Human Reliability Program

AGENCY:

Office of Security, Department of Energy.

ACTION:

Final rule.

SUMMARY:

The Department of Energy (DOE or Department) today is publishing a final rule to establish the Human Reliability Program. This rule consolidates the Personnel Security Assurance Program (PSAP) and Personnel Assurance Program (PAP) into a single program, which incorporates all the important facets of each into a coherent, comprehensive, and concise regulation. The PSAP was an access authorization program for individuals who applied for or occupied certain positions critical to the national security. The PSAP required an initial and annual supervisory review, medical assessment, management evaluation, and DOE personnel security review of all applicants or incumbents. The PAP was a nuclear explosive safety program for individuals who occupied positions that involved hands-on work with, or access to, nuclear explosives. The PAP used many of the same evaluations as the PSAP to ensure that employees assigned to nuclear explosive duties did not have a mental/personality disorder or physical condition that could result in an accidental or unauthorized detonation of nuclear explosives.

EFFECTIVE DATE:

This rule is effective April 22, 2004.

FOR FURTHER INFORMATION CONTACT:

Ms. Lynn Gebrowsky, Security Policy Staff, Office of Security, Department of Energy, 1000 Independence Avenue, SW., Washington, D.C., 20585, (301) 903-3200, or Mr. Charles Westfall, Office of Nuclear Weapons Surety, Department of Energy, 1000 Independence Avenue, SW., Washington, D.C. 20585, (301) 903-4051.

For information concerning Subpart B, Medical Standards, contact: Mr. Kenneth O. Matthews, Office of Health, Department of Energy, 1000 Independence Avenue, SW., Washington, DC 20585, (301) 903-6398.

SUPPLEMENTARY INFORMATION:

I. Background

II. Discussion of Public Comments

A. Section-by-Section Review and Discussion of Public Comments

B. Other Public Comments

III. Regulatory Review

A. Executive Order 12866

B. Regulatory Flexibility Act

C. National Environmental Policy Act

D. Paperwork Reduction Act

E. Executive Order 13132

F. Unfunded Mandates Reform Act of 1995

G. Executive Order 12988

H. Executive Order 13084

I. Treasury and General Government Appropriations Act, 1999

J. Review Under the Treasury and General Government Appropriations Act, 2001

K. Executive Order 13211

L. Congressional Notification

I. Background

Pursuant to the Atomic Energy Act of 1954 (the AEA), the DOE owns, leases, operates or supervises activities at facilities in various locations in the United States. Many of these facilities are involved in researching, testing, producing, disassembling, or transporting nuclear explosives, which, when combined with Department of Defense delivery systems, become nuclear weapons systems. These facilities are often involved in other activities that affect the national security. Compromise of these and other DOE facilities would severely damage national security. To guard against such compromise, DOE has implemented security and safety reliability programs designed to ensure that individuals who occupy positions affording unescorted access to certain materials, facilities, and programs meet the highest standards of reliability as well as physical and mental suitability.

In 1989, as part of its ongoing efforts to protect national security, DOE established regulations at 10 CFR part 710, subpart B, “Criteria and Procedures for Establishment of the Personnel Security Assurance Program and Determinations of an Individual's Eligibility for Access to a Personnel Security Assurance Program Position.” These Personnel Security Assurance Program (PSAP) regulations apply to individuals who occupy positions throughout the DOE complex that involve access to, or responsibility for, special nuclear material or who otherwise have the potential to cause unacceptable damage to national security. In 1998, DOE established regulations at 10 CFR part 711, “Personnel Assurance Program (PAP).” The PAP codified longstanding certification procedures for individuals who occupy positions that involve hands-on work with, or access to, nuclear explosives.

As the PSAP and PAP evolved, significant similarities developed in the objectives, requirements, and administration of the two programs. DOE has concluded that the monetary and time requirements of administering two very similar programs with similar goals, the protection of special nuclear material and nuclear explosives, could not be justified as consistent with good management practices when compared to the benefits of consolidation.

On July 17, 2002, DOE published a notice of proposed rulemaking (NOPR) to establish a Human Reliability Program (HRP) (67 FR 46912). Subpart A of the proposed rule contained the provisions that established the HRP and the HRP certification requirements, while Subpart B contained the medical standards provisions required for HRP certification. The NOPR proposed to establish a single unified HRP management structure that incorporated all of the important elements of the PSAP and PAP into one comprehensive regulation. By adopting a uniform set of requirements applicable to both PSAP and PAP employees, DOE has developed a stronger, more efficient, and more effective human reliability program for personnel who occupy these positions.

The HRP, published today as 10 CFR part 712, is designed to protect the national security through a system of continuous evaluation of individuals working in positions affording unescorted access to certain materials, facilities, and programs. The purpose of this continuous evaluation is to identify, in a timely manner, individuals whose judgment may be impaired by physical, mental/personality disorders; the use of illegal drugs or the abuse of legal drugs or other substances; the abuse of alcohol; or any other condition or circumstance that may represent a reliability, safety, or security concern.

The HRP requires that all individuals who work in positions affording unescorted access to certain materials, facilities, and programs be certified as meeting the highest standards of reliability and physical, mental/personality suitability before such access may be granted. An individual's certification is subject to immediate review in the event that the individual's behavior indicates a reliability or security risk to nuclear explosive operations or national security. During the review the individual will be removed from assigned duties. This immediate removal is an interim, precautionary action and does not constitute a final determination of reliability or access authorization status. Individuals who are removed from HRP duties for reasons that are not related to security are entitled to resolve these issues through a formal procedure outlined in § 712.19 through § 712.23 of today's final rule. If the removal is based on a security concern, 10 CFR part 710, subpart A, provides procedures for resolving issues concerning eligibility for an access authorization. These regulations require that the individual be given a written statement of the issues, an opportunity to respond, including an opportunity for a hearing before a DOE Hearing Officer, and an opportunity to have the opinion of the hearing officer reviewed at a higher level before a final determination is made.

Most of the provisions of the HRP rule are taken directly from the PSAP and PAP regulations. However, the HRP rule has several new requirements applicable to all HRP positions and some new requirements for certain HRP positions. These include:

1. Random alcohol testing for all individuals in HRP positions. The decision by DOE to require random alcohol testing for all individuals in HRP positions is supported by scientific research that shows that cognitive and physical task performance decreases as a result of alcohol abuse (Hartwell et al., “Workplace alcohol testing programs: Prevalence and trends,” Monthly Labor Review, V121, 1998; Mangione et al., “Employee drinking practices and work performance,” Journal of Studies on Alcohol, V60, 1999; Ames et al., “The relationship of drinking and hangovers to workplace problems: An empirical study,” Journal of Studies on Alcohol V58, 1997; Yesavage and Leirer, “Hangover effects on aircraft pilots 14 hours after alcohol ingestion: A preliminary report,” American Journal of Psychiatry, V143, 1986).

