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DOE G 441.1-3A, Internal Dosimetry Program Guide for Use with Title 10, Code of Federal Regulations, Part 835, Occupational Radiation Protection

Functional areas: Radiation Protection, Work Processes, Worker Protection

This Guide provides an acceptable methodology for establishing and operating an internal dosimetry program that will comply with DOE requirements specified in 10 CFR 835. Cancels: DOE G 441.1-3
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Section 1

NOT MEASUREMENT SENSITIVE DOE G 441.1-3A 6-11-05 INTERNAL DOSIMETRY PROGRAM GUIDE for Use with Title 10, Code of Federal Regulations, Part 835, Occupational Radiation Protection [This Guide describes suggested nonmandatory approaches for meeting requirements. Guides are not requirements documents and are not to be construed as requirements in any audit or appraisal for compliance with the parent Policy, Order, Notice, or Manual.] U.S. Department of Energy Washington, D.C. 20585 AVAILABLE ONLINE AT: INITIATED BY: http://www.directives.doe.gov Office of Environment, Safety and Health CANCELE D (THIS PAGE INTENTIONALLY LEFT BLANK) CANCELE D DOE G 441.1-3A i (and ii) 6-11-05 CONTENTS ACRONYMS................................................................................................................................. iii 1. PURPOSE AND APPLICABILITY ...........................................................................................1 2. DEFINITIONS............................................................................................................................2 3. DISCUSSION.............................................................................................................................5 4. IMPLEMENTATION GUIDANCE............................................................................................6 4.1 PROGRAM MANAGEMENT AND ADMINISTRATION..............................................7 4.1.1 General Requirements ............................................................................................7 4.1.2 Organization, Staffing, and Facilities .....................................................................8 4.1.3 Technical Basis Document .....................................................................................9 4.1.4 Internal Dosimetry Procedures Manual .................................................................9 4.1.5 Quality Assurance...................................................................................................9 4.2 AIR MONITORING AND CONTAMINATION CONTROL PROGRAMS....................9 4.2.1 Air Monitoring When There Is No Practical Radiobioassay Method ..................10 4.2.2 Recourse for Technology Shortfall (DIL<MDA).................................................10 4.3 INDIVIDUAL MONITORING PROGRAM...................................................................11 4.3.1 Establishing the Need for Individual Monitoring.................................................12 4.3.2 Investigation Levels/Derived Investigation Levels ..............................................12 4.3.3 Minimum Detectable Amount (MDA) .................................................................12 4.3.4 Frequency of Measurement ..................................................................................13 4.3.5 Detection and Confirmation of Intakes ................................................................14 4.3.6 Internal Dose Management...................................................................................15 4.3.7 Planned Special Exposures...................................................................................15 4.3.8 Medical Response.................................................................................................15

Section 2

4.4 INTERNAL DOSE EVALUATION ................................................................................16 4.4.1 Required Dose Calculations .................................................................................16 4.4.2 Interpretation of Radiobioassay Data ...................................................................16 4.4.3 Evaluation of Internal Dose from Radiobioassay and Air Monitoring Data ...................................................................................................16 4.4.4 Periodic Reevaluation of Internal Dose................................................................17 4.5 RECORD KEEPING AND REPORTING.......................................................................17 5. REFERENCES .........................................................................................................................18 6. SUPPORTING DOCUMENTS ................................................................................................20 ATTACHMENT 1. REQUEST FOR CHANGES TO INTERNAL DOSIMETRY PROGRAM GUIDE CANCELE D DOE G 441.1-3A iii (and iv) 6-11-05 ACRONYMS AEC Atomic Energy Commission ALARA as low as is reasonably achievable ALI annual limit on intake ANSI American National Standards Institute BZ breathing zone CEDE committed effective dose equivalent CFR Code of Federal Regulations DAC derived air concentration DL decision level DIL derived investigation level DOE U.S. Department of Energy DOELAP DOE Laboratory Accreditation Program EPA Environmental Protection Agency FR Federal Register ICRP International Commission on Radiological Protection IL investigation level MDA minimum detectable amount/activity NCRP National Council on Radiation Protection and Measurements TEDE total effective dose equivalent CANCELE D DOE G 441.1-3A 1 6-11-05 INTERNAL DOSIMETRY PROGRAM 1. PURPOSE AND APPLICABILITY This Guide provides an acceptable methodology for establishing and operating an internal dosimetry program that will comply with U.S. Department of Energy (DOE) requirements specified in Title 10 of the Code of Federal Regulations (CFR), Part 835, Occupational Radiation Protection (DOE 1998a); hereinafter referred to as 10 CFR 835. In particular, this Guide provides guidance for achieving compliance with subpart E, paragraphs 402(c) and 402(d) of 10 CFR 835 for the establishment, operation, and accreditation of bioassay programs. For completeness, this Guide also identifies applicable recommendations provided in DOE-STD- 1121-98, Internal Dosimetry (DOE 1998b), and recommendations contained in secondary documents (American National Standards Institute (ANSI) Standards, etc.). This Guide amplifies the regulatory requirements of 10 CFR 835 and provides guidance for the structure, function, and operations of an internal dosimetry program. The criteria for internal dosimetry programs to serve epidemiology, risk assessment, and litigation are not within the scope of this Guide. The requirements of 10 CFR 835 are enforceable under the provisions of Sections 223(c) and 234A of the Atomic Energy Act of 1954, as amended (AEC 1954). Except for requirements established by a regulation, a contract, or by administrative means, the provisions in this Guide are DOE's views on acceptable methods of program implementation and are not mandatory. Conformance with this Guide, however, will create an inference of compliance with the related regulatory requirements. Alternate methods that are demonstrated to provide an equivalent or better level of protection are acceptable. Where alternate methods are used, DOE expects these methods to be fully documented in the supporting technical basis document. Contractors are encouraged to go beyond the minimum requirements and to pursue excellence in their programs.

