[Federal Register Volume 61, Number 247 (Monday, December 23, 1996)]
[Proposed Rules]
[Pages 67600-67621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32107]
[[Page 67599]]
_______________________________________________________________________
Part II
Department of Energy
_______________________________________________________________________
10 CFR Part 835
Occupational Radiation Protection; Proposed Rule
Federal Register / Vol. 61, No. 247 / Monday, December 23, 1996 /
Proposed Rules
[[Page 67600]]
DEPARTMENT OF ENERGY
10 CFR Part 835
[Docket No. EH-RM-96-835]
RIN 1901-AA59
Occupational Radiation Protection
AGENCY: Department of Energy.
ACTION: Notice of proposed rulemaking and public hearings.
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SUMMARY: The Department of Energy (DOE) is proposing to amend its
primary standards for occupational radiation protection. This proposed
rule amendment 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
a result of this analysis, DOE proposes amendments to all of the
subparts of 10 CFR part 835. The analysis included a review of the
requirements in DOE Notice 441.1, ``Radiological Protection for DOE
Activities,'' (extended by DOE N 441.2) that resulted in the proposed
codification of certain provisions of that Notice, including
requirements for posting of areas where radioactive material is present
and for control of sealed radioactive sources. Several additional
changes are proposed to ensure continuity in DOE's system of radiation
protection standards by codifying in part 835 critical provisions of
the ``DOE Radiological Control Manual'' (Manual), which is no longer a
mandatory standard. DOE also proposes to explicitly exclude from part
835 radioactive material transportation conducted in compliance with
applicable DOE Orders and certain activities conducted on foreign soil.
DATES: Written comments must be received by DOE by February 21, 1997 to
ensure consideration. In addition, a computer disk containing the
comments in WordPerfect 5.0 or later or as an ASCII file would be
greatly appreciated. DOE has scheduled two public hearings to encourage
public participation through oral comments on the proposed amendment.
(Section III of this notice discusses some of the issues on which DOE
would encourage the public to comment.)
1. Las Vegas, NV--January 22, 1997, beginning at 9:00 am (PST)
2. Washington, DC--February 6, 1997, beginning at 9:00 am (EST)
Requests to speak at a hearing should be received no later than
4:00 pm, January 17, for the Las Vegas hearing and February 4 for the
Washington, DC hearing, (202) 586-3012.
ADDRESSES: The hearings will be held at the following addresses:
Las Vegas, NV--DOE Nevada Operations Office Auditorium, 2753 South
Highland Drive
Washington, DC--U.S. Department of Energy, 1000 Independence Avenue,
SW, Room 1E-245
Written comments (5 copies and a computer disk) and requests to
speak at a hearing should be submitted to Dr. Joel Rabovsky, U.S.
Department of Energy, EH-52, ``EH-RM-96-835 Rulemaking,'' 1000
Independence Avenue, SW, Washington, DC 20585, telephone (202) 586-
3012. Comments may also be submitted electronically to the following
address--http://tis-nt.eh.doe.gov/wpphm/835/835.htm. Such comments are
subject to the same submittal deadline as that provided above for
written comments.
Copies of the hearing transcripts, written or electronic comments
received, and any other docket material received may be read and copied
at the DOE Freedom of Information Reading Room, U.S. Department of
Energy, Room 1E-190, 1000 Independence Avenue, SW, Washington, DC
20585, (202) 586-6020, between the hours of 8:30 a.m. and 4:00 p.m.,
Monday through Friday, except Federal holidays. The docket file
material will be filed under ``EH-RM-96-835.'' DOE's analysis
supporting the proposed amendment, including regulatory position papers
providing detailed information on certain significant proposed changes,
proposed revisions to DOE's Implementation Guides, accreditation
program technical standards, a supporting Environmental Assessment, the
DOE Radiological Control Standard, copies of the DOE Orders referenced
herein, and a side-by side comparison of the existing rule and the
proposed amendment may also be examined at this location.
For more information concerning public participation in this
rulemaking proceeding, see Section III of this notice (Public Comment
Procedures).
FOR FURTHER INFORMATION CONTACT: Dr. Joel Rabovsky, U.S. Department of
Energy, Office of Worker Protection Programs and Hazards Management,
EH-52, 1000 Independence Avenue, SW, Washington, DC 20585, (301) 903-
2135.
For information concerning the public hearings and submission of
comments, contact Andi Kasarsky, (202) 586-3012.
SUPPLEMENTARY INFORMATION:
I. Background
II. Proposed Actions and Analysis
III. Public Comment Procedures
IV. Review Under the National Environmental Policy Act
V. Review Under the Regulatory Flexibility Act
VI. Review Under Executive Order 12866
VII. Review Under Executive Order 12612
VIII. Review Under Executive Order 12988
IX. Review Under Paperwork Reduction Act
X. Review Under the Unfunded Mandates Reform Act
I. Background
On December 14, 1993, DOE published a final rule, 10 CFR part 835,
``Occupational Radiation Protection'' (56 FR 64334). The rule codified
certain requirements previously promulgated in DOE Order 5480.11,
``Radiation Protection for Occupational Workers,'' which implemented
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). In
addition, the ``as low as reasonably achievable'' (ALARA) process was
codified in 10 CFR part 835 as the primary means of maintaining
occupational radiation doses below regulatory limits.
This Notice of Proposed Rulemaking would modify the scope of 10 CFR
part 835 to explicitly exclude radioactive material transportation
conducted in compliance with applicable DOE Orders and exclude certain
activities conducted on foreign soil. DOE also proposes to add
standards for area posting and sealed radioactive source control. In
addition, DOE would add a removable surface radioactivity value for
tritium, to be used to identify the need for area posting and
imposition of certain radioactive material controls. DOE also proposes
several revisions that would expand and clarify provisions of the rule
to address radiation protection issues (1) identified through analysis
of operational data and (2) which need to be added because of the
elimination of the Manual as a mandatory standard. This proposed
amendment would also clarify and correct minor errors in part 835.
The proposed changes to part 835 result from a critical 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 current rule. DOE also evaluated approaches used by
national and international radiation protection organizations and
experience DOE has gained since 10 CFR part 835 was issued. The results
of
[[Page 67601]]
this evaluation are contained in an analysis supporting the proposed
changes, ``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 the address provided above.
In September 1995, DOE canceled DOE Order 5480.11, ``Radiation
Protection for Occupational Workers,'' DOE Order 5480.15, ``Department
of Energy Laboratory Accreditation Program for Personnel Dosimetry,''
and DOE Notice 5400.13, ``Sealed Radioactive Source Accountability,''
and eliminated the Manual as a mandatory standard. These actions were
taken consistent with initiatives to reduce the overall burden of
prescriptive and redundant requirements imposed through DOE's system of
contractually-implemented directives. DOE selected and updated certain
key provisions of the canceled Orders and the Manual and published them
in DOE Notice 441.1. At that time, DOE indicated its intent to evaluate
the importance of these elements and, based upon that evaluation, to
codify those elements considered necessary for achievement of DOE's
radiation protection objectives.
In general, the proposed amendments would codify requirements
currently used within the DOE complex. DOE has determined that these
requirements must be codified to assure that worker health and safety
programs are maintained at a level commensurate with workplace hazards.
These amendments would establish nuclear safety requirements that, if
violated, would provide a basis for assessment by DOE of civil
penalties under the Price-Anderson Amendments Act 1 (PAAA) of
1988.
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\1\ Price-Anderson Amendments Act, Pub. L. 100-408, August 20,
1988.
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Section 309 of the Department of Energy Organization Act (Pub. L.
95-91), Executive Order 12344, and Pub. L. 98-525 establish the
responsibilities and authority of the Director, Naval Nuclear
Propulsion Program, over all facilities and activities that comprise
the Program, a joint Navy-DOE organization solely responsible for the
military application of nuclear energy in connection with naval warship
propulsion. Pursuant to the purpose and direction of these actions, the
standards, regulations, and requirements prescribed by the Director
continue to apply to Program facilities and activities in lieu of the
regulations in this part.
The proposed rule would establish a schedule for implementation of
final amendments to 10 CFR part 835 as follows. The final rule would
become effective 30 days following publication in the Federal Register.
As provided in Sec. 835.101(h), updated radiation protection programs
(RPPs) would be due to DOE within 180 days following the effective date
of the final rule. Changes that do not decrease the effectiveness of
the RPP could be implemented immediately. As further provided in
Sec. 835.101(j), DOE would undertake efforts to approve all RPP changes
within 180 days of submittal. In Sec. 835.101(f), DOE has proposed
provisions requiring full compliance with the regulatory changes
(except for radiobioassay program accreditation) within 180 days of RPP
approval. Because of the breadth of the joint DOE/DOE contractor effort
needed to accomplish the proposed accreditation of radiobioassay
programs, DOE proposes an implementation schedule of approximately
three years for compliance with radiobioassay program accreditation
requirements. Based on the expected duration of the public comment and
comment resolution periods, in the proposed rule, DOE has proposed
January 1, 2000 as the compliance date for the radiobioassay program
accreditation requirements. DOE may change this compliance date in the
final rule to reflect unforeseen changes in the rulemaking schedule or
public comments addressing this proposal.
II. Proposed Actions and Analysis
A. Exclusions from 10 CFR Part 835
Radioactive Material Transportation
To avoid dual regulation of certain activities, DOE has excluded in
Sec. 835.1(b)(1) those activities that are regulated through a license
by the U.S. Nuclear Regulatory Commission (NRC) or a State under an
Agreement with the NRC, and activities certified by the NRC under
section 1701 of the Atomic Energy Act. Although addressed in the
preamble to the final rule (see 58 FR 65465), transportation of
radioactive material conducted in compliance with applicable DOE
requirements was not excluded from the scope of part 835, as originally
adopted.
DOE standards for packaging and transporting radioactive material
are addressed in various DOE Orders and were never intended to be
covered by 10 CFR part 835. DOE Orders 460.1, ``Packaging and
Transportation Safety,'' and 460.2, ``Departmental Materials
Transportation and Packaging Management,'' provide DOE standards
related to 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
Offsite 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
a more appropriate framework for ensuring transportation safety than 10
CFR part 835. 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, and receiving radioactive materials from,
transportation. Consistent with its original intent, as expressed in
the preamble to the final rule, DOE proposes to add an exclusion to
Sec. 835.1(b) for radioactive material transportation conducted in
compliance with applicable DOE Orders.
DOE proposes to add a definition of ``radioactive material
transportation'' in 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 are subject
to 10 CFR part 835.
DOE recognizes that questions may arise with regard to when a
package of radioactive material may be considered to be in
transportation and subject to transportation safety requirements. Due
to the wide range of affected activities and facilities, DOE does not
believe that it can foresee and prescribe detailed requirements for all
possible scenarios under which radioactive materials may be shipped
from and received at its facilities. The initiation and termination of
transportation activities are commonly documented by signature of the
transport worker and shipping/receiving facility representative on a
shipping manifest or other transportation document. DOE believes that
these formal changes of custody ordinarily should be used to determine
when material is in transport. DOE has published suitable guidance in
the Manual and expects that corresponding facility-specific
requirements will be included in the RPPs developed to ensure
compliance with the final rule. Many documented RPPs already reflect
such facility-specific requirements.
[[Page 67602]]
DOE Activities Conducted on Foreign Soil
Questions have arisen regarding the applicability of 10 CFR part
835 to the conduct of certain DOE activities on foreign soil outside
the jurisdiction of the United States government. DOE proposes to add
an exclusion to Sec. 835.1(b) to recognize the primacy of foreign
governments' occupational radiation protection requirements when such
requirements have been agreed to by the United States.
Nuclear Explosives and Weapons Safety Program
DOE proposes to clarify the nuclear weapons program exclusion in
Sec. 835.1(b)(3) so that it clearly 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 provides the necessary flexibility to ensure
implementation of programs that realize the overriding goal of
preventing such incidents. The appropriate application of this
exclusion is highly dependent upon activity-specific conditions which
turn on issues of professional judgment. DOE expects that appropriate
measures to implement this exclusion would be included in the RPPs
developed to ensure compliance with the rule.
Applicability of Occupational Dose Received from Excluded Activities
DOE proposes to add Sec. 835.1(c) to clearly provide that, even
though certain activities are excluded from the scope of the rule,
occupational doses received as a result of excluded activities apply
toward determination of compliance with the yearly occupational dose
limits established in subpart C. However, radiation doses excluded by
proposed Sec. 835.1(b)(6) (i.e., radiation doses 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.
Radiation doses resulting from planned special exposures and authorized
emergency actions, whether within DOE facilities or facilities operated
under the auspices of other regulatory agencies, also would not be
considered in determining compliance with the occupational dose limits.
See Section II.E. of this notice, ``Limitation of Occupational Doses,''
for further discussion of this issue.
B. Radiological Hazard Warning and Area Entry Control
Area Posting Requirements
DOE proposes several changes to simplify requirements for area
posting and provide additional flexibility in implementing these
requirements. Section 835.601(a) would be revised to clearly indicate
that posting of radiological areas is required, regardless of the
activities taking place in the area. The existing requirement refers to
``working areas,'' which does not clearly establish the need for
posting all accessible areas meeting the radiological area and
controlled area definitions of Sec. 835.2(a). The requirement in
Sec. 835.601(b) for DOE approval of radiological warning signs and
labels would be deleted because the nature and content of the
prescribed radiological warning signs and labels are adequately
described in Secs. 835.601, 835.603, and 835.605. DOE proposes to
revise Sec. 835.601(b) to include the requirement for the standard
radiation warning trefoil (previously referred to less precisely as the
``radiation symbol'') to be included on the required postings and
labels. Formats for warning signs and labels that meet the requirements
of Sec. 835.601 are described in Implementation Guide G-10 CFR 835/G1,
``Posting and Labeling for Radiological Control.''
DOE also proposes to revise Sec. 835.601(e) (redesignated as
Sec. 835.601(d)) to address both posting and labeling in privately-
owned homes and businesses and to make the provision applicable to all
of subpart G, not only Sec. 835.601. DOE proposes to simplify the
language in Sec. 835.602(a) for clarity and to avoid conflict with the
flexibility provided in Sec. 835.602(b). In Sec. 835.603, revisions to
paragraphs (a) through (f) are proposed to eliminate redundancy with
the definitions in Sec. 835.2(a). Consistent with NRC requirements
published in Sec. 20.1902 of 10 CFR part 20, ``Standards for Protection
Against Radiation,'' DOE proposes to allow use of the words ``Caution''
or ``Danger'' on postings for high radiation, high contamination,
radioactive material, and airborne radioactivity areas.
