Review of the National Ambient Air Quality Standards for Particulate Matter Scientific and Technical Background Briefing Office of Air and Radiation, USEPA November 8, 2005 2 Overview

We're nearing the completion of the review of the 1997 standards for particulate matter

The decision is an important one for the nation, and must be complete by September 2006.

This briefing will provide background on how we review air standards and technical and scientific details on particles and their health and environmental effects 3 Overview of NAAQS Review Process

The Clean Air Act calls for national ambient air quality standards ( NAAQS) for common air pollutants, based on the latest scientific criteria

" Primary" standards are those ` requisite' to ` protect public health' with an ` adequate margin of safety;'

" Secondary" standards protect public welfare and the environment ( visibility, crops, vegetation, wildlife, buildings & national monuments, climate)

EPA has set NAAQS for six common air pollutants:

ground level ozone ( smog), particulate matter, carbon monoxide, lead,

nitrogen dioxide, sulfur dioxide

EPA considers only human health and environmental effects in setting the NAAQS

EPA considers costs and time to attain cleaner air in achieving the standards

The Act requires EPA to review the scientific criteria and these standards at least once every five years, with advice from the Clean Air Scientific Advisory Committee ( CASAC) 4 Scientific studies related to health and environmental effects EPA Criteria Document:

integrative assessment of scientific studies EPA Staff Paper:

policyrelevant assessments leading to staff recommendations on standards Scientific peer review of published studies Reviews by CASAC and the public Reviews by CASAC and the public Public hearings and comments on proposal EPA proposed decision on standards EPA final decision on standards Interagency review We are here PM NAAQS Review  Process 5

Final PM Air Quality Criteria Document  October 2004

Final PM Staff Paper   June 2005

CASAC letters and recommendations   June and September 2005

Rulemaking on PM NAAQS:

Federal Register proposal to be signed by December 20, 2005

Public comment period: 90 days

Final Federal Register notice to be signed by September 27, 2006

Simultaneous Rulemakings:

° PM NAAQS, FRM, & Data Handling ( Part 50)

° Ambient Air Monitoring Regulations: Requirements for Reference and Equivalent Methods, Network Design Requirements ( Parts 53 & 58)

° Exceptional & Natural Events PM NAAQS Review  Schedule Web address for Staff Papers:

http:// www. epa. gov/ ttn/ naaqs/ standards/ pm/ s_ pm_ cr_ sp. html 6 Anatomy of a NAAQS

Four major components of standards that determine degree of protection:

 Indicator: e. g., PM10, PM2.5, O3, SO2  Averaging Time: e. g., 1 hr, 24 hr,

annual average  Form: e. g., number of exceedances,

percentile, mean  Level: e. g., 15 µ g/ m3 7 History of Particulate Matter NAAQS

1971   EPA promulgates NAAQS for " total suspended particulate" ( particles smaller than ~ 25 45 µ m in diameter)

1987   EPA revises PM NAAQS, changing the indicator from TSP to PM 10 to focus on " inhalable"

particles (< 10 µ m)

1997   EPA revises PM NAAQS to focus separately on the " fine" and " coarse" fractions of PM 10

New standards established for " fine" particles < 2.5 µ m in diameter ( PM2.5)

PM10 standards retained to focus on " coarse fraction" ( particles between 2.5 and 10 µ m in diameter)

A number of events delayed the implementation of PM2.5.

Industry organizations and state governments challenged EPA in the U. S. District Court.

In 2001, the U. S. Supreme Court upheld EPA's authority under the Clean Air Act to set standards.

Several unresolved issues were sent back to the District Court.

In 2002, the District Court rejected all remaining legal challenges to EPA's 1997 standards for PM2.5.

 2004 EPA designated 224 counties, as well as DC, as not meeting the standards for PM2.5.

 2005 6   Complete review/ revision of PM NAAQS ( process underway) 8 Relative Mass 0.1 0.3 2.5 1.0 10 100 30 Particle Diameter, um PM2.5 PM10 TSP Typical Urban PM Size Distribution PM10 2.5 Particle Diameter, µ m PM10 2.5 Fine Particles Combustion, gases to particles Sulfates/ acids Nitrate Ammonium Organics Carbon Metals Water Sources Coal, oil, gasoline, diesel, wood combustion Transformation of SOx, NOx, organic gases including biogenics High temperature industrial processes ( smelters, steel mills)

Forest fires Exposure/ Lifetime Lifetime days to weeks, regional distribution over urban scale to 1000s of km Coarse Particles Crushing, grinding, dust Resuspended dusts ( soil, street dust) Coal/ oil fly ash Aluminum, silica, iron oxides Sea salt Tire wear Biological Materials ( Pollen, mold,

plant/ insect fragments)

Sources Resuspension of dust tracked onto roads Suspension from disturbed soil ( farms, mines, unpaved roads Construction/ demolition Industrial fugitives Biological sources, sea spray Exposure/ Lifetime Coarse fraction ( 2.5 10) lifetime of hours to days, distribution over smaller scales up to 100s km PM Components: fine and coarse 9 Public Health Risks of are significant 1997 review found PM linked to:

Premature death from heart and lung disease

Aggravation of heart and lung diseases

Hospital admissions

Doctor and ER visits

Medication use

School and work absences  . all at levels permitted by the old PM10 NAAQS

And possibly to

Lung cancer deaths

Infant mortality

Developmental problems, such as low birth weight,

in children  Fine particles ( PM 2.5 ) appeared to present the most significant risks, including 10s of thousands of premature deaths 10 1997 PM NAAQS Decision

New standards established for PM2.5  " Generally controlling" annual standard set at 15 µ g/ m3 ° Averaged over 3 years, with allowance for spatial averaging of monitors within certain constraints  " Supplemental" 24 hour standard set at 65 µ g/ m3, to protect against peak concentrations that might occur due to strong local or seasonal sources over limited areas and/ or time periods ° Annual 98th percentile, averaged over 3 years

PM10 standards were retained to focus on " coarse fraction"

particles ( between 2.5 and 10 µ m)

 50 µ g/ m3, annual average  150 µ g/ m3, 24 hr average, but form of standard changed to 99th percentile 11 PM2.5 and Ozone Nonattainment Areas Designated Nonattainment PM2.5 only*

Both 8 hour Ozone and PM2.5*

8 hour Ozone Only * For PM2.5, the designated partial county areas are shown as actual boundaries designated. OAQPS, AQSSD April 28, 2005 12

Hundreds of new short term exposure studies  New outcomes: physician visits, cardiovascular effects ( myocardial infarction, biomarkers), and possibly developmental effects  New multi city and source apportionment studies

Extensive reanalyses/ validation and extended analyses of key longterm exposure studies  New evidence of association with lung cancer mortality

Intervention studies reporting health improvement with reduction in PM and gaseous pollutants

Controlled human exposure studies and toxicologic studies provide insights into potential mechanisms

Exposure studies

Greatly expanded risk assessment  Based on data from extensive PM 2.5 monitoring network and results from new health studies What's new since 1997? . . . an unprecedented number of new studies 13 Staff recommendations  indicator and averaging times

Current indicator based on mass, using size cutpoint at 2.5 µ m  Staff concludes that mass based indicator remains appropriate ° Health studies implicate various PM components ( sulfates, nitrates,

elemental carbon, organic compounds, metals) are linked with adverse effects ° Likely that different components more closely linked with different effects ° No basis to exclude any components ° Staff emphasizes need for continued research on effects from different PM components, PM from various sources, or different size classes ( e. g., ultrafine particles)

 Staff concludes that size cut of 2.5 µ m remains appropriate  More completely captures fine particles under all conditions in U. S., particularly under high humidity conditions, while recognizing that some small coarse particles may be captured

Staff concludes that annual and 24 hour averaging times remain appropriate 14 Staff recommendations on primary PM2.5 standards

Consideration should be given to alternative suites of PM2.5 standards:

An annual standard at the current level of 15 µ g/ m3 together with a revised 24 hour PM 2.5 standard in the range of 35 to 25 µ g/ m3, based on a 98th percentile form for a standard set at the middle to lower end of this range, or a 99th percentile form for a standard set at the upper end of this range OR

A revised annual PM 2.5 standard, within the range of 14 to 12 µ g/ m3, together with a revised 24 hour PM 2.5 standard in the range of 40 to 30 µ g/ m3. Staff judges that a suite of standards that includes either the annual or 24 hour standard, or both, set at the middle to lower end of these ranges could provide an appropriate degree of health protection 15 CASAC recommendations on primary PM2.5 standards

CASAC found staff recommendations " scientifically well reasoned"

and advised that primary PM2.5 standards should be revised " to provide increased public health protection"

Consensus in agreement with staff recommendations that focused primarily on lowering the 24 hr PM 2.5 standard ° In addition, Panel " did not endorse the option of keeping the annual standard at its present level"

Most Panel members favored a 24 hr standard in the range of 35 to 30 µ g/ m3 together with a revised annual standard in the range of 14 to 13 µ g/ m3

Most Panel members favored continued use of 98th percentile form,

along with continued use of annual and 24 hour averaging times 16 Staff/ CASAC recommendations for secondary PM NAAQS to address visibility impairment

Staff recommends revising current standards to provide increased and more targeted protection primarily in urban areas from visibility impairment related to fine particles

Staff recommends that a revised secondary standard consider:

An averaging time of 4 to 8 daylight hours

A level in the range of 30 to 20 µ g/ m3, depending in part on the form of the standard

A percentile based form, focusing on a range from the 92nd to the 98th percentile of the annual distribution of daily short term PM 2.5 concentrations, averaged over 3 years

CASAC panel members recommended considering a 92nd to 98th percentile form, combined with a level toward the upperend of the proposed range of 30 to 20 µ g/ m3

Decision on secondary linked to decision on health based NAAQS 17 Basis for 1997 decisions on PM10 standards .

