# Occupational Radiation Protection

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URL: https://www.frixlaw.com/law-library/documents/fr%3A98-27366

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** November 4, 1998
- **Citation:** 63 FR 59662

## Text

DEPARTMENT OF ENERGY

10 CFR Part 835

[Docket No.: EH-RM-96-835]
RIN 1901-AA59

Occupational Radiation Protection

AGENCY: Department of Energy.

ACTION: Final rule.

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SUMMARY: The Department of Energy (DOE) is amending its primary
standards for occupational radiation protection. This final rule is the
culmination of a systematic analysis to identify the elements of a
comprehensive radiation protection program and determine those elements
of such a program that should be codified as DOE continues its
transition from a system of contractually-based nuclear safety
standards to regulatory-based requirements. The final rule codifies
requirements previously established in DOE's contractually-based
standards, clarifies certain issues identified during implementation of
programs to ensure compliance with the original rule, and corrects
minor errors.

EFFECTIVE DATE: The amendments to this regulation become effective on
December 4, 1998.

FOR FURTHER INFORMATION CONTACT: Dr. Joel Rabovsky, U.S. Department of
Energy, Office of Worker Protection Programs and Hazards Management,
EH-52, 19901 Germantown Road, Germantown, MD 20874, (301) 903-2135.

SUPPLEMENTARY INFORMATION:

I. Background
II. Discussion of Significant Changes
III. Review Under the National Environmental Policy Act
IV. Review Under the Regulatory Flexibility Act
V. Review Under Executive Order 12866
VI. Review Under Executive Order 12612
VII. Review Under Executive Order 12988
VIII. Review Under Paperwork Reduction Act
IX. Review Under the Unfunded Mandates Reform Act
X. Review Under Small Business Regulatory Enforcement Fairness Act
of 1996

I. Background

On December 14, 1993, DOE published a final rule, 10 CFR part 835,
``Occupational Radiation Protection'' (58 FR 65458), which established
regulatory requirements consistent with the ``Radiation Protection
Guidance to Federal Agencies for Occupational Exposure'' (52 FR 2822)
(Guidance to Federal Agencies), as well as guidance issued by
authoritative organizations, including the National Council on
Radiation Protection and Measurements (NCRP) and the International
Commission on Radiological Protection (ICRP). Many of the codified
requirements were previously established in DOE Order 5480.11,
``Radiation Protection for Occupational Workers.'' In addition, DOE
codified in 10 CFR part 835 the ``as low as is reasonably achievable''
(ALARA) process as the primary means of maintaining occupational
radiation doses below regulatory limits.
As a result of an initiative to eliminate redundant and
unnecessarily stringent requirements, DOE conducted a systematic
analysis to identify the elements of a comprehensive radiation
protection program and determine those elements of such a program that
should be codified as DOE continues its transition from a system of
contractually-based nuclear safety standards to regulatory-based
requirements. The systematic analysis included an evaluation of DOE's
objectives for occupational radiation protection programs, including
structured analyses of existing standards for similar programs,
operational occurrences within the DOE complex, and provisions in the
original rule. The analysis also included reviews of the requirements
in DOE Notice 441.1, ``Radiological Protection for DOE Activities,''
(extended by DOE N 441.2 and 441.3) and the provisions of the ``DOE
Radiological Control Manual'' (Manual). DOE proposed to codify
requirements in use within the DOE complex to ensure that worker health
and safety programs would continue to be maintained at a level
commensurate with workplace hazards. DOE also considered approaches
used by national and international radiation protection organizations
and experience throughout the DOE complex in achieving compliance with
10 CFR part 835. The systematic analysis is documented in a report
entitled, ``Development of the 1996 Proposed Amendment to 10 CFR part
835, Occupational Radiation Protection,'' (regulatory development
document, November 1996) which may be viewed in the DOE Freedom of
Information Reading Room at Room 1E-190, 1000 Independence Avenue, SW,
Washington, DC, 20585, (202) 586-6020.
On December 23, 1996, DOE published a Notice of Proposed Rulemaking
that would amend 10 CFR part 835 by:
1. Modifying the scope to explicitly exclude radioactive material
transportation and certain activities conducted on foreign soil;
2. Adding requirements for area posting and sealed radioactive
source control;
3. Adding a removable surface contamination value for tritium, to
be used to identify the need for area posting and imposition of certain
radioactive material controls;
4. Expanding and clarifying provisions of the rule to address
emergent radiation protection issues;
5. Deleting certain provisions, as appropriate, to eliminate
redundant and excessively stringent regulatory requirements; and
6. Clarifying and correcting minor errors.
As discussed in this Notice of Final Rulemaking, the final rule was
developed in consideration of the extensive input received during two
public hearings and through written and electronic public comments.
The schedule for achieving compliance with the amendments to 10 CFR
part 835 is as follows. The final rule will become effective 30 days
following publication in the Federal Register. As provided at
Sec. 835.101(g)(3), updated radiation protection programs (RPPs) must
be submitted to DOE within 180 days following the effective date of the
final rule. Changes that do not decrease the effectiveness of the RPP
may be implemented prior to DOE approval. Changes that decrease the
effectiveness of the RPP require DOE approval prior to implementation.
As provided at Sec. 835.101(i), an update of the RPP shall be
considered approved 180 days after its initial submission unless
rejected by DOE at an earlier date. The final rule, at Sec. 835.101(f),
requires full compliance with the regulatory changes within 180 days of
RPP approval except for radiobioassay program accreditation required
under Sec. 835.402(d). Because of the breadth of the joint DOE/DOE-
contractor effort needed to accomplish radiobioassay program
accreditation, at Sec. 835.101(f) DOE has established January 1, 2002
as the compliance date for the radiobioassay program accreditation
requirements.

II. Discussion of Significant Changes

The discussion of the significant changes to 10 CFR part 835 and
the response to public comments is organized according to subpart. When
there was more than one significant change in a subpart the significant
changes are generally listed in order of section. The topic addressed
by each significant change is listed. In many cases, inclusion of a
change to the provisions in one subpart or section required changes to
other subparts or

[[Page 59663]]

sections of the regulation either for internal consistency or to
resolve a public comment. For example a number of changes to the
provisions of the rule required concomitant changes to the definitions
or recordkeeping requirements. Accordingly, the discussion of a change
may reference other subparts in addition to the one in which the
primary change was made. This organization of the discussion of the
significant changes to 10 CFR part 835 and the response to public
comments was chosen to more clearly explain the changes and how DOE
responded to the public comments.

A. General Provisions, Subpart A

1. Nuclear Explosive and Weapon Surety Program
Proposed Amendment
DOE proposed to revise the Nuclear Explosive and Weapon Surety
Program exclusion at Sec. 835.1(b)(3) to clearly indicate that the
exclusion applies only to the extent that compliance with 10 CFR part
835 would compromise the effectiveness of activities essential to
prevention of an accidental or unauthorized detonation. This action was
initiated to ensure that radiation protection programs are implemented
that do not compromise the overriding goal of preventing such
incidents.
Summary of Public Comments and Disposition
DOE received comments indicating that this exclusion should also be
extended to address the provisions of CG-TSS-S2, ``Transportation
Safeguards System Classification and Unclassified Controlled
Information Guide (Supplement),'' which states that ``The fact that a
specific SST (Safe Secure Trailer)/SSR (Safe Secure Railcar) is loaded
or empty is CNSI (controlled nuclear safeguards information).'' The
commenters believe that certain posting and labeling provisions of 10
CFR part 835 would provide indication of the loaded or empty status of
affected vehicles, contrary to the referenced guidance. DOE believes
that the existing exclusion already provides the flexibility needed for
implementation of programs consistent with CG-TSS-S2. Indeed, the
situation presented by the commenters is exactly the type of condition
for which the exclusion is intended.
Final Rule
After further consideration, DOE has determined that the proposed
clarification is not needed. Ruling 1995-1 makes it clear that the
existing language recognizes ``the paramount importance of preventing
accidental or unauthorized nuclear detonations and ensuring that the
requirements in (part 835) do not come into conflict with any
activities necessary to prevent such detonation. However, [the language
is] not intended to relieve the person responsible for a DOE nuclear
facility or a DOE activity from complying with the requirements in
(part 835) to the extent they do not interfere with the conduct of
activities undertaken to prevent an accidental or unauthorized
detonation.'' (61 FR 4212, February 5, 1996.)
2. Radioactive Material Transportation
Proposed Amendment
DOE standards for packaging and transporting radioactive material
are addressed in DOE Orders. DOE Orders 460.1A, ``Packaging and
Transportation Safety,'' and 460.2, ``Departmental Materials
Transportation and Packaging Management,'' provide DOE requirements for
packaging and transportation of radioactive material. Requirements for
radioactive material transported under DOE's national security mission
are provided in DOE Order 5610.12, ``Packaging and Off-site
Transportation of Nuclear Components and Special Assemblies Associated
with the Nuclear Explosive and Weapon Safety Program,'' and DOE Order
5610.14, ``Transportation Safeguards System Program Operations.'' The
requirements of these Orders are consistent with Department of
Transportation (DOT) regulatory requirements and provide the framework
for ensuring transportation safety. Certain provisions of 10 CFR part
835 complement these transportation safety directives by ensuring that
individuals are afforded an adequate level of radiation protection
while preparing radioactive materials for transportation and taking
possession of radioactive material from transportation.
Although the absence of provisions pertaining to radioactive
material transportation was addressed in the preamble for the original
Rulemaking (58 FR 65465), DOE did not explicitly exclude radioactive
material transportation from the scope of 10 CFR part 835. Consistent
with its original intent as expressed in the preamble of the final
rule, DOE proposed an exclusion at Sec. 835.1(b)(4) for radioactive
material transportation conducted in accordance with applicable DOE
Orders. DOE also proposed a definition of ``radioactive material
transportation'' at Sec. 835.2(a) to clarify the distinction between
the process of transporting radioactive materials, which would be
excluded from 10 CFR part 835, and those activities leading to or
resulting from radioactive material transportation, which would be
subject to 10 CFR part 835. The proposed definition included a
specified threshold (specific activity) consistent with DOT
requirements at 49 CFR 171-179.
Summary of Public Comments and Disposition
Public comments supported DOE's intent to exclude radioactive
material transportation, but indicated that the proposed approach did
not clearly establish the interface between 10 CFR part 835 and
applicable transportation requirements. Other comments indicated that
the term ``specific activity'' in the proposed Sec. 835.2(a) definition
of the term ``radioactive material transportation'' could be
misconstrued, potentially resulting in non-compliant conditions.
Final Rule
The final rule clearly establishes the interface between the
occupational radiation protection and transportation requirements. This
approach makes it clear that 10 CFR part 835 does not apply to the
radioactive material transportation, which is defined to be movement of
radioactive material that is subject to DOE Orders or DOT regulations.
The definition of radioactive material transportation is independent of
the geographical location of the material being transported (i.e.,
inside or outside of the area controlled by DOE) and also independent
of the radiological characteristics (e.g., specific activity) of the
material in question. As a result of this revised approach, DOE has not
included the term ``specific activity'' in the Sec. 835.2(a) definition
of the term ``radioactive material transportation.''
3. DOE Activities Conducted on Foreign Soil
Proposed Amendment
DOE proposed to add an exclusion at Sec. 835.1(b)(5) for DOE
activities conducted on foreign soil and under requirements agreed to
between the foreign government and the United States. DOE proposed this
exclusion in recognition of the primacy of foreign governments'
occupational radiation protection requirements.
Summary of Public Comments and Disposition
Several commenters indicated that the development and approval of
agreements with foreign governments may require action by the State
Department and that DOE contractors could not take independent actions
to

