[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]
BILLING CODE 4910-22-M