[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63185-63193]
[FR Doc No: 2013-24852]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2012-0072; FRL-9901-86-OSWER]

Waste Management System; Testing and Monitoring Activities;
Update V of SW-846

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
providing notice of the availability of ``Update V'' to the Third
Edition of EPA publication SW-846, ``Test Methods for Evaluating Solid
Waste, Physical/Chemical Methods.'' Update V contains 23 new and
revised analytical methods that the Agency has evaluated, and
determined to be appropriate and which may be used for monitoring or
complying with the Resource Conservation and Recovery Act (RCRA)
hazardous and non-hazardous waste regulations. Because the analytical
methods contained in Update V are not required by the RCRA hazardous
waste regulations, EPA is issuing this update as guidance. In addition,
the Agency is also taking comment on revisions to Chapters One through
Five of EPA publication SW-846, an ORCR Policy Statement, and other
guidance. The Agency is seeking public comment on Update V, and after
consideration of the public comments, will place these new and revised
methods, guidance, and chapters in the SW-846 methods compendium.

DATES: Comments must be received on or before January 21, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2012-0072, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>Attention Docket ID No. EPA-
HQ-RCRA-2012-0072.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-RCRA-2012-0072.
     Mail: Send comments to: OSWER Docket, EPA Docket Center,
Mail Code 28221T, Environmental Protection Agency, 1200 Pennsylvania
Avenue NW., Washington, DC 20460, Attention Docket ID No. EPA-HQ-RCRA-
2012-0072. Please include two copies of your comments.
     Hand Delivery: Deliver two copies of your comments to:
Environmental Protection Agency, EPA Docket Center,

Room 3334, 1301 Constitution Avenue NW., Washington DC, Attention
Docket ID No. EPA-HQ-RCRA-2012-0072. Such deliveries are only accepted
during the docket's normal hours of operation and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to EPA-HQ-RCRA-2012-0072. EPA's
policy is that all comments received will be included in the public
docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the OSWER Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OSWER
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kim Kirkland, Materials Recovery and
Waste Management Division, Office of Resource Conservation and
Recovery, Office of Solid Waste and Emergency Response (5304P),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 703-
308-0522; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This notice is directed to the public in general. It may, however,
be of particular interest to you if you conduct waste sampling and
analysis for RCRA-related activities. This might include any entity
that generates, treats, stores, or disposes of hazardous or
nonhazardous solid waste and is subject to RCRA subtitle C or D
sampling and analysis requirements, and might also include any
laboratory that conducts waste sampling and analyses for such entities.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information on a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
the procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

C. How can I get copies of Update V and the Third Edition of SW-846 as
amended by its Final Updates?

    Update V is available in the RCRA docket and the final version will
be available on-line after all comments have been addressed. The Third
Edition of SW-846, as amended by Final Updates I, II, IIA, IIB, III,
IIIA, IIIB, IVA, and IVB, is available in portable document format
(PDF) on EPA's Office of Resource Conservation and Recovery (ORCR) Web
page at: http://www.epa.gov/SW-846.

D. How is the rest of this notice organized?

    The rest of this Notice includes the following sections:
    II. What is the subject and purpose of this notice?
    III. Why is the Agency releasing Update V to SW-846?
    IV. What does Update V contain?
    A. OSWER/ORCR Policy Statement
    B. Changes to QA/QC Guidance
    V. Summary

II. What is the subject and purpose of this notice?

    The Agency is announcing the availability of and inviting public
comment on Update V to ``Test Methods for Evaluating Solid Waste,
Physical/Chemical Methods'', EPA Publication SW-846. Update V of SW-846
contains analytical methods that the Agency has evaluated, and/or
revised and determined to be appropriate and may be used for monitoring
or complying with the RCRA hazardous waste regulations. Because the
analytical methods contained in Update V are not required by the RCRA
hazardous waste regulations, EPA is issuing this update as guidance.
This guidance does not add or change the RCRA regulations, and does not
have any impact on existing rulemakings associated with the RCRA

program. To date, the Agency has finalized Updates I, II, IIA, IIB,
III, IIIA, IIIB, IVA, and IVB to the SW-846 manual, which can be found
on the EPA's ORCR Web page at: http://www.epa.gov/SW-846.