[[Page 59664]]

ensure that appropriate agreements have been reached. However, DOE
activities, including those performed on foreign soil, are conducted
under the cognizance of the responsible DOE Program Office and these
offices are responsible for ensuring that such agreements are in effect
before authorizing the conduct of the activities. The only action
required of the DOE contractor will be to ensure that the DOE Program
Office has established, or verified the establishment of, the
appropriate agreements. Also, the activity is not excluded unless there
are occupational radiation protection requirements agreed upon.
Final Rule
The final rule includes the exclusion for DOE activities conducted
on foreign soil at Sec. 835.1(b)(5).
4. Applicability of Occupational Dose Received From Excluded Activities
Proposed Amendment
At Secs. 835.1(c), 835.202(a), and 835.202(b), DOE proposed changes
to clarify the requirements for accounting for occupational doses
received from non-DOE activities. The proposed amendment indicated
that, even though certain activities are excluded from the scope of the
rule at Sec. 835.1(b), an individual's occupational dose resulting from
excluded activities would be applied toward determination of compliance
with the occupational dose limits established in subpart C of 10 CFR
part 835. This is necessary to ensure that an individual's annual
aggregate occupational dose is maintained below the limits specified in
the Federal Guidance. This would include occupational doses received
from activities licensed by the Nuclear Regulatory Commission (NRC) and
its agreement states, activities conducted under the authority of the
Director, Naval Nuclear Propulsion Program, activities conducted under
the Nuclear Explosive and Weapon Surety Program, radioactive material
transportation activities, and activities conducted under the auspices
of foreign governments. However, radiation doses received from
background radiation, as a patient for the purposes of medical
diagnosis or therapy, and from participation as a subject in medical
research programs are not considered occupational doses and would not
be considered in determining compliance with the occupational dose
limits. Furthermore, occupational dose received as a result of
authorized emergency exposures and planned special exposures, although
occupational in nature, would not be considered in determining
compliance with the dose limits established at Sec. 835.202(a).
Summary of Public Comments and Disposition
Commenters generally supported this clarification of DOE policy.
Final Rule
The final rule adopts the proposed clarification that all
occupational doses, other than doses resulting from authorized
emergency exposures and planned special exposures, shall be considered
in determining compliance with the limits set forth in Secs. 835.202,
and 835.207. Section Sec. 835.206, Limits for the embryo/fetus, was
included in this provision for consistency and completeness. Because
Sec. 835.1302 establishes the appropriate criteria for authorizing
exposures under emergency conditions, DOE has instituted an editorial
change to reference this section. Procedures for handling doses
resulting from authorized emergency exposures and planned special
exposures are discussed in Section II.C of this Notice of Final
Rulemaking, ``Limitation of Individual Doses.''
5. Definitions
DOE proposed to add, revise, or remove the definitions of a number
of terms that appear at Sec. 835.2(a) and (b) as follows:
a. Adding definitions of the terms ``accountable sealed radioactive
source,'' ``derived air concentration-hour,'' ``occupational dose,''
``radioactive material area,'' ``radioactive material transportation,''
``radiological control technician,'' ``real time air monitoring,''
``respiratory protective device,'' ``sealed radioactive source,''
``source leak test,'' and ``week.''
b. Revising the definitions of the terms ``airborne radioactive
material or airborne radioactivity,'' ``airborne radioactivity area,''
``contamination area,'' ``controlled area,'' ``DOE activity,'' ``high
contamination area,'' ``member of the public,'' ``monitoring,''
``radiological area,'' ``year,'' ``committed dose equivalent,''
``cumulative total effective dose equivalent,'' ``effective dose
equivalent,'' ``external dose or exposure,'' ``internal dose or
exposure,'' ``quality factor,'' ``total effective dose equivalent,''
and ``weighting factor.''
c. Removing the definitions of the terms ``ambient air,''
``continuous air monitor,'' ``collective dose,'' and ``occupational
exposure.''
The effects of these proposed changes, significant public comments
on these proposed changes, and any resulting changes are discussed in
this Notice of Final Rulemaking as these terms appear in the final
rule.
6. Intervals Between Required Activities
Proposed Rule
DOE proposed to revise the required intervals for internal audits,
instrument and equipment calibration and maintenance, and radiation
safety retraining from the specified number of years to the equivalent
number of months. This change was proposed to eliminate any confusion
resulting from the Sec. 835.2(a) definition of the term ``year,'' which
specifically defined the year in terms necessary to ensure compliance
with the subpart C dose limits.
Summary of Public Comments and Disposition
DOE received a number of comments indicating that the required
intervals appeared to be somewhat arbitrary and should therefore
include some degree of flexibility to accommodate operational and
scheduling needs. DOE agrees with these observations.
Final Rule
DOE has included a provision at Sec. 835.3(e) that will allow a 30
day automatic extension in the required time interval to accommodate
operational and scheduling constraints. The extension is considered to
be automatic in that there is no requirement to obtain DOE or other
approval for the extension. This provision addresses the requirements
of Secs. 835.102, 835.901, and 835.1202 for internal audits, radiation
safety training, and sealed radioactive source inventories and leak
tests, respectively. Because of the varying lengths of the calendar
months, DOE has not provided a definition of the term ``month.'' DOE
expects that those entities responsible for ensuring compliance with 10
CFR part 835 will undertake those measures necessary to perform the
required activities within the prescribed time frame (i.e., if a sealed
radioactive source is leak tested on January 15, DOE would expect the
subsequent leak test to be performed on or before July 15 of the same
year). When operational or scheduling considerations preclude adherence
to that schedule, then one may consider utilization of the 30 day
extension (i.e., the leak test could be performed no later than August
14 of the same year).

[[Page 59665]]

7. Radiological Units
Proposed Amendment
DOE proposed to delete the Sec. 835.4 prohibition on use of the
international (SI) radiological units. The international system of
radiological units is commonly used for calculational and reference
purposes. As proposed, Sec. 835.4 would continue to require the use of
the special radiological units in required records. Consistent with its
historical endorsement of the special units and in recognition of the
capabilities of many commercially-available instruments in use
throughout the DOE complex, DOE also proposed to specifically allow for
use of subunits and multiples of the unit ``roentgen.''
Summary of Public Comments and Disposition
Although some comments indicated that DOE should proceed toward use
of the SI units for required records, DOE believes that considerations
of consistency with records required by the NRC and its agreement
states override the impetus toward use of SI units.
Final Rule
As proposed, Sec. 835.4 of the final rule allows the use of the
international system of units for calculations or reference purposes.
Records required by 10 CFR part 835 will continue to be maintained
using the special radiological units of curie, rad, roentgen, and rem.

B. Management and Administrative Requirements, Subpart B

1. Documented Radiation Protection Programs
Proposed Rule
Paragraph 835.101(g) of the original rule requires that those
entities subject to the requirements of 10 CFR part 835 submit an
update of the documented radiation protection program (RPP) within 180
days of the effective date of any regulatory modifications. DOE
proposed to establish provisions at Sec. 835.101(f) requiring
compliance with amendments to 10 CFR part 835 no later than 180 days
following approval of the updated RPP, except for the provisions of
Sec. 835.402(d) for radiobioassay program accreditation. Because of the
extent of the joint DOE/DOE contractor effort necessary to complete the
radiobioassay program accreditations, DOE proposed a compliance date of
January 1, 2000 for this provision. DOE also proposed to delete
outdated provisions codified at Sec. 835.101 (f) and (g).
Summary of Public Comments and Disposition
Several commenters indicated that DOE's proposed compliance date of
January 1, 2000 for radiobioassay program accreditation may be
inappropriate due to the lack of experience in implementing the
accreditation program. Other comments indicated that DOE delays in
implementing the program might result in a state of non-compliance for
DOE-contractors. DOE agrees that more time may be necessary to complete
the required program accreditations.
Final Rule
DOE has codified the proposed 180 day period for achieving
compliance with the amendments to 10 CFR part 835, except for the
radiobioassay program accreditation requirements of Sec. 835.402(d).
DOE has extended the date for compliance with the radiobioassay program
accreditation requirements until January 1, 2002 to accommodate the
planned schedule to complete program accreditations throughout the DOE
complex. DOE expects this extension to provide ample time for
completion of the program accreditations. Should significant delays
occur in performing the program accreditations, DOE could exercise
appropriate enforcement discretion. These changes will not affect the
compliance status of personnel dosimetry programs currently accredited,
or excepted from accreditation, under the existing Department of Energy
Laboratory Accreditation Program (DOELAP) standards.
DOE has deleted the outdated provisions of Sec. 835.101 (f) and (g)
as proposed.
2. Education and Training of Cognizant Individuals
Proposed Amendment
To address a number of shortcomings in its provisions for training
radiological control technicians identified during its systematic
analysis, DOE proposed to codify a definition of ``radiological control
technician'' at Sec. 835.2(a). DOE also solicited comments on four
alternative approaches that were discussed in the preamble of the
Notice of Proposed Rulemaking.
Summary of Public Comments and Disposition
Public comments indicated that DOE's proposed definition of the
term ``radiological control technician'' did not adequately describe
the roles and responsibilities of individuals filling this position.
DOE received comments endorsing each of the proposed alternative
approaches, with the majority of the comments endorsing Alternative
Approach 4 as discussed in the preamble of DOE's Notice of Proposed
Rulemaking.
Final Rule
To satisfy its programmatic objectives for occupational radiation
protection programs, DOE has codified an approach consistent with that
discussed as Alternative Approach 4 in its Notice of Proposed
Rulemaking. Under this approach, DOE has eliminated the specific
requirements for radiological control technician training from subpart
J of 10 CFR part 835 and added at Sec. 835.103 a requirement for all
individuals responsible for ensuring compliance with the rule to have
the appropriate education, training, and skills. This approach provides
the flexibility necessary to address the wide range of individuals
involved in developing and implementing measures necessary for ensuring
compliance with 10 CFR part 835, including cognizant managers,
supervisors, auditors, engineers, clerks, and technicians.
3. Written Procedures
Proposed Rule
In its Notice of Proposed Rulemaking, DOE noted that the existing
rule did not establish requirements for written procedures that
consistently addressed the hazards associated with the specified
activity. DOE believes that, due to the wide variation of radiological
activities and their associated hazards conducted at DOE facilities,
requiring written procedures for specific types of activities may
divert resources from active management of higher-hazard activities to
administrative control of lower-hazard activities. DOE discussed two
alternative approaches in its Notice of Proposed Rulemaking.
Alternative Approach 1 would eliminate most or all of the requirements
for written procedures and leave the determination of the need for
written procedures to the cognizant DOE Program Office. Alternative
Approach 2 would eliminate most or all of the existing requirements for
written procedures in favor of a general requirement that written
procedures be developed and implemented commensurate with the
radiological hazards created by the activity and consistent with the
education, training, and skills of the affected individuals.

[[Page 59666]]

Summary of Public Comments and Disposition
Public comments overwhelmingly favored Alternative Approach 2.
Commenters indicated that this approach would provide for an
appropriate level of radiological safety while providing the
flexibility needed to address the wide range of DOE activities. DOE
agrees with the public comments.
Final Rule
DOE has established a requirement at Sec. 835.104 consistent with
that described as Alternative Approach 2 in its Notice of Proposed
Rulemaking. As a result of this change, DOE has deleted specific
requirements for written procedures from Secs. 835.501(d), 835.1001(a),
835.1001(b), 835.1003(a), 835.1101(c), and 835.1102(c)(3) (formerly
835.404(d)). In addition, proposed requirements for written procedures
at Secs. 835.405(f) and 835.1201(a) were omitted from the final rule.
DOE's adoption of this approach is not intended to imply a global
requirement that written procedures be developed and implemented to
address all of the requirements of 10 CFR part 835. In evaluating the
need for written procedures addressing any particular provision of 10
CFR part 835, consideration must be given to the nature and extent of
the radiological hazards, the complexity of the measures necessary to
achieve compliance, and the education, training and skills of the
individuals who must implement those measures. Under such a regimen, a
low hazard activity employing a stable staff of highly educated and
skilled workers having an advanced knowledge of radiation protection
principles and practices could have fewer and less detailed procedures
than a higher hazard activity employing a transient force of workers
with less knowledge of radiation protection principles and practices.
The adequacy of the written procedures is ultimately determined by the
appropriate implementation of the necessary compliance measures by the
affected individuals.
Because the scope of subpart B of 10 CFR part 835 has been
expanded, DOE has changed the title of this subpart to ``Management and
Administrative Requirements.''

