[Federal Register: July 24, 2008 (Volume 73, Number 143)]
[Rules and Regulations]
[Page 43059-43066]
[DOCID:fr24jy08-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 61, 65, 67, and 183

[Docket No.: FAA-2007-27812; Amdt. Nos. 61-121, 65-52, 67-20, and 183-
13]
RIN 2120-AI91

Modification of Certain Medical Standards and Procedures and
Duration of Certain Medical Certificates

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule extends the duration of first- and third-class
medical certificates for certain individuals. A first-class medical
certificate is required when exercising airline transport pilot
privileges and at least a third-class medical certificate when
exercising private pilot privileges. Certain conforming amendments to
medical certification procedures and some general editorial amendments
are also adopted. The intent of this action is to improve the
efficiency of the medical certification program and service provided to
medical certificate applicants.

DATES: These amendments become effective August 25, 2008 except for the
amendments to Sec.  61.23(d) which become effective on July 24, 2008.

FOR FURTHER INFORMATION CONTACT: Judi Citrenbaum, Office of the Federal
Air Surgeon, Federal Aviation Administration, 800 Independence Avenue,
SW., Washington, DC 20591; telephone<PHONE_NUMBER>; e-mail;
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106,
describes the authority of the FAA Administrator, including the
authority to issue, rescind, and revise regulations. Subtitle VII,
Aviation Programs, describes, in more detail, the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart III, Chapter 447, Sections 44701, 44702
and 44703. Under Section 44701 the Administrator has the authority to
prescribe regulations and minimum standards for practices, methods and
procedures necessary for safety in air commerce and national security.
Under Section 44702 the Administrator has the authority to issue
certificates. More specifically, under Section 44703(b)(C) the
Administrator has the authority to decide terms necessary to ensure
safety in air commerce, including terms on the duration of certificates
and tests of physical fitness. This rule extends the duration of first-
and third-class medical certificates for certain individuals in order
to improve the efficiency of the medical certification program and
service provided to medical certificate applicants, without
compromising the safety of air commerce. For this reason, the proposed
change is within the scope of our authority and is a reasonable and
necessary exercise of our statutory obligations.

Background

Summary of the Notice of Proposed Rulemaking

    Currently, the maximum duration on a first-class medical
certificate is 6 months regardless of age and, on a third-class medical
certificate, 36 months for individuals under age 40. On April 10, 2007
[72 FR 18092], the FAA proposed to amend Sec.  61.23(d) to extend the
duration of first- and third-class medical certificates for individuals
under the age of 40. First-class medical certificates for individuals
under age 40 would be extended from 6 months to 1 year and third-class
medical certificates for individuals under the age of 40 would be
extended from 3 years to 5 years.
    The FAA developed this proposal through review of relevant medical
literature, its own aeromedical certification data, and accident data.
Additionally, the FAA considered the long-standing International Civil
Aviation Organization (ICAO) standards requiring annual medical
certification for airline transport and commercial pilots in multi-crew
settings and also the ICAO standards adopted in November 2005 extending
medical duration for private pilots from 2 years to 5 years under the
age of 40. These ages and examination periods were selected based on
current ICAO standards, in effect since 2005, which have not had an
adverse impact on safety, and based on trends with younger applicants
indicating no significant increase in undetected pathology between
required examinations. Those individuals manifesting conditions that
represent a risk to safety will continue to be denied certification or,
after individual evaluation, will continue to be restricted in their
flying activities, or examined more thoroughly and frequently, or both.
Further, this rule will continue, and not affect, the long-standing
regulatory prohibition in Sec.  61.53 against exercising privileges
during periods of medical deficiency.
    In addition to extending the duration of first- and third-class
medical certificates, the FAA also proposed the following minor, mostly
editorial, changes:
Add New Section Sec.  67.4
     To provide more specific direction to applicants applying
for a medical certificate, including how to locate an Aviation Medical
Examiner (AME).
     To codify that applicants must fill out a form to apply
for a medical certificate and thereby conform part 67 with existing
language under Sec.  61.13 that requires pilot certificate applicants
to make application ``on a form and in a manner acceptable to the
Administrator.''
     To codify that applicants must present proof of age and
identity for airman medical certification.
Amend Sec.  183.15
     To remove a specific time limit for the duration of the
designation of AMEs. The FAA had done this previously under rulemaking
effective in November 2005 but it was made applicable only for
designees of the Flight Standards and Aircraft Certification Services.
This action will make a consistent standard for all FAA designees,
including AMEs, by having duration set at the discretion of the FAA.
Edit Sec. Sec.  61.29, 65.16, 67.3, 67.401, 67.405, 67.411, 67.413, and
183.11
     Sec. Sec.  61.29 and 65.16: To provide a new P.O. Box for
applicants to use when they need a replacement medical certificate or
when they need to change their name on a medical certificate. While the
current P.O. Box listing is valid, the FAA finds that requests sent to
this alternate P.O. Box are received more expeditiously thus allowing
the FAA to provide better service to applicants. In the proposal the
FAA inadvertently amended Sec.  65.16(b) with the new P.O. Box when we
intended to amend Sec.  65.16(c). The final rule correctly amends Sec.
65.16(c).
     Sec.  67.405: To move certain provisions of this paragraph
under new Sec.  67.4.
     Sec.  67.411: To delete this section that addresses
military flight surgeons on a specific military base being designated
as AMEs. Because the FAA has ceased designating AMEs at particular
military installations in favor of designating individual military
personnel as AMEs (just as it does civilian AMEs) the

distinction made in this provision is no longer needed.
     Sec.  67.413: To re-format this section to make it easier
to read and understand.
     Sec.  183.11: To make an editorial change (revising
``his'' to ``his or her'') to be consistent with a conforming amendment
in Sec.  67.407(d) that says ``his or her.''

Summary of Comments

    The FAA received 36 comments to the April 10, 2007 proposal.
Commenters generally supported the proposed changes. The National
Transportation Safety Board (NTSB) commented as did eight aviation
associations including the Aerospace Medical Association, the National
Air Transport Association, the Air Line Pilots Association
International, the Aircraft Owners and Pilots Association, the
Experimental Aircraft Association, the Civil Aerospace Medical
Association (CAMA), the Helicopter Association International, and the
National Business Aviation Association. One manufacturer, Cessna
Aircraft Company, indicated that it appreciated the opportunity to
comment but had no specific comment at this time.
    The remaining comments were from individuals. Among these
commenters, a few opposed it, including an AME, who indicated that
under-age-40 individuals should be examined as frequently as over-age-
40 individuals. More commenters indicated, however, that the proposed
action is appropriate but should be further amended, for example, to
extend the duration of medical certificates for over-age-40
individuals.
    Commenters requested specifically that the FAA consider the
following for the final rule:
     Extend the duration of medical certificates for
individuals over age 40. (4 comments)
     Extend the duration of student pilot certificates to 60
months. (1 comment)
     Extend the duration of second-class medical certificates
beyond 12 months. (1 comment)
     Allow a U.S. driver's license as medical qualification in
lieu of an FAA medical certificate to exercise recreational pilot
privileges. (4 comments)
     Develop policy to address the impact (at the third-class
level) of the 3-year limit on the National Driver Registry (NDR) search
once the interval between medical applications is extended to 5 years.
(2 comments)
     Require pilots to report in a timely fashion to the FAA
any medical conditions that may develop between examinations. (2
comments)
     Develop a more efficient method for medical certificate
holders to report changes in medical conditions, rather than relying on
self-assessment policies during periods of medical deficiency. (2
comments)
     Clarify the intent of Sec.  61.23(d) regulatory language
with regard to how the proposed duration periods will be implemented.
(3 comments)

Discussion of Final Rule

Analysis of Comments

    As noted above, some commenters requested that the FAA provide
relief beyond what was proposed, while others requested that the FAA
adopt more rigid policies, even reporting requirements, to more closely
monitor any changes in medical qualification status that a medical
certificate holder may experience. We have considered the comments and
provide our analysis below.

