ML20245E827

Discussion of Barbiturate & Benzodiazepine Urinalysis in Workplace Drug Testing Programs

ML20245E827
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Issue date:	06/30/1989
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A DISCUSSION OF BARBITURATE AND BENZODIAZEPINE URINALYSIS IN WORKPLACE DRUG TEST]NG PROGRAMS .j l

U. 2. NUCLEAR REGULATORY COMMISSION JUNE 1989 1

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Developed with the assistance cf the Battelle Human Affairs Research Centers

'T Enclosure 4' B y B 3 g 9j g [ 2 G CORRESPONDENCE FDR

1.0 INTRODUCTION

This paper provides information pertaining to the inclusion of barbiturates and benzodiazepines in the panel of drugs for which tests are performed, in workplace drug testing programs.

Sedatives are among the most commonly prescribed and used drugs. Familiar sedatives are anxiolytics or minor tranquilizers (which include benzodiazepines), barbiturates, ethanol, and general anesthetics. Because of the prevalence of sedative use, some employee drug testing programs have recognized the need to test workers for the use of certain sedatives, particularly barbiturates and benzodiazepines (Critical Issues In Urinalysis, 1988; Sunshine, 1988). The U.S. Navy currently tests about 10's oi all urine samples for barbiturates (Irving,1988). Thus, in addition to the drugs identified in the HHS drug panel, barbiturates and benzodiazepines are among the drugs most often included in workplace drug testing programs.

The NRC published a proposed fitness-for-duty rule in the Federal Register (53 FR 36795, 1988) and requested public comments on the rule. Many commentors stated that the panel of drugs for which urine tests are conducted should not be limited to illegal drugs, but should be expanded to include legal prescription drugs including barbiturates, benzodiazepines, or both.

These commentors included numerous utilities and the Nuclear Management and Resources Council, Inc. (NUMARC). NUMARC is the nuclear power industry organization responsible for coordinating the combined efforts of all utilities licensed by the NRC to construct or operate power plants and other nuclear industry organizations in all matters involving generic regulatory policy issues. Every nuclear utility in the U.S. is a member of NUMARC, as are some major architect-engineering firms and all of the major nuclear steam supply system vendors.

Among the reasons offered for expanding the panel of drugs where the I following:

• The logic of focusing only on illegal drugs, while ignoring legal drugs that may also lead to on-the-job impairment that creates safety risks, is questionable. The omission of such legal drugs from a urine testing program could cause the progrcm to miss the primary point of the NRC's fitness-for-duty program, which is to ensure a safe workplace.

• There are numerous documented cases of workers' use of benzodiazepines and barbiturates resulting in adverse worker performance and poor judgment on the job.

Many leg)al purposes . drugs are subject to misuse or abuse (use for non-medical

• Barbiturates and benzodiazepines are used prevalently in some geographic areas.

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• The effects of barbiturates and benzodiazepines on human performance can have serious implications for safety. The drugs impact directly on  ;

vigilance, ability to handle complex tasks, and motor s'. ills.

Much of the information presented here on the impairing effe:ts of  ;

barbiturates and benzodiazepines has been previously reportej by Radford, Rankin, Barnes, McGuire, and Hope (1983) and Barnes, et al. (1988).

2.0 BARBITURATES i

The information presented here indicates that it is appropriate to include barbiturates in workplace drug testing programs for the following three reasons: (1)theextentthatthesedrucsareusedandmisusedwarrants I concern, (2) these drugs can have pronounced impairing effects on a worker's j performance, and (3) a reliable urine testing technology exists that is suitable for large-scale urine testing programs.

2.1 Extent of Use, Misuse and Abuse 4

Sedatives are widely used, misused and abused in American society. According {

to Bassuk, Schoonover, and Gelenberg (1983), the prevalence of sedative abuse '

probably exceeds that of the opiates. Though benzodiazepines have replaced barbiturates to some degree in recent years, barbiturates are still widely used. Blum (1984) describes the overuse of barbiturates as " America's hidden drug problem, parhaps comparable in scope to the hidden opiate dependence around the turn of the century" (p.165).

2.2 Impairing Effects The impairing effects of barbiturates are highly significant when their use l

by workers in safety sensitive jobs is considered. For example, the National Transportation Safety Board (NTSB) determined that an engineer's use of a prescription medication containing butalbital (a barbiturate) contributed to a j train accident in Pittsburgh, Penns):vania, on April 11, 1987 (53 FR 47108,  ;

1988). The accident resulted in th; release of lazardous materials, the evacuation of 22,000 people from nearby neighborhoods, rad 122 minor injuries.

The engineer had acquired the medication fram a family member and was using it to treat flu symptoms. i Barbiturates may impair sensory functions. Holzman, Levy, Uhlenhuth, l Proctor, and Freedman, (1975) studied the effects of barbiturates on perception. Results indicated that the ability of the eyes to track a moving object is disrupted at therapeutic doses. This finding suggests that abilities needed by many workers with safety-sensitive jobs may be impaired

, by barbiturate use. For example, a worker's ability to drive, operate heavy equipment, or to monitor dials and gauges may be affected.

Barbiturates also impair one's ability to sustain attention. Results from several studies indicate that the number of errors subjects make on vigilance tasks increases after consumin Higgins, 1968; Lehembre, 1963)g barbiturates (Hutt, Jackson, Belsham, and I

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Barbiturates slow reaction times. Studies of simple reaction time show that response speed decreases under the influence of barbiturates (Blum, Stern, and Melville, 1964; Goldstein, Searle, and Schimke, 1960). Barbiturates also increase choice reaction tinie, but were not found to increase the error rate 1 (Rundell, Williams, and Lester,1978).

The effects of barbiturates on psych e tor performance depend upon the size of the dose administered. At the Me$ typically prescribed by physicians, simple motor performance (e.g., finger or toe tapping) is not noticeably affected, but it is impaired when the detage is increased (Epstein and Lasagna,1968). For more complex tests of psychomotor performance, however, barbiturates taken at therapeutic doses impair performance. For example, barbiturates have been shown to impair eye-hand coordination and manual dexterity (Billings, Gerke, and Wick,1975).

Barbiturates affect a broad range of cognitive abilities. For example, long-term memory, the ability to retain information for hours, days, or longer, is adversely affected by barbiturates (Rundell, et al., 1978). Research has also shown that therapeutic doses of barbiturates impair the ability to perform arithmetic problems. Experimental subjects required more time and made more errors than did drug-free subjects (Epstein and Lasagna,1968; Blum, Stern, and Melville, 1964).

At high doses, both barbiturates and benzodiazepines can have similar effects j to those caused by alcohol intoxication. These effects include nausea, l incoordination, loss of inhibitions, violence, and hangovers (Brecher, 1972). I 1

It is also noteworthy that the combination of fast-acting barbiturates and alcohol is one of the potentially most harmful combinations of drugs possible. Both of these drugs are metabolized in the liver, and the same factors limit the rate of metabolism of each drug-(slow-acting barbiturates i are secreted through the kidneys). When consumed together, fast-acting l barbiturates and alcohol compete for metabolic time in the liver. Alcohol '

always wins this competition. When alcohol and barbiturates are both present in the body, barbiturates are not metabolized for some time (Hughs and Brewin, 1979).

There are two very important implications of this phenomenon. First, if an ,

individual is consuming alcohol and taking barbiturates over a period of  !

time, the dose of barbiturates in the body continues to rise each time an additional dose of the drug is taken. Because the metabolism of barbiturates is delayed, a rate of barbiturate consumption that would normally result in a .

very low but prolonged level of barbiturate in the body can result in very high levels. Second, as the metabolism of barbiturates is delayed, the effects of the barbiturate will last longer. Thus, a worker who has been drinking and using fast-acting barbiturates may report to work a considerable time after last having taken barbiturates and still have within his or her system the entire, or a large portion, of the barbiturates consumed.

It should also be noted that it does not take extremely heavy drinking to effectively " tie up" the liver. The rate of alcohol metabolism varies from person to person, but the normal range is between 7.5 grams and 10.0 grams 3

per hour (Winek and Esposito, 1985). Thus, drinking at this same rate prevents the liver from metabolizing any barbiturate consumed. As a standard

" shot" or mixed drink (one ounce of 80-proof liquor) contains 11 grams of alcohol, drinking between three-quarters of a drink and one full drink per hour can be expected to prevent the metabolism of fast-acting barbiturates from occurring until drinking ceases and the alcohol in the body is metabolized.

2.3 Recommended Urine Testing Protocol Barbiturate tests can be conducted using urine specimens with an immunoassay screening test followed by a GC/MS confirmatory test. With the exception of identifying the drug (s) or metabolites and the appropriate cutoff levels to be used in the tests, there are no special or unique problems associated with barbiturate testing that require modification of the HHS Guidelines (John Irving, personal communication, 1988). The urine testing protocol for barbiturates differs from the protocol used for other drugs in that the appropriate immunoassay screening test is a broad spectrum test, used to detect a number of barbiturate drugs, rather than a test specific to a single drug. This difference, however, does not require any variation of the HHS  !

Guidelines with regard to issues such as chain-of-custody and laboratory quality control.

The U.S. Navy has established a precedent for conducting urine screening tests for barbiturates by testing for secobarbital using the 200 ng/ml cutoff level. Gas chromatography / mass spectrometry tests are then used for confirmatory testing for specific barbiturates, also at the 200 ng/ml cutoff level (Irving, 1988). Lower cutoff levels are technically possible and may be preferable to the cutoff level used by the Navy. However, the 200 ng/ml cutoff level (as would any lower cutoff level) limits the types of screening assays that can be used to detect barbiturate use. A higher cutoff level that would expand the number of assays that could be used may have practical advantages.

2.3.1 Screening tests for barbiturates Screening tests for barbiturates can test urine for the presence of the barbiturate secobarbital. When tests are conducted for secobarbital, other commonly used barbiturates will be detected due to cross-reactions.

Different immunoassays use different antibodies, and the degree to which the different antibodies will cross-react with specific barbiturates varies.

Thus, it is impossible to directly compare the assays. Each assay is very sensitive for some barbiturates and less sensitive for others. The assay of choice will vary depending upon which barbiturate one is most interested in detecting.

Although both EMIT and RIA assays are very sensitive when testing for secobarbital, radioimmunoassays tests are significantly more sensitive than are enzyme immunoassays (Jain, Budd, Sneath, Chinn & Leung; 1976). A product brochure provided by Roche Diagnostic Systems (1986) states that the Abuscreenr assay is sensitive to 5 ng secobarbital per ml of blood. While the assay has been shown to be capable of detecting barbiturates at 4

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concentrations this low, it is unlikely that the assay is reliable when l testing for barbiturates at this concentration. The positive reference j standard provided with the test kit is designed for a 200 ng/ml cutoff level.  !

While lower cutoff levels can be prepared from reagents supplied in the '

product, only a limited amount of information sertaining to the reliability of the assay at cutoff levels below 200 ng/ml las been identified. The standard cutoff level used in the EMIT barbiturate assay is 300 ng/ml (Hanson,1986).

Although the 200 ng/ml cutoff level used by the U.S. Navy may adequately detect abuse of secobarbital, this cutoff level may be too high to provide an acceptable probability of detecting abuse of other barbiturates. When  ;

conducting a screening test for secobarbital, other barbiturates present in J the specimen can cross-react to produce a positive test result. l Unfortunately, in the case of a few commonly abused barbiturates, these j cross-reactions will only produce positive test results when the barbiturates j are present in the specimen in high concentrations. Enzyme tests may fail to  ;

detect two frequently abused barbiturates, amobarbital and pentobarbital. J When screening for the presence of secobarbital with the RIA Abuscreenr using a 200 ng/ml cutoff level, 3,069 ng/ml of amobarbital or 946 ng/mi of pentobarbital are required to produce a positive test result (Roche Diagnostic Systems, 1986). If an EMIT test is used with a 200 ng/ml cutoff level, then 350 ng/ml of amobarbital must be present in the sample to yield a positive result (Jain, et al., 1976).

Because some frequently abused barbiturates may not be readily detected when screening urine for the presence of secobarbital, a cutoff level lower than 200 ng/mi may be useful. Further, it appears that a lower cutoff level can be used without challenging the reliability of the testing technology. According to Jain, et al. (1976), RIA tests can detect secobarbital at concentrations of 100 ng/ml with 99 percent accuracy. This evidence suggests that the 200 ng/mi urinary barbiturate concentration level used by the U.S. Navy may be inappropriately high, and that a cutoff level of 100 ng/ml may be preferable.

It may, however, be preferable to raise the cutoff level rather than lowering it in order to enhance detection. If the cutoff level is raised to 300 ng/m1, then both the EMIT assay and the Abuscreenr can be used for testing.

Because of variations in cross-reactivity between the two assays, the EMIT assay, with a 300 ng/ml cutoff level, may actually be a more sensitive method of detecting the presence of some barbiturates than would the Abustreenr assay using a 200 ng/ml cutoff level. Optimal detection for a wide range of barbiturates could be created by performing two or more assays using different immunoassays. Therefore it is recommended that the cutoff level be set at the lowest level that currently can be supported by the EMIT assay (300 ng/ml).

2.3.2 Confirmation tests for barbiturates The Navy's GC/MS confirmatory tests f ar barbiturates test for specific barbiturates at the same cutoff level used in the screening test, 200 ng/ml (Irving,1988). As explained above, both the EMIT and the RIA assays are designed to detect unchanged secobarbital in the urine and, due to cross-5

T reactions, they will detect other barbiturates as well. When a screening assay is sensitive to multiple substances and the confirmation test is sensitive to only a single substance, it may be desirable to set screening  ;

cutoff levels higher than confirmation cutoff levels. This procedure is i necessary to guard against unconfirmed positive test results, and is an I I

important 1 actor in determining appropriate cutoff levels for marijuana and benzodiazepines. However, this issue is only of concern when it is likely that more than one c,f the substances that the screening test is sensitive to .

will be present in a drug user's urine. In the cases of marijuana and 1 benzodiazepine screening tests, which are designed to detect drug metabolites, it is likely that several metabolites will be present in a drug user's urine.

I However, in the case of barbiturate screeninD tests, which are designed to  !

detect unchanged barbiturates in the urine, it is less likely that more than  !

ew barbiturate will be present in the urine. The conditions that could lead to unconfirmed positive test results for barbiturates when the same cutoff levels are used for screening and confirmation tests are probably rare.

Unconfirmed positive test results would be expected when an individual has consumed more than one barbiturate and his or her urine contains a total barbiturate concentration that exceeds the cutoff level while the l

concentration of each individual barbiturate is below the cutoff level. As i l this scenario is relatively unlikely, it appears unnecessary to establish a l l confirmation cutoff level for barbiturates that is lower than the screening )

l cutoff level. If the cutoff level used in the screening test is raised to 300 i ng/mi as is proposed here, then it appears reasonable to raise the l confirmation test cutoff level to 300 ng/ml as well.

Although GC/MS analysis is highly specific, it is not possible to test for every barbiturate in a large-scale drug testing program. Over 2,500 different barbiturates have been synthesized, and about 50 different barbiturates have been accepted for medical use (Brecher, et al., 1972). Because of the large number of barbiturates in existence, the confirmation tests should focus only on commonly used and abused barbiturates. However, it is unnecessary and impractical to test for a few barbiturates that are used medicinally with relative frequency. For example, the U.S. Navy drug testing program does not test for phenobarbital when conducting barbiturate screening tests (Irving, 1988).  !

Confirmation testing for phenobarbital is unnecessary for two reasons.  !

First, it is unlikely that phenobarbital is abused by workers. Barbiturates 4 are classified according to their duration of action. The shorter acting barbiturates (such as pentobarbital, secobarbital, and amobarbital) are the i most commonly) phenobarbital areabused barbiturates, rarely subject and to abuse long-(acting Hawks barbiturates

& Chiang, 1986). The(such as faster acting barbiturates produce more pronounced alcohol-like intoxication and are more addicting than are slow acting barbiturates (Brecher, et al.,

1972). As phenobarbital is the longest acting barbiturate (Bassuk, et al., l 1983), it has a relatively low abuse potential.  ;

A second reason that confirmation testing for phenobarbital is unnecessary is that it is unlikely that the presence of phenobarbital in the urine will cause a positive screening test result. When conducting a screening test for 6

secobarbital, phenobarbital can cross-react to aroduce a positive test result. However, this will only occur if phenobarbital is in the urine in very high concentrations. When screening for the presence of secobarbital with the RIA Abuscreenr and using a 200 ng/ml cutoff level, 3,396 ng/ml of phenobarbital must be present in the specimen to yield a positive result (Roche Diagnostic Systems, 1986). If an ENIT test is used with a 200 ng/ml cutoff level, then 400 ng/ml of phenobarbital must be present in the sample to yield a positive result (Jain, et al., 1976).

Confirmation tests for the presence of phenobarbital can also be impractical.

Phenobarbital is contained in a variety of medications, and it can be detected in the urine for weeks after the medication has been used. Thus, it  ;

is likely that a worker may have been given medication by a dcctor or a  ;

dentist some weeks prior to the drug test and forgot to report this use at i the time of the test (John Irving, esonal communication,1988).

Although it is impossible to test for all barbiturates by GC/MS confirmation analysis, the analysis should test for those barbiturates that are most apt to present fitness-for-duty concerns. At a minimum, confirmatory GC/MS analysis should test for all of the shorter acting barbiturates that are commonly used, as shown in Table 1. Further, there should be the option of testing for butabarbital, an intermediate-acting barbiturate.

TABLE 1. Classification of Barbiturates by Duration of Pharmacologic Effects

• Intermediate Ultrashort Acting Short Acting Acting Long Acting 1/4 to 3 Hours 3 to 6 Hours 6 to 12 Hours 12 to 24 Hours Thiopental Amobarbital Butabarbital Phenobarbital Pentobarbital I Secobarbital Aprobarbital Hexobarbital l

• Adapted from Blum, K. (1984). Handbook of Abusable Drugs (p. 178). New York: Gardner Press; and Windholz, M., Budavari, S., Blumetti, R. F. &

Otterbein (Eds.), The Merck Index: An Encyclo3edia of Chemicals, Drugs, and Biologicals (10th ed.) (pp. 777 and 4598). Ralway, NJ: Merck & Co., Inc.

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i 3.0 BENZODIAZEPINES I

Included in the minor tranquilizer category are benzodiazepines and I dicarbamate derivatives. There are more than 2,000 benzodiazepine compounds; those most commonly 3rescribed are alprazolam (Xanax), diazepam (Valium), {

chlordiazepoxide (Li)rium), and flurazepam (Dalmane). Among dicarbamates, i meprobamate (Miltown or Equanil) is the most widely prescribed. These drugs i are used to treat tension, anxiety, and psychosomatic disorders. They are also used to treat alcoholism and phobic states (Gaston and Walker, 1981).

Benzodiazepines meet the same three criteria for being included in an employee drug testing program that are met by barbiturates. Benzodiazepines are very widely used, and they have impairing effe:ts similar to those of barbiturates. 1 Further, a reliable testing technology exists for conducting large scale urine )

testing programs for benzodiazepines.

3.1 Extent of Use, Misuse, and Abuse  !

The benzodiazepines, having replaced the use of barbiturates to a large degree, are very widely used. The benzodiazepines are considered by many as ,

the most widely prescribed drugs in the U.S. (Hawks and Chiang, 1986). In '

1978, 128 million prescriptions were written for sedative-hypnotic drugs in the U.S. (Bassuk, Schoonover, and Gelenberg, 1983). Prescriptions for benzodiazeaines rose steadily through the 1960s and early 1970s to a peak l level of a>out 100 million prescriptions per year in 1975. The number of '

prescriptions written per year dropped to about 65 million by 1981, and has remained at about that level (Griffiths and Sannerud, 1987). Rickels, et al.

(1981) report that Hellinger and Balter (1981) estimate that 1.6% of the adult American population have been using minor tranquilizers, primarily benzodiazepines, for one year or longer. As benzodiazepines are classified as Schedule IV drugs in the Controlled Substances Act, prescriptions can be refilled without a physician's approval. Therefore, individuals may use these drugs for extended periods of time while having little or no contact with the physician who prescribed the medication.

Benzodiazepines are among the most frequently encountered drugs in both postmortem and emergency toxicology analyses (Poklis, 1981). The Drug Abuse Warning Network (DAWN), a program sponsored by the National Institute on Drug Abuse, provides data indicating that the benzodiazepines have a very high incidence of emergency room mentions. For the years 1980 through 1984 inclusively, DAWN reported more emergency room mentions of diazepam than any other controlled substance, and in 1985, diazepam was the third most often mentioned drug, surpassed only by heroin and cocaine (Frank, 1987). In 1985, benzodiazepines as a class accounted for over half (61%) of all emergency room illicit drug mentions, and alprazolam, which was (after diazapam) the second most often mentioned benzodiazepine, accounted for 5.7% of all illicit drug mentions (Joern and Joern, 1987). The frequency of benzodiazepine mentions in emergency room reports has been on the increase, rising from 52% of all illicit drug mentions in 1980 to 61% in 1985.

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3.2 Impairing Effects The Effects of minor tranquilizers on sensory functioning have not been extensively examined. Studies indicate that 5 mg or more of Valium will slow the rate at which neurons fire in the eyes, optic nerve, and brain, indicating that vision my be impaired (Kleinknecht and Donaldson, 1975). Results from studies in which hearing was assessed also indicate that Valium slows the rate l at which aural neurons fire, suggesting that hearing sensitivity is decreased I (Healy, Robinson, and Vickers, 1970). j i

For minor tranquilizers, vigilance perfomance appears to be impaired to a greater extent than visual and auditory performance. Performance decrements are found with 5 to 10 mg of Valium on measures designed to assess the ability to detect visual signals, which suggests that the ability to sustain attention and concentration decreases following ingestion of minor tranquilizers even, in prescribed doses.

The effect of minor tranquilizers on recction time is influenced by the dose and individual tolerance to the drug. In general, low doses (5 to 10 mg) do .

not appear to affect simple reaction time whether administered on only one '

occasion or over a period of days (Bernheim and Michiels, 1973; Tansella, l Zimmermann-Tansella, and Lader, 1974; Ghoneim, Mewaldt, and Thatcher, 1975). I Choice reaction time, a reaction time measure involving decision making, is  !

affected when a drug-free individual consumes drugs during the experiment or l when a drug user is given a dose higher than normal. When minor tranquilizers are chronically used at low doses, no changes in speed of reaction or number of response errors have been found (Bernheim and Michiels, 1973; Ghoneim, et al., 1975; Landauer, Pocock, and Prott, 1974; Bond and Lader,1973).

Standard or low doses of minor tranquilizers do not appear to significantly impair most motor performance. For example, in tests assessing the speed with which one taps a pencil or presses a key, subjects given minor tranquilizers were able to perform as quickly as subjects given a placebo (Bernheim and Michiels, 1973; Milner and Landauer, 1973; Bond and Lader, 1973; Ghoneim, et al., 1975). Other studies have also shown that eye-hand coordination is not impaired with minor tran Donaldson, 1975; Linnoila and Mattila, 1973)quilizers (Kleinknecht and Within the cognitive ability domain, minor tranquilizers appear to have the greatest efftets on learning and, to some extent, memory. Substantial evidence exists to suggest that tranquilizers impair short-tenn memory (i.e.,

the ability to retrieve information presented seconds or a few minutes beforehand) but only when the subject is in a drug-induced state at the time the information is presented. If the infonnation is presented to the subject l in a non-drugged state and the subject is asked to recall the items in a drug-induced state, no impairment is observed. (Ghoneim, et al., 1975; Liljequist, Linnoila, and Mattila, 1978; Ghoneim and Mewaldt, 1975). Research has also shown that minor tranquilizers do not affect long-term memory (Peterson and Ghoniem, 1980; Ghoneim and Newtidt, 1975; McKay and Dundee, 1980).

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r Minor tranquilizers do, however, affect learning. These drugs can induce amnesia for events as well as for words and digits (McKay and Dundee, 1980).

Subjects given minor tranquilizers also require more time than drug-free subject; to memorize a series of digits or pairs of words (Liljequist, et al.,

1978; Ghoneim, et al., 1975; Peterson and Ghoneim, 1980). These findings suggest that tranquilizers in; pair the ability to store new information in memory.

When misused or abused, benzodiazepines may cause more significant impairment. High doses of sedatives have been reported to lead to l irritability and quarrelsomeness. This behavio_r, temed " paradoxical rage reaction," is unpredictable, but appears to be stress related (Brecher, 1972).

This phenomenon has significant implications'when considering the effects that use and abuse of these drugs could have on some workers in some situations (e.g., nuclear power plant control room operators during an emergency).

As is the case with barbiturates, the combination of alcohol and benzodiazepines also has a multiplying effect (Hughes and Brewin, 1979).

The abrupt termination of long-term sedative use can also result in significant withdrawal symptoms, including delirium and grand mal convulsions (Griffiths and Sannerud, 1987), anxiety, agitation, tremulousness, insomnia, dizziness, headaches, tinnitus, blurred vision, diarrhea, hypotension, hypothermia, neuromuscular irritability, psychosis, and seizures (Bassuk, et al., 1983). Obviously many of these reactions can lead to on-the-job impairment. At least 39 symptoms have been specifically associated with benzodiazepine withdrawal (Rickels, Case, Schweizer, Swenson, and Fridman, 1986). Bassuk, et al. (1983) note that withdrawal reactions to benzodiazepines were once considered relatively rare, but that clinicians have recently been noting withdrawal reactions following abrupt termination of benzodiazepine for long periods ofuse by drug-using time. In a study patients whoethave by Rickles, been, taking)benzodiazepines al. (1986 82% of the patients who discontinued use of benzodiazepines suffered withdrawal symptoms.

3.3' Chemical Testing Protocol Tests for benzodiazepines can be conducted using urine specimens with an immunoassay screening test followed by a GC/MS confirmatory test. Since these drugs are not excreted in the urine in unchanged forms in significant quantities, the methods for their detection have focused on the identification of metabolites in the urine (Kaistha, 1977).

The standard reagent used in urine immunoassays for benzodiazepines detects exazepam in the saecimen; oxazepam is also a suitable metabolite to test for wher, confirming t1e screening test with GC/MS. 0xazepam is a benzodiazepine and is produced as a metabolite when many benzodiazepines are metabolized (see Table 2). Oxazepam has been reported to be the major metabolite of diazepam, which is the most widely used benzodiazepine.

The majority of oxazepam metabolized from benzodiazepines is in the form of glucuronide conjugates (Tjaden, Meeles, Thys & Van der Kaay,1980; Foltz, fentiman & Foltz, 1980). Though some free exazepam is present in the urine, 10 i

l TABLE 2. Common Metabolites of Several Benzodiazepine Drugs

• Approximate Dose Drug Equivalents (mg) Active Metabolites Alprazolam 0.5 a-Hydroxyalprazolam, desmethylalprazolam, 4-hydroxyalprazolam Chlordiazepoxide 10 Desmethylchlordiazepoxide, demoxepam, desmethyldiazepam, oxazepam Clorazepate 7.5 Desmethyldiazepam, oxazepam Diazepam 5 Desmethyldiazepam, oxazepam Halazepam 20 Desmethyldiazepam, oxazepam Lorazepam 1 None Oxazepam 15 None Prazepam 10 Desmethyldiazepam, oxazepam

• Adapted from Bassuk, E. L., (1983).

Schoonover,drugs The practitioner's guide to psychoactive S. C. (2nd

& Gelenberg(, A. J.

ed.) pp.180-181).

New York: Pler.um Medical Book Company.

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the concentration of free oxazepam is very low relative to the concentration '

of glucuronide conjugates of oxazepam (oxazepam glucuronide). For example, in one study the urine of a patient who had been taking diazepam was found to contain over 14,000 ng/ml of conjugated oxazepam while the concentration of free oxazepam was only 32 ng/ml (Tjaden, et al.,1980). Other benzodiazepine l metabolites are also typically excreted as conjugates. For example, '

alprazolam metabolites probably exist primarily as glucuronide (and possibly sulfate) conjugates (Joern & Joern, 1987). ,

Therefore, both screening and confirmation tests should test for conjugated i metabolites. Detection of conjugated metabolites can be done directly, using i an assay that is capable of detecting the conjugated metabolites, or an i additional step, such as hydrolysis, can be added to the testing process to  :

extract free metabolites from the conjugated metabolites. l 1

3.3.1 Screening tests  !

Immunoassay technology can be used to detect oxazepam conjugates at levels low enough to reliably detect benzodiazepine use. Though the discussion presented here focuses on the EMIT assay, it is not the intention of this discussion to suggest that EMIT is the only assay that is adequate for  !

performing benzodiazepine screening tests. The cutoff level used in the EMIT assay, 300 ng/ml, is higher than the cutof' level used in other assays (e.g.,

the Abuscreenr assay uses a 100 ng/mi cutoff level). The purpose of this discussion is to evaluate whether or not this 300 ng/ml cutoff level is adequate. Any assay that provides results comparable to those produced oy the EMIT system using a 300 ng/ml cutoff level should be considered adequate.

As with barbiturates, immunoassay tests for benzodiazepines are generally not specific to a single drug. They are designed to test for benzodiazepines as a class of drugs. The assays typically test for the presence of a metabolite that is common to many benzodiazepines. For example, both the Abuscreenr assay and the EMIT assay test for oxazepam. Cross-reactions further increase the breadth of the testing capabilities because they cause the presence of a number of benzodiazepines in a specimen to produce positive test results.

For example, 8 ng/ml of diazepam in a specimen will produce the same results as 5 ng/ml of oxazepam when using the EMIT test. In one case, a cross-reaction is actually more sensitive than is the test for oxazepam itself.

The presence of 4.5 ng/ml of N-desmethyldiazepam will produce results comparable to the presence of 5 ng/ml of oxazepam. The degrees to which the metabolites of several benzodiazepines cross-react with the EMIT system are shown in Tables 3 and 4.

The standard cutoff levels used when conducting screening tests for exazepam are 100 ng/ml for the Abuscreenr assay and 300 ng/ml for EMIT assay. As explained below, the higher of these cutoff levels (300 ng/ml) is adequate when testing for benzodiazepines provided that the antibody used in the assay reacts with conjugated metabolites (as is the case with the EMIT assay), and provided that the assay can be expected to detect a range of benzodiazepines and metabolites through cross-reactions (as is the case with the EMIT assay).

12

9 9 TABLE 3. EMIT Response to Benzodiazepines and Their Metabolites

• Approximate concentration.in urine which can be expected to -

Substance produce a result equivalent to

.5 units of oxazepam N-desmethyldiazepam 0.45 0xazepam 0.5 Diazepam 0.8 Hydroxydiazepam 1.1

• Adapted from Budd, R. D. & Walkin, E. (1980). Mass screening and confirmation of diazepam in urine by EMIT-thin-layer chromatography.

Clinical Toxicology, 16(2),204.

TABLE 4. Relative Sensitivity of Benzodiazepines and Benzodiazepine Metabolites to EMIT Benzodiazepine Metabolite Assay

• Approximate concentration in urine which can be expected to Benzodiazepine produce a result equivalent to

.5 units of oxazepam Chlordiazepoxide 1.5 i Clorazepate 2.0 '

N-desalkylflurazepam 0.5 Desmethylchlordia: epoxide 3.0 Diazepam 1.5' Flurazepam 100.0 3-hydroxydesalkylflurazepam 1.0 i Hydroxyethylflurazepam 75.0 j Nordiazepam 0.5  ;

• Adapted from Polkis, A. (1981). An evaluation of EMIT-d.a.u.

benzodiazepine metabolite assay for urine drug screening. Journal of Analytical Toxicology, }, 175.

I I i

13 j i

1

As discussed in Section 3.2, t'.re is substantial evidence indicating that consumption of therapeutic doses of benzodiazepines can lead to impainnent, and that such impairment can have significant adverse effects on work performance. Thus, it appears appropriate to set the cutoff levels for benzodiazepines low enough to detect therapeutic drug use, if the testing technology can support such cutoff levels.

An immunoassay ' sting for conjugated oxazepam using a 300 ng/ml cutoff level should be capr .e of detectin In a study described by saden, et al. (g therapeutic use of diazepam.1980), a patient who was receiving diazepam daily had a urinary concentration of oxazepam (free and conjugated) of over 14,000 ng/ml. Clearly, a 300 ng/ml cutoff is adequate to detect this use of diazepam. It should be noted, however, that the concentration of free oxazepam in the sample was only 32 ng/ml, and the total concentration of free benzodiazepines and metabolites was only 145 ng/ml. Thus, while a 300 ng/ml cutoff wit 1 an assay that detects conjugated oxazepam is perfectly adequate, an assay that only detected free metabolites would have to use a much lower cutoff level (i.e., as low as 25 or 30 ng/ml if testing for free oxazepam).

As explained previously, the cutoff level used in the confirmation test should be substantially lower than the cutoff level used in the screening test.

Thus, an assay that detects only free metabolites would require a cutoff level so low that it may challenge the reliability of both the screening cssay and the GC/MS confirmatory assay. Any assay that does not detect conjugated metabolites should be used only if a process is used to recover free drugs and free metabolites from the conjugated substances in the urine.

It has been demonstrated that the EMIT system with a 300 ng/ml cutoff level will also detect alprazolam, although it appears that it will not detect therapeutic use of triazolam. Fraser (1987) describes an experiment that tested the ability of the EMIT urine screen to detect therapeutic use of alprazolam and triazolam. The results indicate that the assay will detect therapeutic use of alprazolam, but that it will not reliably detect the use of triazolam at therapeutic levels. As stated previously, alprazolam is the benzodiazepine that is second to diazepam in frequency of emergency room drug mentions. This suggests that it is important that the benzodiazepine screening test be capable of detecting alprazolam use.

Fraser (1987) t; sed the standard procedure provided by SYVA Company when conducting the tests and obtained urine specimens from patients being treated with benzodiazepines. Urine specimens from 27 patients receiving alprazolam were analyzed, and 24 of the specimens tested positive. The three specimens that tested negative were provided by patients who were receiving small doses (0.25 mg/ day) of the drug. Urine specimens from 19 patients receiving 0.25 mg to 0.50 mg of triazolam were also tested with the EMIT system; 11 of these tested negative.

Abuscreenr can also be expected to detect alprazolam use. The cross-reaction value of alprazolam when Abuscreenr is used is 72 percent (Roche Diagnostics Systems,1987); that is,100 ng/ml of alprazolam produces a reaction comparable to 72 ng/ml of oxazepam.

14

1 The information presented here suggests that an immunoassay test that detects oxazepam glucuronide, using a 300 ng/ml cutoff level,, will provide a high I probability of detecting use of benzodiazepines. Immunoassay levels capable '

of testing for exazepam glucuronide.at this level are available. Assays that are sensitive only to free metabolites should be used only after a process such as hydrolysis has been used to extract free metabolites. Since the purpose of benzodiazepine testing is to detect the use of any benzodiazepine q drug, cross-reactions that increase the ability of the assay to detect a wide 1 range of benzodiazepine drugs are useful. Thus, any assay that is specific to j a single benzodiazepine or only a few benzodietepines is not recommended. '

3.3.2 Confirmatory tests for benzodiazepines Confirmation testing for benzodiazepines can be done with GC/MS, although i there are some special concerns when testing for benzodiazepines. First, care must be taken to ensure that the metabolites identified with the immunoassay will chromatograph when using GC/MS techniques (Hawks & Chiang,

{

1986). Second, GC/MS has not been routinely applied to benzodiazepine analysis and there are few reports on the technique (Critical issues in Urinalysis,1988). Third, the fact that most benzodiazepine metabolites are present as glucuronide conjugates complicates GC analysis. For example, Tjaden, et al. (1980) explain that because of the high polarity of these conjugates, the assay of diazepam using high performance liquid chromatography requires the use of a different phase system and a modified extraction procedure or an enzymatic hydrolysis to obtain free benzodiazepines. Because of difficulties in extraction of the conjugates, these researchers chose to hydrolyze the conjugates. This is also the procedure used by Joern and Joern (1987) when they perfomed dual-column, dual-nitrogen detector gas chromatograph analysis of urine specimens for alprazolam. However, when the proper GC column technology is used, at least some benzodiazepines and benzodiazepine metabolites (e.g., diazepam and  ;

N-desmethyldiazepam) can be chromatographed without performing these chemical i transformations (Foltz, et al., 1980).

Althougn GC/MS has not been extensively used in benzodiazepine analysis, gas chromatography with electron capture has been widely applied to benzodiazepine analysis and is an excellent method of detecting most common benzodiazepines. l This technique may not, however, be the optimal technique for the detection of  !

some of the newer benzodiazepines (Critical Issues In Urinalysis, 1988). A chromatographic technique exists for the detection of two of the newer benzodiazepines, alprazolam and triazolam (Joern & Joern,1987). The analysis for these drugs uses a dual capillary column, dual nitrogen gas chromatographic system. High performance liquid chromatography is the preferred technique for testing for chlordiazepoxide (Critical Issues In Urinalysis,1988). A combination of these GC techniques with MS should be used for confinnation of initial positive benzodiazepine test results. l Confirmatory tests for benzodiazepines should be performed using a GC/MS test for exazepam glucuronide. A positive test result should be considered verification of benzodiazepine use, and additional tests are recommended to ,

determine, if possible, the specific benzodiazepine used. '

15

)

^

For two reasons, the confirmatory test should use a cutoff level lower than the cutoff level used in the screening tests. First, due to cross-reactions, a specimen could have a concentration of oxazepam lower than the concentration used as o screening-test cutoff level and still test positive.

Second, some portion o# the metabolites in the specimen may be lost in the process of sample prer.aration. For example, in an analysis using high-performance liquid chromatography, described by Tjaden, et al. (1980),

only 88.8 percent of the oxazepam in samples was recovered for ~ analysis. For these reasons, a confirmation test cutoff level should be substantially lower than the cutoff level used in the screening test.

Gas chromatography / mass spectrometry can reliably detect benzodiazepines end their metabolites at the 150 ng/ml level. When performing confirmatory tests procedure  !

used by Joern and Joern (1987) were as follows:for alprazolam alprazolam, 11 ng use, the detection limits 3-hydroxymethyl-5-methyltriazolyl chlorobenzophenome (3-HM), 12 ng/ml; and a-hydroxyalprazolam (a-OH), 10 ng/ml. Foltz, et al. (1980) state thct ~

am can be measured in blood samples with GC/MS at 1evels metabolites of diazep(These authors also state that the analytic procedures as low as 5 ng/ml.

they describe for blood analysis can be applied to other specimens, including urine.) Thu:, it appears that GC/MS analysis can detect benzodiazepines and ,

their metabolites at levels well below 150 ng/ml. However, because GC/MS  !

analysis has not been routinely appliec! to urinalysis for benzodiazepines, and I because relatively little information is available on this subject, it would be prudent to set the cutoff levels well above the limits of the technology in '

order to ensure reliable results. The 150 ng/ml cutoff appears to be adequately high to ensure reliability, and adecuately low to minimize occurrence of unconfirmed positives when benzociazepines are present in the ,

specimen. j In addition to testing for oxazepam, it would be beneficial to test for "

specific benzodiazepines or metabolites that can be used to specifically identify a given benzodiazepine. Because users of benzodiazepines develop .

tolerances to the drug, they may obtain multiple prescriptions for different '

benzodiazepines from several doctors (Hughes & Brewin, 1977). Tasting urine for specific benzodiazepines can detect this pattern of substance abuse.

It is impossible to identify the use of'some benzodiazepines through urine testing, because the drugs themselves are also metabolites of other benzodiazepines (e.g., oxazepam). Also, the set of benzodiazepines for which tests will be conducted must be limited to a manageable number, since over 2,000 benzodiazepines derivatives have been synthesized (Blum, 1984).

Unfortunately, it also appears that it is impossible to test specifically for diazepam use. Intact diazepam has not been reported in more than trace amounts in the urine (Foltz, et al., 1980), and, as shown in Table 2, the abundant metabolites of diazepam (desmethyldiazepam and oxazepam)-are common metabolites of several benzodiazepines (e.g., diazepam, clorazepate, halazepam,andprazepam). In spite of this, some assays can be perfomed to identify specific drugs, and it is recommended that these assays be performed.

16

Joern and Joern (1987) describe a chromatographic method that can detect alprazolam use by testing the sample for alprazolam and for metabolites unique l to alprazolam--a-OH and 3-HM. The technique can alst, be used to test for the l presence of a-hydroxytriazolam as a means of detecting triazolam use. Gas chromatography /niass spectrometry assays have been developed for detecting ,

desmethyldiazepam, and the presence of this metabolite would indicate tht.t an 1 individual with a prescription for oxazepam or locazapam was using other I benzodiazepines.

The tests for specific drugs and specific metabolites should use the same cutoff level as is used when conducting the exazepam confirmation test. If oxazepam is detected, and a specific benzodiazepine is not identified, the  !

test result should still be considered positive, but it may be useful to also '

identify the specific benzodiazepine taken.

