![](media/image1.png){width="1.6680555555555556in" height="1.7in"}
Theodore F. Shults, MS, JD

Chairman

\(919\) 489-5407

[American Association of Medical Review Officers]{.underline}

**Federal Register Document Number 04-7984**

**Public Comment 8400121**

June 30, 2004

Walter F. Vogl, Ph.D.

Division of Workplace Programs

CSAP, SAMHSA

5600 Fishers Lane, Rockwall II, Suite 815

Rockville, MD 20857

> RE: Comments to Proposed Revisions to Mandatory Guidelines for Federal
> Workplace Drug Testing Programs, 69 FR 19673‑0l

Dear Dr. Vogl:

I would like to take this opportunity to express some of the major
concerns presented by the Proposed Revisions to the Mandatory Guidelines
for Federal Workplace Drug Testing Programs. As chair of the American
Association of Medical Review Officers, I can say that I have not
received a significant number of written comments from MROs concerning
the proposals, and silence may be viewed as an endorsement. I believe,
however, that the minimal response from the MRO community reflects the
understanding of most MROs that the proposed rules are not simply
technical amendments, but rather represent fundamental political and
policy decisions.

Drug testing procedures are inextricably integrated with legal and
policy considerations. I believe that the concerns presented in this
letter reflect the concerns of many or most MROs, but not all. To that
degree, the comments can be viewed simply as information that should be
considered in developing the federal policy.

I find it difficult to be critical of the proposed amendments, because
for over 20 years I have been a strong supporter of drug testing as a
method of control to reduce demand and mitigate the adverse impact of
drug abuse on society. I have had a number of unique opportunities to
work in this field. I have worked as a toxicologist, developing drug
testing methods. I worked in what was at the time the country's leading
drug testing laboratory as part of its management and as its corporate
counsel. I have also worked as a technical and legal consultant to
federal agencies and private employers. For the past 10 years I have had
the opportunity to work with the medical community and other leading
experts in the field, training physicians to be Medical Review Officers
as the founder and chair of the American Association of Medical Review
Officers.

I have written in the *Medical Review Officer Handbook* that the two
decades of urinalysis testing programs have made America a safer place
to travel and work. I was reminded during the recent funeral and
eulogies of President Reagan that another part of his significant legacy
was the conception and implementation of federal workplace drug testing
programs. This was a forward-thinking solution to the substance abuse
crisis at the time. It was a sound response to the public consensus that
substance abuse was the most pressing problem facing America. In the
post 9/11 world, there is now a consensus that drug abuse is not the
most pressing problem facing America. Paradoxically, effective drug
testing programs are required as much in 2004 as they were back in 1984.

**I. Specimen Validity**

Unfortunately, the history of workplace drug testing includes prolonged
periods of regulatory stagnation, with the result that urine drug
testing is not as effective today as it was twenty years ago. This is
largely due to the lack of a mandatory and comprehensive specimen
validity strategy. The specimen validity rules finally published on
April 13, 2004 are long overdue, and they represent a sound technical
strategy for significantly reducing adulteration.

**Invalid Tests**

A general policy concern of the specimen validity rule is worth
mentioning here, and that is the increased reporting of invalid tests.
Employers have a difficult time interpreting the significance of an
invalid test. An invalid test can be relatively benign, or it can be
sinister. In general, the "invalid" designation will create a stigma for
the donor. For better or worse, workplace urine drug testing has been a
black-and-white, up-or-down, positive or negative process. Now we have
the "do-over"---the invalid specimen where the donor must return to the
collection site for an immediate observed collection.

I understand that these invalid specimens are "suspect" specimens, but
using that rationale, how do we ignore the significant number of urine
specimens that are found to actually have drugs in them below the
administrative cutoff levels? From a scientific perspective, these
below-cutoff specimens are as positive as those above the cutoff. Even
with the existing cutoff levels, are these specimens not suspect
specimens also? Yet there is no need to recollect. Why not?