. . built upon earlier PM NAAQS reviews

1971: set NAAQS for " total suspended particulate" ( particles smaller than ~ 25 45 µ m in diameter)

1987: revised PM NAAQS, changing the indicator from TSP to PM10 to focus on " inhalable" or " thoracic" particles (< 10 µ m)

Crustal materials,

road dust, dirt,

biologicals Sulfates, nitrates, ammonium,

elemental carbon, organics,

metal compounds Extra thoracic Combustion,

atmospheric reactions thoracic Sulfates, nitrates, ammonium,

elemental carbon, organics,

metal compounds Crustal materials,

road dust, biological materials Fine Particles Coarse Particles " Bimodal" Distribution of Ambient PM: Particle Deposition in Humans: 18 Concentration ug/ m3 Meets Does Not Meet Note: Based on AQS data as of July 8, 2005. Excludes Regionally concurred flagged values.

County level status for PM10 NAAQS, 2002 2004 based on 24 hour standard only ( 150 ug/ m3, 1 expected exceedence)

Preliminary draft 19

In conjunction with new PM2.5 standards, generally strong public and CASAC support for retaining standards to protect against the effects of coarse fraction particles ( PM10 2.5)

 Dosimetry evidence shows deposition in lower respiratory tract  Limited PM10 short term exposure studies linked coarse fraction particles to respiratory effects  Possible long term exposure effects considered based on potential build up in the lung

PM10 retained as indicator  Only health studies of clear relevance used PM10 in areas where coarse fraction was dominant  Very limited PM10 2.5 air quality data; but extensive PM10 data

Both 24 hr and annual PM10 standards retained at same levels  Only evidence from 2 studies in areas that exceeded current standards

Form of 24 hr standard revised to a concentration based form ( 99th percentile), to retain generally equivalent level of protection  Court found " ample support" for decision to regulate coarse particles, but . . .

 Vacated revision, finding PM10 to be a poorly matched indicator for coarse fraction particles because it includes fine particles 1997 Decision on PM10 NAAQS 20 Current review:

approach based on new information

Focus on new information indexed by PM 10 2.5

Growing, but still limited, body of PM10 2.5 epidemiologic evidence

Much more PM10 2.5 air quality data

New studies report statistically significant associations between short term exposure to PM 10 2.5 and morbidity,

including hospitalization and respiratory symptoms

Magnitudes of associations similar to those for PM2.5, but generally less precise estimates, likely due to increased exposure measurement error 21 Results of US and Canadian time series epidemiologic studies, in order of high to low precision from left to right in each health outcome group. ( PM Staff Paper Figure 3 2)

U. S. and Canadian studies of associations between short term PM exposure and mortality 22 U. S. and Canadian studies of associations between short term PM exposure and morbidity Results of US and Canadian time series epidemiologic studies, in order of high to low precision from left to right in each health outcome group. ( PM Staff Paper Figure 3 2) 23 Considerations in defining an indicator for thoracic coarse particles

Most obvious choice is size differentiated, mass based indicator used in epidemiologic studies, PM10 2.5  Upper size cut consistent with dosimetric evidence  Lower size cut consistent with choice of PM2.5 for fine particles  Insufficient information available to define an indicator solely in terms of other metrics, such as specific components  Available epidemiologic evidence quite limited and with large uncertainties, reflective of more heterogeneous spatial distribution and chemical composition

Evidence for focus on coarse particles common in urban environments  Toxicologic evidence suggests effects with several components of particles typical of urban areas ( e. g., road dust particles), but not particles of geologic origin ( e. g., Mt. St. Helens dust)

 Epidemiologic studies ( e. g., Spokane) find no association between mortality and PM10 from wind storms ( when natural crustal particles predominate)

 Lack of epidemiologic evidence related to thoracic coarse particles typical of non urban areas 24 Considerations in defining an indicator ( cont.)

Also considered evidence related to coarse particles in communities predominantly influenced by agricultural or mining activities  Absence of evidence at community level exposures ( in contrast to effects reported at occupational exposure levels)

 Unlikely to be contributing to effects observed in recent urban studies

Clear distinctions noted in the nature of coarse particles found in urban and non urban/ rural areas, leading to consideration of more narrowly defined indicator that focuses on particles characteristic of sources generally present in urban areas  Higher exposures in urban than in near by rural areas, due to local urban sources ( resuspended dust from high traffic density paved roads; industrial sources)

 Urban coarse particles enriched by contaminants ( e. g., metals, other air toxics) not commonly found in natural geologic crustal materials typical of rural particles

Staff concludes that, given differences in composition and effects evidence, it is not appropriate to assume that effects related to the mix of coarse particles commonly found in urban environments would also apply to particles characteristic of rural areas 25 Coarse Particle Composition 0 5 10 15 20 25 USC BHM CTR ATL YRK Concentration,

ug/

m3 unknown EC OCM Crustal Sulfates Nitrates Average PM 10 2.5 composition for Los Angeles and two eastern urban rural pairs. Based on USC Supersite data ( 10/ 2002 to 9/ 2003), and Birmingham, AL ( BHM, urban), Centerville, AL ( CTR, rural), Atlanta, GA ( ATL, urban) and Yorkville, GA ( TRK, rural) monitoring sites in the Southeastern Aerosol Research and Characterization ( SEARCH) Study, 4/ 2003 12/ 2003. In general, urban coarse particles have higher concentrations and more components from urban sources such as combustion and industrial activities than rural sites. Western sites also show higher crustal contributions. 26 Considerations in recommending ranges of levels

Evidence of effects associated with short term exposure to thoracic coarse particles: morbidity  Significant associations reported with respiratory or cardiovascular hospitalization in areas ( e. g., Detroit, St. Louis,

Seattle) with 98th percentile PM 10 2.5 values in the range of 30 40 µ g/ m3  Uncertainty in population exposure characterized by ambient PM 10 2.5 levels ° Greater spatial variation in PM 10 2.5 concentrations ( than for PM 2.5 )

influences interpretation of epidemiologic study results as a basis for recommending standard levels ° Detroit example ° Time series study used PM 10 2.5 concentrations obtained from Windsor monitors ° PM data well correlated with other Detroit monitors, but analysis suggests that Windsor levels are generally less than half the levels recorded at urban center Detroit monitors,

though more similar to suburban areas well outside the city 27 Considerations in recommending ranges of levels ( cont.)

Evidence of effects associated with short term exposure to thoracic coarse particles: mortality  Associations with mortality less consistent than with morbidity;

reported only in areas with relatively high concentrations ° Significant or nearly significant associations reported in several areas ( Steubenville, Phoenix, Coachella Valley) where 98th percentile PM 10

2.5 values ranged from 53 to 107 µ g/ m3 ° No significant associations reported in a number of areas where 98th percentile PM 10 2.5 values were generally below 50 µ g/ m3  Uncertainty in interpreting PM 10 2.5 levels in epidemiologic studies remains, as in morbidity studies ° Coachella Valley example ° Monitor in one community with highest levels was used in study,

although a portion of study population likely experienced appreciably lower exposure levels ° PM 10 2.5 measurements used in epidemiologic study appear to represent concentrations at the high end of levels for communities in the Coachella Valley 28 Considerations in recommending ranges of levels ( cont.)