In summary, GC/MS confirmation of positive benzodiazepine initial test results should hydrolyze specimens to obtain free drugs and free metabolites, or use a GC technique that can reliably chromatograph the conjugated q substance. Analysis should be conducted for the following substances with a 150 ng/mi cutoff level: oxazepam, desmethyldiazepam, alprazolam, a-OH, 3-HM, and a-hydroxytriazolam. Detection of any of the substances should be considered confirmati o of benzodiazepine use. In cases were an employee has I a doctor's prescription for a benzodiazepine drug, the test results should be )

forwarded to the Medical Review Officer. If the Medical Review Officer i concludes that the test results show that the employee ingested a i benzodiazepine other than the one prescribed, the test results should be l considered positive.  !

i

4.0 CONCLUSION

I l

The information presented here suggests that if employce drug testing d programs are to ensure that the workplace is free of the effects of drugs that can endanger the workers' and the public's health and safety, then the testing programs should include tests for barbiturates and benzodiazepines.

The extent to which these drugs are used, and their impairing effects warrants this concern and an adequate technology exists for practical and reliable urinalysis for these drugs. Tne screening test and confirmation test cutoff levels recommended for these drugs are presented in Tables 5 and 6. j l

17

l TABLE 5. Proposed Initial Test Cutoff Levels Specific drug or metabolite Cutoff. level Drug class for which test is conducted in ng/ml Barbiturate Secobarbital 300 l l

Benzodiazepines Conjugated 0xazapam 300 l

I TABLE 6. Proposed Confirmatory Test Cutoff Levels Specific drug or metabolite Cutoff level Drug class for which test is conducted in ng/ml Barbiturate Secobarbital 300 Thiopental - 300 Amobarbital 300 Pentobarbital 300 Secobarbital 300 Aprobarbital 300 Hexobarbital 300 l Benzodiazepines* 0xazapam 150 Desmethyldiazepam 150 Alarazolam 150 a-1ydroxyalprazolam 150 3-HM 150 a-hydroxytriazolam 150 ,

Conjugated drugs and metabolites.

i

}

i 18 i

)

5.0 REFERENCES

53 FR, No. 69, April 11, 1988. Department of Health and Human Services.

Mandatory guidelines for federal workplace drug testing programs. Federal .

Register.  !

l 53 FR, No. 184, September 22, 1988. Nuclear Regulatory Commission. Fitness- I for-Duty Program. Federal Register. )

53 FR, Part 6, November 21, 1988. Federal Railroad Administration. Random drug testing; amendments to alcohol / drug regulations. Federal Register. ,

i Barnes, V., Fleming, I., Grant, T., Hauth, J., Hendrickson, J., Kono, B.,

Moore, C., Olson, J., Saari, L., Toquam, J., Wieringa, D., Yost, P.,

Hendrickson, P., Moon, D. & Scott, W. Fitness for Duty in the Nuclear Power Industry: A Review of Technical Issues. NUREG/CR-5227, PNL-6652, BHARC- I 700/88/018. Springfield, VA: National Technical Information Service, 1988. )

Bassuk, E. L., Schoonover, S. C. & Gelenberg, A. J. (1983). The practitioner's guide to psychoactive drugs (2nd ed.). New York: Plenum Medical Book Company.

Bernheim, J., Michiels, W. (1973). Effets pychephysiques du diazepam (Valium) et d'une faible dose d'alcool chez l'homme. Schweiz. Med.

Wochenschr. 103, 863-870. I Billings, C., Gerke, R. & Wick, R. (1975). Comparisons of pilot performance in simulated and actual flight. Aviation, Space and Environmental Medicine, l 46, 304-308. j Blum, B., Stern, M. H. & Melville, K. I. (1964). A comparative evaluation of the action of depressant and stimulant drugs on human performance.

Psychophamacologia, 6_, 173-177. ]

Blum, K. (1984). Handbook of abusable drugs. New York: Gardner Press, Inc.

Bond, A. & Lader, M. (1973). The residual effects of flurazepam.

Psychopharmacologia, 32, 223-235.

Brecher, D. M. & Editors of Consumer Reports. (1972). Licit & Illicit i Drugs. Boston, MA: Little, Brown and Company.

Budd, R. D. & Walkin, E. (1980). Mass screening and confirmation of diazepam in urine by EMIT-thin-layer chromatography. Clinical Toxicology, 1_6(2),204.

Critical issues in urinalysis of abused substances: Report of the substance-abuse testing committee [S;ecial Reports]. (1988). Clinical Chemistry, M(3),605-632.

19 i

4 Epstein, L. C. & Lasagna, L. (1968). A comparison of the effects of orally administered barbiturate salts and barbiturate acids on human psychomotor performance. The Journal of Pharmacology and Experimental Therapeutics, 164(2),433-441.

Foltz, R. L. , Fentiman, A. F. , Jr. & Foltz, R. B. (1980). GC/MS Assays for Abused Drugs in Body Fluids: Research Monograph Series #32. Rockville, MD:

U.S. Department of Health and Human Services.

Frank, R. S. (1987, November / December). Drugs of abuse: Data collection

! systems of DEA and recent trends. Journal of Analytical Toxicology, 11(6),

237-241.

Gaston, M. t Walker, N. R. (1981). Psychophamacology. In Premratory Course for the National and State Licensing Examinations in Psyc1 ology.

Berkeley, CA: Association for Advanced Training in the Behavioral Sciences.

Ghoneim, M. & Mewaldt, S. (1975). Effects of diazepam and scopolamine on storage, retrieval and organizational processo in memory.

Psychopharmacologia, M , 257-262.

Ghoneim, M. , Hewaldt, S. & Thatcher, J. (1975). The effect of diazepam and fentanyl on mental, psychomotor and electroencephalographic functions and their rate of recovery. Psychopharmacologia, 44, 61-65.

Goldstein, A., Searle, B. & Schimke, R. (1960). Effects of secobarbital and of d-amphetamine on psychomotor performance of normal subjects. Journal of Pharmacological and Experimental Therapeutics, 130, 55-58.

Grif fiths, R. R. & Sannerud, C. A. (1987). Abuse of and dependence on benzodiazepines and other ar.xiolytic/ sedative drugs. In Meltzer, H. Y.

(Ed.),Pychopharmacology: The third generation of progress. New York:

Raven Pren.

Hanson, E. J. (1986). Drug abuse testing programs gaining acceptance in workplace. C&EN, June 2, 7-14.

Hawks, R. L. & Chiang, C. N. (1986). Examples of specific drug assays. In Hawks, R. L. & Chiang, C. N. (Eds.), Urine Testing for Drugs of Abuse, NIDA Research Monograph 73. Rockville, MD: Department of Health and Human Services, National Institute on Drug Abuse.

Healy, T., Robinson, J. & Vickers, M. (1970). Physiological responses to intravenous diazepam as a sedative for conservative dentistry. British Medical Journal, 3, 10-13.

Holzmai. . Levy, D., Uhlenhuth, E., Proctor, L. & Freedman, D. (1975).

Smooth pursu't eye movements and diazepam, CPZ, and secobarbital.

Psychopharmacologia, 44, Ill.

Hughes, R. & Brewin, R. (1979). The tranquilizing of America: Pill popping and the American way of life. New York: Harcourt Brace Jovanovich, Inc.

20

Hutt, S., Jackson, P., Belsham, A. & Higgins, G. (1968). Perceptual-motor behavior in relation to blood phenobarbitone level. Developmental Medicine and Child Neurology, J0, 626-632.

Irving, J. (1988). Drug testing in the military--Technical and legal problems. Clinical Chemistry, 34(3),637-640.

B., Foltz, R. L., Cook, C. E., Bursey, J. T. & Willette, Irving,(J.,

R. E. 1984,Leeb, July / August). Evaluation of immunoassays for cannabinoids in urine. Journal of Analytical Toxicology, 8, 192-196.

Jain, N. C. , Budd, R. D. , Sneath, T. C. , Chinn, D. M. & Leung, W. J. (1976).

Mass screening and confirmation of barbiturates in urine by RIA/ Gas Chromatography. Clinical Toxicology, 9(2),221-233.

Joern, W. A. & Joern, A. B. (1987, November / December). Detection of  !

alprazolam (Xanax) and its metabolites in urine using dual capillary column, dual nitrogen detector gas chromatography. Journal of Analytical Toxicology, JJ,247-251.

Maistha, K. K. (1977). Guide to urine testing in drug abuse prevention and multi-modality treatment programs. Journal of Chromatography, 141, 145-196. I Kleinknecht, R. & Donaldson, D. (1975). A review of the effects of diazepam on cognitive and psychomotor performance. Journal of Nervous and Mental Disease, 161, 399-411.

Landauer, A., Pocock, D. & Prott, F. (1974). The effect of medazepam and alcohol on cognitive and motor skills used in car driving. l' Psychopharmacologia, 37, 159-168.

Lehembre, J. (1963). An experimental study of the effect of psychotropic drugs on mental function. Nederl. T. Geneesk, 107, 1227.

Liljequist, R., Linnoila, M. & Nattila, M. (1978). Effect of diezepam and chlorpromazine on memory functions in man. European Journal of Clinical  !

Pharmacology, J3, 339-343.

Linnoila, M. & Mattila, M. J. (1973). Drug interaction on psychomotor l skills related to driving: Diazepam and alcohol. European Journal of l Clinical Pharniacology, 5, 186-194.

McKay, A. & Dundee, J. (1980). Effect of oral benzodiazepines on memory.

British Journal of Anesthesiology, 52, 1247-1257.

< Mellinger, G. D. & Balter, M. B. (1986). Prevalence and patterns of use of psychotherapeutic drugs: Results from a 1979 national survey of American adults. In Rickels, K., Case, W. G., Schueizer, E. E., Swenson, C. & Fridman, R. B., Low-dose dependence in chronic benzodiazepine users: A preliminary report on 119 patients. Psychopharmacolooy Bulletin, 22(2),407-41S.

21

_ _ _ - _ _a

i, Petersen, R. & Ghroneim, M. (1980). Diazepam and human memory: Influence on acquisition, retrieval, and state-dependent learning. Progress in Neuro-

.Psychopharmacology, 4, 81-89.

Poklis, A. (1981, July / August). An evaluation of EMITr-dau benzodiazepine  !

metabolite assay for urine drug screening. Journal of Analytical Toxicology, 5, 174-176.

1 Radford, L. R., Rankin, W. L., Barnes, V. E., McGuire, M. V. & Hope, A. M.

(1983). Drug and alcohol abuse: The bases for employee assistance programs in the nuclear industry. NUREG/CR-3196. Washington, DC: 'U.S. Nuclear Regulatory Commission.

Rickels, K., Case, W. G., Schweizer, E. E., Swenson, C. & Fridman, R. B.

(1986). Low-dose dependence in chroaic benzodiazepine users: A preliminary report on 119 patients. Psychopharmacology Bulletin, 22(2),407-415.

l Roche Diagnostic Systems. (1987). Abuscreen: Radioimmunoassays for l ben:odiazepines, Item 43343 - 100 tests, Item 43344 - 2,500 tests (package j insert). Nutley, NJ: Roche Diagnostic Systems, Division of Hoffmann-La Roche, Inc.

Roche Diagnostic Systems. (1986). Abuscreen: Radioimmunoassays for barbiturate (product brochure). Nutley, NJ: Roche Diagnostic Systems, Division of Hoffmann-La Roche, Inc.

Runde11, O. H., Williams, H. L. & Lester, B. K. (1978). Secobarbital and 1 information processing. Perceptual and Motor Skills, 46, 1255-1264.

Sunsaine, I. (1988). Preliminary tests for drugs of abuse. Clinical Chemist _ry, M(2), 331-334.

Tansella, M., Zimmemann-Tansella, C. & Lader, M. (1974). The residual I effects of n-desmethyldiazepam in patients. Psychopharmacologia, 38, 81-90.

Tjaden, U. R., Meeles, M. T. H. A., Thys, C. P. & Van der Kaay, M. (1980).

• Determination of some benzodiazepines and metabolites in serum, urine and l saliva by high-performance liquid chromatography. Journal of Chromatography, 181, 227-241.

Winek, C. L. & Esposito, F. M. (1985). Blood alcohol concentrations:

Factors affecting predictions. Legal Medicine, 34-61.

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Fhness For-Duty Programs; Fir.al Rule R and Statement of Policy Y-R w ,

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24468 Federal Regisier / Vd. 54. N).106 / Wsdn;eday, June 7.1939 / Ruhe and Regulati:ns NUCLEAR REGULATOMY EFFECTrvt DAts: July 7.1980. noa Pmposed Rulemaking (NPRM).The NRC *. '

COMMISSION information coDection requiremtetts in -- cenaldered all comments submitted in a this final rde do act become efractive thna!y manner in response to the NPRM .

until they an approved by the OfBea of and comments and questions received 10 CFM Parts 2 and 26 ,

Management and Budget (OMB).no during a pubbe meetmg on the draft rule {

pust 31so-Acs1 NRC will announce the date that the held by the NRC.The comment period 1 information coUection requinments are for Ibe NPRM closed on November 21.

Fitnese for Duty Programs approved in the Federal Register, isse. i Post PuerTNtst IssPCsts& Aft 0st 00errAcT: Comments were received from the  !

cincy: Nuclear Regulatory Loren Bush. Reactor Safeguards Breach, general public; from workers in nuclear Commission. Division of Reactor Inspection and power psants: from union locala, cersoec Final rule and statement of Safeguarda. Office of Nuclear Reactor oatsanal and international headquarters policy. Regulation. U.S. Nuden.r Regulatacy of enfons: from the Nudear Management Commission. Washington. DC 20556, r.nd Resources Counci!(NUMARC). 55 svuuAar:ne Nudear Regulatory Telephone:(301) 492-0944 power teactor licensees, severa! non- i Commission (NRC)is issuing its power reactor licensees: from several i suPPsmTMrY estromuATsooc vendor and contracter organizabona:

regulations to require licensees  ;

authorized to construct or operate Background and from other interested parties.  ;

nudear power nactors to implernent a On September 22.1988. the Nuclear Dars were several major issues fitness.for-duty propam. The general Regulatory Commission pubhahed in the prisented by the commenters.There an objecuve of this propam is to provide Federal Register (53 TR 36795) proposed eummarized along with the NRC reasonable assurance that nudear amendments that would tenue a new responses in the sections that foUow. An power plant personnel are rehable- reFu!ston to CTR part 28. Titnese4cr. overview of these comments is provided trustworthy, and not under the inDuence Duty Propam." which would requir, in this ecction.

, cf any substance. legal or tilegal, or licensees who an author! zed to operate Of prhary concern to roughly half.of 1 mentally or physicauy impaired from nuclear powerteactors to implement a aD commenters was the requirement for I eny cause, which in any way adversely fitness-for duty program that met rsadom drug tes ' . Although these ,

affects their abtbey to safely and uniform standards estabbsbed by the commenters dearl objected to the use  !

cc=petent!y perform their duties. A rule to promote the public bealth and of iUegal drugs wi the nudear power Ltness.for-duty propas developed safety, indutry, this provision of the proposed under the requirements of this rde is Interested parties were invited to rule drew a strong negabve reaction intended to create an environ =ent submit commente in connection wrth the from private citizens. labor unions, and which is free of drugs and the effects of proposed amendments within 60 days workers covered by the proposed rde. l such substances. after publicaoon in the Federal Registar. Vigorous objections were stated based The Com=!ssion is taking this action There were a total of 3.073 comments on the perceptions of invasion of i to significantly increase assurance of made by 378 responders sad attendees privacy and confhet with Constitutional pubbc he alth and safety.The 6cientific dunas a public meeting held on October rights resdting from the drug tesung evidence is condusave that significant 17.1988. A detated summary and provision.Many of these commenters decrements in cognitive and physical analysis of the comments are contained ' streseed that the level of substance task performance result frc:a in NUPIG-1154. Titness.for-Duty in the abue in the nuclear power industry is intoxication due to illicit drts abue. as Nuclear Power Industry: Responses to insuf5cient to justify such strong action, j weU as the use and misvae oflegal Pcblic Comments." Upon consideration that nuclear power plant workers have demons *reted their rebability over the j substances. Given the addictive and of the comments received both in l impairing nature of certain drugs, while writir;g and during the public meeting years, and that it is both demoralinns l l recogunna that the presence of drts and other factors involved, the Noclear and insulting to require proof of their ,

I I metabobtes does not necessarily relata Regulatory Comaussion has adopted the reliability through random drug tests.

directly to a current != paired state the proposed regulations, with certain Other issues were raised concerning the l

presence of drugs does strongly suggest mo&f) cations generaDy set forth below. legality of the proposed rde,includmg  ;

the likehbood of ps st. present. or future Copies of NUREG-1354 may be its relationship to labor laws and state i impairment affectmg job activibes. In purchased from the Superintendent of andlocal statutes.These objections are ed6 tion. the NRC bebeves that the Documents. U.S. Government Printing suanmarized more fuUy in the foUowing rebsbibty, intepnty, and trustworthiness Office. P.O. Box 37082 Washingtort. DC sect ons.

of persons work-mg within nuclear 20Cr1>7082. Copies an also available Those commenters opposing random power plants is important to assure from the National Techrdcal Information testing were usuaDy supportive of one et 4 public bealth and safety. Since there is Service. 5285 Port Royal Road, more ahernatives. Foremost among  ;

cr underlying arsumpton that workers Spr4 field. Virginia 22181. A copy la thema was a cortbination of supernsor wiU abide by the licensee's policies and also available for public inspection and/ behaviors) observation and for-cane procedures, any involvement with illegal or copying at the NRC Public Docume:t testing. While a few commenters ,

drugs shows that the worker cannot be Room.1120 L Street NW lower level of opposed chemical testing of any type.

rebed upon to obeylaws of a health and the Gelman Buil&ng. Washington. DC. most of the commenters, including umen safety nature,in6cs ting that the organizations and members expressed j Comments and Responses to the egport for fmue 1% Preaaess in&vidual may not scrupdously follow rigorous procedural requirernents with Pr Pos*d Rula authorization testing also received some the integnty required in the nuclear LO Genere10meriew swport and very little opposition.

pow er industry to assure public beslth A ma)or criticism of the proposed rde Summary of Comments end safety. in ad& ton, the Cornm:ssion was raised concerning whether the NRC is revising its enforcement policy to The NRC received YB comment was basing the rule on concerns about reflect this fitness-for-duty rue. letters in resporae to the Notce of on-thedob impairment or en concerns e

m Federal Esgister / Vol. 50 No. *10B / W;dneeday. June 7.1989 / Rules an ons 2469 cbout basic .-tayu mbability, or evez s:poe more teneral comoerns with pebbe read in a 6 perosas p-ine rate. i corahty. Soc.e cornmenters expressed Anoebu bcensee reported that such as ran&rn d o approuestely 2 percent of on connern over an g testing. were based the opinao that oK-ane devg ene a?ould theiob impairment 1

r of be a caccers af the NRC, and that approumately 5,000 nesta d enspioyees or were bued on concern over the l the NRC abrmld not reqmte e testag and cratrao6 ors were positew.179 rehabbty and trustworthiness of the I

pregam dat is not d recd 3orsented so persons 6ese$ postive for cacae. and worker.One set of commenters detschag currea t inpaun. eat that the dNge P.wolved sock 2ded PCP. er. pressed the atmngly held beiref dat In cantraat, mos h:.easm.s and me.rijaana, c ,curw. ampte tammes, mandstory chet:kal testing is ecly NUMARC prended peneral support for barbeurein. alcohol a nd other drugs. appropnate s'there is evit ience to NotonaP s uggest that workers are impaired oc the  !

the pronsion for rundcm nesura, impluoe:y. amang bconsees vie av.g it as as effectie daterrent to .ung randmo d.w tesarts p. Comnrterrs also ets ted tha t. l i

the use c'iuega] dry;sJioue6 cr. they propama, an averste of 4 roed 1 orcause armalyras does not measure percent of the random tests an poutive. imperment, the thtector, of ilhet drug  !

6d chicci to the posaib ty that they would be too severe 4 hat.:ted by the la ik Aret asce taanths of 1968 there ase throngb artnalysis is irnlevant to {

pronaiou thrst hcerne tuting propsms were 3&7 evec*s involvinF drvps aid the safe operation ofmoclear power l alcohol reported to the NRC. These plank, and thas abould not be an must follew the HMS Guideh They wasted pcster f"niNht) 6 the events included Lcensee and contractor element of the raie. Two ecmmeters employe es b all organir.s t>onal leveh requerted further evidence reganhas the estahWest cJcat<dilenels and the and 6acjphnes. Of particular concern to impact of cif theiob drug use or, job i panel cJ drgs to be cotwei Most of the i beenseu expressed cancern eve.t the the NRC rs thet durmg the last year performance.One commente stated test =s rate to be required by the rn, 028) 12 bessedreactor opersto's that, akborgb a @ntrve tricalysis test l in6cating that it should be at an a nd w.se reporaed u being invoked svish tesult does not estabbsb whethet an rate equivalerJ to or less than 200 drugs and tao w are repcrtad a: abustns inhdual was ucpared at the tune that percent of the workforce subie:t to akd cl mane e6ece oslag tbsee the sample was g vea it allows the teetzr4 They fretter eyected to a.:y e,bstar.ces wl.;c on duty, ercplayer to detera: ice drug use and provisions that wmad erke the btessee The uccher af @Wt ewents condede ressacably that the poeniary repo td to the NRC tha tinscAe d.y exists fw future impJrme=1 schad can use' stance pregam semce=: toresponsMe use or atne hasforpmvitng been it. creasinge seyee impect werkplace safety, coctractor persorcel and objected to the dr-cally ainae 2eM. The.te was a +4 Other enmmters coted thet extent and type ef trairJng required by pertcJ.! increase 6 reported esents im7ainment is not the safe issue. A the propored rule.Other tsrues raised between uc and sea A ?J pt cent fundamental concert of d up sk Se end cert dr' ail tm these irsues are increue was crpmed in 257. This predominandy rdstes to de nhabitt prended m the se:ti:=s that fonow. bcrtame apptan to be ee: rand to the and trutwer* W be order do g' ,

ez;hasis on f=.eu far duty by r-dear knowicpty uses dngs arbch are suegal pow er b;.acan.s ao d the recent4 tensed Ses erst commar:ters. inch 6ng 22 Sur cy of Com:nents sategued reporttr.a requirex.ena theI NUMARC. noted the importance of A Mr d ca=. neances ra. sed the o%Metedy>e;nta. heres thecontair.ed an eccess estbonmNw:ex;Oct pregrnidance

• am, and br report isss.e thet thue o.as msa!Lcwet 6cnass may a stated that the use ofiliega3 c!n:gs on or  !

evidence d a tw a bae protk m ic the "" O O# qbe an ir.:hca too of a.c oudear pow er inchat > ao p:tr') the *'d'n=e oW probler.: a t mclear pow a p!anu-eff the @ codd e6ersely affeet the safety of eac'aearpower plant need for the rde SesersJ cc:sterr.ters Taue dau prowde adLcacra operations, cr adversely reneet en the ,

66cated tbat the NRC hes lailed to " d * *W n CI dr*S I integrity, echtddrty and tnistworthanets establab a factmJ ra cord regardag the use Wse employed in 6e madear e arJ utent d the dry a y powu inchty ta npport ita nes.d br a of m oders with esencarted access who problem. Also mentioned wee the .es - an respene;ble for andear power plan t safety.

opinion that the sp arent letk of Ea smry su .rnant b 6e uniformily among n;uclear etihty protect the A c= he of cacc> eaters objev:ted to P"u' h""4 "80 **N'}'y tN'c MC must spenhe word =g m the pmposed rule pmpass is not sufbrae nt justica t.on 8 N 'D*'C '

related to smpormer17hese by the NRC for the ruk. v d' 0 88 " d 8 P0"*f P'"8 an ret hmune ta em comunesters stased that the tern 1.2 Summary of Responses insdated frar dry ase or ahuse d "tmpsinnent"as areprecise and subject Akhoegh drug cae amang nudess substances that may a.flect safety- to canocs We'-yutsn Ano'M p,,,.er piant wankers moe3 cet be as N aO3b Pedst e.The NRC co.,,,,,,utand h fedens widesp end as an atter eepuents of the be.Lewes that any iq sae la the uclsar pow plant woh an pdid to Powu popds ten. th2 NRC daes beve preecoinLstry avanaras preetntiac and mak e a p.dg ment d wde.r impairmet.

re sa tenetm by the NRC to and that the term maws an W info:ina bac to sub arte thet ti.are is e ensun pWac safe.!y. h NRC beken es standuM'

,,dt,cier pece b the pdear powe..

that this vew is canair'e.nt wmb the pedar*==y M 6e wha @

indertry Ia werrant see frmess-for duty = can be ancasared incnesing a woness d ude.ar pow er 3.2 rde. For rsample, data provided by one Suma:aty of Responses beensee 66cetes that (7 of bc4nsees that beve. as addressed in opprasmaWy 4.acorsche tests of theWwa, dng te s*ag and The MC errrynites that (lheit drug rehabihtstion propams for smie abuse and the muscse die i emrk>yees we e pomost. 4 penent of " D'A "5-the appbcents he empk yrnent have subetam smh as W mm drugs. eed overthe counter ee6cm tens tested poetwe for dNg use.. rod 30 3 p hapraissient es Mehebility a:nplo)ces and 60costrecio s tested can tapair usorkes in the performance positis e br es,ase. Prew merse sestung of 81 S'm:5"'T CI'*''"!8 of sfest aafecy <eisted ch:taes and result crarly n/m30 contracer perwcund A nu=hr eh.mers snaes tioned 6 sg4 ed ,,oh hbercaesais proramoon af the rule. reha bihty. The scrrent:fa: er 3ecce is condas:ve that sgm8=m decrems::: "

j R 244/0 l -

Federal Registae / Vd. 34. No.108 / W:dn:sday. June 7,1989 / Rules f in cognitive and pbg* cal taak aad Regde g ,

performance result 6-intc~.ication pubbe health and safety. is considered due to illicit drug abue as well as the substuce misuse within the scope of no NRC this rule. .

use and misuse of legal cubstances. no impairment may roses g"%

NRC undentands thet. except in the ne debibtsting effects oflong-term abue, peychologieg *** man injury or ailment wbj ss case of alcobot chemical test results dodrug abue are also weU documented in '

8 4 '48 not reveal any direct information the scientific literature. and have the unacceptable safety d** M

regarding drug impairment per se. potential for affecting complex phyefcal reDects this pont% **dl'4 However, the NRC disagrees with the and cognitive functions long aftar the that trained competen .O*a

', trustworthy workers ar, pW5 argument made by commenten that, as effecte of acuteintoxication have '"8 j dissipated For example, residual effecta the safe operation of eg I* y ass' a reruit. chemical testa do not provide plants. ne Etness.for-d '* M informs tion that is nievnt to a fitnese- ofintoxice Jon tss~ persist when the ad6 esses the potentid for%* sed

for-duty program. ne NRC beheves that worker retuma to work the foUowing the nbability, integrity, and day. Hangover effects, withdrawal impairment of any kind. in W

1. 88

'#8

trustworthiness of workers within symptoma, and cycles of drug abue and substance abuse that could 188

8' nuclear power plants are important to abstinence can also reeult in decreased safe operation of euclear pn,, I' W8 "I pubbe health and safety. ne granting of rebabiDty and diligence. Off site dry use may also result in increased in the assessment of a worke a license is based on the assumption application for access ausedr' d88#

that worters wiU abide by the licensees' absenteeism. medical costs, and staffing requirements. thus having adverse background of the worker state, and criminal recorda.

W.

pobefes and procedures in all areas.

Indications oflack ofnhabibty. effects on overall workforce rehability. Similarly any we of or icve "

integrity or trustworthiness, therefore. Lfitimately, drug abuse directly and with illicit druge. on or en%N88#',

• even so far as they pertain to off-site indirectly affects actfvities which bear misuse of a!cticolandcierb$y t w'

1. s bebsviors. are relevant to the NRC*a on safety. It is therefore a reasonable not be fit for duty. provide evidence th a

' need to anure that nuclear power plants conclusion that the abue ofillicit drugs an operated safely. ne relationship and the misuse oflicit drugs pose safety The NRC recognizes that evec q' s-N between reliability, integrity and concerns in the nuclen pc wer industry nlauvely high rate of random tes impairment is by no means tc6tect in and is pre 6ctive of a Istk of reliability, and with vigilance cc the pa t at est integnty, and trustwodhinesa* g:su the case of drug abuse.Most of the licensees to detect impairmentor sM substances under consideration are ne wide rarge of potential on-the-job potentialimpairmed in 6 wegg we either physically or psycholopeally impairment is complex in esture and the existence of drug pmblems %

addictive to many in6viduals. De NRC wid dif5eult to observe. and therefore the workplace cannet be etterly sW cannot be confident of the m6viduale requires a breed approach to assure eliminated. ne undetected presenr.: g @

ability tolimit the use of addictne nudear power plant safety. In adchtien drugs can be hierred from O substances to situanons that do not to supervisory observation, other means positve test rate. However,evmtheb cdversely affect plant safety. are required to detect drug abue, FL!

concludes that the dese featurn ' 58D' Illegd drug use can reeult in on-duty psycholopeal stress, and physicalinjur7 redundancy of safety systed '81*

impairment. Then is a ponibihty that a or illness. To detect illicit drug abuse extensive training for unexpected U*

worker who uses LUegal drup off duty and the misuse of alcohol and otherequipment licit and personnel malfuncten, e' '

may be impelted from those drugs while substances, the NRC has adopted a provide reasonable anurance thatth "'I

! on-duty, and, even if the worker does mandatory chemical testing protocol for pubbe health and safetyis protected M not use drugs while on duty be or she these drugs. The rule provides for provided drug abun coetnues to W

may be impaired from eitber hangover mandatory chemical testing prior to the aspessively addrened by the oudeu or withdrawal effects anocfated with initial granting of unescorted access or industry.ne finalrule provides #

drug use. In a d6 tion to impair: tent, say assigsment to activities within the scope ressonable measures to assure that ""

illegal drug use establishes that the of the rule (l 28.24[s)l1]). Mandatory nudear power ple.nt workers can safely chemical testing is to be ccnducted on a worker cannot be rebed upon to obey laws of a health and safety nature, random basis to effectively detect and competently, and reliably perfo m their' dutes. ' 'I inacatinE that the worker also may not deter ilbcit substance abuse and misuse M ScopeofRule am be rebsble in terms of scrupulously (128.24(a){2)). For cause testing is to be 8' following the rules and regulabons that conducted after an accident in which 4.1 theSummary of Comments 88 beve been established to the nuclear contnbution of employee performance qu workplace to ensure the protection of cannot be ruled out or based on 4.1.1 Non PowerReocton cododer 85 pubbe beslth and safety. For these reasonable suspicion thet an individual Licensees. Several comments were reasons, a worker who uses illegal drugs is intoxicated or demonstrates received bebsviorfrom universities and others k" may not be sufficiently trustworthy or indicative of substance abuse or other involved with research ne ctors or otherF rebsble to perform his or her duties en involvement with drugs () 28.24(a) 3]). non-power reactors. ne commetters the job in a manner that assures public FoDewing a positive test for drug a[buse, stated that there is no need to extend f Lealth and safety. In contrast. the follow up chemical testing will be used coverage of the rule to these faciht)es "

hgitimate use oflegal drugs does not on an unannounced basis to verify because a drgrelsted problem has not automa tacaUy demonstrate this lack of abstention from the use of drugs or been demonstrated to exist sad tbst a ",

rebsbihty. However, workers who do misuse of alcohol and other licit drugs relatively minor threat is posed by these (l 2824(a)[4]). facihties to the public safety, "g use alcohol or!egal drugs are expected to use those substance s responsibly, ne NRC specs that on the-job Unbearable costs andimpracticabry t' 1 responsible use of ttese subetances in impairment is a result of many complex were also cited as arFuments sgsinst 4 e m2nner that results or is hkely to factors. and that Iztpa inclusion of these facibties in the rule. A result in on duty impairment, or complex phenomenon,irment is a depending on the few comments were recch ed from cause of impairment,in6vidual individuals involved with $NM j otherwise demonstrates a 6stigud for g etrtumstances, and the job tsok at hand bandling. makir;g the same general points. Here were no comrcents i

\

i l

Federal Regia 8ar / Val. M. No. Sob / Wodatedry. June 7.1989 / RrJes and Regaletians 24m rupporthe ef--% oeversee cf the la ahe rWe are nogeared to estia y the rule to incib ry types other das nuolaar concerns addrened by the com(mtats, tamans. In mrciama af the emaparary power toaetera. sola tranship heewers heeasees and most bocamee &c rule is presently h= wadto 4.1.2 Constructic.a r-" were nuclear pom at smectors. De NRCmay of their contractoca and eendora tb NEC does not regn!n the L- - _ to receved from twolacennaas cansMar eaterwhea the coomage of the recommendarg that the laturaape of the rule at a fcesre tune. ensure thert EAPsaaraces are rule be c.harge.d te Ir.chde plants daar.g to contract s=uckers.L prwended the construooan phase. ut cameltwesen. he NRCepses , moth.ag in the rule prohibits licensees from u .3 with the commeras reeshed stat rsodom testTJpu of Wothers 6g provisinns Cost:J Le L _ blAne ouestruction permets of the teakir4 these services sean d te to contractor "

ahmead fall asder the acope of thes rule .

proposed rule would apply to aD 4.2.5 Tecinic.c/Sqpper Crnter persons granted unescorted access to to er entent that a amarie sen progrunn is provided. Werdes ledaceung the /75C)andEmegency opercuoss

. preaected anas at operating auclet.t rocifjtyfro.s7Sm#.Re NEC believes powernmalors.Most of the r-e provishrn of the rule that pertaan to s construcuas af tes has hees added at that 11le partiedarly ireportant ht who ot}ected to this provision Sectases 36.2(b) and (c)- individcats do beve 73C and EDT commented to the e!!ect that indudlag 4.2.3 y allindividuals with amencartad aocess to NRC bebe)vor that the hechasion of allpes plant safety of Waders can be relied Coseved on to pedorm he ass protreied anse is unnecessary, and work ers with onescoeted access to the under b ency codhons est asstrted that many of theselodividuals, would require em plysically to repcut e g.; vrndors. sesetaries, derks, and pro 6ected ares withia she sonpe af the rule is the properreapanee to de threat to the TSC at the EOF. To clarify the some ear.neeriza and management consttaaed by enhstenar abuse. All soch Cor-mission's in'entions in this metier personnel, have nopo!entisi!or g.e vrords physicaDynport" han been workare he re the abth!y to carry in and precipitating er escalating a safety. distnbute impasrms e daniannes. All wind added to 126.21s) cf the rde. State and related incident. As an sternative,it morirrs can ensege e debbersee or locai representatives who may be

~

was suggested that o or ooctacter penonM"v those bcenseesocidental actaans that can land to pnsent in licensee emargency fa cnities wit snesearted ahahpes to saleer stanace er misciere located outside the protected area and access to vital p? ant anas sht de be with abe alahty o(other erarkers e subject to mrSom terting since t:ia do not beve responsibnwes cbrectly more.hmited gwp was viewed as safeb apanue and maintain the plant. r>fertir,g na ctor safety an not covere'd Akhough Fed 3ral requirements preempt by the ru$e.Disewise.these incind:ng all ed:vrdeels vrt6 the crpacity to do sig=inta=t. Safe *y.rdated State and loca) coceecos in the ares of representathes scodd be covered by ibe radaosagmal saky. is those stades thet bon ' d harau suppr as oe-mle 9 c, ',, jfR '

4.14 Ccmtractors Ms=y w== nesters unesported acoema presemoe roquarsr4 ebe NRCmay 1.iccarce employees. contractors, e r pointed eet the led of specifretty connader providtng eccess to abe vend rnpmntatwWeatm coocerning treveece vs. cer:trettar respeerWhtres Most d tbere.maNv checucal aesaas portsoas af ahe NRC's "'* M d* "

6taes>4cr duty sros mm if oo roge erted *:e7Feney facihtes enrir from beene sea, wen d the oproon that by att sadsvedma)staaes.

the omrtrwetor shodd kare fdl an alsc wt emma %a rwp anas:cident e rde 6 respensburty kr e quehfied 8tneis4or. m Case prus. ne EC beheves ched ed My to be md dey pqcum. tiet at is appropsaic to hold beenames cdy WMW capsWes.

413 TecMcolSupport Cernter mponsMe for aU woriare is erham the u.B #8tCS:.gfandMtc hennme g mars weemsed sooass. Repmentathes.%e NRC agnes mth fySQarmf Aircryency Operations racihty(DOO 5taff. Seve rs1 oorumeets whether the worknes are haemose the co=menters veo asse.ged that hTC employees oc contreater er vunder ed and repme:tstwes sadd deo be reaciend no tiss lasse stated thet permaamel. The meraer is arbsch the tune es or costrector peroorow( who subject to funess.for dcty nquirements.

asy be requrwd to et sprad to k '!SC bcensee assa os that aantractor and However.h NRC cannot allow the or BOF foe been panted moseoorted varador persacaelare ashreat to the access ofits employees to any part of requimments of the fnnese4ar duty the boenser s pudear power facibtres to access and so see aiready severed mader proput ekscriiped en abis part is left to the nde amd mead mee bc specifice'Jy be teetncted. He ffRC meeds prere;n.

snentsoned in i 26.3. Commenters Ucent.ee decretaac heereves.Per unfeeend ecoces to y upe:'y perfo tn its enwa ar. pie, mething in the tsk prohibats regu! story dvties ar.d the proper que semoraf whe ther muy cux>hmosee or Laurwees from accepenas the E tanss4or, pe-formsene cMm dWes returns non ecne:rses x pers :munal armined artth duty prormarr af ther larpe contractors pubirc em:5dsece het NRC en:pleyers

& TSC ar ROF wou6d horn to be armi se m/.ars e4 en those progame ar coveued amp'.er th e fr.ne m 4mdsey artd be tetrmdsted er bnpeded in any program. effecun s nd spoet the coqueneeem o,f muy ty than thy am responsible fer this pan. At their 4incretsuo, boensees 41.6 MICSanffandNRC nuy ales chum.e ta peeride obenmaal F'Td8tL*4 in general.& NRC expects Keprerestacrees. IAar.y enzmanters thet any NRC employee who rep:res testang and tre ning for eruptrarmar and anos,maded ekst NRC etaff should he smescor9ed eccees setD be rubtect to the veador parscanal who are y,metad chenucal testing gm.h d b NRC's eubject to the same 6tness.for.dsey unescortad access ao pro tecned areas of rest ***ev *s 6tnem 4ae de*y program.The

• • +'d"'f '"hs testice as are he,mese sesE Same thcagdct thet a plant 3ms s'ovasses moeid Ekely be Osenwse urust emm the NRCropa sruatr,es shendd be seWect used when the aostractsag orgamssa>ons obtain uneswr9ed eccess por a@ny W ben smaskiaur sesonroes to aupport estsippens.

to three seWa also. their eere Leasse4mr day p*opams. The ne NRC aimo eyees that les 4.2 Sunncary cMnponses rde isonad wqvire the kanance es proe)de a precedare to seable a contractors umst be its far d ury and unsy m AheaA.msAa2cwsandelaar cover certain of ses coatmcayrs under the Liccasaac The NRC ames as seasme at contre oser amployee t o appe al a pasitrve chesaical testing pre- af the NRC this hme ao criead ces aregte af the rimle a.lcraket er sirie ds+aruminatsome the plan The Commission exymiss lhet 75tC would emot apply a hers the emtreetor la to other lacn.t; types No mom.cataans controcaars w6o are granted =aameted admin:stenas has ewe amadug and drug socess wiU either be s obpect en the I

24472 b.

. 4 Federal Re% / Vd. 54. N2.108 / Wednesday June 71980 /

NRC's pyram, the !scensee's program.' Rules and Reguleg, or to a pcm that tbs NRC accepts as of quahBed and drugtoe wken from' edequata. Tc be condstent with ths the industry, and A i

Commwlou's intent.

• representatives"

• Inaccursciee in the testing praceas has been ddered from i 2L2 s)ofwilllead the toinnocent people bein sp*ciSc oboerv inGdmg computer.

