Interagency Steering Committee on Radiation Standards Subcommittee on Federal Guidance Comments on the Draft 2005 Recommendations of the International Commission on Radiological Protection The Interagency Steering Committee on Radiation Standards (ISCORS) is comprised of Federal Agencies in the United States who facilitate consensus on acceptable levels of radiation risk to the public and workers and promote consistent risk approaches in setting and implementing standards for protection from ionizing radiation. A goal of ISCORS is to improve consistency in Federal radiation protection programs. Specific objectives include: facilitating consensus on acceptable levels of radiation risk; promoting consistent risk-assessment and risk-management approaches in setting and implementing standards for protection from ionizing radiation; promoting completeness and coherence of Federal standards for radiation protection; and identifying interagency issues and coordinating their resolution. ISCORS is also a forum for Federal agencies to keep abreast of national and international radiation protection activities. The following observations present views on the draft 2005 Recommendations that have been developed by the Federal agency staff participating in the Federal Guidance Subcommittee of ISCORS and the Environmental Subcommittee of ISCORS. They are not intended to represent the official views of the Agencies. Individual Federal Agencies will be submitting general and specific comments reflecting their unique roles and responsibilities within the United States. Given the recently announced changes to schedules for the foundation documents and the recommendations themselves, ISCORS has not attempted to prepare more formally agreed interagency viewpoints. The comments which follow are made from the viewpoint of issues that would appear to have a significant impact on our ability to consider implementation of the science and policy recommendations within the United States. Schedule and Supporting Information: We greatly appreciate the public consultation process that has occurred to date, and the opportunity to provide our thoughts on the draft recommendations. We are pleased to learn of the changes in schedule for the recommendations, and we look forward to additional opportunities for discussion and input. There are a number of instances where the draft recommendations appear to be a “work-in-progress”. There are at least four major “foundation” documents that should provide the technical basis for the 2005 Recommendations, but these documents are not available for stakeholder review, and will not be available for review until after the next Main Commission meeting in March 2005. Consequently, much of the information needed to understand the basis for, and implications of the recommendations is not yet available. This makes it difficult to understand the degree to which changes can be considered and justified in a regulatory analysis as required by legislation within the United States. We encourage the ICRP to use the comments on the draft 2005 Recommendations as input in preparing the foundations documents that have not yet been completed. Implications for Current Regulatory Framework: The recommendations, as presented, are not likely to result in substantial improvements to public health and safety as measured by doses received by individual workers and members of the public. We support improvements to the underlying scientific basis and calculations of dose as desirable to improve realism in conducting risk informed regulation. We also support clarifying issues that have been difficult to understand and implement from ICRP Publication 60. However the draft 2005 Recommendations also propose a number of changes in terms, philosophy, and regulatory approach that, taken as a whole, could necessitate time-consuming, contentious, and possibly expensive changes to documents prepared by national regulatory authorities. The draft, as currently presented, is not internally consistent on some of the concepts and terms, and in many parts is not sufficiently clear and explicit to be useable as a basis for decisions on radiation protection programs. Thus the regulatory agencies within the United States could face significant regulatory analysis and justification challenges. Protectiveness is often defined through statute and/or regulations. The ICRP is encouraged to reconsider the need for many of the changes that will necessitate modification of existing regulatory programs that already achieve the protection objectives of the ICRP. In particular, we believe that the ICRP should be able to explain how proposed changes provide a level of improvement to public and worker protection that is commensurate with potential costs of implementation to either the regulatory systems (e.g., government costs) or the regulated community. For example, what is the decrease in detriment realized by adopting the new recommendations? Basis for Quantitative Recommendations: ICRP appears to be moving away from linking the dose and risk information with the considerations for setting the quantitative values. The proposed recommendations use background radiation exposure as a benchmark for determining whether regulatory action is needed. While a relationship can certainly be implied in this presentation, the more formal rationale for the recommendations appears to have been lost. One consequence of moving away from dose and risk is that it is unlikely that a unified (i.e., harmonized) system for controlling chemical and radioactive pollutants can be developed. Although our knowledge of radiation effects is subject to uncertainty, and we recognize the complex relationship that exists, we believe that the information should be used to assist in uniformly treating public health and safety hazards. The ICRP is encouraged to re-establish the relationship of the quantitative recommendations with the underlying information on radiation risk and detriment. Constraints: ICRP proposes adopting a system of protection that appears to consist of multiple tiers of constraints and limits. Practically speaking, such systems already exist in the United States and elsewhere, although the terminology may be different. Unfortunately, the current draft recommendations do not add to a coherent or simplified understanding of the general system of radiological protection, and can be read to suggest that significant changes should be made. The regulatory usage (legal definition) of the term “limit” and its relationship to the recommended constraints has not been adequately described, and we believe this is different