Mandatory Guidelines for Federal Workplace Drug Testing Programs, 71858-71907 [E8-26726]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Substance Abuse and Mental Health Services Administration

[Federal Register Volume 73, Number 228 (Tuesday, November 25, 2008)]
[Notices]
[Pages 71858-71907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26726]



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Part V





Department of Health and Human Services





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Substance Abuse and Mental Health Services Administration



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Mandatory Guidelines for Federal Workplace Drug Testing Programs; 
Notice

Federal Register / Vol. 73, No. 228 / Tuesday, November 25, 2008 / 
Notices

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Mandatory Guidelines for Federal Workplace Drug Testing Programs

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Revised Mandatory Guidelines.

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SUMMARY: This Final Notice of Revisions to the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs (Revisions to Mandatory 
Guidelines) addresses collection and testing of urine specimens, the 
requirements for the certification of Instrumented Initial Test 
Facilities (IITFs), and the role of and standards for collectors and 
Medical Review Officers (MROs). Additional notices of Proposed 
Revisions to the Mandatory Guidelines addressing the use of point of 
collection testing (POCT), oral fluid testing, sweat patch testing, 
hair testing, and associated issues will be published at a later date. 
With regard to the use of alternative specimens including hair, oral 
fluid, and sweat patch specimens in Federal Workplace Drug Testing 
Programs, significant issues have been raised by Federal agencies 
during the review process which require further examination, and may 
require additional study and analysis. As part of the review process 
for these alternative tests, the Department of Health and Human 
Services (``HHS'' or ``Department'') plans to issue a notice in the 
Federal Register requesting information and assistance from the general 
public to provide or identify data and research findings that address 
specific areas of interest.

DATES: Effective Date: March 25, 2008.

FOR FURTHER INFORMATION CONTACT: Donna M. Bush, Ph.D., Division of 
Workplace Programs, CSAP, SAMHSA, 1 Choke Cherry Road, Room 2-1033, 
Rockville, Maryland 20857, (240) 276-2600 (phone), (240) 276-2610 
(Fax), or e-mail at donna.bush@samhsa.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Background

    The Guidelines were first published in the Federal Register on 
April 11, 1988, (53 FR 11970), and have since been revised in the 
Federal Register on June 9, 1994, (59 FR 29908), on September 30, 1997, 
(62 FR 51118), on November 13, 1998 (63 FR 63483), and on April 13, 
2004, (69 FR 19644). The Guidelines establish the scientific and 
technical guidelines for Federal workplace drug testing programs and 
establish standards for certification of laboratories engaged in drug 
testing for Federal agencies under authority of section 503 of Public 
Law 100-71, 5 U.S.C. Section 7301 note, and Executive Order (E.O.) 
12564.
    The Department also published Proposed Revisions to Mandatory 
Guidelines in the Federal Register on April 13, 2004, (69 FR 19673). 
These Proposed Revisions to Mandatory Guidelines described changing the 
Guidelines into a plain language format, expanding the Federal drug 
testing program to include use of alternative specimens including 
testing hair, oral fluid, and sweat patch specimens, allowing the use 
of ``point of collection testing'' (POCTs) for urine and oral fluid 
specimens, establishing the requirements for certifying ``instrumented 
initial test facilities'' (IITFs) to test specimens, and providing 
specific standards for collectors, POCT testers, and MROs. There was a 
90-day public comment period during which 285 commenters submitted 
comments on the proposed changes to the Guidelines. These commenters 
were individuals and public and private entities. The comments are 
available for public view on the Department's Internet Web site (http:/
/workplace.samhsa.gov).
    Section 503 of Public Law 100-71, 5 U.S.C. Section 7301 note, 
required the Department to establish scientific and technical 
guidelines and amendments in accordance with Executive Order 12564, and 
to publish Mandatory Guidelines which establish comprehensive standards 
for all aspects of laboratory drug testing and procedures, including 
standards that require the use of the best available technology for 
ensuring the full reliability and accuracy of drug tests and strict 
procedures governing the chain of custody of specimens collected for 
drug testing. These revisions to the Mandatory Guidelines promote and 
establish standards that use the best available technology for ensuring 
the full reliability and accuracy of urine drug tests, while reflecting 
the ongoing process of review and evaluation of legal, scientific, and 
societal concerns.
    The submitted public comments and additional comments raised by 
Federal Agencies during subsequent internal review of the proposed 
changes to the Guidelines raised significant scientific, legal, and 
public policy concerns about the use of alternative specimens and POCT 
devices in Federal agency workplace drug testing programs. Since each 
alternative specimen and drug testing using POCT devices poses 
different concerns, the Department established a staggered timeline for 
issuing final guidance that allows for further study and research. In 
assessing the complexity of the task, the Department has decided to 
publish these final Guidelines with regard to collection and testing 
urine specimens, establishing the requirements for the certification of 
IITFs, and establishing specific standards for collectors and MROs. The 
Department considered several options for issuing one or more Final 
Notices in the Federal Register that may require additional public 
comment periods, concerning the use of alternative specimens and drug 
testing technologies such as POCT devices. Since the scientific, legal, 
and public policy information for drug testing oral fluid, hair, and 
sweat patch specimens, and using POCT devices is not as complete as it 
is for the laboratory-based urine drug testing program, developing 
Final Notices concerning the use of these is more challenging. As 
described in the notice of Proposed Revisions to Mandatory Guidelines 
issued April 13, 2004, the performance of alternative specimens in 
pilot performance testing (PT) programs has been encouraging, with 
individual laboratory and group performance improving over time. 
However, there are still three areas of concern. First, the data from 
the pilot PT programs to date show that not all participants have 
developed the capability to test for all required drug classes, nor to 
perform such tests with acceptable accuracy. Second, some drug classes 
are more difficult to detect than others, for any given type of 
specimen. Third, the specific drug classes that are difficult to detect 
vary by type of specimen. As a result, it will require additional study 
to assist agencies in determining how to select the appropriate type of 
specimen to be collected from a specific donor, when the use of a 
specific drug is suspected. Nevertheless, HHS believes that the 
addition of alternative specimens to the Federal Workplace Drug Testing 
Program would complement urine drug testing and aid in combating the 
risks posed from available methods of suborning urine drug testing 
through adulteration, substitution, and dilution. Thus, HHS will 
continue to pursue testing using alternative specimens. HHS anticipates 
issuing further revisions to the Mandatory Guidelines addressing the 
use of oral fluid, sweat patch, and hair, and the use of POCT devices 
for urine and oral fluid. These revisions will be published in the 
Federal Register, with opportunity for public comment.
    All written comments were reviewed and taken into consideration in 
the

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preparation of these revised Guidelines. The preamble only addresses 
sections of the draft Guidelines regarding urine testing that were 
commented on during the public comment period or that the Department is 
changing. Most section numbers for the Guidelines issued in April 2004 
were changed in these Guidelines due to the removal of those sections 
concerning alternative specimens and POCT as well as for clarity. To 
make it easier for the public, the preamble refers to the new section 
number and, where appropriate, the corresponding section number in the 
Proposed Revisions to Mandatory Guidelines issued in April 2004. 
Similar comments are considered together in the discussion.