There are and will always be technical limitations to what can be
accomplished in any drug testing technology. As a matter of policy, I
would encourage the minimization of invalid tests, which are ambiguous
to employers. I would also eliminate the confusion created by a
laboratory report that states that the specimen is both "positive" and
"invalid." Where there is a positive result, or a finding of
substitution or adulteration, why not simply state the specific cause
for the "invalid" finding (e.g., the actual pH measurement) rather than
the generic and confusing term "invalid"? It is not hard to imagine a
hearing officer, law judge or employer looking at a "positive --
invalid" result and simply throwing out the whole laboratory report.

**Lowering Cutoff Values**

There is general support for the proposal to lower cutoff levels for
amphetamine and cocaine. This represents a significant enhancement to
the existing program.

I would also recommend lowering the cutoff levels for THC. Or
alternatively, lower the cutoff levels for THC in dilute specimens. In
the past, the issue of "passive inhalation" of marijuana smoke has been
raised as the reason for not lowering the THC cutoffs. Lowering the
cutoff level for THC in a dilute specimen does not increase the
probability of "passive inhalation" as compared to the existing cutoff
levels in "normal" specimens. There is a general consensus in the
technical community that these measures would result in a significant
increase in positive results.

**On-Site Screening for Specimen Validity**

Finally, it would seem that on-site screening of urine specimens for
"specimen validity" would be a convenient way to immediately flag
suspect specimens and trigger an observed collection. This on-site
screening for adulterants presents its own policy and implementation
issues; nevertheless, it is somewhat surprising that this concept is not
even addressed in the proposed amendments.

**II. Alternative Technologies**

It is reassuring and exciting that the regulatory pipeline has become
unplugged. At the same time, very little of what came out of the
pipeline on April 13, 2004 appears to be ready for implementation. It is
highly unlikely that any federal agency would adopt using oral fluids
under the conditions outlined in the proposed rule, or take on the costs
of implementing a point-of-collection test, or even gravitate toward
sweat testing, except for monitoring an individual in a return-to-work
program. Oral fluid and point-of-collection testing offer significant
benefits to program managers and federal agencies, but not as conceived
here. It is hoped that the technical and policy issues that require a
donor to "spit" into a test tube, and then have the collector split the
specimen, and the requirement to also collect a urine specimen can be
resolved.

**Hair Testing**

What is left, and apparently it is warmly endorsed, is hair testing.
There is no doubt that hair testing holds the promise of providing a
powerful tool for the identification of drug use or exposure for a
relatively long period of time---essentially the age of the hair segment
being tested. Hair testing has been promoted not only as a method of
identifying drug use but for revealing patterns of use by means of
segmental analysis and the interpretation of quantitative results. These
are very seductive promises, but hair testing is not going to be a night
of romance.

There have been and continue to be serious technical, legal, policy, and
perhaps even ethical questions about how hair testing technology should
be utilized. Many of these concerns are identified in the proposed
amendment and essentially discounted. Given the seriousness of the
concerns and the lack of definitive answers to the concerns raised in
the rule itself, there can be little doubt that if the proposed hair
testing rules are adopted substantially as written, there will be an
extensive period of legal---specifically, constitutional---challenge.

As we all know, the federal government is subject to the constitutional
limitations of the Fourth Amendment in respect to performing and/or
requiring drug tests. Thus, drug testing practices that may be
acceptable for a private employer may be unconstitutional when applied
by the government. A good example of this is the private employer's
practice of screening applicants or employees with an immunoassay screen
and not providing any laboratory confirmation of these presumptive
results or even the opportunity for the donor to provide a prescription
as an alternative medical explanation to a Medical Review Officer. Even
if throwing the occasional baby out with the wash water makes good
business sense for a private employer, it does not pass constitutional
muster when attempted by a government agency. For one thing, it is not
reasonable.

So what are the constitutional issues presented by hair testing? If
urine testing is okay, why shouldn't we believe that hair testing is
acceptable also? Some of the essential elements required by the Supreme
Court to carve out an exception to the Fourth Amendment for
suspicionless searches, including urine testing, are the presence of a
compelling government interest, the "reasonableness" of the search, the
"effectiveness" of the search and an acceptable "level of intrusion."

There has simply not been an opportunity for the courts to decide
whether the use of hair as a drug testing specimen meets the
constitutional requirements of a governmentally mandated suspicionless
test. There is universal agreement that public safety and national
security are compelling government interests. But is there a compelling
government interest in determining whether a job applicant for a
clerical position used an illegal drug two months ago? Where is the data
that supports this?

