April 7, 2000
Docket Clerk
Attn: Docket No. OST-99-6578
U.S. Dept. of Transportation
400 7th St., S.W., Rm. PL-401
Washington, DC 20590
Following are the comments of the Drug and Alcohol Testing Industry
Association (DATIA) on the U.S. Dept. of Transportation's (DOT) Notice of Proposed
Rulemaking (NPRM) to revise its drug and alcohol testing program regulations for
49 CFR Part 40. DATIA is an 1,100+ member non profit national trade association
representing the entire spectrum of service providers in the drug and alcohol
testing industry, including consortia, third party administrators, specimen collectors,
medical review officers, laboratories, and testing equipment manufacturers. DATIA's
comments on behalf of its constituency are based upon considerable member input,
including two extensive surveys of the membership and comments collected at the
association's annual conference, and during the three listening sessions recently
hosted by DOT.
DATIA wishes to commend the department on its effort to update
the regulation for use in the 21st Century, and consolidating myriad interpretations
and guidance. In addition, the "Plain English" format of the NRPM is a vast improvement
over NPRMs of the past, and will surely allow more people to participate in the
review process.
1. Public Interest Exclusions (PIE) [Sections 40.361-385]:
DOT is proposing a new section creating a Public Interest Exclusion
(PIE) to sanction a service agent for non-compliance with Part 40 regulations,
rather than sanctioning the employer using a service agent whom is non-compliant.
DATIA supports holding all service agents accountable for their
actions. The primary goal of any service agent should be to provide their employer
client with the highest level of compliant service possible in support of public
safety. Those service agents who commit egregious violations, placing their client
and the safety of the public at risk, and bring into question the integrity of
the entire testing industry, need to be sanctioned. The question is the proper
and fair means to accomplish this goal
1. DATIA recommends that DOT, working with the industry, defines
an objective and specific list of what actions on the part of any service agent
would trigger a PIE, and allow for other undefined, yet obviously equivalent violations
to be considered as well. Specific examples could include:
a) A non-medical person acting in the role of Medical Review
Officer (MRO) without the necessary qualifications;
b) Any service agent altering test results on the basis of a
monetary incentive;
c) Any service agent willfully violating confidentiality regulations
in the furtherance of their business success; and
d) Any service agent verifying positive test results without
performing an employee interview by an MRO, with the exception of the three circumstances
outlined in 40.133.
2. DATIA recommends that, rather than suspending all business
operations of a service agent for between 9 months and 5 years as DOT is proposing,
it would be more appropriate, less punitive, and not as disruptive to the client
base for DOT to suspend only that/those service(s) of the service agent that triggered
the PIE, and only at the facility committing that/those violation(s). This consideration
would be particularly beneficial in rural areas, where a facility forced to close
completely could have a devastating impact on regulated employers in the area,
or where several facilities in a rural area were owned by the same entity.
3. As an alternative to suspending a service agent's business
operations as proposed in the NPRM, or as suggested in the preceding point, DATIA
alternatively recommends that DOT consider a monetary fine commensurate with the
severity of the violation. A fine would also allow for consistency in keeping
with actions taken against regulated transportation employers. DATIA suggests
that, if DOT does not currently have the authority to implement civil sanctions
against a service agent (as DOT's modal agencies do against noncompliant transportation
operators), or to suspend the business operations of a service agent committing
egregious violations of Part 40, that it obtain legal clarification on the authority
that it has relative to PIE, and/or seek such authority through the legislative
process.
4. DATIA recommends that new elements be introduced to increase
the "due process" of the PIE procedure. In addition, the association recommends
that DOT clearly delineate the process through which allegations against a service
agent would flow prior to the issuance of a PIE as the final step.
5. DATIA recommends that any PIE enforcement efforts be undertaken
only after the new 49 CFR Part 40 regulations have been in effect for a minimum
of one year. Employers and service agents will need time to adjust contracts,
procedures, and practices to conform to new rules after having operated under
previous regulations for almost 12 years.
2. Reporting of Test Results [Section 40.351(e)]
DOT's NPRM proposes to require MROs to report all test results
to the "actual employer," not to a consortium or third party administrator. DATIA
believes it is essential for consortia and third party administrators to receive
test results from the MRO after they have been verified for the following reasons:
The consortia and third party administrators know to contact
the appropriate local DOT authorities in the case of a verified positive test
result to ensure employee removal from a safety sensitive function. For example,
if an MRO reports directly to an owner-operator or small employer, that employer
is not likely to report him/herself to the appropriate DOT agency, or remove him/herself
from the random pool.