Reason for the Effective Date

    An effective date of 18 months from the date of publication of 
these revised Mandatory Guidelines was chosen to permit the following 
activities:
    (1) It will take at least 12 months for manufacturers of 
immunoassay test kits to modify or manufacture immunoassay test kits 
and ensure compliance with any applicable statutory and regulatory 
requirements before commercialization of the modified kits.
    (2) It will take the HHS-certified laboratories at least one month 
to validate and implement the new test kits.
    (3) It will take 2 to 3 months for the National Laboratory 
Certification Program (NLCP) to challenge the HHS-certified 
laboratories with performance testing (PT) samples to ensure that the 
test kits and test results satisfy the required performance criteria.
    The effective time frame of 18 months will encompass many 
activities that will overlap or occur at the same time within different 
industries and Federal agencies.

Summary of Public Comments and the HHS Response

    The following comments were directed to the information and 
questions in the preamble.

Initial Test Kit Issues

    In the proposed Guidelines, the Department requested comments on 
issues regarding the testing for amphetamine analogs using one or two 
immunoassay test kits because the laboratory or IITF would be required 
to test specimens for the target analytes listed under amphetamines. 
Two commenters believed that two separate initial test kits would be 
needed to appropriately screen specimens for amphetamines as specified 
in Section 3.4. One commenter believed three separate initial test kits 
may be required. Six commenters believed that one initial test kit 
could be used to screen for amphetamine, methamphetamine, and their 
analogs. For the most part, the commenters provided justifications for 
their comments. The Department has evaluated the comments and has 
concluded that using either a single initial test kit or multiple 
initial test kits is acceptable depending on the specificity and 
sensitivity that the single initial test kit has with amphetamine and 
methamphetamine and its cross-reactivity with 
methylenedioxymethamphetamine (MDMA).

Subpart A--Applicability

    The Department has revised Section 1.1 to state that the 
requirements in these Guidelines also apply to collectors and MROs. 
This revision ensures that collectors and MROs are notified of the 
applicable requirements under these Guidelines.
    In Section 1.5, where terms are defined, the Department has added 
several new definitions for terms that appear in the Guidelines, and 
revised several definitions that needed clarification even though no 
comments were received from the public.
    The Department has changed the term to be defined from 
``adulterated'' to ``adulterated specimen.'' The meaning of the term 
has not changed. Only the wording has been changed to make the 
definition clearer.
    Definitions were added for ``alternate responsible person'' and 
``alternate responsible technician,'' the individuals who are pre-
approved by HHS to assume responsibility for the HHS-certified drug 
testing laboratory or IITF, respectively, when the responsible person 
or responsible technician is absent for an extended period.
    The definition for ``cancelled test'' was reworded for 
clarification. The definition is the same.
    The term ``carryover'' was defined. Carryover, as used in these 
Guidelines, refers to the condition that results when the test result 
for one sample has been affected by a preceding sample during analysis. 
For example, if the concentration of a drug in one sample is very high 
and cannot be completely eliminated from the analytical instrument 
before the next sample is tested, the residual drug in the analytical 
instrument contributes to the concentration of that drug in the next 
sample.
    The definition for ``certifying scientist'' was revised to indicate 
that a certifying scientist can report any test result reported from an 
HHS-certified laboratory. The proposed definition referred to ``non-
negative or invalid result.'' Since the term ``non-negative'' was 
deleted from these Guidelines, the definition for certifying scientist 
needed to be revised.
    The definition for ``certifying technician'' was revised to state 
that a certifying technician can report on the chain of custody and 
scientific reliability of negative, negative/dilute, and rejected for 
testing results. This revised definition clarifies which types of 
results a certifying technician can report. The proposed definition 
incorrectly permitted the certifying technician to report on the chain 
of custody and scientific reliability of only negative test results.
    The term ``confirmatory validity test'' was changed to 
``confirmatory specimen validity test.'' The term ``validity test'' was 
changed to ``specimen validity test'' throughout the Guidelines, to be 
consistent with current terminology used by the Department.
    The definition for a ``cutoff'' was revised to apply to specimen 
validity tests, as well as drug tests. The term is used in both 
contexts.
    The definition for ``dilute specimen'' was revised to state that 
the term applies to a urine specimen with creatinine and specific 
gravity values that are lower than expected but still physiologically 
possible. This change shows that a dilute specimen is different from a 
substituted specimen.
    The definition for ``failed to reconfirm'' was revised to clarify 
that the term applies when a second laboratory tests a split (Bottle B) 
specimen and is unable to corroborate the original test result reported 
by the primary laboratory.
    The definition for ``follow-up test'' was removed. The definition 
for ``follow-up test'' is provided in Federal agency drug testing plans 
and does not need to be repeated in the Guidelines.
    The definition for an ``initial validity test'' was changed to 
``initial specimen validity test'' throughout the Guidelines to be 
consistent with current terminology used by the Department. The term 
was also revised to include an ``invalid result'' because an ``invalid 
result'' requires using an initial specimen validity test as would an 
adulterated, diluted, or substituted test result.
    To avoid confusion, the definitions for an ``instrumented initial 
test facility'' and for a ``laboratory'' were revised to show that 
these are permanent locations.
    The definition for ``invalid result'' was revised to clarify that 
this type of result is reported when the test results