'4piang M rula and replaced with emp(loyees." accused and punished for wronggdoin neurophysiol08dedand

• 8 6.L2

• A0 CAemicelTetW SuppoifforRandom Testirg.g. neuropsychologkg 8#

5.1 Summuy of th==mts t tirg as e dy oc pa o$ testa such u thou #4 Aluge number of comments were comptsbetsive 8tnese forwirty-progrua. egg and oog, W' e

most bcansees and NUMARC expressed '

received concarnWg the chemical testing provisiens of the rule.These pertained strong support for random testin drug abue eitherannualphysical

""'"I' be major component of an efectiv*g as a testmgoro'bs sh diesn,g #

primarily to the random testing provisions, but comments were also progrsm. This view wu shared by randommedY '*'

received concerning testing befor*

several other organ!utions, such as hrepose.h D****"*'t*e

[

grantng unescorted access, for-caus* contractors and vendcrw. as well na anany individuals. NUMARC cfted oflu program baud. strict prwided trating, and follow.up testing- industry experience that th*

The comments on random testing implementation of random testkg trained medical * "*% bl n

were directed both towed random was also cited b sIeIo$" **

testing. in genera.! and the proposed uselevels of drug pmblems. programs has typically reeulted in lowerI com of urine. lysis as a testing technique. in LocalNo.61 of theInternational seye,al commenters r particular. Comments were received th drug awueness and be$1

• asI provided statements of eneraleuppor'at Brotherbcod of CectricalWorken were more efectve d Wow l expressed support for random testing commenten atated that i i

or opposition to the ran om testing previsions Comments were Oso when it is supplemented by beha vioralemphasis on rehabihtat h observa tion. The loca! reported that the " peb received that raised westions aboutaffected workforce at the almoismore Power efective than random *ut 98 82 'asta spect5c elements of be random testingClinton Nuclear Sta tion is Company ^ gew c =mutm sugguwd ,,g statp, {

program in the propcsed r.tle. tested on a tsndom basis each day e.nd*"*8 emp;cyment wpm-sccus bug **m 511 wu adegusu. A [m j this testmg program. coucled with*

Opposition to random testingthat wasOpposition to Rnndom Testig. *g m #

e pressed by numerous indvaduala; behavioral observa ton. has epparently ed proven to be a deterrent to drug abusa. [(t ad pe 'ed ed y, g

{

3 1

seseral unions tecludes the This testmh prog tm was achievedcommenten Bmtberbood of Cepenten and joiners through co ective bargaining and is sugested t{ tat t ,,,,

be of America. the Utity Workers of considered by the local to be a valuable, &nns attuton to de unduhr4 America, and the International working practice. A check with the cann

'II of dmg abuse. nch n 6e A, P )

Broderbood of Cectrical Workers; overutlty revealed that 100 perant of tb, ed oor work environmental 300 union members as part of a letter workforce is given an unannounced test Duj' ear Power planto retber *%*'thtt wnting campaign: one utibry; and a few on an annual besis; and in ad6 tion. all de!'Ct2g andP unishing drug usera 514 Specific ChcVe other organir.aw ons. While most pe" Psons are rubject to random testing at i free workplace oppositionpositrve c to % ercent rate. Since the rate randomexpbeitly of hr Testms rupported Pmmens.Amotg thewhogoal sin Aander W, of atheaccepted drug. the tests has signi$cantly decitned, com= enters genera!!y testing as a mea,ns to achieve this was stated in the strongest terms. goal the utibty eney plan to Icwer the rates.provision for random drug testng : P']

85 513 AlterneuvestoRando Tert;ig A number of commen'.m numbu of commuts concerning the specific approach wue mccived {3, A r umber of teasons were given for  : were outhned in the proposed rule. Mary ofd opposition to random testing Many received in response commenters were speci$cally opposed request for information on alterr.atm:

to the NRth do with drug types and cut-o61

'g to random tesung as an unwarranted to random testing ne unions and ,

inission of privacy. Numemus are sumes.rced el affilia ted locals and individuals. aconoem, how e ver,sewbere. One espr

, j commenters expressed the opir. ion that number of other individuals. two had to do with the I,  ;

random testmg is an infnngement of licensees. and a few otbrr organisaNRC. tions rate of testag to lar required by the Cons titutional rights. Several questoned npressed the opinbo that tbs goals Altbo og whether the extent of the drug problemrandom testing could better be request the NRC had specifica!)y in the nuclear industry warranted such ad&ened through other methoda. ne comments on the preferred drastic sction. me}ority of these commenters stated rate of testing, ms.cy commenters felt {g.

Other reasons cited for opposition m that a combination of behavioral that the inteation of the NRC was to random testmg mcludei observation, primarily on the pet of the regiure turmg at a rate of 300 percent eupervisor, and for cause testing was annually.Most of the comments *

• The view that randam testing to .

in2ffective in schievmg the NRC's goals both at quote and e5ective. Opinions received. therefore, addressed whethers M"D m trpess.ed that behavtoral 300 percent annualrate of testmg should of deterrence and detection. be imposed. liC" .

= Better techniques are availa c.bservation and for-cause testing have 6fe I deternns and detecung drug use.ble fo' the advontages of not subjecting The 300 perunt lestag rate received *

everyoce to ceedless testa, deaktg with verylittle support among those who burdensome and expensive,*Ltness-for-duty Random testing problerns in edition toothermee supported random tesang. IP" is excessively the .

i drug abuse, and being mort likely to NUMARC anc most licer: sees stated and demeaning.

• Random testag is embarrassing stand up under review of tSe courts than that industry experience demonstn W ted

""I randem urinalysis. Most licensees alsothat many fitnesefor-duty preg ass bag bein e Random testng crvates morale supported behaviorst observation and been successful with eubstantally lower "Dd problems and may thus lead to the lossfor-cause testing. although not as a rates of testing Severalcommenten subsntute for tsadom testing. the 3 stated the opinion that a 300 percent PDP' testing rate would be unnecessanly O' ' '

9 4

~24472 Federal Registae / Vgl. 54, No.108 / Wednesday, June 7,1989 / Pules and Regulations f ,

of quali$od and drug-free workers from? A number of commenters suggested ' l NRC's propam, the Econsee's program

• speciSc observational techniques I or to a program that the NRC accepts as the industry, and -

• Inaccurades in the testing process including computer assisted adequate.To be consistent with the neurophysiological and

• Commission's intent. " representatives" willlead to innoamt people be has been deleted from i 262(a) of the -

accused and penished for einF neuropsychological testa, physical skills ,

5.1.2 Suppoif for Random tii@ tests auch as those used by law i rule and replaced with "amployees." enforcement personne!. and Ocular l While many licensees viewed rudoes u ChemloolTestly testing as only one part of a Kinetics.Others suggested that the 5.1 Summary of Comments comprehensive 8tnes&for-duty-program, annual physical be used to screen for most licensees and t VMARC axpressed drug abuse either through chemical A large number of comments were strong support for random testing as a testing or observation. Unannounced. .

received concerning the chemical testing major component of an effectiv* random medical exa*ations were also l provisions of the rule.nese pertained program.This view was shared by primarily to the random testing several other organizations, such as breposed. Sacramento Munidpal trict provided a detailed descri Utility provisions.but comments were also contractors and vendora, as well as of its program based on screening htio received conce testing befor' many Individuals. NUMARC died trained medical personnel. %is program granting neocort access, for.cause industry experience that the was also dted by a few other testing and follow.up testin8- implementation of random testing commentera. j ne comrnents on random testing programs has typically resulted in lower Several commenters proposed that were directed both toward random levels of drug problema. drug awareness and health education 1 Local No. 53 of the International were more effective deterrenta. Other l testing, in general, and the proposed use of urinalysis as a testing technique,in Brotherhood of Electrical Workers commenters stated that greater particular. Comments were received that expressed support for random testing emphasis on rehabilitation would be provided statements of general support when it is supplemented by behavioral more effective the random drug testing. '

or opposition to the random testing observatfort ne local reported that the A few commenters suggested that pre-

' prov;sions. Comments were also affected workforce at the 11hnois Power **EI "Y"N " F * * "' dru8 received that raised uestions about Company Clinton Nuclear Station is ' * '"  !

speciBc elements of t e random testing tested on a random basis each day'and g nten h^f program in the proposed rule. that this testing program, coupled with amounad or perio6c monad 5.1.1 Opposition to Random Testig. behavioral observation, has apparently testing to random testing. Finally a few I

l Oppositien to random testing was proven to be a deternnt to drug abuse. commenten suggested that the NRC .

I expressed by numerous individuals: program was achieved " direct its attenton to the underlY E8 i several unions including the Ris throughtestigJective co bargaining and is caum of drug abuse. such as the i

Brotherhood of Carpenten and Joiners considered by the Local to be a ealasble alleSed poor work environment at of America, the Utity Workers of working practice. A check with the nuclear power planta rether than at America, and the International utibty revealed that 100 percent of the detecting and punishing drug users.

Brotherhood of Electrical Workers; over workforce is given an unannounced test 5.14 Specific Changes m Random i

200 union members as part of a letter on an annual basis; and in addition, all Drug Testing Provisens. Among the writing campaign: one utlity; and a few persons are putject to random testmg at commenters who generally accepted the other organizations. While most a 20 percent rate. Since the rete of provision for random drug testmg. a explicitly supported the goal of a drug- positive tests bas signiBcantly declined, numbu of comments were received free workplace, opposition to random the utility may plan to lower the rates, conceming the specine approach testing as a means to achieve this goal 5.1.3 Alternatives to Random outlined in the proposed rule. Many of was stated to the strongest terms. Testins. A number of comments were thue commenta, such as those baning to received in response to the NRC's do with drug types and cut off levela, A number af reasons were given for request for information on alternatives opposition to rendo n testing.Many to random testing. ne unions and are summarized elsewbere. One malor commenters were specifically opposed e ffiliated locals and individuals, a concem.how ver bad to do with the to random testing as an unwarranted number of other individuals, two rate of testing to be required by the in asion of pnvscy.Numerou, licensees, and a few other organizations NRC.

d th inion that Although the NRC tad specifically expressed the opinion that the goals of ad ts g infringement of random testing could better be requested comments on he preferred Cons titutional rights. Several questioned addressed through other methoda.no rate of testing. many cou.menters felt whether the extent of the crug problem majority of these commenters stated that the intention of the t:RC was to in the nuclear industry warranted such require testing at a rats of 300 percent that a combination of behavioral d'" * *

• U "' observation, primanly on the part of the annually.Most of the commente Other reasons cited for opposition to received, therefore addressed whether a l supervisor, and for cause testing was random '.esting included: 300 percent annual rate of testing should both adequate and effective. Opinions a ne view that random testing is were expressed that behavioras be imposed.

IneIIe.tve in achieving the NRC's goals observation and for-cause testing have ne 300 pe.rsent testing rate received of dete rence and detection. the advantages of not subjecting very httle support among those who 1kttet techniques are available for everyone to needless testa, dealing with otherwise supported random testing.

deter.ng ud detectmg drug use. Smess-for-duty problems in addition to NUMARC and most licensees stated

= Random testing is excessively drug abuse. and being more hkely to that industry experience demonstrated l

burdensorne and expensiva. stand up under review of the courts than that many fitness-for-Juty programs had raadom urinalysia. Most licensees also been successful with substutially lower

• Random testingis embarrassing supported behavioral observation and rates of testing.Several commen'ers and demeaning.

for causelesting. although not as a stated the opin'en that a 300 percent

. Random testing creates morals substitute for random testing. testing rate would be unnecessarily problems and may thus lead to the loss

= nr ** - --e =*******'

==

Fed:ral Registir / Vol. 54. No.108 / Wsdnesday June 7,1989 / Rules and Regulations 24473 burdenome to the beensee in terms cf felt that the burden af testing would be costs, and to the in&vidualin tenns of areas. It is prepared to moddy the repested testing. A number of &stributed mon fairly.

Two inquiries were recched, requirements of the Etness.for duty f commenters questioned whether conceming pohey for those randomly testmg program to incorporate such /

information imm mlbtary experience alements as they become viable. as long that was apparently used in the NRC's selected in6viduals who an not on site at the time they an selected One as the techniques address the reliabihty decsion to propose a 300 percent testng commenter asked how they would and rate was appropriate to the nudear be trustworthiness issue of use as we.1 folded back into the testing population. as the safetyissue of current power industry with its older and anon impairment ne other stated the position that the stable workforce. Fmally. one ne NRC la sensitive to the workers should not be required to return commenter questioned whether the importane4 of employee morale to plant testag laboratories could effectvely to work solely for the drug test.,

Several comments were received safety, and has taken care to provide handle the workload impbed by a 300 nquesting changes in the derm!tions of safeguards in the program to assure the percent testing rate.

random and unannounced testa fairness, uniformity, and accuracy of the Numerous commenters suggested contained in i 26.3. random testmg ne NRC also

c. alternatives to the 300 perant tesung neognizes the value of health education rate. proposals ranged from a 5 percent 5.2 Summary of Respones and rehabibtation programs in assisting per yent rate to a 200 percent per year De ECis embu 2 &inues workers and in deterrms substance rate.Howeve .NUMARC and most raleed in opposition to random testing in abuse, and notes evidence that random boensees proposed a 100 percent annual 8 "" ' E testing programs have been found to be test rate for the random testing program. ,[ [, ,y ney further requested that the W percent rate be reevaluated besed en

(]beves th' at een seek supp rtmg 6e e&chmsa of random is encient evidac*

an effective incentive for workers to information and assistance. To this the experience of uti'ities, and be de e end the NRC has includedin the rde as

,,'b detectins discussed below, requirements for a nduced to a 25 percent rate if f beensed physician to review posinve warranted by experience. A few ds c e test readts pnor to notiScation of the commenten requested that the testmg pe p]

d licensee. and is requirms that licensee rate be left to the &acretion of the unescorted access to the protected area wor en han access 2,an empbe .

in6vidual beensee, because bunsee of nuclear power facibties is warranted assistance program designed to provide anaagement would be most at &is eme. As bicated below,6 assessment, abort term counseheg.

knowledgeable about their partiedar napope to b unsidve issues of attuatiors. privacy and protection ofindvidual Ireferral U services and treatment and 8

A number of other testing strategies rights. 6 NRC has taken .at care to wen proposed. One basic approacb that provide strict specimen cc ction "P 8BO'i10'U :dered a number ne NRC has consi ahemative rales and samplag .

was favored by several commenters was procedures, chain-of-custody. laboratary procedures to address the many to reqdre unannounced annual testm8 certication. test corirma ton. and comments received The NRC ag ees of at worken, augmented by random contdentiahty requirements within the that the high rates of testmg needed in terung at a lower rate. such as 25 rde. The NRC is conymoed by evidence the mihtary may not be as enential for percent per year. Several other from b mibtary and from beepees the nuclear power industry, as long as commenten suggested techniques for already implementmg random tesung adequate coverage and deterrence is .

pmcedures that random testing is an  ;

protecting indmduals from being over assund in this regard the NRC notes tested nen included a request that a essental and effectise cor ponent of the that the Navy.using a 300 percent per worker not be re. tested until all other Etnen.for duty program. The NRC has year testing rate, observes about 5 workers have been tested. 4. request that designed the rule to mWmire, to the percent positive testa. Commenten in tested workers be cubjected to a lower extent possible. the expense and burden the nuclearindustry rate of testing for the balance of the of the chem. cal testing component upon testing prog ams, rep.with random i year, and that there be hmits imposed licensees. contracton, vendors, and orted lese than 2 Percent positive tests, with a utity  !

en the maximum nuteber of tests for a upon their workers. Strmgent quabry using a 100 percent per yeat rate j pirbedsJ worker in a given year, assurance requirements an imposed reporting 0.5 percent positive.This Commenters also expressed the upon b littnsees, contra CtDrs, and appean to be afleCDve of a opinion that workers of different types vendors as weU as upon the laboratories substantially 6ffennt workforte thould be tested at different rates A that will be conducting the chemical 7pulation. The approaches considered few commenters expressed the opinion tests to enstre that test results will be were:

that the 1:stmg rete abodd be relaxed accurate and that false positive result 3 will be essentially chminated

• Altemative A from the proposed for workers in non-aafety critical Dbs. rde. which sets the two goals that at Many commenters requested that Although the NRC beheves that lessT peternt of the workforce be licensees be allowed to estabhsb behavioral observation and fer cause th!ferent testing programs for their own, testing comprise important elements of a tested and that the testing rate for the substance sbuse deterrence and already-tested population during a year venus contractor or vendor, employees. not be act lower than a rate equal to 30 Speci$cally a number of stihbes stated preventioy program. and has included bm in its rale. It does not bebeve that, percent of the workforce.ne that treating all workers as one at present. Gene elements alone are disadvantage of this ahemative is its population wodd reeult in those sufLeient to provide the level of complexity of administration and the worken who are per=anently on stte i being tested more frequently than those detenence and detection necessary. prtwisten of a leomer deternnt durms l part of the year.

workers who are on-site for only part of Nevertheless. the NRC appreef stes the i the yenr. By having separate testing potential value of developing techniques

• A!temative B from the draft rule '

that requires testing at a rate equal to populations for licensee and contracQt in behsvioral observe tion and detection 300 pertent of the workforce.De sa ecndor employees, the commenters ofirnpairmer t through testing. and intends to norJtor preg'ess in these disadvantsF of this altemative is the possible excessive disrupbon of work

M474 Fedesa! Regisser / Vct K No.108 / Wedmandey, June y, toegr / tales and Ragdadosu cetivitans and the of a few . delsat sense of the danament sahan af i EbstdeenWaskare(piEW)uden .. .

indvidaals at a very rata which - testing. Several of the abows> -. mesober asserted that tasang .G may impact morals.N cast of this rate alternatives wedd have the eBast af - laboratoda in qm= ===3 have bed dalme .--

. may be ~*=*1ve gives b reprtadlow limittas the ammount of reemat6ng en positive rotse of 30 paresma to se n=w f positive o taata for tasting rates partWar Whvidenla. pertame. .The Weted -

at 100 perceal paz year or bwer in the . The !GC recognises that vandar and Brotherb d Carpenses and inesses

. nuclear industry. contmstar per== mal sodd be sub6 acted og A-,-= and two stan knaala, ens e4

• A method whenby each workar is to lower estes of testing to the extent b IBEW and =='*6' = d ik Ch randomly aseq' ped a day during the next thet they are mot asHeee far she estare of cahE==a U%ty Workara, eland 365 daye oc which to be tested, and then ynne.The t&C belasves that these as* Center for Dtename Canarai (Q)C) seedy is randomly renaaIgned to a day in the several strasegies available to deel with data Piem h early usk to clahm eine I following 3t5dsy pedod.h worker the I:mpbed over4estmg of hasasse tutW techmalogies are too h i codd be tested several times in one employees.The be=== can devede on, ,,e ,g ,,, -== ts, mandy tran em I year, but is guaranteed at leaat one test those being testad isle dassrate IBEW, wanted the NHC to assues a top i per year.This allows for testing of the populations (e.g. empbrees and -

pucas, e arch hettag rum. I contractors, or even by contractor).h' entire workforce during any ad& day Com munbusdinhe W to period and reduces the testing rate la NRC expects that a5 categories of low whE hveh. crees m comparison to Aftercatfva B (estimated workers will be testad in sacerdanza betnes % nd b % bombt rate: 200 percent). However, there is a with the ahurnettve rate asad procedes volded mensboDess b the body possibility that more workers may be setarhet for the iba! suis The NRC wiB to e ma One selected for testing oc a sfven day than permit the Ecsesee to sample witlen ==-stw, hr W Wat m N the licensee hee a capecity to tast. N categories of workers, to aansphr of Amerien, thought thatindividsets diredvantage of this alterestfre fs the reade)y on et !aest a weekJy bests who had received false positivw should need to select testing dates wuB in among thoes carmstfy assiste, or to be awarded moedery empensetsen.

advance and the seenrtty problams ec:ptay see ether method thet setis6es An ther commenter, the Urdled r which ma7 rern!t. the etendards of the selected alternattue Br therbood of Carperwes and Joinere

• A metne:f whereby aR worken are for all categories of workers covered of Americe, contended ther the EMrf" subjected to una:mounced terting ance under this part, during the year, and random tertmg at a N NRC does act beheve Ibat 100 test used in tr.itial screamng had too low rate (e g.,25 percent se percent)is additional yutdance is needed on heer to hi.h i false negative rufes.

also cred during the yeer to arrure deal with workers wbe are not an-etta Some commenters, mostly NUMARC ongoing deterrence. when they are randornly schieted for and 79 Ecensees supporting the

• A method wheeeby reedoen feetW testing. Carmat practice is to eitber test NUMARC comment, thought that the is conducted at a rate egoal to them immediately spos roterm to the sies valdsty of the test terutts could be approximately 100 penent of th' Mtb a espporting p 4 . thet challenged either by the generation of workforce. reen'tmg in about two4hirde prevects discioenn of their selection), true positives from use of over.the-of the =wkus being treted donna the piece them is a special pool of people to cor.ntar drugs and other legal course of a rhee yearEs la th*' t>e reridom!y pelected wtthin a few substances or by the m' Sa~N of altunst!ve selected try the Casanelon weeks, or to return the person to tie samples. Tour other commenters an h tea ting pool and select sovocame else. (Florida power acd light the 00, et ,g *

• UsuaDy, the beensee artsrve itself thet r%*=t and Atomic Workera Udom oumber of alternatnes.severalcf the ther is a legraste s.eeson br time pp EW & wh &

"It""" "" abseece. end,if ary petterns are cefdent privata ladividual)identfSed tha

\

i u nto ic.e, thaTnQg pere Y an **[%*"t*** per 5' M e=d'ed along with !or. cense ferts. Current (dewins == Posamla chaDenses to tha validity of test tesulta: midaWe or

((hW RC MH P d.

ider redoc%

testing rates after several years based indastry prectice le czmeidered edeqoste misiriantirdn= of aamph a una af on W impoper sampla coE*% techmques; les' equate safeguards aga.nal on pentrve expenet.ce to the industry. M hW.i'ity of Test Jiaouke 1 For the time best.g. however the NRC tamperir4 aHuref oflaborstnry l Summary of Constm# equipment; passive inhahtina d  !

belie >ea that testryt reles cubstannally b NRC received namarous marilmna: t.me of day of the sang!a.

below the 100 pertant rste wonld mae assure adequate deterrence. The NRC couunents partaining to the reliability of and erroneous reading of tast resalta.

does not antacipate bessess test resulta. Several c.ammesta in this NUMARC and OCAW r-r- W category expressad scncern about the adherence to chain of c:ustody i expenencmg agMe'mM problems in '

perceived hirph rete of faina positive proced trea, in gecatal, whCe the fmdmglaborstury caracty to sepwart rata in cu:ess of too percent. Becaues resdia and the possible conseguances to Wisconsin E actric Powerrnepavy and of & ceed to amare an adequate workare. An oft. cat of the Ut;1iry the UnitedIbrotherhood of Carpestara nummu:n rate of testag, the NRC r.ra.na Worken Union of Amanca mnt r.rt.d and }o.aars of America sperh'4 leave the choice of a testingrete solely that immursanasay screening testa hava r=~ ~ ~ tad those procedures outlaned to the dancretaan of the indivukaan false positrve rates of 5 percent, A in the HHS CWel&== m Duraesna licensee, private indwidual cited a Hannan IJsht Company rar-ended that m proposal that workers not be Relationslannurts a Clinic's report chain-of custody procadaras be id:cwed retested until all other worLats are claiming that laboratories uaios faltaal at the sits and in the laboretory, tested and the proposal that thus be a and codirmatory test proceda.rea have Hematrm IJghting and Power asked the specified maximu:n nam % d timas that had falso positive rater ranging fross 4.5 NRC to proL%t personnal from working work ers are tasted within a year cannot perce.1 to tia partanL.Tw1 in the *Titneu4ce-Daty Program"(that be agperted because they wodd make commenters. a privata irakndaal and is,tha testing program) who have the process arm-randem and wo6.kl an International Brothubood of relativas wocking at the nita.

1 a

~~n- .. - --- - _ _ _ _

6.2 Su:amurydRaspInses Anothar dne tastrg fatn.Pharmchem Gujdelines arguim bcurnamesto rm My .

laborato waAse caducted smar44 ht. seteet persecs vanpourQ21e for ne NRC mehnwledoes the conarms " edmkostarmg the testmg pett sm based regaidr; tb tate of fahe poastves and , oy [,8 apcm the tugheat MM Mariesty speccmen coum.*W and handhng be eres beki sc Set Francisco en Iane S. t986. aadirseg .ty and so unplement tschniques, and r mtr-n== that these Pternoern u etee thet eevem1 w.:rts hen cxicoe:: s are based upon problems that deer ==4 hse abe GC/MS conformation east toeasures appreposte to ensure that meted ee eural pars apo seen d.ug is vunmiirtacpemem secnesic mar.mung tbese r=4 de are ma=tained.

testmg propams were bems tatroduced. that mdainhamae4 p==nadsm an Background crakutmas crf testmg k W *** programpmaanet said be osmdected The Fedetal Aviation Mmirtistraten.In to vertfy the hoseltrity ef euob m8mdvals their response to pebhc comments on Th e NEC has aSep'.ad the previassne given the potes tsal amause d the1 the same matter (Es FR 47032.Noeember of the MS Gddelsmee =rith some {

medsfaceinaus so furth or ensure abe pos itwn. 8cb e v6aral observe tion end 2t 194 primded e dear response that 1 we find noaenece to isaprove; kreg:sry and accurwy of teat eerutts periodicve-condwet of the bookgrmmd j using apprepnste scientifa: met'avods and evaluatons would issure contmoed

, . . W eurh d@W ud Fil ed chamofw:mstody procedure.s et the integmty.krperekory peroonnel arra en analysm labomar > urta sudsmaly'd in6v1&uefa coaserkers would be pmcodme hed eet e echad nedere level g eise and ts the testang tabcratory.%e ,

i oophant.catoo raisepeartee neetace.Jts coe.firinatog testin6 procees sino prohibl*ed frorn performing as coUection occur pnmar4 in aamb a.s af a apactmen eliminates emy false presumptive ske penennel and emtreguently from ,

durtra an to3 cal ocne:ura tesc s'thousb pos:tm terns rer.hmg from a cross- beingtrrvc4 edin the cham-of curtody coctecrporary scrnotna iests. euch as reactir.g den 6 detected &.rtng h:ttial process immanoassey teets ben hemme extremety screemng, As cross,reaotmg substances The NPIdoes not bi'Jeve 0181

(( [as us:ree med trata al ecreanns imet 'uates e lem espesen

[ are ponerdh pnsamption or am4be-cmaer ame&an tions, testing procedure o

panerveinhalatioC of mari}cana emoke 1silliea5 to felse pasitives.

ed 1 to is a h:ensee's Etaen4cr<isty program Studies conaneted to almaata t,4 3 yiee a pmimmi.3 in6catoc of the pc.a.hk premesa af dnas wth melude amistruin on the conitbas fhat nadlt in pasalve er drus zoetabcaseA la arcle.r to ar.m re the individual's use cJ ttone inescetions- inhalationhawe act a:curately reIected integng and accursey ci am tret nam't. each Chain ok:nFtDdy PTOoodure.& Snd a m mn,.A guigde jhelabor6%'dten pos: eve sc*tal scrnninF ter1 reedt inur, be system of rrriews checks. sad t sianoes usinF ar'JLtdaD, devised arg! extremely EYM,[MMe CCf dunng couectson and snatyus of spmsens emCmed in the NRC confmed areas wah poor wentihten/

foUowed by imme&ste test.ng after

)

eeeu ote and sepLetcated test and is Guidehme hemt and pre,re::t emriand vetually enw-free mhen used 1: cm ptan:e prolonged egosurt.%e cut eff }e,els in with the DHMS pu.dtt.r.co * *

• Z2.e P""'"Ee Sabmun ons.To premem the the NEC Ctedehnes esiU be act Mandator) Testes Gwdehnes wiD provide a worker fzxt sne;grepnate sanctma doe suffeierdly high % prdade h system of che* '.nd baletmas therics to any errors in the lestang process. possibihty d metrover@ to coLect>c o ar.d ensfroas d upemtem Thas cross reactmF substancas, orleptimiste channes that a porttive test resched age e anwes the s.nesso and amacy of rne& cal use of cc troDed sustances, a the tests usara erprtpr. ale seter.:.Is m'" from Pa un kahaletma The 94 notes Me6 cal Revu w Moe@RO) screens th !a trur**mthmans tpsuunn stry be and ng,d chain of custody procabres ' ' ' aU pmuned paz n.e aesWW and raised ewmit the tase of pasere Sices the ::6Scitr% istorn oriestrve mayMe.mihcaear.idab who beor me incmrr.T; se;'rri:atrd tn tetr irtbalation. Dre nat) effect asso::seted andyti:mi see.as ami dtm of cuiody have kated positive m2 the GC/MS wie et ter of de d h s@ is pmeedureA 1 star y taba unona 1.sn compGod confamatary lash The MRO is traced in that artne saraples coUected tistle.tn extaasree c+meds sk-ametzung. -* pres::=ptms and oster,the counter [OTC) the day contein h.gber mroentrerms of accuracy mad restecuem d ond'ondmal drug interaction as weU es 1he phyakal chp a hgWAm spe N M Tarea.a @ f'm [mi gigns ofiUACal drbag ahinae. A gggggggg ,,4, gg ggggpggx'% g taboratones a major dr g tEauLg h mw) comprthem M'T'N MOeM3 822:r8te MK8T faI8e Pur t;ses es ar.itad .

has arafyted over Statw unne asc$es. *P E8g8 "8d 8 d*Cu'8E SI ce=6vetng tLacrere tranns for rute iferent positives an stiU confirmed wzithe l matters awth as dtnicalagne of abuse GC/MS sest E:roneitars cesdmg d teet c!nige wbdh met 4!in nesr}y fm trilhes e ,une, e.gy, g o.,,e ,pe.,u,,, ,uiee are cantamed im ae %&A!Reriew resahs would be ittnited by d.ris.of-we courvetnut senc Ime e ar.s!ywed Of'cer Mar.urd.' A Guide to EdmaPAS custody prsoedares asid the system of app-or a:ssach PAGaoc arme ==rr p=a 6ar the Urtne inIhng Asa!yais7Seplecker m eeW d tm hWratom' prescer.e a' twe dafir rent chrnes --W in 1968) publ d *A by the Nat;ana! &nalitute t e atly 1.s mi% ar aJy sen af skese ct Doug Akkase. The wora.ar haan an 7.0 Trainittgc:an'Behanarci s;+cunens pursuant to its toctrsc! with the ~ q es a.na r y se irientJy any W M Obscus: ion matary.%ne cf te ever six scEbon prescnptuart O7C draga a e are.11 as ,

ccelynes rebetned im DOT.de taitaary. certais food embatan:es that z.sy aHect ~"~ ~ i d "'8 c.md other gr tvett ermi pebhc enceanises a test result. Tbe rAr n-of-canansdy and The NRC e-cdved trumie.ams g s ,a g g w 3,,1 ,,,,,t in as e ase?.e CrumpoChre esenan]wasker '#"*^o tw.nahea ou(Leedin the cocments segardtag de moope of '

l incorrwna khea.d emac .amples simu NRC Gui:maans.sha:q wie osaruser training asqmred af honneee, as setraosor.

baLas=d to DOT marA*m. E&h.s t.ms teohnairmas dt:wd.ist apermans hunit and w.nder pe.reatmel greeted shes the nest esashs iu.zw quess,oned I;y de the probabil4y drainhamebat unescorted access to protected a ana Me&ralReview Dmcer. CountaChetc and the usuatsMars, ased rm.arksttfaosthea eI Mast carnaceters rea:au: red that MeSc.amenewtEccrhad identmed and ea$es. He NECGnho also tremaag thonld be prevaded to sB C"*d O' ena acompCbem was em outhne p=n-Lee foreecounctionaf en:Scre es opmered sunder the visie to N$N.d co,.m.

im.ir

,i.es.

S,. , M. -#s E ***

""CT *' .'*o*d e"* *e mimeertiy of a.,the enawe ehat they "-- w=' te uc- es u.a.s % n r amabmr systzn of revww try O=r-,=Charc mi sample 4amparang To furtherlianit the cespanshibtnes the cer.acqcences o' and ex.puierMs. to sumee ehmt -' - - possiMlity ddC elthe satnignty substance atame and the aymtawy of tbs ar., at a anM.a omr w2 sa: anacoat. cf the tes&ang peooeas.4he hiRC assistance enmust abe L.n;c b . "

24478 Tedecal Reglater / Vol. 54. No.106 / Wednesday, June 7,1989 / Ruhe and Regulations it I Assistance Program (EAp). In problema,it is critical that they be . determined by a physician or other- .

eccordance with NUMARC. many trained to recognize these problems and health care professional. Others thought '

l commenters supported the training of handle them appropriately.nerefors, that a minimum of two management supervisory and managerial personnel in the NRC believes that the training of ofBcials must document an empleyee's i behaviorsl observation te hniques and supervisory and managerial personnel in impairment. One comment rr stated that i procedures for initiating appropriate behavioral observation techniques will - fer cause testing should not be the result i provids licensees with an invaluable of a "d:screte arpression of concern by l corrective action. includmg referral of employees for medical assessment or tool for the detection and deterrence of a nameless accuser." I counselmg. However, a majority of drug-and alcohol-related impairment  !

commenters also expressed strong and for the detection of impairment from 84 Summary of Responses cpposition to the proposed level of other causes. Becaue of the sign 1Beant he NRC agrees wi.h the commenters I training required of non. supervisory level of knowledge and training requind that the defirJtion of the circumstances personnel assigned escort duties to accuretely deteet subtle indications of in which "for caue testing"is l (l 2&2.2[b)). drug or alcoholimpairment and the appropriate should be clariBed. ne l ne NRC also received a s,gm,Bcant t entical need to identify drug and alcohol deEniton provided in i 26.3 has been i number of comments regard;ng the abuen before they compromise public deleted and the language in i 2tL24(a)(3) I requirement that initial training of safety. the NRC believes it is prudent to has been revised. De NRC does not I licensee personnel be completed prior to requin rapervisory training on an agree that impaired behavior can only -

assignment of duties within the sco of annual basis, or more freqv.ently when be determined by a r bysician or other I this rule and within three months o necessary. In addition. the NRC will health can prdenional. Supervison an I initin! supervisory assignment, as continue to require annual refresher close to their workers and directly applicab.e (li 2a.21[b] and 2&2.2[c]). training of all non-supervisory penoncal monitor worker performance, eften on a 4 Most of these commenters requested to ensure that licensee and contractm daily basis.ne NRC also does not I that the NRC revise the proposed rde to emplosees undentand the requinments agree that e. minimum of two managers l cllow drug sweeneu and behanoral of the beensee's 6tnewfor-duty abould be required to document a I observaton tronme to be completed program. an awan of their I within six months ofinital supervisors responsibilities, and. in the case of wdn's %M Me 6 m '

cases, the impaired behavior may be assignment. Com= enters also suggested licensee employees, an awars of b ed b d that refresher training be completed opportunities for assistance available task at c not be es il re at every two yean rsther than annually. through EAp services. NRC audits of l 7.2 Sum of Reeponses licensee programs and interviews with A0 Scactions l

' P* 9.1 Summuy of Com=ents De NRC has revised the propowd t a lo le el !

rtfresher training- 9.1.1 Period fDenial fAccess.

nn e not r q t receive Sections 2A27(b)(2) and fc)(3) stipulate traimng in supervisory responsibihties. &O Tor-Couse Testing that as a minimum, the Erst positve test ne rensed rule requires thet all non- El Summuy of Comments conErmed by the Medical Review supervisory personnel assigned to escort Of5cer shall reeult in immediate dutes must be fa=ibu with techniques E1.1 Su!!chility ofFo.~Couse Testing As summanzed carber many removal from access for at least 14 days for recogmnns drugs and indicacons of and referral to an EAp for assessment the use, sale, or possession of drugs; be commenters stated that they were in favor of fer-case testing in place of and counseling. Any subsequent famiLar with techniques for recc gmzmg conErmed positive test would result in aberrant behanor: and be altemative testing methods such as removal from unescorted accesa for a knowledgeable of the proper procedures sandom testing. mmimum of th re yeus. A worker who for repornng incidents of abereant E1.2 Defaution offmpoinnent.

is involved in the sale, we. or behanor to the appmpriate management Several commenters including NUMARC stated that the current possession of illegal drugs while within authenties. the protected ans of a power plant ne NRC received many comments deEninon of for-cause testmg is too broa d. Suggestions for improvement would be removed from covered opposing the required completon of activities for a mmtmum of Sve years.

drug aweeness and behenoral included replacing % impaired" with observation training of supervisory and "may be impaired" or 'msy have nis section further specifies that the demonstrated aberrant bebsvior - rule does not prohibit the licensee fro n managenal personnel within three months of inital supervisory Finally, com nenters stated that most of taking more stringent setions.

essiEnznent However,because of the the examples in parag*epb 28.24(s)(3) of This section prompted many and enttal positon that supervisory and when for-cause testing should be varied comments. Many licensee managenal personnel serve in detectng required need better definition. Several commenters includmg NUMARC arFued impnited workers the NRC has examples were suggested. that the e:.Ne i 2L27 should be deleted detennined that the current prossion E1.3 Testing Followirg en Accident. because licensee management has the reg:rdmg supervisory training is Severa! commenten stated that responsibility to decide these issues.

oecessary and will remain as stated in requinng for-cause testing following an Rey belnve that establishing sanctions the rule. accident would inhibit root cause is not within the Commission's ststutory ne NRC has also determined that the analysis of the accident.One commenter authority.Otherlicensee recommended provision requinng licensee personnel to stated that for-cause testing should be that the rule should not prescribe any vceive annual re' fresher t sming in drug required after a serious acmdent. speciSc time periods for these events l e.we.reness and behanoral observation E14 In/Liction of Testing Several because each must be treated on a case-techniques + 31 remain as stipu!sted in commenters addressed who should be by-case beals. For instance, a licensee the proposd atle. Because supervisory allowed to initiate for-cause testmg. commented that some relstvely minor personce! rqresent the first bne of Several commectors stated that aituations do not require evec fourteen defense asamst Etness.for-duty "i= paired behav;or" can only be da)e to assess the worker's drug usage.

) Federal ReglMer f Vol. 54. No.1st f Wedneedey. June 1, 'Itse f Mrs an8 Regdetiene 24477

}

deterodoe a sesuee to de problem,and Ran6e 5eco's psectke h sudh the pmon h teestlikdy not able to stop nfely ntura Qe worker to meeoorted chrumetances nqidres weeldy using the subetanor in eneeton and ecosee urtnelysis dormsabe fcit arearterafter could therefore. pose a thaeat to safety.

[ nere wee nepestrec)er urneeneus ntum to work en8 month) teetmg De severity dia three yearksa of -

i among 6ose commenters who themaher.tne length d e probstron

' unesoorted accaos may dso pro >ide an mentioned spectf c time perkde ler Period wu net mentiesedJ A third set incentive for employees to voluntarDy removal trom ecoces.lecal No. 51 d the oCoonuseeters trr&cmd 6at the entericle echab@.atjan pragrams when intemstsananrotbedood d Doctnco8 frequeecy and durethm of euch foTiow- they resliae the merhs of Abe worksm wcensen6ed Ibet a worknbe upteris need not be presen'bedin fbe sahstance shase problem.

euepen6ed for En deye eher1be Bret rde but AcrJd be left to the enrployefs Section 2A27(b)(3)alsoappaan to be conArtned yesl6ve tee! and for ten deys deterndustion. weU auf tad to ibe ade's goal ne tenor eher the ecceni%e Sye.ee Osame:D U-2 W the EEW mconnnemkse diedberge 9.2 h=ag affteaponses. ef anaf -wa ac this asetaan ApnodefDees. forared more stnagent measures than for sh isostbo eher te secuma 9.2.1 o lefAcreesThe the se.ctinn wodd co codirtoed positive.1mcal No. T1 eaeo sce o trnetin Iams &et a wishes these - quire. and the NRC

' ara ao note thet believed theithe three year wm nal ***""b **F pm a hoet to esfety the five-year periodislains dad a he frase econee k too sevm se H wonld be someend !>om se)genddn &su" caly the she ansoualimn almost cereerdylesa to &emiser.1 as beg as bm de weetne such a Permaneot&eminalww w._ g3 thnet%ese vesetime nte manm unamentted access mesemeary to protact

'M*"' puhhc health and safary.ne nve-year by HeestonLighting errd pown eveneks b *"" .H M Thus ne m6en eMows but de pened shodd aposte es both a I the worker's first confittned ettive detenant so the proscrsbed activities i tret. Carchne ytrwer sund t bebened not aanoste te permanent denial d and u a ===- nat mayin fut reset that abe M<hr) rogurernert is adeguate. menteo een epewd mu in in pennanent denial of access 2 snort Miny beensees beceed that Ibey any d g3 menved M obodd ben h opte m endet teke evenas.The section also neogntees thet cases whese hvolvementin iDegal drugs ,

mesewrw canpng troen conneehng *'"'"'I#0"** N N* W cadk W m '

thmgh &darte foDowmg(be fut 8 ' S2.2 Foibwg Tasu.ne NRC be e recognizes de need to adpsi the positive test result. Rey etnes ht ibey M M be a fc arornehs &reet frequencyof fousw<ep esetmg as muom M@ % dodem than a teavstremet manjvene teee.Yet. "4 "I8 M O it takes to seem ot le eet a chance et

"", % g % indiesles that recidmsa e moet hke}y l soooverful nbebExstion of the worker nere was cemewbet less eerience to

,p a d probens g 3,  %"" duang the fint so de),6aHowms teatment fHabbard and Marsden* 2966.

the connets en the ep;reyrste RocasenDe.teS Most selapour e respee to e determisets that a h}t is the NRC's bdact tbH PA2fbMZ) woder k:s ben hwo%d b the ede-includes an appropriate mim of sche use d se@m dunes use.er popeseron of & tral eruge enthin fleu%ry and strugency.ne 14 day ea!&nr1 ndayperedif a peme can ,

perkd ocems toponeble in that.tn remain substance. free dung thet

• Prowcwd ma.5emal hoecem period he er she erihaw a cbeam to stated thet h weAer sonld be almost aD osses.H would take atleest ,

chs:A>e>yed in vooh ceresmetances- that long to hgoose a workee's contanne tobe abetmem.

prelem, deerwrie s edsnon.snd inbght of this seseed.the NUMARCtocomumended (be te usun thM & prdiemb eddressed wt'*"be pnamec0y bem8fmn Com:sseion has emanded tbs secten.

bekn the wo4er cum again be sranted Rether then segnanns a unilorm accees. Arrether bcensce would acoeen tlus uney.h came anses.ipe freger ney of eestag lar the entime three.

doaharpe the ersteeyee but eBew the petoonto be consioewd for eetse eher hmhed to comedwig Also.tbe WRC yearprobaten pened,the bespnened three years.

beheves ht 54 days is needed to Potential for accidmsra during tie early M2 prUew-ep Tests.Section conclode erst h fret oorifhmed saares of that pened should be positive teat mey beee reouhed frem nsegn.ned wit a re6e of testeig more 32Mb)(3) d the propove6 tsie behader thet does not in fact pose a fuegeent than once usery neee months.

