FITNESS FOR DUTY PROGRAMS

• Citation: 10 CFR Part 26
• Sections: 103

§ 26.1 Purpose.

This part prescribes requirements and standards for the establishment, implementation, and maintenance of fitness-for-duty (FFD) programs.

§ 26.3 Scope.

(a) Licensees who are authorized to operate a nuclear power reactor under 10 CFR 50.57, and holders of a combined license under 10 CFR Part 52 after the Commission has made the finding under 10 CFR 52.103(g) shall comply with the requirements of this part, except for subpart K of this part. Licensees who receive their authorization to operate a nuclear power reactor under 10 CFR 50.57 after the date of publication of this final rule in the Federal Register and holders of a combined license under 10 CFR Part 52 after the Commission has made the finding under 10 CFR 52.103(g) shall implement the FFD program before the receipt of special nuclear material in the form of fuel assemblies.

(b) Licensees who are authorized to possess, use, or transport formula quantities of strategic special nuclear material (SSNM) under Part 70 of this chapter, and any corporation, firm, partnership, limited liability company, association, or other organization who obtains a certificate of compliance or an approved compliance plan under Part 76 of this chapter, only if the entity elects to engage in activities involving formula quantities of SSNM shall comply with the requirements of this part, except for subparts I and K of this part.

(c) Before the receipt of special nuclear material in the form of fuel assemblies, the following licensees and other entities shall comply with the requirements of this part, except for subpart I of this part; and, no later than the receipt of special nuclear material in the form of fuel assemblies, the following licensees and other entities shall comply with the requirements of this part:

(1) Combined license applicants (under Part 52 of this chapter) who have been issued a limited work authorization under § 50.10(e), if the limited work authorization authorizes the applicant to install the foundations, including the placement of concrete, for safety- and security-related structures, systems, and components (SSCs) under the limited work authorization;

(2) Combined license holders (under Part 52 of this chapter) before the Commission has made the finding under § 52.103(g);

(3) Construction permit applicants (under Part 50 of this chapter) who have been issued a limited work authorization under § 50.10(e), if the limited work authorization authorizes the applicant to install the foundations, including the placement of concrete, for safety- and security-related SSCs under the limited work authorization;

(4) Construction permit holders (under Part 50 of this chapter); and

(5) Early site permit holders who have been issued a limited work authorization under § 50.10(e), if the limited work authorization authorizes the early site permit holder to install the foundations, including the placement of concrete, for safety- and security-related SSCs under the limited work authorization.

(d) Contractor/vendors (C/Vs) who implement FFD programs or program elements, to the extent that the licensees and other entities specified in paragraphs (a) through (c) of this section rely on those C/V FFD programs or program elements to meet the requirements of this part, shall comply with the requirements of this part.

(e) This part does not apply to either spent fuel storage facility licensees or non-power production or utilization facility licensees who possess, use, or transport formula quantities of irradiated SSNM.

§ 26.4 FFD program applicability to categories of individuals.

(a) All persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c) and perform the following duties shall be subject to an FFD program that meets all of the requirements of this part, except subpart K of this part:

(1) Operating or onsite directing of the operation of systems and components that a risk-informed evaluation process has shown to be significant to public health and safety;

(2) Performing health physics or chemistry duties required as a member of the onsite emergency response organization minimum shift complement;

(3) Performing the duties of a fire brigade member who is responsible for understanding the effects of fire and fire suppressants on safe shutdown capability;

(4) Performing maintenance or onsite directing of the maintenance of SSCs that a risk-informed evaluation process has shown to be significant to public health and safety; and

(5) Performing security duties as an armed security force officer, alarm station operator, response team leader, or watchman, hereinafter referred to as security personnel.

(b) All persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c) and who do not perform the duties described in paragraph (a) of this section shall be subject to an FFD program that meets all of the requirements of this part, except §§ 26.205 through 26.209 and subpart K of this part.

(c) All persons who are required by a licensee in § 26.3(a) and, as applicable, (c) to physically report to the licensee's Technical Support Center or Emergency Operations Facility by licensee emergency plans and procedures shall be subject to an FFD program that meets all of the requirement of this part, except §§ 26.205 through 26.209 and subpart K of this part.

(d) Any individual whose duties for the licensees and other entities in § 26.3(b) require him or her to have the following types of access or perform the following activities shall be subject to an FFD program that meets all of the requirements of this part, except subparts I and K of this part:

(1) All persons who are granted unescorted access to Category IA material;

(2) All persons who create or have access to procedures or records for safeguarding SSNM;

(3) All persons who measure Category IA material;

(4) All persons who transport or escort Category IA material; and

(5) All persons who guard Category IA material.

(e) When construction activities begin, any individual whose duties for the licensees and other entities in § 26.3(c) require him or her to have the following types of access or perform the following activities at the location where the nuclear power plant will be constructed and operated shall be subject to an FFD program that meets all of the requirements of this part, except subparts I and K of this part:

(1) Serves as security personnel required by the NRC, until the licensees or other entities receive special nuclear material in the form of fuel assemblies, at which time individuals who serve as security personnel required by the NRC must meet the requirements applicable to security personnel in paragraph (a)(5) of this section;

(2) Performs quality assurance, quality control, or quality verification activities related to safety- or security-related construction activities;

(3) Based on a designation under § 26.406 by a licensee or other entity, monitors the fitness of the individuals specified in paragraph (f) of this section;

(4) Witnesses or determines inspections, tests, and analyses certification required under Part 52 of this chapter;

(5) Supervises or manages the construction of safety- or security-related SSCs; or

(6) Directs, as defined in § 26.5, or implements the access authorization program, including—

(i) Having access to the information used by the licensee or other entity to make access authorization determinations, including information stored in electronic format;

(ii) Making access authorization determinations;

(iii) Issuing entry-control picture badges in accordance with access authorization determinations;

(iv) Conducting background investigations or psychological assessments used by the licensee or other entity to make access authorization determinations, except that he or she shall be subject to behavioral observation only when he or she is present at the location where the nuclear power plant will be constructed and operated, and licensees and other entities may rely on a local hospital or other organization that meets the requirements of 49 CFR Part 40, “Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs” to collect his or her specimens for drug and alcohol testing;

(v) Adjudicating reviews or appeals of access authorization determinations;

(vi) Auditing the access authorization program; or

(vii) Performing any of the activities or having any of the duties listed in paragraph (e)(6) of this section for any C/V upon whom the licensee's or other entity's access authorization program will rely.

(f) Any individual who is constructing or directing the construction of safety- or security-related SSCs shall be subject to an FFD program that meets the requirements of subpart K of this part, unless the licensee or other entity subjects these individuals to an FFD program that meets all of the requirements of this part, except for subparts I and K of this part.

(g) All FFD program personnel who are involved in the day-to-day operations of the program, as defined by the procedures of the licensees and other entities in § 26.3(a) through (c), and, as applicable, (d), and whose duties require them to have the following types of access or perform the following activities shall be subject to an FFD program that meets all of the requirements of this part, except subparts I and K of this part, and, at the licensee's or other entity's discretion, subpart C of this part:

(1) All persons who can link test results with the individual who was tested before an FFD policy violation determination is made, including, but not limited to the MRO;

(2) All persons who make determinations of fitness;

(3) All persons who make authorization decisions;

(4) All persons involved in selecting or notifying individuals for testing; and

(5) All persons involved in the collection or onsite testing of specimens.

(h) Individuals who have applied for authorization to have the types of access or perform the activities described in paragraphs (a) through (d) of this section shall be subject to §§ 26.31(c)(1), 26.35(b), 26.37, 26.39, and the applicable requirements of subparts C, and E through H of this part.

(i) The following individuals are not subject to an FFD program under this part:

(1) Individuals who are not employed by a licensee or other entity in this part, who do not routinely provide FFD program services to a licensee or other entity in this part, and whose normal workplace is not at the licensee's or other entity's facility, but who may be called on to provide an FFD program service, including, but not limited to, collecting specimens for drug and alcohol testing, performing behavioral observation, or providing input to a determination of fitness. Such individuals may include, but are not limited to, hospital, employee assistance program (EAP) or substance abuse treatment facility personnel, or other medical professionals;

(2) NRC employees, law enforcement personnel, or offsite emergency fire and medical response personnel while responding on site;

(3) SSNM transporter personnel who are subject to U.S. Department of Transportation drug and alcohol FFD programs that require random testing for drugs and alcohol; and

(4) The FFD program personnel of a program that is regulated by another Federal agency or State on which a licensee or other entity relies to meet the requirements of this part, as permitted under §§ 26.4(j), 26.31(b)(2), and 26.405(e), if the FFD program personnel are not employed by the licensee or other entity and their normal workplace is not at the licensee's or other entity's facility.

(j) Individuals who are subject to this part and who are also subject to a program regulated by another Federal agency or State need be covered by only those elements of an FFD program that are not included in the Federal agency or State program, as long as all of the following conditions are met:

(1) The individuals are subject to pre-access (or pre-employment), random, for-cause, and post-event testing for the drugs and drug metabolites specified in § 26.31(d)(1) at or below the cutoff levels specified in § 26.163(a)(1) for initial drug testing and in § 26.163(b)(1) for confirmatory drug testing;

(2) The individuals are subject to pre-access (or pre-employment), random, for-cause, and post-event testing for alcohol at or below the cutoff levels specified in § 26.103(a) and breath specimens are subject to confirmatory testing, if required, with an EBT that meets the requirements specified in § 26.91;

(3) Urine specimens are tested for validity and the presence of drugs and drug metabolites at a Department of Health and Human Services (HHS)-certified laboratory, as defined in § 26.5;

(4) Training is provided to address the knowledge and abilities (KAs) listed in § 26.29(a)(1) through (a)(10); and

(5) Provisions are made to ensure that the testing agency or organization notifies the licensee or other entity granting authorization of any FFD policy violation.

§ 26.5 Definitions.

Acute fatigue means fatigue from causes (e.g., restricted sleep, sustained wakefulness, task demands) occurring within the past 24 hours.

Adulterated specimen means a urine specimen that has been altered, as evidenced by test results showing either a substance that is not a normal constituent of urine or showing an abnormal concentration of an endogenous substance.

Alertness means the ability to remain awake and sustain attention.

Aliquot means a portion of a specimen that is used for testing. It is taken as a sample representing the whole specimen.

Analytical run means the process of testing a group of urine specimens for validity or for the presence of drugs and/or drug metabolites. For the purposes of defining the periods within which performance testing must be conducted by any licensee testing facility or HHS-certified laboratory that continuously processes specimens, an analytical run is defined as no more than an 8-hour period. For a facility that analyzes specimens in batches, an analytical run is defined as a group of specimens that are handled and tested together.

Authorization means that a licensee or other entity in § 26.3 has determined that an individual has met the requirements of this part to be granted or maintain the types of access or perform the duties specified in § 26.4(a) through (e), and, at the licensee's or other entity's discretion, § 26.4(f) or (g).

Best effort means documented actions that a licensee or other entity who is subject to subpart C of this part takes to obtain suitable inquiry and employment information in order to determine whether an individual may be granted authorization, when the primary source of information refuses or indicates an inability or unwillingness to provide the information within 3 business days of the request and the licensee or other entity relies on a secondary source to meet the requirement.

Blood alcohol concentration (BAC) means the mass of alcohol in a volume of blood.

Calibrator means a solution of known concentration in the appropriate matrix that is used to define expected outcomes of a measurement procedure or to compare the response obtained with the response of a donor specimen or quality control sample. The concentration of the analyte of interest in the calibrator is known within limits ascertained during its preparation.

Cancelled test means the test result reported by the MRO to the licensee or other entity when a specimen has been reported to the MRO by the HHS-certified laboratory as an invalid result (for which the donor has no legitimate explanation), a specimen has been rejected for testing by the licensee testing facility or HHS-certified laboratory, or the retesting of a single specimen or the testing of Bottle B of a split specimen fails to reconfirm the original test result. For alcohol testing only, cancelled test means a test result that was not acceptable because testing did not meet the quality assurance and quality control requirements in § 26.91.

Carryover means the effect that occurs when a test result has been affected by a preceding sample or specimen during analysis.

Category IA material means SSNM that is directly usable in the manufacture of a nuclear explosive device, except if the material meets any of the following criteria:

(1) The dimensions are large enough (at least 2 meters in one dimension, greater than 1 meter in each of two dimensions, or greater than 25 centimeters in each of three dimensions) to preclude hiding the item on an individual;

(2) The total weight of an encapsulated item of SSNM is such that it cannot be carried inconspicuously by one person ( i.e. , at least 50 kilograms gross weight); or

(3) The quantity of SSNM (less than 0.05 formula kilograms) in each container requires protracted diversions to accumulate 5 formula kilograms.

Certifying Scientist means the individual at an HHS-certified laboratory responsible for verifying the chain of custody and scientific reliability of any test result reported by an HHS-certified laboratory.

Chain of custody means procedures to account for the integrity of each specimen or aliquot by tracking its handling and storage from the point of specimen collection to final disposition of the specimen and its aliquots. “Chain of custody” and “custody and control” are synonymous and may be used interchangeably.

Circadian variation in alertness and performance means the increases and decreases in alertness and cognitive/motor functioning caused by human physiological processes (e.g., body temperature, release of hormones) that vary on an approximately 24-hour cycle.

Collection site means a designated place where individuals present themselves for the purpose of providing a specimen of their urine, oral fluids, and/or breath to be analyzed for the presence of drugs or alcohol.

Collector means a person who is trained in the collection procedures of subpart E, instructs and assists a specimen donor at a collection site, and receives and makes an initial examination of the specimen(s) provided by the donor.

Commission means the U.S. Nuclear Regulatory Commission (NRC) or its duly authorized representatives.

Confirmatory drug or alcohol test means a second analytical procedure to identify the presence of alcohol or a specific drug or drug metabolite in a specimen. The purpose of a confirmatory test is to ensure the reliability and accuracy of an initial test result.

Confirmatory validity test means a second test performed on a different aliquot of the original urine specimen to further support a validity test result.

Confirmed test result means a test result that demonstrates that an individual has used drugs and/or alcohol in violation of the requirements of this part or has attempted to subvert the testing process by submitting an adulterated or substituted urine specimen. For drugs, adulterants, and substituted specimens, a confirmed test result is determined by the Medical Review Officer (MRO), after discussion with the donor subsequent to the MRO's receipt of a positive confirmatory drug test result from the HHS-certified laboratory and/or a confirmatory substituted or adulterated validity test result from the HHS-certified laboratory for that donor. For alcohol, a confirmed test result is based on a positive confirmatory alcohol test result from an evidential breath testing device (EBT) without MRO review of the test result.

Constructing or construction activities mean, for the purposes of this part, the tasks involved in building a nuclear power plant that are performed at the location where the nuclear power plant will be constructed and operated. These tasks include fabricating, erecting, integrating, and testing safety- and security-related SSCs, and the installation of their foundations, including the placement of concrete.

Contractor/vendor (C/V) means any company, or any individual not employed by a licensee or other entity specified in § 26.3(a) through (c), who is providing work or services to a licensee or other entity covered in § 26.3(a) through (c), either by contract, purchase order, oral agreement, or other arrangement.

Control means a sample used to evaluate whether an analytical procedure or test is operating within predefined tolerance limits.

Cumulative fatigue means the increase in fatigue over consecutive sleep-wake periods resulting from inadequate rest.

Cutoff level means the concentration or decision criteria established for designating and reporting a test result as positive, of questionable validity (referring to validity screening or initial validity test results from a licensee testing facility), or adulterated, substituted, dilute, or invalid (referring to initial or confirmatory test results from an HHS-certified laboratory).

Dilute specimen means a urine specimen with creatinine and specific gravity values that are lower than expected but are still within the physiologically producible ranges of human urine.

Directing means the exercise of control over a work activity by an individual who is directly involved in the execution of the work activity, and either makes technical decisions for that activity without subsequent technical review, or is ultimately responsible for the correct performance of that work activity.

Donor means the individual from whom a specimen is collected.

Eight (8)-hour shift schedule means a schedule that averages not more than 9 hours per workday over the entire shift cycle.

Employment action means a change in job responsibilities or removal from a job, or the employer-mandated implementation of a plan for substance abuse treatment in order to avoid a change in or removal from a job, because of the individual's use of drugs or alcohol.

Fatigue means the degradation in an individual's cognitive and motor functioning resulting from inadequate rest.

Federal custody and control form (Federal CCF) means any HHS-approved form, which has not expired, that is published in the Federal Register and is used to document the collection, custody, transport, and testing of a specimen.

Formula quantity means SSNM in any combination in a quantity of 5000 grams or more computed by the formula, grams = (grams contained U-235) + 2.5 (grams U-233 + grams plutonium). This class of material is sometimes referred to as a Category I quantity of material.

