal Regulations are proposed to

be amended as follows:

[[Page 65796]]

PART 53--[AMENDED]

1. The authority citation for part 53 continues to read as follows:

Authority: Sec. 301(a) of the Clean Air Act (42 U.S.C. Sec.

1857g(a)) as amended by sec. 15(c)(2) of Pub. L. 91-604, 84 Stat.

1713, unless otherwise noted.

2. Subpart A is revised to read as follows:

Subpart A--General Provisions

Sec.

53.1 Definitions.

53.2 General requirements for a reference method determination.

53.3 General requirements for an equivalent method determination.

53.4 Applications for reference or equivalent method determinations.

53.5 Processing of applications.

53.6 Right to witness conduct of tests.

53.7 Testing of methods at the initiative of the Administrator.

53.8 Designation of reference and equivalent methods.

53.9 Conditions of designation.

53.10 Appeal from rejection of application.

53.11 Cancellation of reference or equivalent method designation.

53.12 Request for hearing on cancellation.

53.13 Hearings.

53.14 Modification of a reference or equivalent method.

53.15 Trade secrets and confidential or privileged information.

53.16 Supersession of reference methods.

Tables to Subpart A of Part 53

Table A-1--Summary of Applicable Requirements for Reference &

Equivalent Methods for Air Monitoring of Criteria Pollutants

Appendix A to Subpart A of Part 53--References

Subpart A--General Provisions

Sec. 53.1 Definitions.

(a) Terms used but not defined in this part shall have the meaning

given them by the Act.

(b) Act means the Clean Air Act (42 U.S.C. 1857-1857l), as amended.

(c) Agency means the Environmental Protection Agency.

(d) Administrator means the Administrator of the Environmental

Protection Agency or the Administrator's authorized representative.

(e) Reference method means a method of sampling and analyzing the

ambient air for an air pollutant that is specified as a reference

method in an appendix to part 50 of this chapter, or a method that has

been designated as a reference method in accordance with this part; it

does not include a method for which a reference method designation has

been canceled in accordance with Sec. 53.11 or Sec. 53.16.

(f) Equivalent method means a method of sampling and analyzing the

ambient air for an air pollutant that has been designated as an

equivalent method in accordance with this part; it does not include a

method for which an equivalent method designation has been canceled in

accordance with Sec. 53.11 or Sec. 53.16.

(g) Candidate method means a method of sampling and analyzing the

ambient air for an air pollutant for which an application for a

reference method determination or an equivalent method determination is

submitted in accordance with Sec. 53.4, or a method tested at the

initiative of the Administrator in accordance with Sec. 53.7.

(h) Manual method means a method for measuring concentrations of an

ambient air pollutant in which sample collection, analysis, or

measurement, or some combination thereof, is performed manually. A

method for PM10 or PM2.5 which utilizes a sampler that

requires manual preparation, loading, and weighing of filter samples is

considered a manual method even though the sampler may be capable of

automatically collecting a series of sequential samples.

(i) Automated method or analyzer means a method for measuring

concentrations of an ambient air pollutant in which sample collection

(if necessary), analysis, and measurement are performed automatically

by an instrument.

(j) Test analyzer means an analyzer subjected to testing as part of

a candidate method in accordance with subparts B, C, D, E, or F of this

part, as applicable.

(k) Applicant means a person or entity who submits an application

for a reference or equivalent method determination under Sec. 53.4, or

a person or entity who assumes the rights and obligations of an

applicant under Sec. 53.7. Applicant may include a manufacturer,

distributer, supplier, or vendor.

(l) Ultimate purchaser means the first person who purchases a

reference method or an equivalent method for purposes other than

resale.

(m) PM10 sampler or PM2.5 sampler means a device,

associated with a manual method for measuring PM10 or PM2.5

(respectively), designed to collect PM10 or PM2.5

(respectively) from an ambient air sample, but lacking the ability to

automatically analyze or measure the collected sample to determine the

mass concentration of PM10 or PM2.5 in the sampled air.

(n) Test sampler means a PM10 sampler or a PM2.5 sampler

subjected to testing as part of a candidate method in accordance with

subparts C, D, E or F of this part.

(o) Collocated describes two or more air samplers, analyzers, or

other instruments which sample the ambient air that are operated

simultaneously while located side by side, separated by a distance that

is large enough to preclude the air sampled by any of the devices from

being affected by any of the other devices, but small enough so that

all devices obtain identical or uniform ambient air samples that are

equally representative of the general area in which the group of

devices is located.

