Nuclear Safety Management and Radiation Protection of the Public and the Environment

DEPARTMENT OF ENERGY

10 CFR Parts 830 and 834

[Docket Nos. NE-RM-91-830 and EH-RM-93-834]

RIN 1901-AA34 and 1901-AA38

Nuclear Safety Management and Radiation Protection of the Public

and the Environment

AGENCY: Department of Energy.

ACTION: Notice of limited reopening of comment periods.

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SUMMARY: On December 9, 1991, the Department of Energy (DOE) published

a Notice of Proposed Rulemaking to add regulations establishing a body

of rules for DOE contractor and subcontractor activities to ensure safe

operation of DOE's nuclear facilities. On March 25, 1993, DOE published

a Notice of Proposed Rulemaking to add regulations establishing

standards for the protection of the public and the environment against

radiation from DOE activities. The purpose of this notice is to reopen

the comment periods in these two rulemakings for 30 days in order to

solicit comments on options now being considered in light of (1) public

comments received during the initial comment periods, (2) comments

received from the Defense Nuclear Facilities Safety Board (DNFSB), and

(3) comments raised in connection with Departmental initiatives

concerning the management of the DOE complex. This notice also

announces the availability of current draft language for these

regulations, as well as a draft discussion

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of the regulatory system under development by DOE.

DATES: Written comments (11 copies) on the issues presented in this

notice must be received by the Department on or before October 2, 1995.

ADDRESSES: Part 830: Written comments on Part 830 (11 copies) should be

addressed to PART 830, Mr. Orin Pearson, U.S. Department of Energy,

Office of Environment, Safety and Health, EH-10, Forrestal Building,

1000 Independence Avenue SW, Washington, DC 20585.

Part 834: Written comments on Part 834 (11 copies) should be addressed

to PART 834, Mr. Andrew Wallo, U.S. Department of Energy, Office of

Environment, Safety and Health, EH-412, 1000 Independence Avenue SW,

Washington, DC 20585.

Public Reading Room: Copies of the December 9, 1991 Notice of

Proposed Rulemaking, written comments received on the December 9, 1991

Notice, and current draft regulatory language for 10 CFR part 830 are

contained in Docket No. NE-RM-91-830. Copies of the March 25, 1993

Notice of Proposed Rulemaking, written comments received on the March

25, 1993 Notice, and the current draft regulatory language for 10 CFR

part 834 are contained in Docket No. EH-RM-93-834. These docket are

available for examination in DOE's Freedom of Information Reading Room,

1E-190, Forrestal Building, 1000 Independence Avenue SW, Washington, DC

20585, (202) 586-6020, between 9 a.m. and 4 p.m., Monday through

Friday, except Federal holidays.

Internet: The draft regulatory language for part 830 and for part

834, as well as the draft discussion of the regulatory system under

development, is available on the internet at ``gopher://

nattie.eh.doe:gov:2011/11/.Drafts''.

FOR FURTHER INFORMATION CONTACT:

Part 830: Mr. Richard Stark, U.S. Department of Energy, Office of

Environment, Safety and Health, EH-31, 19901 Germantown Road,

Germantown, Maryland 20874-1290, (301) 903-4407.

Part 834: Mr. Andrew Wallo, or Mr. Harold T. Peterson, Jr., U.S.

Department of Energy, Office of Environment, Safety and Health, EH-412,

1000 Independence Avenue SW, Washington, DC 20585, (202) 586-2409, fax

(202) 586-3915. Written Comments: Ms. Andi Kasarsky, (202) 586-3012.

