Procedural Rules for DOE Nuclear Activities and Occupational Radiation Protection, 31904-31941 [E7-10477]

Agencies

• DEPARTMENT OF ENERGY

[Federal Register Volume 72, Number 110 (Friday, June 8, 2007)]
[Rules and Regulations]
[Pages 31904-31941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10477]



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Part II





Department of Energy





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10 CFR Parts 820 and 835



Procedural Rules for DOE Nuclear Activities and Occupational Radiation 
Protection; Final Rule

Federal Register / Vol. 72, No. 110 / Friday, June 8, 2007 / Rules 
and Regulations

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DEPARTMENT OF ENERGY

10 CFR Parts 820 and 835

[Docket No. EH-RM-02-835]
RIN 1901-AA95


Procedural Rules for DOE Nuclear Activities and Occupational 
Radiation Protection

AGENCY: Office of Health, Safety and Security, Department of Energy.

ACTION: Final rule.

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SUMMARY: The Department of Energy (DOE) today amends its Procedural 
Rules for DOE Nuclear Activities, and its Occupational Radiation 
Protection requirements. The amendments to 10 CFR part 820, the 
Procedural Rules for DOE Nuclear Activities, update its provisions to 
take into account the establishment of the National Nuclear Security 
Administration (NNSA). The amendments to 10 CFR part 835, the 
Occupational Radiation Protection requirements, update its provisions 
to account for lessons learned since the initial adoption of these 
regulations, comments from the Defense Nuclear Facilities Safety Board 
(DNFSB) and members of the public, new recommendations from the 
International Commission on Radiological Protection (ICRP), and the 
establishment of the NNSA.

DATES: This rule is effective July 9, 2007.

FOR FURTHER INFORMATION CONTACT: Mr. Peter V. O'Connell, U. S. 
Department of Energy, Office of Worker Safety and Health Policy (HS-
11), 1000 Independence Avenue, SW., Washington, DC 20585; (301) 903-
5641.

SUPPLEMENTARY INFORMATION:

I. Background of 10 CFR Part 820
II. Discussion of Changes to 10 CFR Part 820
III. Background of 10 CFR Part 835
IV. Discussion of Changes to 10 CFR Part 835
V. Regulatory Review
    A. Review Under Executive Order 12866
    B. Review Under Executive Order 12988
    C. Review Under Executive Order 13132
    D. Review Under Regulatory Flexibility Act
    E. Review Under the Paperwork Reduction Act of 1995
    F. Review Under the National Environmental Policy Act
    G. Review Under the Unfunded Mandates Reform Act
    H. Review Under Executive Order 13211
    I. Review Under the Treasury and General Government 
Appropriations Act, 1999
    J. Review Under the Treasury and General Government 
Appropriations Act, 2001
    K. Congressional Notification
VI. Approval of the Office of the Secretary

I. Background of 10 CFR Part 820

    Part 820 sets forth the procedural rules relating to DOE nuclear 
safety requirements. Among other matters, 10 CFR part 820 sets forth 
the process for granting exemptions from nuclear safety requirements 
and the process for issuing civil penalties for violations of nuclear 
safety requirements. DOE proposed 10 CFR part 820 on December 9, 1991 
(56 FR 64290) and issued a clarification on May 15, 1992 (57 FR 20796). 
DOE published 10 CFR part 820 as a final rule on August 17, 1993 (58 FR 
43680) and amended it on October 8, 1997 (62 FR 52479), on March 22, 
2000 (65 FR 15218), and on November 28, 2006 (71 FR 68727).
    DOE proposed its latest amendments to 10 CFR part 820 on August 10, 
2006 (71 FR 45996). Today's final rule modifies 10 CFR part 820 by:
    (1) Formalizing the use of enforcement letters; and
    (2) Making explicit the role of NNSA in giving direction to NNSA 
contractors pursuant to 10 CFR part 820.
    As discussed in this notice of final rulemaking, this final rule 
was developed after consideration of comments received during a public 
hearing and through written and electronic public comments on the 
notice of proposed rulemaking (NOPR).

II. Discussion of Changes to 10 CFR Part 820

    The National Nuclear Safety Administration Act (NNSA Act) (Title 
XXXII of Pub. L. 106-65, 50 U.S.C. 2401 et seq.) established the NNSA. 
The Act contains provisions that affect 10 CFR part 820. In particular, 
non-NNSA DOE personnel, other than the Secretary and Deputy Secretary, 
are prohibited from giving direction to NNSA contractors. On November 
28, 2006, DOE published a final rule that amended the Code of Federal 
Regulations to address the fact that several Assistant Secretaries and 
the Deputy Assistant Secretary for Naval Reactors positions were 
converted into NNSA Deputy Administrator positions by the NNSA Act (71 
FR 68727-38).

A. Definition of ``Secretarial Officer''

    The November 28, 2006 final rule revised the definition of 
``Secretarial Officer'' in 10 CFR 820.2 to mean an individual who is 
appointed to a position in the Department of Energy by the President of 
the United States with the advice and consent of the Senate or the head 
of a departmental element who is primarily responsible for the conduct 
of an activity under the Atomic Energy Act of 1954, as amended. The 
revised definition in the final rule also states that with regard to 
activities and facilities covered under E.O. 12344, 42 U.S.C. 7158 
note, pertaining to Naval nuclear propulsion, Secretarial Officer means 
the Deputy Administrator for Naval Reactors.

B. Investigations

    DOE adds two new subsections to Sec.  820.21 to codify current 
practices. The final rule adds section 820.21(g), which recognizes the 
use of enforcement letters to communicate expectations during an 
investigation into a possible violation of a nuclear safety 
requirement. It also adds section 820.21(h), which provides that the 
Director may sign, issue and serve subpoenas during an investigation. 
These changes were in the proposal and DOE received no comments on 
them.

C. Direction of NNSA Contractors

    The NNSA Act provides at 50 U.S.C 2410(b) that non-NNSA DOE 
personnel (other than the Secretary and Deputy Secretary) are 
prohibited from giving direction to NNSA contractors. Since the 
establishment of the NNSA, the NNSA and other elements of DOE, 
including the Office of Enforcement, have worked together to ensure 10 
CFR part 820 operates in a manner consistent with section 2410(b). New 
Sec.  820.13 codifies current practices and makes clear that NNSA is 
responsible for signing, issuing and serving actions that give 
direction to NNSA contractors. These changes were in the proposal and 
DOE received no comments on them.

D. Appendix on Enforcement Policy

    DOE updates the Appendix on Enforcement Policy to reflect the 
changes this final rule makes to 10 CFR part 820. These changes were in 
the proposal and DOE received no comments on them.