III. Why is the Agency releasing Update V to SW-846?

    The Agency revises the content of SW-846 over time as new
information and data become available. We continually review advances
in analytical instrumentation and techniques and periodically
incorporate such advances into SW-846 as method updates by adding new
methods to the manual, and replacing existing methods with revised
versions of the same method. These updates improve analytical method
performance and cost effectiveness. Since the publication of the
Methods Innovation Rule (MIR) (70 FR 34537, June 14, 2005), the Agency
no longer needs to use a rulemaking process for publication of an
update to SW-846, as long as the update does not contain a method
required by the RCRA regulations (e.g., Method-Defined Parameter (MDP),
such as the Toxicity Characteristic Leaching Procedure (TCLP) (Method
1311)), see 40 CFR 260.11. The Agency instead can make an SW-846 update
available to the public more efficiently through a Federal Register
notice announcing its availability and inviting public comment on the
update.
    In addition, the MIR allows flexibility in method selection and use
for meeting the analytical needs of the RCRA program, with the
exception of those methods specifically required by the RCRA
regulations. This approach is consistent with the Agency's commitment
to fully implement a performance-based measurement system (PBMS),
whereby the analytical focus is on measurement objectives and
performance rather than specific measurement technologies. Furthermore,
the Agency's PBMS approach has evolved resulting in the Agency adopting
the new ``Flexible Approaches to Environmental Measurement--The
Evolution of the Performance Approach'' as developed by the Forum on
Environmental Measurements (FEM) at the direction of EPA's Science
Policy Council (i.e., now the Science and Technology Policy Council
(STPC)). One of the main goals of the Performance Approach is to
increase flexibility in choosing sampling and analytical approaches to
meet regulatory requirements for measurements. For more information on
the Performance Approach, see: http://www.epa.gov/fem/approach.htm.
    In using the SW-846 methods, the regulated entity need only
demonstrate that an analytical method generates data that meet the
project-specific data quality objectives (DQOs) and performance
acceptance criteria. The Agency finds this flexible approach to be
particularly useful, and sufficient in most cases, during the
characterization of the complex matrices of RCRA-related wastes. Thus,
a method user can modify an SW-846 method (provided it is not one
specifically required by regulation, e.g., 40 CFR 260.11), in order to
best meet a waste matrix-specific analytical need, as long as the
modifications meet the project-specific DQOs and performance acceptance
criteria. The public should note that in some cases the method
established certain requirements (e.g., conducting a calibration curve,
using specific reagents, analyzing a Quality Control (QC) check sample
to demonstrate precision and accuracy). While these standard principles
are not regulatory requirements, they are necessary to yield data of
acceptable quality as intended and are called for by sound science.
(The public can obtain more information about the MIR and PBMS at the
Agency's Web site dedicated to SW-846 and the testing of RCRA-regulated
wastes: http://www.epa.gov/SW-846.)
    The subject of today's notice, Update V to SW-846, contains 23 new
and revised analytical methods and revises Chapters One through Five of
SW-846. After the comment period, and based on the Agency's evaluation
of the comments received, the new and revised methods and revised
chapters will be formally included in the SW-846 methods compendium.
Most of the Update V methods previously resided under the heading ``New
Methods'' at EPA's SW-846 Web site as either revised versions of
existing SW-846 methods or as new methods that the Agency planned to
add to SW-846. Although these methods were not yet part of an official
update to any edition of the SW-846 manual at the time of their posting
on the Web site, the Agency wanted to make these Agency-evaluated
methods available for use and comment as soon as possible. The Agency
believed that public access to these new and revised methods, for
guidance purposes, would assure that reliable and innovative methods
are provided to the regulated community in a timely and cost-effective
manner. Therefore, these methods could be used for any RCRA
applications, other than one specifically required by regulation, for
which their performance could be demonstrated to be appropriate and
meet project-specific DQOs, and thus be consistent with implementation
and promotion of a flexible and performance-based approach to RCRA-
related analyses.
    The Agency is also responding to concerns expressed by the
Environmental Laboratory Advisory Board (ELAB), a Federal Advisory
Committee Act (FACA) committee that advises the Agency on measurement,
monitoring, and laboratory science issues, who contacted EPA's FEM with
several issues regarding the use of SW-846. The ELAB specifically
contacted EPA regarding which version of a revised method is
recommended. Historically, as noted above, the Agency has posted new
and revised methods on the SW-846 Web site under the ``New Test Methods
Online'' (at: http://www.epa.gov/epawaste/hazard/testmethods/sw846/new_meth.htm), for use by the laboratory community, the States, and
the regulated community pending publication of these methods in the
Federal Register. The Agency was subsequently contacted by the ELAB,
who identified several concerns regarding the process for updating and
posting updates on the ``New Test Methods Online'' link on the SW-846
Web site.
    ELAB requested that EPA clarify those issues that caused some
confusion with some entities of the user community. Specifically,
confusion existed when a method had multiple versions available on the
web. For example, Method 8000C, on the ''New Test Methods Online'' link
has quality control (QC) guidelines that differ from Method 8000B (the
official version) in the SW-846 compendium. The public was confused by
the difference in QC guidelines in the two available versions of the
method. The Agency subsequently decided that the revisions to Method
8000C were more significant than those previously posted, and has
decided to replace Method 8000C with Method 8000D, and is issuing
Method 8000D as part of Update V.
    In response to ELAB's concerns, ORCR prepared a Policy Statement
that identifies the status of methods (e.g., validated methods, final
methods, etc.), and provides the rationale for identifying when changes
to methods are significant, through a letter designation and by noting
the date the method was revised by ORCR. For more information on the
ORCR Policy Statement, see section IV of this Notice.
    Finally, the Agency is requesting public comment on the Update V
methods and the other relevant updated materials presented in this
Notice for

inclusion in the SW-846 manual (i.e., Table of Contents and Chapters
One through Five). See the ADDRESSES section of this notice for the
procedure for submitting comments. The Agency will consider public
comments submitted on or before the comment period deadline and
subsequently finalize Update V as an official part of SW-846. In
addition, the EPA SW-846 Web site contains an updated version of the
``Method Status Table for SW-846,'' which identifies the update history
for each document in SW-846.
    The Agency strongly recommends the use of the latest version of an
SW-846 method, especially for new analyte monitoring situations. The
Agency, however, is not imposing restrictions on the use of earlier
versions of non-required SW-846 methods or precluding the use of
previous guidance, if such use is appropriate. For example, earlier
versions of an SW-846 method may be more appropriate for regulatory
purposes (e.g., for compliance with an existing permit or consent
decree), or when new method versions may be more costly than necessary
for meeting project-specific objectives. In the future, the Agency
plans to make electronic copies of earlier versions of SW-846 methods
available through a separate hyperlink from the SW-846 Web site.
    The Agency hopes that the posting of this information on the Web
site for immediate public access will mitigate any remaining confusion
regarding the use of SW-846 methods. In addition, the public can also
access the Methods Information Communication Exchange (MICE) for
answers to their questions or concerns regarding SW-846 methods. MICE
can be accessed by phone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>,
or by email at<EMAIL_ADDRESS>
IV. What does Update V contain?

    Update V contains 23 new and revised analytical methods, revised
versions of Chapters One through Five of EPA publication SW-846, the
ORCR Policy Statement, and other guidance (e.g., quality assurance/
quality control (QA/QC) guidance on lower limit of quantitation (LLOQ),
relative standard error (RSE), initial demonstration of proficiency
(IDP), etc.), each dated October 2012 and identified as ``Update V'' in
the document footer. For the convenience of the reader, EPA has
identified key areas of interest in the sections below, but all the
methods and other information for which the Agency is seeking comments
are contained in the docket for this Notice. Table 1 (included at the
end of this Notice) provides a listing of the five revised chapters and
twenty-three methods (eight new and fifteen revised methods) in Update
V. After consideration of comments received from publication of this
Notice, Update V, including the revised versions of Chapters One
through Five, will be incorporated into the SW-846 methods compendium.

