Occupational Radiation Protection

DEPARTMENT OF ENERGY

10 CFR Part 835

[Docket No.: EH-RM-96-835]

RIN 1901-AA59

Occupational Radiation Protection

AGENCY: Department of Energy.

ACTION: Final rule.

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SUMMARY: The Department of Energy (DOE) is amending its primary

standards for occupational radiation protection. This final rule is the

culmination of a systematic analysis to identify the elements of a

comprehensive radiation protection program and determine those elements

of such a program that should be codified as DOE continues its

transition from a system of contractually-based nuclear safety

standards to regulatory-based requirements. The final rule codifies

requirements previously established in DOE's contractually-based

standards, clarifies certain issues identified during implementation of

programs to ensure compliance with the original rule, and corrects

minor errors.

EFFECTIVE DATE: The amendments to this regulation become effective on

December 4, 1998.

FOR FURTHER INFORMATION CONTACT: Dr. Joel Rabovsky, U.S. Department of

Energy, Office of Worker Protection Programs and Hazards Management,

EH-52, 19901 Germantown Road, Germantown, MD 20874, (301) 903-2135.

SUPPLEMENTARY INFORMATION:

I. Background

II. Discussion of Significant Changes

III. Review Under the National Environmental Policy Act

IV. Review Under the Regulatory Flexibility Act

V. Review Under Executive Order 12866

VI. Review Under Executive Order 12612

VII. Review Under Executive Order 12988

VIII. Review Under Paperwork Reduction Act

IX. Review Under the Unfunded Mandates Reform Act

X. Review Under Small Business Regulatory Enforcement Fairness Act

of 1996

I. Background

On December 14, 1993, DOE published a final rule, 10 CFR part 835,

``Occupational Radiation Protection'' (58 FR 65458), which established

regulatory requirements consistent with the ``Radiation Protection

Guidance to Federal Agencies for Occupational Exposure'' (52 FR 2822)

(Guidance to Federal Agencies), as well as guidance issued by

authoritative organizations, including the National Council on

Radiation Protection and Measurements (NCRP) and the International

Commission on Radiological Protection (ICRP). Many of the codified

requirements were previously established in DOE Order 5480.11,

``Radiation Protection for Occupational Workers.'' In addition, DOE

codified in 10 CFR part 835 the ``as low as is reasonably achievable''

(ALARA) process as the primary means of maintaining occupational

radiation doses below regulatory limits.

As a result of an initiative to eliminate redundant and

unnecessarily stringent requirements, DOE conducted a systematic

analysis to identify the elements of a comprehensive radiation

protection program and determine those elements of such a program that

should be codified as DOE continues its transition from a system of

contractually-based nuclear safety standards to regulatory-based

requirements. The systematic analysis included an evaluation of DOE's

objectives for occupational radiation protection programs, including

structured analyses of existing standards for similar programs,

operational occurrences within the DOE complex, and provisions in the

original rule. The analysis also included reviews of the requirements

in DOE Notice 441.1, ``Radiological Protection for DOE Activities,''

(extended by DOE N 441.2 and 441.3) and the provisions of the ``DOE

Radiological Control Manual'' (Manual). DOE proposed to codify

requirements in use within the DOE complex to ensure that worker health

and safety programs would continue to be maintained at a level

commensurate with workplace hazards. DOE also considered approaches

used by national and international radiation protection organizations

and experience throughout the DOE complex in achieving compliance with

10 CFR part 835. The systematic analysis is documented in a report

entitled, ``Development of the 1996 Proposed Amendment to 10 CFR part

835, Occupational Radiation Protection,'' (regulatory development

document, November 1996) which may be viewed in the DOE Freedom of

Information Reading Room at Room 1E-190, 1000 Independence Avenue, SW,

Washington, DC, 20585, (202) 586-6020.

On December 23, 1996, DOE published a Notice of Proposed Rulemaking

that would amend 10 CFR part 835 by:

1. Modifying the scope to explicitly exclude radioactive material

transportation and certain activities conducted on foreign soil;

2. Adding requirements for area posting and sealed radioactive

source control;

3. Adding a removable surface contamination value for tritium, to

be used to identify the need for area posting and imposition of certain

radioactive material controls;

4. Expanding and clarifying provisions of the rule to address

emergent radiation protection issues;

5. Deleting certain provisions, as appropriate, to eliminate

redundant and excessively stringent regulatory requirements; and

6. Clarifying and correcting minor errors.

As discussed in this Notice of Final Rulemaking, the final rule was

developed in consideration of the extensive input received during two

public hearings and through written and electronic public comments.

The schedule for achieving compliance with the amendments to 10 CFR

part 835 is as follows. The final rule will become effective 30 days

following publication in the Federal Register. As provided at

Sec. 835.101(g)(3), updated radiation protection programs (RPPs) must

be submitted to DOE within 180 days following the effective date of the

final rule. Changes that do not decrease the effectiveness of the RPP

may be implemented prior to DOE approval. Changes that decrease the

effectiveness of the RPP require DOE approval prior to implementation.

As provided at Sec. 835.101(i), an update of the RPP shall be

considered approved 180 days after its initial submission unless

rejected by DOE at an earlier date. The final rule, at Sec. 835.101(f),

requires full compliance with the regulatory changes within 180 days of

RPP approval except for radiobioassay program accreditation required

under Sec. 835.402(d). Because of the breadth of the joint DOE/DOE-

contractor effort needed to accomplish radiobioassay program

accreditation, at Sec. 835.101(f) DOE has established January 1, 2002

as the compliance date for the radiobioassay program accreditation

requirements.

II. Discussion of Significant Changes

The discussion of the significant changes to 10 CFR part 835 and

the response to public comments is organized according to subpart. When

there was more than one significant change in a subpart the significant

changes are generally listed in order of section. The topic addressed

by each significant change is listed. In many cases, inclusion of a

change to the provisions in one subpart or section required changes to

other subparts or

[[Page 59663]]

sections of the regulation either for internal consistency or to

resolve a public comment. For example a number of changes to the

provisions of the rule required concomitant changes to the definitions

or recordkeeping requirements. Accordingly, the discussion of a change

may reference other subparts in addition to the one in which the

primary change was made. This organization of the discussion of the

significant changes to 10 CFR part 835 and the response to public

comments was chosen to more clearly explain the changes and how DOE

responded to the public comments.

A. General Provisions, Subpart A

1. Nuclear Explosive and Weapon Surety Program

Proposed Amendment

DOE proposed to revise the Nuclear Explosive and Weapon Surety

Program exclusion at Sec. 835.1(b)(3) to clearly indicate that the

exclusion applies only to the extent that compliance with 10 CFR part

835 would compromise the effectiveness of activities essential to

prevention of an accidental or unauthorized detonation. This action was

initiated to ensure that radiation protection programs are implemented

that do not compromise the overriding goal of preventing such

incidents.

Summary of Public Comments and Disposition

DOE received comments indicating that this exclusion should also be

extended to address the provisions of CG-TSS-S2, ``Transportation

Safeguards System Classification and Unclassified Controlled

Information Guide (Supplement),'' which states that ``The fact that a

specific SST (Safe Secure Trailer)/SSR (Safe Secure Railcar) is loaded

or empty is CNSI (controlled nuclear safeguards information).'' The

commenters believe that certain posting and labeling provisions of 10

CFR part 835 would provide indication of the loaded or empty status of

affected vehicles, contrary to the referenced guidance. DOE believes

that the existing exclusion already provides the flexibility needed for

implementation of programs consistent with CG-TSS-S2. Indeed, the

situation presented by the commenters is exactly the type of condition

for which the exclusion is intended.

Final Rule

After further consideration, DOE has determined that the proposed

clarification is not needed. Ruling 1995-1 makes it clear that the

existing language recognizes ``the paramount importance of preventing

accidental or unauthorized nuclear detonations and ensuring that the

requirements in (part 835) do not come into conflict with any

activities necessary to prevent such detonation. However, [the language

is] not intended to relieve the person responsible for a DOE nuclear

facility or a DOE activity from complying with the requirements in

(part 835) to the extent they do not interfere with the conduct of

activities undertaken to prevent an accidental or unauthorized

detonation.'' (61 FR 4212, February 5, 1996.)

2. Radioactive Material Transportation

Proposed Amendment

DOE standards for packaging and transporting radioactive material

are addressed in DOE Orders. DOE Orders 460.1A, ``Packaging and

Transportation Safety,'' and 460.2, ``Departmental Materials

Transportation and Packaging Management,'' provide DOE requirements for

packaging and transportation of radioactive material. Requirements for

radioactive material transported under DOE's national security mission

are provided in DOE Order 5610.12, ``Packaging and Off-site

Transportation of Nuclear Components and Special Assemblies Associated

with the Nuclear Explosive and Weapon Safety Program,'' and DOE Order

5610.14, ``Transportation Safeguards System Program Operations.'' The

requirements of these Orders are consistent with Department of

Transportation (DOT) regulatory requirements and provide the framework

for ensuring transportation safety. Certain provisions of 10 CFR part

835 complement these transportation safety directives by ensuring that

individuals are afforded an adequate level of radiation protection

while preparing radioactive materials for transportation and taking

possession of radioactive material from transportation.

Although the absence of provisions pertaining to radioactive

material transportation was addressed in the preamble for the original

Rulemaking (58 FR 65465), DOE did not explicitly exclude radioactive

material transportation from the scope of 10 CFR part 835. Consistent

with its original intent as expressed in the preamble of the final

rule, DOE proposed an exclusion at Sec. 835.1(b)(4) for radioactive

material transportation conducted in accordance with applicable DOE

Orders. DOE also proposed a definition of ``radioactive material

transportation'' at Sec. 835.2(a) to clarify the distinction between

the process of transporting radioactive materials, which would be

excluded from 10 CFR part 835, and those activities leading to or

resulting from radioactive material transportation, which would be

subject to 10 CFR part 835. The proposed definition included a

specified threshold (specific activity) consistent with DOT

requirements at 49 CFR 171-179.

Summary of Public Comments and Disposition

Public comments supported DOE's intent to exclude radioactive

material transportation, but indicated that the proposed approach did

not clearly establish the interface between 10 CFR part 835 and

applicable transportation requirements. Other comments indicated that

the term ``specific activity'' in the proposed Sec. 835.2(a) definition

of the term ``radioactive material transportation'' could be

misconstrued, potentially resulting in non-compliant conditions.

Final Rule

The final rule clearly establishes the interface between the

occupational radiation protection and transportation requirements. This

approach makes it clear that 10 CFR part 835 does not apply to the

radioactive material transportation, which is defined to be movement of

radioactive material that is subject to DOE Orders or DOT regulations.

The definition of radioactive material transportation is independent of

the geographical location of the material being transported (i.e.,

inside or outside of the area controlled by DOE) and also independent

of the radiological characteristics (e.g., specific activity) of the

material in question. As a result of this revised approach, DOE has not

included the term ``specific activity'' in the Sec. 835.2(a) definition

of the term ``radioactive material transportation.''

3. DOE Activities Conducted on Foreign Soil

Proposed Amendment

DOE proposed to add an exclusion at Sec. 835.1(b)(5) for DOE

activities conducted on foreign soil and under requirements agreed to

between the foreign government and the United States. DOE proposed this

exclusion in recognition of the primacy of foreign governments'

occupational radiation protection requirements.

Summary of Public Comments and Disposition

Several commenters indicated that the development and approval of

agreements with foreign governments may require action by the State

Department and that DOE contractors could not take independent actions

to

[[Page 59664]]

ensure that appropriate agreements have been reached. However, DOE

activities, including those performed on foreign soil, are conducted

under the cognizance of the responsible DOE Program Office and these

offices are responsible for ensuring that such agreements are in effect

before authorizing the conduct of the activities. The only action

required of the DOE contractor will be to ensure that the DOE Program

Office has established, or verified the establishment of, the

appropriate agreements. Also, the activity is not excluded unless there

are occupational radiation protection requirements agreed upon.

Final Rule

The final rule includes the exclusion for DOE activities conducted

on foreign soil at Sec. 835.1(b)(5).

4. Applicability of Occupational Dose Received From Excluded Activities

Proposed Amendment

At Secs. 835.1(c), 835.202(a), and 835.202(b), DOE proposed changes

to clarify the requirements for accounting for occupational doses

received from non-DOE activities. The proposed amendment indicated

that, even though certain activities are excluded from the scope of the

rule at Sec. 835.1(b), an individual's occupational dose resulting from

excluded activities would be applied toward determination of compliance

with the occupational dose limits established in subpart C of 10 CFR

part 835. This is necessary to ensure that an individual's annual

aggregate occupational dose is maintained below the limits specified in

the Federal Guidance. This would include occupational doses received

from activities licensed by the Nuclear Regulatory Commission (NRC) and

its agreement states, activities conducted under the authority of the

Director, Naval Nuclear Propulsion Program, activities conducted under

the Nuclear Explosive and Weapon Surety Program, radioactive material

transportation activities, and activities conducted under the auspices

of foreign governments. However, radiation doses received from

background radiation, as a patient for the purposes of medical

diagnosis or therapy, and from participation as a subject in medical

research programs are not considered occupational doses and would not

be considered in determining compliance with the occupational dose

limits. Furthermore, occupational dose received as a result of

authorized emergency exposures and planned special exposures, although

occupational in nature, would not be considered in determining

compliance with the dose limits established at Sec. 835.202(a).

Summary of Public Comments and Disposition

Commenters generally supported this clarification of DOE policy.

Final Rule

The final rule adopts the proposed clarification that all

occupational doses, other than doses resulting from authorized

emergency exposures and planned special exposures, shall be considered

in determining compliance with the limits set forth in Secs. 835.202,

and 835.207. Section Sec. 835.206, Limits for the embryo/fetus, was

included in this provision for consistency and completeness. Because

Sec. 835.1302 establishes the appropriate criteria for authorizing

exposures under emergency conditions, DOE has instituted an editorial

change to reference this section. Procedures for handling doses

resulting from authorized emergency exposures and planned special

exposures are discussed in Section II.C of this Notice of Final

Rulemaking, ``Limitation of Individual Doses.''