III. Background of 10 CFR Part 835

    Part 835 of title 10 of the CFR sets forth the nuclear safety 
requirements that provide radiological protection for DOE workers and 
members of the public in a controlled area at a DOE facility. DOE 
proposed 10 CFR part 835 on December 9, 1991 (56 FR 64334) and 
published it as final on December 14, 1993 (58 FR 65458). DOE amended 
10 CFR part 835 on November 4, 1998 (63 FR 59662) and on November 28, 
2006 (71 FR 68727).
    DOE proposed its latest amendment to 10 CFR part 835 on August 10, 
2006 (71 FR 45996). Today's final rule amends 10 CFR part 835 by:
    (1) Clarifying those requirements in 10 CFR part 835 which apply to 
radioactive material transportation;

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    (2) Excluding from the scope of 10 CFR part 835 material, 
equipment, and real property approved for release in accordance with 
DOE approved authorized limits which have been approved by a 
Secretarial Officer in consultation with the Chief Health, Safety and 
Security Officer. (Note: At the time of DOE's proposed amendment, 
August 10, 2006, this function was to be accomplished by the Office of 
the Assistant Secretary for Environment, Safety and Health. After 
publication of the NOPR, DOE reorganized the Office of Environment, 
Safety and Health into the Office of Health, Safety and Security. Under 
this reorganization the Secretarial Officer responsible for 
environment, safety and health matters is the Chief Health, Safety and 
Security Officer);
    (3) Updating the dosimetric models and dose terms to be consistent 
with newer recommendations from ICRP, including use of updated tissue 
and radiation weighting factors and updated derived air concentration 
(DAC) values;
    (4) Establishing DAC values for Special Tritium Compounds (STCs);
    (5) Lowering the maximum amount of radioactive material which need 
not be labeled;
    (6) Allowing use of thresholds for recording occupational 
exposures;
    (7) Establishing DAC default values for radionuclides not listed in 
the rule; and
    (8) Revising values in Appendix E to be consistent with newer 
dosimetric models and adding values for STCs.
    These final amendments were developed after consideration of input 
received during a public hearing and through written and electronic 
public comments on the NOPR.
    The schedule for achieving compliance with the amendments to 10 CFR 
part 835 is as follows. As provided at Sec.  835.101(g)(3), updated 
radiation protection programs must be submitted to DOE within 180 days 
following the effective date of this final rule or January 4, 2008. 
Changes that do not decrease the effectiveness of the radiation 
protection program (RPP) may be implemented prior to DOE approval. 
Changes that decrease the effectiveness of the RPP require DOE approval 
prior to implementation. As provided at Sec.  835.101(i), an update of 
the RPP shall be considered approved 180 days after its initial 
submission unless rejected by DOE at an earlier date. Consistent with 
the proposal, today's final rule, at Sec.  835.101(f), requires that 
RPPs include plans, schedules, and other measures for achieving 
compliance with regulations of this part such that full compliance with 
the regulatory changes is achieved within three years of the effective 
date of the final rule, which is July 9, 2007.

IV. Discussion of Changes to 10 CFR Part 835

    DOE is amending 10 CFR part 835 for a number of reasons. In some 
cases, an analysis of the operating experience with 10 CFR part 835 
indicated that DOE's needs could be met more effectively if there was a 
change. In other cases, the DNFSB staff or members of the public have 
suggested changes. In addition, the ICRP has issued newer 
recommendations on areas covered by 10 CFR part 835.
    DOE received several comments proposing new changes, not related to 
proposed changes in the NOPR. DOE has decided there is no need to 
consider these proposed changes now and, if it were to do so, it would 
be required by section 553 of the Administrative Procedures Act (5 
U.S.C. 553) to engage in further notice and comment proceedings. DOE is 
not making any new changes that are unrelated to the proposed changes 
in the NOPR.

A. Scope of 10 CFR Part 835

    1. U.S. Nuclear Regulatory Commission (NRC) Regulated Activity 
Exclusion. One comment noted that the exclusion in 10 CFR 835.1(b)(1) 
refers to activities regulated through a license by the NRC, or a State 
under an agreement with the NRC, including activities certified by the 
NRC under section 1701 of the Atomic Energy Act. The exclusion is 
limited by 10 CFR 835.1(c) which indicates that occupational doses 
received as a result of excluded activities shall be considered when 
determining compliance with DOE's occupational dose limits. The 
preamble to the proposed rule indicates that ICRP Publication 68, Dose 
Coefficients for Intakes of Radionuclides by Workers, will be the basis 
for the rule's terminology and methodology. Under certain 
circumstances, when a DOE worker conducts multiple activities involving 
both excluded and un-excluded activities under 10 CFR 835.1(b)(1), 
clarification is needed as to how the rule would be applied when using 
different dose coefficients and weighting factors to calculate the 
overall cumulative total effective dose for the worker. DOE agrees with 
this comment and will provide guidance (see discussion of 10 CFR part 
835.2).
    2. Material, Equipment, and Real Property Exclusion. DOE proposed 
to amend Sec.  835.1 (Scope) by inserting a new paragraph (b)(6) which 
would exclude radioactive material on or within material, equipment, 
and real property that is approved for release when the radiological 
conditions of the material, equipment, and real property have been 
documented to comply with the criteria for release set forth in a DOE 
authorized limit that has been approved by a Secretarial Officer in 
consultation with the Office of the Assistant Secretary for 
Environment, Safety and Health. The NOPR explained that under DOE O 
5400.5, Radiation Protection of the Public and the Environment, real 
property on a DOE site and material and equipment from a DOE site may 
be released for unrestricted or restricted use by members of the public 
in accordance with a process to determine the risk to an individual 
from the residual radioactive material remaining on or within the 
material, equipment, or property. Such material, equipment, or real 
property may sometimes contain contaminated surfaces which exceed the 
surface contamination levels in 10 CFR part 835 appendix D. The 
appendix D values trigger application of occupational radiological 
controls for contaminated areas.
    Accordingly, prior to today's final rule, even though DOE may have 
determined that this material, equipment, or property posed a minimal 
risk to individuals, if DOE activities were still associated with the 
material, equipment, or property, then certain radiological controls in 
10 CFR part 835, such as those for access control, posting and 
training, would apply to portions of this material, equipment, or 
property.
    To eliminate this potential inconsistency, DOE proposed a new Sec.  
835.1(b)(6) that would exclude from the scope of 10 CFR part 835 
radioactive material on or within material, equipment, and real 
property which has been approved by DOE for release.
    In this final rule, DOE modifies the language in the new Sec.  
835.1(b)(6) to exclude radioactive material on or within material, 
equipment, and real property which is approved for release when the 
radiological conditions of the material, equipment, and real property 
have been documented to comply with the criteria for release set forth 
in a DOE authorized limit which has been approved by a Secretarial 
Officer in consultation with the Chief Health, Safety and Security 
Officer. As previously noted, the functions of the Office of the 
Assistant Secretary for Environment, Safety and Health have been 
transferred to the Chief Health, Safety and Security Officer and the 
final rule reflects that change.
    DOE recognizes that, depending on the potential exposure, requiring 
approval at the Secretarial Officer, level may be a higher level of 
approval than required by DOE O 5400.5. However,