Actually, this is not the hard part of the constitutional challenge
facing hair testing. First and perhaps foremost is the fundamental
variability of hair as a drug testing specimen. All biological specimens
exhibit a degree of variability between individuals and between
collections. There is, though, no more variable a human toxicology
specimen than human hair. For thousands of years, men and women have
been grooming, styling, cleaning, straightening, curling, dyeing,
bleaching, perfuming, conditioning, powdering and perming their hair.
Much of this cosmetic treatment represents a chemical assault on the
specimen, resulting in everything from burnt ends and brittle hair to
coated hair, discolored hair and even hair loss.

Hair is highly stylized. Look around any room full of people. Both men
and women invest heavily in the appearance of their hair. Men pay a lot
to get some to grow. Hair follicle transplants are expensive, as are
pharmacological treatments. Hair is not a waste product like urine. The
claim that collecting a hair specimen is easy is only true in the
morgue. The reality is that it is very difficult to collect hair without
adversely impacting the cosmetic appearance of the donor.

A significant number of both men and women have closely cropped hair;
does this mean that they enjoy a shorter detection time? The general
rule seems to be that in any population, 10--25 percent of the donors
will not have sufficient head hair to collect. Does this mean that a
larger swath of hair must be cut from their scalps to have a sufficient
quantity to test? There are incidents where companies have implemented
hair tests, only to find the employees "protesting" by shaving their
heads. Is this a refusal to test? Will this be allowed, or will there be
a requirement to obtain hair from other sources? When the adulteration
industry gins up its product line for adulterating hair, will employers
have to create a list of prohibited products?

Over the years I have heard proponents of hair testing, and what can be
referred to as the "anything goes" crowd, recommend that in the absence
of sufficient head hair the collector should collect chest hair
(presumably from men), arm hair, underarm hair, and even pubic hair.
These recommendations have varied from laboratory to laboratory and over
time. One year something is recommended, the next year it is not, and
then it is recommended again. Where are you going to get a comparable
length and amount of hair from a female donor? What does the collector
report when no hair is available anywhere---"None is available"?

In the absence of individualized suspicion, obtaining hair specimens
from alternative body sites is an offensive idea, and it is probably
constitutionally repugnant as well. I know that employers do this today,
but it is a different ballgame when the government mandates the testing.
I do not think you have to be a constitutional scholar to understand
that the collection of body hair, simply because a person may have short
hair or no hair, can raise a serious question of
invasiveness---particularly in a regulatory framework that would allow a
federal agency to voluntarily "choose" hair or urine or sweat. It is
true that urine is also invasive, yet it is illustrative to note that in
the absence of individualized suspicion the donor is allowed privacy to
provide the specimen. Thus, I appreciate HHS's restraint in not
proposing the collection of hair from "alternative sites." However,
without alternative sites, will suspicionless hair testing work? Even
proponents of hair testing believe that hair testing becomes hobbled
without alternative sites.

The Hobson's choice presented is to recommend hair testing with the
requirement for alternative collection sites, which will not pass
constitutional muster for governmentally mandated suspicionless testing,
or to recommend hair testing without allowing for alternative sites,
which is expensive and relatively ineffective.

The challenge to the constitutional viability of suspicionless
employment hair testing is not just limited to the intrinsic problems of
collection without cosmetic insult, or of short hair and whether or not
to go hunting alternative sites, or even the interference in the
analytical procedures from treated hair. Plain, untreated long hair also
presents an insidious variable as well, one that raises the most
concern---the color variable. Hair color varies from individual to
individual, family to family, and ethnic group to ethnic group. Hair
color is genetically determined. As discussed in the proposed amendment,
there is a well-established relationship between the color of hair and
the concentration of drugs found in all of the *in vitro* and *in vivo*
controlled animal and human studies that have been performed.