Specific Reporting Requirement

    The NTSB suggested that pilots be required to report potentially
disqualifying medical conditions to the FAA in a timely fashion if such
conditions develop between examinations. The NTSB referenced
international reporting requirement practices, including the ICAO
Recommended Practice <IP_ADDRESS>.1, which states the following:
    <IP_ADDRESS>.1 Recommendation.--License holders should inform the
Licensing Authority of confirmed pregnancy or any decrease in medical
fitness of a duration of more than 20 days or which requires continued
treatment with prescribed medication or which has required hospital
treatment.
    It also referenced a requirement of the European Joint Aviation
Authorities, JAR FCL 3.040 which states the following:
JAR-FCL 3.040 Decrease in Medical Fitness
    (c) Holders of medical certificates shall, without undue delay,
seek the advice of the AMS, an AMC or an AME when becoming aware of:
    (1) Hospital or clinic admission for more than 12 hours; or
    (2) surgical operation or invasive procedure; or
    (3) the regular use of medication; or
    (4) the need for regular use of correcting lenses.
    The CAMA also suggested that the FAA develop a more sophisticated
system for pilots to report medical conditions.
    The FAA disagrees that a specific reporting requirement is
warranted and believes that FAA policy and existing regulation meet the
intent of the international standard. Long-standing FAA regulation
(Sec.  61.53) requires that before every flight a pilot should evaluate
fitness to fly, not just when the decrease in medical fitness would
last more than 20 days or when it requires continued treatment.
Existing Sec.  61.53 also specifies that medical certificate holders
may not exercise pilot privileges if they are ``taking medication or
receiving other treatment for a medical condition that results in the
person being unable to meet the requirements for the medical
certificate necessary for the pilot operation.'' Individuals with a
medical certificate who choose to exercise pilot privileges are bound
by the FAA's disqualifying medical conditions set forth under part 67
as they are by any decrease in general medical condition as set forth
under Sec.  61.53. The provisions of Sec.  61.53 are referenced on the
reverse side of the medical certificate which pilots are required to
carry with them at all times when they exercise flight privileges. The
ability to certify no known medical conditions in order to ensure the
safe operation of aircraft is a required, critical component of a
pilot's flight planning procedures.
    Pilot safety brochures, widely disseminated to the pilot community
on our Web site and by our system of approximately 4,000 AMEs across
the country, emphasize the importance of good decision-making before
flying. We have many brochures that provide guidance about issues such
as medications, fatigue, vision, and spatial disorientation among many
others. We always advise pilots to check with the FAA or their AME if
they have any concerns, and to have their private physicians and
pharmacists check with their AME if there is any uncertainty about
medical status before flying. By way of example, our pilot safety
brochure entitled ``Medications and Flying'' emphasizes the importance
of fully understanding an existing or underlying medical condition and
the potential for adverse reactions or side effects of medications.
This brochure advises pilots of the following:
     If you must take over-the-counter medications:
     Read and follow the label directions
     If the label warns of significant side effects, do not fly
after taking the medication until at least two dosing intervals have
passed. For example, if the directions say to take the medication every
6 hours, wait until at least 12 hours after the last dose to fly.

     Remember that you should not fly if the underlying
condition that you are treating would make you unsafe if the medication
fails to work.
     Never fly after taking a new medication for the first
time.
     As with alcohol, medications may impair your ability to
fly--even though you feel fine.
     If you have questions about a medication, ask your
aviation medical examiner.
     When in doubt don't fly.
    Adding a specific reporting requirement for our system of
approximately a half million pilots would be difficult to implement and
hard to enforce. There are no apparent adverse trends that would
indicate a need for a specific reporting requirement. Adding a specific
reporting requirement would require further rulemaking, new forms,
increased paperwork and recordkeeping requirements, and further
guidance to pilots and to AMEs. The FAA also notes that a modification
for current ICAO Recommended Practice <IP_ADDRESS>.1 (referenced above) is
in the planning stages that would remove language that indicates a
decrease in medical fitness of more than 20 days should be reported.

National Driver Registry Access

    At the time of application for FAA medical certification,
individuals must provide express consent to grant the FAA the right to
review their NDR records. This information allows the FAA to check
applicants' driving records for any instances of substance abuse and
dependence disorders which may provide cause for denying a medical
certificate.
    The NTSB commented that ``an unintended effect of extending the
time interval between examinations might be to increase the interval
between NDR inquiries.'' The CAMA stated that ``if the examination
frequency is extended to a 60-month period, it would be possible for an
airman to receive a DWI and have it dropped from the NDR database
before presenting for their next required examination.'' The NTSB
indicated that the FAA should ``require policy changes as necessary to
ensure an appropriate frequency of NDR database evaluations that is no
less than currently performed.''
    Currently, on Item 20 of FAA Form 8500-8, Application for Airman
Medical Certificate, an applicant gives express consent for FAA to
access his or her NDR records as part of the evaluation for a medical
certificate. Such consent is required by the National Driver Registry
Act, which provides that the FAA's access to the NDR records be made
upon an express request from the medical certificate applicant to
search his or her driving records. With the applicant's consent, the
FAA is authorized to obtain a single, 3-year look-back of the
applicant's driving records. As some commenters noted, adoption of the
proposal to extend the duration of certain medical certificates from 3
to 5 years would result in a situation where the FAA would not obtain
the applicant's NDR records for the first 2 years of the 5-year period
prior to the next application for a medical certificate. This reality,
however, is not sufficiently problematic to justify abandoning the
proposal for a number of reasons.
    First and most importantly, the medical certification process,
including the duration of a medical certificate to engage in specific
aviation activities, should be based on appropriate medical information
and judgment, not on the availability of a particular compliance tool
to cross-match information.
    Second, even as a compliance tool, NDR access does not cover all
piloting activities. Glider and balloon piloting, as well as operation
of an ultralight vehicle under 14 CFR Part 103, do not require medical
certification, and thus there is no NDR access undertaken. Similarly,
sport piloting does not require a medical certificate if an individual
chooses to use a U.S. driver's license as a medical qualification.
    Third, current regulations obligate pilots to provide the FAA with
a written report of any motor vehicle action within 60 days of the
action. This includes any conviction related to the operation of a
motor vehicle while intoxicated or impaired by alcohol or a drug, as
well as any action taken by the State to cancel, suspend, or revoke a
license to operate a motor vehicle based on intoxication or impairment.
    As required under long-standing Sec.  61.15(e) reporting
requirements, all medical certificate holders must provide ``a written
report of each motor vehicle action to the FAA.'' The intent of this
requirement is explained in detail to pilots under ``Frequently Asked
Questions'' on the FAA Web site. All pilots must send a Notification
Letter to the FAA's Security and Investigations Division within 60
calendar days of the effective date of an alcohol-related conviction or
administrative action. Each event, conviction, or administrative
action, requires a separate Notification Letter.
    The inability to reach back to the fourth and fifth year of the
prior 5-year period through the NDR would have an impact only if the
individual had violated the reporting requirements. The failure to have
reported the information to the FAA would itself be a violation that
could lead to the suspension or revocation of the individual's pilot
certificate. Thus, there are substantial incentives to provide the
information.
    Fourth, the FAA is considering seeking a statutory change to permit
a 5-year access period through the NDR. At the time of the original
statute in the late 1980s that gave the FAA a 3-year period of access
to the NDR, the period authorized exceeded the duration of all classes
of medical certificates issued by the FAA. Later legislative action
under the Pilot Records Improvement Act of 1996 authorized a 5-year
access to the NDR in the context of air carrier operations. In light of
the change to the duration of certain medical certificates made by this
final rule, the FAA believes a corresponding change to NDR access would
receive substantial support by the Congress.

Unintended Effects of Amending Sec.  61.23(d): Medical Certificates:
Requirement and Duration

    Some commenters requested clarification regarding the intent of the
regulatory language in the proposed Sec.  61.23(d) table.
    The National Air Transport Association (NATA) commented that the
proposal indicates the specified period of duration on a medical
certificate is applied ``from the date of examination.'' According to
NATA, however, in some cases the medical certificate is not issued on
the same day as the examination. The medical certificate may be issued
at a later date after further review is conducted. NATA stated that
duration should be calculated from the date of issuance, not the date
of examination. ``This is currently how expiration dates are typically
determined, although it is not specified in the regulations.''
    According to another commenter: ``for some pilots around age 40,
the proposed rules actually reduce the duration of some medical
certificates and increase the burden of compliance.'' The commenter
indicated that, under existing Sec.  61.23(d), the age at examination
sets duration while under proposed Sec.  61.23(d), the age at operation
sets duration. The commenter interpreted this to mean that ``a medical
used for third-class operations that is obtained shortly before the
40th birthday will expire in 24 months under the proposed rules instead
of 36 months under the existing rules.'' He stated: ``For example, a
pilot born June 1, 1965, gets a third-class medical on May 15, 2005.
Under the current rule, this

expires on May 31, 2008, but under the proposed rule, the expiration
date will be May 31, 2007.''
    One commenter indicated that the second column of the proposed
table for Sec.  61.23(d) is confusing and suggested that it be modified
to read ``And you are at the date of the examination'' rather than
``And you are.''
    The FAA's intent on the duration of medical certificates has not
changed. As specified in the preamble to the proposal, these standards
are applied ``according to the date of examination placed on the
medical certificate and in accordance with duration periods specified
under Sec.  61.23(d).'' An FAA medical certificate lists only a ``Date
of Examination,'' not a date of issuance and duration standards are
applied according to the date of examination placed on the medical
certificate unless otherwise limited, as indicated under the section of
the certificate entitled ``Limitations.'' Each medical certificate must
bear the same date as the date of medical examination regardless of the
date the certificate is actually issued. To respond to commenters, the
FAA has revised the Sec.  61.23(d) table to better clarify its intent.
    The new duration periods will be effective the day this rule is
published and will affect current medical certificates holders. First-
and third-class medical certificate holders, who were under age 40 on
the date of the application of their medical certificate, will be
covered by the new, longer durations established under Sec.  61.23(d).
To determine the duration of one's medical certificate, one should
examine two pertinent dates displayed on each medical certificate: The
date of the applicant's birth, which determines the applicant's age at
the time of the application, and the date of the applicant's medical
examination. This means, for example, if you were under age 40 at the
time of the application and you hold a first-class medical certificate
with a date of examination dating back 5 months prior to the adoption
of this provision of the final rule, then your medical certificate for
airline transport pilot operations will expire according to the new
annual standard and not the current 6-month standard. Using another
example, if you were under age 40 at the time of the application and
you hold a third-class medical certificate, then your medical
certificate for private or recreational operations will expire
according to the new 5-year standard and not the current 3-year
standard. Affected first- and third-class medical certificate holders
must look at the date of examination on their existing medical
certificate and recalculate duration as set forth under new Sec.
61.23(d).
    In addition, it should be noted that the ``Conditions of Issue'' on
the reverse side of the existing medical certificate (FAA Form 8500-9)
for affected first- and third-class medical certificate holders no
longer will be accurate for certain medical certificate holders once
this rule becomes effective because existing Sec.  61.23 duration
standards are referenced. The FAA will be using new medical
certificates with updated ``Conditions of Issue'' on the reverse side
of the medical certificate following rule issuance. Until such time as
you renew your medical certificate, therefore, you should be aware of
these outdated ``Conditions of Issue'' on the reverse side of your
existing medical certificate. You should carry a copy of the new
duration standards with you when you fly, especially if you fly
internationally, in order to demonstrate that the duration of your
existing medical certificate is in compliance with new FAA medical
certificate duration standards.