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satisfy the criteria established in Section 3.8. The definition in the 
draft issuance did not include all of the criteria described in Section 
3.8.
    A definition for ``limit of detection'' (LOD) has been added to 
these Guidelines because the Guidelines require the laboratory to 
determine the LOD for each confirmatory drug test during assay 
validation. In addition, to validate specimen validity tests, 
laboratories and IITFs are required to demonstrate and document 
appropriate assay characteristics, which may include the LOD.
    A definition for ``limit of quantitation'' (LOQ) has been added to 
these Guidelines because the Guidelines require the laboratory to 
determine the LOQ for each confirmatory drug test during assay 
validation. In addition, to validate tests used to determine specimen 
validity, laboratories and IITFs are required to demonstrate and 
document appropriate assay characteristics, which may include the LOQ. 
Lastly, laboratories and IITFs are required to use the established LOQ 
as the decision point for adulterants without a program-specified 
cutoff.
    A definition for a ``lot'' has been added to these Guidelines 
because throughout the Guidelines there are requirements to validate or 
verify the performance characteristics of various items (e.g., drug 
test kits, reagents, quality control material) and to establish an 
expiration date. The term ``lot'' refers to the item(s) manufactured 
from the same starting materials within a specified period of time 
which have essentially the same performance characteristics and the 
same expiration date.
    The definition for a ``negative result'' was revised to clarify 
that the specimen must not only be negative for drugs but must also be 
a valid urine specimen. Since these Guidelines require that specimen 
validity tests be conducted on each specimen, this definition states 
that a ``negative result'' indicates that a specimen is not only 
negative for drugs but also that the specimen validity tests conducted 
on the specimen indicate that the specimen is a valid specimen.
    The definition for a ``non-negative'' result was removed from the 
list of definitions and replaced with more specific reporting terms as 
follows: Positive result, substituted specimen, adulterated specimen, 
or invalid specimen result.
    The definition for a ``performance testing (PT) sample'' was 
revised to show that it refers to samples that are program-generated 
and sent to a testing facility. The proposed definition did not 
indicate the source of the samples.
    The definition for a ``post-accident test'' was removed. The 
definition for ``post-accident test'' is provided in Federal agency 
drug testing plans and does not need to be repeated in the Guidelines.
    The definition for a ``pre-employment test'' was removed. The 
definition for ``pre-employment test'' is provided in Federal agency 
drug testing plans and does not need to be repeated in the Guidelines.
    The definition for a ``quality control (QC) sample'' was revised to 
clarify that the term refers to calibrators or controls.
    The definition for a ``random test'' was removed. The definition 
for ``random test'' is provided in Federal agency drug testing plans 
and does not need to be repeated in the Guidelines.
    The definition for a ``reasonable suspicion/cause test'' was 
removed. The definition for ``reasonable suspicion/cause test'' is 
provided in Federal agency drug testing plans and does not need to be 
repeated in the Guidelines.
    The definition for ``reconfirmed'' was revised to clarify that the 
definition applies to a split specimen (Bottle B) tested by a second 
laboratory.
    The definition for ``return to duty test'' was removed. The 
definition for ``return to duty test'' is provided in Federal agency 
drug testing plans and does not need to be repeated in the Guidelines.
    The definition for ``rejected for testing'' was revised to clarify 
that this result may be reported by an IITF, as well as a laboratory.
    Three commenters noted the terms ``sample'' and ``specimen'' were 
used interchangeably throughout the Guidelines and suggested that the 
definitions be defined and the text updated accordingly. The Department 
agrees and has revised the definitions for these terms and has revised 
the Guidelines text to consistently use the terms as they are defined 
in this section. ``Sample'' refers to a performance testing (PT) 
sample, a quality control sample, or a representative portion of a 
donor specimen. ``Specimen'' refers to the donor specimen (i.e., urine 
provided by the donor for the drug test).
    The term ``split specimen'' was replaced by ``split specimen 
collection.'' The definition of a ``split specimen collection'' states 
that one urine specimen of sufficient volume is collected and then 
divided into two separate specimen bottles. A ``split specimen 
collection'' does not permit collecting two different urine specimens 
at two different times that are, respectively, transferred to a Bottle 
A and a Bottle B.
    The definition for ``substituted'' was changed to ``substituted 
specimen'' and revised to define this as a specimen submitted in place 
of the donor's urine, as evidenced by creatinine and specific gravity 
values outside physiologically producible ranges of human urine.
    Section 1.6 describes what an agency is required to do to protect 
employee records. The policy in this section is the same as the policy 
in the Proposed Revisions to Mandatory Guidelines. The Department has 
included a discussion on the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA).
    The Department has included a new Section 1.7, to clarify refusals 
to test and who ultimately determines if the conditions for verifying 
them are met (i.e., the collector, the MRO, the Federal agency).

Subpart B--Specimens

    Section 2.1 states that urine is the only specimen that can be 
collected by a Federal agency under the Guidelines for its workplace 
drug testing program to clarify that Federal agencies are prohibited 
from collecting any other type of specimen.
    Section 2.2 describes the circumstances under which a Federal 
agency may collect a specimen. The Department has included this section 
to ensure that the circumstances described are consistent with the 
reasons for collecting a specimen as listed on the Federal CCF.
    Section 2.3 requires each urine specimen to be collected as a split 
specimen. This policy is the same as the policy described in the 
Proposed Revisions to Mandatory Guidelines. Five commenters opposed the 
part that the single urine specimen collection procedure was being 
eliminated. The Department disagrees with the commenters and has 
eliminated the single urine specimen collection procedure, not because 
the procedure is forensically or scientifically unsupportable, but 
because the split specimen procedure ensures that the donor will have 
access to a split specimen that was not opened by the laboratory 
testing the primary specimen. Additionally, there are a number of 
Federal employees working for agencies that have employees subject to 
both Federal drug testing guidelines and Department of Transportation 
workplace drug testing regulations. Requiring the use of a split 
specimen collection procedure will ensure that employees working in 
these dual regulation situations are treated the same.

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Subpart C--Drug and Specimen Validity Tests

