I have the pleasure to transmit comments from the Spanish Nuclear Safety Council to the new draft Recommendations of the ICRP (June, 2006). These comments were prepared by a technical group and approved by a plenary meeting of the CSN Commission last September, 13th. COMMENTS OF THE SPANISH ”NUCLEAR SAFETY COUNCIL” (CSN) TO THE DRAFT RECOMMENDATIONS OF THE ICRP ( 02/276/06 - 5 June 2006) First of all CSN wants to acknowledge the opportunity to participate in the process of developing ICRP recommendations through this second round of consultation. We recognise the great effort made by ICRP in analysis of the items included in comments and suggestions made both by CSN and the Spanish Radiation Protection Society (SEPR) derived from previous consultation of the draft recommendations, The whole document shows a significant improvement both in structure, content and wording with respect to previous draft. Fundamentals, principles and criteria as well as the model for the radiation protection system and policies for its practical implementation appear now clear and well explained. The document now is more self sustained and mature. CSN technical staff has again participated in a working group created by SEPR to analyse the draft. CSN fully endorses comments and suggestions made by SEPR (included in Annex) as they represent the opinion of the radiation protection community in our country. As a summary of the result from the draft review, we want to point out the following general considerations related to items of special regulatory relevance: 1. Content of new draft better shows that new recommendations are intended to attain an evolution of the RP system with a reasonable degree of continuity. Some fundamentals for the new recommendations are now included but additional explanation on the basis should be useful. Incorporation of a summary identifying changes introduced from previous RP system based on ICRP 60 will help to clarify the scope of the new recommendations. 2. Radiation protection principles appear now very similar to those in ICRP 60 but some aspects need additional clarification (i.e. justification as a prerequisite for any RP decision; optimisation and safety culture...). This may be easily implemented incorporating to the draft a limited number of statements from respective foundation documents. 3. Some new aspects related to the scope of the RP system (i.e. exemption from within; exemption from intervention) are needed for additional explanation in the draft. Again clarification can be transferred from respective foundation document. 4. ICRP has decided to maintain its position to leave to international/national regulations development of criteria to implement some important aspects of the RP system. We are still convinced that recommendations from ICRP for these aspects, even with the sole objective of serve as an starting point, will be very useful to build international/national consensus, specially in those matters (exemption values…) for which absence of harmonisation between different countries may have undesirable consequences in trade or technical exchange and co-operation 5. Excessive emphasis has been made in the limitations of the use of the quantity Effective Dose. Our experience shows that effective dose is a fundamental and very useful tool in a large number of situations. We recognise that limitations identified by ICRP have good scientific basis, nevertheless we consider that some changes may be incorporated to the draft allowing for the wide use of effective dose with the exception of situations where specific/detailed assessment is needed. 6. After clarification in last USA August Conference, additional practical guidance is still needed for new approach related to application of optimisation in emergency and existing situations, especially for the use of intervention/action levels and constraints. 7. Stakeholders’ involvement is now proposed to be a decision-aiding tool which results should be used as an input to the decision-making process. We fully support this position but consider that additional clarification about its practical implementation is needed in the draft. ANNEX SPANISH RADIOLOGICAL PROTECTION SOCIETY COMMENTS TO THE DRAFT RECOMMENDATIONS OF THE ICRP (SEPTEMBER 2006) GENERAL COMMENTS: The new draft appears to be basically “complete” and “sound”. It should be rather easy to achieve a final version capable of being published. The structure of the draft is much clearer than the previous one which facilitates its future use. However, the document maintains, perhaps unavoidably, a