(p) Sequential samples for particulate matter samplers means two or

more particulate matter samples for sequential (but not necessarily

contiguous) time periods that are collected automatically by the same

sampler without the need for intervening operator service.

(q) Class I equivalent method means an equivalent method for

PM2.5 which is based on a sampler that is very similar to the

sampler specified for reference methods in Appendix L of part 50 of

this chapter, with only minor deviations or modifications, as

determined by the EPA. A common example of a Class I PM2.5 sampler

is a reference method sampler that has been modified to provide

automatic collection of sequential samples, as defined in paragraph (p)

of this section.

(r) Class II equivalent method means an equivalent method for

PM2.5 that utilizes a PM2.5 sampler in which an integrated

PM2.5 sample is obtained from the atmosphere by filtration and

subjected to a subsequent filter equilibration process followed by a

gravimetric mass determination, but which is not a Class I equivalent

method because of substantial deviations from the design specifications

of the sampler specified for reference methods in Appendix L of part 50

of this chapter, as determined by the EPA.

(s) Class III equivalent method means an equivalent method for

PM2.5 that has been determined by the EPA not to be a Class I or

Class II equivalent method. This fourth type of PM2.5 method

includes alternative equivalent method samplers and continuous

analyzers, based on designs and measurement principles different from

those specified for reference methods (e.g., a means for estimating

aerosol mass concentration other than by conventional integrated

filtration followed by equilibration and gravimetric analysis). These

samplers (or monitors) are those deemed to be substantially different

from reference method samplers and may use components and methods other

than

[[Page 65797]]

those specified for reference method samplers. Class III candidate

samplers or analyzers require full equivalency testing and must meet

all requirements specified in subpart F of this chapter.

(t) An ISO-registered facility shall be defined as a manufacturing

facility that is either:

(1) An International Organization for Standardization (ISO) 9001-

registered manufacturing facility, with registration maintained

continuously; or

(2) A facility that can be demonstrated, on the basis of

information submitted to the EPA, to be operated according to an EPA-

approved and periodically audited quality system which meets, to the

extent appropriate, the same general requirements as an ISO registered

facility for the design and manufacture of designated reference and

equivalent method samplers and monitors.

(u) An ISO-certified auditor shall be defined as an auditor either

certified by an ISO accredited registrar or an auditor who, based on

information submitted to the EPA, meets the same general requirements

as provided for ISO-certified auditors.

Sec. 53.2 General requirements for a reference method determination.

The following general requirements for a reference method

determination are summarized in Table A-1 of this subpart.

(a) Manual methods. (1) For measuring SO2 and lead, Appendices

A and G of part 50 of this chapter specify unique manual reference

methods for those pollutants. Except as provided in Sec. 53.16, other

manual methods for SO2 and lead will not be considered for

reference method determinations under this part.

(2) A reference method for measuring PM10 must be a manual

method that meets all requirements specified in Appendix J of part 50

of this chapter and must include a PM10 sampler that has been

shown in accordance with this part to meet all requirements specified

in subpart D of this part.

(3) A reference method for measuring PM2.5 must be a manual

method that meets the requirements specified in Appendix L of part 50

of this chapter and must include a PM2.5 sampler that has been

shown in accordance with this part to meet the applicable requirements

specified in subpart E of this part. Further, reference method samplers

must be manufactured in an ISO 9001-registered facility as defined in

Sec. 53.1(t) and , as set forth in Sec. 53.51 (subpart E, of this

part), and the Product Manufacturing Checklist set forth in subpart E

of this part must be completed by an ISO 9001-certified auditor, as

defined in Sec. 53.1(u), and submitted to the EPA annually to retain a

PM2.5 reference method designation. In addition, all designated

reference methods for PM2.5 must meet requirements for network

operating performance determined annually as set forth in section 6 of

Appendix A of part 58 of this chapter.

(b) ``Automated methods.'' An automated reference method for

measuring CO, O3, and NO2 must utilize the measurement

principle and calibration procedure specified in the appropriate

appendix to part 50 of this chapter and must have been shown in

accordance with this part to meet the requirements specified in subpart

B of this part.

Sec. 53.3 General requirements for an equivalent method determination.

(a) Manual methods. A manual equivalent method must have been shown

in accordance with this part to satisfy the applicable requirements

specified in subpart C of this part. In addition, PM10 or

PM2.5 samplers associated with manual equivalent methods for

PM10 or PM2.5 must have been shown in accordance with this

part to satisfy the following additional requirements:

(1) A PM10 sampler associated with a manual method for

PM10 must satisfy the requirements of subpart D of this part.