Section 3

The word "shall" is used in this Guide to designate requirements from 10 CFR 835. Compliance with 10 CFR 835 is mandatory except to the extent an exemption has been granted pursuant to 10 CFR 820, Procedural Rules for DOE Nuclear Activities (DOE 1997a). The words "should" and "may" are used to represent optional program recommendations and allowable alternatives, respectively. This Guide is applicable to all DOE activities that are subject to the requirements of 10 CFR 835. CANCELE D 2 DOE G 441.1-3A 6-11-05 2. DEFINITIONS Terms defined in 10 CFR 835 are used in this Guide consistent with their regulatory definitions. Alpha (α): The probability (not to be confused with an alpha particle) of a Type I error or false positive. Also called the false positive probability. Analyte: The particular radionuclide to be determined in a sample of interest. Baseline bioassay: An appropriate bioassay measurement obtained from a radiobioassay program participant prior to beginning or resuming work with radioactive material. Beta (β): The probability (not to be confused with a beta particle) of a Type II error or false negative. Also called the non-detection probability. Confirmed intake: An intake confirmed by follow-up radiobioassay, by association with a known incident, or by investigation. Decision level (Lc): The amount of a count (Lc or L′c) as final instrument measurement of a quantity of analyte (Dc or D′c) at or above which a decision is made that the analyte is definitely present. Derived investigation level (DIL): A value of a radiobioassay or air monitoring measurement that indicates an intake resulting in a dose exceeding an Investigation Level (IL). Direct (in vivo) radiobioassay: The measurement of radioactive material in the human body utilizing instrumentation that detects radiation emitted from the radioactive material in the body. DOELAP: The Department of Energy Laboratory Accreditation Program. This program defines a set of reference performance tests and provides a description of the minimum levels of acceptable performance for personnel dosimetry systems and radiobioassay programs under DOE STD-1112-98, The Department of Energy Laboratory Accreditation Program for Radiobioassay (DOE 1998c). Elimination: The biological removal of a radionuclide from the body by excretion, perspiration, exhalation, secretion (e.g., breast milk), exfoliation (sloughing of dead tissue), or excision. Evaluation: The process of arriving at a value for intake or dose that uses, among other inputs, measurement results. Excretion: The biological removal of a radionuclide from the body via one or more excretion pathways: urine and feces. Exposure: The general condition of being subjected to ionizing radiation, such as by exposure to ionizing radiation from external sources or to ionizing radiation sources inside the body. In CANCELE D DOE G 441.1-3A 3 6-11-05 this document, exposure does not refer to the radiological physics concept of charge liberated per unit mass of air. False negative: A Type II (β) error, that is, concluding that analyte is not present when in fact it is. False positive: A Type I (α) error concluding that there is analyte present when it is not. Indirect (in vitro) radiobioassay: The measurement or analysis of radionuclides in excreta or other biological samples removed from the body.

Section 4

Intake: The amount of radionuclide taken into the body by inhalation, absorption through intact skin, injection, ingestion, or through wounds. Depending on the radionuclide involved, intakes may be reported in mass (e.g., μg, mg), activity (e.g., μCi, Bq), or potential alpha energy (e.g., MeV, J) units. Investigation level (IL): The value of the committed effective dose equivalent from an intake(s) of a radioactive material by a worker at or above which, for regulatory purposes, is regarded as sufficiently important to justify further investigation. Minimum detectable amount (MDA): The smallest amount (activity or mass) of an analyte in a sample that will be detected with a probability, β, of non-detection (Type II error) while accepting a probability, α, of erroneously deciding that a positive (non-zero) quantity of analyte is present in an appropriate blank sample (Type I error). The MDA is computed using the same value of α as used for the Lc. The MDA depends on both α and β. Measurement results are compared to the Lc, not the MDA; the MDA is used to determine whether a program has adequate detection capability. The MDA will be greater than or equal to the Lc. Radon: Unless otherwise specified, the isotope 222Rn. Retention: The amount of material which, after being taken into the body by inhalation, ingestion, entry through an open wound, or absorption through the skin, exists in the whole body, a compartment, an organ, or a tissue at a specified time. Routine radiobioassay monitoring: Any radiobioassay measurement made on a predetermined, periodic schedule, to establish whether a worker has had any intake of radioactive material since previous radiobioassay measurements. Special radiobioassay monitoring: Any radiobioassay measurement that is required for confirmation of a suspected intake of radionuclides, or is required for follow-up evaluation of confirmed intakes. State-of-the-art: The most advanced technology that is commercially available and successfully field tested. CANCELE D 4 DOE G 441.1-3A 6-11-05 Technology shortfall: A technology shortfall for routine radiobioassay exists when the derived investigation level (DIL) for a well-designed and appropriate routine radiobioassay program, using current or state-of-the-art methods and equipment, is less than the minimum detectable amount/activity of the routine monitoring method (e.g., the DIL is less than the MDA). Termination radiobioassay: A radiobioassay measurement performed for the purpose of documenting the retention of radioactive materials in the body due to occupational exposure either upon termination of employment or upon the cessation of potential exposure to a specific nuclide. Thoron: Unless otherwise specified, the isotope 220Rn. Type I error: Incorrectly concluding from a result that there is analyte present; the probability (α) of a Type I error is usually taken as 0.05. The decision level is determined on the basis of an acceptable level of Type I errors. Type II error: Incorrectly concluding from a result that there is no analyte present; its probability (β) is usually taken as 0.05. CANCELE D DOE G 441.1-3A 5 6-11-05 3. DISCUSSION

Section 5

Radiation protection programs for limiting intakes of radioactive material are based on the DOE policy of controlling radioactive material at the source. It is nonetheless recognized that low- level, chronic, or intermittent occupational exposures to some materials may be difficult to avoid due to the types of material handled or processed, their chemical or physical forms, and the nature of operations, and that incidents may cause unplanned releases of radioactive material. 10 CFR 835.402(c) requires internal dosimetry programs (including routine radiobioassay programs) be conducted for radiological workers, declared pregnant workers, occupationally exposed minors, and members of the public entering controlled areas who are likely to receive intakes that exceed specified levels for committed effective dose equivalent in a year. An internal dosimetry program generally consists of three elements: · an air monitoring program, using a combination of real-time, fixed, and portable devices, as appropriate; · an individual monitoring program, using direct and/or indirect radiobioassay, and personal breathing zone (BZ) air monitoring, as appropriate; and · a dose evaluation program that evaluates the data collected by the air and individual monitoring programs to determine the magnitude of individual doses. CANCELE D 6 DOE G 441.1-3A 6-11-05 4. IMPLEMENTATION GUIDANCE This section provides guidance for establishing and conducting internal dosimetry programs for individuals who have the potential for intakes of radioactive materials. It includes guidance for design and implementation of the radiobioassay program, and guidance for evaluating, recording, reporting, and managing internal doses. Additional technical guidance is provided in DOE-STD-1121-98 and the National Council on Radiation Protection and Measurements (NCRP) Report No. 87, Use of Radiobioassay Procedures for Assessment of Internal Radionuclide Deposition (NCRP 1987). An acceptable internal dosimetry program includes the following features: · adequate staff with appropriate technical training; · internal dosimetry technical basis documentation providing scientific information and other rationale explaining essential elements of the internal dosimetry program to support dose evaluation methods; · written policies and procedures covering essential steps in the activities used to determine worker internal dose; · criteria and methods for implementing an appropriate air monitoring program; · defined criteria for identifying workers who need to participate in the individual monitoring program; · appropriate radiobioassay measurement methods and frequencies; · methods for control, accountability, and safe handling of samples; · appropriate dosimetric models and default parameters for evaluating internal dose; · timely analysis of radiobioassay samples and measurements, transmission of results, dose evaluation, and recommendations to operations management; · adequate detection capability and quality of radiobioassay measurements; · defined criteria and actions for identifying individuals with suspected intakes, based on workplace measurements and radiobioassay measurements; · appropriate action level guidelines; · defined program to report internal doses to workers, management, and DOE; · historical records of radiobioassay measurement results and dose evaluations; · historical records of the program, and changes in the program over time; and CANCELE D

