[Federal Register Volume 64, Number 238 (Monday, December 13, 1999)]
[Notices]
[Pages 69586-69590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32104]
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DEPARTMENT OF TRANSPORTATION
Office of Motor Carrier Safety
[OMCS Docket No. 99-5473 (formerly FHWA Docket No. 99-5473)]
Qualification of Drivers; Exemption Applications; Vision
AGENCY: Office of Motor Carrier Safety (OMCS), DOT.
ACTION: Notice of final disposition.
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SUMMARY: The OMCS announces its decision to exempt James F. Durham from
the vision requirement in 49 CFR 391.41(b)(10).
DATES: December 13, 1999.
FOR FURTHER INFORMATION CONTACT: For information about the vision
exemptions in this notice, Ms. Sandra Zywokarte, Office of Motor
Carrier Safety, (202) 366-2987; for information about legal issues
related to this notice, Ms. Judith Rutledge, Office of the Chief
Counsel, (202) 366-0834, Federal Highway Administration, Department of
Transportation, 400 Seventh Street, SW., Washington, DC 20590. Office
hours are from 7:45 a.m. to 4:15 p.m., e.t., Monday through Friday,
except Federal holidays.
SUPPLEMENTARY INFORMATION:
Electronic Access
Internet users may access all comments received by the U.S. DOT
Dockets, Room PL-401, by using the universal resource locator (URL):
http://dms.dot.gov. It is available 24 hours each day, 365 days each
year. Please follow the instructions online for more information and
help.
An electronic copy of this document may be downloaded using a modem
and suitable communications software from the Government Printing
Office's Electronic Bulletin Board Service at (202) 512-1661. Internet
users may reach the Office of the Federal Register's home page at:
http://www.nara.gov/fedreg and the Government Printing Office's
database at: http://www.access.gpo.gov/nara.
Background
On May 18, 1999, the FHWA published notice of its preliminary
determination to grant Mr. Durham an exemption from the vision standard
applicable to drivers of commercial motor vehicles (CMVs) in interstate
commerce (64 FR 27025). We refer readers to that notice for the history
of his application. Two public comments were received and have been
considered in our final decision to grant Mr. Duncan an exemption. On
October 9, 1999, the Secretary of Transportation transferred the motor
carrier safety functions performed by the FHWA to the Office of Motor
Carrier Safety, a new office created in the Department of
Transportation. This transfer was performed pursuant to section 338 of
the Department of Transportation and Related Agencies Appropriations
Act, FY 2000, Public Law 106-69, 113 Stat. 986, as amended by Public
Law 106-73, 113 Stat. 1046, As a result of the transfer of functions,
the OMCS now administers the driver qualification standards in 49 CFR
part 391 and processes requests for exemptions from the vision standard
under 49 U.S.C. 31315 and 31136(e). Accordingly, an OMCS docket number
has been assigned to this proceeding.
Mr. Durham's Vision and Driving Experience
The vision requirement in 49 CFR 391.41(b)(10) provides:
A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of at least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70 deg. in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing standard
red, green, and amber.
Since 1992, we have undertaken studies to determine if this vision
standard should be amended. The latest report from our medical panel
recommends changing the field of vision standard from 70 deg. to
120 deg., while leaving the visual acuity standard unchanged. (See
Frank C. Berson, M.D., Mark C. Kuperwaser, M.D., Lloyd Paul Aiello,
M.D., and James W. Rosenberg, M.D., ``Visual Requirements and
Commercial Drivers,'' October 16, 1998, filed in Docket FHWA-98-4334).
The panel's conclusion supports the OMCS's view that the present
standard is reasonable and necessary as a general standard to ensure
highway safety. The OMCS also recognizes that some drivers do not meet
the vision standard but have adapted their driving to accommodate their
vision limitation and demonstrated their ability to drive safely.
Mr. Durham falls into this category. He suffered a penetrating
trauma to his right eye in 1992 that caused aphakia and corneal and
retinal scarring. As a result, vision in his right eye has been reduced
to finger counting. Uncorrected vision in his left eye falls well
within the regulation's standard, however, and his doctor has stated
that Mr. Durham is capable of performing tasks related to driving a
CMV.
Mr. Durham's driving record supports the doctor's opinion. He drove
a CMV for 4 years with his limited vision (1992 to April 1996) until
his employer disqualified him for failing to meet the vision
qualification standard. Following an 18-month break, he resumed driving
part-time from October 1997 until July 1998, giving him about 5 years
of experience driving with his vision
[[Page 69587]]
deficiency. Mr. Durham committed no traffic violations while driving
with his limited vision and was involved in 1 non-injury accident. His
driving performance supports the doctor's conclusion that Mr. Durham
can safely perform the tasks related to driving a CMV.