For consistency with the preceding proposed changes, DOE proposes
to revise the Sec. 835.2(a) definitions of ``airborne radioactivity
area,'' ``contamination area,'' and ``high contamination area'' to
include accessibility provisions, consistent with the existing
definitions of ``radiation area,'' ``high radiation area,'' and ``very
high radiation area.''
DOE also proposes to add Sec. 835.604 delineating specific
exceptions to all of the radiological area posting requirements of
Sec. 835.603. These exceptions are proposed because DOE recognizes that
compensatory measures may be implemented that would obviate the need
for area posting. The radiological area posting exceptions would not
apply to the radiological area entry controls established in
Secs. 835.501 and 835.502 or to the training requirements of
Sec. 835.901. The exceptions proposed in Sec. 835.604 are similar to
those established by the NRC in 10 CFR 20.1903.
Radioactive Material Area Posting
DOE Notice 441.1 (extended by DOE Notice 441.2) requires posting of
areas where quantities of radioactive materials exceed specified
threshold values. DOE considers this posting important, particularly to
provide adequate warning to general employees who do not have the
requisite training to enter these areas. DOE also notes that the NRC
imposes similar requirements on its licensees in 10 CFR 20.1902. To
codify these requirements, DOE proposes to define ``radioactive
material area'' and include this term in the definition of
``radiological area'' in Sec. 835.2(a), and to establish requirements
for posting radioactive material areas in Sec. 835.603(g). Posting
would be required at each access point to any area accessible to
individuals where containers or items of radioactive materials are
present in quantities exceeding 10 times the values established in the
proposed appendix E. Consistent with the requirements for other
radiological areas, entry into radioactive material areas would also be
subject to the entry control measures established in Sec. 835.501 and
the radiation safety training requirements of Sec. 835.901. DOE
proposes to add, in Sec. 835.604(b), certain exceptions to the
radioactive material area posting requirement.
Contamination Area Postings
Experience in implementing the provisions of the Manual has
revealed an opportunity to simplify DOE requirements for posting and
control of areas with surface contamination that exceeds the values
listed in appendix D to 10 CFR part 835. DOE's primary purpose in
establishing requirements for radiological area postings is to provide
information sufficient to elicit an appropriate protective response
from affected individuals. Under the current provisions of
Sec. 835.603, no distinction is made between the required postings for
areas having only fixed surface
[[Page 67603]]
contamination and those having removable surface contamination, even
though the hazards and desired protective responses are quite
different. DOE proposes to revise the Sec. 835.2(a) definitions of
``contamination area'' and ``high contamination area'' to be based upon
removable surface contamination levels only.
Under Sec. 835.404(d), surfaces located outside of radiological
areas bearing total (fixed plus removable) surface contamination in
excess of appendix D values, but removable surface contamination less
than appendix D values, would continue to be subject to distinct
marking and routine survey requirements to minimize the chance of
inadvertent removal or disturbance of the radioactive material.
However, unless the fixed contamination creates radiation levels
sufficient to warrant posting for external radiation hazards, these
areas would not be considered radiological areas and would be excepted
from the radiological area posting and entry control requirements.
Radioactive Material Labeling
General requirements for radioactive material labeling are
currently provided in Sec. 835.601(a). These requirements were
supplemented by detailed provisions in the Manual. To ensure that
appropriate requirements for radioactive material labeling remain in
effect, DOE proposes to add Sec. 835.605 which would impose
requirements for labeling items and containers of radioactive
materials, with appropriate exceptions being proposed in Sec. 835.606.
These provisions are similar to the provisions in the Manual and
requirements imposed by the NRC in 10 CFR 20.1904 and 20.1905. Related
to this change, DOE proposes to add Sec. 835.1101(d) requiring the
removal of labels prior to releasing materials and equipment from
radiological areas in accordance with Sec. 835.1101(a). To consolidate
recordkeeping requirements, DOE proposes to move the existing
requirements of Sec. 835.1101(d) to Sec. 835.703(c). DOE also proposes
minor format and language revisions to Sec. 835.1101 to clarify its
intent.
Surface Radioactivity Value for Tritium
When 10 CFR part 835 was published for public comment on December
9, 1991, the surface radioactivity values for tritium were not included
in appendix D because DOE was in the process of determining appropriate
values. An appropriate value for removable tritium surface
radioactivity, consistent with the value published in the Manual, was
identified during the public comment period of the original proposed
rule. Public comments suggested a value consistent with the value now
being proposed, but DOE determined that this value should not be
included in the final rule because public comments had not been invited
on this issue. Reopening the public comment period on this issue would
have delayed publication of the final rule.
DOE has determined that a value for total (fixed plus removable)
tritium surface contamination is inappropriate. Fixed tritium surface
contamination presents no likely occupational exposure hazard and few
practical technologies are available to facilitate field measurements.
Therefore, DOE is not proposing a total surface radioactivity value for
tritium. The basis for this decision is explained in more detail in the
Environmental Assessment published concurrent with this proposed rule.
To address these issues, DOE proposes to amend appendix D to 10 CFR
part 835 by adding a removable surface radioactivity value of 10,000
disintegrations per minute per 100 square centimeters and adding
footnote 6 to discuss tritium that has migrated into the surface in
question. The tritium surface radioactivity value is used to determine
the applicability of the area posting requirements of Sec. 835.603 and
the radioactive material control requirements of Sec. 835.1101.
Radiological Area Entry Control
Section 835.501 currently establishes only general requirements for
administrative control of radiological work. As documented in the
regulatory development document, analysis of operational occurrences
throughout the DOE complex indicates that a significant portion of
radiation protection-related occurrences result from inadequate work
control. Therefore, DOE proposes more detailed provisions for written
work authorizations in Sec. 835.501(e). DOE expects that these
provisions would be implemented through a system that imposes
progressively more specific and limiting written control mechanisms as
the potential radiological hazards and complexity of requisite controls
increase. For instance, requirements for tours or limited work in low
hazard areas may be specified in generally applicable procedures, while
requirements for higher hazard work may be specified in short-term
technical documents requiring pre-job briefings and worker
acknowledgment of specific work controls. This approach is consistent
with that previously specified in the Manual. The proposed amendment
provides substantial flexibility for implementation on a facility- and
hazard-specific basis.
DOE proposes to revise Sec. 835.502 to add measures for control of
access to high radiation areas where an individual may receive a deep
dose equivalent exceeding 0.1 rem (0.001 sievert) in one hour. These
requirements supplement the existing requirements (proposed for
redesignation as Sec. 835.502(b)) for areas where an individual might
receive a deep dose equivalent exceeding 1 rem in one hour. The
proposed control measures include requirements for use of a
supplemental dosimetry device and appropriate area surveys. These
requirements are similar to those implemented by DOE facilities in
accordance with the Manual and are consistent with the DOE ALARA
process. The NRC has imposed similar requirements on its commercial
reactor facility licensees. DOE proposes to revise the heading of
Sec. 835.502(b) to reflect its content. DOE also proposes to revise the
text of proposed Sec. 835.502(b) to replace the undefined term
``personnel'' with the defined term ``individual,'' and to delete the
reference to the posting requirements for very high radiation areas
from proposed Sec. 835.502(c). These conditions are adequately
described in the definition of ``very high radiation area'' in
Sec. 835.2(a).
C. Control of Sealed Radioactive Sources
In promulgating 10 CFR part 835, DOE stated that it would codify
sealed radioactive source control requirements in subsequent
rulemakings. DOE Notice 5400.9, ``Sealed Radioactive Source
Accountability'' (extended through DOE Notice 5400.13), established
requirements for control of sealed radioactive sources. The
requirements in DOE Notice 5400.9 were eventually superseded by those
in DOE Notice 441.1. DOE now proposes to include certain of the
requirements from DOE Notices 5400.9 and 441.1 in 10 CFR part 835.
DOE proposes to add requirements for sealed radioactive source
control in Secs. 835.1201 and 835.1202. For sealed radioactive sources
meeting the definition of ``accountable sealed radioactive source''
proposed in Sec. 835.2(a) and the accountability criteria proposed in
appendix E, the proposed amendment would require written procedures for
source control, including labeling, inventory, leak testing, and
recordkeeping. Accountable sealed radioactive source inventory and leak
testing would be required at least every six months, with exceptions
from the source leak testing requirements
[[Page 67604]]
established for sources that are either inaccessible or out of service.
DOE determined the proposed accountability values as follows. For
each radionuclide, DOE calculated two values: (1) the activity that
would result in a deep dose equivalent from external radiation of 0.01
rem (0.0001 sievert) in a year assuming an individual was irradiated
continuously at a distance of 1 meter from the source; and (2) the
activity that would result in a committed effective dose equivalent of
0.01 rem (0.0001 sievert) assuming that an intake of 1% of the material
by an individual occurred during the incident. DOE compared the
external and internal dose values and selected the more conservative
value as the basis for the accountability value. The selected values
were subsequently rounded to facilitate grouping in appendix E. The
0.01 rem value supports DOE requirements found in DOE Order 5400.5,
``Radiation Protection of the Public and the Environment,'' for
reporting doses to members of the public in excess of that value.
DOE proposes related changes to definitions and recordkeeping
requirements in Secs. 835.2(a) and 835.704(f), respectively. The terms
that would be added to Sec. 835.2(a) are ``accountable sealed
radioactive source,'' ``sealed radioactive source,'' and ``source leak
test.''
D. Workplace Monitoring and Determination of Individual Doses
Use of the Terms ``Monitor'' and ``Survey''
In reviewing the requirements of 10 CFR part 835, DOE noted that
the terms ``monitor'' and ``survey'' are not consistently used. DOE is
proposing changes to the definition of the term ``monitoring'' in
Sec. 835.2(a) that more clearly establish that ``monitoring'' involves
measurement of radiological conditions and the subsequent use of the
results of these measurements for evaluation of potential and actual
doses. ``Survey,'' on the other hand, is more directly related to
assessment of workplace or material radiological conditions through
direct measurement, assessment, or calculation for the purposes of
hazards assessment. DOE proposes changes throughout the rule to ensure
consistent application of these terms.
DOE also noted that the requirements of Sec. 835.403(b) are
redundant with those established in Sec. 835.401. Therefore, DOE
proposes to delete Sec. 835.403(b) and, consistent with this change, to
change the heading of Sec. 835.403 to reflect the content of that
section. DOE also proposes to clarify the requirements of
Secs. 835.401(c) and 835.703(d) by making the calibration requirements
apply to both ``instruments'' and ``equipment.'' DOE believes that 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 include any
instrumentation.
Individual Monitoring and Dose Determination
In Sec. 835.402 (b) and (d), DOE proposes to clarify the
requirements for external and internal dose monitoring programs by
providing that such programs must be capable of demonstrating
compliance with all of the individual dose limits in subpart C. This
revision is consistent with DOE's previously established requirements
for records required under Sec. 835.701(a). DOE recognizes that, in
some cases, individual monitoring programs (i.e., external dosimetry
and radiobioassay) may not be capable of quantifying doses at levels
near the monitoring thresholds established in Sec. 835.402. In these
instances, DOE expects that a combination of individual and workplace
monitoring would be used to assure compliance with these monitoring
thresholds. This monitoring may include calculational or statistical
methods (such as the conversion of derived air concentration (DAC)-
hours to calculated doses).
Recent occurrences have revealed weaknesses in certain
radiobioassay programs implemented at DOE facilities. To enhance the
integrity of radiobioassay programs and prevent recurrence of these
adverse events, DOE proposes to amend Sec. 835.402(d) to require
program accreditation through the recently developed DOE Laboratory
Accreditation Program (DOELAP) for Radiobioassay or demonstration of
equivalent performance. These proposed requirements are analogous to
existing DOE requirements for accreditation of external dosimetry
programs. Proposed Sec. 835.402(e) provides that the Secretarial
Officer responsible for environment, safety and health matters
(currently the Assistant Secretary for Environment, Safety and Health)
may authorize alternatives to the DOELAP accreditation process for
programs whose performance is demonstrated to be equivalent to that of
accredited programs.
DOE also proposes in Sec. 835.402(e) to require programs to 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. These provisions will
ensure that, to the extent practicable, DOE radiation protection
programs continue to reflect the latest advances in the sciences of
external and internal dosimetry. Language will be included in the
DOELAP technical standards to indicate that changes in the standards
become effective only during the next scheduled accreditation cycle.
This will prevent the automatic loss of accreditation status as a
result of changes to the DOELAP technical standards.
DOE has also proposed to update the external dosimetry program
accreditation requirements, provided in Sec. 835.402(b), to reflect the
program features for radiobioassay program accreditation discussed
above. These proposed changes would not affect the compliance status of
dosimetry programs currently accredited, or excepted from
accreditation, under the existing DOELAP standards.
Implementing standards for DOELAP are published in a DOE Technical
Standard, ``Department of Energy Laboratory Accreditation Program
Administration'' (a standard number will be assigned when the standard
is completed). This standard provides requirements for administration
of DOE's accreditation programs and cites the technical requirements
provided in DOE-STD-1095-95 (for accreditation of personnel dosimetry
programs) and a separate standard (a standard number will be assigned
when the standard is completed) for accreditation of radiobioassay
programs. The DOELAP technical standards may be reviewed at the DOE
Freedom of Information Reading Room at the address provided above.
DOE also proposes to revise Sec. 835.402 (b) and (d) to clearly
indicate that program accreditation requirements apply only to
personnel dosimetry and radiobioassay programs implemented to
demonstrate compliance with Sec. 835.402 (i.e., monitoring when doses
are likely to exceed the stated thresholds). DOE recognizes that many
DOE activities conduct stringent monitoring programs for individuals
even when those individuals are not expected to receive doses exceeding
the applicable monitoring thresholds in Secs. 835.402. However, DOE
believes that it is inappropriate to impose, through regulation,
accreditation requirements upon monitoring programs that are not
required by regulation. Existing regulatory provisions in Sec. 835.402
(a) and (c) would continue to require individual monitoring for all
individuals likely to receive a dose equivalent exceeding the
applicable
[[Page 67605]]
thresholds. Measures used to identify individuals likely to receive
doses exceeding the thresholds should include comprehensive, documented
workplace surveys and could include, if management so chooses,
individual monitoring. As required by Sec. 835.701(a), the monitoring
and survey results must be documented.
In a related change, because DOELAP for Personnel Dosimetry
provides appropriate dosimetry system performance criteria, DOE
proposes to delete the dosimeter calibration requirement from
Sec. 835.402(b).