A. OSWER/ORCR Policy Statement

    In 2008, ELAB requested that ORCR describe their plan for releasing
Updates to SW-846, as well as clarify the status of deleted, obsolete,
previous versions or revised methods, and a statement regarding the
status of previous versions of methods. In addition, ELAB raised the
following additional concerns and suggestions:
     Clarification is needed regarding which method is the
final version in SW-846.
     Many states are not adopting the final version of new
methods.
     States may not have the resources to certify multiple
versions of final methods.
     Some of the regulated community doesn't know how the
method revision varied.
    EPA has engaged in several face-to-face meetings with the ELAB at
national conferences to address their requests and resolve their
concerns and suggestions. As a result of those meetings, ORCR developed
a policy statement intended to clarify the basic terminology used in
SW-846 regarding the status of methods and how the SW-846 Methods
program develops and releases methods to the public. That policy
statement, entitled ``USEPA Office of Resource Conservation and
Recovery Policy on the Use of Test Methods for Evaluating Solid Waste,
Physical/Chemical Methods (SW-846)'' provides background on SW-846,
general guidance on the procedures for adopting methods into SW-846,
and defines key terms used to identify the status of methods in SW-846.
Below is the ORCR Policy Statement, a copy of which has also been
placed in the docket associated with this Federal Register Notice:
USEPA Office of Solid Waste and Emergency Response/Office of Resource
Conservation and Recovery Policy on the Use of ``Test Methods for
Evaluating Solid Waste, Physical/Chemical Methods'' (SW-846)
    The United States Environmental Protection Agency's (EPA) Office of
Resource Conservation and Recovery (ORCR) provides analytical and
sampling methods to assist the regulated and regulatory community and
others in implementing the Resource Conservation and Recovery Act
(RCRA). These methods are published in the Test Methods for Evaluating
Solid Waste, Physical/Chemical Methods (SW-846) and are available on
the ORCR Web site (www.epa.gov./epawaste/hazard/testmethods/index.htm).
With the exception of those particular methods which are promulgated in
the regulations to implement RCRA (see 40 CFR 260.11), the remaining
methods are considered guidance, and users may select any
scientifically appropriate method when conducting analyses to comply
with the RCRA regulatory program.
    The Methods Innovation Rule (MIR) published on June 14, 2005 (70 FR
34538), reemphasized the flexible approach in method selection, when
appropriate, when testing for compliance, under RCRA. Since the
publication of this rule, ORCR no longer uses a formal rulemaking
process for publication of method updates to SW-846. EPA informs the
regulated and regulatory community of new methods and updates to SW-846
and solicits comments on them through a Notice of Availability
published in the Federal Register. This approach is consistent with
ORCR's commitment to fully implement the Agency's performance-based
measurement system (PBMS) approach to regulation.
    A new effort was developed and approved to reinvigorate the goals
of PBMS with the versatility of each of our program's needs. It is
called the Flexible Approaches to Environmental Measurements--The
Evolution of the Performance Approach which the Science and Technology
Policy Council (STPC) approved on February 15, 2008. In 2009, ORCR
subsequently adopted the new ``Performance Approach'' as defined by the
Forum on Environmental Measurements (FEM). The FEM is a standing
committee of senior EPA Environmental Protection managers established
to develop policies to guide the Agency's measurement community in:
validating and disseminating methods for sample collection and
analysis; for ensuring that monitoring studies are scientifically
rigorous, statistically sound, and yield representative measurements;
and for employing a quality systems approach that ensures that the data
gathered and used by the Agency are of known and documented quality.
    After shortening the name of the PBMS effort to the ``Performance
Approach,'' the FEM's Performance Approach Action Team took a look at
the issues surrounding the lack of the program's progress with the
ultimate conclusion that the ``one size fits all''

approach does not work for the diversely different programs and
authorities each of our major program offices (i.e., air, pesticides,
waste, and water) has in carrying out their work. To avoid the
proliferation of terminology, ORCR has adopted the ``Flexible
Approach'' which is consistent with ORCR's approach to environmental
management, based on the goals and statutes of EPA program offices.
    Under the PBMS approach for RCRA, when labs conducted regulatory
required monitoring, the regulated community had to either employ a
scientifically appropriate method published in SW-846 or use any other
scientifically appropriate method from another reliable source. This is
still true under the Flexible Approach. However, when choosing a
reliable alternative source, the focus should be on measurement
objectives, rather than on measurement technologies. In all cases, the
user must demonstrate the method selected generates data that are
appropriate for the intended use. Although both approaches are
applicable for RCRA, ORCR had dropped the term PBMS, and strongly
supports the use of the new Flexible Approach to be consistent with the
Agency's new guidance that allows each program to determine program
specific flexibility when addressing waste analysis issues.
    ORCR strongly recommends that persons use the latest version of a
SW-846 method whenever possible, especially in new monitoring
situations, since updated versions of the methods EPA publishes
generally are in the Agency's view less subject to misinterpretation,
yield improved precision and/or bias, or provide for the use of newer
and, often, more cost-effective technologies. In situations where it
may not be appropriate to use the latest method in SW-846, earlier
versions may be used. These situations may include, but are not limited
to, those where an earlier version of a method is required for existing
permits, consent decrees, waste analysis plans or sampling analysis
plans. In addition, laboratories, especially small laboratories, may
find a previous version of a SW-846 method appropriate if it is more
cost-effective in meeting the project-specific objectives. The Agency
is not imposing restrictions on the use of earlier versions of non-
required methods contained in SW-846 or precluding the use of previous
guidance. Nonetheless, the adoption of the latest method version is
recommended and should be accomplished as soon as possible, as
appropriate. When methods are employed, it is the responsibility of the
user to ensure that the method yields data of a quality appropriate for
the particular application for which it is being used.
    EPA views the methods in the SW-846 compendium as tools for the
user to employ in developing individual standard operating procedures
to meet the goals and objectives of specific projects. This approach
enables the user to optimize and modify methods for effective
performance on unique projects. The SW-846 methods are for most
applications considered as guidance with the exception of those methods
required by the RCRA regulations (i.e., Method-Defined Parameters
(MDPs), see 40 CFR 260.11).
    In situations where the user is not certain whether the selected
method or method modification is appropriate, EPA recommends regulated
entities contact and seek approval as needed from the appropriate
regulatory agency (e.g., Federal or State/local government) before
applying any method on a specific project, including situations where
the method is used verbatim.
    EPA may publish new methods, revise existing methods, or withdraw
methods from the SW-846 compendium whenever it deems it appropriate.
For example, methods may be updated in order to reflect new
advancements in technology, to reflect the addition of new performance
data, or to clarify areas of the procedure that experience indicates
may be misunderstood. Methods may also be revised to reflect new EPA
policy regarding the use of certain chemicals and reagents. In other
cases, methods are removed if the technology is no longer available or
applicable. ORCR has developed specific procedures for releasing
updates, revisions, or withdrawing methods, which are designed to
minimize disruption to regulatory processes. Specific definitions for
the terms associated with a method's status, which support the change
procedures, have been developed and provided below.
    The Agency will only post the most recent version of a final SW-846
method on the ORCR Web page as part of the SW-846 methods compendium
(www.epa.gov./epawaste/hazard/testmethods/index.htm). Prior versions of
methods formerly contained in SW-846 and still considered appropriate
for use will be available through a separate hyperlink in the future.
EPA's objective is to identify and make available on the Agency's SW-
846 Web site the latest information regarding the methodologies that
generate effective data at minimum costs in response to new
technological or scientific advancements, while, at the same time,
making available earlier versions for those situations where such
methods may be needed or appropriate (e.g., to determine how a
particular analysis had been performed, to determine how to comply with
a specific permit requirement, etc.).
SW-846 Methods Status Definitions
    Analytical methods are officially made a part of the SW-846 manual
through a rigorous process of technical evaluation both within the
Agency and through external review. Methods are also revised as needed
after a formal evaluation process by analytical experts (e.g., SW-846
work and focus groups) and an announcement of method availability and
request for public comment in the Federal Register as a Notice of
Availability. During the method development/evaluation process, the
methods go through various stages of review and revision. The methods
are officially included as part of an update to the most current
edition of SW-846 at the conclusion of this process.
    ORCR employs a specific naming convention (i.e., method number and
letter suffix) when publishing methods. The naming convention is
intended to minimize confusion within the user community regarding a
method's developmental status. The method number designates the
underlying technology (e.g., 8000 series methods designate
determinative procedures for organic compounds). A revision to a method
where the underlying technology does not change is indicated by
continued use of the same method number and letter, but with a new
issuance date. If the revision retains the underlying technology, but
does not affect the precision and/or accuracy of the data, the revision
is considered to be minor or nonsignificant and the method number and
letter is not changed or sequenced.
    If, on the other hand, the revision retains the underlying
technology, but changes the precision and/or accuracy of the data, the
change is considered to be significant and is indicated by a subsequent
letter suffix (e.g., changes from 8270C to 8270D) and a new issuance
date. For example, if the quality control recommendations are changed
in a manner that improves the bias or precision of the method, but does
not change the underlying technology (e.g., a tightening of the
calibration acceptance criteria), the method number stays the same, but
the letter suffix is sequenced to the next letter. The differences
between the