certain degree of discretion in the application of the recommendations, which implies of loosing the present degree of international harmonization. The present draft covers situations not envisaged specifically in the previous draft, for instance the new chapter 9 devoted to emergency and existing situations. Nevertheless, the content of this chapter appears “too light” and would probably have to be expanded a little bit, using perhaps some information of chapter 5, as well as some of the arguments being now discussed in the two on-going WG of Committee 4 on “Emergencies” (for instance a clear distinction is needed between “preparedness” and “actuation”, as well as between the different post-accidental phases). A Glossary of Terms has been included, which is considered an important item in order to improve the general understanding of the document. Additional terms should perhaps be added like: safety culture, action level, supervised area, intervention level, physician and others. Finally definitions of certain terms appear along the text, and it would be better for those terms to be introduced in the glossary albeit directing to the paragraph number where the definition is written. It appears convenient to “re-ensure” a fully coherent use of words like “exposure”, “source”, “practice”, etc., throughout the document. JUSTIFICATION (SUBCHAPTERS 1.2. AND 5.7) In paragraphs 11th to 23rd, the document tries to present the main reasons, explanation and basis for the new recommendations. The first remark to make is that “justification” is almost forgotten in this discussion, while it is a necessary prerequisite for any decision regarding Radiological Protection actions or approvals. Re-justification is somehow diluted in the text. See specific comment in (188). “THE SCOPE OF THE RECOMMENDATIONS” (SUBCHAPTER 2.3.) It is important to be very clear as to whether the document talks about the “scope of the recommendations” or the “recommended scope of the regulations”. See paragraph “a” of the Executive Summary as well as paragraphs 1 and 3 in the main text of the draft document “The Scope of Radiological Protection Regulations”. This issue was subject to comments in that document. Some of the paragraphs under this subchapter could perhaps be better placed in subchapters 2.1. and/or 2.2. Adapt the final wording in this subchapter to the final version of the specific ICRP document on “scope” now being revised. And finally, a mention to “unjustified practices” should be made. EXCLUSION AND EXEMPTION (SUBCHAPTER 2.4) Changes regarding the previous draft are considered very positive, as more continuity with ICRP-60 is maintained. Nevertheless and due to the importance of these items, specific statements of the draft document “The Scope of Radiological Protection Regulations” should be included here, for better understanding and self- sustainability. It is considered important to avoid any statement that could generate lack of harmonization in the practical application of these concepts. See specific comments in (46). OPTIMIZATION (SUBCHAPTER 5.8) The issue of “Stakeholders involvement” has evolved in a positive way in relation to the previous draft, but the main principles of their participation are better presented in the foundation document. Consequently (23), (40), and (41) of the draft document “The Optimization of Radiological Protection” should perhaps be included to the actual draft of the Recommendations. Association between optimization and safety culture without further clarification could give rise to misunderstandings. See specific comment in (194). DOSE CONSTRAINTS (SUBCHAPTER 5.8.1) Important modifications have been introduced in relation to this concept, including how they could be applied in emergency and existing situations. However, additional clarification is necessary as there remain certain confusion in the meaning of action or intervention levels, when related to dose constraints. Some examples follow: (279) indicates that previous action levels are effectively constraints i.e., levels of aspiration often set by national authorities and not a mandatory level which must be achieved. In circumstances where doses exceed the value of constraints, optimised protective actions should be taken to reduce doses. Later on at the end of the paragraph it is written that below action levels no action is required. (339) establishes that intervention levels given in publications 60 and 63 are now regarded as constraints. However in (348) it is said: “Results of the optimisation process below the dose constraint will lead