C. Limitation of Individual Doses, Subpart C

1. Summing of Internal and External Doses
Proposed Amendment
DOE proposed to revise Sec. 835.203(a) to provide flexibility in
requirements for summing of individual internal and external dose
equivalents to determine the total effective dose equivalent. As
proposed, Sec. 835.203(a) would require summing only when the
individual was monitored in accordance with Sec. 835.402 (that is, when
the individual's dose was likely to exceed the mandatory individual
monitoring thresholds) or when the individual's dose exceeded the
mandatory monitoring thresholds, regardless of a priori expectations.
DOE also proposed to delete Sec. 835.203(c) because this provision
is redundant with provisions included in the Sec. 835.2(b) definition
of the term ``weighting factor.''
Summary of Public Comments and Disposition
DOE received comments indicating that all monitored individual
internal and external doses should be summed to determine the total
effective dose equivalent. Commenters noted that these data were
available and could be important in future dose reconstruction or
litigation efforts. DOE agrees with these comments. Although DOE is
concerned about the administrative burden associated with the need to
sum trivial internal and external doses, DOE has provided ample
flexibility for ameliorating such burdens through codification of the
individual monitoring thresholds provided at Sec. 835.402.
Final Rule
DOE has omitted the proposed change from Sec. 835.203(a), but
deleted the second sentence of Sec. 835.203(a) because this sentence is
redundant with provisions included in the definition of the term
``effective dose equivalent'' at Sec. 835.2(b). DOE has deleted
Sec. 835.203(c), as proposed.
2. Planned Special Exposures
Proposed Amendment
DOE proposed changes to the 10 CFR part 835 requirements for
conducting planned special exposures in excess of the dose limits
established at Sec. 835.202. The proposed changes included:
a. Changing the Sec. 835.204(a)(1) reference from
Sec. 835.202(a)(1) to Sec. 835.202(a) to indicate that all of the
Sec. 835.202 dose limits apply.
b. Revising Sec. 835.204(c) to indicate that doses resulting from
planned special exposures may exceed the numerical values established
at Sec. 835.202(a) without actually exceeding the occupational dose
limits.
c. Clarifying documentation requirements for planned special
exposures at Sec. 835.204(d).

DOE also solicited comments on the possibility of deleting the
provisions for planned special exposures because these provisions have
not been used to date.
Summary of Public Comments and Disposition
Commenters generally supported the proposed changes to the
provisions for planned special exposures. Many commenters indicated
that the provisions for planned special exposures should be retained to
provide the maximum practical degree of flexibility.
Final Rule
Consistent with the comments received, DOE has retained the
provisions for planned special exposures, with the proposed revisions,
in the final rule.
3. Radiation Dose Limits
Proposed Amendment
DOE proposed editorial changes to Sec. 835.207 and the heading of
that section to clarify that the dose limits for minors apply to doses
resulting from occupational exposure only. DOE also proposed to add
deterministic dose limits for minors consistent with the Federal
Guidance. Non-occupational exposure of minors is subject to the dose
limits established at Sec. 835.208 for members of the public entering a
controlled area. DOE also proposed changes to Sec. 835.208 to clarify
that the member of the public dose limit applies to members of the
public in the controlled area only. DOE proposed to revise the
definition of ``member of the public'' at Sec. 835.2(a) to clearly
distinguish members of the public from temporary or transient workers
or visiting scientists who could receive occupational doses.
DOE proposed to revise the definition of ``cumulative total
effective dose equivalent'' (CTEDE) at Sec. 835.2(b) to include all
total effective dose equivalent (TEDE) values, where available, from
January 1, 1989, whether or not the dose was received at that DOE site
or facility.
Summary of Public Comments and Disposition
Several commenters questioned DOE's proposed approach to
controlling doses to minors, pointing out that a minor could possibly
receive 0.1 rem in a year occupational dose and 0.1 rem in a year as a
member of the public. Although this scenario is possible, the resulting
maximum dose is well below the most recent recommendations of
scientific bodies for exposures that do not occur repeatedly.

[[Page 59667]]

DOE did not receive any substantive comments on the proposed change
to the definition of the term ``cumulative total effective dose
equivalent.''
Final Rule
DOE has adopted the changes, essentially as proposed. DOE has also
made editorial changes to Secs. 835.207 and 835.208 for clarity. These
changes include omitting, in Sec. 835.207, the proposed occupational
dose limit for minors of 10% of the Sec. 835.202(a)(2) limit. This
limit is redundant because the 0.1 rem total effective dose equivalent
limit for minors is always more restrictive.
4. Exposures to Airborne Radionuclides
Proposed Amendment
DOE proposed to delete Sec. 835.209(b) because of redundancy with
other rule requirements for inhalation exposures and external exposures
from airborne radionuclides.
Summary of Public Comments and Disposition
DOE did not receive any substantive comments on the proposed
deletion.
Final Rule
DOE has deleted Sec. 835.209(b) and redesignated Sec. 835.209(c) as
Sec. 835.209(b). In addition, DOE has initiated an editorial change by
deleting the word ``representative'' from Sec. 835.209(c)(3)
(redesignated as Sec. 835.209(b)(3)). This word was redundant with the
remaining requirement that the internal dose estimate based upon air
concentration values must be as or more accurate than that based upon
bioassay results.

D. Monitoring of Individuals and Areas, Subpart E

1. General Requirements for Area and Individual Monitoring
Proposed Amendment
In reviewing the requirements of 10 CFR part 835, DOE noted that
the terms ``monitoring'' and ``survey'' were not used consistent with
the definitions provided at Sec. 835.2(a). DOE proposed changes to the
definition of the term ``monitoring'' at Sec. 835.2(a) to clearly
establish that ``monitoring'' involves measurement of radiological
conditions and the subsequent use of the results of these measurements
to evaluate potential and actual exposures to ionizing radiation. As
proposed, the term ``survey,'' would be more directly related to the
assessment of workplace or material radiological conditions through
direct measurement, assessment, or calculation for the purposes of
hazards assessment. DOE proposed changes throughout the rule to ensure
consistent application of these terms.
DOE proposed to clarify the requirements of Secs. 835.401(c) and
835.703(d) by making the calibration requirements apply to both
``instruments'' and ``equipment.'' This clarification is consistent
with current field practice with regard to equipment, such as an air
sampler, that, although incorporated into or associated with
instrumentation systems, does not have any instrumentation.
Summary of Public Comments and Disposition
DOE received a number of comments supporting its attempt to clarify
the ``monitoring'' and ``surveying'' terminology. However, comments
indicated that the usage of these terms remained inconsistent.
With regard to the proposed Sec. 835.401(c) requirements for
calibration and maintenance of instruments and equipment, DOE received
a number of comments indicating that the required one year calibration
frequency was overly stringent given the reliability of many modern
instruments, particularly certain fixed monitors. Other commenters
indicated that the term ``equipment'' could conceivably be extended to
include vehicles, calculators, and other equipment routinely used in
the course of area monitoring.
Commenters indicated that the use of the undefined term
``workplace'' in this subpart could result in confusion regarding the
scope of the requirements. Commenters also indicated that the use of
the term ``area monitoring'' at Sec. 835.401(b) seemed to imply that
stationary area monitors were required under certain conditions.
Final Rule
DOE has determined that, for regulatory purposes as established in
10 CFR part 835, there is no substantive difference between the uses of
the terms ``monitoring'' and ``survey.'' Therefore, in the final rule
DOE has revised the definition of the term ``monitoring'' and deleted
the term ``survey,'' replacing this term with ``monitoring'' (as
modified) throughout the rule. DOE has also deleted the undefined terms
``sampling'' and ``measurements'' in favor of the defined term
``monitoring.''
DOE has deleted the term ``workplace'' from subpart E of 10 CFR
part 835, instead adopting a performance-oriented approach of
``monitoring of individuals and areas.'' In a related editorial change,
DOE has deleted the term ``area monitoring'' from proposed
Sec. 835.401(b) and redesignated the remaining text as
Sec. 835.401(a)(6) to eliminate any connotation regarding requirements
for stationary radiation monitors. DOE has also substituted the defined
term ``individual'' for the undefined term ``personnel'' in this
provision.
In response to comments on DOE's requirements for calibration and
maintenance of instruments and equipment, DOE has revised these
requirements (at redesignated Sec. 835.401(b)(1)) such that calibration
and maintenance will be required ``periodically'' on an ``established
frequency.'' This change is consistent with NRC requirements at 10 CFR
20.1501 and provides flexibility for acceptance of recommendations
provided in various consensus standards accepted by the instrument
calibration community and used within the DOE complex. DOE will provide
guidance regarding measures for establishing appropriate maintenance
and calibration frequencies and proper application of these
requirements to ``equipment'' used for monitoring.
As used in 10 CFR part 835, instruments and equipment used for
monitoring includes devices used for both area monitoring (e.g.,
portable and installed radiation, contamination, and airborne
radioactivity sampling and monitoring devices) and individual
monitoring devices (e.g., thermoluminescent dosimeters, pocket ion
chambers, track etch dosimeters, and electronic dosimeters). Note that
the calibration of personnel dosimeters that are required under
Sec. 835.402 is addressed by the DOELAP for personnel dosimetry.
2. Individual Monitoring and Dose Determination
Proposed Amendment
DOE proposed several changes to the existing requirements for
monitoring individual radiation doses. The proposed changes included:
a. Clarifying the requirements for external and internal dose
monitoring programs at Sec. 835.402(b) and (d) by providing that such
programs must be capable of demonstrating compliance with all of the
individual dose equivalent limits in subpart C. This approach is
consistent with DOE's previously established requirements for records
required under Sec. 835.701(a).
b. Revising the monitoring requirements for minors at
Sec. 835.402(a)(3) and (c)(3) to expressly state that these
requirements apply to occupationally exposed minors only.

[[Page 59668]]

Minors who are not occupationally exposed are subject to the member of
the public monitoring requirements found at Sec. 835.402(a)(4) and
(c)(4).
c. Deleting from Sec. 835.402(c)(1) the monitoring threshold based
on organ and tissue committed dose equivalent. The monitoring threshold
based upon committed effective dose equivalent obviates the need for
this threshold because, through application of the weighting factors
defined at Sec. 835.2(b), the committed effective dose equivalent
always provides a more restrictive basis for individual monitoring.
d. Changing Sec. 835.402(a)(1)(i) to require individual monitoring
on the basis of deep dose equivalent rather than effective dose
equivalent because deep dose equivalent is the parameter actually
monitored by existing dosimetry programs.
e. Removing provisions at Sec. 835.402(a)(1)(iv) for measuring deep
dose equivalent from external sources to any organ or tissue other than
the lens of the eye because any doses meeting this condition are
adequately addressed by Sec. 835.402(a)(1)(i).
f. Clarifying Sec. 835.402(a)(4) and (c)(4) to indicate that these
provisions apply to members of the public inside the controlled area
only.
Summary of Public Comments and Disposition
Commenters indicated that the proposed Sec. 835.402(a)(1)(i)
requirement for monitoring of deep dose equivalent, as worded, would
challenge the capabilities of modern dosimetry systems. While the
technical basis for the comments was not clear, reflection on these
comments revealed that the wording in the proposed rule could suggest
the basis for initiating monitoring was the highest dose received by
any portion of the whole body. Furthermore, although deep dose
equivalent is the quantity most commonly measured, effective dose
equivalent is the appropriate criterion upon which the mandatory
individual monitoring threshold should be based because the
corresponding occupational dose limits are stated in terms of effective
dose equivalent.
Final Rule
DOE agrees with the public comments regarding the proposed change
to Sec. 835.402(a)(1)(i). The language in the original version of 10
CFR part 835 has been retained. DOE has included the other proposed
changes in the final rule.
3. Program Accreditation
Proposed Amendment
DOE proposed a number of enhancements and additions to the existing
requirements for the DOELAP. These proposed changes included:
a. Amending Sec. 835.402(b) to indicate that, except as discussed
below, personnel dosimetry programs must be either accredited under the
DOELAP or excepted from accreditation under that program.
b. Amending Sec. 835.402(d) to require radiobioassay program
accreditation or exception through the recently developed DOELAP for
Radiobioassay. This proposed change was intended to ensure the
integrity of radiobioassay programs and prevent recurrence of recent
adverse events.
c. Revising Sec. 835.402(b) and (d) to limit the scope of the
DOELAP requirements to personnel dosimetry and radiobioassay programs
implemented to ensure compliance with Sec. 835.402 (i.e., monitoring
when individual doses are likely to exceed the stated thresholds). In a
related change, because Sec. 835.401(b) addresses calibration of
instruments and equipment used for monitoring and DOELAP for Personnel
Dosimetry provides appropriate dosimetry system performance criteria,
DOE proposed to delete the dosimeter calibration requirement from
Sec. 835.402(b).
d. Adding Sec. 835.402(e) to require that external dosimetry and
bioassay programs conform to the most recent revisions of the DOELAP
technical standards or be subject to review and approval of the
Secretarial Officer responsible for environment, safety, and health
matters (currently the Assistant Secretary for Environment, Safety and
Health). For those programs that are not accredited or excepted from
the accreditation program, this provision would also allow this same
officer to provide approval if the programs demonstrate performance
equivalent to those accredited under the DOELAP. This provision would
ensure that, to the extent practical, DOE radiation protection programs
will reflect the latest advances in the sciences of external and
internal dosimetry. To prevent the automatic loss of accreditation
status as a result of changes to the DOELAP technical standards, the
DOELAP technical standards provide that changes in the standards become
effective only during the ensuing accreditation cycle.
Summary of Public Comments and Disposition
Several commenters suggested that all individual dose measurements
be performed under an accredited dosimetry program in order to maintain
credibility of all monitoring data. However, DOE does not believe that
is appropriate to impose regulatory accreditation requirements on
monitoring programs that are not required by regulation. Existing
regulatory provisions at Sec. 835.402(a) and (c) require individual
monitoring for all individuals likely to receive a dose equivalent
exceeding the specified thresholds. As part of a comprehensive
radiation protection program, measures used to identify these
individuals should include comprehensive, documented area monitoring
and could include, if management so chooses, individual monitoring.
Section 835.401 establishes minimum requirements for performing such
monitoring, including requirements for calibration and maintenance of
instruments and equipment used to perform the monitoring. As required
by Secs. 835.701(a) and 835.703, the monitoring results must be
documented.
Several commenters recommended that DOE revise the rule to permit
DOE facilities to procure the services of dosimetry processors who are
accredited by the National Voluntary Laboratory Accreditation Program
(NVLAP) administered through the National Institute of Standards and
Technology, as an alternative to accreditation under the DOELAP for
personnel dosimetry. These comments noted the NRC's regulations require
licensees to use dosimetry processors with NVLAP accreditation. They
argued that permitting NVLAP accreditation in lieu of DOELAP
accreditation, would maximize private sector competition for DOE
contracts. DOE has not accepted the commenters' recommendations because
NVLAP accreditation does not meet DOE's requirement for an external
dose monitoring program. DOELAP accreditation covers both the
facility's and the processor's quality assurance program, whereas NVLAP
only deals with the dosimetry processor. The commenter's reference to
the NRC's use of NVLAP accreditation for dosimetry processors ignores
the fact that NRC has the resources to perform frequent on-site
inspections of a facility's dosimetry program. In the absence of such
resources at DOE facilities, DOE relies upon the DOELAP accreditation
to ensure that a facility's personnel dosimetry program provides
accurate results.