Section 6

DOE G 441.1-3A 7 6-11-05 · a quality assurance program covering essential steps in the activities that determine worker internal dose. 4.1 PROGRAM MANAGEMENT AND ADMINISTRATION 4.1.1 General Requirements The internal dosimetry program shall be adequate to demonstrate compliance with the dose limits established in Subpart C of 10 CFR 835 [10 CFR 835.402(d)]. In addition, radiobioassay programs implemented to demonstrate compliance with the requirements in 10 CFR 835.402(c) (individual monitoring thresholds) shall be: · accredited or excepted from accreditation in accordance with the DOELAP for Radiobioassay [10 CFR 835.402(d)(1]; or · determined by the Secretarial Officer responsible for environment, safety and health matters, currently the Assistant Secretary for Environment, Safety, and Health, to have performance substantially equivalent to that of programs accredited under DOELAP for radiobioassay [10 CFR 835.402(d)(2]. Guidance for achieving accreditation or exception from accreditation under DOELAP is provided in DOE-STD-1111-98, Department of Energy Laboratory Accreditation Program Administration (DOE 1998d). Requests for other program determinations will be considered by DOE on a case-by-case basis. The provision requiring accreditation for radiobioassay programs implemented to demonstrate compliance with 10 CFR 835.402(c) does not reflect an intent to provide a lesser degree of protection to individuals unlikely to receive doses exceeding the regulatory monitoring thresholds, nor does it express a desire to establish two separate radiobioassay programs (i.e., an accredited program for individuals likely to exceed the regulatory monitoring thresholds and a nonaccredited program for individuals who are unlikely to exceed these thresholds). Rather, those individuals who are unlikely to exceed the regulatory monitoring thresholds are provided an adequate degree of protection by the various engineering and administrative controls that limit their internal doses. Implementation of a comprehensive air monitoring program in accordance with 10 CFR 835.401 and 403 verifies the effectiveness of these controls. When an accredited radiobioassay program already exists and management of any given facility chooses to provide monitoring for those individuals who are unlikely to exceed the regulatory monitoring threshold, consideration should be given to using the accredited program. This will obviate the need to implement two radiobioassay programs, one accredited and the other not. In addition, it will avoid giving workers who are not required to be monitored the impression that they are being provided a lesser degree of protection. However, this does not imply that the monitoring program for those unlikely to exceed the monitoring threshold must be accredited. Sections 401 through 403 of 10 CFR 835 establish specific monitoring requirements for areas and individuals. 10 CFR 835 also establishes requirements for maintaining individual CANCELE D 8 DOE G 441.1-3A 6-11-05 monitoring records (10 CFR 835.702) and reporting radiation doses to individuals (10 CFR 835.801). 4.1.2 Organization, Staffing, and Facilities 4.1.2.1 Organization The internal dosimetry program should be administered by the radiological control organization under the leadership of the radiological control manager. The internal dosimetry program should have a designated leader with demonstrated expertise in internal dose evaluation.

Section 7

When elements of the internal dosimetry program are performed by one or more subcontractors, the radiological control organization should establish an arrangement of contractual standards and assessments that ensure that subcontractors meet all applicable requirements in 10 CFR 835, the documented Radiation Protection Program (RPP), DOELAP standards, and the internal dosimetry technical basis document. 4.1.2.2 Staffing The radiological control organization management should ensure that the internal dosimetry program is adequately staffed to carry out its functions. The analysis of workplace and radiobioassay measurement data and the evaluation of internal dose involve complex evaluation and professional judgment. Personnel with responsibility for internal dose evaluation should have the necessary expertise and skill, based on appropriate education and training in conjunction with practical experience, to perform their assigned duties. Additional guidance on education, skills, and training is provided in DOE G 441.1-1A, Management and Administration of Radiation Protection Programs Guide (DOE 1999a). It is important that internal dosimetry specialists be capable of recognizing conditions warranting follow-up radiobioassay and dose evaluation. Personnel should be familiar with the relevant internal dosimetry literature and the recommendations of national and international scientific organizations with regard to internal dose evaluation. Management of the radiological control organization should establish minimum requirements for those staff who evaluate internal doses. These requirements should include both experience and education requirements. Suggested educational background and formal training needed for internal dosimetry program key positions are listed in DOE-STD-1107-97, Knowledge, Skills, and Abilities for Key Radiation Protection Positions at DOE Facilities (DOE 1997b). Members of the internal dosimetry staff should meet these requirements, or the staff should have access to individuals with the required background (perhaps through interdepartmental agreements or contracted services). It is not necessary for all personnel on the staff to have expertise in all of the listed subject areas. 4.1.2.3 Facilities and Resources Computational facilities and software tools used by internal dosimetry personnel should be adequate for performing calculations required for the evaluation of dose from radionuclides in the body. A library of handbooks, reference materials, scientific publications, and other resources pertaining to internal dosimetry should be readily available. Suggested reference CANCELE D DOE G 441.1-3A 9 6-11-05 materials include the documents listed as references and other supporting documents provided in Sections 5 and 6 of this Guide. 4.1.3 Technical Basis Document Internal dosimetry technical basis documentation should be developed and should include technical methods, supporting evidence, and reference information used to provide the technical foundation for the internal dosimetry program. The internal dosimetry technical basis documentation should provide the approach to evaluating internal doses from radiobioassay data, and for situations in which there is no practical radiobioassay, from representative air monitoring or other appropriate data. The technical basis documentation should address all of the topics listed under section 3.1, Internal Dosimetry Technical Basis Documentation, of DOE-STD-1121- 98. The technical basis documentation should be reviewed periodically and updated as necessary to ensure that the scientific bases are appropriate for current conditions. The technical basis documentation should be controlled and retained as a radiation protection program record.