SUPPLEMENTARY INFORMATION:

Background

On December 9, 1991, the Department published a Notice of Proposed

Rulemaking (56 FR 64316) to add a new part (10 CFR part 830) to its

regulations establishing a body of rules for DOE contractor and

subcontractor activities to ensure safe operation of DOE's nuclear

facilities. The proposed rule contained nine specific sections covering

(1) safety analysis reports, (2) unreviewed safety questions, (3)

quality assurance requirements, (4) defect identification, (5) conduct

of operations, (6) technical safety requirements, (7) training, (8)

maintenance, and (9) operational occurrences, as well as general

provisions for the application of these rules. A public hearing was

held on February 25, 1992 in Germantown, Maryland and the 60-day

comment period closed on March 25, 1992. A final rule on the quality

assurance requirements and the general provisions for their application

was published in the Federal Register on April 5, 1994 (59 FR 15843).

The rulemaking remains open with respect to all areas other than the

quality assurance requirements.

On March 25, 1993, the Department of Energy (DOE) published a

Notice of Proposed Rulemaking (58 FR 16268) to add a new part (10 CFR

Part 834) to its regulations establishing standards for the protection

of the public and environment against radiation. The requirements would

be applicable to the control of radiation exposures to the public and

to the environment from normal operations under the control of DOE and

DOE contractor personnel. The March 25, 1993 Notice described the four

basic elements of the radiation protection system it proposed to

implement for protection of the public and environment:

(1) Establish dose limits for exposure of members of the public to

radiation and implementation of the Department's ``as low as is

reasonably achievable'' (ALARA) policy;

(2) Manage radioactive materials in liquid waste discharges, in

soil columns, and in selected solid waste containing radioactive

materials, including a ground water protection program for each DOE

site;

(3) Establish requirements for decontamination, survey and release

of buildings, land, equipment, and personal property containing

residual radioactive material and the management, storage and disposal

of wastes generated by these activities; and

(4) Establish an Environmental Radiation Protection Program (ERPP)

and plan (including an effluent monitoring and environmental

surveillance program) to set forth the programs, plans, and other

processes to protect the public from exposures to radiation.

A public hearing was held on May 13, 1993 in Germantown, Maryland

and the 60-day comment period closed on June 22, 1993. The rulemaking

remains open with respect to all areas.

The Department has considered (1) public comments received during

the initial comment periods on part 830 and on Part 834, (2) comments

received from the Defense Nuclear Facilities Safety Board (DNFSB), and

(3) comments raised in connection with Departmental initiatives

concerning the management of the DOE complex. As a result of this

consideration, the Department has refined its views concerning the

objectives and operation of the regulatory system which will include

part 830 and part 834.

In general, the public comments received during the initial comment

period relate to the details of the proposed rules and the scope of

their coverage. They also raise questions concerning (1) the transition

from the requirements in existing DOE Orders, (2) implementation of the

rules, and (3) compliance with the rules.

The DNFSB has commented on numerous occasions on the relationship

between the proposed rules and the establishment of a standards-based

safety program at the Department. For example, in Recommendation 94-5

the DNFSB called for the Department to integrate its development of

safety rules, orders, and other requirements into an integrated safety

management program and, in particular, expressed its concern that the

process of converting DOE Orders to rules not be used as an occasion to

(1) unduly relax or eliminate important nuclear safety requirements in

Orders, (2) relegate good nuclear safety practices extant in existing

Orders to optional status, or (3) forego or delay current efforts to

bring safety practices into compliance with mutually-agreed

implementation plans that respond to recommendations of the Board.

In 1993, Vice President Gore established the National Performance

Review to evaluate the operation of the Federal Government and make

recommendations on how to reduce the cost and increase the efficiency

of government. In its report on improving regulatory systems, the

National Performance Review made several recommendations on achieving

regulations that are effective, consistent, sensible, and

understandable. In general, these recommendations encourage innovation,

cooperation, public involvement and the use of existing commercial

standards, while discouraging ``command and control'' approaches.