earlier and later versions of a method are detailed in the method
summary section of the revised version regardless of the type of
change.
    Examples of changes that may be considered minor or nonsignificant
include, but are not limited to: Language added to a method to provide
increased clarity or guidance; expansion of lists of acceptable
instrumentation, applicability of the method to a matrix not previously
referenced, adding new compounds to the list of applicable compounds,
or changes to instrument specifications which do not result in an
existing acceptable instrument being rendered unacceptable; or
formatting and editorial changes that are designed to improve
readability or correct spelling or grammatical errors.
    ORCR has defined a ``significant change'' as a change that results
in improved analytical results (e.g., changes that result in reducing
analytical bias or improving data precision). Examples of significant
changes may include, but are not limited to: a change in the operating
parameter which reduces analytical flexibility; a change in
instrumentation specification which minimizes interference and/or
optimizes instrument performance (if the use of such interference
reduction technique or performance enhancement is required); a change
in calibration guidance which results in more restrictive
recommendations; a change that institutes tighter QC recommendations;
or a change in the reagents that are required by the method.
    ORCR understands revisions are sometimes necessary to either
enhance the performance of the method or to allow flexibilities due to
the complexity of sample matrices. In situations where the user is not
certain whether the selected method, method modification or
modification to their plan is appropriate, EPA recommends the regulated
community seek approval from the appropriate regulatory agency (e.g.,
Federal or State/local government, client) before their use of a
revised method; amend their plan (e.g., Project Plan, Quality Assurance
Project Plan (QAPP), Sampling and Analysis Plan (SAP), Standard
Operating Procedure (SOP)); and properly document the change when
reporting analytical results.
    The following method status definitions reflect the current method
development process and have been developed to add clarity for the
method users. ORCR uses these definitions and the terms may vary for
other program offices.
    Final Method--A method that has been formally adopted into the most
recent version of the SW-846 compendium. Before a method becomes final,
the validated version would have been made available for public review
and comment in a Notice of Availability (NOA) or a proposed rulemaking,
as appropriate.
    Validated Method--A method that has undergone development and
technical review by EPA, but has not been formally adopted into the SW-
846 method compendium and published through a Federal Register Notice.
Since this review includes technical work group approval and/or inter-
laboratory validation, validated methods are included on the Agency Web
site for evaluation and use by the public and as a means of soliciting
comment from the broader scientific community. The public may use a
validated method prior to its inclusion in the SW-846 compendium,
provided that the users demonstrate that it generates data that are
appropriate for the intended use.
    Revised Method--A method included in SW-846 that has been updated
to reflect changes that may be editorial in nature and do not impact
data or performance comparability, that broaden the method to introduce
new technologies that may increase productivity, but do not change the
fundamental technology, or that change the quality control requirements
to increase bias or precision.
    The number of a method that has been revised does not change, but
the method may receive a subsequent letter suffix. If the revision is a
significant one (as defined above) then both the letter suffix and the
issuance date are updated. If, on the other hand, the revision is
editorial in nature, or consists of the addition of new performance
data, then only the issuance date is changed. Previous versions are not
precluded from being used provided that the users demonstrate that it
generates data that are appropriate for the intended use.
    Draft Method--A new method that is being evaluated for possible
inclusion into SW-846. It represents the latest innovative
technological advancements in scientific methodology, but has not
completed technical review by EPA nor been subject to notice and
comment in the Federal Register.
    Superseded Method--A superseded method is an earlier version of an
SW-846 method or other guidance that is no longer included in the SW-
846 compendium and has been replaced by a newer version. Revised
versions of Superseded methods should be viewed as the preferred
method. Methods in this category are removed from the compendium, but
remain available on line and are not precluded for use where required
for existing projects or where an adequate justification for use
exists. The term ``Superseded'' is documented in the method title as
listed on the EPA Web site for prior versions of final methods followed
by the date it was superseded.
    Withdrawn Method--A method or other guidance that EPA strongly
recommends not be used, (e.g., cyanide and sulfide reactivity guidance
withdrawn, June 14, 2005). EPA has determined that such procedures or
methods, for the use or technical objectives for which they were
originally published, are technically inadequate and/or no longer meet
such use or technical objectives. This does not mean, however, that
there would be no situations under which the procedures or methods may
be appropriate. In any situation in which a person may believe that the
withdrawn method is appropriate, we strongly encourage consultation
with applicable regulatory agencies at the state or federal level. The
prospective user of the method will need to demonstrate the old method
is, indeed, appropriate. Any use of these methods, without any such
consultation and demonstration, will be done at the user's risk.
    The Agency understands that earlier versions of the SW-846 methods
that aren't required may still be in use to meet project specific
criteria (e.g., permits, sampling plans, Consent Decrees, etc.).
Permits and other plans formally approved by regulatory authorities
that specify the use of particular methods for required analysis
continue in effect unless they are changed. However, the Agency
encourages the regulated community to use the latest version of SW-846,
when applicable. EPA will continue to update the Methods Status Table
to inform the public as to the status of methods in SW-846 and the
Policy Statement will be added to the SW-846 methods compendium when
the Update V package is finalized.
    [end of policy statement]