DOE proposes to revise the Sec. 835.402(a)(3) and (c)(3) monitoring
requirements for minors by expressly stating that these requirements
apply to occupationally exposed minors only. Minors who are not
occupationally exposed are subject to the member of the public
monitoring requirements found in Sec. 835.402(a)(4) and (c)(4). Doses
received by a minor as a member of the public entering the controlled
area would not be included in any occupational dose received. DOE also
proposes to revise the member of the public monitoring requirements by
clarifying that these requirements apply only to members of the public
while inside the controlled area of a DOE site or facility. Individuals
who enter a controlled area without entering radiological areas are not
expected to receive a total effective dose equivalent exceeding 0.1 rem
in a year.
DOE proposes to delete from Sec. 835.402(c)(1) the individual
monitoring threshold for organs and tissues based upon committed dose
equivalent. DOE has determined that the threshold based upon committed
effective dose equivalent, also provided in Sec. 835.402(c)(1),
provides an equivalent or more restrictive basis for monitoring. A
technical correction is proposed to 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. DOE also proposes to
delete Sec. 835.402(a)(1)(iv) because any doses meeting this condition
are adequately addressed by Sec. 835.402(a)(1)(i).
Use of Appendices
To clarify application of the data presented in the appendices to
10 CFR part 835, DOE proposes to add introductory text to each appendix
providing references to those sections of the rule requiring use of the
appendix.
DOE has determined that 10 CFR part 835 establishes no substantive
requirements for use of the data presented in appendix B, and therefore
proposes to delete appendix B. 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.'' DOE also proposes to delete the absorption factor
(f1) values and the related footnote (Footnote 5) from appendix A
to part 835. The absorption factors and alternative absorption factors
are neither used nor referenced in the rule.
DOE's review of exemption requests concerning occupational exposure
to radon and thoron and their daughter products revealed that air
immersion DAC values for Rn-220 and Rn-222 are not appropriate.
Therefore, DOE proposes to delete the air immersion DAC values for Rn-
220 and Rn-222 from appendix C. Experience in implementing 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 a gross over-estimation of individual doses. In appendix
C, DOE proposes to allow modifications to 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.
Workplace Air Monitoring
Section 835.403 establishes requirements for monitoring the
concentrations of radioactive material in the ambient air of the
workplace, emphasizing use of real-time air monitors. These
requirements are augmented by Secs. 835.209 and 835.402 which establish
requirements for determining internal doses through radiobioassay
except under specific conditions. Despite these codified requirements,
DOE has noted a number of recent occurrences indicating significant
problems in air monitoring and internal dose evaluation programs. To
address these problems, DOE proposes to amend Sec. 835.403 to establish
more practical and technically correct criteria for the use of real-
time air monitors, based upon potential releases that would exceed
defined threshold exposure levels. DOE would also require air sampling
when respiratory protective devices are prescribed to protect
individuals from exposure to airborne radionuclides. This latter
provision addresses recent occurrences at DOE facilities reflecting a
need for more stringent controls and is consistent with requirements
imposed by both the NRC and the Occupational Safety and Health
Administration (OSHA) (see 10 CFR 20.1703(a)(3) and 29 CFR part 1910,
``Occupational Safety and Health Standards,'' Sec. 1910.134(a)(8),
respectively).
DOE proposes to base air sampling criteria upon likely exposure to
a threshold value of DAC-hours in a year, rather than the existing
criterion based upon a percentage of the annual limit of intake. The
established values are equivalent; this change would simply reflect the
provision of data in the referenced appendices (A and C) in units of
DAC values and will eliminate the need for field calculations and
inherent mathematical rounding errors. DOE proposes to add to
Sec. 835.2(a) definitions for the terms ``derived air concentration-
hour (DAC-hour),'' ``real-time air monitoring,'' ``respiratory
protective device,'' and ``week,'' which are used in Sec. 835.403. In
addition, DOE proposes to delete the definitions of ``ambient air'' and
``continuous air monitor'' because these terms would no longer be used
in part 835.
DOE has also determined that the requirements for use of DAC values
in Sec. 835.209(b) are redundant and therefore proposes to delete this
provision.
Receipt of Radioactive Material Packages
DOE currently establishes no substantive requirements for receipt
of packages containing radioactive material and is concerned with the
frequency of occurrences involving packages that were not shipped in
accordance with DOT requirements and corresponding DOE Orders. DOE
proposes to add Sec. 835.405 to ensure adequate protection of
individuals, such as warehouse and office workers, who may be exposed
to such materials after transport. The proposed provisions include
requirements for receiving radioactive material packages from transport
and performing radiological surveys of these packages. The proposed
requirements are similar to NRC requirements in 10 CFR 20.1906.
E. Limitation of Occupational Doses
Occupational Dose Limits
Section 835.202(b) requires that all occupational doses received
during the current year be included when demonstrating compliance with
the occupational dose limits in Sec. 835.202(a). This requirement is
consistent with the
[[Page 67606]]
recommendation made in the Guidance to Federal Agencies. However, the
Guidance to Federal Agencies also indicates that the numerical values
(dose limits) do not apply to workers responsible for emergency
management and response situations and that the cognizant agency may
make provisions for exceeding the numerical values during emergencies
and other unusual situations. DOE has made such provisions in
Secs. 835.1301 and 835.1302 for emergency situations and in
Sec. 835.204 for planned special exposures. Therefore, DOE proposes to
add the phrase ``from all occupational doses'' in Sec. 835.202(a),
delete the phrase ``resulting from DOE activities'' in the heading of
Sec. 835.203 and clearly state these exceptions in Sec. 835.202(b), to
clarify that all occupational doses received during the year, except
those resulting from planned special exposures and emergency exposures,
shall be included when demonstrating compliance with the occupational
dose limits in Sec. 835.202(a).
In Sec. 835.207, DOE proposes to clarify that the limits apply to
doses resulting from occupational exposure only and to add
deterministic dose limits for minors consistent with the Guidance to
Federal Agencies. Non-occupational exposure of minors is subject to the
dose limits established in Sec. 835.208 for members of the public
entering a controlled area. In a related change, DOE would revise the
definition of ``member of the public'' in 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 would
also revise Sec. 835.208 to unambiguously state that the member of the
public dose limit applies to members of the public in the controlled
area only.
DOE also proposes to revise the definition of ``cumulative total
effective dose equivalent'' (CTEDE) in Sec. 835.2(b). The current
definition includes only those total effective dose equivalent (TEDE)
values from a specific DOE site or facility from January 1, 1989. The
proposed revision would include all available TEDE values from January
1, 1989, whether or not the dose was received at that DOE site or
facility. DOE recognizes that records of CTEDE may not be available for
all individuals due to differences between DOE requirements and those
of other regulatory agencies. However, it is DOE's expectation that,
consistent with the requirements previously imposed through DOE Order
5480.11 and the Manual, TEDE values will be available for all
individuals who have received occupational dose at DOE and DOE
contractor facilities since January 1, 1989.
Planned Special Exposures
Section 835.204 establishes requirements for authorizing,
conducting, and reporting planned special exposures which result from
planned operations and may result in doses exceeding the occupational
dose limits established in Sec. 835.202. Upon reexamination of these
requirements, DOE notes that, unlike NRC requirements, no provisions
have been made for authorizing planned special exposures in excess of
the deterministic dose limits established in Sec. 835.202. To provide
for the maximum reasonable flexibility on the part of its contractors,
DOE proposes to amend Sec. 835.204 to establish such provisions
consistent with the NRC's requirements at 10 CFR 20.1206.
DOE also proposes to amend Secs. 835.2(a) (definition of the term
``occupational dose'') and 835.202(a) to clearly indicate that doses
resulting from planned special exposures are considered occupational
doses which would be documented in an individual's occupational dose
record, but would not apply toward determination of compliance with the
occupational dose limits in Sec. 835.202. In a related change, DOE
proposes to change the word ``and'' to ``or'' in Sec. 835.204(c)(1) to
clarify that the annual and cumulative dose limitations apply
independently. DOE also proposes to revise Sec. 835.204(c) to indicate
that doses resulting from planned special exposures may exceed the
numerical values established in Sec. 835.202 without actually exceeding
the occupational dose limits. Finally, DOE proposes to clarify the
Sec. 835.204(d) documentation requirements for planned special
exposures.
Design and Control
Experience in implementing the provisions of 10 CFR 835 has
revealed that the design objectives currently included in Sec. 835.1002
(b) and (c) may not be practical in development of modifications to
existing facilities. Because the provisions of Sec. 835.1001 adequately
address DOE's facility design objectives, DOE proposes to delete
Sec. 835.1002 (b) and (c). DOE expects that these performance
objectives would be utilized to the extent practical in the design and
modification of facilities and DOE will include these objectives in
guidance documents. DOE also proposes to move the remaining
requirements in paragraphs (a) and (d) of Sec. 835.1002 to
Sec. 835.1001.
The design criteria established in Sec. 835.1003(a) do not include
the lens of the eye dose limit established in Sec. 835.202(a)(3). This
omission creates an inference that the design of new facilities or
modification of existing facilities can include design features that
would result in doses exceeding the lens of the eye dose equivalent
limit of 15 rem. DOE proposes to correct this omission by including all
applicable occupational dose limits in this section.
Accident and Emergency Exposures
DOE proposes several corrections and clarifications of the
requirements for accident and emergency exposures to individuals. DOE
proposes to correct Sec. 835.1301(a), (b), and (d) by deleting the
references to Sec. 835.205, which provides no dose limits. Consistent
with the proposed changes to Sec. 835.204, DOE proposes to revise
Sec. 835.1301(a) to indicate that doses resulting from emergency
exposures may exceed the numerical values established in Sec. 835.202
without violating the occupational dose limits. Both accident and
emergency doses would be considered occupational doses and included in
a general employee's occupational dose record, but emergency doses
would be explicitly excluded from consideration in determining
compliance with the occupational dose limits in Sec. 835.202(a).
Section 835.1302 provides guidelines for control of individual
doses under emergency conditions. Although the heading of the table
currently in Sec. 835.1302 indicates that the stated values are
``guidelines,'' the text of the rule and the column heading in the
table indicate that the dose values are regulatory limits. To eliminate
this contradiction and allow for the uncertainties involved in
emergency operations, DOE proposes to remove Sec. 835.1302(d). These
issues are adequately addressed in related DOE Orders and emergency
management guides.
In Sec. 835.1304, DOE proposes to substitute the defined term
``individual'' for the term ``personnel'' to eliminate confusion
regarding the coverage of the personal nuclear accident dosimetry
provisions. DOE also proposes to remove the reference to ``all
personnel'' to provide flexibility in implementing the personal nuclear
accident dosimetry provisions. The approach taken must be technically
justifiable and documented accordingly.
F. Radiation Safety Training
Radiation safety training requirements for general employees,
radiological workers, and radiological control
[[Page 67607]]
technicians are provided in subpart J of 10 CFR part 835. These
requirements were previously augmented by the Manual, which established
detailed training requirements based upon the hazards present in posted
areas to which an individual might have unescorted access. DOE proposes
to reformat Secs. 835.901, 902, and 903 into one section to incorporate
an approach similar to that previously published in the Manual and to
eliminate redundancy.
The Manual required the use of standardized radiological control
core courses 2 developed for training general employees,
radiological workers, and radiological control technicians. DOE Notice
441.1 established a requirement to use those portions of these courses
appropriate to facility hazards and operations. After considering
public comments on the original rule, DOE determined that the detailed
radiation safety training requirements in the Manual obviated the need
to specify minimum training course content in 10 CFR part 835. Since
the Manual has become non-mandatory, DOE now proposes to specify the
minimum training course content requirements in Sec. 835.901(b). In
Sec. 835.901(b), DOE also proposes to more broadly allow acceptance of
previous radiation safety training received by an individual. These
proposed provisions would ensure that all occupationally exposed
individuals and unescorted individuals attain an appropriate level of
radiation safety knowledge. The level of training required would be
based upon the individual's prior training, potential for exposure to
radiological hazards, and actual and anticipated assignments. DOE
believes that this hierarchal approach will result in the appropriate
level of knowledge for general employees, with a progressively higher
level of knowledge required for radiological workers and radiological
control technicians. This approach is consistent with field experience
and feedback from DOE operating contractors and is similar to the
approach taken by the NRC in 10 CFR part 19, ``Notices, Instructions
and Reports to Workers: Inspection and Investigations.''
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\2\DOE/EH-0258T-1, General Employee Radiological Training and
Radiological Worker Training, Program Management Manual, and DOE/EH-
0262T-1, Radiological Control Technician, Training Program
Management Manual, 1992.
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Field experience in implementing the existing training requirements
of Sec. 835.901 shows that little benefit is derived from requiring an
examination upon completion of general employee radiological training.
This is due to the limited training content and occupational exposure
expectations for general employees who are not classified as
radiological workers. Therefore, DOE proposes to eliminate the
examination requirement for general employees who are not permitted
unescorted access to radiological areas. Examinations would still be
required for general employees who are permitted unescorted access to
radiological areas and for radiological workers prior to performing
unescorted assignments. DOE also proposes to add in Sec. 835.901(f)
specific requirements for individuals who may act as escorts of
individuals who have not completed required training.
DOE proposes to add a definition of ``radiological control
technician'' to Sec. 835.2(a) to specifically identify the class of
individuals subject to the radiological control technician training
requirements. DOE also proposes to clarify in Sec. 835.901(g) the
requirements for retraining, which include examinations for
radiological workers and radiological control technicians.
G. Individual Dose Records and Reports
Section 835.402 establishes requirements for monitoring
individuals' exposures to radiation and radioactive materials. In
concert with these requirements, Sec. 835.702 establishes requirements
for maintaining individual dose records, including records of doses
that were determined, but not required to be monitored under
Sec. 835.402. To reduce the burden of recordkeeping and in keeping with
the recommendations in the Guidance to Federal Agencies, DOE proposes
to revise 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. However, adequate records of workplace
conditions, obtained through area monitoring and surveys, should be
maintained to provide assurance that doses to unmonitored individuals
remain below the monitoring thresholds. These records could be
supplemented by records of individual monitoring performed, but not
required by Sec. 835.402. DOE is also proposing to revise
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). DOE proposes to delete
the words ``caused by contamination on the skin'' in Sec. 835.702(b) to
ensure consistency with the referenced requirements in Sec. 835.205.