Section 8

4.1.4 Internal Dosimetry Procedures Manual 10 CFR 835 requires that written procedures be developed and implemented as necessary to ensure compliance, 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 CFR 835.104). Essential elements of the internal dosimetry program should be addressed in written procedures. These procedures should be consistent with 10 CFR 835, the DOELAP standard and technical basis documentation. Detailed guidance on topics that should be addressed in the internal dosimetry procedures manual are discussed in Section 3.2, Internal Dosimetry Procedures Manual, of DOE-STD- 1121-98. Additional guidance on written procedures is provided in DOE G 441.1-1A. 4.1.5 Quality Assurance Quality Assurance for internal dosimetry programs is addressed in DOE-STD-1121-98, Section 11, Quality Assurance. Quality assurance in support of internal dosimetry programs should be conducted in accordance with this DOE standard. The internal dosimetry program should be included as a functional element subject to the internal audit requirements of 10 CFR 835.102. DOE G 441.1-1A provides guidance on internal audit programs. External peer-review by qualified individuals, on a periodic basis, is also recommended. 4.2 AIR MONITORING AND CONTAMINATION CONTROL PROGRAMS The objectives of an air monitoring program are to verify the integrity of radioactive material containment, detect the release of radioactive materials from some routine operations, detect inadvertent releases of those materials in the workplace, evaluate and provide the basis for modification to containment systems, provide a basis for the design of radiobioassay programs, and verify that selected groups do not need to participate in a radiobioassay program. Air monitoring programs and internal dosimetry programs are complimentary. The air monitoring CANCELE D 10 DOE G 441.1-3A 6-11-05 program provides an indication of the effectiveness of engineering and administrative controls in preventing or minimizing worker intakes and the internal dosimetry program provides verification of the adequacy of these controls in preventing or minimizing worker intakes. The air monitoring and contamination control programs supplement the individual monitoring program by providing a prospective assessment of radiological conditions, facilitating decisions regarding postings, access controls, work authorizations, and individual monitoring, and providing back-up data for use in individual dose evaluations. Because of the need to evaluate individual internal doses from intakes of radioactive material from uncontained sources, airborne radioactive material, and surface contamination, the air monitoring and contamination control programs should include methods for assessing the degree of hazard arising from each of these hazards to which individuals may be exposed. Guidance for implementing contamination control and air monitoring programs is provided in DOE G 441.1-9, Radioactive Contamination Control Guide (DOE 1999b), and DOE G 441.1-8, Air Monitoring Guide (DOE 1999c) respectively. In most cases, the air monitoring program is used to supplement and validate the individual monitoring program. However, in the case when there is no practical radiobioassay method or when there is a technology shortfall (e.g., the DIL is less than the MDA) the air monitoring program may be the basis for the determination of internal doses. These two cases are discussed below.

Section 9

4.2.1 Air Monitoring When There Is No Practical Radiobioassay Method In situations where no radiobioassay method is available for the radionuclides in question, and no radiobioassay program, either routine or special, can show compliance with 10 CFR 835, personal (BZ) air monitoring may be used for demonstrating compliance with 10 CFR 835. BZ air monitoring is part of the Individual Monitoring Program, which is detailed below. However, other fixed or portable monitoring instruments that provide either real-time (such as continuous air monitors) or retrospective (such as grab sampling which is analyzed at some time after the sample is collected) may be required when BZ monitoring data is not available or to supplement or validate the BZ data if it is available. Radionuclides with short half-lives, including the short- lived decay products of 222Rn (“radon” decay products 218Po, 214Pb, 214Bi, and 214Po) and 220Rn (“thoron” primary decay products 212Pb and 212Bi) are examples of radionuclides where intakes cannot be determined through radiobioassay and must be determined from personal air monitoring. For detailed information on non-background exposures to radon and thoron, see DOE-STD-1121-98, Section 4.5, Measurements of Workplace Radon and Thoron Concentrations, Potential Alpha Energy Concentrations, and Measurements of (or Assumptions About) Equilibrium Factors. Monitoring programs for Radon and Thoron should be in accordance with the DOE standard. 4.2.2 Recourse for Technology Shortfall (DIL<MDA) DILs for reasonable and practical routine radiobioassay programs may be significantly less than the achievable MDA for certain radionuclides, such as plutonium. Since a technology shortfall for routine radiobioassay exists, the facility should consider the following actions (note that CANCELE D DOE G 441.1-3A 11 6-11-05 some of these suggested actions fall under the category of individual as opposed to area monitoring, but for completeness, they are all listed below): · enhance contamination and air monitoring and the use of indicators (e.g., unexpected glove or surface contamination, increase in airborne radioactive material contamination) to trigger early special radiobioassay monitoring; · enhance personal contamination monitoring (e.g., clothing, skin, nasal smears) to trigger special radiobioassay monitoring; · use the best practicable radiobioassay monitoring methods; · implement enhanced design, operation, controls, and personnel protection equipment and procedures to minimize intakes; · implement supplementary air monitoring; and · document and justify the planned supplementary approach in the facility's internal dosimetry technical basis documentation. When air monitoring data are used, each worker's stay times (in hours) and the average concentration (in DACs) to which the worker is exposed should be multiplied to yield exposures to airborne radioactive materials in units of DAC-hours. Forty (40) DAC-hours corresponds to 0.1 rem (0.001 Sv) committed effective dose equivalent for radionuclides with stochastic Annual Limits on Intake. A technology shortfall for routine radiobioassay should not be sufficient cause for failing to place individuals on a minimum or best-available radiobioassay program. Refer to DOE-STD- 1121-98, Section 4.4.4, Supplementing Routine Radiobioassay Programs when DIL<MDA, for a discussion and examples of technology shortfalls and suggested methods to handle such situations.

Section 10

4.3 INDIVIDUAL MONITORING PROGRAM Individual monitoring programs should be designed in accordance with Section 4 of DOE-STD- 1121-98 and should: · provide for investigation of suspected intakes; · provide data for evaluating internal dose; and · provide results that are adequate to demonstrate compliance with the radiation dose limits given in 10 CFR 835. The primary methods of routine and special worker radiobioassay are direct (in vivo) radiobioassay and indirect (in vitro) radiobioassay. International Commission on Radiological Protection (ICRP) Publication 54, Individual Monitoring for Intakes of Radionuclides by Workers: Design and Interpretation (ICRP 1989) as well as the previously referenced NCRP Report No. 87 are suggested supplementary references CANCELE D 12 DOE G 441.1-3A 6-11-05 for individual monitoring program design. In situations where there is no practical radiobioassay, representative air monitoring (e.g. breathing zone (BZ) air monitoring) is the preferred measurement method on which to base dose evaluations. Additional guidance on air monitoring programs may be found in DOE G 441.1-8. 4.3.1 Establishing the Need for Individual Monitoring Radiological workers who could likely receive intakes resulting in 0.1 rem or more committed effective dose equivalent in a year shall participate in an internal dose evaluation program [10CFR 835.402(c)(1)]. Declared pregnant workers, occupationally exposed minors, and members of the public are also required, under specific conditions [see 10 CFR 835.402(c)] to participate in internal dosimetry programs. Criteria for participation in individual monitoring programs which include baseline radiobioassay, routine radiobioassay and/or air sampling, radon and thoron monitoring, special radiobioassay, and termination or task-ending radiobioassay, radiobioassay for declared pregnant women, and confirmatory radiobioassay are covered in DOE-STD-1121-98, Section 5, Individual Monitoring for Internal Dosimetry. This section of the technical standard also discusses timely receipt of radiobioassay results. Participation in individual monitoring programs for internal dosimetry should be in accordance with the DOE technical standard. ICRP Publication 54 is also a recommended reference. Situations may arise where a decision is made to monitor radiological workers who are not likely to receive intakes that exceed 0.1 rem committed effective dose equivalent in a year. Such monitoring may be useful for demonstrating compliance with 10 CFR 835.401(a) or established for other purposes. The internal dosimetry program documentation should clearly identify those individuals or groups of individuals being monitored for such purposes. 4.3.2 Investigation Levels/Derived Investigation Levels Refer to DOE-STD-1121-98, Sections 4.3 and 4.4 for a discussion of and reference levels for Investigation Levels (ILs) and Derived Investigation Levels (DILs). Programs should be designed in accordance with this technical standard. Refer to DOE-STD-1121-98, Section 4.4.1 for a discussion of factors affecting the DIL. Additionally, section 4.4.2 provides guidance for calculating the DIL for a given sample frequency, Section 4.4.3 discusses factors affecting the DIL for air sampling, and Section 4.4.4 deals with supplementing routine radiobioassay programs when DIL< MDA (technology shortfall). Programs should be designed in accordance with this technical standard. 4.3.3 Minimum Detectable Amount (MDA)