5. Definitions

DOE proposed to add, revise, or remove the definitions of a number

of terms that appear at Sec. 835.2(a) and (b) as follows:

a. Adding definitions of the terms ``accountable sealed radioactive

source,'' ``derived air concentration-hour,'' ``occupational dose,''

``radioactive material area,'' ``radioactive material transportation,''

``radiological control technician,'' ``real time air monitoring,''

``respiratory protective device,'' ``sealed radioactive source,''

``source leak test,'' and ``week.''

b. Revising the definitions of the terms ``airborne radioactive

material or airborne radioactivity,'' ``airborne radioactivity area,''

``contamination area,'' ``controlled area,'' ``DOE activity,'' ``high

contamination area,'' ``member of the public,'' ``monitoring,''

``radiological area,'' ``year,'' ``committed dose equivalent,''

``cumulative total effective dose equivalent,'' ``effective dose

equivalent,'' ``external dose or exposure,'' ``internal dose or

exposure,'' ``quality factor,'' ``total effective dose equivalent,''

and ``weighting factor.''

c. Removing the definitions of the terms ``ambient air,''

``continuous air monitor,'' ``collective dose,'' and ``occupational

exposure.''

The effects of these proposed changes, significant public comments

on these proposed changes, and any resulting changes are discussed in

this Notice of Final Rulemaking as these terms appear in the final

rule.

6. Intervals Between Required Activities

Proposed Rule

DOE proposed to revise the required intervals for internal audits,

instrument and equipment calibration and maintenance, and radiation

safety retraining from the specified number of years to the equivalent

number of months. This change was proposed to eliminate any confusion

resulting from the Sec. 835.2(a) definition of the term ``year,'' which

specifically defined the year in terms necessary to ensure compliance

with the subpart C dose limits.

Summary of Public Comments and Disposition

DOE received a number of comments indicating that the required

intervals appeared to be somewhat arbitrary and should therefore

include some degree of flexibility to accommodate operational and

scheduling needs. DOE agrees with these observations.

Final Rule

DOE has included a provision at Sec. 835.3(e) that will allow a 30

day automatic extension in the required time interval to accommodate

operational and scheduling constraints. The extension is considered to

be automatic in that there is no requirement to obtain DOE or other

approval for the extension. This provision addresses the requirements

of Secs. 835.102, 835.901, and 835.1202 for internal audits, radiation

safety training, and sealed radioactive source inventories and leak

tests, respectively. Because of the varying lengths of the calendar

months, DOE has not provided a definition of the term ``month.'' DOE

expects that those entities responsible for ensuring compliance with 10

CFR part 835 will undertake those measures necessary to perform the

required activities within the prescribed time frame (i.e., if a sealed

radioactive source is leak tested on January 15, DOE would expect the

subsequent leak test to be performed on or before July 15 of the same

year). When operational or scheduling considerations preclude adherence

to that schedule, then one may consider utilization of the 30 day

extension (i.e., the leak test could be performed no later than August

14 of the same year).

[[Page 59665]]

7. Radiological Units

Proposed Amendment

DOE proposed to delete the Sec. 835.4 prohibition on use of the

international (SI) radiological units. The international system of

radiological units is commonly used for calculational and reference

purposes. As proposed, Sec. 835.4 would continue to require the use of

the special radiological units in required records. Consistent with its

historical endorsement of the special units and in recognition of the

capabilities of many commercially-available instruments in use

throughout the DOE complex, DOE also proposed to specifically allow for

use of subunits and multiples of the unit ``roentgen.''

Summary of Public Comments and Disposition

Although some comments indicated that DOE should proceed toward use

of the SI units for required records, DOE believes that considerations

of consistency with records required by the NRC and its agreement

states override the impetus toward use of SI units.

Final Rule

As proposed, Sec. 835.4 of the final rule allows the use of the

international system of units for calculations or reference purposes.

Records required by 10 CFR part 835 will continue to be maintained

using the special radiological units of curie, rad, roentgen, and rem.

B. Management and Administrative Requirements, Subpart B

1. Documented Radiation Protection Programs

Proposed Rule

Paragraph 835.101(g) of the original rule requires that those

entities subject to the requirements of 10 CFR part 835 submit an

update of the documented radiation protection program (RPP) within 180

days of the effective date of any regulatory modifications. DOE

proposed to establish provisions at Sec. 835.101(f) requiring

compliance with amendments to 10 CFR part 835 no later than 180 days

following approval of the updated RPP, except for the provisions of

Sec. 835.402(d) for radiobioassay program accreditation. Because of the

extent of the joint DOE/DOE contractor effort necessary to complete the

radiobioassay program accreditations, DOE proposed a compliance date of

January 1, 2000 for this provision. DOE also proposed to delete

outdated provisions codified at Sec. 835.101 (f) and (g).

Summary of Public Comments and Disposition

Several commenters indicated that DOE's proposed compliance date of

January 1, 2000 for radiobioassay program accreditation may be

inappropriate due to the lack of experience in implementing the

accreditation program. Other comments indicated that DOE delays in

implementing the program might result in a state of non-compliance for

DOE-contractors. DOE agrees that more time may be necessary to complete

the required program accreditations.

Final Rule

DOE has codified the proposed 180 day period for achieving

compliance with the amendments to 10 CFR part 835, except for the

radiobioassay program accreditation requirements of Sec. 835.402(d).

DOE has extended the date for compliance with the radiobioassay program

accreditation requirements until January 1, 2002 to accommodate the

planned schedule to complete program accreditations throughout the DOE

complex. DOE expects this extension to provide ample time for

completion of the program accreditations. Should significant delays

occur in performing the program accreditations, DOE could exercise

appropriate enforcement discretion. These changes will not affect the

compliance status of personnel dosimetry programs currently accredited,

or excepted from accreditation, under the existing Department of Energy

Laboratory Accreditation Program (DOELAP) standards.

DOE has deleted the outdated provisions of Sec. 835.101 (f) and (g)

as proposed.

2. Education and Training of Cognizant Individuals

Proposed Amendment

To address a number of shortcomings in its provisions for training

radiological control technicians identified during its systematic

analysis, DOE proposed to codify a definition of ``radiological control

technician'' at Sec. 835.2(a). DOE also solicited comments on four

alternative approaches that were discussed in the preamble of the

Notice of Proposed Rulemaking.

Summary of Public Comments and Disposition

Public comments indicated that DOE's proposed definition of the

term ``radiological control technician'' did not adequately describe

the roles and responsibilities of individuals filling this position.

DOE received comments endorsing each of the proposed alternative

approaches, with the majority of the comments endorsing Alternative

Approach 4 as discussed in the preamble of DOE's Notice of Proposed

Rulemaking.

Final Rule

To satisfy its programmatic objectives for occupational radiation

protection programs, DOE has codified an approach consistent with that

discussed as Alternative Approach 4 in its Notice of Proposed

Rulemaking. Under this approach, DOE has eliminated the specific

requirements for radiological control technician training from subpart

J of 10 CFR part 835 and added at Sec. 835.103 a requirement for all

individuals responsible for ensuring compliance with the rule to have

the appropriate education, training, and skills. This approach provides

the flexibility necessary to address the wide range of individuals

involved in developing and implementing measures necessary for ensuring

compliance with 10 CFR part 835, including cognizant managers,

supervisors, auditors, engineers, clerks, and technicians.

3. Written Procedures

Proposed Rule

In its Notice of Proposed Rulemaking, DOE noted that the existing

rule did not establish requirements for written procedures that

consistently addressed the hazards associated with the specified

activity. DOE believes that, due to the wide variation of radiological

activities and their associated hazards conducted at DOE facilities,

requiring written procedures for specific types of activities may

divert resources from active management of higher-hazard activities to

administrative control of lower-hazard activities. DOE discussed two

alternative approaches in its Notice of Proposed Rulemaking.

Alternative Approach 1 would eliminate most or all of the requirements

for written procedures and leave the determination of the need for

written procedures to the cognizant DOE Program Office. Alternative

Approach 2 would eliminate most or all of the existing requirements for

written procedures in favor of a general requirement that written

procedures be developed and implemented commensurate with the

radiological hazards created by the activity and consistent with the

education, training, and skills of the affected individuals.

[[Page 59666]]

Summary of Public Comments and Disposition

Public comments overwhelmingly favored Alternative Approach 2.

Commenters indicated that this approach would provide for an

appropriate level of radiological safety while providing the

flexibility needed to address the wide range of DOE activities. DOE

agrees with the public comments.

Final Rule

DOE has established a requirement at Sec. 835.104 consistent with

that described as Alternative Approach 2 in its Notice of Proposed

Rulemaking. As a result of this change, DOE has deleted specific

requirements for written procedures from Secs. 835.501(d), 835.1001(a),

835.1001(b), 835.1003(a), 835.1101(c), and 835.1102(c)(3) (formerly

835.404(d)). In addition, proposed requirements for written procedures

at Secs. 835.405(f) and 835.1201(a) were omitted from the final rule.

DOE's adoption of this approach is not intended to imply a global

requirement that written procedures be developed and implemented to

address all of the requirements of 10 CFR part 835. In evaluating the

need for written procedures addressing any particular provision of 10

CFR part 835, consideration must be given to the nature and extent of

the radiological hazards, the complexity of the measures necessary to

achieve compliance, and the education, training and skills of the

individuals who must implement those measures. Under such a regimen, a

low hazard activity employing a stable staff of highly educated and

skilled workers having an advanced knowledge of radiation protection

principles and practices could have fewer and less detailed procedures

than a higher hazard activity employing a transient force of workers

with less knowledge of radiation protection principles and practices.

The adequacy of the written procedures is ultimately determined by the

appropriate implementation of the necessary compliance measures by the

affected individuals.

Because the scope of subpart B of 10 CFR part 835 has been

expanded, DOE has changed the title of this subpart to ``Management and

Administrative Requirements.''

C. Limitation of Individual Doses, Subpart C

1. Summing of Internal and External Doses

Proposed Amendment

DOE proposed to revise Sec. 835.203(a) to provide flexibility in

requirements for summing of individual internal and external dose

equivalents to determine the total effective dose equivalent. As

proposed, Sec. 835.203(a) would require summing only when the

individual was monitored in accordance with Sec. 835.402 (that is, when

the individual's dose was likely to exceed the mandatory individual

monitoring thresholds) or when the individual's dose exceeded the

mandatory monitoring thresholds, regardless of a priori expectations.

DOE also proposed to delete Sec. 835.203(c) because this provision

is redundant with provisions included in the Sec. 835.2(b) definition

of the term ``weighting factor.''

Summary of Public Comments and Disposition

DOE received comments indicating that all monitored individual

internal and external doses should be summed to determine the total

effective dose equivalent. Commenters noted that these data were

available and could be important in future dose reconstruction or

litigation efforts. DOE agrees with these comments. Although DOE is

concerned about the administrative burden associated with the need to

sum trivial internal and external doses, DOE has provided ample

flexibility for ameliorating such burdens through codification of the

individual monitoring thresholds provided at Sec. 835.402.

Final Rule

DOE has omitted the proposed change from Sec. 835.203(a), but

deleted the second sentence of Sec. 835.203(a) because this sentence is

redundant with provisions included in the definition of the term

``effective dose equivalent'' at Sec. 835.2(b). DOE has deleted

Sec. 835.203(c), as proposed.

2. Planned Special Exposures

Proposed Amendment

DOE proposed changes to the 10 CFR part 835 requirements for

conducting planned special exposures in excess of the dose limits

established at Sec. 835.202. The proposed changes included:

a. Changing the Sec. 835.204(a)(1) reference from

Sec. 835.202(a)(1) to Sec. 835.202(a) to indicate that all of the

Sec. 835.202 dose limits apply.

b. Revising Sec. 835.204(c) to indicate that doses resulting from

planned special exposures may exceed the numerical values established

at Sec. 835.202(a) without actually exceeding the occupational dose

limits.

c. Clarifying documentation requirements for planned special

exposures at Sec. 835.204(d).

DOE also solicited comments on the possibility of deleting the

provisions for planned special exposures because these provisions have

not been used to date.

Summary of Public Comments and Disposition

Commenters generally supported the proposed changes to the

provisions for planned special exposures. Many commenters indicated

that the provisions for planned special exposures should be retained to

provide the maximum practical degree of flexibility.

Final Rule

Consistent with the comments received, DOE has retained the

provisions for planned special exposures, with the proposed revisions,

in the final rule.

3. Radiation Dose Limits

Proposed Amendment

DOE proposed editorial changes to Sec. 835.207 and the heading of

that section to clarify that the dose limits for minors apply to doses

resulting from occupational exposure only. DOE also proposed to add

deterministic dose limits for minors consistent with the Federal

Guidance. Non-occupational exposure of minors is subject to the dose

limits established at Sec. 835.208 for members of the public entering a

controlled area. DOE also proposed changes to Sec. 835.208 to clarify

that the member of the public dose limit applies to members of the

public in the controlled area only. DOE proposed to revise the

definition of ``member of the public'' at Sec. 835.2(a) to clearly

distinguish members of the public from temporary or transient workers

or visiting scientists who could receive occupational doses.

DOE proposed to revise the definition of ``cumulative total

effective dose equivalent'' (CTEDE) at Sec. 835.2(b) to include all

total effective dose equivalent (TEDE) values, where available, from

January 1, 1989, whether or not the dose was received at that DOE site

or facility.

Summary of Public Comments and Disposition

Several commenters questioned DOE's proposed approach to

controlling doses to minors, pointing out that a minor could possibly

receive 0.1 rem in a year occupational dose and 0.1 rem in a year as a

member of the public. Although this scenario is possible, the resulting

maximum dose is well below the most recent recommendations of

scientific bodies for exposures that do not occur repeatedly.

[[Page 59667]]

DOE did not receive any substantive comments on the proposed change

to the definition of the term ``cumulative total effective dose

equivalent.''

Final Rule

DOE has adopted the changes, essentially as proposed. DOE has also

made editorial changes to Secs. 835.207 and 835.208 for clarity. These

changes include omitting, in Sec. 835.207, the proposed occupational

dose limit for minors of 10% of the Sec. 835.202(a)(2) limit. This

limit is redundant because the 0.1 rem total effective dose equivalent

limit for minors is always more restrictive.

4. Exposures to Airborne Radionuclides

Proposed Amendment

DOE proposed to delete Sec. 835.209(b) because of redundancy with

other rule requirements for inhalation exposures and external exposures

from airborne radionuclides.

Summary of Public Comments and Disposition

DOE did not receive any substantive comments on the proposed

deletion.