[[Page 59669]]

DOE received comments on its proposal to require DOELAP
accreditation, exception from accreditation under DOELAP, or DOELAP
equivalency, for radiobioassay programs that would satisfy the internal
dose monitoring program requirement in the rule. The commenters argued
that it would be premature to impose this requirement because DOE has
not completed the process for developing accreditation standards for
radiobioassay programs. As discussed in connection with Sec. 835.101,
concerning the effective date of the rule, DOE has responded to these
concerns by extending the deadline for complying with this provision to
January 1, 2002. In any event, Sec. 835.402(d) provides for Secretarial
Officer approval of radiobioassay programs that are not accredited
under DOELAP.
Several commenters objected to proposed Sec. 835.402(e), which
would have required Secretarial Officer approval of personnel dosimetry
and radiobioassay programs that do not comply with the latest edition
of DOE's technical standards governing program accreditation. They
argued that incorporation by reference of the technical standards was
inappropriate because the requirements in the technical standards had
not been proposed for public comment in a rulemaking. In light of these
comments, DOE has deleted the reference to DOE's technical standards
for accreditation in the regulatory text of the final rule. DOE does
not intend to codify the accreditation standards through this
rulemaking. DOE technical standards are guidance documents to assist
contractors in implementing regulatory requirements. As a matter of
policy (DOE P 450.2A, May 15, 1996), DOE routinely seeks public
comments on guidance documents issued to implement environment, safety
and health requirements at DOE sites. On April 24, 1997, DOE published
a notice of availability of draft guides and technical standards for
the Occupational Radiation Protection Program (62 FR 19940). At that
time, DOE invited public comment on draft technical standard,
``Department of Energy Laboratory Accreditation Program
Administration,'' which includes requirements for personnel dosimetry
and radiobioassay program accreditation. The revised regulatory
provisions will accomplish DOE's purpose of providing that programs
which DOE accredits, or excepts from accreditation, under DOELAP will
satisfy the requirements in this rule for programs that are implemented
to demonstrate compliance with Sec. 835.402(a) and (c). Accreditation
under DOELAP will obviate the need for contractors to secure approval
of the Assistant Secretary for Environment, Safety and Health.
Final Rule
In the final rule DOE has revised Sec. 835.402(b) and (d) to
provide that contractors may demonstrate the adequacy of external and
internal dose monitoring programs, respectively, by submitting their
programs to the Secretarial Officer responsible for environment, safety
and health for approval in lieu of accreditation or exception from
accreditation under the DOELAP. Alternative programs will be approved
if their performance is demonstrated to be substantially equivalent to
that of accredited programs. This change makes unnecessary, and DOE has
deleted, proposed Sec. 835.402(e), which would have required
Secretarial Officer approval of programs not complying with the latest
edition of the technical standards for DOELAP accreditation.
DOE has adopted the other changes as proposed, with minor editorial
corrections.
4. Air Monitoring
Proposed Amendment
DOE proposed to revise the Sec. 835.403(a)(1) air sampling
requirement to be based on potential individual exposures in derived
air concentration (DAC)-hours in a year rather than a percentage of the
annual limit on intake (ALI) because the values provided in appendices
A and C of 10 CFR part 835 are listed as DACs. DOE proposed to add
Sec. 835.403(a)(2) to require that air sampling be performed when
respiratory protective devices are prescribed to protect individuals
from exposure to airborne radionuclides. DOE also proposed an editorial
change to delete Sec. 835.403(b), eliminating redundancy with
Sec. 835.401(b).
To enhance air monitoring programs, DOE proposed to provide more
practical and technically accurate criteria at Sec. 835.403 for the use
of real-time air monitors based on potential releases that would exceed
a defined threshold exposure levels of 40 DAC-hours in a week. In a
related change, DOE proposed to replace the term ``continuous air
monitor'' with the term ``real-time air monitor'' with supporting
changes to the definitions provided at Sec. 835.2(a). DOE also proposed
to add a definition of the term ``week'' at Sec. 835.2(a).
Summary of Public Comments and Disposition
DOE received a number of comments indicating that the proposed
revision of the requirements for real-time air monitoring was unclear
and did not acknowledge the actual capabilities of available monitors.
Other commenters indicated that the proposed definition of the term
``week,'' based upon a period beginning on Monday, might cause
unnecessary changes in existing schedules for real-time air monitor
filter changes. Several commenters indicated that the proposed
provisions for air sampling when respiratory protective devices are
prescribed could be construed to mean that an air sample must be taken
each time an individual enters an area wearing a respiratory protective
device.
DOE received comments indicating that the existing criterion based
upon the percentage of an ALI was more appropriate for prospective
establishment of air monitoring programs. DAC-hours are related to the
fraction of an ALI in a consistent and fixed manner; therefore,
potential exposures in units of DAC-hours are an appropriate basis for
prospectively determining the need for air sampling.
Final Rule
As suggested through public comments, DOE clarified the mandatory
airborne radioactivity monitoring criteria in the final rule. Section
835.403(a) of the final rule requires the implementation of air
sampling programs in areas in which an individual is expected to be
exposed in excess of 40 DAC-hours in a year. The final rule clarifies
that airborne radioactivity monitoring during use of respiratory
protective equipment is required ``as necessary'' to characterize the
hazard. This provision is consistent with requirements imposed by both
the NRC and the Occupational Safety and Health Administration (OSHA)
(see 10 CFR 20.1703(a)(3), ``Use of individual respiratory protection
equipment,'' and 29 CFR part 1910, ``Occupational Safety and Health
Standards,'' Sec. 1910.134(d)(1)(iii), respectively).
The Sec. 835.403(b) criterion for real-time air monitoring is based
upon the need to alert potentially exposed individuals of the need for
action to reduce or terminate exposures to airborne radioactive
material. This approach provides more flexibility for implementation on
a site-and facility-specific basis, taking into account realistic event
scenarios, source terms, and instrument capabilities. This requirement
acknowledges the wide

[[Page 59670]]

variety of configurations and hazards associated with DOE activities
and the limitations of currently available real-time air monitoring
equipment. DOE's implementing guidance provides an acceptable approach
for achieving compliance with this provision. The restructuring of the
requirements for real-time air monitoring rendered proposed
Sec. 835.403(c) redundant; DOE has therefore deleted this provision.
In support of the revised provisions, Sec. 835.2(a) provides
definitions for the terms ``derived air concentration-hour (DAC-
hour),'' ``real-time air monitoring,'' ``respiratory protective
device,'' and ``week'' which are used at Sec. 835.403. In consideration
of public comments, DOE has revised the proposed definition of the term
``week'' to omit a mandatory starting day. In addition, DOE has deleted
the definitions of ``ambient air'' and ``continuous air monitor''
because these terms are no longer used in 10 CFR part 835.
5. Contamination Monitoring
In consideration of public comments received, DOE has revised the
Sec. 835.404 requirements for contamination monitoring and control and
moved these requirements to Sec. 835.1102. The proposed changes, public
comments, and final rule provisions are discussed in full in Section
II.J of this Notice of Final Rulemaking.
6. Receipt of Packages of Radioactive Material
Proposed Amendment
DOE proposed to add requirements at Sec. 835.405 for surveys of
packages of radioactive material received from radioactive material
transportation to ensure adequate protection is provided to
individuals, including warehouse and office workers, who may be exposed
to these materials. The proposed provisions included requirements for
taking possession of radioactive material packages from transport and
performing surveys of these packages. At 835.405(d), DOE proposed to
establish requirements for completion of the necessary surveys within
three hours of receipt of the package (if received during working
hours) or within three hours of the beginning of the following working
day (if received after working hours). The proposed requirements are
similar to NRC requirements at 10 CFR 20.1906.
Summary of Public Comments and Disposition
Several commenters suggested that the time provision included in
the proposed amendment was unnecessarily stringent. During evaluation
and resolution of these comments, DOE determined that the nature of
many of its sites and facilities and the stringency of the requirements
for radioactive material transportation indicate that this observation
is accurate.
Final Rule
In deference to the comments received and in recognition of the
variety of sites and facilities subject to 10 CFR part 835, DOE has
extended the time required for monitoring packages received from
radioactive material transportation to 8 hours after the beginning of
the working day following the receipt of the package. In practice, the
actual interval may also be constrained by the requirements for
individual monitoring and radiation safety training at Secs. 835.402
and 835.901 respectively, and by the ALARA requirements at
Sec. 835.101.
As used in Sec. 835.405, a ``working day'' is considered to be the
interval of time within each 24 hour period during which the building
or area in which the received package is stored is routinely occupied
or available for operations other than emergency activities. For
example, if the received package is stored in a warehouse awaiting the
required monitoring and that warehouse is occupied or accessible to
shipping and receiving personnel, then the working day is that period
of time within each 24 hour period during which the shipping and
receiving personnel are scheduled to be working or to have ready access
to the warehouse. The working day does not include periods during which
shipping and receiving personnel would have to return to work on a non-
scheduled basis to address emergent issues requiring their attendance.