Section 11

The internal dosimetry program staff should determine the minimum detectable amount (MDA) for each radiobioassay and BZ air monitoring method for each radionuclide present. The MDAs should be documented in procedures and their statistical bases given in the internal dosimetry CANCELE D DOE G 441.1-3A 13 6-11-05 technical basis documentation. ANSI Standard N13.30-1996, Performance Criteria for Radiobioassay, (ANSI 1996) provides extensive guidance on the calculation of MDAs. As MDAs are affected by various aspects involved with individual monitoring methods, procedures should contain descriptions of the method(s) of individual monitoring measurements (e.g., urinalysis, fecal analysis, in vivo counting, BZ air monitoring), analytical methodology (e.g., chemical separation followed by alpha counting), and measurement parameters (e.g., counting time or instrument efficiency) to be used in each component of the individual monitoring program. Several other factors affect the method of radiobioassay used and associated MDA. They include: · the possible need for improved detection capability to assess individual dose during the special radiobioassay following an intake requiring internal dose evaluation, due to diminishing amounts of material in compartments as time goes on; · the need for improved precision and accuracy if residual retention and excretion from prior intakes interferes with the detection of additional intakes in subsequent years; · timeliness of results needed to manage individuals and keep subsequent intakes low enough to avoid exceeding dose limits; · convenience to the affected individuals; · costs, including lost production time while individuals are participating in the radiobioassay program; and · the impact of the method of radiobioassay on the frequency of radiobioassay measurements. Where practicable, the method of individual monitoring, analytical methodology, and measurement parameters should result in an MDA less than the corresponding DIL for all radionuclides to which an individual might be exposed. The methods of radiobioassay and air monitoring measurements, their MDAs, and their accuracies should be specified in the internal dosimetry technical basis documentation, along with a rationale or justification for the methods chosen. 4.3.4 Frequency of Measurement The routine radiobioassay measurement frequency depends on the radiobioassay measurement method and associated MDA. The frequency should be chosen so that it is unlikely that intakes by an individual in a year will result in doses exceeding one IL without detection. CANCELE D 14 DOE G 441.1-3A 6-11-05 4.3.5 Detection and Confirmation of Intakes Section 6 of DOE-STD-1121-98 provides acceptable methods for detecting and confirming intakes through workplace monitoring and radiobioassay. Statistical methods for confirming that an intake has occurred are also discussed. Decisions regarding the detection and confirmation of suspected occupational intakes of radioactive material should be based on answers to the following questions: · Can it be concluded reliably that the analyte is present in the measured sample (>Lc)? · Is the measurement result unexpected? In other words, is the result beyond the range of values that would be expected due to environmental “background” sources or due to previously recognized intakes? · Is the intake (and resulting dose) implied by the measurement significant enough (e.g., greater than the IL) to warrant follow-up measurements or investigation?

Section 12

If the answer to all these questions is “yes,” then follow-up measurements or investigation is warranted. Internal dosimetry programs should establish appropriate and technically-based decision criteria to assist in answering these questions. Such decision criteria should be included in the technical basis document for the site or facility. The proper decision criteria for the first question is the Lc which is a purely statistical concept based on an acceptable probability of “false positive” conclusions. The Lc for radiobioassay and air sample measurements should be set by considering the acceptable rate of false positives, the cost and consequences of false positives, and the dosimetric consequences of false negatives. The analytical laboratory Lc should be based on a reagent blank. Radiobioassay results above the Lc may be expected in the absence of a new intake due to normal statistical fluctuations, non-occupational or environmental sources, or prior confirmed intakes. In the case of environmental sources of interference (e.g., uranium in urine) an “occupational decision level” should be established, above which the measurement result is concluded to be statistically significant and above the range of values that would normally be expected from environmental sources of the radionuclide. In the case of prior confirmed intakes, an individual-specific “occupational decision level” should be established, which takes into account the expected contribution from the prior intakes. Finally, for each route of intake, measurement type, and radioactive material of interest (taking into account particle size, inhalation class, etc.), time-dependent DILs should be established. Such DILs are based solely on dosimetric considerations, and typically correspond to an implied intake (and corresponding dose) of 1 investigation level, i.e., 0.1 rem. This Guide has adopted the value of 0.1 rem CEDE as the value which, for regulatory purposes, is regarded as sufficiently important to justify further investigation. However, a site or facility may wish to establish lower follow-up levels for ALARA purposes. CANCELE D DOE G 441.1-3A 15 6-11-05 If the measurement result is statistically significant, unexpected, and dosimetrically significant, then follow-up measurements and/or an investigation should be done to attempt to confirm or rule out the intake. An intake should be considered confirmed if the three criteria above are satisfied and the measurement result is associated with a known incident, or appropriate follow- up measurements meet the three criteria above, or follow-up investigation indicates that an intake has occurred. Refer to DOE-STD-1121-98, Section 6, for additional information on the detection and confirmation of intakes. Table 3 addresses reference levels for interpreting or responding to intake monitoring results. Program elements, which address detection and confirmation radionuclide intakes, should be in accordance with the DOE technical standard. ANSI N13.30- 1996 and ICRP Publication 54 are suggested references. Additionally, NCRP Report No. 84, General Concepts for the Dosimetry of Internally Deposited Radionuclides (NCRP 1985) and ICRP Publication 30, Limits for Intakes of Radionuclides by Workers (ICRP 1979), may be useful references. 4.3.6 Internal Dose Management