Final Rule

DOE has deleted Sec. 835.209(b) and redesignated Sec. 835.209(c) as

Sec. 835.209(b). In addition, DOE has initiated an editorial change by

deleting the word ``representative'' from Sec. 835.209(c)(3)

(redesignated as Sec. 835.209(b)(3)). This word was redundant with the

remaining requirement that the internal dose estimate based upon air

concentration values must be as or more accurate than that based upon

bioassay results.

D. Monitoring of Individuals and Areas, Subpart E

1. General Requirements for Area and Individual Monitoring

Proposed Amendment

In reviewing the requirements of 10 CFR part 835, DOE noted that

the terms ``monitoring'' and ``survey'' were not used consistent with

the definitions provided at Sec. 835.2(a). DOE proposed changes to the

definition of the term ``monitoring'' at Sec. 835.2(a) to clearly

establish that ``monitoring'' involves measurement of radiological

conditions and the subsequent use of the results of these measurements

to evaluate potential and actual exposures to ionizing radiation. As

proposed, the term ``survey,'' would be more directly related to the

assessment of workplace or material radiological conditions through

direct measurement, assessment, or calculation for the purposes of

hazards assessment. DOE proposed changes throughout the rule to ensure

consistent application of these terms.

DOE proposed to clarify the requirements of Secs. 835.401(c) and

835.703(d) by making the calibration requirements apply to both

``instruments'' and ``equipment.'' This clarification is consistent

with current field practice with regard to equipment, such as an air

sampler, that, although incorporated into or associated with

instrumentation systems, does not have any instrumentation.

Summary of Public Comments and Disposition

DOE received a number of comments supporting its attempt to clarify

the ``monitoring'' and ``surveying'' terminology. However, comments

indicated that the usage of these terms remained inconsistent.

With regard to the proposed Sec. 835.401(c) requirements for

calibration and maintenance of instruments and equipment, DOE received

a number of comments indicating that the required one year calibration

frequency was overly stringent given the reliability of many modern

instruments, particularly certain fixed monitors. Other commenters

indicated that the term ``equipment'' could conceivably be extended to

include vehicles, calculators, and other equipment routinely used in

the course of area monitoring.

Commenters indicated that the use of the undefined term

``workplace'' in this subpart could result in confusion regarding the

scope of the requirements. Commenters also indicated that the use of

the term ``area monitoring'' at Sec. 835.401(b) seemed to imply that

stationary area monitors were required under certain conditions.

Final Rule

DOE has determined that, for regulatory purposes as established in

10 CFR part 835, there is no substantive difference between the uses of

the terms ``monitoring'' and ``survey.'' Therefore, in the final rule

DOE has revised the definition of the term ``monitoring'' and deleted

the term ``survey,'' replacing this term with ``monitoring'' (as

modified) throughout the rule. DOE has also deleted the undefined terms

``sampling'' and ``measurements'' in favor of the defined term

``monitoring.''

DOE has deleted the term ``workplace'' from subpart E of 10 CFR

part 835, instead adopting a performance-oriented approach of

``monitoring of individuals and areas.'' In a related editorial change,

DOE has deleted the term ``area monitoring'' from proposed

Sec. 835.401(b) and redesignated the remaining text as

Sec. 835.401(a)(6) to eliminate any connotation regarding requirements

for stationary radiation monitors. DOE has also substituted the defined

term ``individual'' for the undefined term ``personnel'' in this

provision.

In response to comments on DOE's requirements for calibration and

maintenance of instruments and equipment, DOE has revised these

requirements (at redesignated Sec. 835.401(b)(1)) such that calibration

and maintenance will be required ``periodically'' on an ``established

frequency.'' This change is consistent with NRC requirements at 10 CFR

20.1501 and provides flexibility for acceptance of recommendations

provided in various consensus standards accepted by the instrument

calibration community and used within the DOE complex. DOE will provide

guidance regarding measures for establishing appropriate maintenance

and calibration frequencies and proper application of these

requirements to ``equipment'' used for monitoring.

As used in 10 CFR part 835, instruments and equipment used for

monitoring includes devices used for both area monitoring (e.g.,

portable and installed radiation, contamination, and airborne

radioactivity sampling and monitoring devices) and individual

monitoring devices (e.g., thermoluminescent dosimeters, pocket ion

chambers, track etch dosimeters, and electronic dosimeters). Note that

the calibration of personnel dosimeters that are required under

Sec. 835.402 is addressed by the DOELAP for personnel dosimetry.

2. Individual Monitoring and Dose Determination

Proposed Amendment

DOE proposed several changes to the existing requirements for

monitoring individual radiation doses. The proposed changes included:

a. Clarifying the requirements for external and internal dose

monitoring programs at Sec. 835.402(b) and (d) by providing that such

programs must be capable of demonstrating compliance with all of the

individual dose equivalent limits in subpart C. This approach is

consistent with DOE's previously established requirements for records

required under Sec. 835.701(a).

b. Revising the monitoring requirements for minors at

Sec. 835.402(a)(3) and (c)(3) to expressly state that these

requirements apply to occupationally exposed minors only.

[[Page 59668]]

Minors who are not occupationally exposed are subject to the member of

the public monitoring requirements found at Sec. 835.402(a)(4) and

(c)(4).

c. Deleting from Sec. 835.402(c)(1) the monitoring threshold based

on organ and tissue committed dose equivalent. The monitoring threshold

based upon committed effective dose equivalent obviates the need for

this threshold because, through application of the weighting factors

defined at Sec. 835.2(b), the committed effective dose equivalent

always provides a more restrictive basis for individual monitoring.

d. Changing Sec. 835.402(a)(1)(i) to require individual monitoring

on the basis of deep dose equivalent rather than effective dose

equivalent because deep dose equivalent is the parameter actually

monitored by existing dosimetry programs.

e. Removing provisions at Sec. 835.402(a)(1)(iv) for measuring deep

dose equivalent from external sources to any organ or tissue other than

the lens of the eye because any doses meeting this condition are

adequately addressed by Sec. 835.402(a)(1)(i).

f. Clarifying Sec. 835.402(a)(4) and (c)(4) to indicate that these

provisions apply to members of the public inside the controlled area

only.

Summary of Public Comments and Disposition

Commenters indicated that the proposed Sec. 835.402(a)(1)(i)

requirement for monitoring of deep dose equivalent, as worded, would

challenge the capabilities of modern dosimetry systems. While the

technical basis for the comments was not clear, reflection on these

comments revealed that the wording in the proposed rule could suggest

the basis for initiating monitoring was the highest dose received by

any portion of the whole body. Furthermore, although deep dose

equivalent is the quantity most commonly measured, effective dose

equivalent is the appropriate criterion upon which the mandatory

individual monitoring threshold should be based because the

corresponding occupational dose limits are stated in terms of effective

dose equivalent.

Final Rule

DOE agrees with the public comments regarding the proposed change

to Sec. 835.402(a)(1)(i). The language in the original version of 10

CFR part 835 has been retained. DOE has included the other proposed

changes in the final rule.

3. Program Accreditation

Proposed Amendment

DOE proposed a number of enhancements and additions to the existing

requirements for the DOELAP. These proposed changes included:

a. Amending Sec. 835.402(b) to indicate that, except as discussed

below, personnel dosimetry programs must be either accredited under the

DOELAP or excepted from accreditation under that program.

b. Amending Sec. 835.402(d) to require radiobioassay program

accreditation or exception through the recently developed DOELAP for

Radiobioassay. This proposed change was intended to ensure the

integrity of radiobioassay programs and prevent recurrence of recent

adverse events.

c. Revising Sec. 835.402(b) and (d) to limit the scope of the

DOELAP requirements to personnel dosimetry and radiobioassay programs

implemented to ensure compliance with Sec. 835.402 (i.e., monitoring

when individual doses are likely to exceed the stated thresholds). In a

related change, because Sec. 835.401(b) addresses calibration of

instruments and equipment used for monitoring and DOELAP for Personnel

Dosimetry provides appropriate dosimetry system performance criteria,

DOE proposed to delete the dosimeter calibration requirement from

Sec. 835.402(b).

d. Adding Sec. 835.402(e) to require that external dosimetry and

bioassay programs conform to the most recent revisions of the DOELAP

technical standards or be subject to review and approval of the

Secretarial Officer responsible for environment, safety, and health

matters (currently the Assistant Secretary for Environment, Safety and

Health). For those programs that are not accredited or excepted from

the accreditation program, this provision would also allow this same

officer to provide approval if the programs demonstrate performance

equivalent to those accredited under the DOELAP. This provision would

ensure that, to the extent practical, DOE radiation protection programs

will reflect the latest advances in the sciences of external and

internal dosimetry. To prevent the automatic loss of accreditation

status as a result of changes to the DOELAP technical standards, the

DOELAP technical standards provide that changes in the standards become

effective only during the ensuing accreditation cycle.

Summary of Public Comments and Disposition

Several commenters suggested that all individual dose measurements

be performed under an accredited dosimetry program in order to maintain

credibility of all monitoring data. However, DOE does not believe that

is appropriate to impose regulatory accreditation requirements on

monitoring programs that are not required by regulation. Existing

regulatory provisions at Sec. 835.402(a) and (c) require individual

monitoring for all individuals likely to receive a dose equivalent

exceeding the specified thresholds. As part of a comprehensive

radiation protection program, measures used to identify these

individuals should include comprehensive, documented area monitoring

and could include, if management so chooses, individual monitoring.

Section 835.401 establishes minimum requirements for performing such

monitoring, including requirements for calibration and maintenance of

instruments and equipment used to perform the monitoring. As required

by Secs. 835.701(a) and 835.703, the monitoring results must be

documented.

Several commenters recommended that DOE revise the rule to permit

DOE facilities to procure the services of dosimetry processors who are

accredited by the National Voluntary Laboratory Accreditation Program

(NVLAP) administered through the National Institute of Standards and

Technology, as an alternative to accreditation under the DOELAP for

personnel dosimetry. These comments noted the NRC's regulations require

licensees to use dosimetry processors with NVLAP accreditation. They

argued that permitting NVLAP accreditation in lieu of DOELAP

accreditation, would maximize private sector competition for DOE

contracts. DOE has not accepted the commenters' recommendations because

NVLAP accreditation does not meet DOE's requirement for an external

dose monitoring program. DOELAP accreditation covers both the

facility's and the processor's quality assurance program, whereas NVLAP

only deals with the dosimetry processor. The commenter's reference to

the NRC's use of NVLAP accreditation for dosimetry processors ignores

the fact that NRC has the resources to perform frequent on-site

inspections of a facility's dosimetry program. In the absence of such

resources at DOE facilities, DOE relies upon the DOELAP accreditation

to ensure that a facility's personnel dosimetry program provides

accurate results.

[[Page 59669]]

DOE received comments on its proposal to require DOELAP

accreditation, exception from accreditation under DOELAP, or DOELAP

equivalency, for radiobioassay programs that would satisfy the internal

dose monitoring program requirement in the rule. The commenters argued

that it would be premature to impose this requirement because DOE has

not completed the process for developing accreditation standards for

radiobioassay programs. As discussed in connection with Sec. 835.101,

concerning the effective date of the rule, DOE has responded to these

concerns by extending the deadline for complying with this provision to

January 1, 2002. In any event, Sec. 835.402(d) provides for Secretarial

Officer approval of radiobioassay programs that are not accredited

under DOELAP.

Several commenters objected to proposed Sec. 835.402(e), which

would have required Secretarial Officer approval of personnel dosimetry

and radiobioassay programs that do not comply with the latest edition

of DOE's technical standards governing program accreditation. They

argued that incorporation by reference of the technical standards was

inappropriate because the requirements in the technical standards had

not been proposed for public comment in a rulemaking. In light of these

comments, DOE has deleted the reference to DOE's technical standards

for accreditation in the regulatory text of the final rule. DOE does

not intend to codify the accreditation standards through this

rulemaking. DOE technical standards are guidance documents to assist

contractors in implementing regulatory requirements. As a matter of

policy (DOE P 450.2A, May 15, 1996), DOE routinely seeks public

comments on guidance documents issued to implement environment, safety

and health requirements at DOE sites. On April 24, 1997, DOE published

a notice of availability of draft guides and technical standards for

the Occupational Radiation Protection Program (62 FR 19940). At that

time, DOE invited public comment on draft technical standard,

``Department of Energy Laboratory Accreditation Program

Administration,'' which includes requirements for personnel dosimetry

and radiobioassay program accreditation. The revised regulatory

provisions will accomplish DOE's purpose of providing that programs

which DOE accredits, or excepts from accreditation, under DOELAP will

satisfy the requirements in this rule for programs that are implemented

to demonstrate compliance with Sec. 835.402(a) and (c). Accreditation

under DOELAP will obviate the need for contractors to secure approval

of the Assistant Secretary for Environment, Safety and Health.

Final Rule

In the final rule DOE has revised Sec. 835.402(b) and (d) to

provide that contractors may demonstrate the adequacy of external and

internal dose monitoring programs, respectively, by submitting their

programs to the Secretarial Officer responsible for environment, safety

and health for approval in lieu of accreditation or exception from

accreditation under the DOELAP. Alternative programs will be approved

if their performance is demonstrated to be substantially equivalent to

that of accredited programs. This change makes unnecessary, and DOE has

deleted, proposed Sec. 835.402(e), which would have required

Secretarial Officer approval of programs not complying with the latest

edition of the technical standards for DOELAP accreditation.

DOE has adopted the other changes as proposed, with minor editorial

corrections.

4. Air Monitoring

Proposed Amendment

DOE proposed to revise the Sec. 835.403(a)(1) air sampling

requirement to be based on potential individual exposures in derived

air concentration (DAC)-hours in a year rather than a percentage of the

annual limit on intake (ALI) because the values provided in appendices

A and C of 10 CFR part 835 are listed as DACs. DOE proposed to add

Sec. 835.403(a)(2) to require that air sampling be performed when

respiratory protective devices are prescribed to protect individuals

from exposure to airborne radionuclides. DOE also proposed an editorial

change to delete Sec. 835.403(b), eliminating redundancy with

Sec. 835.401(b).

To enhance air monitoring programs, DOE proposed to provide more

practical and technically accurate criteria at Sec. 835.403 for the use

of real-time air monitors based on potential releases that would exceed

a defined threshold exposure levels of 40 DAC-hours in a week. In a

related change, DOE proposed to replace the term ``continuous air

monitor'' with the term ``real-time air monitor'' with supporting

changes to the definitions provided at Sec. 835.2(a). DOE also proposed

to add a definition of the term ``week'' at Sec. 835.2(a).