E. Entry Control Program, Subpart F

Proposed Amendment
DOE proposed more detailed provisions for written work
authorizations at Sec. 835.501(e) to address operational occurrences
throughout the DOE complex. DOE also proposed to revise Sec. 835.502 to
add measures for control of access to high radiation areas. The
proposed control measures were consistent with those previously
established in the Manual and included requirements for use of a
supplemental dosimetry device and appropriate area surveys.
Summary of Public Comments and Disposition
Commenters expressed concern that the proposed Sec. 835.501(e)
entry control requirements were inappropriate for relatively minor
hazards present in areas such as radiation areas. With regard to the
proposed high radiation area access control requirements, commenters
also indicated that devices capable of rendering an immediate
indication of an individual's integrated dose resulting from neutron
radiation are not commercially available. Several commenters also
indicated that the proposed Sec. 835.502(c) requirements for control of
access to very high radiation areas could be taken to mean that the
required controls must be impenetrable. DOE agrees that these issues
require clarification.
Final Rule
Regarding low-hazard radiological areas, the final rule provides
significant flexibility for implementation of access controls on a
facility-and hazard-specific basis. The written authorizations required
by 835.501(d) must specify radiation protection measures consistent
with existing and potential hazards. DOE does not intend for this
provision to establish a global requirement for the development and
implementation of radiological work permits to address all entries into
radiological areas. The written authorization may take the form of
generally applicable procedures, as appropriate. Guidance on the use of
written authorizations will be published in DOE's Radiological Control
Standard. As a result of the deletion of specific requirements for
written procedures (discussed in Section II.B.3 of this Notice of Final
Rulemaking), DOE has redesignated proposed Sec. 835.501(e) as
Sec. 835.501(d) in the final rule.
To address the unavailability of devices capable of providing an
immediate indication of an individual's dose resulting from exposure to
neutron radiation in a high radiation area, Sec. 835.502(a)(2) allows
for supplemental dosimeters or other means of immediately estimating or
measuring the individuals' integrated doses during the area entry. The
other means may include knowledge of the area exposure rates combined
with tracking of individual access times. Consistent with the existing
definition of the terms ``high radiation area'' and ``very high
radiation area,'' DOE has revised the proposed requirements to indicate
that the required devices and measures must be capable of estimating
the affected individual's deep dose equivalent, rather than the dose
equivalent. DOE also provided an editorial correction at
Sec. 835.502(b)(2), substituting the defined term ``individuals'' for
the undefined term ``personnel.''

[[Page 59671]]

In response to public comments, DOE has clarified Sec. 835.502(c)
to indicate that the additional controls required for very high
radiation areas need to be sufficient to prevent ``unauthorized or
inadvertent'' entries rather than to prohibit entry into the area.

F. Posting and Labeling, Subpart G

1. Controlled Area and Radiological Area Posting Requirements
Proposed Amendment
DOE proposed several changes to clarify and simplify requirements
for area hazard posting and to provide additional flexibility in
implementing these requirements. In acknowledgment of the differing
hazards and controls associated with removable and fixed radioactive
contamination, DOE proposed to revise the Sec. 835.2(a) definitions of
``contamination area'' and ``high contamination area'' to be based upon
removable surface contamination levels only and to clearly establish
these areas based on accessibility rather than the general reference to
``working areas'' which appeared at Sec. 835.601(a). DOE proposed a
similar change to the Sec. 835.2(a) definition of the term ``airborne
radioactivity area.'' DOE also proposed to move the controlled area
maximum dose expectation from the Sec. 835.2(a) ``controlled area''
definition to the Sec. 835.602(a) controlled area posting provision.
Because radiological area terms are defined at Sec. 835.2(a), DOE
proposed to remove redundant definitions imbedded in the posting
provisions at Sec. 835.603. DOE also proposed to delete the requirement
for DOE approval of warning signs from Sec. 835.601(b) because
acceptable signs are described in DOE's implementing guidance and DOE
did not intend to establish a formal process for approval of
radiological postings and labels. In addition, DOE proposed to expand
its provision at Sec. 835.601(e) (redesignated as Sec. 835.601(d) in
the proposed amendment) allowing modification of postings and labels to
accommodate special considerations of DOE activities involving private
residences to also include private businesses.
Consistent with NRC requirements published at 10 CFR 20.1902, DOE
proposed to amend Sec. 835.603(b), (d), and (f) to allow use of the
words ``Caution'' or ``Danger'' on postings for high radiation, high
contamination, and airborne radioactivity areas, respectively. This
proposed change would accommodate the wide range of radiological
conditions that may be present in these areas to provide some degree of
flexibility in their posting.
Proposed Sec. 835.604(a) would create an exception from posting
requirements for periods of less than 8 continuous hours as long as the
radiological area is placed under continuous observation and control of
a person able to implement the required access and exposure control
measures. This exception would cover temporary conditions or activities
such as maintenance, repair or cleanup activities so long as the
absence of posting is kept to within the prescribed time and the
prescribed control measures are implemented.
DOE also proposed to add Sec. 835.604(b) and (c) delineating
specific exceptions from the radiological area posting requirements of
Sec. 835.603, recognizing that compensatory measures may be implemented
that would obviate the need for area posting. The proposed exceptions
are similar to those established by the NRC at 10 CFR 20.1903.
Summary of Public Comments and Disposition
DOE received several comments indicating that the proposed
definition of the term ``airborne radioactivity area'' should include
an exposure-based criterion (i.e., based upon potential individual
exposures in term of dose, percentage of an ALI, or DAC-hours) instead
of, or in addition to, the existing criterion based upon the absolute
airborne radioactivity concentration. DOE agrees that this issue
requires clarification.
Some commenters expressed support for the current 10 CFR part 835
posting provisions based upon the identification of ``working areas.''
However, the term ``working areas'' is not defined and DOE does not
believe that posting of only ``working areas'' provides adequate
protection of individuals approaching or entering radiological areas in
which there is no work in progress. The commenters did not provide any
evidence that such a practice would provide for adequate protection.
DOE received a number of comments on the proposed allowance for the
use of ``Caution'' or ``Danger'' on certain radiological hazard warning
signs. Commenters indicated that the terms ``Caution'' and ``Danger''
are not interchangeable and that the term ``Danger'' generally carries
a connotation of greater hazard than ``Caution.'' While DOE agrees with
these observations, DOE believes that, in the continuum of possible
radiological conditions associated with DOE activities, the threshold
at which ``Danger'' becomes more appropriate than ``Caution'' most
likely lies somewhere within those conditions described in the
Sec. 835.2(a) definitions of ``airborne radioactivity area,'' ``high
radiation area,'' and ``high contamination area.'' Furthermore,
individual protective actions required for entry into these areas are
dependent upon the radiological area title, not the ``Caution'' or
``Danger'' heading. DOE believes that the demarcation between those
conditions requiring ``Caution'' and ``Danger'' headings is best left
to the discretion of those responsible for individual DOE activities to
ensure that activity-specific conditions are addressed. Therefore, DOE
believes that it is appropriate to allow flexibility in the use of the
``Caution'' and ``Danger'' headings for posting of high radiation, high
contamination, and airborne radioactivity areas.
Some commenters indicated that provisions for alternative measures
for DOE activities conducted at private residences and businesses
should be extended to DOE activities conducted on state- and Federally-
owned lands. However, DOE does not believe that considerations of
individual property rights and property value impacts extend to DOE
activities conducted on state and Federal lands. Furthermore, the great
majority of DOE activities are conducted at state-and Federally-owned
sites. Such an exception would negate the specific posting requirements
for essentially all DOE activities.
Commenters generally supported DOE's proposed exceptions to the
radiological posting requirements. However, comments indicated that the
proposed Sec. 835.604(c) exception for packages received from
radioactive material transportation should not apply to damaged
packages. DOE agrees that this issue requires specific attention.
Final Rule
DOE has revised the Sec. 835.2(a) definition of the term ``airborne
radioactivity area'' such that posting and control of these areas will
be required when the airborne radioactivity concentration exceeds the
DAC values provided in appendix A or C of 10 CFR part 835 or when an
individual present in the area without a respiratory protective device
could be exposed to airborne radioactive material in excess of 12 DAC-
hours in a week. This definition is similar to that provided by the NRC
at 10 CFR 20.1003.
DOE has codified the changes to the radiological hazard posting
requirements as proposed. In the final rule, DOE has deleted
Sec. 835.601(a) to eliminate redundancy. As a result, Sec. 835.601(b)--
(d) have been redesignated as Sec. 835.601(a)--(c), respectively. The
Sec. 835.604 radiological

[[Page 59672]]

area posting exceptions do not apply to the radiological area entry
control requirements established at Secs. 835.501 and 835.502 or to the
radiation safety training requirements at Sec. 835.901. In response to
public comments, DOE has restricted the scope of the posting exception
for packages received from radioactive material transportation to those
packages received in a non-degraded condition.
2. Radioactive Material Area Posting
Proposed Amendment
To ensure that individuals entering controlled areas but not
entering radiological areas are adequately protected, DOE proposed
requirements for posting of radioactive material areas similar to the
existing requirements of DOE N 441.1 (extended by DOE N 441.2 and DOE N
441.3). The proposed posting requirements were based on quantities of
radioactive materials that exceeded 10 times the threshold values
proposed in appendix E of 10 CFR part 835 and were similar to NRC
requirements at 10 CFR 20.1902. DOE proposed to define ``radioactive
material area'' and include this term in the definition of
``radiological area'' at Sec. 835.2(a) and establish requirements for
posting radioactive material areas at Sec. 835.603(g). DOE also
proposed exceptions to the radioactive material area posting
requirements at Sec. 835.604(b).
Summary of Public Comments and Disposition
DOE received numerous comments on these proposed requirements. The
major issues included: (1) The threshold values (based on ten times the
activity levels provided in proposed appendix E of 10 CFR part 835)
which would require posting of radioactive material areas were overly
restrictive; (2) the hazards present in a radioactive material area, as
defined, did not warrant the imposition of specific entry controls and
radiation safety training programs required for radiological areas; (3)
posting of radioactive material areas should not be required when the
radioactive material consists solely of activated structures or
installed components; and (4) there is no apparent difference between
the hazards in a controlled area and a radioactive material area, as
defined at Sec. 835.2(a).
DOE agrees that: (1) The proposed appendix E values, as a basis for
defining a radioactive materials area, were somewhat restrictive; (2)
posting of radioactive material areas should not be required when the
material solely consists of structures or installed components which
have been activated; and (3) the hazards present in a radioactive
material area, as defined, are not always significantly different than
the hazards in a controlled area and would not always warrant
imposition of the entry controls required for the defined radiological
areas.
Final Rule
DOE recognizes the fact that the radiological conditions expected
in radioactive material areas, as proposed, are less hazardous than
those present in radiological areas as defined in the original rule.
Accordingly, a less restrictive approach to radiological protection is
warranted. In the final rule, DOE has omitted the term ``radioactive
material area'' from the Sec. 835.2(a) definition of ``radiological
area.'' Therefore, radioactive material areas will not be subject to
the specific entry control provisions of Sec. 835.501. As a result of
the codification of hazard-based radiation safety training requirements
at Sec. 835.901 (discussed in Section II.H. of this Notice of Final
Rulemaking), applicability of the radiation safety training
requirements for entry into radioactive material areas will be subject
to an evaluation of the activities to be performed in the area and the
degree of actual or potential exposure to radiological hazards.
Section 835.603(g) of the final rule requires posting of
radioactive material areas at the entry points to accessible areas
where there exist items or containers of radioactive material in excess
of the revised appendix E values as published, rather than ten times
the appendix E values, as proposed. The basis for the revised appendix
E values is discussed in detail in Section II.K of this Notice of Final
Rulemaking. Because of the minimal hazards present in radioactive
material areas, DOE has omitted the allowance for the use of the
``Danger'' heading from the Sec. 835.603(g) requirement for posting of
radioactive material areas.
DOE has included proposed exceptions to the radioactive material
area posting requirement at Sec. 835.604. In response to the comments
received, DOE has included another posting exception for areas in which
the radioactive material consists solely of structures or installed
components which have been activated, such as activation by exposure to
neutron radiation or radiation incident to operation of a particle
accelerator. DOE expects that this exception will most commonly be
applied to building and shielding structures associated with nuclear
reactors and particle accelerators. Note that these structures and
components are not excepted from the radiological area posting
requirements.
Because the term ``radioactive material area'' has been deleted
from the Sec. 835.2(a) definition of the term ``radiological area,''
DOE has revised the heading of Sec. 835.603 and the provisions of
Sec. 835.602(a) to reflect the inclusion of the radioactive material
area posting requirements in subpart G of 10 CFR part 835.
3. Radioactive Material Labeling
Proposed Amendment
To augment and clarify existing requirements, DOE proposed to add
requirements for labeling items and containers of radioactive materials
at Sec. 835.605, with appropriate exceptions being proposed at
Sec. 835.606. These proposed provisions are similar to those in the
Manual and consistent with requirements imposed by the NRC at 10 CFR
20.1904 and 20.1905.
Summary of Public Comments and Disposition
DOE received comments indicating that, because the proposed
labeling provisions were based upon the proposed appendix E total
activity values, they were not adequate to ensure proper labeling of
items having removable contamination exceeding the 10 CFR part 835
appendix D surface radioactivity values. However, even though labeling
of contaminated items is not explicitly required by the rule, adequate
controls are established under Secs. 835.1101 and 835.1102 which will
require that either labeling or equivalent measures be implemented to
inform individuals of the contamination hazard.
DOE also received comments on the proposed exceptions from the
labeling requirements. Commenters indicated that exceptions should also
be provided for nuclear weapons and their components, for inaccessible
radioactive material, and for activated building components. DOE agrees
with these comments.
Final Rule
DOE has codified the proposed requirements for labeling with minor
editorial changes. Section 835.605 requires labeling of radioactive
items and containers of radioactive materials. Section 835.606 provides
an exception from the labeling requirements for items and containers
having a total activity of less than \1/10\ of the appendix E values
rather than at the proposed appendix E values because DOE has
reevaluated the appendix E values to address concerns regarding the
stringency of the proposed

[[Page 59673]]

requirements for accountable sealed radioactive sources (see discussion
in Section II.K. of this Notice of Final Rulemaking). Because
Secs. 835.1101 and 835.1102 establish appropriate requirements for
control of contaminated material and equipment, DOE has not included
specific requirements for labeling of contaminated items in this
subpart.
In response to the comments received, DOE has revised the
radioactive material labeling exceptions proposed at Sec. 835.606 to
include nuclear weapons and their components and inaccessible
radioactive material. In addition, the exception from the Sec. 835.601
design and color specifications for labels applied to sealed
radioactive sources, proposed at Sec. 835.1201(b), has been codified at
Sec. 835.606(b).