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this level of approval is consistent with other provisions of 10 CFR 
part 835 for which there are alternative means of compliance, such as 
alternatives to the DOELAP, use of planned special exposures, and 
exemptions from specified provisions of 10 CFR part 835. The 
requirement for consultation with the Chief Health, Safety and Security 
Officer would be satisfied by providing copies of a Secretarial 
Officer's approved authorized limits and supporting documentation to 
the cognizant office within the Office of Health, Safety and Security 
(currently the Office of Nuclear Safety and Environment (HS-20)) for 
review and comment. The Office of Nuclear Safety and Environment will 
coordinate the review and comment with the Office of Worker Safety and 
Health Policy (HS-11). After comments have been resolved, the 
consultation process is complete. The intent for this change is to 
allow for the exclusion to apply for material, equipment, or real 
property regardless of whether the property has been released from DOE 
control. The Department also expects the material, equipment, or real 
property to which this exclusion is applied will be released from DOE 
control according to a specified time interval.
    DOE received several comments that the proposed change would be 
beneficial and may promote better harmony between DOE occupational 
radiation protection and environmental protection requirements.
    DOE also received a comment requesting clarification of the 
applicability of this exclusion to real property which has been 
remediated under the criteria and conditions specified in an approved 
Record of Decision under the Comprehensive Environmental Response, 
Compensation, and Liability Act of 1980 (CERCLA). The process for 
determining CERCLA remediation criteria and conditions is analogous to 
the process for determining an authorized limit pursuant to the 
requirements of DOE O 5400.5. Accordingly, for the purpose of excluding 
real property from the scope of 10 CFR part 835, approved CERCLA 
remediation criteria may be considered equivalent to an authorized 
limit if the DOE site office has determined that the criteria meet DOE 
requirements for authorized limits and provided that the use of these 
criteria as DOE authorized limits is documented and approved as would 
be an authorized limit, i.e., by a Secretarial Officer or designee in 
consultation with the Chief Office of Health, Safety, and Security 
Officer.
    3. Radioactive Material Transportation. DOE proposed revising Sec.  
835.1 to clarify which requirements in 10 CFR part 835 apply to the 
transportation of radioactive material by or on behalf of the DOE. 
Specifically, DOE proposed to delete existing Sec.  835.1(b)(4) and 
replace it with a new Sec.  835.1(d) that would state clearly that 
subparts F (Entry Control Program) and G (Posting and Labeling) do not 
apply to radioactive material transportation conducted by a DOE 
individual or DOE contractor, when the radioactive material is under 
the continuous observation and control of an individual who is 
knowledgeable of and implements required exposure control measures. 
This proposed change was not intended to affect the application of 
requirements to radioactive material transportation in the other 
subparts of 10 CFR part 835.
    The proposal stated that DOE did not intend 10 CFR part 835 to 
apply to transportation by the U. S. Postal Service or a commercial 
carrier, such as Fedex or UPS, which transport radioactive material as 
part of their normal operations. A company or subsidiary of a 
corporation that operates a DOE facility would not be considered a 
commercial carrier--even if such an organization transports radioactive 
material as part of its contractual agreement with DOE. This position 
is consistent with NRC practice. See, for example, 10 CFR 30.13, 40.12, 
and 70.12. DOE requested comments as to whether there should be an 
explicit exclusion of these carriers from the scope of 10 CFR part 835.
    DOE also proposed changes to the definition of ``radioactive 
material transportation'' in Sec.  835.2(a) to improve the regulatory 
language. The NOPR stated that these proposed changes were not intended 
to affect the existing scope of this definition, which excludes 
activities related to transportation such as the preparation of 
material or packagings for transportation, storage of material awaiting 
transportation, or application of markings and labels required for 
transportation.
    DOE received comments requesting guidance on the new exclusion, 
particularly the proposed ``continuous observation'' provision. One 
commenter noted that, if the radioactive material ceases to be under 
``continuous observation'' the requirements of subparts F and G should 
apply because to do otherwise, could result in potential exposure of 
workers or the public. DOE agrees with this comment. However, DOE 
recognizes that there are some cases when it may be impractical to 
maintain ``continuous observation.'' To address this situation and 
still provide adequate warning to workers and members of the public, 
DOE adds a provision to Sec.  835.1(d) to allow exception from subparts 
F and G for transportation by DOE and DOE contactors for radioactive 
material transportation conducted in accordance with Department of 
Transportation (DOT) regulations or DOE orders that govern such 
movements. For radioactive material transportation that is not subject 
to DOT regulations or DOE transportation orders (for situations where 
DOE and a contractor had not included such orders in the contract), the 
conditions for the exception from subparts F and G would be met by 
conducting the transportation activity per DOT regulations or DOE 
orders whether or not these are regulatory or contractually required 
for the transportation activity. DOE believes that the provisions at 
Sec.  835.1(d) fulfill its intentions with regard to protection of 
workers and the public.
    Another commenter noted that material staged for some period on DOE 
property was still technically in transit and requested guidance for 
continuous observation for such material. DOE disagrees with this 
comment, and the definition of ``radioactive material transportation'' 
does not include preparation of material or packagings for 
transportation or storage of material awaiting transportation such as 
what might occur when material is staged on DOE property. In accordance 
with the definition of ``radioactive material transportation,'' the 
exclusion applies while the material is in the process of undergoing 
movement, including nominal stoppages such as for traffic 
considerations or refueling activities.
    Another commenter stated that this change should lead to cost 
savings for DOE laboratories. A commenter also requested a definition 
of ``radioactive material'' be added to the rule.
    DOE also received a comment that there should be a specific 
exclusion for a ``company or subsidiary of a corporation that operates 
a DOE facility.'' At most DOE facilities the prime contractor 
transports radioactive materials as part of routine facility 
operations. DOE disagrees with the comment that its contractors 
conducting radioactive material transportation should be excluded from 
all the provisions of 10 CFR part 835. While DOE agrees that, at most 
DOE facilities, the prime contractor commonly transports radioactive 
materials as part of routine facility operations, it is the 
Department's position that all DOE occupational exposures to ionizing 
radiation to DOE and DOE contractor employees should, to the extent 
practicable, be subject to the provisions