Summary of Public Comments and Disposition

DOE received a number of comments indicating that the proposed

revision of the requirements for real-time air monitoring was unclear

and did not acknowledge the actual capabilities of available monitors.

Other commenters indicated that the proposed definition of the term

``week,'' based upon a period beginning on Monday, might cause

unnecessary changes in existing schedules for real-time air monitor

filter changes. Several commenters indicated that the proposed

provisions for air sampling when respiratory protective devices are

prescribed could be construed to mean that an air sample must be taken

each time an individual enters an area wearing a respiratory protective

device.

DOE received comments indicating that the existing criterion based

upon the percentage of an ALI was more appropriate for prospective

establishment of air monitoring programs. DAC-hours are related to the

fraction of an ALI in a consistent and fixed manner; therefore,

potential exposures in units of DAC-hours are an appropriate basis for

prospectively determining the need for air sampling.

Final Rule

As suggested through public comments, DOE clarified the mandatory

airborne radioactivity monitoring criteria in the final rule. Section

835.403(a) of the final rule requires the implementation of air

sampling programs in areas in which an individual is expected to be

exposed in excess of 40 DAC-hours in a year. The final rule clarifies

that airborne radioactivity monitoring during use of respiratory

protective equipment is required ``as necessary'' to characterize the

hazard. This provision is consistent with requirements imposed by both

the NRC and the Occupational Safety and Health Administration (OSHA)

(see 10 CFR 20.1703(a)(3), ``Use of individual respiratory protection

equipment,'' and 29 CFR part 1910, ``Occupational Safety and Health

Standards,'' Sec. 1910.134(d)(1)(iii), respectively).

The Sec. 835.403(b) criterion for real-time air monitoring is based

upon the need to alert potentially exposed individuals of the need for

action to reduce or terminate exposures to airborne radioactive

material. This approach provides more flexibility for implementation on

a site-and facility-specific basis, taking into account realistic event

scenarios, source terms, and instrument capabilities. This requirement

acknowledges the wide

[[Page 59670]]

variety of configurations and hazards associated with DOE activities

and the limitations of currently available real-time air monitoring

equipment. DOE's implementing guidance provides an acceptable approach

for achieving compliance with this provision. The restructuring of the

requirements for real-time air monitoring rendered proposed

Sec. 835.403(c) redundant; DOE has therefore deleted this provision.

In support of the revised provisions, Sec. 835.2(a) provides

definitions for the terms ``derived air concentration-hour (DAC-

hour),'' ``real-time air monitoring,'' ``respiratory protective

device,'' and ``week'' which are used at Sec. 835.403. In consideration

of public comments, DOE has revised the proposed definition of the term

``week'' to omit a mandatory starting day. In addition, DOE has deleted

the definitions of ``ambient air'' and ``continuous air monitor''

because these terms are no longer used in 10 CFR part 835.

5. Contamination Monitoring

In consideration of public comments received, DOE has revised the

Sec. 835.404 requirements for contamination monitoring and control and

moved these requirements to Sec. 835.1102. The proposed changes, public

comments, and final rule provisions are discussed in full in Section

II.J of this Notice of Final Rulemaking.

6. Receipt of Packages of Radioactive Material

Proposed Amendment

DOE proposed to add requirements at Sec. 835.405 for surveys of

packages of radioactive material received from radioactive material

transportation to ensure adequate protection is provided to

individuals, including warehouse and office workers, who may be exposed

to these materials. The proposed provisions included requirements for

taking possession of radioactive material packages from transport and

performing surveys of these packages. At 835.405(d), DOE proposed to

establish requirements for completion of the necessary surveys within

three hours of receipt of the package (if received during working

hours) or within three hours of the beginning of the following working

day (if received after working hours). The proposed requirements are

similar to NRC requirements at 10 CFR 20.1906.

Summary of Public Comments and Disposition

Several commenters suggested that the time provision included in

the proposed amendment was unnecessarily stringent. During evaluation

and resolution of these comments, DOE determined that the nature of

many of its sites and facilities and the stringency of the requirements

for radioactive material transportation indicate that this observation

is accurate.

Final Rule

In deference to the comments received and in recognition of the

variety of sites and facilities subject to 10 CFR part 835, DOE has

extended the time required for monitoring packages received from

radioactive material transportation to 8 hours after the beginning of

the working day following the receipt of the package. In practice, the

actual interval may also be constrained by the requirements for

individual monitoring and radiation safety training at Secs. 835.402

and 835.901 respectively, and by the ALARA requirements at

Sec. 835.101.

As used in Sec. 835.405, a ``working day'' is considered to be the

interval of time within each 24 hour period during which the building

or area in which the received package is stored is routinely occupied

or available for operations other than emergency activities. For

example, if the received package is stored in a warehouse awaiting the

required monitoring and that warehouse is occupied or accessible to

shipping and receiving personnel, then the working day is that period

of time within each 24 hour period during which the shipping and

receiving personnel are scheduled to be working or to have ready access

to the warehouse. The working day does not include periods during which

shipping and receiving personnel would have to return to work on a non-

scheduled basis to address emergent issues requiring their attendance.

E. Entry Control Program, Subpart F

Proposed Amendment

DOE proposed more detailed provisions for written work

authorizations at Sec. 835.501(e) to address operational occurrences

throughout the DOE complex. DOE also proposed to revise Sec. 835.502 to

add measures for control of access to high radiation areas. The

proposed control measures were consistent with those previously

established in the Manual and included requirements for use of a

supplemental dosimetry device and appropriate area surveys.

Summary of Public Comments and Disposition

Commenters expressed concern that the proposed Sec. 835.501(e)

entry control requirements were inappropriate for relatively minor

hazards present in areas such as radiation areas. With regard to the

proposed high radiation area access control requirements, commenters

also indicated that devices capable of rendering an immediate

indication of an individual's integrated dose resulting from neutron

radiation are not commercially available. Several commenters also

indicated that the proposed Sec. 835.502(c) requirements for control of

access to very high radiation areas could be taken to mean that the

required controls must be impenetrable. DOE agrees that these issues

require clarification.

Final Rule

Regarding low-hazard radiological areas, the final rule provides

significant flexibility for implementation of access controls on a

facility-and hazard-specific basis. The written authorizations required

by 835.501(d) must specify radiation protection measures consistent

with existing and potential hazards. DOE does not intend for this

provision to establish a global requirement for the development and

implementation of radiological work permits to address all entries into

radiological areas. The written authorization may take the form of

generally applicable procedures, as appropriate. Guidance on the use of

written authorizations will be published in DOE's Radiological Control

Standard. As a result of the deletion of specific requirements for

written procedures (discussed in Section II.B.3 of this Notice of Final

Rulemaking), DOE has redesignated proposed Sec. 835.501(e) as

Sec. 835.501(d) in the final rule.

To address the unavailability of devices capable of providing an

immediate indication of an individual's dose resulting from exposure to

neutron radiation in a high radiation area, Sec. 835.502(a)(2) allows

for supplemental dosimeters or other means of immediately estimating or

measuring the individuals' integrated doses during the area entry. The

other means may include knowledge of the area exposure rates combined

with tracking of individual access times. Consistent with the existing

definition of the terms ``high radiation area'' and ``very high

radiation area,'' DOE has revised the proposed requirements to indicate

that the required devices and measures must be capable of estimating

the affected individual's deep dose equivalent, rather than the dose

equivalent. DOE also provided an editorial correction at

Sec. 835.502(b)(2), substituting the defined term ``individuals'' for

the undefined term ``personnel.''

[[Page 59671]]

In response to public comments, DOE has clarified Sec. 835.502(c)

to indicate that the additional controls required for very high

radiation areas need to be sufficient to prevent ``unauthorized or

inadvertent'' entries rather than to prohibit entry into the area.

F. Posting and Labeling, Subpart G

1. Controlled Area and Radiological Area Posting Requirements

Proposed Amendment

DOE proposed several changes to clarify and simplify requirements

for area hazard posting and to provide additional flexibility in

implementing these requirements. In acknowledgment of the differing

hazards and controls associated with removable and fixed radioactive

contamination, DOE proposed to revise the Sec. 835.2(a) definitions of

``contamination area'' and ``high contamination area'' to be based upon

removable surface contamination levels only and to clearly establish

these areas based on accessibility rather than the general reference to

``working areas'' which appeared at Sec. 835.601(a). DOE proposed a

similar change to the Sec. 835.2(a) definition of the term ``airborne

radioactivity area.'' DOE also proposed to move the controlled area

maximum dose expectation from the Sec. 835.2(a) ``controlled area''

definition to the Sec. 835.602(a) controlled area posting provision.

Because radiological area terms are defined at Sec. 835.2(a), DOE

proposed to remove redundant definitions imbedded in the posting

provisions at Sec. 835.603. DOE also proposed to delete the requirement

for DOE approval of warning signs from Sec. 835.601(b) because

acceptable signs are described in DOE's implementing guidance and DOE

did not intend to establish a formal process for approval of

radiological postings and labels. In addition, DOE proposed to expand

its provision at Sec. 835.601(e) (redesignated as Sec. 835.601(d) in

the proposed amendment) allowing modification of postings and labels to

accommodate special considerations of DOE activities involving private

residences to also include private businesses.

Consistent with NRC requirements published at 10 CFR 20.1902, DOE

proposed to amend Sec. 835.603(b), (d), and (f) to allow use of the

words ``Caution'' or ``Danger'' on postings for high radiation, high

contamination, and airborne radioactivity areas, respectively. This

proposed change would accommodate the wide range of radiological

conditions that may be present in these areas to provide some degree of

flexibility in their posting.

Proposed Sec. 835.604(a) would create an exception from posting

requirements for periods of less than 8 continuous hours as long as the

radiological area is placed under continuous observation and control of

a person able to implement the required access and exposure control

measures. This exception would cover temporary conditions or activities

such as maintenance, repair or cleanup activities so long as the

absence of posting is kept to within the prescribed time and the

prescribed control measures are implemented.

DOE also proposed to add Sec. 835.604(b) and (c) delineating

specific exceptions from the radiological area posting requirements of

Sec. 835.603, recognizing that compensatory measures may be implemented

that would obviate the need for area posting. The proposed exceptions

are similar to those established by the NRC at 10 CFR 20.1903.

Summary of Public Comments and Disposition

DOE received several comments indicating that the proposed

definition of the term ``airborne radioactivity area'' should include

an exposure-based criterion (i.e., based upon potential individual

exposures in term of dose, percentage of an ALI, or DAC-hours) instead

of, or in addition to, the existing criterion based upon the absolute

airborne radioactivity concentration. DOE agrees that this issue

requires clarification.

Some commenters expressed support for the current 10 CFR part 835

posting provisions based upon the identification of ``working areas.''

However, the term ``working areas'' is not defined and DOE does not

believe that posting of only ``working areas'' provides adequate

protection of individuals approaching or entering radiological areas in

which there is no work in progress. The commenters did not provide any

evidence that such a practice would provide for adequate protection.

DOE received a number of comments on the proposed allowance for the

use of ``Caution'' or ``Danger'' on certain radiological hazard warning

signs. Commenters indicated that the terms ``Caution'' and ``Danger''

are not interchangeable and that the term ``Danger'' generally carries

a connotation of greater hazard than ``Caution.'' While DOE agrees with

these observations, DOE believes that, in the continuum of possible

radiological conditions associated with DOE activities, the threshold

at which ``Danger'' becomes more appropriate than ``Caution'' most

likely lies somewhere within those conditions described in the

Sec. 835.2(a) definitions of ``airborne radioactivity area,'' ``high

radiation area,'' and ``high contamination area.'' Furthermore,

individual protective actions required for entry into these areas are

dependent upon the radiological area title, not the ``Caution'' or

``Danger'' heading. DOE believes that the demarcation between those

conditions requiring ``Caution'' and ``Danger'' headings is best left

to the discretion of those responsible for individual DOE activities to

ensure that activity-specific conditions are addressed. Therefore, DOE

believes that it is appropriate to allow flexibility in the use of the

``Caution'' and ``Danger'' headings for posting of high radiation, high

contamination, and airborne radioactivity areas.

Some commenters indicated that provisions for alternative measures

for DOE activities conducted at private residences and businesses

should be extended to DOE activities conducted on state- and Federally-

owned lands. However, DOE does not believe that considerations of

individual property rights and property value impacts extend to DOE

activities conducted on state and Federal lands. Furthermore, the great

majority of DOE activities are conducted at state-and Federally-owned

sites. Such an exception would negate the specific posting requirements

for essentially all DOE activities.

Commenters generally supported DOE's proposed exceptions to the

radiological posting requirements. However, comments indicated that the

proposed Sec. 835.604(c) exception for packages received from

radioactive material transportation should not apply to damaged

packages. DOE agrees that this issue requires specific attention.

Final Rule

DOE has revised the Sec. 835.2(a) definition of the term ``airborne

radioactivity area'' such that posting and control of these areas will

be required when the airborne radioactivity concentration exceeds the

DAC values provided in appendix A or C of 10 CFR part 835 or when an

individual present in the area without a respiratory protective device

could be exposed to airborne radioactive material in excess of 12 DAC-

hours in a week. This definition is similar to that provided by the NRC

at 10 CFR 20.1003.

DOE has codified the changes to the radiological hazard posting

requirements as proposed. In the final rule, DOE has deleted

Sec. 835.601(a) to eliminate redundancy. As a result, Sec. 835.601(b)--

(d) have been redesignated as Sec. 835.601(a)--(c), respectively. The

Sec. 835.604 radiological

[[Page 59672]]

area posting exceptions do not apply to the radiological area entry

control requirements established at Secs. 835.501 and 835.502 or to the

radiation safety training requirements at Sec. 835.901. In response to

public comments, DOE has restricted the scope of the posting exception

for packages received from radioactive material transportation to those

packages received in a non-degraded condition.

2. Radioactive Material Area Posting

Proposed Amendment

To ensure that individuals entering controlled areas but not

entering radiological areas are adequately protected, DOE proposed

requirements for posting of radioactive material areas similar to the

existing requirements of DOE N 441.1 (extended by DOE N 441.2 and DOE N

441.3). The proposed posting requirements were based on quantities of

radioactive materials that exceeded 10 times the threshold values

proposed in appendix E of 10 CFR part 835 and were similar to NRC

requirements at 10 CFR 20.1902. DOE proposed to define ``radioactive

material area'' and include this term in the definition of

``radiological area'' at Sec. 835.2(a) and establish requirements for

posting radioactive material areas at Sec. 835.603(g). DOE also

proposed exceptions to the radioactive material area posting

requirements at Sec. 835.604(b).