B. Changes to Chapters One Through Five and QA/QC Guidance (Chapter One
and Individual Methods) in SW-846

    In general, EPA's revisions to Chapters One through Five to EPA
publication SW-846 reflects the new method style guide format and added
all the Update V methods and new letters/version to the appropriate
related method sections. Specifically:

     Chapter One of SW-846 was revised to make it more user
friendly and to be more consistent with the Agency's official guidance
on QA/QC implementation and procedures (e.g., Quality Assurance Project
Plans (QAPPS), Data Quality Objectives (DQOs), and the Flexible
Approach to Environmental Measurement).
     Chapter Two now includes a Table of Contents to make
finding the information easier. In addition, a typographical error was
found for bis(2-chloroisopropyl) ether and was corrected to bis(2-
chloro-1-methylethyl) ether in Tables 2-1, 2-4, 2-15, 2-22, and 2-34.
Furthermore, Table 2-40(A) was revised to reflect the current sample
preservation guidance for styrene and vinyl chloride in aqueous samples
(i.e., deletion of previously recommended practice of collecting a
second set of samples without acid preservatives and analyze
immediately, if styrene and vinyl chloride are analytes of interest)
and Table 2-40(B) was revised to include Mercury Speciation hold times
in addition to totals.
     Chapter Three was revised so that the definition for
instrument detection limit (IDL) is consistent with the revised methods
6010D and 6020B. In addition, the term ``accuracy'' was replaced by
``bias'' where appropriate; the definition for linear range was revised
to be consistent with methods 6010D and 6020B; the definition of
interference check sample (ICS) was replaced with the spectral
interference check (SIC) solution to be consistent with methods 6010D
and 6020B; and the definition of ``laboratory control sample'' was
revised to recommend the use of a spiking solution from the same source
as the calibration standards. Also, the collision/reaction cell
technology was added to Sections 3.6 and 3.7 as an effective method for
removing isobaric interferences when analyzing by ICP-MS and a minimum
collection mass of 100 g was added to Table 3-2 for solid samples
collected for sulfide analysis.
     Chapter Four (see Table 4-1) was reformatted and updated
by removing the recommendation to collect a second set of samples
without adding an acid preservative and analyze in a shorter time frame
if vinyl chloride and styrene are analytes of concern for aqueous
samples.
     Chapter 5 had no significant changes outside of general
ones specified above (e.g., updated format changes and method reference
to chapters).
    In addition, EPA is incorporating three new and revised QC features
in Chapter One and the Update V methods, where appropriate, for RCRA
compliance monitoring which warrant further discussion here. A summary
of changes to chapters in SW-846 are provided in Appendix A of each
chapter.
    The new and revised features that have been added to Chapter One
(Quality Control) and individual methods (where appropriate) are:
     Lower Limit of Quantitation (LLOQ)--References to the
Method Detection Limit (MDL) have been replaced with the LLOQ. It is
recommended to establish the LLOQ as the lowest point of quantitation,
which, in most cases, is the concentration of the lowest calibration
standard in the calibration curve that has been adjusted for the
preparation mass and/or volume. The LLOQ value is a function of both
the analytical method and the sample being evaluated.
Why is MDL removed and replaced by LLOQ for SW-846?
    ORCR has removed references to the MDL procedure (i.e., 40 CFR 136,
Appendix B) beginning with Update IV and from the revised and new
Update V methods and has recommended establishing the LLOQ. We continue
to refine the procedure for establishing the LLOQ. The refined
procedure considers sample matrix effects; provides a provision to
verify the reasonableness of the reported quantitation limit (QL); and
recommends a frequency of LLOQ verification (found in Chapter One and
each method) to be balanced between rigor and practicality. (Note: The
agency understands that previous versions of methods published in SW-
846 may contain the MDL reference. However, as methods are updated, EPA
will remove the reference to the MDL, and will remove the reference in
older methods that have not yet been updated, as time and resources
allow. Therefore, ORCR recommends that LLOQ be used, as appropriate,
for the methods that have not yet been updated. See the Section 9.8 in
Method 6020B for inorganic analytes and Section 9.7 in Method 8000 for
organic analytes on LLOQ for further information on implementation.)
    ORCR understands that other EPA programs may continue to use MDLs
to meet their program use and needs (e.g., the National Pollutant
Discharge Elimination System (NPDES) permit program). However, ORCR has
found that the procedure in 40 CFR 136, Appendix B, for the
determination of MDLs, developed for the Clean Water Act (CWA) program
uses a clean matrix (e.g., reagent water for preparing ``spiked''
samples, or samples with known constituent concentrations). Analytical
laboratories often have difficulty demonstrating they can meet the MDL
established using Part 136 when evaluating complex matrices, such as
wastes. The procedure outlined in Part 136 is generally not suitable
for RCRA wastes or materials because the MDL approach generally yields
unrealistic and/or unachievable method detection limits for the complex
matrices (e.g., soils, sludges, wipes, and spent materials) encountered
under the RCRA program. The MDLs are normally calculated from analysis
of a sample that does not cause matrix interferences (typically
determined using spiked reagent water). However, most wastes evaluated
for compliance with RCRA consist of complex matrices. The LLOQ
considers the effect of sample matrix (e.g., components of a sample
other than the analyte) by taking the sample through the entire
analytical process, including sample preparation, clean up (to remove
sample interferences), and determinative procedures. Also, if method
users choose, the LLOQ sample can be included at the end of the run to
see if it meets the established acceptance criteria. Lastly, results
above the LLOQ are quantifiable within an acceptable precision and
bias. Thus, the LLOQ approach better suits the needs of the RCRA
program, because it provides reliable and defensible results,
especially at the lower level of quantitation, and can be reported with
a known level of confidence for the complex matrices being evaluated.
    SW-846 methods are being used by various programs in implementing
various statutes, including RCRA, the Comprehensive Environmental
Response, Compensation and Liability Act (CERCLA), the Toxic Substances
Control Act (TSCA), and Homeland Security Presidential Directives, for
waste and materials characterization, compliance testing, site/incident
characterization and risk assessment for protection of human health and
the environment, and better management and use of wastes and materials,
for a wide range of difficult matrices. ORCR believes that the LLOQ
approach is an important improvement, and supports the essential need
to provide data that are verified to meet the precision and accuracy
requirements of the Agency's program needs.
    Establishing LLOQ for Inorganic analytes: When performing methods
for inorganic analyses, the LLOQ should be verified by the analysis of
at least seven replicate samples (prepared in a clean matrix or control
material) and spiked at the LLOQ and processed through all preparation
and analysis steps of the method. The mean recovery and relative
standard deviation (RSD) of these