DOE believes that the misuse or abuse of alcohol represents a risk that is incompatible with the nature of work performed by individuals in HRP positions. DOE has a compelling interest in ensuring that individuals who hold HRP positions are functioning at the highest level of reliability because they have unescorted access to certain materials, facilities, and programs. This interest outweighs the diminished privacy expectations resulting from intrusions caused by a carefully tailored alcohol testing program. The government must ensure the unimpaired judgment of persons who perform hands-on work with, or have access to, nuclear explosives or have access to, or responsibility for, special nuclear material. It also must ensure that the persons charged with the security of these research and production facilities do not pose a risk to the life of the citizenry by the use of deadly force resulting from impaired perception or judgment.

The part of the HRP regulation pertaining to random alcohol testing is consistent with regulations of other Federal agencies charged with overseeing critical activities, and specifically the regulations of the Department of Transportation. On February 15, 1994, the Department of Transportation (DOT) operating agencies promulgated alcohol testing regulations for the aviation, motor carrier, rail, transit, and pipeline transportation industries. In the common preamble to those regulations, the operating agencies discussed the research regarding the effects of blood alcohol and recommendations of expert bodies, including the National Highway Traffic Safety Administration (NHTSA), the National Transportation Safety Board, the National Academy of Sciences, and the Transportation Research Board (59 FR 7302, 7318-19). DOT concluded, based on this body of research, that while impairment of performance of safety-sensitive functions clearly was increased above 0.04 percent blood alcohol concentration, there was evidence of some impairment at levels as low as 0.02, the lowest level that can be reliably measured. Alcohol affects individuals differently; indeed, even a minimal level of blood alcohol impairs some individuals. Based on this evidence, DOT adopted a standard that requires removal from a safety-sensitive position of an employee with an alcohol concentration of 0.02 percent or greater. The DOT regulations requiring random alcohol testing already apply to some DOE and contractor employees at certain sites.

The Nuclear Regulatory Commission (NRC) also considers the misuse of alcohol to be a serious and pervasive workplace problem (Barnes et al., “Fitness for Duty in the Nuclear Power Industry: A Review of Technical Issues,” 1988, NUREG/CR-5227, U.S. Nuclear Regulatory Commission, Washington, D.C.; Moore et al., “Fitness for Duty in the Nuclear Power Industry: A Review of Technical Issues,” 1989, NUREG/CR-5227, Supplement 1, U.S. Nuclear Regulatory Commission, Washington, DC). The NRC requires random alcohol testing in its fitness-for-duty program contained in 10 CFR part 26.

The job tasks performed by individuals in the HRP are equally or more sensitive than those performed by workers in the transportation and the nuclear power industries, and the HRP tasks have added security-sensitive elements. An individual in the HRP who misuses or abuses alcohol has the potential capability to (1) cause an accidental or unauthorized detonation of a nuclear explosive; (2) misuse deadly force in guarding or transporting special nuclear materials or nuclear weapons; (3) cause a criticality incident involving special nuclear material; or (4) misuse classified information. DOE believes that random alcohol testing will enhance the safety and reliability aspects of the HRP and deter the use of alcohol on the job, as well as during a period prior to reporting for work. Individuals in HRP positions also will be subject to testing if they are involved in an incident, unsafe practice, or occurrence as defined in § 712.3 of the regulation, or if there is reasonable suspicion that their judgment may be impaired.

2. Eight-hour abstinence rule for alcohol. In the past, individuals reporting for nuclear explosive duties under PAP have been prohibited from drinking alcohol during the eight hours before their work assignments. This eight-hour abstinence requirement is retained in the HRP for those employees and is now applicable to employees in specific positions to be designated by the National Nuclear Security Administration (NNSA) Administrator or his or her designee, or the appropriate Lead Program Secretarial Officer, or his or her designee or the Manager of the Chicago, Idaho, Oak Ridge, Richland, and Savannah River Operations Offices; Manager of the Rocky Flats Office; Manager of the Pittsburgh Naval Reactors Office and the Schenectady Naval Reactors Office; Site Office Managers for Livermore, Los Alamos, Sandia, Y-12, Nevada, Pantex, Kansas City, and Savannah River; Director of the Service Center, Albuquerque; Assistant Deputy Administrator for the Office of Secure Transportation, Albuquerque; and for the Washington, DC area, the Director, Office of Security (hereinafter collectively referred to as the “Manager” in accordance with § 712.3 of the regulation). This abstinence requirement is in addition to the random alcohol testing requirement.

3. Annual Submission of Questionnaire for National Security Positions (QNSP), Part 2. Submission of this Questionnaire previously had been required only for participants in the PSAP DOE now has made this a requirement for all individuals in the HRP, thereby underscoring DOE's commitment to evaluating personnel security concerns. This annual requirement will assist in ensuring that HRP-certified individuals are reliable and trustworthy.

4. Psychological evaluations. This requirement previously was in effect only for PAP individuals and now is required for all HRP candidates and HRP-certified individuals. The psychological evaluation, as part of the overall medical assessment, addresses an individual's mental or behavioral state as it relates to security and safety concerns. This evaluation includes the completion of a psychological assessment (test) and a semi-structured interview with the Designated Psychologist, or a psychologist under his or her supervision. The psychologist conducting the semi-structured interview has the latitude to vary the focus and content of questions based on the results of the psychological test and/or the interviewee's response to certain questions. Through this evaluation process, an assessment is made of whether the individual shows at-risk behavior or conditions that raise a security concern or may impact the ability to perform his or her duties in a safe and reliable manner. Individuals will be subject to an initial psychological evaluation and annual evaluations thereafter. Every third year individuals in an HRP position will be required to take another psychological assessment (test). This process will assist medical personnel in their efforts to monitor participants and ensure that individuals in HRP positions are reliable and trustworthy.

5. Counterintelligence polygraph examinations. A counterintelligence-scope polygraph examination in accordance with DOE's Polygraph Examination Regulation, 10 CFR part 709, was required for individuals who occupied or applied for PAP and PSAP positions. HRP positions will continue to be subject to the requirements of 10 CFR part 709 and any subsequent revisions to that regulation. Refusal to submit to a polygraph examination will result in rejection of the initial application for, or removal from, an HRP position, consistent with procedures in 10 CFR part 709.

II. Discussion of Public Comments

DOE received a total of two hundred and twelve written comments and forty-one oral comments during public hearings held in Albuquerque, New Mexico, Livermore, California, Amarillo, Texas, and Oak Ridge, Tennessee. DOE has carefully considered all of these comments in preparing this final rule.

A. Section-by-Section Review and Discussion of Public Comments

Comments Regarding § 712.1 Purpose

A commenter questioned the use of “facilities” and “programs” without specific definitions of these terms. The Department disagrees that definitions are needed because these terms are commonly used throughout DOE.

The Department disagrees with a commenter's suggestion to replace the phrase “or any other condition or circumstance that may be of a security or safety concern” with “ * * * or by their personality or behavioral tendencies.” As written, the text clearly conveys the intent of the rule and allows a broader assessment of individuals.