[[Page 45383]]

In addition to the National Performance Review, there have been

several initiatives concerning management of the DOE complex. For

example, the Galvin Commission examined alternative futures for the

national laboratories. In general, the Galvin Commission found that the

Department currently micromanages the laboratories and recommended that

the laboratories be run as a corporation to the extent practicable. In

the alternative, the Commission recommended changes to the current

system, including (1) replacement of compliance-based directives with

simple, well-defined performance measures, (2) elimination of approval

by the Department of the laboratories' internal procedures, and (3)

operation of the laboratories according to industry-wide regulatory

standards.

In response to the National Performance Review and initiatives

concerning the management of the DOE complex, the Department has

conducted an extensive review of the system of safety standards for its

nuclear facilities, including the proposed rules in part 830 and part

834, to determine the extent to which this system (1) emphasizes

performance and (2) empowers those most affected by the system to play

a major role in deciding how an adequate level of performance is

achieved. In conjunction with this review, the Department has

undertaken several specific actions, including (1) the Directives

Reduction Initiative and (2) the development of the ``necessary and

sufficient'' process.

As part of the Directives Reduction Initiative, the Department is

reviewing existing DOE Orders to decide which of the provisions therein

should be retained as requirements or as guidance concerning acceptable

implementation methods. The Department also is considering the extent

to which requirements should be modified to provide clear performance

standards. The Department intends to issue revised DOE Orders to set

forth those nuclear safety requirements that it decides to retain,

except for those requirements that are contained in DOE rules already

issued or proposed. The Directives Reduction Initiative has generated

comments on the proposed rules because many of the provisions in the

existing Orders cover the same subject matter as the proposed rules.

The Department is developing the ``necessary and sufficient''

process to permit the Department, its contractors, and other interested

parties to work as partners in determining the requirements, standards,

and implementing actions that, taken together, will ensure an adequate

level of protection for a particular facility or activity, taking into

account the hazards associated with that facility or activity and other

relevant factors. The necessary and sufficient process is intended to

move away from the ``one size fits all'' approach towards a tailored

approach that recognizes the differences among the diverse DOE

facilities that can range from an accelerator to a research reactor to

a weapons dismantlement plant to a clean-up site. When fully developed,

the necessary and sufficient process will provide a better way of

ensuring adequate protection by assessing the work to be performed,

analyzing the hazards involved, and then determining the requirements

and implementing procedures, programs, plans and other actions that are

``necessary and sufficient'' to address those hazards. The development

of the necessary and sufficient process has generated comments

concerning the intended relationship between the operation of that

process and the proposed rules.

Request for Comments

The Department is issuing this notice to solicit comments from the

public on issues raised by the comments and options under consideration

to respond to these comments. In connection with the reopening of the

comment periods, the Department is making available to the public draft

regulatory language for part 830 and for part 834 currently under

consideration. The Department also is making available a draft

discussion of the regulatory system which will result from the

Department's current rulemaking activities. These draft documents do

not represent a final position of the Department, but are being made

available to assist in the formulation of comments.

In particular, comments are solicited on the following topics.

Part 830

1. Detailed requirements versus performance objectives. Much of the

discussion concerning the proposed Part 830 rules has focused on

whether the proposed rules should be revised to contain more of the

detailed requirements in the existing Orders or whether some of the

proposed rules are too detailed and should be revised to focus on

performance objectives. Those comments that favor more detailed

requirements should specify the requirements to be added and the

reasons why a particular requirement should be imposed uniformly

throughout the DOE complex. Likewise, those comments that favor

requirements more in the form of performance objectives should describe

such objectives in sufficient detail to permit an evaluation of the

extent to which they are sufficient to ensure adequate protection of

workers, the public, and the environment.

2. Exclusion of below hazard category 3 facilities. Many comments

related to whether the nuclear safety management requirements of part

830 should cover all nuclear facilities, especially those below hazard

category 3. The Department is considering an option that would respond

to these comments by excluding nuclear facilities below hazard category

3 from the scope of part 830. Comments also might consider the extent

to which specific requirements in part 830 are needed for hazard

category 2 or 3 facilities. It should be noted that the exclusion of

certain facilities from the requirements of part 830 is not intended to

affect their coverage by the radiation protection requirements of 10

CFR part 834 and 10 CFR part 835, Occupational Radiation Protection.

