§26.3. Scope. — Inbound Citations

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

(a) The requirements of this subpart apply to the FFD programs of licensees and other entities specified in § 26.3(a) through (d), except for FFD programs that are implemented under subpart K of this part.

(b) The regulations in this part that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 26.1, 26.3, 26.5, 26.7, 26.8, 26.9, 26.11, 26.51, 26.81, 26.121, 26.151, 26.181, 26.201, 26.601, 26.823, and 26.825.

(a) The requirements in this subpart, with the exception of § 26.202, apply to the licensees and other entities identified in § 26.3(a); if applicable, (c), (d), and (f), for licensees and other entities not implementing the requirements in subparts K and M. For the licensees and other entities to whom the requirements in this subpart, with the exception of § 26.202, apply, the requirements in §§ 26.203 and 26.211 apply to the individuals identified in § 26.4(a) through (c). In addition, the requirements in § 26.205 through § 26.209 apply to the individuals identified in § 26.4(a).

The licensees and other entities specified in § 26.3(a) through (c) and (f) (for those licensees and other entities that do not implement the requirements in subparts M and K of this part) 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 satisfy the applicable requirements of this part.

(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) and (f) 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.

(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 subparts K and M of this part, and those persons who are granted unescorted access to either nuclear power reactor protected areas or remote facilities where safety-significant systems or components may be operated within the design basis of a licensed commercial nuclear plant, by the licensees and other entities in § 26.3(f) and perform the following duties must be subject to an FFD program that satisfies the requirements in subpart M of this part, unless the licensee or other entity subjects these individuals to an FFD program that satisfies all of the requirements of this part except for those requirements in subparts K and M:

(1) For persons who are granted unescorted access by the licensees in § 26.3(a) and, as applicable, (c), 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; for those persons who are granted unescorted access by the licensees and other entities in § 26.3(f), operating or 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) For persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c), 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; for those persons who are granted unescorted access to nuclear power reactor protected areas by the licensees and other entities in § 26.3(f), performing maintenance or 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.

(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.

Change as used in § 26.603(e) means an action that results in a modification of, addition to, or removal from the licensee's or other entity's FFD program.

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.

Consortium/Third-party administrator (C/TPA) means a contractor/vendor that provides or coordinates one or more FFD program elements for a group of licensees or other entities, such as administering a collective random testing pool and random testing selections under § 26.607(b)(2)(vi), that otherwise could not be independently implemented by those licensees or other entities. A C/TPA also could provide access to, for example, the services of medical review officers, substance abuse experts, employee assistance programs, and HHS-certified laboratories under contract to perform drug testing.

Constructing or construction activities means, 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. For a licensee or other entity described in § 26.3(f), construction is defined in § 53.020 of this chapter.

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) and (f), who is providing work or services to a licensee or other entity covered in § 26.3(a) through (c) and (f), 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.

Illicit substance means a substance that causes impairment and possible addiction but is not an illegal drug as defined in this section.

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:

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 satisfy the requirements of this subpart. Certain requirements in this subpart also apply to the individuals specified in § 26.4(h). The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

(e) Licensees and other entities in § 26.3(a) through (c) and (f) 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) and (f) 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) and (f) 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.

(d) When any licensee or other entity in § 26.3(a) through (d) and (f) 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.

(a) The requirements of this subpart apply to the FFD programs of licensees and other entities specified in § 26.3(a) through (d), except for FFD programs that are implemented under subpart K of this part.

(c) The licensees and other entities specified in § 26.3(a) and, as applicable, (c), (d), and (f), shall inform each individual of his or her right to review information about the individual that is collected and maintained under this part to assure its accuracy. Licensees and other entities shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is documented by licensees and other entities about the individual.

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 satisfy the requirements of this subpart. The regulations in this subpart also apply to the individuals specified in § 26.4(h) and (j), as appropriate. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605(b).

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 section and under §§ 26.4(j) and 26.31(b)(2) and subpart K of this part. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

The licensees and other entities specified in § 26.3(a) through (c) and (f) (for those licensees and other entities that do not implement the requirements in subparts M and K of this part) 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 satisfy the applicable requirements of this part.

(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) and (f) 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.

(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

(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.

Change as used in § 26.603(e) means an action that results in a modification of, addition to, or removal from the licensee's or other entity's FFD program.

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.