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of 10 CFR part 835. For example, provisions in 10 CFR part 835 that 
should apply to workers involved in radioactive material 
transportation, are qualification and training requirements, necessary 
radiation exposure monitoring, and As Low As is Reasonably Achievable 
(ALARA) requirements.
    The NOPR stated DOE's intention that 10 CFR part 835 not apply to 
transportation by the U.S. Postal Service or a commercial carrier, such 
as Fedex or UPS, which transport radioactive material as part of their 
normal operations. DOE adds a provision to Sec.  835.1(b) explicitly 
excluding all radioactive material transportation from the scope of 10 
CFR part 835 that is not performed by DOE or a DOE contractor. This 
change clarifies the applicability of the transportation exclusion by 
making it an explicit regulatory provision.
    There may be situations where DOE or DOE contractor personnel also 
perform radioactive material transportation activities for other than 
DOE related purposes (such as DOE or DOE contractor personnel 
performing work for a commercial transportation company after normal 
work hours). This situation is comparable to that where a DOE 
individual or a DOE contractor works part-time at an NRC regulated 
facility. Occupational exposure resulting from working at a NRC 
regulated facility (i.e., an excluded activity) is considered when 
evaluating compliance with the dose limits. Accordingly, DOE is 
including in 10 CFR 835.1(c) a provision that occupational doses 
received as a result of radioactive material transportation performed 
by other than the DOE or a DOE contractor, be considered to the extent 
practicable when determining compliance with the occupational dose 
limits.
    One commenter suggested imposing a time limit on the radioactive 
material transportation exclusion. The commenter noted that there is 
already a time-based exception for posting radiological areas when 
there is a knowledgeable person controlling access to the area, for up 
to eight hours (Sec.  835.604(a)). A comparable approach was suggested 
for radioactive material transportation. DOE believes this is an 
impractical approach for the radioactive material transportation 
exclusion due to the wide variation in shipment circumstances 
(including variable time periods) expected to be encountered across the 
DOE complex.
    This final rule includes the changes to the radioactive material 
transportation provisions in the NOPR with the following additional 
changes: Section 835.1(b)(7) is added excluding radioactive material 
transportation not performed by the DOE or a DOE contractor. Section 
835.1(c) is modified such that occupational doses received as a result 
of radioactive material transportation performed by other than the DOE 
or a DOE contractor, must be considered to the extent practicable when 
determining compliance with the occupational dose limits.
    Section 835.1(4) is added excluding radioactive material 
transportation not performed by the DOE or a DOE contractor. Section 
835.1(d) is modified to exclude DOE and DOE contractors performing 
radioactive material transportation from subpart G and F if such 
transportation is conducted under the continuous observation and 
control of an individual who is knowledgeable of and implements 
required exposure control measures or if the transportation is 
conducted in accordance with DOT regulations or DOE orders that govern 
such movements.

B. Definitions in 10 CFR Part 835

    DOE proposed to change most of the dosimetric terms used in 10 CFR 
part 835 to reflect the recommendations for assessing dose and 
associated terminology from ICRP Publication 60, 1990 Recommendations 
of the ICRP on Radiological Protection, and ICRP Publication 68, Dose 
Coefficients for Intakes of Radionuclides by Workers. DOE proposed this 
change mainly because these recommendations are based on updated 
scientific models and more accurately reflect the occupational doses to 
workers than the models currently used by DOE. DOE currently uses 
models that were used in developing Radiation Protection Guidance to 
Federal Agencies for Occupational Exposures, published by the 
Environmental Protection Agency (52 FR 2822, January 27, 1987), which 
are based upon 1977 recommendations from the ICRP. In the NOPR, DOE 
noted that other federal agencies, including the Environmental 
Protection Agency (EPA), the Food and Drug Administration (FDA), and 
the National Institute of Occupational Safety and Health (NIOSH), have 
already adopted parts of the current ICRP recommendations related to 
dosimetry in recent guidance documents and requirements. NIOSH uses the 
newer recommendations in performing DOE worker dose assessments under 
the Energy Employees Occupational Illness Compensation Program Act of 
2000, which is contained in the Floyd D. Spence National Defense 
Authorization Act for Fiscal Year 2001 (Pub. L. 106-398). EPA has 
adopted the recommendations in Federal Guidance Report Number 13, 
Cancer Risk Coefficients for Environmental Exposure to Radionuclides. 
In addition, recommendations published by the National Council on 
Radiation Protection and Measurements for the past several years, as 
well as several standards issued by the American National Standards 
Institute, have used the newer dosimetric quantities and units endorsed 
by the ICRP.
    Internal doses would still be calculated based on a 50-year 
committed dose. The following ``cross-walk'' was provided in the NOPR 
to show the new terms DOE proposed and the terms that would be 
replaced:

------------------------------------------------------------------------
         Current dosimetric terms             Proposed dosimetric terms
------------------------------------------------------------------------
Committed effective dose equivalent.......  Committed effective dose.
Committed dose equivalent.................  Committed equivalent dose.
Cumulative total effective dose equivalent  Cumulative total effective
                                             dose.
Deep dose equivalent......................  Deep equivalent dose.
Dose equivalent...........................  Equivalent dose.
Effective dose equivalent.................  Effective dose.
Lens of the eye dose equivalent...........  Lens of the eye equivalent
                                             dose.
Quality factor............................  Radiation weighting factor.
Shallow dose equivalent...................  Shallow equivalent dose.
Weighting factor..........................  Tissue weighting factor.
Total effective dose equivalent...........  Total effective dose.
------------------------------------------------------------------------


    Note: Throughout the text of the NOPR, the above terms were 
proposed to be revised.

    In addition, DOE proposed revising the following definitions: 
Annual limit on intake, Derived air concentration, Radiation area, 
Radiological worker, Dose, External dose or exposure, and Internal dose 
or exposure. Also, consistent with ICRP Publication 60, the table of 
weighting factors for neutrons would no longer list a column for 
neutron flux density.
    DOE recognized that the proposed changes to most of the dosimetric 
terms used in 10 CFR part 835 to reflect the recommendations for 
assessing dose and associated terminology from ICRP Publications 60 and 
68 would require revising many site documents and updating training 
materials. Although in June 2004 and again in June 2006, the ICRP 
released a draft of updated recommendations, which included some 
adjustment of Tissue Weighting Factors and Radiation Weighting Factors, 
DOE expressed its belief that

[[Page 31908]]