In Sec. 835.702(c)(4)(iii), DOE proposes to eliminate the
requirement to record the estimated intake associated with internal
dose assessments. This change is proposed because determination of the
estimated intake is not necessary for all radionuclides, such as
tritium. The requirement for recording of the estimated intake was
originally intended to facilitate reevaluation of internal doses at a
later date. However, DOE has concluded that Sec. 835.702(g) requires
recording of sufficient information to allow future verification or
reassessment of recorded doses.
Section 835.702(d) establishes requirements for obtaining records
of an individual's previous occupational doses during the current year
to facilitate demonstration of compliance with the occupational dose
limits in Sec. 835.202(a). Section 835.702(e) establishes similar
requirements for records of prior years doses to facilitate compliance
with requirements for determining each affected individual's cumulative
total effective dose equivalent. DOE proposes to revise Sec. 835.702
(d) and (e) such that acceptance of written estimates of an
individual's prior occupational dose would be based upon an inability
to obtain formal records, rather than the absence of those records. DOE
also proposes to amend Sec. 835.702(e) to clarify its requirements for
obtaining records of previous years doses. Consistent with the Guidance
to Federal Agencies, which discourages implementation of burdensome
recordkeeping requirements for tracking of trivial doses, in
Sec. 835.702(e), DOE proposes to require historical record searches
only for radiological workers monitored in accordance with
Sec. 835.402.
DOE proposes other technical and editorial changes to clarify the
recordkeeping provisions and to ensure consistency with other changes
proposed in subparts J and M of 10 CFR part 835. DOE also proposes to
revise Sec. 835.704(d) to require documentation of revocations of
declarations of pregnancy.
Based on field experience and feedback from DOE operating
contractors, DOE proposes to delete from Sec. 835.4 the prohibition on
use of the international radiological units. These units are commonly
used for calculational and reference purposes and are included in
records related to workplace conditions and individual doses. Except
for these calculations or references, records required by 10 CFR part
835 would continue to be
[[Page 67608]]
maintained using the special units. Consistent with its historical
endorsement of the special radiological units of curie, rad, and rem,
DOE also proposes to specifically allow for use of subunits and
multiples of the unit ``roentgen.''
Section 835.801(a) requires that individual dose reports contain
the individual's social security number or employee number. Some
individuals may not have a social security or employee number;
therefore, DOE proposes to modify the text of the reporting
requirements to allow the use of another unique identification number
in these situations.
H. Corrections and Clarifications
DOE proposes editorial corrections and technical clarifications
that do not change the requirements of the rule or the measures
necessary to ensure regulatory compliance. Editorial changes correct
the structure and format of certain sections of the rule. Technical
clarifications improve the accuracy of certain provisions in the rule.
These changes include: clarification of the definition and explanation
of occupational dose in Secs. 835.1(b)(6), 835.2(a), and 835.202(c);
deletion of the definition of ``collective dose'' (Sec. 835.2(b)); and
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)). The definition of ``controlled
area'' (Sec. 835.2(a)) has been modfied by deleting the second sentence
``Individuals who enter only the controlled area without entering
radiological areas are not expected to receive a total effective dose
equivalent of more than 100 mrem (0.001 sievert) in a year''. This
sentence is not appropriate for the definition section and now follows
the first sentence of Sec. 835.602(a).
DOE proposes to clarify application of the mean quality factors for
neutrons provided in Sec. 835.2(b) by indicating that, when the neutron
energy falls between the values provided in the table, the more
conservative value must be used. DOE proposes to delete Sec. 835.2(d)
since the convention stated in that paragraph for the use of singular,
plural, masculine, and feminine terms is not used in part 835.
Paragraphs (f) and (g) of Sec. 835.101 include provisions for the
initial development and approval of documented radiation protection
programs. Because the operative dates in those paragraphs have passed,
DOE proposes to revise paragraph (f) and to delete paragraph (g) to
remove the obsolete requirements.
DOE proposes to clarify the required frequency of internal audits
(Sec. 835.102), instrument calibration (Sec. 835.401), and radiation
safety retraining (Sec. 835.901) from an established number of years to
an equivalent number of months to avoid confusion caused by the dose
limit-based definition of ``year'' provided in Sec. 835.2(a). DOE also
proposes to revise the requirements of Sec. 835.102 for clarity.
DOE proposes to change the heading of Sec. 835.202 to
``Occupational dose limits for general employees'' to accurately
reflect the content of that section.
DOE proposes to delete 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 in Sec. 835.2(b).
DOE proposes to delete Sec. 835.203(c), which allows the use of a
weighting factor of unity (1) for determination of the effective dose
equivalent under conditions of uniform external irradiation. This
provision is redundant with the notes accompanying the weighting factor
table in Sec. 835.2(b).
DOE proposes to clarify the language in Sec. 835.404(f) to more
clearly address the role of contamination monitoring in the
occupational radiation protection program.
DOE has also proposed a correction to the appendix D values for
uranium surface radioactivity to indicate that these values apply to
emitted alpha radiation only. This correction is consistent with the
requirements previously imposed through the Manual. DOE is also
proposing several minor clarifications of the footnotes to appendix D.
III. Public Comment Procedures
A. Participation in Rulemaking
DOE encourages the maximum level of public participation possible
in this rulemaking. DOE urges interested parties to submit written
comments and also encourages individuals to participate in the public
hearings to be held at the times and places indicated at the beginning
of this notice.
DOE has established a period of 60 days following publication of
this notice for individuals to comment on this notice of proposed
rulemaking. All public comments and the transcripts of public hearings
and other docket material will be available for review in the DOE
Freedom of Information Reading Room at the address given at the
beginning of this notice. The docket file material will be filed under
``EH-RM-96-835.''
DOE is requesting comments on the proposed amendments to 10 CFR
part 835, particularly with regard to the potential impact of the
proposed amendments on the level of radiation protection afforded
individuals affected by DOE activities. Where appropriate, comments
should be supported by substantive technical and/or financial analyses
and justifications to facilitate DOE's evaluation of the submitted
comments. DOE particularly invites comments on the following issues and
alternatives; however, comments need not be limited to these issues.
1. Transportation
DOE is proposing clarifications to the scope of 10 CFR part 835
with respect to activities involving transportation of radioactive
materials, as discussed in Section II of this Supplementary Information
section. DOE seeks public comment on the proposal and any other
alternatives that members of the public would like DOE to consider.
2. Planned Special Exposures
DOE is proposing changes to the Sec. 835.204 requirements for
conduct of planned special exposures, including provisions for planned
special exposures exceeding the values of the deterministic dose limits
in Sec. 835.202. Addition of deterministic dose limits would be
consistent with provisions established by the NRC at 10 CFR 20.1206.
However, DOE notes that planned special exposures have not been
conducted and, in light of current activities and doses within the DOE
complex, may not be warranted. DOE is therefore seeking comments on the
possible impact of eliminating all of the planned special exposure
provisions in Sec. 835.204.
3. Sealed Radioactive Source Control
DOE invites comments regarding the sealed radioactive source
accountability values proposed for inclusion as appendix E to 10 CFR
part 835. The basis for these values is explained in detail in Section
II.C. DOE has also selected a multiple of these values as the basis for
identifying radioactive material areas as defined in Sec. 835.2(a). DOE
is interested in receiving public comments regarding other options for
determining appropriate values and the technical bases supporting any
proposed alternatives.
[[Page 67609]]
4. Radiation Safety Training
DOE is proposing changes to the radiation safety training
requirements in subpart J. Due to the limited course content and
exposure restrictions in controlled areas, DOE is proposing to
eliminate the Sec. 835.901 requirement for general employees to
complete written examinations upon completion of general employee
radiological training. DOE is interested in receiving comments
regarding the impact of this change and possible benefits of retaining
the requirement.
Consistent with the current requirements of 10 CFR part 835, DOE
would retain radiation safety training requirements for three classes
of individuals. The proposed requirements of Sec. 835.901 (c) and (d)
(analogous to current requirements of Secs. 835.901 and 835.902,
respectively) are based upon the radiological hazards in the areas to
which unescorted access is permitted and the activities to be
undertaken by individuals in these areas. However, the proposed
requirements, while appropriate to the needs of general employees and
radiological workers, may not adequately address the duties and
responsibilities of radiological control technicians (RCTs). DOE is
concerned about the efficacy of the proposed rule, as it would apply to
RCTs, because: (1) the education, training, and responsibilities of
RCTs throughout the DOE complex vary greatly; (2) the training course
subject matter requirements proposed for inclusion in Sec. 835.901(b)
may not always be specifically related to the responsibilities of RCTs
at the varied DOE facilities; (3) specification of explicit training
requirements for RCTs may establish an inferred primacy for that
position that is unwarranted in relation to the responsibilities of
other individuals who fill various technical support, supervisory, and
management positions; and (4) there are no requirements for any DOE
activity to actually employ RCTs. Therefore, DOE is seeking public
comment on the following alternative approaches and invites comments on
any other viable approaches for ensuring that radiation safety training
is provided in a manner sufficient to ensure adequate implementation of
the radiation protection program.
4a. Alternative Approach 1
The first alternative approach under consideration would be to add
to Sec. 835.901 a separate paragraph that establishes specific RCT
training course content requirements that reflect the wide range of
duties and responsibilities of RCTs employed by DOE activities. This
approach would, in effect, codify training course content distinctions
that are currently established in the standardized core training
courses distributed by DOE. For example such requirements might expand
the training course content requirements of Sec. 835.901(b) to more
clearly indicate that, for RCTs, ``basic radiological fundamentals''
(Sec. 835.901(b)(2)) includes fundamentals of radiation detection and
measurement theory and techniques and that ``individual
responsibilities for implementing ALARA measures'' (Sec. 835.901(b)(5))
includes provisions for providing job-site radiation protection
coverage for general employees.
4b. Alternative Approach 2
The second alternative approach under consideration would be to add
to Sec. 835.901 separate paragraphs that establish specific training
requirements for RCTs and other key positions in the radiological
control organization, e.g., radiological control manager, RCT
supervisor, ALARA engineer, and radiological control support personnel.
4c. Alternative Approach 3
The third alternative approach under consideration would be to
remove from 10 CFR part 835 all requirements for RCT training. This
approach is based upon a presumption that compliance with the
performance requirements established in 10 CFR part 835 provides for an
adequate degree of radiation protection, regardless of the training
provided to RCTs.
4d. Alternative Approach 4
The fourth alternative approach under consideration would be to
remove the RCT training requirements from subpart J and add to
Sec. 835.101 a general requirement for individuals responsible for
implementing the requirements of 10 CFR part 835 to have the
appropriate education, training, and skills to effectively discharge
these responsibilities.
5. Written Procedures
In reviewing the requirements of 10 CFR part 835 and the proposed
amendment, DOE noted that various requirements for written procedures
have been established without consistent consideration of the hazards
involved in the wide range of DOE activities (see Secs. 835.404(d),
835.405(f), 835.501(d), 835.1001(b), 835.1003(a), 835.1101 (b) and (c)
and 835.1201(a)). For instance, proposed Sec. 835.1201(a) establishes
requirements for written procedures for control of accountable sealed
radioactive sources, regardless of their activity, but there is no
parallel requirement for control of planned special exposures. DOE is
concerned that this inconsistency, while historically present under DOE
Order 5480.11, may divert resources from active management of high-risk
activities to administrative control of low-risk activities. DOE is
seeking public comment on the proposed amendment, on the alternative
approaches that follow, and on any other viable approaches.
5a. Alternative Approach 1
The first alternative approach under consideration would be to
remove from 10 CFR part 835 most or all of the specific requirements
for written procedures. Such requirements would be left to the
discretion of cognizant DOE line management in discharging their
responsibilities for approval of documented radiation protection
programs.
5b. Alternative Approach 2
The second alternative approach under consideration would be to
replace most or all of the specific requirements for written procedures
in 10 CFR part 835 with a general requirement, added to Sec. 835.101,
requiring written procedures to be developed and implemented consistent
with the potential hazards created by the activity and the education,
training, and skills of the individuals who might be exposed to these
hazards.
6. Lung Retention Factors
As explained in ``Use of Appendices'' in Section II.D. of this
preamble, DOE is proposing to delete appendix B to 10 CFR part 835 and
place the data into a guidance document. Although DOE is proposing to
delete appendix B because it does not contain substantive requirements,
DOE is seeking public comment on the possible impact of removing the
alternative absorption factors and lung retention classes from 10 CFR
part 835.
7. Emergency Situations
DOE is proposing revisions to Secs. 835.1301 and 835.1302 to
clarify requirements for applying the emergency dose guidelines. In
light of the uncertainties involved in emergency operations and the
fact that the numerical dose values provided are guidelines rather than
limits, DOE is proposing to delete the table containing these values
from 10 CFR part 835 and relegate them to appropriate emergency
management documents. DOE is seeking comments regarding the impact of
this
[[Page 67610]]
proposal and other alternatives for ensuring adequate radiation
protection during emergency operations.
8. Implementation Schedule
In Sec. 835.101(f), DOE has established its proposed schedule for
implementing the revised regulatory requirements (approximately three
(3) years for the radiobioassay program accreditation requirements and
six (6) months after RPP approval for all other requirements). DOE is
seeking comments on any possible benefits or drawbacks associated with
adhering to this proposed schedule.
B. Written Comment Procedures
Interested parties are invited to participate in this proceeding by
submitting written data, views, or arguments with respect to the
subjects set forth in this notice. Instructions for submitting written
comments are set forth at the beginning of this notice. Written
comments (5 copies and a computer disk) should be labeled on the
envelope, computer disk, and the documents, ``EH-RM-96-835,'' and must
be received by the date specified at the beginning of this notice. All
comments and other relevant information received by the date specified
at the beginning of this notice will be considered by DOE.
Pursuant to the provisions of 10 CFR 1004.11, any person submitting
information or data that is believed to be confidential and exempt by
law from public disclosure should submit one complete copy of the
document and 3 copies, if possible, from which the information believed
to be confidential has been deleted. DOE will make its own
determination with regard to the confidential status of the information
or data and treat it according to its own determination.
C. Public Hearings
1. Procedures for Submitting Requests To Speak
The dates, times, and locations of the public hearings are
indicated at the beginning of this notice. DOE invites any individual
who has an interest in these proceedings to make a request for an
opportunity to make an oral presentation at the public hearings.
Requests may be submitted by telephone at (202) 586-3012. The
individual making the request should provide a telephone number where
he or she may be contacted. Individuals will be notified as to the
approximate time they will be speaking. Each individual who will be
speaking is requested to submit 5 copies of his or her statement at the
registration desk prior to the beginning of the hearing. In the event
any individual wishing to testify cannot meet this request, that
individual may make alternate arrangements by calling (202) 586-3012 in
advance or by so indicating in the letter requesting to make an oral
presentation.