Consortium/Third-party administrator (C/TPA) means a contractor/vendor that provides or coordinates one or more FFD program elements for a group of licensees or other entities, such as administering a collective random testing pool and random testing selections under § 26.607(b)(2)(vi), that otherwise could not be independently implemented by those licensees or other entities. A C/TPA also could provide access to, for example, the services of medical review officers, substance abuse experts, employee assistance programs, and HHS-certified laboratories under contract to perform drug testing.

Constructing or construction activities means, 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. For a licensee or other entity described in § 26.3(f), construction is defined in § 53.020 of this chapter.

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) and (f), who is providing work or services to a licensee or other entity covered in § 26.3(a) through (c) and (f), 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.

Illicit substance means a substance that causes impairment and possible addiction but is not an illegal drug as defined in this section.

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:

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 satisfy the requirements of this subpart. Certain requirements in this subpart also apply to the individuals specified in § 26.4(h). The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

(e) Licensees and other entities in § 26.3(a) through (c) and (f) 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) and (f) 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) and (f) 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.

(d) When any licensee or other entity in § 26.3(a) through (d) and (f) 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.

(a) The requirements of this subpart apply to the FFD programs of licensees and other entities specified in § 26.3(a) through (d), except for FFD programs that are implemented under subpart K of this part.

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 satisfy the requirements of this subpart. The regulations in this subpart also apply to the individuals specified in § 26.4(h) and (j), as appropriate. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605(b).

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 section and under §§ 26.4(j) and 26.31(b)(2) and subpart K of this part. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

The licensees and other entities specified in § 26.3(a) through (c) and (f) (for those licensees and other entities that do not implement the requirements in subparts M and K of this part) 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 satisfy the applicable requirements of this part.

(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) and (f) 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) When construction activities, as defined in § 26.5, 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, K, and M of this part, and for any individual whose duties for the licensees and other entities in § 26.3(f) require him or her to have the following types of access, perform construction activities as defined in § 26.5, or perform the following activities must be subject to an FFD program as described in subpart M or an FFD program that satisfies all of the requirements of this part, except subparts I, K, and M:

(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 or 53 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.

(a) At the licensee's or other entity's discretion, a licensee or other entity in § 26.3(c) may establish, implement, and maintain an FFD program that meets the requirements of this subpart to apply to the individuals specified in § 26.4(f). If a licensee or other entity in § 26.3(c) does not elect to implement an FFD program that meets the requirements of this subpart, the individuals specified in § 26.4(f) shall be subject to an FFD program that meets the requirements of subparts A through H, N, and O of this part.

(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.

Change as used in § 26.603(e) means an action that results in a modification of, addition to, or removal from the licensee's or other entity's FFD program.

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.

Consortium/Third-party administrator (C/TPA) means a contractor/vendor that provides or coordinates one or more FFD program elements for a group of licensees or other entities, such as administering a collective random testing pool and random testing selections under § 26.607(b)(2)(vi), that otherwise could not be independently implemented by those licensees or other entities. A C/TPA also could provide access to, for example, the services of medical review officers, substance abuse experts, employee assistance programs, and HHS-certified laboratories under contract to perform drug testing.

Constructing or construction activities means, 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. For a licensee or other entity described in § 26.3(f), construction is defined in § 53.020 of this chapter.

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) and (f), who is providing work or services to a licensee or other entity covered in § 26.3(a) through (c) and (f), 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.

Illicit substance means a substance that causes impairment and possible addiction but is not an illegal drug as defined in this section.

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:

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 satisfy the requirements of this subpart. Certain requirements in this subpart also apply to the individuals specified in § 26.4(h). The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

(e) Licensees and other entities in § 26.3(a) through (c) and (f) 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) and (f) 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) and (f) 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.

(d) When any licensee or other entity in § 26.3(a) through (d) and (f) 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.

(a) The requirements of this subpart apply to the FFD programs of licensees and other entities specified in § 26.3(a) through (d), except for FFD programs that are implemented under subpart K of this part.

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 satisfy the requirements of this subpart. The regulations in this subpart also apply to the individuals specified in § 26.4(h) and (j), as appropriate. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605(b).

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 section and under §§ 26.4(j) and 26.31(b)(2) and subpart K of this part. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

(8) 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.

Reduction in FFD program effectiveness means, for a part 53 licensee or other entity implementing subpart M of this part, a change or series of changes to an element of the FFD program that reduces or eliminates the licensee's ability to satisfy or maintain site-specific FFD program performance when compared to historical site-specific performance, the licensee's fleet-level program performance, or industry performance.