this was still an opportune time to make these changes rather than 
waiting for the draft recommendations to be finalized. It may be 
several years before the ICRP finalizes and issues the revised 
recommendations and accompanying dose conversion factors. DOE evaluated 
the effect of the June 2004 proposed revisions to Tissue Weighting 
Factors on derivation of dose conversion factors used in ICRP 
Publication 68. The evaluation found, for radionuclides of most 
interest to DOE, that the ICRP proposed Tissue Weighting Factors 
revisions would have minimal impact on the ICRP Publication 68 derived 
secondary limits (i.e., the DACs and Sealed Radioactive Source 
Accountability values). The ICRP's June 2006 proposed revisions to 
Tissue Weighting Factors will also have minimal impact. Any future need 
by DOE to revise weighting factors should have minimal administrative 
impact for such activities as revising procedures and training 
materials. It is envisioned that, over time, updated recommendations to 
make revisions to dosimetry calculation models will periodically be 
made by national and international consensus groups. Given that fact, 
and the significant financial and resource impact, DOE recognizes that 
historical doses, recorded and reported to individuals prior to the 
effective implementation date of this proposed amendment, should still 
be considered to be the official doses of record. Barring some 
unforeseen reason or factor (e.g., discovery of a site or vendor 
specific miscalculation in assigned doses), DOE would not require the 
updating of historical doses to reflect these changes. DOE considered 
several options for amending part 835 including:
     Allowing sites to choose either converting to the newer 
dosimetric terminology and Tissue and Radiation Weighting Factors or 
retaining the existing requirements;
     Not specifying in part 835 a specific set of Tissue and 
Radiation Weighting Factors, but requiring sites to specify in their 
DOE approved Radiation Protection Program the weighting factors to be 
used and the technical basis for that determination;
     Updating the Tissue and Radiation Weighting Factors to 
reflect the newer research without revising the dose terminology;
     Updating the Tissue and Radiation Weighting Factors to 
reflect the newer research and revising the dose terminology; and
     Converting to the newer dosimetric terminology and Tissue 
and Radiation Weighting Factors and not updating the DAC values 
(appendices A and C to part 835) and appendix E to part 835 values.
    DOE considered the best approach, which it proposed, was to convert 
all terminology and methodology, including the appendices A, C and E to 
part 835 values, to reflect ICRP Publications 60 and 68. DOE solicited 
comments on all of these different options.
    DOE recognized in the NOPR that the proposed dosimetric changes 
would result in the need to update numerous site documents and proposed 
a three-year implementation schedule to alleviate the burden of making 
the changes. Therefore, DOE considered that many of the changes can be 
made during the regularly scheduled document updating processing. An 
extended implementation date also was proposed because DOE recognized 
that the benefit of updating documents to reflect the dosimetric 
changes may not justify the cost at sites nearing closure. The NOPR 
stated that DOE would allow sites to use the exemption process in 10 
CFR part 820 to request relief, if appropriate, for closure sites which 
are scheduled to continue operation beyond the implementation date for 
the proposed changes. In the proposal, DOE requested input on any other 
constructive ways to reduce the costs of implementing this proposed 
change.
    DOE received several comments supporting DOE's proposed changes to 
reflect the recommendations for assessing dose and associated 
terminology from ICRP Publications 60 and 68. Comments noted that there 
would be associated costs and appreciated DOE's three-year 
implementation schedule to meeting this change. The same comments 
applied to the updates to appendices A, C and E to part 835 to reflect 
ICRP Publications 60 and 68 methodologies.
    One commenter stated that DOE should be aware that some 
difficulties in communications with radiation workers and perhaps even 
members of the public will likely linger for many years, and there did 
not appear to be an identifiable benefit in terms of worker protection 
to be gained from this change.
    Comments were also received stating that DOE should not incorporate 
draft ICRP recommendations into this revision of 10 CFR part 835. DOE 
is not incorporating draft ICRP recommendations into this revision of 
10 CFR part 835. DOE agrees that this action would be premature.
    DOE agrees that these changes will have some impact on site 
operations, particularly in updating site documents and training of 
workers on the new terminology. Accordingly, to lessen the impact, DOE 
proposed and is adopting in Sec.  835.101 a three-year implementation 
schedule. DOE intends to provide revised guidance documents during this 
time period to facilitate site implementation of these changes.
    Comments were received that DOE should consult with the NRC and 
other federal agencies and not make these changes unless the NRC makes 
these changes. In preparing the NOPR, DOE did consult with the NRC and, 
as a member of the Interagency Scientific Committee on Radiation 
Standards, consulted with other federal agencies having radiation 
protection responsibilities. No significant objections were raised 
prior to publication of the proposed rule. Other federal agencies, 
including EPA, FDA, and NIOSH, have already adopted dosimetric aspects 
of the current ICRP recommendations in recent guidance documents and 
requirements. The NRC was the only federal agency who submitted public 
comments on the proposed rule. The NRC recommended postponing updating 
the dosimetric models and terms.
    A review of significant unplanned radiation exposures at DOE 
facilities over the past several years reflects that, at DOE 
facilities, significant unplanned radiation exposures have been from 
internal exposures, resulting from intakes of radioactive material. As 
the owner and regulator of these facilities, DOE believes it is prudent 
and warranted to assess these exposures using dose assessment methods 
more current than those in the current rule. DOE notes that the NRC has 
authorized selected fuel cycle facilities to use this approach. DOE 
continues to believe that, for DOE facilities, these changes are an 
improvement.
    DOE received a comment that, under certain circumstances, when an 
individual conducts multiple activities involving both activities under 
10 CFR 835.1(b)(1) and excluded activities (e.g., activities involving 
NRC licensed activities) it is ambiguous as to how the rule would be 
applied when using different dose coefficients and weighting factors to 
calculate the total effective dose for the worker from both activities. 
DOE agrees that guidance is needed for this provision. For the purpose 
of compliance with 10 CFR 835.1(b)(1), DOE considers the following 
terms to be equivalent:

[[Page 31909]]



------------------------------------------------------------------------
  Dosimetric term as defined by excluded
       activity cognizant regulator          DOE amended dosimetric term
------------------------------------------------------------------------
Committed effective dose equivalent.......  Committed effective dose.
Committed dose equivalent.................  Committed equivalent dose.
Cumulative total effective dose equivalent  Cumulative total effective
                                             dose.
Deep dose equivalent......................  Equivalent dose to the whole
                                             body.
Dose equivalent...........................  Equivalent dose.
Effective dose equivalent.................  Effective dose.
Lens of the eye dose equivalent...........  Equivalent dose to the lens
                                             of the eye.
Quality factor............................  Radiation weighting factor.
Shallow dose equivalent...................  Equivalent dose to the skin
                                             or
                                            Equivalent dose to any
                                             extremity.
Weighting factor..........................  Tissue weighting factor.
Total effective dose equivalent...........  Total effective dose.
------------------------------------------------------------------------