    Section 3.1 describes the tests that are performed on each urine 
specimen. The policy in this section applies to each specimen collected 
by a Federal agency regardless of the circumstance for which it was 
collected as described in Section 2.2. The Department believes that the 
wording of the policy in the current and Proposed Revisions to 
Mandatory Guidelines may be incorrectly interpreted such that the 
required tests only apply to specimens collected from Federal agency 
applicants and specimens collected at random. However, this is not the 
case. The wording in this section has been revised to state that each 
specimen collected will be tested for the same drugs and specimen 
validity tests. This section was also revised to describe the specimen 
validity tests that must be performed on each urine specimen. The 
requirements and explanations described for the specimen validity tests 
are the same as those described in the current and Proposed Revisions 
to Mandatory Guidelines.
    Section 3.2 provides guidance on how a Federal agency may test a 
specimen for additional drugs. Three commenters requested additional 
guidance on how a Federal agency would request permission to test for 
an additional drug on a case-by-case basis. The Department believes the 
policy in Section 3.2(a) adequately describes how a Federal agency 
would request to test a donor's specimen for a suspected Schedule I or 
Schedule II drug that is not part of the Federal program.
    After further review of Section 3.2(a), however, the Department 
recognized that the Guidelines do not address how to proceed if the 
Federal agency is requesting to test for a Schedule I or II drug for 
which an immunoassay test is not available. The Department thus has 
added that when the need to test for an additional drug occurs and 
there is no immunoassay test available, an HHS-certified laboratory 
should be permitted to test for the drug by testing two separate 
aliquots of the specimen using the same confirmatory drug test. The 
confirmatory drug test used by the laboratory must satisfy the 
requirements in Section 11.13, the laboratory must validate the 
confirmatory drug test in accordance with the requirements in Section 
11.14, and must satisfy the quality control requirements as stated in 
Section 11.15. The Department believes that testing the specimen twice 
using a validated confirmatory drug test is scientifically and 
forensically acceptable. Additionally, when a specimen is reported as 
positive, adulterated, or substituted, the Department allows the donor 
to request that Bottle B be tested at another HHS-certified laboratory 
by the confirmatory method. The testing of the split specimen by a 
second HHS-certified laboratory to reconfirm the drug reported positive 
by the first laboratory is sufficient to protect the donor's interests.
    Section 3.3 states that urine specimens collected for Federal 
agency workplace drug testing programs may only be tested for the 
purpose of detecting drug use and to determine the validity of the 
specimen unless otherwise authorized by law. Several commenters 
expressed concern over the possibility that DNA testing could be 
conducted on a specimen. The Department states in Section 3.3(a) that 
``Federal agency specimens * * * must only be tested for drugs and to 
determine their validity unless otherwise authorized by law.'' The 
Department is satisfied that the policy, as stated, prohibits DNA 
testing on a specimen but has removed the phrase ``unless otherwise 
authorized by law'' from this section to clarify that Federal agency 
specimens must only be tested for drugs and to determine their 
validity.
    Section 3.4 lists the drugs and drug metabolites and the initial 
and confirmatory cutoff concentrations used to test and report urine 
specimens as negative or positive for a drug. The initial and 
confirmatory cutoff concentrations are the same as in the Proposed 
Revisions to Mandatory Guidelines, but the tables have been combined to 
make it easier for the readers.
    Several commenters suggested including the scientific rationale 
used to support the proposed changes to the cocaine metabolite 
(benzoylecgonine) and amphetamine cutoff concentrations. Three 
commenters disagreed with the proposal to lower the amphetamines 
initial test cutoff concentration. Two of the three commenters were 
concerned that the lower cutoff will result in higher costs and more 
false initial test positives due to medications available over the 
counter. The third commenter stated that their laboratory currently has 
customers who use the lower amphetamine cutoff concentration and have 
no more confirmed positives than compared to a 1000 ng/mL initial test 
cutoff, but who do have more unconfirmed specimens.
    The Department believes the revised cutoff concentrations will 
increase the window of detection for these drugs, i.e., the number of 
hours after a drug is ingested by an individual that the concentration 
of the drug or drug metabolite in urine will likely remain above the 
cutoff concentration. Lower cutoff concentrations will increase the 
number of urine specimens that are identified as containing cocaine 
metabolites and amphetamines and, thereby, will increase the deterrent 
effect of the program and improve identification of employees using 
illicit substances. Based on results reported by laboratories in the 
current urine PT program, the Department believes that certified 
laboratories (and IITFs after they are certified) will have the ability 
to report accurate test results using these revised cutoff 
concentrations. There is no evidence available to the Department to 
indicate that lowering these cutoff concentrations will increase the 
possibility that a donor who has not actually used cocaine or 
amphetamines will be identified as a drug user. The Department also 
points out that the individual can always challenge the result with the 
MRO.
    Several commenters raised questions regarding the proposed options 
for HHS-certified laboratories and IITFs to perform an initial test for 
6-AM. The commenters stated that the policy options were unclear as 
presented in Section 3.4, and recommended that HHS provide additional 
guidance to prevent inconsistent treatment of specimens. The Department 
has revised the table and footnotes in Section 3.4 to clarify that all 
specimens tested for opiates must be tested for 6-AM. This policy 
allows a laboratory to confirm and report 6-AM by itself, in contrast 
to the current Guidelines policy which requires 6-AM to be tested and 
reported in conjunction with a positive morphine result. Data from 
laboratories indicate that 6-AM is present in specimens even when the 
morphine concentration is below 2000 ng/mL.
    Sections 3.5, 3.6, 3.7, and 3.8 describe the criteria for reporting 
a urine specimen as adulterated, substituted, dilute, and invalid, 
respectively. Each section was revised to clarify that only a certified 
laboratory may report a specimen as adulterated, substituted, or 
invalid; that only a certified laboratory may report a specimen as 
dilute when creatinine is equal to or less than 5 mg/dL; and that a 
laboratory or an IITF may report a specimen as dilute when creatinine 
is greater than 5 mg/dL. For an adulterated or invalid urine specimen, 
one commenter requested the rationale for changing from the 20 mcg/mL 
chromium (VI) [Cr (VI)] initial validity test cutoff in a previous 
draft (several preliminary versions of the Guidelines were posted on 
the

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SAMHSA workplace Web site before the Proposed Revisions to Mandatory 
Guidelines were published in the Federal Register to 50 mcg/mL in these 
Guidelines. One commenter recommended using the 20 mcg/mL Cr (VI) 
cutoff instead of 50 mcg/mL and provided supporting data. Although the 
Department agrees with the data provided, the 50 mcg/mL cutoff is 
consistent with the capabilities of current assays' sensitivity and 
specificity. Additionally, most, but not all, oxidants are quantified 
at concentrations greater than 50 mcg/mL when they are used as urine 
adulterants. Unpublished evaluations of samples spiked with Cr (VI) 
have shown that for Cr (VI) to be effective as an adulterant, the urine 
concentration is usually much greater than 100 mcg/mL. For these 
reasons, the Department believes that the 50 mcg/mL Cr (VI) cutoff is 
sufficient to identify adulteration with Cr (VI) and is appropriate. 
One commenter recommended using the limit of quantitation (LOQ) instead 
of the limit of detection (LOD) as the decision point for adulterant 
tests without a program specified cutoff. The commenter stated that an 
LOQ ensures that the adulterant has been both appropriately identified 
and quantified. The Department agrees and has revised the testing 
requirements in Sections 3.5 and 3.8 to require that the adulterant's 
concentration be equal to or greater than the LOQ that was determined 
by the HHS-certified laboratory.
    The Department has revised Section 3.7 to clarify that a dilute 
result may only be reported in conjunction with either a positive test 
result or a negative test result. When a urine specimen is determined 
to be adulterated or when an invalid result is being reported, the 
Department does not consider finding a dilute result for such a 
specimen as being correct. It is assumed that an adulterated or invalid 
urine specimen has been tampered with and, if it also happens to 
satisfy the dilute criteria, the dilute result would actually be 
meaningless. Additionally, by definition, when a urine specimen is 
reported as substituted it cannot be a dilute specimen. Therefore, a 
dilute result cannot be reported in conjunction with a substituted 
result.