G. Records and Reports, Subparts H and I

Proposed Amendment
DOE proposed a number of changes to its requirements for records
demonstrating compliance with 10 CFR part 835. The proposed changes
included:
1. Revising Secs. 835.203(a) and 835.702(b) to provide that, when
monitoring is performed, but not required by Sec. 835.402, internal and
external doses must be summed and records must be maintained only if
the doses determined by the non-mandatory monitoring exceed the
thresholds of Sec. 835.402. This proposed change was intended to reduce
the burden of recordkeeping consistent with the recommendations in the
Guidance to Federal Agencies.
2. Deleting the words ``caused by contamination on the skin'' from
Sec. 835.702(b) to ensure consistency with the referenced requirements
at Sec. 835.205.
3. Revising Sec. 835.702(c)(1) to provide that records must be
sufficient to demonstrate compliance with all of the subpart C dose
limits. This provision is consistent with Sec. 835.701(a).
4. Deleting the requirement at Sec. 835.702(c)(4)(iii) to record
the estimated intake associated with internal dose assessments. This
change was necessary because determination of the individual dose
equivalent resulting from intakes of certain radionuclides, such as
tritium, does not require determination of the estimated intake.
5. Revising Sec. 835.702(d) and (e) such that acceptance of written
estimates of an individual's prior occupational dose is based upon an
inability to obtain formal records, rather than the absence of those
records. DOE also proposed to revise Sec. 835.702(d) consistent with
the previously discussed clarification of the components of
occupational dose and to reference DOE Orders for authorizing emergency
exposures. DOE further proposed to revise Sec. 835.702(e) to indicate
that efforts to obtain records of prior years doses were necessary only
for those individuals monitored in accordance with Sec. 835.402.
6. Technical and editorial changes to clarify the recordkeeping
provisions and to ensure consistency with other changes included in
subparts J and M. DOE also proposed to revise Sec. 835.704(d) to
require documentation of revocations of declarations of pregnancy.
7. Because some individuals may not have social security numbers,
DOE proposed to revise Sec. 835.801(a) to allow for use of another
unique identification number in reports associated with such
individuals.
Summary of Public Comments and Disposition
DOE received a number of comments indicating that the results of
all individual monitoring that is performed should be recorded. DOE
agrees that this approach has merit. Furthermore, DOE has provided
adequate flexibility under the individual monitoring requirements of
Sec. 835.402 to eliminate any onerous administrative burdens resulting
from records of trivial doses.
DOE received comments indicating that the term ``accident'' was not
clearly defined, resulting in uncertainty about the proper application
of the individual monitoring records requirement of Sec. 835.702(a).
DOE received comments suggesting that the proposed change to
Sec. 835.702(e) was not needed because, in the absence of a cumulative
dose limit, written estimates would not serve any substantive purpose.
DOE agrees with this observation.
Final Rule
DOE has revised Sec. 835.702(a) to delete reference to accidents
and to specify that records be maintained to document unplanned doses
exceeding the monitoring thresholds of Sec. 835.402.
In consideration of the comments received, DOE has not included the
proposed changes to Sec. 835.702(b) in the final rule.
Consistent with the changes to Sec. 835.1302 discussed in Section
II.L of this Notice of Final Rulemaking, DOE has revised
Sec. 835.702(d) to reference the emergency exposure authorization
measures included in that section.
DOE has also not included in the final rule the proposed change to
Sec. 835.702(e) allowing written estimates of prior years doses. DOE
has included the remaining changes with minor editorial corrections to
enhance clarity.
DOE's review of 10 CFR part 835 revealed the fact that
Sec. 835.702(c)(2) inappropriately invoked the requirements of certain
DOE Orders. The applicability of these Orders is established through
DOE contractual processes. DOE has revised the text to delete this
invocation of DOE Orders.
Consistent with changes discussed elsewhere in this Notice of Final
Rulemaking, DOE has revised the heading of Sec. 835.703 and language at
Sec. 835.703(a) and (e) to eliminate the use of the term ``workplace''
and to reference those subparts of the rule (subparts E and L) that
establish monitoring requirements.
Because individuals generally do not record the results of
contamination monitoring upon exiting contamination and high
contamination areas and there is little perceived value in maintaining
such records, DOE has clarified Sec. 835.703(a) to permit such a
practice. In consideration of comments on the specificity of the
proposed Sec. 835.703(c) recordkeeping provisions, DOE has not included
the second portion of proposed Sec. 835.703(c) regarding informational
content of these records in the final rule. DOE has revised the
recordkeeping requirements of Sec. 835.703(d) consistent with the
changes made to Sec. 835.401.
In recognition of the need to record the estimated date of
conception for a declared pregnant worker (in order to determine
compliance with the applicable dose limit for the embryo/fetus), DOE
has clearly stated this as a requirement at Sec. 835.704(d). Also,
consistent with the changes made at Sec. 835.401, DOE has deleted the
term ``workplace'' from Sec. 835.704(e).

H. Radiation Safety Training, Subpart J

1. Training Course Content and Administration
Proposed Amendment
When 10 CFR part 835 was originally developed, the detailed
radiation safety training requirements provided in the Manual obviated
the need to specify minimum training course content in the rule.
Because the Manual is no longer mandatory, DOE proposed to specify
minimum training course content at Sec. 835.901(b). Also at
Sec. 835.901(b), DOE proposed requirements that would allow more
liberal acceptance of an individual's previous radiation safety
training.
DOE proposed to further consolidate and simplify its requirements
for

[[Page 59674]]

radiation safety training. Under the proposed amendment, the level of
training required would be based upon the areas entered by the
individual unescorted, the activities performed, and the likely doses,
rather than the individual's classification as a member of the public,
general employee, or radiological worker. Implementation of this
hierarchical approach to training would result in the appropriate level
of radiation safety training for general employees, with a higher level
of training required for radiological workers. This approach is
consistent with field experience and feedback from DOE operating
contractors and is similar to the approach previously taken by DOE in
DOE Order 5480.11 and currently taken by the NRC in 10 CFR part 19,
``Notices, Instructions and Reports to Workers: Inspection and
Investigations.'' DOE proposed to eliminate the examination requirement
for individuals who are not permitted unescorted access to radiological
areas and who do not perform unescorted assignments as a radiological
worker. DOE also proposed to provide specific requirements at
Sec. 835.901(f) for individuals who may act as escorts of individuals
who have not completed required training.
Summary of Public Comments and Disposition
Public comments generally endorsed DOE's proposed hierarchical
approach to radiation safety training. However, some commenters were
concerned that the proposed approach, which would require an individual
to complete radiation safety training prior to being occupationally
exposed to radiation, would needlessly penalize those facilities that
conduct training inside the controlled area or in other areas in which
trivial occupational exposures may occur. However, as proposed,
Sec. 835.901(c) (Sec. 835.901(b) in the proposed rule) requires
training to the extent appropriate to the individual's degree of
exposure to potential radiological hazards. Under the circumstances
described, the ``extent appropriate'' may be minimal (perhaps a
briefing on appropriate alarm responses).
Comments indicated that the proposed Sec. 835.901(b)(3) requirement
to provide training on ``measures implemented at the facility to
minimize exposures'' was inappropriate, as there is no requirement to
``minimize exposures.'' Other comments indicated that it was
unnecessary for the required training to be appropriate to
``anticipated and actual'' work assignments; training appropriate to
the individual's work assignments should be sufficient. DOE agrees with
these observations.
DOE received comments indicating that the existing Sec. 835.2(a)
definition of the term ``radiological worker'' was overly restrictive
and unclear due to its inclusion of individuals who operate radiation
producing devices. Commenters indicated that this inclusion could
require extensive training and testing of individuals who operate
devices emitting nominal amounts of radiation or those who operate
devices such as televisions and computer monitors. However, consumer
devices that emit nominal amounts of radiation are clearly excluded
from the scope of 10 CFR part 835 under the provisions of 835.1(b)(6)
and the related Sec. 835.2(a) definition of ``background.'' Although
the proposed provisions of Sec. 835.901(d) (see Sec. 835.901(b) in the
final rule) would require training and testing of individuals who
operate other radiation producing devices, the provisions of
Sec. 835.901(c) (see Sec. 835.901(b) in the proposed rule) would only
require that such training be appropriate to the extent of the
individual's potential exposure to radiological hazards.
Although many commenters favored DOE's proposed relaxation of the
examination requirements, other commenters indicated that an
examination should be required for all forms of training to ensure that
the student has an understanding of the material presented. DOE agrees
that examinations are useful tools for assessing the retention of
information by the student. However, as stated in DOE's Notice of
Proposed Rulemaking, the radiological hazards present in those portions
of controlled areas which are outside of radiological areas are so
minimal that the information needed prior to entry does not warrant a
regulatory requirement for an examination. However, the absence of this
regulatory requirement does not preclude DOE's operating entities from
administering an examination.
Several commenters indicated that DOE's proposed requirements for
use of escorts in lieu of training were unclear because of the use of
the phrase ``where an escort is required.'' These commenters correctly
pointed out that the proposed Sec. 835.901(c) and (d) would permit, but
would not explicitly require, the use of escorts.
Other commenters were concerned that the retraining requirements of
proposed Sec. 835.901(g) might require individuals to complete the full
introductory radiation safety training course every 24 months. DOE
agrees that this issue requires clarification.
Final Rule
As proposed, DOE has reformatted subpart J into one section in the
final rule, codifying an approach similar to that previously published
in the Manual and eliminating redundancy. DOE has omitted proposed
Sec. 835.901(a) from the final rule because that paragraph would not
establish any substantive requirements. DOE has also eliminated the
examination requirement for individuals who are not permitted
unescorted access to radiological areas and who do not perform
unescorted assignments as a radiological worker, as proposed. Although
not a regulatory requirement, DOE contractors may still choose to
administer examinations or to undertake other means of assessing
individual understanding, such as interactive classroom discussions.
DOE has included at Sec. 835.901(c) (Sec. 835.901(b) in the
proposed amendment) a requirement for training to be provided to the
extent appropriate to the individual's work assignment. DOE has also
included at Sec. 835.901(c)(3) (proposed Sec. 835.901(b)(3)) a
requirement that the training address measures used to ``manage doses
and maintain doses ALARA,'' rather than ``minimize'' doses. This
modification makes clear the distinction between maintaining doses well
below the dose limits using the ALARA process and maintaining doses
well below the dose limits by minimizing doses regardless of other
considerations.
DOE has established requirements applicable to instances in which
escorts are used, rather than required, in lieu of training at revised
Sec. 835.901(d) (Sec. 835.901(f) in the proposed amendment).
With regard to the requirements for biennial retraining, DOE has
eliminated the use of the undefined term ``retraining.'' Section
835.901(e) of the final rule requires affected individuals to complete
the required training at least every 24 months. Like the initial
training, this follow-on training is for individuals subject to the
requirements of Sec. 835.901(a) and (b), and is subject to the
provisions of Sec. 835.901(c). Thus, the content and scheduling (prior
to the end of the two year time interval) of such training needs to
incorporate considerations of the individual's prior training, work
assignments, and degree of exposure to radiological hazards, as well as
significant changes to radiation protection policies and procedures
that affect the individual.