to intervention levels“. The articulation of the old and the new concepts needs to be much clearer, even more when present values of intervention and action levels are considered constraints in the draft. NATURAL RADIATION Changes are welcome as the new draft looks at this complex item more in depth than the previous one and it is generally aligned with present regulatory approaches. However the text needs some rearrangements; perhaps it is sometimes too prescriptive while in other subjects additional guidance is needed. See detailed comment in (288). OTHER GENERAL COMMENTS: Chapter 4: “Dosimetric quantities” This chapter should perhaps be revised with two key ideas in mind: a) Reduce its size, and b) Try to reinforce the value of the “effective dose”, at least to maintain its credibility as the most generally known and used dosimetric quantity. The document emphasises that effective dose should not be used for epidemiological evaluations, nor should it be used for any specific investigation of human exposure. Rather, absorbed dose should be used with the most appropriate biokinetic biological effectiveness and risk factor data. This scientifically right statement could cause a lot of problems from a practical point of view if it is considered in a too rigid way (see detailed proposals in specific paragraphs). For example, according to the new draft, in such situations doses should be evaluated in terms of absorbed dose, using appropriate values of RBE when currently there is no methodology to evaluate internal doses in terms of absorbed dose. Chapter 6: “Medical Exposure of Patients” On this chapter, some more clear advice on the way to use effective dose in medical exposures should be included and the need of training on radiation protection for medical doctors and other health professionals should be properly reinforced throughout this chapter. Chapter 8: “Potential Exposures” Security is considered in this chapter (8.2) and there is a new section (8.5) about exposures with malicious intent. Mention to these relevant items is welcome. However, in subchapter 8.2 (“Radiation safety and security”), in general terms, the content is rather ambiguous and to some extent, even unclear and elusive as to define, what exactly are the ICRP recommendations in this field. SPECIFIC COMMENTS Chapter 3: “Biological aspects of radiological protection” Throughout this chapter, the term “Tissue reactions” is used to describe deterministic effects. This term (“tissue reactions”) does not sufficiently reflect what a deterministic effect is. The deterministic effect occurs only when a relatively high number of cells in a tissue are killed after radiation exposure, and this is not reflected by the term “reaction”. Furthermore, if the term “tissue reactions” is used instead of “deterministic effect” some of the affirmations made in this chapter would not be true. For example in (50) it is said that “The induction of tissue reactions is generally characterized by a dose-threshold”, but the reality is that tissues react almost at any dose and this does not necessarily mean that a “deleterious effect will take place” (deterministic effect). It will be more appropriate to use after “tissue” the world “damage, injury, impairment, malfunction”. Subchapter 3.2.6: “Non-cancer diseases after radiation” It is entitled “Non-cancer diseases after irradiation”, whereas section 3.2 refers to “The induction of cancer and hereditary effects”, which obviously does not include the aforementioned diseases. For this reason a change in numerical order is proposed, changing 3.2.6 into 3.3 Subchapter 5.1: “The definition of a single source”. It will be very much appreciated whatever effort possible to further clarify this definition, because it is basic to promote coherent approaches by different countries and organizations. Common to subchapters 5.4.1; 5.4.2 and 5.4.3. The basic content of these three subchapters should be common; that is: a) It should be identified “who” are the exposed individuals; and b) It should be said something regarding the specificities in the application of the requirements for each one. Accordingly: 5.4.1. Nothing is said related to the peculiarities (if any) in the application of the requirements. 