Duration of a Medical Certificate When Exercising Sport Pilot
Privileges (When You Choose To Medically Qualify With an FAA Medical
Certificate Rather Than a U.S. Driver's License)

    A commenter indicated that proposed and existing Sec.  61.23(d) do
not address individuals who may choose to hold a medical certificate
rather than use their U.S. driver's license to medically qualify to
exercise sport pilot privileges. This commenter holds a first-class
medical certificate and will soon stop flying professionally. He plans
to maintain a current FAA first-class medical certificate but will be
exercising sport pilot privileges only. This commenter requested that
the FAA clarify in the final rule the intended duration period of a
medical certificate when used as medical qualification to exercise
sport pilot privileges rather than a U.S. driver's license.
    The FAA believes that the comment has merit and has adjusted Sec.
61.23(d) accordingly.

Comments Beyond the Scope of the Notice

    The FAA received comments requesting changes beyond what was
proposed. One commenter requested extended duration on a second-class
medical certificate and others suggested extended duration for
individuals over, as well as under, age 40. Further, some commenters
asked that recreational pilots be allowed to medically qualify using a
U.S. driver's license in lieu of an FAA medical certificate.
    All these proposed changes are beyond the scope of the proposal.
    Existing U.S. medical certificate duration standards for commercial
pilots under age 40 in a multi-crew setting currently are the same as
the ICAO standards; therefore, the FAA did not propose a change to FAA
second-class medical certificate duration standards. Proposing or
adopting such a change would create a difference with existing
international standard. The FAA proposed to extend duration and limit
it to under-age-40 individuals for the same reason. Extending the
duration any further would put the United States out of compliance with
international standards, and we have no experience or basis to support
doing so at this time. Today's action is based, in part, on
international experience and on 10 years of FAA experience with
extended duration on third-class medical certificates (from 2 years to
3 years) for individuals under age 40.
    The FAA proposal did not address, or propose to amend, standards
for recreational pilots other than, for certain pilots, the duration of
a third-class medical certificate, required when exercising
recreational pilot privileges. The only pilots currently allowed to
medically qualify using a U.S. driver's license are sport pilots. The
FAA did not find cause during sport pilot rulemaking deliberations, and
at this time does not have sufficient experience certificating sport
pilots, to reconsider the third-class medical certificate standard for
the exercise of recreational pilot privileges.

Related Activity

Student Pilot Certificate Duration

    On February 7, 2007, the FAA issued a proposal that would amend, in
part, existing Sec.  61.19(b) to extend the duration of a student pilot
certificate from 24 months to 36 months for individuals under age 40
[72 FR 5806]. Subsequently this proposed action was issued to extend
the duration of medical certificates. The FAA received comments to both
proposals that support extending the duration of a student pilot
certificate. The FAA will take these comments into consideration and
dispose of them in the final rule that will address the February 7,
2007 proposal.

ICAO Audit

    ICAO, the aviation wing of the United Nations, audited the United
States Government's civil aviation safety oversight system from
November 5-19, 2007, as part of the Universal Safety Oversight Audit
Program (USOAP). The

ICAO USOAP teams assess whether a signatory state meets international
aviation standards. The audit is very comprehensive and part of the
focus is on licensing systems and keeping them aligned with
international aviation standards.
    ICAO findings for many signatory states, including the United
States, have revealed a need to revise licensing systems to ensure
conformance with ICAO Standards and Recommended Practices.
Specifically, ICAO recommends endorsements on licenses for any person
holding a license who does not satisfy in full the conditions set forth
in international standards. These individuals must have endorsed on or
attached to their license a complete enumeration of the particulars in
which they do not satisfy such conditions.
    In order to comply with our international obligations to ICAO, the
FAA has determined that affected persons, those who have been granted
an Authorization for Special Issuance of a Medical Certificate
(Authorization) or a Statement of Demonstrated Ability (SODA) must
carry their Authorization or SODA with them when exercising pilot
privileges. In order to satisfy this ICAO obligation, the FAA has
amended existing Sec.  67.401(j) accordingly.

Paperwork Reduction Act

    As required by the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), the FAA submitted a copy of the amended information
collection requirements in this final rule to the Office of Management
and Budget for its review. The paperwork burdens and cost impact
associated with revising, reprinting, and re-distributing this form, as
described in the proposal, have been addressed and no longer apply as a
cost of the rule. OMB approved the collection of this information and
assigned OMB Control Number 2120-0034.

International Compatibility

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to comply with ICAO
Standards and Recommended Practices to the maximum extent practicable.
The intent of this final rule, in part, is to come into compliance with
existing ICAO medical assessment duration standards. Therefore, this
final rule will not create any differences with ICAO.

Regulatory Evaluation, Regulatory Flexibility Determination,
International Trade Impact Assessment, and Unfunded Mandates Assessment

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In developing U.S.
standards, this Trade Act requires agencies to consider international
standards and, where appropriate, that they be the basis of U.S.
standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub.
L.104-4) requires agencies to prepare a written assessment of the
costs, benefits, and other effects of proposed or final rules that
include a Federal mandate likely to result in the expenditure by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $100 million or more annually (adjusted for inflation with
base year of 1995). This portion of the preamble summarizes the FAA's
analysis of the economic impacts of this proposed rule. We suggest
readers seeking greater detail read the full regulatory evaluation, a
copy of which we have placed in the docket for this rulemaking.
    In conducting these analyses, FAA has determined that this final
rule: (1) Has benefits that justify its costs, (2) is not an
economically ``significant regulatory action'' as defined in section
3(f) of Executive Order 12866, (3) is not ``significant'' as defined in
DOT's Regulatory Policies and Procedures; (4) will not have a
significant economic impact on a substantial number of small entities;
(5) will not create unnecessary obstacles to the foreign commerce of
the United States; and (6) will not impose an unfunded mandate on
State, local, or tribal governments, or on the private sector by
exceeding the threshold identified above. These analyses are summarized
below.
    This rule extends the duration of first- and third-class medical
certificates for certain individuals. A first-class medical certificate
is required when exercising airline transport pilot privileges and at
least a third-class medical certificate when exercising private pilot
privileges. Certain conforming amendments to medical certification
procedures and some general editorial amendments also are adopted. The
intent of this action is to improve the efficiency of the medical
certification program and service provided to medical certificate
applicants. Over 10 years, this final rule is estimated to generate
$91.7 million ($68.9 million, discounted) of cost-savings.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (RFA) (Pub. L. 96-354)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    This final rule will not impact small entities. It will impact
primarily first- and third-class medical certificate holders who are
expected to save about $300.00 each time that they do not have to renew
their medical certificates. Consequently, as the Acting Administrator
of the Federal Aviation Administration, I certify that the rule will
not have a significant economic impact on a substantial number of small
entities.

International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39) prohibits Federal
agencies from establishing any standards or engaging in related
activities that create unnecessary

obstacles to the foreign commerce of the United States. Legitimate
domestic objectives, such as safety, are not considered unnecessary
obstacles. The statute also requires consideration of international
standards and, where appropriate, that they be the basis for U.S.
standards. The FAA has assessed the potential effect of this final rule
and has determined that it will have only a domestic impact and
therefore no effect on international trade.

Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(adjusted annually for inflation with the base year 1995) in any one
year by State, local, and tribal governments, in the aggregate, or by
the private sector; such a mandate is deemed to be a ``significant
regulatory action.'' The FAA currently uses an inflation-adjusted value
of $136.1 million in lieu of $100 million. This final rule does not
contain such a mandate. The requirements of title II do not apply.

Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action will not have a substantial direct effect on the States, or the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government, and, therefore, does not have federalism implications.

Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. If you are a small entity and you have a question
regarding this document, you may contact your local FAA official, or
the person listed under the FOR FURTHER INFORMATION CONTACT heading at
the beginning of the preamble. You can find out more about SBREFA on
the Internet at http://www.faa.gov/regulations_policies/rulemaking/
sbre_act/.

Good Cause for Immediate Adoption of Sec.  61.23(d)

    Section 553(d) of the Administrative Procedures Act requires that
rules become effective no less than 30 days after their issuance.
Paragraph (d)(1) allows an agency to make a rule effective immediately,
however, if the agency provides good cause for immediate adoption. The
FAA finds that good cause exists for immediate adoption of the
provisions of Sec.  61.23(d) of this final rule. Adopting Sec.
61.23(d) immediately--on the date of publication, rather than 30 days
after issuance--prevents individuals whose medical certificate might
expire within that 30-day interim from having to renew a medical
certificate that otherwise may have remained valid if not for the 30-
day effective date requirement.