Summary of Public Comments and Disposition

DOE received numerous comments on these proposed requirements. The

major issues included: (1) The threshold values (based on ten times the

activity levels provided in proposed appendix E of 10 CFR part 835)

which would require posting of radioactive material areas were overly

restrictive; (2) the hazards present in a radioactive material area, as

defined, did not warrant the imposition of specific entry controls and

radiation safety training programs required for radiological areas; (3)

posting of radioactive material areas should not be required when the

radioactive material consists solely of activated structures or

installed components; and (4) there is no apparent difference between

the hazards in a controlled area and a radioactive material area, as

defined at Sec. 835.2(a).

DOE agrees that: (1) The proposed appendix E values, as a basis for

defining a radioactive materials area, were somewhat restrictive; (2)

posting of radioactive material areas should not be required when the

material solely consists of structures or installed components which

have been activated; and (3) the hazards present in a radioactive

material area, as defined, are not always significantly different than

the hazards in a controlled area and would not always warrant

imposition of the entry controls required for the defined radiological

areas.

Final Rule

DOE recognizes the fact that the radiological conditions expected

in radioactive material areas, as proposed, are less hazardous than

those present in radiological areas as defined in the original rule.

Accordingly, a less restrictive approach to radiological protection is

warranted. In the final rule, DOE has omitted the term ``radioactive

material area'' from the Sec. 835.2(a) definition of ``radiological

area.'' Therefore, radioactive material areas will not be subject to

the specific entry control provisions of Sec. 835.501. As a result of

the codification of hazard-based radiation safety training requirements

at Sec. 835.901 (discussed in Section II.H. of this Notice of Final

Rulemaking), applicability of the radiation safety training

requirements for entry into radioactive material areas will be subject

to an evaluation of the activities to be performed in the area and the

degree of actual or potential exposure to radiological hazards.

Section 835.603(g) of the final rule requires posting of

radioactive material areas at the entry points to accessible areas

where there exist items or containers of radioactive material in excess

of the revised appendix E values as published, rather than ten times

the appendix E values, as proposed. The basis for the revised appendix

E values is discussed in detail in Section II.K of this Notice of Final

Rulemaking. Because of the minimal hazards present in radioactive

material areas, DOE has omitted the allowance for the use of the

``Danger'' heading from the Sec. 835.603(g) requirement for posting of

radioactive material areas.

DOE has included proposed exceptions to the radioactive material

area posting requirement at Sec. 835.604. In response to the comments

received, DOE has included another posting exception for areas in which

the radioactive material consists solely of structures or installed

components which have been activated, such as activation by exposure to

neutron radiation or radiation incident to operation of a particle

accelerator. DOE expects that this exception will most commonly be

applied to building and shielding structures associated with nuclear

reactors and particle accelerators. Note that these structures and

components are not excepted from the radiological area posting

requirements.

Because the term ``radioactive material area'' has been deleted

from the Sec. 835.2(a) definition of the term ``radiological area,''

DOE has revised the heading of Sec. 835.603 and the provisions of

Sec. 835.602(a) to reflect the inclusion of the radioactive material

area posting requirements in subpart G of 10 CFR part 835.

3. Radioactive Material Labeling

Proposed Amendment

To augment and clarify existing requirements, DOE proposed to add

requirements for labeling items and containers of radioactive materials

at Sec. 835.605, with appropriate exceptions being proposed at

Sec. 835.606. These proposed provisions are similar to those in the

Manual and consistent with requirements imposed by the NRC at 10 CFR

20.1904 and 20.1905.

Summary of Public Comments and Disposition

DOE received comments indicating that, because the proposed

labeling provisions were based upon the proposed appendix E total

activity values, they were not adequate to ensure proper labeling of

items having removable contamination exceeding the 10 CFR part 835

appendix D surface radioactivity values. However, even though labeling

of contaminated items is not explicitly required by the rule, adequate

controls are established under Secs. 835.1101 and 835.1102 which will

require that either labeling or equivalent measures be implemented to

inform individuals of the contamination hazard.

DOE also received comments on the proposed exceptions from the

labeling requirements. Commenters indicated that exceptions should also

be provided for nuclear weapons and their components, for inaccessible

radioactive material, and for activated building components. DOE agrees

with these comments.

Final Rule

DOE has codified the proposed requirements for labeling with minor

editorial changes. Section 835.605 requires labeling of radioactive

items and containers of radioactive materials. Section 835.606 provides

an exception from the labeling requirements for items and containers

having a total activity of less than \1/10\ of the appendix E values

rather than at the proposed appendix E values because DOE has

reevaluated the appendix E values to address concerns regarding the

stringency of the proposed

[[Page 59673]]

requirements for accountable sealed radioactive sources (see discussion

in Section II.K. of this Notice of Final Rulemaking). Because

Secs. 835.1101 and 835.1102 establish appropriate requirements for

control of contaminated material and equipment, DOE has not included

specific requirements for labeling of contaminated items in this

subpart.

In response to the comments received, DOE has revised the

radioactive material labeling exceptions proposed at Sec. 835.606 to

include nuclear weapons and their components and inaccessible

radioactive material. In addition, the exception from the Sec. 835.601

design and color specifications for labels applied to sealed

radioactive sources, proposed at Sec. 835.1201(b), has been codified at

Sec. 835.606(b).

G. Records and Reports, Subparts H and I

Proposed Amendment

DOE proposed a number of changes to its requirements for records

demonstrating compliance with 10 CFR part 835. The proposed changes

included:

1. Revising Secs. 835.203(a) and 835.702(b) to provide that, when

monitoring is performed, but not required by Sec. 835.402, internal and

external doses must be summed and records must be maintained only if

the doses determined by the non-mandatory monitoring exceed the

thresholds of Sec. 835.402. This proposed change was intended to reduce

the burden of recordkeeping consistent with the recommendations in the

Guidance to Federal Agencies.

2. Deleting the words ``caused by contamination on the skin'' from

Sec. 835.702(b) to ensure consistency with the referenced requirements

at Sec. 835.205.

3. Revising Sec. 835.702(c)(1) to provide that records must be

sufficient to demonstrate compliance with all of the subpart C dose

limits. This provision is consistent with Sec. 835.701(a).

4. Deleting the requirement at Sec. 835.702(c)(4)(iii) to record

the estimated intake associated with internal dose assessments. This

change was necessary because determination of the individual dose

equivalent resulting from intakes of certain radionuclides, such as

tritium, does not require determination of the estimated intake.

5. Revising Sec. 835.702(d) and (e) such that acceptance of written

estimates of an individual's prior occupational dose is based upon an

inability to obtain formal records, rather than the absence of those

records. DOE also proposed to revise Sec. 835.702(d) consistent with

the previously discussed clarification of the components of

occupational dose and to reference DOE Orders for authorizing emergency

exposures. DOE further proposed to revise Sec. 835.702(e) to indicate

that efforts to obtain records of prior years doses were necessary only

for those individuals monitored in accordance with Sec. 835.402.

6. Technical and editorial changes to clarify the recordkeeping

provisions and to ensure consistency with other changes included in

subparts J and M. DOE also proposed to revise Sec. 835.704(d) to

require documentation of revocations of declarations of pregnancy.

7. Because some individuals may not have social security numbers,

DOE proposed to revise Sec. 835.801(a) to allow for use of another

unique identification number in reports associated with such

individuals.

Summary of Public Comments and Disposition

DOE received a number of comments indicating that the results of

all individual monitoring that is performed should be recorded. DOE

agrees that this approach has merit. Furthermore, DOE has provided

adequate flexibility under the individual monitoring requirements of

Sec. 835.402 to eliminate any onerous administrative burdens resulting

from records of trivial doses.

DOE received comments indicating that the term ``accident'' was not

clearly defined, resulting in uncertainty about the proper application

of the individual monitoring records requirement of Sec. 835.702(a).

DOE received comments suggesting that the proposed change to

Sec. 835.702(e) was not needed because, in the absence of a cumulative

dose limit, written estimates would not serve any substantive purpose.

DOE agrees with this observation.

Final Rule

DOE has revised Sec. 835.702(a) to delete reference to accidents

and to specify that records be maintained to document unplanned doses

exceeding the monitoring thresholds of Sec. 835.402.

In consideration of the comments received, DOE has not included the

proposed changes to Sec. 835.702(b) in the final rule.

Consistent with the changes to Sec. 835.1302 discussed in Section

II.L of this Notice of Final Rulemaking, DOE has revised

Sec. 835.702(d) to reference the emergency exposure authorization

measures included in that section.

DOE has also not included in the final rule the proposed change to

Sec. 835.702(e) allowing written estimates of prior years doses. DOE

has included the remaining changes with minor editorial corrections to

enhance clarity.

DOE's review of 10 CFR part 835 revealed the fact that

Sec. 835.702(c)(2) inappropriately invoked the requirements of certain

DOE Orders. The applicability of these Orders is established through

DOE contractual processes. DOE has revised the text to delete this

invocation of DOE Orders.

Consistent with changes discussed elsewhere in this Notice of Final

Rulemaking, DOE has revised the heading of Sec. 835.703 and language at

Sec. 835.703(a) and (e) to eliminate the use of the term ``workplace''

and to reference those subparts of the rule (subparts E and L) that

establish monitoring requirements.

Because individuals generally do not record the results of

contamination monitoring upon exiting contamination and high

contamination areas and there is little perceived value in maintaining

such records, DOE has clarified Sec. 835.703(a) to permit such a

practice. In consideration of comments on the specificity of the

proposed Sec. 835.703(c) recordkeeping provisions, DOE has not included

the second portion of proposed Sec. 835.703(c) regarding informational

content of these records in the final rule. DOE has revised the

recordkeeping requirements of Sec. 835.703(d) consistent with the

changes made to Sec. 835.401.

In recognition of the need to record the estimated date of

conception for a declared pregnant worker (in order to determine

compliance with the applicable dose limit for the embryo/fetus), DOE

has clearly stated this as a requirement at Sec. 835.704(d). Also,

consistent with the changes made at Sec. 835.401, DOE has deleted the

term ``workplace'' from Sec. 835.704(e).

H. Radiation Safety Training, Subpart J

1. Training Course Content and Administration

Proposed Amendment

When 10 CFR part 835 was originally developed, the detailed

radiation safety training requirements provided in the Manual obviated

the need to specify minimum training course content in the rule.

Because the Manual is no longer mandatory, DOE proposed to specify

minimum training course content at Sec. 835.901(b). Also at

Sec. 835.901(b), DOE proposed requirements that would allow more

liberal acceptance of an individual's previous radiation safety

training.

DOE proposed to further consolidate and simplify its requirements

for

[[Page 59674]]

radiation safety training. Under the proposed amendment, the level of

training required would be based upon the areas entered by the

individual unescorted, the activities performed, and the likely doses,

rather than the individual's classification as a member of the public,

general employee, or radiological worker. Implementation of this

hierarchical approach to training would result in the appropriate level

of radiation safety training for general employees, with a higher level

of training required for radiological workers. This approach is

consistent with field experience and feedback from DOE operating

contractors and is similar to the approach previously taken by DOE in

DOE Order 5480.11 and currently taken by the NRC in 10 CFR part 19,

``Notices, Instructions and Reports to Workers: Inspection and

Investigations.'' DOE proposed to eliminate the examination requirement

for individuals who are not permitted unescorted access to radiological

areas and who do not perform unescorted assignments as a radiological

worker. DOE also proposed to provide specific requirements at

Sec. 835.901(f) for individuals who may act as escorts of individuals

who have not completed required training.

Summary of Public Comments and Disposition

Public comments generally endorsed DOE's proposed hierarchical

approach to radiation safety training. However, some commenters were

concerned that the proposed approach, which would require an individual

to complete radiation safety training prior to being occupationally

exposed to radiation, would needlessly penalize those facilities that

conduct training inside the controlled area or in other areas in which

trivial occupational exposures may occur. However, as proposed,

Sec. 835.901(c) (Sec. 835.901(b) in the proposed rule) requires

training to the extent appropriate to the individual's degree of

exposure to potential radiological hazards. Under the circumstances

described, the ``extent appropriate'' may be minimal (perhaps a

briefing on appropriate alarm responses).

Comments indicated that the proposed Sec. 835.901(b)(3) requirement

to provide training on ``measures implemented at the facility to

minimize exposures'' was inappropriate, as there is no requirement to

``minimize exposures.'' Other comments indicated that it was

unnecessary for the required training to be appropriate to

``anticipated and actual'' work assignments; training appropriate to

the individual's work assignments should be sufficient. DOE agrees with

these observations.

DOE received comments indicating that the existing Sec. 835.2(a)

definition of the term ``radiological worker'' was overly restrictive

and unclear due to its inclusion of individuals who operate radiation

producing devices. Commenters indicated that this inclusion could

require extensive training and testing of individuals who operate

devices emitting nominal amounts of radiation or those who operate

devices such as televisions and computer monitors. However, consumer

devices that emit nominal amounts of radiation are clearly excluded

from the scope of 10 CFR part 835 under the provisions of 835.1(b)(6)

and the related Sec. 835.2(a) definition of ``background.'' Although

the proposed provisions of Sec. 835.901(d) (see Sec. 835.901(b) in the

final rule) would require training and testing of individuals who

operate other radiation producing devices, the provisions of

Sec. 835.901(c) (see Sec. 835.901(b) in the proposed rule) would only

require that such training be appropriate to the extent of the

individual's potential exposure to radiological hazards.

Although many commenters favored DOE's proposed relaxation of the

examination requirements, other commenters indicated that an

examination should be required for all forms of training to ensure that

the student has an understanding of the material presented. DOE agrees

that examinations are useful tools for assessing the retention of

information by the student. However, as stated in DOE's Notice of

Proposed Rulemaking, the radiological hazards present in those portions

of controlled areas which are outside of radiological areas are so

minimal that the information needed prior to entry does not warrant a

regulatory requirement for an examination. However, the absence of this

regulatory requirement does not preclude DOE's operating entities from

administering an examination.

Several commenters indicated that DOE's proposed requirements for

use of escorts in lieu of training were unclear because of the use of

the phrase ``where an escort is required.'' These commenters correctly

pointed out that the proposed Sec. 835.901(c) and (d) would permit, but

would not explicitly require, the use of escorts.

