Occupational Radiation Protection

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