2. Conduct of Hearing
DOE reserves the right to select the individuals to be heard at the
hearings, to schedule the respective presentations, and to establish
the procedures governing the conduct of the hearings. The length of
each presentation is limited to 10 minutes.
A DOE official will be designated to preside at the hearings. The
hearings will not be judicial- or evidentiary-type hearings, but will
be conducted in accordance with 5 U.S.C. 533 and section 501 of the DOE
Organization Act, 42 U.S.C. 7191. At the conclusion of all initial oral
statements, each person who has made an oral statement will be given
the opportunity to make a rebuttal or clarifying statement, subject to
time limitations. Any further procedural rules regarding proper conduct
of the hearings will be announced by the presiding official.
Transcripts of the hearings will be made and the entire record of
this rulemaking including the transcript will be retained by DOE and
made available for inspection at the DOE Freedom of Information Reading
Room as provided at the beginning of this notice. Any individual may
purchase a copy of the transcript from the transcribing reporter.
IV. Review Under the National Environmental Policy Act
DOE has reviewed the promulgation of this proposed 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 proposed amendment. 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. Comments on this finding should be provided to DOE at the
address listed for all other comments.
V. 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).
The proposed rule would amend 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. See
Small Business Administration, Final Rule on ``Small Business Size
Standards,'' 61 FR 3280, at 3289-94 (January 31, 1996). DOE's M&O
contractors exceed 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 proposed rule. For these
reasons, DOE certifies that the proposed rule, if promulgated, will not
have a significant economic impact on a substantial number of small
entities.
VI. 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
[[Page 67611]]
Regulatory Affairs within the Office of Management and Budget.
VII. 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 proposed rule would not have a substantial direct effect on
the institutional interests or traditional functions of States.
VIII. 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: (a) 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 any; (2) clearly specifies any effect on existing
Federal law or regulation; (3) provides a clear legal standard for
affected conduct while promoting simplification and burden reduction;
(4) specifies the retroactive effect, if any; (5) adequately defines
key terms; and (6) addresses other important issues affecting clarity
and general draftsmanship under any guidelines issued by the Attorney
General. Section 3(c) of Executive Order 12988 requires Executive
agencies to review regulations in light of applicable standards in
section 3(a) and section 3(b) to determine whether they are met or it
is unreasonable to meet one or more of them. DOE has completed the
required review and determined that, to the extent permitted by law,
the proposed amendments to 10 CFR part 835 meet the relevant standards
of Executive Order 12988.
IX. Review Under Paperwork Reduction Act
The information and reporting requirements in this part would not
be substantially different from existing reporting requirements
provided in DOE contracts with DOE prime contractors covered by this
rule. This proposed amendment would codify recordkeeping and reporting
requirements currently provided in Departmental standards implemented
by DOE contractors through contractual commitments. DOE will submit the
collection of any new information requests concerning this rule to the
Office of Management and Budget for approval in accordance with the
Paperwork Reduction Act of 1980, 44 U.S.C. 3501.1 et seq., and the
procedures implementing that Act, 5 CFR 1320.1 et seq.
X. Review Under the Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (the Act),
enacted as Pub. L. 104-4 on March 22, 1995, requires each Federal
agency, to the extent permitted by law, to prepare a written assessment
of the effects of any Federal mandate in a proposed or final agency
rule that may result in the expenditure by State, local, and tribal
governments, in the aggregate or by the private sector, of $100 million
or more (adjusted annually for inflation) in any one year. Section
204(a) of the Act, 2 U.S.C. 1534(a), requires the Federal agency to
develop an effective process to permit timely input by elected officers
(or their designees) of State, local, and tribal governments on a
proposed ``significant intergovernmental mandate.'' Section 203 of the
Act, which supplements section 204(a), provides that before
establishing any regulatory requirements that might significantly or
uniquely affect small governments, the agency shall have developed a
plan that, among other things, provides for notice to potentially
affected small governments, if any, and for a meaningful and timely
opportunity to provide input in the development of regulatory
proposals. 2 U.S.C. 1533.
The proposed rule published today does not contain any Federal
mandate. The provisions on 10 CFR part 835 apply only to activities
conducted by or for DOE. Any costs resulting from implementation of
DOE's occupational radiation protection program are ultimately borne by
the Federal government. Therefore, the requirements of Title II of the
Unfunded Mandates Reform Act of 1995 do not apply.
List of Subjects in 10 CFR Part 835
Emergency radiation exposures, Nuclear material, Occupational
safety and health, Radiation exposures, Radiation protection,
Radioactive material, Reporting and recordkeeping requirements, Safety
during emergencies, Training.
Issued in Washington, DC, on December 12, 1996.
Tara O'Toole,
Assistant Secretary, Environment, Safety and Health.
For the reasons set forth in the preamble, Title 10, Code of
Federal Regulations, Part 835 is proposed to be amended as set forth
below:
10 CFR PART 835--OCCUPATIONAL RADIATION PROTECTION
1. The authority citation for Part 835 continues to read as
follows:
Authority: 42 U.S.C. 2201; 7191.
Subpart A--General Provisions
2. Section 835.1 is amended by revising the introductory text of
paragraph (b) and paragraph (b)(3), redesignating paragraph (b)(4) as
(b)(6), and revising it, and by adding paragraphs (b)(4), (b)(5), and
(c) as follows:
Sec. 835.1 Scope.
* * * * *
(b) Exclusion. Except as discussed in paragraph (c) of this
section, the requirements in this part do not apply to: * * *
(3) Activities conducted under the Nuclear Explosives and Weapons
Safety Program relating to the prevention of accidental or unauthorized
nuclear detonations to the extent a requirement under this part cannot
be implemented without compromising the effectiveness of such
activities;
(4) Radioactive material transportation conducted in compliance
with DOE Orders for such transportation;
(5) DOE activities conducted outside the United States on territory
under the jurisdiction of a foreign government to the extent governed
by occupational radiation protection requirements agreed to between the
United States and the cognizant government; or
(6) Background radiation, radiation doses received as a patient for
the purposes of medical diagnosis or therapy, or radiation doses
received from participation as a subject in medical research programs.
[[Page 67612]]
(c) Occupational doses received as a result of excluded activities
and radioactive material transportation, as listed in paragraphs (b)(1)
through (b)(5) of this section, shall be considered when determining
compliance with the occupational dose limits in Secs. 835.202 and
835.207. Occupational doses resulting from authorized emergency
exposures and planned special exposures shall not be considered when
determining compliance with the dose limits in Secs. 835.202 and
835.207.
3. In Sec. 835.2, paragraph (a) is amended by removing definitions
of the terms ``ambient air'' and ``continuous air monitor''; ``DOE
activities'' and ``occupational exposure'' by adding in alphabetical
order definitions for the terms ``accountable sealed radioactive
source'', ``derived air concentration-hour'', ``DOE activity'',
``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'' as follows;
and revising the definitions of the terms ``airborne radioactive
material or airborne radioactivity'', ``airborne radioactivity area'',
``contamination area'', ``controlled area'', ``declared pregnant
worker'', ``high contamination area'', ``member of the public'',
``monitoring'', ``radiological area'', and ``year'' to read as follows.
In Sec. 835.2, paragraph (b), the definition of ``collective dose'' is
removed and the definitions of the terms ``cumulative total effective
dose equivalent'', ``effective dose equivalent'', ``external dose or
exposure'', ``quality factor'', ''total effective dose equivalent'',
and ''weighting factor'' are revised as follows. Paragraph (d) of
Sec. 835.2 is removed.
Sec. 835.2 Definitions.
(a) As used in this part:
Accountable sealed radioactive source means a sealed radioactive
source having a half-life equal to or greater than 30 days and an
isotopic activity equal to or greater than the corresponding value
provided in appendix E to this part.
Airborne radioactive material or airborne radioactivity means
radioactive material dispersed in the air in the form of dusts, fumes,
particulates, mists, vapors, or gases.
Airborne radioactivity area means any area, accessible to
individuals, where the concentration of airborne radioactivity, above
natural background, exceeds or is likely to exceed 10 percent of the
derived air concentration (DAC) values listed in appendix A or appendix
C to this part.
* * * * *
Contamination area means any area, accessible to individuals, where
removable contamination levels exceed or are likely to exceed the
surface radioactivity values specified in appendix D to this part, but
do not exceed 100 times those values.
* * * * *
Controlled area means any area to which access is managed by or for
DOE to protect individuals from exposure to radiation and/or
radioactive material.
Declared pregnant worker means a woman who has voluntarily declared
to her employer, in writing, her pregnancy for the purpose of being
subject to the occupational dose limits to the embryo/fetus as provided
in Sec. 835.206. This declaration may be revoked, in writing, at any
time by the declared pregnant worker.
* * * * *
Derived air concentration-hour (DAC-hour) is the product of the
concentration of radioactive material in air (expressed as a fraction
or multiple of the DAC for each radionuclide) and the time of exposure
to that radionuclide, in hours.
DOE activity means an activity taken for or by DOE in a DOE
operation or facility that has the potential to result in the
occupational exposure of an individual to radiation or radioactive
material. The activity may be, but is not limited to, design,
construction, operation, or decommissioning. To the extent appropriate,
the activity may involve a single DOE facility or operation or a
combination of facilities and operations, possibly including an entire
site or multiple DOE sites.
* * * * *
High contamination area means any area, accessible to individuals,
where removable contamination levels exceed or are likely to exceed 100
times the surface radioactivity values specified in appendix D to this
part.
* * * * *
Member of the public means an individual who is not a general
employee. An individual is not a ``member of the public'' during any
period in which the individual receives an occupational dose.
* * * * *
Monitoring means the measurement of radiation levels, airborne
radioactivity concentrations, radioactive contamination levels, or
quantities of radioactive material and the use of the results of these
measurements to evaluate potential and actual exposures to ionizing
radiation.
* * * * *
Occupational dose means an individual's ionizing radiation dose
(external and internal) as a result of that individual's work
assignment. Occupational dose does not include doses received as a
medical patient or doses resulting from background radiation or
participation as a subject in medical research programs.
* * * * *
Radioactive material area means any area, accessible to
individuals, in which items or containers of radioactive material exist
and the total activity of radioactive material exceeds ten times the
applicable values provided in appendix E to this part.
Radioactive material transportation means the movement of
radioactive material having a specific activity in excess of 0.002
microcurie per gram by aircraft, rail, vessel, or highway vehicle
outside of a controlled area. Radioactive material transportation does
not include preparation of material or packagings for transportation,
conduct of surveys required by this part, or application of markings
and labels required for transportation.
Radiological area means any area(s) within a controlled area
defined as a ``radioactive material area,'' ``radiation area,'' ``high
radiation area,'' ``very high radiation area,'' ``contamination area,''
``high contamination area,'' or ``airborne radioactivity area'' in
accordance with this section.
Radiological control technician means a radiological worker whose
primary job assignment involves monitoring of workplace radiological
conditions, specification of protective measures, and provision of
assistance and guidance to other individuals in implementation of
radiological controls.
* * * * *
Real-time air monitoring means measurement of the concentrations or
quantities of airborne radioactive materials on a continuous basis.
* * * * *
Respiratory protective device means an apparatus, such as a
respirator, used to reduce an individual's intake of airborne
radioactive materials.
Sealed radioactive source means a radioactive source manufactured,
obtained, or retained for the purpose of utilizing the emitted
radiation. The sealed radioactive source consists of a known or
estimated quantity of radioactive material contained within a sealed
capsule, sealed between layer(s) of non-radioactive material, or firmly
fixed to a non-radioactive surface by electroplating or other means
intended to prevent leakage or escape of the radioactive material.
[[Page 67613]]
Source leak test means a test to determine if a sealed radioactive
source is leaking radioactive material.
* * * * *
Week means a period of seven consecutive days beginning on Sunday.
Year means the period of time beginning on or near January 1 and
ending on or near December 31 of that same year used to determine
compliance with the provisions of this part. The starting and ending
date of the year used to determine compliance may be changed provided
that the change is made at the beginning of the year and that no day is
omitted or duplicated in consecutive years.
(b) * * *
Cumulative total effective dose equivalent means the sum of all
total effective dose equivalent values recorded for an individual,
where available, for each year occupational exposure was received,
beginning January 1, 1989.
* * * * *
Effective dose equivalent (HE) means the summation of the
products of the dose equivalent received by specified tissues of the
body (HT) and the appropriate weighting factor (wT)--that is,
HE=wTHT. It includes the dose from radiation
sources internal and/or external to the body. For purposes of
compliance with this part, deep dose equivalent to the whole body may
be used as effective dose equivalent for external exposures. The
effective dose equivalent is expressed in units of rem (or sievert).
External dose or exposure means that portion of the dose equivalent
received from radiation sources outside the body (i.e., ``external
sources'').
* * * * *
Quality factor (Q) means the principal modifying factor used to
calculate the dose equivalent from the absorbed dose; the absorbed dose
(expressed in rad or gray) is multiplied by the appropriate quality
factor.
(i) The quality factors to be used for determining dose equivalent
in rem are shown below:
Quality Factors
------------------------------------------------------------------------
Quality
Radiation type factor
------------------------------------------------------------------------
X-rays, gamma rays, positrons, electrons (including tritium
beta particles).............................................. 1
Neutrons, 10 keV................................... 3
Neutrons, >10 keV............................................. 10
Protons and singly-charged particles of unknown energy with
rest mass greater than one atomic mass unit.................. 10
Alpha particles and multiple-charged particles (and particles
of unknown charge) of unknown energy......................... 20
------------------------------------------------------------------------
When spectral data are insufficient to identify the energy of the
neutrons, a quality factor of 10 shall be used.
(ii) When spectral data are sufficient to identify the energy of
the neutrons, the following mean quality factor values may be used:
Quality Factors for Neutrons
[Mean quality factors, Q (maximum value in a 30-cm dosimetry phantom),
and values of neutron flux density that deliver in 40 hours, a maximum
dose equivalent of 100 mrem (0.001 sievert). Where neutron energy falls
between listed values, the more restrictive mean quality factor shall be
used.]