One commenter suggested adding the term “quality” when using the terms “safety and security.” The Department disagrees with this suggestion because it adds no clarity to the sentence.

Comments Regarding § 712.3 Definitions

A number of commenters raised issues pertaining to the definitions section. All definitions were reviewed and several were modified for clarification.

One commenter raised a question regarding the use of the Accelerated Access Authorization Program (AAAP) for HRP certification since it does not require a random alcohol test. The AAAP is a program for granting an interim access authorization and is not used for HRP certification purposes. Once individuals have successfully completed the AAAP, they are required to meet all of the HRP certification requirements including initial and random alcohol testing.

Several commenters suggested including the term “special assembly” in the phrase “nuclear explosive and/or Category I SNM” in paragraph (2) in the definition of access and throughout the text. The Department disagrees that adding this term would enhance the definition of access; the definition as proposed covers access to “special assembly.”

A commenter indicated that the definition of alcohol abuse is overly broad. The Department disagrees with the commenter. The definition of alcohol abuse is derived from the scientific literature dealing with alcohol-related disorders.

Several commenters suggested changing the definition of blood alcohol concentration to indicate that it is measured as a percentage. The text has been modified to parallel the DOT definition of alcohol concentration set forth at 49 CFR 40.3.

Several other commenters noted that the definition of the certifying official was not consistent with the NNSA organizational structure. The Department concurs and the text has been changed to reflect the organizational structure.

One commenter suggested that as written, the definition of Designated Psychologist could include a licensed person with a master's or bachelor's degree. The Department concurs and has changed the text to better define the term.

Commenters suggested changing HRP individual to HRP candidate. The Department agrees this would clarify the meaning. The text has been changed.

One commenter proposed a less vague definition of HRP management official. The Department is not making this change because the current definition allows sites the flexibility to identify the most appropriate person to be responsible for the HRP.

Another commenter suggested revising the definition of job task analysis because the recommended process would be burdensome and require frequent updates. The Department has modified the text to better reflect the intent of the rule.

One commenter suggested adding additional examples for the definition of occurrence. The Department believes that the definition is appropriate as written and does not need additional examples.

Another commenter criticized the definition of occurrence claiming that it “conflicts with itself.” The Department believes that the definition is correct and covers the various aspects of an occurrence at its sites.

A commenter questioned the term “national security protection significance” in the definition of occurrence and asked for examples of this term as well as the definition of “immediate” under occurrence testing in § 712.15(d)(1). “National security protection significance,” also referred to as “National Security Assets” (Safeguards and Security Glossary of Terms, December 18, 1995), refers to nuclear weapons and their design, Category I quantities of special nuclear material, classified information, sensitive information, critical facilities, and valuable government property. The immediate reporting requirement is based on the criteria set forth in DOE M 232.1-1A, “Occurrence Reporting and Processing of Operations Information.”

A commenter suggested adding a definition for psychological assessment or test. The Department concurs and has added new text to reflect this suggestion.

One commenter suggested, in addition to defining random alcohol testing, the regulations should include a definition for annual unannounced testing. The Department does not believe that a definition is needed. However, after reviewing the definition for random alcohol testing the Department has changed the text of the definition to better define the term and its requirements.

A commenter stated that the definition of safety concern is difficult to follow. The Department concurs and the text has been changed.

Another commenter suggested adding text to the supervisor definition to better define matrix management situations. The Department concurs with this suggestion and has modified the definition of supervisor to reflect the suggestion.

Several commenters suggested adding the word “inclination” to the definition for reliability. The Department disagrees with this suggestion because it does not enhance the current definition.

Comments Regarding § 712.10 Designation of HRP Positions

Several commenters contended the proposed provision on designation of HRP positions was “broad and vague.” The Department disagrees and believes that the description clearly identifies the HRP population.

Several commenters questioned why individuals having “access to information/material regarding” weapons of mass destruction were not included in the HRP. While the Department recognizes the importance of programs pertaining to weapons of mass destruction, it believes that it is not appropriate to expand the HRP beyond the current PAP and PSAP populations, because the purpose of this rulemaking is to combine two programs with similar administrative requirements into one stronger, more efficient and more effective program.

One commenter suggested designating positions with specific sigma levels as HRP positions. The Department disagrees with this suggestion and believes that the current position descriptions are appropriate as listed.

Several commenters suggested that, since the HRP is a fitness for duty program, the application of procedures and requirements should be graded based on the job task analysis. The Department disagrees with this suggestion. The HRP is not a fitness for duty program. It is a security/safety program which includes some aspects of fitness for duty.

One commenter suggested changes in the NNSA organizational structure make the job titles in the proposed rule incorrect. The text has been modified to address these changes.

Comments Regarding § 712.11 General Requirements of HRP Certification

One commenter asked why only security police officers could obtain a “Q” access authorization through the AAAP. The AAAP provision was incorporated into the PSAP to allow security police officers to assume their duties as soon as possible to enhance the physical security of the various DOE sites. The Department adopted the provision because of the urgent need for additional security police officers in the aftermath of the terrorist acts of September 11, 2001.

A number of commenters questioned the requirement for a counterintelligence polygraph examination in proposed § 712.11(a)(10). This requirement was mandated by Congress in the National Defense Authorization Act of 2000. In response to that legislation, DOE issued a Polygraph Examination Regulation (10 CFR part 709); DOE's Office of Counterintelligence is responsible for administering this requirement of the HRP.

A commenter questioned the need for the requirement in proposed § 712.11(a)(2) for providing selective service registration information within Part 2 of the Questionnaire for National Security Positions. This is a standard form used throughout the government. The Department cannot modify the form.

Other commenters questioned the omission of the flashback issue in proposed § 712.37 on evaluation for hallucinogen use. A new paragraph (b) has been added to § 712.37 to reflect this issue.

Several commenters questioned whether the proposed § 712.11(a)(9) random alcohol testing element of the HRP is necessary for security-related jobs. The Department recognizes that the consumption of alcohol is legal; however, the misuse and abuse of alcohol represent a risk that is incompatible with the nature of work performed by individuals in HRP positions. The Department believes that random alcohol testing will enhance the safety and reliability aspects of the HRP and deter the use of alcohol on the job as well as during the period immediately prior to reporting to work.

Other commenters questioned the appropriateness of adopting specific components of the DOT alcohol test regulation, 49 CFR part 40, including: breath alcohol technician training requirements, the NHTSA Conforming Products List of Evidential Breath Measurement Devices, the specifications for alcohol used to calibrate the testing equipment, and the EBT manufacturer quality assurance plan. Early in the process of developing proposed 10 CFR part 712 for the HRP, the Department made the decision to use the DOT Procedures for Transportation Workplace Drug and Alcohol Testing Program set forth at 49 CFR part 40 because this regulation has established proven procedures and is cost-effective for DOE to utilize since most facilities already have the trained technicians and equipment to perform the tests. After considering the public comments, the DOE affirms its decision to follow the DOT regulations for the reasons given above.