HHS-certified laboratory means a laboratory that is certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (the HHS Guidelines) at the time that testing of a specimen is performed for a licensee or other entity and performs that testing for a licensee or other entity in accordance with the HHS Guidelines, unless otherwise specified in this part.

Illegal drug means, for the purposes of this regulation, any drug that is included in Schedules I to V of section 202 of the Controlled Substances Act [21 U.S.C. 812], but not when used pursuant to a valid prescription or when used as otherwise authorized by law.

Increased threat condition means an increase in the protective measure level, relative to the lowest protective measure level applicable to the site during the previous 60 days, as promulgated by an NRC Advisory.

Initial drug test means a test to differentiate “negative” specimens from those that require confirmatory drug testing.

Initial validity test means a first test used to determine whether a specimen is adulterated, dilute, substituted, or invalid, and may require confirmatory validity testing.

Invalid result means the result reported by an HHS-certified laboratory in accordance with the criteria established in § 26.161(f) when a positive, negative, adulterated, or substituted result cannot be established for a specific drug or specimen validity test.

Legal action means a formal action taken by a law enforcement authority or court of law, including an arrest, an indictment, the filing of charges, a conviction, or the mandated implementation of a plan for substance abuse treatment in order to avoid a permanent record of an arrest or conviction, in response to any of the following activities:

(1) The use, sale, or possession of illegal drugs;

(2) The abuse of legal drugs or alcohol; or

(3) The refusal to take a drug or alcohol test.

Licensee testing facility means a drug and specimen validity testing facility that is operated by a licensee or other entity who is subject to this part to perform tests of urine specimens.

Limit of detection (LOD) means the lowest concentration of an analyte that an analytical procedure can reliably detect, which could be significantly lower than the established cutoff levels.

Limit of quantitation (LOQ) means for quantitation assays, the lowest concentration at which the identity and concentration of the analyte can be accurately established.

Lot means a number of units of an item ( e.g., drug test kits, reagents, quality control samples) manufactured from the same starting materials within a specified period of time for which the manufacturer states that the items have essentially the same performance characteristics and the same expiration date.

Maintenance means, for the purposes of § 26.4(a)(4), the following onsite maintenance activities: Modification, surveillance, post-maintenance testing, and corrective and preventive maintenance.

Medical Review Officer (MRO) means a licensed physician who is responsible for receiving laboratory results generated by a Part 26 drug testing program and who has the appropriate medical training to properly interpret and evaluate an individual's drug and validity test results together with his or her medical history and any other relevant biomedical information.

Nominal means the limited flexibility that is permitted in meeting a scheduled due date for completing a recurrent activity that is required under this part, such as the nominal 12-month frequency required for FFD refresher training in § 26.29(c)(2) and the nominal 12-month frequency required for certain audits in § 26.41(c)(1). Completing a recurrent activity at a nominal frequency means that the activity may be completed within a period that is 25 percent longer or shorter than the period required in this part. The next scheduled due date would be no later than the current scheduled due date plus the required frequency for completing the activity.

Other entity means any corporation, firm, partnership, limited liability company, association, C/V, or other organization who is subject to this part under § 26.3(a) through (c), but is not licensed by the NRC.

Oxidizing adulterant means a substance that acts alone or in combination with other substances to oxidize drugs or drug metabolites to prevent the detection of the drugs or drug metabolites, or a substance that affects the reagents in either the initial or confirmatory drug test. Examples of these agents include, but are not limited to, nitrites, pyridinium chlorochromate, chromium (VI), bleach, iodine/iodide, halogens, peroxidase, and peroxide.

Positive result means, for drug testing, the result reported by a licensee testing facility or HHS-certified laboratory when a specimen contains a drug or drug metabolite equal to or greater than the cutoff concentration. A result reported by an HHS-certified laboratory that a specimen contains a drug or drug metabolite below the cutoff concentration is also a positive result when the laboratory has conducted the special analysis permitted in § 26.163(a)(2). For alcohol testing, a positive result means the result reported by a collection site when the BAC indicated by testing a specimen is equal to or greater than the cutoff concentrations established in this part.

Potentially disqualifying FFD information means information demonstrating that an individual has—

(1) Violated a licensee's or other entity's FFD policy;

(2) Had authorization denied or terminated unfavorably under §§ 26.35(c)(2), 26.53(i), 26.63(d), 26.65(g), 26.67(c), 26.69(f), or 26.75(b) through (e);

(3) Used, sold, or possessed illegal drugs;

(4) Abused legal drugs or alcohol;

(5) Subverted or attempted to subvert a drug or alcohol testing program;

(6) Refused to take a drug or alcohol test;

(7) Been subjected to a plan for substance abuse treatment (except for self-referral); or

(8) Had legal action or employment action, as defined in this section, taken for alcohol or drug use.

Protected area has the same meaning as in § 73.2(g) of this chapter: An area encompassed by physical barriers and to which access is controlled.

Quality control sample means a sample used to evaluate whether an analytical procedure is operating within predefined tolerance limits. Calibrators, controls, negative samples, and blind performance test samples are collectively referred to as “quality control samples” and each is individually referred to as a “sample.”

Questionable validity means the results of validity screening or initial validity tests at a licensee testing facility indicating that a urine specimen may be adulterated, substituted, dilute, or invalid.

Rejected for testing means the result reported to the MRO by a licensee testing facility or HHS-certified laboratory when no tests can be performed on a specimen.

Responsible Person means the person at the HHS-certified laboratory who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS-certified laboratory.

Reviewing official means an employee of a licensee or other entity specified in § 26.3(a) through (c), who is designated by the licensee or other entity to be responsible for reviewing and evaluating any potentially disqualifying FFD information about an individual, including, but not limited to, the results of a determination of fitness, as defined in § 26.189, in order to determine whether the individual may be granted or maintain authorization.

Safety-related structures, systems, and components (SSCs) mean, for the purposes of this part, those structures, systems, and components that are relied on to remain functional during and following design basis events to ensure the integrity of the reactor coolant pressure boundary, the capability to shut down the reactor and maintain it in a safe shutdown condition, or the capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposure comparable to the guidelines in 10 CFR 50.34(a)(1).

Security-related SSCs mean, for the purposes of this part, those structures, systems, and components that the licensee will rely on to implement the licensee's physical security and safeguards contingency plans that either are required under Part 73 of this chapter if the licensee is a construction permit applicant or holder or an early site permit holder, as described in § 26.3(c)(3) through (c)(5), respectively, or are included in the licensee's application if the licensee is a combined license applicant or holder, as described in § 26.3(c)(1) and (c)(2), respectively.

Shift cycle means a series of consecutive work shifts and days off that is planned by the licensee or other entity to repeat regularly, thereby constituting a continuous shift schedule.

Standard means a reference material of known purity or a solution containing a reference material at a known concentration.

Strategic special nuclear material (SSNM) means uranium-235 (contained in uranium enriched to 20 percent or more in the uranium-235 isotope), uranium-233, or plutonium.

Substance abuse means the use, sale, or possession of illegal drugs, or the abuse of prescription and over-the-counter drugs, or the abuse of alcohol.

Substituted specimen means a specimen that has been submitted in place of the donor's urine, as evidenced by creatinine and specific gravity values that are outside the physiologically producible ranges of human urine.

Subversion and subvert the testing process mean a willful act to avoid being tested or to bring about an inaccurate drug or alcohol test result for oneself or others at any stage of the testing process (including selection and notification of individuals for testing, specimen collection, specimen analysis, and test result reporting), and adulterating, substituting, or otherwise causing a specimen to provide an inaccurate test result.

Supervises or manages means the exercise of control over a work activity by an individual who is not directly involved in the execution of the work activity, but who either makes technical decisions for that activity without subsequent technical review, or is ultimately responsible for the correct performance of that work activity.

Ten (10)-hour shift schedule means a schedule that averages more than 9 hours, but not more than 11 hours, per workday over the entire shift cycle.

Transporter means a general licensee, under 10 CFR 70.20(a), who is authorized to possess formula quantities of SSNM, in the regular course of carriage for another or storage incident thereto, and includes the driver or operator of any conveyance, and the accompanying guards or escorts.

Twelve (12)-hour shift schedule means a schedule that averages more than 11 hours, but not more than 12 hours, per workday over the entire shift cycle.

Unit outage means, for the purposes of this part, that the reactor unit is disconnected from the electrical grid.

Validity screening test means a test to determine the need for initial validity testing of a urine specimen, using a non-instrumented test in which the endpoint result is obtained by visual evaluation (read by the human eye), or a test that is instrumented to the extent that results are machine-read.

Validity screening test lot means a group of validity screening tests that were made from the same starting material.

§ 26.7 Interpretations.

Except as specifically authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized to be binding on the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly.

§ 26.8 Information collection requirements: OMB approval.

(a) The NRC has submitted the information collection requirements contained in this part for approval by the Office of Management and Budget (OMB), as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0146.

(b) The approved information collection requirements contained in this part appear in §§ 26.9, 26.27, 26.29, 26.31, 26.33, 26.35, 26.37, 26.39, 26.41, 26.53, 26.55, 26.57, 26.59, 26.61, 26.63, 26.65, 26.67, 26.69, 26.75, 26.77, 26.85, 26.87, 26.89, 26.91, 26.93, 26.95, 26.97, 26.99, 26.101, 26.103, 26.107, 26.109, 26.111, 26.113, 26.115, 26.117, 26.119, 26.125, 26.127, 26.129, 26.135, 26.137, 26.139, 26.153, 26.157, 26.159, 26.163, 26.165, 26.167, 26.168, 26.169, 26.183, 26.185, 26.187, 26.189, 26.203, 26.205, 26.207, 26.211, 26.401, 26.403, 26.405, 26.406, 26.407, 26.411, 26.413, 26.415, 26.417, 26.711, 26.713, 26.715, 26.717, 26.719, and 26.821.

§ 26.9 Specific exemptions.

Upon application of any interested person or on its own initiative, the Commission may grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security, and are otherwise in the public interest.

§ 26.11 Communications.

Except where otherwise specified in this part, all communications, applications, and reports concerning the regulations in this part must be sent either by mail addressed to ATTN: NRC Document Control Desk, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland 20852-2738, between the hours of 8:15 a.m. and 4 p.m. eastern time; or, where practicable, by electronic submission, for example, via Electronic Information Exchange, e-mail, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to [email protected]; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information. Copies of all communications must be sent to the appropriate regional office and resident inspector (addresses for the NRC Regional Offices are listed in Appendix D to Part 20 of this chapter).

§ 26.21 Fitness-for-duty program.

The licensees and other entities specified in § 26.3(a) through (c) shall establish, implement, and maintain FFD programs that, at a minimum, comprise the program elements contained in this subpart. The individuals specified in § 26.4(a) through (e) and (g), and, at the licensee's or other entity's discretion, § 26.4(f), and, if necessary, § 26.4(j) shall be subject to these FFD programs. Licensees and other entities may rely on the FFD program or program elements of a C/V, as defined in § 26.5, if the C/V's FFD program or program elements meet the applicable requirements of this part.

§ 26.23 Performance objectives.

Fitness-for-duty programs must—

(a) Provide reasonable assurance that individuals are trustworthy and reliable as demonstrated by the avoidance of substance abuse;

(b) Provide reasonable assurance that individuals are not under the influence of any substance, legal or illegal, or mentally or physically impaired from any cause, which in any way adversely affects their ability to safely and competently perform their duties;

(c) Provide reasonable measures for the early detection of individuals who are not fit to perform the duties that require them to be subject to the FFD program;

(d) Provide reasonable assurance that the workplaces subject to this part are free from the presence and effects of illegal drugs and alcohol; and

(e) Provide reasonable assurance that the effects of fatigue and degraded alertness on individuals' abilities to safely and competently perform their duties are managed commensurate with maintaining public health and safety.

§ 26.27 Written policy and procedures.

(a) General. Each licensee and other entity shall establish, implement, and maintain written policies and procedures to meet the general performance objectives and applicable requirements of this part.

(b) Policy. The FFD policy statement must be clear, concise, and readily available, in its most current form, to all individuals who are subject to the policy. Methods of making the statement readily available include, but are not limited to, posting the policy in multiple work areas, providing individuals with brochures, or allowing individuals to print the policy from a computer. The policy statement must be written in sufficient detail to provide affected individuals with information on what is expected of them and what consequences may result from a lack of adherence to the policy. At a minimum, the written policy statement must—

(1) Describe the consequences of the following actions:

(i) The use, sale, or possession of illegal drugs on or off site;

(ii) The abuse of legal drugs and alcohol; and

(iii) The misuse of prescription and over-the-counter drugs;

(2) Describe the requirement that individuals who are notified that they have been selected for random testing must report to the collection site within the time period specified by the licensee or other entity;

(3) Describe the actions that constitute a refusal to provide a specimen for testing, the consequences of a refusal to test, as well as the consequences of subverting or attempting to subvert the testing process;

(4) Prohibit the consumption of alcohol, at a minimum—

(i) Within an abstinence period of 5 hours preceding the individual's arrival at the licensee's or other entity's facility, except as permitted in § 26.27(c)(3); and

(ii) During the period of any tour of duty;

(5) Convey that abstinence from alcohol for the 5 hours preceding any scheduled tour of duty is considered to be a minimum that is necessary, but may not be sufficient, to ensure that the individual is fit for duty;

(6) Address other factors that could affect FFD, such as mental stress, fatigue, or illness, and the use of prescription and over-the-counter medications that could cause impairment;

(7) Provide a description of any program that is available to individuals who are seeking assistance in dealing with drug, alcohol, fatigue, or other problems that could adversely affect an individual's ability to safely and competently perform the duties that require an individual to be subject to this subpart;

(8) Describe the consequences of violating the policy;

(9) Describe the individual's responsibility to report legal actions, as defined in § 26.5;

(10) Describe the responsibilities of managers, supervisors, and escorts to report FFD concerns; and

(11) Describe the individual's responsibility to report FFD concerns.

(c) Procedures. Each licensee and other entity shall prepare, implement, and maintain written procedures that describe the methods to be used in implementing the FFD policy and the requirements of this part. The procedures must—

(1) Describe the methods and techniques to be used in testing for drugs and alcohol, including procedures for protecting the privacy and other rights (including due process) of an individual who provides a specimen, procedures for protecting the integrity of the specimen, and procedures used to ensure that the test results are valid and attributable to the correct individual;

(2) Describe immediate and followup actions that will be taken, and the procedures to be used, in those cases in which individuals are determined to have—

(i) Been involved in the use, sale, or possession of illegal drugs;

(ii) Consumed alcohol to excess before the mandatory pre-work abstinence period, or consumed any alcohol during the mandatory pre-work abstinence period or while on duty, as determined by a test that measures BAC;

(iii) Attempted to subvert the testing process by adulterating or diluting specimens (in vivo or in vitro), substituting specimens, or by any other means;

(iv) Refused to provide a specimen for analysis; or

(v) Had legal action taken relating to drug or alcohol use, as defined in § 26.5;

(3) Describe the process that the licensee or other entity will use to ensure that individuals who are called in to perform an unscheduled working tour are fit for duty. At a minimum—

(i) The procedure must require the individual who is called in to state whether the individual considers himself or herself fit for duty and whether he or she has consumed alcohol within the pre-duty abstinence period stated in the policy;

(ii) If the individual has consumed alcohol within this period and the individual is called in for an unscheduled working tour, including an unscheduled working tour to respond to an emergency, the procedure must—

(A) Require a determination of fitness by breath alcohol analysis or other means;

(B) Permit the licensee or other entity to assign the individual to duties that require him or her to be subject to this subpart, if the results of the determination of fitness indicate that the individual is fit to safely and competently perform his or her duties;

(C) Prohibit the licensee or other entity from assigning the individual to duties that require him or her to be subject to this subpart, if the individual is not required to respond to an emergency and the results of the determination of fitness indicate that the individual may be impaired;

(D) State that consumption of alcohol during the 5-hour abstinence period required in paragraph (b)(4)(i) of this section may not by itself preclude a licensee or other entity from using individuals who are needed to respond to an emergency. However, if the determination of fitness indicates that an individual who has been called in for an unscheduled working tour to respond to an emergency may be impaired, the procedure must require the establishment of controls and conditions under which the individual who has been called in can perform work, if necessary; and

(E) State that no sanctions may be imposed on an individual who is called in to perform any unscheduled working tour for having consumed alcohol within the pre-duty abstinence period stated in the policy.

(iii) If the individual reports that he or she considers himself or herself to be unfit for duty for other reasons, including illness, fatigue, or other potentially impairing conditions, and the individual is called in, the procedure must require the establishment of controls and conditions under which the individual can perform work, if necessary;

(4) Describe the process to be followed if an individual's behavior raises a concern regarding the possible use, sale, or possession of illegal drugs on or off site; the possible possession or consumption of alcohol on site; or impairment from any cause which in any way could adversely affect the individual's ability to safely and competently perform his or her duties. The procedure must require that individuals who have an FFD concern about another individual's behavior shall contact the personnel designated in the procedures to report the concern.