{l E"T(by4) to the fmal eule] would serious sefety t)evetThis trAirnum require thet wohors whose secess is As a:nended.eds oceben witairee thet period is net meont tocosetirme worken whose eccess is veinsteted be reinMeted *Aall be 3 cen! unnamormee8 punishment. Insteai this period is pren unannoiamed JeIlowmy tests at foBow.sp tens et kastonce veery Onte inteeded to ens ure an e6eguate time for months for three yenes aftn leest once eeery month ecuing the fast assesswartof the eerker'seenettion four mar:ths d restored eccess.thering w/we to vedfy emftmund and m.m .~..he NRC doce met the ned two years and eight strnths.the obstmenee trem druss* Dis take a posMron en whethera worberin worker should be tested vt kost tmee reg.urameni v.M a vene'y of this viseetkm 4ould bedenie6 every Gove menths tevedfy eentmved m .,- s.Tartons union teescarted acaen ionen t>en14 deys, abstmence. As compared tothe

..y .mtiets cowd thet tire testmg Tbstis to bede:aded by 9,e beensee. proposed ede's wguirement. the higlher cete cad duretronwonid be *excesetet. Remesm19remenceoorted sooeos Ier e terthg To te deems 1be feret four wor:ths i hinh. cad punitis e" and argued forlees sninterum of shioe yees efter a eeoon5 - weisd preH6e the workerwith en I freq9ent teatrg; tur a 4erter prebsten conFwned posteree test is, en ese etber ' 1 pertot MD.tARC+ commended ib t imenssed ineeneve te wmain abstment I band,ifmise a ewsngestesquirement. as wellas treete untaceased I wo&ere .y.Wy ecoees be temed once Some cemameraere metod Ebet 8 emessel .

every three spoethsbet1or em year probabDeryof lgs nywoumpSena  !

ms) ooeur nn esecoars.De NRC of substinee use that mayoccur. I caly.Onthe e&n side d eve 7,sm behews eiet eds sessureis Thereaf.et the lownteeting erte woulo cf Mews.pebbe sereine Electr6c an6  ;

aPrropiese.however.inhgk eteris be less enettus'Ior the wartsr whilt etill Ces ete te6 6et Be cendrte of see rule's goshieseunns het wohers are prtrvHhas sided moeuranceetet wodere eageres Nicoe anonitertg. not imps 4 red eve te ecbetence *nse. A resumpta tfedbetance use wocid be j arecking.end sentmced wine sempting

• scound poettm te rt wonio indicate thet denere6 {

e

twed

' Lt'td Register / Vcl. 54. N:.108 / Wednesday, June 7.1900 / Rules and Regulationsl i l'. 20.0 lazpairmantham OtherCauses be hmited t)!!! aldrug ues. Another .-

20.2 Summary of Comman.'c commenter thi agilnst on-the-job impairment. One J. .

t that tha language of  !

the rule should changed to stata that commenter indicated that the A number of commenters discussed h seat prescribing physician could be consulted l

inues pertaining to hnpairment frca #

woricp: ,of theafille rule la to achieve a when msking this determination.

free causes drugs. other than workers' use ofilmgs! effects rather than adrug-fm "geldmye and hir Other commenters stated that it was -

appropriate to expand the testing 10.1.1 IdentifiedAdditione/Souress workplace." n!s commentar also noted ef tmpairment Wort ers' use of that this change should not preclude a program to include legal druse that map -

substances was mentfoned most often in bcensee from pmhJbf ting on-site use of cause impairment. Some of thne these comments. especially the use of alcohol. Several commenten stated that commentars want the rule to specifically

. alcohol, prescription medcation. and expanding the rule to address 1 state thia while others want the rule -

over.the-counter medications the use of drugs would rejse substantial al eddrns the tuting protocol for these caffeine wu a!m nentioned. Comments concerns (e.g., making the use o legs! drugs in detail, as has been done for the wen also made about the foUowing dmgs illegal, forcing a violation of - daues of drugs for which b rule does specific sources of worker impairment physician / patient conSdences) and one nquire testing.De following drugs or (1) Emotional and mental stren in commenter thought that these concerns drug clanes were identiSed by variou  !

general and stress speciScally related to merely highlight the fact that any drug commenters as wananting special I poor a ttitudes. poor morale, and femtly testing is an affront to personallibe ty, concerp: barbitura tes, benzodiazepine. .

methaqualone, methadone, and l e

NUMARC stated thet prescription

{

problems:

caused by mandatory (2) fatigue, long boun toduding fapduty. drugs should be generally workers should be addressedsome propoxyphene.For onlyof these drugs and drug clanes, cut.cfflevels were rots ting shifts, and workers working to propcmd. i{

shifts incompatible with their biologica3 nouty their supemsors ofinten ed u" clocks: [3) illneu. including allergies: of prneripten drugs and can should be Commanten also pointed out that .

{

and (4) physical and physiological taken in response to positive testa that some of the c!sases of drugs currently I impairments. One commenter noted ht occur as a result of prescription drug tested for include drugs tha t can be used I illneues, particular!y colds and Du. are use. lf prescription drugs are included in forlegitimate medical reasons without  !

meJor causes ofimpeirment because the tuting pregram. the ru ase to enstng sig JLeant bpairment. and b I positive test results should based on rule should be expanded to ensure such both the illness and the medica tion a worker takes to treat the inness can medical advice and workers must not be legitirtste me of these drugs is cause impairment. With regards to penahzed unlen they are abusin protected. Several commenters stated fatigue, one commenter objected to the legal /prueripton drug. nje pos:g tion the ht nquiring worken 2 report b up proposed rule beca use, under the rule. It was strongly supported. with about half of prnenpton @ 2 bit supervison 3 was his interpretation that workers may of those commenters who discussed adequately addressed the concerns be diserplmed and possibly terminated legal drugs supporting the NUMARC * ""ing &

due to fatigue esund by work u.hedules position. 3 M Q fI'galdrug' Y y

and overtme. Several commenters stated that only made statements about whether or not the , a bated in the HMS Cuidelines A number of commenters 6d not should alc bc! should be added to the rule.ne spec;Scally ed6ess any ene cf these the basis for induatry testig majority of thne commenters, about so source ofimpairment. but expressed ne edition of drugs beyond those percent. stated that the rule abould be one or more of the foDowing general specSed in the HHS Cuidehnes would expanded to addren alcohol but that concerns:(1) The tu e should be creste a conflict with HHS metrictona. details of how alcohol will be addressed j expanded to addren several or all of Further, a nuber of commenters were - should be published Lr pubbe comment these potential causes ofimpairment. onncerned tt.at the p'ocedures before the che.nges an in:plementtid.

regardjees of the source of the apectfying how beensees an to identify Tbne commuters incbde WMARC, a impairment; (2)it is inappropria te for the ad6tional drugs and incorporets them number of commenters who stated that rule to focus on IUegal drug use and not into their prognms would defeat the they support the positon stated by to also addresa. in detail the use oflegal goal of estabhshing uniformity. WMARC. and a number of commenters drugs, alcohol. or both; and (3) the rde Commenters also thought that these procedures were unworkable, who made this statement without hnkmg requires bcensees to sodras it to NUMARC. About 25 percent of the impairnent from sources other than burdensome, and open to lesaj challenges. commenters addressing this issue stated illegal drug use and to provide A number of cummenters stated that that alcohol should be addressed in the reasonable aasurance that on-duty rule without such a quahtication. About workers an not impaired from the use the rule should not be expanded to 15 percent of the commenters who of any eubetance, but it provides no address legal drugs, and that worken guidehnen or direenon towards this end. should not be denied the use of addressed this issue stated that alcohol medicauens necessary or beneficial to should not be addrened in the rule.

Some commenters noted that urine Other commenters expreued the tesung is an inadequete means of their health and well-being. Several concern that the extent to which alcohol detectirig impairment caused by many of commenters stated that regulation on is addressed in b rule should not make bse fsetors, and thought that speci$c pruaription drugs is outside of the implementation an insurmountable tests for impairment. seedical appropriate scope of NRC regulations burden.

chrifics tion exams, or supervisors

• and ht such decisions should be made The following reasons were given for by pbysicians and on an individual dela observabons should be used to detect basis. Other commenters Wought thet rule:ying implernentstion of an alcohol impairment.

10.2.2 legotDrugs. Some testing for legal drugs is unnecessary. (1) Time should be allowed for the but workeis abould report the use of Indtstry to study and develop ad&tional commenters thought that the rule should suitable and e!!ective programs to not address legal drugs. One commenter thou to the drugs either medical departmentto their for ansupervisors oc handle alcohol related problems. muc stated that impairment abould not be in6vidual decision to be made about the same as has been provided for drug sddrened and that the concern should program development, and (2) prior to what actions should be taken to ensun fmalrulemakmg. the details of the l

JW3 *"

, _ m alcob 1 r,quinmr.ts sh uld be made virlstions cf the alcob:1 pobey sh:uld svausble for public comment. and cecid&ntal misuse sommhire in the diIIer from sancti:ns for vi latiin of the middle. For thise re: sons, the NRC ne f:Uowing ressons wm given for drug pobey and sh uld be 1:ft t3 the beheves that a licensee's policies

! cluding dcoh:1in the rule:(1) Alcobot d:scretion cf she hcensee.

regar ting wirk:rs' use ofleg-1 drugs tse and misne is prevdent. (2) dcob:1 One commenter recommended a rule and alcobd is cs important for ernsuring j ase can lead to on-duty impairment. (3) reqdring a riod of pre. work '

I alcobol mieue creates Stoces for-duty abstinence m ddnking. such as the {ubbe bes!th and safety as the censee's pobey reganimg illegal drug problIma comparable to and perhaps eight bour rule usedin the avistion use.

enre substantal than the problems industry. %e nexus between IUegal drug abuse caued by illegal drug me and (4) an and the abuse or misuse of legal drugs NRC regulation recuiring testing for 10.2 S.unmary of Responses ar d alcohol makes it difBeult to alcohol would lend su septrete thm isnuJa exam e. in established progmma,pport to ne NRC agrees that the pouible sources ofimpairment identiLad by some cases the proposed rule afdresses ne foUowing reasons were given for classes of drugs that an both abused excluding eJochol from the rule;(1) these ccmmenters constitute important Stness-for duty concerns that should be megaUy and medin legalme6 canons Programs already in place and guidance (e.g. opiates and amphetamines).

being produced by Edaon Electric addnssed in bcensees' p ams.

institute (EEI) effectively deal with Further, the f PC bebeves t the rule %mim. a dmg tnung pmgram does addnst these issues. in that the adhering to the proposed rule. an elcohti-related problems, making overlsp between IUrgal and legal drugs editi:n .! guidance or regulations rule requires beensees to provide noonsble asaance that workers are alnady exists.

unnecessary.(2)if ad6tional Ad6tionaUy.many of the issues that prescriptive detailis provided, and if not impaired from any cane and requires bcensees to make EAPs must be recolved when addressing each that guidance conflicts with established of these areas an very s!=Utr.For pmgrnms, the rule could nsult in a los avaHable to workers to anist them with these types of problems. example. !!chmicalinting is to be sIIsetive approach to dealing with c!cohol-relsted 6tnus.for duty 1011 A &.on h urces # med to detect the use of one or more legal drug (s) or alcobol, then the inves pgg, impairmentNet Warmntmg Action et pertaining to the testing protocol that M:ny specific recommendations were # '

made cbout the desirable characteristics ht[bEalb saf ty of u$c mun

1. 8" a dnmd wbu tuung fu

" " 0" ,

ef en alcohol testing prog *am. A number b WH served by the NRC provi ng,at "" Y of commenters recommended using this tune, editional prescnptive esta W s h a @ M s."la k ato n ' - {

regulations re8ardmg emotional and #*"** "8 ' *U N breath tests for blood elechol 9""D""."Further aU of these addnssed issues  !

concentra+ ions (BACs). although some commenters said that blood tests an

(, d pby l bp enu. abould be addnued because indvidual w rkers may have closely-related ,

1 mon accurste and should therefon be an a ne NRC beheves thafthere, hat often number of ways of eHective substance abuse problems involving und. Most commenters stated that illegal drugs. legal drugs, and/or alcohol.

addressing these problems, t cicobot should be tnsted in a manner the appmach used must be tailored to E!!ectively detecting and deterring the simil:r to other drugs, and that testn8 for alcohol and other drugs should be the specite case at hand. and that sound abuse of some substances (iUegal drugs) management practices, which an while falling to detect and deter the done en the same occasions. NUMARC- abuse or misuse of others (legal drugs.

clong with about 85 other comroenters- coesistent with the licensee's 1 mr.nagement style. can be expected to alc hol, or both) may result in some stated that tests for alcohol should be workers who have dmg problems {

done on a random besia. as compand to be more fruitful than would detaued i prescriptive ngulations. mmly sub% tutu.g one impairing dmg three commenters who stated that td ener rather than giving up the alcohol should only be included in for' Additional Sources of impairment unacceptable use of any drugs.%is cause ttsta. A few commenters thought Warranting Action as his Time chee tie between illegal drq abuse as a that cicobol testmg as part of pre-access cr reemployment sc:reening was 6tnen-for duty concern and mal dmgs unnewunty Sevealcomroenters %e NRC ag*ees with the commenters and alcohol as Stness for-duty contema, who stated that the rule should be along with the significance of these cddressed BAC cut offlevels by stating expanded to addns: impatrment that is lasues, warrants the NRC addressing all the level they recommended. stating tbc caused by workers' use of alcohol and of thue issues in a 5tness for duty rule.

level they were cunently using. or legal drugs. He NRC believes that these urging the NRC to estabbsb a cut off ne NRC does not agree that it is are especially significant areas of beneficial to wait until licensees have level. Recommended or currently used concern because of the negative effects stu6ed these problems and attempted to cut-off levels ranged from 0.04 percent to of alcohol and prescription sedatives on develop their own solutions before o.10 perecnt.with the vast ma}ority of viguance and judgment, which an comm2ntzrs citing the 0.04 percent cut- taking a etion. ne NRC believes that. as important components of many febs was toe case when the NRC delayed e!! level. One licenace requested the within protected anas.ne NRC also rulemaking regardmg illegal drug use, NRC to utablish the 0.04 percent cut off believes that there is often a such a practice may contribute to nevel. but stated that if the NRC does not relationship between IUegal drug abuse inconsistent policies in the industry and establish this level, they would use the and the abuse and m! sue oflegal drugs that it is possible tha t some policies will o.10 percent BAC cut off inel used in and alcohol ne distinction between be developed that prove to be their local state motor vehicle codes. some types of medication use and drug inadequate.Further, such c wetting '

With regards to sanctions in the event of abuse la not absolute. AU use of a violation of alechol pohey, period would reenit in an unacceptable 6 prescription and over tbe. counter drugs delay in the implementation of commenters expressed both the op'.nion lies somewhere in a spectmm that has important components of the NRC's that it is appropriate to regard a positive responsible safe use at one end. Etne s-for duty rule.

c]cohol12st the same as a positive drug dangerous abuse at the other end. and seat cad de opinion that sanctions for 1012 Lepo1 Drugs. %e NRC does practices such as irresponalble misuae not think that it is appropriate to pubhsh i

r

' de*aua4 replehem a==*ar=iatlesel ~r Pedermansa Alen.nu Bos wtek . -: . < h M4C does met epse utslo thoeur ' . i i, commentars abo sent)bt abeminat me6catspos et ghia time,ns )GtG ramments,the NRC eserpts that - - i sebowiedges that *: ush of che mical tertare for some Isoal drage is '. test ser er>4str elsehol-censed astahhhg time ! .sel el drup lar which appropriate. howeves, whether to test tapearinnet need only be poetanned en , l t for the.ae druas, such as barbitars.tas and cartein drug tesdag aan=amaa. auch as . ,

tutzt o warre aesk and the benzodiame. pine.a. ta left to the discretinsk Wien lar-ce aan teenag is padermed.The l appropdata turns protocols to km aned I when perixadog thoes teman, is an of aaah licenses.na Commissian has NEC be&seves that in=== en ahtaM met troportant and difScult taak that aaked the staff to sup2nra with the in6saae to weekers that a&sehen ese that Secretary, DHHS, the ad6 boo of thaas results in anHiury impemmaat is of less warran ta cars! .1 <==idarettoa. Further.

drugs to the required testing pansL consers them is hans drug usa. Further, tha NRC beheves that an of the the NRC beheves that any ese el doana appros ches rau-r ended by 10J 3. AlcoholThe NRC balisees ,

coramantan repr6ag the righaa el - that alcoholis a Etnew-for duty that ren:!ts b en-duty lang ahn== t ponen j workers' use of lepl drugs may prow concern. The NRC believes that no cie ae cant potential threat to pehlia unacceptable.Some of the duty alcohot conr.cnptfer abeufd be th and safety.

recommarw!=d approarkaa can bs pe=rdtted. knd that wubig beseth Finalty, the NRC ogrees wink j comenenes bt etate that it wooki be expected to provde Landeguate terts to deterrrrins workers' BACs is a anarance that a warbr's ne of legal necesscT reap tewards detectfag and easy for a worker to pese se anno =aast ,

drugs does not resut in orsk.ty deternng any on-duty see er any test for eacabal eneese, sur.h as a pro- l impairment.Other approaches stay unacceptable eff-d:rty use of alcebol. empicyment er pe, are=== amaharisataan prove to be unnecessarily intruelve.For Bnath terts, when conducted semenx4 However,this is trea ser exampla, it may be marassary iss fotewing the pmtocols in the NXC many ilhcit drugs that kie alcohaA, are workers to report to a superemor or "Culdelines for Wefear Power P! ant ellennaamd from the body relatively Mz6 cal Revrew OfLcar their use or Drug and Alachot Testing Programs" qwckly. As is the case when testing for intended ue of some prucript on dnes- (Appendix A to Part 2t1 pmvfde these huegel drup, detecsica of rule ne NRC bakeves that requirma relatively accurate and rehabfe violationa may be rare,as workere some workars to repcet to the Medical Renew toessuns of BACs, and an rafficient for only abstam for a reme=W period prior to the test to be assured n! paamias Officar hir na or mtended ue of == a aU alcobol teets. Workers abould beve the taat. Hcwever, kt la also vary nely types of drup is emenbak bom ever, and the right te beve furier confirmatory shodd be consdered by t-een, terts performed at their requeet. Becanos that thcme whe are detected thron6h .

Ilowever, the NRC bebens that of the impreved eccurecy obteined such testa will have a very adstantial defining then drup in tarma such as when using Nood sampfes. further problem that mut be addreseed.Some "su pmenptxn drugs" or au drugs confirmatory tests wiD be pn fad bcensees who et.rrisstly bclude tests for that may cause imperment" rsay be a using Mood saepies analyzed wtth gas alcoholin thur pree:spneyanant poor method ci deveksp6g such a hat. chremetogrephic rcethods. scruning procesa have 6scovated ner, may be over the co oter drup. ne NRC believes that the scientle severaj alcohol abuse.rs whn wo.ald hw ruch as over the-caa:er stMaats and literatun strong *y dwwL.tes that gone undetected wilic.ut the screuing sedatma tht has =P=nt potecnal BACs can be ectrelated with prnesst Fct thena ranoon, the NRC r for cansms arHL ty incpairs eat and thaas impairment, and that a BAC cut c!! level req res that rkmscal tanta for the wurant being reportad. Comverse)y. of a os pertert is appmprfrte. R!s ent- misuse of alerAnl be conducted there may be prucnption dngis ht off levelis low ene gh to provide whenever testa for inegal suhstance have very tirtle potenbal for causing nasocable arrrance that alcobof- abue are performed. Furtharnnes, to i=pairment and do not warraat baans catrsed imrdr=ent will be detected aasure detarnnce against " lunch tune reported. Specific pohcaes rodd be wbeo breath tests are perfor:med and ddaking" the ru!a ws3 require bt produced that wodd ehmunate the coed h:gh enough to eli: t!nate practical and rando:n testing be e-~W a,t vanous for workers to report thear use of thase technological pohlems anociated with timaa dunna the day.

drugs.For emarpia it may be pessible very low cut-offIrvels.ne NRC Wah regards to saacbcas related to to em.re bt some drugs do not cit. ate therefore requires that blood e? cobol alcobal in tba Loal rue, the NRC agrees <

signi5 cant proWza s.mpf) by provuhng ennrertratics cut oc levela be set si that it may not be essential that b I Fiudance to werLars about when the 0 04 percent. Licensee.s h ave thz general actions takan to ad6sas alcohol musuma drugs can be used or atout the respona;hihty (nr evaluates the Etn*= be identi:a! to b actmns taken to i rmimum dosca ci the drugs that can be of their personnel wbether or not soma addreu & gal subatanc4 abuu. '

I used by en-duty workers. De speed.ed hn.it is indicated for either However, the NRC does bebeve that Lt is development of such guidan:a codd druFs or alechot Licensees may erseatial that hcensees test for the simphfyf e>=* fitasma for-cury estabhshlower cut-o!!leve!s.be %1d misues of minM an:1 that detected programs, promote e.ortatsrey recognize that there an practical inpaired workers are removeci frca throughout the imhnstry, and reduce the prdlems suociatad wits a saro at near- duty. Further, unen- unast be intnmive nature of the fitnew for-dnty zero cut o!! level for alcohat and should semquataly avere to deter drmbag programa. However, the NRC bebevea consider the potent.a! Impacts of 5t .r= proetices tha! resda in orH!ary that such guidanca abould be developed problems canfuDy before using vary impairment, and nevere enouBh. as I by the industry. Input froar. the =hrM low cat c!!levela. coacpared to the sametions suocasted

=~nunity would be espedsIly na NRC rmenrus tb valas c.f a with heal drug us, to enture that i valuable in this area and shodd ba required period of atstinence from wo:kers who abusa illegal dr:6s are not sos.shi, Shodd tuneJy prog eas not be drmisng that shodd precede all encouraged to marsly awite.b from a ma de in this area, th.2 NRC soay instituta schedWed tours of work.ne NRC pat:arn d unacceptaW drug iahng a d6tional rel> dig therefore is requinog benues ta actwity to a patzern d scaccaptable ne rule has beeD FMI*A te requart inc'.ade a3 "h*"a period d allaast alcohol rocaumption. One way d dning licer. sees to educate worksrs abcaa h 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> in tbs;r !?na u.[or. duty this la to take actions in the event of a c!Tects tgal dn.gs may have om job progrann. vicaation d the slechal policy that ase l

' ~

Focktral Registae / Vd. 54. No.106 / Wadreaday, June 7.1980 / Rules and Regulations 24481 )

the same as. or similar h the ections requimm eerts in the proposed ($ 2625) progra2n shal! be pmv6ded b heenseas saken when the libcit drug pobey is on employee assistance programs and and contreetors subject so this part but violateiIn the aboence of such actions. stated that soci prve were only upon a written release by the an effeebve program must prende necessary for the progrsms to be affected worker. Appopnate language l courance that a high level of deterrence successful Another commenter stated has been added to i 2627[e).De affect 6 pment and that workm who are that the term

• safety maaiderations? as of the language la '. hat if the wort.er impatred as a resdt of alcohol misuse used b this sectron, should be de"ned. elects not to previde such a release to an removed from duty. A commenter also requested that the hiring br=*: or contractor, the language be added that employse worker would be denied ==--ted n.0 Cor/Idantiality of 7bst&sub asasstance MP omamelors ocwas to protected areas.

i 11.1 hmary of r-ments would no* management when a bebef The oorcment that Me6 cal Review A number of commenters were

@ eat any wh a Moe (selb Officers enbocribe to the AOMA Code referred or notj may constitute a hasard cf Ethical Conduct and their ethical concerned abcnrt the oor.fidentiabty of

'" N*# *'

• guidelines for drog ecreening b the test results and the potentialimpact of %g 3 the rule on the privacy of workers nere cc * "" "

was concern tbst teet tern!ts might be faters e ted that acce to the o utinue to etudy this suggestion. For mdts d chical teshg shodd be inappropriately releared to the detmnent of workm. A number of gjonited to the greatest extent possible [urPoon owever, thed bNRCis pmmtsatisfied mlmaMng. that the 11 O al d 8' rpeciSc sagyestions were made to protect workers' rights.

' Net a ifah statemerrt of goalifiestions for Me6 cal Review Of5xrs b ( 2.9(b) of the NRC dts b particdar 11.1.1 Ccnfidentioffry ofReahs.

One commenter favored identifymg

((i n$ believed that te sNta Guidelines is adequete and en!!icient.

11.2.2 Use ofScmplesforOther abould not be released to law simples by a number coded to an enforcement spendes. Pwposes. De NRC bebeves that individu .! worker rather than by name. nere were a number of wmments Provisions in the rule 11rn! ting use cf Other commenters bebeved that there concerning sceen to Stoess fu -duty laboratory results to the purpose and abould be a protocol defming wtJcb records by NRC emp'oyees and acope of the rde are adequate.ne ,

beensee a workm should have accen representatives. Several ecmmenters projections afforded by the NRC to fitnen-for duty records at vanous expwned the view that the NRC has no Guidelines and i 28.29(b) are deemed to etages of the iming proeres. Several need for eccess to individual names and be suf$cient. Specifically, t 2.1[d) of the commenters axpmsed the n,ew that that if such information were provi& d it NRC Tes'.fcg Guidelines requim thet test results abould not be n4easable to might be toe- specimens collected under Part ze may bwnsees a omtractos urder 10 CFR made evet!abyropriately le to the pubbc.discloeed

!! was or only be des! pated or approved for 2627(b) withosrt the written approval of noted that Ircensees an expnnly testing as described in Part 26, and shall the c.ffected worker. Ooe commenter directed not to indede the es.mes of not be used to conduct any other propotrd that aD medcal personnel in6viduals under the p opoeed reportmg analysis or test without the pennission involved in the fitnes*.for-duty pro =ss requf*ments to NRC (i 28.73la][3]). but of the tested individual. Moreover, the*e odbere to the Amencan Ocerpetional that NRC is ehgible to receive names abould be no incuttve for employers to Me6 cal Association's (ADMA's)

• Code under propored i 26.29(b). disclose the information to unautbonzed of Ethical Conduct for Phyridans Two commentm suggested that the persons because of the possibiluy of Proviing Oxrpetimal Medical Protection of Information (126.29) liability related to euch chsdoenre Services? and the ADMA " Ethical belude nferences to contractors and Guidelmes for Drug Screening in the m 7m w g g9 vendors as well as beenmees.Ny icensee.ne NRC concurs that there is Workplace. further rugreeted that the refeream to 11.1.2 use of Scagesfor Oder a p tential for abese of positrve test ernployment decisions be replaced by results from preliminary terts exmducted Pwposes. A riurnber of commenters .cee,s decisions. Another cxxnznenter were also concerned that speci:nens rained the quesinon of whether by the bcensec.nese prehminary tests ta} en from workers wodd be need for do not beve tne accuracy oflaboratory-contractors as well as bcensees abound purposee beyond the scope of th* be able to obtain 2taew-for-duty moducted confirmatory tests, proposed Etneet.for duty ra!es and infor=stion ender the proposed Consequendy, de Snal rde halts suggested that language be aMed to the reFulation at i 2fL2p(b). An ad6tional accen to be prehminary test nsdts to regdetiaos hminns use of the samples commenter saggestsd that release af the boensee a testmg personnel.

' to desipated purposeA fitnew-for-duty informs tien under a 11 2.4 Carfidentialityfor Employee 11.2.3 Testr Conducted by the court order be added to the bst of Assistance Programs.The EAP Lacansee. The propcsed rule (to CFR permitted d:adosmes under I an.2e(b). require:nent at i 28 25 speciSes that 26241dj) weald allow lunaces to such programs are to provide conduct prehminary tests of a sample 11.1 S .ary of Responses rmhtial ascistance axmpt when before forwading it to a labweto y. 21Jt.1 Confident /alitycfResults ne safety occaiderations must prerail ne severn! courmenters were concerned NRC bebeves that further regrarusnemia NRC believes that the plain men Hng of that results af socb prehm. nary tests for the protectiam of worker somstle at these tenna is suf5 dent for this would be taeppropnately 6sdoeed and the tesung laboratory beyond the rulemahng and that further clari$ cation ected u;en pnar in catfirmation by the requinments of the NRC Guihaa are in the rule is not required.The NRC -

contract laboratory. ney proposed tha.t not needed at this tt:o L Section 3.1 cl concurs in the saggestion that suorloyee eccess to the resuhs of such preWwy the Gtadehnes coetains speci5c asa.5tance program counselors notify tests abould be etncth hmited.perhaps prcsecthoos for auch remrds. . mm pe.inent when there is a reamanable to the bcensee's laborstory staff only. The NRC concurs in the er-t that belief that any urke.r's cxubtma may 11.1.4 Confidentsaht,vfx Fn@yee informaton oc a worker denied Assistema ,%pciras. One coan:nenter uneomrted access or removed from hisor,others. mnstitute a basard and the to leasifhas rule's Language or bereelf motsd tbc Isck of epeciLca-nt4ty ponraon moder a f tmess-forsiuty been clanLed. , ,

• h((eTetadUt5n the provisions ca to emp3cyee sadstance propsma - . a @censcs physician."as shh2c3 cotites. achtled to access to laboratoey . services and that contractor employee Review 05cer, review all t:st resultst records as proposed in i 26.29(b) with 4 casistance programs meet the criteria of (5) the confhet with on-sits testint the execption that release cf the the licensee's employee essistanos ensted by the requirement that au informaton under a court order la programs, ne NRC h:s clso noted that tcsting be done by certifled laborettries:

cdded.The NRC does not anticipata supervisory penannel should not refsr . (e) laboratory certBcation procedur.s; requesung the results of laborstory testa employees directly to counsehng or and (7) limitations on sphtting specimen correlated to individual namas. tne tment. Rsther, supervisory personnel samples.To ensure that the HHS Nevertheless, the NRC wishes to reserve shodd refer employees to an employee Guidehnes are appropriately adapted to the nght to have acceas to speciSc assistance program counselor for the proposed rule. many commenters results when needed for particular assistance and further evaluation and recommended that the pertinent sections situations involving safety and referral. of the HHS Guidehnes be incorporated investigative matters such as no Imponance of#ecle endHuman into the rule Mack malfeseance in the administration oe Services Gwdehnes 1313 Limitat.rons in the Panelof management oi the 6tness for-duty Drugs for Which CertifiedLabontories propam. The NRC also has decided to 13.1 Summary of Comments - Can Test A number of commenters i retain the provision providmg access to 13.1.1 ProposedAlternatives to the 8peci5cally supported the intention and appropriate Isw enforcement officials. MIS Guidelines. Several commenters value of estabbshing uniformity across but has added the provision that such suggested that an altemative to the IMS licensees in the panel of drugs, with a ,

ofEcials must be under court order.It is Gmdehnes is the CoUege of American smauer number supportng a incre noted that there is no requirement to pathologists (cap) Forensic Urine Drup flexible approach that allows licensees routmely provide such ofLcials with Tesung (F1JDT) propam.The discretion to deal with local variability laboratory resulta. Moreover. It is commenters contend that the cap IVDT in drug use.

unhkely that such results would be progam is as equally rigorous as the A number of commenters objected to requested because the ofScials would HHS Cuidehnes but better suited to the procedures specifying how licensees have no prior knowledge of the resdts Ucensee's needs because:(illt has an are to identJy additionalillegal drugs of laboratory tests. educa tional component for laboratories, and incorporate them into their The NRC concurs in the comment that (2)it has accre6ted 25 laboratones as of pregama. on the grounds that these contractors within the scope of the October n.1988, whereas NIDA has mechanisms defeat the purpose of rulemaking should be included in the accre6ted none. (3) the cap FUDT uniformity. are unworkable, are d:sclosure and access provisions of program aUows laboratories to test for burdensome, and open licensees to legal Im:9(b) and the final rule reflects this ad6tional drugs and at other cut-off challenges.Some of these same ad6uon. The reference to employment levels than those speciSed in the }ES commenters. along with others, decisions in the proposed rde has been Guidehnes, and (4) the cap FUDT recommended that the HHS-specified replaced by access decisions. propam does not require approval from panel of drugs be expanded toinclude n.0 Employer Assistance Prvpcms the HHS Secretary. (for example) alcohol. methadone.

One commenter sussested that an brbitura tes, benzodiarepine.

111 Seary of Comments alternsove to the HHS Cuidehnes is the propoxyphene, methaqualone, and The NRC received a significant *AFL-CIO Guide for Drug and Alcohol prescripbon and over.the-counter drugs.

number of comments from bcensees Testng on the job." Several commenters Commente made at the pubbe meeting regardmg employee assistane, pconted out that stnngent quahty expressed concem about the potential j propama.The majonty of cor.menters centrols are required of testing for intrusion into personal medical l areed that employee assistance laboratories under state propame; two information if the panel of drugs is not pregams services are an effective commenters stated that New York State strictly speciEed and hmited.

roethod of combatting the broad had a stringent laboratory ceruncahon 13.1.4 Cut off Levels Definedfor 1 spectrum fltnees.for duty problems. program. Screening and Confirmatory Tests. A 1 Howe ver. most of the commenters 13.1.2 Applicability ofHMS substantial number of comments were spectLed that under the proposed rule Guidelines to the Nuclear Power received on the cut-off levd. for the scope of bcensee employee lodust.y. A few commenters indicated screening and confirmatory tests, many assistance propam services shodd be that the HHS Guidehnen shodd be suggesung specific cut off levels for hmited to regular. full. time Lcensee adopted by the NRC in their entirety. particular drugs. An i=portant personnel, contractor or vendor The large majonty of commenters stated disspeement among commenters personnel should not be covered that, although the HHS Guidehnes centered around the usue of uniformity several other commenters in6cated that prov;de many exceDent procedures for in cut-off levels. Some commenters employee assistance propam services ensuring the quality of drug testira recommended that standard cut off abodd not be regulated by the NRC rule propams. the HMS Guidehnes contain levels be established and applied by aU in any manner, and would be better terminolyy and provisions that are licensees in order to mirumtze addressed by the bcensees themselves. Insppropnate for appbcation to the inconsistency act-)ss licensees.

nuclear power industry.The maxim.re the defensibibry of the cut off 12.2 Summary of Responses inappropnate terminology and levela and avoid conflict with the The NRC bebeves that employee provisions noted by the commenters certified laboratory tesung procedures.

assistance pregam sernces provide a include (1) ref rrences to " agencies." to These commenters thought that salusble toolin cornbattt g fitness for- Pub. L 100-71. to the Pnvecy Act and to 6scret onary cut-c!! levels were duty problems in the nuclear power the HHS Secretary;[2] limitations in the unworkable because they wodd be industry. Therefore, as currently panel of drugs for which certified cha!!cnged in court knd were atmulated in the rule. It is the laboratories can test: (3) cut cf! level inconsistent with certified laboratory traponsibibry of each bcensee to ensure specifications defined for screening and procedures specified in the HMS

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Federal Register / Vol. 54, No/20e / Wednesday. june 7. 2580 / Rules and Regulations 344t3 CdMw Among these commanters, screening and coelinnatary eut-off recocumended that the requimnent for some supported the enstmg HMS cutoff levels for in6ndual drug types. heensees to esbmft bhnd samples be 1 levels and some recommer.ded thet the 13.1.5 Regulation of OrsSise elimirmed or substantiaDy reduced One tuiS levels be mod. Sed. guoerally to be Screenity Test Although the majartty of commenter pointed out the potentially more etnagent. A ruunber o' comments in this category addressed negstive effects of having boensees commenters suggested standards specmc aspects of on of te testing. prepan the false rtar-ntation reatchmg those used by the anbtary. several r=m,nters objected to associated with bhnd samples, and Other commenters, particularly these conductics onarita screenmg tests by othm goestioned wbether a sufficient representag bcenaces with cngoing drug bcensees on the 3 ocnds that euch supply of bhnd sami les would be testmg p ograms, recommended that testmg shou'd not be conducted by evalleble on a tunely basis. A number of Lcecaeca be allowed 6ametion to employm and that it would be acre commenters also questoned whether satabhah cut offlevels more etnntent costly, create too high a nsk ed ialse sufficient certified laboratory cape city 4 than the w=mcm spec 6ed in the rule, results, and result in claims of would be ava!!sb!c to implettent the i As a comprum.se, some commenters inequitable treatment. Other proposed rule. Comments both suggested that laboretory procedures re men tars, principally represents tives supported and opposed the nquirement ,

and testing be modded to require them of bcenaces and a health can products that laboratories be certined by 1015.  :

to comptle results at both the =*m manufacturer, supported oo-aite Those supportmg such certi$ cation uniform standard cut off and the screenin6 tests as effectiva, tunely, and recommended modJicahoe of the discntaccary levels estahHahad by the lesa casuy particularly if cmly proposed n;le to specifv that beensee, beensees. specimens that tested poaluve 6 the on- are to ese 106-certined blestones These corr. menten provided different site ahquot test are sent to the certiLed that are directed to ec A :t drug tests reasons for estakhahme various cut eff laboratory. Some commenten favored coortstent with NRC m Jcensee levels, reemp from very stnnpent to modificatwn of the proposed rule requirements. Several other cormnenters more lenient. A few mmmenten (i 28.:yd)) to allow bcenames to objected to the requirement for }0IS supported the estabbshment of cut.c5 estabhsh FOG-certined oc.aite cert $ cation. noting that it would bkely 125 els based oc an objective of laborstones and to avoid confhet with prevent them from using h?h-qual +f .

sstabhahing a dru& free workplace, the HHS Guidahmea. Changa in the locallabontorie A and wou,d pms et recom=~+9 essent> ally zero spec 6ed procedures for on-alte testing them from testing ad6tional d.up -

or tolere_nce and settmg cut off Icvels just , were also recemended inc!cding setting more stnngent cut oU levels high enough to avoid positves from enabhas ceruned laboratories to match (unless such tsodications are made in chetary coast:nption of legal rubsta:xes. the cut offleve.!s estaN by the on. the appbcation of the certication Othm proposed the estabLsh: ment of site propam. The need for canful process, as discossed above). They cut off levels that were the lowest Imost attention to conCitts with speciDe recommended that the NRC adopt a

• stnngent)leve!s assoosted with wordmg in the HHS Guidehnes was provision authorizing licensees to utilize impeinnect. Others, sometunes noted. (Furtber iscussion of the cut og a drug testing laboratory that is either expbcrtly recognizing that the levelIsrue is provided elsewhere.) certified via the ISIS Guidehoes or is estabhshment of ett cU levels invo}res 13.1 A Requincents forReview of cernfied under a state program that is a Am%ntratve cor.siderations. Test Results by a Me6calReview gennsUy comparable to the HMS recommended the us e of " standard" and Q7/cer. A cumber of comments were prog *am Other commetters suggested moderate levels that ansat in the nceived concerning the quallScotions authonzation oflaboratones ce-t$ed by estabbshment of an accepted, wide $y- and role of the Me6ca! Review OfDeer The CoUege of American Pathologists used standard and reduce vulnersbthty as specified in the HHS Guidelines. Forensic Urine Drug Testing (CAP to legal challenge s. Still others, parapapb J[b)(33 FR 11965, dated FUDT) program.

gener3Dy those representmg the workars Apr011.1968) Commenters 13 1.8 SplittingSpecimenSemples A and unions, supported cut-c5 levels thet recommended thet, should the IDG number of com=entm recommended test for impairment rather than noe and Guidehnes be generally adopted. these the use of split sampics to provide an thet set levels where }ob performarx:e is speci$ cations should be roodiErd to additional quality control meseun and probebly affected. e!!minate the requirement that the MRO to further protect the rights of the A number oflicensees commented be a beensed physicia:Mey workm by aHowing a second check on that they an cumetl 3operstmg d ng reocmm nded broadening the dennition confL med positive results. Commenters testing programs which beve more to inebde other beensed me6 cal care differed in their specific stringent (lowcr) cut off levels than the providers with training and knewladge recommendations concerning the HHS Guidehnes, especially for in substance atmse disordm and their number (2 or 3) and specific procede es marijuana. Commenters were &vided in treatment. identification and use of for testing the reserved sample (s).

their positon retrardmg adoption of the controUed substances, and perecrfption fDE Guidelines for cut-off les els. Sosse practices of pharmacies. and to pruride 13 2 Summary @esponen supported the 10E Gaidehner, others for consultation of the MRO with a 13.2.1 Propc'sedAlternatives to the eupported the more stringert levels licensed pbyeietan for resolution of IOfS Guide /mes. 'Ite NRC beberes tha t proposed by NUMARC. A istge enumber unusual circumstances. One commenter the ngor required by the HHS of commenters thought that the 105 recommended changing the tern Guidelines is not estched by any of the l cet off nevel for mantuans was too "Medimi Review O*ficer" to "Me6 cal propoeed alternatives. The NRC 1:nient. etnns experienw from ongoing Review Profes sionals* to avoid poorfble Guidehnes eddress many of the proFrums that a very high proportson confusion wtth beensee executive concerns erpressed by the comrnenters.