Basis for Exemption Determination
Under revised 49 U.S.C. 31315 and 31136(e), the OMCA may grant an
exemption from the vision standard in 49 CFR 391.41(b)(10) if the
exemption is likely to achieve an equivalent or greater level of safety
than would be achieved without the exemption. Without the exemption,
Mr. Durham cannot drive a CMV in interstate commerce. With the
exemption, he can. Thus, our analysis focuses on whether allowing Mr.
Durham to drive in interstate commerce will negatively affect the level
of safety that presently exists.
To evaluate the effect of his exemption, the OMCS has considered
not only the medical reports about Mr. Durham's vision but also his
driving record and experience with the vision deficiency. Recent
driving performance is especially important in evaluating future
safety, according to several research studies designed to correlate
past and future driving performance. Results of these studies support
the principle that the best predictor of future performance by a driver
is his/her past record of accidents and traffic violations. Copies of
the studies are filed in Docket No. FHWA-97-2625.
We believe we can properly apply the principle to monocular drivers
because data from the vision waiver program clearly demonstrate the
driving performance of monocular drivers in the program is better than
that of all CMV drivers collectively. (See 61 FR 13338, March 26,
1996). That monocular drivers in the waiver program demonstrated their
ability to drive safety supports a conclusion that other monocular
drivers, with qualifications similar to those required by the waiver
program, can also adapt to their vision deficiency and operate safely.
The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that accident rates for the same
individual exposed to certain risks for two different time periods vary
only slightly. (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting accident proneness from accident history coupled
with other factors. These factors, such as age, sex, geographic
location, mileage driven and conviction history, are used every day by
insurance companies and motor vehicle bureaus to predict the
probability of an individual experiencing future accidents. (See Weber,
Donald C., ``Accident Rate Potential: An Application of Multiple
Regression Analysis of a Poisson Process,'' Journal of American
Statistical Association, June 1971). A 1964 California Driver Record
Study prepared by the California Department of Motor Vehicles concluded
that the best overall accident predictor for both concurrent and
nonconcurrent events is the number of single convictions. This study
used 3 consecutive years of data, comparing the experiences of drivers
in the first 2 years with their experiences in the final year.
Applying principles from these studies to Mr. Durham's record, we
note that he has committed no traffic violations and had 1 non-
preventable accident since 1994. The accident resulted in property
damage but no bodily injury. Mr. Durham achieved this record of safety
while driving with his vision impairment, demonstrating he has adapted
his driving skills to accommodate his condition. Moreover, his clean
driving record between October 1997 until July 1998 demonstrates that
the break in driving experience from April 1996 to July 1997 did not
diminish his driving skills. As Mr. Durham's driving history with his
vision deficiency is a predictor of future performance, the OMCS
concludes his ability to drive safely can be projected into the future.
Consequently, the OMCS finds that exempting Mr. Durham from the vision
standard in 49 CFR 391.41(b)(10) is likely to achieve a level of safety
equal to that existing without the exemption. For this reason, the
agency will grant the exemption for the 2-year period allowed by 49
U.S.C. 31315 and 31136(e).
We recognize that Mr. Durham's vision may change and affect his
ability to operate a commercial vehicle as safely as in the past. As a
condition of the exemption, therefore, the OMCS will impose
requirements on his exemption consistent with the grandfathering
provisions applied to drivers who participated in the agency's vision
waiver program.
Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the standard in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provide a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in its driver
qualification file, or keep a copy in his/her driver qualification file
if he/she is self-employed. The driver must also have a copy of the
certification when driving so it may be presented to a duly authorized
Federal, State, or local enforcement official.
Discussion of Comments
Advocate for Highway and Auto Safety (AHAS) filed two comments in
this proceeding. Each comment was considered and is discussed below.
In its first submission filed on June 16, 1999, the AHAS commented
that the agency has misinterpreted statutory language related to
exemptions (49 U.S.C. 31315 and 31136(e)), questioned the agency's
reliance on conclusions drawn from the vision waiver program, and
raised procedural objections to this proceeding. We will address these
comments in order.