(2) A PM2.5 Class I equivalent method sampler must satisfy all

requirements of subparts C and E of this part, which include

appropriate demonstration that each and every deviation or modification

from the reference method sampler specifications does not significantly

alter the performance of the sampler.

(3) A PM2.5 Class II equivalent method sampler must satisfy

the requirements of subparts C, E, and F of this chapter.

(4) Requirements for PM2.5 Class III equivalent method

samplers are not provided in this part because of the wide range of no-

filter-based measurement technologies that could be applied and the

likelihood that these requirements will have to be specifically adapted

for each such type of technology. Specific requirements will be

developed as needed.

(5) All designated equivalent methods for PM2.5 must be

manufactured in an ISO 9001-registered facility, as defined in

Sec. 53.1(t) and as set forth in Sec. 53.51 (subpart E) of this part,

and the Product Manufacturing Checklist set forth in Appendix E of this

part must be completed by an ISO 9001-certified auditor, as defined in

Sec. 53.1(u), and submitted to the EPA annually to retain a PM2.5

equivalent method designation.

(6) All designated equivalent methods for PM2.5 must also meet

annual requirements for network operating performance determined as set

forth in section 6 of Appendix A of part 58 of this chapter.

(b) Automated methods. (1) Automated equivalent methods for

pollutants other than PM2.5 or PM10 must have been shown in

accordance with this part to satisfy the requirements specified in

subparts B and C of this part.

(2) Automated equivalent methods for PM10 must have been shown

in accordance with this part to satisfy the requirements of subparts C

and D of this part.

(3) Requirements for PM2.5 Class III automated equivalent

methods for PM2.5 are not provided in this part because of the

wide range of non-filter-based measurement technologies that could be

applied and the likelihood that these requirements will have to be

specifically adapted for each such type of technology. Specific

requirements will be developed as needed.

(4) All designated equivalent methods for PM2.5 must be

manufactured in an ISO 9001-registered facility, as set forth in

Appendix E of this part, and the Product Manufacturing Checklist set

forth in Appendix E of this part must be completed by an ISO 9001-

certified auditor and submitted to the EPA annually to retain a

PM2.5 equivalent method designation.

(5) All designated equivalent methods for PM2.5 must also meet

annual requirements for network operating performance determined as set

forth in section 6 of Appendix A of part 58 of this chapter.

Sec. 53.4 Applications for reference or equivalent method

determinations.

(a) Applications for reference or equivalent method determinations

shall be submitted in duplicate to: Director, National Exposure

Research Laboratory, Department E (MD-77B), U.S. Environmental

Protection Agency, Research Triangle Park, North Carolina 27711.

(b) Each application shall be signed by an authorized

representative of the applicant, shall be marked in accordance with

Sec. 53.15 (if applicable), and shall contain the following:

(1) A clear identification of the candidate method, which will

distinguish it from all other methods such that the method may be

referred to unambiguously. This identification must consist of a unique

series of descriptors such as title, identification

[[Page 65798]]

number, analyte, measurement principle, manufacturer, brand, model,

etc., as necessary to distinguish the method from all other methods or

method variations, both within and outside the applicant's

organization.

(2) A detailed description of the candidate method, including but

not limited to the following: The measurement principle, manufacturer,

name, model number and other forms of identification, a list of the

significant components, schematic diagrams, design drawings, and a

detailed description of the apparatus and measurement procedures.

Drawings and descriptions pertaining to candidate methods or samplers

for PM2.5 must meet all applicable requirements in Reference 1 of

Appendix A to this subpart, using appropriate graphical, nomenclature,

and mathematical conventions such as those specified in References 3

and 4 of Appendix A to this subpart.

(3) A copy of a comprehensive operation or instruction manual

providing a complete and detailed description of the operational and

calibration procedures prescribed for field use of the candidate method

and all instruments utilized as part of that method (see Sec. 53.9a).

(i) As a minimum this manual shall include:

(A) Description of the method and associated instruments;

(B) Explanation of all indicators, information displays, and

controls;

(C) Complete setup and installation instructions, including any

additional materials or supplies required;

(D) Details of all initial or startup checks or acceptance tests

and any auxiliary equipment required;

(E) Complete operational instructions;

(F) Calibration procedures and required calibration equipment and

standards;

(G) Instructions for verification of correct or proper operation;

(H) Trouble-shooting guidance and suggested corrective actions for

abnormal operation;

(I) Required or recommended routine, periodic, and preventative

maintenance and maintenance schedules,

(J) Any calculations required to derive final concentration

measurements; and

(K) Appropriate references to 40 CFR part 50, Appendix L, Reference

6, and any other pertinent guidelines.