(d) Review. The NRC may, at any time, review the written policy and procedures to assure that they meet the performance objectives and requirements of this part.

§ 26.29 Training.

(a) Training content. Licensees and other entities shall ensure that the individuals who are subject to this subpart have the following KAs:

(1) Knowledge of the policy and procedures that apply to the individual, the methods that will be used to implement them, and the consequences of violating the policy and procedures;

(2) Knowledge of the individual's role and responsibilities under the FFD program;

(3) Knowledge of the roles and responsibilities of others, such as the MRO and the human resources, FFD, and EAP staffs;

(4) Knowledge of the EAP services available to the individual;

(5) Knowledge of the personal and public health and safety hazards associated with abuse of illegal and legal drugs and alcohol;

(6) Knowledge of the potential adverse effects on job performance of prescription and over-the-counter drugs, alcohol, dietary factors, illness, mental stress, and fatigue;

(7) Knowledge of the prescription and over-the-counter drugs and dietary factors that have the potential to affect drug and alcohol test results;

(8) Ability to recognize illegal drugs and indications of the illegal use, sale, or possession of drugs;

(9) Ability to observe and detect performance degradation, indications of impairment, or behavioral changes; and

(10) Knowledge of the individual's responsibility to report an FFD concern and the ability to initiate appropriate actions, including referrals to the EAP and person(s) designated by the licensee or other entity to receive FFD concerns.

(b) Comprehensive examination. Individuals who are subject to this subpart shall demonstrate the successful completion of training by passing a comprehensive examination that addresses the KAs in paragraph (a) of this section. The examination must include a comprehensive random sampling of all KAs with questions that test each KA, including at least one question for each KA. The minimum passing score required must be 80 percent. Remedial training and testing are required for individuals who fail to answer correctly at least 80 percent of the test questions. The examination may be administered using a variety of media, including, but not limited to, hard-copy test booklets with separate answer sheets or computer-based questions.

(c) Training administration. Licensees and other entities shall ensure that individuals who are subject to this subpart are trained, as follows:

(1) Training must be completed before the licensee or other entity grants initial authorization, as defined in § 26.55, and must be current before the licensee or other entity grants an authorization update, as defined in § 26.57, or authorization reinstatement, as defined in § 26.59;

(2) Individuals shall complete refresher training on a nominal 12-month frequency, or more frequently where the need is indicated. Indications of the need for more frequent training include, but are not limited to, an individual's failure to properly implement FFD program procedures and the frequency, nature, or severity of problems discovered through audits or the administration of the program. Individuals who pass a comprehensive annual examination that meets the requirements in paragraph (b) of this section may forgo the refresher training; and

(3) Initial and refresher training may be delivered using a variety of media (including, but not limited to, classroom lectures, required reading, video, or computer-based training systems). The licensee or other entity shall monitor the completion of training and provide a qualified instructor or designated subject matter expert to answer questions during the course of training.

(d) Acceptance of training. Licensees and other entities may accept training of individuals who have been subject to another training program that meets the requirements of this section and who have, within the past 12 months, either had initial or refresher training, or have successfully passed a comprehensive examination that meets the requirements in paragraph (b) of this section.

§ 26.31 Drug and alcohol testing.

(a) General. To provide a means to deter and detect substance abuse, licensees and other entities who are subject to this part shall implement drug and alcohol testing programs for individuals who are subject to this subpart.

(b) Assuring the honesty and integrity of FFD program personnel. (1) Licensees and other entities who are subject to this subpart shall carefully select and monitor FFD program personnel, as defined in § 26.4(g), based on the highest standards of honesty and integrity, and shall implement measures to ensure that these standards are maintained. The measures must ensure that the honesty and integrity of these individuals are not compromised and that FFD program personnel are not subject to influence attempts attributable to personal relationships with any individuals who are subject to testing, an undetected or untreated substance abuse problem, or other factors. At a minimum, these measures must include the following considerations:

(i) Licensees and other entities shall complete appropriate background investigations, credit and criminal history checks, and psychological assessments of FFD program personnel before assignment to tasks directly associated with administration of the FFD program. The background investigations, credit and criminal history checks, and psychological assessments that are conducted to grant unescorted access authorization to individuals under a nuclear power plant licensee's access authorization program are acceptable to meet the requirements of this paragraph. The credit and criminal history checks and psychological assessments must be updated nominally every 5 years;

(ii) Individuals who have personal relationships with a donor may not perform any assessment or evaluation procedures, including, but not limited to, determinations of fitness. These personal relationships may include, but are not limited to, supervisors, coworkers within the same work group, and relatives of the donor;

(iii) Except if a directly observed collection is required, a collector who has a personal relationship with the donor may collect specimens from the donor only if the integrity of specimen collections in these instances is assured through the following means:

(A) The collection must be monitored by an individual who does not have a personal relationship with the donor and who is designated by the licensee or other entity for this purpose, including, but not limited to, security force or quality assurance personnel; and

(B) Individuals who are designated to monitor collections in these instances shall be trained to monitor specimen collections and the preparation of specimens for transfer or shipping under the requirements of this part;

(iv) If a specimen must be collected under direct observation, the collector or an individual who serves as the observer, as permitted under § 26.115(e), may not have a personal relationship with the donor; and

(v) FFD program personnel shall be subject to a behavioral observation program designed to assure that they continue to meet the highest standards of honesty and integrity. When an MRO and MRO staff are on site at a licensee's or other entity's facility, the MRO and MRO staff shall be subject to behavioral observation.

(2) Licensees and other entities may rely on a local hospital or other organization that meets the requirements of 49 CFR Part 40, “Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs” to collect specimens for drug and alcohol testing from the FFD program personnel listed in § 26.4(g).

(c) Conditions for testing. Licensees and other entities shall administer drug and alcohol tests to the individuals who are subject to this subpart under the following conditions:

(1) Pre-access. In order to grant initial, updated, or reinstated authorization to an individual, as specified in subpart C of this part;

(2) For cause. In response to an individual's observed behavior or physical condition indicating possible substance abuse or after receiving credible information that an individual is engaging in substance abuse, as defined in § 26.5;

(3) Post-event. As soon as practical after an event involving a human error that was committed by an individual who is subject to this subpart, where the human error may have caused or contributed to the event. The licensee or other entity shall test the individual(s) who committed the error(s), and need not test individuals who were affected by the event whose actions likely did not cause or contribute to the event. The individual(s) who committed the human error(s) shall be tested if the event resulted in—

(i) A significant illness or personal injury to the individual to be tested or another individual, which within 4 hours after the event is recordable under the Department of Labor standards contained in 29 CFR 1904.7, “General Recording Criteria,” and subsequent amendments thereto, and results in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant illness or injury as diagnosed by a physician or other licensed health care professional, even if it does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness;

(ii) A radiation exposure or release of radioactivity in excess of regulatory limits; or

(iii) Actual or potential substantial degradations of the level of safety of the plant;

(4) Follow-up. As part of a follow-up plan to verify an individual's continued abstinence from substance abuse; and

(5) Random. On a statistically random and unannounced basis, so that all individuals in the population subject to testing have an equal probability of being selected and tested.

(d) General requirements for drug and alcohol testing —(1) Substances tested. At a minimum, licensees and other entities shall test for marijuana metabolite, cocaine metabolite, opioids (codeine, morphine, 6-acetylmorphine, hydrocodone, hydromorphone, oxycodone, and oxymorphone), amphetamines (amphetamine, methamphetamine, methylenedioxymethamphetamine, and methylenedioxyamphetamine), phencyclidine, and alcohol.

(i) In addition, licensees and other entities may consult with local law enforcement authorities, hospitals, and drug counseling services to determine whether other drugs with abuse potential are being used in the geographical locale of the facility and by the local workforce that may not be detected in the panel of drugs and drug metabolites specified in paragraph (d)(1) of this section.

(A) When appropriate, the licensee or other entity may add other drugs identified under paragraph (d)(1)(i) of this section to the panel of substances for testing, but only if the additional drugs are listed in Schedules I through V of section 202 of the Controlled Substances Act [21 U.S.C. 812].

(B) The licensee or other entity shall establish appropriate cutoff limits for these substances.

(C) The licensee or other entity shall establish rigorous testing procedures for these substances that are consistent with the intent of this part, so that the MRO can evaluate the use of these substances.

(D) The licensee or other entity may not conduct an analysis for any drug or drug metabolites except those identified in paragraph (d)(1) of this section unless the assay and cutoff levels to be used are certified in writing as scientifically sound and legally defensible by an independent, qualified forensic toxicologist who has no relationships with manufacturers of the assays or instruments to be used or the HHS-certified laboratory that will conduct the testing for the licensee or other entity, which could be construed as a potential conflict of interest. The forensic toxicologist may not be an employee of the licensee or entity, and shall either be a Diplomate of the American Board of Forensic Toxicology or currently holds, has held, or is eligible to hold, the position of Responsible Person at an HHS-certified laboratory. All new assays and cutoff levels must be properly validated consistent with established forensic toxicological standards before implementation. Certification of the assay and cutoff levels is not required if the HHS Guidelines are revised to authorize use of the assay in testing for the additional drug or drug metabolites and the licensee or other entity uses the cutoff levels established in the HHS Guidelines for the drug or drug metabolites, or if the licensee or other entity received written approval of the NRC to test for the additional drug or drug metabolites before April 30, 2008.

(ii) When conducting post-event, followup, and for-cause testing, as defined in § 26.31(c), licensees and other entities may test for any drugs listed on Schedules I through V of section 202 of the Controlled Substances Act [21 U.S.C. 812] that an individual is suspected of having abused, and may consider any drugs or metabolites so detected when determining appropriate action under subpart D of this part. If the drug or metabolites for which testing will be performed under this paragraph are not included in the FFD program's drug panel, the assay and cutoff levels to be used in testing for the additional drugs must be certified by a forensic toxicologist under paragraph (d)(1)(i)(D) of this section. Test results that fall below the established cutoff levels may not be considered when determining appropriate action under subpart D of this part, except if special analyses of the specimen is performed under § 26.163(a)(2) by the HHS-certified laboratory.

(iii) The licensee or other entity shall document the additional drug(s) for which testing will be performed in written policies and procedures in which the substances for which testing will be performed are described.

(2) Random testing. Random testing must—

(i) Be administered in a manner that provides reasonable assurance that individuals are unable to predict the time periods during which specimens will be collected. At a minimum, the FFD program shall—

(A) Take reasonable steps to either conceal from the workforce that collections will be performed during a scheduled collection period or create the appearance that specimens are being collected during a portion of each day on at least 4 days in each calendar week at each site. In the latter instance, the portions of each day and the days of the week must vary in a manner that cannot be predicted by donors; and

(B) Collect specimens on an unpredictable schedule, including weekends, backshifts, and holidays, and at various times during a shift;

(ii) At a minimum, be administered by the FFD program on a nominal weekly frequency;

(iii) Require individuals who are selected for random testing to report to the collection site as soon as reasonably practicable after notification, within the time period specified in the FFD program policy;

(iv) Ensure that all individuals in the population subject to testing have an equal probability of being selected and tested;

(v) Require that individuals who are off site when selected for testing, or who are on site and are not reasonably available for testing when selected, shall be tested at the earliest reasonable and practical opportunity when both the donor and collectors are available to collect specimens for testing and without prior notification to the individual that he or she has been selected for testing;

(vi) Provide that an individual completing a test is immediately eligible for another unannounced test; and

(vii) Ensure that the sampling process used to select individuals for random testing provides that the number of random tests performed annually is equal to at least 50 percent of the population that is subject to the FFD program.

(3) Drug testing. (i) Testing of urine specimens for drugs and validity, except validity screening and initial drug and validity tests performed by licensee testing facilities under paragraph (d)(3)(ii) of this section, must be performed in a laboratory that is certified by HHS for that purpose, consistent with its standards and procedures for certification. Urine specimens sent to HHS-certified laboratories must be subject to initial validity and initial drug testing by the laboratory. Oral fluid specimens sent to HHS-certified laboratories must be subject to initial drug testing by the laboratory. Specimens that yield positive initial drug test results or are determined by initial validity testing to be of questionable validity must be subject to confirmatory testing by the laboratory, except for invalid specimens that cannot be tested. Licensees and other entities shall ensure that laboratories report results for all specimens sent for testing, including blind performance test samples.

(ii) Licensees and other entities may conduct validity screening, initial validity, and initial drug tests of urine aliquots to determine which specimens are valid and negative and need no further testing, provided that the licensee's or other entity's staff possesses the necessary training and skills for the tasks assigned, the staff's qualifications are documented, and adequate quality controls for the testing are implemented.

(iii) At a minimum, licensees and other entities shall apply the cutoff levels specified in § 26.163(a)(1) for initial drug testing at either the licensee testing facility or HHS-certified laboratory, and in § 26.163(b)(1) for confirmatory drug testing at the HHS-certified laboratory. At their discretion, licensees and other entities may implement programs with lower cutoff levels in testing for drugs and drug metabolites.

(A) If a licensee or other entity implements lower cutoff levels, and the MRO determines that an individual has violated the FFD policy using the licensee's or other entity's more stringent cutoff levels, the individual shall be subject to all management actions and sanctions required by the licensee's or other entity's FFD policy and this part, as if the individual had a confirmed positive drug test result using the cutoff levels specified in this subpart. The licensee or other entity shall document the more stringent cutoff levels in any written policies and procedures in which cutoff levels for drug testing are described.

(B) The licensee or other entity shall uniformly apply the cutoff levels listed in § 26.163(a)(1) for initial drug testing and in § 26.163(b)(1) for confirmatory drug testing, or any more stringent cutoff levels implemented by the FFD program, to all tests performed under this part and equally to all individuals who are tested under this part, except as permitted in §§ 26.31(d)(1)(ii), 26.163(a)(2), and 26.165(c)(2).

(C) In addition, the scientific and technical suitability of any more stringent cutoff levels must be evaluated and certified, in writing, by a forensic toxicologist who meets the requirements set forth in § 26.31(d)(1)(i)(D). Certification of the more stringent cutoff levels is not required if the HHS Guidelines are revised to lower the cutoff levels for the drug or drug metabolites in Federal workplace drug testing programs and the licensee or other entity implements the cutoff levels published in the HHS Guidelines, or if the licensee or other entity received written approval of the NRC to test for lower cutoff levels before April 30, 2008.

(4) Alcohol testing. Initial tests for alcohol must be administered by breath or oral fluids analysis using alcohol analysis devices that meet the requirements of § 26.91(a). If the initial test shows a BAC of 0.02 percent or greater, a confirmatory test for alcohol must be performed. The confirmatory test must be performed with an EBT that meets the requirements of § 26.91(b).

(5) Medical conditions. (i) If an individual has a medical condition that makes collection of breath, oral fluids, or urine specimens difficult or hazardous, the MRO may authorize an alternative evaluation process, tailored to the individual case, to meet the requirements of this part for drug and alcohol testing. The alternative process must include measures to prevent subversion and achieve results that are comparable to those produced by urinalysis for drugs and breath analysis for alcohol.

(ii) If an individual requires medical attention, including, but not limited to, an injured worker in an emergency medical facility who is required to have a post-event test, treatment may not be delayed to conduct drug and alcohol testing.

(6) Limitations of testing. Specimens collected under NRC regulations may only be designated or approved for testing as described in this part and may not be used to conduct any other analysis or test without the written permission of the donor. Analyses and tests that may not be conducted include, but are not limited to, DNA testing, serological typing, or any other medical or genetic test used for diagnostic or specimen identification purposes.

§ 26.33 Behavioral observation.

Licensees and other entities shall ensure that the individuals who are subject to this subpart are subject to behavioral observation. Behavioral observation must be performed by individuals who are trained under § 26.29 to detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty; or impairment from fatigue or any cause that, if left unattended, may constitute a risk to public health and safety or the common defense and security. Individuals who are subject to this subpart shall report any FFD concerns about other individuals to the personnel designated in the FFD policy.

§ 26.35 Employee assistance programs.

(a) Each licensee and other entity who is subject to this part shall maintain an EAP to strengthen the FFD program by offering confidential assessment, short-term counseling, referral services, and treatment monitoring to individuals who have problems that could adversely affect the individuals' abilities to safely and competently perform their duties. Employee assistance programs must be designed to achieve early intervention and provide for confidential assistance.

(b) Licensees and other entities need not provide EAP services to a C/V's employees, including those whose work location is a licensee's or other entity's facility, or to individuals who have applied for, but have not yet been granted, authorization under subpart C of this part.