List of Subjects

14 CFR Part 61

    Aircraft, Airmen, Aviation Safety, and Reporting and recordkeeping
requirements.

14 CFR Part 65

    Airmen other than flight crewmembers.

14 CFR Part 67

    Aircraft, Airmen, Alcohol abuse, Drug abuse, Recreation and
recreation areas, Reporting and recordkeeping requirements.

14 CFR Part 183

    Aircraft, Airmen, Authority delegations (Government agencies),
Reporting and recordkeeping requirements.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends chapter I of title 14, Code of Federal Regulations as follows:

PART 61--CERTIFICATION: PILOTS, FLIGHT INSTRUCTORS, AND GROUND
INSTRUCTORS

0
1. The authority citation for part 61 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701-44703, 44707, 44709-
44711, 45102-45103, 45301-45302.

0
2. Amend Sec.  61.23 by revising paragraph (d)(1) to read as follows:

Sec.  61.23  Medical certificates: Requirement and duration.

* * * * *
    (d) Duration of a medical certificate. (1) Use the following table
to determine duration for each class of medical certificate:

----------------------------------------------------------------------------------------------------------------
                                                                                Then your medical
                                      And on the date of                                certificate expires, for
            If you hold              examination for your   And you are conducting an    that operation, at the
                                     most recent medical      operation  requiring       end of the last day of
                                     certificate you were                                         the
----------------------------------------------------------------------------------------------------------------
(i) A first-class medical           (A) Under age 40.....  an airline transport pilot  12th month after the
 certificate.                                               certificate.                month of the date of
                                                                                examination shown on the
                                                                                medical certificate.
                                    (B) Age 40 or older..  an airline transport pilot  6th month after the month
                                                            certificate.                of the date of
                                                                                examination shown on the
                                                                                medical certificate.
                                    (C) Any age..........  a commercial pilot          12th month after the
                                                            certificate or an air       month of the date of
                                                            traffic control tower       examination shown on the
                                                            operator certificate.       medical certificate.
                                    (D) Under age 40.....  a recreational pilot        60th month after the
                                                            certificate, a private      month of the date of
                                                            pilot certificate, a        examination shown on the
                                                            flight instructor           medical certificate.
                                                            certificate (when acting
                                                            as pilot in command or a
                                                            required pilot flight
                                                            crewmember in operations
                                                            other than glider or
                                                            balloon), a student pilot
                                                            certificate, or a sport
                                                            pilot certificate (when
                                                            not using a U.S. driver's
                                                            license as medical
                                                            qualification).

                                    (E) Age 40 or older..  a recreational pilot        24th month after the
                                                            certificate, a private      month of the date of
                                                            pilot certificate, a        examination shown on the
                                                            flight instructor           medical certificate.
                                                            certificate (when acting
                                                            as pilot in command or a
                                                            required pilot flight
                                                            crewmember in operations
                                                            other than glider or
                                                            balloon), a student pilot
                                                            certificate, or a sport
                                                            pilot certificate (when
                                                            not using a U.S. driver's
                                                            license as medical
                                                            qualification).
(ii) A second-class medical         (A) Any age..........  a commercial pilot          12th month after the
 certificate.                                               certificate or an air       month of the date of
                                                            traffic control tower       examination shown on the
                                                            operator certificate.       medical certificate.
                                    (B) Under age 40.....  a recreational pilot        60th month after the
                                                            certificate, a private      month of the date of
                                                            pilot certificate, a        examination shown on the
                                                            flight instructor           medical certificate.
                                                            certificate (when acting
                                                            as pilot in command or a
                                                            required pilot flight
                                                            crewmember in operations
                                                            other than glider or
                                                            balloon), a student pilot
                                                            certificate, or a sport
                                                            pilot certificate (when
                                                            not using a U.S. driver's
                                                            license as medical
                                                            qualification).
                                    (C) Age 40 or older..  a recreational pilot        24th month after the
                                                            certificate, a private      month of the date of
                                                            pilot certificate, a        examination shown on the
                                                            flight instructor           medical certificate.
                                                            certificate (when acting
                                                            as pilot in command or a
                                                            required pilot flight
                                                            crewmember in operations
                                                            other than glider or
                                                            balloon), a student pilot
                                                            certificate, or a sport
                                                            pilot certificate (when
                                                            not using a U.S. driver's
                                                            license as medical
                                                            qualification).
(iii) A third-class medical         (A) Under age 40.....  a recreational pilot        60th month after the
 certificate.                                               certificate, a private      month of the date of
                                                            pilot certificate, a        examination shown on the
                                                            flight instructor           medical certificate.
                                                            certificate (when acting
                                                            as pilot in command or a
                                                            required pilot flight
                                                            crewmember in operations
                                                            other than glider or
                                                            balloon), a student pilot
                                                            certificate, or a sport
                                                            pilot certificate (when
                                                            not using a U.S. driver's
                                                            license as medical
                                                            qualification).
                                    (B) Age 40 or older..  a recreational pilot        24th month after the
                                                            certificate, a private      month of the date of
                                                            pilot certificate, a        examination shown on the
                                                            flight instructor           medical certificate.
                                                            certificate (when acting
                                                            as pilot in command or a
                                                            required pilot flight
                                                            crewmember in operations
                                                            other than glider or
                                                            balloon), a student pilot
                                                            certificate, or a sport
                                                            pilot certificate (when
                                                            not using a U.S. driver's
                                                            license as medical
                                                            qualification).
----------------------------------------------------------------------------------------------------------------

* * * * *

0
3. Amend Sec.  61.29 by revising paragraph (b) to read as follows:

Sec.  61.29  Replacement of a lost or destroyed airman or medical
certificate or knowledge test report.

* * * * *
    (b) A request for the replacement of a lost or destroyed medical
certificate must be made by letter to the Department of Transportation,
FAA, Aerospace Medical Certification Division, P.O. Box 26200, Oklahoma
City, OK 73125, and must be accompanied by a check or money order for
the appropriate fee payable to the FAA.
* * * * *

PART 65--CERTIFICATION: AIRMEN OTHER THAN FLIGHT CREWMEMBERS

0
4. The authority citation for part 65 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701-44703, 44707, 44709-
44711, 45102-45103, 45301-45302.

0
5. Amend Sec.  65.16 by revising paragraph (c) introductory text to
read as follows:

Sec.  65.16  Change of name: Replacement of lost or destroyed
certificate.

* * * * *
    (c) An application for a replacement of a lost or destroyed medical
certificate is made by letter to the Department of Transportation,
Federal Aviation Administration, Aerospace Medical Certification
Division, Post Office Box 26200, Oklahoma City, OK 73125, accompanied
by a check or money order for $2.00.
* * * * *

PART 67--MEDICAL STANDARDS AND CERTIFICATION

0
6. The authority citation for part 67 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701-44703, 44707, 44709-
44711, 45102-45103, 45301-45302.

0
7. Revise Sec.  67.3 to read as follows:

Sec.  67.3  Issue.

    A person who meets the medical standards prescribed in this part,
based on medical examination and evaluation of the person's history and
condition, is entitled to an appropriate medical certificate.

0
8. Add Sec.  67.4 to read as follows:

Sec.  67.4  Application.

    An applicant for first-, second- and third-class medical
certification must:
    (a) Apply on a form and in a manner prescribed by the
Administrator;
    (b) Be examined by an aviation medical examiner designated in
accordance with part 183 of this chapter. An applicant may obtain a
list of aviation medical examiners from the FAA Office of Aerospace
Medicine homepage on the FAA Web site, from any FAA Regional Flight
Surgeon, or by contacting the Manager of the Aerospace Medical
Education Division, P.O. Box 26200, Oklahoma City, Oklahoma 73125.
    (c) Show proof of age and identity by presenting a government-
issued photo identification (such as a valid U.S. driver's license,
identification card issued by a driver's license authority, military
identification, or passport). If an applicant does not have government-
issued identification, he or she may use non-photo, government-issued
identification (such as a birth certificate or voter registration card)
in conjunction with photo identification (such as a work identification
card or a student identification card).

0
9. Amend Sec.  67.401 by revising paragraph (j) to read as follows:

Sec.  67.401  Special issuance of medical certificates.

* * * * *
    (j) An Authorization or SODA granted under the provisions of this
section to a person who does not meet the applicable provisions of
subparts B, C, or D of this part must be in that person's physical
possession or readily accessible in the aircraft.

0
10. Revise Sec.  67.405 to read as follows:

Sec.  67.405  Medical examinations: Who may perform?

    (a) First-class. Any aviation medical examiner who is specifically
designated for the purpose may perform examinations for the first-class
medical certificate.
    (b) Second- and third-class. Any aviation medical examiner may
perform examinations for the second-or third-class medical certificate.

Sec.  67.411  [Removed and Reserved]

0
11. Remove and reserve Sec.  67.411.

0
12. Revise Sec.  67.413 to read as follows:

Sec.  67.413  Medical records.