(ii) The manual shall also include adequate warning of potential

safety hazards that may result from normal use and/or malfunction of

the method and a description of necessary safety precautions. [See

Sec. 53.9(b)] However, the previous requirement shall not be

interpreted to constitute or imply any warranty of safety of the method

by the EPA. For samplers and automated methods, the manual shall

include a clear description of all procedures pertaining to

installation, operation, preventative maintenance, and troubleshooting

and shall also include parts identification diagrams. The manual may be

used to satisfy the requirements of paragraphs (b) (1) and (2) of this

section to the extent that it includes information necessary to meet

those requirements.

(4) A statement that the candidate method has been tested in

accordance with the procedures described in subparts B, C, D, E, and/or

F of this part, as applicable.

(5) Test data, records, calculations, and test results as specified

in subparts B, C, D, E, and/or F of this part, as applicable. Data must

be sufficiently detailed to meet appropriate principles described in

paragraphs 4 through 6 of Reference 2, Part b, sections 3.3.1

(paragraph 1) and 3.5.1 (paragraphs 2 and 3) and in paragraphs 1

through 3 of Reference 5 (section 4.8, Records) of appendix A of this

subpart. Salient requirements from these references include the

following:

(i) The applicant shall maintain and include records of all

relevant measuring equipment, including the make, type, and serial

number or other identification, and most recent calibration with

identification of the measurement standard or standards used and their

NIST traceability. These records shall demonstrate the measurement

capability of each item of measuring equipment used for the application

and include a description and justification (if needed) of the

measurement setup or configuration in which it was used for the tests.

The calibration results shall be recorded and identified in sufficient

detail so that the traceability of all measurements can be determined

and any measurement could be reproduced under conditions close to the

original conditions, if necessary, to resolve any anomalies.

(ii) Test data shall be collected according to the standards of

good practice and by qualified personnel. Test anomalies or

irregularities shall be documented and explained or justified. The

impact and significance of the deviation on test results and

conclusions shall be determined. Data collected shall correspond

directly to the specified test requirement and be labeled and

identified clearly so that results can be verified and evaluated

against the test requirement. Calculations or data manipulations must

be explained in detail so that they can be verified.

(6) A statement that the method, analyzer, or sampler tested in

accordance with this part is representative of the candidate method

described in the application.

(c) For candidate automated methods and candidate manual methods

for PM10 and PM2.5, the application shall also contain the

following:

(1) A detailed description of the quality system that will be

utilized, if the candidate method is designated as a reference or

equivalent method, to ensure that all analyzers or samplers offered for

sale under that designation will have essentially the same performance

characteristics as the analyzer(s) or samplers tested in accordance

with this part. In addition, the quality system requirements for

candidate methods for PM2.5 must be described in sufficient

detail, based on the elements described in section 4 of Reference 1

(Quality System Requirements) of appendix A of this subpart. Further

clarification is provided in the following sections of Reference 2:

Part A (Management Systems), sections 2.2 (Quality System and

Description), 2.3 (Personnel Qualification and Training), 2.4

(Procurement of Items and Services), 2.5 (Documents and Records), and

2.7 (Planning); Part B (Collection and Evaluation of Environmental

Data), sections 3.1 (Planning and Scoping), 3.2 (Design of Data

Collection Operations), and 3.5 (Assessment and Verification of Data

Usability); and Part C (Operation of Environmental Technology),

sections 4.1 (Planning), 4.2 (Design of Systems), and 4.4 (Operation of

Systems) of appendix A of this subpart .

(2) A description of the durability characteristics of such

analyzers or samplers [see Sec. 53.9(c)]. For methods for PM2.5,

the warranty program must ensure that the required specifications (see

Table A-1 of this subpart) will be met throughout the warranty period

and that the applicant accepts responsibility and liability for

ensuring this conformance, or resolving any nonconformities, including

all necessary components of the system, regardless of the original

manufacturer. The warranty program must be described in sufficient

detail to meet appropriate provisions of the ANSI/ASQC and ISO 9001

standards (References 1 and 2 in appendix A of this subpart) for

controlling conformance and resolving nonconformance, particularly

sections 4.12, 4.13, and 4.14 of Reference 1 in appendix A of this

subpart.

[[Page 65799]]

(i) Section 4.12 in appendix A of this subpart requires the

manufacturer to establish and maintain a system of procedures for

identifying and maintaining the identification of inspection and test

status throughout all phases of manufacturing to ensure that only

instruments that have passed the required inspections and tests are

released for sale.