First, the AHAS believes that the agency misinterpreted the current
law on exemptions by considering them slightly more lenient than the
previous law. This was unquestionably the intention of Congress in
drafting section 4007 of the Transportation Efficiency Act for the 21st
Century (TEA-21), Public Law 105-178, 112 Stat. 107 (See 63 FR 67601,
quoting from H.R. Conf. Rep. No. 105-550, at 489-490). Regardless of
how one characterizes the new exemption language, the OMCS strictly
adheres to the statutory standard for granting an exemption. In short,
we determine whether granting the exemption is likely to achieve an
equal or greater level of safety than exists without the exemption.
Next, the AHAS maintains that the OMCS cannot rely on data from the
waiver study program as a standard for evaluating Mr. Durham's
qualifications for an exemption. Its opinion is based on the fact that
a valid research model was not used for the vision waiver study
program; thus, the results cannot be extrapolated to other drivers who
were not in the program. The validity of research designs cannot be
accepted or dismissed in a blanket, simplistic statement. The approach
used by the agency for the assessment of risk is a valid design that
has been used in epidemiology for studies of occupational health. These
observational studies compare a treated or exposed group of finite size
to a
[[Page 69588]]
control group that is large and represents outcomes for the nation as a
whole (e.g. national mortality rates or truck accident rates.) This
design has been used to investigate risk relative to the hazards of
asbestos and benzene with regulatory decisions based on the outcomes.
The strength of the design is that it provides a high level of
external validity. Being able to compare outcomes to a national norm
places the focus in proper perspective for regulatory matters. This, of
course, is the strength relative to the waiver program where the
General Estimates System (GES) accident rates represent a national
safety norm. While the design has been successfully used in critical
risk areas, its application has not been without challenges. Most of
the criticism has focused on the data used in the models. It has been
correctly argued that exposure to hazards has not always been clearly
measured because recordkeeping is not accurate or complete. Criticism
has also focused on the poor measurement of health outcomes. Vagueness
in the assessment of outcomes was due to poor recordkeeping or exposed
individuals not being examined. Threats to the validity of measurement
do not appear to be as large an issue in the waiver program's risk
assessment. Exposure, for example, in the assessment is manifested by
participation in the waiver program (as exposure to a treatment) and
through vehicle miles traveled (as exposure to risk). The measurement
of participation in the program had no vagueness by virtue of the
required recordkeeping. Exposure to risk by vehicle miles traveled was
measured by self-report and could, of course, contain errors. As
reports were made on a monthly basis, however, it was not expected that
the reporting for these short periods would contain significant
systematic error over the life of the program. Risk outcomes in this
assessment were determined through accident occurrence. Accident
occurrence was verified in multiple ways through self-report (a program
requirement), the Commercial Driver License Information System, State
driving records, and police accident reports. As a result, it is
believed that the research approach used in the waiver program did not
suffer serious flaws relative to the validity of measurement.
Criticism of the approach taken by the waiver program relative to
internal validity could have some merit. Even the original design
proposed for the waiver study received concern for its internal
validity. That design proposed to use a sample of commercial motor
vehicle (CMV) operators without vision deficiencies as a comparison
group. While the design was appealing, it had potential for flaws
relative to internal validity. Due to the nature of the vision
deficiencies examined, the drivers could not be randomly assigned to
the waiver and comparison groups as is done in clinical trials. As the
desirable paradigm for science, clinical trials go to great length to
guarantee internal validity. But, as is being increasingly pointed out
in medical research where randomized trials are seen as the basis of
good science, even these studies can have flaws which undermine their
external validity (U.S. General Accounting Office, ``Cross Design
Synthesis; A New Strategy for Medical Effectiveness Research,'' March
1992, GAO/PEMD-92-18).
In the source cited above, it was suggested that the results
obtained through randomized clinical trials be adjusted to apply to a
patient population which was not represented in the trial, and,
thereby, enhanced external validity. Moreover, it was also suggested
that the results from other observational (i.e., non-random) studies be
used to support the evidence provided by clinical trials. Of course,
these studies would have to be assessed to determine the degree of bias
present relative to internal validity. If it existed, adjustments would
be required. As is more often being recognized, all aspects of
scientific endeavor contain flaws; design, measurement, and even the
research questions asked (Cook, J.D. ``Postpositivist Critical
Multiplism'' in L. Shortland and H.M. Mark (eds.) Social Science and
Social Policy. Newbury Park, CA: Sage 1985). The necessary approach to
obtaining valid results is to thoroughly examine a study for bias and
make adjustments where possible. If the original waiver study
comparative design had been implemented, it would have probably
required adjustments related to both internal and external validity.