Several commenters suggested the use of alternative alcohol screening devices for initial screening, such as a saliva test strip. The Department does not agree with this suggestion and believes that the use of an evidential-grade breath alcohol device is the appropriate and industry accepted standard for evaluating alcohol concentrations.

One commenter suggested making the proposed random alcohol testing discretionary and using a “for cause” or “reasonable suspicion” standard. The Department disagrees with the suggestion and believes the procedure outlined in the proposed rule adequately addresses the concerns regarding alcohol testing. DOE believes that job tasks performed by individuals in the HRP are equally, or more safety-sensitive than those performed by workers in the transportation industry and the nuclear power industry. Therefore, it is appropriate that the DOE regulations for alcohol testing be at least as stringent as the DOT and NRC regulations.

A commenter suggested adding the words “safety” and “quality-reliability and assessing continuous suitability to the activity at hand” to the general requirements for HRP certification. The Department agrees in part and has added “safety” to the certification text (§ 712.11(b)(1)). DOE does not believe the remaining suggested text is necessary programmatically or to improve upon the clarity of the proposed language, which is retained in today's rule.

Another commenter raised a question concerning the use of over-the-counter medications that contain alcohol. The proposed rule, § 712.11(d), did not differentiate between alcohol purchased for consumption and alcohol contained in over-the-counter medications for purposes of testing for alcohol use by individuals reporting for unscheduled nuclear explosive duties. Both can impair an individual's judgment and reliability while performing HRP duties. For this reason, DOE has not revised the final rule to differentiate over-the-counter medications containing alcohol.

A commenter suggested changing the text in proposed § 712.11(d) for the eight-hour abstinence requirement to include text that identifies individuals who may perform nuclear explosive duties on an irregular basis. The Department disagrees with this suggestion and believes the text as written provides appropriate guidance for all individuals performing nuclear explosive duties and is sufficient in describing this requirement.

Several commenters questioned the need for the eight-hour abstinence requirement. As explained in item 2 of the Background section, this requirement has always been a part of the PAP for individuals performing nuclear explosive duties. The requirement has been expanded to also include specific positions designated by the NNSA Administrator, the appropriate Lead Program Secretarial Office, or the Manager of the Chicago, Idaho, Oak Ridge, Richland, and Savannah River Operations Offices; Manager of the Rocky Flats Office; Manager of the Pittsburgh Naval Reactors Office and the Schenectady Naval Reactors Office; Site Office Managers for Livermore, Los Alamos, Sandia, Y-12, Nevada, Pantex, Kansas City, and Savannah River; Director of the Service Center, Albuquerque; Assistant Deputy Administrator for the Office of Secure Transportation, Albuquerque; and for the Washington, DC area, the Director, Office of Security. The Department believes the requirement (§ 712.11(d)), which affects only a small portion of the HRP population, is necessary to ensure the reliability of personnel in HRP position.

One commenter, who questioned the need for the eight-hour abstinence requirement, also objected to the proposed 0.02 blood alcohol levels (§ 712.11(c)). The commenter suggested DOE adopt the less stringent NRC Fitness for Duty Policy. The Department believes the HRP requirement is appropriate because HRP job requirements differ from those covered under the NRC rule.

One commenter questioned why the proposed unscheduled work and alcohol consumption provision, § 712.11(c), should apply to exempt workers attending to work responsibilities outside of normal work hours. This requirement, which was a requirement under PAP, applies to all workers performing nuclear explosive safety duties or those designated by the Manager, the NNSA Administrator, or Lead Program Secretarial Office. The sensitive nature of the work performed by individuals in these positions requires that exempt employees also be subject to the eight-hour abstinence provision.

Several commenters suggested removing the proposed unscheduled work reporting requirement in § 712.11(d). They claimed the requirement is “unenforceable, impractical to implement, and only serves to agitate interpersonal relationships.” The Department disagrees with this suggestion. This is a longstanding requirement for individuals performing nuclear explosive duties, and the Department believes that it is a valuable and essential component of the HRP.

One commenter, concerned about the 12-hour abstinence requirement, suggested it should be replaced by the former eight-hour standard. The proposed HRP regulations do not have a 12-hour abstinence requirement but rather an eight-hour abstinence requirement (§ 712.11(c)) as recommended by the commenter.

Another commenter suggested that an individual be allowed to obtain a confirming blood alcohol test in addition to the current testing procedure. The Department disagrees and believes the procedures in § 712.11(e), which conform to 49 CFR part 40, are appropriate.

A number of commenters questioned the lack of guidance in proposed §§ 712.11(e) and 712.15(c) concerning an individual who has a breath alcohol concentration of 0.02 percent or greater. The Department concurs and has added specific language in § 712.15(c)(3) to address these concerns.

A number of commenters questioned the 0.02 percent blood alcohol concentration limit in proposed §§ 712.11(e) and 712.15(c), and suggested that the level be increased to at least 0.04. The Department disagrees with this change and, as discussed in the Background section, this follows the DOT regulations. The Department believes that the 0.02 level of blood alcohol is appropriate. The rule has not been changed to adopt the commenters' suggestion.

One commenter contended that § 712.11(e) and § 712.15(d)(1) pertaining to “occurrence testing,” are redundant regarding testing for alcohol and/or drugs. The Department disagrees with this comment and points out that these two sections support each other regarding the procedures which would be followed and potential actions taken in occurrence testing situations.

Another commenter questioned the “must” requirement in proposed § 712.11(f) for alcohol/drug testing for any type of incident or unsafe practice. The Department concurs and has changed the text (replacing “must” with “may” in § 712.11(e)) to give greater flexibility to the sites.

A commenter asked whether individuals could be tested under the eight-hour requirement after stating they had not consumed alcohol. As § 712.11(d) makes clear, “If they answer ‘no,’ they may perform their assigned duties but still may be tested.”

Comments Regarding § 712.12 HRP Implementation

A commenter criticized the extensive discussions of roles of numerous individuals, the lack of information for the HRP management official, and the incorrectness of the role of the Operations Office Managers. The Department has changed the text regarding Operations Office Managers to reflect the new NNSA organizational structure. In addition, the commenter noted that even if an organization performs all the tasks specified in the HRP it could still fail to identify potential security and safety risks. The commenter is correct. Even if all the HRP tasks are performed as required, the process still could fail. This is true for any program, and for this reason the Department has established specific objectives and requirements to help reduce the possibility of a failure. The key elements in the process are the individuals who work in HRP positions and their commitment to its success.

Another commenter stated that the role of the supervisor in the Supervisory Review section, proposed § 712.13, is unclear. The Department disagrees but has revised the text to describe the process more clearly.