samples provide an initial statement of precision and bias at the LLOQ.
In most cases, the mean recovery should be 35% of the true
value and the RSD should be <=20%. Ongoing LLOQ verification, at a
minimum, is on a quarterly basis to validate quantitation capability at
low analyte concentration levels. This verification may be accomplished
either with clean control material (e.g., reagent water, method blanks,
Ottawa sand, diatomaceous earth, etc.) or a representative sample
matrix free of target compounds. Optimally, the LLOQ should be less
than the desired regulatory action levels based on the stated project-
specific requirements. For more information, please see the individual
methods (e.g., Methods 6010 and 6020) and Chapter One of SW-846.
    Establishing LLOQ for organic analytes: When performing methods for
organic analyses, the LLOQ should be verified using either a clean
control material (e.g., reagent water, method blanks, Ottawa sand,
diatomaceous earth, etc.) or a representative sample matrix free of
target compounds. Optimally, the LLOQ should be less than the desired
regulatory action levels based on the stated project-specific
requirements.
    For organic analyses, the acceptable recovery ranges of target
analytes will vary more than for other types of analyses, such as
inorganics. The recovery of target analytes in the LLOQ check sample
should be within established limits, or other such project-required
acceptance limits, for precision and bias to verify the data reporting
limits. Until the laboratory has sufficient data to determine
acceptance limits statistically, a limit of 20% +/- the Laboratory
Control Sample (LCS) criteria may be used for the LLOQ acceptance
criteria. This approach acknowledges the poorer overall response at the
low end of the calibration curve. Historically based LLOQ acceptance
criteria should be determined as soon as practical once sufficient data
points have been acquired.
    In-house limits for bias (e.g., % Recovery) and precision (e.g.,
Relative Percent Difference, %RPD) of the LLOQ for a particular sample
matrix may be calculated when sufficient data points exist. The
laboratory should have a documented procedure for establishing its in-
house acceptance ranges. Sometimes the laboratory instrument and/or
analyst performance vary or test samples cause problems with the
detector (e.g., samples may have interferences; may clog the
instruments cells, wall or tube; may cause contamination; etc.).
Therefore, the limits of acceptance (for precision and bias) are
established by a lab with sufficient data to demonstrate that they can
report down to the LLOQ with a certain level of confidence. The
acceptance limits (for precision and bias) for LLOQ may be established
by the laboratory or at the project level through the data quality
objectives in a quality assurance project plan. The frequency of the
LLOQ check is not specified for organic analytes.

    Note:  The LLOQ check sample should be spiked with the analytes
of interest at the predicted LLOQ concentration levels and carried
through the same preparation and analysis procedures as
environmental samples and other QC samples. For more information,
please see individual methods (e.g., Method 8000) and Chapter One of
SW-846.

How is LLOQ used?
    The RCRA program deals with complex wastes and materials that are
managed or used in many different ways (e.g., landfilling, land
application, incineration, recycling). The thresholds (e.g., action or
remediation levels) for data users (e.g., engineers or risk assessors)
to make their decisions, therefore, vary. Method users will need to
properly plan their analytical strategy to ensure the LLOQs for
targeted analytes are lower than the thresholds needed to generate data
used to determine how waste or materials can be properly managed or
used.
     Initial Demonstration of Performance (IDP)--The laboratory
must make an initial demonstration of ability to generate results with
acceptable accuracy and precision for each preparation and
determinative method they perform. This demonstration should be
performed prior to independently analyzing real sample matrices by each
analytical method and should be repeated if other changes occur (e.g.,
significant change in procedure, new staff are trained, etc.).
Documentation of the IDP should be maintained by the Quality Assurance
Manager. Each laboratory should have a training program documenting
that a new analyst is capable of performing the method or portion of
the method for which the analyst is responsible. This demonstration
should document that the new analyst is capable of successfully
following the standard operating procedure (SOP) based on the
laboratory's IDP policy.
    For Update V, changes to the IDP have been specified in the
individual Update V methods where appropriate (e.g., screening method
where there is not a quantitative reporting limit such as a bioassay
method). The IDP changes allow laboratories to use their time and
resources effectively, especially for the organic analyses.
    Key Changes in the IDP for the Determination of Organic Analytes:
    The IDP section was expanded to describe two situations:
    When a significant change to instrumentation or procedure occurs:
Reliable performance of the methods is dependent on careful adherence
to the instructions in the written method, and aspects of the method
are mandatory to ensure that the method performs as intended.
Therefore, if a major change to the sample preparation procedure is
made (e.g., a change of solvent), the IDP must be repeated for that
preparation procedure to demonstrate the laboratory technician's
continued ability to reliably perform the method. EPA considers
conducting IDPs as part of good laboratory practice procedures and has
already included these procedures in EPA's laboratories practices.
    Alterations in instrumental procedures only (e.g., changing Gas
Chromatograph (GC) temperature programs or High Performance Liquid
Chromatography (HPLC) mobile phases or the detector interface), require
a new calibration, but not a new IDP because the preparation procedure
is unchanged.
    When new staff members are trained: A new analyst needs to be
capable of performing the method, or portion of the method, for which
the analyst is responsible. For example, when analysts are trained for
a subset of analytes for an 8000 series method, the new sample
preparation analyst should prepare reference samples for a
representative set of analytes (e.g., the primary analyte mix for
Method 8270, or a mix of Aroclor 1016 and 1260 for Method 8082) for
each preparation method the analyst will be performing. The instrument
analyst being trained will need to analyze prepared samples (e.g.,
semi-volatile extracts).
     Relative Standard Error (RSE)--ORCR evaluated and
included, as the analytical community recommended, RSE as an option (in
addition to calculation of the % error) in SW-846 for the determination
of the acceptability for a linear or non-linear calibration curve. RSE
refits the calibration data back to the calibration model and evaluates
the difference between the measured and the true amounts or
concentrations used to create the model.