    (a) Whenever the Administrator finds that additional medical
information or history is necessary to determine whether you meet the
medical standards required to hold a medical certificate, you must:
    (1) Furnish that information to the FAA; or
    (2) Authorize any clinic, hospital, physician, or other person to
release to the FAA all available information or records concerning that
history.
    (b) If you fail to provide the requested medical information or
history or to authorize its release, the FAA may suspend, modify, or
revoke your medical certificate or, in the case of an applicant, deny
the application for a medical certificate.
    (c) If your medical certificate is suspended, modified, or revoked
under paragraph (b) of this section, that suspension or modification
remains in effect until you provide the requested information, history,
or authorization to the FAA and until the FAA determines that you meet
the medical standards set forth in this part.

PART 183--REPRESENTATIVES OF THE ADMINISTRATOR

0
13. The authority citation for part 183 continues to read as follows:

    Authority: 31 U.S.C. 9701; 49 U.S.C. 106(g), 40113, 44702,
44721, 45303.

0
14. Amend Sec.  183.11 by revising paragraph (a) to read as follows:

Sec.  183.11  Selection.

    (a) The Federal Air Surgeon, or his or her authorized
representatives within the FAA, may select Aviation Medical Examiners
from qualified physicians who apply. In addition, the Federal Air
Surgeon may designate qualified forensic pathologists to assist in the
medical investigation of aircraft accidents.
* * * * *

0
15. Revise Sec.  183.15 to read as follows:

Sec.  183.15  Duration of certificates.

    (a) Unless sooner terminated under paragraph (b) of this section, a
designation as an Aviation Medical Examiner or as a Flight Standards or
Aircraft Certification Service Designated Representative as described
in Sec. Sec.  183.21, 183.23, 183.25, 183.27, 183.29, 183.31, or 183.33
is effective until the expiration date shown on the document granting
the authorization.
    (b) A designation made under this subpart terminates:
    (1) Upon the written request of the representative;
    (2) Upon the written request of the employer in any case in which
the recommendation of the employer is required for the designation;
    (3) Upon the representative being separated from the employment of
the employer who recommended him or her for certification;
    (4) Upon a finding by the Administrator that the representative has
not properly performed his or her duties under the designation;
    (5) Upon the assistance of the representative being no longer
needed by the Administrator; or
    (6) For any reason the Administrator considers appropriate.

    Issued in Washington, DC, on July 10, 2008.
Robert A. Sturgell,
Acting Administrator.
 [FR Doc. E8-16911 Filed 7-23-08; 8:45 am]

BILLING CODE 4910-13-P


MEMORANDUM

SUBJECT:	Key Issues Related to PM10-2.5 Speciation Monitoring

FROM:	Joann Rice, OAQPS/AQAD/AAMG

TO:	PM NAAQS Review Docket (EPA-HQ-OAR-2007-0492)

As part of the recent revision to the Ambient Air Monitoring Regulations
(U.S. EPA 2006a), PM10-2.5 speciation monitoring is required at National
Core (NCore) multi-pollutant monitoring stations by January 1, 2011.
PM10-2.5 speciation monitoring may also be useful in other locations
where characterization of thoracic coarse particle speciation would be
of high value.  This paper describes the PM10-2.5 speciation monitoring
requirements specified in the ambient air monitoring rule and provides
an overview of the monitoring issues, discussion of the potential use of
existing PM10-2.5 speciation sampling and analysis techniques in a pilot
study to inform the implementation and decision-making process, and
related research questions to inform the planning and implementation
process.  This document also serves as a discussion piece for obtaining
feedback and comments on the development and implementation of a
long-term PM10-2.5 speciation monitoring program.

INTRODUCTION

The EPA issued revisions to the Ambient Air Monitoring Regulations (40
CFR Parts 53 and 58) on October 17, 2006 (U.S. EPA 2006a).  The final
rule establishes ambient air monitoring requirements for an indicator of
thoracic coarse particles (PM10-2.5) to support continued research on
particle distribution, sources, and health effects. At the same time,
EPA also promulgated a new Federal Reference Method (FRM) for measuring
the mass concentration of PM10-2.5 in ambient air.  Although EPA is not
adopting a National Ambient Air Quality Standard (NAAQS) for PM10-2.5 at
this time, the FRM for PM10-2.5 is of value to aid in a variety of
research studies and the development of speciation samplers capable of
providing improved characterization and understanding of the composition
of thoracic coarse particles.

The final monitoring rule contains a requirement for PM10-2.5 speciation
at NCore multi-pollutant monitoring sites by January 1, 2011, with state
monitoring implementation plans due July 1, 2009.  As compared to the
proposed rule, the final rule increases the number of monitoring sites
from ~20 to ~75 and shifts the focus from urban monitoring to both urban
and rural monitoring locations.  Manually-operated PM10-2.5 speciation
samplers must operate on at least a 1-in-3 day schedule and be
collocated with PM2.5 speciation at NCore stations.  Since EPA is
requiring PM10-2.5 speciation monitoring primarily for scientific
purposes, it is appropriate to have monitoring at a variety of urban and
rural locations to increase the diversity of areas that will have
available chemical species data.  NCore will have about 75 sites mostly
in urban areas, with a subset of about 20 rural sites. For more
information on NCore, see:   HYPERLINK
"http://www.epa.gov/ttn/amtic/ncore/index.html"
http://www.epa.gov/ttn/amtic/ncore/index.html .

The primary objective for PM10-2.5 speciation data in the monitoring
rule is to support further research in understanding the chemical
composition and sources of PM10, PM10-2.5, and PM2.5.  In addition, more
specific uses for the data can be inferred and include:

Collection of PM10-2.5 composition data to inform health effect studies,
both in terms of the relationship between specific PM10-2.5 species and
health, and between PM emitted from different source types and health.

Advancement of PM10-2.5 speciation monitoring methods in anticipation of
wider use under a PM10-2.5 NAAQS if one is adopted later.

Use of PM10-2.5 speciation data to promote advancement of source
attribution methods.

Determination of spatial and temporal variations in PM10-2.5
concentrations in urban and rural environments.

PM10-2.5 SPECIATION MEASUREMENT ISSUES

The Criteria Document (CD), prepared for the previous PM NAAQS review,
provides an overview of the current information on coarse particle
formation, sources, composition, and mass measurement issues (U.S. EPA
2004).  No clear recommendations were given for an approach to
collecting PM10-2.5 speciation data.  It was noted that “satisfactory
techniques are available to separate fine particles from coarse
particles and to collect the fine particles on a filter.  However, no
consensus exists as yet on the best technique for collecting a coarse
particle sample for determination of mass and composition. Candidates
include multistage impaction, virtual impaction, and difference
(subtracting PM2.5 mass or composition from PM10 mass or
composition).”

Since the writing of the CD, the EPA Office of Research and Development
(ORD) has conducted a multi-site field evaluation of candidate
methodologies for PM10-2.5 mass (U.S. EPA 2006b).  Five PM10-2.5
measurement approaches were initially selected for study and included
virtual impaction (dichotomous sampling), difference, and continuous
methods.  In addition to continuous monitoring devices, integrated
filter-based monitors were used to collect filters for subsequent
speciation analysis.  The ORD results from speciation analyses of the
filters are pending and when available, can be used to inform this
planning process.  So far, ORD has found that when reconstructing
PM10-2.5 mass using the speciation results (sum of species), there is a
significant portion (10-50%) of the mass that is unaccounted for or
unidentified in some locations.  It is important to note that this
includes uncertainties associated with the factors used in
reconstructing mass (e.g., the factor used in conversion from OC to OM).
 Although the level of agreement between the reconstructed mass and the
measured mass was not always high, linear regression comparisons between
constructed mass and measured mass did show high correlation.  The
PM2.5, PM10-2.5 and PM10 mass comparisons of the dichotomous (dichot)
sampler with FRMs in Phoenix, AZ showed the dichot to be 10% higher for
PM2.5, 7% lower for PM10-2.5 and 4% lower for PM10. It was hypothesized
that the higher PM2.5 dichot mass was due to coarse particle intrusion
into the fine mode and significant measurement biases will occur only if
the coarse fraction of PM10 appreciably exceeds the PM2.5 size fraction,
as was seen in Phoenix.  Mass comparisons in other locations
(Birmingham, AL and Lindon, UT) showed very good agreement (± 4%)
between the dichots and FRMs for PM2.5, PM10-2.5 and PM10. High
correlations (R > 0.986) were found in all cases, indicating that the
response between the dichot and FRM is very consistent from one sampling
event to another.

Limited PM10-2.5 speciation monitoring studies have been conducted in
the U.S. and most of these studies were conducted using the difference
method.  The uncertainties and inconsistencies between the analytical
techniques used in these studies are unknown.  PM10-2.5 speciation has
been studied at both urban locations (Chow et al., 1996; Chow et al.,
1993; Sardar et al., 2005, Edgerton et al., 2005) and rural IMPROVE
monitoring locations (Eldred et al., 1997; Malm et al., 2007; Lee et
al., 2007).  Soil components (e.g., Si, Al, Ti, Ca, Fe, K), and organic
carbon (OC) were consistently found to be dominant components of
PM10-2.5 and the significance of nitrate and sulfate found was dependent
on the location studied.  For coarse mass in rural locations, Malm et
al. (2007) found the soil components (61%) and particulate organic
carbon mass (24%) to be the major components, with nitrate at 8%,
elemental carbon (EC) at 1%, sea salt at only 2%, and sulfate as
negligible.  Particulate organic carbon mass was defined as OM = OC*1.8.
 In southeastern urban locations, Edgerton et al., (2005) found similar
results to Malm et al. (2007), but also showed a significant portion
(26-38%) of the reconstructed PM10-2.5 mass to be unidentified when
accounting for OM as OC*1.4 and on the order of 16-23% when using OM as
OC*2.5.  In the San Joaquin Valley, Chow et al., (1996) also found total
carbon aerosol (TC); ions (e.g., nitrate, sulfate, sodium, chloride);
and soil components to be abundant in the PM10 fraction and in Southern
California, Sardar et al., (2005) found the soil components, OC and
nitrate to be dominant.