One commenter questioned the omission of the role of the Deputy Administrator for Defense Programs, NNSA, regarding responsibility for nuclear materials at NNSA sites. The Deputy Administrator for Defense Programs has many responsibilities, which include the safety and security of nuclear materials at NNSA sites. The responsibilities identified in § 712.12, HRP Implementation, deal specifically with nuclear explosive duties and their requirements. The Department believes that text as written clearly identifies this specific requirement and does not need to be expanded.

A commenter suggested adding the term “following temporary removal” to clarify the HRP certifying official's responsibilities in § 712.12(g)(1). The Department concurs and the text has been changed.

Several comments were received regarding the requirement in proposed § 712.12(h)(2) for reporting prescription drugs and over-the-counter medication to only the Site Occupational Medical Director (SOMD). The text has been changed to allow this reporting requirement to include the Designated Physician and the Designated Psychologist. One commenter supported the proposed requirement that over-the-counter medications be reported; several others questioned the need for such a requirement. In addition, several commenters proposed that the individual's private physician provide such information. The Department does not believe that a person's private physician adequately knows and understands the individual's work requirements. Since the Designated Physician, the Designated Psychologist, or the SOMD can refer to the individual's job task analysis, a decision can be made based on a clear understanding of job requirements. Both prescription drugs and over-the-counter medications can affect an individual's judgment and reliability, and thus the Department believes this reporting is an important part of the HRP. It is not the intent of this rule to list categories or names of drugs that should be reported to the Designated Physician, the Designated Psychologist, or the SOMD. Common sense should be applied. Taking medications that can impact an individual's physical or mental capabilities (for example, those with instructions not to drive or operate motorized machinery) should be reported to the Designated Physician, the Designated Psychologist, or the SOMD. If an individual is unsure of possible side effects, he or she should consult with the Designated Physician, the Designated Psychologist, or the SOMD. Medications that do not have physical and/or mental side effects, such as medicated shampoos or dermatological ointments, would not be reportable.

One commenter objected to the proposed requirement in § 712.12(h)(4) to report another HRP-certified individual, specifically if they observe the individual purchasing, possessing, or using alcohol at any time. DOE believes that the text as written clearly indicates that this reporting requirement is based on the judgment of the individual observing the behavior. The purchase, possession, or use of alcohol is not a reportable issue. If, however, it is believed that the observed use is chronic and excessive, thereby indicating a reliability concern, then it should be reported to a supervisor and/or the Designated Physician, the Designated Psychologist, or the SOMD.

A commenter read the preamble to the notice of proposed rulemaking as not authorizing the HRP certifying official to temporarily remove an individual from an HRP position. The HRP certifying official does have this authority as stated in proposed § 712.12(g)(1). The commenter also suggested that the HRP certifying official temporarily remove individuals who have missed their recertification date. This is already addressed in proposed § 712.12(g)(4). If an individual fails to meet the 12-month recertification requirements, he or she is removed from the HRP. An exception is made if the personnel security element cannot resolve an issue within the 12-month requirement. New text has been added in § 712.11(a)(5)(i) to address this issue.

Another commenter suggested adding language that would require an individual to do a self-assessment of his or her ability to perform HRP duties. The Department agrees and has added text in § 712.12(h)(5) of this rule.

Comments Regarding § 712.13 Supervisory Review

A commenter stated that the supervisory review requirements in proposed § 712.13(b) and (c) should identify the types of security concerns the supervisor is expected to evaluate. The Department disagrees and believes the training requirement for supervisors will provide the necessary knowledge to address the security and safety issues outlined under the supervisory reviews.

One commenter suggested adding “domestic violence” and “workplace incident leading to disciplinary action” to the proposed list of reportable behaviors and conditions supervisors are required to report. The Department believes that these behaviors are covered in the existing examples listed in § 712.13(c). The list is not intended to be exhaustive or comprehensive.

Several commenters contended there was a need for greater clarity in proposed § 712.13(d)(2), authorizing “temporary removal” by the SOMD and the HRP-certifying official. The Department agrees and has added text allowing the Designated Physician and Designated Psychologist to recommend temporary removal of individuals from HRP positions. The HRP Certifying Official already has this authority so no new text was added.

A commenter questioned why § 712.13(e) applies only to Federal employees. Federal employees have a different set of rules relating to their removal or transfer. This section addresses this issue. The Department has added additional text to describe this requirement more accurately.

Another commenter stated that alcohol should be included in the list of concerns to be recognized and reported. The Department concurs and has added this language to the rule in § 712.13(f).

Comments Regarding § 712.14 Medical Assessment

A commenter noted that a Physician's Assistant (PA) and a Nurse Practitioner (NP) currently perform some medical evaluations and asked if they could conduct an HRP medical assessment. This is allowed in the HRP as long as the Designated Physician oversees the process and is responsible for signing the certification or recertification form.

One commenter questioned the utility of the job task analysis requirement in proposed § 712.14(e). The Department believes that this detailed information regarding an employee's job tasks is vital to the physician who is conducting the medical assessment, because it may have bearing on both physical and mental health status. The job task analysis also is a requirement in DOE Order 440.1A, “Worker Protection Management for DOE Federal and Contractor Employees.”

One commenter raised the concern that the job task analysis does not take into consideration psychological factors such as mental stress, fatigue, or boredom. The Department disagrees and believes that the job task analysis as part of the medical assessment addresses this concern. Another commenter suggested replacing the term “condition” in proposed § 712.14(a)(2) with “demonstrates problems with reliability or judgment.” The Department disagrees with this suggestion because the term “condition” in this context refers to a factor that restricts or modifies physical health, which includes one's psychological status. In addition, the term suggested already is part of the supervisory review process.

Another commenter asked what criteria the medical staff would use in applying proposed § 712.14(c) to determine if an individual represents a security concern. The criteria in 10 CFR 710.8 identify the following: An illness or mental condition, alcohol abuse or dependency, use or experimentation with drugs or other illegal substances, or unusual conduct which raises a question about an individual's judgment, reliability, and trustworthiness. These criteria and those listed in § 712.13(c) are the basis for a medical security concern.

One commenter suggested adding the phrase “and other examiners working under the direction of the Designated Physician” in proposed § 712.14(b)(2). The Department has incorporated the language in this section even though Subpart B, § 712.32(c) specifically provides that a portion of the assessment may be performed by another physician, a physician's assistant (PA), or nurse practitioner (NP).

A commenter suggested adding revealed substance abuse problems to the list of reasons in proposed § 712.14(b)(2) to conduct an intermediate medical evaluation. The Department believes the referral by management under § 712.14(b)(2)(ii) for a medical evaluation adequately covers this situation.

One commenter questioned the use of the term “intermediate” in proposed § 712.14(b)(2). The Department concurs and has omitted this term.