(ii) Section 4.13 in appendix A of this subpart requires documented

procedures for control of nonconforming product, including review and

acceptable alternatives for disposition; section 4.14 requires

documented procedures for implementing corrective (4.14.2) and

preventive (4.14.3) action to eliminate the causes of actual or

potential nonconformities. In particular, section 4.14.3 requires that

potential causes of nonconformities be eliminated by using information

such as service reports and customer complaints to eliminate potential

causes of nonconformities.

(d) For candidate reference or equivalent methods for PM2.5,

the applicant shall provide to EPA for test purposes one sampler or

analyzer that is representative of the sampler or analyzer associated

with the candidate method. The sampler or analyzer shall be shipped FOB

destination to Department E, (MD-77B), U.S. EPA, 79 T.W. Alexander

Drive, Research Triangle Park, NC 27709, scheduled to arrive concurrent

with or within 30 days of the arrival of the other application

materials. This analyzer or sampler may be subjected to various tests

that the EPA determines to be necessary or appropriate under

Sec. 53.5(e), and such tests may include special tests not otherwise

described in this part. If the instrument submitted under this

paragraph malfunctions, becomes inoperative, or fails to perform as

represented in the application before the necessary EPA testing is

completed, the applicant shall be afforded an opportunity to repair or

replace the device at no cost to the EPA. Upon completion of the EPA

testing, the analyzer or sampler submitted under this paragraph shall

be repacked by the EPA for return shipment to the applicant, using the

same packing materials used for shipping the instrument to the EPA

unless alternative packing is provided by the applicant. Arrangements

for, and the cost of, return shipment shall be the responsibility of

the applicant. The EPA does not warrant or assume any liability for the

condition of the analyzer or sampler upon return to the applicant.

Sec. 53.5 Processing of applications.

After receiving an application for a reference or equivalent method

determination, the Administrator will publish notice of the application

in the Federal Register and, within 120 calendar days after receipt of

the application, take one or more of the following actions:

(a) Send notice to the applicant, in accordance with Sec. 53.8,

that the candidate method has been determined to be a reference or

equivalent method;

(b) Send notice to the applicant that the application has been

rejected, including a statement of reasons for rejection;

(c) Send notice to the applicant that additional information must

be submitted before a determination can be made and specify the

additional information that is needed (in such cases, the 120-day

period shall commence upon receipt of the additional information);

(d) Send notice to the applicant that additional test data must be

submitted and specify what tests are necessary and how they shall be

interpreted (in such cases, the 120-day period shall commence upon

receipt of the additional test data);

(e) Send notice to the applicant that the application has been

found to be substantially deficient or incomplete and cannot be

processed until additional information is submitted to complete the

application and specify the general areas of substantial deficiency; or

(f) Send notice to the applicant that additional tests will be

conducted by the Administrator, specifying the nature of and reasons

for the additional tests and the estimated time required (in such

cases, the 120-day period shall commence one calendar day after the

additional tests have been completed).

Sec. 53.6 Right to witness conduct of tests.

(a) Submission of an application for a reference or equivalent

method determination shall constitute consent for the Administrator or

the Administrator's authorized representative, upon presentation of

appropriate credentials, to witness or observe any tests required by

this part in connection with the application or in connection with any

modification or intended modification of the method by the applicant.

(b) The applicant shall have the right to witness or observe any

test conducted by the Administrator in connection with the application

or in connection with any modification or intended modification of the

method by the applicant.

(c) Any tests by either party that are to be witnessed or observed

by the other party shall be conducted at a time and place mutually

agreeable to both parties.

Sec. 53.7 Testing of methods at the initiative of the Administrator.

(a) In the absence of an application for a reference or equivalent

method determination, the Administrator may conduct the tests required

by this part for such a determination, may compile such other

information as may be necessary in the judgment of the Administrator to

make such a determination, and on the basis of the tests and

information may determine that a method satisfies applicable

requirements of this part.

(b) In the absence of an application requesting the Administrator

to consider revising an appendix to part 50 of this chapter in

accordance with Sec. 53.16, the Administrator may conduct such tests

and compile such information as may be necessary in the Administrator's

judgment to make a determination under Sec. 53.16(d) and on the basis

of the tests and information make such a determination.

(c) If a method tested in accordance with this section is

designated as a reference or equivalent method in accordance with

Sec. 53.8 or is specified or designated as a reference method in

accordance with Sec. 53.16, any person or entity who offers the method

for sale as a reference or equivalent method thereafter shall assume

the rights and obligations of an applicant for purposes of this part,

with the exception of those pertaining to submission and processing of

applications.