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) and (f), 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) means, for part 50 or 52 licensees and other entities described in § 26.3(a) through (d), those SSCs 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 § 50.34(a)(1) of this chapter. For part 53 licensees and other entities described in § 26.3(d) and (f), safety-related has the same meaning as that in § 53.020 of this chapter.

Security-related SSCs means, 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 (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 (2), respectively, or a licensee or other entity described in § 26.3(d) or (f).

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.

Special nuclear material (SNM) has the same meaning as that in § 70.4 of this chapter.

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, for electricity-generation units, that the reactor unit is disconnected from the electrical grid. Unit outage means, for the purposes of this part, for non-electricity-generation units, that the reactor unit is disconnected from the loads to which its output is supplied under normal operating conditions.

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.

(8) 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.

Reduction in FFD program effectiveness means, for a part 53 licensee or other entity implementing subpart M of this part, a change or series of changes to an element of the FFD program that reduces or eliminates the licensee's ability to satisfy or maintain site-specific FFD program performance when compared to historical site-specific performance, the licensee's fleet-level program performance, or industry performance.

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) and (f), 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) means, for part 50 or 52 licensees and other entities described in § 26.3(a) through (d), those SSCs 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 § 50.34(a)(1) of this chapter. For part 53 licensees and other entities described in § 26.3(d) and (f), safety-related has the same meaning as that in § 53.020 of this chapter.

Security-related SSCs means, 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 (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 (2), respectively, or a licensee or other entity described in § 26.3(d) or (f).

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.

Special nuclear material (SNM) has the same meaning as that in § 70.4 of this chapter.

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, for electricity-generation units, that the reactor unit is disconnected from the electrical grid. Unit outage means, for the purposes of this part, for non-electricity-generation units, that the reactor unit is disconnected from the loads to which its output is supplied under normal operating conditions.

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.

(8) 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.

Reduction in FFD program effectiveness means, for a part 53 licensee or other entity implementing subpart M of this part, a change or series of changes to an element of the FFD program that reduces or eliminates the licensee's ability to satisfy or maintain site-specific FFD program performance when compared to historical site-specific performance, the licensee's fleet-level program performance, or industry performance.

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) and (f), 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) means, for part 50 or 52 licensees and other entities described in § 26.3(a) through (d), those SSCs 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 § 50.34(a)(1) of this chapter. For part 53 licensees and other entities described in § 26.3(d) and (f), safety-related has the same meaning as that in § 53.020 of this chapter.

Security-related SSCs means, 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 (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 (2), respectively, or a licensee or other entity described in § 26.3(d) or (f).

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.

Special nuclear material (SNM) has the same meaning as that in § 70.4 of this chapter.

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, for electricity-generation units, that the reactor unit is disconnected from the electrical grid. Unit outage means, for the purposes of this part, for non-electricity-generation units, that the reactor unit is disconnected from the loads to which its output is supplied under normal operating conditions.

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.

(8) 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.

Reduction in FFD program effectiveness means, for a part 53 licensee or other entity implementing subpart M of this part, a change or series of changes to an element of the FFD program that reduces or eliminates the licensee's ability to satisfy or maintain site-specific FFD program performance when compared to historical site-specific performance, the licensee's fleet-level program performance, or industry performance.

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) and (f), 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) means, for part 50 or 52 licensees and other entities described in § 26.3(a) through (d), those SSCs 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 § 50.34(a)(1) of this chapter. For part 53 licensees and other entities described in § 26.3(d) and (f), safety-related has the same meaning as that in § 53.020 of this chapter.

Security-related SSCs means, 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 (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 (2), respectively, or a licensee or other entity described in § 26.3(d) or (f).

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.

Special nuclear material (SNM) has the same meaning as that in § 70.4 of this chapter.

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, for electricity-generation units, that the reactor unit is disconnected from the electrical grid. Unit outage means, for the purposes of this part, for non-electricity-generation units, that the reactor unit is disconnected from the loads to which its output is supplied under normal operating conditions.

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.

(8) 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.

Reduction in FFD program effectiveness means, for a part 53 licensee or other entity implementing subpart M of this part, a change or series of changes to an element of the FFD program that reduces or eliminates the licensee's ability to satisfy or maintain site-specific FFD program performance when compared to historical site-specific performance, the licensee's fleet-level program performance, or industry performance.

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) and (f), 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) means, for part 50 or 52 licensees and other entities described in § 26.3(a) through (d), those SSCs 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 § 50.34(a)(1) of this chapter. For part 53 licensees and other entities described in § 26.3(d) and (f), safety-related has the same meaning as that in § 53.020 of this chapter.