Based on close look at epidemiologic studies, evidence suggests consideration down to at least 50 µ g/ m3  Recognizes that exposure measurement error is potentially quite large  Consideration of lower levels, to provide a margin of safety against morbidity effects that may possibly occur at such low levels, may not be warranted

An even more cautious or restrained approach to interpreting epidemiologic evidence led to staff consideration of a standard that would provide generally " equivalent" protection to that afforded by current standards  A PM10 2.5 level of approximately 60 µ g/ m3 ( 98th percentile value) would be roughly equivalent on average to a PM10 level of 150 µ g/ m3 (

oneexpected exceedence form)

 Comparison of areas that would likely not meet possible alternative standards indicates that a PM10 2.5 standard of about 65 70 µ g/ m3 ( 98th percentile form) would likely provide protection for approximately the same number of counties or number of people as the current PM10 standards 29 Staff recommendations based on initial CASAC advice

Replace PM10 indicator with a more narrowly defined indicator of urban thoracic coarse particles, UPM10 2.5  Primarily based on particle size, but also on recognition that coarse particles from urban type sources have been associated with health effects  Would not include particles generally present in rural areas typically characterized by high proportions of natural geologic materials ( e. g.,

windblown dust; coarse particles from mining or agricultural operations)

Specify minimum monitoring network design requirements and exceptional/ natural events rule consistent with intent of new indicator

Alternative levels for a 24 hour standard of approximately 50 to 85 µ g/ m3 ( depending in part on the form of the standard)

 More precautionary approach would focus on lower end of range taking into account levels reported in epidemiologic studies  Placing more weight on uncertainties would focus on upper end of range

Little basis for retaining an annual standard 30 Final CASAC advice ( September 15, 2005 letter)

Panel found Staff Paper to be responsive to previous advice

Committee agrees with summary of scientific data  Several studies provide convincing data of associations with morbidity endpoints; mortality associations suggestive  Coarse particles in urban or industrial areas are likely to be enriched by anthropogenic pollutants inherently more toxic than windblown crustal material  Most concurred that scarcity of data on rural toxicity makes it necessary to base standard on known toxicity of urban derived coarse particles  While data are limited " several US and Canadian studies do provide convincing data that there is an association between short term exposure to PM10 2.5 and various morbidity endpoints. Associations with mortality endpoints were suggestive but not as convincing"

General concurrence among Panel members on the need for a standard for particles between 2.5 and 10 µ m ( 17 of 17 members)

 Supports 24 hour averaging time; agrees that annual standard not warranted  Strongly recommends use of 98th percentile form

Most but not all Panel members support an urban oriented indicator  Considered as a surrogate for urban type components that differ in composition from natural crustal particles; research needed  However, some recommended a PM10 2.5 indicator accompanied by monitoring and exceptional events guidance to emphasis urban influences

Agreement that staff presented reasonable justification for range of levels  Most members favored levels at upper end of range  Several supported lower end of range 31 Potential Implementation Schedules 32 Timelines if PM2.5 NAAQS are revised Up to April 2019 / April 2020 April 2014 ( based on 2011 2013 data) / April 2015 ( based on 2012

2104 data)

April 2012 / April 2013 April 2009 / April 2010 Nov. 2008 / Nov. 2009 Nov. 2007 2004 2006 Nov. 2006 2006 PM 2.5 Primary NAAQS Up to April 2015 Attainment Date with Extension Jan. 2009 ( Phase I NOx)

Jan. 2010 ( Phase I SOx)

Jan. 2015 ( Phase 2  NOx and SOx)

April 2010 ( based on 2007 2009 data)

Attainment Date Sept. 2006 April 2008 SIPs Due April 2005 Effective Date of Designations Dec. 2004 Final Designations Signature Feb. 2004 State Recommendations to EPA 2001 2003 Monitoring Data Used for State Recommendations March 2005 July 1997 Promulgation of Standard CAIR 1997 PM 2.5 Primary NAAQS Milestone 33 Timeline if PM10 2.5 Standard is adopted*

Up to July 2022 23 July 2017 18 ( based on 2014 2016 data)

July 2015 16 July 2012 13 May 2012 13 July 2011 12 2008/ 9 2011 Nov. 2006 2006 PM10 2.5 NAAQS Attainment Date with Extension Attainment Date SIPs Due Effective Date of Designations Final Designations Signature State Recommendations to EPA Monitoring Data Used for State Recommendations Effective date of Standard Milestone * Schedule based on monitor deployment in 2007 or 08


[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Notices]
[Pages 60359-60360]
[FR Doc No: 2016-21040]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Advisory Committee; Endocrinologic and Metabolic Drugs Advisory
Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by
the Commissioner of Food and Drugs (the Commissioner). The Commissioner
has determined that it is in the public interest to renew the
Endocrinologic and Metabolic Drugs Advisory Committee for an additional
2 years beyond the charter expiration date. The new charter will be in
effect until August 27, 2018.

DATES: Authority for the Endocrinologic and Metabolic Drugs Advisory
Committee will expire on August 27, 2016, unless the Commissioner
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Endocrinologic and Metabolic Drugs Advisory Committee.
The committee is a discretionary Federal advisory committee established
to provide advice to the Commissioner. The Endocrinologic and Metabolic
Drugs Advisory Committee advises the Commissioner or designee in
discharging responsibilities as they relate to helping to ensure safe
and effective drugs for human use and, as required, any other product
for which FDA has regulatory responsibility.
    The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of endocrine and metabolic disorders, and makes
appropriate recommendations to the Commissioner of Food and Drugs.

    The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of endocrinology, metabolism, epidemiology or statistics, and
related specialties. Members will be invited to serve for overlapping
terms of up to 4 years. Almost all non-Federal members of this
committee serve as Special Government Employees. The core of voting
members may include one technically qualified member, selected by the
Commissioner or designee, who is identified with consumer interests and
is recommended by either a consortium of consumer-oriented
organizations or other interested persons. In addition to the voting
members, the Committee may include one non-voting member who is
identified with industry interests.
    Further information regarding the most recent charter and other
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm100261.htm or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no change has been made to the
committee name or description of duties, no amendment will be made to
21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21040 Filed 8-31-16; 8:45 am]
 BILLING CODE 4164-01-P


Lydia Wegman/RTP/USEPA/US

04/30/2008 12:10 PM

To

<EMAIL_ADDRESS> cc

"Tricia Crabtree"<EMAIL_ADDRESS>"Karen Martin" <EMAIL_ADDRESS>"Deirdre Murphy"<EMAIL_ADDRESS>"Zachary Pekar"<EMAIL_ADDRESS> Subject

Fw: Files for OMB

Heidi,

Attached are the three things we discussed yesterday--two tables, one on CR functions and the other on IQ loss using the 5 air-to-blood ratios, and the preamble language on air-to-bood ratios.  We can discuss this later today.

Lydia

    ----- Original Message -----

    From: Karen Martin

    Sent: 04/30/2008 11:59 AM EDT

    To: Lydia Wegman; Deirdre Murphy; Zachary Pekar

    Subject: Files for OMB

Karen Martin, Ph.D.

Office of Air Quality Planning and Standards

U.S. EPA (C504-06)

Research Triangle Park, NC 27711

phone:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

<EMAIL_ADDRESS>


[Federal Register: August 14, 2008 (Volume 73, Number 158)]
[Rules and Regulations]
[Page 47542-47546]
[DOCID:fr14au08-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2006-0571; FRL-8703-3]

Approval and Promulgation of Implementation Plans for Arizona;
Maricopa County PM-10 Nonattainment Area; Serious Area Plan for
Attainment of the 24-Hour and Annual PM-10 Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action under the Clean Air Act (CAA) to
approve the Best Available Control Measure (BACM) and the Most
Stringent Measure (MSM) demonstrations in the serious area particulate
matter (PM-10) plan for the Maricopa County portion of the metropolitan
Phoenix (Arizona) nonattainment area (Maricopa County area). EPA is
also confirming that it appropriately granted Arizona's request to
extend the attainment deadline from 2001 to 2006. EPA originally
approved these demonstrations and granted the extension request on July
25, 2002. Thereafter EPA's action was challenged in the U.S. Court of
Appeals for the Ninth Circuit. In response to the Court's remand, EPA
reassessed the BACM demonstration for the significant source categories
of on-road motor vehicles and nonroad engines and equipment exhaust,
specifically regarding whether or not California Air Resources Board
(CARB) diesel is a BACM and/or MSM. As a result of this reassessment,
EPA in 2006 again approved the BACM and MSM demonstrations in the plan
and granted the request for an attainment date extension. In light of
its 2007 finding that the Maricopa County area failed to attain the 24-
hour PM-10 National Ambient Air Quality Standard (NAAQS) by December
31, 2006, EPA has again reassessed the BACM and MSM demonstrations and
is again approving these demonstrations.

DATES: Effective Date: This rule is effective on September 15, 2008.