------------------------------------------------------------------------
Neutron
Mean flux
Neutron energy (MeV) quality density
factor (cm-2s-1)
------------------------------------------------------------------------
2.5 x 10-8 thermal................................ 2 680
1 x 10-7.......................................... 2 680
1 x 10-6.......................................... 2 560
1 x 10-5.......................................... 2 560
1 x 10-4.......................................... 2 580
1 x 10-3.......................................... 2 680
1 x 10-2.......................................... 2.5 700
1 x 10-1.......................................... 7.5 115
5 x 10-1.......................................... 11 27
1................................................. 11 19
2.5............................................... 9 20
5................................................. 8 16
7................................................. 7 17
10................................................ 6.5 17
14................................................ 7.5 12
20................................................ 8 11
40................................................ 7 10
60................................................ 5.5 11
1 x 10 2.......................................... 4 14
2 x 10 2.......................................... 3.5 13
3 x 10 2.......................................... 3.5 11
4 x 10 2.......................................... 3.5 10
------------------------------------------------------------------------
* * * * *
Total effective dose equivalent (TEDE) means the sum of the
effective dose equivalent (for external exposures) and the committed
effective dose equivalent (for internal exposures).
Weighting factor (wT) means the fraction of the overall health
risk, resulting from uniform, whole body irradiation, attributable to
specific tissue (T). The dose equivalent to tissue, HT, is
multiplied by the appropriate weighting factor to obtain the dose
equivalent to that tissue. The weighting factors are as follows:
Weighting Factors for Various Organs and Tissues
------------------------------------------------------------------------
Weighting
Organs or tissues, T factor, wT
------------------------------------------------------------------------
Gonads...................................................... 0.25
Breasts..................................................... 0.15
Red bone marrow............................................. 0.12
Lungs....................................................... 0.12
Thyroid..................................................... 0.03
Bone surfaces............................................... 0.03
Remainder \1\............................................... 0.30
Whole body \2\.............................................. 1.00
------------------------------------------------------------------------
\1\ ``Remainder'' means the five other organs or tissues with the
highest dose (e.g., liver, kidney, spleen, thymus, adrenal, pancreas,
stomach, small intestine, and upper large intestine). The weighting
factor for each remaining organ or tissue is 0.06.
\2\ For the case of uniform external irradiation of the whole body, a
weighting factor (wT) equal to 1 may be used in determination of the
effective dose equivalent.
* * * * *
Sec. 835.4 [Amended]
4. Section 835.4 is amended by adding ``roentgen,'' after ``rad,''
in the first sentence and removing the last sentence.
Subpart B--Radiation Protection Programs
5. Section 835.101 is amended by revising paragraph (f) to read as
follows, removing paragraph (g), and redesignating paragraphs (h), (i),
and (j) as (g), (h), and (i) respectively; in paragraph (d), the
reference to ``Sec. 835.101(i)'' is changed to ``Sec. 835.101(h)''.
Sec. 835.101 Radiation protection programs.
* * * * *
(f) The RPP shall include plans, schedules, and other measures for
achieving compliance with regulations of this part. Unless otherwise
specified, compliance with amendments to this part shall be achieved no
later than 180 days following approval of the revised RPP by DOE.
Compliance with the requirements of Sec. 835.402(d) for radiobioassay
program accreditation must be achieved no later than January 1, 2000.
* * * * *
6. Section 835.102 is revised to read as follows:
Sec. 835.102 Internal audits
Internal audits of the radiation protection program, including
examination of program content and implementation, shall be conducted
through a process that ensures that all functional elements are
reviewed no less frequently than every 36 months.
7. Section 835.202 is amended by revising the section heading,
revising
[[Page 67614]]
the introductory text of paragraph (a), and revising paragraphs (b) and
(c) to read as follows:
Sec. 835.202 Occupational dose limits for general employees.
(a) The occupational exposure to general employees resulting from
DOE activities, other than planned special exposures under Sec. 835.204
and emergency exposures conducted in compliance with DOE Orders for
emergency operations, shall be controlled so the following limits from
all occupational doses are not exceeded in a year:
* * * * *
(b) All occupational doses received during the current year, except
doses resulting from planned special exposures under Sec. 835.204 and
emergency exposures conducted in compliance with DOE Orders for
emergency operations, shall be included when demonstrating compliance
with Secs. 835.202(a) and 835.207.
(c) Exposures from background, therapeutic and diagnostic medical
radiation, and participation as a subject in medical research programs
shall not be included in dose records or in the assessment of
compliance with the occupational dose limits.
8. Section 835.203 is amended by revising the section heading and
paragraph (a) to read as follows and by removing paragraph (c):
Sec. 835.203 Combining internal and external dose equivalents.
(a) For individuals monitored in accordance with Sec. 835.402 (a)
and (c), the total effective dose equivalent during a year shall be
determined by summing the effective dose equivalent from external
exposures and the committed effective dose equivalent from intakes
during the year. For individual monitoring that is performed, but not
required by either Sec. 835.402(a) or Sec. 835.402(c) (non-mandatory
monitoring), summing of the external and internal doses is required
only when the dose determined by the non-mandatory monitoring exceeds
the associated monitoring threshold established in Sec. 835.402(a) or
Sec. 835.402(c).
* * * * *
9. Section 835.204 is amended by revising paragraphs (a)(3),
(c)(1), (c)(2) and (d) to read as follows:
Sec. 835.204 Planned special exposures.
(a) * * *
(3) Joint written approval is received from the appropriate DOE
Headquarters program office and the Secretarial Officer responsible for
environment, safety and health matters.
* * * * *
(c) * * *
(1) In a year, the numerical value of the dose limits established
in Sec. 835.202; or
(2) Over the individual's lifetime, five times the numerical value
of the dose limits established in Sec. 835.202.
(d) Prior to a planned special exposure, written consent shall be
obtained from each individual involved. Each such written consent shall
include:
(1) The purpose of the planned operations and procedures to be
used;
(2) The estimated doses and associated potential risks and specific
radiological conditions and other hazards which might be involved in
performing the task; and
(3) Instructions on the measures to be taken to keep the dose ALARA
considering other risks that may be present.
* * * * *
10. Section 835.207 is revised to read as follows:
Sec. 835.207 Occupational dose limits for minors.
No minor shall be occupationally exposed to radiation and/or
radioactive material during direct on-site access at a DOE site or
facility in excess of 0.1 rem (0.001 sievert) total effective dose
equivalent or be occupationally exposed in excess of 10 percent of the
limits for general employees specified in Sec. 835.202(a) (2), (3), and
(4) in a year.
11. Section 835.208 is revised to read as follows:
Sec. 835.208 Limits for members of the public entering a controlled
area.
No member of the public shall be exposed to radiation and/or
radioactive material during access to the controlled area at a DOE site
or facility in excess of 0.1 rem (0.001 sievert) total effective dose
equivalent in a year.
Sec. 835.209 [Amended]
12. Section 835.209 is amended by removing paragraph (b) and
redesignating paragraph (c) as (b).
Subpart E--Monitoring in the Workplace
13. Section 835.401 is amended by revising the introductory text of
paragraphs (a) and (c) and paragraph (c)(1) to read as follows:
Sec. 835.401 General requirements.
(a) Monitoring and surveys shall be performed to:
* * * * *
(c) Instruments and equipment used for monitoring and surveys shall
be:
(1) Periodically maintained and calibrated on an established
frequency of at least once every twelve months;
* * * * *
14. Section Sec. 835.402 is revised to read as follows:
Sec. 835.402 Individual monitoring.
(a) For the purpose of monitoring individual exposures to external
radiation, personnel dosimeters shall be provided to and used by:
(1) Radiological workers who, under typical conditions, are likely
to receive one or more of the following:
(i) A deep dose equivalent to any portion of the whole body of 0.1
rem (0.001 sievert) or more in a year;
(ii) A shallow dose equivalent to the skin or to any extremity of 5
rems (0.05 sievert) or more in a year;
(iii) A lens of the eye dose equivalent of 1.5 rems (0.015 sievert)
or more in a year;
(2) Declared pregnant workers who are likely to receive from
external sources a dose equivalent to the embryo/fetus in excess of 10
percent of the applicable limit in Sec. 835.206;
(3) Occupationally exposed minors likely to receive a dose in
excess of 50 percent of the applicable limits in Sec. 835.207 in a year
from external sources;
(4) Members of the public entering a controlled area likely to
receive a dose in excess of 50 percent of the limit in Sec. 835.208 in
a year from external sources; or
(5) Individuals entering a high or very high radiation area.
(b) External dose monitoring programs shall be adequate to
demonstrate compliance with the dose limits established in subpart C of
this part. Except as provided in paragraph (e) of this section,
personnel dosimetry programs implemented to demonstrate compliance with
Sec. 835.402(a) shall:
(1) Be accredited in accordance with the DOE Laboratory
Accreditation Program for Personnel Dosimetry; or,
(2) Be excepted from accreditation in accordance with the DOE
Laboratory Accreditation Program for Personnel Dosimetry.
(c) For the purpose of monitoring individual exposures to internal
radiation, internal dosimetry programs (including routine bioassay
programs) shall be conducted for:
(1) Radiological workers who, under typical conditions, are likely
to receive 0.1 rem (0.001 sievert) or more committed effective dose
equivalent from all occupational radionuclide intakes in a year;
[[Page 67615]]
(2) Declared pregnant workers likely to receive an intake resulting
in a dose equivalent to the embryo/fetus in excess of 10 percent of the
limit stated in Sec. 835.206;
(3) Occupationally exposed minors who are likely to receive a
committed effective dose equivalent in excess of 50 percent of the
applicable limit stated in Sec. 835.207 from all radionuclide intakes
in a year; or
(4) Members of the public entering a controlled area likely to
receive a committed effective dose equivalent in excess of 50 percent
of the limit stated in Sec. 835.208 from all radionuclide intakes in a
year.
(d) Internal dose monitoring programs shall be adequate to
demonstrate compliance with the dose limits established in subpart C of
this part. Except as provided in paragraph (e) of this section,
radiobioassay programs implemented to demonstrate compliance with
Sec. 835.402(c) shall:
(1) Be accredited in accordance with the DOE Laboratory
Accreditation Program for Radiobioassay; or
(2) Be excepted from accreditation in accordance with the DOE
Laboratory Accreditation Program for Radiobioassay.
(e) Personnel Dosimetry or Radiobioassay Programs implemented to
demonstrate compliance with Sec. 835.402(a) or Sec. 835.402(c)
respectively, that do not comply with the DOE Laboratory Accreditation
Program Administration Technical Standard (latest version) require the
approval of the Secretarial Officer responsible for environment, safety
and health matters. Approval may be given if such programs demonstrate
performance equivalent to that of programs accredited under the
applicable DOE Laboratory Accreditation Program.
15. Section 835.403 is revised to read as follows:
Sec. 835.403 Air monitoring.
Monitoring of airborne radioactivity concentrations shall be
performed in accordance with the provisions of this section.
(a) Air sampling shall be performed:
(1) Where an individual is likely to receive an exposure of 40 or
more DAC-hours in a year. Samples representative of air inhaled by
workers shall be taken as necessary to detect and evaluate the level or
concentration of airborne radioactive material at work locations; or
(2) Where respiratory protective devices for protection against
airborne radionuclides have been prescribed.
(b) Real-time air monitoring shall be performed where unexpected
increases in airborne radioactivity levels are likely to result in an
exposure to an individual exceeding 40 DAC-hours in one week.
(c) For the airborne radioactive material that could be
encountered, real-time air monitors shall have alarm capability and
sufficient sensitivity to alert potentially exposed individuals that
immediate action is necessary in order to minimize or terminate
inhalation exposures.
16. Section 835.404 is amended by revising paragraphs (d) and (f)
to read as follows:
Sec. 835.404 Radioactive contamination control and monitoring.
* * * * *
(d) Areas accessible to individuals where the measured total
contamination levels exceed the total surface radioactivity values
specified in appendix D to this part, but the removable contamination
levels are less than the removable surface radioactivity values
specified in appendix D to this part, shall be controlled as follows
when located outside of radiological areas:
(1) The area shall be routinely surveyed to ensure the removable
contamination level remains below the values specified in appendix D to
this part;
(2) The area shall be conspicuously marked to warn individuals of
the contaminated status; and
(3) Written procedures shall be established and implemented to
prevent unplanned or uncontrolled removal of the radioactive material.
* * * * *
(f) Appropriate monitoring to detect the presence of contamination
shall be performed by individuals exiting radiological areas
established to control removable contamination and/or airborne
radioactivity.
* * * * *
17. Section 835.405 is added to subpart E to read as follows:
Sec. 835.405 Receipt of radioactive packages.
(a) If packages containing quantities of radioactive material in
excess of a Type A quantity (as defined in 10 CFR 71.4) are expected to
be received, arrangements shall be made to either:
(1) Take possession of the package when the carrier offers it for
delivery; or
(2) Receive notification as soon as practicable after arrival of
the package at the carrier's terminal and to take possession of the
package expeditiously after receiving notification.
(b) External surfaces of packages known to contain radioactive
material shall be surveyed for radioactive contamination if the
package:
(1) Is labeled with a Radioactive White I, Yellow II, or Yellow III
label (as specified in 49 CFR 172.403 and 172.436-440); or
(2) Has been transported as low specific activity material on an
exclusive use vehicle (as these terms are defined in 10 CFR 71.4); or
(3) Has evidence of degradation, such as packages that are crushed,
wet, or damaged.
(c) External surfaces of packages known to contain radioactive
material shall be surveyed for radiation levels if the package:
(1) Is labeled with a Radioactive White I, Yellow II, or Yellow III
label (as specified 49 CFR 172.403 and 172.436-440) and contains a Type
A (as defined in 10 CFR 71.4) or greater quantity of radioactive
material; or
(2) Has been transported as low specific activity material on an
exclusive use vehicle (as these terms are defined in 10 CFR 71.4); or
(3) Has evidence of degradation, such as packages that are crushed,
wet, or damaged.
(d) The surveys required by paragraphs (b) and (c) of this section
shall be performed as soon as practicable after receipt of the package,
but not later than 3 hours after the package is received if it is
received during normal working hours, or not later than 3 hours from
the beginning of the next working day if it is received after working
hours.
(e) Surveys of received packages for radioactive contamination are
not necessary if the package contains only special form (as defined in
10 CFR 71.4) or gaseous radioactive material.
(f) Written procedures for safely opening packages in which
radioactive material is received shall be established and implemented.
These procedures shall give due consideration to special instructions
for the type of package being opened.
Subpart F--Entry Control Program
18. Section 835.501 is amended by revising paragraph (d),
redesignating paragraph (e) as paragraph (f), and adding a new
paragraph (e) to read as follows:
Sec. 835.501 Radiological areas.