A commenter objected to the evaluation requirement in proposed § 712.14(d) of the medical assessment requirement, stating that such a requirement was in essence a “fishing expedition.” The Department disagrees with this characterization of the evaluation. The medical examination requirements clearly identify the areas that require assessment. The job task analysis provided to the Designated Physician/Designated Psychologist provides the framework for determining what conditions are significant to an individual's ability to perform work in a safe and secure manner. If a medical/psychological condition is believed to be clinically insignificant, then it is not an issue and would not be identified.

Several commenters requested guidance on what specific medical tests are required for the HRP medical assessment and for a clearance. In considering this comment, the Department referred to DOE Order 440.1A, “Worker Protection Management for DOE Federal and Contractor Employees,” which states under Employee Health Examinations: “Health examinations shall be conducted * * * in accordance with current sound and acceptable medical practices.” The minimum elements of a comprehensive medical evaluation are further described in DOE Guide 440.1-4 as a medical/occupational history, physical examination, laboratory studies, and review and evaluation of findings. The Department reviewed what current medical tests were routinely performed at the various DOE sites. The tests that are routinely performed are: complete blood count, blood chemistry, electrocardiogram, pulmonary function tests, urinalysis, vision, and hearing acuity. These should be the minimum for an HRP medical assessment. Additional tests such as a graded stress test may be performed at the physician's discretion. The tests listed above also may indicate a problem that is or may become a security concern as described in 10 CFR 710.8, e.g., alcohol abuse or dependency and illegal substance use. DOE believes that it is inappropriate to specify in the regulation which medical tests should be performed because these are decisions best left to the physician's discretion.

A commenter suggested including text in proposed § 712.14(e) that would require the Designated Physician/Designated Psychologist to use the job task analysis when performing assessments. The Department believes that no change is needed because it is implicit in § 712.14(e) that the Designated Physician and Designated Psychologist must use the job task analysis in conducting the medical assessment and psychological evaluation.

A commenter suggested that language be incorporated in proposed § 712.14(f)(3) that would allow the testing portion of the psychological evaluation to be phased in within a three-year period. The Department agrees and has added appropriate text to the rule.

Another commenter questioned whether proposed § 712.14(h) would permit another health care provider, i.e., Designated Physician, PA, or NP, to temporarily remove or restrict an individual. Section 712.14(h) has been modified to allow the Designated Physician and Designated Psychologist to recommend temporary removal or restrictions on an HRP-certified individual.

One commenter suggested changing the psychological assessment test requirement in proposed § 712.14(f)(3) from every three years to every five years. The Department disagrees with this suggestion. This three-year requirement was a PAP requirement and will be continued in the HRP.

A commenter questioned the use of the term “certain circumstances” in proposed § 712.14(g) pertaining to return to work after sick leave. The Department agrees those words are unnecessary and has removed them from the text.

A commenter requested proposed § 712.14(g) be clarified to specify which official could approve “return to work.” Text has been added that allows the Designated Physician, the Designated Psychologist, or the SOMD to perform this function.

Another commenter asked what other evaluations are the sole responsibility of the SOMD. The responsibilities of the SOMD are listed in subpart B, Medical Standards, § 712.34.

A commenter suggested changing the language in proposed § 712.14(j) regarding the medications and treatment section within the medical assessment to include changes in an existing medication regimen. The Department has not included the suggested language because the text as written clearly identifies the requirements.

Comments Regarding § 712.15 Management Evaluation

A commenter questioned whether the 0.02 percent or greater alcohol concentration requirement in proposed § 712.15(c) must be maintained at all times, such as “midnight on Friday.” The 0.02 percent alcohol concentration requirement is for any HRP-certified individual who is performing HRP duties during any work cycle.

One commenter raised a concern regarding requirements appearing in multiple sections. The Department does not believe this is a problem since each section defines the specific requirement for that section. The Department feels that combining all the requirements under just one section would increase the possibility of error and inconsistency.

Another commenter suggested deleting the terms “incident” and “unsafe practice,” in § 712.15(b), because the testing protocol in 10 CFR part 707 is referenced and those terms are not used in that part. The Department utilizes the testing protocol set forth in 10 CFR part 707 but in proposed § 712.15(c) also requires testing when an HRP-certified individual is involved in an incident, unsafe practice, or occurrence, as defined in the regulation, or if there is a reasonable suspicion they may be impaired.

A commenter suggested adding text to proposed § 712.15(c) to indicate that the random unannounced testing would be conducted if necessary to achieve the requirement at least once in a 12-month period. The Department disagrees and believes the text as written clearly conveys the intent of the requirement.

One commenter raised a question regarding dual compliance issues between the HRP and DOT requirements. The Department does not believe a problem exists regarding dual compliance. The HRP requirements in proposed § 712.15(c)(2) regarding alcohol testing parallel the DOT requirements. In the event of a conflict between the two sets of requirements, the DOT regulation will take precedence.

A commenter questioned when the initial alcohol test is to be conducted (e.g., prehire, during posthire processing, or prework). As clarified in § 712.15(c), the initial alcohol test for an individual coming into the HRP will be conducted during the individual's orientation into the HRP and prior to performing HRP duties.

Another commenter suggested requiring a preshift alcohol breath test. The Department does not agree and believes that the proposed testing requirement in § 712.15(c) allows ample latitude to address the circumstances under which testing should be conducted.

One commenter suggested that the word “annual” be included in the proposed alcohol testing requirement in § 712.15(c). The Department disagrees and notes that the requirement is once every 12 months.

A commenter suggested removing the text “if involved in an incident, unsafe practice or occurrence, or based on reasonable suspicion” from proposed § 712.15(c) and referencing sections (d) and (e) of this section. The Department disagrees with the proposed suggestion because it only identifies occurrence and reasonable suspicion and omits incident and unsafe practice, which also are reasons to test.

Several commenters questioned the two-hour time period allowed between notification and reporting for alcohol testing in proposed § 712.15(c)(3)(i) and provided information that showed if such an allowance was made, a person's blood alcohol level could fall below 0.02 percent in the interval. The commenters suggested that, for alcohol testing, the person should be required to report immediately to the testing facility. The Department is sensitive to the commenters' concern and notes that nothing prohibits a facility from having more stringent requirements. Text has been added to § 712.15(c)(3)(i) to allow facilities to establish a shorter time period from notification to testing. Such a requirement should be described in detail in the facility implementation plan.

Another commenter suggested removing the phrase “or the individual's behavior creates the basis for reasonable suspicion” from the occurrence testing provision in § 712.15(d) because this language appears in § 712.15(e) (Testing for reasonable suspicion). The Department concurs and the text has been changed.

A commenter questioned why proposed § 712.15(e)(1) required two or more supervisory or management officials for reasonable suspicion testing for alcohol when the DOT regulation requires only a single supervisor/manager. The Department is not bound to incorporate all aspects of the DOT regulation and believes that two or more supervisors/managers provide a greater degree of protection to management and even more importantly, to the individual. If an individual is subject to the DOT alcohol testing regulation, then DOT test procedures take precedence over the HRP regulation with respect to that individual.