    In response to another comment, DOE replaces the term 
``nonstochastic'' with the term ``deterministic.''
    One commenter stated that there did not appear to be significant 
benefit to changing the dosimetric methodologies. DOE disagrees with 
the comment and, to the contrary, believes that using more up-to-date 
models for assessing worker dose is beneficial. Under the 10 CFR part 
820 exemption process, DOE already authorizes the Y-12 and Savannah 
River Site facility to use ICRP Publications 60 and 68 methodologies 
for assessing doses. The contractors requested the change and noted 
that the improved accuracy in determining worker doses would be 
beneficial. Similarly, as noted previously, the NRC authorized selected 
fuel cycle facilities to use this approach.
    DOE also received a comment that DOE should move the phrase ``(1 
rem = 0.01 sieverts)'' to the end of the definition for ``annual limit 
on intake,'' rather than with the definition of ``committed equivalent 
dose,'' because this would be the first use of the term ``Sievert.''
    DOE makes these editorial changes, with the exception that the 
phrase ``(1 rem = 0.01 Sv)'' is included in the definition of ``annual 
limit on intake,'' the first usage of the term ``Sievert'' in 10 CFR 
part 835.
    One commenter noted that the definition of ``absorbed dose'' should 
refer to energy imparted and not energy absorbed. DOE agrees with this 
comment and changes the definition. One commenter requested the 
addition of several additional dosimetric terms/operational quantities 
in the rule such as ``ambient dose'' and ``personal dose equivalent.'' 
DOE agrees that these quantities are important because they are the 
operational quantities that have been recommended by ICRP for use in 
assessing compliance with the numerical dose criteria for external 
exposure specified in this part. However, DOE does not believe it is 
necessary to define or revise additional dosimetric terms, such as 
``ambient dose,'' and ``personal dose equivalent.'' Definitions of such 
terms are best left in supporting documents, such as implementation 
guides for 10 CFR part 835 and the technical standards for the DOELAP. 
For clarification, DOE provides a discussion of this topic in section U 
of this part.
    One commenter requested that DOE not use the terms ``deep 
equivalent dose,'' ``lens of the eye equivalent dose'' and ``shallow 
equivalent dose'' because these terms are not defined in the referenced 
ICRP publications. DOE agrees with this comment and replaces these 
terms with ``equivalent dose to the whole body,'' ``equivalent dose to 
the lens of the eye,'' ``equivalent dose to the skin,'' or ``equivalent 
dose to the extremity,'' as appropriate, in Sec. Sec.  835.202, 
835.205, 835.402, 835.502, and 835.702. DOE adds the following sentence 
to the definition of ``equivalent dose'' in Sec.  835.2(b) ``For 
external dose, the equivalent dose to the whole body is assessed at a 
depth of 1 cm in tissue; the equivalent dose to the lens of the eye is 
assessed at a depth of 0.3 cm in tissue, and the equivalent dose to the 
extremity and skin is assessed at a depth of 0.007 cm in tissue.''
    DOE received a comment that it should clarify the definition of 
``committed effective dose'' to assure consistency with the equations 
of Section 6 of ICRP Publication 68 and the methodology for calculating 
the ``remainder'' dose. DOE agrees with these comments and revises the 
definition of ``committed effective dose'' and footnote number 1 under 
the table of Tissue Weighting Factors to be consistent with ICRP 
Publication 68.
    One commenter pointed out that footnote 2 to the table on radiation 
weighting factors in the definition of ``radiation weighting factor'' 
in Sec.  835.2(b) did not provide information on the radiation 
weighting factor for Auger electrons emitted by radioactive atoms 
incorporated into DNA and requested either deletion of the exclusion or 
clarification on the appropriate radiation weighting factor.
    After reevaluation of this topic, DOE has determined that from a 
regulatory perspective, the benefits of this footnote to worker health 
and safety may be outweighed by difficulties in complying with the 
footnote. The reasons are: (1) This footnote only applies to dose 
received by the DNA of a cell and, thus, is a very small fraction of 
the dose received by the entire tissue; (2) assessment of doses and 
risks will require information on the distribution of radionuclides 
within tissues and cells which may not be readily available, and which 
will depend on the chemical form involved; and (3) except for 
accidents, most exposures of this type are therapeutic and would not be 
covered by provisions of 10 CFR part 835. Accordingly, footnote 2 to 
the table on radiation weighting factors in Sec.  835.2(b) from the 
proposed rule is not included in the final rule and DOE will develop 
guidance to address the infrequent situations and complex dosimetry 
resulting from incorporation of Auger electron emitters in DNA.
    DOE received a comment recommending DOE permit sites to choose to 
either convert to the newer tissue and radiation weighting factors or 
remain with the existing requirements. Another option suggested by the 
commenter was for DOE to not include tissue weighting factors, 
radiation weighting factors, and DACs in the rule. Rather, this 
information may be placed into a set of guidance documents and 
incorporated by reference in the rule. After considering all the 
comments DOE has received, DOE still considers the best approach to be 
to convert all terminology and methodology, including the appendices A, 
C and E values, to reflect ICRP Publications 60 and 68. DOE did not 
propose excluding tissue weighting factors, radiation weighting 
factors, and DACs from the rule and is not making this change.
    DOE received a comment that the dose methodology in the proposed 10 
CFR part 835 is not consistent with DOE's requirements for the 
protection of the public. The commenter believed that the standards for 
the public and environment and the standard for DOE workers should be 
revised at the same time to avoid situations where some DOE standards 
are based on new ICRP recommendations and some standards are based on 
older ICRP recommendations. DOE does not agree with this comment. DOE 
has already initiated adoption of the more recent ICRP recommendations 
as demonstrated by its guidance on radiation risk estimation (endorsing 
Federal Guidance Report Number 13, which is consistent with ICRP 
Publication 60). DOE sees no conflict in making this change at this 
time and no benefit in waiting until all

[[Page 31910]]