Sec. 53.8 Designation of reference and equivalent methods.

(a) A candidate method determined by the Administrator to satisfy

the applicable requirements of this part shall be designated as a

reference method or equivalent method (as applicable), and a notice of

the designation shall be submitted for publication in the Federal

Register not later than 15 days after the determination is made.

(b) A notice indicating that the method has been determined to be a

reference method or an equivalent method shall be sent to the

applicant. This notice shall constitute proof of the determination

until a notice of designation is published in accordance with paragraph

(a) of this section.

(c) The Administrator will maintain a current list of methods

designated as reference or equivalent methods in accordance with this

part and will send a copy of the list to any person or group

[[Page 65800]]

upon request. A copy of the list will be available for inspection or

copying at EPA Regional Offices.

Sec. 53.9 Conditions of designation.

Designation of a candidate method as a reference method or

equivalent method shall be conditioned on the applicant's compliance

with the following requirements. Failure to comply with any of the

requirements shall constitute a ground for cancellation of the

designation in accordance with Sec. 53.11.

(a) Any method offered for sale as a reference or equivalent method

shall be accompanied by a copy of the manual referred to in

Sec. 53.4(b)(3) when delivered to any ultimate purchaser.

(b) Any method offered for sale as a reference or equivalent method

shall generate no unreasonable hazard to operators or to the

environment during normal use or when malfunctioning.

(c) Any analyzer, PM10 sampler, or PM2.5 sampler offered

for sale as a reference or equivalent method shall function within the

limits of the performance specifications referred to in Sec. 53.20(a),

Sec. 53.40(a), Sec. 53.50(a), or Sec. 53.60(a), as applicable, for at

least 1 year after delivery and acceptance when maintained and operated

in accordance with the manual referred to in Sec. 53.4(b)(3).

(d) Any analyzer, PM10 sampler or PM2.5 sampler offered

for sale as a reference or equivalent method shall bear a prominent,

permanently affixed label or sticker indicating that the analyzer or

sampler has been designated by EPA as a reference method or as an

equivalent method (as applicable) in accordance with this part and

displaying any designated method identification number that may be

assigned by the EPA.

(e) If an analyzer is offered for sale as a reference or equivalent

method and has one or more selectable ranges, the label or sticker

required by paragraph (d) of this section shall be placed in close

proximity to the range selector and shall indicate clearly which range

or ranges have been designated as parts of the reference or equivalent

method.

(f) An applicant who offers analyzers, PM10 samplers, or

PM2.5 samplers for sale as reference or equivalent methods shall

maintain an accurate and current list of the names and mailing

addresses of all ultimate purchasers of such analyzers or samplers. For

a period of 7 years after publication of the reference or equivalent

method designation applicable to such an analyzer or sampler, the

applicant shall notify all ultimate purchasers of the analyzer or

PM2.5 or PM10 sampler within 30 days if the designation has

been canceled in accordance with Sec. 53.11 or Sec. 53.16 or if

adjustment of the analyzer or sampler is necessary under Sec. 53.11(b).

(g) If an applicant modifies an analyzer, PM10 sampler, or

PM2.5 sampler that has been designated as a reference or

equivalent method, the applicant shall not sell the modified analyzer

or sampler as a reference or equivalent method nor attach a label or

sticker to the modified analyzer or sampler under paragraph (d) or (e)

of this section until the applicant has received notice under

Sec. 53.14(c) that the existing designation or a new designation will

apply to the modified analyzer, PM10 sampler, or PM2.5

sampler or has applied for and received notice under Sec. 53.8(b) of a

new reference or equivalent method determination for the modified

analyzer or sampler.

(h) An applicant who has offered PM2.5 samplers or analyzers

for sale as part of a reference or equivalent method may continue to do

so only so long as the reference or equivalent method meets the annual

requirements for network operating performance determined as set forth

in section 6 of Appendix A of part 58 of this chapter. In the event

that the annual network operating performance does not meet those

requirements, the EPA shall, within 90 days after the end of the

calendar year, notify the applicant of the unacceptable network

performance assessment and issue a preliminary finding and notification

of possible cancellation of the reference or equivalent method

designation under Sec. 53.11. (Net performance is generally assessed

for each calendar year, although when the number of samples for a

specific method is not great enough to determine precision with

adequate confidence, more than 1 calendar year of data may be

combined.)