(c) The EAP staff shall protect the identity and privacy of any individual (including those who have self-referred) seeking assistance from the EAP, except if the individual waives the right to privacy in writing or a determination is made that the individual's condition or actions pose or have posed an immediate hazard to himself or herself or others.

(1) Licensees and other entities may not require the EAP to routinely report the names of individuals who self-refer to the EAP or the nature of the assistance the individuals sought.

(2) If EAP personnel determine that an individual poses or has posed an immediate hazard to himself or herself or others, EAP personnel shall so inform FFD program management, and need not obtain a written waiver of the right to privacy from the individual. The individual conditions or actions that EAP personnel shall report to FFD program management include, but are not limited to, substantive reasons to believe that the individual—

(i) Is likely to commit self-harm or harm to others;

(ii) Has been impaired from using drugs or alcohol while in a work status and has a continuing substance abuse disorder that makes it likely he or she will be impaired while in a work status in the future; or

(iii) Has ever engaged in any acts that would be reportable under § 26.719(b)(1) through (b)(3).

(3) If a licensee or other entity receives a report from EAP personnel under paragraph (c)(2) of this section, the licensee or other entity shall ensure that the requirements of §§ 26.69(d) and 26.77(b) are implemented, as applicable.

§ 26.37 Protection of information.

(a) Each licensee or other entity who is subject to this subpart who collects personal information about an individual for the purpose of complying with this part, shall establish, use, and maintain a system of files and procedures that protects the individual's privacy.

(b) Licensees and other entities shall obtain a signed consent that authorizes the disclosure of the personal information collected and maintained under this part before disclosing the personal information, except for disclosures to the following individuals:

(1) The subject individual or his or her representative, when the individual has designated the representative in writing for specified FFD matters;

(2) Assigned MROs and MRO staff;

(3) NRC representatives;

(4) Appropriate law enforcement officials under court order;

(5) A licensee's or other entity's representatives who have a need to have access to the information to perform their assigned duties under the FFD program, including determinations of fitness, FFD program audits, or some human resources functions;

(6) The presiding officer in a judicial or administrative proceeding that is initiated by the subject individual;

(7) Persons deciding matters under review in § 26.39; and

(8) Other persons pursuant to court order.

(c) Personal information that is collected under this subpart must be disclosed to other licensees and entities, including C/Vs, or their authorized representatives, who are legitimately seeking the information for authorization decisions as required by this part and who have obtained a signed release from the subject individual.

(d) Upon receipt of a written request by the subject individual or his or her designated representative, the FFD program, including but not limited to, the collection site, HHS-certified laboratory, substance abuse expert (SAE), or MRO, possessing such records shall promptly provide copies of all FFD records pertaining to the individual, including, but not limited to, records pertaining to a determination that the individual has violated the FFD policy, drug and alcohol test results, MRO reviews, determinations of fitness, and management actions pertaining to the subject individual. The licensee or other entity shall obtain records related to the results of any relevant laboratory certification, review, or revocation-of-certification proceedings from the HHS-certified laboratory and provide them to the subject individual on request.

(e) A licensee's or other entity's contracts with HHS-certified laboratories and C/Vs providing specimen collection services, and licensee testing facility procedures, must require test records to be maintained in confidence, except as provided in paragraphs (b), (c), and (d) of this section.

(f) This section does not authorize the licensee or other entity to withhold evidence of criminal conduct from law enforcement officials.

§ 26.39 Review process for fitness-for-duty policy violations.

(a) Each licensee and other entity who is subject to this subpart shall establish procedures for the review of a determination that an individual who they employ or who has applied for authorization has violated the FFD policy. The review procedure must provide for an objective and impartial review of the facts related to the determination that the individual has violated the FFD policy.

(b) The review procedure must provide notice to the individual of the grounds for the determination that the individual has violated the FFD policy, and must provide an opportunity for the individual to respond and submit additional relevant information.

(c) The review procedure must ensure that the individual who conducts the review is not associated with the administration of the FFD program [ see the description of FFD program personnel in § 26.4(g)]. Individuals who conduct the review may be management personnel.

(d) If the review finds in favor of the individual, the licensee or other entity shall update the relevant records to reflect the outcome of the review and delete or correct all information the review found to be inaccurate.

(e) When a C/V is administering an FFD program on which licensees and other entities rely, and the C/V determines that its employee, subcontractor, or applicant has violated its FFD policy, the C/V shall ensure that the review procedure required in this section is provided to the individual. Licensees and other entities who rely on a C/V's FFD program need not provide the review procedure required in this section to a C/V's employee, subcontractor, or applicant when the C/V is administering its own FFD program and the FFD policy violation was determined under the C/V's program.

§ 26.41 Audits and corrective action.

(a) General. Each licensee and other entity who is subject to this subpart is responsible for the continuing effectiveness of the FFD program, including FFD program elements that are provided by C/Vs, the FFD programs of any C/Vs that are accepted by the licensee or other entity, any FFD program services that are provided to the C/V by a subcontractor, and the programs of the HHS-certified laboratories on whom the licensee or other entity and its C/Vs rely. Each licensee and other entity shall ensure that these programs are audited and that corrective actions are taken to resolve any problems identified.

(b) FFD program. Each licensee and other entity who is subject to this subpart shall ensure that the entire FFD program is audited as needed, but no less frequently than nominally every 24 months. Licensees and other entities are responsible for determining the appropriate frequency, scope, and depth of additional auditing activities within the nominal 24-month period based on the review of FFD program performance, including, but not limited to, the frequency, nature, and severity of discovered problems, testing errors, personnel or procedural changes, and previous audit findings.

(c) C/Vs and HHS-certified laboratories. (1) FFD services that are provided to a licensee or other entity by C/V personnel who are off site or are not under the direct daily supervision or observation of the licensee's or other entity's personnel and HHS-certified laboratories must be audited on a nominal 12-month frequency.

(2) Audits of HHS-certified laboratories that are conducted for licensees and other entities who are subject to this subpart need not duplicate areas inspected in the most recent HHS certification inspection. However, the licensee and other entity shall review the HHS certification inspection records and reports to identify any areas in which the licensee or other entity uses services that the HHS certification inspection did not address. The licensee or other entity shall ensure that any such areas are audited on a nominal 12-month frequency. Licensees and other entities need not audit organizations and professionals who may provide an FFD program service to the licensee or other entity, but who are not routinely involved in providing services to a licensee's or other entity's FFD program, as specified in § 26.4(i)(1).

(d) Contracts. (1) The contracts of licensees and other entities with C/Vs and HHS-certified laboratories must reserve the right to audit the C/V, the C/V's subcontractors providing FFD program services, and the HHS-certified laboratories at any time, including at unannounced times, as well as to review all information and documentation that is reasonably relevant to the audits.

(2) Licensees' and other entities' contracts with C/Vs and HHS-certified laboratories must also permit the licensee or other entity to obtain copies of and take away any documents, including reviews and inspections pertaining to a laboratory's certification by HHS, and any other data that may be needed to assure that the C/V, its subcontractors, or the HHS-certified laboratory are performing their functions properly and that staff and procedures meet applicable requirements. In a contract with a licensee or other entity who is subject to this subpart, an HHS-certified laboratory may reasonably limit the use and dissemination of any documents copied or taken away by the licensee's or other entity's auditors in order to ensure the protection of proprietary information and donors' privacy.

(3) In addition, before awarding a contract, the licensee or other entity shall ensure completion of pre-award inspections and/or audits of the procedural aspects of the HHS-certified laboratory's drug-testing operations, except as provided in paragraph (g)(5) of this section.

(e) Conduct of audits. Audits must focus on the effectiveness of the FFD program or program element(s), as appropriate, and must be conducted by individuals who are qualified in the subject(s) being audited. The individuals performing the audit of the FFD program or program element(s) shall be independent from both the subject FFD program's management and from personnel who are directly responsible for implementing the FFD program.

(f) Audit results. The result of the audits, along with any recommendations, must be documented and reported to senior corporate and site management. Each audit report must identify conditions that are adverse to the proper performance of the FFD program, the cause of the condition(s), and recommended corrective actions. The licensee or other entity shall review the audit findings and take corrective actions, including re-auditing of the deficient areas where indicated, to preclude, within reason, repetition of the condition. The resolution of the audit findings and corrective actions must be documented.

(g) Sharing of audits. Licensees and other entities may jointly conduct audits, or may accept audits of C/Vs and HHS-certified laboratories that were conducted by other licensees and entities who are subject to this subpart, if the audit addresses the services obtained from the C/V or HHS-certified laboratory by each of the sharing licensees and other entities.

(1) Licensees and other entities shall review audit records and reports to identify any areas that were not covered by the shared or accepted audit.

(2) Licensees and other entities shall ensure that FFD program elements and services on which the licensee or entity relies are audited, if the program elements and services were not addressed in the shared audit.

(3) Sharing licensees and other entities need not re-audit the same C/V or HHS-certified laboratory for the same period of time.

(4) Each sharing licensee and other entity shall maintain a copy of the shared audit and HHS certification inspection records and reports, including findings, recommendations, and corrective actions.

(5) If an HHS-certified laboratory loses its certification, in whole or in part, a licensee or other entity is permitted to immediately use another HHS-certified laboratory that has been audited within the previous 12 months by another NRC licensee or entity who is subject to this subpart. Within 3 months after the change, the licensee or other entity shall ensure that an audit is completed of any areas that have not been audited by another licensee or entity who is subject to this subpart within the past 12 months.

§ 26.51 Applicability.

The requirements in this subpart apply to the licensees and other entities identified in § 26.3(a), (b), and, as applicable, (c) for the categories of individuals in § 26.4(a) through (d), and, at the licensee's or other entity's discretion, in § 26.4(g) and, if necessary, § 26.4(j). The requirements in this subpart also apply to the licensees and other entities specified in § 26.3(c), as applicable, for the categories of individuals in § 26.4(e). At the discretion of a licensee or other entity in § 26.3(c), the requirements of this subpart also may be applied to the categories of individuals identified in § 26.4(f). In addition, the requirements in this subpart apply to the entities in § 26.3(d) to the extent that a licensee or other entity relies on the C/V to meet the requirements of this subpart. Certain requirements in this subpart also apply to the individuals specified in § 26.4(h).

§ 26.53 General provisions.

(a) In order to grant authorization to an individual, a licensee or other entity shall ensure that the requirements in this subpart have been met for either initial authorization, authorization update, authorization reinstatement, or authorization with potentially disqualifying FFD information, as applicable.

(b) For individuals who have previously held authorization under this part but whose authorization has since been favorably terminated, the licensee or other entity shall implement the requirements for either initial authorization, authorization update, or authorization reinstatement, based on the total number of days that the individual's authorization is interrupted, to include the day after the individual's last period of authorization was terminated and the intervening days until the day on which the licensee or other entity grants authorization to the individual. If potentially disqualifying FFD information is disclosed or discovered about an individual, licensees and other entities shall implement the applicable requirements in § 26.69 in order to grant or maintain an individual's authorization.

(c) The licensee or other entity shall ensure that an individual has met the applicable FFD training requirements in §§ 26.29 and 26.203(c) before granting authorization to the individual.

(d) Licensees and other entities who are seeking to grant authorization to an individual who is maintaining authorization under another FFD program that is implemented by a licensee or entity who is subject to this subpart may rely on the transferring FFD program to satisfy the requirements of this subpart. The individual may maintain his or her authorization if he or she continues to be subject to either the receiving FFD program or the transferring FFD program, or a combination of elements from both programs that collectively satisfy the applicable requirements of this part. The receiving FFD program shall ensure that the program elements to which the individual is subject under the transferring FFD program remain current.

(e) Licensees and other entities in § 26.3(a) through (c) may also rely on a C/V's FFD program or program elements when granting or maintaining the authorization of an individual who is or has been subject to the C/V's FFD program, if the C/V's program or program elements meet the applicable requirements of this part.

(1) A C/V's FFD program may grant and maintain an individual's authorization, as defined in § 26.5, under the C/V's FFD program. However, only a licensee or other entity in § 26.3(a) through (c) may grant or maintain an individual's authorization to have the types of access or perform the duties specified in § 26.4(a) through (e) and (g), and, at the licensee's or other entity's discretion, § 26.4(f).

(2) If a C/V's FFD program denies or unfavorably terminates an individual's authorization, and the individual is performing any duties for a licensee or other entity that are specified in § 26.4(a) through (e) and (g), or, at the licensee's or other entity's discretion, § 26.4(f), then the C/V shall inform the affected licensee or other entity of the denial or unfavorable termination. The licensee or other entity shall deny or unfavorably terminate the individual's authorization to perform those duties on the day that the licensee or other entity receives the information from the C/V, or implement the applicable process in § 26.69 to maintain the individual's authorization.

(3) If an individual is maintaining authorization under a C/V's FFD program, a licensee or other entity in § 26.3(a) through (c) may grant authorization to the individual to have the types of access and perform the duties specified in § 26.4(a) through (e) and (g), and, at the licensee's or other entity's discretion, § 26.4(f), and maintain his or her authorization, if the individual continues to be subject to either the receiving FFD program or a combination of elements from the receiving FFD program and the C/V's program that collectively satisfy the applicable requirements of this part. The receiving licensee's or other entity's FFD program shall ensure that the program elements to which the individual is subject under the C/V's FFD program remain current.

(f) Licensees and other entities who are seeking to grant authorization to an individual who has been subject to an FFD program under subpart K may not rely on that program or its program elements to meet the requirements of this subpart, except if the program or program element(s) of the FFD program for construction satisfy the applicable requirements of this part.

(g) The licensees and other entities specified in § 26.3(a) and, as applicable, (c) and (d), shall identify any violation of any requirement of this part to any licensee who has relied on or intends to rely on the FFD program element that is determined to be in violation of this part.

(h) The licensees and other entities specified in § 26.3(a) and, as applicable, (c) and (d), may not initiate any actions under this subpart without the knowledge and written consent of the subject individual. The individual may withdraw his or her consent at any time. If an individual withdraws his or her consent, the licensee or other entity may not initiate any elements of the authorization process specified in this subpart that were not in progress at the time the individual withdrew his or her consent, but shall complete and document any elements that are in progress at the time consent is withdrawn. The licensee or other entity shall record the individual's application for authorization; his or her withdrawal of consent; the reason given by the individual for the withdrawal, if any; and any pertinent information gathered from the elements that were completed (e.g., the results of pre-access drug tests, information obtained from the suitable inquiry). The licensee or other entity to whom the individual has applied for authorization shall inform the individual that—

(1) Withdrawal of his or her consent will withdraw the individual's current application for authorization under the licensee's or other entity's FFD program; and

(2) Other licensees and entities will have access to information documenting the withdrawal as a result of the information sharing that is required under this part.

(i) The licensees and other entities specified in § 26.3(a) and, as applicable, (c) and(d), shall inform, in writing, any individual who is applying for authorization that the following actions related to providing and sharing the personal information required under this subpart are sufficient cause for denial or unfavorable termination of authorization:

(1) Refusal to provide written consent for the suitable inquiry;

(2) Refusal to provide or the falsification of any personal information required under this part, including, but not limited to, the failure to report any previous denial or unfavorable termination of authorization;

(3) Refusal to provide written consent for the sharing of personal information with other licensees or other entities required under this part; and

(4) Failure to report any legal actions, as defined in § 26.5.

§ 26.55 Initial authorization.

(a) Before granting authorization to an individual who has never held authorization under this part or whose authorization has been interrupted for a period of 3 years or more and whose last period of authorization was terminated favorably, the licensee or other entity shall ensure that—

(1) A self-disclosure has been obtained and reviewed under the applicable requirements of § 26.61;

(2) A suitable inquiry has been completed under the applicable requirements of § 26.63;

(3) The individual has been subject to pre-access drug and alcohol testing under the applicable requirements of § 26.65; and

(4) The individual is subject to random drug and alcohol testing under the applicable requirements of § 26.67.

(b) If potentially disqualifying FFD information is disclosed or discovered, the licensee or other entity may not grant authorization to the individual, except under § 26.69.

§ 26.57 Authorization update.

(a) Before granting authorization to an individual whose authorization has been interrupted for more than 365 days but less than 3 years and whose last period of authorization was terminated favorably, the licensee or other entity shall ensure that—

(1) A self-disclosure has been obtained and reviewed under the applicable requirements of § 26.61;

(2) A suitable inquiry has been completed under the applicable requirements of § 26.63;

(3) The individual has been subject to pre-access drug and alcohol testing under the applicable requirements of § 26.65; and

(4) The individual is subject to random drug and alcohol testing under the applicable requirements of § 26.67.

(b) If potentially disqualifying FFD information is disclosed or discovered, the licensee or other entity may not grant authorization to the individual, except under § 26.69.

§ 26.59 Authorization reinstatement.