The waiver program and its research design were reviewed on several
occasions. Most of the critical discussion concerned analytic
methodology given the nature of the GES comparison group. The risk
monitoring aspect of the design was largely endorsed. However, one
researcher correctly criticized the comparison with the national GES
data because it would not be possible to assess the potential for
comparison bias as a threat to internal validity.This criticism was
correct because such potential confounding factors as age and driving
patterns are not available in the GES data to determine if a lack of
balance exists between the waiver group and the comparison data. If the
factors were not balanced, adjustments could not be made. The bias, if
it existed, would therefore be hidden. This was a concern to us. To
address this concern, a sensitivity analysis was performed to assess
the impact of possible hidden bias (Rosenbaum, P.R. Observational
Studies, New York, Springer-Verlag 1995). The analysis examined
outcomes under various levels of hidden bias and the results showed
that the comparison with GES accident rates is largely insensitive to
hidden bias. The results of this sensitivity analysis, filed in Docket
No. FHWA-99-5578, provide evidence to support the internal validity of
the comparison to GES data.
Based on the various assessments, it would appear that the results
of the waiver program risk analysis are basically valid. The
measurement of exposure and risk outcomes were conducted with virtually
no error. The external validity is ensured because a national norm is
the focus of comparison and, based on the sensitivity analysis, the
degree of internal validity is strengthened. To obtain valid results
that point to a clear casual connection between an action and an
outcome basically rests on ruling out other influences on the outcome.
While these appear to be largely accomplished based on an examination
of the various types of validity, there remains an additional threat to
the validity of the results. Relative to this, it has been argued that
the drivers in the various waiver programs have lower accident rates
because they are aware of being monitored, and monitoring is a strong
motivation to exercise care. Given the possible threat, the agency
conducted a follow up assessment after the wavered drivers were given
grandfather rights in March 1996. Conducted in June 1998, an assessment
of the drivers' accident experience was made for the period to December
1996. The results, on file in Docket No. FHWA-99-5578, showed that the
drivers who had been in the program continued to have an accident rate
that was lower than the national norm.
Based on the information discussed above, it is reasonable to
conclude that the results generated by the waiver program have a high
degree of validity. It then remains to determine how these results can
be used, i.e., what inferences can be drawn from results and what are
the boundaries on these inferences? The AHAS states categorically that
``the agency cannot extrapolate from the experience of drivers in the
vision waiver program to other vision impaired
[[Page 69589]]
drivers who did not participate in the program.'' To some degree this
statement is correct. Based on the design, data collection and analysis
associated with the waiver program, the agency does not wish to
generalize the results of the study to other drivers with vision
deficiencies per se. That is, drivers are not the focus of inference.
They are associated with the inference but are not necessarily the
subject of inference. Nor are the vision standards the focus of
inference from the results. As the AHAS pointed out, ``The FHWA
recognizes that there were weaknesses in the waiver study design and
believes that the waiver study has not produced, by itself, sufficient
evidence upon which to develop new vision and diabetes standards.'' (61
FR 13338, 13340). In making this statement, the FHWA merely recognized
that the study design did not ask questions concerning whether there
are vision characteristics other than those in standards that could
permit safe operating of a CMV. The agency conducted a feasibility
assessment to determine if such a study could be designed and
implemented. It was concluded that resources were not available to do
this.
The target of inference in the waiver study is suggested in another
quote offered by the AHAS. The AHAS points out that the agency has
stated ``that monocular drivers in the waiver program demonstrated
their ability to drive safely supports a conclusion that other
monocular drivers, with qualifications similar to those required by the
waiver program, can also adapt to their vision deficiency and operate
safely.'' This statement captures the focus of inference while being
somewhat restrictive relative to the type of vision deficiency
involved. The target of the test in the research design was the process
of granting waivers. That is, it can be inferred that drivers with
vision deficiencies who are approved by the screening process in the
waiver program will be able to operate CMVs in a manner that is as safe
or safer than the prevailing national safety norm. The inference is not
being made to screening processes in general. It is only being inferred
for the single process in the waiver program and that this process is
viable for the purpose intended. That the AHAS has stated such a
conclusion is not tenable because a valid research design was not used
is in itself a proposition that does not enjoy support. The discussion
of the validity of the approach clarifies the value of results. If the
inferences drawn from these results focus on the process tested, the
conclusions are valid. It follows ipso facto that the application of
the waiver process to future screening should also produce valid
results.
The AHAS points out that Mr. Durham differs from other drivers in
the vision waiver study program in that his driving record contained a
``gap,'' whereas drivers in the program had 3 years of continuous
experience immediately prior to receiving their waiver. As the AHAS
notes, that fact contributed to the agency's previous denial of Mr.