ADDRESSES: EPA has established docket number EPA-R09-OAR-0091 for this
action. The index to the docket is available electronically at http://
www.regulations.gov and in hard copy at EPA Region 9, 75 Hawthorne
Street, San Francisco, California. While all documents in the docket
are listed in the index, some information may be publicly available
only at the hard copy location, e.g., copyrighted material, and some
may not be publicly available in either location, e.g., confidential
business information. To inspect the hard copy materials, please
schedule an appointment during normal business hours with the contact
listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Carol Weisner, EPA Region IX, (415)
947-4107<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

I. Summary of Proposed Action

    On June 8, 2007, EPA proposed to re-approve the BACM and MSM
demonstrations in Arizona's serious area PM-10 plan for the Maricopa
County area. EPA also proposed to confirm that it appropriately granted
Arizona's request for an extension of the area's attainment deadline
from December 31, 2001 to December 31, 2006. 72 FR 31778. EPA
originally approved the BACM and MSM demonstrations and granted the
attainment date extension in 2002.\1\ EPA's 2002 action was
subsequently challenged in the U.S. Court of Appeals for the Ninth
Circuit. On May 10, 2004, the Court issued its opinion which upheld
EPA's final approval in part but remanded to EPA the issue of whether
CARB diesel must be included in the serious area plan as a BACM and a
MSM. See Vigil v. Leavitt, 366 F.3d 1025, amended at 381 F.3d 826 (9th
Cir. 2004).
---------------------------------------------------------------------------

    \1\ On July 25, 2002, EPA approved multiple documents submitted
to EPA by Arizona for the Maricopa County area as meeting the CAA
requirements for serious PM-10 nonattainment areas for the 24-hour
and annual PM-10 national ambient air quality standards (NAAQS).
Among these documents is the ``Revised MAG 1999 Serious Area
Particulate Plan for PM-10 for the Maricopa County Nonattainment
Area,'' February 2000 (MAG plan) that includes the BACM
demonstrations for all significant source categories (except
agriculture) for both the 24-hour and annual PM-10 standards and the
State's request and supporting documentation, including the most
stringent measure analysis (except for agriculture) for an
attainment date extension for both standards. EPA's July 25, 2002
final action included approval of these elements of the MAG plan.
For a detailed discussion of the MAG plan and the serious area PM-10
requirements, please see EPA's proposed and final approval actions
at 65 FR 19964 (April 13, 2000), 66 FR 50252 (October 2, 2001) and
67 FR 48718 (July 25, 2002).
    Note that, effective December 18, 2006, EPA revoked the annual
PM-10 standard. 71 FR 61144 (October 17, 2006). References to the
annual standard in this final rule are for historical purposes only.
EPA is not taking any regulatory action with regard to this former
standard.
---------------------------------------------------------------------------

    In response to the Ninth Circuit's remand, EPA re-examined the
feasibility of CARB diesel for both the on-road motor vehicle exhaust
and nonroad engines and equipment exhaust significant source
categories. On August 3, 2006, EPA again approved the BACM and MSM
demonstrations in the MAG plan for these significant source categories
without CARB diesel and granted the State's request to extend the
attainment deadline from 2001 to 2006. 71 FR 43979. In this final
action, EPA concluded that implementation of CARB diesel was not
feasible for (1) on-road motor vehicle exhaust because Arizona would
not be able to make a ``necessity'' showing for CARB diesel and thus,
would not be able to obtain a waiver of federal preemption under CAA
section 211(c)(4)(C)(i) in light of EPA's prior approval of the PM-10
attainment demonstration that did not rely on reductions associated
with the use of CARB diesel, and (2) nonroad engines and equipment
exhaust because of the uncertainties with fuel availability, storage
and segregation and

concerns about program effectiveness due to owners and operators
fueling outside the Maricopa County area.
    On June 6, 2007, EPA issued a finding that the Maricopa area failed
to attain the 24-hour PM-10 NAAQS by December 31, 2006. 72 FR 31183. As
a result, EPA can no longer rely on its August 3, 2006 conclusion that
CARB diesel is not necessary for the attainment of the PM-10 NAAQS.
Thus, EPA reassessed the BACM demonstration for the on-road motor
vehicle exhaust source category in light of the new provisions in the
Energy Policy Act of 2005 (EPAct) which we had mentioned but not
addressed in the August 3, 2006 approval because, as noted earlier, we
had concluded that we could not approve CARB diesel into the Arizona
State implementation plan (SIP) under CAA section 211(c)(4)(C)(i). EPA
concluded that it could not approve a CAA section 211(c)(4)(C)(i)
waiver for Arizona for CARB diesel because the effect of such an
approval would unlawfully increase the total number of fuels approved
under section 211(c)(4)(C) as of September 1, 2004. Therefore, EPA
again proposed to approve the BACM demonstration for the on-road motor
vehicle exhaust source category in the MAG plan without CARB diesel.
    Because our August 3, 2006 approval of the BACM demonstration for
nonroad engines and equipment exhaust relied to some extent on our
conclusion with respect to on-road motor vehicle exhaust, we also
proposed again to find that CARB diesel is not required as a BACM for
the nonroad category because of the uncertainties with fuel
availability, storage and segregation and concerns about program
effectiveness due to owners and operators fueling outside the Maricopa
County area.
    Finally, because the December 31, 2006 attainment deadline has
passed since EPA granted the State's request for an attainment date
extension in its August 3, 2006 action, the extension request is moot.
However, if CARB diesel had been required as a MSM in order for EPA to
grant the extension request, the State would now be required to
implement it absent the requisite showing under CAA section 110(l).
Therefore EPA again proposed to approve the MSM demonstration in the
MAG plan without CARB diesel. We also proposed to confirm that we had
appropriately granted the State's request for an attainment date
extension in our 2002 and 2006 actions.

II. Public Comments and EPA Responses

    EPA received one comment letter, from Joy E. Herr-Cardillo, Senior
Staff Attorney, Arizona Center for Law in the Public Interest (ACLPI),
on behalf of Phoenix area residents Robin Silver, Sandra L. Bahr and
David Matusow. EPA appreciates the time and effort expended by the
commenter in reviewing the proposed rule and providing comments. We
have summarized the comments and provided our responses below.

A. On-Road Motor Vehicle Exhaust

    Comment 1: ACLPI asserts that EPA inappropriately relies upon an
amendment to CAA section 211(c) by EPAct when re-evaluating a prior EPA
approval on remand from the Court of Appeals. ACLPI notes that at the
time Arizona submitted its BACM demonstration for approval, the section
211(c) waiver restrictions now relied upon did not exist and could not
have served as a ``reasoned justification'' for rejecting CARB diesel.
    Response: As authority for its conclusion that EPA's reliance on an
amendment to section 211(c) by EPAct is inappropriate, ACLPI cites
without elaboration only Disimone v. EPA, 121 F.3d 1262 (9th Cir.
1997). This case is inapt. The Disimone case involved a unique set of
circumstances. Prior to Disimone, in 1990, the Ninth Circuit had
ordered EPA to disapprove the Arizona SIP and to promulgate in its
place a Federal implementation plan (FIP). Delaney v. EPA, 898 F.2d 687
(9th Cir. 1990), cert. denied 498 U.S. 998 (1990). Later in 1990
Congress amended the CAA and EPA requested that the Ninth Circuit
recall its mandate in Delaney so that the Agency could take into
account the 1990 Amendments in its action on remand. The Ninth Circuit
denied EPA's request. EPA subsequently disapproved the Arizona SIP and
promulgated a FIP as mandated by the Delaney court. EPA thereafter
approved a SIP revision and rescinded its FIP. The Disimone court held
that in so doing EPA acted contrary to a prior direct mandate of the
Ninth Circuit and its action thus violated the law of the case. In
addition the court held that EPA was collaterally estopped from
claiming its action was required by the Act's statutory scheme, as
amended in 1990, because the Delaney court had denied its motion to
amend the judgment to conform to those amendments.
    In contrast to Disimone, here there has been no prior judicial
action with respect to the effect of the 2005 amendment that would have
precluded EPA from proceeding with this regulatory action. Therefore
the doctrines on which that court relied do not apply. We must comply
with EPAct, the applicable current law, even though it did not exist at
the time of EPA's original approval action.
    Comment 2: ACLPI asserts that, regardless of the intervening EPAct
restrictions, it does not agree that these restrictions prevent EPA
from approving a waiver of preemption in order to allow CARB diesel
fuel or other low emission diesel fuel as BACM. ACLPI argues that
although CARB diesel fuel is not included on the Boutique Fuels List by
virtue of its inclusion in the California SIP, the list does include
``low emission diesel,'' a fuel approved in the Texas SIP, and this
fuel includes CARB diesel fuel as an approved low emission diesel fuel.
ACLPI further states that because CARB diesel is already approved in
California, it is also approved in the applicable Petroleum
Administration for Defense District (PADD).
    Response: As noted in our June 8, 2007 proposal, at 72 FR 31780,
EPAct amended the CAA by requiring EPA, in consultation with the
Department of Energy (DOE), to determine the total number of fuels
approved into all SIPs under section 211(c)(4)(C), as of September 1,
2004, and to publish a list that identifies these fuels, the states and
PADD in which they are used. CAA section 211(c)(4)(C)(v)(II). It also
placed three additional restrictions on EPA's authority to waive
preemption by approving a State fuel program into the SIP. These
restrictions are as follows:
     First, EPA may not approve a state fuel program into the
SIP if it would cause an increase in the total number of fuel types
approved into SIPs as of September 1, 2004.
     Second, in cases where EPA approval of a fuel would
increase the total number of fuel types on the list but not above the
number approved as of September 1, 2004, because the total number of
fuel types in SIPs is below the number of fuel types as of September 1,
2004, we are required to make a finding after consultation with DOE,
that the new fuel will not cause supply or distribution interruptions
or have a significant adverse impact on fuel producibility in the
affected or contiguous areas.
     Third, with the exception of 7.0 psi RVP, EPA may not
approve a state fuel into a SIP unless that fuel type is already
approved in at least one SIP in the applicable PADD. CAA Section
211(c)(4)(C)(v)(I), (IV) and (V).
    On December 28, 2006, EPA published a list of the total number of
fuels approved into all SIPs, under

section 211(c)(4)(C), as of September 1, 2004 , in the Federal
Register. 71 FR 78192. The final list (known as the Boutique Fuels
List) includes eight types of fuels approved into SIPs under section
211(c)(4)(C) as of September 1, 2004, but does not include CARB diesel
fuel because it is not approved into California's SIP under section
211(c)(4)(C).\2\
---------------------------------------------------------------------------