(a) In order to grant authorization to an individual whose authorization has been interrupted for a period of more than 30 days but no more than 365 days and whose last period of authorization was terminated favorably, the licensee or other entity shall ensure that—

(1) A self-disclosure has been obtained and reviewed under the applicable requirements of § 26.61;

(2) A suitable inquiry has been completed under the requirements of § 26.63 within 5 business days of reinstating authorization. If the suitable inquiry is not completed within 5 business days due to circumstances that are outside of the licensee's or other entity's control and the licensee or other entity is not aware of any potentially disqualifying information regarding the individual within the past 5 years, the licensee or other entity may maintain the individual's authorization for an additional 5 business days. If the suitable inquiry is not completed within 10 business days of reinstating authorization, the licensee or other entity shall administratively withdraw the individual's authorization until the suitable inquiry is completed;

(3) The individual has been subject to pre-access drug and alcohol testing under the applicable requirements of § 26.65; and

(4) The individual is subject to random drug and alcohol testing under the applicable requirements of § 26.67.

(b) If a licensee or other entity administratively withdraws an individual's authorization under paragraph (a)(2) of this section, and until the suitable inquiry is completed, the licensee or other entity may not record the administrative action to withdraw authorization as an unfavorable termination and may not disclose it in response to a suitable inquiry conducted under the provisions of § 26.63, a background investigation conducted under the provisions of this chapter, or any other inquiry or investigation. The individual may not be required to disclose the administrative action in response to requests for self-disclosure of potentially disqualifying FFD information, except if the individual's authorization was subsequently denied or terminated unfavorably by the licensee or other entity.

(c) Before granting authorization to an individual whose authorization has been interrupted for a period of no more than 30 days and whose last period of authorization was terminated favorably, the licensee or other entity shall ensure that—

(1) A self-disclosure has been obtained and reviewed under the applicable requirements of § 26.61;

(2) The individual has been subject to pre-access drug and alcohol testing under the applicable requirements of § 26.65, if the individual's authorization was interrupted for more than 5 days; and

(3) The individual is subject to random drug and alcohol testing under the applicable requirements of § 26.67.

(d) If potentially disqualifying FFD information is disclosed or discovered, the licensee or other entity may not grant authorization to the individual, except under § 26.69.

§ 26.61 Self-disclosure and employment history.

(a) Before granting authorization, the licensee or other entity shall ensure that a written self-disclosure and employment history has been obtained from the individual who is applying for authorization, except as follows:

(1) If an individual previously held authorization under this part, and the licensee or other entity has verified that the individual's last period of authorization was terminated favorably, and the individual has been subject to a behavioral observation program that includes arrest reporting, which meets the requirements of this part, throughout the period since the individual's last authorization was terminated, the granting licensee or other entity need not obtain the self-disclosure or employment history in order to grant authorization; and

(2) If the individual's last period of authorization was terminated favorably within the past 30 days, the licensee or other entity need not obtain the employment history.

(b) The written self-disclosure must—

(1) State whether the individual has—

(i) Violated a licensee's or other entity's FFD policy;

(ii) Had authorization denied or terminated unfavorably under §§ 26.35(c)(2), 26.53(i), 26.63(d), 26.65(g), 26.67(c), 26.69(f), or 26.75(b) through (e);

(iii) Used, sold, or possessed illegal drugs;

(iv) Abused legal drugs or alcohol;

(v) Subverted or attempted to subvert a drug or alcohol testing program;

(vi) Refused to take a drug or alcohol test;

(vii) Been subject to a plan for substance abuse treatment (except for self-referral); or

(viii) Had legal action or employment action, as defined in § 26.5, taken for alcohol or drug use;

(2) Address the specific type, duration, and resolution of any matter disclosed, including, but not limited to, the reason(s) for any unfavorable termination or denial of authorization; and

(3) Address the shortest of the following periods:

(i) The past 5 years;

(ii) Since the individual's eighteenth birthday; or

(iii) Since the individual's last period of authorization was terminated, if authorization was terminated favorably within the past 3 years.

(c) The individual shall provide a list of all employers, including the employer by whom the individual claims to have been employed on the day before he or she completes the employment history, if any, with dates of employment, for the shortest of the following periods:

(1) The past 3 years;

(2) Since the individual's eighteenth birthday; or

(3) Since authorization was last terminated, if authorization was terminated favorably within the past 3 years.

§ 26.63 Suitable inquiry.

(a) In order to grant authorization, licensees and other entities shall ensure that a suitable inquiry has been conducted, on a best effort basis, to verify the individual's self-disclosed information and determine whether any potentially disqualifying FFD information is available, except if all of the following conditions are met:

(1) The individual previously held authorization under this part;

(2) The licensee or other entity has verified that the individual's last period of authorization was terminated favorably; and

(3) The individual has been subject to a behavioral observation program that includes arrest reporting, which meets the requirements of this part, throughout the period of interruption.

(b) To meet the suitable inquiry requirement, licensees and other entities may rely on the information that other licensees and entities who are subject to this subpart have gathered for previous periods of authorization. Licensees and other entities may also rely on those licensees' and entities' determinations of fitness that were conducted under § 26.189, as well as their reviews and resolutions of potentially disqualifying FFD information, for previous periods of authorization.

(c) The licensee or other entity shall ensure that the suitable inquiry has been conducted, on a best effort basis, by questioning former employers, and the employer by whom the individual claims to have been employed on the day before he or she completes the employment history, if an employment history is required under § 26.61.

(1) For the claimed employment period, the suitable inquiry must ascertain the reason for termination, eligibility for rehire, and other information that could reflect on the individual's fitness to be granted authorization.

(2) If the claimed employment was military service, the licensee or other entity who is conducting the suitable inquiry shall request a characterization of service, reason for separation, and any disciplinary actions related to potentially disqualifying FFD information. If the individual's last duty station cannot provide this information, the licensee or other entity may accept a hand-carried copy of the DD 214 presented by the individual which on face value appears to be legitimate. The licensee or other entity may also accept a copy of a DD 214 provided by the custodian of military records.

(3) If a company, previous employer, or educational institution to whom the licensee or other entity has directed a request for information refuses to provide information or indicates an inability or unwillingness to provide information within 3 business days of the request, the licensee or other entity shall document this refusal, inability, or unwillingness in the licensee's or other entity's record of the investigation, and obtain a confirmation of employment or educational enrollment and attendance from at least one alternate source, with suitable inquiry questions answered to the best of the alternate source's ability. This alternate source may not have been previously used by the licensee or other entity to obtain information about the individual's character. If the licensee or other entity uses an alternate source because employer information is not forthcoming within 3 business days of the request, the licensee or other entity need not delay granting authorization to wait for any employer response, but shall evaluate and document the response if it is received.

(d) When any licensee or other entity in § 26.3(a) through (d) is legitimately seeking the information required for an authorization decision under this subpart and has obtained a signed release from the subject individual authorizing the disclosure of information, any licensee or other entity who is subject to this part shall disclose whether the subject individual's authorization was denied or terminated unfavorably as a result of a violation of an FFD policy and shall make available the information on which the denial or unfavorable termination of authorization was based, including, but not limited to, drug or alcohol test results, treatment and followup testing requirements or other results from a determination of fitness, and any other information that is relevant to an authorization decision.

(e) In conducting a suitable inquiry, a licensee or other entity may obtain information and documents by electronic means, including, but not limited to, telephone, facsimile, or e-mail. The licensee or other entity shall make a record of the contents of the telephone call and shall retain that record, and any documents or electronic files obtained electronically, under §§ 26.711 and 26.713(a), (b), and (c), as applicable.

(f) For individuals about whom no potentially disqualifying FFD information is known (or about whom potentially disqualifying FFD information is known, but it has been resolved by a licensee or other entity who is subject to this subpart) at the time at which the suitable inquiry is initiated, the licensee or other entity shall ensure that a suitable inquiry has been conducted as follows:

(1) Initial authorization. The period of the suitable inquiry must be the past 3 years or since the individual's eighteenth birthday, whichever is shorter. For the 1-year period immediately preceding the date on which the individual applies for authorization, the licensee or other entity shall ensure that the suitable inquiry has been conducted with every employer, regardless of the length of employment. For the remaining 2-year period, the licensee or other entity shall ensure that the suitable inquiry has been conducted with the employer by whom the individual claims to have been employed the longest within each calendar month, if the individual claims employment during the given calendar month.

(2) Authorization update. The period of the suitable inquiry must be the period since authorization was terminated. For the 1-year period immediately preceding the date on which the individual applies for authorization, the licensee or other entity shall ensure that the suitable inquiry has been conducted with every employer, regardless of the length of employment. For the remaining period since authorization was terminated, the licensee or other entity shall ensure that the suitable inquiry has been conducted with the employer by whom the individual claims to have been employed the longest within each calendar month, if the individual claims employment during the given calendar month.

(3) Authorization reinstatement after an interruption of more than 30 days. The period of the suitable inquiry must be the period since authorization was terminated. The licensee or other entity shall ensure that the suitable inquiry has been conducted with the employer by whom the individual claims to have been employed the longest within the calendar month, if the individual claims employment during the given calendar month.

§ 26.65 Pre-access drug and alcohol testing.

(a) Purpose. This section contains pre-access testing requirements for granting authorization to an individual who either has never held authorization or whose last period of authorization was terminated favorably and about whom no potentially disqualifying FFD information has been discovered or disclosed that was not previously reviewed and resolved by a licensee or other entity under the requirements of this subpart.

(b) Accepting tests conducted within the past 30 days. If an individual has negative results from drug and alcohol tests that were conducted under the requirements of this part before the individual applied for authorization from the licensee or other entity, and the specimens for such testing were collected within the 30-day period preceding the day on which the licensee or other entity grants authorization to the individual, the licensee or other entity may rely on the results of those drug and alcohol tests to meet the requirements for pre-access testing in this section.

(c) Initial authorization and authorization update. Before granting authorization to an individual who has never held authorization or whose authorization has been interrupted for a period of more than 365 days, the licensee or other entity shall verify that the results of pre-access drug and alcohol tests, which must be performed within the 30-day period preceding the day the licensee or other entity grants authorization to the individual, are negative. The licensee or other entity need not conduct pre-access testing if—

(1) The individual previously held authorization under this part and has been subject to a drug and alcohol testing program that includes random testing and a behavioral observation program that includes arrest reporting, which both meet the requirements of this part, from the date the individual's last authorization was terminated through the date the individual is granted authorization; or

(2) The licensee or other entity relies on negative results from drug and alcohol tests that were conducted under the requirements of this part at any time before the individual applied for authorization, and the individual has remained subject to a drug and alcohol testing program that includes random testing and a behavioral observation program that includes arrest reporting, which both meet the requirements of this part, beginning on the date the drug and alcohol testing was conducted through the date the individual is granted authorization and thereafter.

(d) Authorization reinstatement after an interruption of more than 30 days. (1) To reinstate authorization for an individual whose authorization has been interrupted for a period of more than 30 days but no more than 365 days, except as permitted in paragraph (d)(2) of this section, the licensee or other entity shall—

(i) Verify that the individual has negative results from alcohol testing and collect a specimen for drug testing within the 30-day period preceding the day the licensee reinstates the individual's authorization; and

(ii) Verify that the drug test results are negative within 5 business days of specimen collection or administratively withdraw authorization until the drug test results are received.

(2) The licensee or other entity need not conduct pre-access testing of these individuals if—

(i) The individual previously held authorization under this part and has been subject to a drug and alcohol testing program that includes random testing and a behavioral observation program that includes arrest reporting, which both meet the requirements of this part, beginning on the date the individual's last authorization was terminated through the date the individual is granted authorization; or

(ii) The licensee or other entity relies on negative results from drug and alcohol tests that were conducted under the requirements of this part at any time before the individual applied for authorization, and the individual remains subject to a drug and alcohol testing program that includes random testing and a behavioral observation program that includes arrest reporting, which both meet the requirements of this part, beginning on the date the drug and alcohol testing was conducted through the date the individual is granted authorization.

(e) Authorization reinstatement after an interruption of 30 or fewer days. (1) The licensee or other entity need not conduct pre-access testing before granting authorization to an individual whose authorization has been interrupted for 5 or fewer days. In addition, the licensee or other entity need not conduct pre-access testing if the individual has been subject to a drug and alcohol testing program that includes random testing and a behavioral observation program that includes arrest reporting, which both meet the requirements of this part, from the date the individual's last authorization was terminated through the date the individual is granted authorization.

(2) In order to reinstate authorization for an individual whose authorization has been interrupted for a period of more than 5 days but not more than 30 days, except as permitted in paragraph (e)(1) of this section, the licensee or other entity shall take the following actions:

(i) The licensee or other entity shall subject the individual to random selection for pre-access drug and alcohol testing at a one-time probability that is equal to or greater than the normal testing rate specified in § 26.31(d)(2)(vii) calculated for a 30-day period;

(ii) If the individual is not selected for pre-access testing under paragraph (e)(2)(i) of this section, the licensee or other entity need not perform pre-access drug and alcohol tests; or

(iii) If the individual is selected for pre-access testing under this paragraph, the licensee or other entity shall—

(A) Verify that the individual has negative results from alcohol testing and collect a specimen for drug testing before reinstating authorization; and

(B) Verify that the drug test results are negative within 5 business days of specimen collection or administratively withdraw authorization until negative drug test results are received.

(f) Administrative withdrawal of authorization. If a licensee or other entity administratively withdraws an individual's authorization under paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this section, and until the drug test results are known, the licensee or other entity may not record the administrative action to withdraw authorization as an unfavorable termination. The individual may not be required to disclose the administrative action in response to requests for self-disclosure of potentially disqualifying FFD information, except if the individual's authorization was subsequently denied or terminated unfavorably by a licensee or entity. Immediately on receipt of negative test results, the licensee or other entity shall ensure that any matter that could link the individual to the temporary administrative action is eliminated from the donor's personnel record and other records.

(g) Sanctions. If an individual has confirmed positive, adulterated, or substituted test results from any drug, validity, or alcohol tests that may be required in this section, the licensee or other entity shall, at a minimum and as appropriate—

(1) Deny authorization to the individual, as required by § 26.75(b), (d), (e)(2), or (g);

(2) Terminate the individual's authorization, if it has been reinstated, under § 26.75(e)(1) or (f); or

(3) Grant authorization to the individual under § 26.69.

§ 26.67 Random drug and alcohol testing of individuals who have applied for authorization.

(a) When the licensee or other entity collects specimens from an individual for any pre-access testing that may be required under §§ 26.65 or 26.69, and thereafter, the licensee or other entity shall subject the individual to random testing under § 26.31(d)(2), except if—

(1) The licensee or other entity does not grant authorization to the individual; or

(2) The licensee or other entity relies on drug and alcohol tests that were conducted before the individual applied for authorization to meet the applicable requirements for pre-access testing. If the licensee or other entity relies on drug and alcohol tests that were conducted before the individual applied for authorization, the licensee or other entity shall subject the individual to random testing when the individual arrives at a licensee's or other entity's facility for in-processing and thereafter.

(b) If an individual is selected for one or more random tests after any applicable requirement for pre-access testing in §§ 26.65 or 26.69 has been met, the licensee or other entity may grant authorization before random testing is completed, if the individual has met all other applicable requirements for authorization.

(c) If an individual has confirmed positive, adulterated, or substituted test results from any drug, validity, or alcohol test required in this section, the licensee or other entity shall, at a minimum and as appropriate—

(1) Deny authorization to the individual, as required by § 26.75(b), (d), (e)(2), or (g);

(2) Terminate the individual's authorization, if it has been granted, as required by § 26.75(e)(1) or (f); or

(3) Grant authorization to the individual under § 26.69.

§ 26.69 Authorization with potentially disqualifying fitness-for-duty information.

(a) Purpose. This section defines the management actions that licensees and other entities who are subject to this subpart shall take to grant or maintain, at the licensee's or other entity's discretion, the authorization of an individual who is in the following circumstances:

(1) Potentially disqualifying FFD information within the past 5 years has been disclosed or discovered about the individual by any means, including, but not limited to, the individual's self-disclosure, the suitable inquiry, drug and alcohol testing, the administration of any FFD program under this part, a self-report of a legal action, behavioral observation, or other sources of information, including, but not limited to, any background investigation or credit and criminal history check conducted under the requirements of this chapter; and

(2) The potentially disqualifying FFD information has not been reviewed and favorably resolved by a previous licensee or other entity under this section.