[GRAPHIC] [TIFF OMITTED] TN23OC13.003

Where:

xi = True amount of analyte in calibration level i, in
mass or concentration units.
x[acute]i = Measured amount of analyte in calibration
level i, in mass or concentration units.
p = Number of terms in the fitting equation (average = 1, linear =
2, quadratic = 3, cubic = 4).
n = Number of calibration points.

    The RSE acceptance limit criterion for the calibration model is the
same as the RSD limit in the determinative method. If the RSD limit is
not defined in the determinative method, the RSE limit should be set at
<=20% for good performing compounds and <=30% for poor performing
compounds.

V. Summary

    EPA believes that these changes in Update V will assist the method
users to demonstrate method competency and generate better quality
data. For the convenience of the analytical community, the Agency will
revise the OSWER Methods' Team homepage on EPA's Web site with updated
information to better communicate new policy and analytical procedures,
and will include Update V and selected documents at that Web site after
Update V is finalized.
    Please see the Web site: http://www.epa.gov/epawaste/hazard/testmethods/index.htm for more information. Table 1 provides a listing
of the five chapters and twenty-three methods (eight new and fifteen
revised methods) in Update V.

           Table 1--Update V (Methods, Chapters and Guidance)
------------------------------------------------------------------------
    Analytical method No.               Method or chapter title
------------------------------------------------------------------------
                               Table of Contents.
                               Chapter One--Quality Control.
                               Chapter Two--Choosing the Correct
                                Procedure.
                               Chapter Three--Inorganic Analytes.
                               Chapter Four--Organic Analytes.
                               Chapter Five--Miscellaneous Test Methods.
                               Methods Status Table.
1030.........................  Ignitability of Solids.
3200 *.......................  Mercury Species Fractionation and
                                Quantification by Microwave-Assisted
                                Extraction, Selective Solvent Extraction
                                and/or Solid Phase Extraction.
3511 *.......................  Organic Compounds in Water by
                                Microextraction.
3572 *.......................  Extraction of Wipe Samples for Chemical
                                Agents.
3620C........................  Florisil Cleanup.
4025 *.......................  Screening for Polychlorinated
                                Dibenzodioxins and Polychlorinated
                                Dibenzofurans (PCDD/Fs) by Immunoassay.
4430 *.......................  Screening for Polychlorinated Dibenzo-p-
                                Dioxins and Furans (PCDD/Fs) by Aryl
                                Hydrocarbon Receptor PCR Assay.
4435 *.......................  Method for Toxic Equivalent (TEQS)
                                Determination for Dioxin-Like Chemical
                                Activity With the CALUX[supreg]
                                Bioassay.
5021A........................  Volatile Organic Compounds in Various
                                Sample Matrices Using Equilibrium
                                Headspace Analysis.
6010D........................  Inductively Coupled Plasma-Atomic
                                Emission Spectrometry.
6020B........................  Inductively Coupled Plasma-Mass
                                Spectrometry.
6800.........................  Elemental and Speciated Isotope Dilution
                                Mass Spectrometry.
8000D........................  Determinative Chromatographic
                                Separations.
8021B........................  Aromatic and Halogenated Volatiles by Gas
                                Chromatography Using Photoionization and/
                                or Electrolytic Conductivity Detectors.
8111.........................  Haloethers by Gas Chromatography.
8270D........................  Semivolatile Organic Compounds by Gas
                                Chromatography/Mass Spectrometry.
8276 *.......................  Toxaphene and Toxaphene Congeners by Gas
                                Chromatography/Negative Ion Chemical
                                Ionization Mass Spectrometry (GC-NICI/
                                MS).
8410.........................  Gas Chromatography/Fourier Transform
                                Infrared Spectrometry for Semivolatile
                                Organics: Capillary Column.
8430.........................  Analysis of Bis (2-Chloroethyl) Ester and
                                Hydrolysis Products by Direct Aqueous
                                Injection.
9013A........................  Cyanide Extraction Procedure for Solids
                                and Oils.
9014.........................  Titrimetric and Manual Spectrophotometric
                                Determinative Methods for Cyanide.
9015 *.......................  Metal Cyanide Complexes by Anion Exchange
                                Chromatography and UV Detection.
9320.........................  Radium 228.
------------------------------------------------------------------------
* New Methods.

    Dated: September 27, 2013.
Barnes Johnson,
Acting Director, Office of Resource Conservation and Recovery.
[FR Doc. 2013-24852 Filed 10-22-13; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION 4

Sam Nunn Atlanta Federal Center

61 Forsyth Street SW

Atlanta, Georgia 30303-8960

DATE:	October 6, 2009

SUBJECT:	Technical Support Document for Notice of Proposed Rulemaking
– Determination of Attaining Data for the 1997 Fine Particulate Matter
Standard

FROM:	Joel Huey, Environmental Scientist /s/

Regulatory Development Section

TO:		File

THRU:	Lynorae Benjamin /s/

		Chief, Regulatory Development Section

A.  BACKGROUND

On July 18, 1997 (62 FR 36852), EPA established health-based PM2.5
National Ambient Air Quality Standards (NAAQS) as 15.0 micrograms per
cubic meter (µg/m3) based on a 3-year average of annual mean PM2.5
concentrations, and 65 µg/m3 based on a 3-year average of the 98th
percentile of 24-hour concentrations.  EPA established the standards
based on significant evidence and numerous health studies demonstrating
that serious health effects are associated with exposures to particulate
matter.  The process for designating areas following promulgation of a
new or revised NAAQS is contained in section 107(d)(1) of the Clean Air
Act.