A list of coarse particle constituents was provided in the Criteria
Document and includes suspended soil or dust; fly ash;
nitrates/chlorides/sulfates; soil components (Si, Al, Ti, Ca, Fe); sea
salt; tire/brake/road wear debris; and biological materials.  Not all of
these components can be measured directly through a filter-based
speciation monitoring program (e.g., fly ash, tire/brake/road wear
debris); however, some components or species may be represented by
components that can be measured with existing techniques used for PM2.5
speciation (e.g., sodium and chloride ion for sea salt).

The current PM10-2.5 FRM difference method, dichotomous sampler, and
current speciation filter-based samplers serve as logical choices for
the basis of a PM10-2.5 speciation sampler design.  A combination of
filter types and analytical methods are currently being used in both the
PM2.5 Chemical Speciation Network (CSN) and IMPROVE monitoring programs
to collect components of PM2.5.  These existing techniques can also be
applied to a PM10-2.5 speciation monitoring program, but not without
some complication.

The FRMs for PM2.5 and PM10 (low-volume sampling at 16.7 Lpm) provide
relatively precise (within ± 10%) methods for determining the mass on a
Teflon filter.  However, uncertainties remain about the relationship
between the mass and composition of material remaining on the filter as
determined by the FRM and the mass and composition of material that
existed in the atmosphere.  Measurement errors of concern for PM10
sampling include uncertainty in cut point tolerances, particle bounce
and re-entrainment, impaction surface overloading, and losses to sampler
internal surfaces (U.S.EPA 2004).  Another measurement uncertainty for
PM2.5 sampling is the potential for inclusion of a small fraction of
coarse particles in the fine mass fraction under some circumstances.

Modification of the PM2.5 speciation sampler inlets to PM10 was
suggested by CASAC (EPA-SAB-CASAC-CON-04-005) as an option for PM10-2.5
speciation by difference.  This may be a viable alternative as long as
both speciation samplers have identical flow rates, filter sizes, and
filter handling procedures.  One limitation of the most widely used
PM2.5 speciation sampler (MetOne SASS) is the difference in flow rate
(6.7 Lpm) from the PM2.5 and PM10 FRMs (16.7 Lpm).  Differences in flow
rates result in differences in filter face velocity and pressure drop
across the filters, which may adversely affect the volatile species and
subsequent comparison of mass closure or reconstructed mass with the FRM
total mass; however, volatility issues are most likely less important
for PM10-2.5 particles than for PM2.5.

PM10-2.5 FRM Difference Method

As is the case with all PM measurement methods, uncertainties exist with
the PM10-2.5 difference method. These include data loss if either the
PM2.5 or the PM10 sampler fails; uncertainties in flow rate and filter
weights (both before use and after collection and equilibration of
particles); and uncertainties due to the loss of semi-volatile
components which may occur for each size cut.  Allen et al. (1999) have
suggested ways to improve coarse particle difference measurements by
instituting careful control of sampling aspects (e.g., flow rate
control), management of gravimetric analysis issues, and proper
implementation of field blanks.  The viability of PM10-2.5 speciation by
a difference method requires further evaluation.  However, preliminary
regression comparisons for speciation by difference and the dichot
method have shown high levels of agreement and high correlation for
predominant species.  While there is currently no consensus on whether
the mixing of PM2.5 and PM10-2.5 aerosols causes a bias in either
measurement, CASAC mentioned the need for sampling separation and
collection of filters with only coarse particles to avoid mixing of
PM2.5 and coarse particles and the potential for subsequent chemical
interaction.  Allen et al. (1999) also mentions the importance of
maintaining filter flow rates greater than 10 Lpm, preferably 16.7 Lpm,
to avoid degraded precision.  As mentioned above, the most widely used
speciation sampler has a flow rate of 6.7 Lpm. per channel.  The impact
of this low flow rate should be evaluated if the low-flow speciation
samplers are used for PM10-2.5 by difference.

Dichotomous Samplers (Dichots)

continues to evaluate and characterized virtual impactors.  As mentioned
previously, results from the multi-site evaluation of PM2.5, PM10-2.5
and PM10 mass comparisons of the dichotomous sampler with FRMs showed
very good agreement (except in Phoenix) and very good correlations (U.S.
EPA 2006b).

PM10-2.5 Species or Components

Table 1 provides a list of candidate or potential PM10-2.5 species that
can be measured with the existing PM2.5 speciation methods.  The
specific species that need to be measured for PM10-2.5 must be
identified in order to design a monitoring program.  For example, ions
(e.g., nitrate and sulfate) have been identified as only minor
components of PM10-2.5 in some locations.  It is not clear whether the
resources to measure ions are needed to support research needs for
PM10-2.5 speciation.  Elemental analysis methods (e.g., X-Ray
Fluorescence) can provide sulfur, potassium, chloride, and sodium
elements; therefore, it needs to be determined if these elements are
sufficient surrogates for the information needed for PM10-2.5.  If ions
are not needed, then it would eliminate the need to collect an
additional filter (nylon) and resources for an additional lab analysis.
In addition, the need for elements by XRF versus extractable or water
soluble elements by ICP/MS should be determined.

Table 1. List of Candidate PM10-2.5 Species

Species	Filter Type	Denuder	Analysis Method

PM10-2.5 Gravimetric Mass	Teflon	None	Filter weighing

Elements:

Crustal or soil (Si, Al, Ti, Ca, Fe)

Several other elements currently measured routinely for PM2.5,
including: K, Cl, P, Mg, Cr, etc.	Teflon	None	EDXRF (Energy Dispersive
X-Ray Fluorescence) or alternative extraction method

Soluble Ions

Nitrate, sulfate, sodium, potassium, chloride, ammonium	Nylon or Teflon
MgO	Ion Chromatography

Carbon

Organic and Elemental Carbon

Carbonate Carbon	Quartz	None	Thermal Optical Reflectance (TOR) and
transmittance (TOT) by IMPROVE_A

Separate acidification and analysis

Biological Material (Bioaerosols)

	Teflon or Quartz	None	Scanning Electron Microscopy (SEM) or

Total Protein Assay as indicator

Fly ash	Teflon	None	Scanning Electron Microscopy (SEM)

Potential issues with XRF measurement of particles have been identified.
 XRF is typically done under vacuum to improve performance, enhance
detection limits, and reduce contamination of detector sources.  Use of
XRF under vacuum and the loss of volatile nitrate (as much as 30%) have
been demonstrated (U.S. EPA 2001).  In the PM2.5 speciation program, the
effects of vacuum are eliminated by analyzing the filter for mass prior
to analysis of elements by XRF.  A separate, denuded nylon filter is
used for nitrate and other ionic species.  Large or coarse particle size
effects may also be problematic for XRF.  Larger particles (greater than
3 micrometers) may absorb some of the incident and emitted x-rays for
light elements such as sodium, magnesium, aluminum, silicon, phosphorus,
sulfur, chlorine, and potassium (Chow 1995).  Absorption corrections
procedures for particle size effects on XRF results can be applied (Van
Dyck et al., 1985) and these factors will have to be optimized for
PM10-2.5 element analysis by XRF.  Another issue to consider is the
sensitivity of XRF and the sampling method or sampler chosen.

Alternative techniques like Inductively Coupled Plasma/Mass Spectrometry
(ICP/MS).  ICP/MS have some advantages (e.g., improved detection limits
for many species but lower for some), but also some disadvantages which
include increased cost, labor intensive sample preparation, the need for
strong acid extraction, incomplete extraction efficiencies, and sample
filter destruction (XRF is a non-destructive analysis).  If the particle
size effects are addressed with XRF and the method sensitivity is
adequate for dichotomous sampling, then XRF may be a more appropriate
choice for elemental analysis.

PM10-2.5 organic and elemental carbon (OC and EC) species can be
measured using the same thermal-optical analysis (TOA) method that is
used for PM2.5 speciation.  It is well known that both positive and
negative OC sampling artifacts exist (Eatough et al., 1990; Turpin et
al., 1994, Mader et al., 2001).  Some of the positive artifact can be
addressed by the use of backup quartz filter collection and subsequent
subtraction.  The artifact correction method to be applied to the urban
PM2.5 CSN is currently being evaluated and developed.  Once developed,
it will need to be evaluated for use in the PM10-2.5 program.  Organic
vapor denuders are not currently being used for either the PM2.5 CSN or
IMPROVE programs.  Although denuders may be appropriate, they are still
not ready for “prime time” and may introduce negative OC artifacts
due to the disruption of the gas-particle equilibrium during sampling.
Han et al., (2007) mention an interference with metal oxides (e.g., iron
oxides) and TOA analysis; whereby certain metal oxides can serve as a
source of O2 in the helium atmosphere.  Since the soil component of
PM10-2.5 is expected to be significant, any effects of metal oxides on
the OC and EC results will need to be explored.  Carbonate carbon may
also be a significant constituent of PM10-2.5 and a separate punch from
the quartz filter will have to be analyzed to quantify it.