Security-related SSCs means, 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 (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 (2), respectively, or a licensee or other entity described in § 26.3(d) or (f).

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.

Special nuclear material (SNM) has the same meaning as that in § 70.4 of this chapter.

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, for electricity-generation units, that the reactor unit is disconnected from the electrical grid. Unit outage means, for the purposes of this part, for non-electricity-generation units, that the reactor unit is disconnected from the loads to which its output is supplied under normal operating conditions.

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.

(8) 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.

Reduction in FFD program effectiveness means, for a part 53 licensee or other entity implementing subpart M of this part, a change or series of changes to an element of the FFD program that reduces or eliminates the licensee's ability to satisfy or maintain site-specific FFD program performance when compared to historical site-specific performance, the licensee's fleet-level program performance, or industry performance.

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) and (f), 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) means, for part 50 or 52 licensees and other entities described in § 26.3(a) through (d), those SSCs 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 § 50.34(a)(1) of this chapter. For part 53 licensees and other entities described in § 26.3(d) and (f), safety-related has the same meaning as that in § 53.020 of this chapter.

Security-related SSCs means, 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 (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 (2), respectively, or a licensee or other entity described in § 26.3(d) or (f).

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.

Special nuclear material (SNM) has the same meaning as that in § 70.4 of this chapter.

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, for electricity-generation units, that the reactor unit is disconnected from the electrical grid. Unit outage means, for the purposes of this part, for non-electricity-generation units, that the reactor unit is disconnected from the loads to which its output is supplied under normal operating conditions.

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.

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 satisfy the requirements of this subpart. Certain requirements in this subpart also apply to the individuals specified in § 26.4(h). The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

(d) When any licensee or other entity in § 26.3(a) through (d) and (f) 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.

(a) The requirements of this subpart apply to the FFD programs of licensees and other entities specified in § 26.3(a) through (d), except for FFD programs that are implemented under subpart K of this part.

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 satisfy the requirements of this subpart. The regulations in this subpart also apply to the individuals specified in § 26.4(h) and (j), as appropriate. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605(b).

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 section and under §§ 26.4(j) and 26.31(b)(2) and subpart K of this part. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

(b) The requirements in this subpart, with the exception of § 26.203, apply to the licensees or other entities identified in § 26.3(f) implementing this subpart under § 26.605. For these licensees and other entities, the requirements in §§ 26.202 and 26.211 apply to the individuals identified in § 26.4(a) through (c) and any person licensed to operate under 10 CFR part 53; and the requirements in §§ 26.205 through 26.209 apply to the individuals identified in § 26.4(a).

(ii) A supervisor assesses the individual face-to-face and determines that there is reasonable assurance that the individual will be able to safely and competently perform his or her duties during the additional work period for which the waiver will be granted. The supervisor performing the assessment shall be trained as required by either §§ 26.29 and 26.203(c) or §§ 26.202(c) and 26.608 and shall be qualified to direct the work to be performed by the individual. If there is no supervisor on site who is qualified to direct the work, the assessment may be performed by a supervisor who is qualified to provide oversight of the work to be performed by the individual. At a minimum, the assessment must address the potential for acute and cumulative fatigue considering the individual's work history for at least the past 14 days, the potential for circadian degradations in alertness and performance considering the time of day for which the waiver will be granted, the potential for fatigue-related degradations in alertness and performance to affect risk-significant functions, and whether any controls and conditions must be established under which the individual will be permitted to perform work. For licensees and other entities in § 26.3(f), the assessment may be performed remotely using electronic communications. In such instances, the assessment must be supported by someone who is present in-person with the individual whose alertness may be impaired, and that supporting person must be trained under the requirements of either §§ 26.29 and 26.203(c) or §§ 26.202(c) and 26.608.

The licensees and other entities specified in § 26.3(a) through (c) and (f) (for those licensees and other entities that do not implement the requirements in subparts M and K of this part) 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 satisfy the applicable requirements of this part.

(b) Only supervisors and FFD program personnel who are trained under either §§ 26.29 and 26.203(c) or §§ 26.202(c) and 26.608 may conduct a fatigue assessment. The fatigue assessment must be conducted face-to-face with the individual whose alertness may be impaired. For licensees and other entities in § 26.3(f), a fatigue assessment may be performed remotely using electronic communications. In such instances, the fatigue assessment must be supported by someone who is present in-person with the individual whose alertness may be impaired, and that supporting person must be trained in accordance with the requirements of either §§ 26.29 and 26.203(c) or §§ 26.202(c) and 26.608.