* * * * *
(d) Written procedures shall be established and implemented as
necessary to demonstrate compliance with the provisions of this
subpart. The procedures shall include actions required to ensure the
effectiveness and operability of barricades, devices, alarms, and
locks.
[[Page 67616]]
(e) Written authorizations shall be required to control entry into
and perform work within radiological areas. These authorizations shall
specify radiation protection measures commensurate with the existing
and potential hazards.
* * * * *
19. In Sec. 835.502, paragraphs (a), (b), and (c) are redesignated
as paragraphs (b), (c), and (d) respectively; the paragraph heading of
redesignated paragraph (b) is revised to read ``Physical controls'';
and new paragraph (a) is added and redesignated paragraph (c) is
revised as follows:
Sec. 835.502 High and very high radiation areas.
(a) The following measures shall be implemented for each entry into
a high radiation area:
(1) The area shall be surveyed as necessary during access to
determine the exposure rates to which the individual is exposed; and
(2) Each individual shall be provided a supplemental dosimetry
device capable of providing an immediate indication of the individual's
integrated dose during the entry.
* * * * *
(c) Very high radiation areas. In addition to the above
requirements, additional measures shall be implemented to ensure
individuals are not able to gain access to very high radiation areas.
Subpart G--Posting and Labeling
20. Section 835.601 is revised to read as follows:
Sec. 835.601 General requirements.
(a) Areas shall be posted in accordance with this subpart to
provide warning to individuals of the presence, or potential presence,
of radiation or radioactive materials.
(b) Except as provided in Sec. 835.602(b), postings and labels
required by this subpart shall include the standard radiation warning
trefoil in black or magenta imposed upon a yellow background.
(c) Signs required by this subpart shall be clearly and
conspicuously posted and may include radiological protection
instructions.
(d) The posting and labeling requirements in this subpart may be
modified to reflect the special considerations of DOE activities
conducted at private residences or businesses. Such modifications shall
provide the same level of protection to individuals as the existing
provisions in this subpart.
21. Section 835.602 is amended by revising paragraph (a) to read as
follows:
Sec. 835.602 Controlled areas.
(a) Each access point to a controlled area (as defined in
Sec. 835.2) shall be posted whenever radiological areas exist in the
area. Individuals who enter only the controlled area without entering
radiological areas are not expected to receive a total effective dose
equivalent of more than 100 mrem (0.001 sievert) in a year.
* * * * *
22. Section 835.603 is revised to read as follows:
Sec. 835.603 Radiological areas.
Each access point to a radiological area (as defined in Sec. 835.2)
shall be posted with conspicuous signs bearing the wording provided in
this section.
(a) Radiation Area. The words ``Caution, Radiation Area'' shall be
posted at each radiation area.
(b) High Radiation Area. The words ``Caution, High Radiation Area''
or ``Danger, High Radiation Area'' shall be posted at each high
radiation area.
(c) Very High Radiation Area. The words ``Grave Danger, Very High
Radiation Area'' shall be posted at each very high radiation area.
(d) Airborne Radioactivity Area. The words ``Caution, Airborne
Radioactivity Area'' or ``Danger, Airborne Radioactivity Area'' shall
be posted at each airborne radioactivity area.
(e) Contamination Area. The words ``Caution, Contamination Area''
shall be posted at each contamination area.
(f) High Contamination Area. The words ``Caution, High
Contamination Area'' or ``Danger, High Contamination Area'' shall be
posted at each high contamination area.
(g) Radioactive Material Area. The words ``Caution, Radioactive
Material(s)'' or ``Danger, Radioactive Material(s)'' shall be posted at
each radioactive material area.
23. Section 835.604 is added to subpart G to read as follows:
Sec. 835.604 Exceptions to posting requirements.
(a) Areas may be excepted from the posting requirements of
Sec. 835.603 for periods of less than 8 continuous hours when placed
under continuous observation and control of an individual knowledgeable
of, and empowered to implement, required access and exposure control
measures.
(b) The following areas are excepted from the radioactive material
area posting requirements of Sec. 835.603(g):
(1) Areas posted in accordance with Sec. 835.603(a) through (f);
and
(2) Areas in which each item or container of radioactive material
is clearly and adequately labeled such that individuals entering the
area are made aware of the hazard.
(c) Areas containing only packages received from radioactive
material transportation need not be posted in accordance with
Sec. 835.603 until the packages are surveyed in accordance with
Sec. 835.405.
24. Section 835.605 is added to subpart G to read as follows:
Sec. 835.605 Labeling items and containers.
Except as provided in Sec. 835.606, each item or container of
radioactive material shall bear a durable, clearly visible label
bearing the standard radiation warning trefoil and the words ``Caution,
Radioactive Material'' or ``Danger, Radioactive Material.'' The label
shall also provide sufficient information to permit individuals
handling or using the items or containers, or working in the vicinity
of the items or containers, to take precautions to avoid or minimize
exposures.
25. Section 835.606 is added to subpart G to read as follows:
Sec. 835.606 Exceptions to labeling requirements.
Items and containers are excepted from the radioactive material
labeling requirements of Sec. 835.605 when:
(a) Used, handled, or stored in areas posted and controlled in
accordance with Secs. 835.603 and 835.604 and sufficient information is
provided to permit individuals to take appropriate protective actions;
or
(b) The quantity of radioactive material is below the values
specified in appendix E to this part; or
(c) Packaged, labeled, and marked in accordance with the
regulations of the Department of Transportation or corresponding DOE
Orders; or
(d) Accessible only to individuals authorized to handle or use
them, or to work in the vicinity; or
(e) Installed in manufacturing or process equipment, such as
reactor components, piping, and tanks.
Subpart H--Records
26. Section 835.702 of subpart H, paragraphs (b), (c), (d), and (e)
are revised to read as follows:
835.702 Individual monitoring records.
* * * * *
(b) The results of individual external and internal dose monitoring
that is performed, but not required by Sec. 835.402, shall be recorded
if the resulting doses exceed the monitoring thresholds of
Sec. 835.402(a) or
[[Page 67617]]
Sec. 835.402(c). Recording of the non-uniform shallow dose equivalent
to the skin as determined under Sec. 835.205 is not required if the
dose is less than 2 percent of the limit specified for the skin in
Sec. 835.202(a)(4).
(c) The records required by this section shall:
(1) Be sufficient to evaluate compliance with subpart C of this
part;
(2) Be sufficient to provide dose information necessary to complete
reports required by subpart I of this part and by DOE requirements for
occurrence reporting and processing;
(3) Include the following quantities for external dose received
during the year:
(i) The effective dose equivalent from external sources of
radiation (deep dose equivalent may be used as effective dose
equivalent for external exposure);
(ii) The lens of the eye dose equivalent;
(iii) The shallow dose equivalent to the skin; and
(iv) The shallow dose equivalent to the extremities.
(4) Include the following information for internal dose resulting
from intakes received during the year:
(i) Committed effective dose equivalent;
(ii) Committed dose equivalent to any organ or tissue of concern;
and
(iii) Identity of radionuclides.
(5) Include the following quantities for the summation of the
external and internal dose:
(i) Total effective dose equivalent in a year;
(ii) For any organ or tissue assigned an internal dose during the
year, the sum of the deep dose equivalent from external exposures and
the committed dose equivalent to that organ or tissue; and
(iii) Cumulative total effective dose equivalent.
(6) Include the dose equivalent to the embryo/fetus of a declared
pregnant worker.
(d) Documentation of all occupational doses received during the
current year, except for doses resulting from planned special exposures
under Sec. 835.204 and emergency exposures conducted in compliance with
DOE Orders for emergency operations, shall be obtained to demonstrate
compliance with Sec. 835.202(a). If complete records documenting
previous occupational dose during the year cannot be obtained, a
written estimate signed by the individual may be used to demonstrate
compliance.
(e) For radiological workers whose occupational exposure is
monitored in accordance with Sec. 835.402, efforts shall be made to
obtain complete records of prior years occupational internal and
external doses. If complete records documenting prior years
occupational doses cannot be obtained, a written estimate signed by the
individual may be accepted.
* * * * *
27. In Sec. 835.703, paragraphs (b), (c) and (d)(1) are revised to
read as follows:
Sec. 835.703 Monitoring and workplace records.
* * * * *
(b) Monitoring and survey results used to determine individual
occupational dose from external and internal sources;
(c) Results of surveys for the release and control of material and
equipment as required by Sec. 835.1101. These records shall describe
the property, date on which the survey was performed, identity of the
individual who performed the survey, type and identification number of
the survey instrument used, and results of the survey; and
(d) * * *
(1) Instruments and equipment used for surveys and monitoring as
required by Sec. 835.401; and
* * * * *
28. Section 835.704, paragraph (a) is amended by removing the
reference to ``, 835.902, and 835.903''; paragraph (b) is amended by
removing the reference to ``, 835.1002,''; paragraph (d) is revised and
a new paragraph (f) is added as follows:
Sec. 835.704 Administrative records.
* * * * *
(d) Written declarations of pregnancy and revocations of
declarations of pregnancy shall be maintained.
* * * * *
(f) Records shall be maintained as necessary to evaluate compliance
with the requirements of Secs. 835.1201 and 835.1202 for sealed
radioactive source written procedures, inventory, and source leak
tests.
Subpart I--Reports to Individuals
29. Section 835.801, paragraph (a) is revised to read as follows:
Sec. 835.801 Reports to individuals.
(a) Radiation exposure data for individuals monitored in accordance
with Sec. 835.402 shall be reported as specified in this section. The
information shall include the data required under Sec. 835.702(c). Each
notification and report shall be in writing and include: the DOE site
or facility name, the name of the individual, and the individual's
social security number, employee number, or other unique identification
number.
* * * * *
Subpart J--Radiation Safety Training
30. In subpart J, Sec. 835.901 is revised to read as follows:
Sec. 835.901 Radiation safety training.
(a) Radiation safety training programs shall be established as
necessary to ensure compliance with the requirements of this section.
(b) Radiation safety training shall include the following topics,
to the extent appropriate to each individual's prior training,
anticipated and actual assignments, and degree of exposure to potential
radiological hazards:
(1) Risks of exposure to radiation and radioactive materials,
including prenatal radiation exposure;
(2) Basic radiological fundamentals and radiation protection
concepts;
(3) Controls, limits, policies, procedures, alarms, and other
measures implemented at the facility to minimize exposures to radiation
and radioactive materials, including both routine and emergency
actions;
(4) Individual rights and responsibilities as related to
implementation of the facility radiation protection program;
(5) Individual responsibilities for implementing ALARA measures
required by Sec. 835.101; and
(6) Individual exposure reports that may be requested in accordance
with Sec. 835.801.
(c) Individuals shall complete radiation safety training before
being permitted unescorted access to controlled areas and prior to
receiving occupational exposure during access to controlled areas at a
DOE site or facility.
(d) Each individual shall demonstrate knowledge of the radiation
safety training topics established in Sec. 835.901(b), commensurate
with the hazards in the area and required controls, by successful
completion of an examination and performance demonstrations prior to
being permitted unescorted access to radiological areas and prior to
performing unescorted assignments as a radiological worker.
(e) Each radiological control technician shall demonstrate
knowledge of the radiation safety training topics established in
Sec. 835.901(b), commensurate with the hazards and required controls,
by successful completion of an examination and performance
demonstrations prior to performing unescorted assignments.
[[Page 67618]]
(f) Where an escort is required in accordance with paragraph (c),
(d), or (e) of this section, the escort shall:
(1) Have completed required training, examinations, and performance
demonstrations for the area to be entered and the work to be performed;
and
(2) Ensure that all escorted individuals comply with the documented
radiation protection program.
(g) Retraining shall be provided to individuals when there is a
significant change to radiation protection policies and procedures that
may affect the individual and at intervals not to exceed 24 months.
Retraining provided for individuals subject to the requirements of
Sec. 835.901(d) and (e) shall include successful completion of an
examination.
Secs. 835.902 and 835.903 [Removed and Reserved]
31. Sections 835.902 and 835.903 of subpart J are removed and
reserved.
Subpart K--Design and Control
32. In Sec. 835.1001, paragraph (a), the phrase in the first
sentence ``facility and equipment design'' is revised to read
``physical design features'' and paragraph (c) is added as follows:
Sec. 835.1001 Design and control.
* * * * *
(c) During the design of new facilities or modification of existing
facilities:
(1) Optimization methods shall be used to assure that occupational
dose is maintained ALARA in developing and justifying facility design
or modification and physical controls; and
(2) The design or modification of a facility and the selection of
materials shall include features that facilitate operations,
maintenance, decontamination, and decommissioning.
33. Section 835.1002 is removed and reserved.
Sec. 835.1002 [Removed and Reserved]
34. Section 835.1003 is amended by revising paragraph (a)(1);
removing paragraph (a)(2); and redesignating paragraph (a)(3) as
paragraph (a)(2):
Sec. 835.1003 Control procedures.
(a) * * *
(1) The anticipated occupational dose to general employees shall
not exceed the limits established in Sec. 835.202; and
* * * * *
Subpart L--Releases of Materials and Equipment From Radiological
Areas
35. Section 835.1101 is revised to read as follows:
Sec. 835.1101 Releases of materials and equipment from radiological
areas.
The following requirements apply to the release of materials and
equipment from radiological areas for use in controlled areas:
(a) Except as provided in paragraphs (b) and (c) of this section,
in radiological areas established to control surface or airborne
radioactive material, material and equipment shall be treated as
radioactive material and shall not be released from radiological areas
to controlled areas if either of the following conditions exist:
(1) Surveys of accessible surfaces show that either the total or
removable contamination levels exceed the values specified in appendix
D to this part; or
(2) Prior use suggests that the contamination levels on
inaccessible surfaces are likely to exceed the values specified in
appendix D to this part.
(b) Material and equipment exceeding the total or removable surface
radioactivity values specified in appendix D to this part may be
conditionally released for movement on-site from one radiological area
for immediate placement in another radiological area only if
appropriate surveys are performed and appropriate procedures to control
the movement are established and exercised.
(c) Material and equipment with fixed contamination levels that
exceed the values specified in appendix D to this part may be released
for use in controlled areas outside of the radiological areas only
under the following conditions:
(1) Removable contamination levels are below the values specified
in appendix D to this part; and
(2) Materials are routinely surveyed and clearly marked, labeled,
or tagged to alert individuals of the contaminated status; and
(3) Appropriate written procedures are established and exercised to
maintain control of these items.
(d) Prior to removal of materials and equipment from radiological
areas in accordance with paragraph (a) of this section, all radioactive
material markings and labels shall be removed or defaced.