    \2\ Pursuant to section 211(c)(4)(B), California is not subject
to the restriction in section 211(c)(4)(A) which triggers
applicability of section 211(c)(4)(C).
---------------------------------------------------------------------------

    ACLPI is correct that Texas Low Emission Diesel fuel (also known as
Texas LED fuel) is one of the eight types of fuels on the Boutique
Fuels List. ACLPI is not correct, however, in asserting that because
CARB diesel fuel is included as an approved low emission diesel fuel
under the Texas LED rules, CARB diesel fuel is therefore already
included among the fuels on the Boutique Fuels List. Texas LED fuel
requirements allow CARB diesel fuel as a compliance option in lieu of
meeting the regulatory standard for aromatic hydrocarbons and cetane
number, but they also allow other compliance options that would not
meet CARB diesel fuel requirements.\3\
---------------------------------------------------------------------------

    \3\ See Summary Comparison of CA and TX Diesel Fuel Programs in
the docket for this rulemaking for a table describing major features
of both programs. See also description of the Texas LED fuel program
in EPA rulemaking actions at 66 FR 57196 (November 14, 2001), 70 FR
17321 (April 6, 2005), 70 FR 58325 (October 6, 2005), and 73 FR 8026
(February 12, 2008).
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    Specifically, Texas LED fuel requirements allow four compliance
options in lieu of meeting the 10% (volume) maximum aromatic
hydrocarbon limit and the minimum cetane number of 48: (1) Fuel meeting
CARB diesel requirements (except those for small refiners) as of
January 18, 2005, including the designated equivalent limits; (2) fuel
meeting the requirements of a CARB certified alternative diesel
formulation (except those for small refiners) approved before January
18, 2005 to meet CARB diesel regulations in effect as of October 1,
2003; (3) fuel meeting the Texas LED requirements for alternative
diesel fuel formulations; and (4) fuel meeting the requirements of an
alternative emission reduction plan approved as a substitute fuel
strategy that will achieve equivalent oxides of nitrogen
(NOX) emission reductions. Based on quarterly reports
submitted to the Texas Commission on Environmental Quality for 2007,
more than half the volume of Texas LED fuel in 2007 consists of fuel
meeting compliance options (3) and (4) noted above.\4\ Compliance
options (3) and (4) do not exist in CARB diesel fuel.
---------------------------------------------------------------------------

    \4\ See July 29, 2008 Memorandum, ``Summary of total TxLED
production volumes reported for 2007'' in the docket for this
rulemaking. This summary indicates that 41% of TxLED fuel volume
consists of fuel meeting the Alternative Emission Reduction Plan
compliance option, and 11% of TxLED fuel volume consists of fuel
meeting the TxLED requirements for alternative diesel fuel
formulations. Forty-seven percent of TxLED fuel volume for 2007
consists of fuel meeting either the California diesel fuel standards
(except those for small refiners) or the California certified
alternative fuel formulations (except those for small refiners).
---------------------------------------------------------------------------

    The Texas LED fuel program was modeled on the CARB diesel fuel
program, but Texas has adapted the program to meet needs specific to
the Texas ozone nonattainment areas, especially the Houston-Galveston
ozone nonattainment area, for which the Texas LED fuel program is
approved into the SIP. As a result, the two diesel fuel programs are
similar but not equivalent, as we noted in our August 3, 2006 final
rule, in response to ACLPI's comment that we had failed to account for
availability of similar diesel fuel in Texas in assessing the
feasibility of using CARB diesel for nonroad engines. See 71 FR at
43981-82.\5\
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    \5\ We described two significant differences between the two
types of fuel: First, Texas LED rules allow the use of substitutes
for LED fuel that achieve equivalent NOX reductions but
not necessarily equivalent PM reductions, and second, Texas LED
rules have been amended to remove the ultra low sulfur requirement,
which directly affects PM emissions, from diesel fuel, while as of
September 1, 2006, there is now a 15 ppm sulfur content requirement
at the retail level for CARB diesel fuel. See 71 FR at 43981-82.
Compliance option (4) mentioned above corresponds to the first
difference noted here.
---------------------------------------------------------------------------

    ACLPI also asserts that, because CARB diesel is already approved in
California, it is also approved in the applicable PADD. This is a
reference to the PADD restriction, which is mentioned above and can be
found in section 211(c)(4)(C)(v)(V). Under the PADD restriction, we are
allowed to approve a fuel if it is ``approved in at least one [SIP] in
the applicable [PADD].'' Arizona is in PADD 5, the same PADD as
California, and Texas is in PADD 3. Our approval would, however, be
subject to the other restrictions listed and discussed above. Thus, our
approval must not cause an increase in the number of fuel types above
those approved as of September 1, 2004, i.e., there must be ``room'' on
the Boutique Fuels List, and we must consult with DOE on the effect of
such a fuel on fuel supply and distribution in the affected or
contiguous areas. As earlier mentioned, CARB diesel is approved into
the California SIP. We would therefore, not be prohibited from
approving CARB fuels for states within PADD 5, if there were room on
the Boutique Fuels List. At this time, however, there is no room on the
list, and therefore, we are prohibited from approving CARB diesel into
Arizona's SIP since it would be a different fuel type that is not
already on the list. Because CARB diesel fuel and Texas LED fuel are
not equivalent, as noted above, the two are not interchangeable on the
Boutique Fuels List, and thus the only type of low emission diesel fuel
on the Boutique Fuels List is the Texas LED fuel program. This program
is approved into a SIP in PADD 3, but is not approved into a SIP in the
applicable PADD, which is PADD 5. Thus, EPA is further prohibited from
approving a low emission diesel fuel program into the Arizona SIP
because of the PADD restriction.

B. Nonroad Engines and Equipment Exhaust

    Comment 3: Since EPA relies upon its previous assessment in the
August 3, 2006 final rule, ACLPI reasserts the objections raised in its
comments submitted in response to that rulemaking in its letter dated
August 1, 2005.
    Response: As noted in the June 8, 2007 proposed rule, EPA is not
changing its assessment in the August 3, 2006 final rule that requiring
CARB diesel fuel for the control of nonroad engines and equipment
exhaust is not currently feasible and is therefore not required as a
BACM in the Maricopa County area. Except as specifically modified
below, EPA is relying for this final rule on its discussion of Nonroad
Engines and Equipment Exhaust in Section II.B(2) of the Agency's July
1, 2005 proposed rule, 70 FR at 38066-38067. We are also relying on our
responses to public comments on this issue in Section II.B of our
August 3, 2006 final rule, 71 FR at 43981-43983.
    We note one further update to the information in footnote 7 of the
August 3, 2006 final rule. There are currently thirteen, rather than
six, approval letters on the Texas LED fuel program Web site \6\
providing for the use of alternative diesel fuel formulations. The
second sentence in footnote 7 should now read as follows: ``Although
Section 114.312(f) provides that alternative diesel fuel formulations
must provide comparable or better reductions of NOX and PM,
four of the thirteen alternative diesel fuel formulation approval
letters to date have cited NOX reductions alone, or (in one
case) reductions of NOX and

hydrocarbons, but not PM, as the basis of approval.''
---------------------------------------------------------------------------

    \6\ As noted in footnote 7 of the August 3, 2006 final rule, the
Web site location is: http://www.tceq.state.tx.us/implementation/
air/sip/cleandiesel.html.
---------------------------------------------------------------------------