(over ao percent in Com:nor. wealth ouicers. The NRC believes that the highest E6 son's e year old prog sm) of positive ~13.1.7 Zaterotory Cart /fketion standards an r eeded to assure thet the marijuana lesi reesits f all betweco 20 Procedun a. A number of commenters testira process is ecetrate. produces cnd sto ng fml. A onmber of commeetm thcaght that the evmber of blind valid results, and provides auf tobic provided spedfic recommendations for samples was exceertw and -

protection for these being teeted.

t

. I 24484- Federal RegiMar / Vtl. 54. No.106 / Wsdnesday. June 7.1989 / Rules and Regulations 1313 Applicability of1059 , specimana from the pre soones foe. r - Services, and may taeue an am-nA==nt Guidelines so the NuclearPowar - caus. random, and follow-up testing to Part 28 if deemed appropriate. .

Industry.The NRC bebeves that many , pmpam an to be tested by adding i . In response to objections by beensen ,

cf the basic requirements of the HHS alecholin addition to marituaa. to the requirement that they must <

Guidehnes must remain a vital . cocaine, opiate metaboutes, consult with locallaw enforosment l component of the NRC drug testing phencychdine. and amphetamines, authorities and drug counseling servicer  ;

regulations.Howevar the NRCis aware Furthermore the rule will allow to determine whether other drugs are that the Guldehnes. as written by HHS licensees to indude additional drusa. beint used in the geographical locale of I to apply tu testing by Federal agencies. especially those found to be prevalent in the facility and the local workforce and. I do not perfectly fit the circumstances of- their geographic area. Licensees would where approprista, add these drugs to the licensees regulated by the NRC. be required to develop appropriate test the list of decgs being tested. the NRC -

There are many references to legal protocols an ! cut offlevels. For cause - has made this element of the program authorities and other matters that are - tests are not t'imited to a specified panel optional.To addreas the issue of peculiar to Federal agencies (e.8- of substances. - changing drug use patterns, the NRC -

references to the Pnvecy Act, to In determini"F which drugs to include may conduct periodic reviews of the Executive Order 1564 to the Secretary) in the NRC Guidehnes, the Commission . minimum drug panel that could result in and terminology that may be confusing assessed evidence regarding the extent the indusion of addibonal substances.

in the NRC regulatsd industry contax1. of use of the vadous drugs 1314 C#f"0/IldFels Oe[ined[of ,

in addition, the 1015 drafted the recommended by commenters and the Screening and Confirmatory Tests. In l Guidehnes to apply to the physical and response to comments concerning the potential for impairment from the licit organizational circumstances of Federal use, where appropriate. or abuse of appropriate cut off levels at which agencies. Obviously, the circumstances samples will be considered positive, the those dress. The NRC conduded that NRC proposes the screening and cf industries regulated by the NRC are the pud d drugs in the HMS very dderent from those of Federal Guidehnes adequately covers the moet confirmatory cut offlevels set forth in egencies. Furthermore, as discussed extensively abused illeFal drugs, but the NRC " Guidelines for Nudcar Power does not suffidently address the major Plant Drug and Alcohol Testing below, permission other aspects to expand the of theofrule panel d i.e rugs Propama." These levels define the drug dass of sedatives [1 e~ standards for establishing presumptive and estabbsb more stringent cut-off benzodiazepines and barbiturates).%e levels. require modification of the HHS use and abure of sedatives by nuclear positive and negative results for the Guidehnes to facihtste implementation. minimum panel accor6ng to the NRC pcwer plant workers are d s@ cut rule. However, in response to numerous Consequent y, the NRC apees with concern for several reasons. {

nany commenters and is in its rule, comments by licensees, many of whom drectly implementing in its own Altboph most sedstive drugs are h e &'ug prop 4 m I regulations specific testng program obtaim. Wally through prescriptions or stringent cut o!! levels for the '

Fwdehnes (sn .dsption of the HMS in over the-counter medications. these substances induded in the proposed Guidehned that are appbcable tc NRC crugs are subject to abuse.In faet, some minimum drug panel, the NRC rule bcensee fitness for duty propams, researchers han sugEested that estabbshes eninimum standards for the l

These testing guidehnes are intended to sedetve abuse is more prevalent that panel of drugs and allows licensees the l leave intaet the safeguards for aecuracy the abuse of opiates in this country. In ditcretion of setting more strmgent cut-end privacy in drug testing eetabbshed ad6 tion. contmued abuse of these off levels for these drugs. For example, substances can lead to dependency and instead of using their normal cut o!!

by the HHS Guidelme6 while ensurms that the parties regulated by the NRC "pbysician bopping

• or ilkgal behaviors levels for for-cause and follow-up l to obtain suppbes of the drugs. testing. Licensees could obtain dna on can practically implement the requirements. Editorial changes have Consequently, detecton of the use of uy trace amot'nts d dmgs for dal sedatives and an evaluation by the evaluation of at risk persons.Cernfied been made ta the HHS Gwdehnes to adapt the terminology to the NRC and Medical Review Officer of the manner in laboratories are authorized to test and its bcensees' fitness.for duty props na, which a worker is using sedatives are reprFt results at these more strmgent Special note should be made that the important to prevent the development cf cut ofilevels. if so requested by the sedative-abuse problems. Licensee. In keeping with the objective of lir.t of substances to be tested and cut.

off levels es'abhsbed in the testing Of g eater significate.e is that the use uniformity and the estabbshment of a guidebnes are subject to change by the of sedatives while on the job, even at comparable database, however, the NRC in response to industry experience physician-presenbed deses. may result laboratories are also required to report l cod changes by the Departmer ; of in significant tmpairment. Although results for the standard" cut-off levels Health and Human Services as many types of performance are established in the rule.

advances in technoiogy, ad6tional detnmentally affected by the use of 13.2.5 Regulation of On-Site experience, or other considerations sa dat ves, attention and the abibty to Screenittg Test Although the NRC is I wanant indusion of ad6tiend c.ainta!*. vigilance are particularly sensitive to the concerns of workers i substances and other concentration impaired And, when combined with expressed in the comments. the stringent Jevels. alcohol, the impairing effects of quabty assurance requirements of the l 13.2.3 Lirnitorions in the Parelof secatives. especially bartituratea. are rule and the rigor of the HHS I long lasting and severe. However, to certification process have convinced the Substences That Certified Loborctories mamtain consistency with the HHS NRC to retain the option of on-site Can Test Under the HHS Guidelines (2.1[a]) a Federal agency's random drug progam the Commission has decided testing. Under the NRC rule. bcensees testing pregam may test a urine se.mple not to melude ber.zodiazepines and may perform the breath tests for alcohol only for certain specified drugs.De barbiturates in the required panel of and the preliminary screening tests M NRC Guidebnes at Section 2.1 modify drugs at this time.The NRC will further urine specimens provided that the this requirement by expan6ng the explore this matter with the Secretary of licensee's staff possess the necessary minimum panel of substances for which the Department of Health and Human training and skills for the tasks

-- .AV

Federe*, R: sister / Vol. 54. No.108 / Wednesday, June 7.1989 / Rules and Regulations 2C enigned, t%r qualiBcatons an rule. In addition to } dis certification. confbets with the background docume .cd t.nd adequate quahty laboratories used by beensees must investigation elements section of the controls are implemented. These demonstrate comparable performance requirements have been include % % AAPS. Proposed i 28.27(s) requires tha t and rigor in testmg for the additional hcusees conduct a suitable inquiry i

NRC Gu delines.FoDowmg prea nr3 substances included in the Lcensee's print to granting unescorted access to screening. these Ucensees woule. WJ. spectfied panel of substances (La the c11 presurnptive positive specimens .no determine if a worker has tested NRC mWmum panel plus any positive for drugs in the past.The term o sample of negative specimens to an discretional ad6tions of the bcensee).

• suitable inquiry" as defined in i 28.3

} dis.certned laboratory for a second 1318 SphtungS ecimenScmples.

P requires veri $ cation of employment scnen and for confirmatory testing This ne NRC is sensieve to the concems of history for the previous Eve yean end to will substantiaDy reduce the number of nuclear power plant workers regardmg specimens that must be packaged, sent, determine whether the worker had a.ny the adverse consequences of false positive drug testa.Many commenters cod handled at the ceruLed laboratory, positive test results and the advantages pointed out that this requinment will be The NRC rule does not prohibit of using spbt samples to provide an bcensees from estabbshing laboratories very difEcult and costly to treet in part ed6tional quabry control measure and because prior employers will be end seeking }0IS certifica tion. Shoald further protect the rights of workers by reluctant, because ofliability concems.

} DIS cert.ficetion be obtained the aDowing a second check on confirmed to relesse records of drug use. even with licensee would be allowed to conduct positve results.The fint abguot. along a signed release form. One commenter both screening and confirmatory tests at with appropriate chain-of-custody pointed out, for example, that under this laboratory, documentation could be (1) transmitted i 26.::9(b) a bcensee would not be 13.2.6 Requiremen sforRenew of to the } dis-certified laboratory for TestResuhs by o Me&cc1 Renew authorized to release such information screening and confirmatory testing or (2) to another employer who is not also a Offwer. After carefulreview of the transmitted to the authorized on site boensee.

comments received regar&ng the screening labora tory for prehminary Me6 cal Review OfLeer and Tbc commenters noted that the testmg The second abquot of the spbt required background investigation in ,

examination of the Me6cc/ Review sample. along with appropriate chain-of- Secton E11 of the Industry Guidelmes OffwerManuelprepared by the custody documentati Department of liealth and tiuman in a secure refrigerat,on, on unit orcould be placed appended to the AAPS covers similar Servic s (September %68). which material to the 6tness-for-duty rule, but forwarded to a second laboratory for is not as severe.The investigation desenbes the role and responsibthties of retenton. Sbodd the specin st contrine several elements, one of which the MRO. the NRC has concluded that Posibve. the second abquot cc.a be is a check on an appbcant's character this posibon does require the tested by the second }GiS certiLed cuahScatons of a bcensed ph)sician. laboratory, and reputatica includmg prior ides al use To ma mtain consistency with ;be }OIS or opasession of a controUed substance.

k 'he case of on-site screening. the program, the NRC has decided to retain sund abquot codd be discarded if the info: mane is to be obtained from four references. two supplied by the the ttle Me6 cal Review OfLcer. prehminary test (screen)is negative 11 1317 laborctory Cemfecodon the screening test is conducted off. site.

applicant and two developed by the the second abquot codd be d;scarded stibty. Onployment veriScaton in to be Pwedures. The NRC has g:ven ca.reful immediately upon notification of a obtained for a minimum of three yean.

consideration to the nu=ber of bhnd in addition, the evaluation enteria in s+mples bcensees must submit to the negatve test result for the specimen.

certified laboratory and has determined Section 7.1 of the AApS require utibtes Even though there is a high degree of that the number specGed in the NRC assurance of the accuracy of the test to assess the impact of past ibegal use Guidel'oes is necess try to maintain or possession of a controDed substance.

reeults provided by the chain of custody One commenter po!nted out that the adequete quality control. In ad6 ton. and }GIS certiSed laboratory proposed suitabibty ingmry bcensees which expand their drug panel Procedures, chain-of custody concerns requirements wi'J cordbet with the bey ond the NRC speciDed rMrumum by tested workers would remain no panel tre responsible for submittmg a matter bow precise the process or talid required background checks for security sufficient number of appropriately the resyts.Therefere, the NRC has perammelin to CFR Part 73. Appenix

• spiked" bhnd samples to meet decided not to mandate nor prohibit B. These beekg ound checks require the equivalent laboratory quabty control licer.see toinvestigate a number of requirements for those editonal drugs.

spbt samples: the by licmees where ad6tionalapproach may be need elements related to selection of secunty Tbr NRC has consdted veth penonnel penormelincludmg whether an j confidence in the process by the of the OfLce of workplace Initiatves in workforce is sought. in6vidual has any history of alcoholism the NationalInsttute on Drug Abuse o? drug addiction.There are no specific H.0 Reladonship to Access time periods associeled with the and his been asrured that sufLcient Authorizouon required background checks.

bhnd samples ar.d laboratory capacity will be avallsble to implement the 14 1 Summary of Comments 14L2 Overlapin TmininE proposed rde on a timely basis. Requirements. One commenter stated This section covers comments relating that the training requhtments for Gtven the importance of protectmg to the potential overlap of the proposed workers from false positive test results supervison and escorts in i 2823 FTD rde and lodustry Guidehnes already exist in Section 9(c) of the~

cod the absence of clear evidence that appended to the proposed Access Industry Guidehnes and that the cJternative certtficaton procedures Authorization Policy Statement (AAPS) provide an equf valent level of rigor, the requirements in the 8tness-for-duty rde appearir,g at 53 FR 7534. March 9,1988. could therefore be ehminated.

NRC rde maintains the requittment ior 14L1 Whatis an Appropriate l hboretones to obtain HHS certibcation Tuitchie inquiry 7. A number of 14L3 ReJouonship ofEmployee in order to perform corLrmstory Assistance Programs to the Proposed sommenters raised tbe issue that the Access Authonzouon Pohcy Statement.

chemical tests on specimens submitted

• suitable inquiry" requirement in for tests under the provision of the NRC One commenter raised the question of i 2827(a)is too severe and aleo whether a voluntarj referrsJ to an

. en.ployee essistroce progra:n raises an Accees Authorization N/cy Statemed

• system. PubBe C!tizen expressed general access authonzation forue under the

• ne NRC recognizes that there is a- . support of the reporting requirements Industry Guidelines app;nded to the - connectice between the employee and recommended that thiy be proposed access authorization policy assistance program and proposed seases augmented 13 include adttiinal . -

etstement. Under the Guidelines. Illigal authorization policy statement - information, use of drugs is an evaluation criterion requirements. Under Section 26.2& 1513 Reporting 7Yme Requ/rements.

for unescorted access (l 7.1[b]) and an amployee suistanos peogram etaff wfD Se-tion 26.73(s)(2) requires detailed element of the continual behaviorsl provide confidential assistance exespt nports on au sigr.ificant fitnew-for-duty observation program (l 9[a]). when safety considerations must events and actions to be made to the 1414 Temporcry UnesconedAccese pmvaD and when the employee NRC Operations Center by phone within Authoritorion. One commenter noted assistance program counselor believes 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> and in writing within .40 days.

the temporary unescorted access that a worker's condition poses a hazard Many commenters claimed thet the 24-authorization in I 6.4 of the Guidelines ' to himself or herself or others. hour requirement is excessive. Others and ststed that it abould be made clear Otherwise, voluntary self-referrals to pointed out confile.s or potential that during the sultable inquiry penod. the employee assistance program are

• confilets between reporting the temporary access'authonation treated confidentially and am not requirtuents in the fitnew for-duty rule woulo be available- reported to management; therefore. that and those cited in te CFR 73.M.10 CFR 24.2 Summary of Respcues information would not be available for 50.72. and Reg. Guide 5.62.

disclosure in respone to as inquiry of 15.1.4 IncidentLocole. Commenters-1411 Whatis an Appropritree previous etnployers.ne NRCis posed questions as to whether drug or

,Suitab/c inquiry 7. The NRC satisfied that there is not an recognizes the potental overlap alcohol related incidents should be inconsistency in the en.ploye' reported if they occur outside protected I between the required bach;round ass stance program and caed access anae-either on site or off site.

investigations in the Etness-for-duty rule authoruation policy statement ,

end the proposed AAPS.ne NRC requirements and consequently no 15.2 Summary of Respotaea  !

agrees that the background investigation changes are made in the final rule. 15.2.1 Titress for Duty Program required in the Etnen for-duty rule may 14.2.4 Temporary Unescorted Accese Performance Data Form. ne NRC does be 6fficult to conduct in some cases and Authorization. NRC agrees that not believe that co!!ection of data in a thet the desired informat on may not licensees may grant temporary 4

always be forthcoming Consequently, standard format unnecessarily burdens unescorted access authorization licensees. CoDecting data in a standard has provided that all requirements h',[,*odYed p f a a t format would assun that appropriate pertaining to the granting of temporary data is collected and would facilitate effort" venfica tion. that is, attempts access have been completed and the should be made to obtain mformacon periodic analysis and au6ts. Certain pr spective w rker has passed a information is necessary for the NRC to l for the entire Eve par period but under chemical test. Clarifying langua ge has no c.rcumstances may unesecrted evaluate the effecoveness of the rule acceu be granted besed on an been added to i 2er(s). (and if neceseary, make appropriate j employment check ofless than three W Reportira andRecordieeping improvement or changes) and industry programs and a stsndard data format j bests. In ad6 tion, a requirement has 15. Srnmary f Comments would provide e tool for the '

een added to l 28r(s) that a suitable inquiry will be conducted only after 1511 Tefness for. Duty Program Commission's periodic review program.

obtammg a signed release from the Performance Dcto Term. Many No specific improvements to the form worker or prospecuve worker comments on the data form were were suggested by commenters.

received. All were severely negative. Hewever. NUMARC ha,e developed af.d authonzing the inquiry, ne NRC recogmzes t he potential ne consensus was that the stated data proposed to the NRC a standard form editonal requirements under the requirements are excessiva, for data coUection.ne NRC will epectfy fitness for-duty rule as compared to unnecessary, and expensive and win only the general types of data to be currently required be tkground checha contnbute nothing to the public health coUected in the rule with the for secunty personnel contained in and safety. Virtually all respondents expectation that all power reector Appendix B to part 73.Nevertheless, the asked for deletion of the form andits licensees will use an NRC-approved required checks with prior employers in associated requirements. NUMARC form.

the fitness for-duty rule are considered 1512 Repotu to NRC Section 26.73 1512 Reports to NRC ne NRt: sees necessary fcr the safety and security dtreets the bcensee to provide no reason to change the rule in response reasons noted earber, information concerning fitness for duty to comments that sensitive information 1412 Over/opin Trcining events. This was presumed to include not be provided ne reporting Requirements. The NRC recognizes that identces of violators and a record of requirements in i 26.73 have bet n

- there is some overlap in the two training the incident and its disposition. Some mod fled to add alcohol and delete l requirements, but does not find any commenters thought that the NRC is not writ $en reports of reportable events.ne I inconsistencies. Moreover, the fitness- qualified to ensure the necessary degne rule has been modified to require for-duty requirements are more of cortfidentiality demanded for these periodic submittal of program comprehensive. to include techniques records, while others poir ted out that performance data.

for recoptizing dregs and understanding the NRC band'es much sent;itive 1513 Reporting Time Requirements.

the role and responsibilities of other infermaton includtng classified ne NRC will maintain the 24-hour fitness for duty program elements such information and thus is well qualified to reporting deadline for fitness-for duty as the employee assistance program. receive specific fitness for duty data, events invching licensed operators and Consequently, no changes were made in Among the latter, one commenter went supervisory personnel. Licensees should the final rule. so far as to suggest that the NRC.rather note that this provision supersedes and 1413 Re/ctionship of Employee than the licensees. implernent and relaxes the 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> reporting period Assistcze Progrnen to the Proposed a6ninister the violations tracking required for the fitnen.for duty .

Tod:ral Register / Vol 54. No.106 / Wedn:sday, June 7,1989 / Rules and Regulations 24487 categories of safeguards events in to maintaining the reports at sach site CFR 73.71.The NRC will pubbsb a licensee employee. Ocly by monitoring would be a redundant effort. the effectiveness of contractor programs revision to Regulatory Guide 5.62 to ensun consistency with this rule. 16.2 Summary of Responses that the beensee accepts and requing necessary changes can the bcensee be  ;

15.2.4 Inc.identloccle. The NRC has The NRC bas maintained the '

modined the wordmg of i 26.73, i E8Ms) nquirement for an audit assured that the trust imphed by the branting of unescorted access is

' F.eportmg !!equiremer ts," to make it frequency of cominaDy every 12 months. warranted.

cliar that incidents involving bcensed Th a bcision is based on the need to cperators or supervisory personnel assun the nbabihty and accuracy of The intent of the wording in the occurring off site or external to chendcal tes' r.g procedures. As indust 7 proposed rde is to reduce the burden on protected areas must be nported. expuience m Stnnsdor&ty beentees by allowing audits of propame accumula tes and is made contractors to be shared between Ja0 Audits ofTitness.for Duty available to the NRC, the Commission beensees and to nduce the burden on Programs may re. evaluate the frequency of contractors who provide persormel to several utibties by reducing the number 16.1 Summan of Comments Approximately one-third of the ThR s k (b) and of required au6ts.However, each to 80(a) of the proposed rule contained a bcenne has Be ultimate mpusW mmments received concerning audits of confbet concerning protection of to ensure that aU contractors performmg fitness.for duty programs addressed the schn n wi so pe oMe rule frequency requirement for the audits informa tion. Secton 26.29(b) has been compfy wi e e. 3 revised to expbcitly aDow licensees to which is 13 months in the eroposed rule. have access to personalinformation that {

The NRC spees it is unnecessary to The majority of these c. :.senters stated may need to be examined during audits. dictate where the licensees abould l that the rule should be revised to require The NRC inte ationaDy has used the maintain ceptes of the su61 reports as an audit every three years, after en word

• effectiveness' throughout the rule long as a copy is avallable for NRC inical audit is performed within 13 to ensure thet aD affected parties inspectie. Section 26.80(a) has been months ofimplementacon of the maintain an overaD concern for the changed accordagly.

propam. Most of the other commenters rule's objectives rather than focusing on stated that the audt frequency should documentation of progam compbance 27.0 ImplementationSchedule 1 be once every three or Sve years. One with *the letter of the law." Although 17.1 Summary of Comments i

commenter stated that the suit penod comphance is important, the abodd remain on a IFmonth cycle. Commission's over.ndmg concern is an The NRC received numerous Two commenters questioned how answet t the questior "Is the program co on tb pos information that is protected under

• g R eb t t Lghteen comments were rece erd from u tr d o o$tr c rs as d bed wordmg in the rbe de e to define in6vidual beensees. In ad6 tion. a t i 28.80(a). Section 26.29(b) prchibits au6 tor quahfications. The intent of this numbu of othu beensees submitted uisclosing some of the informaton that secten is to ensure that an individual, lett to dorsing eh C posib,on would be couected during an au61. I p w no a ed M:ny commenters stated that the ej g[Rys -[s tion on the word ' effectiveness ,in il 26.84a) and substance abuse is not assigned to implemutatin schedult Commenters 26.CO[b]is too subjectve and that_ evah, ate the effectivene,ss o5 e pa-ticular generally areed that 90 days was

'comphance with the regdations pgp g a decision insufficient tune to implement the ,

1 abould be the requirement. making Similarly, the NRC expects that provisions of the rule. Problems with the Several commenters stated that the rsons who are evaluating testing development of training meterial.

phrase in i 28.80'b). "m6viduals (boratories wiD be knowledgeable mo6ficatie of existing EAPs.

quzhfied in the subjects being audted,o about the forensic implications of development of ariministrative chould be clardied. laboratory procedures.Because procedures, neFotiatiens w.tb unions, indviduals who possess the requisite and the estabbshment of contracts with One commenter stated that i 26.83(a) skills to conduct these su6ts an likely chemical testing laboratones were cited chould be revised to delete the to be relatively rare and their services requirement for the beensee to be by many of the commenters as reasons responsible for the effectiveness of needed only infrequently. licensees wiU for the need for a longer period for contractor propams and probably find it necessary to contract implementation. Most commenters for appropriate audt staff rather than augFested that too days be allowed for implementation of appropriate staffmg an entire su61 team from the corrective action for contractor implementation of allprovisions of the prognms since this abould be the beenare's Quahty Assure'.ce Program, rule. Some commenters proposed that Current wording in the ruie le intended additional time beyond 180 days be contractor's responsibibty.

to recognize and encourage such an allowed for the implementation of the Two commenters stated that approach to staffing program audita. random testing provisicna of the rule.

I 2e 80(s) abould be clarified as to W NRC does not agree with the whatber or not a licensee may accept commenter who suggested that licensees it2 Summary cGupusu su6ts for contractors conducted by abould not be responsible for contractor ether licensees. b NRC p!sces a high priority on the propams. As noted in the discussion of One commenter stated that the implementation of the $tness.for-duty commenta pertahung to the scope of the programs and policies required by the requirement in iI 26.80(a) and 26 80(c) rule, the licenz.ee is the granting that su61 reports be maintained co-alte present rule. Many licensees already authority for unescorted access to .

c.nd at corperste headquarters be have in place mest of the key propam protected areas and so is responsible for elements.However,because of the chacFed to corporate headquarters only. the fitness.for duty and the rehabibty of complex provisions of the rule, the need The basis for this comment is that some any indviduals to whom usescorted etdines have sescral reactor altes and for some licensees to estabbsb a ocess is granted, whether contractor or contractual relations with laboratories.

0 e

l

', 24483 Federal Register / Vd. 54, No.108 / Wedn:sday. June 7,1980 / Rules'and Regulations the n:ed to develop implementatsoe

• 1&1.2 redern/Rahabiuscuan Act. A' 18.2 Summ-y of Responses procedures the need to augment few commenters euggested that tbs cxisting training mater.51a. and the need Comre.fssion should addreas the Federal 18.2.1 Consufvuocol@ ofRule. It la

. to coor6 sate the provisions of the rale Rehabibtstion Act of t973, as amended the Commission a considered opinion at by the Rebabuitation. Comprehenalve this point that continued assurance of with numemus contractors and nigotiate with unions, the NRC is Services, and Developmental nudear salm in the operation of power i convinced that the quality of the nactors fuDy' fustmes the rule being Disabilities Amendments of1979(29 pmmulgated.De imperatives of safe propams will be =4mca d by extending U.S.C. 701-790)in relation to its fitnese.-

the implementation of all provicions of for-duty rule. oPerstion of nudaar powar nactors the rule until180 days after the eficctive 18.1.3 Preempuon of State andkool demand a workplace where the date of the final rule. Because of the Laws. Several commenters noted that. reliability. intagnty and physical and ,

importana of the rule. & NFC cannot some states have enacted laws that mental Stness for their assigned duties l support the further extension of the appear to conflict with the of all categories of workers with -

implementation of the random testmg Commiesion's rule. and requested unescorted access to plant equipment is provision of the rule past the llKkiay darification whether the Commission's unquestioned.The program being i d:adline. rule would be preemptive of state and mandated by this rule is nasor. ably Although licensees need not submit locallaw. nlated to the achievement of the wntten pobefes and procedures to b I E1.4 APPeoIProcedure. Some Commission's safety objective.no i NRC for apprcval pr.<or to implementing commenters questfoned the need for and Commission has no doubt ht the ru!e i their progams, the Commission has scope of the appeal procedum requimd will signincantly enhance safety of reserved to itself the authority to review by the rule. Reference to due process operations at nudear power reactors. It the propam at any time to assure that was seen as importing unnecessarily goes without saying. bowever, that the the propam meets the performance complicated judicial type procedures. Cocun!ssion will review this rule in light ebjectives of the rule. II the review or and that fairness was the goal. of relevant future Supreme Court other inspections detect a shortcoming Reference t3 collective bargaining decisions, and make whatever revisions in the propam. the Commission can Procedures was viewed as undesirable those decisions require.

then require corrective acton. occause those procedures often %e two cases cited above were -

incorporate binding arbitration which decided or, March 2'1.1989 in favor of 28.0 Lego11ssues would also unduly compbcate the drug testing as presented by the 184 Summary of Comments appeal of denial of unescorted acmas l circumstances of those cases (Skinner v.

• U'I Railwaykborbecutives Association.

18.1.1 Constitudonality ofRule. Ry* y, , , h'* l Several commenters noted that lunited to permanent employees of the 8 usk anmumWomy ,

signincantissees of consutsticnality mployees Union v. Von Roob. No. SS-licensee and not be extended to the 1879). Neither presented issues to the with regard to drug testing in the employeee of contractors. i workplace base been raised under the Court for its consideration in the crert 18.1.5 Pmsecuan of tnfonnodon of the imperstfves of nuclear safety not Fourth Amendment and that these Some commenten raised questions issues are currently being reviewed about the protection of information, addressed random testing. However, the withm the judicial system. Two dmg specif c4Dy reporting ofinformation to be of eose casts ;ves &

testing cases are on the current calendar local police, and d2sclosure of Cornmission added assure.nce that this of the United States Supreme Court. irkrmation to arbitrators and the rule represents t proper and prudent l regulatory actie.n for the protection of j (Nadonal Treasury.*mployees Union v- affected ind2viduale. One commenter Von Roob. 316 F.2d 170 (5th Cir.1987), asked the Commission to address tbc public health and safe *y. ,

cert. granted.108 S Ct.1072 (1988): relationship between protection of  !!is already well established tbtt l Railway Lcbor Decutives Associcuon information under tbc Commission's rula Persons working in nuclear power plants

v. Bumley. 839 F.2d 575 [9th Cir.1988). and the information protection have diminished expectations of privacy ce.s gmored,108 S Ct. 2033 (1988))- requirements of 42 CFR Ps.rt 2. dealing in the workplace with respect to fitness-Generally, commenters representmg with drug and alcobol abuse treatment for-duty issues. For example, control I operetors of power reacton support the programs. room operaton are licensed under rules constitutionality of the rule, while 181.6 Co!!ecure Borgoining Rights. (to CFR part 55) that require medical commenters representmg labor A commenter raised a question about examination biennially and general organizations or individuals challenge the relationship of the Commission's good health. Security penonne4 are the rule's constitutionahty. A few of rule to the rights of workers under the subject to medical and mental these commenters suggested that the Nabonal Labor Relations Act to bargain qualifications. Including use of alcohol Commission delay its rule unbl the over conditions of employment and ar'd drugs (see 10 CFR part 73. Appendix Suprerne Court has acted on the cases asked that the Commission state its B). All personnel and their hand-carried before it. position. Items (such as lunch bcxes) are subject A few commenters stated that the 18.1.7 Employee Assistance to search upon entering the prciected taking of the urine sample for analysis Pmprom. A commenter asked for the areas of nuclear power planta, including presented a violation of a person's right Commission to indicate its legal pat down searches when metal and of pnvecy under the First Amendment to authority for including employee explos!ve detectors are not working or the Const2 tut on. assistance programs in the rule. when there is suspicicn that the person A few commenters questioned 18.1.8 Admmistmuve Procedures for may be attempting to brms prosenbed wbetber the rule nught not violate the Alcohol A few commenters questoned items into the protected area (see to ntf inenmination provision of the Fdth whether the notice of proposed CFR 73.55). Most. if not all. Licensees of Amendment to the Construction in rulema. king was edequate to address nuclear power plants also are committed parncular with regard to the potential issues reFarding alcohol use and to through their secunty plans under to for relesse of adverse test results to support the inclusion of alcohol-related CFR part 73, to conduct background jocal pobes. provmons in the final rule. investigacons admmister psychological

Federal Register / Vol. 54. No.108 / Wednesday June 7.1989 / Rules and Regulations 24489 examinations end observe employees at 10 CPR 44(d) and means ennentially for indications of abettant bebedor, proceduto is not being hm!ted to the proviolon by the Faderal permeent employees of the licensee.

Licensees also have behavioral Govarnment of any funds or penannel observation programs that fo!!ow Edison or property free of charge or at reduced ne Commisalon notes. bowevar. that in union plants the review procedure Electric Institute guidehnes. Finally. all persons with unescorted access to rates The Commission does not provide cavers drug and alcoholissues subject any Federal financial assistance to to coUective bargaining and that the nuclear powei plants are, by Federal nude at power reactor licenseen. On the law subject to a criminal history removal of the reference to coUective contrary, the Commission charges bargaining agreements in the rule does records check that requires the taking af power reactor licensees for the not preclude bugained for procedures.

Engerprints and the submission of the regulatory services it renders (see to fingerprints to the Federal Bureau of including binding arbitration, bom being CFR Paris 17D and 171). Whether or not employed in resolving 6sputet over Investigation (see 10 Cm 73.57).ne other Federal agencies provide such A tnes s-for. duty de terminations. He provision of a urine sample or taking of assistance is not known to the allowance of aninternalmanagement a breatbalyzer test is a smaD increment Commissien. Each licensee review is discetior.ary only, and not in the 6minished expectation of privacy implementing the Commission's fitness.

un6er which persons verk in a nuclear mandatory except in the absence of any for-duty rule wiU need to determine for other procedure.

power plant. Accordmgly, the itself whether!!Is recejving such Commission concludes that its rale does assistance. 16.2.5 Protection offnformation.itin not constitute an unconstitutional not the Commission's intention that bvasion of the right of privacy. Indeed. 1a.2.3 Preemption ofState endlocc/ reedts of testing be routinely available Zows.ne Atomic Energy Act of1954. to locallaw enforcement agencies persons working in nuclear power plants as amended preempts to the Taderal except under court order since the test mey already be considered to be highly d ation of resdt does not,in and ofitself, regulated and in regard to Fourth Government the Eeld of reF audear power reactors in au matters demonstrate whether the use of the drug Arneninent issues. within the vnbit of pertaining to raioloWeal safety of or alcohol was on-site or off site, legal Shoemcher v. Handel. 795 F.2d 11 *e (2-d operstion. See 10 CFR 84. Pacific Ocs or illegal.The Commisslon is. hewever.

Cir.19ee). cert denied. (79 U.S. 260 and E'ectric Co., v. State Enegy firmly convinced thet on-site enminal *

(1986). Resources Conservation and conduct. such as sale or possession of On the assumption that the rule being promulysted is within the Constt tion Development Comm.,461 U.S.190 (1983). - illegal substances. not be protected by However. State laws on possession, sale the Commission's rde.ne Commission in other re.spects, the rule's provisions or use of controDed substances and en protecten of information do not spees that the individual to whcm the alechol were enacted with broad social information pertains abould be able to inhnte vpon the right of a person to not goals in mind rather than radiological see the records in which the informatico incnminste himse'f. In the Commission's safety.nus, such laws wodd not be view. the case af Schmerter v. is contained ne Commission also preemptei here wodd be preemption ag ees that such records shodd be Colsfornia. 584 U.S. 757 (1966) controls in the rare case where a State sought to available to an arbit'ator, or other the issoe. In that use. the Coaui Upbeld control fitness for-duty of nuclear plant the takmg of a blood sample for alcobol adjudicator whc is being asked to employees for radiological safety resolve a fitness.for-duty dispute.

entlysis apinst a Fifth Amendment purposes or a State law made provided the recordt are relevant to the chauenge. A urine sample is no more compliance with NRC's 5tness.for. duty inenminating particular dirpute. Section 26.29 bas rule difficult or impossible. t>een modiEed to darify its appbcatien 1s.2.2 TederolRehabilitation Act. 18.2.4 Appro1 Procedure. %e accorktg1y.

%e Fedetti Rebabihts tion Act of 1973. Commission bebeves that an appeal or s: amended does not indude, within With regard to (2 CPR part 2.11is the review procedure with respect to Commission's conclusion tht it has no the concept of handicapped person", an positive e.loohol or drug detcrtninstions relationship to the Commission's rde. 42 in6vidual who is an alcohol or drug is needec because elementary fairness CFR part 2 comprises the regulations of sbuser wbose current use of alcobol or to the adversely affected tndividual will the Department of Health and Human drugs prevents tht in6vidual from belp sssure employee cooperation in the performing the duties of the job in Services implementing Section 406 of the implementation of the licensee's Drug Abuse Prevention. Treatment, and

! question or whose employteent by program. Such cooperation abould reason of roch current alcohol or drug Rehabilltotion Act (t: U.S C. 290 et.

i contribute to cuecessfulimplementation seg 1. It states the rules for maintaining abuse. would constitute a direct threat of the rule. Fairness is represented in the con $dentiality of patient records for to property or the safety of others (see rule by the employee assistance persons in drug or alcohol abuse 20 CFR 4.101(a) and 29 U.S.C. 706(7)(B)). program, the appe al pmcedure, and the prevention and treatment programs An in&vidual wbone urine or breath protection c' .nformation. nerefore. the regulated by or receiving assistance sample testo positive for drugs or -

appeal procedure is retained, but elcoholis obviously a current user fmm the United States Government.

codi$ed to trp!:ce referena to due First the Comm1=alon is providmg no whose cacthued anesco-ted socess to proces s with reference to impartiality plant equipment constitutes a threat to assistance to any such prog tm in the and objectivity and removal of reference private sector. Seconi tt is not nucleer safety. However, a person who to couretive bargaining agree:nents.

enters fato so employee assistance regulating such a program.* be Because the focus of the rule is on requirement for an employee assistance program and whose subsequent taats are Etness for unescorted access and not progam does not scands.te a treatment negative is not a current unct and would directed at an employment relationship. program that would fall under the be entitled to the protection of the and because the beensee wiD be making regulations in 42 CFR part 2. As noted in Federal Rehabibtstion Act ifit were the accese determitstion besed on applicable to his place of work because the response to the issue of preemption, Eto-rs.for-duty for all persons needmg the employee aislatance prog tm is not of his employer's receipt of or benett noescorted access, whether they are a preempted area. lts content is open to from Federal financial assirtance. permanent employees, temporary bargaining and the appbeation of other Federe3 finacef al assirtance is defmed employees or contractor employees the nonconfbeting State laws. Parther.

,. 24490 Federal Register / Vrl. 54. No.106 / Wednesday, June 7.1W9 / Rules and Regulations ,,

licensees an net precluded from the terms or substance of the proposed in addition to theos comments, one referring employees to treatment rule or a description of the subject and person, whose comments were included,

' propams to which the HHS rules might inues involved. W!th respect to alcobel, ar enclosures by two respondents from apply as long as the minimum program the proposed rule specificaUy included it one union contended that the number requind by section 26.25 is provided by in the scope of the ifcensees' fitness-for- of persons that would be tested is the licensee. In that case outside patient duty propams (l 26.20).no raderestimated and did not include ncords would be totaDy separate f om performance objectives an applicable te contra ctor personnel; incremental cos ta ,

records required by to CFh Part 26 and any substance, legal or ulegal, that ca.3 an incorrect beca use not all plants have would be protected accord 2g to other adversely affect a person's abuity to fully developed propama; average life of

-applic.sble rules. perform. There is no doubt that alcohol plants should be 40 years rather than 25, 18.2.6 Collective Bargelnks Rights. is such a substance.The rule text did use of 10 percent discount rate is According to Memorandum CC 874 n(t. however. include prescriptive unrealistic and costs associated witti

- issued by the General Counsel of the . requirements for alcohol. However, the alcohol. legal drug use, and other idads National! abor Relstfons Board on Commission expressly asked for of performance imoairment were September 6,1987, drug or alcohol comment on the extent to which ignored, testing for current employees and job ruldance si.ould be given as to alcohol This commenter also contends that applicants is a mandatory subject of and prescription drugs. Standards for written policies and procedures and collective bargaining and that the blood alcohol content were extensively labor contract modi 8ications involve implementation of a drug or alcohol discussed in the Statement of recurring as weH as initial costs:

testing propam is a substantial change Considerations along with a employee turnover needs to be factored in working conditions. Although the Commiselon request for comment on into training and testing c.osts of Commission's rule requins a drug and whether the Commission should employee anistance propams do not alcohol testing propam and sets certain prescribe a cutofflevel for alcohol. include medical and counsehng staff. ,

standards for it. the rule is not one Thus, the notice of propued rulemakin8 training ma teriala, and medical testing i directed at labor relationA, but rather at clearly covered alcohol both in the and treatment costs of IPgal Challenges nuclear safety.The Commi ston's rule terms of he proposed rule end in resulting from the progam omitted saplies equaDy to union and nor. union desc-ibing in some detail the subject awards of back pay and/or damages workers. it does not affect, even and issues involved.ne pubic was and underestimated volume of appea!r:

indaectly, the nght of self-organization well advised that alcohol testing was a and,inirect costs to workers from false  ;

provided by the National Labor subject within the rulemakhg and that positives (lost jobs or wages.

Relations Act The rule does not the Comm!ssion expected to resolve humiliation, etc.) are not included.

preclude coUective bargaining over basic issues regarding testing for alcohol In addition to these cost comments, issues in drug or elcohol testing in the comment period en the proposed one person whose comments were propams that an not addressed by it. In rule. Therefen, the inclesion in the final the Commission's view. its rule and the rule of basic edinonal requirements respondents for . included fromasoneenclosures by two union, contended opinion of the NLRB General Counsel alcohol testing is. in the Commission's view, well within the scope of the that benefits are overestimated and not are compatble documents. Sea, documented. In particular, the Metmpolitan Life Insurance Co. v. proposal.nere is no requirement that commenter challenged; beneSts of Mossochusetts. 4r1 U.S. 724. 755 (1985). the additional rule text dealing with reduction in lost productivity due to 16.2.7 Employee Assistanc, alcohol testing be published for separate employees being unBt for duty; the Pmpam. ne authority statement ;y comment, and not as part of the final rule, nexus between use ofiDegal drugs and g the rule states that it is promulgated impainnent of work performance; and.

under Section 161. among others, of the fpp Costs / Benefits reduction in insurance rates resultit.g Atomic Energy Act. Included within from more comprehensive drug tesung.