Subpart M--Sealed Radioactive Source Control
36. Subpart M is amended by adding sections 835.1201 and 835.1202
as follows:
Sec. 835.1201 General provisions.
(a) Written procedures shall be established and implemented to
control accountable sealed radioactive sources.
(b) Accountable sealed radioactive sources, or their storage
containers or devices, shall be labeled in accordance with
Sec. 835.605. Such labels are exempt from the design and color
specifications of Sec. 835.601(b).
Sec. 835.1202 Inventories and leak tests.
(a) Each accountable sealed radioactive source shall be inventoried
at intervals not to exceed six months. This inventory shall:
(1) Establish the physical location of each accountable sealed
radioactive source;
(2) Verify the presence and adequacy of associated postings and
labels; and
(3) Establish the adequacy of storage locations, containers, and
devices.
(b) Except for sealed sources consisting solely of gaseous
radioactive material or tritium, each accountable sealed radioactive
source having an activity in excess of 0.005 Ci shall be
subject to a source leak test upon receipt, when damage is suspected,
and at intervals not to exceed six months. Source leak tests shall be
capable of detecting radioactive material leakage equal to or exceeding
0.005 Ci.
(c) Notwithstanding the requirements of paragraph (b) of this
section, an accountable sealed radioactive source is not subject to
periodic source leak testing if that source has been removed from
service. Such sources shall be stored in a controlled location, subject
to periodic inventory as required by paragraph (a) of this section, and
subject to source leak testing prior to being returned to service.
(d) Notwithstanding the requirements of paragraph (b) of this
section, an accountable sealed radioactive source is not subject to
periodic inventory and source leak testing if that source is located in
an area that is unsafe for human entry.
(e) An accountable sealed radioactive source found to be leaking
radioactive material shall be controlled in a manner that prevents the
escape of radioactive material to the workplace.
37. In Sec. 835.1301, paragraphs (b) and (d) are amended by
removing the phrase ``or 835.205'' and the introductory text of
paragraph (a) is revised as follows:
Sec. 835.1301 General provisions.
(a) A general employee whose occupational dose has exceeded the
numerical value of any of the limits specified in Sec. 835.202 as a
result of an accident or emergency may be permitted to return to work
in radiological areas
[[Page 67619]]
during the current year providing that all of the following conditions
are met:
* * * * *
38. Section 835.1302, paragraph (c) is revised to read as follows,
paragraph (d) is removed, and paragraph (e) is redesignated as (d) and
revised to read as follows:
Sec. 835.1302 Emergency exposure situations.
* * * * *
(c) No individual shall be required to perform rescue action that
might involve substantial personal risk.
(d) Each individual selected shall be trained in accordance with
Sec. 835.901(d) and briefed beforehand on the known or anticipated
hazards to which the individual will be subjected.
Sec. 835.1304 [Amended]
39. In Sec. 835.1304, paragraphs (a) and (b)(1), the word
``personnel'' is revised to read ``individuals''; in paragraph (b)(4),
the phrase ``all personnel'' is revised to read ``individuals''.
40. Appendix A to Part 835 is amended by removing footnote 5 and
adding the following paragraph at the beginning of the introductory
text:
Appendix A to Part 835--Derived Air Concentrations (DAC) for
Controlling Radiation Exposure to Workers at DOE Facilities
The data presented in appendix A are to be used for determining
individual internal doses in accordance with Sec. 835.209, identifying
the need for air monitoring in accordance with Sec. 835.403, and
identifying airborne radioactivity areas as defined in Sec. 835.2(a).
* * * * *
41. Appendix B to Part 835 is removed and reserved.
42. Appendix C to Part 835 is amended by removing the entries for
the radionuclides Rn-220 and Rn-222 and their corresponding half-lives
and air immersion DACs from the table and revising the introductory
text preceding the table as follows:
Appendix C to Part 835--Derived Air Concentration (DAC) for Workers
From External Exposure During Immersion in a Contaminated Atmospheric
Cloud
a. The data presented in appendix C are to be used for
identifying airborne radioactivity areas as defined in
Sec. 835.2(a), determining individual internal doses in accordance
with Sec. 835.209, and identifying the need for air monitoring in
accordance with Sec. 835.403.
b. The air immersion DAC values shown in this appendix are based
on a stochastic dose limit of 5 rems (0.05 Sv) per year or a
nonstochastic (organ) dose limit of 50 rems (0.5 Sv) per year. Four
columns of information are presented: (1) radionuclide; (2) half-
life in units of seconds (s), minutes (min), hours (h), days (d), or
years (yr); (3) air immersion DAC in units of Ci/ml; and
(4) air immersion DAC in units of Bq/m3. The data are listed by
radionuclide in order of increasing atomic mass. The air immersion
DACs were calculated for a continuous, nonshielded exposure via
immersion in a semi-infinite atmospheric cloud. The DACs listed in
this appendix may be modified to allow for submersion in a cloud of
finite dimensions.
c. The DAC value for air immersion listed for a given
radionuclide is determined either by a yearly limit on effective
dose equivalent, which provides a limit on stochastic radiation
effects, or by a limit on yearly dose equivalent to any organ, which
provides a limit on nonstochastic radiation effects. For most of the
radionuclides listed, the DAC value is determined by the yearly
limit on effective dose equivalent. Thus, the few cases where the
DAC value is determined by the yearly limit on shallow dose
equivalent to the skin are indicated in the table by an appropriate
footnote. Again, the DACs listed in this appendix account only for
immersion in a semi-infinite cloud and do not account for inhalation
or ingestion exposures.
d. Three classes of radionuclides are included in the air
immersion DACs as described below.
(1) Class 1. The first class of radionuclides includes selected
noble gases and short-lived activation products that occur in
gaseous form. For these radionuclides, inhalation doses are
negligible compared to the external dose from immersion in an
atmospheric cloud.
(2) Class 2. The second class of radionuclides includes those
for which a DAC value for inhalation has been calculated, but for
which the DAC value for external exposure to a contaminated
atmospheric cloud is more restrictive (i.e., results in a lower DAC
value). These radionuclides generally have half-lives of a few hours
or less, or are eliminated from the body following inhalation
sufficiently rapidly to limit the inhalation dose.
(3) Class 3. The third class of radionuclides includes selected
isotopes with relatively short half-lives. These radionuclides
typically have half-lives that are less than 10 minutes, they do not
occur as a decay product of a longer lived radionuclide, or they
lack sufficient decay data to permit internal dose calculations.
These radionuclides are also typified by a radioactive emission of
highly intense, high-energy photons and rapid removal from the body
following inhalation.
e. The DAC values are given for individual radionuclides. For
known mixtures of radionuclides, determine the sum of the ratio of
the observed concentration of a particular radionuclide and its
corresponding DAC for all radionuclides in the mixture. If this sum
exceeds unity (1), then the DAC has been exceeded. For unknown
radionuclides, the most restrictive DAC (lowest value) for those
isotopes not known to be absent shall be used.
* * * * *
43. Appendix D to part 835 is revised as follows:
Appendix D to Part 835--Surface Radioactivity Values
The data presented in appendix D are to be used in identifying
contamination and high contamination areas as defined in
Sec. 835.2(a), identifying the need for surface contamination
monitoring and control in accordance with Sec. 835.404, identifying
the need for radioactive material controls in accordance with
Sec. 835.1101.
Surface Radioactivity Values \1\
[In dmp/100 cm \2\]
------------------------------------------------------------------------
Total (fixed +
Radionuclide Removable 2, 4 removable) 2, 3
------------------------------------------------------------------------
U-nat, U-235, U-238, and 1,000............ 5,000
associated decay products.
Transuranics, Ra-226, Ra-228, Th- 20............... 500.
230, Th-228, Pa-231, Ac-227, I-
125, I-129.
Th-nat, Th-232, Sr-90, Ra-223, Ra- 200.............. 1,000.
224, U-232, I-126, I-131, I-133.
Beta-gamma emitters (nuclides 1,000............ 5,000.
with decay modes other than
alpha emission or spontaneous
fission) except Sr-90 and others
noted above \5\.
Tritium and tritiated compounds 10,000........... N/A.
\6\.
------------------------------------------------------------------------
1 The values in this appendix, with the exception noted in footnote 6,
apply to radioactive contamination deposited on, but not incorporated
into the interior of, the contaminated item. Where surface
contamination by both alpha- and beta-gamma-emitting nuclides exists,
the limits established for alpha- and beta-gamma-emitting nuclides
apply independently.
2 As used in this table, dpm (disintegrations per minute) means the rate
of emission by radioactive material as determined by correcting the
counts per minute observed by an appropriate detector for background,
efficiency, and geometric factors associated with the instrumentation.
3 The levels may be averaged over one square meter provided the maximum
surface activity in any area of 100 cm2 is less than three times the
value specified. For purposes of averaging, any square meter of
surface shall be considered to be above the surface radioactivity
value if: (1) from measurements of a representative number of sections
it is determined that the average contamination level exceeds the
applicable value; or (2) it is determined that the sum of the activity
of all isolated spots or particles in any 100 cm2 area exceeds three
times the applicable value.
[[Page 67620]]
4 The amount of removable radioactive material per 100 cm2 of surface
area should be determined by swiping the area with dry filter or soft
absorbent paper, applying moderate pressure, and then assessing the
amount of radioactive material on the swipe with an appropriate
instrument of known efficiency. (Note--The use of dry material may not
be appropriate for tritium.) When removable contamination on objects
of surface area less than 100 cm2 is determined, the activity per unit
area shall be based on the actual area and the entire surface shall be
wiped. It is not necessary to use swiping techniques to measure
removable contamination levels if direct scan surveys indicate that
the total residual surface contamination levels are within the limits
for removable contamination.
5 This category of radionuclides includes mixed fission products,
including the Sr-90 which is present in them. It does not apply to Sr-
90 which has been separated from the other fission products or
mixtures where the Sr-90 has been enriched.
6 Tritium contamination may diffuse into the volume or matrix of
materials. Evaluation of surface contamination shall consider the
extent to which such contamination may migrate to the surface in order
to ensure the surface radioactivity value provided in this appendix is
not exceeded. Once this contamination migrates to the surface, it may
be removable, not fixed, therefore a ``Total'' value does not apply.
44. Appendix E to Part 835 is added as follows:
Appendix E to part 835--Values for Establishing Sealed Radioactive
Source Accountability and Radioactive Material Posting and Labeling
Requirements
The data presented in appendix E are to be used for identifying
accountable sealed radioactive sources and radioactive material
areas as those terms are defined in Sec. 835.2(a) and establishing
the need for radioactive material labeling in accordance with
Secs. 835.605 and 835.606.
Note: The data in this table are listed in order of increasing
atomic weight.
Less than 300 Ci (10 MBq)
H-3
Be-7
C-14
S-35
Ca-41
Ca-45
V-49
Mn-53
Fe-55
Ni-59
Ni-63
As-73
Se-79
Rb-87
Tc-99
Pd-107
Cd-113
In-115
Te-123
Cs-135
Ce-141
Gd-152
Tb-157
Tm-171
Ta-180
W-181
W-185
W-188
Re-187
Tl-204
Less than 30 Ci (1 MBq)
Cl-36
K-40
Fe-59
Co-57
Se-75
Rb-84
Sr-85
Sr-89
Y-91
Zr-95
Nb-93m
Nb-95
Tc-97m
Ru-103
Ag-105
In-114m
Sn-113
Sn-119m
Sn-121m
Sn-123
Te-123m
Te-125m
Te-127m
Te-129m
I-125
La-137
Ce-139
Pm-143
Pm-145
Pm-147
Sm-145
Sm-151
Eu-149
Eu-155
Gd-151
Gd-153
Dy-159
Tm-170
Yb-169
Lu-173
Lu-174
Lu-174m
Hf-175
Hf-181
Ta-179
Re-184
Re-186m
Ir-192
Pt-193
Au-195
Hg-203
Pb-205
Np-235
Pu-237
Less than 3 Ci (100 kBq)
Be-10
Na-22
Al-26
Si-32
Sc-46
Ti-44
Mn-54
Fe-60
Co-56
Co-58
Co-60
Zn-65
Ge-68
Rb-83
Y-88
Zr-88
Zr-93
Nb-94
Mo-93
Tc-95m
Tc-97
Tc-98
Ru-106
Rh-101
Rh-102
Rh-102m
Ag-108m
Ag-110m
Cd-109
Sn-126
Sb-124
Sb-125
Te-121m
I-129
Cs-134
Cs-137
Ba-133
Ce-144
Pm-144
Pm-146
Pm-148m
Eu-148
Eu-150
Eu-152
Eu-154
Gd-146
Tb-158
Tb-160
Ho-166m
Lu-176
Lu-177m
Hf-172
Ta-182
Re-184m
Os-185
Os-194
Ir-192m
Ir-194m
Hg-194
Pb-202
Bi-207
Bi-210m
Cm-241
Less than 0.3 Ci (10 kBq)
Sr-90
Cd-113m
La-138
Hf-178m
Hf-182
Po-210
Ra-226
Ra-228
Pu-241
Bk-249
Es-254
Less than 0.03 Ci (1 kBq)
Sm-146
Sm-147
Pb-210
Np-236
Cm-242
Cf-248
Fm-257
Md-258
Less than 0.003 Ci (100 Bq)
Gd-148
Th-228
[[Page 67621]]
Th-230
U-232
U-233
U-234
U-235
U-236
U-238
Np-237
Pu-236
Pu-238
Pu-239
Pu-240
Pu-242
Pu-244
Am-241
Am-242m
Am-243
Cm-243
Cm-244
Cm-245
Cm-246
Cm-247
Bk-247
Cf-249
Cf-250
Cf-251
Cf-252
Cf-254
Less than 0.0003 Ci (10 Bq)
Ac-227
Th-229
Th-232
Pa-231
Cm-248
Cm-250
Any alpha emitting radionuclide not listed above and mixtures of
alpha emitters of unknown composition have a value of 0.001
Ci.
Any radionuclide other than alpha emitting radionuclides not
listed above and mixtures of beta emitters of unknown composition
have a value of 0.01 Ci.
Note: Where there is involved a combination of radionuclides in
known amounts, derive the value for the combination as follows:
determine, for each radionuclide in the combination, the ratio
between the quantity present in the combination and the value
otherwise established for the specific radionuclide when not in
combination. If the sum of such ratios for all radionuclides in the
combination exceeds unity (1), then the accountability criterion has
been exceeded.
[FR Doc. 96-32107 Filed 12-20-96; 8:45 am]
BILLING CODE 6450-01-P