Biological materials (bioaerosols) are collected with the filter-based
particle sampling techniques used for PM10-2.5 or PM2.5 monitoring and
included in the OC measurement, but are not quantified separately from
other components.  If bioaerosol species (e.g., pollens and molds) need
to be qualitatively or quantitatively identified for the PM10-2.5
speciation program, an appropriate measurement technique will need to be
identified (or developed) and evaluated.  Some biological materials can
be identified using the scanning electron microscopy (SEM) technique
(U.S. EPA 2002).  Existing bioaerosol monitoring programs (e.g.,
BioWatch) collect particles using filters and qualitatively test for
biological pathogens (e.g., anthrax). Total protein has been measured
from filters with an assay technique and used as an indicator of total
biological material (Menetrez et al, 2007). The specific bioaerosol
species of interest (or indicator/surrogate species) need to be
specified in order to explore appropriate collection and analysis
techniques.

Fly ash is also included in the list of PM10-2.5 constituents of
interest in the CD.  Like bioaerosols, fly ash is collected with the
filter-based particle sampling techniques used for PM10-2.5 or PM2.5,
but not quantified separately from other components.  If fly ash is
needed for the PM10-2.5 speciation program, an appropriate measurement
technique will need to be identified or developed and evaluated.  Some
fly ashes can be identified using the SEM analytical technique (U.S. EPA
2002).

NETWORK DESIGN ISSUES

The final monitoring rule contains a requirement for PM10-2.5 speciation
at NCore multi-pollutant monitoring sites by January 1, 2011.  As
mentioned previously, this was revised from the proposed rule.  The
NCore will have about 75 sites mostly in urban areas, with a subset of
about 20 rural sites.  Spatially, the candidate NCore locations (see
map) may not be the best choice for PM10-2.5 speciation given that the
highest PM10-2.5 mass concentrations are in the Southwest and Southern
CA (summer peak).  The NCore site selection is based on representative
monitoring to provide community-wide characterization of exposure and
sites leveraged with other measurement systems (e.g., PAMS, NATTS).
Since PM10-2.5 mass is more likely to be influenced by local sources or
wind-blown dust in areas with little vegetation, NCore is not
necessarily the optimal design for PM10-2.5 speciation.  The spatial
adequacy and representativeness of the NCore sites for long-term
PM10-2.5 speciation monitoring will need to be evaluated.

PM10-2.5 MONITORING PLAN AND METHOD RESEARCH NEEDS

There are still many unanswered questions regarding PM10-2.5 speciation
monitoring; however, a few PM10-2.5 by difference and dichotomous
monitoring sites (3 to 5 locations) should be used for pilot monitoring
to answer some of the questions outlined below and to fine tune the
final monitoring approach. The CASAC (EPA-SAB-CASAC-CON-04-005)
expressed concerns about speciation by difference due to the cumulative
effects of the imprecision in both PM2.5 and PM10 measurements.  White
(1998) showed the uncertainty in coarse mass by difference to be about 3
times the uncertainty in the fine measurement.  An evaluation of the
practicality and validity of PM10-2.5 speciation by difference method is
needed.  The CASAC comments also leaned toward virtual impaction and
felt it had significant advantages (e.g., collects the PM10-2.5 size
fraction directly).  For those PM10-2.5 species that are in common with
the PM2.5 speciation program, the existing National Laboratory Contract
for PM2.5 speciation can be used to analyze the filters.  In order to
sample for the current suite of species in the PM2.5 speciation program
(including ions) by difference, identical PM10 versions of the PM2.5
speciation sampling devices can be collocated with existing PM2.5
samplers.  PM10 sharp cut cyclones would need to be commercially
available at a flow rate of 6.7 Lpm for the MetOne SASS speciation
samplers and the vendor has been contacted about developing and
characterizing such cyclones.  A PM10 cyclone is already available for
the 22 Lpm speciation carbon sampling device.  The existing SASS sampler
could be retrofitted to have two PM2.5 channels with Teflon and nylon
filters and two PM10 channels with Teflon and nylon filters if needed.
One additional PM10 speciation carbon sampler would need to be
collocated with the existing PM2.5 sampler for OC/EC aerosol species.
If PM10-2.5 speciation was based on the dichotomous sampler, it would
require three samplers at each location to collect the Teflon, nylon,
and quartz filters for speciation if elements, ions, and carbon species
are needed.

Some of the questions relevant to PM10-2.5 speciation monitoring are
outlined below:

What are the important PM10-2.5 species to measure?

Are ions important PM10-2.5 species? If so, what ions should be on the
target species list?

What are the PM10-2.5 speciation sampling artifacts that may be
encountered and how should they be addressed in the monitoring program?
Is speciation by the difference method problematic for PM10-2.5
speciation and if so what specific issues make it problematic?

The current and most widely used PM2.5 speciation sampler is the MetOne
SASS and it has a flow rate of 6.7 Lpm which is significantly lower than
either the FRM for PM10-2.5 mass or the dichotomous sampler (16.7 Lpm).
If this sampler was configured to do PM10-2.5 by difference, would the
6.7 Lpm flow rate be problematic, especially with our knowledge of
concerns about low-flow cut-points and particle intrusion, and the need
to compare to what is collected by the PM10-2.5 FRM for mass?

What analysis methods should be used? What PM2.5 speciation analysis
methods are appropriate to also use in the PM10-2.5 speciation program?

Is XRF the most appropriate method for PM10-2.5 speciation? Can the
complication of particle size and absorption effects in XRF be
adequately resolved using absorption correction factors? Does XRF
provide adequate sensitivity (detection limits)?  If XRF sensitivity is
not adequate, should some other more sensitive and potentially more
expensive and destructive analytical technique be considered? If an
elemental method that has more sensitivity and applies acid extraction
is needed, is the recovery of extractable metals adequate versus total
metals by XRF?

Are metal oxides a significant source of interference in thermal-optical
analysis (TOA) of PM10-2.5 for OC and EC given the large expected soil
component?

If biological particles and fly ash need to be characterized, what
specific types of biological materials and fly ashes should be measured?
What analysis methods should be used to identify and quantify these
species? Is scanning electron microscopy (SEM) on Teflon filters
adequate to quantify and identify the biological material present? Is
the use of other assay techniques necessary to adequately obtain a
quantitative indicator (e.g., total protein) of the total biological
material present?

When reconstructing PM10-2.5 mass using the sum of PM10-2.5 species
concentrations, a significant portion of unidentified mass has been
identified. Are there other PM10-2.5 target species or analysis methods
that can be used to help identify the source of this mass in order to
reduce the amount of unidentified mass and obtain better mass closure?

What factors should be considered in the selection of pilot monitoring
site locations or areas? One key issue in the proposed PM rule (January
2006) was the need to distinguish urban from rural coarse particles.
What pilot site selection criteria would help in selecting urban and
rural sites for collecting data to address this issue? What analysis
methods or target species are particularly important to inform this
issue?

Various sampling devices, including dichotomous samplers, MetOne SASS
speciation monitors, PM10 and PM2.5 FRMs are potential sampling devices
(with the appropriate filter types) for PM10-2.5 speciation. Which of
these sampler types should be included or excluded from the pilot
network design?

Additional information may be provided to inform some of the questions
above when ORD publishes results on PM10-2.5 speciation from the
multi-city field evaluation.  In addition, any pilot monitoring program
that is developed and implemented for PM10-2.5 speciation may also
provide information to resolve some of these issues.

QUALITY ASSURANCE (QA)

The PM10-2.5 speciation monitoring program is expected to follow similar
requirements as specified for the PM2.5 speciation monitoring program,
which include collocation for precision estimates and sampler flow-rate
audits.  PM10-2.5 species-specific goals for bias and precision have not
been specified.  Additional QA procedures and possibly DQOs will need to
be developed for PM10-2.5 speciation.

REFERENCES

Allen, G.A., Oh, J.A., Koutrakis, P., Sioutas, C. (1999). Techniques for
High-Quality Ambient Coarse Particle Mass Measurements, Journal of the
Air & Waste Management Association 49, PM-133-141.

Chow, J.C., Watson, J.G., Lowenthal, D.H., Solomon, P.A., Magliano,
K.L., Ziman, S.D., Richards, L.W. (1993). PM10 and PM2.5 Compositions in
California’s San Joaquin Valley, Aerosol Science and Technology 18,
105-128.

Chow, J.C. (1995). Measurement Methods to Determine Compliance with
Ambient Air Quality Standards for Suspended Particles, Journal of the
Air & Waste Management Association 45, 320-382.

Chow, J.C., Watson, J.G., Lu, Z., Lowenthal, D.H., Frazier, C.A.,
Solomon, P.A., Thuillier, R.H., Magliano, K. (1996). Descriptive
analysis of PM2.5 and PM10 at Regionally Representative Locations during
SJCAQS/AUSPEX, Atmospheric Environment: 30 (12), 2079-2112.