Subpart D--Collectors

    Section 4.1 describes who may collect a specimen for a Federal 
agency. Three commenters recommended allowing direct supervisors to 
routinely collect specimens for federal agency applicant tests. The 
Department disagrees and has always prohibited an immediate supervisor 
or hiring official from routinely acting as a collector, unless no 
other collector is available and only when the supervisor or hiring 
official is a trained collector.
    Section 4.2 describes who may not collect a specimen. Seven 
commenters were opposed to the policy which prohibits testing facility 
employees from collecting specimens if they could link the donor's 
identity to the test results. The Department has always prohibited 
testing facility (HHS-certified laboratory) employees from collecting 
specimens if they could link the donor's identity to the test results 
and believes that this policy is appropriate. The Department revised 
this section to prohibit an employee who is in a testing designated 
position and subject to the Federal agency drug testing rules from 
serving as a collector for co-workers who are in the same testing pool 
or who work together with that employee on a daily basis, and to 
prohibit an individual from collecting his or her own urine for a 
federally regulated drug test.
    Section 4.3 describes the requirements for an individual to be a 
collector for a Federal agency. Seven commenters disagreed with 
requiring collectors to read and understand the Guidelines and felt 
this should be limited to the sections pertaining to the collection of 
specimens. The Department agrees and has revised the policy in Section 
4.3(a) to reflect that a collector must be knowledgeable of the 
collection procedure described in the Guidelines. Four commenters 
suggested that there should be standardized collector training 
requirements and documentation requirements for all collectors. The 
Department has revised Section 4.3 to provide more details on the 
requirements for collector training and the documentation requirements. 
The Department believes the requirements as described in this section 
are sufficient and appropriate to ensure that the collector can 
properly collect a specimen and correctly complete the Federal Drug 
Testing Custody and Control Form (Federal CCF).
    Several commenters believe it is not sufficient to allow the agency 
to select the observer if there is no collector of the same gender 
available, as stated in the Proposed Revisions to Mandatory Guidelines. 
To address this concern, the Department has included a new Section 4.4 
that specifies training requirements for an individual to serve as an 
observer for a direct observed collection (as described in Section 
8.9). The training requirements are designed to ensure that any 
individual serving as an observer has been trained in procedures for a 
direct observed collection, although he or she may not be a trained 
collector. Other training elements are included to ensure that the 
observer interacts with the donor in a professional manner, respecting 
the donor's modesty and privacy, and that he or she maintains the 
confidentiality of collection information. The Department also revised 
this section to allow the collector or collection site supervisor to 
select the observer.
    Section 4.5 describes the requirements for an individual to be a 
trainer for collectors. Three commenters noted that the Guidelines did 
not address approval and monitoring of the ``train the trainer'' 
courses. Currently there are organizations (e.g., manufacturers, 
private entities, contractors, Federal agencies) that offer ``train the 
trainer'' courses. The Department does not believe that it is necessary 
or appropriate to approve the content of the ``train the trainer'' 
courses. If a trainer does not properly train individuals to be 
collectors, collector errors will result as the Guidelines are enforced 
and will demonstrate the need to retrain those trainers.
    Section 4.6 describes what a Federal agency must do before an 
individual is permitted to collect specimens. Five commenters disagreed 
with the requirement for an organization that manages/employs 
collectors to retain the collector training documents, saying this 
would be burdensome. The commenters recommend that collectors be 
responsible for their own documentation. The Department agrees that 
many collectors currently retain their training records and has revised 
the policy to indicate that a collector (who may be self-employed) or 
organization (e.g., collector training company, third party 
administrator, Federal agency that employs its own collectors) must 
maintain a copy of the record that documents his or her training. The 
Department has also revised the question to require the Federal agency 
to ensure that the requirements of this section are satisfied before a 
collector is permitted to collect specimens rather than placing the 
burden on an organization to satisfy the requirements. The Federal 
agency is always responsible for ensuring that a collector is properly 
trained.

Subpart E--Collection Sites

    Section 5.1 describes a collection site as a permanent or temporary 
facility. The requirement for a collection site to have provisions for 
donor privacy during the collection procedure has been moved from 
Section 5.1 to Section

[[Page 71863]]

5.2, which describes the specific requirements for a facility that is 
being used as a collection site.
    Two commenters recommended including additional criteria in Section 
5.2 for a collection site to have a secure working area and donor 
privacy. The Department agrees and is requiring the collection site in 
Section 5.2(a) to have provisions to ensure donor privacy. Privacy 
requirements are set forth in Section 8.1. In addition, Section 5.2(b) 
has been revised to reflect the need for a suitable clean working area 
that is not accessible to the donor. The Department believes the clean 
working area must not be accessible to the donor because, if given an 
opportunity, a donor may attempt to tamper with records, documents, or 
supplies. The Department also added Section 5.2(g) to require 
facilities to have the ability to limit donor access to potential 
contaminants, adulterants, or diluents.
    Section 5.3 describes how long records must be stored by collection 
sites. The record storage requirements in this section are the same as 
those described in the Proposed Revisions to Mandatory Guidelines. The 
Department revised the section to specify the records that must be 
retained.

Subpart F--Federal Drug Testing Custody and Control Forms

    Section 6.1 states that an OMB-approved Federal CCF must be used to 
document the collection of a urine specimen. The requirement in this 
section is the same as the requirement described in the Proposed 
Revisions to Mandatory Guidelines.
    Section 6.2 describes what happens if the correct Federal CCF is 
not available or is not used. The Department recognizes that 
occasionally a current Federal CCF will not be available or a non-
Federal form or expired Federal CCF will be used by mistake. The 
Department does not want this discrepancy to cause a laboratory or IITF 
to automatically reject the specimen for testing, or cause an MRO to 
automatically cancel the test. If the collector discovers the error 
before the specimen is packaged for shipment to a laboratory or IITF, 
the collector must note on the form that the specimen is a Federal 
agency specimen and give the reason for using the incorrect form. When 
this information is provided on the form, the laboratory or IITF simply 
proceeds with testing the specimen as a Federal agency specimen. If the 
laboratory, IITF, or MRO discovers that an incorrect form was used and 
there is no explanation given, the laboratory, IITF, or MRO must 
attempt to obtain a Memorandum For Record (MFR) from the collector 
explaining why an incorrect form was used. If a MFR cannot be obtained 
from the collector, the laboratory or IITF must report a rejected for 
testing result (i.e., when they discovered the error) and the MRO 
reports a cancelled test result.