    Comment 4: ACLPI further asserts that, with respect to EPA's
concerns that nonroad diesel fuel users will refuel outside the
nonattainment area to avoid paying the higher cost of CARB diesel, the
Texas LED rule provides guidance for Arizona since it applies to 102
counties even though only 8 of those counties are in the Houston
nonattainment area. Citing EPA's November 14, 2001 final rule approving
the Texas LED rule into the SIP, ACLPI asserts that the principal
reason for extending the scope of the rule to so many counties was to
prevent refueling outside the nonattainment area. 66 FR 57196, 57216.
ACLPI states there is no reason that a similar approach could not be
adopted in Arizona.
    Response: In addition to the Texas LED fuel program, EPA has
approved two other state fuel programs under CAA Section 211(c)(4)(C)
in which the covered area included attainment areas outside the
nonattainment area for which SIP approval was sought. See 66 FR 20927
(April 26, 2001) for the Gasoline Volatility Program in Eastern and
Central Texas, and 67 FR 8200 (February 22, 2002) for the Gasoline
Sulfur and Volatility Program in Atlanta, Georgia. In each of these
three cases, EPA's approval of the state fuel program in attainment
areas was based on the State's demonstration that emission reductions
attributable to the state fuel program in the attainment areas was
necessary to help achieve attainment in the nonattainment area for
which SIP approval was sought.
    Specifically, in the case of the Texas LED fuel program, EPA noted
three reasons for Texas' conclusion that requiring LED fuel in the 110-
county covered area benefits the 8-county Houston ozone nonattainment
area. First, it will help ensure that LED fuel is used by intrastate
and long-haul trucks that travel through the nonattainment area but
purchase fuel in Texas outside the nonattainment area and within the
covered area. Second, it will help reduce possible transport of ozone
from the surrounding covered areas to the nonattainment area. Third, it
will reduce the transport of NOX from the surrounding
covered areas to the nonattainment area. See 66 FR at 57214 and 66 FR
36542, 36545.
    ACLPI's reference to EPA's statement at 66 FR 57216 is misquoted;
in this part of the November 14, 2001 final rule approving the Texas
LED rule into the SIP, EPA stated that ``a principal purpose of
extending the coverage of the LED rule to the 102 counties outside the
8-county Houston nonattainment area is to ensure that intrastate and
long-haul trucks traveling through the Houston area but re-fueling
outside the Houston area are re-fueling with LED fuel.'' (Emphasis
added.) Thus preventing re-fueling with non-LED fuel outside the
Houston area was one of three reasons for the expanded scope of the
covered area, as described above, but it was not ``the'' principal
reason, as ACLPI mistakenly asserts.
    With respect to the potential use of CARB diesel fuel for nonroad
engines and equipment, the preemption of state fuel controls in CAA
section 211(c)(4)(A) does not extend to fuels used solely in nonroad
engines and equipment and not for use in motor vehicles. See 70 FR
38064, 38066 (July 1, 2005), 69 FR 38958, 39072-73 (June 29, 2004). The
choice of covered areas for a state diesel fuel program for nonroad
engines and equipment might very well be affected, however, by the same
kinds of reasons that would influence the design of the program if it
were to include diesel fuel for on-road motor vehicles. We agree that
the possible enlargement of the covered area beyond the nonattainment
area is a factor Arizona could consider in evaluating the feasibility
of a diesel fuel program for nonroad engines and equipment, but it is
not the only factor Arizona would need to consider.
    Such an enlarged program might help avoid the problem of re-fueling
outside the Maricopa County area, but it would still face the same
obstacles we have evaluated in our prior notices, i.e., the uncertainty
of fuel availability and the problem of fuel segregation and storage.
Additionally, we note that the geographic considerations in assessing
potential re-fueling avoidance are different in Arizona and Texas.
Population in the Houston-Galveston ozone nonattainment area is about
22% of the statewide population but represents only 3% of the State's
land area. By expanding the covered area to include the Dallas-Fort
Worth and Beaumont-Port Arthur ozone nonattainment areas as well as 95
nearby counties, the Texas LED fuel program covers about 79% of
statewide population and 35% of the State's land area. By contrast,
population in the Phoenix nonattainment area is about 60% of statewide
population but only 8% of the State's land area. If a fuel program were
expanded to include Pima County, which includes the next largest
metropolitan area in Arizona, the population in the covered area would
be about 76% of statewide population but only 16% of the State's land
area. (Statistics are based on 2000 Census Bureau data).\7\
---------------------------------------------------------------------------

    \7\ See July 30, 2008 Memorandum, ``Statistical Data for Arizona
and Texas Based on 2000 Census'' in docket for this rulemaking.
---------------------------------------------------------------------------

C. MSM Demonstration and Extension of Attainment Date

    Comment 5: ACLPI states that, because EPA did not undertake a new
analysis of CARB diesel as a MSM for purposes of the attainment date
extension, ACLPI incorporates by reference comments it submitted ``in
response to previous rulemakings, as well as the arguments and analysis
set forth in the Opening and Reply briefs filed in Vigil * * *
(specifically Opening Brief, pp. 21-27; \8\ Reply Brief, pp. 9-18.)''
---------------------------------------------------------------------------

    \8\ EPA notes that the discussion of MSM begins on p. 24 of
ACLPI's Opening Brief.
---------------------------------------------------------------------------

    Response: The Vigil Court's remand of EPA's approval of the
attainment date extension is limited. The Court concluded that ``[w]e
also remand the question of Arizona's eligibility for the extension,
insofar as that question depends on EPA's determination regarding
MSM.'' (Emphasis added.) 381 F.3d at 487. Therefore to the extent that
ACLPI intends to incorporate by reference its comments and arguments on
aspects of the extension other than MSM, it is precluded from raising
them in this rulemaking.
    While ACLPI does not specify, we assume that by ``previous
rulemakings'' it is referring to EPA's proposed approvals of the
serious area PM-10 plan for the Maricopa County area at 65 FR 19964
(April 13, 2000) and 66 FR 50252 (October 2, 2001). ACLPI commented on
these proposed actions in letters from Joy Herr-Cardillo to Frances
Wicher, EPA Region 9, dated July 20, 2000 and November 1, 2001. EPA has
previously addressed the arguments relating to MSM and the attainment
date extension as it relates to MSM raised by ACLPI in its briefs and
these letters. See 67 FR at 48722-48725 and EPA's Response Brief in
Vigil at 10-12 and 30-34. Discussions also relevant to these issues can
be found in EPA's proposed approvals of the serious area PM-10 plan for
the Maricopa County area at 65 FR 19964 and 66 FR 50252.

III. Final Action

    EPA is again approving the BACM demonstration in the MAG plan for
the source categories of on-road and nonroad vehicle exhaust without
CARB diesel. EPA has concluded that it cannot approve a CAA section
211(c)(4)(C)(i) waiver for Arizona for CARB diesel because the effect
of such an approval would unlawfully increase the total

number of fuels approved into SIPs under section 211(c)(4)(C) as of
September 1, 2004. Therefore, EPA is again approving the BACM
demonstration in the MAG plan for the on-road source category without
CARB diesel. Because EPA has found that CARB diesel is not feasible for
nonroad engines and equipment because of the uncertainties with fuel
availability, storage and segregation and concerns about program
effectiveness due to owners and operators fueling outside the Maricopa
County area, we are again approving BACM demonstration in the MAG plan
for the nonroad source category without CARB diesel. For the reasons
discussed above, EPA is also again approving the MSM demonstration in
the MAG plan and is confirming that we appropriately granted in 2002
and 2006 the State's request for an extension of the attainment
deadline for the area from December 31, 2001 to December 31, 2006.
These actions are codified at 40 CFR 52.123(j)(2), (4) and (7) and
remain in effect. See 67 FR at 48739.

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely approves a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. Executive Order 12898 (59 FR 7629, February 16, 1994)
establishes a Federal policy for incorporating environmental justice
into Federal agency actions by directing agencies to identify and
address, as appropriate, disproportionately high and adverse human
health or environmental effects of their programs, policies, and
activities on minority and low-income populations. Today's action will
not have disproportionately high and adverse effects on any communities
in the area, including minority and low-income communities.
    This rule also is not subject to Executive Order 13045 ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it is not economically significant.
    The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
This rule does not impose an information collection burden under the
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.).
    The Congressional Review Act, 5 U.S.C. section 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 14, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Particulate matter, Reporting and recordkeeping
requirements.

    Dated: August 4, 2008.
Laura Yoshii,
Acting Regional Administrator, Region IX.
[FR Doc. E8-18626 Filed 8-13-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Notices]
[Pages 4283-4286]
[FR Doc No: 2023-01261]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket Nos. FMCSA-2012-0332; FMCSA-2013-0122; FMCSA-2013-0123; FMCSA-
2013-0124; FMCSA-2015-0326; FMCSA-2015-0328; FMCSA-2015-0329; FMCSA-
2016-0004; FMCSA-2017-0058; FMCSA-2017-0059; FMCSA-2017-0060; FMCSA-
2017-0061; FMCSA-2018-0135; FMCSA-2018-0138]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for 24
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on August 22, 2022. The
exemptions expire on August 22, 2024.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room
W64-224, Washington, DC 20590-0001,<PHONE_NUMBER>,
[email protected]. Office hours are from 8:30 a.m. to 5 p.m. ET
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2012-0332, FMCSA-2013-0122, FMCSA-2013-0123, FMCSA-2013-
0124, FMCSA-2015-0326, FMCSA-2015-0328, FMCSA-2015-0329, FMCSA-2016-
0004, FMCSA-2017-0058, FMCSA-2017-0059, FMCSA-2017-0060, FMCSA-2017-
0061, FMCSA-2018-0135, or FMCSA-2018-0138) in the keyword box, and
click ``Search.'' Next, sort the results by ``Posted (Newer-Older),''
choose the notice posted August 17, 2022, and click ``Browse
Comments.'' If you do not have access to the internet, you may view the
docket online by visiting Dockets Operations in Room W12-140 on the
ground floor of the DOT West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through
Friday, except Federal holidays. To be sure someone is there to help
you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption requests. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov. As described in the system of records
notice DOT/ALL 14--Federal Docket Management System (FDMS), which can
be reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the
name of the submitter.