These requirements would assure that workers, members of the public,

and the environment are adequately protected from the harmful effects

of radiation.

In commenting on this option, consideration should be given to

whether the hazard categories in DOE Standard 1082-92 should be

incorporated as definitions in part 830 and, in particular, whether the

description of hazard category 3 in DOE Standard 1082-92 is more

appropriate than the description of hazard category 3 in the Notice of

Proposed Rulemaking. In considering the use of the definitions in DOE

Standard 1082-92, attention should be given to the potential effect on

the portion of the definition of nonreactor nuclear facility that

includes activities or operations relating to the design, manufacture,

or assembly of items for use with radioactive materials and/or

fissionable materials in such form or quantity that a nuclear hazard

potentially exists. This portion of the definition of nonreactor

nuclear facility covers activities where no nuclear material is present

(such as activities at facilities that prepare the nonnuclear

components of nuclear weapons or that assemble or manufacture safety

related equipment for nuclear facilities), but which could affect

activities in facilities where nuclear material is present.

3. Transportation. Some comments on the scope of part 830 relate to

the coverage of transportation in light of the exclusion of

transportation activities from the definition of nonreactor nuclear

facilities. This exclusion is intended to avoid regulatory duplication

since most transportation of radioactive

[[Page 45384]]

materials occurs off site where it is typically governed and regulated

by agencies other than the Department. DOE is considering responding to

the comments by (1) deleting the exclusion of transportation activities

from the definition of nonreactor nuclear facilities and (2) excluding

from the scope of part 830 those transportation activities governed and

regulated by either the U.S. Department of Transportation, the national

security provisions of 49 CFR 173.7(b), or the U.S. Nuclear Regulatory

Commission.

4. Weapons program. Some comments requested clarification of the

exclusion of activities relating to the prevention of accidental or

unauthorized detonations of nuclear weapons. This exclusion is drafted

narrowly to cover only those activities whose purpose is to prevent

nuclear detonations (that is, where the component parts of a nuclear

weapon have been assembled in a manner such that a nuclear detonation

could take place). The basis for this exclusion is the paramount

importance of preventing accidental or unauthorized nuclear detonations

and ensuring that the regulatory requirements in part 830 do not come

into conflict with activities necessary to prevent any such detonation.

These exclusions do not relieve the person responsible for a DOE

nuclear facility from complying with regulatory requirements to the

extent they do not interfere with the conduct of activities undertaken

to prevent a nuclear detonation. The Department is considering an

option to incorporate this clarification explicitly in the regulatory

language. Comments on this issue also should consider an option under

which the exclusion would be eliminated, but which would make clear

safe management requirements must be tailored to take into account the

paramount importance of preventing accidental or unauthorized

detonations.

5. Offsite coverage. Some comments relate to the coverage of

activities that do not occur at a DOE nuclear facility. For example,

many training, maintenance, and quality assurance activities are

conduct outside the facility to which they relate. The Department is

considering responding to these comments with an option that would

expand the scope of part 830 to cover conduct that could affect the

safe management of nuclear facilities without any limitation that such

conduct must occur at nuclear facilities.

6. Coverage of DOE employees and DOE operated facilities. Some

comments question why the scope of part 830 does not extend to DOE

employees and to facilities operated by the Department (and not by a

contractor). The Department is considering responding to these comments

with an option that would modify the scope of part 830 to cover DOE

employees and DOE operated facilities in the same manner as part 835.