5.4.2. and 5.4.3. It is not identified who are the exposed individuals. On the other hand, the term “radiation worker” should be changed by the term “exposed workers” and define it based on the liability to receive doses exceeding one or other of the dose levels equal to the dose limits for members of the public. Subchapter 6.5. “Release of patients after therapy with unsealed radionuclides” What about the case of releases with "sealed radionuclides"?. The problem is qualitatively different, but at least it should be mentioned. No mention is made to the potential implication of professional bodies in this context. Subchapters 7.2 and 7.3 should perhaps be placed in reverse order. Subchapter 8.3: “Assessment of potential exposures” A new paragraph should be added (taken from ICRP 81), to clearly state the peculiarities when the long term future is considered. Subchapter 8.4. Optimization of protection against potential exposures. Once again something should be added to consider the peculiarities when the long term future is involved. There is a very short and clear statement in ICRP 81. Subchapter 8.6 “Accidents in radioation therapy" It includes examples of reported accidents. The list of examples is not considered to be strictly necessary. Additionally It is not well understood the reason why this section is included when other situations equally specific are not taken into account. For example, potential exposures for waste disposal facilities due to human intrusion, as well as natural events. Chapter10: “Protection of the Environment” This chapter has been deeply reviewed and it is now focused on policy aspects. Additionally, previous Appendix B has been deleted. These changes are considered very positive. COMMENTS ON PARAGRAPHS: Note: Every suggested changes are expressed in capital letter. (9) Fifth line: “This complexity involved the justification of practices, the optimisation of protection”. Here the use of the word “practice” is not appropriate. The sentence refers also to “interventions” in this context. Perhaps the word “practice" should be deleted here. (10) It should be good to mention also the 96/29 European Directive, because its international character. (12) Delete the last sentence (“Thus, the revised recommendations should not be interpreted as suggesting any changes to radiological protection regulations that are appropriately based on its previous Recommendations in ICRP 60 and subsequent policy guidance.”) because regulatory changes cannot be excluded. (21) and (34) In (21), it is said: “The Commission’s Recommendations cover exposures to sources insofar as they are controllable”, while in (34), it’s said: “The Commission’s System of radiological protection applies to all radiation exposures from any source, regardless of its size and origin”. There is a need for a clear and coherent use of these two “fields of application” throughout the document and if this distinction is to be maintained, the two “fields” should be better explained. (22) Seventh line The statement “… and therefore should not be used for epidemiological evaluations…”, looks too strong. See also (17) and (57). (26) First two sentences: “This aim cannot be achieved solely on the basis of scientific knowledge on radiation exposure and its health effects. It also requires a paradigm, i.e., a model for protecting humans and the environment against radiation.” Reverse the message. There is a need of a “paradigm” based, to the possible extent, on the existing scientific knowledge. Fifth line: “condition, but societal and economic aspects of protection” Add a new phrase for clarification: “…condition, BUT THE ENUNCIATION OF THE PARADIGM NEEDS ALSO TO CONSIDER ITS PRACTICALITY AND FOR ITS APPLICATION societal and economic…” Twelfth line: “scientific estimations and value judgements should be made clear” Add a word: “…Scientific estimation, PRACTICALITY and value judgements…” (30) “The principle of optimization of protection” Third line: ”To avoid serious inequities” Perhaps could be changed the word serious by "significant": ”To avoid SIGNIFICANT inequities” In the one but the last line: “as well as any inequity in the distribution of doses” the words “any inequity” could be changed by “inequities”: “as well as INEQUITIES in the distribution of doses”. (41) Third line: “can or need to be regulated. There are two unique aspects” Could be changed by: “…can or need to be EQUALLY CONSIDERED WHEN ESTABLISHING THE LEGAL SYSTEM FOR THEIR APPLICATION. There are two unique… ” Tenth line: “not sufficient reasons for including all exposures and all sources” Perhaps could be changed by: “…no sufficient reasons for including OR EQUALLY TREATING all exposures…”. (42) First two lines: “There are two distinct concepts that define the extent of radiological protection control, namely (i) the exclusion”. Perhaps could be changed by: “…There are two distinct concepts that CAN HELP to define