II. Background

    On August 17, 2022, FMCSA published a notice announcing its
decision to renew exemptions for 24 individuals from the hearing
standard in 49 CFR 391.41(b)(11) to operate a CMV in interstate
commerce and requested comments from the public (87 FR 50688). The
public comment period ended on September 16, 2022, and four unique
comments were received.
    FMCSA has evaluated the eligibility of these applicants, evaluated
the comments received, and determined that renewing these exemptions
would likely achieve a level of safety equivalent to, or greater than,
the level that would be achieved by complying with Sec.  391.41(b)(11).
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing aid
(35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 8, 1971),
respectively).

III. Discussion of Comments

Summary of Comments

    FMCSA received four unique comments in these consolidated
proceedings. One is from United Parcel Service, Inc. (UPS) in
opposition to FMCSA's decision to renew a hearing exemption for Mr.
Quinton Murphy, an employee.\1\ Because Mr. Murphy was not able to meet
FMCSA's hearing standard, he was unable to obtain a Medical Examiner's
Certificate, making him not physically qualified for any driving of a
CMV with UPS. In 2014, Mr. Murphy applied for a Federal hearing
exemption and was issued one in 2015. Mr. Murphy has since renewed his
hearing exemption multiple times. Mr. Murphy applied for driving
positions at UPS and UPS allowed him to take the preliminary road test
that applicants must pass before starting driver training. According to
UPS, Mr. Murphy failed that test on five different occasions between
2014 and 2018. UPS then adopted a policy in 2019 providing it would not
accept the Medical Examiner's Certificates that must be accompanied by
hearing exemptions. UPS states that ``anything less than the hearing
requirement set forth in the Safety Regulations would amount to an
unacceptable experiment with safety and would conflict with the
company's own high safety and training standards.'' At that time, Mr.
Murphy had another pending application for a driving position. UPS
denied that application because Mr. Murphy could not obtain a Medical
Examiner's Certificate without a hearing exemption. UPS contends that
``FMCSA has not made the statutorily required safety findings to
support the granting of a renewed exemption to Mr. Murphy.''
---------------------------------------------------------------------------

    \1\ The UPS comment is available at https://www.regulations.gov/comment/FMCSA-2013-0124-0031.
---------------------------------------------------------------------------

    UPS' position is that: ``The grant of another categorical hearing
exemption to Mr. Murphy poses a serious safety risk and, given the lack
of evidence to support a finding that an exemption will maintain or
improve safety, would be inconsistent with federal law.'' UPS
supplemented its comment with 15 exhibits to support its opposition to
renewing Mr. Murphy's hearing exemption and to oppose the overall basis
for the exemptions.
    According to UPS, ``FMCSA opaquely asserts'' that each applicant
included in the August 17, 2022 notice has satisfied the renewal
conditions for obtaining an exemption, but does not specify the renewal
conditions. UPS questions the use of driving records relating to

personal vehicles for applicants for a hearing exemption. It asserts
that FMCSA's consideration of such driving records when issuing
exemptions is not a reliable proxy for assessing an individual's
ability to operate a CMV safely.
    UPS states that Mr. Murphy is completely deaf and has limited
ability to read or communicate in English. UPS continues that Mr.
Murphy is unable to participate in critical on-road training that
involves real-time communication while driving.
    UPS provides that ``FMCSA's decision to issue an exemption on such
a scant evidentiary record with so little reasoning is arbitrary and
capricious. And by issuing a renewed exemption before providing an
opportunity for public comment, FMCSA has only compounded these
problems. The agency has made a significant safety determination that
is not provided for by statute before considering outside evidence [. .
.] regarding the safety risks posed by Mr. Murphy. Such absence of
evidence is insufficient for an affirmative safety finding'' (original
italics). It also provides a lengthy discussion regarding an evidence
report titled ``Hearing, Vestibular Function, and Commercial Motor
Driving Safety'' that was presented to FMCSA in August 2008 and other
literature. UPS states that the 2008 report did not find any
affirmative evidence supporting the grant of exemptions to non-hearing
individuals and that FMCSA failed to identify other current medical
literature used to support its decision to grant these exemptions.
    UPS indicates that FMCSA has not addressed a 2016 study that UPS
states reports ``that drivers with hearing loss are up to 3.1 times
more likely to be involved in an accident and 10 times more likely to
be injured.'' \2\ It also states that ``FMCSA has never acknowledged or
addressed a recent analysis of its hearing-exemption program undertaken
at the agency's own behest that confirms the absence of empirical
support for the agency's position.'' UPS contends that the 2020 study
found no statistically significant evidence that CMV operators with
profound hearing loss are equally as safe as those who meet FMCSA's
standard. It states that ``despite the research demonstrating the vital
link between hearing and safety, and despite the absence of any current
data calling that link into doubt, FMCSA has chosen to press forward
granting exemptions without further empirical inquiry. It has elected
not to commission a further study to assess whether exempting non-
hearing drivers from the Safety Regulations' standards is likely to
achieve the same or a greater level of safety.'' UPS asserts that
``FMCSA's track record of reflexively granting one-size-fits-all
hearing exemptions to all who seek them is particularly concerning and
demonstrates a lack of rigor in conducting the review the statute
mandates and applying the safety-first standard Congress prescribed.''
UPS suggests the need for further research and states that ``FMCSA's
decision to issue exemptions to individuals like Mr. Murphy is both
unreasonable and inconsistent with FMCSA's statutory mandates.'' UPS
concludes that Mr. Murphy's exemption is improper and must be
rescinded.
---------------------------------------------------------------------------

    \2\ See UPS comment at 14, citing Gordon M. and Pearson J.,
Preliminary Analysis of Roadway Accidents Rates for Deaf and Hard-
of-Hearing Drivers--Forensic Engineering Application, 33 J. Nat'l
Academy of Forensic Eng'rs 47 (2016).
---------------------------------------------------------------------------

    An anonymous comment was submitted that does not support granting a
hearing exemption to Mr. James Queen.\3\ The commenter states that Mr.
Queen ``has extra health issues that could not show on his medical
card.'' The commenter requests that FMCSA review Mr. Queen's medical
care and reports before granting him an exemption.
---------------------------------------------------------------------------

    \3\ This comment was submitted in multiple dockets in this
proceeding, see, e.g., https://www.regulations.gov/comment/FMCSA-2017-0059-0020.
---------------------------------------------------------------------------

    The Commercial Vehicle Training Association (CVTA) also submitted
comments in these proceedings.\4\ CVTA does not address the merits of
any individual renewal application. Instead, CVTA states that ``without
a comprehensive understanding of the Agency's reasoning behind
providing certain exemptions and additional research on the subject,
our members are not able to provide a consistent standard without
sacrificing safety or opening themselves up to liability.''
---------------------------------------------------------------------------

    \4\ CVTA's comment was submitted in multiple dockets in this
proceeding, see e.g., https://www.regulations.gov/comment/FMCSA-2013-0122-0022.
---------------------------------------------------------------------------

    CVTA also states ``that not enough research has been made available
to the public on this matter and the Agency has not been transparent
with their standards of how exemptions are granted or extended.'' It
requests additional research, public data, and guidance on this matter.
CVTA says that the Agency vaguely asserted that recent decisions to
renew some exemptions ``were based `on their merits.' '' CVTA continues
that in ``order for an agency's assessment to not run afoul of the
`arbitrary and capricious' standard for judicial review set forth by
the Administrative Procedure Act (APA), the Agency must engage in
reasoned decision making by examining the relevant data and
articulating a satisfactory explanation for its action. Further, there
must be a rational connection between the facts found and the choice
made. CVTA does not believe that FMCSA has satisfied this standard.''
    CVTA also states that ``FMCSA provided little to no relevant data
other than noting that they `searched for crash and violation data' and
`driving records from the State Driver's Licensing Agency' when making
the decision.'' CVTA continues that it understood this database has
never been a factor in determining whether a hearing-impaired
commercial driver's license (CDL) driver meets the medical fitness
examination required by the FMSCRs to operate a CMV. CVTA states that
the ``Agency did not articulate a satisfactory explanation of why this
data was relevant when determining if this exemption would likely
achieve a level of safety that is equivalent to, or greater than, the
level that would be achieved absent such exemption.''
    In addition, CVTA states that it ``does not feel the statutory
requirements have been met by the extension of these exemptions, there
has been a lack of transparency in the decision making, and the
regulation has not been articulated in a way that can produce a
reliable and consistent standard our members can rely on when making
accommodations.'' Finally, CVTA states it ``cannot support this rule
without additional research, data, and an articulated explanation on
the subject that can be consistently employed throughout the
industry.''
    An anonymous comment was submitted opposing CVTA's comments.\5\ The
commenter states that FMCSA's search for crash and violation data and
driving records proves that there were few or no crashes reported.
According to the commenter, that also proves that passing FMCSA's
hearing test is not required to operate a CMV and that the drivers who
applied for an exemption are safe drivers.
---------------------------------------------------------------------------

    \5\ This comment was submitted in multiple dockets in this
proceeding, see, e.g., https://www.regulations.gov/comment/FMCSA-2017-0059-0018.
---------------------------------------------------------------------------