[[Page 59675]]

2. Radiological Control Technician Training [Sec. 835.903]
DOE also proposed changes to the 10 CFR part 835 requirements for
training of radiological control technicians. These changes are
discussed in detail in Section II.B.3. of this Notice of Final
Rulemaking.

I. Design and Control, Subpart K

Proposed Amendment
Experience in implementing programs to ensure compliance with 10
CFR part 835 revealed that the design objectives currently included at
Sec. 835.1002(b) and (c) may not be practical in developing certain
modifications to existing facilities. Therefore, DOE proposed to delete
Sec. 835.1002(b) and (c). DOE also proposed to move the remaining
requirements in paragraphs (a) and (d) of Sec. 835.1002 to
Sec. 835.1001.
The design criteria established at Sec. 835.1003(a) did not include
all of the occupational dose limits of Sec. 835.202, e.g. the lens of
the eye dose limit established at Sec. 835.202(a)(3). This omission
implied that the design of new facilities or modification of existing
facilities could include design features that would result in doses
exceeding the lens of the eye dose equivalent limit of 15 rem
established at Sec. 835.202. DOE proposed to correct this omission by
including all applicable occupational dose limits established at
Sec. 835.202 in this section.
Summary of Public Comments and Disposition
Comments indicated that the phrase ``as low as is reasonably
achievable'' at Sec. 835.1001(a) could be construed to have a meaning
that differed from ``ALARA'' as defined at Sec. 835.2(a).
Many commenters stated that DOE should retain the numerical design
objectives provided at Sec. 835.1002. Although achievement of the
numerical design objectives may not be practical in some cases
(particularly for minor modifications of existing facilities), the
design objectives are important components of the ALARA process. Public
comments suggested that elimination of the numerical design objectives
could result in confusion over when to apply quantitative design
objectives and the appropriate magnitude of those objectives. Comments
also indicated that Sec. 835.1003(b) did not establish any substantive
requirements beyond those established in subpart E of 10 CFR part 835.
DOE agrees with these observations.
Final Rule
At Sec. 835.1001(a), DOE has substituted ``ALARA'' for ``as low as
is reasonably achievable.''
Because procedural requirements are a type of administrative
control, DOE has deleted the term ``procedural requirements'' from
Sec. 835.1001 and deleted the term ``procedures'' from Sec. 835.1003 to
eliminate redundancy. For consistency, DOE has revised the heading of
Sec. 835.1003 to read ``Workplace Controls.''
Because the use of quantitative design objectives plays a
significant role in the ALARA process as it applies to facility design,
DOE has chosen to defer this critical change until more experience is
gained through implementation of these regulatory provisions. DOE has
accepted the public comments and has retained the numerical design
objectives of Sec. 835.1002; however, DOE has retained the proposed
editorial change at Sec. 835.1002 (proposed Sec. 835.1001(c))
substituting the term ``existing facilities'' for the term ``old
facilities.'' DOE will address its concerns with the application of
these requirements through enhanced guidance for achieving compliance.
DOE has included in the final rule the proposed change related to the
lens of the eye dose limit. In consideration of public comments, DOE
has also deleted Sec. 835.1003(b) from the final rule.

J. Radioactive Contamination Control, Subpart L

Proposed Amendment
Consistent with the changes to the Sec. 835.2(a) definitions of the
terms ``contamination area'' and ``high contamination area,'' DOE
proposed changes to the Sec. 835.404 requirements for areas having only
fixed contamination exceeding the appendix D total surface
radioactivity values.
DOE proposed several changes to appendix D of 10 CFR part 835,
which provides mandatory surface radioactivity values for contamination
control. DOE proposed to add the word ``alpha'' after the values for
uranium isotopes in appendix D to clarify the applicability of these
values. DOE also proposed to add to appendix D of 10 CFR part 835 a
contamination control value of 10,000 disintegrations per minute per
100 square centimeters for surfaces contaminated with tritium and
Footnote 6 to explain the use of this value. The surface contamination
value would be used to determine the applicability of the Sec. 835.603
contamination hazard posting provisions and the Secs. 835.404 and
835.1101 contamination control provisions. DOE has prepared an
Environmental Assessment, available at DOE's Freedom of Information
Reading Room at the address provided above, that addresses this change
in detail.
DOE also proposed to move the existing requirements of
Sec. 835.1101(d) to Sec. 835.703(c) to consolidate recordkeeping
requirements and to add a new requirement for removal of radioactive
material labels from released materials and equipment at
Sec. 835.1101(d).
Summary of Public Comments and Disposition
Public comments were generally supportive of DOE's proposed changes
to the requirements for control of radioactive contamination. Public
comments also indicated that the recordkeeping requirements of proposed
Sec. 835.703(c) were overly prescriptive in comparison to related
requirements of the rule. Public comments also indicated that a literal
reading of Sec. 835.404(f) would indicate that the performance of
individual contamination monitoring by someone other than the
individual exiting a contamination or high contamination area (i.e.,
individual frisking by radiological control technicians) would be
contrary to 10 CFR part 835. DOE agrees with these observations.
Comments indicated that the related requirements of Secs. 835.404
and 835.1101 were confusing and possibly contradicting. The existing
provisions of Sec. 835.404 establish requirements for control of areas
contaminated by radioactive material; the provisions of Sec. 835.1101
establish similar requirements for materials and equipment contaminated
by radioactive materials. Upon reexamination of these requirements in
light of the comments received, DOE believes that there is opportunity
for simplification and clarification of the rule.
Final Rule
DOE has combined and simplified the requirements of Secs. 835.404
and 835.1101 in the final rule as follows:
a. Although the provisions of Sec. 835.404 were specifically
related to controlling the spread of contamination, they were located
in subpart E, which was entitled ``Monitoring in the Workplace.''
Therefore, DOE has moved these requirements, with revisions discussed
below, to subpart L.
b. Although the title of subpart L indicates that the subject
matter is related to ``Releases of Materials and Equipment from
Radiological Areas,'' the requirements are more specifically related to
retention and control of

[[Page 59676]]

contaminated materials in radiological areas. Therefore, DOE has
retitled subpart L, ``Radioactive Contamination Control.''
c. DOE has clarified and simplified the structure of
Sec. 835.1101(a).
d. DOE has retained paragraphs 835.1101(b) and (c) with minor
editorial clarifications. Consistent with the discussion in Section
II.B.3 of this Notice of Final Rulemaking regarding written procedures,
DOE has omitted the requirement for written procedures (formerly
Sec. 835.1101(c)(3)).
e. Because the existing requirements of Sec. 835.404(a) established
no substantive requirements, DOE has omitted this paragraph from the
final rule.
f. DOE has redesignated paragraph 835.404(b) as Sec. 835.1102(a) in
the final rule.
g. DOE has edited paragraph 835.404(c) and redesignated it as
Sec. 835.1102(b) in the final rule. DOE has omitted the provision
related to posting of contamination hazards (formerly
Sec. 835.404(c)(1)) because this provision is redundant with
Sec. 835.603(e) and (f).
h. DOE has edited paragraph 835.404(d) and redesignated it as
Sec. 835.1102(c) in the final rule. Consistent with the discussion in
Section II.B.3 of this Notice of Final Rulemaking regarding written
procedures, DOE has omitted the requirement for written procedures
(formerly Sec. 835.404(d)(5)).
i. Because of the changes to the Sec. 835.2(a) definitions of
``contamination area'' and ``high contamination area'' discussed above,
the areas discussed at Sec. 835.404(d) (i.e., those having fixed
contamination at levels exceeding the appendix D total contamination
values, but removable contamination levels below the appendix D
removable contamination values) would no longer be considered
radiological areas. This renders the provisions of Sec. 835.404(e)
redundant; therefore, DOE has omitted these requirements from the final
rule.
j. DOE has clarified Sec. 835.404(f) and redesignated it as
Sec. 835.1102(d).
k. DOE has revised the language at Sec. 835.404(g) for clarity and
redesignated it as Sec. 835.1102(e).
DOE has reconsidered its proposal to add Sec. 835.1101(d)
establishing requirements for removal of radioactive material labels
from released materials and equipment. Although DOE considers materials
and equipment meeting the requirements of Sec. 835.1101(a) to be
appropriate for release from radiological areas, such materials and
equipment are not necessarily ``non-radioactive'' and conditions may
arise under which retention of the radioactive material labels is
appropriate. DOE has therefore omitted this provision from the final
rule.
As before, the requirements of Sec. 835.1101 address release of
materials and equipment from radiological areas to controlled areas.
DOE requirements for release of materials and equipment from its
control are addressed in DOE environmental protection standards.

K. Control of Sealed Radioactive Sources, Subpart M

Proposed Amendment
DOE proposed to add subpart M to 10 CFR part 835 to establish
requirements for control of sealed radioactive sources. These
requirements would supersede similar requirements established in DOE
Notice 5400.9, ``Sealed Radioactive Source Accountability'' (extended
through DOE Notice 5400.13 and superseded by DOE N 441.1 through DOE N
441.3). DOE proposed to add the terms ``accountable sealed radioactive
source,'' ``sealed radioactive source,'' and ``source leak test'' at
Sec. 835.2(a) and to add recordkeeping requirements at Sec. 835.704(f).
DOE also proposed to add appendix E to 10 CFR part 835 to establish
threshold values for sealed radioactive source accountability,
radioactive material labeling, and radioactive material area posting.
Summary of Public Comments and Disposition
Although many commenters supported DOE's efforts to codify
requirements for sealed radioactive source control, several commenters
indicated that the accountability threshold values proposed for
inclusion in appendix E of 10 CFR part 835 were overly restrictive.
Commenters also indicated that the definition of ``sealed radioactive
source'' was too broad to allow for exclusion of certain items, such as
reactor fuel elements, that are not commonly produced or used as sealed
radioactive sources. In addition, several commenters indicated that
DOE's proposed minimum activity requiring performance of periodic leak
tests (0.005 microcuries) was overly restrictive.
Commenters indicated that inaccessible sources should be excepted
from the requirements for leak testing and inventory. Such a measure
would obviate the need to disassemble facility components and
instruments for the purpose of performing the inventories and leak
tests. Commenters also indicated that common contamination control
measures are capable of minimizing, but perhaps not preventing, the
spread of contamination as would be required by proposed
Sec. 835.1202(e).
DOE agrees with these observations.
Final Rule
In response to public comments, DOE has revised the Sec. 835.2(a)
definition of the term ``sealed radioactive source'' to exclude reactor
fuel elements, nuclear explosive devices, and radioisotope
thermoelectric generators. DOE has included the definitions of
``accountable sealed radioactive source'' and ``source leak test'' at
Sec. 835.2(a) as proposed. DOE has revised Sec. 835.1202(d) to provide
an exception from leak testing and inventory for sealed radioactive
sources that are inaccessible. DOE has also revised Sec. 835.1202(e) to
indicate that the required contamination control measures must
``minimize'' the spread of contamination.
DOE has revised the proposed appendix E values. DOE determined the
appendix E values in the final rule as follows: For each radionuclide,
DOE considered two scenarios: (1) the activity quantity resulting in a
deep dose equivalent from external radiation of 0.1 rem (0.001 sievert)
assuming an individual was irradiated for a period of 12 hours per day
at a distance of 1 meter from the source for 365 days; and (2) the
activity quantity resulting in a committed effective dose equivalent of
0.1 rem (0.001 sievert) assuming an instantaneous intake of 0.001% of
the material by an individual. DOE compared the activity quantities for
the deep dose equivalent and the committed effective dose equivalent
and selected the more restrictive value as the basis for the
accountability threshold value. DOE selected the value of 0.1 rem as
the basis for the revised appendix E values for consistency with DOE's
mandatory threshold for monitoring of general employee dose (see
Sec. 835.402) and dose limit for members of the public in controlled
areas (see Sec. 835.208). DOE also assumed more realistic values for
the exposure time and intake factor and eliminated the arbitrary 300
microcurie activity cap. The basis for the appendix E values is
discussed in more detail in a technical basis document available in
DOE's Freedom of Information Reading Room at the address provided
above.
Because all of the revised appendix E values are greater than 0.005
microcuries, DOE has deleted this threshold from the requirements for
sealed radioactive source leak tests (proposed Sec. 835.1202(b)). DOE
has also omitted the proposed requirement for written procedures from
the final rule. For details on this omission, see Section II.B.3 of
this Notice of Final Rulemaking. Finally, because DOE's

[[Page 59677]]

reevaluation of the appendix E values resulted in significant increases
in all of the accountability threshold values, DOE has codified a
general requirement at Sec. 835.1201 for all radioactive sources (both
accountable and non-accountable) to be used, handled, and stored in a
manner commensurate with the radiological hazards created by the
operation involving the sources. DOE will provide implementing guidance
to discuss acceptable methods for achieving compliance with this
provision.
The basis for the control of sealed radioactive sources is a
hierarchy of increasing radiological controls based upon the maximum
credible dose consequence resulting from the loss of a source. The
maximum credible dose consequence should not be considered to be a
release criterion. Under the requirements of 10 CFR part 835, some
degree of radiological control is required for all sealed radioactive
sources, regardless of their activity. This hierarchy of controls
reduces the likelihood of losing a sealed radioactive source. Thus the
approach to sealed radioactive source control is analogous to that
taken in nuclear safety. As the potential consequences of a credible
incident increase, additional controls are imposed to reduce the
probability that the incident will occur and mitigate the consequences
of that incident.
For the lowest activity sealed radioactive sources, a minimal level
of radiological control is required based upon the hazards associated
with the operations involving the sources. More specific actions are
not considered necessary and are therefore not specified.
For sealed radioactive sources whose loss could result in a maximum
credible dose consequence of 0.1 rem or more in a year, additional
controls are imposed. The requirement for semi-annual inventories
reduces the possibility of losing the source and, by triggering
investigative action, mitigates the consequences of a lost source. The
requirement for semi-annual leak testing provides a means of monitoring
the integrity of the source and likewise triggers action to mitigate
the consequences of a leaking source.