of its environmental policy and guidance is updated.
    As part of DOE's response to a comment regarding application of 
appendix D surface contamination values to areas of fixed contamination 
consisting of special tritium compounds (STCs), DOE is adding a 
definition of ``special tritium compound.'' The definition is from DOE 
technical standard, Radiological Control Programs for Special Tritium 
Compounds, DOE-HDBK-1184-2004.
    One commenter requested clarification of the term ``personal 
property'' which is used in the definition of ``real property.'' DOE 
revised the definition of ``real property'' to not include the term 
``personal property.''
    DOE received a comment that a definition of ``activity median 
aerodynamic diameter'' (AMAD) should be included in the rule. DOE 
agrees with is comment and has added a definition, based on ICRP 
Publication 66, Human Respiratory Tract Model for Radiological 
Protection, for AMAD. DOE also clarifies, in the appendix A notes, that 
AMAD is the appropriate particle size value.
    DOE received a comment that, because of the uncertainties in the 
biological effect of high energy radiation and difficulties in 
measuring radiation at such levels, DOE should insert a binding 
statement in 10 CFR part 835 requiring DOE contractors to evaluate and 
justify the radiation weighting factors used for photon and particle 
energies above 10 MeV.
    DOE agrees that at high energies, such as those above 10 MeV, the 
biological impact of particles on human tissue may be more uncertain 
than at other energies and that monitoring of workplaces and 
individuals exposed to particles with these energies may be very 
challenging. However, other challenging radiological conditions exist 
in the DOE complex that are not explicitly addressed in 10 CFR part 
835. Moreover, radiation fields consisting of particles greater than 10 
MeV do not occur extensively within the DOE complex. When such 
conditions are identified, efforts should be focused on significantly 
limiting exposure to these types of radiation fields through the 
application of engineered and administrative controls. If doses to 
workers result from exposure to such radiation fields, provisions in 
subpart E of 10 CFR part 835 require that instruments and equipment 
used for monitoring individuals and workplaces be appropriate for the 
types, levels and energies of the radiations encountered, and that 
monitoring be performed to detect changes in radiological conditions. 
Finally, DOE notes that the purpose of radiation weighting factors is 
to establish dose limits, set up other dose dependent criteria for 
protection purposes, and plan radiological work. They are not for the 
purpose of measuring radiation fields and individual doses. 
Accordingly, DOE does not believe there is a need to include a specific 
provision in the final rule specifying evaluation and justification of 
the radiation weighting factors used for photon and particle energies 
above 10 MeV. DOE, however, will include in guidance a recommendation 
to evaluate and document the technical bases for the equivalent dose 
response of instruments and equipment used to monitor workplaces and 
individuals exposed to photon and particle energies above 10 MeV.
    A commenter proposed that neutron flux to dose conversion factors 
be added as conversion factors in 10 CFR part 835 and that DOE sites be 
permitted to use different values if they could defend their position.
    DOE believes that if the neutron energy spectrum is known in 
sufficient detail to permit the use of more radiation weighting factors 
than are currently provided in the proposed amendment to 10 CFR part 
835, a more detailed set of radiation weighting factors would be 
appropriate. Such an approach was used in the previous versions of 10 
CFR part 835 which included a table containing mean quality factors for 
21 values of neutron energy. Accordingly, the formula recommended in 
ICRP Publication 60 relating to neutron energy and radiation weighting 
factors is added to footnote 3 of the radiation weighting factors table 
in the definition of ``radiation weighing factor.''
    DOE will not provide neutron fluence to dose conversion factors, as 
proposed by the commenter, because they are a function of many more 
factors than the relationship between neutron energy and radiation 
weighting factors and would not be as widely applicable throughout the 
DOE complex.
    Regarding a comment to permit DOE sites to use different neutron 
fluence to dose conversion factors, DOE's decision to include the 
formula relating neutron energy and radiation weighting factors 
obviates the need for such a change to the final rule. As long as the 
neutron fluence to dose conversion factors incorporate the radiation 
weighting factors permitted by 10 CFR part 835, DOE sites may use 
conversion factors appropriate to local conditions to relate neutron 
fluence to equivalent dose and effective dose.
    Note that the radiation weighting factors are only for use in 
calculating equivalent dose, effective dose, committed effective dose, 
and total effective dose. The operational radiation dose quantities 
used in the measurement of radiation dose use other modifiers of 
absorbed dose, such as quality factors, to account for the biological 
impact of the radiation type. However, to ensure compliance with the 
dose quantities specified in 10 CFR part 835, the operational radiation 
dose quantities must provide a dose estimate equal to or greater than 
the dose quantities specified in 10 CFR part 835.
    In summary, DOE makes the proposed changes to the dosimetric terms 
used in 10 CFR part 835 to reflect the recommendations for assessing 
dose and associated terminology from ICRP Publications 60 and 68. DOE 
revises the definition ``nonstochastic effects'' to read 
``deterministic effects.'' As previously discussed, DOE revises the 
definitions of ``committed effective dose,'' ``committed equivalent 
dose,'' and ``absorbed dose.'' DOE adds definitions for ``activity 
median aerodynamic diameter'' and ``special tritium compound.'' DOE 
deletes the proposed definitions of ``deep equivalent dose,'' ``lens of 
the eye equivalent dose,'' ``shallow equivalent dose,'' and footnote 2 
to the table on radiation weighting factors in Sec.  835.2(b) that 
addresses the radiation weighting factor for Auger electrons emitted by 
radioactive atoms incorporated into DNA.
    DOE adds the following formula to the definition of ``radiation 
weighting factor (wR):''
[GRAPHIC] [TIFF OMITTED] TR08JN07.000


[[Page 31911]]


    DOE revises 10 CFR 835.2(c) to state that terms defined in the 
Atomic Energy Act of 1954 or in 10 CFR part 820 and not defined in this 
part are used consistent with the meanings given in the Atomic Energy 
Act of 1954 or in 10 CFR part 820. Accordingly DOE removes the 
definitions of ``Contractor'' and ``Secretarial Officer'' from 10 CFR 
part 835 and uses the terms as defined in 10 CFR part 820.

C. Radiological Units in 10 CFR Part 835

    DOE proposed to revise the text of Sec.  835.4 to allow use of 
additional units, such as dpm, mass units, [mu]Ci/cc, and dpm/100cm\2\ 
in records required by this part. The original intent of this provision 
was to preclude the exclusive use of the SI units of becquerel, gray 
(Gy) and sievert (Sv). As stated in the NOPR, the intent was not to 
preclude use of other conventional units, such as those previously 
listed. The proposed change was intended to achieve the original intent 
of this section. DOE received comments that the allowance for the 
additional units of measurement should prove to be beneficial and the 
continued preclusion of the exclusive use of the SI units is beneficial 
and appreciated. The final rule makes the changes as proposed in the 
NOPR.

D. Radiation Protection Programs

    DOE proposed to add a new sentence at the end of Sec.  835.101(f) 
that would provide that unless otherwise specified in part 835, 
compliance with the amendments made by this final rule shall be 
achieved no later than three years following the effective date of the 
final rule. The reasons DOE proposed an extended implementation date 
are the same as those discussed in connection with the changes to the 
dosimetric terms.
    DOE received several comments that given the extensive changes 
proposed, the proposed three-year implementation period would be 
beneficial. One commenter believed that the three-year implementation 
period was excessive and could cause confusion at sites with multiple 
contractors where each contractor may implement the amendments at 
different times. DOE will provide guidance for this situation. One 
commenter believed that the three-year implementation time period may 
not be adequate for all sites. DOE believes that the three-year period 
is reasonable. Contractors still have the option of requesting an 
extension of the implementation date through the 10 CFR part 820 
exemption process, on a case by case basis. The final rule makes the 
changes as proposed in the NOPR.

E. Occupational Dose Limits for General Employees

    DOE proposed amending Sec.  835.202 by revising the dosimetric 
terms to be consistent with the revised definitions. One commenter 
noted that the phrase ``for external exposures'' was redundant because 
that phrase was already included in the definitions of ``deep 
equivalent dose' and ``shallow equivalent dose.'' As discussed 
previously, DOE is not including in the final rule definitions for 
``deep equivalent dose'' or ``shallow equivalent dose.'' The term ``for 
external exposures'' is no longer redundant in Sec.  835.202(a)(2). DOE 
makes the following changes: Sec.  835.202(a)(2) is rewritten as ``The 
sum of the equivalent dose to the whole body for external exposures and 
the committed equivalent dose to any organ or tissue other than the 
skin or the lens of the eye''; Sec.  835.202(a)(3) is rewritten as an 
``equivalent dose to the lens of the eye''; and Sec.  835.202(a)(4) is 
rewritten as ``The sum of the equivalent dose to the skin or to any 
extremity for external exposures and the committed equivalent dose to 
the skin or to any extremity.''

F. Combining Internal and External Equivalent Doses

    DOE proposed amending Sec.  835.203 by revising the dosimetric 
terms to be consistent with the revised definitions. DOE received a 
comment requesting clarification on the proposed change to Sec.  
835.203(b) by specifying that the radiation weighting factor values, in 
addition to the tissue weighting factor values, provided in Sec.  835.2 
shall be used in determining effective dose. Although the definition of 
``radiation weighting factor'' already specifies the factors to be 
used, DOE agrees that the additional words in Sec.  835.203(b) will 
clarify the requirement. DOE makes the changes as proposed in the NOPR 
with the exception that the phrase ``radiation and'' is added before 
the phrase ``tissue weighting factor.''