An elegant illustration of the profound differences in drug
concentration and hair color is seen in the Rollins controlled-dose hair
study. \[The Effect of Hair Color on the Incorporation of Codeine into
Human Hair. Rollins et al., *Journal of Analytical Toxicology, 27(8):545
(2003).*\] In the Rollins study, 16 male and female volunteers with
various hair colors were selected. Each subject received a 30 mg oral
dose of codeine 3 times daily for 5 days (450 mg). The plasma
concentration (ACU) for a single 30 mg dose of codeine was determined
for each subject. Urine was collected for the 5 days of codeine
administration. Hair was collected (cutting) before, and at weeks 4, 5,
6, and 7 after drug administration. As you know, the study carefully
measured the amount of drug found in each individual's hair.

The published data showed that the individual with black hair had about
5 times more drug in her hair than the donor with brown hair, 10 times
more drug than the donor with blond hair, and more than 15 times more
drug than the redhead. The data also reveals that within the black hair
subgroup, an American Indian had the highest concentration of
drug---essentially 20 times the concentration of the redhead. This is
not random variability; it is genetically based variability. The authors
note: *"When a 500 pg/mg (0.5 ng/mg) cutoff is applied to these data,
\>80% of subjects with black hair receiving this therapeutic dose would
be reported 'positive' for codeine,"* and *"When the same cutoff is
applied to subjects with other hair colors (brown, blonde, red) none
would be reported 'positive' for codeine."*

Who in HHS or the administration, or for that matter the Congress, is
willing to sign on to a policy proposing that if an American Indian
wants to work for the federal government he or she would be subject to a
drug test with a functional cutoff level that is 15 to 20 times lower
than his or her European counterpart? Can you imagine any federal agency
setting up a background check for applicants that goes back one year for
blond applicants and 10 years for applicants with black hair? Would the
agency claim that it is not race bias, it is simply hair color bias?

This color bias issue is often obscured by the fact that the increased
probability of identifying drugs in dark hair is not an issue of "false
positives." Positive tests are positive tests. It is also true that hair
testing does not single out African-Americans, since individuals of
Mediterranean ancestry, Asians, Hispanics and American Indians are in
the same dark hair class. This color bias does, however, raise a
fundamental issue of equality and fairness in employment standards.
Could an employer implement a drug testing program using urine that only
tested individuals with black hair, and survive a claim of
discrimination? I can tell you that in over ten years of teaching
physicians, there are few who do not appreciate the concern over this
color bias, and fewer minority physicians who do not view all this as a
veiled form of discrimination and disparate impact.

Social studies of population groups have concluded that the differences
in positive rates between white and black populations are due to drug
preferences and patterns of use. These studies do not address the
ultimate question of what the very large differences in concentration
between black and blond hair mean in terms of actual consumption of drug
and the probability of detection by hair analysis. That is the study
that must be done to address this issue.

The severe penalties of our nation's drug laws are currently viewed as
having a discriminatory impact on minority communities. Chris Rock, the
well-known African-American comic, states the very un-comic opinion that
all drug laws are racist in nature. It is not just minorities who share
this view. So how does the federal government lead the drug testing
community in addressing this inflammatory issue? Is this moving drug
testing forward in the public's mind? Is this building trust and
confidence in the hearts and minds of the 95% of workers who are
drug-free? Or is that no longer an issue? There needs to be funding of a
broader study to understand the potential disparate impact of the
well-established color bias, and a further policy analysis of how the
benefits of hair testing can be realized.

A different legal issue, and a good example of a technology-driven
policy, is the proposal to use hair for return-to-duty testing. No
federal agency has a policy in place that states if an employee has a
positive drug test they will be suspended for a minimum of 90 days. Yet
under this proposed rule, a federal agency can require a hair test for
return to duty, which effectively does the same thing.

The proposed rule states that drugs will be detected in hair for 90
days. So including the 7-10 day grow-out period of positive hair below
the scalp, this effectively provides a 100-day period where the hair
test would be inappropriate, and therefore a 100-day period where the
employee could not be returned to work. This is one example of a
technology-driven policy. If federal employees are paid while they are
out of service, how many drug-using federal employees will be given a
three-month paid vacation? In my view, this is not simply a change in
technology but a change in the conditions of employment for federal
employees.

**Costs of Laboratory Certification for Hair Tests**

Separate from the legal, political and public relations issues is the
cost of hair testing. Hair testing requires a great deal of art and
physical manipulation of the hair specimen in the laboratory; it does
not appear that increased volume of hair testing will result in
decreased costs. From a laboratory perspective, increased volumes, in
the absence of robotics, will present significant operational
challenges, and maintaining quality will require vigorous effort by the
management.