Subpart G--Specimen Collection Containers

    Section 7.1 describes the items to be used to collect a urine 
specimen. The Department added volume requirements for specimen 
containers to this section to ensure that the containers used would be 
of a sufficient size to hold the required amount of urine for primary 
and split specimens.
    Section 7.2 describes the requirement that the collection items 
used must not affect the specimen collected. The requirement in this 
section is the same as the requirement described in the Proposed 
Revisions to Mandatory Guidelines. However, the proposed statements 
regarding FDA clearance for these collection items has been removed. 
FDA has regulatory oversight of a collection item as a ``device'' 
within the meaning of Section 201(h) of the Federal Food, Drug, and 
Cosmetic Act (the FFDCA) (21 U.S.C. 321(h)), and a manufacturer must 
comply with all statutory and regulatory requirements for these 
devices.

Subpart H--Specimen Collection Procedure

    Section 8 establishes the procedures for collection of a urine 
specimen. The Department revised and reorganized the urine collection 
procedures in the Proposed Revisions to Mandatory Guidelines for 
clarity and to address issues raised as described below.
    Section 8.1 states the privacy requirements for specimen 
collections. The procedure used to collect a urine specimen must ensure 
that a donor is given a sufficient amount of privacy under normal 
circumstances. That is, a donor is allowed to provide a urine specimen 
in the privacy of a restroom or an enclosed stall. Four commenters 
raised concerns with the privacy requirements that should be given a 
donor. The Department evaluated these comments and believes that it is 
more appropriate to address the privacy requirements in subpart H 
(which addresses the collection procedure) rather than discussing the 
privacy requirements in subpart E (which specifies the requirements for 
a collection site). Section 8.1(a) addresses the comments submitted by 
stating who may be present during a collection procedure. Section 
8.1(b) states that the collector may be a different gender than the 
donor, but the observer of a direct observed collection procedure must 
be the same gender, and a monitor for a monitored collection must be 
the same gender unless the monitor is a medical professional. Section 
8.1(c) clarifies that the privacy given to a donor is visual privacy 
because there may be situations where it is not possible to prevent the 
collector from hearing sounds in the enclosure where the donor is 
providing the specimen.
    Section 8.2 describes what a collector must do before starting a 
specimen collection procedure. One commenter noted that the proposed 
requirement to have ``no other source of water (e.g., no shower or 
sink) in the enclosure where urination occurs'' may not address 
temporary collection sites. The commenter recommended that the 
procedure be revised to state that the collector must disable or secure 
other sources of water in the restroom before starting the collection 
procedure. One commenter noted that many public restrooms are equipped 
with toilets that have sensors for automatic flushing. The Department 
agrees and has revised this section to read ``There must be no other 
source of water (e.g., no shower or sink) in the enclosure where 
urination occurs that is not secured during the collection.'' If the 
enclosure used by the donor to provide a specimen has a sink or other 
source of water besides the toilet that cannot be disabled or secured, 
the collector must perform a monitored collection in accordance with 
Section 8.11. The monitor will listen for any sounds that may suggest 
possible attempts by the donor to tamper with the specimen.
    Section 8.3 describes the preliminary steps in the collection 
process. Four commenters recommended that the Guidelines describe the 
type of identification the collector provides to the donor. The 
Department has revised Section 8.3(c) and included some examples of the 
type of identification that may be provided (e.g., driver's license, 
employee badge issued by the employer, any other picture identification 
issued by a Federal, State, or local government agency). Two commenters 
suggested that the collector must point out to the donor, but not 
require the donor to read, the collection procedure instructions on the 
back of the Federal CCF. The Department agrees with the comment and has 
revised Section 8.3(f) to direct the collector only to inform the donor 
where the donor can find the instructions for the collection on the 
back of the Federal CCF. The collector will allow the donor to read the 
procedure if the donor prefers. One commenter suggested that

[[Page 71864]]