Other commenters were concerned that the retraining requirements of

proposed Sec. 835.901(g) might require individuals to complete the full

introductory radiation safety training course every 24 months. DOE

agrees that this issue requires clarification.

Final Rule

As proposed, DOE has reformatted subpart J into one section in the

final rule, codifying an approach similar to that previously published

in the Manual and eliminating redundancy. DOE has omitted proposed

Sec. 835.901(a) from the final rule because that paragraph would not

establish any substantive requirements. DOE has also eliminated the

examination requirement for individuals who are not permitted

unescorted access to radiological areas and who do not perform

unescorted assignments as a radiological worker, as proposed. Although

not a regulatory requirement, DOE contractors may still choose to

administer examinations or to undertake other means of assessing

individual understanding, such as interactive classroom discussions.

DOE has included at Sec. 835.901(c) (Sec. 835.901(b) in the

proposed amendment) a requirement for training to be provided to the

extent appropriate to the individual's work assignment. DOE has also

included at Sec. 835.901(c)(3) (proposed Sec. 835.901(b)(3)) a

requirement that the training address measures used to ``manage doses

and maintain doses ALARA,'' rather than ``minimize'' doses. This

modification makes clear the distinction between maintaining doses well

below the dose limits using the ALARA process and maintaining doses

well below the dose limits by minimizing doses regardless of other

considerations.

DOE has established requirements applicable to instances in which

escorts are used, rather than required, in lieu of training at revised

Sec. 835.901(d) (Sec. 835.901(f) in the proposed amendment).

With regard to the requirements for biennial retraining, DOE has

eliminated the use of the undefined term ``retraining.'' Section

835.901(e) of the final rule requires affected individuals to complete

the required training at least every 24 months. Like the initial

training, this follow-on training is for individuals subject to the

requirements of Sec. 835.901(a) and (b), and is subject to the

provisions of Sec. 835.901(c). Thus, the content and scheduling (prior

to the end of the two year time interval) of such training needs to

incorporate considerations of the individual's prior training, work

assignments, and degree of exposure to radiological hazards, as well as

significant changes to radiation protection policies and procedures

that affect the individual.

[[Page 59675]]

2. Radiological Control Technician Training [Sec. 835.903]

DOE also proposed changes to the 10 CFR part 835 requirements for

training of radiological control technicians. These changes are

discussed in detail in Section II.B.3. of this Notice of Final

Rulemaking.

I. Design and Control, Subpart K

Proposed Amendment

Experience in implementing programs to ensure compliance with 10

CFR part 835 revealed that the design objectives currently included at

Sec. 835.1002(b) and (c) may not be practical in developing certain

modifications to existing facilities. Therefore, DOE proposed to delete

Sec. 835.1002(b) and (c). DOE also proposed to move the remaining

requirements in paragraphs (a) and (d) of Sec. 835.1002 to

Sec. 835.1001.

The design criteria established at Sec. 835.1003(a) did not include

all of the occupational dose limits of Sec. 835.202, e.g. the lens of

the eye dose limit established at Sec. 835.202(a)(3). This omission

implied that the design of new facilities or modification of existing

facilities could include design features that would result in doses

exceeding the lens of the eye dose equivalent limit of 15 rem

established at Sec. 835.202. DOE proposed to correct this omission by

including all applicable occupational dose limits established at

Sec. 835.202 in this section.

Summary of Public Comments and Disposition

Comments indicated that the phrase ``as low as is reasonably

achievable'' at Sec. 835.1001(a) could be construed to have a meaning

that differed from ``ALARA'' as defined at Sec. 835.2(a).

Many commenters stated that DOE should retain the numerical design

objectives provided at Sec. 835.1002. Although achievement of the

numerical design objectives may not be practical in some cases

(particularly for minor modifications of existing facilities), the

design objectives are important components of the ALARA process. Public

comments suggested that elimination of the numerical design objectives

could result in confusion over when to apply quantitative design

objectives and the appropriate magnitude of those objectives. Comments

also indicated that Sec. 835.1003(b) did not establish any substantive

requirements beyond those established in subpart E of 10 CFR part 835.

DOE agrees with these observations.

Final Rule

At Sec. 835.1001(a), DOE has substituted ``ALARA'' for ``as low as

is reasonably achievable.''

Because procedural requirements are a type of administrative

control, DOE has deleted the term ``procedural requirements'' from

Sec. 835.1001 and deleted the term ``procedures'' from Sec. 835.1003 to

eliminate redundancy. For consistency, DOE has revised the heading of

Sec. 835.1003 to read ``Workplace Controls.''

Because the use of quantitative design objectives plays a

significant role in the ALARA process as it applies to facility design,

DOE has chosen to defer this critical change until more experience is

gained through implementation of these regulatory provisions. DOE has

accepted the public comments and has retained the numerical design

objectives of Sec. 835.1002; however, DOE has retained the proposed

editorial change at Sec. 835.1002 (proposed Sec. 835.1001(c))

substituting the term ``existing facilities'' for the term ``old

facilities.'' DOE will address its concerns with the application of

these requirements through enhanced guidance for achieving compliance.

DOE has included in the final rule the proposed change related to the

lens of the eye dose limit. In consideration of public comments, DOE

has also deleted Sec. 835.1003(b) from the final rule.

J. Radioactive Contamination Control, Subpart L

Proposed Amendment

Consistent with the changes to the Sec. 835.2(a) definitions of the

terms ``contamination area'' and ``high contamination area,'' DOE

proposed changes to the Sec. 835.404 requirements for areas having only

fixed contamination exceeding the appendix D total surface

radioactivity values.

DOE proposed several changes to appendix D of 10 CFR part 835,

which provides mandatory surface radioactivity values for contamination

control. DOE proposed to add the word ``alpha'' after the values for

uranium isotopes in appendix D to clarify the applicability of these

values. DOE also proposed to add to appendix D of 10 CFR part 835 a

contamination control value of 10,000 disintegrations per minute per

100 square centimeters for surfaces contaminated with tritium and

Footnote 6 to explain the use of this value. The surface contamination

value would be used to determine the applicability of the Sec. 835.603

contamination hazard posting provisions and the Secs. 835.404 and

835.1101 contamination control provisions. DOE has prepared an

Environmental Assessment, available at DOE's Freedom of Information

Reading Room at the address provided above, that addresses this change

in detail.

DOE also proposed to move the existing requirements of

Sec. 835.1101(d) to Sec. 835.703(c) to consolidate recordkeeping

requirements and to add a new requirement for removal of radioactive

material labels from released materials and equipment at

Sec. 835.1101(d).

Summary of Public Comments and Disposition

Public comments were generally supportive of DOE's proposed changes

to the requirements for control of radioactive contamination. Public

comments also indicated that the recordkeeping requirements of proposed

Sec. 835.703(c) were overly prescriptive in comparison to related

requirements of the rule. Public comments also indicated that a literal

reading of Sec. 835.404(f) would indicate that the performance of

individual contamination monitoring by someone other than the

individual exiting a contamination or high contamination area (i.e.,

individual frisking by radiological control technicians) would be

contrary to 10 CFR part 835. DOE agrees with these observations.

Comments indicated that the related requirements of Secs. 835.404

and 835.1101 were confusing and possibly contradicting. The existing

provisions of Sec. 835.404 establish requirements for control of areas

contaminated by radioactive material; the provisions of Sec. 835.1101

establish similar requirements for materials and equipment contaminated

by radioactive materials. Upon reexamination of these requirements in

light of the comments received, DOE believes that there is opportunity

for simplification and clarification of the rule.

Final Rule

DOE has combined and simplified the requirements of Secs. 835.404

and 835.1101 in the final rule as follows:

a. Although the provisions of Sec. 835.404 were specifically

related to controlling the spread of contamination, they were located

in subpart E, which was entitled ``Monitoring in the Workplace.''

Therefore, DOE has moved these requirements, with revisions discussed

below, to subpart L.

b. Although the title of subpart L indicates that the subject

matter is related to ``Releases of Materials and Equipment from

Radiological Areas,'' the requirements are more specifically related to

retention and control of

[[Page 59676]]

contaminated materials in radiological areas. Therefore, DOE has

retitled subpart L, ``Radioactive Contamination Control.''

c. DOE has clarified and simplified the structure of

Sec. 835.1101(a).

d. DOE has retained paragraphs 835.1101(b) and (c) with minor

editorial clarifications. Consistent with the discussion in Section

II.B.3 of this Notice of Final Rulemaking regarding written procedures,

DOE has omitted the requirement for written procedures (formerly

Sec. 835.1101(c)(3)).

e. Because the existing requirements of Sec. 835.404(a) established

no substantive requirements, DOE has omitted this paragraph from the

final rule.

f. DOE has redesignated paragraph 835.404(b) as Sec. 835.1102(a) in

the final rule.

g. DOE has edited paragraph 835.404(c) and redesignated it as

Sec. 835.1102(b) in the final rule. DOE has omitted the provision

related to posting of contamination hazards (formerly

Sec. 835.404(c)(1)) because this provision is redundant with

Sec. 835.603(e) and (f).

h. DOE has edited paragraph 835.404(d) and redesignated it as

Sec. 835.1102(c) in the final rule. Consistent with the discussion in

Section II.B.3 of this Notice of Final Rulemaking regarding written

procedures, DOE has omitted the requirement for written procedures

(formerly Sec. 835.404(d)(5)).

i. Because of the changes to the Sec. 835.2(a) definitions of

``contamination area'' and ``high contamination area'' discussed above,

the areas discussed at Sec. 835.404(d) (i.e., those having fixed

contamination at levels exceeding the appendix D total contamination

values, but removable contamination levels below the appendix D

removable contamination values) would no longer be considered

radiological areas. This renders the provisions of Sec. 835.404(e)

redundant; therefore, DOE has omitted these requirements from the final

rule.

j. DOE has clarified Sec. 835.404(f) and redesignated it as

Sec. 835.1102(d).

k. DOE has revised the language at Sec. 835.404(g) for clarity and

redesignated it as Sec. 835.1102(e).

DOE has reconsidered its proposal to add Sec. 835.1101(d)

establishing requirements for removal of radioactive material labels

from released materials and equipment. Although DOE considers materials

and equipment meeting the requirements of Sec. 835.1101(a) to be

appropriate for release from radiological areas, such materials and

equipment are not necessarily ``non-radioactive'' and conditions may

arise under which retention of the radioactive material labels is

appropriate. DOE has therefore omitted this provision from the final

rule.

As before, the requirements of Sec. 835.1101 address release of

materials and equipment from radiological areas to controlled areas.

DOE requirements for release of materials and equipment from its

control are addressed in DOE environmental protection standards.

K. Control of Sealed Radioactive Sources, Subpart M

Proposed Amendment

DOE proposed to add subpart M to 10 CFR part 835 to establish

requirements for control of sealed radioactive sources. These

requirements would supersede similar requirements established in DOE

Notice 5400.9, ``Sealed Radioactive Source Accountability'' (extended

through DOE Notice 5400.13 and superseded by DOE N 441.1 through DOE N

441.3). DOE proposed to add the terms ``accountable sealed radioactive

source,'' ``sealed radioactive source,'' and ``source leak test'' at

Sec. 835.2(a) and to add recordkeeping requirements at Sec. 835.704(f).

DOE also proposed to add appendix E to 10 CFR part 835 to establish

threshold values for sealed radioactive source accountability,

radioactive material labeling, and radioactive material area posting.

Summary of Public Comments and Disposition

Although many commenters supported DOE's efforts to codify

requirements for sealed radioactive source control, several commenters

indicated that the accountability threshold values proposed for

inclusion in appendix E of 10 CFR part 835 were overly restrictive.

Commenters also indicated that the definition of ``sealed radioactive

source'' was too broad to allow for exclusion of certain items, such as

reactor fuel elements, that are not commonly produced or used as sealed

radioactive sources. In addition, several commenters indicated that

DOE's proposed minimum activity requiring performance of periodic leak

tests (0.005 microcuries) was overly restrictive.

Commenters indicated that inaccessible sources should be excepted

from the requirements for leak testing and inventory. Such a measure

would obviate the need to disassemble facility components and

instruments for the purpose of performing the inventories and leak

tests. Commenters also indicated that common contamination control

measures are capable of minimizing, but perhaps not preventing, the

spread of contamination as would be required by proposed

Sec. 835.1202(e).

DOE agrees with these observations.

Final Rule

In response to public comments, DOE has revised the Sec. 835.2(a)

definition of the term ``sealed radioactive source'' to exclude reactor

fuel elements, nuclear explosive devices, and radioisotope

thermoelectric generators. DOE has included the definitions of

``accountable sealed radioactive source'' and ``source leak test'' at

Sec. 835.2(a) as proposed. DOE has revised Sec. 835.1202(d) to provide

an exception from leak testing and inventory for sealed radioactive

sources that are inaccessible. DOE has also revised Sec. 835.1202(e) to

indicate that the required contamination control measures must

``minimize'' the spread of contamination.

DOE has revised the proposed appendix E values. DOE determined the

appendix E values in the final rule as follows: For each radionuclide,

DOE considered two scenarios: (1) the activity quantity resulting in a

deep dose equivalent from external radiation of 0.1 rem (0.001 sievert)

assuming an individual was irradiated for a period of 12 hours per day

at a distance of 1 meter from the source for 365 days; and (2) the

activity quantity resulting in a committed effective dose equivalent of

0.1 rem (0.001 sievert) assuming an instantaneous intake of 0.001% of

the material by an individual. DOE compared the activity quantities for

the deep dose equivalent and the committed effective dose equivalent

and selected the more restrictive value as the basis for the

accountability threshold value. DOE selected the value of 0.1 rem as

the basis for the revised appendix E values for consistency with DOE's

mandatory threshold for monitoring of general employee dose (see

Sec. 835.402) and dose limit for members of the public in controlled

areas (see Sec. 835.208). DOE also assumed more realistic values for

the exposure time and intake factor and eliminated the arbitrary 300

microcurie activity cap. The basis for the appendix E values is

discussed in more detail in a technical basis document available in

DOE's Freedom of Information Reading Room at the address provided

above.