7. Coverage of nonradioactive hazards. Some comments have

questioned the extent to which the proposed rules relate to chemical or

other nonradioactive hazards. These comments point out that some of

these hazards have the ability to (1) cause or exacerbate accidents

involving the release of radioactive material, (2) reduce the level of

nuclear safety and/or (3) have a significant affect on the hazard level

of the facility. DOE is considering options under which the rules would

address (1) only radioactive hazards at a nuclear facility, (2) only

radioactive hazards and those hazards which could cause or exacerbate

an accident involving radioactivity or reduce the level of nuclear

safety, or (3) all hazards which could present a substantial safety

hazard at a nuclear facility. Comments on this issue should indicate

what changes, if any, might be needed to the proposed rules to

accommodate the option favored by a comment.

8. Applicability to non-nuclear facilities. Some comments have

suggested that the scope of the proposed safety management rules in

part 830 be extended to non-nuclear facilities. These comments point

out that many DOE sites have nuclear and non-nuclear facilities and

that many of the rules (e.g., training) could be applicable to both

nuclear and non-nuclear facilities and thus result in integrated and

coordinated site-wide safety management programs that would be more

efficient and effective. The Department is considering responding to

these comments with an option to make the language in some of the rules

in part 830 more general and applicable to non-nuclear, as well as

nuclear facilities. This option would not expand the scope of part 830

beyond DOE nuclear facilities or subject non-nuclear facilities to the

procedural and enforcement requirements delineated in part 820. This

option would permit the Department, however, to impose contractually

the relevant requirements in part 830 on non-nuclear facilities and

thus result in a more uniform and coordinated safety program for a

site.

9. Implementation plans. Implementation plans were the subject of

many comments. These comments related to (1) the timing of their

submission and effectiveness, (2) the possibility of integrating the

plans for a facility or site, (3) the relationship to the necessary and

sufficient process under development, (4) the relationship to

Standards/Requirements Identification Documents (SRIDs) and Order

compliance activities, and (5) the relationship to the authorization

basis. In response to these comments, the Department is considering

options to clarify the role of implementation plans and to make them a

more effective tool for cooperation between the Department and its

contractors.

10. Compliance. Some comments concerned the manner in which the

Department would evaluate compliance with the regulatory requirements

in part 830. The Department is considering options to make clear that

compliance with regulatory requirements will be evaluated in terms of

(1) a hazard analysis of the work to be performed, (2) the

identification of standards and other actions appropriate for the

hazards in a particular workplace, (3) the application of those

standards and actions to the workplace, and (4) the obligation for

ongoing self-assessment.

Part 834

1. Detailed requirements versus performance objectives. Some

comments suggested the proposed rules should be revised to contain more

detailed requirements, while other comments indicated the proposed

rules are too detailed and should be revised to focus on performance

objectives. In general, the Department believes it has balanced these

concerns to ensure that the requirements established in the rule

include those that are necessary to ensure protection of the public and

environment from hazards associated with radioactive material and are

sufficiently flexible to afford cost effective implementation. In

particular, the Department's application of the ``as low as reasonably

achievable'' (ALARA) process to permit individual operations to select

site specific goals and appropriate means of achieving them in a manner

that considers social, technical, economic, practical and public policy

considerations along with dose reduction provides flexibility to

address site specific factors and avoids the ``one size fits all''

concept. The adoption of specific dose limits below which the ALARA

process operates provides added assurance that the rules are

protective.

Those comments that favor the addition of more detailed

requirements should specify the requirements to be added and the

reasons why a particular requirement should be imposed uniformly

throughout the DOE complex. Likewise, those comments that favor

[[Page 45385]]

requirements more in the form of performance objectives should describe

such objectives in sufficient detail to permit an evaluation of the

extent to which they are sufficient to ensure adequate protection of

workers, the public, and the environment.

2. Organization of the draft final rule. In response to public

comments, the Department is considering revising the structure of the

rule to make the presentation easier to follow. The Department also is

considering whether definitions should be added, revised or deleted for

consistency and to eliminate ambiguity.