Section 13

Internal dose management, which includes routine radiological worker dose management, management of dose from previous intakes (work restrictions), control of dose to the embryo/fetus, control of dose to minors and students, dose limitation, interface with the external dosimetry program, lifetime dose control, accidental dose control, and internal dose control after an incident, is covered in DOE-STD-1121-98, Section 8, Internal Dose Management. Individual programs should be in accordance with the DOE technical standard. 4.3.7 Planned Special Exposures Planned special exposures are included in an individual’s occupational dose record, but shall not be considered when determining compliance with the occupational dose limits of 10 CFR 835 [10 CFR 835.204(a), (e)]. In order to maintain separate records of doses resulting from planned special exposures and routine occupational exposures, dosimetry adequate to measure the potential doses and appropriate for the work to be performed and specific radiological circumstances should be provided for the planned special exposure. 4.3.8 Medical Response Medical response is addressed in DOE-STD-1121-98, Section 10, Medical Response. The standard addresses situations where internal dosimetry actions and medical treatment occur simultaneously, the role of the health physicist in medical treatment, when to treat, how to treat, the impact of therapy on dosimetry, and the counseling of workers. Medical response should be handled in accordance with the DOE technical standard. CANCELE D 16 DOE G 441.1-3A 6-11-05 4.4 INTERNAL DOSE EVALUATION 10 CFR 835 requires internal dose evaluation programs for assessing intakes of radionuclides and for maintaining adequate worker exposure records. Technical details and extensive references for internal dose evaluation are given in DOE-STD-1121-98. ICRP Publications 30 and 54, NCRP Report No. 84, and ANSI N13.30 are additional suggested references. 4.4.1 Required Dose Calculations Internal doses should be evaluated for all confirmed intakes, as defined in Section 4.3.5 of this guide. For intakes confirmed with radiobioassay results below the DIL, no further investigation or follow-up radiobioassay are indicated. For intakes confirmed with radiobioassay results above the DIL or exposures greater than 40 DAC-hours, follow-up radiobioassay (if practical) and investigation should be performed. The extent of the investigation and the number and frequency of special radiobioassay measurements following a suspected or confirmed intake should be determined and documented on an individual, case-specific basis, taking into account the potential magnitude of the intake, the effective clearance half-time, the health of the worker, and the number of measurements needed to evaluate the internal dose. The schedule and frequency of long-term special radiobioassay measurements to evaluate the CEDE to an individual who has had an intake resulting in a dose in excess of one IL should depend on the expected magnitude of the CEDE and the likelihood of the individual receiving additional intakes. While the investigation should be tailored to the specific individual and exposure circumstances, the trigger levels and preliminary actions to be taken for exposures to the different radionuclides encountered at the facility should be documented in the internal dosimetry technical basis documentation and procedures. 4.4.2 Interpretation of Radiobioassay Data

Section 14

Technical details on the interpretation of radiobioassay data including the use of biokinetic models are given in DOE-STD-1121-98, Section 7, Internal Dose Evaluation. Radiobioassay data should be interpreted in accordance with the applicable portions of this DOE technical standard. Evaluations of CEDE from a specific intake should account for expected values of radiobioassay measurements from prior confirmed intakes. 4.4.3 Evaluation of Internal Dose from Radiobioassay and Air Monitoring Data Methods for evaluating the various doses from intakes should be specified in the internal dosimetry technical basis documentation. The methods should be based on recommendations given in ICRP Publications, NCRP Reports, and ANSI standards, which embody improvements and updates of the science of internal dosimetry. Other methods may be used provided they are CANCELE D DOE G 441.1-3A 17 6-11-05 documented and justified in the procedures and/or internal dosimetry technical basis documentation. In the calculation of internal doses less than one IL, default parameters may be used. These parameters (e.g., intake date, deposition fractions, retention functions, organ masses, absorption fractions) should be based on the recommendations of the ICRP, NCRP, other relevant technical references, or facility-specific factors as documented in the internal dosimetry technical basis documentation. If the initial evaluation of an intake indicates a dose in excess of 10 times an IL, individual- specific and facility-specific factors should be used when appropriate parameters are expected to change the dose calculations by a factor of 1.5 or more (ICRP Publication 54, paragraph 74). Between 1 and 10 times the IL, either default parameters or individual- and facility-specific parameters may be used, as deemed appropriate and documented by the internal dosimetry staff. The basis for determining which individual-specific and facility-specific factors are expected to change the dose calculations by a factor of 1.5 or more should be documented in the internal dosimetry technical basis documentation. Determination of individual retention patterns for a worker requires participation in the special radiobioassay program and may require temporary work restriction or reassignment to prevent subsequent intakes from confounding the dose evaluation. 4.4.4 Periodic Reevaluation of Internal Dose In the case of certain well-retained radionuclides (e.g., plutonium), long-term follow-up and reevaluation of doses may be required. The internal contribution to lifetime occupational dose should continue to be reevaluated as further radiobioassay results and improved methods for evaluating internal dose become available. Evaluations for general employees with prior confirmed intakes should be revised when information demonstrates a change in the currently evaluated CEDE of 0.5 rem (0.005 Sv) or a factor of 1.5 of the previously assigned dose for that intake, whichever is higher. In cases where intakes are detected or confirmed in a year subsequent to the year of the intake, the CEDE should be attributed to the known or assumed year of the intake, and all records and reports for that year should be amended as appropriate. 4.5 RECORD KEEPING AND REPORTING Requirements and guidance for recording and reporting internal doses and related information are provided in 10 CFR 835 DOE G 441.1-11, Occupational Radiation Protection Record- Keeping and Reporting Guide (DOE 1999d) and DOE-STD-1121-98, Section 9, Records and Reports. Record keeping and reporting of internal doses and related information should be in accordance with these DOE documents.