(b) Authorization after a first confirmed positive drug or alcohol test result or a 5-year denial of authorization. The requirements in this paragraph apply to individuals whose authorization was denied or terminated unfavorably for a first violation of an FFD policy involving a confirmed positive drug or alcohol test result and individuals whose authorization was denied for 5 years under § 26.75(c), (d), (e)(2), or (f). To grant, and subsequently maintain, the individual's authorization, the licensee or other entity shall—

(1) Obtain and review a self-disclosure and employment history from the individual that addresses the shorter period of either the past 5 years or since the individual's last period of authorization was terminated, and verify that the self-disclosure does not contain any previously undisclosed potentially disqualifying FFD information before granting authorization;

(2) Complete a suitable inquiry with every employer by whom the individual claims to have been employed during the period addressed in the employment history obtained under paragraph (b)(1) of this section, and obtain and review any records that other licensees or entities who are subject to this part may have developed related to the unfavorable termination or denial of authorization;

(3) If the individual was subject to a 5-year denial of authorization under this part, verify that he or she has abstained from substance abuse for at least the past 5 years;

(4) Ensure that an SAE has conducted a determination of fitness and concluded that the individual is fit to safely and competently perform his or her duties.

(i) If the individual's authorization was denied or terminated unfavorably for a first confirmed positive drug or alcohol test result, ensure that clinically appropriate treatment and followup testing plans have been developed by an SAE before granting authorization;

(ii) If the individual was subject to a 5-year denial of authorization, ensure that any recommendations for treatment and followup testing from an SAE's determination of fitness are initiated before granting authorization; and

(iii) Verify that the individual is in compliance with, and successfully completes, any followup testing and treatment plans.

(5) Within 10 business days before granting authorization, perform a pre-access alcohol test, collect a specimen for drug testing under direct observation, and ensure that the individual is subject to random testing thereafter. Verify that the pre-access drug and alcohol test results are negative before granting authorization.

(6) If the individual's authorization was denied or terminated unfavorably for a first confirmed positive drug or alcohol test result and a licensee or other entity grants authorization to the individual, ensure that the individual is subject to unannounced testing at least quarterly for 3 calendar years after the date the individual is granted authorization. Both random and followup tests, as defined in § 26.31(c), satisfy this requirement. Verify that the individual has negative test results from a minimum of 15 tests distributed over the 3-year period, except as follows:

(i) If the individual does not continuously hold authorization during the 3-year period, the licensee or other entity shall ensure that at least one unannounced test is conducted in any quarter during which the individual holds authorization;

(ii) If the 15 tests are not completed within the 3-year period specified in this paragraph due to periods during which the individual does not hold authorization, the followup testing program may be extended up to 5 calendar years to complete the 15 tests;

(iii) If the individual does not hold authorization during the 5-year period a sufficient number of times or for sufficient periods of time to complete the 15 tests required in this paragraph, the licensee or other entity shall ensure that an SAE conducts a determination of fitness to assess whether further followup testing is required and implement the SAE's recommendations; and

(7) Verify that any drug and alcohol tests required in this paragraph, and any other drug and alcohol tests that are conducted under this part since authorization was terminated or denied, yield results indicating no further drug abuse, as determined by the MRO after review, or alcohol abuse, as determined by the result of confirmatory alcohol testing.

(c) Granting authorization with other potentially disqualifying FFD information. The requirements in this paragraph apply to an individual who has applied for authorization, and about whom potentially disqualifying FFD information has been discovered or disclosed that is not a first confirmed positive drug or alcohol test result or a 5-year denial of authorization. If potentially disqualifying FFD information is obtained about an individual by any means, including, but not limited to, the individual's self-disclosure, the suitable inquiry, the administration of any FFD program under this part, a self-report of a legal action, behavioral observation, or other sources of information, including, but not limited to, any background investigation or credit and criminal history check conducted under the requirements of this chapter, before granting authorization to the individual, the licensee or other entity shall—

(1) Obtain and review a self-disclosure and employment history that addresses the shortest of the following periods:

(i) The past 5 years;

(ii) Since the individual's eighteenth birthday; or

(iii) Since the individual's last period of authorization was terminated;

(2) Complete a suitable inquiry with every employer by whom the individual claims to have been employed during the period addressed in the employment history required under paragraph (c)(1) of this section. If the individual held authorization within the past 5 years, obtain and review any records that other licensees or entities who are subject to this part may have developed with regard to potentially disqualifying FFD information about the individual from the past 5 years;

(3) If the designated reviewing official determines that a determination of fitness is required, verify that a professional with the appropriate qualifications, as specified in § 26.189(a), has indicated that the individual is fit to safely and competently perform his or her duties;

(4) Ensure that the individual is in compliance with, or has completed, any plans for treatment and drug and alcohol testing from the determination of fitness, which may include the collection of a urine specimen under direct observation; and

(5) Verify that the results of pre-access drug and alcohol tests are negative before granting authorization, and that the individual is subject to random testing after the specimens have been collected for pre-access testing and thereafter.

(d) Maintaining authorization with other potentially disqualifying FFD information. If an individual is authorized when other potentially disqualifying FFD information is disclosed or discovered, in order to maintain the individual's authorization, the licensee or other entity shall—

(1) Ensure that the licensee's or other entity's designated reviewing official completes a review of the circumstances associated with the information;

(2) If the designated reviewing official concludes that a determination of fitness is required, verify that a professional with the appropriate qualifications, as specified in § 26.189(a), has indicated that the individual is fit to safely and competently perform his or her duties; and

(3) If the reviewing official determines that maintaining the individual's authorization is warranted, implement any recommendations for treatment and followup drug and alcohol testing from the determination of fitness, which may include the collection of urine specimens under direct observation, and ensure that the individual complies with and successfully completes the treatment plans.

(e) Accepting followup testing and treatment plans from another FFD program. Licensees and other entities may rely on followup testing, treatment plans, and determinations of fitness that meet the requirements of § 26.189 and were conducted under the FFD program of another licensee or entity who is subject to this subpart.

(1) If an individual leaves the FFD program in which a treatment and/or followup testing plan was required under paragraphs (b), (c), or (d) of this section, the licensee or other entity who imposed the treatment and/or followup testing plan shall ensure that information documenting the treatment and/or followup testing plan is identified to any subsequent licensee or other entity who seeks to grant authorization to the individual. If the individual is granted authorization by the same or another licensee or entity, the licensee or other entity who grants authorization to the individual shall ensure that any followup testing requirements are met and that the individual complies with any treatment plan, with accountability assumed by the granting licensee or other entity. If it is impractical for the individual to comply with a treatment plan that was developed under another FFD program because of circumstances that are outside of the individual's or licensee's or other entity's control (e.g., geographical distance, closure of a treatment facility), then the granting FFD program shall ensure that an SAE develops a comparable treatment plan, with accountability for monitoring the individual's compliance with the plan assumed by the granting licensee or other entity.

(2) If the previous licensee or other entity determined that the individual successfully completed any required treatment and followup testing, and the individual's last period of authorization was terminated favorably, the receiving licensee or entity may rely on the previous determination of fitness and no further review or followup is required.

(f) Sanctions. If an individual has confirmed positive, adulterated, or substituted test results from any drug, validity, or alcohol test required in this section, the licensee or other entity shall, at a minimum and as appropriate—

(1) Deny authorization to the individual, as required by § 26.75(b), (d), (e)(2), or (g); or

(2) Terminate the individual's authorization, if it has been granted, as required by § 26.75(e)(1) or (f).

§ 26.71 Maintaining authorization.

(a) Individuals may maintain authorization under the following conditions:

(1) The individual complies with the licensee's or other entity's FFD policies and procedures, as described in § 26.27, including the responsibility to report any legal actions, as defined in § 26.5;

(2) The individual remains subject to a drug and alcohol testing program that meets the requirements of § 26.31, including random testing;

(3) The individual remains subject to a behavioral observation program that meets the requirements of § 26.33; and

(4) The individual successfully completes required FFD training on the schedule specified in § 26.29(c).

(b) If an authorized individual is not subject to an FFD program that meets the requirements of this section for more than 30 continuous days, then the licensee or other entity shall terminate the individual's authorization and the individual shall meet the requirements in this subpart, as applicable, to regain authorization.

§ 26.73 Applicability.

The requirements in this subpart apply to the licensees and other entities identified in § 26.3(a), (b), and, as applicable, (c) for the categories of individuals specified in § 26.4(a) through (d) and (g). The requirements in this subpart also apply to the licensees and other entities specified in § 26.3(c), as applicable, for the categories of individuals in § 26.4(e). At the discretion of a licensee or other entity in § 26.3(c), the requirements of this subpart also may be applied to the categories of individuals identified in § 26.4(f). In addition, the requirements in this subpart apply to the entities in § 26.3(d) to the extent that a licensee or other entity relies on the C/V to meet the requirements of this subpart. The regulations in this subpart also apply to the individuals specified in § 26.4(h) and (j), as appropriate.

§ 26.75 Sanctions.

(a) This section defines the minimum sanctions that licensees and other entities shall impose when an individual has violated the drug and alcohol provisions of an FFD policy. A licensee or other entity may impose more stringent sanctions, except as specified in paragraph (h) of this section.

(b) Any act or attempted act to subvert the testing process, including, but not limited to, refusing to provide a specimen and providing or attempting to provide a substituted or adulterated specimen, for any test required under § 26.31(c) must result in the immediate unfavorable termination of the individual's authorization and permanent denial of authorization thereafter.

(c) Any individual who is determined to have been involved in the sale, use, or possession of illegal drugs or the consumption of alcohol within a protected area of any nuclear power plant, within a facility that is licensed to possess or use formula quantities of SSNM, within a transporter's facility or vehicle, or while performing the duties that require the individual to be subject to this subpart shall immediately have his or her authorization unfavorably terminated and denied for a minimum of 5 years from the date of the unfavorable termination of authorization.

(d) Any individual who resigns or withdraws his or her application for authorization before authorization is terminated or denied for a first violation of the FFD policy involving a confirmed positive drug or alcohol test result shall immediately have his or her authorization denied for a minimum of 5 years from the date of termination or denial. If an individual resigns or withdraws his or her application for authorization before his or her authorization is terminated or denied for any violation of the FFD policy, the licensee or other entity shall record the resignation or withdrawal, the nature of the violation, and the minimum sanction that would have been required under this section had the individual not resigned or withdrawn his or her application for authorization.

(e) Lacking any other evidence to indicate the use, sale, or possession of illegal drugs or consumption of alcohol on site, a confirmed positive drug or alcohol test result must be presumed to be an indication of offsite drug or alcohol use in violation of the FFD policy.

(1) The first violation of the FFD policy involving a confirmed positive drug or alcohol test result must, at a minimum, result in the immediate unfavorable termination of the individual's authorization for at least 14 days from the date of the unfavorable termination.

(2) Any subsequent confirmed positive drug or alcohol test result, including during an assessment or treatment period, must result in the denial of authorization for a minimum of 5 years from the date of denial.

(f) Paragraph (e) of this section does not apply to the misuse of prescription and over-the-counter drugs, except if the MRO determines that misuse of the prescription or over-the-counter drug represents substance abuse. Sanctions for misuse of prescription and over-the-counter drugs must be sufficient to deter misuse of those substances.

(g) For individuals whose authorization was denied for 5 years under paragraphs (c), (d), (e)(2), or (f) of this section, any subsequent violation of the drug and alcohol provisions of an FFD policy must immediately result in permanent denial of authorization.

(h) A licensee or other entity may not terminate an individual's authorization and may not subject the individual to other administrative action based solely on a positive test result from any initial drug test, other than positive initial test results for marijuana or cocaine metabolites from a specimen that is reported to be valid on the basis of either validity screening or initial validity testing performed at a licensee testing facility, unless other evidence, including information obtained under the process set forth in § 26.189, indicates that the individual is impaired or might otherwise pose a safety hazard. The licensee or other entity may not terminate an individual's authorization or subject an individual to any other administrative action under this section based on the results of validity screening or initial validity testing performed at a licensee testing facility indicating that a specimen is of questionable validity.

(i) With respect to positive initial drug test results from a licensee testing facility for marijuana and cocaine metabolites from a valid specimen, licensee testing facility personnel may inform licensee or other entity management of the positive initial drug test result and the specific drugs or metabolites identified, and licensees or other entities may administratively withdraw the donor's authorization or take lesser administrative actions against the donor, provided that the licensee or other entity complies with the following conditions:

(1) For the drug for which action will be taken, at least 85 percent of the specimens that were determined to be positive as a result of initial drug tests at the licensee testing facility during the past 12-month data reporting period submitted to the NRC under § 26.717 were subsequently reported as positive by the HHS-certified laboratory as the result of confirmatory testing;

(2) There is no loss of compensation or benefits to the donor during the period of temporary administrative action;

(3) Immediately on receipt of a negative report from the HHS-certified laboratory or MRO, any matter that could link the donor to the temporary administrative action is eliminated from the donor's personnel record and other records; and

(4) Licensees and other entities may not disclose the temporary administrative action against an individual whose initial drug test result is not subsequently confirmed by the MRO as a violation of the FFD policy in response to a suitable inquiry conducted under the provisions of § 26.63, a background investigation conducted under the provisions of this chapter, or to any other inquiry or investigation.

(i) To ensure that no records are retained, access to the system of files and records must be provided to personnel who are conducting reviews, inquiries into allegations, or audits under the provisions of § 26.41, and to NRC inspectors.

(ii) The licensee or other entity shall provide the donor with a written statement that the records specified in §§ 26.713 and 26.715 have not been retained with respect to the temporary administrative action and shall inform the donor in writing that the temporary administrative action that was taken will not be disclosed and need not be disclosed by the individual in response to requests for self-disclosure of potentially disqualifying FFD information.

§ 26.77 Management actions regarding possible impairment.

(a) This section defines management actions that licensees and other entities who are subject to this subpart must take when an individual who is subject to this subpart shows indications that he or she may not be fit to safely and competently perform his or her duties.

(b) If an individual appears to be impaired or the individual's fitness is questionable, except as permitted under §§ 26.27(c)(3), 26.207, and 26.209, the licensee or other entity shall take immediate action to prevent the individual from performing the duties that require him or her to be subject to this subpart.

(1) If an observed behavior or physical condition creates a reasonable suspicion of possible substance abuse, the licensee or other entity shall perform drug and alcohol testing. The results must be negative before the individual returns to performing the duties that require the individual to be subject to this subpart. However, if the physical condition is the smell of alcohol with no other behavioral or physical indications of impairment, then only an alcohol test is required and the results must be negative before the individual returns to performing his or her duties.

(2) If a licensee or C/V who is subject to subpart I of this part is certain that the observed behavior or physical condition is the result solely of fatigue, the licensee or C/V shall ensure that a fatigue assessment is conducted under § 26.211. If the results of the fatigue assessment confirm that the observed behavior or physical condition is the result solely of fatigue, the licensee or C/V need not perform drug and alcohol tests or implement the determination of fitness process otherwise required by § 26.189.

(3) For other indications of possible impairment that do not create a reasonable suspicion of substance abuse (or fatigue, in the case of licensees and C/Vs who are subject to subpart I of this part), the licensee or other entity may permit the individual to return to performing his or her duties only after the impairing or questionable conditions are resolved and a determination of fitness indicates that the individual is fit to safely and competently perform his or her duties.

(c) If a licensee or other entity has a reasonable belief that an NRC employee or NRC contractor may be under the influence of any substance, or is otherwise unfit for duty, the licensee or other entity may not deny access but shall escort the individual. In any such instance, the licensee or other entity shall immediately notify the appropriate Regional Administrator by telephone, followed by written notification (e.g., e-mail or fax) to document the oral notification. If the Regional Administrator cannot be reached, the licensee or other entity shall notify the NRC Operations Center.

§ 26.81 Purpose and applicability.

This subpart contains requirements for collecting specimens for drug testing and conducting alcohol tests by or on behalf of the licensees and other entities in § 26.3(a) through (d) for the categories of individuals specified in § 26.4(a) through (d) and (g). At the discretion of a licensee or other entity in § 26.3(c), specimen collections and alcohol tests must be conducted either under this subpart for the individuals specified in § 26.4(e) and (f) or the licensee or other entity may rely on specimen collections and alcohol tests conducted under the requirements of 49 CFR Part 40 for the individuals specified in § 26.4(e) and (f). The requirements of this subpart do not apply to specimen collections and alcohol tests that are conducted under the requirements of 49 CFR Part 40, as permitted in this paragraph and under §§ 26.4(j) and 26.31(b)(2) and Subpart K.

§ 26.83 Specimens to be collected.

Except as permitted under § 26.31(d)(5), licensees and other entities who are subject to this subpart shall—

(a) Collect either breath or oral fluids for initial tests for alcohol. Breath must be collected for confirmatory tests for alcohol; and

(b) Collect only urine specimens for both initial and confirmatory tests for drugs, unless the licensee or other entity establishes through its policy and procedures that an oral fluid specimen can be collected and tested for any of the observed specimen collection conditions under § 26.115(a)(1) through (3) and (5). For each observed collection condition under § 26.115(a)(1) through (3) and (5), the licensee or other entity shall always collect and test the same specimen type.