There exists a significant cost differential between hair testing, which
is currently unregulated, and urine testing, which is heavily regulated.
This cost differential will increase with the additional operational
costs of inspections and various conditions of certification. The
production and costs of quality control and proficiency specimens is
significant. The base costs of inspection and developing a sound
certification program will, in the absence of federal appropriations, be
borne by the few laboratories who apply for certification. Establishing
an equivalent level of certification oversight for hair testing as it
exists for urine will cost hundreds of thousands of dollars.

**Recommendation**

Despite all of these flaws and limitations, I believe that hair testing
and the hair collection, with the option of using alternative sites, may
be a reasonable employment practice where the job has a legitimate
requirement for an extensive and comprehensive background check, such as
for police officers. (In this context, hair testing is similar to the
limited use of polygraphs in employment hiring and investigations.)
Outside of the workplace testing segment, hair testing is a useful tool
in the courts and has great potential for use in substance abuse
evaluations---particularly with at-risk adolescents.

In conclusion, I do not believe that it is in the best interest of hair
testing to implement the proposed rules at this time. I do not believe
that the government has the data available to adequately defend hair
testing in a well-pled Fourth Amendment challenge based on our current
understanding of the technology and process, even with the strong
anti-drug sentiment of the federal judiciary.

**III. Medical Review Officer Certification Proposals**

In Subpart N of the proposed amendment, HHS states that it will
establish who may serve as a Medical Review Officer. It establishes the
requirement that the individual successfully complete an examination
administered by a nationally recognized entity that certifies MROs or a
subspecialty board for physicians performing a review of federal
employee drug test results, which has been approved by the Secretary.

Subpart N also establishes the requirements for nationally recognized
entities to seek and obtain approval by the Secretary to certify MROs or
for subspecialty boards for physicians performing a review of federal
employee drug test results to submit their qualifications and sample
examination. The proposal goes on to state that based on this annual
objective review of the qualifications and content of the examination,
the Secretary shall annually publish a list in the Federal Register of
those entities and boards that have been approved.

For over a decade, the Medical Review Officer certification process
created and established by AAMRO has been regarded as remarkably
successful in providing physicians with the knowledge, expertise and
guidance to fulfill their duties as MROs and to serve as expert
consultants in the area of workplace drug and alcohol testing. The
examination and recertification process has been regarded by the medical
communities as a model of efficiency and efficacy in assuring that MROs
are technically competent and understand the legal and regulatory
framework and what is necessary to successfully support the divergent
interests of the government, employers and American workers.

There are, however, concerns among MROs about the necessity of the new
proposals to require certification and to oversee the MRO certification
process. The first concern is that the added administrative burden on
the boards would result in significantly higher costs. As will be
discussed below, there are a host of issues that will contribute to
higher costs.

But first, let's not forget that there are relatively few Medical Review
Officers whom this rule actually covers---it covers only those MROs who
work for federal agencies covering federal employees. In addition, there
is no level of federal oversight of certification or certification
boards, or review of exam items, or any guarantee that increasing
training time would assure that any particular MRO in the federal
employment program is in fact practicing in compliance with an agency's
policy, the requirements of the Mandatory Guidelines, or the
government's expectations.

A much more effective and much less expensive approach would be the
annual audit of federal MRO records. This audit process has long been
established for MROs who are working in nuclear utilities. Such an audit
also sheds a great deal of light on the agency's program, the collection
process, and management decisions.

For the private certified MRO, the additional costs of HHS requiring
certification and the approval process of certification boards simply
represents a subsidy for the federal program. In the National Laboratory
Certification Program the costs of federal laboratory certification are
underwritten to a large degree by private-sector drug testing. The
benefit to the laboratories in the past has been their ability to market
their federal certification to private-sector employers for
private-sector testing. There is no benefit in the MRO market for an MRO
to distinguish his or her professional certification as being
"federally" approved.