L. Accident and Emergency Exposures, Subpart N

Proposed Amendment
DOE proposed to correct Sec. 835.1301(a), (b), and (d) by deleting
references to Sec. 835.205, which provides no dose limits. Consistent
with changes to Sec. 835.204, DOE proposed to revise Sec. 835.1301(a)
to indicate that doses resulting from accident and emergency exposures
may exceed the numerical values established at Sec. 835.202(a) without
violating the occupational dose limits. Both accident and emergency
doses are considered occupational doses and are included in a general
employee's occupational dose record, but emergency doses are explicitly
excluded from consideration in determining compliance with the
occupational dose limits at Sec. 835.202(a).
DOE proposed to delete Sec. 835.1302(d) because these provisions
are adequately addressed in related DOE Orders and emergency management
guides.
DOE clarified Sec. 835.1304 by substituting the defined term
``individual'' for the term ``personnel'' which eliminates any
confusion regarding the coverage of the personal nuclear accident
dosimetry provisions. DOE also proposed to remove the reference to
``all personnel'' to provide flexibility in implementing the personal
nuclear accident dosimetry provisions.

Summary of Public Comments and Disposition

Regarding accident and emergency exposures, public comments
indicated that DOE had failed to clearly define the terms ``accident''
and ``emergency,'' resulting in uncertainty about the proper
application of these provisions.
Comments regarding the proposed approach basing personal nuclear
accident dosimetry requirements on the need for nuclear criticality
alarms indicated that this approach would be impractical due to the
vagueness of the referenced requirements for these alarms.
DOE agrees with these observations.
Final Rule
DOE has included the proposed changes into the final rule.
Consistent with the clarification of the requirements for
accounting for occupational doses, including doses resulting from
authorized planned special exposures and emergency exposures, DOE has
deleted the term ``accident'' from Sec. 835.1301(a). This deletion
results from DOE's recognition that, except for doses resulting from
planned special exposures and authorized emergency exposures, all doses
in excess of the regulatory limits may be considered to be
``accidents.'' Under such circumstances, DOE believes that provisions
allowing affected individuals to return to work without further
detailed review subverts the intent of the Sec. 835.202 occupational
dose limits. DOE believes that it is most appropriate for this section
to address doses resulting from authorized emergency exposures. Despite
this change, DOE recognizes the fact that issues of individual work
rights and DOE liability may arise as a result of ``accidental''
exposures exceeding the regulatory dose limits. Mechanisms for
addressing doses resulting from accidents, and authorizations to return
affected individuals to work, exist within the exemption process
established in 10 CFR part 820.
In response to public comments, DOE revised the text in
Sec. 835.1301(c) and (d) to eliminate the terms ``emergency'' and
``accident'' and specify that the notification and resumption
provisions apply when doses were received in excess of the limits of
Sec. 835.202, except those doses received in accordance with
Sec. 835.204.
As discussed above with regard to Sec. 835.702(c)(2), DOE found
that Sec. 835.1301(e) inappropriately invoked the requirements of DOE
Orders. The applicability of these Orders is established through DOE
contractual processes. Therefore, DOE has deleted this provision.
To resolve issues related to requirements for personal nuclear
accident dosimetry, DOE has revised the requirement to simply indicate
that the nuclear accident dosimetry system must include personal
nuclear accident dosimeters. This approach will allow for flexible
implementation on a site-and facility-specific basis.

M. Use of Appendices

Proposed Amendment
DOE proposed to clarify the application of the data presented in
the appendices of 10 CFR part 835 by adding introductory text to each
appendix referencing those sections of the rule requiring use of the
appendix. DOE also proposed to delete the absorption factor (f1) values
and the related footnote (footnote 5) from appendix A of 10 CFR part
835 because absorption factors and alternative absorption factors are
neither used nor referenced in the rule. DOE determined that 10 CFR
part 835 established no substantive requirements for use of the data
presented in appendix B, and therefore proposed to delete appendix B.
DOE's review of exemption requests concerning occupational exposure
to 220Rn and 222Rn and their daughter products revealed that DAC values
for these radioisotopes are inappropriately referenced in both
appendices A and C. Exposure to these radionuclides results in a lung
dose and therefore, the air immersion DACs in appendix C are
inappropriate. Accordingly, DOE

[[Page 59678]]

proposed to delete the air immersion DAC values for 220Rn and 222Rn
from appendix C.
Experience in implementing programs that ensure compliance with 10
CFR part 835 has proven that the exposure conditions used to determine
the appendix C DAC values (immersion in a semi-infinite cloud) often
differ from those at DOE facilities (i.e., exposure in relatively small
enclosures). Use of the appendix C DAC values under these conditions
can result in the overestimation of individual doses. Therefore, DOE
proposed to revise appendix C, note b., to allow modification of the
DAC values to compensate for immersion in a cloud of finite dimensions
and to provide instructions for determining the DAC of a mixture of
radionuclides.
Summary of Public Comments and Disposition
Although several commenters suggested that the data in appendix B
were useful and should be retained, the correlation of chemical form to
lung retention class is available directly from Table 3 of Federal
Guidance Report Number 11, ``Limiting Values of Radionuclide Intake and
Air Concentration and Dose Conversion Factors for Inhalation,
Submersion, and Ingestion.''
Commenters favored DOE's proposal to allow for modification of the
appendix C values. However, contrary to the information provided in
appendix C, note b., these values were calculated based upon an
exposure of 2000 hours per year, and not based upon a continuous
exposure.
Final Rule
DOE has included the proposed changes in the final rule with minor
editorial corrections. For consistency with the existing provisions
associated with appendix C of 10 CFR part 835, DOE has included a note
with appendix A of 10 CFR part 835 that will allow use of the sum of
the fractions rule when there exists a mixture of radionuclides in the
area of interest. DOE has also revised appendix C, note b., to reflect
the 2000 hour per year exposure basis of the values.
Consistent with terminology used throughout the rule and in DOE's
guidance documents, DOE has also retitled the table in appendix D of 10
CFR part 835 ``Surface Contamination Values.''

N. Corrections and Clarifications

Proposed Amendment
DOE proposed numerous editorial corrections and technical
clarifications that do not change the requirements of the rule or the
measures necessary to ensure regulatory compliance. The proposed
changes included:
1. Correction of the definitions of ``airborne radioactive
material'', and ``year'' (Sec. 835.2(a)) and ``external dose or
exposure,'' and ``quality factor'' (Sec. 835.2(b));
2. Clarification of the application of the mean quality factors for
neutrons provided at Sec. 835.2(b);
3. Deletion of Sec. 835.2(d) because the convention stated in that
paragraph for the use of singular, plural, masculine, and feminine
terms is not used in part 835;
4. Revision of the requirements of Sec. 835.102 for clarity;
5. Change of the heading of Sec. 835.202 to ``Occupational dose
limits for general employees'' to accurately reflect the content of
that section;
6. Deletion from Sec. 835.203(a) and the Sec. 835.2(b) definition
of ``total effective dose equivalent'' the provision related to
substitution of deep dose equivalent for effective dose equivalent from
external exposure. This provision is redundant with the revised
definition of ``effective dose equivalent'' proposed at Sec. 835.2(b).
Summary of Public Comments and Disposition
DOE received no substantive comments on these changes.
Final Rule
DOE has included the proposed changes in the final rule.

III. Review Under the National Environmental Policy Act

DOE has reviewed the promulgation of this amendment to 10 CFR part
835 under the National Environmental Policy Act (NEPA) of 1969 (42
U.S.C. 4321 et seq.) and the Council on Environmental Quality
regulations for implementing NEPA (40 CFR parts 1500-1508). DOE has
completed an Environmental Assessment and on the basis of that
information has issued a Finding of No Significant Impact (FONSI) for
this amendment. The FONSI and the Environmental Assessment update the
FONSI and Environmental Assessment issued when the proposed amendment
was published for public comment and reflect changes in the final rule
made in response to public comments. The Environmental Assessment and
FONSI are available for inspection at the DOE Freedom of Information
Reading Room, 1E-190, 1000 Independence Ave. SW, Washington, DC 20585,
between the hours of 9 a.m. and 4 p.m., Monday through Friday, except
Federal holidays.

IV. Review Under Regulatory Flexibility Act

The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires that an
agency prepare an initial regulatory flexibility analysis and publish
it at the time of publication of general notice of rulemaking for the
rule. This requirement does not apply if the agency certifies that the
rule will not, if promulgated, have a significant economic impact on a
substantial number of small entities. 5 U.S.C. 605(b).
Today's action amends DOE's regulations governing programs
established at DOE facilities to protect individuals from ionizing
radiation resulting from DOE activities. The contractors who manage and
operate DOE facilities are responsible for implementing the
occupational radiation protection program. DOE has considered whether
management and operating (M&O) contractors are ``small businesses,'' as
that term is defined by the Regulatory Flexibility Act (5 U.S.C.
601(3)). The Regulatory Flexibility Act's definition incorporates the
definition of ``small business concern'' in the Small Business Act,
which the Small Business Administration (SBA) has developed through
size standards in 13 CFR part 121. Small businesses are business
concerns which, together with their affiliates, have no more than 500
to 1500 employees, varying by SIC category, and annual receipts of
between $0.5 million to $25 million, again varying by SIC category--
Title 13 CFR part 121. DOE's M&O contractors exceed the SBA's size
standards for small businesses. In addition, it is noted that M&O
contractors are reimbursed through their contracts with DOE for the
costs of complying with DOE occupational radiation protection
requirements. They will not, therefore, be adversely impacted by the
requirements in the rule. For these reasons, DOE certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities.

V. Review Under Executive Order 12866

Today's regulatory action has been determined not to be a
``significant regulatory action'' under Executive Order 12866,
``Regulatory Planning and Review,'' (58 FR 51735, October 4, 1993).
Accordingly, today's action was not subject to review under the
Executive Order by the Office of Information and Regulatory Affairs

[[Page 59679]]

within the Office of Management and Budget.

VI. Review Under Executive Order 12612

Executive Order 12612, 52 FR 41685 (October 30, 1987) requires that
regulations, rules, legislation, and any other policy actions be
reviewed for any substantial direct effects on States, on the
relationship between the National Government and the States, or in the
distribution of power and responsibilities among various levels of
government. If there are sufficient substantial direct effects, then
the Executive Order requires preparation of a federalism assessment to
be used in all decisions involved in promulgating and implementing a
policy action.
This final rule would not have a substantial direct effect on the
institutional interests or traditional functions of States.

VII. Review Under Executive Order 12988

With respect to the review of existing regulations and the
promulgation of new regulations, section 3(a) of Executive Order 12988,
``Civil Justice Reform,'' 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. With regard to the review required
by section 3(a), 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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-27366. Public record. Not legal advice.