(1) In the case of a fatigue assessment conducted for cause, the individual who observed the condition of impaired alertness may not conduct the fatigue assessment.

(2) In the case of a post-event fatigue assessment, the individual who conducts the fatigue assessment may not have—

(i) Performed or directed (on site) the work activities during which the event occurred;

(ii) Performed, within 24 hours before the event occurred, a fatigue assessment of the individuals who were performing or directing (on site) the work activities during which the event occurred; and

(iii) Evaluated or approved a waiver of one or more of the limits specified in § 26.205(d)(1) through (d)(5)(i) and (d)(7) for any of the individuals who were performing or directing (on site) the work activities during which the event occurred, if the event occurred while such individuals were performing work under that waiver.

(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 subparts K and M of this part, and those persons who are granted unescorted access to either nuclear power reactor protected areas or remote facilities where safety-significant systems or components may be operated within the design basis of a licensed commercial nuclear plant, by the licensees and other entities in § 26.3(f) and perform the following duties must be subject to an FFD program that satisfies the requirements in subpart M of this part, unless the licensee or other entity subjects these individuals to an FFD program that satisfies all of the requirements of this part except for those requirements in subparts K and M:

(1) For persons who are granted unescorted access by the licensees in § 26.3(a) and, as applicable, (c), 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; for those persons who are granted unescorted access by the licensees and other entities in § 26.3(f), operating or 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) For persons who are granted unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable, (c), 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; for those persons who are granted unescorted access to nuclear power reactor protected areas by the licensees and other entities in § 26.3(f), performing maintenance or 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.

(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.

Change as used in § 26.603(e) means an action that results in a modification of, addition to, or removal from the licensee's or other entity's FFD program.

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.

Consortium/Third-party administrator (C/TPA) means a contractor/vendor that provides or coordinates one or more FFD program elements for a group of licensees or other entities, such as administering a collective random testing pool and random testing selections under § 26.607(b)(2)(vi), that otherwise could not be independently implemented by those licensees or other entities. A C/TPA also could provide access to, for example, the services of medical review officers, substance abuse experts, employee assistance programs, and HHS-certified laboratories under contract to perform drug testing.

Constructing or construction activities means, 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. For a licensee or other entity described in § 26.3(f), construction is defined in § 53.020 of this chapter.

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) and (f), who is providing work or services to a licensee or other entity covered in § 26.3(a) through (c) and (f), 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.

Illicit substance means a substance that causes impairment and possible addiction but is not an illegal drug as defined in this section.

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:

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 satisfy the requirements of this subpart. Certain requirements in this subpart also apply to the individuals specified in § 26.4(h). The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.

(e) Licensees and other entities in § 26.3(a) through (c) and (f) 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) and (f) 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) and (f) 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.

(a) A licensee or other entity in § 26.3(f), at its discretion, may establish, implement, and maintain a fitness-for-duty (FFD) program that satisfies the requirements of this subpart for those categories of individuals in § 26.4, as applicable, and any person licensed to operate under part 53 of this chapter. If a licensee or other entity in § 26.3(f) does not elect to implement an FFD program that satisfies the requirements of this subpart, then those categories of individuals in § 26.4, as applicable, and any person licensed to operate under part 53 of this chapter must be subject to an FFD program that satisfies all requirements under this part, except for those requirements in subpart K and this subpart.

(b) For the licensees and other entities in § 26.3(f), other than the holder of a manufacturing license (ML), the FFD program must be maintained until the NRC's docketing of the license holder's certifications described in § 53.1070 of this chapter. For holders of an ML, the FFD program must be maintained until expiration of the ML.

(d) When any licensee or other entity in § 26.3(a) through (d) and (f) 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.

(b) The requirements in this subpart apply to the FFD programs of licensees and other entities specified in § 26.3(f) that elect not to implement the requirements in subpart M or elect to implement the requirements in § 26.605(b).

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 satisfy the requirements of this subpart. The regulations in this subpart also apply to the individuals specified in § 26.4(h) and (j), as appropriate. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605(b).

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 section and under §§ 26.4(j) and 26.31(b)(2) and subpart K of this part. The requirements in this subpart apply to the FFD programs of licensees and other entities identified in § 26.3(f) that elect not to implement the requirements in subpart M of this part for the categories of individuals in § 26.4 and those licensees and other entities that elect to implement the requirements in § 26.605.