Over the past 12 years, businesses, both small and large, have
come to rely upon the value-added benefits that consortia and third party administrators
have provided to keep them in compliance with the very complex drug and alcohol
testing regulations. The business climate has changed, too, where companies have
outsourced many operational functions to take advantage of economies of scale
provided by consortia and third party administrators and thereby cost effectively
streamline their enterprises. Now, the services provided by consortia and third
party administrators are as common to businesses as payroll and accounting services,
to name a few. Most businesses do not have the knowledge, much less the resources
or incentive, to remain compliant on their own.
DOT itself should acknowledge the valuable role that consortia
and third party administrators have played in DOT's compliance efforts. Without
consortia and third party administrator's services acting essentially as an arm
of DOT, most companies (especially small ones) would not have the knowledge or
resources needed to be compliant. DOT, with its chronic lack of resources, would
find it almost impossible to police the compliance efforts of the millions of
employers mandated to be a part of the DOT drug and alcohol-testing program.
DATIA proposes the following alternatives for consideration:
1. Allow consortia and third party administrators to act as
an "agent of the employer" for small businesses (defined here as those
business entities with 50 or fewer employees). This is the best alternative according
to our member survey and input;
2. Allow consortia and third party administrators to continue
to act as an "agent of the employer" in receiving test results and performing
other duties for all employers; and
3. Allow consortia and third party administrators to receive
and report all negative results, and allow MRO's and consortia/third party administrators
to simultaneously report positive results.
3. Definition of Employer [Section 40.3]
The DOT proposes to make a significant change in the testing
industry by removing the term "consortium" as part of the definition
of "employer," as it has existed for the past 11 years in 49 CFR Part
40. The current definition is the foundation for the testing industry's creation
and continued existence. Removal of the term "consortium" from the definition
is a major concern to the members of DATIA, and DATIA strenuously opposes this
part of the DOT NPRM.
DATIA proposes that consortia of small employers (defined as
fewer than 100 employees) continue to be defined as an "employer" for
the purpose of the drug and alcohol testing regulation. This would allow the small
employer to contract with the consortium or third party administrator to be their
"Designated Employer Representative." The current DOT 49 CFR Part 40
rule defines all "industry consortia" the same as employers, and the
NPRM defines none of them as employers. DATIA's solution would allow for those
small employers to continue to use consortia to fulfill necessary roles on their
behalf, including receiving and reporting test results, filing MIS reports, reporting
to the appropriate federal agency, maintaining employers records, advising the
employer on substance abuse treatment options, serving as consultant to regulated
businesses in establishing drug testing and treatment programs, etc.
4. Statistical Reports from Laboratories [Section 40.111]
DOT proposes that the laboratory be required to send to the
consortium or the employer a statistical report every six (6) months detailing
all tests by the employer. DATIA is concerned that millions of small employers
will never have a sufficient number of tests (three to six per quarter) to rate
a statistical count, and the form is left blank. At a random testing rate of 50%,
an employer would have to have between 24 and 48 employees to even have any information
printed on the form at all. At a 25% testing rate, the employer would have to
have a minimum of 48 to 96 employees to have a report of any value. Further, this
statistical report is a source of significant confusion among small employers,
as it contains information on positive tests which were later overturned by the
MRO, and frequent mistakes on account and employer information. None of DATIA's
members have ever reported any real utility from these reports despite their high
cost.
For example, one of DATIA's members is a consortium of 3,600
employers. The average number of employees is three to five per company. None
of these companies generate enough tests to have any information on the laboratory
Statistical Report, but the lab must forward these blank reports, as required
by the current (and proposed) regulation. Under the current 49 CFR 40 regulation,
this consortium forwards to their employer members 14,400 blank quarterly reports
per year. It is commonly accepted in the direct mail industry that one piece of
first class mail costs $0.75 each (which includes postage, printing, and mailing
fees). Therefore, first the laboratory incurs a cost (ultimately passed along
to the client) of $10,800, then, second the consortium processes the 14,400 envelopes,
and sends them on to the employer clients, incurring another cost of $10,800 as
they are repackaged to the correct addresses. Then third, the employer member
must process the incoming blank forms in some manner, for an undetermined cost
of time of filing and questioning of the information contained on the report.