Section 15

CANCELE D 18 DOE G 441.1-3A 6-11-05 5. REFERENCES AEC (Atomic Energy Commission) 1954. U.S. Atomic Energy Act of 1954, as amended. Public Law 83-703 (68 Stat. 919), Title 42 U.S.C. sec. 2011. ANSI (American National Standards Institute) 1996. ANSI/HPS N13.30-1996, Performance Criteria for Radiobioassay. McLean, VA 22101. DOE (U.S. Department of Energy) 1997a. 10 CFR 820, U.S. Department of Energy, Procedural Rules for DOE Nuclear Activities. 58 FR 43680, Federal Register Vol. 58, No. 157, dated 10-8-97. Washington, D.C. DOE 1997b. DOE-STD-1107-97. Knowledge, Skills, and Abilities for Key Radiation Protection Positions at DOE Facilities, dated 1-97. Washington, D.C. DOE 1998a. 10 CFR 835, U.S. Department of Energy, Occupational Radiation Protection. 63 FR 59662, Federal Register, Vol. 63, No. 213, dated 11-4-98. Washington, D.C. DOE 1998b. DOE-STD-1121-98. Internal Dosimetry, reaffirmed May 2004. Washington, D.C. DOE 1998c. DOE-STD-1112-98. Department of Energy Laboratory Accreditation Program for Radiobioassay, dated May 1998. Washington, D.C. DOE 1998d. DOE-STD-1111-98. Department of Energy Laboratory Accreditation Program Administration, dated December 1998. Washington, D.C. DOE 1999a. DOE G 441.1-1A. Management and Administration of Radiation Protection Programs Guide, revision dated 10-20-2003. Washington, D.C. DOE 1999b. DOE G 441.1-9. Radioactive Contamination Control Guide, dated 06-17-99. Washington, D.C. DOE 1999c. DOE G 441.1-8. Air Monitoring Guide, dated 3-17-99. Washington, D.C. DOE 1999d. DOE G 441.1-11 Occupational Radiation Protection Record-Keeping and Reporting Guide, dated 05-20-99. Washington, D.C. ICRP (International Commission on Radiological Protection) 1979. ICRP Publication 30. Limits for Intakes of Radionuclides by Workers: Design and Interpretation, dated 1979. Pergamon Press. New York, New York. CANCELE D DOE G 441.1-3A 19 6-11-05 ICRP 1989. ICRP Publication 54, Individual Monitoring for Intakes of Radionuclides by Workers: Design and Interpretation, dated 1989. Pergamon Press. New York, New York. NCRP (National Council on Radiation Protection and Measurements) 1985. NCRP Report No. 84, General Concepts for the Dosimetry of Internally Deposited Radionuclides, dated 1985. Bethesda, Maryland. NCRP 1987. NCRP Report No. 87, Use of Radiobioassay Procedures for Assessment of Internal Radionuclide Deposition, dated 1987. Bethesda, Maryland. CANCELE D 20 DOE G 441.1-3A 6-11-05 6. SUPPORTING DOCUMENTS American National Standards Institute. Internal Dosimetry Programs for Tritium Exposure— Minimum Requirements. ANSI N13.14-1983. New York, New York. Faust, L. G., et al. Health Physics Manual of Good Practices for Plutonium Facilities. PNL-6534. Pacific Northwest Laboratory. Richland, Washington. 1988. International Commission on Radiological Protection. Report of the Task Group on Reference Man. ICRP Publication 23. Pergamon Press. New York, New York. 1975. International Commission on Radiological Protection. The Metabolism of Plutonium and Related Elements. ICRP Publication 48. Pergamon Press. New York, New York. 1986. Johnson, J. R. and M. B. Carver. A General Model for Use in Internal Dosimetry. Health Physics, 40:341-348. 1981. Johnson, J. R. and R. C. Myers.. Alkaline Earth Metabolism: A Model Useful in Calculating Organ Burdens, Excretion Rates, and Committed Effective Dose Equivalent Conversion Factors. Radiation Protection Dosimetry, 1(2):87-95. 1981.

Section 16

Lawrence, J. N. P. A History of PUQFUA - Plutonium Body Burden (Q) From Urine Assays. LA-7403-H. Los Alamos National Laboratory. Los Alamos, New Mexico. 1978. Leggett, R. W. and K. F. Eckerman. Estimating Systemic Pu Burden From Urinalyses. Health Physics, 52:337-346. 1987. Lessard, E. T., et al. Interpretation of Radiobioassay Measurements. NUREG/CR-4884. Brookhaven National Laboratory. Upton, New York. 1987. Rich, B. L., et al. Health Physics Manual of Good Practices for Uranium Facilities. EGG-2530. EG&G Idaho, Inc. Idaho Falls, Idaho. 1988. Sikov, M. R., et al. Contribution of Maternal Radionuclide Burdens to Prenatal Radiation Doses. NUREG/CR-5631, Rev. 1. U.S. Nuclear Regulatory Commission. Bethesda, MD. 1992. U.S. Department of Energy. DOE-STD-1098-99. Radiological Control. Reaffirmed December 2004. Washington, D.C. U.S. Environmental Protection Agency. Limiting Values of Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submersion, and Ingestion. Federal Guidance Report No. 11, EPA-520/1-88-020. Washington, D.C. 1988. CANCELE D DOE G 441.1-3A 21 (and 22) 6-11-05 Watson, S. B., and M. R. Ford. A User’s Manual to the ICRP Code–A Series of Computer Programs to Perform Dosimetric Calculations for the ICRP Committee 2 Report. ORNL/TM-6980. Oak Ridge National Laboratory. Oak Ridge, Tennessee. 1980. CANCELE D DOE G 441.1-3A Attachment 1 6-11-05 23 (and 24) UNITED STATES DEPARTMENT OF ENERGY Office of Worker Protection Policy and Programs (EH-52/270CC) 19901 Germantown Road, Germantown, MD 20874-1290 Request for Changes to INTERNAL DOSIMETRY PROGRAM GUIDE (Use multiple pages as necessary.) Page No. ___________ Column No. _________ Line No. ____________ Facility Requesting Change:_____________________________ Contact Person:_______________________________________ Telephone No./Fax No.:________________________________ Description of Change Request: _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ Suggested Specific Word Changes: _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ _______________________________________________________________________________ EH-52 Technical Staff Contact Peter O’Connell (301) 903-5641 CANCELE D COVER CONTENTS ACRONYMS 1. PURPOSE AND APPLICABILITY 2. DEFINITIONS 3. DISCUSSION 4. IMPLEMENTATION GUIDANCE 4.1 PROGRAM MANAGEMENT AND ADMINISTRATION 4.1.1 General Requirements 4.1.2 Organization, Staffing, and Facilities 4.1.3 Technical Basis Document 4.1.4 Internal Dosimetry Procedures Manual 4.1.5 Quality Assurance 4.2 AIR MONITORING AND CONTAMINATION CONTROL PROGRAMS 4.2.1 Air Monitoring When There Is No Practical Radiobioassay Method 4.2.2 Recourse for Technology Shortfall (DIL<MDA) 4.3 INDIVIDUAL MONITORING PROGRAM 4.3.1 Establishing the Need for Individual Monitoring 4.3.2 Investigation Levels/Derived Investigation Levels 4.3.3 Minimum Detectable Amount (MDA) 4.3.4 Frequency of Measurement 4.3.5 Detection and Confirmation of Intakes 4.3.6 Internal Dose Management 4.3.7 Planned Special Exposures 4.3.8 Medical Response