the extent of radiological protection control IN THE LEGAL AND REGULATORY SYSTEMS, namely (i) the exclusion…”. Fourth line: “regulatory instruments, and (ii) the exemption” Perhaps could be changed by: “…regulatory instruments (CANNOT BE REGULATED), and (ii) the exemption…”. Sixth and seventh lines: “…controlled because the associated risk is negligible under any conceivable circumstance. A legislative system…” Perhaps could be changed by: “…controlled because EITHER the associated risk is negligible under any conceivable circumstance OR BECAUSE EXEMPTION IS THE OPTIMIZED DECISION (DOES NOT NEED TO BE REGULATED). A legislative system…”. (46) Third line. End of the first sentence. Perhaps it could be good to bring here the essence of the last two sentences in paragraph “h” of the Executive Summary of the draft document “The Scope of Radiological Protection Regulations”. Try to provide as much practical guidance as possible, and finally consider the possibility to discuss, even only basically, the “old” concepts of “clearance” and “exemption from intervention”, in the new context. The last sentence in (46): “National regulators should decide the criteria for exemption on a case-by-case basis and the dosimetric boundary of 10 ìSv y-1 should be only one of the criteria used.” should be deleted. (57) Third line: “biological information that would ambiguously verify the hypothesis”. Change by: “biological information that would UNAMBIGUOUSLY verify the hypothesis”. (121) Third line: “…assessment of effective dose or mean doses in tissues or organs. …” Change by: “…assesment of effective dose or mean EQUIVALENT dose in tissues or organs. …”. (122) Throughout the paragraph use coherently the term “operational quantities” only, as defined in the Glossary. Avoid the use of other words like “dose” or “equivalent”. (143) See the comment made to (22). (162) Third “bullet” (existing exposure situations). Third line: “…from past practices that were operated outside the…” Perhaps could be changed by: “… from past practices OR OTHER ENDEAVOURS that were operated…”. (177) Seventh and eighth lines: “…protection at work for women who are or may be pregnant should provide a level of protection for the fetus broadly comparable to that provided for members of the general public. This should not be understood as an ethical position of the Commission on the status of the fetus.” The sentence about the status of the fetus from the ethical viewpoint of the Commission is unclear and potentially unnecessary. In fact very often is much easier to explain the reason to specially protect the fetus using ethical reasons. (185) The principle of limitation. Delete the word “maximum” from the heading of the principle: “The principle of limitation of maximum doses” (188) Add a new sentence to consider the possibility to re-examine existing practices from time to time: “Finally alternatives to existing practices may develop overtime, which would probably require these practices that do exist to be periodically re-examined to ensure that they are still justified”. (198) Sixth line: The optimum level of dose may be equal to the constraint in some cases. Therefore it should be better to say that resulting dose “do not exceed the relevant constraint” instead of “below the relevant constraint”. The same comment applies in the last line of (216). (205) “The second band, from 1 mSv to 20 mSv, applies in circumstances where […] in planned situations. In the event of an accident, countermeasures such as sheltering and iodine prophylaxis would fall within this band.” This “second band” is also applicable in cases of exposures to natural radioactivity and appears to be especially important in practice. Some changes in the paragraph are suggested, as follows: “The second band, from 1 mSv to 20 mSv, applies NORMALLY in circumstances, where […] in planned situations. IT ALSO APPLIES in the event of an accident, BECAUSE SOME RATHER SIMPLE countermeasures such as sheltering and iodine prophylaxis would fall within this band, AS WELL AS IN SITUATIONS OF EXPOSURE TO NATURAL RADIONUCLIDES.” (207), (208) and others related. Please re-assure that the constraints are to be always specified in terms of projected “incremental” individual dose (not “total”), with the corresponding interpretation also as “averted” dose due to specific countermeasures or interventions. (216) Last line. See comment to (198). Substitute “be smaller” by “not be greater”. Table 4. Instead of “Examples”, perhaps it would be better to say “Representative Examples”. Add some other “examples” in the