Durham's request for an exemption. When the FHWA, and now OMCS,
reconsidered that decision, however, we concluded that Mr. Durham does
meet the criteria in the study program notwithstanding his break in
driving experience. He had over 3 years of continuous driving
experience with this vision deficiency and established a safe driving
record from 1992 to April 1996. This experience exceeded the driving
required by the study program criteria and provides a basis for
projecting his future performance. The 18-month break from April 1996
to October 1997 would have undermined the reliability of that
experience, as a predictor of his ability to drive safely, if he had
not resumed driving. By driving from October 1997 until July 1998
without an accident or traffic citation, Mr. Durham demonstrated he
still has the ability to adapt his driving skills to accommodate his
limited vision. Based on these specific facts, we have concluded that
Mr. Durham satisfies the criteria applied in the vision waiver study
program and qualifies for an exemption, notwithstanding his break in
driving.
In its third point, the AHAS objects to the procedure employed in
processing these petitions for exemptions, contending that there is no
statutory basis for making a ``preliminary'' determination which tends
to pre-judge the outcome. The AHAS makes an analogy to an interim final
rule where an agency ``has already made its decision and the burden is
unduly and improperly placed on the public to overcome the agency's
initial decision to grant the exemption.'' This analogy is misplaced.
The agency's ``preliminary determination'' is more aptly compared to a
notice of proposed rulemaking, wherein the agency analyzes the basis
upon which a new or amended regulation has been considered, and then
proposes that the new rule take effect. The agency then considers the
information obtained in response to the NPRM and issues a final rule.
In a similar vein, the agency analyzes the information provided in an
exemption application. Some applications are denied outright. Only when
the agency proposes to grant a petition does it publish that proposal,
with its analysis of the information submitted in support of the
exemption, for public comment. After consideration of public comment, a
final decision is published. This procedure is consistent with 49
U.S.C. 31315(b)(4)(A) which requires the OMCS, and previously the FHWA,
to publish in the Federal Register a notice explaining the request that
has been filed, giving the public an opportunity to inspect the safety
analysis and any other relevant information known to the agency and
allowing the public to comment on the exemption request.
The AHAS filed its second comment on July 7, 1999, to urge that the
FHWA reconsider its application of Rauenhorst v. United States
Department of Transportation, Federal Highway Administration, 95 F.3d
715 (8th Cir. 1996), in light of the U.S. Supreme Court's decision in
Albertson's Inc. v. Kirkingburg, 119 S.Ct. 2162 (June 22, 1999).
According to the AHAS, the court's decision supports its view that this
agency cannot rely on data collected in the vision waiver program to
justify issuing additional exemptions. We disagree with the AHAS's
interpretation of the Kirkingburg case. The court specifically stated
in Footnote 21 that the current exemption program was not challenged or
considered in its opinion. For that reason, we do not view the case as
affecting Mr. Durham's exemptions.
Conclusion
After considering the comments and evaluating Mr. Durham's
qualifications in accordance with Rauenhorst, supra, the OMCS exempts
James F. Durham from the vision requirement in 49 CFR 391.41(b)(10),
subject to the following conditions: (1) That he be physically examined
every year (a) by an ophthalmologist or optometrist who attests that
the vision in his left eye continues to meet the standard in 49 CFR
391.41(b)(10), and (b) by a medical examiner who attests that he is
otherwise physically qualified under 49 CFR 391.41; (2) that he provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (3) that he
provide a copy of the annual medical certification to his employer for
retention of in its driver qualification file, or keep a copy in his
driver qualification file if he is self-employed. Mr. Durham must also
have a copy of the certification when driving so it may be presented to
a duly authorized Federal, State, or local enforcement official.
[[Page 69590]]
In accordance with revised 49 U.S.C. 31315 and 31136(e), Mr.
Durham's exemption will be valid for 2 years unless revoked earlier by
the OMCS. The exemption will be revoked if (1) he 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 before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31315 and 31136(e). If the
exemption is still effective at the end of the 2-year period, Mr.
Durham may apply to the OMCS for a renewal under procedures in effect
at the time.
Authority: 49 U.S.C. 322, 31315 and 31136; 49 CFR 1.73.
Issued on: December 6, 1999.
Brian M. McLaughlin,
Director of Policy and Program Management, Office of Motor Carrier
Safety.
[FR Doc. 99-32104 Filed 12-10-99; 8:45 am]
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