3. Demonstrating compliance with dose limits. The primary dose

limit of 100 mrem is based on all sources of radiation. To demonstrate

compliance with dose limits, the rule requires evaluations of doses to

members of the public who live in or occupy an area most likely to

receive the highest doses. It also requires consideration of the likely

exposure pathways through air, water, food, and surfaces of property

and the location of those sources. Doses from radiation sources other

than those from DOE activities must also be evaluated. DOE is

considering modifying the proposed rule to require evaluation of doses

from non-DOE activities only when: (1) The dose from DOE activities

exceeds 30 mrem in a year, and, (2) the dose from the non-DOE

activities also exceeds 30 mrem in a year to the same individuals. This

allocation of the primary dose limit to different sources of radiation

exposure is consistent with national and international guidelines and

is a practical approach which ensures that the primary dose limit will

likely not be exceeded.

4. Doses from accidental releases of radioactive materials. Some

commenters were concerned with the application of the part 834 dose

limits to accidents. The Department is considering deleting Sec. 834.9

of the proposed rule which resulted in confusion. The proposed rule was

unclear as to whether and when these doses were subject to the dose

limits. The Department is considering clarifying the applicability of

the dose limits by adding Sec. 834.1(b) stating ``The public dose

limits in this rule are intended to apply to doses to members of the

general public from routine operations and operational occurrences. The

dose limits are not intended to be safety design criteria or guides for

mitigating the consequences of accidents.'' DOE would continue to

require that doses from accidents be evaluated and reported.

5. Requirements applicable to liquid sources of radioactive

materials--liquid discharges. The Department is considering an option

to clarify that stormwater runoff and purge water containing residual

radioactive material are considered to be liquid waste streams.

Moreover, to reduce dual regulation, the Department is considering an

option to allow DOE activities operated in accord with a National or

State Pollution Discharge Elimination System permit to be exempt from

selected requirements.

6. Discharges of liquid waste to aquifers and phaseout of soil

columns. The proposed rule provided for discontinuance of existing soil

columns and the prohibition or increased discharges to soil columns.

The Department is considering an option that would provide for

exceptions where the discharges to the soil columns are treated by the

Best Available Technology (BAT) and would result in less risk to the

public and the environment than any other practicable alternative waste

management practice. This process would allow case-by-case exceptions,

include requirements to ensure the National Primary Drinking Water

regulations are not exceeded, and require monitoring of actual

concentrations in the soil column and aquifers.

7. Discharges to sanitary sewerage. The Department is considering

an option to make its requirements for discharges to sanitary sewerage

more consistent with the NRC requirements on discharges of radioactive

materials from NRC-licensed facilities in Sec. 20.2003 of 10 CFR part

20. This option would limit the released material to dissolved or

dispersible biologic materials.

8. Radiation protection of aquatic organisms. As proposed, part 834

contained requirements for the protection of aquatic organisms. Some

commenters were concerned about implementation of the 1 rad per day

aquatic limit. There was concern with the difficulty and cost

associated with adequately defining dose to organisms in an exposed

population. DOE is considering establishing a screening criterion to

simplify the demonstration of compliance. If it can be shown that the

estimated dose to a representative individual of an exposed population

is less that 0.1 rad per day, then compliance with the primary aquatic

limit may be assumed; otherwise more detailed analyses are needed. The

Department is seeking comments on the use of this screening criterion.

9. Appended Guides. The Department is considering omitting the

tables of Derived Concentration Guides (DCGs) appended to the proposed

rule as Appendix A in order to permit periodic revision of the

information found in the appendix. This option would require that DCG

values and other factors be taken from DOE-approved references or

calculated by DOE-approved methods.

The Department urges interested members of the public to comment on

the important issues discussed above.

Issued in Washington, DC, on August 28, 1995.

Peter N. Brush,

Principal Deputy Assistant Secretary, Environment, Safety and Health.

[FR Doc. 95-21648 Filed 8-30-95; 8:45 am]

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