A conservative estimate of the aggregate labor cost imposed on the three entities
(laboratory, consortium, and employer) amount to $2.00 per envelope, plus the
$1.50 postage printing and mailing costs, amounting to (14,400 envelopes X $3.50
each = $50,400 annually). The NPRM would lower this cost to $25,200 annually for
one consortium but there would still be zero benefit for this consortium, its
employers, and the hundreds of thousands like it.
A true economic cost benefit analysis, including all labor related
paperwork burdens of this part of the rule, would find that the Statistical Report's
costs even higher, and would find it to have no utility for small employers. But
the facts above show that the cost would be a minimum of $7.00 per company annually,
times the approximately 500,000 small employers (75 percent of the 673,000 employers
have been estimated at less than 50 employees) the cost is $3.5 million annually,
or $17.5 million over the next five years.
In DATIA's view, there is no better way to save a significant
amount of (totally) unnecessary cost than to eliminate the statistical reports
entirely, or at a minimum eliminate it for employers of fewer than 50 employees.
Therefore, DATIA proposes at a minimum that all employers of
fewer than 50 employees be relieved from the responsibility and administrative
burden of receiving statistical summary reports, and for "service agents"
to forward these reports only to clients with more than 50 employees. Alternatively,
laboratories could be relieved of the responsibility of sending blank statistical
reports, and consortia and third party administrators could, therefore, be relieved
of the responsibility of forwarding blank reports to their clients.
5. MRO and Collector Training [Sections 40.123 and 40.33]
DOT proposes that MROs take a training course every two years,
or self-certify that they have reviewed and understand Part 40 and applicable
DOT agency regulations and guidance. For collectors, DOT is proposing that a person
"who is sufficiently knowledgeable in the applicable collection procedures
of this part to be able to evaluate the collector's performance" train collectors
and attest to their proficiency.
Any "service agent" in the drug and alcohol testing
industry should be as current on technique, technology, and regulations as possible.
As such, DATIA believes MROs should be certified by an outside or independent
entity through a face-to-face educational session using a DOT approved or reviewed
curriculum and passing a proficiency test covering the MRO role in the DOT's Part
40 regulation.
Concerning collectors, DATIA believes the term "sufficiently
knowledgeable" is extremely vague and could easily lead to improper techniques
being taught, especially since the trainer is the one who will ultimately attest
to the collector's proficiency. As such, DATIA recommends that the DOT further
outline the requirements that must be met for training the trainer. Collectors
should not "self certify" that they are "sufficiently knowledgeable."
DATIA members suggest the trainer should attend a face-to-face training session,
which includes a DOT approved or reviewed curriculum, and pass a proficiency test
covering the procedures outlined in Part 40 prior to being determined "sufficiently
knowledgeable."
In general, DATIA believes that in an effort to maintain the
quality and integrity of the services provided and ultimately the safety of the
public, all service agents in the drug and alcohol testing industry should be
certified as to their proficiency. A DOT approved or reviewed training, testing,
and certification procedure should be instituted by a variety of non-profit and
for profit programs. In addition to maintaining each service agent's proficiency
as the industry evolves, it also provides the employer with a benchmark to determine
quality of service and products.
6. Removal of Boots [Section 40.61(f)(5)]
DOT is proposing to require that donors remove boots (i.e. work
and/or cowboy) prior to the collection taking place.
DATIA's members have indicated that requiring donors to remove
boots will not have a positive effect on the drug testing process, and should
therefore be removed. Although the intent behind this proposed regulation is correct,
it is a very arbitrary proposal. Why require the construction worker to remove
his work boots and not the airline pilot's loafers? Should a donor be required
to remove his/her boots before a collection, and then see another donor begin
the process without having to remove his/her shoes, may cause more problems than
the one person that is caught with an adulterant in his/her shoe.
Another consideration is that once word spreads that removal
of boots is now a requirement, those determined enough to adulterate their specimen
will simply conceal the adulterant on another part of their body or wear another
type of footwear. In effect, this proposed regulation will not deter adulteration
attempts, but will only serve to offend donors and create a potentially uncomfortable
situation for the collector.
7. Failure to Drink Liquids as Instructed [Sections 40.191(a)(5)
and 40.193(b)(2)]
DOT is proposing that a donor's failure to drink liquids as
directed will result in the collection process being terminated and will constitute
a refusal to test. In part 40.191(a)(2), the proposal states that failure to provide
a specimen will result in a refusal to test, as will refusing to cooperate with
any part of the testing process in 40.191(a)(7). DATIA believes that refusing
to drink liquids is in keeping with these portions of the proposed rules and should
remain in the regulation. Many collectors have indicated that it has been their
experience that many donors produce a "shy bladder" to delay returning
to work or because they are afraid they will test positive. By including this
regulation, both of these reasons for a "shy bladder" will be eliminated.