the donor be given the collector's full name, name of the collector's 
supervisor, name of the company conducting the test, and the MRO's 
name, telephone, and address. The Department agrees with this comment. 
With the exception of the name of the collector's supervisor, the rest 
of the commenter's request for information is recorded on the donor's 
copy of the Federal CCF. If some of the information is missing on the 
Federal CCF, it is the responsibility of the collector to obtain the 
information and to complete the Federal CCF in accordance with the 
instructions for the use of the Federal CCF for Federal agency 
workplace drug testing programs.
    Section 8.4 describes the steps that the collector takes in the 
collection process before the donor provides a urine specimen. The 
steps are the same as in the Proposed Revisions to Mandatory 
Guidelines, but include additional detail.
    Section 8.5 specifically addresses the situation where a donor 
states that he or she is unable to provide a urine specimen. Over 50 
commenters expressed concern with the Department's urine collection 
policy. They stated that some individuals have what the commenters 
refer to as a ``shy bladder.'' The commenters noted that these 
individuals may be physically unable to provide a urine specimen upon 
demand, and forcing them to drink fluids creates a great deal of stress 
and may not change their ability to provide a specimen. The commenters 
were concerned with how a collector interacts with a donor who is 
unable to provide a sufficient amount of urine to perform a drug test. 
The Department's urine collection policy was designed to prevent an 
individual from intentionally circumventing the requirement to provide 
a urine specimen during a required collection. The policy is not 
intended to cause harm to anyone who has a condition that prevents them 
from providing a urine specimen when requested. The Department has 
always expected a collector to treat the donor with respect when the 
donor is unable to provide a specimen within a reasonable period of 
time (3 hours is considered reasonable). To address the concern, 
however, the Department has revised the urine specimen collection 
procedure. If the donor states that he or she cannot provide a 
specimen, the collector requests the donor to go into the restroom 
(stall) and attempt to provide a specimen. This attempt demonstrates 
the donor's inability to provide a specimen when the donor comes out of 
the stall with an empty collection container. At that time, if the 
donor states that he or she could provide a specimen after drinking 
some fluids, the collector allows the donor to drink some liquid (as 
stated in Section 8.5(b)(1)) and continues with the collection 
procedure. If the donor states that he or she simply needs more time, 
without a need to drink fluids, before attempting to provide a urine 
specimen, the collector gives the donor up to 3 hours to provide a 
urine specimen. If the donor states that he or she is unable to provide 
a urine specimen even after 3 hours, the collector records the reason 
for not collecting a urine specimen on the Federal CCF, notifies the 
Federal agency's designated representative, and sends the Federal CCF 
to the MRO and the Federal agency for further evaluation of the donor. 
The requirement for the further evaluation of the donor by an MRO will 
prevent individuals from being falsely accused of a refusal to test.
    Sections 8.5(b)(1) and 8.6(e)(2) describe the amount of fluid that 
a donor may be given at the collection site in order to collect a 
sufficient amount of urine. The reason why a limit is imposed at all is 
the concern for the welfare of the donor, as well as the concern that 
the urine specimen may become diluted. Several commenters expressed 
concern with the amount of fluids given to a donor at the collection 
site. The Proposed Revisions to Mandatory Guidelines instruction to the 
collector to give the donor a reasonable amount of liquid to drink is 
flexible in the amount given (note that the parenthetical in the 
Guidelines is stated as an example, not as a requirement). However, in 
response to the comment, the Department has changed the example in the 
Proposed Revisions to Mandatory Guidelines (``an 8 ounce glass of water 
every 30 minutes, but not to exceed a maximum of 24 ounces'') to read 
``an 8 ounce glass of water every 30 minutes, but not to exceed a 
maximum of 40 ounces over a period of 3 hours or until the donor has 
provided a sufficient urine specimen.'' This change retains the 
flexibility that has always existed in the Federal program and sets a 
reasonable time limit within which most donors would be able to provide 
an acceptable amount of urine. Although the Department has changed the 
guidance on the amount of fluid given the donor, the Department does 
not require anyone to drink more fluid than he or she could comfortably 
drink. A statement has also been added to these sections to clearly 
state that the donor is not required to drink any fluids during this 
waiting time. The Department believes that most individuals who are 
unable to provide a sufficient specimen simply need some additional 
time to provide the required specimen without having a need to drink 
fluids.
    Section 8.6 describes the steps that the collector takes in the 
collection process after the donor provides a urine specimen. One 
commenter recommended that the collector be instructed to inspect the 
stall for signs of tampering before the donor is permitted to flush the 
toilet. While this practice is acceptable, the Department has not 
included this detail in the Guidelines. Sections 8.2 and 8.3 include 
pre-collection procedures to prevent or detect specimen tampering. 
Furthermore, Section 8.4(b) instructs the collector to perform a 
recollection under direct observation if the donor's conduct indicates 
a possible attempt to adulterate or substitute the specimen.
    Section 8.6 also includes procedures for the collector to measure 
the specimen temperature, visually inspect the specimen, and determine 
the specimen volume. Three commenters recommended deleting the proposed 
requirements for a collector to send a Bottle A specimen to the testing 
facility when there is an insufficient volume of urine collected for 
the split (Bottle B) specimen as required because this contradicted the 
proposed policy that a failure to provide 30 mL of urine for the second 
specimen collection prompts the collector to obtain guidance on the 
action to be taken. The Department agrees and has revised the 
collection procedures to stop the collection when the donor does not 
provide at least 45 mL, the amount required for a split specimen 
collection, after two attempts. When this occurs, the collector 
notifies the Federal agency's designated representative immediately, 
and notes on the Federal CCF the donor's failure to provide sufficient 
urine. The Federal CCF is sent to the Federal agency and the MRO. 
Subsequent actions by the MRO are described in Sections 13.5 and 13.6.
    Section 8.8 is a new section that combines the reasons that appear 
in different sections of the current Guidelines regarding when a direct 
observed collection is used. The reasons are the same; they have simply 
been combined in one section. Section 8.8(c) requires the collector to 
notify a collection site supervisor to review and concur with the 
collector's decision to perform a direct observed collection procedure. 
Three commenters disagreed with this policy. One commenter recommended 
requiring an agency representative in addition to the supervisor to 
review and concur with

[[Page 71865]]

the decision. The Department believes obtaining permission from a 
supervisor is necessary when a decision is needed to conduct a direct 
observed collection. The concurrence from a supervisor will ensure that 
the collector is justified in using a direct observed collection 
procedure. The Department also included in this section the actions a 
collector must take when the donor refuses to provide a specimen under 
direct observation.
    Section 8.9 is a new section that describes how a direct observed 
collection procedure is conducted. The Proposed Revisions to Mandatory 
Guidelines discussed when a direct observed collection procedure is 
permitted, but did not provide guidance on how it is to be conducted. 
The Department has included additional information regarding direct 
observed collections. This information has been available from the 
Department and has been used since the beginning of the Federal drug 
testing program. The Department believes that the procedure will ensure 
that all direct observed collection procedures are conducted the same 
way regardless of the reason for using the direct observed procedure. 
In response to submitted comments, in addition to requiring the 
observer to be the same gender as the donor, the Department has 
specified in Section 8.9 that individuals must be trained in direct 
observed collection procedures in order to serve as an observer. 
Training requirements are included in a new Section 4.4. The Department 
included two new sections, Sections 8.9 and 8.10, to address when and 
how monitored collections are performed.
    Section 8.12 establishes how the collector reports a donor's 
refusal to test. The Proposed Revisions to Mandatory Guidelines 
discussed what constituted a refusal to test during the collection 
process, but did not provide guidance to the collector on how to report 
a refusal to test. Additional information regarding urine collection is 
available from the Department. In addition, the Department included an 
instruction for the collector to discard any urine collected when a 
refusal to test occurred during the collection process.
    Section 8.13 establishes the responsibilities for Federal agencies 
regarding collection sites. Many commenters disagreed with requiring 
Federal agencies to inspect all of their collection sites. The 
commenters believe this requirement to inspect the hundreds of 
collection sites would be cost-prohibitive and logistically impossible, 
and there does not seem to be evidence that errors by collectors are 
common enough to justify such an inspection program. Other commenters 
suggested that, in lieu of annual inspections of all collection sites, 
HHS require agencies to inspect only collection sites which have 
generated ``fatal flaws.'' The Department agrees that requiring Federal 
agencies to investigate and possibly inspect collection sites with 
``rejected for testing'' errors ensures that collectors will receive 
appropriate training to prevent the recurrence of such errors. However, 
the Department maintains that random inspections are important to 
identify any collection procedure problems that may exist, but are not 
readily evident from the Federal CCF because the forms appear to be 
properly completed by the collector. The Department has revised the 
inspection requirements in this section accordingly. Federal agencies 
must inspect only 5 percent of the current number of collection sites, 
or up to a maximum of 50, selected randomly, of their collection sites 
each year. Additionally, Federal agencies are required to investigate 
reported collection site deficiencies (e.g., ``rejected for testing'' 
by either an HHS-certified laboratory or HHS-certified IITF) and take 
appropriate action which may include inspecting the collection site. 
The number of collection sites inspected because they have had 
``rejected for testing'' results are not included in the 5 percent or 
maximum of 50 requirement.