Because all of the revised appendix E values are greater than 0.005

microcuries, DOE has deleted this threshold from the requirements for

sealed radioactive source leak tests (proposed Sec. 835.1202(b)). DOE

has also omitted the proposed requirement for written procedures from

the final rule. For details on this omission, see Section II.B.3 of

this Notice of Final Rulemaking. Finally, because DOE's

[[Page 59677]]

reevaluation of the appendix E values resulted in significant increases

in all of the accountability threshold values, DOE has codified a

general requirement at Sec. 835.1201 for all radioactive sources (both

accountable and non-accountable) to be used, handled, and stored in a

manner commensurate with the radiological hazards created by the

operation involving the sources. DOE will provide implementing guidance

to discuss acceptable methods for achieving compliance with this

provision.

The basis for the control of sealed radioactive sources is a

hierarchy of increasing radiological controls based upon the maximum

credible dose consequence resulting from the loss of a source. The

maximum credible dose consequence should not be considered to be a

release criterion. Under the requirements of 10 CFR part 835, some

degree of radiological control is required for all sealed radioactive

sources, regardless of their activity. This hierarchy of controls

reduces the likelihood of losing a sealed radioactive source. Thus the

approach to sealed radioactive source control is analogous to that

taken in nuclear safety. As the potential consequences of a credible

incident increase, additional controls are imposed to reduce the

probability that the incident will occur and mitigate the consequences

of that incident.

For the lowest activity sealed radioactive sources, a minimal level

of radiological control is required based upon the hazards associated

with the operations involving the sources. More specific actions are

not considered necessary and are therefore not specified.

For sealed radioactive sources whose loss could result in a maximum

credible dose consequence of 0.1 rem or more in a year, additional

controls are imposed. The requirement for semi-annual inventories

reduces the possibility of losing the source and, by triggering

investigative action, mitigates the consequences of a lost source. The

requirement for semi-annual leak testing provides a means of monitoring

the integrity of the source and likewise triggers action to mitigate

the consequences of a leaking source.

L. Accident and Emergency Exposures, Subpart N

Proposed Amendment

DOE proposed to correct Sec. 835.1301(a), (b), and (d) by deleting

references to Sec. 835.205, which provides no dose limits. Consistent

with changes to Sec. 835.204, DOE proposed to revise Sec. 835.1301(a)

to indicate that doses resulting from accident and emergency exposures

may exceed the numerical values established at Sec. 835.202(a) without

violating the occupational dose limits. Both accident and emergency

doses are considered occupational doses and are included in a general

employee's occupational dose record, but emergency doses are explicitly

excluded from consideration in determining compliance with the

occupational dose limits at Sec. 835.202(a).

DOE proposed to delete Sec. 835.1302(d) because these provisions

are adequately addressed in related DOE Orders and emergency management

guides.

DOE clarified Sec. 835.1304 by substituting the defined term

``individual'' for the term ``personnel'' which eliminates any

confusion regarding the coverage of the personal nuclear accident

dosimetry provisions. DOE also proposed to remove the reference to

``all personnel'' to provide flexibility in implementing the personal

nuclear accident dosimetry provisions.

Summary of Public Comments and Disposition

Regarding accident and emergency exposures, public comments

indicated that DOE had failed to clearly define the terms ``accident''

and ``emergency,'' resulting in uncertainty about the proper

application of these provisions.

Comments regarding the proposed approach basing personal nuclear

accident dosimetry requirements on the need for nuclear criticality

alarms indicated that this approach would be impractical due to the

vagueness of the referenced requirements for these alarms.

DOE agrees with these observations.

Final Rule

DOE has included the proposed changes into the final rule.

Consistent with the clarification of the requirements for

accounting for occupational doses, including doses resulting from

authorized planned special exposures and emergency exposures, DOE has

deleted the term ``accident'' from Sec. 835.1301(a). This deletion

results from DOE's recognition that, except for doses resulting from

planned special exposures and authorized emergency exposures, all doses

in excess of the regulatory limits may be considered to be

``accidents.'' Under such circumstances, DOE believes that provisions

allowing affected individuals to return to work without further

detailed review subverts the intent of the Sec. 835.202 occupational

dose limits. DOE believes that it is most appropriate for this section

to address doses resulting from authorized emergency exposures. Despite

this change, DOE recognizes the fact that issues of individual work

rights and DOE liability may arise as a result of ``accidental''

exposures exceeding the regulatory dose limits. Mechanisms for

addressing doses resulting from accidents, and authorizations to return

affected individuals to work, exist within the exemption process

established in 10 CFR part 820.

In response to public comments, DOE revised the text in

Sec. 835.1301(c) and (d) to eliminate the terms ``emergency'' and

``accident'' and specify that the notification and resumption

provisions apply when doses were received in excess of the limits of

Sec. 835.202, except those doses received in accordance with

Sec. 835.204.

As discussed above with regard to Sec. 835.702(c)(2), DOE found

that Sec. 835.1301(e) inappropriately invoked the requirements of DOE

Orders. The applicability of these Orders is established through DOE

contractual processes. Therefore, DOE has deleted this provision.

To resolve issues related to requirements for personal nuclear

accident dosimetry, DOE has revised the requirement to simply indicate

that the nuclear accident dosimetry system must include personal

nuclear accident dosimeters. This approach will allow for flexible

implementation on a site-and facility-specific basis.

M. Use of Appendices

Proposed Amendment

DOE proposed to clarify the application of the data presented in

the appendices of 10 CFR part 835 by adding introductory text to each

appendix referencing those sections of the rule requiring use of the

appendix. DOE also proposed to delete the absorption factor (f1) values

and the related footnote (footnote 5) from appendix A of 10 CFR part

835 because absorption factors and alternative absorption factors are

neither used nor referenced in the rule. DOE determined that 10 CFR

part 835 established no substantive requirements for use of the data

presented in appendix B, and therefore proposed to delete appendix B.

DOE's review of exemption requests concerning occupational exposure

to 220Rn and 222Rn and their daughter products revealed that DAC values

for these radioisotopes are inappropriately referenced in both

appendices A and C. Exposure to these radionuclides results in a lung

dose and therefore, the air immersion DACs in appendix C are

inappropriate. Accordingly, DOE

[[Page 59678]]

proposed to delete the air immersion DAC values for 220Rn and 222Rn

from appendix C.

Experience in implementing programs that ensure compliance with 10

CFR part 835 has proven that the exposure conditions used to determine

the appendix C DAC values (immersion in a semi-infinite cloud) often

differ from those at DOE facilities (i.e., exposure in relatively small

enclosures). Use of the appendix C DAC values under these conditions

can result in the overestimation of individual doses. Therefore, DOE

proposed to revise appendix C, note b., to allow modification of the

DAC values to compensate for immersion in a cloud of finite dimensions

and to provide instructions for determining the DAC of a mixture of

radionuclides.

Summary of Public Comments and Disposition

Although several commenters suggested that the data in appendix B

were useful and should be retained, the correlation of chemical form to

lung retention class is available directly from Table 3 of Federal

Guidance Report Number 11, ``Limiting Values of Radionuclide Intake and

Air Concentration and Dose Conversion Factors for Inhalation,

Submersion, and Ingestion.''

Commenters favored DOE's proposal to allow for modification of the

appendix C values. However, contrary to the information provided in

appendix C, note b., these values were calculated based upon an

exposure of 2000 hours per year, and not based upon a continuous

exposure.

Final Rule

DOE has included the proposed changes in the final rule with minor

editorial corrections. For consistency with the existing provisions

associated with appendix C of 10 CFR part 835, DOE has included a note

with appendix A of 10 CFR part 835 that will allow use of the sum of

the fractions rule when there exists a mixture of radionuclides in the

area of interest. DOE has also revised appendix C, note b., to reflect

the 2000 hour per year exposure basis of the values.

Consistent with terminology used throughout the rule and in DOE's

guidance documents, DOE has also retitled the table in appendix D of 10

CFR part 835 ``Surface Contamination Values.''

N. Corrections and Clarifications

Proposed Amendment

DOE proposed numerous editorial corrections and technical

clarifications that do not change the requirements of the rule or the

measures necessary to ensure regulatory compliance. The proposed

changes included:

1. Correction of the definitions of ``airborne radioactive

material'', and ``year'' (Sec. 835.2(a)) and ``external dose or

exposure,'' and ``quality factor'' (Sec. 835.2(b));

2. Clarification of the application of the mean quality factors for

neutrons provided at Sec. 835.2(b);

3. Deletion of Sec. 835.2(d) because the convention stated in that

paragraph for the use of singular, plural, masculine, and feminine

terms is not used in part 835;

4. Revision of the requirements of Sec. 835.102 for clarity;

5. Change of the heading of Sec. 835.202 to ``Occupational dose

limits for general employees'' to accurately reflect the content of

that section;

6. Deletion from Sec. 835.203(a) and the Sec. 835.2(b) definition

of ``total effective dose equivalent'' the provision related to

substitution of deep dose equivalent for effective dose equivalent from

external exposure. This provision is redundant with the revised

definition of ``effective dose equivalent'' proposed at Sec. 835.2(b).

Summary of Public Comments and Disposition

DOE received no substantive comments on these changes.

Final Rule

DOE has included the proposed changes in the final rule.

III. Review Under the National Environmental Policy Act

DOE has reviewed the promulgation of this amendment to 10 CFR part

835 under the National Environmental Policy Act (NEPA) of 1969 (42

U.S.C. 4321 et seq.) and the Council on Environmental Quality

regulations for implementing NEPA (40 CFR parts 1500-1508). DOE has

completed an Environmental Assessment and on the basis of that

information has issued a Finding of No Significant Impact (FONSI) for

this amendment. The FONSI and the Environmental Assessment update the

FONSI and Environmental Assessment issued when the proposed amendment

was published for public comment and reflect changes in the final rule

made in response to public comments. The Environmental Assessment and

FONSI are available for inspection at the DOE Freedom of Information

Reading Room, 1E-190, 1000 Independence Ave. SW, Washington, DC 20585,

between the hours of 9 a.m. and 4 p.m., Monday through Friday, except

Federal holidays.

IV. Review Under Regulatory Flexibility Act

The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires that an

agency prepare an initial regulatory flexibility analysis and publish

it at the time of publication of general notice of rulemaking for the

rule. This requirement does not apply if the agency certifies that the

rule will not, if promulgated, have a significant economic impact on a

substantial number of small entities. 5 U.S.C. 605(b).

Today's action amends DOE's regulations governing programs

established at DOE facilities to protect individuals from ionizing

radiation resulting from DOE activities. The contractors who manage and

operate DOE facilities are responsible for implementing the

occupational radiation protection program. DOE has considered whether

management and operating (M&O) contractors are ``small businesses,'' as

that term is defined by the Regulatory Flexibility Act (5 U.S.C.

601(3)). The Regulatory Flexibility Act's definition incorporates the

definition of ``small business concern'' in the Small Business Act,

which the Small Business Administration (SBA) has developed through

size standards in 13 CFR part 121. Small businesses are business

concerns which, together with their affiliates, have no more than 500

to 1500 employees, varying by SIC category, and annual receipts of

between $0.5 million to $25 million, again varying by SIC category--

Title 13 CFR part 121. DOE's M&O contractors exceed the SBA's size

standards for small businesses. In addition, it is noted that M&O

contractors are reimbursed through their contracts with DOE for the

costs of complying with DOE occupational radiation protection

requirements. They will not, therefore, be adversely impacted by the

requirements in the rule. For these reasons, DOE certifies that the

final rule will not have a significant economic impact on a substantial

number of small entities.

V. Review Under Executive Order 12866

Today's regulatory action has been determined not to be a

``significant regulatory action'' under Executive Order 12866,

``Regulatory Planning and Review,'' (58 FR 51735, October 4, 1993).

Accordingly, today's action was not subject to review under the

Executive Order by the Office of Information and Regulatory Affairs

[[Page 59679]]

within the Office of Management and Budget.

VI. Review Under Executive Order 12612

Executive Order 12612, 52 FR 41685 (October 30, 1987) requires that

regulations, rules, legislation, and any other policy actions be

reviewed for any substantial direct effects on States, on the

relationship between the National Government and the States, or in the

distribution of power and responsibilities among various levels of

government. If there are sufficient substantial direct effects, then

the Executive Order requires preparation of a federalism assessment to

be used in all decisions involved in promulgating and implementing a

policy action.

This final rule would not have a substantial direct effect on the

institutional interests or traditional functions of States.

VII. Review Under Executive Order 12988

With respect to the review of existing regulations and the

promulgation of new regulations, section 3(a) of Executive Order 12988,

``Civil Justice Reform,'' 61 FR 4729 (February 7, 1996), imposes on

Executive agencies the general duty to adhere to the following

requirements:

(1) Eliminate drafting errors and ambiguity; (2) write regulations

to minimize litigation; and (3) provide a clear legal standard for

affected conduct rather than a general standard and promote

simplification and burden reduction. With regard to the review required

by section 3(a), section 3(b) of Executive Order 12988 specifically

requires that Executive agencies make every reasonable effort to ensure

that the regulation: (1) clearly specifies the preemptive effect, if

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 the amendments to 10 CFR part 835 meet the relevant

standards of Executive Order 12988.

VIII. Review Under Paperwork Reduction Act

DOE submitted the proposed collections of information in this rule

to the Office of Management and Budget for review under section 3507(d)

of the Paperwork Reduction Act of 1995 (42 U.S.C. 3507(d)), and, by

separate notice on May 26, 1998, invited public comment on DOE's

statement of need and estimates of the burden of the collection of

information in 10 CFR part 835 (63 FR 28495). The information that DOE

management and operating contractors are required to produce, maintain

and report is necessary to permit the Department and its contractors to

manage and oversee health and safety programs that control worker

exposure to radiation. DOE estimates that the total annual burden of

the collection of information requirements to be 50,000 hours for the

approximately 50 contractors subject to the rule.

The Office of Management and Budget has approved the collections of

information in 10 CFR part 835 and assigned to the part OMB Number

1910-5105. An agency may not conduct or sponsor, and a person is not

required to respond to a collection of information unless it displays a

currently valid OMB control number (5 CFR 1320.5(b)).

IX. Review Under the Unfunded Mandates Reform Act

Title II of the Unfunded Mandates Reform Act of 1995 (the Act),

Pub.L. 104-4 on March 22, 1995, codified at 2 U.S.C. 1501-1571,

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, codified at 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 proposals containing

``significant Federal intergovernmental mandates.'' Section 203(a) of

the Act, codified at 2 U.S.C. 1533(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 enables officials of affected

small governments to provide meaningful and timely input in the

development of regulatory proposals containing significant

intergovernmental Federal mandates.