(i) An applicant who has offered PM2.5 samplers or analyzers

for sale as part of a reference or equivalent method may continue to do

so only so long as the facility in which the samplers or analyzers are

manufactured continues to be an ISO-registered facility, as set forth

in subpart E of this part. In the event that the ISO registration for

the facility is withdrawn, suspended, or otherwise becomes

inapplicable, either permanently or for some specified time interval,

such that the facility is no longer an ISO-registered facility, the

applicant shall notify EPA within 30 days of the date the facility

becomes other than an ISO-registered facility, and upon such

notification, the EPA shall issue a preliminary finding and

notification of possible cancellation of the reference or equivalent

method designation under Sec. 53.11.

(j) An applicant who has offered PM2.5 samplers or analyzers

for sale as part of a reference or equivalent method may continue to do

so only so long as updates of the Product Manufacturing Checklist set

forth in subpart E of this part are submitted annually. In the event

that an annual Checklist update is not received by the EPA within 12

months of the date of the last such submitted Checklist or Checklist

update, the EPA shall notify the applicant within 30 days that the

Checklist update has not been received and shall, within 30 days from

the issuance of such notification, issue a preliminary finding and

notification of possible cancellation of the reference or equivalent

method designation under Sec. 53.11.

Sec. 53.10 Appeal from rejection of application.

Any applicant whose application for a reference or equivalent

method determination has been rejected may appeal the Administrator's

decision by taking one or more of the following actions:

(a) The applicant may submit new or additional information in

support of the application.

(b) The applicant may request that the Administrator reconsider the

data and information already submitted.

(c) The applicant may request that any test conducted by the

Administrator that was a material factor in the decision to reject the

application be repeated.

Sec. 53.11 Cancellation of reference or equivalent method designation.

(a) Preliminary finding. If the Administrator makes a preliminary

finding on the basis of any available information that a representative

sample of a method designated as a reference or equivalent method and

offered for sale as such does not fully satisfy the requirements of

this part or that there is any violation of the requirements set forth

in Sec. 53.9, the Administrator may initiate proceedings to cancel the

designation in accordance with the following procedures.

(b) Notification and opportunity to demonstrate or achieve

compliance.

(1) After making a preliminary finding in accordance with paragraph

(a) of this section, the Administrator will send notice of the

preliminary finding to the applicant, together with a statement of the

facts and reasons on which the preliminary finding is based, and will

publish notice of the preliminary finding in the Federal Register.

(2) The applicant will be afforded an opportunity to demonstrate or

to

[[Page 65801]]

achieve compliance with the requirements of this part within 60 days

after publication of notice in accordance with paragraph (b)(1) of this

section or within such further period as the Administrator may allow,

by demonstrating to the satisfaction of the Administrator that the

method in question satisfies the requirements of this part, by

commencing a program to make any adjustments that are necessary to

bring the method into compliance, or by taking such action as may be

necessary to cure any violation of the requirements of Sec. 53.9. If

adjustments are necessary to bring the method into compliance, all such

adjustments shall be made within a reasonable time as determined by the

Administrator. If the applicant demonstrates or achieves compliance in

accordance with this paragraph (b)(2), the Administrator will publish

notice of such demonstration or achievement in the Federal Register.

(c) Request for hearing. Within 60 days after publication of a

notice in accordance with paragraph (b)(1) of this section, the

applicant or any interested person may request a hearing as provided in

Sec. 53.12.

(d) Notice of cancellation. If, at the end of the period referred

to in paragraph (b)(2) of this section, the Administrator determines

that the reference or equivalent method designation should be canceled,

a notice of cancellation will be published in the Federal Register and

the designation will be deleted from the list maintained under

Sec. 53.8(c). If a hearing has been requested and granted in accordance

with Sec. 53.12, action under this paragraph (d) will be taken only

after completion of proceedings (including any administrative review)

conducted in accordance with Sec. 53.13 and only if the decision of the

Administrator reached in such proceedings is that the designation in

question should be canceled.

Sec. 53.12 Request for hearing on cancellation.

Within 60 days after publication of a notice in accordance with

Sec. 53.11(b)(1), the applicant or any interested person may request a

hearing on the Administrator's action. If, after reviewing the request

and supporting data, the Administrator finds that the request raises a

substantial issue of fact, a hearing will be granted in accordance with

Sec. 53.13 with respect to such issue. The request shall be in writing,

signed by an authorized representative of the applicant or interested

person, and shall include a statement specifying:

(a) Any objections to the Administrator's action; and

(b) Data or other information in support of such objections.

Sec. 53.13 Hearings.