One commenter questioned why the term “in possession of” was included in the proposed § 712.15(e)(2) reasonable suspicion text and again in the observable phenomena provision in § 712.15(e)(2)(i). The Department believes that the first part of the text identifies articulable belief, whereas the later reference identifies direct observation, which differs from beliefs that can be articulated.

Comments Regarding § 712.16 DOE Security Review

A commenter suggested adding text that would allow information from the personnel security file to be the basis for immediate removal if the information indicated a life-threatening risk. The Department believes that the proposed text in § 712.16(c) would allow the SOMD, the Designated Physician, or the Designated Psychologist to recommend removal of an individual who may pose a life-threatening risk to themselves or others as determined either through the medical assessment or on the basis of information received from DOE personnel security.

Comments Regarding § 712.17 Instructional Requirements

A commenter suggested that non-HRP-certified supervisors and managers also be required to receive appropriate training in the HRP. The Department concurs and has added appropriate text to the proposed § 712.17(a)(1).

One commenter asked if a reasonable suspicion component would be a part of the proposed behavioral training requirement in § 712.17(b)(1) as it relates to alcohol and controlled substance use. These elements will be part of the overall training requirement.

Another commenter suggested changing the text “HRP medical personnel” in proposed § 712.17(a)(2) to allow more flexibility. The Department disagrees and believes the text clearly identifies the appropriate personnel and allows flexibility in accomplishing the objective.

A commenter suggested adding additional text to the program training elements in proposed § 712.17(b) to allow for more flexibility. The Department concurs and has added text to reflect this change.

Comments Regarding § 712.18 Transferring HRP Certification

A commenter suggested changing the requirement in proposed § 712.18(b)(3) pertaining to transferring an HRP certificate requirement to allow the new site flexibility regarding the initial approval date. The Department concurs and the text has been modified.

Another commenter questioned language in proposed § 712.18(a) regarding the transfer of an HRP certification, indicating that as written it implied an individual could initiate a transfer request. The Department concurs and has modified the text.

One commenter questioned why proposed § 712.18(b) did not mention the personnel security process in connection with transferring an HRP certification. The Department did not include this in the HRP rule because transferring an HRP certification is a separate process from transferring an access authorization.

Comments Regarding § 712.19 Removal From HRP

A commenter suggested adding a new section that addresses immediate removal from HRP duties at the request of the HRP certifying official. The Department agrees that a supervisor must remove an HRP-certified individual immediately when requested by the HRP certifying official, and language has been added to § 712.19(a) to make this clear.

One commenter suggested changing the proposed text in § 712.19(a)(3) to delay the 24-hour written notification to an individual to be removed from HRP duties if the notification could have a negative impact on a psychiatric or medical condition. The Department is confident responsible officials will implement the requirements with appropriate sensitivity to the individual while simultaneously meeting DOE requirements.

Another commenter contended that the proposed provisions, §§ 712.19(a) and (c), respectively, prescribing supervisory and HRP management responsibilities in removal situations did not clearly provide for an evaluation and determination of the individual's reliability. The Department disagrees, and declines to adopt the alternative text proposed by the commenter.

Comments Regarding § 712.32 Designated Physician

Several commenters stated that it was not clear which other qualified personnel could perform parts of the medical assessment and that no clear guidelines existed for a PA and NP. The Department believes the proposed text in § 712.32(c) clearly allows the Designated Physician to utilize both PAs and NPs to conduct parts of the medical assessment. It is the responsibility of the Designated Physician to supervise the evaluation process, interpret the medical test results, and indicate if the individual is medically qualified to perform his or her HRP duties.

One commenter requested clarification of the requirement in proposed § 712.32(b)(4) regarding the Designated Physician's eligibility for a DOE access authorization. The Department does not require the Designated Physician to have an access authorization, but only to be eligible for an access authorization if one is required.

Comments Regarding § 712.34 Site Occupational Medical Director

Several commenters questioned the utility of the proposed requirement in § 712.34(b) for the SOMD to submit a renomination report biennially through the Manager to the Deputy Assistant Secretary for Health evaluating the performance of Designated Physician and Designated Psychologist and asked for more information regarding the proposed report's content. The Department believes these reports will be an important aspect of the medical assessment process and will provide needed information regarding the effectiveness of the various components of the medical assessment. The Office of Health will be responsible for detailing the specific content of these reports.

Comments Regarding § 712.35 Deputy Assistant Secretary for Health

One commenter suggested that greater detail regarding the responsibilities of the Deputy Assistant Secretary for Health be incorporated into the rule. The Department disagrees and believes the proposed rule allows the latitude needed to develop appropriate policies and standards for the medical assessment.

Comments Regarding § 712.36 Medical Assessment Process

A commenter recommended modifying proposed § 712.36(d)(4) to reference the types of behavior or conditions enumerated in proposed § 712.13(c), which a supervisor must report following the annual evaluation of an HRP-certified individual, as reasons for conducting additional psychological or psychiatric evaluations. The Department concurs and the text has been modified to reflect this change.

One commenter asked whether proposed § 712.36(e) would permit a PA or NP to recommend a return-to-work and work accommodations. The rule does not give a PA or NP this responsibility.

Several commenters requested the disqualifying conditions, including criteria necessary for judgment determinations, be listed and defined. The Department disagrees and notes that under § 712.36(h) disqualifying conditions are based on the job task, fitness-for-duty requirements, and the Designated Physician's medical judgment relating to the physical and mental capabilities necessary to successfully perform required work.

A commenter asked if the HRP certification process would be suspended under proposed § 712.36(h) if the required documentation is not provided. The Department affirms that if the required medical documentation is not provided, the HRP process will be suspended until the documentation is provided.

B. Other Public Comments

DOE also received several general comments that did not address any specific sections of the NOPR. These are discussed below.

One commenter raised a question regarding the costs involved in the additional testing requirements. The Department recognizes that these new requirements have additional costs; however these costs are minimal because many of the requirements already are in place or in some cases are currently required for other programs.

We agree with the comment expressing concerns regarding the use of the “term emotional and mental disorders” and have substituted the term “mental/personality disorder” in the final rule.

Another commenter suggested that the regulation should contain procedures similar to the PAP regulation permitting an HRP-certified individual to request a medical assessment (i.e., self-referral). Text has been added at § 712.12(h)(5) to include this requirement.

A commenter asked whether being under the influence of alcohol would be treated differently than being under the influence of an illegal drug. Being under the influence of alcohol will be treated differently than being under the influence of an illegal drug or other substance. The consequences are described in the applicable subject sections.

A commenter asked if individuals who currently are in a PAP or PSAP position will be grandfathered into the HRP. Appropriate text has been added in § 712.2 to reflect that individuals who currently are in a PAP or PSAP position will be grandfathered into the HRP.

A commenter raised the question of how to measure the effectiveness of the HRP. DOE will measure the effectiveness of the HRP through site evaluations and continuous monitoring of the program elements.