second band: one for some countermeasures in radiological emergencies, and another for exposures (other than radon) to natural radioactivity. Similarly, the wording of the “Characteristics of the situation” should perhaps be changed for the second band,taking into account that it also apply to emergency exposures. (234) This paragraph results rather complex, because it combines in one single text the three types of exposures (planned, emergency and existing) and tries to express what the three categories (unacceptable, tolerable or acceptable) can be in the three cases, while in reality the meaning is rather different. In fact if one tries to draw a diagram with the “dose limit”, the “dose constraint”, and the “optimized dose”, there are areas with different meaning, depending on the type of exposure. Please clarify. (246) The following wording is proposed: “The physicians AND OTHER HEALTH PROFESSIONALS involved in the processes that irradiate patients should always be trained in the principles of radiological protection. Radiation exposures in medicine are not limited by any regulatory process, BUT THE FINAL RESPONSIBILITY LIES with the physicians, who therefore should be aware of the risks and benefits of the procedures involved.” Where it was also deleted the phrase “THIS IS BECAUSE OF THE DELIBERATE NATURE OF THE EXPOSURES.“ This paragraph should be additionally emphasized, because of its crucial importance. In third line, please clarify that only some of the exposures in medicine (those to patients and a few other) are not limited. (249) In the text: “The generic justification of the radiological procedure is a matter for NATIONAL professional bodies, sometimes in conjunction with NATIONAL regulatory agencies.” The following change is proposed: “The generic justification of the radiological procedure is a matter for professional bodies, sometimes in conjunction with regulatory agencies.” (250) In: “It will often be possible to speed up the procedure by defining criteria and patient categories in advance.” The following change is proposed: “It will often be possible to speed up the procedure by defining REFERRAL criteria and patient categories in advance.” (251) In: “The medical procedures causing patient exposures have to be justified AND ARE USUALLY FOR THE DIRECT BENEFIT OF THE EXPOSED INDIVIDUAL AND CONSEQUENTLY SOMEWHAT LESS ATTENTION HAS BEEN GIVEN TO OPTIMISATION OF PROTECTION IN MEDICAL EXPOSURE OF PATIENTS THAN IN OTHER APPLICATIONS OF RADIATION SOURCES. The optimisation of protection in patient …” The following new wording is proposed: “The medical procedures causing patient exposures have to be justified BUT SPECIAL ATTENTION SHALL ALWAYS BE GIVEN TO OPTIMISATION. The optimisation of protection in patient …” (252) In: “The Commission now uses the same conceptual approach in the source-related protection, irrespective of the type of source. THIS MEANS THAT OPTIMISATION OF PROTECTION IS ALWAYS CONSTRAINED BY A LEVEL OF DOSE WHERE ACTION IS ALMOST ALWAYS WARRANTED. THIS LEVEL OF DOSE, OR CONSTRAINT, IS AIMED AT NOT SELECTING FROM THE PROCESS OF OPTIMISATION ANY PROTECTION OPTIONS THAT WOULD INVOLVE INDIVIDUAL DOSES ABOVE THE APPROPRIATE CONSTRAINT. In the case of exposure from diagnostic medical procedures…” The following change is proposed: “The Commission now uses the same conceptual approach in the source-related protection, irrespective of the type of source. In the case of exposure from diagnostic medical procedures ...” (254) In: “The selected values will be specific to a country or region” The following wording is proposed: “The selected values COULD be specific to a country or region” (255) First line: “Diagnostic reference are used in medical diagnosis…” Perhaps could be changed by: “Diagnostic reference LEVELS are used in medical diagnosis…” (262) The following wording is proposed: “It is important to ascertain whether a female patient is pregnant prior to radiotherapy AND SOME ABDOMINAL INTERVENTIONAL OR CT PROCEDURES. In pregnant patients, cancers that are remote from the pelvis usually can be treated with radiotherapy. This requires careful treatment planning. UTERO DOSES SHOULD ALWAYS BE ESTIMATED IN THESE CASES. Cancers in the pelvis can rarely be adequately treated during pregnancy without severe or lethal consequences for the fetus.” (267) In “The use of volunteers in biomedical research makes …” The following change is proposed: “The PARTICIPATION of volunteers in biomedical research makes…” (269) This paragraph on medico-legal exposures should be deleted or treated with more detail probably