Secton 151 is section 1611(3) which 19.1 Sum =ary of Comments gives the Commission authority to Several commenters stated that the W Summary o uponsu y promu!gste rules to govern any activity NRC should justify the rulemkg under The NRC agrees with the comments authonzed pursuant to the Atomic the provisions of 4 50.109(a)(3).however. that the rulemaking should be jusufied Energy Act including operation of no commenters supported the under the provisions of to CFR 50.109 facihtes, to protect beslth and safety. alternative that a backStting analysis la (a)(3).The Backfit Analysis has been l j

The employee assistance propam not necessary under the provisions of modified based on consideration of the required by the rule is an incremental l 50.109(a)(ii). above cost comments as follows:

ad6non to safety by giving persons with Several commenters said that the Stness for-duty prcblems a 19.2.1 Cost to Administer the Testir;g estimated costs in the BackSt Analysis cnd Training Pivgrams. Staff spees and contbrestening avenue to resolve tbose were substantia 1'y underestimated in has adjusted the cost estimate to include problema, thus removing a potentja! for the foUowing cost element areas: costs the costs of:

compromising the safety of operation of to administer the testmg and traininF a nuclear power reactor. In the a. Additional personnel to administer programs, particularly the estimate of the testing and training programs:

Commission a view the employee the numbers of additional staff that

• assistance pregam can be incorporated would be necessary to administer the b. Ons rerson for propam I in a Commission rule under the broad propam: length of time estimated for administration and recordkeeping- l scope of Section tot of the Atomic in6vidual employee training. both initirI c. One person for coUection and j Energy Act. and refresber; time to take a test processing of specimens; and 16.2.6 Administrative Procedures for between lesving and returning to work d. A Medical Review Officer.

Alcohol. Under the Administrative area; added cost of using } dis certined Miscellaneous costs have also been Procedure Act [5 U.5 C. 553) the laboratories and quality control increased to better reflect the costs of Commission is obligsted to provide in measures; and. costs to conduct forms and record development, and the its r.ouce of proposed rulemaking either bac1 pound checks. costs of protected storage for records.

Federal Register f Vol. 54. No/106 / WJdnesdsy, June 7.1989 / Rules tnd Regulations 34491 - -

= . .

1912 Zangth of Tme forhxtividual 13 change tbs Backfit Analysis cost renewalis somewhat speculative and Training. Based on the comments. the estimates of $20 par trdtial screening and has not been e maidered.However, the estimate of traming costs has been $75 per conarmatory test. effect on the total cost will be smaU in cdjustid to reDect the following An additional cost of quatty controlls any event because costs beyond 25 '

(a) At least one hour of initial training the bhnd samples to be included along years contribute little te the total cost in for oliamployees: with the employee specimena.%e the present worth approach the NRC is (b) At least four odditionalhours of Backfit Aralysis included a cost to the using for its cost estimates.

initial training for supervisors. stilides of $50 per blind performance 1919 t/se of 20 Percent Discount 1913 Tee do TcAs o Test Several test specimen.1*de cost is in addition to Rote.%e NRC uses a 10 percent satunate of the cost ofinitial screemn3 and discount rate in its regulatory impa ct )

commenters 30 minutes of an noted that the,e lost employee oo.*tfirmatory tests on these specimens.

analyses to be consistent with  !

productive tame is too low. lest Staff believes that this is a reasonable I applicable OMB guidance. Because of  !

productive time can include time to represen:stion of the quality control ~ concerns that We atmy be secure and restart work in progress and costs that will be incurred. and has unrealistic at the present time the NRC i travel between the emplo)ee a work mada no change to tius cost.

1915 Coets to Conduct Rockgrouad aIeo abows tbe costs sesociated with a station and the specimea couection Pdsps mom naMc 5 percent station.De BackSt Anal)sia estimate ChecAs.%e staff disagrees that there is a need to include the costs cf conductbg discount rate.

was based on an assumption of 15 ,

minutes for travel to and from the background checks in the incremental 19110 Costs Associated with Other coUection site and 15 minutes at the cost estimate. Industry has already Performance ImpamnentJ. Staff coDIction station.%is was based on committed to then backgrmed checks disagrees that any change to the BackLt the assumption that the majonty of through NUMARCinits Access Analys Activit:,is is neededwith es associated forpreventing these costs, employees tested would have work Authorization Program, und thus costs stations within the protected area and anociated with background c. becks alcohol abuse legal drug use. and other that ct most sites the coUection stat, ion would be expended regardless of kinds of performance impairment would be efLciently located in nr near whether or not they were required by consist of training, testing and employee the protected area to accommodate the the Fitness.For. Duty Rule. assistance programa.ne costs assumed l'.rge number of tests to be conducted. 1918 NumberofPersons to be for these cost elements already cover ,

Also. the sta5 had assumed that after Tested.De Beck $t Analysis assumed these activities.

celecting an inividual for testing on a an average of1600 employees and 19111 Recurning Costs.%e staH given day. selection of when the test contractors would be tested randomly at disagrees that any change to the Backht wiU be conducted that day would take each plant.%is estimate was bemed on Analysis is reeded for recurnag costs of into account bolding down lost expenence with the Engerprint cards wntten procedures and contract ,'

production tune. Staff discussed these autnitted to the NRC in compbance modt$ cations. Staff agrees that  ?

resumptions with licenseea who have with 10 Cm 73.57, which requires these licensees incur rece.rrtng costs for i been conducting testing Some suggested cards to be submitted for au persons periodic revision to these documents.

90 minutes might be appropriate. Other granted unescorted sooess to the but sees no signiScant difference to licensees questioned said that 30 protected area.%is is the same these recurdng oosts attributable to the minutes is adequate. but that longer population as would be covered by the Fitness.For Duty Rale. Costs of perio6e I

- times conld result from administrative Fitness.Fct-Duty Rule. After receiving nvisions wodd me even e.*1thout the inefficiencies. Based on the comments the comments. staU checked these  !

estimates with severallicensees and Fimen-Fo@ Rule.Furthermore.

c.nd the further discussions the only the costs for comphance with the '

setimated time has been increased to 50 wa: satisfied that the estimate is rule need be considered, not costs of elective chantes,ne BackSt Analysis 9 Added Cesf of f/ sing RHS- ck s d to this ent o the catains only ee one ene cost to Certifsed Laboratones cad Quchty cost estimate. m dify these documents to meet the rule contro/ Measures. Staff reexamined the 1917 incremes talCosts.%e nquirements, mst eetime.tes of initial and comment that not all plants have fully conErmatory tests by contacting three developed programs would be 19112 Ernployee Turnocer. One laboratories to determi.te their charges inconsistent with fuL implementation of commenter noted that the NRC seemed for initial screening and confirmatory industry commitraents tc toUow the EEI to assume an employee turnover rate of tesis. pnces quoted were $16. gl7. E20. guidebes. Any costs incurreci because *ero. Staff recognizes that newly hired emd $25 per initial test, and $50,965, and courrJtments have not been met are workers also would need orientation

$75 per confinnatory test.De lab that considered costs for corrective action training, but considers this to not odd to we: on the high end tir initial test cost and not an hopect of the p esent the incremental costs because such w .s on the low end for contrmatory test rulemaking. training is sbeedy part of the industry's cost, cnd tsd two prices. which 1918 Aeringe L/fe ofFlants.%e existing fitness 4or duty prog ama. Staff depended on the number of samples to NRC iss. es licenses with a 40 year hmit. considers the one time cost for cu* rent the contrset. It is speculative to assess For many plants this time starts at the employees to be en additional cost -

whether the it be contacted would here date c.f the construction permit.resniting beyond the current industry fitness.for-to undtgo any addtt onal expenditures in 30 years remaining for operetion. duty costs because ihm revisions to the to be co certified and whether they Some plants are being licensed for 40 industry program at many plants wiB would pass such coets on to their years from the date of the operating require retraining of existing staffin cutomers or would absorb those costs tieenee. re sulting in a longer opersting these new procedu:res and rules of to remain coepetit!ve. Coets could go period. Some plants an Just beginning employment insefar as they differ from down due to economies of scale, but their opentions while others bare existing fitness 4ar. duty procedures and coc!d to op in!tlally due to increased - aiready been opere ting under license for rules of emplo1 ment. Staff 6 sag ees demand fo* certified labs exceeding the snany years Whether the usefullife of that any che.nge to the incremental cos's cupply. Staff sees no compelling reason some will be extended through license is needed for employee turno er.

u

1puu / ruucs anc newswu.

a.- ,

- the Nuclear power IndustrT: A Review e : A requirement has beer eddtd to limit 19.5.13 Cos3 ofTaployee cccess to the results of pre'imbary tests. l cf the Technicallssues." .

Assistance Progrcms. Staff agrees that T;s3 for alcohol an requ: red to be . (

the costs of nie6c.i and counsehng g _ ,7 g g %,,, Changes From , perfomed its catuncton wid othar .

str.fi, training materials, and medical . the Propoeed Rule substance tests. Tests are to be tesung and Instment were ne NRC amended several sectioos of admiMatered by a breath analvei: A ,

l undereetmated, and has revised the the proposed rule in response to . conEmatory test may be dose'w'.th BackSt Analysis to include additional l comments received from the pubhc on another bnath measurement !nstrument. '

penonnel to adm! Mater the testing and or if demanded by the penon being l the issues and in response to questions l training programs, in addition to the rejsed in ths Notice of Proposed - tested. by gas chromatography analysis .

cd6tior J employee assistance program Rulemane ne fonowingis a summary of blood.

staH provided for in the draft analysis. of the significant changas. The requirements for management 19214 Cosis ofLegalChallegr. The scope of the rule was amended k actions were revised to add the use nf  !

Staff agrees that there may be sr.ne include powar reactors under alcohol which resulted in on-duty costs associated wath these legal construction and to extend the date for impairment as a subject of the inquiry to challenges but has no basis for implemmtada d au mquinments to previous employers.

casessing these costs. Attention to 180 days aftu de effectve data d es The requirement for making available quabty controls v/ hose costs were inf nnab2 c3 uning pdor vioistons of a Etness-for-duty program was included legal costs. abould serve to m!Mmm these '

' ' ,,e deEnition of"conarmed amended topositive include a requirement that 1k115 Indirect Costs to Workerr t is ot o es the inquiry be supported by a signad from False Positives.ne prog-tm has Medical Review Of5cer has reviewed release fr m the individual being been designed to ear.ctially chminate the test results.The Medical Review kmtgewd.

false pose < s by i.se of diverse state of Officer's review must be completed and he Inqumcy of unannandests the art testng pro.4dures and quality licensee management confied within 10 foUowing reinstatement was smended to controls,indudm:i the use of certfied days of the inital presumpuve positive require snore frequ nt testing for the first laboratones, bbt samples, chains of IO"# 5 D*8-custody, and retenton effortions of "C"N$st.gon n d "suitchle ingdry A requirement was added to the specimens for retestng.The staff egnes was amended to clanfy that a best- sectin a managemet actom for .

that the costs to an in6vidual could be effort verification of employment history licensees to impose sufkient sanctions substantal should such an event occur is intended. A conforming amendment for alC hol. presenpton drugs and over-but has not included these indirect costs was mad + to the management actions thun}er drugs to dete substance in a quanutatve manner forlack of a section that required the inquiry. substmton. ,

means for esumsung them fairly.The The general performance objectives De appeals process n.;uiremmts  ;

NRC has considered these indrect costs were amended to clearly show

• hat the wne clanned.

in a quahtatve sense, and has rehabibty and trus:worthmess of The requirements to protect determined that the beneSts warrant madear power plant personnel must also informeton have been amended to cny such m6 rect costs (which are be assund. danfy that persond information can be highly unlaely)in editon to the De requirements for writ en pohcies disclosed to persons deci6ng matters on quanufied direct costa. and procedures were amended to review Jr appeal. to persons pursuant to 19116 Bettefits Overestimated. include a ptchibition against the a coun order, and to au6 tors (in BeneSta an descr bed in ftems 3 and 4 consumpton of alocholpnor o aad ed6 tion to those list:d in the proposed of the Backfit Analysis.The latter dunng work, and the requirement to rule). l j address situat2ons where a person has included the .uiternent that. in addition Records retention periods have been  ;

to the more importent benents ci been caUed in to per'orm unscheduled changed to Dve yeera.  !

preventmg unacceptable risk to the work. A requirement was added for  !

pubbe froen ra6olcycal relessea- The requirements for training of licemess to periodically submit propam benents wiu hkely accrue to Ucensees escorts have been amended to clanty performece data.

from the potennd eductenin NRC's intent that escorts need not be Reportmg requirements have been absenteeism. lost worker productivity, tamed as supervisors. i amended to include abuse of alcohol me6 cal and insurance costs and plant The penod in wtuch a test must be onsita by s licensed reactor operator or downtime. Staff apees that these performed pnor to the inical pantmg of supervisory personnel.

unescorted access was speciSed as ao claimed benents have not been De requirement to maintain a copy of quantified er docu:nented. Staff did not days. the audit vport onde has been deleted.

intend to imply that the cost reducbons The random testing rate wse .

established as ic3 percent per year. cada Noamat Policy associated with these beneSta would outweigh the costs of unplementation of The basis for for-cause tests was The Commission is too6fying its the Fitness.For. Duty Program. only that clanhed. General Staternent of Pobey and NRC testing guidehnes modeled sJter these benents would cust and would the HMS Guidehces, have been Procedure for NRC ErJorcement

- serve to somewhat offset the exper.ses Actions.10 CFR Part 2. Appendix C of the progam. lack of quanufication of developed as the standards for the (TrJorcement Pobey) to reDect the i couecuon. protection. and testing of these benents tends to mrke the Bar.kfit Commission's new rul on Fatness For-Andysis cost increase estmates specunens for drugs and alcohol.

Licensees wtU be required to cerrJy to Duty.10 CTA Part 26.Re changes to the i

conservable. Enforcement Policy it', being pubbshed the NRC thet tb ir Ltness-for-duty With respect to the relationship of concurrtotly with the new rule. ,

illegal drugs and impairment of work pregams base been i:npkmented. f Testmg laboratories shaU be he modifications to the Enforcement performance see 6scussion under Item laboratories certited by the Department Policy are being made in Supplement VU t

3. Impairment vs Rehabihty, above, and %ceDaneous Matters" to provids NUREG/ CR !a;. *Titnesofor.Dury in of Health and Humo Services.

3

~ '

Federal Regist:r / Vol. 54. No.106 / Wednesday. June 7.1989 / Rules and ReFulati:ns 24493 cxamples of violations of fitness.for- activities conducted under any other Workplace Act of 1988."This law duty requirements.The examples are Part of its regulations.This hmited requires any person being awarded a A.B. B.6. B.7. E.8. C.6. C.7. C.B C.9, D.4. application of Part 26 does not mean. Government contraet for property or ,

D.5 cnd E4. As with the exaples in however, that the Commission will not arrvices of a value of $25.000 or more to  !

the ctbsr Supplements to the respond to Etness-for-duty issues certify to the contracting agency that it i Enforcement Pobey, the new examples involving other Lcensees that affect will provide a drug free workplace for 1 are neither controlling nor exhaustive bealth and safety. Under the Atomic the performance of the contract. The  ;

nor do they establish new requirements. Energy Act of 1954, as amended, and its precise requirements an in Section 5n2 i The examples are to be used as regulations, the Commission may to 5t60 of the Anti-Drug Abuse Act.The l guid:.nce in considering the severity respond to such cases by the issuance of Commistion has compand the i levels of violabons of requirements. appropriate orders. requirements of the Drug-Free in developing the examples, the As explained in the Commission's Workplace Act to the requirements ofits l Commission notes that it is not the unfit Enforcement Policy (see 53 FR 40c27 rule on Fitness For-Duty and finds no I person that estcbbsbes the violation but Thursday. October 23.1988), the inconsistency. Any beemee rather the licensee's f auures. including Commission may take enforcement implementing to CFR part 2e who may those cfits contractors and vendors, action where the conduct of the also be subject to Subtitle D abould beve 4 that create violation. For example,if the individual places in question the NRC's no difficulty meeting the supplemental I licensee has effectively implemented na reasonable assurance that licensed provisions of the 16tter concerning 6tness for-duty program meeting NRC activities will be properly conducted. notification of the contractmg agency of requirements and, based on beb0 vior The Commission may take enforcement convictions of onsite criminal drug observation. identiSee and removes a action for reasons that w ould warrant activities @ection $152(a)(1)(D) of the person not Et for duty, there may not be refusal to issue a Ucense on an original Anti Drag Abue Act) for those j o reFulatory violation. appbcation. Accordindy, enforcement employees within the scope of a The exs.mple for Severity kvelIis of action may be taken regarding matters program meeting the provisions of to l very significant concern because it that raise issues of integrity. CFR part 26. Whether or not any represents the fauure to implement a co=petence. 6tness for duty, or other licensee subject to to CFR part 20 is miro Etness for-duty program.This example matters that mir not necessarily be a subject to the Drug Free Workplace Act would be appbcable to a situabon violation of specific Commission of 1988 is a question that the where essentaUy the beensee doe not requirements. And in taking such Commission cannot answer. Each have a program in place. enforcement acton, the Com=ission bcence wiu have to examine its own The examples for Severity kvel D are may exercise independent discretion as contractual relationships with agencies also very sis uficant because they to the standard of Stness for duty to be of the United States Government.if any, involve the f ailure to take action when appbei depending on the circumstances to ascertainif those contractual there is the potential to have a direct of the case and the significance of the relatomhips are of a kind that caU the related setyttes. issue to maintaining reasonable Drug Free Wmkplace Act into play.

impset on Tbe examplessafetyfor Seventy kvelID assurance in the protecton of the public cre significant becaune they represent bealth and safety in the use and Finding of No Significant Environmental signincant in6vidual violabons or possession of nuclear materials.For Impect Avaliabibty significant breakdowns in basic example, the Commission could take elements of a Etness.for-duty program. acton to modify. revoke or suspend the An mronmental assusmut was included in the notice of the proposed Basic elements include it.portant license of anindmduallylia.ensed aspects of the program, smb as: training. person seen as not St for duty on ruled.g at 53 m m Th standards more strict than provided in Commission has determined under the eppeals, records, testmg integnty, randomness in testmg. audits. Part:8.if necessary to protect the brahb National Environmental Pobey Act of ,

1R as amended, and the Commission a premeer.ing. management response, and safety of the public or other worken. Sunilarly. the Commission Ngulabons in Subpart A of 10 CFR part contra-tor oversight and employee ess: stance. A breakdown in the program could tale appropriate actio.iresard=g 31 that this rule is not a mefor Federal categoriz.ed at a Severity kvelIII will a materials bcensee where an employee sebon sWantly affecung the quaMy of the human pronment and therefore corra Uy involve mote than one was seen as endangering health and safety because be or she was not Et for an environmental impact statement is signhcant failure of a single element or single fauures of a number of elemects. duty. not nquind.

In addition, a fauure to ensure that Individuals who are not reliable and Paperwork Reduction Act Statement specimens coUected in accordance with trustworthy. under the inDuence of any 10 CFR Part 26 are not used for purpens substance. or mentaUy or physically This final rule contains information ether than those provided by the rule impaired in any way that adveaely coUection requirements that are subject witbout the permission of the tested affects their abibty to safely and to the Paperwork Reduction Act of1980 in6vidual may also be considered a competently perform their duties, aball (44 U.S.C. 3501 et acq). These significant violation. not be Ucensed or permitted to perform requirements were approved by the Severity Isvel TV and V violations are responsible health and safety functions. OfLee of Management and Budget scenen which, whue nquiring (OMBJ at the proposed rule stage, g,.ippinmental Provisions of tbs Drug- appr valnumber 3150-0246.The final correction, are less significant to the Fm Mplace Ad of1988 cretall 6tness-for duty program. rule adds new informabon coUection in promulgating this rule the requirements and increases records Inforament in Other f le- d Commission bea taken note of the fact ntention periods.Therefore, an AdiViti**

• that the Cong ess of the United States amended clearance pack:Fe is being i The Comminion notes that this rule has recently enacted Subbtle D of Title submitted to 02 The informabon 5 cppliza to 10 CFR Part 50 bcecsees only. V of the Anti-Drug Abuse Aet of1968 coUection requirements costained in the it does not establish standards or (Pub. L 200 690. enacted November 1E. Enal rule will not become effect ve untd ]

crite.ria to be appbed to liornsed 1968). entitled. "Ihe Drug-Free they are approved by OMB.

w

- - _ L --. - ~ ~~L ,

Pubbe repordn3 tardem foe this Ust of Subjuer , . * ' '

8L n%:s fauure d the leoensw's - - .

collection of information la estimeted to g gg g * Emphree Ase' stance program to nonfy everage 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> per response,induding . m beenseel mageers when we staffis the time for reviewing instructone, Mministrative praction and , ,

awan d.at an in&M e con &t a may Procedun. Andtrust. Byproduct * *@7,nlated acNem searching existing dets sources, gathering and mamtaining the data catenal, assified inf til g7 ] g,g pmaty, orcmant, needed. and completing and reviewing the buis of to CFR part 1 keep records the collecten of information. Send protecnon. Nucles' ma tedala, Nuclear pown plants and nacmts. Pnah Sex . concerning the denla! of eccen. or respond to commenta rege.-ding this burden inquiries concerning each denfals euch that.

estimate or any other arpect of this de 'imination. Source mate ;al.Special as a result of the fadm. e person previonsty nuclear matenal. Violations, Waste derJett accem for Stnewfor4oty repons -

coUeetion of informa tion, inch, ding e'88estions for reducing this burden, to tnamnt and &posal wu impropdy gnnwd saae.

Jg pg,,'t 26 7. Padan to take the required actico toe a the Records and Reports Management person odrmed m hvs Wen tund Branch (P-530). U.S. Nudear Regulatory Alcohol abusa. Alcobollestins, pos.evs foe t!!esa! drue um or tale acnon far Comm.ission. Weahmgton, DC 20555; Appeala, Cbemical testing. Drug absma, onsite alcohol pe: not amounnes to a and to the Paperwork Reduction Project Drug testing. Employee assistance Severity IJrvel U violatos (3450 0146), Office of Management and programa, Fitness for duty. Management a Fadure to aum. s.s required. that Budget. Wa shington, DC 20503. actone. Nuclear power reactors, contnetors or nodors have an eft.covo Regulatory Anafysia Protection of informa tion, Reporting and . Atnewfor. duty prog as or nc @ ephs b'mh B Breakdown in the Emewfor duty An snalysis of the cx>sts and benefits program involving a number of violations of For the reasons set out in the the basic elements of the $tness for-duty of the feal rule is included in the beckfit preamble and under the authority of the program that coUectvely nGect a sig .ificant analysis described be ow. Atomic Energy Act of1854, as amended, lack of attention or cantessness towartis Backfit Analysia the 'a.nergy Reorganization Act of 1974, mang the obeenv;s,of to Cm mm as amended. and 5 U.S.C 553 the NRC la D. Senny IV.

Several commenters stated that tbs adopting a new to CFR Part 28. and 4. la isted faum, to meet buic elements NRC should justdy the rulemaking undee amendmg 10 CFR Part 2. 'I th' U ***I '#"4 W8'" " ' i****i"8 the provisions of I 50109(a)(3).ne NRC a Senny Isul L E or El nolstion. .

PART 2-RtJ1.ES OF PRACTICE FOR E. Failun to rep rt acts of boensed apee provi[s and finds e a eubstantalincreaee in the that the rule wiuDoldESTIC UCENSING PROCEEDINGS g *p[n a supemson pauanuo 10 Cm overall protection of public health and F. Sc.inty V. * *

• 1.De authority citation for Part 2 safety. and that the & rect and indrect continues to read in part as follows: 4 Manolat no of 6mewfor dun costs ofimplementation are justified in requirements.

new of the increased protection. Authority. Sec tel. 68 Stat. M ae amend.d (a2 U.S.C. 22:ril sec. 2:ri, se Stat. 3. Part 28 is added to to CFR Chepter !

he back$t analysis is available for 1m. as amended M2 U.S.C 5641). to read as follows:

inspection a.nd copytng for a fee at the NRC Pubbe Document Room at 2120 L 2. A

""*"ypendix C, Supplement

ed by ading example 6 toVH. is MRT 2hffmESS FOR DUTY Street NW., Washington. DC 20555, PROGRAntS Smgie copies may be rabtained by panpap1. A, examplo 6,7. aM 8 to I wnung to the U.S. Nuclear Regulatory pang @ E examp!n 6,7. 6, and 9 to General Pmh

+

paragraph C, examplev 4 and 5 to Corr:ssion. Washington. DC 20555.

parapsph D. and examp's 4 to t' Regulatory Maxibility Act Cmtificatico paragraph E to read as follows: d $poM. p, In accordance with the ReFulatory Appendix C-Genean! Statement of 26.3 DefWtons.

Flexibibry Act of 1980. 5 U.S.C. 005(b). Policy and Procedurs for NRC 2e 4 Interpntstona.

the Commission hereby certdies that En!orcemeut Actions no F.umphons.

• • *D W"*" "

this rule will not beve a siguficant * * * *

• o pp,,7 Suppleme t VU-Sewrity Categoria* General Performance Objectives nu:rbe of m Il enttes. ew 10

l 2tL10 General performance objecoves.

CFR Part 26 sppbes to certain owners hp [o n'ht n% impht &

and operston of civtban nuclear power teammd fitmen-for-duty progran sa Pmsrum I3ements and Procedures reaetors and their contractors.De B. Seventy D. * *

• 2t.2o Wntten pchey and procedures.

companies that own power resctor e Fedure to remove an in6adual trosa m 21 pohey commuincanons and facihties do not faU withm the scope of unescorted access who has been mvolved in awannen trammg.

small entities" set forth in the th sale.uma or possession of aUesal dmgo 28.22 Trairung of supernsore and escorta.

- Regulatory Flexibility Act or the emall wittun the protected ans or to take acbon for 23 Contractors and vendors.

80 duty cu8u" of alcoh L pre *:nPtoo drust.

busmeu size standards set out in 2sa Cbeaucaltest2r4 gnms regulations issued by the Scal! Business 7 un Ifo wkn oburved Pjo w _,assast

, g ,

Admmistration tn so CFR Part 121. Any behanor within the protected arse or credMe mformadon concerning acovides k im m ed.

costo to the r inor c unber of accall 282.8 Appaala.

entates afferted. in contraetora, will wi'. tun th protected ans in6 cates possible 28.3 Protecton ofinformsbon.

epply only O those contractor unf.tness for dut3 besed on drug or thx>bol uH'. M D8p*C ona. En 8 Pets employees workir.g at the nucles,r power resetors and would probably be 2ato Inepnbons.

- reimbarsed %-gh the contract. " D"'*@u fu no!.hons for towtwenty 2831 Reewdkwpng nquimmenta.

re.ie io noi.imns or to en Pan sa m ?3 Repornr4 mqmrements.

Fed:ral Regist!r / Vol. 54. No.108 / Wednesday June 7.1989 / Rules end Regulations 24495 5"- (insert date 180 days after the effective who has knowledge of e;estance abuse

^* date of the finalrde). d;sorders and has appropriate ms6 cal M.so Aud* training to interpret and evaluate an

--" ' " ~ - individual's positve test reeu!! together Enfarossent Abquot*."means a portion of a with his or her medical history and any Appenda A dehnes for Nudear Power 9P sydife other relevant biome 6 cal informabon.

Plant Drug and AlcoholTestna ReFulatory Com=!ssion or its duly " Protected ans"has the same D' ~ meaning as in 173.2(g) of this cbspter, an Authortry: Secs n F1.103.104107.1tt. ee au.t.horized representaeves. ana encompassed by physical bamers

, te t. m en s)e. e37, s39. 946 e e amended Corformatory test"means a second u analyncalprocedure toidentif3 the and to which access is controUrd.

e iNNeN$x . 4.

Presence of a specific drug or drug metabohte which is independent of the

" Random test"means a system of unannounced drug testmg a administered

'j U4L ss amended (C U.S C 6641. 660. 6646).

For the purposes of sec. 223. se Stat osa u initial screening test and which uses a in a statsucaUy random manner to a different technique and chemical group so that all persons within that amended (C U.S C 73)ll 3 20.2621.

26n 2an 2ex 2an 2c27.2cm z.2s and pnnciple from that of the initial smup beve an equalprobabibty of 2e 60 c.re isswed under seca selb and 1. se screening test in order to ensure selection.

SteL 948, and 96 a e amended [C U.S C rebabihty and accuracy. For determining "Suluble inquiry" means best effort 22o1(b) and (il). 2e 70, 2tL*1. and 26.73 are blood alcohollevels, a " confirmatory verification of employseent history for issued under sec. telo. 68 Stat 9!A as test"means a second test using another the past five years, but in no case less amended [G U.S C 2201(o))' breatb alcobol analysis device. Further tban three yean. obtained through Gueral Provisions corfmation upon demand wiU be by contacts with previous employers to gas chromatopaphy analysis of blood- determine if a penon was.in the past.

I H.1 hapose "Corfmed posieve test"means the tested positive for luegel drugs. rub}ect Tbjs Part prescribes requirements and resdt of a corJLrmatory test that has to a plan for treating substante abuser standards for the estabbshment and established the presence of druFs dru8 removed from or made inehpble for maintenance of certain aspects of metabohtes or alcoholin a specimen at activities within the scope of 10 CFR Emens for duty propa=s and or above the cut off level, and that has Part 26. or denied unescorted access at procedures by the hcensed nuclear been deerned positive by the Me& cal any other nucJear power plant or other i power sndustry. Review 0$cer 20) after evaluation. employment in accordance with e A

• confirmed pesinve test" for alcohol 6D'"'for du4 Pohcy.

!M2 scope. can also be obtained as a result of s (a) The regulations in this Part apply cerformation of blood alcohollevels endor..means any company or to Ucensees authonzed to operate a with a second breath analysis without in6vidual. not under contract to a j nucleat power teactor. Each bcensee MRO evaluation. Licensee, providing services in protected .

sballimplement a Emess.for-duty " Contractor" mears eny company or anas. l propam which ccepbes with this Part. in6vidual with which the bcensee has gna "-- ~ ~-  !

The p ovisions of the 6 tress-for-duty contracted for work or service to be l propam must apply to all penons performed inside the protected ana Except as specificaUy authonzed by I panted unescorted accese to protected boundary, either by contract, purchase the Commission in wntmg. no cns s. and to licecsee vendor, or order or verbal aprement. interpretation of the meanmg of the contre clor personnel required to " Cut offlevel"means the value set for regulations in this part by any officer or physicaUy report to a bcensee's derignatmg a test result as positve, employee of the Com:nission other than Technical Support Center (EC) or "FoDow-up testmg" means chemical a wntten interpretation by the General EmerFency Operations Tacibty (EOP)in testing at unannounced intervals, to Counsel wiU be recognined to be bindmg accordance with bcensee emerEency ensure that an employee is maintaimng upon the Commission.

plans and procedures The rendations in abatmence from the abuse of drugs or this Part do not a; ply to NRC alcohol. I

• E' ***

ec:ployees, or to law enforcement "IUegal drugs" means those drugs The Commission may.Upon penonnel or offsite emergency fire and included in Schedules I through V of the appbcation of any interested person or me6 cal naponse personnel while Controlled Substances Act (CSA). but upon its own initiative, pant such respondmg on-site. not when used pursuant to a valid exemptions from the requirements of the (b) Certain reFdstions in this Part prescription or when used as otherwise regulations in this Part as it determines apply to Lcensees boldmg permits to authonzed by la w. an authorized by law and will not const uct a nuclear power plant. Each "Init2a1 or screening tests" means an endanger hfe or property or the common construction permit holde:.with a plant immunoassay screen for drugs or drug defense and security and are otberwise under active construction. shall comply metabolites to eliminate " negative" in the public interest.

with sections 26.10, 26m 26.23. 26.70. unne specimens from furder and 26.?3 of this part, shallimplement a consideration of the first breathalyter iM Wnaum cosecum chemical testeg progam. includes test for alcohol. Inf tial screening may be * *"88* 8*8 N L -

random testa and abaU make provisions performed at the licensee's testeg

. (a)The Nuclear ReFdatory for amployee assfstance propams. f acibty; a second screen and Commission has submitted the imposition of sanctions, appeal confirmation testing for drugs or dmg information coUection requirements procedures, the protection of metsbobses must be conducted by a contained in this Part to the Office of infor:natior. and recordiceping. HHS-certafied labors 1ory. Manegetnent and BudFet (OMB) for (c) The requirements in this Part must "Me6 cal Review O!Lcer" means e approval as required by the Paperwork be implemented by each bcensee beensed ph)sician responsible f'r Reduction Act of 1980 M4 U.S C. 3501 et authonzed to construct or operate a receiving laboratory results Fenersted seg 1. OMB bas epproied the nuclear power nector ne later than by an employ er's drug testmg propam infor=stion coUecton requirements

_ _ _ ~ _

y l

' co:tained in this Part ander control the written polley must proldbit the. I asat posey eene,meenseens and number 3160.c146. consumption of alcohop ewareness treeens (b) na cppmved informatico (1) Within an abstinence period cf et (s) Persons cosigned to setfeisee collection requirements contained in this least 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> preading any scheduled - within the scope of this Part shat be Pnst appear in Ii 2.20. 28A 2&22, working tour, and provided with appropriate training to ensun they understand-282 2624,2A2L 26.29,2em aa#L (2) During the period of any working 28J3,26.80 and Appandix A. tour. (1) Ucenses policy and procedures.

inclading the methods that will be used ]

(c) The total burden for these Ucensee Policy should also aMrese 1 recoMkeepkg requimmanu is estimated other factors that could affect Stness for to implement the policy; I

to be 313 bours per site r year la (2) The panonal ud public bde and duty such as mental stress, fatigue and safety hazards anockted wie abue cf l implementing the reco eeping 08"8-requirements the affected licensee shall drugs and misme of alcobah report to the Commission any comm,n,. (b) A description of programs which (3) ne effect of preseiption and over-concernmg the accuracy of the estimats an available to pereonnel destring the. counter drugs and dietary conditions'

' end any suggestions for reducing the ass! stance in deshng with drug. alcohol on job performance and on chemical teet burden. or other problems that could adeem Y results, and the role of the Medical affect the performance of activities geview ofncen General Pedow= Ob ectfees t

• within the scope of thie Part. (4) Employee aasistance propams I ts.to conormt perforrnance otiecttves. (c) Proceduns to be utilized in treting provided by the licenses; and i r drugs and alcohol, including (5) What is expected of them and Fitnew-for-duty pmpams must procedures for protecting the employas what consequences may result from leck j (a) Provide reasonable usurance that and the intepiry of the specircen, and of adherence to the pobey, )

j g g the quality controls used to ensure the (b) Initial training must be completed j o eir tasks in a re le and test results are valid and attributable to prior to assign =ent to activities within j trustworthy manner and an not under the scope of this Part. Refresber training the conect individuah the influence of any substance, legal or taust be completed on a nominal 12 iUegal, or mentaDy or pbyaically (d) A description ofimmediate and loDow en actons which will be takan, snoctb frequency or more frequently impaired from any causa, which in any way adversely affects their abibry to and the procedures to be unhzed. La where the need is indicatei A record.of those cases where employees, vendors, the training must be retabed for a aufely and competently perform their penod of at least three years.

dutice; or contracton assigned to duties within the scope of this part ars detarmmed to gg g (b) Provide reasonable menuns for has e been involved in the use, sala, or the early detetton of persons who are ,,e,,,,,

not St to perform actintes within the possession of LUegal drugs; or to have consa=ed alcohol during the mandatory (a) Managers and supervisors of scoIe of this part and activitin within the scope of this pan al of chi drug. pre-work abstmence penoi while on free workplace and a wo ce free of duty. or to excess pnor to reporting to Qt be pro d d a mpriate training to aa de ns w a s st the efrects of such substances. , ,, co o (1) eir role and responsibilities in Program Dements and Procedures concentration. Lepimenting the pmram:

(2)ne roln and responsibilities of g pg,po wr,e,,n poney ,no p,,e,c, (e) A pmcedun that will ensure that others, such as the personnel, medical.