(a)(1) After granting a request for a hearing under Sec. 53.12, the

Administrator will designate a presiding officer for the hearing.

(2) If a time and place for the hearing have not been fixed by the

Administrator, the hearing will be held as soon as practicable at a

time and place fixed by the presiding officer, except that the hearing

shall in no case be held sooner than 30 days after publication of a

notice of hearing in the Federal Register.

(3) For purposes of the hearing, the parties shall include the

Environmental Protection Agency, the applicant or interested person(s)

who requested the hearing, and any person permitted to intervene in

accordance with paragraph (c) of this section.

(4) The Deputy General Counsel or the Deputy General Counsel's

representative will represent the Environmental Protection Agency in

any hearing under this section.

(5) Each party other than the Environmental Protection Agency may

be represented by counsel or by any other duly authorized

representative.

(b)(1) Upon appointment, the presiding officer will establish a

hearing file. The file shall contain copies of the notices issued by

the Administrator pursuant to Sec. 53.11(b)(1), together with any

accompanying material, the request for a hearing and supporting data

submitted therewith, the notice of hearing published in accordance with

paragraph (a)(2) of this section, and correspondence and other material

data relevant to the hearing.

(2) The hearing file shall be available for inspection by the

parties or their representatives at the office of the presiding

officer, except to the extent that it contains information identified

in accordance with Sec. 53.15.

(c) The presiding officer may permit any interested person to

intervene in the hearing upon such a showing of interest as the

presiding officer may require; provided that permission to intervene

may be denied in the interest of expediting the hearing where it

appears that the interests of the person seeking to intervene will be

adequately represented by another party (or by other parties),

including the Environmental Protection Agency.

(d)(1) The presiding officer, upon the request of any party or at

the officer's discretion, may arrange for a prehearing conference at a

time and place specified by the officer to consider the following:

(i) Simplification of the issues.

(ii) Stipulations, admissions of fact, and the introduction of

documents.

(iii) Limitation of the number of expert witnesses.

(iv) Possibility of agreement on disposing of all or any of the

issues in dispute.

(v) Such other matters as may aid in the disposition of the

hearing, including such additional tests as may be agreed upon by the

parties.

(2) The results of the conference shall be reduced to writing by

the presiding officer and made part of the record.

(e)(1) Hearings shall be conducted by the presiding officer in an

informal but orderly and expeditious manner. The parties may offer oral

or written evidence, subject to exclusion by the presiding officer of

irrelevant, immaterial, or repetitious evidence.

(2) Witnesses shall be placed under oath.

(3) Any witness may be examined or cross-examined by the presiding

officer, the parties, or their representatives. The presiding officer

may, at his discretion, limit cross-examination to relevant and

material issues.

(4) Hearings shall be reported verbatim. Copies of transcripts of

proceedings may be purchased from the reporter.

(5) All written statements, charts, tabulations, and data offered

in evidence at the hearing shall, upon a showing satisfactory to the

presiding officer of their authenticity, relevancy, and materiality, be

received in evidence and shall constitute part of the record.

(6) Oral argument shall be permitted. The presiding officer may

limit oral presentations to relevant and material issues and designate

the amount of time allowed for oral argument.

(f)(1) The presiding officer shall make an initial decision which

shall include written findings and conclusions and the reasons therefor

on all the material issues of fact, law, or discretion presented on the

record. The findings, conclusions, and written decision shall be

provided to the parties and made part of the record. The initial

decision shall become the decision of the Administrator without further

proceedings unless there is an appeal to, or review on motion of, the

Administrator within 30 calendar days after the initial decision is

filed.

(2) On appeal from or review of the initial decision, the

Administrator will have all the powers consistent with making the

initial decision, including the discretion to require or allow briefs,

oral argument, the taking of additional evidence or the remanding to

the presiding officer for additional proceedings. The decision by the

[[Page 65802]]

Administrator will include written findings and conclusions and the

reasons or basis therefor on all the material issues of fact, law, or

discretion presented on the appeal or considered in the review.

Sec. 53.14 Modification of a reference or equivalent method.

(a) An applicant who offers a method for sale as a reference or

equivalent method shall report to the Administrator prior to

implementation any intended modification of the method, including but

not limited to modifications of design or construction or of

operational and maintenance procedures specified in the operation

manual [see Sec. 53.9(g)]. The report shall be signed by an authorized

representative of the applicant, marked in accordance with Sec. 53.15

(if applicable), and addressed as specified in Sec. 53.4(a).

(b) A report submitted under paragraph (a) of this section shall

include:

(1) A description, in s

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