[Federal Register Volume 60, Number 169 (Thursday, August 31, 1995)]
[Proposed Rules]
[Pages 45381-45385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21648]
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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
[[Page 45382]]
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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