Each licensee subject to this part shall h*"cfed and reployee assistance program stafia:

wr t are $tto (3) Techniques for recogninns drugs estabhab and t=plement wntten pobcies pedom de task uspi As a and indications of the use, sale, or and pmcedures designed to meet the minimum, tbs pmWun musW general performance objectves and possession of drugs; (1) Require a statement to be made by (4) Behavioral observation techniques spectSc requirements of this part. Each bcensee shad 'etsin a copy of the e ne t for detecting depsda ten in

, ',d current wntten pobey and precedures se {C" d

performance, impairment. or changes in length of tune ststed in the pre. duty employee behanor, and I a record umul the Comnussion absunnrce pobey; termmates each bcense for which the (5)Procedura forinitiating pobey and proced. ins m ere developed (211f alcoho! has been conrumed appropriate co re:tive action. to include and,if any porton of the pobcies and withm this perici requin a referral to the employee assistance procedures are superseded. retain the determinston of fitness for duty by pmpam. j

~

superseded matenal for thne years after breeth analysis or other means: and (b) persons assigned te escort duties each change. As a -mum, wntten (3) Require the establishment of shall be provided appropriate training in pobcies and proceduns must address contmls and con 6tions under which a techniques for recognizing drugs and fitness for duty through the foDowmg- person who has been cated-in can indications of the use, sale, or (a) An eserall descripton of licensee perform work. If necessary, although ponession of drugs. techniques for pobey on fitness for duty.ne pobey alcohol has been consumei recognizing aberrant behanor, and the must address use of illegal drugs and Consumpton of alcohol during the procedures for reporting problems to abuse of legal drugs (e s.. alcobot abstmence period shall not by itself supervisory or security personnel.

prescnption and over the. counter preclude a bcensee from using (c)1nitial training must be completed drugs). Wntten pobey documents must in6viduals needed to respnd to an prior to assignment of duties within the be m sufficient detail to provide affected e=crgency. scope of this Part and within 3 months indandua!s with informatwo on what is (f) ne Commission may at en time after initial s upervisory a ssign=ent, as expected of them, and what renew the bcensee's written pobey and appbcable. Refnaher training must be consequences may result fromlack of procedures to assure that they meet the completed on a nominal 22 month adherence to the pobey. As a minunum. performance objectises of this Part. frequency, c,r mon inque:4 when the i,

I

, i Federal Regist:.r / 'fol. H. No.108 / Wednesday June 7. '1989 / Rules and Regulations 244'97 need is indicated. A record of the substantial degradations of the level of motified within to days of the initial training must be retained for a period of safety of the plant if there is reasonable presumptive positve screening test.

at leset three years. Suspicion that the worker's behavior (f) AD testing of specimens for urme contnbuted to the event or after drug testing. except onsite testing under l E23 Co@ seton @ Won- receiving credible information that an paragraph (d) above, must be perfonned (a) All contractor and vendor in&vidualis abusing drugs or alophol. in s laboratory certified by the U.S.

personnel performing activitaes wtthin (4) Fouow-up tesung on an Department of Health and Human the scope af this Part for a bcerre must ane.nnounced basis to verify continued Services for that purpose consistent be subject to either the beensee's abstention from the use of substances program relaung to 6tness for duty, or to covered under this Part. with its standards and procedures for a prog <am, fortnaDy reviewed and certines. tion.Except fot suspect Cpproved by the bcensee, which toeets (b) Testing for drugs and alcohol must specimens submitted for special at a minimum, conform to the '

the requirements of this Part Wntten promasing (Section 15(d) of Appendix

• Cuide!mes for Nuclear Power Plant A), au specimens sent to cernfied agreements between licensees and Drug and AlcoholTesting Programa." laboratones shau be subject to irutial contractors or vendors for activibes issued by the Nuclear Regulatory within the scope of this Part must be semening by the laboratory and au Commission and appearing in Appendix retained for the life of the contract and A to this rule, hereinafter referred to as specimens screened as pnsumptively wiD cle.arly obcw that- the NRC Gudehnes. Ucenseca, at their positive obsU be subject to confmnacon testing by the laboratory.Ucensees (1) The contractor or eendor is discretion, u.ay h:.plement programs shat! submit bhnd performance test responsible to the Ucensee for adhering with more etnngent standards (e.g.,

to the beensee's $tnewfor duty pobey. specimens to certified labora tones in lower cutoff levels, broader panel of er n.aintaining and adherms to an drugs). AU requirements in this Part accordance with the NRC Guidehnes effecove 6tness.for duty pmgram: which apply to penons who fa0 a more . (Appendix A) l meets the standards of this Pan, and sinngent standard, but do not test (g) Tests fer alcohol must be (2) Personnel having been denied positive under the NRC Guidehnes; administered by brestb analysis using cecess or removed from setvities within mansgement actions must be the same breath alcobol analyses devices nieetmg ,

the scope of this Part at any nuclear as if the in6vidual faded the NRC evidental standards described in l power plant for violations of a fitness- standards. Section 2.'7(O)(3)of Appendix A. A j for duty pebey wiu not be assigned to (c) Ucensees abaU test for aD bneth alcohol content m6catmg a '

work within the scope of this Part substances described in paragraph 2.1(a) blood alcohnl conception of 0 W without the knowledge and consent of of the NRC Guidehnes. In ad6 tion, percent or g eater must be a poEve test result. The confir=s tory test for {

the beensee. bcensees may consult with locallaw j (b) Eaeb sicensee subject to this Part enforcement suthoribes. hospitals and alcohol shall be done mth another '

shaU s asute that contracton whose own drug cou: sehng services to determine bnetb seea sure:ntnt instrument. Should 6 tom-for duty programs are nhed on wheiber other substances with abuse the person demat d furd er confirmation.

by the licetree adhere to an effective potential are being used in the the test must be a gas chrotostography program. which snects the requirements geog'ephicallocale of the facibty and analysis of blood.

cf this Part and sbaU conduct su6ts the local workforce. When apprepnate, pursuant to l 26.80 for this purpose. other substances so identiSed may be N ******" P N "'"'

added to the panel of substances for I 2c.34 w tes**- test ng Appropriate cutoff hmits must Eecb licensee subject to this Part shall (a) To provide a means to deter and be estabbabet by the beensee for these maintain an employee assistance detect cubstance abuse. the bcensee substances. program to strengthen htness-for. duty shaU implement the foDowing chemical (d) Ucensees may conduct in!tial programs by offering assessment, short-testing programs for persons subject to senening tests of an abquot prior to term counsehng. referral services. and this Part form animg selected epecimens to a treatment monitoring to e=ployees with (t) Testing within en days prior to the laboratory cert:fied by the Department Problen.: that could advenely affect the inital g sntmg of unescorted access to of Henkb and Human Services, provided Performance of acev ces withm the protected areas or assignment to the beensee's staff possesses the scope of this Part. Employee assistance actmtes within the scope of this Part. accessary training and skills for the prog sms abould be designed to achieve (2) Unannounced tests imposed in a tasks asaigned, their qualifications are early intervention and provide for rsnoom manner.The tests must be I documented, and adequate quabty confidential nasistance.The employee l cdme%d so that a person controls an implemented. Quabry assistance program staff aballinform omnpletmg a test is imme6stely eligible contml procedures for initial screening licensee management when a for another unannounced test. As a tests by a beensee's testing facibty must . detednation has been made that any minimum, tests must be admmatered on include the processing of bhnd todividual's cou6 tion cor.stitutes e a nominal weekly frequency and at perforenance test specimens and the hazard to himself or bemelf or others various tunes during the day. Random submission to the HHS cern$ad (including thou who have self-referred).

testing shall be conducted at a rate laborstory of a samphng of eper-equal to at least too percent of the kiinaDy tested as neganve. Accase to I 3L27 Management actions ans workforce. the results of prelimmary tests snust be aanetons to em W j (3) Testag for cause.14 as soor. as hmited 13 the licensee's testmg staff, the (a) Prior to the initialgranting of l ible fotowmg any observed Medical Review OfLeer, the Fitnew For. unescorted access to a protected ans or havior inicatmg possible cabstance Duty Prog tm Manager. and employee the assignment to activities within the abuse; after scradents involving a faDure assistance prog sm staff when scope of this part to any person, the to in6vidual performance resulung in appropriate. licensee shaU obtain a wntten statement penenalinjury. 6 e re6shon exposure (e) The Medical Review Offur's from the in6vidual as to whether er reles se of red.osetmty in excess of eeview of the test results must be setmties within the scope of this Part reguleto y hab. or actual or potental completed and beensee management were ever denied the in6vidualThe l

. 24498 Federal Registar / Vol. 54. No.108 / Wednesd7. Jime 7,1960 / Rules and Regulations -;3e15 Licensee shaU complete a suitble perform activities within the scope of

• recorded as removals foe eeuw. Noe inquiry on a best. efforts basis t3 this P:rt must be cbtin:d bef re - records must be retained fm the purpose ,

determine if that perso a was.in the permittir4 the inthvidual to be returned of meetirag the requirements of  !

to these activitfes. Any subsequent I past. tested posit ve for - s or use of i 28.27(a). -

c] cobol that resulted in cb ty confirmed positive test snust rentit in (d)If a licensee has a reasonable impairment, subject to a plan for removal from unescorted access to belief that a.r* NRC employee may be t eatu*.g substance abue (except for pmtected areas e.nd activities within the under the influence of any substance, or self referral for treetwent), or removed scope of this Part for a minimum of three otherwise un5t for duty, the licensee from setvities withm the scope of this years frorn the date of removal ansy not deny access but shall escoet the Part, or denied unescorted access at uy (3) Any individual determined to heve intviduah in ny instance of this other nucleu power plant in accordance been involved in the sala, use, or occurrence, the appropriate Regional with a htness.for. duty pobey.lf such a pos session of inegal drugs whue within Administrator must be notiEed record is estabbshed, the new a protected area of any nucleu power immediately by telephone. Durmg other assignmaat to actvities within the scope plant must be removed from actvities than norme.1 working hourt, the NRC of this part or granting of unescorted within the scope of this Part."Ite Operations Center must be notiSed.

cccess Inust be based upon a inividual may not be granted l 28.28 Appeasa, managernent and me6 cal determination unescorted acceas to protected ceas or of Etness for duty and the establishm=.nt assigned to activites within the scope of Each licensee subject to this Part, and j of an appropnate foDow-up testmg this Part for a minimum of Sve yeus each contractor or vendor implementing progra,m. provided the restrictions of from the date of removat a 5tness-for-duty program under the, puagraph (b) of this secton are (4) Persons removed for periods of provisions of ( 2M.3. shall establish a observed. To teeet this requirement, the three years or more under the provf sions procedure for lice 16ee af d contractor or identity of persons denied unescorted of paragraphs (b)(2) and (3) of this vendor employees to appeal a positive access or removed under the provinons section fcr the IUegal sale, use or alcohol er drug determinabon.The of this Part and the cimumstances for possession of drugs and who would procedure must provide notice and an such denial or removat inclu6ng test hase been removed under the current opmrtunity to respond a.nd .tsy be an results, wiU be Inade available in standards of a hirig licensee, may be imp ud internal!=anegement review.

response to a bcensee's. contractor'a, or granted unescorted access emd assigned A licensee review procedure need col f, sendor's ingrary supported by a siped duties within the scope of this Part by a be provided to employees of contractors release fro:n the indmdual. Failum to licensee subject to this Part only when or vendors when the contractor or Ust reasons for retLoval or revocation of the hing bcensee receives satisfactory vendor is administering his own alcohol unescorted access shaU be sufLcient me6 cal assurante that the person has and drag testmg.

cause for detual of unescorted accesa. abstained from drugs for at least three Ip M tee m W m na m .

Temporary access provisions shaU not years. Satisfactory canagement and )

be affected by tbs Part provided that me6 cal assurance of the in6vidual's (a) Each licensee subject to this Part. )

the prespectne worker passes s 6tness to adequately perform activities who coUects personal infor=aton on an l cher:ucal test conducted accor6ng to within the scope of this Part I::ust be in6vidual for the purpose of complying the requ'rements of 26.24(a)(1). obtained before permittng the with this Part. shall estabhsh and (b) Each bcensee subject to this Part in6vidual to perform acbvites within maintain a systern of fues and shall. as a trarumum, take the foUomng the scope of this Part. Any person procedures for the protecton of the , l actons Noth.ng herem shaU probabit granted unescorted access or whose personalinformabon.This system must  !

I the bcensee from taking more stnngent access is remstated under these be snaintained until the Commissica j acton. provtsions must be given unanacanced terminates eoch bcense for which the 3' (1) Impaired workers. or those whose foUow.up tests at least once every system was developed.

fitness may be questionable. shall be month for four mocthe and at least once (b) Licenseen. contractors, and removed from actmues within the scope es try three months for the next two vendors abau not 6sclose the personal of th s Part. and reay be returned only years and eight months after unescorted information coUected and teamtamed to after detenraned to be fit to safely and access is temsts ted to senfy contnued persons other than assigned Me6 cal co=petently perforto actmtes wittan abstnence from prestabed substances. Review OfLcers, other bcensees or their  !

the scope of tlas Part. Any confir=ed use of drugs through this authorized representatives legitimately (2) LatLing any other evdence to process or any other determinacon of seeking the info nation as required by in6cate the use. sale. or possession of subsequent involvement in the sale. use this Part for unescorted access decisions illeFal drugs onsite, a confirmed rositve er possession of iUegal substancer must and who have obtained a release from test result must be presumed to be an resujt m permanent c'enial of unescorted current or prospecove employees or in6caton of offsite drug use. The first access. contractor personnel NRC conhrmed positive test must, as a (5) Paragraphs (b) (2). (3), and (4) of representatives, appropnate law mirumum. result in imme6a:e removal this secton do not apply to alcohol enforcement officaals under court order.

from actmbes withm the scope of this vabd prescriptions or over.the-counter the subject individual or his or her Part for at least 14 days and teferral to drugs. Licensee sanctions for confirmed representative, or to those licensee tbc EAP fcr assess cent and counsebng misuse of alcohol vabd prescnpten. representatives who have a need to dunng smy suspension penod. Plans for and es er.the-counter drugs shall be have access to the infonnton in treatment foUow.up, and future sufficent to deter abuse of leFaUy performing e asigned dates. including I 2:nployment must be des cloped, and obtstnable substances as a substrute au6ts of bcensee's, contractor's, and c.ny rehabthtabon program deemed for abuse of proscnbed drugs. vendor's programs, to persons deci6ng appropnate tcust be imtated dunng (c) Refusal to provide a specimen for_ matters on review or appeth and to such suspension period. Satisfactory testeg and res!gnation prior to removal other persons pu suant to court order.

mansFement and me6 cal sssurance of for violaton of company fitness.for-duty This ecction does not authonte the the mdmdaars Emess to adequately pobey concerning drugs murt be licensee. c.ontractor, or s endor to

{

l e , , . ,

\

... - - -y .ggymngppmy i i

Fed:ral R: gist:r / Vol. 54. No.10B / Wednraday lune 7,1989 / Rules and R:gulations 2M 99 a.1.

withhold evidence of cnminal oced.ct population and type of test (i.e pre-frote isw enforcement ofLcials. badg.ng rsndom, for<ause, etc . (b) Auits must foens on the -

substances identfei rummary)of effectiveness of the pmpam and be Inspections. Records, and Reports cenducted by inividuale quahfied in l gnro n --_ scanagement actions; and a hat of events the subject (s) beleg suitei and reponed.n' detse must be analyzed (s) Each bcensee subject to & Part and appnenste actions taken to correct independent of both Liness for-duty I

' chaU permit du!y authorized program weaknesns The dets and program management and personnel representatives of the Cornmission to analysis taust be retained for three 6rectly responsible for implementation inspect copy. or tale away copies ofits years. of the Etnew-for-duty program.

records and inspect its premises. (c)The result of the sait along with I nn Naportang roowwmarita. recommendations.if any, must be ccuvibes. and penonnel as may be (s)Escb bcensee cubject to this Put documented s.nd reported to senior necessary this ParL to accomphab the pu. poses of sbaU inform the Commission of corporate and site management. The (b) Written agreements between significant Erness.for-duty events resoluton of tbr suit En6ngs and bdudmg. o nective actions must be documentei bcensees and their contractors and vendors must clearly show that the- (1) Safe.use, or ponenfon of13esal Then documents must be retained for (1) Licensee is nsponsible to the drugs witbn the protected area and, three years NRC Guidehnes requiry Commission for maintaining an effective (2) Any sets by any person beensed bcensee sudits of FD45-certif,ed )

Etness-for. duty prog tm in accordan::e eder10 CFR Part 66 to operate a power laboratories as describedin Appen&x with 2 Part; and reactor or by any eupervisorypersonnel A-(2) Ddy authorued representa tives of an;goed to perform duties within the scope of tbs Pan- Enforcement the Comnussion may inspect. copy. or W Invdving b ule, un or tale away copies o. any bcensee, ( x.co nossoorri.

poneuion of a controDed substance. (a) An injunction or other cou-t order recor [sepor.: rel ted o. (u) Reedtmg in conf nned positne may be obtained to prohibit a violston ,

y 3 tests en such persons, of any provision of-se r r or en r's to e or-duty M)invdrang use of s)c hol within the (1)The Atomic Energy Act of tr.54 sa

}

pmg am under the scope of the protected area, or amendei contracted eetivities. (iv) Resultmg in a determination of (2) Title D of the Energy I n71 Mewdkeeping regulromerrta, unfitness for scheduled work due to the Reor;anizabon Act ofIM or consumption of alcohol.

Each beensee eubject to % Part and (3) Any rerdabon or order iseurd (c) Notfies tions must be mode to the under these Acts.

each contractor and vendor NRC Opers bons Center by telephone ircplementmg a boensee appreved (b) A court order snay be obtained for witbn N hours of the 6scovery of the prv am under the pronsions of i 2&23 e$ ent by the beensee. h payment of a civil penalty i= posed sh:- (c) F:tness for-d.ity events shaU be tmder nction 234 of the Atomic Energy (a) Retain records ofinquiries reported under this neton rather than Act of 19M. for vLatons of -.

conducted in accedance with i 2e27(a). reported under the provisions cf i '73.7L (1) Se etic 1 E3, E7. 22, 03. fl. E2.101.

that. result tn the grantng of enescorted (d) By (msert date 180 days (fter the 103.100107. or 109 of the Act.

access to pmtected anss.until Eve (2) Secuon 236 of & Energy years foDowing terminsbon of euch effectre date of the Enalrule)each ReorFemuton Act of1974; Lceuce shall certdy te the NRC that it I ccces: autbornabons: has 1::plemented a Etnen-for-daty (3) Any rule, regdeton, or order (b) Retain recorus of confirmed pmcram that meets the requirements of issued under then Sections-positve test results which 'n concur ed 10 CFR Part 2A The certifica Lion shad (4) Any term. con 6 tion. ch hmitation in by the Me6 cal Review O!Lcer, and descnbe any bcenne cut-cfflevels mort of any bcense issued under these the related personnel acbons for a etnnget.t than thon imposed by th.s Secuou or (5) Any p*9eisions for wbtb a boense (c . eta of rsons made a er.sy be revoled under sechen 114 of the inebgible for three ) eare or loryper for c e etch M ess!gnment to actrces wtthm the se:pe l M.D0 haires. (c) Ar.y person who willfully n,olates cf this Pert under b provnions of (a) Ead bcenset subject to this Part any pmnsion of the Atomic Energy Act I 1627(b) (2). (3) (4) or (c). until the shad eudit the fitness-for-dut) program of 19M. ea amended, er any regulston Comcassion terminstre each beer.se nonunaUy etcry 12 months. In a d6 tion. or order issued under the requirements under which the records were created, su6ts must be conducted, commal}y of the Act,indude regulations under this and every 12 months. of those portons of Part. may be guury of a crune and. upon (d) Conect and compile Etnewfor. Etnen-for duty pmg tmo implemented duty progsm performance data on a eenweb n. may be punished by fine or by contreetors and vendors. Ucensees j impna nment or beth, u prended by standard form and submit this data to may accept audits of contraetern and la w.

the rhasion within so days of the vendors conducted by other bcennes end of eoch e month reportmg pened Appeodix A Caidstnes for Nudear and nee $ not re-audit the same Onnunty-June and Ny December). The Power Plant Drug and Man 1 Testing date for each eite (co porate snd other centractor or vendor for the same period Pwyrama c.f tune.Each stating utility shall

.-eupport sta!!!ocations may be #"

ocparate!y consolidated) st.sU :nclude:

snaintain a copy of the su6t report to Andude fAndtngs. reoemmenda bons and L1 AMWtr random testing ra te; drugs tested for and correctise actons Licetacca rstain u N.runens cut of!!evels.indudag readts of tests responsibibry for the eflactivera.as of using lower cct offlevels and lesta far Subpc r B-Semesc and7ecAriccJ contractor and bendor programs and the TWwerner.k ciner drtst workforce populabons istplementatien of appropnate trsted. zumbers cf tants and reachs by correcta a acton. L1 The fdr.amase U Ger.eral Mir r at-etana e'Teshc3 3

. Es . Prennting Subvemon d Teeung Con!1nnat ry test? A second analytical : Subpoff B,Scienttficand Tschamol ,

14 Specwin Couection Procedures . procedun to Idantify the preeence tf a Asouirements LS 10iS-Cert 5ed laboretory Penonnel spect$c drug or drug metabobb which b 34 %e Subetancne. -

L6 Ucecm Tesung Facibry Personnel independent (f the initti screening test and 17 Laboretory cad Tesung Facibt7 which uses a dierent technige and

• • • • I Antl>8's Procedum che'rJul prindple from that of the initial test m ** * *E*"*"am'd amphe not I" L8 Quabty Assurance and Quabty Control' b uey in order to ensure rehability and accuracy, for ca us.hdme, a, random, and alcohol testa.

and fobow-ep for pre-access.

Le Reportes and Review of Results (At this time gas chromatography / mass (b) Ucensees may test for any IUegal drugs Subparr C-Employee Proteccan spectrometry (GC/MS)is the ordy authwized dunna a for cause test. or analysis of any 31 Prote: don of Employee Recorde conarmabon method for cocaina. mar $mna, specimen nrpected of be!cs adulterated or s.2 in6ndual Access to Test and opfams amphetmt= phencyddinopae ddoted through bydretion or oler means.

taborstory Cert $cadon Results determining blood alcohollevels, a (c) Ucensees shall establish ritorous "conarmatory test" means a second test testing proosdtres that are connstant with Subpctr D-Ceruficocon of Labwotorw using another breath almbol analysis device. Iba intent of these guidehnes for any other Egagedia Chemn:al Testeg Further cor.firmacon upon demand will be by draypi not spect$ed in tuese guidelines for 4.1 Use of DHMS-CertLed Laboratories ses chromatography analysis of blood, nbcb testmg is actbortrad under to CFR 2e. l Subporf A-Cereml . "Conhed posaive tut"The mult of a ao eat the appropno nna d the un of I conarmatory test that has estabbsbed the these substances can be evaluated by the L1 Appbcab..T presenor of dmga drug metabobtsc.or Me& cal Review 05cer to ensure that (1) new giudelines apply to Ucer.sces alcoholin a specimen at or above the cut ogy inisiduals granted unescorted access are Et eethonted to operste nuc. lear power reactors- level and that has been deemed posidve by for maintamma access to and for performms (2) Ucensees may set mon strmgent cut o!! the Me& cal Review Officer (MRO) ther duues in protected anas.

levels than speched berem or test for (d) Specimens collected under NRC substances other than spectfied herem and

,,,y,,3,,,3. confirmed posidvs test" for l

• al bol can also be obtaind as a neult of a regulations requinng cotephance with this  ;

eballinform the Comnussion of such part may only be designated or approved for I devianon withm 60 days of urplementes c n" madon d Wood deobo!!cvels wt'A e tesung as described in this part and shall not l such change Ucennes may not denste from accond bneth analyeu &MO be used to conduct any other analysis or test the prons.ons of these swdehnes without the evalua ton. without the permission of the tested I wnnen approval of the Commitsion. "HHS-certned laboratory.,, A urbe and 66ndual. i (3) On!y laboratones wh;ch are HHS. blood tesong laborstory that maintains (e) Ris secton does not prohibit ceruf.ed an authorned to perform unne drug cert $caton to perfonn drug testmg under the prodse masouMy Mdent to andysis of tistng for NRC beensees. vendors, and Depam.ent of Health and Human Services a spacin.cn for controUed substances (e gf bcensee contractors. (HHS)" Mandatory Gwdehnes for Federal deterumation of pH oc tests for spectfic L2 DeEntcons. Workplace Drug Testmg Programs"(53 FR gra vity. creatmine concentrecoa, or presence For the pumoses of this part. the foUowmg 16 of adWterantsk deEnicons apply "fUef al crugs." nose drugs 6duded in

• Abquot" A porton of a specmen used for Schedules I through V of the Controued u Gewd Adds'en d Tm testmg Sub;iantes Act (CSA). but not when used ne beenm testr$ actbbesf and HPS-

• BAC." Blood alcohol concentration [MC). pmant to a vahd presenpton or when used certhed laboratones desenbed in this part wbch ce be measured d.re:t!y from blood as oderese outbon.ted by law, shat develop and maintatn clear and well-or derned from a m+asun of the " Initial or scnenmg test." An docmted pmcedures for coUecton, j shipmen cod mession of urme and blood con:.entraton of alcobolin a brestb immucousay screen fer drugs or dnts spmceu andar tba part. Such procedures

[

epensen,is a meseure of the man of alcobo! metabobles to eliminsto "negatve" unne in s volume of blood euch that an inen(rue.) specirens from fcther consideration or the " *"C b ICUne #4 (a) se a" au * "'*'dyt fwm.

i 1

{ with 100 mg of alcobol per too ml of bled has a BAC of 0 to percent first breathalys.er test for alec,5ot or$nalshaU ac ompany the specimen to tb

• "" 8 1" 88 4A '"tm8 HHS-certled laboratory. A copy sbau "Comm,ssion? ne U.S Nodear i 8 W8 ' *M n' 8 accompany any srbt sample 3e form shaU Peruistor, Commissen or its duly authonted vendors or contractors to perform the inital be a per=nnent record on which is retained npresenta ties.

" Cham of custody." Procedures to account testas of unne samples and to perform inital identty data (or codes) on the employee and for the mtegnty of estb spwimes by trechng breath tests for alcobot Such a teetma facibry informa bor, on the specimen coDecbon its hand.ir3 and storsy from the potnt of Le optonal and not requ! red to maintam HMS procen and transfers of custody of the specimen coUceton to fes! d.sposioon of the certicston under this part. specunen.

spec men. *Med. .al Renew OfLeer? A bcensed (b) Uw of a tamperevident sethng systern "Couceton site

• A place des:gnated by the physican responsible for rewiving destgned to a manner such that the spmmee Lcensee when in6nduals present laboratory resuts generated by an container top can be waled agamot themselves for the pu. pose of prendmg a ec:pl oyer's dn.g testr;g prog tm who has undetteted opes.cg. the contamer can be specimen of their urce, bresth. and/or blood Laowledge of s"cetana ebuse daorders and identied with a uraque identfyms number to be analysed for the presence of d ugs or bu appropr, ate me&ca vaining tointerpret idental to that appeanr4 on the chain of-alcobot. and es aluate an in6ndaal's positve teu custody forts and space has been prended "Couecton site person

• A person who resJt together wth %s or her me6 cal history to tratal the container affemmg its identry.

instructs and ess.sts tn6nduats at a and any other relenant bicmedical br pumosn d clanm mis mquanment ceuecton site and who recean and makes bfwmatom assumes use of a system made up of one or

- cm irunal enammaton of the epemmen(s) anore pre pnnted labels and seals (or a

" Permanent record book." A permanently prended by these in&nduals. A coUecton uratary label / seal). but use of other, equaDy site person sbau Lase successfuDy completed bound book in which identfymg data on each effectve technolospes is autbonzed.

t-sming to cany out tbs functon or shaU be s Ated H e hon & an (c) Use of a abppmg contamer in which a bcecsed me6 cal professional or techruoan permanently recorded in the sequence of one or mon specunens and associated wbe is prended itstruenons for coUceton couection. paperwork may be transferred and wbcb can under tbs part and c4ra$es completon as " Reason to bebeve.' Resaca to bebeve that be scaled and trutaUed to present undetected required herem In any case where. (a) a a partcular in6vidual may alter or subu rute tarnpenng.

couecton is observed or (b) ccUecuon is the urtne specimen. (d) Wntien procedures. instructions. and mon to ed by corune6 cal personnel the "Spht sample." A por3on of a urine training shall be provided as fouows; coUecton site person must be a person of the specmen that may be stored by the hcenses (t) tacensee couection site procedures and same gender sa the donor to be tested in the event nf appeal tratruns of coueeton site personnel shall

.A..% s; *F' [., ,

. N Y- & } ?. l l~. _

l5fQ '

fine i. ,b , ' & f. . L ['l . f %. fEa

Federal Register / Vol. 54. No.108 / Wednesday June L 1989 / Rules and Regulations 24501 clearly emphasize that the coueetion alte proper!y equipped mobile facibty that meets ensure assinst any corJusion in the person is responsible for maintaining the '

integnty of the s the requirements of tbs part is an seceptable collectoo site. ident$caton of specimens a coureton site transfer process.pecimen ooUecton camfuuy ensurtry b ar d person shaU conduct only one coueckon (b)"CoUecton Site person." A coUecton anodesty and prtisey of the inevidual tested, procedure at any given tee. For tbs purpose, and is to svo;d any conduct or remuka that site person shallhave successfuUy completed tralrung to carry out this functon. In any case a coDecton procede is complete when b a4ht be construed n cecusatorial or specimen container has been waled and otherwae oHensive or inappropriate. when the couecton of urine is ob6erve& the initaled the chainsf custody form h4s been coUecuon site person tnust be a pemon of the (2) A non me& cal coUecton site person earcuted. and the in&ndual has departed the shad re'celwe traints in emphance with this same gender as the donor Persons drswing ooUecton site.

blood shad t4 quahned to perform that task.

appenda arid staD demonstrate pro $cfency (c)"Secuntyr ne purpose of this (f) "pnyseyr Proceduru for coUect.ng b the appbcaton of tbs appendix prior to pararspb is to prevent unauthonzed access unne specimens shau aDow in&ndual semag as a coUecton site perom A ene& cal privsey urJese there is reason to bebeve that professional, technolog:st, or techruoan wbch ciould compromise 'he integnty of 6 couceton process or the specimen. Secunty a parbeular b6ndual may alter or subsetute bcensed or otherwise approved to precoce in procedures shd prende for the dessnated b spectmen to be providei For prposes of the juns&cton in wbch coUceton occurs coUecton site to be secum. lf a couecton site this appenda the foDowmg circumstances may serve ./ a coUcetion site percon if that facibty cannot be de6ca ted solely to dmg person is pruded the instruccons described are b exclusive smunds consutunna a in 2.213) and performs coUectons in and aJcohol testag. the porton of the factbty nason to bebeve that the in6ndual may saed for testag thaD be secured dunng that alter or substrute a urme spectmen.

2 accordance with tbose instruccons. test =g (1)ne in6ndual has presented a unne (3) CoUecton site persons abau be (1) A fac!bry normaDy used for other specimen that falls outside the normal prended with detailed clearly-iDustrated. purposes, such as a pubbe rest room or temperature range. and the in&ndual wnnen ins *ructons on the coUecton of bespital ena mMg room. tesy be peured by dechoes to pmnde a measurement of oral epecimens in compbance with this part naualinspececa to essa other persons an body tempersfure by startle thermometer, as in&viduals subject to testrag shad also be prended m pangrepb (g104) of tbs prended esedard wnnen instructions not present, and that undetected access (e.g.

thmt.gn a reat door not in the new of the appenda, or the orsj ten:pers fure does not settmg forth their responsibites.

couecton site person)is impotajble Security or exceed &st of de specmea (4) ne opton to prende a blood specimen durms coUecton insy be maintained by (2)ne last unne specunen prended by the for cor&= story analysis foDoweg a positve e5cctve restneton of emess to colecton in&ndual(i.e on a p enous occasion) wu bresth test shall be specL5ed to the wntien instweuons pmnda d to ininduals tested unatenals and specimens. In the case of a determned by de laborstory to have a pebbe rest room. the fachty must be posted speciEc g snt) ofless than 1403 or a ne instructions shaU also state that faum to request a corirmatory blood test in& cates ass;nst scorse during the entn coueeton creatmine concentrecon below J g/L that the in&ndual accepts the breath test procedure to avoid sebarrassment to the D)h COUnton one puun obsmo

,,, aj ts . inindual or &straccon of the coUect.on site co duet cjearly and unequivocdy in& cat =g pem an stiempt to eubsetute or adulterste the 2.3 Preventmg Subversion of Testag (2)If it is imptsetcal to mamtain saWe kg, nbetuu unu in plam new.

Ucensees shaU carebUy ulect and contnuous physical secunty of a poUecbon blue dye in speccen presented etc )

mon: tor persons responsible for ota he se tse b specmen is preuntd (4)ne in&ndual has prenously been 4 a dcunistenng the testng propam (s4, en l he waled contamer is transferred for determined to have used a substance couecton site perwns. Labots tory shipment, the foUowmg memum procedces inappropriately or enthout ce& cal

- technicans. specimen couners. and those shaU apply.ne specmen dd rum.am under outbonucon and the parbeular test is bemg E meleetng and notfr.ng persennel to be the dreet contre! of de coUecton site person o eductet u a part of a rehabibtaton a=

tes ted). bued upot, the h#ce t standards for fan dehvery toits being scaled in a maDer propam or on return to sernce after honesty and integnty. and staU implement or secured for abpment ne maDer shd be evajusten and/or treatment for a cerarmed snesrures to ensure that thew standuds an & dd m6M 6 m Pestve test result

" " " storage. or remab un*.! maDed under b (g)"Integnty and Identity of Specimens "

A e. e a eg- f euc pe a perment) control of the coUecton site pe son. Ucensees att.U ta.ke precautons to ensun is not ocepromaed or subsect to efforts to nese mWum procedurn shaU spply to the that a urine specimen le not adulterated or comproc.ae due to pe sonal relatonabps mailmg of speconens to hansee tsstag M W b NUecton prwedum ist a with any toinduals sub;ect to testeg facQtu from counton sites (except where blood sample or breath edsjent tube cannot 2

As e mmeum. co-located) u meu sa to the m=hr of be nbsttuted or tampered wnh. and that the (1) Supernso s co workers, and n!stves specimens to fMS cert $ed laboratones. As of the inindual beeg tested abaU not informaton on the (gedmen container and in an opton, hcus ms) abp several che remrd book can idertfy the in&ndual perform any coUecton, assessment or epecmens Irfa couner in a, locked or sealed evaluaeen procedurn from whom the epecimen was ccUected The abpptng container.

foUowing minimum precautons shaU be (1) Appropnate backg ound chechs and (d) *na m ofastody? Ucer.see chain of.

taken to ensure that authenne specmens ar-peycholefcal evaluatons shd be completed custody forms shd be properly executed by obtained and correctly identhed.

pnot to assigwent of any taalJ associated authoraed ootecton site pe monna! upon (1) To deter the dducon of unne specunens with the artmWatratoo of the prog tm. and receipt of spectmens Handhng and shall be conducted at least once every three at the coUecton site. touet bluing agents shd transportston of urine and blood spedmens be placed in toilet tanks wherever possMe.

trom one a utherned inindual or pleos to

($fPersons responsible for admir.!stering anotbu dat alwaye be socomphabed ao the reservoir of weter in the todet bowl always recAins blue. Wre shaU be no other the testmg propam shat be rubreeted to a through chaw eustody procedures. Every behanoral observaton prog am designed to source of m ster (e4. no shower or sink)in

' e5crt shaU be made to mirim!u the number anure that they contnue to meet the Egbest of puuns handleg b specimens. the enclosure where urcaton occurs. lf there

% standards for bonssty and interity. As anoder purce of watu in the enclosum n (e) Access to Authonsed Personnel Only?

2.4 Speamen Cotecton Procedures. No unauthorued personnel shaU be permitted shd be c5ecevaly secured or monitored to In any part of the designated ceUechon sJte ensure it is not used (undetected) as a source (s)"Designaton of C4ection Sito? Es cb for diluting the speamen.

where spedmens an cotected oc stored drug testma prog am shat have one or more (2) When an in&ndual arrtves at the Only the coUecton site person ny handje desumated coUecton sitas which have aU specmens pnor to their acursment in b coUceton site for a anne or breath test the neces sary personnel, ma tenals, equipment coUecton site persoe shaU ensure that the maihng or shipping containeror anonstor or facdsnes and supenwon to premie for the obsen e spec. men couceton (under the in&ndualis positvely identhed as the coDeetoc, secunt). temporary etorate. and coninons apectLed in this paM) In order to pe son selected for testmg (es through abppmg or transportstoe of unne or blood promote securtry of specmens,evoid presents ton of photo identicauon or specunens to a d.ug tentag laborntory. A 6denticabon by the emplo t's

&st seton of the coUectoo site person, and erpreuntatve) If the mind aj s identty d

. i

. . es an ons

, cent be setsbUabed the coDectfoo atte (%e 6.,-.6. of the pertfal specimen D

• CoeSraato y testing D secaseptabed by penoo'obeB rot prtweed wtth the oeBection egrch sepen te container streU be measured hr repeatzng the aboes procee.rre on anotbe?

. (3) If the Individual faf!a to arr+re for e accordance with parag*sph (f)(tJJ of this '

wirw ce bree'.h tese et the seelgrmd time. the evidenta!-s ade breath analysis devkE

' sectf on. and the partial specinwns shall be

.i edarnas rtte person abaB opetect the (16)If the alcohol bnath tests indicatn combtred in one containst ) ne indtrkfual thet the indMoualis poelt!ve for a BAC af or esproprts to eetboetty to obeate psidence os mey be s'ern s reesceable ameant of Squfd the ecuae to be tahan, above the C.04 percent cut-efflent the to dar.1 for thfr purpone (e g.. e g!ase cf individual may request a cor.Ztmatory blood (4) Mtar tp tudrvidual has base we+er) If the indtvidua! fsDa kr any reason identied. the couectoo s:te peroom aball to provide 90 cz.Elters of urine. tbs test, at his or har dtscretion. AD vacuum tabe the 1:ndreutaal to sisp a consent to tescas coBretfee arte perece sha!! contact the and need!s tuar.Ws und far Mood form and to tot ajj at the prescrtptawa celectica shad be factory-etuilisad N spproprts to evtherf'y to obtain gufdanos se i r ==ar,t ame ersi owr the<aeotar the actice to be taken- cdection aira person sha3 ensure that they '

prvparataans that be cr she can r===b- remain preparly analed untQ used Ancasptw f!rl A$er the artos e secfearn bee been twsbbing of the skin shaU be perfarmed wuh 4 unang withm the past 30 doye. prorfded and roba:ttte<f to the ooDectfon ette (5) N ouUection atte persom shad ask the . g a g gg gg I person. the indvidual sha!! be aSowed to l Eddal to remove any armecessary outer wesh his or her bands. aban be foUowed w a duaa Wed and l garments s ch as a coat or jachet that might (13) !cune d"siety after the artre specimen trausstr.'ng b b;ood to a store um l concealitemas or sabotason that couW be is coUected. the coUec:fon she person abaU inad&

y gi,g boa. b e h m he M M used to tampas i.te os adul:areto the meneurs the trepersta of the specturen.

indma; e urina, breeth. os tJood ep-h ne temperature measuring device used w (E Bod b bdinded W woud M N couectca sus persos sha; ecaure that eecurately nflect tbr temperature of the the couection site person sha2 keep unce and l, au pr.ncmal belongmga euch u a purse or specimes and not coetarninste the spect:nen. Wood e- in M et dl m p e Leafcase rsMn with the outar gar:sente ne t:me frotn artnacon to their bema ses.imd aadlebeied. Af a artne cutside cf the rme e etch the teood, toeestretners to crttkal and in n ,"e c"a"e'shd s opecban u @ W h b d a h lt tresLA or uru.e samp!s w cc:acsed na tc6vidual may totam tua at her s anat.

exceed a mfer.rtes. W)Ww we od scetam, the hoe sus rarsom atrd M u (14)If the tentperaten of a artne rpedmen (e)The haindW ataL be lutructed to is octrirle the rangs of 32.5% r'J 'C/so.5% shat mqunt tk MN to obens the w uh and dry his or har hasda pnas to 99.8 T. that is e rewson to beffere that the s#tmg he a sa@ or the tmnsk of t.rtna con. indek*.r:J ery have ehered or rebetteted th speaan med he Mme1rt of the (7J After wdy Essda prior to urmatics, the spectmen. and anether spectmen abaD be ta-We seal m de camatursee the indmdca sham nmain tn the pr-a of coDeeted under dreet et servetten of a ruine *

• the couection site penen and stat not han gender ceDrecen ette person and both '8Wd Nd""' col'h' m'*5"' Cf IIand rue peme '

• the e = cess te acy watar fountain fascat, sc.ap spec.mne shad be fo warded to the miaal y be pnsent at be atw ems c'apensar, clesama agent or any cL5sr lebors tarp for feettng. An 6dtetd. mal mer during m . - outbr.ed a paragra,*a (b) retarials =tuch could be used to adultera:s volanteer to han La or her oral temperst av 6W W of this secton.

t'e urine spectran, taken to pr:mde e*+de tee to concrier the M N de saa penos shat piece 1 (e) The icindaaf cay provida Lis/hsr nasce to beben the iv$ndus! mey beve secunly on ud contam an identicaton sc.no spe:wn in the pnveey c,f a otsU or eMe ,d or tobet+tuted the r,metmen cenred by label wtJch containe the data, the c.borw.se pa-ttoned aress that aUom e for the rpectnen's t*mpe sturt faL%g otr. ride inindual a specimen number. and any oGer 1-d;vidua prnacy. the preecr' bed rartre ident30stico infer =ston prended or (9) N co"ection site person sha3 note any f15)ImedLa tely aher a cr6e spectmen is nquimd by the dr.4 testing prog-am. E tm.sual betanor or a; pea ance in the couee'ed the ceCectree of e pe=soe shd! also upara te bem the !s beIs, the tarpanvide.nt p r:nanent record book and on the chain-of. inspect tte r;ecimen to dete mine its toior seals sha; also be apphed custody fert:u andlook for a:y s'ps of morarJnants. Ary (D) N inividual sha3 i:stial the (10)In the eaceptanal event that e unures! find:nge shad be neted le th, idemtiScataan labals on the specisas dn psted coUect;on s!te is Insceasile and  ; err:aneet recerd book. cor. tamers for the purpcse of cert!y.r.g that it iton is an tr.:neiste reghe=ent for urine (16) AC arbe %.4m respectedof bef g is the apea:nen ecuacted imm Lim or Lu.

a spac=en ccreeton (e4, an s:: cadent t vnt aeon) a pubbe or errsite net rocm adelte stad er found to be dhted ebe*J be (i) L indvidual stan be uiad in rud form arded to the le bees bry for testag. and a.gn a statet:mt on a2ther the chaeof ery be used secorcrg to the fotowteg (17) Wherwear there is tre son to be be,, custody farm or in ti.e pennsnamt record

ocet.

rce. A coUecten tre persen of the tha t a perrujer ind*vk6as! may sher oc book certfytr.g that the sper- kiest/.ed sane gerdrr as the irddal atall substtote the urtae spect:nen to be prov6ded, a ce= par.y the tn6r:draf into t6e rest roe:s a e ha nns beta ecOeued from han or har are a second rpecr ce staD be cbtabed as seen in fact the specea Le or ate provwhsd, wbcb shaU be cade serre dc.::g tte -

as poertse ander the ditect ebeervsbon of a (i')m ardv.d al shat be prended as evJo:te'r.Ptced:re ff pose % e todet same sender coUecten site person. Wher, opportarvy to set forth on the 6.r.z.e claeo!-

h:ning agent sha2 be Ps&d tn the bowi and s pprornate. tr u runs will be t. ken to any access;b!c tSet tank. N celle -fen rrte custody form informst.oo emer ng pn eent oddrtknal bydrs tfort snedoxos takes or

• med in the past Iwe sF eD r*:~sen to the rer' roots, but (18) Akofnl brerth teste ehsD be deleyed 30 hys.

c erde t6e rall net) the rpecirnen te et leset 15 eMnctn if ar'y courte of moeth (24)The cc.0cction mae person sLa3 estee a ennected if r o blu: 4 egme is evefisble to aldol fe S. bree th frnhene s) or arry ether the perr. anear racard book CJ ir.forn.a tion drier r;acunec 6)cbert the ceEcetree s te subr'anoes are enreced (e g. estrg etnokt rs, ident.fr.r.g the speci= ens. The col;ecuen ene r enon shsU inrtreet the uwimd,a! not to resurgnadon of storroch coctents frois persoo sk.a3 sign the pt.rmaner.1 round book fxsb the tedet aritil the epeci:sen is det eered ve:aatre or buryingVThe ceDectice site next to the identdytoq; tr.brtsa tra ta tbo cxOccwon ette pervert Af*er the person sheD eneure thet coch breetb c ol:eeten ette pe-son has poeeestion of the (25) A tugher leval supervisoe a the drug epecimen talm cornes froos the e .d. rsther testant prog

• ass thaU nvaw and conew in apetrecat the indmdvol wsU be tr rtructed to thac the begrting. of the bresti erptracon, advance with at:y der;aaon by a codecisas f.nsb the tal-t and to pertetpete w:th the for e+ch s: nee.tng tcyt two breath site person to obtals.e urtne specu:;e.n under cotectaen s:te person in creepNtzng the chale. specreens shaU be coUected froen each the direct ebetrvation of a same gender cf-esstody procedores. indmdoal ne le so ths.n two stdnetn sport collecticn ette person besed on a maeon to (91)L'pon recetving e a+>r spactreeti froen and r o cron thee 10 nunutes epart The test the LD6V0do01. the coUee'Jon orie person shaE beIteve that the 6dmdval n'ey alter or res.d's shad be COMeidered ecCWrs19 If the awbsDttle the speh to be pmvQed deter:ntr.e (%st se contal*W et letet 40 resJt of sech ines furetnerft !e venthin p!9s or (;8) N coDection stie pe-sen shall Ir Ull. tars of inr'erse. E therW is Iesa than to antnus to percer t of the everse of ese two cotrrp4eee ths chsh>.ek.ve*ody forers for t.oth in.UJite s ef ur ne in the can'stvr. e&htsocal rnesearetnents. If the two terts do not ag,ve, the ai>quot and the aptit at:rple. if corice'ed.