Section 17

4.4 INTERNAL DOSE EVALUATION 4.4.1 Required Dose Calculations 4.4.2 Interpretation of Radiobioassay Data 4.4.3 Evaluation of Internal Dose from Radiobioassay and Air Monitoring Data 4.4.4 Periodic Reevaluation of Internal Dose 4.5 RECORD KEEPING AND REPORTING 5. REFERENCES 6. SUPPORTING DOCUMENTS ATTACHMENT 1. REQUEST FOR CHANGES TO INTERNAL DOSIMETRY PROGRAM GUIDE << /ASCII85EncodePages false /AllowTransparency false /AutoPositionEPSFiles true /AutoRotatePages /All /Binding /Left /CalGrayProfile (Dot Gain 20%) /CalRGBProfile (sRGB IEC61966-2.1) /CalCMYKProfile (U.S. Web Coated \050SWOP\051 v2) /sRGBProfile (sRGB IEC61966-2.1) /CannotEmbedFontPolicy /Warning /CompatibilityLevel 1.4 /CompressObjects /Tags /CompressPages true /ConvertImagesToIndexed true /PassThroughJPEGImages true /CreateJDFFile false /CreateJobTicket false /DefaultRenderingIntent /Default /DetectBlends true /DetectCurves 0.0000 /ColorConversionStrategy /LeaveColorUnchanged /DoThumbnails false /EmbedAllFonts true /EmbedOpenType false /ParseICCProfilesInComments true /EmbedJobOptions true /DSCReportingLevel 0 /EmitDSCWarnings false /EndPage -1 /ImageMemory 1048576 /LockDistillerParams false /MaxSubsetPct 100 /Optimize true /OPM 1 /ParseDSCComments true /ParseDSCCommentsForDocInfo true /PreserveCopyPage true /PreserveDICMYKValues true /PreserveEPSInfo true /PreserveFlatness true /PreserveHalftoneInfo false /PreserveOPIComments false /PreserveOverprintSettings true /StartPage 1 /SubsetFonts true /TransferFunctionInfo /Apply /UCRandBGInfo /Preserve /UsePrologue false /ColorSettingsFile () /AlwaysEmbed [ true ] /NeverEmbed [ true ] /AntiAliasColorImages false /CropColorImages true /ColorImageMinResolution 300 /ColorImageMinResolutionPolicy /OK /DownsampleColorImages true /ColorImageDownsampleType /Bicubic /ColorImageResolution 300 /ColorImageDepth -1 /ColorImageMinDownsampleDepth 1 /ColorImageDownsampleThreshold 1.50000 /EncodeColorImages true /ColorImageFilter /DCTEncode /AutoFilterColorImages true /ColorImageAutoFilterStrategy /JPEG /ColorACSImageDict << /QFactor 0.15 /HSamples [1 1 1 1] /VSamples [1 1 1 1] >> /ColorImageDict << /QFactor 0.15 /HSamples [1 1 1 1] /VSamples [1 1 1 1] >> /JPEG2000ColorACSImageDict << /TileWidth 256 /TileHeight 256 /Quality 30 >> /JPEG2000ColorImageDict << /TileWidth 256 /TileHeight 256 /Quality 30 >> /AntiAliasGrayImages false /CropGrayImages true /GrayImageMinResolution 300 /GrayImageMinResolutionPolicy /OK /DownsampleGrayImages true /GrayImageDownsampleType /Bicubic /GrayImageResolution 300 /GrayImageDepth -1 /GrayImageMinDownsampleDepth 2 /GrayImageDownsampleThreshold 1.50000 /EncodeGrayImages true /GrayImageFilter /DCTEncode /AutoFilterGrayImages true /GrayImageAutoFilterStrategy /JPEG /GrayACSImageDict << /QFactor 0.15 /HSamples [1 1 1 1] /VSamples [1 1 1 1] >> /GrayImageDict << /QFactor 0.15 /HSamples [1 1 1 1] /VSamples [1 1 1 1] >> /JPEG2000GrayACSImageDict << /TileWidth 256 /TileHeight 256 /Quality 30 >> /JPEG2000GrayImageDict << /TileWidth 256 /TileHeight 256 /Quality 30 >> /AntiAliasMonoImages false /CropMonoImages true /MonoImageMinResolution 1200 /MonoImageMinResolutionPolicy /OK /DownsampleMonoImages true /MonoImageDownsampleType /Bicubic /MonoImageResolution 1200 /MonoImageDepth -1 /MonoImageDownsampleThreshold 1.50000 /EncodeMonoImages true /MonoImageFilter /CCITTFaxEncode /MonoImageDict << /K -1 >> /AllowPSXObjects false /CheckCompliance [ /None ] /PDFX1aCheck false /PDFX3Check false /PDFXCompliantPDFOnly false /PDFXNoTrimBoxError true /PDFXTrimBoxToMediaBoxOffset [ 0.00000 0.00000 0.00000 0.00000 ] /PDFXSetBleedBoxToMediaBox true /PDFXBleedBoxToTrimBoxOffset [ 0.00000 0.00000 0.00000 0.00000 ] /PDFXOutputIntentProfile () /PDFXOutputConditionIdentifier () /PDFXOutputCondition () /PDFXRegistryName () /PDFXTrapped /False

Section 18

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Section 19

/FRA <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> /ITA <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> /JPN <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> /KOR <FEFFc7740020c124c815c7440020c0acc6a9d558c5ec0020b370c2a4d06cd0d10020d504b9b0d1300020bc0f0020ad50c815ae30c5d0c11c0020ace0d488c9c8b85c0020c778c1c4d560002000410064006f0062006500200050004400460020bb38c11cb97c0020c791c131d569b2c8b2e4002e0020c774b807ac8c0020c791c131b41c00200050004400460020bb38c11cb2940020004100630072006f0062006100740020bc0f002000410064006f00620065002000520065006100640065007200200035002e00300020c774c0c1c5d0c11c0020c5f40020c2180020c788c2b5b2c8b2e4002e> /NLD (Gebruik deze instellingen om Adobe PDF-documenten te maken voor kwaliteitsafdrukken op desktopprinters en proofers. De gemaakte PDF-documenten kunnen worden geopend met Acrobat en Adobe Reader 5.0 en hoger.)

Section 20

/NOR <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> /PTB <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> /SUO <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> /SVE <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>

Section 21

/ENU (Use these settings to create Adobe PDF documents for quality printing on desktop printers and proofers. Created PDF documents can be opened with Acrobat and Adobe Reader 5.0 and later.) >> /Namespace [ (Adobe) (Common) (1.0) ] /OtherNamespaces [ << /AsReaderSpreads false /CropImagesToFrames true /ErrorControl /WarnAndContinue /FlattenerIgnoreSpreadOverrides false /IncludeGuidesGrids false /IncludeNonPrinting false /IncludeSlug false /Namespace [ (Adobe) (InDesign) (4.0) ] /OmitPlacedBitmaps false /OmitPlacedEPS false /OmitPlacedPDF false /SimulateOverprint /Legacy >> << /AddBleedMarks false /AddColorBars false /AddCropMarks false /AddPageInfo false /AddRegMarks false /ConvertColors /NoConversion /DestinationProfileName () /DestinationProfileSelector /NA /Downsample16BitImages true /FlattenerPreset << /PresetSelector /MediumResolution >> /FormElements false /GenerateStructure true /IncludeBookmarks false /IncludeHyperlinks false /IncludeInteractive false /IncludeLayers false /IncludeProfiles true /MultimediaHandling /UseObjectSettings /Namespace [ (Adobe) (CreativeSuite) (2.0) ] /PDFXOutputIntentProfileSelector /NA /PreserveEditing true /UntaggedCMYKHandling /LeaveUntagged /UntaggedRGBHandling /LeaveUntagged /UseDocumentBleed false >> ] >> setdistillerparams << /HWResolution [2400 2400] /PageSize [612.000 792.000] >> setpagedevice

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