from the way in which the ICRP has used the term. For example, restrictions on individual dose from specified sources (e.g., source-constraints) “provide a level of protection for individuals that should be considered as obligatory and not maintaining these levels of protection should be considered as a failure.” It is unclear how this differs from the legal usage of the term “limit” by regulatory agencies. What may be more useful is a non-jargon explanation that an individual should be afforded the recommended level of protection from all sources, and that regulators and users must work together to establish a logical, predictable system for assuring that this is achieved for each type of exposure situation. Finally, a tiered system of constraints as proposed may not promote international consistency (harmonization) in the establishment of source constraints, because the recommendation is that national authorities establish constraints at values less than the recommended maximum constraints. The ICRP is encouraged to remove the inconsistencies in, and clarify the use of, the term constraint in the recommendations. Collective Dose: The role of collective dose in optimization has been substantially revised, and it would be useful for the ICRP to provide additional guidance on how collective dose should be applied and under what circumstances it should not be used. Collective dose, when properly constrained to specific time periods, populations, and locations, is a useful regulatory analysis tool and attribute in making decisions. Conversely, collective dose can be misused in certain circumstances and such misapplications should be avoided. The draft 2005 Recommendations suggest the use of a dose matrix for decision making, but no details are provided on the quantitative or qualitative uses of such a matrix. It is not obvious whether the dose matrix replaces the use of collective dose, or provides a framework for the appropriate application of the concept. The ICRP is encouraged to clarify the conceptual considerations as well as in practical application of collective dose and the dose matrix. Care-Givers: The draft recommendations provide guidance for exposure of non-patient members of the public and care-givers in medicine that appears to be incomplete and potentially inconsistent with other exposure recommendations. In particular, detriment to non-patients is called secondary and constraints for care givers do not recognize circumstances where children or pregnant females may be present. The ICRP is encouraged to clarify how to provide consistent protection for these individuals. Exemption and Exclusion: The ICRP has provided significant new recommendations in the area of exemption and exclusion. Some of these ideas may be very useful for a logical and coherent radiation protection framework. However, the draft 2005 Recommendations do not present a clear and consistent approach to managing low doses and controlling small quantities of radioactive material. For example, the ICRP system of radiological protection generally applies to any actual or potential exposure, whatever its magnitude. In the case of very low levels of exposure (e.g., <10 ìSv per yr) from radioactive materials, application of the optimization principle would indicate that no additional protective action needs to be undertaken. Yet, some items will be excluded from regulatory control without regard to the question of whether anything within reason can be done to control them. Finally, the draft 2005 Recommendations suggest that materials with activity concentrations less than or equal to levels that are associated with 10 ìSv per yr may be considered to be nonradioactive and thus excluded from radiological control. The ICRP is encouraged to reexamine the conflicts within the numeric and conceptual recommendations throughout the document and present a clear and coherent approach. Protection of the Environment: Much of the material presented in the draft is not appropriate for a recommendations document because it lays out a plan of work rather than recommended actions. The presence of this material seems to imply a much greater degree of finality than would appear to be warranted. Several U.S. Federal Agencies have previously commented to ICRP on the topic of environmental protection. The concerns expressed in those comments remain valid. Given that the ICRP has stated that their activities have not been driven by any particular concern over environmental radiation standards, proceeding with the development of a framework parallel to the recommendations for human protection, including a complex, comprehensive biota research and dosimetry development program, appears somewhat premature. An assessment of where, under what exposure scenarios, and to what degree the current system of radiation protection for humans may not be protective of non-human species may be warranted. A capability to compare and benchmark the results of the biota dosimetry methods and tools already developed and readily available through many countries would also be useful. From this assessment of current circumstances and capabilities, the potential need for and degree of complexity of future proposals can be better determined. The ultimate approach for protection should be flexible such that decision makers and users can select and use those biota dose evaluation and modeling tools that match to the specific purpose and data quality objectives of their assessment. As stated in previous U.S. Federal Agency comments, consideration should given to a graded or tiered approach, perhaps including screening levels, to cost-effectively eliminate those situations which pose no harm. The ICRP is encouraged to clarify its intent, and avoid detracting from on-going efforts to improve, integrate, and harmonize the existing assessment tools and framework of protection of the public health and safety and the environment. The ICRP is also encouraged to engage in an ongoing dialogue on their proposals, and take the time necessary to develop an international consensus, since it is not obvious that there is a need for a framework for protection of non-human species that parallels the current framework for protection of humans. Changes or additions to the radiation protection system for the public and the environment should produce benefits that are equal or greater than the costs of development and execution of such a system. This criterion should be a key factor in considering any new guidance for application to protection of non-human species and should be integrated into any process for the development of such guidance.