in another chapter outside of medical exposures. (271) In: “Some public exposure may result from wastes discharged by nuclear medicine departments. The implications of such discharges…” The following change is proposed: “Some public exposure may result from wastes discharged by nuclear medicine or radiotherapy departments (SOME SHORT LIVE SEALED SOURCES SHOULD ALSO BE CONSIDERED). The implications of such discharges …” (272) In: “…This mainly involves the frequently used radionuclide iodine-131, a high-energy gamma emitter.” The following change is proposed: “…This mainly involves the frequently used radionuclide iodine-131.” (273) The following wording is proposed: “When releasing a patient treated with radioiodine OR SOME SEALED SHORT LIVE SOURCES, the exposure to other individuals needs to be considered, although the risk of cancer induction from these patients treated with radioiodine is very low. However, the thyroid gland of young persons is more radiosensitive, so that particular care should be taken to avoid the contamination of infants, children and pregnant women. The risks from internal contamination of others are less significant than those from external exposure.” Where “under the age of 15” and “highly“ were deleted. (275) The following wording is proposed: “The Commission now recommends (Publication 94; ICRP, 2004a) that a dose constraint of a few mSv per episode should not apply to infants, young children and casual visitors. They should be subject to the public dose limit.” Where “of 1 mSv/year” was deleted. (276) In: “The recommendations do not explicitly state that urine should be stored or that patients should be hospitalised after therapy with high activities of radiopharmaceuticals. The public dose limits…” The following wording is proposed: “The recommendations do not explicitly state that urine should be stored (THE RISK DUE TO SPILLING CAN BE HIGH) or that patients should be hospitalised after therapy with high activities of radiopharmaceuticals. STORAGE TANKS AT THE HOSPITALS COULD ONLY BE NEEDED IF MANY TREATMENTS ARE MADE EVERY WEEK. The public dose limits …” (277) Put this text in full coherence with those in paragraphs 21 and 34. (280) Express the principles for the two situations (exclusion and exemption) separately and using exactly the same wording than used in Chapter 2. The reference made to Section 2.2, should be to 2.4. (288) Last two sentences applicable to “new facilities”. Room should be given for decisions by regulatory agencies, by expressing the text in a less prescriptive way, like for example: “New facilities for processing such materials, should be examined by regulatory agencies, to decide whether radiological protection requirements need to be considered during the design stage as planned situations and consequently to define the extent and the requirements for the application of the Commission’s recommendations”. Consequently, some practical guidance from the Commission would be very much appreciated to help the regulatory agencies. (289) In relation with this paragraph, it would also be very much appreciated the provision of additional guidance by the Commission on the proper constraints to be used. Third and fourth lines: “within the Commission’s system. A decision should be made on whether it is justified to reduce exposures. This decision should also…” Perhaps could be changed by: “… within the Commission’s system AS APPROPRIATE, and a decision should be made on whether it is justified TO APPLY THE CRITERIA FOR “EXEMPTION” OR TO DEFINE THE SITUATION AS “PLANNED” AND/OR “EXISTING” AND TO CONTROL CONSEQUENTLY exposures. This decision should also…”. (295) Another paragraph where additional guidance on “exemption” would be appreciated. The reference made to Section 2.2, should be to 2.4.. (307) The final sentence in (307) is not sufficient to clearly emphasize the need of a proper adaptation for the long term future. The references should be ICRP 77 (ICRP 1998a) and ICRP 81 (ICRP 2000a). (316) Add ICRP 81 as another reference for scenario construction. (318) The proper reference is ICRP 1998 a. (351) In line with ICRP 91, it should be explicitly stated that, up today, the application of the existing system is believed to have provided a very good level of environmental protection, although “direct demonstration” of this may be the basic “hole”. EDITORIAL COMMENTS (9) Last line: “…complexity that has not always been easy to explain”. Suggested change: “…complexity that has NEITHER always been easy to explain, NOR TO BE APPLIED IN SOME REAL CASES”. (11) Second “major