FMCSA Response to Comments

    The Agency's decision regarding exemption applications is based on
relevant medical information and literature indicating whether a
licensed driver with the medical condition could operate safely, which
includes the specific bases discussed in a December

29, 2017 Federal Register notice (82 FR 61809). FMCSA also considers
its experience with hearing exemption holders.
    FMCSA supports a decision to grant a hearing exemption by reviewing
each applicant's driving record found in the Commercial Driver's
License Information System, for CDL holders, as well as inspections
recorded in the Motor Carrier Management Information System. For non-
CDL holders, the Agency reviews the driving records from the State
Driver's Licensing Agency. The records for each applicant who has been
granted a hearing exemption demonstrate that the driver has a safe
driving history.
    FMCSA has found that review of driving records relating to personal
vehicles is suitable to predict future driving performance in CMVs for
the purpose of evaluating hearing exemption applications. In some
instances that is the only driving experience available to the Agency.
Applicants applying for hearing exemptions are very diverse in that
some have been deaf or hard of hearing since birth, some suddenly
became deaf or hard of hearing due to trauma or a medical condition,
and others gradually became deaf or hard of hearing. Some applicants
have experience operating CMVs prior to failing to meet FMCSA's hearing
standard. However, if FMCSA does not consider experience driving
personal vehicles, some applicants would be categorically excluded from
exemption eligibility and the opportunity to drive a CMV. FMCSA has
found from experience that certain drivers who are deaf or hard of
hearing and do not have prior CMV driving experience are capable of
operating CMVs safely.
    The information obtained from each applicant's driving record
provides the Agency with details regarding any moving violations or
reported crash data, which demonstrates whether the driver has a safe
driving history and is used as an indicator of future driving
performance. This information assists the Agency in determining whether
these drivers pose a risk to public safety and if granting these
exemptions would likely achieve a level of safety that is equivalent
to, or greater than, the level that would be achieved absent such
exemption. The driving record is reviewed again when a renewal
application is received. The driving record of an applicant for
exemption is useful evidence for consideration in the overall process
of determining whether to grant an exemption.
    FMCSA is not aware of any persuasive data to support the contention
that drivers who are deaf or hard of hearing are at an increased crash
risk. UPS cited a 2016 study by Gordon and Pearson and stated that
hard-of-hearing drivers are up to 3.1 times more likely to be involved
in an accident. However, the study's own authors ``recognized that the
data sets did not completely address [deaf and hard-of-hearing] drivers
in a robust manner, and further data mining may lead to differing
results.'' \6\ FMCSA notes that the study has further limitations
because the data only reflect crash involvement and not crash fault. In
addition, the crashes occurred while driving on a college campus, which
may not reflect driving on the whole or may include more younger
drivers, who typically have higher crash rates. With respect to the
2020 study by Hickman et al.,\7\ UPS mischaracterized the study as an
``analysis of [FMCSA's] hearing-exemption program.'' \8\ The study was
not such an analysis. The report provides, ``[o]nly 72 drivers (0.5
percent) failed the hearing exam. Waiver information for driver
exemptions for the hearing standard are not reflected in these
results.'' \9\ Furthermore, the results related to the driver meeting
or failing to meet FMCSA's hearing standard were not statistically
significant; therefore, no conclusions can be drawn regarding the
hearing standard as it relates to safety.\10\
---------------------------------------------------------------------------

    \6\ Gordon and Pearson at 51.
    \7\ Hickman J, Mabry J, Marburg L, Guo F, Huiying M, Hanowski R,
Whiteman J, and Herbert W., Commercial Driver Safety Risk Factors
(Report No. FMCSA-RRR-17-014), Washington, DC: FMCSA 2020, available
at https://rosap.ntl.bts.gov/view/dot/49620 (last accessed Dec. 12,
2022).
    \8\ UPS comment at 14.
    \9\ Hickman et al. at 40.
    \10\ Id. Tables 106 and 108 at 126 and 128.
---------------------------------------------------------------------------

    FMCSA also does not accept the efforts by the commenters to offer a
broad objection to all exemptions to the hearing standard in Sec.
391.41(b)(11). As explained above, FMCSA finds that there is sufficient
evidence to support a finding that such exemptions generally satisfy
the statutory standard in 49 U.S.C. 31315(b)(1). The Agency is not
engaging in an experiment with safety; rather, the Agency is exercising
the discretion provided by Congress to grant exemptions. Moreover, the
Agency's decision to exercise its discretion and grant the exemptions
is not arbitrary or capricious. Therefore, the Agency will continue to
consider each application for a hearing exemption on an individual
basis and will continue exempting those drivers who do not pose a risk
to public safety when granting the exemption would likely achieve a
level of safety that is equivalent to, or greater than, the level that
would be achieved absent such exemption.
    UPS stated that it has adopted a policy that it will not accept the
Medical Examiner's Certificates that must be accompanied by hearing
exemptions. FMCSA recognizes that the FMCSRs provide in Sec.  390.3T(d)
that nothing in 49 CFR parts 350 through 399 is to be construed to
prohibit an employer, such as UPS, from requiring and enforcing more
stringent requirements relating to safety of operation and employee
safety and health.
    CVTA in essence is renewing the global comments relating to the
standards and bases FMCSA uses in determining whether to grant
exemptions from the hearing standards that it provided on October 21,
2015 in response to a Federal Register notice announcing applications
for exemptions from the hearing requirement in the FMCSRs. FMCSA has
already responded to and addressed those comments in a Federal Register
notice published on December 29, 2017 (82 FR 61809). FMCSA has no basis
for reconsidering its treatment of the matters raised previously by
CVTA.
    FMCSA acknowledges CVTA's concerns about the challenges driver
training schools may experience delivering services for hearing
impaired drivers. In granting these exemptions, however, FMCSA focuses
on whether these individuals are physically able to safely operate a
CMV in interstate commerce. Matters concerning the training of deaf or
hard of hearing individuals to operate CMVs are beyond the scope of the
medical exemptions being granted and are not evidence that FMCSA should
no longer grant exemptions from its hearing standard. FMCSA notes there
are CDL training schools that have successfully trained deaf and hard
of hearing drivers and State driver's licensing agencies have found
ways to conduct CDL skills tests for such individuals. FMCSA believes
that it is not necessary for FMCSA to ``provide a consistent standard''
for training and testing activities when considering an application for
an exemption from the hearing standard.
    As indicated above, the focus in these consolidated proceedings is
to determine whether to renew exemptions from FMCSA's hearing standard
for the applicants. Therefore, it is not necessary for FMCSA to address
other driver qualification requirements in this proceeding. Those
requirements are addressed by other provisions of the FMCSRs and not by
the physical qualification standards.

    FMCSA does not find any of the evidence or contentions presented by
UPS persuasive enough to cause it to rescind Mr. Murphy's exemption. It
also finds that CVTA's concerns about the supposed difficulties of
training CDL drivers with a hearing exemption do not warrant denying
any of the renewal applications for such exemptions. Finally, there is
a basis to renew Mr. Queen's exemption because he has been examined by
a medical examiner and found to satisfy FMCSA's physical qualification
standards, except for the hearing standard.

IV. Conclusion

    Based upon its evaluation of the 24 renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
hearing requirements in Sec.  391.41(b)(11).
    As of August 22, 2022, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following 24 individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers:

Mataio Brown (MS)
Robert Burnett (AZ)
Barry Carpenter (SD)
Lyle Eash (VA)
Buddy Gann (IN)
Jeremy Lampard (SC)
Michael McCarthy (MN)
Quinton Murphy (WI)
Michael Murrah (GA)
Karl Ortiz (MO)
Christopher Poole (OH)
Ricardo Porras-Payan (TX)
Kelly Pulvermacher (WI)
James Queen (FL)
James Redmond (IL)
Willine Smith (GA)
Brandon Soto (MO)
Darren Talley (NC)
Michael Tayman (ME)
Carlos Torres (FL)
Joshua Weaver (GA)
James Weir (AZ)
Joseph Woodle (KY)
Paul Wentworth (WA)

    The drivers were included in docket numbers FMCSA-2012-0332, FMCSA-
2013-0122, FMCSA-2013-0123, FMCSA-2013-0124, FMCSA-2015-0326, FMCSA-
2015-0328, FMCSA-2015-0329, FMCSA-2016-0004, FMCSA-2017-0058, FMCSA-
2017-0059, FMCSA-2017-0060, FMCSA-2017-0061, FMCSA-2018-0135, or FMCSA-
2018-0138. Their exemptions were applicable as of August 22, 2022 and
will expire on August 22, 2024.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) the person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136, 49
U.S.C. chapter 313, or the FMCSRs.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-01261 Filed 1-23-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Page 4462]
[FR Doc No: 2019-02502]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-987-000]

Crystal Lake Wind Energy I, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Crystal Lake Wind Energy I, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is March 4, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link
above. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: February 11, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-02502 Filed 2-14-19; 8:45 am]
 BILLING CODE 6717-01-P