DATIA proposes that to keep the regulations consistent, 40.193(b)(2)
should be modified to read "Direct the employee to drink fluids, up to 40
ounces…" since the current reading of the regulation identifies the
maximum amount of liquids to be consumed, however, it implies that there is no
minimum. There should be a minimum amount included in the regulations…or
does taking a sip constitute drinking fluids? While DATIA does not have the experience
to determine the minimum amount of fluid that should be consumed, it believes
that at least twelve (12) ounces would be sufficient.
8. Direct Observation Immediately Following a Dilute Specimen
[Section 40.67(c)]
DOT's NPRM asks whether or not the presentation of a dilute
specimen by a donor should require an immediate direct observation collection.
Since laboratory results will not be obtained during the collection,
it is DATIA's understanding that a specimen will be determined to be dilute through
visual inspection. DATIA has heard from many collectors about specimens that appear
normal in all ways (temperature, smell, etc.) except for the fact that they were
nearly clear. It should be stated that a direct observation collection would be
performed on any specimen that does not appear to meet the standards for a normal
specimen, which includes color (light color indicating diluteness). Although there
are many occasions where the second specimen will also be dilute owing to a person
being over- hydrated, this will eliminate those donors who substituted or altered
the original specimen. It is the experience of many DATIA members that requiring
a direct observation collection when the original specimen is dilute will help
to validate the testing process and should, therefore, remain in the regulation.
9. Adulterated, Substituted, and Dilute Tests [Section 40.93]
DOT is proposing to mandate testing for adulterated and substituted
specimens ("validity testing"), that will likely increase the number
of situations in which laboratories determine that a specimen has been adulterated
or substituted.
Adulteration and substitution of specimens in an attempt to
frustrate the testing process is a very serious threat to the integrity of the
DOT testing program, the testing industry, and most importantly, to public safety.
The members of DATIA overwhelmingly support validity testing, and believe the
additional costs of a validity testing panel are more than outweighed by the benefits.
As such, DATIA supports the proposal at Section 40.93.
10. Drug Testing Forms and Materials [Sections 40.47 and 40.49]
DOT is proposing that no one can use a DOT drug testing form
for a non-DOT test or vise versa, that collectors use a testing kit conforming
to DOT requirements, and what, if any, additional security measures would be appropriate
for testing materials and supplies. Finally, the proposal would continue existing
policy that allows foreign employers to use foreign-language versions of the forms.
DATIA's members overwhelmingly support a universal chain of
custody form with a check box indicating whether a "Federal" or "Non-Federal"
test was being performed. It is DATIA's opinion that such a form would not compromise
the integrity of the DOT mandated test, and would eliminate the concern that a
DOT form be used only for DOT tests, and non-DOT forms be used for non-DOT tests.
A universal form would likely lessen the chance of a staff person completing an
inappropriate form and reduce printing and storage costs.
DATIA members support use of a testing kit conforming to DOT
standards to help ensure proper and consistent collection procedures.
DATIA members are not aware of any instances of widespread tampering
with, or theft of, testing materials or supplies. As such, it is DATIA's belief
that current security measures are sufficient, and do not warrant additional requirements.
11. Electronic Records and Signatures [No section citation]
While the NPRM is not making any new proposals in the area of
electronic records and signatures, DATIA feels strongly that inter-departmental
consideration of their optional use should be a priority. DATIA members overwhelmingly
believe that the optional use of e-forms and e-signatures will streamline the
collection process and increase the accuracy of the information provided on testing
forms. In addition, electronic media will reduce administrative and storage costs
for service agents.
DATIA recommends that DOT work cooperatively with the U.S. Dept.
of Health and Human Services (HHS) to permit the optional use of e-forms and e-signatures
within three (3) years. While DATIA does not have any specific recommendations
concerning software or other technical protocols, especially as it concerns the
security of confidential data transfers, it does suggest that the departments
look to the private financial services industry as examples when considering specifications
for security, format, and other technical provisions.
12. Service Agent Assurance [Section 40.11]
DOT is proposing that both regulated employers and their service
agents sign a contract provision committing them to compliance with Part 40 provisions.