feature”: Perhaps it should be better to move the phrase “from all regulated sources” from the second line, to the very end of the sentence. Third “major feature”: Perhaps the phrase “in some related protection” in the first line could be deleted. (28) Third line: “aimed at encouraging a structured approach to protection.” Suggestion: “…aimed at encouraging A FEASIBLE AND structured approach…” (29) Last line: “to be the best approach to managing risk from radiation exposure. Suggestion: “…to be the best PRACTICAL AND REASONABLE approach to…” (32) First line: “The principal subdivisions of the system” Consider the possibility to replace “subdivisions” by “components”: “The principal COMPONENTS of the system” Perhaps a new “component” is missing here, referring to the use of a “graded approach” depending on the level of exposure and other surrounding circumstances of the exposure and the radiation protection actions. The concept of “exemption “could be naturally introduced here. (33) Fourteenth line. Delete the phrase “and to report on this topic periodically to the regulator”. (45) First two line: “Certain practices and sources (that in principle are subject to radiological protection regulations) may be exempted from some requirements because their control is not warranted. The principles…”. Change by: “EXEMPTION FROM SOME REQUIREMENTS MIGHT BE APPLIED TO certain practices and sources that in principle are subject to radiological control regulations, because their control is not warranted. The principles…” First bullet. Second line: “practice or source must be insignificant (for man-made sources, this is judged…”. Change by: “… practice or source must be SUFFICIENTLY LOW (for man-made sources, this is judged…” (75) Fourth line The risk coefficient is expressed as “0.00005 per mSv” while in previous paragraphs of this chapter (68, 71, Table 2) the risk coefficients were expressed as a number x10-2 per Sv (or Gy). In paragraph 75 it will be better to give the risk coefficient as “5 x10-2 per Sv” (like in other paragraphs). (147) First line: “…an instrument for optimisation, for comparing” Change by: “… an instrument TO HELP IN THE optimization OF PROTECTION, for companing…”. (201) Third line: “In some rare exceptional situations”. Delete the words “rare exceptional”. It is unneeded. (229). Second line: “…the total collective effective dose is not a useful tool…” Please clarify that the “total collective effective dose” can be only CALCULATED. (281) Third line: “Natural radiation exposures are broadly grouped as cosmic radiation and terrestrial radionuclides,…” Perhaps could be changed by: “Natural radiation exposures are broadly grouped as cosmic radiation and THOSE DUE TO terrestrial radionuclides…”. (282) Eleventh line: “human habitats, making available naturally occurring radioactive materials…” Change by: “… human habitats, making available PRODUCTS CONTAINING naturally occurring radioactive materials…”. (283) Sixth line: Perhaps it could be good to say “effective dose”, at least the first time that the text use the word “dose”. (286) The third sentence appears incomplete. (292) Last line: ”‘man-made’ sources are more readily controllable than natural sources.” Perhaps could be changed by: “… sources are FELT AS more readily controllable…”. (293) Last line: “…the feasibility of control and the perceived demands of those affected.” Perhaps could be changed by: ”…the feasibility of control, THE MAGNITUDE OF THE EXPOSURES and the perceived demands of those affected”. (334) Perhaps this is the right place to face the “general comment” made related to this chapter 9. (336) Tenth line: “Radioactive materials, will need to have broad applicability”. Change by: “…radioactive materials, will need to BE BASED ON THE RELEVANCE OF CONSEQUENCES AND have broad applicability…”. (342) The one but the last sentence could be deleted, because it is already included in (368) for general use. By the same token, the last sentence in 342 could better be placed at the end of the (368). (344) Second line: “Intervention may not be fully effective,…” Change by: “… Intervention may not ALWAYS be fully effective…” (346) Third line: “If the protective action is not justified, consideration…” Change by: “… If the protective action is not GENERALLY justified, consideration…”. (348) First line: “…dose constraint will lead to intervention levels. The constraint..." Change by: “… dose constraint will lead to PRACTICAL intervention levels. The constraint…” (368) As has been said previously, the last sentence of (342) could perhaps be better placed here.