Subpart I--HHS Certification of Laboratories and IITFs

    The proposed section describing the goals and objectives of 
certifying laboratories and IITFs was removed from the Guidelines. Four 
commenters suggested that the discussion should be in the preamble 
rather than in the Guidelines. The Department agrees that the 
discussion in this section does not establish any specific analytical 
requirements and was removed from these Guidelines.
    Section 9.1 (Section 9.2 in the Proposed Revisions to Mandatory 
Guidelines) states that the Secretary has the authority to certify 
laboratories. Four commenters disagreed with the right of the Secretary 
to review private sector specimen results tested under the Guidelines. 
The Department understands the concerns expressed by the commenters; 
however, the review of private sector specimen or non-regulated 
specimen results, only occurs for those private sector specimens that 
are tested in batches that contain federally-regulated specimens. This 
usually occurs with confirmatory test batches because laboratories 
assemble these batches by taking the initial test positive specimens 
from different initial test batches to make the confirmatory test cost 
effective and efficient. Therefore, the policy described in this 
section is the same policy as described in the Proposed Revisions to 
Mandatory Guidelines.
    Section 9.2 (Section 9.3 of the Proposed Revisions to Mandatory 
Guidelines) describes the application process for a laboratory or IITF, 
procedures for maintaining certification, and what a laboratory or IITF 
must do when its certification is not maintained. In the Proposed 
Revisions to Mandatory Guidelines, the term ``imminent harm'' is used 
as a reason to require a laboratory to immediately stop testing Federal 
agency specimens. Three commenters objected to using the term 
``imminent harm'' because they believe the term limits the Department's 
ability to suspend a laboratory or IITF. Although the Department has 
successfully suspended a number of laboratories using ``imminent harm'' 
as the basis for an immediate suspension, the term has been removed 
from these Guidelines. The reasons for taking action against a 
laboratory or IITF are more appropriately discussed in Sections 9.12, 
9.13, and 9.14. The Department has revised Section 9.2(c) to clarify 
the requirements when a laboratory or IITF does not maintain its HHS 
certification.
    Section 9.3 (Section 9.5 of the Proposed Revisions to Mandatory 
Guidelines) describes the composition requirements for the PT samples 
that are used to challenge a laboratory or IITF's drug and specimen 
validity tests. The requirements in this section are the same as those 
contained in the current Guidelines, except for the pH specifications 
in Section 9.3(b)(2). These specifications were revised to challenge 
the pH tests used by IITFs, as described in Section 12.14(c)(1), as 
well as laboratory pH screening tests with a narrow dynamic range, as 
described in Section 11.18(c)(1).
    Section 9.4 (Section 9.9 of the Proposed Revisions to Mandatory 
Guidelines) describes the requirements that an applicant laboratory 
must satisfy when testing the 3 consecutive sets of PT samples sent to 
the laboratory during the initial certification process. Section 9.5 
(Section 9.13 of the Proposed Revisions to Mandatory Guidelines) 
describes the requirements that a certified laboratory must satisfy 
when testing the quarterly sets of PT samples sent to the laboratory as 
part of the maintenance PT program. In both sections, the requirements 
are the same

[[Page 71866]]

as in the current Guidelines with two exceptions concerning the 
evaluation of specific gravity results. The Department has retained the 
acceptable range of no more than 0.0003 specific gravity 
units from the mean for PT samples with a mean less than 1.0100, but 
has increased the acceptable range to 0.0004 specific 
gravity units when a PT sample's mean is equal to or greater than 
1.0100. The Department has retained the limit of 0.0006 
specific gravity units from the mean for assessing errors for PT 
samples with a mean less than 1.0100, but has increased the limit to 
0.0007 specific gravity units when the PT sample's mean is 
equal to or greater than 1.0100. The Department has been evaluating the 
performance of the instruments used to measure specific gravity to 4 
decimal places and believes increasing the precision limits for high 
specific gravity readings is reasonable and appropriate due to the 
nature of the refractive index and calibration methods using oil to 
calibrate the instruments.
    Section 9.6 (Section 9.17 of the Proposed Revisions to Mandatory 
Guidelines) describes the PT requirements an applicant IITF must 
satisfy to conduct urine testing and Section 9.7 (Section 9.21 of the 
Proposed Revisions to Mandatory Guidelines) describes the PT 
requirements that an HHS-certified IITF must satisfy to conduct urine 
testing. Both sections were revised to be consistent with PT challenges 
for the initial testing part of a laboratory (i.e., requirements 
addressing confirmatory test challenges were deleted). One commenter 
noted the requirement to correctly identify and report the total drug 
challenges over 3 sets of PT samples was 80 percent for applicant and 
certified IITFs, while it is 90 percent for applicant and certified 
laboratories. The commenter recommended that the requirement be the 
same for IITFs and laboratories. The Department agrees and has revised 
the requirement in Section 9.6(a)(1) to be 90 percent for applicant 
IITFs for initial testing.
    Section 9.8 (Section 9.22 of the Proposed Revisions to Mandatory 
Guidelines) describes the inspection requirements for an applicant 
laboratory or IITF and Section 9.9 (Section 9.23 of the Proposed 
Revisions to Mandatory Guidelines) describes the inspection 
requirements for an HHS-certified laboratory or IITF. The Proposed 
Revisions to Mandatory Guidelines required using at least two 
inspectors to inspect an applicant laboratory or IITF. Three commenters 
expressed concern with requiring at least two inspectors to inspect an 
applicant laboratory or IITF, while the Proposed Revisions to Mandatory 
Guidelines permit only one inspector to potentially be used to inspect 
an HHS-certified laboratory or IITF. The Department has revised Section 
9.8 to require two inspectors rather than the proposed ``at least two 
inspectors.'' The Department believes that the inspection of an 
applicant laboratory or IITF must be conducted using two inspectors 
because this minimizes the possibility of a laboratory or IITF 
disputing the findings of one inspector as opposed to the findings from 
two inspectors. With regard to HHS-certified laboratories and IITFs, 
the Department retained the Proposed Revisions to Mandatory Guidelines 
requirement which states that an HHS-certified laboratory or IITF ``is 
inspected by one or more inspectors.'' The Department believes that one 
inspector is appropriate to inspect an HHS-certified laboratory or IITF 
when the facility is very small, has an extremely small workload, and 
has a history of acceptable performance on testing the PT samples and 
on previous inspections. The Department believes that using one 
inspector is sufficient to conduct a thorough inspection and makes it 
cost-effective for very small HHS-certified laboratories and IITFs to 
remain in the certification program.
    Section 9.10 specifies the criteria an individual must satisfy to 
be eligible for selection as an inspector for the Secretary under the