Voluntary certification of physicians as Medical Review Officers has
served to attract physicians with specific business or personal
interests in workplace drug testing. The Department of Transportation
requirement for ongoing CME training for MROs and the requirement for
MROs to pass a national exam elegantly and essentially made
certification a de facto standard without increasing costs and while
maintaining the "voluntary" nature of this credentialing. The
certification of certification and all of the intrinsic bureaucracy will
have the effect of turning certification into another death-and-taxes
process.

Another cost consideration that is important but perhaps not obvious is
that when a physician fails the certification exam there may be some
adverse business consequences. Failing an exam for a few may also bruise
egos or harm reputations. In the early days of certification, a
physician threatened to sue AAMRO because he failed the exam. There was
no real legal basis for the suit, for how do you sue over a voluntary
certification that you can retake at no additional cost? It was not
until it was clear to the physician that we would be forced to prove in
court that he was not minimally competent to be an MRO that the issue
resolved itself.

It is, however, a different legal ballgame when the government is going
to approve the examination and the certification board, and then require
certification. An MRO who fails the exam or is de-certified can seek
legal review over the process. Who is going to pay for the board's legal
costs---the private sector MRO, who in theory bills the employers?

The success of the AAMRO certification process is also attributable to
the ongoing close relationship that has existed between AAMRO's faculty
and HHS. There has been a great deal of open communication, both formal
and informal, between AAMRO and the professional staff of the SAMHSA
Division of Workplace Programs and the National Laboratory Certification
Program.

The danger of what appears to be a benign and simple proposal to
"approve" the certification board is that it threatens the open and
cooperative nature of the relationship. A working partnership between
the boards and SAMHSA may quickly transform into a regulator--regulatee
relationship. Problems will have to be worked out through a more
legalistic and political process. It's the same process that made the
government designate "frozen french fries" a fresh vegetable.

Regardless of the final decision on this area of MRO certification, and
regardless of whether alternative testing becomes a reality for federal
agencies in the near future, beginning next year AAMRO will include what
up until now has been optional---training in alternative technologies.
AAMRO will also incorporate the subject matter into its examination as
part of the basic certification process.

Finally, as in any large group there will be some bad examples. Over a
fourteen-year time frame and certification of thousands of MROs, there
have been a few problems. Substance abuse has ironically been a problem.
Mental illness has struck. Ethics, or more accurately the absence of
ethics, has been discovered. We have occasionally been asked to
"de-certify" an identified bad actor (about three). As desirous as that
may have been, AAMRO is not set up to address that issue. Oversight of
certification would not address these issues either. As soon as you
begin a de-certification process, you become the reporting agency for
every positive donor with an ax to grind---and a lot of them do have
axes. Will HHS post its telephone number to handle donor complaints?

What will work is for HHS to adopt a process similar to DOT's "public
interest exclusion" for the few identified bad actors. This list would
be made up of MROs who would be excluded from providing any services to
a federal agency or regulated employer. AAMRO will be happy to post that
list on its website. This list would give employers, the courts, and
interested parties adequate notice of problems.

Readers of these comments must think, if these comments in respect to
the proposed rule represent an example of a good working relationship
with the government, what is a bad one like? A bad one is where there is
no open communication.

In closing, I would like to share my observation and opinion that the
technical staff at the SAMHSA Division of Workplace Programs is composed
of dedicated professionals who have shown nothing but a passion for
overcoming the numerous legal, technical, political and social
challenges to developing a balanced and cost-effective model for
containing and managing drug abuse in America.

This is the first significant drug testing rulemaking since the
inception of the program. I have little doubt that the administration is
committed to maintaining the integrity of the program. I hope these
comments are useful in shaping the department's final analysis, and that
the advances in drug testing technology can be more seamlessly
integrated into the legal framework and social policy goals than is
reflected in this first attempt.

I am acutely aware of the current shortcomings in testing, and the
technical and legal limitations imposed. I nevertheless continue to
maintain the hope that sound drug testing programs may someday offer a
substantive alternative to the evils intrinsic to prohibition by
reducing demand and providing early intervention and thus more effective
treatment. My hope is that drug testing can be an effective alternative
to the high economic and social costs of the criminal justice system. I
hope that these comments are viewed as constructive criticism.

Sincerely,

Theodore F. Shults, JD, MS

Chairman -- American Association of Medical Review Officers