EPA and State air quality agencies initiated monitoring for the 1997
PM2.5 NAAQS in 1999.  On January 5, 2005 (70 FR 944), EPA published its
air quality designations and classifications for the 1997 PM2.5 NAAQS
based upon air quality monitoring data from those monitors for calendar
years 2001-2003.  These designations became effective on April 5, 2005.
The Hickory-Morganton-Lenoir, North Carolina, area (hereafter referred
to as “Hickory, North Carolina”) and the Greensboro-Winston
Salem-High Point, North Carolina, area (hereafter referred to as
“Greensboro, North Carolina”) were designated nonattainment for the
1997 PM2.5 NAAQS (see 40 CFR part 81).  This Technical Support Document
(TSD) summarizes the 2006-2008 data EPA is using to support its
determination that the Hickory and Greensboro areas now have attaining
data.

B.  EPA REQUIREMENTS

A nonattainment area for the 1997 PM2.5 NAAQS is determined to have
attaining data when the design values for the annual and the 24-hour
standards meet the requirements stipulated in 40 CFR Part 50, section
50.7 as follows:

(1) The annual primary and secondary PM2.5 standards are met when the
annual arithmetic mean concentration, as determined in accordance with
40 CFR Part 50, Appendix N, is less than or equal to 15.0 µg/m3;

(2) The 24-hour primary and secondary PM2.5 standards are met when the
98th percentile 24-hour concentration, as determined in accordance with
40 CFR Part 50, Appendix N, is less than or equal to 65 µg/m3.

Upon determination by EPA that an area designated nonattainment for the
PM2.5 NAAQS has attained the standard, 40 CFR section 51.1004(c)
provides that the requirement for such area to submit attainment
demonstrations and associated reasonably available control measures,
reasonable further progress plans, contingency measures, and other
planning SIPs related to attainment of the PM2.5 NAAQS shall be
suspended until the area is redesignated to attainment, at which time
the requirement no longer applies.  However, if EPA subsequently
determines that the area has violated the PM2.5 NAAQS, the requirement
to submit such plans is reinstated.

C.  EPA’S ANALYSIS OF MONITORED DATA

1.  2006-2008 data

EPA’s determination that the Hickory and Greensboro nonattainment
areas have attaining data is based upon quality assured, quality
controlled and certified ambient air monitoring data for the 2006-2008
period, as measured by Federal reference method, Federal equivalent
method, or Approved Regional Method monitors described in 40 CFR Part
50, Appendix N.  The monitors and data used to determine the design
values for the Hickory and Greensboro nonattainment areas are indicated
in Tables 1-4 below.

Table 1.  Design Value for Counties in the Hickory, North Carolina,
Nonattainment Area for 1997 PM2.5 NAAQS – Annual Standard

Location	AQS site ID	2006

Average	2007

Average	2008

Average	2006-2008

Design Value

Catawba County	37-035-0004	15.163	14.592	12.806	14.2

Table 2.  Design Value for Counties in the Hickory, North Carolina,
Nonattainment Area for 1997 PM2.5 NAAQS – 24-Hour Standard

Location	AQS site ID	2006

98th

Percentile	2007

98th

Percentile	2008

98th

Percentile	2006-2008

Design Value

Catawba County	37-035-0004	32.9	30.7	 25.2 	30

Table 3.  Design Value for Counties in the Greensboro, North Carolina,
Nonattainment Area for 1997 PM2.5 NAAQS – Annual Standard

Location	AQS site ID	2006

Average	2007

Average	2008

Average	2006-2008

Design Value

Davidson County

Guilford County	37-057-0002

37-081-0013	15.126

14.497	14.636

13.140	13.611

11.577	14.5

13.1

Table 4.  Design Value for Counties in the Greensboro, North Carolina,
Nonattainment Area for 1997 PM2.5 NAAQS – 24-Hour Standard

Location	AQS site ID	2006

98th

Percentile	2007

98th

Percentile	2008

98th

Percentile	2006-2008

Design Value

Davidson County

Guilford County	37-057-0002

37-081-0013	31.0

31.3	30.9

28.4	24.7

24.6	29

28

2.  2009 data

	EPA does not yet have State certified air quality data for the 2009
calendar year.  The State certified air quality data for the entire 2009
calendar year will not be available until well into calendar year 2010
and, therefore, cannot be used for purposes of design value calculations
during calendar year 2009.  EPA did not rely upon any 2009 data to
support its proposed determination that the above areas have attaining
data.  However, as part of the proposed determination, EPA notes that a
portion of the 2009 air quality data is currently available.  This
partial 2009 data indicates a continuing trend consistent with EPA’s
proposed determination:  the air quality monitors located in the Hickory
and Greensboro areas continue to show attaining data for the 1997 PM2.5
NAAQS.  The portion of the 2009 data that was available when EPA’s
proposed determination was published is provided below.

Table 5.  2009 Data for the Hickory, North Carolina, Nonattainment Area

Location	AQS site ID	First Quarter 2009	Second Quarter 2009

Catawba County	37-035-0004	11.24482759	Not available

Table 6.  2009 Data for the Greensboro, North Carolina, Nonattainment
Area

Location	AQS site ID	First Quarter 2009	Second Quarter 2009

Davidson County

Guilford County	37-057-0002

37-081-0013	11.39333333

9.45862069	9.657142857

8.843181818

D.  CONCLUSIONS AND RECOMMENDED AGENCY ACTION

	The available quality assured, quality controlled, and certified
ambient air monitoring data for 2006-2008 shows that the Hickory and
Greensboro PM2.5 nonattainment areas have monitored attainment for the
1997 PM2.5 NAAQS.  It is therefore recommended that the Hickory and
Greensboro areas be determined to have attaining data for the 1997 PM2.5
NAAQS.

Although the available 2009 data is not relied upon for this
determination, it shows an apparent continuing trend of attaining data
for these areas and is provided in this TSD for informational purposes
only.

 Design values are the metrics that are compared to the NAAQS levels to
determine attainment, and are calculated as follows:

(1) The 3-year average of annual means for a single monitoring site or a
group of monitoring sites (referred to as the “annual standard design
value”).  If spatial averaging has been approved by EPA for a group of
sites which meet the criteria specified in section 2(b) of this appendix
and section 4.7.5 of appendix D of 40 CFR part 58, then 3 years of
spatially averaged annual means will be averaged to derive the annual
standard design value for that group of sites (further referred to as
the “spatially averaged annual standard design value ”). Otherwise,
the annual standard design value will represent the 3-year average of
annual means for a single site (further referred to as the “single
site annual standard design value ”).

(2) The 3-year average of annual 98th percentile 24-hour average values
recorded at each monitoring site (referred to as the “24-hour standard
design value”).  (See 40 CFR part 50 Appendix N.)

 PAGE

 PAGE   4

 PAGE