DATIA members overwhelmingly support accountability in the testing
program. Our members believe that a service agent contract will serve to ensure
accountability and quality of service between industry professionals and their
customers. It will also ensure that employers acknowledge their responsibility
to comply with applicable regulations. However, DOT should clarify that should
an employer be cited for non-compliance, despite the best efforts of the employer's
service agent to keep said employer in compliance, that the service agent is not
determined to be at breach of contract and subject to sanctions.
As this is a new requirement, DATIA recommends that the DOT
implement a phase-in period for this regulation of not less than one year, to
allow service agents to review contract language with their legal representation
and their clients, and to permit the contract inclusion on new printed material.
13. Blind Specimens [Sections 40.103 and 40.103(a)]
DOT proposes to reduce the number of blind specimens sent by
regulated employers to laboratories to test the accuracy of the lab. Entities
with fewer than 2000 DOT covered employees would not have to provide blind specimens,
and those over 2000 covered employees would only have to provide blind specimens
at a one-percent (1%) rate up to a cap of 50 per quarter.
DATIA recommends that the blind specimen requirement be eliminated
entirely. Laboratories are already certified by HHS to ensure that they are meeting
all necessary requirements. Mandating regulated employers to send blind specimens
to the laboratory is an unnecessary and misdirected expense for any size regulated
employer. If the test is considered an absolute necessity to maintain the integrity
of the testing facility, the expense to test for this should be assumed by the
laboratory.
14. Alcohol Test Administration [Section 40.225]
In its NPRM, DOT seeks comment on how well the current alcohol
testing form is working for collection and other concerned personnel, and whether
there are improvements to the form, which should be made.
DATIA makes the following recommendations to improve the use
of the alcohol testing form:
Remove "Breath" from "Breath Alcohol Testing
Form". There is now more than one method used to test for alcohol consumption.
Include on the form the Designated Employer Representative name
and phone number.
Add an area on the form to include the instrument used to test
the employee (breath or saliva), the testing technician's name, name of the company
for which the BAT or STT works, along with an area for their phone number.
Add an area on the front of the form for placement of the test
results.
15. Conflicts of Interest [Sections 40.101 and 40.125]
DOT has indicated concern about potential conflicts of interest
with all service agents, especially where financial benefit could be derived.
DOT is asking whether the long-standing prohibition against the laboratory and
MRO having an affiliation or financial arrangement with one another may be construed
as a conflict of interest and whether this prohibition should be strengthened.
DOT goes on to ask how it can ensure that there exists no conflict of interest
in a laboratory-based third party administrator's selection of an MRO, or in an
MRO-based third-party administrator's selection of a laboratory.
DATIA's members have overwhelmingly indicated that they have
not encountered specific situations where they believe a real conflict of interest
exists between the MRO and laboratory. In addition, they have responded the same
with regards to the relationship between the MRO and a consortium or third party
administrator. As such, DATIA does not see any need to strengthen the current
prohibition between the laboratory and MRO, nor impose similar provisions on other
service agents. DATIA believes that any such regulation would impose burdensome
paperwork requirements on service agents and that the results of such regulation
would not be commensurate with the effort needed to be compliant.
Conclusion
We believe the most significant element that needs to be added
to the DOT's NPRM is to incorporate a differential for small employers, as defined
as fewer than 50 employees. This differential would recognize that small entities
are more negatively impacted by many elements of the regulation from a cost viewpoint.
Small entities also have different situations that general regulations do not
sufficiently address. The initial DOT rule made in 1988 incorporated such a differential
for small employers, and the Regulatory Flexibility Act [5 USC Section 601, Public
Law No. 96-354] requires it as well. Elements of the DOT NPRM discussed above
that cry out for a differential are: the statistical reporting requirements, the
test result reporting process though the "service agent," and the definition
of employer for small entities that do not have the resources for a designated
employer representative.
DATIA appreciates the opportunity to comment on this wide reaching
change to 49 CFR Part 40. In considering the recommendations that DOT has received
at each of its listening sessions, through written comments and other sources,
DATIA sincerely hopes that DOT will consult with the industry's myriad of professionals
and regulated employers when seeking closure on issues with serious implications.
The rewrite to Part 40 should not be done solely by DOT personnel without the
real world input of industry and regulated employers "in the field,"
who must deal with the consequences of either ill conceived or well crafted regulations.
The goal of these regulations is to provide for drug- and alcohol-free
transportation workplaces. We believe the DATIA changes suggested above would
make the DOT proposal most workable and cost effective, therefore encouraging
more compliance with the rules by regulated employers, of which the majority are
small businesses.
Sincerely,
Jeffrey C. Smith
President