ur.no shaU be ecliccted in e sepa ste the breath teste sheD be repaeted on anothee and ebeu certdy prepee cetr.pictee of the '

contamer to rea:A e total of 50 anlLivereL endecuayade brnth anatyrte devme. cotiect>ca.

j iii i g

= Federd Redster / Vol. 54, No.108 / Wednesday June 7,1989 / Rtdes24563 cnd Regulation fonns)an now nody for transfer to Medical the(87 RenewThe specimens Omcer and shaU cod document hef-custody Laboratory or the bcensee's testag tec1Uty. If the noo<ooperation in the permanent record of the procedun mand an described in book and on the specimen custufy and Section17(0)of this apptoda).

b specmens an not immeistely prepared for shipment. they shaU be oppropnotely control form. The Me& cal Review Omcer (6) This in&vidW shaU be responsible for

• safeguarded durmg temporsry storpe. thaD nport the failure to cooperate to tbs snaintaming a quabty auartace program to

44) While any part of the above chain of. appropnats managemect The prevision of assure h p oper performance and reporung custody rmcedures is being performed it to bbod specimens for use to conarm a pos! cts of eu test resulta, for mamtagung acceptable essents) that the specumens and custody bnsth test for alcohol shaU be entrely analytcal performance for aD controls and voluntary, at the in&Wdual's discrecon. In stat.' art!*. for maintainma quabty control documents be ander the control of the involved coUecuan site penon The coueetoo the absence of a voluntary blood test the testmg and for anunna end documentag the site person shau not lo ve, b collecton atte second posieve brestb test shad be vabity, rehabibry, soeurney. precmon, and In the interval between pruentabon of 4be considered a con 5rmed poeidvs. performana charactensbcs of each test and test system.

specimen by the in&nde and securement gl. 106certiedlaboretcry personnel of the samples with identfying labels bearmg (7) This in&vidual shaU be responsible for (s)* Day to Day Management of tbs HHS, takg au ned al secons necessary to the in&nduds cimen tdenunubon ed h b unes numbers and se e imidaUed by the anaintein satsisetory opersbon and inevidualIf the involved coUeston site  %.wrdd h ery shaU havs performoor of the laboratory in neponse to person lea ves his or her work stabon a quahLed indmdual organ!utional educatonal to and assume professional quabty control syses not bems wein somentanly, the specunens and chain of- adcunistrseve responsibibry for the performecoe specibcations. errors in mult custody forms shaU be talen Mth him or her g, , te fa&u. nportog or in analy828 of pMormance or shaU be secund. lf the coUecton site testeg ruulu This in&ndW shaU ensure person is leanng for an extended penod of ) Tbs 6&w ualaM have documented that test results an not reported until au ntic quals bons 2 analytical forusic tee. the specimens shal! be packaged for toucclogy.Mmimum quah5 canons an: cornetve actona have been taken and be or transfer to the laboratory before be or she abe can assun that the test neu!ta prended luvn the sne. g )0Certauton u a la borstory director by an securate and nbable.

gprope Stat, ggowc or chnical (b) *Cotecton Control" To the maximum laborstory toxicoloD; cr (b) 7est Vabdstos" The laborstory's extent pon;ble, coUecton site personnel (U) A ph.D. to ot e of the natural sciences urine drug intng facibry shaU ha ve s shaU keep tbs L1&ndd a specimen wd an adequate underg sduste and qualded in&ndua!;o) who renewe all containers within sight both before and aher g aduate educatoo in biolons chemistry, and perteent data ud quabty control results in the in&ndual has unna ted or prended a pharmacology or toxJcology, or order to suest to the 6ab&ty of the ,

bresth or blood sample. Aher the specimen is (iii) Traitang and experience comparable to Laboratory's test nports. A laborstory may couected and whenever urtne specimens an a p2 6 one d de naNrs] doces, such u designate more than ene renon to perform spbt. they shaU be properly sesJed and e me& calor scient!ic dcree with ad& tonal employee tbs functon. Tbs in&nd4 ) may be any labelet A chain-of-custody form shaU be traming and laboratory /research expenence who is quahned to be responsible used for meantarang control and in biology. chemistry, and pharmacology or for day-to dsy management or opersbon of accountab;hty of each specimen from the tox)cology, and the drug testma laborstory.

point of coUecten to final d;sposibon of the (c)" Day-to Day Opersuons and (iv)In ad& t,oc to the requirements in (i).

epecimet ne date and pu pose shaU be (iit ud (ui) above. min! mum quah5 cations Supernsion of Analysts? Re laboratory's documented on the chaan of custody form also require: unce d us testng facibty shaU have an each t;me a speczen is hudied or (A) Approp tate experience in analytical in&vidual to be responsible for dapto day trauferred and every in6ndualin the chain forenste toccology bclud.ng erpenena with operstons and to supervise the technacal of custody shaU be ident$ed Every u!!crt the analysts et taolopcal matenal for drugs saa!ysts This in6vidual(s)sha3 beve at shaU be made to n - the number of of abuse and leset a bachelor's des ee in the chemicA! or persom bandes specnens (g) Approp, ste tralrW:s and/or experience biologul sc,teceb or me& cal technolop or (i) transportstop to laboratory or in forensic appbcanons of analytical equwalent. He or she shaU ha ve training and Testmg Facity " CoUecton site personnel toalcology. e g. pubbcatons. court testimony, experience in the theory ud pracoce of the thaU arrange to transfer the coUected nsearch concerning analrecal texjcology of procedures used in tbe laboratory. ns dcag spedmens to the drug Wttg la bors tory or dtvgs of ehse, or other factors which quahfy in his or her thorough understan6ag c,f bcensee testtg fa cibry. To transfer the in&vidd as an expert witness in qsakty cont ol prs CDces and procedans. the epectmens obs:te for inital screening and for foress!c toccology. review.interpretaboa and reportmg of test

• a second screen and contr=ston ana!ys.s of p) his in&vidual thaD be engaged to and ersuhs: maintenance of chain of custodyt and presur::ptse posiDve specimens and for responsible for the day to<fsy management proper natial setons to be iden in b arJferre.g suspect epecimera to a' of the testeglaboratory even where another nsponn to test systems beca out of control Labor $ tory for analys!s under epecial itividual ha e overtU mponsibibry for an hms or detectmg aberrant test or quatty pror.essing [Secton 2Md)) the spedmens anun multspecalry laborstory- control results.

shad be placed Le containers designed to (4) Ths inendual abaD be responsible for (d)"Otbar personnel

• Otber technicians or mmimhe the possibibry of damage durma ensuring that there an enough personnel with nontechnical staff shad have the necessary shipment (e.g., specimen bones, padded sdequata training and expenence to training and skiUs for the tasks ase:gned.

mailers of bulk supping contamen with that supernse and conduct the work of their (e) *7 taming " he labora tory's tes tag capsbibty) and those contalners shaU be testag labontories. He or she shaU sseure prog tm shaU male avallabh contnuiag securely sealed to ehminste the poss!bihty of tb6 continued competeney oflaboretory ,ducaton prog tma to meet the needs of personnel by documanung their inserrios laboratory personnel undetected tampering On the tspe seahng the container. the cobeCCon s!te person shaU tre Wg renewmg their work performanos, (f) *Tdes? laboratory personnal fdes thaD ogn and enter the date epecimer.s were and venf%ng they skius. incjude r+eume of trainmg and expenence:

sesied Le the containers for supment. De (E) Tbs inindual shaU be responsible for certLcaton or boense.lf any;miennou. job coUecten ette personnel shaU ensure that tLe the laborstory's having a procedure manual deschptions. records of performance etain of custody documentsbon is artsched which is cetoplete up to-data.svallable for evaluebon and advancement incident to escb container sealed for sh!pernt to the personnel performing testa. and foUcwed by reports, ud resuhs of tests whach utablab drug testing laborotory. those p4rwnnel De procedure manual shah employu competency for the posibon he or (1) *7ailun to Cooperste

• tf the individual be renewei signed and dated by this she holda euch as a test for eclor bhndnesa, wh.us to cooperate with the urine coUecten neponsible inindual whenever procedum tf appropriate.

or bresth analysis process (e4 nfusal to are first p!sted into un or changed or when a u haes Teeung FacGry personnel prende e complete specimen, complets mew in6vidual sasumes recponsibihty for management of the laborntory. Copies of all (s)

• Day to Day Matagement of pa perwork, in!nal spectmen). then the coueccon site penun thaU tr. form the proadures and dates on whsch they are in Operstons

• An; bcensee testing facity e!!ect shaU be maintained (SpectSc contents shaU have an indindual to be responalble for day to day operations and to supentse the

zepe , r *= _

• a ng/mi k haianoasser eP*cdSc lbr bus .

cwedy fans seiseed e its shfpment abat j tueng wSJ=w.nis todtvidualtslokan be nwrted wtthte as hoore to the Bceram. la noorphine.

l teve atlusia becherw ar degra tz the b can d HHs cartmedlaboratortes, and ta .&huan.go.a.e may .pecuy a,s.

I chendeal er bedostcal eeseoose or medHal shall be noted on the laborstory's cha!>4 stringent culo5 levda Raeda ahd be sededosy av egatvalver. He er ebe she5 abs reported Ice both levds is each aana.

l beve tratrnrg and encrince in the theory custody fann wh!a ahd a and precues of the omoedurea used to the spadmana whis they are in tha (a) na hat d Har'==ria= m> be menad ami the ca.oS levels are sub,ect to chanen by shs teensee totire feci16ty. meal.tng is kee et her poupalen. Indications of tamparing with mas a todastry and spe+nna at a testin6 acuity  ! operetad by a NRCin therwab umdarstandise of guetty centrel by ma bczname ahd be t, ported sidia g hears to danges HHE Guidehams practhcne and proced rea: tbn mv'aw, d Hedth and h Sm as Interrvienom and repor N d tes8 med85 unior licensee mannesment.

l (2) Specimes contain=rs wC == maffy be ,g,,,,,, g, gg,,ggy,,g,gg g

and proper resse6el acaces to be tahan as response to detecting aberrant test er trum1HF retained witha b laborsto y's or testing upwiseca, or obe comeldenums warrest ccmtml rum)ts.

fa=1*y s eccesekrn arve tme 45 analysee a

b hadunke d edeond d==a===== and (b) *'Other persminsL* O&st m er beme been r==ap n e Ahquets and the chab- adow ecacentrados levet,s,.

c setechnical etaff shall bsve the asorse-ry of. custody forms than be used by labwetery (f)

• anrestory Tnt.

i t.airuse s,sd skiins kr the tasks === tad er lestiry lec2ty penonosi for esadustaig (1) Specumsue whid test sesstive as a I

(c)'Thies. tar-mases' asettag facshry nW6d and cardruetery hets, as op ***

I

{c)"Shon. Tern Refrigerated Steenge." "# " " '"*""

l rersamo:) Also shd indemis resand af .Specimens that do sat reortve se inttsei test act be avbject to any funhar tv.tng ordves i

t; airdr4 and expernesse, eartscans w Lamme. If sny.rdarisons bib descrtpdans ,g,Ain 7 dne d e.Hvd at b kborotary or

- specia!grocessire of the specimen to dntred l bocaese eduherstion or ddatfon is sospected

"" not eWpped wt6h 8 boare he h

' t-cords of performance evatesman and a dvaar====+ tecidens repons pesatu of 8W Wg (2) All tuine esmp}es idenufied as test wbd estabkah eagleyes songstaary @U 88I@j" ,g b" presumptive posttve on b screer. irs teet for the position he or she bohh sud as a test mfngeen ards3.empenteve eau not performed by a HH5errtded labcustary f.r calarwnctamas,if appropruts and exonM Emergmey pewer W shall be conf.rmed easing saa l appropriate daa to espeart deterestastless d shall be evallable in case of profenged yower cbometogrepb'maes %Mry (CC/

' hacuty and wegnty w==rbe ted h f*h ,,

MS) techniqces at the curef! vstues tieted in e cooretanr= wrth Secmaa 3.3 ed this appsoden. "#" "

e t$ed um e postt!ve gi,, d ytb ca 23 Labo s

,,c,,,m,b,,e o,,,,c , ,_.s Andym.yrmry _ and Teetfig FactinTb, e ucemes.s i .r.g fscuy asd be sh!pped to an HHS eertf ed laboratory for concrmatione aballbe by quanttattve *

(s)"Secartty and Cha!a of-Custody.' tuting. laboretory facmbas far drug testfug andysis. Concrettstions wtdch exceed LEs '

t I (1) HHS-cernSed drug tuting labore todu wc normany process urina specirmens by knear region of the standard curve shaU be and any tmsee tuting fac[bty shd be grouping them into bat:ies.ne number of documented in the laboratory record u l e cun at d emes nsy shd t.sys in plmes I

eEcient secunty rnsuures to contml access spectmens in each batch may vary

• greater than hishast standanf curve wafue.~

to the prem.ses and to assure that no s.grdcantly depend.ng on the eisa of the Cochrmawy test cu@synynglany snauthoriud pwsonna! kante sphs cr labentcry ar.d als woruoad When W

• conducting eider Laitial or coni".rmatory taata Mantenna 4% - 20*

• pin accus to the laboratory procaues or to et sider the licasee's tasnns fachty or as t'ma meta A anos where recards and rpht samp'.es are Opistes: ==

s'ored Access to these secured arsas shd be HMS-cart.f.ad hborstory,avary batch eLa .i,- N con:ain an approprkis numbat of staadants sao Istsd to specif cdy authorisedinividaak for cabbreung the instrumentation and a Codane *a whose authorisationis documented All erhm of to parcant controla.Boe qualety Phency

• a utbansed vwitors and maintenance and control and tind per'.ormaaca last samplea Amphetammes:-

sernca personnel shd be escorted at aD Amphs- 300 t.mes in the HHS cert.f.ed laboretory and In std appau u ord. nary enmptes to - see laborassry ana?pta.Epscial procans.ng m.ay Me ca.mpbe==-

the beensee's testng fa citty. Doct.mentstion Alcobot 04ts RAC ofinividaals eccessing these anas, datea, be cor.dac:md to anaryu apamana suspected cd beme adultarsted or df.ated 'Dehe+ tetnhydrocannsturoNp-sad times of entry and purpcse of entry cust (tocluing bydrebon). Any endentas of ca.rb.oryhc ecH.

Le totintatoed ed4tenton or he=an and any datocsed Beucy k sonbe.

(2)I4boratories and testir,g facultes shd In ad& tion ticensees may specify mon t se che mef<ustody procedures to matetain tnca umounu of dre er meubaf.'.aa, eksil control and secountabt!!ty of rpec.meris frem be reporud to es Wedecalf an.sw O! Lear. stringent cut off levels. F.esults thaD be racerpt through cotepicton of tesu::g. (,3..pnl.a.inary trubalTut. reported los both levels to such cases.

report ng of results, during storage. ar.d D)For the analsse of urtne specimena,any IS)The analybe p Wee for carformate*y contmung can! Anal dispostton of p,e+.nrary wet perkmed by a bcensee's " I woung tecsty a.sid b Mal m M """!)'i' pr nded*Iby bi* # 'P'.a'ls u'3' '"I""I'"iInting positrve b individ6 specimena.ns date and purpose staD be documented an an ep;ropftste chatnd p erformed by a HH.kartised laborotory alcohol on a bresth test sha3 be gas custody farin esch tt:ne a rpecanan is shall use an imenwooemry which sanets the dramates aphy ana ysia.

handled or transfernd and every bdtndos! ,,q,,.smana d the Fcied and Dres M' "I '"D'I""'" D I '"I'd "Dd the cut off leveh are subject to change by the to the cbsin shallbe identeet Accord:r#f. Admirustratw.m kr m.m.m.at carribuesa.  !@C In response to industry upenence and a utborned technicians shd be nsponsibts ne isoW int d bruth loe alanhol

- f or sech arto, specnne or ahquot m their c n 2 Se HHS Cadehnu nade by be poesession and ebaD sign and ccre plete (erbmed at h odectnam arte abd use Department anath of Htalth and Humanmeasurement Services as drnae acted chab-of<nstody forms for those spe.imen' requ.nments al Sectkm 2 7lo)D).no -

arsancea teo%. sha!

er abquote as they an recetved foucw.ng imtal est ot! nevide shall be used empenence, or other considerebons warrant (b) **RecrtetnC who -g spec. mens to hm the tactuaion of editional subetances and D) Whre e abipinent of epettnens le v.he'Juer they an negat:ve far es M other concentrationlevels.

noesved laborettny arrd bcensee's testfrt 8 g 8'** (5) Confirn. story tests for opfstes sha3 f acthey penortnel ebell inspect erch peckage initial test c*efflevellrig/saf) include a test for ermonescetylmorphina for endence of possible ta:cper ng and 100 (MAM)if the screer.m6 testis prnumptive Marijuana uretabottes cornp an mformatace se specames ocatatners 300 positive for morphina.

within a sc.h padage to the taformataos on Cocaine cataboDes- "' (g) " Reporting Resuits."

Opiale esetaboLtes D)De HHS certiLed laboratory sha!!

the octoepanyira chain of<cstody forms. PhencycLdtna. -_

25 Any irect evidence of tampering or 1.03) report test results to the licansee's Med; cal Amphe ta-san -

o.04% BAC Review Oftcar within 5 working days after discrepancies in the infoa.r.ation on specirnen Alcohol _

ccetainen and the licensee's chattrof.

l l ga o - - - - - -

Fed 2ral Registir / Vol. 54. No.108 / Wednesday. Jane 7. '1989 / Rules and Regulations 24505 ' '

ecceipt of the spectmen by thelaboratory. conarmetion data trom HMS certif ed Befon any test result la reported (the results to cordre the presence of b drug or laboratories shall be included for test twu!ts unetabohte.

of hutial tests. confirmatory tests, or quahty reported within that month. Nonnelly this control data). It shaU be reviewed and the summary abaU be forwarded from HHS- (J)"SpDt Samples? Urine specimens sney

• t st certaed as an soeurste report by the be split at the boens e's &semuen.Into two certned laboratories by reldstered or parts et the cotecer a site. One half of euch neponsible in6vidual et the laboretory.no certaed maU and fmtn the beensee's teeting report aballidentfy the substances tested for, facibry not mon than 14 calendar days after sareples (benafter abed b ahquot) ebau be whebr positive or negstive, the cut off(s) for the end of the month covered by the analyzed by the be msee's testmg facWty or esch. the specimen number assigned by the the WG-certi5ed 1 boratory for the summary. ne enamary aball coertain the beensn's purposes se described in this beensee and the drug testing labomtory fc 3owing informaton:

specimes ident$ca non number. h results eppen&x ne o*ber half of the samp e (illnital TestinF (bereafter cated the rpbt sample)may be (posbe and negacre) for au specimens (A) Number of specimens received; subcutted at the same tme to the laboratory ('E) Number of specimens repoMed oot and wstabeld from transfer to the laborstory.

shsU be reported back to the Me& cal Renew (C) Number of specimens screened seded, and storad in a secure marmer by b O!5cer at h same time whee possible. posinve for: bcensee until the abquot has been (2) The FD5artfwd laboremry and any determined to be neganve or until the Marijuana metabobtes bcensee 6esung facib'y abaD report as positive result of s'acreening test has been Cocaine metabobtes conLrmed. As socn as the aLquot has tested megatve aD specimens. sacept suspect Opiste metabobtse specimens being analysed under special Phoneych&ne megatJve b spbt sample in storage may be processur wbcb are nesstve on the initial Amphetamines destroyed. U the abguot testa positive by test or negative on the conannatory tast. contrmatory testag then at the tasted Specimens iesting posieve on the Alcohol indmdual's request. ibe spht sample may be N fearded on 61 day 2 ander WS.

po pe e su Pm tive (A) Number of specimens rece4ved for cartLed laborstory that 6d not tut the conhresbon; -

abquot.ne chain-of custody and tunng es f ci r a t be re d (B) Number t.f specimens conanned procedures to which the spht sample is to boensee management. Po82ttve for sub)ect abau be the same as those used to (3) ne Rd cal Renew 05 car may Marijuana metaboute test the ininal abquor and shad meet the routmely obtain nom the FDG cert 5ed Cocame metabobte stedards for retestmg specimens [Secton laborstory, and the lebors tory shat prende. Morphine. codeme 2.M h quanutabn naults of any seced quanttaban of test results The Ma&ca) Pbeneysbine tettmg process abaU be made svadable to the Revaew 05 car may only disclose Amphetamine MecbW Rensw 05cer and to the indmdual quanttsbon of test resWts for an in6ndsa] Methamphetamine teste6 to boensee managemeet, if req *cd in an ^1cebol G)"Subcontractmg "FDGartSed appeals pmcass. or to the irxbndual under (T) N etsesbcs abat be preser tad for Isdoramnn abau not subcatract and shad the proustons of Seebon 31(Tbs does not both the cut-offlevels in those guidebnas and P'81 'S "U *d "10 bi*D P'MonD'I

,' preclude the promion of progam any more strmeent cutofflevels wbcb and equipment unless otherwise authonaed h

perfo : race data under the provisiou of to beensees may specity. The HHS oertLed by the bcensee.The laboratory must be CTR 2t.31ld)) Quanttaban of negstin tests laboratory and the beensee's tecas facihty capable of performing tesba for unne specuneu shaU not be 6sclosed, shad make aveileble quanetstve results for c!ssses of drugs (man;uana.g of the oocame, opiates, Sve except where deemed appropriate by the all samples tested when requested by the phencychdme. and amphetamines) and of Me& cal Renew Omcer for proper NEC or tbs hoensee for wbcb b laboratory whole bloed and conhrmatory GC/MS d.sposinon of the resdts of testo of suspect is performing drug tvung semoes- methods specified in these guidehnes.

specutens Alcohol cuanutsbon for a blood (8) Unless otberwise instructed by the (1)"Laboretory Facibbes?

spectmen sha4) be prended to beensee beensee on wnnna, aD records pertamme to a management wi1 the Me6 cal Renew (1) MGeertfied labors tones shall comply given unne or blood specunen shad b, W eppbcable pronaaons of any Stats Officer's evalabon. retained by the HHS-certifed drug testing boensurs requiminents.

(4)The laborotory may transmit nsats to laboretort and the hornsee's testag facihty the Me& cal Renew 05cer by venous (3) MGet5ed labo stadn shad have for a sainimum nf a pars. the capabibty, et the same laboratory electronic means (eg , telepnsters, facsimDe, premises. ofPerforming mital tests for each (b)"loca. Term Storare?loca-tens frases or computer)in a manner designed to ensure storage (-20 *C ur less) eneures that posten drug and drug metabobte for wbeb semce is conhdenuatty of the inforcebon.Raadts urine spemmens Mll be avansble for any offeredJ and for performing conErmatrey tests may not be prended verbaUy by telephone esorsaary ntest dunna administration or for aloobol and for och drug ed drug tram MHFxerthed laboratory personnel to &sdpLriary proceeings Unless otherwise metabobte for wbcb semc= La o!Iered. Any the Me6c41 Review Omcar The HHS- authorued in writRg by the k--a. HHS- beensee testng facihtjes aball hace the certfied laboratory must ensure the security certhed la bora tones shal! retain and p'-ace in espabibry, at the same premises, of of the data transmission and hmit access to properly secured long-term f osen storage for perfo wrg initial meenmg testa for each any data trmmission, storage. and ntneval system-a rainimum of 1 year all specunens conarmed drug and drug metabobte for which testmg is Posiuve. Within this 1 year penod a boensee condt eted Bruth tests for alcobo! may be (5)ne laboretory abaD send only to b or the NRC may request the isboretory to perfonned a t the coUection sita.

Me6ca1 Renew OL.cr a certled copy of retain the specimen for an a d6bonal pertad (m)" Inspections? m NRC and any n e ongmal chainef<ustody fcrm signed by b inindus1 responsible f or day to day of tune, trut if no soch request to recatved the boensee stilm4 an HM5eerthed laboratory laborstory may d2scard the specunen after abaU reserve the right to inspect the ma.nagement of the d*ug teetng laborstory or the end of 1 year, exoept tbst the labarstory laboretory at any tune toennee contreets the in6vidual respnnaible for attesting to the shaU be required to maintain any specimens embdity of the test reports and attached to with MGerrthed isborstonn for drug <

wber shad be a copy of the test report. under lers! eballenge for an todennite penod, testmg and alcohol conarmatory twing. as (e) m HHS-certned lebaratory and b shaU Any epht be trensk semretained bylong

' 'd into the boensee weD as contracts for coUection site semoes.

term rtorage ,

shad permit the NRC and the boensee to bcnnsee's testag feetbty abaD provide to the upon determins n by the Me6 cal Review 1 beensee emetal terponsible for morthestice conduct unannounced inspectons,in Omcer that the specimen has e confirmed ed6 tion. prior to the tward of a contreet, the of b fitnestfor-duty program a monthly pesteve sest. Leetate sbat carry ont pre-eward statistaca! rumrcary of ceinatyria and blood (1) 7tetesting Specimens? Beeruse some inspecbons and evaiusSon of the procedural testing and sball not inclode in the sammary analytes detenorste or am losi during any penonalidentifying informattort inttal aspects of the isborstoay's drug testing freemns and/or storage. quanetstion for a test data from the beensee'e testing facibty opers ben. m NRC abau rnerve b nabt to retest is not cubject to a specific evieff and b HHSertted labarstory, and inspect a becuese's tesung facibiy at any requireme=t but nrnet provide data sumesent tune.

-mumilk

j ,,.'-- g

~

... .,',n,- ,

(1)"Cn entation."FDiS-oortiBed dacumentetion that these procedures are : -

laboratories and the licensee's testing faculty fouowed and that aD necessary corrective least one sampb. abau be the laboratory *a sha!! maintain and make eval;able for at actions an taken. nore shall also be to place own quahry control samples, tent 2 years documentauon of aD aspects of (d)"Laborstory Quebty Control systems to verify a!! stases of testing and the testing procese. This 3-year period may be reporting and documentation that these Requirements for Canarmation Tests? Each extended upon written notincetion by the preadures an fouowed. analytical run of speciasons to be comarmed NRC or by any boensee for which laboratory (5)"Perec2nel avadable to testify at shad indude:

utvices are being provided. The required proceedmga." ne licensee's testing facultF (1) Urtne r,pecimens certdod to contain no documentauon shad include personnelIUes drug and HHS cartif ed laboretory shall have 4 on aD individuals authorised to have eccese qualified personnel available to tes ' in an (2) Urine spedmens fortified with known to speamens: chain of custody documents; standads; and administrative or disciplinary proos  :

quabty soeurancelquabty control ncords, gg) pp,igy,,,,.rds Mth th drug or against an individual when that pmceeing is procedure manuals: aD test data (including based on positive bresth analysia or metaboute at or near the threshold (cut o" ca%retion curvu ud any calculations used urinalysis teeults reported by the hoenen's he linearity and precision of the meth:. -

In determirdng test neults): reports; testmg faciDry or the HHS oortdied shad 1.e periodic.Uy documented.

performance records on performance testing: laboratory. implementseen of procedures to ensure that performance on certi!!ca tion impections: and carryour does not conuMute the koting of bard copies of computer genersted data. The gJ @abty Anuranos and Qualty Control. an individuals specimen shall also be HHS-artined laboretory and the licensee e g.gg. FDB. cert. fled laboratorian doewmented.

testing fac2Lty sha!! be required to maintain and the beensee's tutmg facihty shall have a (e) 'Ucensee Blind performanos Test documents for any specimen under legal daUmge for en indefinJte period.

p e Proodures."

. encompaun au aspects of the testing (1) Ucenaces shad purchase chemica!

(c) Addf tional Require'nents for process including but not hmited to specunen testing services ortly from laboratories certdied Laboretc les and Ucensee,HHS- a Testing acquis6 tion, chain of custody, wcurity, certfied by DHHS or a DHMS-recogrused Tscih reportng of results irJtial and con $rmatory certification program in scoo* dance with the testing and vabdation of analytical HMS Guidelines. laboratory participabon la and b,"cenase s teeting facibty shallprocedures. here a(1) Procedure Quebty anurancemas.ual. dures Each laboretory pmeedure manual which includes the shad be desa;ned imp lement encouraged in other pe formance testing surveys by which the laboratory's principles of each test, preparsbon of reviewed to monJtor the conduct of each step performance is compared with peers and reagents. standuds ard controls. cahbration of the process of testing for drugs. .

reference lalaratones.

p-ocedures. dertva tion of results. lineanty of g Ucrun's Tesus heh QMty (2) Nr6g & MNg W of g methods sensitvity of the methods. cutoff Control Requirements for In!bal Tests?

Becauw aD positive prehminary tests for new drug testing program. each Ucenser shall values, mechaAsms for reportmg resulta, drugs are forwarded to an HHS-certned submit bled performance test specimens to controls. cntens for unsoceptable specimens laboratory for scrwnjng and conErmatory each HHS.certfied laborstcry tt contracts and results. reme6al secons to be en within the amont of et least 50 percent of when the test systems are outsi e testes who appupnoe. 6 NRC does not acceptable lumts. nagents and crpiration require licensees to essess their testmg 6wmwhghw foobty's false posieve retu for drugs To a maxicium of 500 samples) and thena'g ter a a dates. and references. Copies o all ensure that the rate of false negatve tests is minimum of to percent of au samples (to a

[t a manua g g ed e art o g

,g kept t the mitumum that the immunoaney technology suppe is, beensees shad process ma.ximum (3) Approximatelyof 250) submitted 80 percent of the b per quaner}ind dIr '

P * *^C88"! W8 8 performance test samples shall be blank (i.e.,

cerufied to contain no drug) and the

( '$tandards and ontrols? HMS-certned [', ,' ."thl

' nmair a sampin abau be positive for one laborstory standards shall be prepared with d pun dng standards wbcb am proputy laboratory. In ed6 tion, the manufseturer- r m m drugs per sample in a cbstnbution required performance tests of the bnath " * *8' ' '" **

leeled as to content and concentrabon. The standards shad be labeled with the fouowmg analysis equipment used by the beensee shad

• E#"*

• I'9"*' 9 ""*."

, dates: when received, when prepared or be conducted as set forth m the aUma posh n=pb shaU be opensd when pisced in service; and manufseturar's spedications. epiled only with those drugs for which the erpiration dats. (c)" Laboratory Quahry Control bcmn is tuting.

l (3) instruments and eqmpment." Requirements for trutial Tests at HMS (4) ne beensee she!!investiga te. or shall (i) Volumetric pipettes and mearuring Certdied Laborniories? Each analyucal run of specucens to be screened shad mclude:

"I" N I I"'"'8' D'n ""Y usatsfactory puformance tun' na nsu't.

devices shad be cert $ed for accursey or be check ed by gre vunetric. colorime tric. or other (1) Unne spec mens certted to contain no and based on this investsa bon. the drug: laborntory shall tahe aetort to correct the ven5 canon procedure. Automatic pipettes and dilutors shall be checked for accursey 12) Urine specimens forthed with known coun ofthe unsausfsetory performance test and reproducibtbry before being placed m standards: and result. A record shat be reade of the service and checked peno&cally therether. (3) Posieve contro!s with the drug or invntastve Andegs and the corrective (u) Alcohol breath analysta equipment metabohte et or near the threshold (cut elT). action taken by the laborstery, and that shau be an evidental-g ade breath alcohol in ad6bcn. with each batch of samples a record shall be dated and signed by the analysis device of a brand and model that sufficient number of standards shau b, in6vsduals responsible for the day to day conforms to National Rghwey Traffic Safety intMed to ensure and document the roanagement and operabon of the HHS Admaustrabon (NHTSA) standards (40 TR hneanty of the assey method over tune in the certhed laboratory. nen the licensee shal!

46e55) and to ariy appbcable State statutes, concentrabon ans of the cut off. After send the docenent to the NRC as a report of (iii)There shad be wntten procedures for acceptable values an obtained for the known the unsatis!setory performance testag standards, those values wiu be used to incident withir 30 days. De .UtC shell instrument sebup and normal operaton. a calculate sample data. Implementation of ensure notincation of the finding to DHHS.

schedule for checung cnucal opersung procedures to ansure that carryovar does not characteristics for all instruments. tolerance (5) Should a false positive error occur on a luruts for seceptable function c. hecks. and contaminate the testmg of an individual's blind performance test specaen and the specimen shaU be documented. A rnirumum instructions for major troubleshootmg and of to percent of all test umples aball be error is determined to be an eininistrative repair. Records shall be available on error (clerical. sample caixup, etc.). the prevenave maintenance. quahty control specimens. Laboratory quahty licensee shall promptly notdy the NRC.ne control sampless pnpared from spiked urtoe (4)

• Remedial setona? Here shad be samples of determined concentration shall licensees shau require the laboratory to take wrttten procedures for the accons to be talen be snel.ded in the run and should appear as correceve scuon to minaire the occurrence when eystems an out of sceeptable hmits or of the particular error in the future; and. if normalsamples to laboratory analysts. One errors are detected.nere shaU be percent of each run, with a minunum of at there is reeson to bebeve the error could have been systemate, the beensee may also h

i

t Fed:ral Regleter / Vol. 54. No.108 / Wednuday, itine 7.1989 / Rules end Regulations 24507 requin review and reanalysis of previously accredance with these Guidehnea, although nault is scientitcaUr tnen5clent for further ,

run specimens- be or she may consider the results of tests on acton and declan the test spemmen (6) Should a false pos!tive error ocesr en a spbt samples in snaking his or her nessuve. In this situation, the Me6 cal bbnd performance test specimen and the determination. u long as those opbt samples Review OfLcer may request reanalysis of the error is determined to be a techn! cal or have been stored and tested in socordance enginal sample before makma this documon.

mtthodologacal error, the becuee shaU with the procedures described in thue (The Me6 cal Renew 05 car may req est instnact me laborstory to submit to them aU Guidehnes. that reanalysis be performed by the same quabty control data from the batch of (c)"Posieve Test Resdts? Pnor to mahng laboratory or that an abquot of the onginal specimens which induded the false positive a Ecal decision to verdy a positve test result, specimen be samt for reanalysis to an specimer. In ed6t on. the boemee shaU the Me6 cal Review 05cer shaU sive the alternate laboratory which is certhed in require the !eboratory to ntest au specumens in6vidual an opportunity to 6scuss the test ecoordance with the } DIS Guidehnes 1 The an2Jyzed posteve for that drug or metabobte reedt with him or her. Fouowma verdicanon bcensee's testing facDiry and the }D{S-from the tme of final resoluton of the error of a positve test nault. the Me6 cal Review cer .!$ed laboratory shall assist in this nview back to the tune of the last setsfactory 05cer shan. es prended in the boensee's process as nquested by the Me6 cal Review performance test cyde.This retestag shaU be pobey. notdy the appbcable employee documented by a statement signed by the assistance propam and the bcensee's 05m bI ma% avadable h in&viduM in6ndual responsible for day to<isy responsible for day to day management of mazagetment official empowered to management of the laborotory's substance the bcaun a test facilary,of the M recommend er take administra tive action (or testas propam The bcensee and the NRC the ofhclal s destgnated agent). certmed la,borstory or other in6nduals who may nquire an on-site renew of the (d)"Venficaton for opiates. review for an forensic toc.colog:sts or who base laboretory which may be conducted presenption me&c40on? Before the Me& cal equivalent forensic experience in urine drug uninneunced during any boun of operation Renew 05cer verdes e confirmed positve testas to provide speci$c consultation es cf the laborstory. Based on informston rudt and the bcensee takes acton for required by the beensee The bunsee shaU prended by the NRC. DHMS has the opton opiates. he or she shaU determine that there maintain records that summartze any cf revokag or suspendmg the laboratorfs is chnical endence--6 ad& con to the unne negatve findings based on scientfic certicacon or recommen6ng that no further test-of unauthorued we of any opium. insusciency and shau make them evauable acton be taken if the case is one of lest, opiate, or opium densative (e s morphine / so the NRC on request but shaU not include cenous error in which correctae aeton has codeine) Chnical signs of abuse include any penonalidentafying informaton in such c.1resdy been taken. thus reasorably assuring recent necie tracts or behovtoral and that the error wiU not occur again. psycholopcal signs of scute opiate nPoru-1.9 Reportmg and Review of Results L*W '* * ** *' "U $'* * * "4" M *M ' Subpcrt C-k.ployee Protecuan does not apply if the GC/MS conhrmaton (s)"Me& cal Renew 05cer shaU renew testmp for opiates corir=s the pnsence of 6 31 Protecton of Employee Records ,

resula " An essential part of the beensen' monoscet>1 morphine For other drugs that art Ucensee contracts with HMS certLed I testmg p opams is the final renew of ruults commonly pruenbed r bommordfancluded laboratones and prowdures for the beansee's 4 A pcs.tve test result does not automstcaDy in over the-counter preparstons (e.g., testag facity shaU require that test records l identJy e nuclear power plant worker se benzo 6asepines in the fint case, be maintained in con $dence. as prended in  ;

henns nsed substances a violaton of the barbiturates in the second) and that an beted to CF'R 263. Records shaU be maintained NRC e r?FWauons or the bceuce a company in the becuee's panel of substances to be an ut ngard fo-bees Anin6ndualwith a detailed tesied. the Me6 cal Renew 05cer shaU also bowlede of possible alternate me6 cal determme whether there is chnical I*b'id"'I "**

I CF-explanstens ta encoual to the renew of evidence-in ed6 ton to the urme tut-of 3.2 In&vidual Access to Test and resulta nas renew shaU be performed by the unauthorued use of any of these substances bboratory Certicaton Results Mr6 cal Review Of5cer pnor to the or their denvatvu.

trans=ission of results to beensee (e)" Reanalysis authorised? Shodd any Any in6vidual who is the subject of a drug snuagement c5cals question anse as to the accuracy or vab6ty or alcohol test under this part shall upon of a posieve test result. only the Me& cal wntten request have acme to any records (b)"Me6 cal Renew Omoer- relatng to his or her tests and any rerords que14 canons and respons.bibtes

• ne Renew Omcer is authortaed to order a Me& cal Renew 05cer shaU be a beensed reanalysis of the crynnst sample and such reletng to the ruda of any relevant phpcian with knowledge of substance abuse reteets a e authorned only atlaborstones laborstory certicator. nnew, or d.sorders and esy be a bcensee or contreet certaed by DHHS ne Me6 cal Renew revocabon of cert $caton proceedings.

seployee.The role of 6 Me& cal Renew 05cer shaU authorae a reanalysts of the Officer is to review and mterpret positve test ongmal aLquot on tmely requot of the Subport D-Cert @ codon ofloboretones results obtained through the becuee's tutma in&ndual tested, ard shau also autbortu an Erwegedin CAemical Testmg progra to carrpng out this responalbibty, analysis of any sample stored by the boensee.

(f) Results consistent with responsible 4.1 Use of DHHS certi$ed laborstones

& Me6 cal Renew Omcer shau examine (e) Ucensees subject to this part and their cJternate me6 cal explanadens for any substance use? If the Me6 cal Renew 050er po:Itve test result (tlas does not include determines that there is a lertsste me& cal contracion shau use only laboretones corkmaton of blood alcohollevels obtained explanebon for the positse test result and eernted under & DHHS " Mandatory through the use of a breath alcohol anayisis that use of the substance identaed through Guidehnes for Federal Workplace Drug dence) nis acton could include conducting testing in the manner and et the desa8e Testag Prog'ams", Subpart C "Certhcation a me6calinterview with the in6edual. presenbed does not reflect a leci of of bboratones Engseed in Urine Drug rensw of the in&ndual e me& cal history,or rebabibry and is unhkely to cnate on the-lob Testmg for Federal Agencies? ($3 F'R 11e*0.

revuw of any other relevant biome 6 cal impairment, the Me6 cal Renew 05oer shau 11986-119e9) dated April 11.1968, and report the test result to the bcensee as subsquem amehu knto for facters ne Me6 cal Renew Omoer shaU review au me6 cal records made availabla by nesstivs. acreening and corirmatory tesung exorpt for (g) " Result scienti$ cavy insumcient. g g, .,

the tested in6vidual when a confirmed AditionaUy. the Me6 cal Review Omcer.

positwe test could have enUteo from legety based on review of inspection reports, quabty 'Y M d EFR resenbed me6caton ne Me6 cal Renew 3 rut 4(d) Information concerning b current control data, mdtple samples. and other Omcar shaU not consider the results of tests certicabon status oflaborstes is that are not obtamed or processed to pertnent rudts. may determine that the

. . ev[qabh from:N Of5os c.f Wertpleos  ? . - -

tainstvcs, NanonalInstitute se Dng Abum,

• Seo0 Fishm lana. Rockville. Maryland 20057. -

(b)IJeensees ce their contractors may use -

ordy HMS certined laboretones that agree to -

follow the same rigorons chemical testing, quahty control and chain of custody procedures when testing for more stringent ,

~*'

cut-offlevels as may be specined by bcensees for the clasees of drugs identified in ,,

this Part for analyels of blood specimens for ,

alcohol and for any other substances induded to Uceneet** drug penis.

Dr ted at Rodrville MD this 24th day of May, tees. -

For & Nuclear Rego! story Commiss6on.

John C. Hoyle.

Actist Secretaryofthe Commissiott i

P'R Doc. a0-12.806 Filed 64-ast a.45 am) ,

an.uma aaos ts- .

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