Eatough, D.J., Aghdaie, N., Cottam, M., Gammon, T., Hansen, L.D., Lewis,
E.A., Farber, R.J. (1990). Loss of Semi-volatile Organic Compounds from
Particles during Sampling on Filters, In: Mathai, C.V. (Ed.),
Transaction of Visibility and Fine Particles, Air and Waste Management
Association, Pittsburgh, PA, pp. 146-156.

Edgerton, E.S., Hartsell, B.E., Saylor, R.D., Jansen, J.J., Hansen,
D.A., Hidy, G.M. (2005). The Southeastern Aerosol Research and
Characterization Study: Part II. Filter-based Measurements of Fine and
Coarse Particulate Matter Mass and Composition, Journal of the Air &
Waste Management Association 55, 1527-1542.

Eldred, R.A., Cahill, T.A., Focchini, R.G. (1997). Composition of PM2.5
and PM10 Aerosols in the IMPROVE Network, Journal of the Air & Waste
Management Association 47, 194-203.

EPA-SAB-CASAC-CON-04-005. Clean Air Scientific Advisory Committee
(CASAC) Ambient Air Monitoring and Methods (AAMM) Subcommittee
Consultation on Methods for Measuring Coarse-Fraction Particulate Matter
(PMc) in Ambient Air (July 2004).

Han, Y., Cao, J., An, Z., Chow, J.C., Watson, J.G., Jin, Z., Fung, K.,
Liu, S. (2007). Evaluation of the thermal/optical reflectance method for
quantification of elemental carbon in sediments, Chemosphere (69),
526-533.

Lee, T., Yu, X-Y., Ayres, B., Kreidenweis, S.M., Malm, W.C., Collett, J.
L., (2007). Observations of fine and coarse particle nitrate at several
rural locations in the United States. Atmospheric Environment (2007),
doi:10.1016/j.atmosenv.2007.05.016.

Loo, B.W. and Cork C.P. (1988). Development of high efficiency virtual
impactors, Aerosol Science & Technology (9), 167–176.

Mader, B.T. and Pankow, J.F. (2001). Gas/solid Partitioning of
Semivolatile Organic Compounds (SOCs) to Air Filters. 3. An Analysis of
Gas Adsorption Artifacts in Measurements of Atmospheric SOCs When Using
Teflon Membrane Filters and Quartz Fiber Filters, Environ. Sci. Technol.
35:3422-3432.

Malm, W.C., Pitchford, M.L., McDade, C., Ashbaugh, L.L. (2007). Coarse
Particle Speciation at Selected Locations in the Rural Continental
United States, Atmospheric Environment 41, 2225-2239.

Menetrez, M.Y., Foarde, K.K., Esch, R.K., Dean, T.R., Betancourt, D.A.,
Moore, S.A., Svendsen, E.R., and Yeatts, K. (2007). The Measurement of
Ambient Bioaerosol Exposure, Aerosol Science and Technology, 41:
884-893.

Querol, X., Minguillon, M.C., Perez, N., Alastuey, A., Viana, M.,
Morenao, T., Bernabe, R.M., Blanco, S., Cardenas, B., Vega, E., Sosa,
G., Escalona, S., Ruiz, H., and Artinano, B. (2007). PM Speciation and
Sources in Mexico During the MILAGRO-2006 Campaign, Atmospheric
Chemistry & Physics Discussion, 7, 10589-10629.

Sardar, B.S., Fine, P.M., Sioutas, C. (2005). Seasonal and spatial
variability of the size-resolved chemical composition of particulate
matter (PM10) in the Los Angeles Basin, Journal of  Geophysical
Research, Vol. 110, D07S08.

  SEQ CHAPTER \h \r 1 Turpin, B.J., Huntzicker, J.J., and Hering, S.V.
(1994). Investigation of Organic Aerosol Sampling Artifacts in the Los
Angeles Basin, Atmos. Environ. 28(19):3061-3071.

U.S. EPA 2001. Evaluation of PM2.5 Chemical Speciation Samplers for Use
in the EPA  National PM2.5 Chemical Speciation Network, Office of Air
Quality Planning and Standards, May 2001; EPA-454/R-01-005.

U.S. EPA 2002. Guidelines for the Application of SEM/EDX Analytical
Techniques to Particulate Matter Samples, Office of Research and
Development, September 2002; EPA-600/R-02/070.

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II; October 2004; EPA-600/P-99/002aF.

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Monitoring Regulations, Federal Register, Vol. 71, No. 200, October 17,
2006.

U.S. EPA 2006b. Multi-site Evaluations of Candidate Methodologies for
Determining Coarse Particulate Matter (PM10-2.5) Concentrations: August
2005 Updated Report Regarding Second-Generation and New PM10-2.5
Samplers; September 2006; EPA-600/R-06/093.

Van Dyck, P., Markowicz, A., and Van Grieken, R. (1985). Influence of
Sample Thickness, Excitation Energy and Geometry on Particle Size
Effects in XRF, X-Ray Spectrometry, Vol. 14 (4), 183-187.

White, W. (1998). Statistical Considerations in the Interpretation of
Size-Resolved Particulate Mass Data,  Journal of the Air & Waste
Management Association, 48:454-458.

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Figure taken from EPA 2006b

Figure taken from EPA 2006b


Kyle Pitsor Vice President, Government Relations National Electrical Manufacturers Association 1300 North 17th Street, Suite 1847 Rosslyn, Virginia 22209 Dear Mr. Pitsor:

This letter is in response to your May 6, 2005, letter to the United States Environmental Protection Agency's ( EPA) Docket Center concerning a March 8, 2005, Federal Register comment request for the proposed information collection for the National Emission Standards for Hazardous Air Pollutants ( NESHAP) for Surface Coating of Miscellaneous Plastic Parts at 40 CFR Part 63, Subpart MMMM ( Subpart MMMM). See 70 FR 11239.

Leonard Lazarus of my staff discussed your letter in May 25, 2005, and June 6, 2005, telephone conversations with Richard LaLumondier of the National Electrical Manufacturers Association and Everett Scherrer of Rea Magnet Wire. We appreciate your letter and the discussions, which clarified the unique burdens and costs experienced by magnet wire facilities complying with Subpart MMMM. In response to your concerns, we have incorporated additional costs into our information collection request ( ICR), EPA ICR Number 2056.02. These costs include capital/ startup costs of $ 500,000 incurred over a three year period by each magnet wire facility to install a compliance parameter monitoring system ( CPMS), as well as a $ 50,000 per year cost for maintenance of the system. We have also adjusted burden for each magnet wire facility to be twenty times the typical industry burden in order to monitor and inspect equipment and gather, process, compile and review data needed to prepare reports.

Your letter suggests that the 40 CFR Section 63.10( e)( 3)( ii)( A) reference to quarterly submittal of excess emissions and continuous monitoring system performance reports may require quarterly reporting of the rolling 12 month organic hazardous air pollutant ( HAP) emission rate calculated by each facility. However, as explained in the May 25, 2005, telephone conversation with Mr. Lazarus, 40 CFR Section 63.10( e)( 3)( i) calls for semiannual submission of compliance reports unless more frequent reporting is specifically required by the standard, or by the Administrator as determined on a case by case basis. To my knowledge, the Administrator has not requested quarterly reports from any magnet wire facility. Therefore, such facilities only need to submit the required semiannual reports as specified at 40 CFR Section 63.3920( a). 2 You also requested that magnet wire facilities be permitted to reduce the reporting of startup/ shutdown and malfunction ( SSM) events and excess emissions events, keeping the same records they do now, but submitting reports of routine SSM without significant hazardous air pollutant ( HAP) emissions only upon state or EPA regional office request. SSM and excess emissions reporting are required for all NESHAP regulated facilities under 40 CFR Sections 63.10( d)( 5) and 63.10( e)( 3) of the General Provisions. Although the reporting activities may be characterized as routine, the semiannual reports are an important tool allowing regulatory authorities to evaluate the continuous compliance status of a facility. Many magnet wire facilities record data electronically using automatic process monitoring which can be submitted electronically to regulatory agencies. As Mr. Lazarus suggested, you should discuss the possibility of utilizing electronic submittals with your state and/ or EPA regional office contacts to reduce the reporting burden.

It may be possible for a magnet wire facility to further reduce its burden through alternative reporting. To request alternative reporting approval, the facility should demonstrate to its EPA regional office how it proposes to meet the NESHAP requirements through reporting in an alternative format. Approval of an alternative reporting request would be on a case by case basis.

Any change in the reporting requirements contained in Subpart MMMM would require an amendment of the standard. The Office of Air Quality Planning and Standards develops NESHAPs for EPA and is the appropriate contact for discussion of rule amendments. To petition for such a change, contact Ms. Kim Teal at the EPA Office of Air Quality Planning and Standards, Coatings and Consumer Products Group, Emission Standards Division ( C539   03), Research Triangle Park, North Carolina 27711, or at telephone number ( 919) 541   5580, or by email at teal. kim@ epa. gov.

Finally, we agree that HAP emissions are calculated for total organic HAPs rather than for each individual HAP. 40 CFR Section 63.3890 establishes limits on organic HAP emissions. These limits are specified as kilograms ( pounds) organic HAP per liter ( gallon) coating solids used during a 12 month compliance period. The limits apply to total organic HAP emissions from the affected source.

If you have any further questions, please contact Leonard Lazarus at ( 202) 564 6369, or by email at lazarus. leonard@ epa. gov.

Very truly yours,

Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance cc: EDocket OECA 2005 0003