G. Occupational Dose Limits for Minors

    DOE proposed amending Sec.  835.207 by revising the dosimetric 
terms to be consistent with the revised definitions. DOE received a 
comment that the term ``equivalent'' in the first line on the proposed 
change to section 835.207 was incorrect. As stated, the sentence 
contradicts the revised definitions in the NOPR. DOE agrees and makes 
the changes as proposed in the NOPR with the exception that the word 
``equivalent'' is deleted from the first sentence.

H. General Requirements for Monitoring Individuals and Areas in 10 CFR 
Part 835

    DOE proposed amending Sec.  835.401(a)(5) by revising the text 
``engineering and process controls'' to read ``engineering and 
administrative controls.'' This change was proposed in order to make 
the use of the terms consistent with DOE Policy 450.4 ``Safety 
Management System Policy.'' DOE considered the terms to be equivalent. 
DOE received comments that the proposed change to Sec.  835.401(a)(5) 
was a beneficial clarification. One commenter recommended that wherever 
the term ``engineering control(s)'' is used in the rule that it be 
changed to ``engineered control(s).'' This is primarily a matter of 
clarity in meaning. ``Engineering control'' can have several meanings. 
``Engineered control'' is less ambiguous. DOE agrees with this 
editorial comment and makes this change throughout the rule.

I. Monitoring of Packages Containing Radioactive Material in 10 CFR 
Part 835

    DOE proposed amending Sec.  835.405(c)(2) by changing ``unless the 
package contains less than a Type A quantity'' to ``if the package 
contains a Type B quantity.'' DOE received comments that the proposed 
change in the requirements pertaining to Type A quantities is a useful 
clarification and should have insignificant associated costs. DOE 
received a comment that its proposed change to the definition of 
``radioactive material transportation,'' by removing the text ``when 
such movement is subject to DOT regulations or DOE orders that govern 
such movements,'' creates ambiguity as to when receipt surveys are 
required under Sec.  835.405. The commenter provided an example: If 
material is transported on-site via a cart, receipt surveys would not 
be required; however, if the same package was transported in a truck 
(i.e., a ``highway vehicle''), surveys would be required. While DOE 
agrees that there is ambiguity in the requirement, DOE does not agree 
that keeping the text ``when such movement is subject to Department of 
Transportation regulations or DOE orders that govern such movements'' 
in the rule addresses this ambiguity.
    Section 835.405(d) requires, in part, that packages received from 
radioactive material transportation, which meet the criteria of Sec.  
835.405(b), be monitored as soon as practicable following receipt of 
the package. The purpose of this monitoring is to verify the 
radiological condition of the package (e.g., contamination levels and/
or radiation

[[Page 31912]]

levels). The verification is needed because, other than the visual 
indications listed in Sec.  835.405(b)(3), the recipient typically has 
no knowledge of the physical rigors the package was subject to while in 
transit. Monitoring is needed to ensure protective actions for 
subsequent package handlers as well as notifying the transporter if 
unexpected radiological conditions are identified.
    The exclusion in Sec.  835.1(d) applies to radioactive material 
transportation conducted by a DOE employee or DOE contractor employee, 
when the radioactive material is under the continuous observation and 
control of an individual who is knowledgeable of and implements 
required exposure control measures. For situations meeting this 
exclusion, DOE sees no benefit in post-transit monitoring of the 
packages to verify the radiological condition of the package (e.g., 
contamination levels and/or radiation levels). The verification is not 
needed because a DOE employee or DOE contractor employee had the 
package under continuous observation and is knowledgeable of the 
physical rigors the package was subject to while in transit.
    Accordingly, DOE adds a new Sec.  835.405(e) to reflect that 
receipt monitoring is not required for packages transported on a DOE 
site which have remained under the continuous observation and control 
of a DOE employee or DOE contractor employee who is knowledgeable of 
and implements required exposure control measures. The final rule makes 
the other changes as proposed in the NOPR.

J. Exception for Labeling Requirements in 10 CFR Part 835

    DOE proposed to establish an upper limit of 0.1 Ci for a quantity 
of radioactive material which would be excepted from the labeling 
requirement in Sec.  835.606(a)(2). After the establishment of the 
radioactive material labeling requirements in the 1998 amendment to 10 
CFR part 835, DOE noted that the exception to labeling requirements for 
radioactive materials appeared excessive for certain isotopes. DOE 
currently exempts from labeling items and containers if a quantity of 
radioactive material is less than one tenth of the values specified in 
appendix E of 10 CFR part 835. For some isotopes this quantity is 
significant. For example, a container of tritiated water need not be 
labeled ``Caution, Radioactive Material'' as long as there is less than 
16 Ci of tritiated water in the container. While the basis for this 
exception, as discussed in the preamble to the 1998 amendment to 10 CFR 
part 835, is technically defensible, DOE believes that it is prudent to 
establish an upper limit for the labeling exception. The approach DOE 
proposed is similar to that taken by the NRC, except that the NRC upper 
limit is 0.001 Ci. DOE believes that the proposed 0.1 Ci upper limit in 
Sec.  835.606 would provide an acceptable level of protection, based on 
the exposure scenario discussed in the preamble to the 1998 amendment 
(63 FR 59672-73, November 4, 1998), and still provides for sufficient 
operational flexibility in not being overly restrictive in the labeling 
requirements.
    DOE received comments that the proposed change to establish an 
upper limit of 0.1 Ci for a quantity of radioactive material which 
would be excepted from the labeling requirement provides an acceptable 
level of protection in harmony with operational flexibility. 
Anticipated costs for compliance would be negligible.
    The final rule makes the changes as proposed in the NOPR.

K. Individual Monitoring Records Requirements in 10 CFR Part 835

    DOE proposed to revise Sec.  835.702(b) to give sites the option of 
not assessing and recording any internal dose monitoring result 
estimated to be less than 10 millirems committed equivalent dose. This 
change was proposed in response to concerns that, under the current 
requirements, there is no threshold for positive internal dose 
monitoring results which need not be assessed and a dose recorded. DOE 
stated in the NOPR that this flexibility would likely be of most 
benefit for routine bioassay results from tritium and uranium 
operations. For tritium, under the current rule, positive bioassay 
results could result in the need to determine and record doses that are 
less than one millirem. DOE proposed the revision to allow some relief 
from the need to perform a dose assessment and to record these very 
small doses. DOE envisioned that this would most easily be achieved 
through the development and use of default values, below which no 
further dose assessment or recording would be required. Establishing a 
dose threshold for any single bioassay and/or air monitoring result 
would make the DOE requirements consistent with nationally accepted 
standards as discussed in ``American National Standard for Design of 
Internal Dosimetry Programs'' (ANSI/HPS N13.39-2000). The proposed 
provision would still require the maintenance of bioassay and/or air 
monitoring results in case they are needed by DOE in the future.
    The NOPR also stated that DOE's policy has been that the current 
monitoring threshold of 100 millirems should not be interpreted as an 
objective for