The final rule published today does not contain any Federal mandate

that would result in any expenditure by State, local or tribal

government. The provisions of 10 CFR part 835 apply only to activities

conducted by or for DOE. Therefore, the requirements of Title II of the

Unfunded Mandates Reform Act of 1995 do not apply.

X. Review Under Small Business Regulatory Enforcement Fairness Act

of 1996

As required by 5 U.S.C. 801, DOE will report to Congress

promulgation of this rule prior to its effective date. The report will

state that it has been determined that the rule is not a ``major rule''

as defined by 5 U.S.C. 804(2).

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 October 29, 1998.

Peter N. Brush,

Acting Assistant Secretary, Environment, Safety and Health.

For the reasons set forth in the preamble, Title 10, Code of

Federal Regulations, part 835 is amended as set forth below:

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 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

Surety Program relating to the prevention of accidental or unauthorized

nuclear detonations;

[[Page 59680]]

(4) Radioactive material transportation as defined in this part;

(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.

(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 at Secs. 835.202 and

835.207, and with the limits for the embryo/fetus at Sec. 835.206.

Occupational doses resulting from authorized emergency exposures and

planned special exposures shall not be considered when determining

compliance with the dose limits at Secs. 835.202 and 835.207.

3. At Sec. 835.2, paragraph (a) is amended by removing definitions

of the terms ``ambient air'', ``continuous air monitor'', ``DOE

activities'', ``occupational exposure'', ``representative'', and

``survey''; 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'', ``real-time air

monitoring'', ``respiratory protective device'', ``sealed radioactive

source'', ``source leak test'', and ``week''; and revising the

definitions of the terms ``airborne radioactive material or airborne

radioactivity'', ``airborne radioactivity area'', ``contamination

area'', ``controlled area'', ``declared pregnant worker'', ``general

employee'', ``high contamination area'', ``member of the public'',

``monitoring'', ``radiological area'', and ``year'' to read as follows.

At Sec. 835.2, paragraph (b), the definition of ``collective dose'' is

removed, the definition of ``dose'' is added, 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 of 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:

(1) The concentration of airborne radioactivity, above natural

background, exceeds or is likely to exceed the derived air

concentration (DAC) values listed in appendix A or appendix C of this

part; or

(2) An individual present in the area without respiratory

protection could receive an intake exceeding 12 DAC-hours in a week.

* * * * *

Contamination area means any area, accessible to individuals, where

removable surface contamination levels exceed or are likely to exceed

the removable surface contamination values specified in appendix D of

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

at Sec. 835.206. This declaration may be revoked, in writing, at any

time by the declared pregnant worker.

* * * * *

Derived air concentration-hour (DAC-hour) means 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.

* * * * *

General employee means an individual who is either a DOE or DOE

contractor employee; an employee of a subcontractor to a DOE

contractor; or an individual who performs work for or in conjunction

with DOE or utilizes DOE facilities.

High contamination area means any area, accessible to individuals,

where removable surface contamination levels exceed or are likely to

exceed 100 times the removable surface contamination values specified

in appendix D of 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,

quantities of radioactive material, or individual doses and the use of

the results of these measurements to evaluate radiological hazards or

potential and actual doses resulting from 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 within a controlled area,

accessible to individuals, in which items or containers of radioactive

material exist and the total activity of radioactive material exceeds

the applicable values provided in appendix E of this part.

Radioactive material transportation means the movement of

radioactive material by aircraft, rail, vessel, or highway vehicle when

such movement is subject to Department of Transportation regulations or

DOE Orders that govern such movements. Radioactive material

transportation does not include preparation of material or packagings

for transportation, monitoring required by this part, storage of

material awaiting transportation, or application of markings and labels

required for transportation.

Radiological area means any area within a controlled area defined

in this section as a ``radiation area,'' ``high radiation area,''

``very high radiation

[[Page 59681]]

area,'' ``contamination area,'' ``high contamination area,'' or

``airborne radioactivity area.''

* * * * *

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, worn by an individual for the purpose of reducing the

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.

Sealed radioactive sources do not include reactor fuel elements,

nuclear explosive devices, and radioisotope thermoelectric generators.

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.

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 dose was received,

beginning January 1, 1989.

* * * * *

Dose is a general term for absorbed dose, dose equivalent,

effective dose equivalent, committed dose equivalent, committed

effective dose equivalent, or total effective dose equivalent as

defined in this part.

* * * * *

Effective dose equivalent (H) means the summation of the

products of the dose equivalent received by specified tissues of the

body (H) and the appropriate weighting factor (w)--

that is, H = wH. 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 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 as follow:

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 0.1 rem (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 effective dose equivalent contribution from 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, excluding the

skin and lens of the eye, 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.

(c) * * *

[[Page 59682]]

4. Section 835.3 is amended by adding paragraph (e) as follows:

Sec. 835.3 General Rule

* * * * *

(e) For those activities that are required by Secs. 835.102,

835.901(e), 835.1202 (a), and 835.1202(b), the time interval to conduct

these activities may be extended by a period not to exceed 30 days to

accommodate scheduling needs.

Sec. 835.4 [Amended]

5. Section 835.4 is amended by adding ``roentgen,'' after ``rad,''

in the first sentence and removing the last sentence.

Subpart B--Management and Administrative Requirements

6. The heading of subpart B is revised to read as set forth above.

6a. 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 in this part, 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 shall be achieved no later than

January 1, 2002.

* * * * *

7. 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.

8. Section 835.103 is added as follows:

Sec. 835.103 Education, training and skills.

Individuals responsible for developing and implementing measures

necessary for ensuring compliance with the requirements of this part

shall have the appropriate education, training, and skills to discharge

these responsibilities.

9. Section 835.104 is added as follows:

Sec. 835.104 Written procedures.

Written procedures shall be developed and implemented as necessary

to ensure compliance with this part, commensurate with the radiological

hazards created by the activity and consistent with the education,

training, and skills of the individuals exposed to those hazards.

10. Section 835.202 is amended by revising the section heading,

revising 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) Except for planned special exposures conducted consistent with

Sec. 835.204 and emergency exposures authorized in accordance with

Sec. 835.1302, the occupational dose received by general employees

shall be controlled such that the following limits are not exceeded in

a year:

* * * * *

(b) All occupational doses received during the current year, except

doses resulting from planned special exposures conducted in compliance

with Sec. 835.204 and emergency exposures authorized in accordance with

Sec. 835.1302, shall be included when demonstrating compliance with

Secs. 835.202(a) and 835.207.

(c) Doses 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.

11. 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) 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.

* * * * *

12. Section 835.204 is amended by revising paragraphs (a)(1),

(a)(3), (c)(1), (c)(2) and (d) to read as follows:

Sec. 835.204 Planned special exposures.

(a) * * *

(1) The planned special exposure is considered only in an

exceptional situation when alternatives that might prevent a

radiological worker from exceeding the limits in Sec. 835.202(a) are

unavailable or impractical;

* * * * *

(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 values of the dose limits established

at Sec. 835.202(a); and

(2) Over the individual's lifetime, five times the numerical values

of the dose limits established at Sec. 835.202(a).

(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.

* * * * *

13. Section 835.207 is revised to read as follows:

Sec. 835.207 Occupational dose limits for minors.

The dose equivalent limits for minors occupationally exposed to

radiation and/or radioactive materials at a DOE activity are 0.1 rem

(0.001 sievert) total effective dose equivalent in a year and 10% of

the occupational dose limits specified at Sec. 835.202(a)(3) and

(a)(4).

14. Section 835.208 is revised to read as follows:

Sec. 835.208 Limits for members of the public entering a controlled

area.

The total effective dose equivalent limit for members of the public

exposed to radiation and/or radioactive material during access to a

controlled area is 0.1 rem (0.001 sievert) in a year.

Sec. 835.209 [Amended]

15. Section 835.209 is amended by changing the first ``to'' to

``of'' in paragraph (a), removing paragraph (b), redesignating

paragraph (c) as (b), and removing the word ``representative'' from

(b)(3).

Subpart E--Monitoring of Individuals and Areas

16. The heading of Subpart E is revised to read as set forth above.

16a. Section 835.401 is amended by removing paragraph (b),

redesignating

[[Page 59683]]

paragraph (c) as (b), revising paragraphs (a), introductory text,

(a)(2), (a)(4), (a)(5), (a)(6), and revising in newly redesignated

paragraph (b), the introductory text, and (b)(1) to read as follows:

Sec. 835.401 General requirements.

(a) Monitoring of individuals and areas shall be performed to:

(1) * * *

(2) Document radiological conditions;

(3) * * *

(4) Detect the gradual buildup of radioactive material;

(5) Verify the effectiveness of engineering and process controls in

containing radioactive material and reducing radiation exposure; and

(6) Identify and control potential sources of individual exposure

to radiation and/or radioactive material.

(b) Instruments and equipment used for monitoring shall be:

(1) Periodically maintained and calibrated on an established

frequency;

* * * * *

17. Section 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) An effective dose equivalent to 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 limit at Sec. 835.206(a);

(3) Occupationally exposed minors likely to receive a dose in

excess of 50 percent of the applicable limits at 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 at Sec. 835.208 in

a year from external sources; and

(5) Individuals entering a high or very high radiation area.

(b) External dose monitoring programs implemented to demonstrate

compliance with Sec. 835.402(a) shall be adequate to demonstrate

compliance with the dose limits established in subpart C of this part

and shall be:

(1) Accredited, or excepted from accreditation, in accordance with

the DOE Laboratory Accreditation Program for Personnel Dosimetry; or

(2) Determined by the Secretarial Officer responsible for

environment, safety and health matters to have performance

substantially equivalent to that of programs accredited under 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 a committed effective dose equivalent of 0.1 rem (0.001

sievert) or more from all occupational radionuclide intakes in a year;

(2) Declared pregnant workers likely to receive an intake or

intakes resulting in a dose equivalent to the embryo/fetus in excess of

10 percent of the limit stated at Sec. 835.206(a);

(3) Occupationally exposed minors who are likely to receive a dose

in excess of 50 percent of the applicable limit stated at Sec. 835.207

from all radionuclide intakes in a year; or

(4) Members of the public entering a controlled area likely to

receive a dose in excess of 50 percent of the limit stated at

Sec. 835.208 from all radionuclide intakes in a year.

(d) Internal dose monitoring programs implemented to demonstrate

compliance with Sec. 835.402(c) shall be adequate to demonstrate

compliance with the dose limits established in subpart C of this part

and shall be:

(1) Accredited, or excepted from accreditation, in accordance with

the DOE Laboratory Accreditation Program for Radiobioassay; or,

(2) Determined by the Secretarial Officer responsible for

environment, safety and health matters to have performance

substantially equivalent to that of programs accredited under the DOE

Laboratory Accreditation Program for Radiobioassy.

18. Section 835.403 is revised to read as follows:

Sec. 835.403 Air monitoring.

(a) Monitoring of airborne radioactivity shall be performed:

(1) Where an individual is likely to receive an exposure of 40 or

more DAC-hours in a year; or

(2) As necessary to characterize the airborne radioactivity hazard

where respiratory protective devices for protection against airborne

radionuclides have been prescribed.

(b) Real-time air monitoring shall be performed as necessary to

detect and provide warning of airborne radioactivity concentrations

that warrant immediate action to terminate inhalation of airborne

radioactive material.

Sec. 835.404 [Reserved]

19. Section 835.404 is removed and reserved.

20. Section 835.405 is added to subpart E to read as follows:

Sec. 835.405 Receipt of packages containing radioactive material.

(a) If packages containing quantities of radioactive material in

excess of a Type A quantity (as defined at 10 CFR 71.4) are expected to

be received from radioactive material transportation, 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 such notification.

(b) Upon receipt from radioactive material transportation, external

surfaces of packages known to contain radioactive material shall be

monitored if the package:

(1) Is labeled with a Radioactive White I, Yellow II, or Yellow III

label (as specified at 49 CFR 172.403 and 172.436-440); or

(2) Has been transported as low specific activity material (as

defined at 10 CFR 71.4) on an exclusive use vehicle (as defined at 10

CFR 71.4); or

(3) Has evidence of degradation, such as packages that are crushed,

wet, or damaged.

(c) The monitoring required by paragraph (b) of this section shall

include:

(1) Measurements of removable contamination levels, unless the

package contains only special form (as defined at 10 CFR 71.4) or

gaseous radioactive material; and

(2) Measurements of the radiation levels, unless the package

contains less than a Type A quantity (as defined at 10 CFR 71.4) of

radioactive material.

(d) The monitoring required by paragraph (b) of this section shall

be completed as soon as practicable following receipt of the package,

but not later than 8 hours after the beginning of the working day

following receipt of the package.

Subpart F--Entry Control Program

21. Section 835.501 is amended by revising paragraph (d) as

follows:

Sec. 835.501 Radiological areas.

* * * * *

[[Page 59684]]

(d) 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.

22. At 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; a new paragraph (a) is added and

redesignated paragraphs (b)(2) and (c) are 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 monitored as necessary during access to

determine the exposure rates to which the individuals are exposed; and

(2) Each individual shall be monitored by a supplemental dosimetry

device or other means capable of providing an immediate estimate of the

individual's integrated deep dose equivalent during the entry.

(b) Physical controls. * * *

(1) * * *

(2) A device that functions automatically to prevent use or

operation of the radiation source or field while individuals are in the

area;

* * * * *

(c) Very high radiation areas. In addition to the above

requirements, additional measures shall be implemented to ensure

individuals are not able to gain unauthorized or inadvertent access to

very high radiation areas.

Subpart G--Posting and Labeling

23. Section 835.601 is revised to read as follows:

Sec. 835.601 General requirements.

(a) Except as otherwise provided in this subpart, postings and

labels required by this subpart shall include the standard radiation

warning trefoil in black or magenta imposed upon a yellow background.

(b) Signs required by this subpart shall be clearly and

conspicuously posted and may include radiological protection

instructions.

(c) 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.

24. 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 at

Sec. 835.2) shall be posted whenever radiological areas or radioactive

material areas exist in the area. Individuals who enter only controlled

areas without entering radiological areas or radioactive material areas

are not expected to receive a total effective dose equivalent of more

than 0.1 rem (0.001 sievert) in a year.

* * * * *

25. Section 835.603 is revised to read as follows:

Sec. 835.603 Radiological areas and radioactive material areas.

Each access point to radiological areas and radioactive material

areas (as defined at 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)'' shall be posted at each radioactive material area.

26. 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) Areas may be excepted from the radioactive material area

posting re

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