§ 26.85 Collector qualifications and responsibilities.

(a) Collector qualifications. Each collector shall be knowledgeable of the requirements of this part and the FFD policy and procedures of the licensee or other entity for whom collections are performed, and shall keep current on any changes to the collection procedures for each specimen the individual is qualified to collect under this part. Each collector shall receive qualification training that meets the requirements of this paragraph and demonstrate proficiency in applying the requirements of this paragraph before serving as a collector. At a minimum, qualification training must provide instruction on the following subjects:

(1) All steps necessary to complete a collection correctly and the proper completion and transmission of the Federal CCF;

(2) Methods to address “problem” collections, including, but not limited to:

(i) Inability to provide a specimen ( e.g., “shy bladder” for a urine specimen, “shy lung” for a breath specimen, dry mouth for an oral fluid specimen); and

(ii) Attempts to tamper with a specimen;

(3) Operation of the particular specimen collection or alcohol testing device(s) ( e.g., alcohol screening device (ASD), EBT, oral fluid) to be used, consistent with the most recent version of the manufacturers' instructions;

(4) How to correct problems in collections; and

(5) The collector's responsibility for maintaining the integrity of the specimen collection process, carefully ensuring the modesty and privacy of the donor, and avoiding any conduct or remarks that might be construed as accusatorial or otherwise offensive or inappropriate, and the specimen transfer process, if applicable.

(b) Alternative collectors. A medical professional, technologist, or technician may serve as a collector without meeting the collector qualification requirements in paragraphs (a) or (b) of this section, as applicable, only if all of the following conditions are met:

(1) A collector who meets the requirements of paragraph (a) of this section cannot reasonably be made available at the time the collection must occur;

(2) The individual is not employed by the licensee's or other entity's FFD program and his or her normal workplace is not at the licensee's or other entity's facility;

(3) The individual does not routinely provide FFD program services to the licensee or other entity;

(4) The individual is licensed or otherwise approved to practice in the jurisdiction in which the collection occurs; and

(5) The individual is provided with detailed, clearly-illustrated, written instructions for collecting specimens under this subpart and follows those instructions.

(c) Personnel available to testify at proceedings. The licensee or other entity shall ensure that qualified collection site personnel, when required, are available to testify in an administrative or disciplinary proceeding against an individual when that proceeding is based on positive drug or alcohol test results or adulterated or substituted test results from specimens collected by or under contract to the licensee or other entity.

(d) Files. Collection site personnel files must include each individual's resume of training and experience; certification or license, if any; references; job descriptions; records of performance evaluations and advancement; incident reports, if any; results of tests to establish employee competency for the position he or she holds, including, but not limited to, certification that collectors are proficient in administering alcohol tests consistent with the most recent manufacturer's instructions for the instruments and devices used; and appropriate data to support determinations of honesty and integrity conducted under § 26.31(b).

§ 26.87 Collection sites.

(a) Each FFD program must have one or more designated collection sites that have all necessary personnel, materials, equipment, facilities, and supervision to collect specimens for drug testing and to perform alcohol testing. Each collection site must provide for the collection, security, temporary storage, and shipping or transportation of specimens to a drug testing laboratory; the testing of specimens for alcohol; the security of specimen collection and testing devices; and test results. A properly equipped mobile facility that meets the requirements of this section is an acceptable collection site.

(b) Visual privacy must be provided to the donor and collector when viewing alcohol test results and during the collection of an oral fluid specimen for drug testing. The donor must be provided with individual privacy while submitting a urine specimen, except if a directly observed urine specimen collection is required. Unauthorized personnel may not be present for the specimen collection.

(c) Contracts for collection site services must permit representatives of the NRC, licensee, or other entity to conduct unannounced inspections and audits and to obtain all information and documentation that is reasonably relevant to the inspections and audits.

(d) Licensees and other entities shall take the following measures to prevent unauthorized access to the collection site that could compromise the integrity of the collection process or the specimens.

(1) Unauthorized personnel may not be permitted in any part of the designated collection site where specimens are collected or stored;

(2) A designated collection site must be secure. If a collection site is dedicated solely to specimen collection, it must be secure at all times. Methods of assuring security may include, but are not limited to, physical measures to control access, such as locked doors, alarms, or visual monitoring of the collection site when it is not occupied; and

(3) If a collection site cannot be dedicated solely to collecting specimens, the portion of the facility that is used for specimen collection must be secured and, during the time period during which a specimen is being collected, a sign must be posted to indicate that access is permitted only for authorized personnel.

(e) The following steps must be taken to deter the dilution and adulteration of urine specimens at the collection site:

(1) Agents that color any source of standing water in the stall or room in which the donor will provide a specimen, including, but not limited to, the toilet bowl or tank, must be placed in the source of standing water, so that the reservoirs of water are neither yellow nor colorless;

(2) There must be no other source of water (e.g., no shower or sink) in the enclosure where urination occurs, or the source of water must be rendered unusable; and

(3) Chemicals or products that could be used to contaminate or otherwise alter the specimen must be removed from the collection site or secured. The collector shall inspect the enclosure in which urination will occur before each collection to ensure that no materials are available that could be used to subvert the testing process.

(f) In the exceptional event that a designated collection site is inaccessible and there is an immediate requirement to collect a specimen for drug testing, including, but not limited to, an event investigation, then the licensee or other entity may use a public rest room, onsite rest room, or hospital examining room according to the following procedures:

(1) The facility must be secured by visual inspection to ensure that no unauthorized persons are present, and that undetected access (e.g., through a rear door not in the view of the collector) is impossible. Security during the collection may be maintained by restricting access to collection materials and specimens. In the case of a public rest room, a sign must be posted or an individual assigned to ensure that no unauthorized personnel are present during the entire collection procedure to avoid embarrassment of the donor and distraction of the collector.

(2) If practical when a urine specimen is to be collected, a water coloring agent that meets the requirements of § 26.87(e)(1) must be placed in the toilet bowl to be used by the donor and in any other accessible source of standing water, including, but not limited to, the toilet tank. The collector shall instruct the donor not to flush the toilet.

(3) A collector of the same gender as the donor shall accompany the donor into the area that will be used for a urine specimen collection , but remain outside of the stall, if it is a multi-stalled rest room, or outside of the door to the room, if it is a single rest room, in which the donor will provide the specimen. If a collector of the same gender is not available, the collector shall select a same-gender person to accompany the donor. This person shall be instructed on the collection procedures specified in this subpart and his or her identity must be documented on the Federal CCF.

(4) Once the collector has possession of the specimen, if the specimen is urine, the collector shall inspect the toilet bowl and area to ensure that there is no evidence of a subversion attempt and shall then flush the toilet, and for any specimen collected for drug testing, the collector shall instruct the donor to participate with the collector in completing the chain of custody procedures.

(5) If it is impractical to maintain continuous physical security of a collection site from the time a specimen for drug testing is presented until the sealed container is transferred for shipment, the specimen must remain under the direct control of an individual who is authorized by the licensee or other entity until the specimen is prepared for transfer, storage, or shipping, as required by § 26.117. The authorized individual shall be instructed on his or her responsibilities for maintaining custody and control of the specimen and his or her custody of the specimen must be documented on the Federal CCF .

§ 26.89 Preparing to collect specimens for testing.

(a) When an individual has been notified of a requirement for testing and does not appear at the collection site within the time period specified by FFD program procedures, the collector shall inform FFD program management that the individual has not reported for testing. FFD program management shall ensure that the necessary steps are taken to determine whether the individual's undue tardiness or failure to appear for testing constitutes a violation of the licensee's or other entity's FFD policy. If FFD program management determines that the undue tardiness or failure to report for testing represents an attempt to subvert the testing process, the licensee or other entity shall impose on the individual the sanctions in § 26.75(b). If FFD program management determines that the undue tardiness or failure to report does not represent a subversion attempt, the licensee or other entity may not impose sanctions but shall ensure that the individual is tested at the earliest reasonable and practical opportunity after locating the individual.

(b) Donors shall provide acceptable identification before testing.

(1) Acceptable identification includes photo-identification issued by a licensee or other entity who is subject to this part, or by the Federal, State, or local government. Licensees and other entities may not accept faxes or photocopies of identification.

(2) If the donor cannot produce acceptable identification before any testing that is required under this part other than pre-access testing, the collector shall proceed with the test and immediately inform FFD program management that the donor did not present acceptable identification. When so informed, FFD program management shall contact the individual's supervisor to verify in-person the individual's identity, or, if the supervisor is not available, take other steps to establish the individual's identity and determine whether the lack of identification was an attempt to subvert the testing process. The donor may not leave the collection site except under supervision until his or her identity has been established.

(3) If the donor is scheduled for pre-access testing and cannot produce acceptable identification, the collector may not proceed with the collection, and shall inform FFD program management that the individual did not present acceptable identification. When so informed, FFD program management will take the necessary steps to determine whether the lack of identification was an attempt to subvert the testing process.

(4) The collector shall explain the testing procedure to the donor, show the donor the form(s) to be used, and ask the donor to sign a consent-to-testing form. The donor may not be required to list prescription medications or over-the-counter preparations that he or she has recently used.

(c) The collector shall inform the donor that, if the donor refuses to cooperate in the specimen collection process (including, but not limited to, behaving in a confrontational manner that disrupts the testing process; admitting to the collector that he or she adulterated, diluted, or substituted the specimen; is found to have a device, such as a prosthetic appliance, the purpose of which is to interfere with providing an actual urine specimen; or leaving the collection site before all of the collection procedures are completed), it will be considered a refusal to test, and sanctions for subverting the testing process will be imposed under § 26.75(b). If the donor refuses to cooperate in the collection procedures, the collector shall inform FFD program management to obtain guidance on the actions to be taken.

(d) In order to promote the security of specimens, avoid distraction of the collector, and ensure against any confusion in the identification of specimens, a collector shall conduct only one collection procedure at any given time, except as described in § 26.109(b)(1). For the collection of specimen(s) for drug testing, the collection procedure is complete when the specimen container has been sealed with a tamper-evident seal, the seal has been dated and initialed, and the Federal CCF has been completed or when a refusal to test has been determined.

§ 26.91 Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use.

(a) Acceptable alcohol screening devices. Alcohol screening devices (ASDs), including devices that test specimens of oral fluids or breath, must be approved by the National Highway Traffic Safety Administration (NHTSA) and listed in the most current version of NHTSA's Conforming Products List (CPL) for such devices. An ASD that is listed in the NHTSA CPL may be used only for initial tests for alcohol, and may not be used for confirmatory tests.

(b) Acceptable evidential breath testing devices. Evidential breath testing devices listed in the NHTSA CPL for evidential devices that meet the requirements of paragraph (c) of this section must be used to conduct confirmatory alcohol tests, and may be used to conduct initial alcohol tests. Note that, among the devices listed in the CPL for EBTs, only those devices listed without an asterisk (*) may be used for confirmatory alcohol testing under this subpart.

(c) EBT capabilities. An EBT that is listed in the NHTSA CPL for evidential devices that has the following capabilities may be used for conducting initial alcohol tests and must be used for confirmatory alcohol tests under this subpart:

(1) Provides a printed result of each breath test;

(2) Assigns a unique number to each completed test, which the collector and donor can read before each test and which is printed on each copy of the test result;

(3) Prints, on each copy of the test result, the manufacturer's name for the device, its serial number, and the time of the test;

(4) Distinguishes alcohol from acetone at the 0.02 alcohol concentration level;

(5) Tests an air blank; and

(6) Permits performance of an external calibration check.

(d) Quality assurance and quality control of ASDs. (1) Licensees and other entities shall implement the most recent version of the quality assurance plan submitted to NHTSA for any ASD that is used for initial alcohol testing.

(2) Licensees and other entities may not use an ASD that fails the specified quality control checks or that has passed its expiration date.

(3) For ASDs that test breath specimens and meet EBT requirements for confirmatory testing, licensees and other entities shall also follow the device use and care requirements specified in paragraph (e) of this section.

(e) Quality assurance and quality control of EBTs. (1) Licensees and other entities shall implement the most recent version of the manufacturer's instructions for the use and care of the EBT consistently with the quality assurance plan submitted to NHTSA for the EBT, including performing external calibration checks no less frequently than at the intervals specified in the manufacturer's instructions.

(2) When conducting external calibration checks, licensees and other entities shall use only calibration devices appearing on NHTSA's CPL for “Calibrating Units for Breath Alcohol Tests.”

(3) If an EBT fails an external check of calibration, the licensee or other entity shall take the EBT out of service. The EBT may not be used again for alcohol testing under this subpart until it is repaired and passes an external calibration check.

(4) In order to ensure that confirmed positive alcohol test results are derived from an EBT that is calibrated, the licensee or other entity shall implement one of the following procedures:

(i) If an EBT fails any external check of calibration, cancel every confirmed positive test result that was obtained using the EBT from any tests that were conducted after the EBT passed the last external calibration check; or

(ii) After every confirmed positive test result obtained from using an EBT, conduct an external check of calibration of the EBT in the presence of the donor. If the EBT fails the external calibration check, cancel the donor's test result and conduct another initial and confirmatory test on a different EBT as soon as practicable.

(5) Inspection, maintenance, and calibration of the EBT must be performed by its manufacturer or a maintenance representative or other individual who is certified either by the manufacturer or by a State health agency or other appropriate State agency.

§ 26.93 Preparing for alcohol testing.

(a) Immediately before collecting a specimen for alcohol testing, the collector shall—

(1) Ask the donor whether he or she, in the past 15 minutes, has had anything to eat or drink, belched, or put anything into his or her mouth (including, but not limited to, a cigarette, breath mint, or chewing gum), and instruct the donor that he or she should avoid these activities during the collection process;

(2) If the donor states that he or she has not engaged in the activities listed in paragraph (a)(1) of this section, alcohol testing may proceed;

(3) If the donor states that he or she has engaged in any of the activities listed in paragraph (a)(1) of this section, inform the donor that a 15-minute waiting period is necessary to prevent an accumulation of mouth alcohol from leading to an artificially high reading;

(4) Explain that it is to the donor's benefit to avoid the activities listed in paragraph (a)(1) of this section during the collection process;

(5) Explain that the initial and confirmatory tests, if a confirmatory test is necessary, will be conducted at the end of the waiting period, even if the donor has not followed the instructions; and

(6) Document that the instructions were communicated to the donor.

(b) With the exception of the 15-minute waiting period, if necessary, the collector shall begin for-cause alcohol and/or drug testing as soon as reasonably practical after the decision is made that for-cause testing is required. When for-cause alcohol testing is required, alcohol testing may not be delayed by collecting a specimen for drug testing.

§ 26.95 Conducting an initial test for alcohol using a breath specimen.

(a) The collector shall perform the initial breath test as soon as practical after the donor indicates that he or she has not engaged in the activities listed in § 26.93(a)(1) or after the 15-minute waiting period has elapsed, if required.

(b) To perform the initial test, the collector shall—

(1) Select, or allow the donor to select, an individually wrapped or sealed mouthpiece from the testing materials;

(2) Open the individually wrapped or sealed mouthpiece in view of the donor and insert it into the device as required by the manufacturer's instructions;

(3) Instruct the donor to blow steadily and forcefully into the mouthpiece for at least 6 seconds or until the device indicates that an adequate amount of breath has been obtained;

(4) Show the donor the displayed or printed test result; and

(5) Ensure that the test result record can be associated with the donor and is maintained secure.

(c) Unless problems in administering the breath test require an additional collection, only one breath specimen may be collected for the initial test. If an additional collection(s) is required, the collector shall rely on the test result from the first successful collection to determine the need for confirmatory testing.

§ 26.97 Collecting oral fluid specimens for alcohol and drug testing.

(a) To perform the initial specimen collection, the collector shall—

(1) Check the expiration date on the device and show it to the donor (the device may not be used after its expiration date);

(2) Open an individually wrapped or sealed package containing the device in the presence of the donor;

(3) Offer the donor the choice of using the device or having the collector use it. If the donor chooses to use it, instruct the donor to insert the device into his or her mouth and use it in the manner described by the device's manufacturer;

(4) If the donor chooses not to use the device, or in all cases when a new specimen collection is necessary because the device failed to activate, insert the device into the donor's mouth, and gather oral fluids in the manner described by the device's manufacturer (wear single-use examination or similar gloves while doing so and change them following each specimen collection); and

(5) When the device is removed from the donor's mouth, follow the manufacturer's instructions regarding necessary next steps to ensure that the device has activated.

(b) If the steps in paragraph (a) of this section could not be completed successfully (e.g., the device breaks, the device is dropped on the floor, the device fails to activate), the collector shall—

(1) Discard the device and conduct a new specimen collection using a new device. The new device must be one that has been under the collector's control before the specimen collection;

(2) Record the reason for the new specimen collection;

(3) Offer the donor the choice of using the device or having the collector use it unless the donor, in the opinion of the collector, was responsible for the new specimen collection needing to be conducted. If the collector concludes that the donor was responsible, then the collector shall use the device to conduct the specimen collection; and

(4) Repeat the procedures in paragraph (a) of this section.