One commenter questioned the use of the term “impairment” in relation to alcohol testing. The Department believes the term “impairment,” defined in § 712.3 as a decrease in functional capacity of a person, is an appropriate term.

A commenter asked what psychological and physiological indicators the medical staff would monitor. These indicators include, but are not limited to, the behaviors and conditions listed in § 712.13(c), and the psychological test and interview and the medical evaluation criteria in § 712.14(d) for determining overall health.

III. Regulatory Review

A. Executive Order 12866

Executive Order 12866, 58 FR 51735 (October 4, 1993) provides for a review by the Office of Information and Regulatory Affairs in the Office of Management and Budget of a “significant regulatory action.” This rule (10 CFR part 712) has been determined not to be a significant regulatory action. Accordingly, this rule has not been reviewed by the Office of Information and Regulatory Affairs.

B. Regulatory Flexibility Act

The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires preparation of an initial regulatory flexibility analysis for every rule that must be proposed for public comment, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking” (67 FR 53461, August 16, 2002), DOE published procedures and policies to ensure that the potential impacts of its draft rules on small entities are properly considered during the rulemaking process (68 FR 7990, February 19, 2003), and has made them available on the Office of General Counsel's Web site: http://www.gc.doe.gov. DOE has reviewed today's rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. This rule does not directly regulate small businesses or small governmental entities. It applies principally to individuals who are employees of, or applicants for employment by, some of DOE's prime contractors, which are large businesses. There may be some affected small businesses that are subcontractors, but the rule will not impose unallowable costs. Accordingly, DOE certifies that the rule will not have a significant economic impact on a substantial number of small entities.

C. National Environmental Policy Act

The rule, which consolidates the PAP and PSAP, relates to personnel qualifications that have no impact on the environment. DOE has determined that this rule is covered under the Categorical Exclusion in DOE's National Environmental Policy Act regulations in paragraph A.6 of Appendix A to subpart D, 10 CFR part 1021, which applies to rulemakings that are strictly procedural. Accordingly, neither an environmental assessment nor an environmental impact statement has been prepared.

D. Paperwork Reduction Act

DOE has determined that the rule does not contain any new or amended record keeping, reporting or application requirements, or any other type of information collection requirements that require the approval of the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501, et seq. The OMB has defined the term “information” to exclude certifications, consents, and acknowledgments that entail only minimal burden [5 CFR 1320.3 (h)(1)].

E. Executive Order 13132

Executive Order 13132, 64 FR 43255 (August 10, 1999), requires agencies to develop an accountable process to ensure meaningful and timely input by state and local officials in the development of regulatory policies that have “federalism implications.” Policies that have federalism implications are defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations (65 FR 13735). DOE has examined this rule and determined that it does not have a substantial direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

F. Unfunded Mandates Reform Act of 1995

The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531 et seq., requires a Federal agency to perform a detailed assessment of the costs and benefits of any rule imposing a Federal mandate with costs to state, local, or tribal governments, or to the private sector of $100 million or more. The rule does not impose a Federal mandate requiring preparation of an assessment under the Unfunded Mandates Reform Act of 1995.

G. Executive Order 12988

Section 3(a) of Executive Order 12988, 61 FR 4729 (February 7, 1996) imposes on executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard, and promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this rule meets the relevant standards of Executive Order 12988.

H. Executive Order 13084

Under Executive Order 13084, 63 FR 27655 (May 19, 1998), DOE may not issue a discretionary rule that significantly or uniquely affects Indian tribal governments and imposes substantial direct compliance costs. This rule does not have such effects. Accordingly, Executive Order 13084 does not apply.

I. Treasury and General Government Appropriations Act, 1999

Section 654 of the Treasury and General Government Appropriations Act of 1999, (Pub. L. No. 105-277), requires Federal agencies to issue a Family Policymaking Assessment for any proposed rule that may affect family well-being. This rule will have no impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has not prepared a Family Policymaking Assessment.

J. Review Under the Treasury and General Government Appropriations Act, 2001

The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed today's rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

K. Executive Order 13211

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) requires Federal agencies to prepare and submit to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. Today's regulatory action is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

L. Congressional Notification

As required by 5 U.S.C. 801, DOE will submit to Congress a report regarding the issuance of today's final rule prior to the effective date set forth at the outset of this notice. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 801(2).

List of Subjects

10 CFR Part 710

• Administrative practice and procedures
• Classified information
• Government contracts
• Government employees, and Nuclear materials

10 CFR Part 711

• Administrative practice and procedure
• Alcohol abuse
• Drug abuse
• Government contracts
• Government employees
• Nuclear safety
• Occupational safety and health

10 CFR Part 712

• Administrative practice and procedure
• Alcohol abuse
• Drug abuse
• Government contracts
• Government employees
• Health
• National security
• Nuclear safety
• Occupational safety and health
• Personnel security, and Security concerns

For the reasons stated in the preamble, the DOE hereby amends Chapter III of Title 10 of the Code of Federal Regulations as set forth below:

PART 710—CRITERIA AND PROCEDURES FOR DETERMINING ELIGIBILITY FOR ACCESS TO CLASSIFIED MATTER OR SPECIAL NUCLEAR MATERIAL

1. The authority citation for part 710 is revised to read as follows:

Authority: 42 U.S.C. 7101, et seq.; 50 U.S.C. 2401, et seq.; Pub. L. 83-703, sec. 141, 68 Stat 940, as amended (42 U.S.C. 2161); Pub. L. 83-703, sec. 145, 68 Stat 942, as amended (42 U.S.C. 2165); Pub. L. 83-703, sec. 161, 68 Stat 948, as amended (42 U.S.C. 2201); E.O. 10450, 3 CFR 1949-1953 comp., p. 936, as amended; E.O. 10865, 3 CFR 1959-1963 comp., p. 398, as amended, 3 CFR Chap. IV; E.O. 12958, 3 CFR 1995, comp., p. 333; E.O. 12968, 3 CFR 1995, comp., p. 391.

Subpart B—[Removed]

2. Subpart B of 10 CFR part 710, is removed.

PART 711—PERSONNEL ASSURANCE PROGRAM

3. The authority citation for part 711 continues to read as follows:

Authority: 42 U.S.C. 2201(p), 7191.

4. Part 711 is removed.

5. Part 712, Human Reliability Program is added to read as follows:

PART 712—HUMAN RELIABILITY PROGRAM

Authority: 42 U.S.C. 2165; 42 U.S.C. 2201; 42 U.S.C. 5814-5815; 42 U.S.C. 7101 et seq.; 50 U.S.C. 2401 et seq.; E.O. 10450, 3 CFR 1949-1953 Comp., p. 936, as amended; E.O. 10865, 3 CFR 1959-1963 Comp., p. 398, as amended; 3 CFR Chap. IV.

Subpart A—Establishment of and Procedures for the Human Reliability Program

General Provisions

Subpart B—Medical Standards