(c) If the second collection attempt in paragraph (b) of this section could not be completed, the collector shall—

(1) End the collection of oral fluids and document the reason(s) that the collection could not be completed; and

(2) Immediately conduct another specimen collection ( i.e., initial test using an EBT for alcohol, or urine specimen collection for drug testing).

(d) For alcohol testing of oral fluids, the collector shall read the result displayed on the device no sooner than the device's manufacturer instructs. In all cases, the collector shall read the result within 15 minutes of the test. The collector shall then show the device and its reading to the donor, record the result, and record that an ASD was used.

(e) Devices, swabs, gloves, and other materials used in collecting oral fluids may not be re-used.

§ 26.99 Determining the need for a confirmatory test for alcohol.

(a) If the initial test result is less than 0.02 percent BAC, the collector shall declare the test result as negative.

(b) If the initial test result is 0.02 percent BAC or higher, the collector shall ensure that the time at which the test was concluded ( i.e. , the time at which the test result was known) is recorded and inform the donor that a confirmatory test for alcohol is required.

§ 26.101 Conducting a confirmatory test for alcohol.

(a) The confirmatory test must begin as soon as possible, but no more than 30 minutes after the conclusion of the initial test.

(b) To complete the confirmatory test, the collector shall—

(1) In the presence of the donor, conduct an air blank on the EBT before beginning the confirmatory test and show the result to the donor;

(2) Verify that the reading is 0.00. If the reading is 0.00, the test may proceed. If not, then conduct another air blank;

(3) If the reading on the second air blank is 0.00, the test may proceed. If the reading is greater than 0.00, take the EBT out of service and proceed with the test using another EBT. If an EBT is taken out of service for this reason, the EBT may not be used for further testing until it is found to be within tolerance limits on an external check of calibration;

(4) Open an individually wrapped or sealed mouthpiece in view of the donor and insert it into the device as required by the manufacturer's instructions;

(5) Read the unique test number displayed on the EBT, and ensure that the donor reads the same number;

(6) Instruct the donor to blow steadily and forcefully into the mouthpiece for at least 6 seconds or until the device indicates that an adequate amount of breath has been obtained; and

(7) Show the donor the result displayed on or printed by the EBT, record the result, and document the time at which the confirmatory test result was known.

(c) Unless there are problems in administering the breath test that require an additional collection, the collector shall collect only one breath specimen for the confirmatory test. If an additional collection(s) is required because of problems in administering the breath test, the collector shall rely on the breath specimen from the first successful collection to determine the confirmatory test result. Collection procedures may not require collectors to calculate an average or otherwise combine results from two or more breath specimens to determine the confirmatory test result.

(d) If an EBT that meets the requirements of § 26.91(b) and (c) was used for the initial alcohol test, the same EBT may be used for confirmatory testing.

§ 26.103 Determining a confirmed positive test result for alcohol.

(a) A confirmed positive test result for alcohol must be declared under any of the following conditions:

(1) When the result of the confirmatory test for alcohol is 0.04 percent BAC or higher;

(2) When the result of the confirmatory test for alcohol is 0.03 percent BAC or higher and the donor had been in a work status for at least 1 hour at the time the initial test was concluded (including any breaks for rest, lunch, dental/doctor appointments, etc.); or

(3) When the result of the confirmatory test for alcohol is 0.02 percent BAC or higher and the donor had been in a work status for at least 2 hours at the time the initial test was concluded (including any breaks for rest, lunch, dental/doctor appointments, etc.).

(b) When the result of the confirmatory test for alcohol is equal to or greater than 0.01 percent BAC but less than 0.02 percent BAC and the donor has been in a work status for 3 hours or more at the time the initial test was concluded (including any breaks for rest, lunch, dental/doctor appointments, etc.), the collector shall declare the test result as negative and inform FFD program management. The licensee or other entity shall prohibit the donor from performing any duties that require the individual to be subject to this subpart and may not return the individual to performing such duties until a determination of fitness indicates that the donor is fit to safely and competently perform his or her duties.

§ 26.105 Preparing for the collection of a specimen for drug testing.

(a) The collector shall ask the donor to remove any unnecessary outer garments, such as a coat or jacket, which might conceal items or substances that the donor could use to tamper with or adulterate his or her specimen. The collector shall ensure that all personal belongings such as a purse or briefcase remain with the outer garments outside of the room or stall in which the specimen is collected. The donor may retain his or her wallet.

(b) The collector shall also ask the donor to empty his or her pockets and display the items in them to enable the collector to identify items that the donor could use to adulterate or substitute his or her urine specimen. The donor shall permit the collector to make this observation. If the donor refuses to show the collector the items in his or her pockets, this is considered a refusal to test. If an item is found that appears to have been brought to the collection site with the intent to adulterate or substitute the specimen, the collector shall contact the MRO or FFD program manager to determine whether a directly observed collection is required. If the item appears to have been inadvertently brought to the collection site, the collector shall secure the item and continue with the normal collection procedure. If the collector identifies nothing that the donor could use to adulterate or substitute the specimen, the donor may place the items back into his or her pockets.

(c) The collector shall instruct the donor to wash and dry his or her hands before providing a specimen.

(d) After washing his or her hands, the donor shall remain in the presence of the collector and may not have access to any water fountain, faucet, soap dispenser, cleaning agent, or other materials that he or she could use to adulterate the specimen.

(e) The collector may select, or allow the donor to select, an individually wrapped or sealed urine specimen collection container from the collection kit materials or an oral fluid specimen collection device. Either the collector or the donor, with both present, shall unwrap or break the seal of the urine specimen collection container. With the exception of the collection container, the donor may not take anything from the collection kit into the room or stall used for urination.

§ 26.107 Collecting a urine specimen.

(a) The collector shall direct the donor to go into the room or stall used for urination, provide a specimen of the quantity that has been predetermined by the licensee or other entity, as defined in § 26.109(a), not flush the toilet, and return with the specimen as soon as the donor has completed the void.

(1) The donor shall provide his or her urine specimen in the privacy of a room, stall, or otherwise partitioned area (private area) that allows for individual privacy, except if a directly observed collection is required, as described in § 26.115;

(2) Except in the case of a directly observed collection, no one may go with the donor into the room or stall in which the donor will provide his or her specimen; and

(3) The collector may set a reasonable time limit for voiding.

(b)(1) The collector shall pay careful attention to the donor during the entire collection process, except as provided in § 26.109(b)(1), to observe any conduct that indicates an attempt to subvert the testing process ( e.g., tampering with a specimen; having a substitute urine specimen in plain view; attempting to bring an adulterant, urine substitute, heating element, and/or temperature measurement device into the room, stall, or private area used for urination). If any such conduct is detected, the collector shall document a description of the conduct on the Federal CCF or through another documentation method consistent with the collection procedures of the licensee or other entity, and contact FFD program management to determine whether a directly observed collection is required, as described in § 26.115.

(2) If a hydration monitor is used to observe a donor during the § 26.109(b)(1) hydration process, this individual shall immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process ( e.g., donor leaves the collection site, donor refuses to follow instructions).

(c) After the donor has provided the urine specimen and submitted it to the collector, the donor shall be permitted to wash his or her hands. The collector shall inspect the toilet bowl and room or stall in which the donor voided to identify any evidence of a subversion attempt, and then flush the toilet.

(d) If a refusal to test is determined at any point during the specimen collection process, the collector shall do the following:

(1) Inform the donor that a refusal to test has been determined;

(2) Terminate the collection process;

(3) Document a description of the refusal to test on the Federal CCF or through another documentation method consistent with the collection procedures of the licensee or other entity;

(4) Discard any urine specimen(s) provided by the donor, unless the specimen was collected for a post-event test under § 26.31(c)(3); and

(5) Immediately inform the FFD program manager.

§ 26.109 Urine specimen quantity.

(a) Licensees and other entities who are subject to this subpart shall establish a predetermined quantity of urine that donors are requested to provide when submitting a specimen. At a minimum, the predetermined quantity must include 30 milliliters (mL) to ensure that a sufficient quantity of urine is available for initial and confirmatory validity and drug tests at an HHS-certified laboratory, and for retesting of an aliquot of the specimen if requested by the donor under § 26.165(b). The licensee's or other entity's predetermined quantity may include more than 30 mL, if the testing program follows split specimen procedures, tests for additional drugs, or performs initial testing at a licensee testing facility. Where collected specimens are to be split under the provisions of this subpart, the predetermined quantity must include an additional 15 mL.

(b) If the quantity of urine in the first specimen provided by the donor is less than 30 mL, the collector shall take the following steps:

(1) The collector shall encourage the donor to drink a reasonable amount of liquid (normally, 8 ounces of water every 30 minutes, but not to exceed a maximum of 40 ounces over 3 hours) until the donor provides a specimen of at least 30 mL. Alternatively, as specified in the licensee's or other entity's FFD program procedures, the collector may assign responsibility for monitoring a donor during the hydration process to another collector who meets the requirements in § 26.85(a) or to a hydration monitor. If another collector or hydration monitor is used, the collector:

(i) Shall explain the hydration process and acceptable donor behavior to the hydration monitor;

(ii) Shall record the name of the other collector or hydration monitor on the Federal CCF; and

(iii) May perform other collections while the donor is in the hydration process;

(2) The collector shall provide the donor with a separate collection container for each successive specimen. Once the donor provides a specimen of at least 30 mL, the collection must end. If the specimen quantity is at least 30 mL but is less than the licensee's or other entity's predetermined quantity, the licensee or other entity may not require the donor to provide additional specimens and may not impose any sanctions on the donor. If the donor provides a specimen of 30 mL or more, but the specimen quantity is less than the predetermined quantity, the collector shall forward the specimen to the HHS-certified laboratory for testing. If the donor provides a specimen of at least the predetermined quantity, the specimen may be processed under the FFD program's usual testing procedures;

(3) If the donor has not provided a specimen of at least 30 mL within 3 hours of the first unsuccessful attempt to provide a specimen of the predetermined quantity, the collector shall discontinue the collection and notify the FFD program manager or MRO to initiate the “shy bladder” procedures in § 26.119; and

(4) Neither the donor nor the collector may combine specimens. The collector shall discard specimens of less than 30 mL, except if there is reason to believe that the donor has diluted, adulterated, substituted, or otherwise tampered with the specimen, based on the collector's observations of the donor's behavior during the collection process or the specimen's characteristics, as specified in § 26.111. If the collector has a reason to believe that a specimen that is 15 mL or more, but less than 30 mL, has been diluted, adulterated, substituted, or altered, the collector shall prepare the suspect specimen for shipping to the HHS-certified laboratory and contact FFD program management to determine whether a directly observed collection is required, as described in § 26.115.

§ 26.111 Checking the acceptability of the urine specimen.

(a) Immediately after the donor provides the urine specimen to the collector, including specimens of less than 30 mL but equal to or greater than 15 mL, the collector shall measure the temperature of the specimen. The temperature-measuring device used must accurately reflect the temperature of the specimen and not contaminate the specimen. The time from urination to temperature measurement may not exceed 4 minutes. If the temperature of a urine specimen is outside the range of 90 °F to 100 °F (32 °C to 38 °C), that is a reason to believe the donor may have altered ( e.g., adulterated or diluted) or substituted the specimen.

(b) Immediately after the donor provides a urine specimen, including specimens of less than 30 mL but equal to or greater than 15 mL, the collector shall also inspect the specimen to determine its color and clarity and look for any signs of contaminants or adulteration. The collector shall note any unusual findings on the Federal CCF or through another documentation method consistent with the collection procedures of the licensee or other entity.

(c) If there is reason to believe that the donor may have attempted to dilute, substitute, or adulterate the specimen based on specimen temperature or other observations made during the collection, the collector shall contact the FFD program manager, who may consult with the MRO, to determine whether the donor has attempted to subvert the testing process or whether other circumstances may explain the observations. The FFD program manager or MRO may require the donor to provide a second specimen as soon as possible under direct observation.

In addition, the collector shall inform the donor that he or she may volunteer to submit a second specimen under direct observation to counter the reason to believe the donor may have altered ( e.g., adulterated or diluted) or substituted the specimen.

(d) Any specimen of 15 mL or more that the collector suspects has been diluted, substituted, or adulterated, and any specimen of 15 mL or more that has been collected under direct observation under paragraph (c) of this section, must be sent directly to the HHS-certified laboratory for initial and, if required, confirmatory testing, and may not be subject to initial testing at a licensee testing facility.

(e) As much of the suspect specimen as possible must be preserved, except under the conditions described in § 26.107(d)(4).

§ 26.113 Splitting the urine specimen.

(a) Licensees and other entities may, but are not required to, use split-specimen methods of collection.

(b) If the urine specimen is to be split into two specimen bottles, hereinafter referred to as Bottle A and Bottle B, the collector shall take the following steps:

(1) The collector shall instruct the donor to urinate into a specimen container;

(2) The collector, in the presence of the donor and after determining specimen temperature as described in § 26.111(a), shall split the urine specimen. The collector shall pour 30 mL of urine into Bottle A and a minimum of 15 mL of urine into Bottle B. If the quantity of urine available for Bottle B is less than 15 mL, the collector shall pour the remaining urine into Bottle B and forward the specimens in Bottles A and B to the HHS-certified laboratory for drug and validity testing; and

(3) The collector shall ask the donor to observe the splitting of the urine specimen and to maintain visual contact with both specimen bottles until the Federal CCF(s) for both specimens are completed, the specimens are sealed, and the specimens and form(s) are prepared for secure storage or shipping.

(c) Licensees and other entities may use aliquots of the specimen collected for validity screening and initial validity and drug testing at the licensee testing facility, as permitted under § 26.31(d)(3)(ii), or to test for additional drugs, as permitted under § 26.31(d)(1)(i)(A), but only if sufficient urine is available for this testing after the specimen has been split into Bottle A and Bottle B.

§ 26.115 Collecting a urine specimen under direct observation.

(a) Procedures for collecting urine specimens must provide for the donor's privacy unless directed by this subpart or the MRO or FFD program manager determines that a directly observed collection is warranted. The following circumstances constitute the exclusive grounds for performing a directly observed collection:

(1) The donor has presented, at this or a previous collection, a urine specimen that the HHS-certified laboratory reported as being substituted, adulterated, or invalid to the MRO and the MRO reported to the licensee or other entity that there is no adequate medical explanation for the result;

(2) The donor has presented, at this collection, a urine specimen that falls outside the required temperature range;

(3) The collector, or the hydration monitor if one is used as permitted in § 26.109(b)(1), observes conduct by the donor indicating an attempt to subvert the testing process;

(4) A directly observed collection is required under § 26.69; or

(5) The donor requests a retest and either Bottle B or the single specimen is not available due to circumstances outside of the donor's control, as described in § 26.165(f)(2).

(b) Before collecting a urine specimen under direct observation, the collector shall obtain the agreement of the FFD program manager or MRO to obtain a urine specimen under direct observation. After obtaining agreement, the collector shall ensure that a specimen is collected under direct observation as soon as reasonably practicable.

(c) The collector shall explain to the donor the reason for direct observation of the collection under paragraph (a) of this section.

(d) The collector shall complete a new Federal CCF for the specimen that is obtained from the directly observed collection. The collector shall record that the collection was observed and the reason(s) for the directly observed collection on the form.

(e) The collector shall ensure that the observer is the same gender as the donor. A person of the opposite gender may not act as the observer under any conditions. The observer may be a different person from the collector and need not be a qualified collector. If the observer is not a qualified collector, the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) of this section before proceeding with the directly observed collection.

(f) The individual who observes the collection shall follow these procedures:

(1) The observer shall instruct the donor to adjust his or her clothing to ensure that the area of the donor's body between the waist and knees is exposed;

(2) The observer shall watch the donor urinate into the collection container. Specifically, the observer shall watch the urine go from the donor's body into the collection container. A reflective mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room, stall, or private area used for urination is not sufficient to meet this direct observation requirement; the use of a video camera to assist in the observation process is not permitted;

(3) If the observer is not the collector, the observer may not touch or handle the collection container but shall maintain visual contact with the specimen until the donor hands the collection container to the collector; and

(4) If the observer is not the collector, the collector shall record the observer's name on the Federal CCF.

(g) If a donor declines to allow a directly observed collection that is required or permitted under this section, the donor's refusal constitutes an act to subvert the testing process, and the collector shall follow the procedures in § 26.107(d).

(h) If a collector learns that a directly observed collection should have been performed but was not, the collector shall inform the FFD program manager, or his or her designee. The FFD program manager or designee shall ensure that a directly observed collection is immediately performed.