The comments offered for consideration by ICRP have been discussed in a Working Party of the Group of Experts under Article 31 of the EURATOM Treaty in consideration of the ongoing process of review of the Basic Safety Standards. The European Commission forwards these comments on its own initiative, since there is no time for consultation of the full Group within the time period for public consultation. The Group of Experts is organising a scientific seminar in October related to the new Recommendations. This may give rise to further, possibly more fundamental, comments. The European Commission feels that further reflection is needed for the two topics concept of "constraints" and "natural radiation sources" before adoption of the Recommendations. In addition, the use of effective dose in the case of medical exposures should be addressed. The development of the recommendations is emphasised, but the reader which is interested in the recommendations themselves would have difficulties to use them without an extensive study of previous recommendations or other texts of the ICRP. The draft as such is not an independent self consistent text to be used in radiation protection field. Examples: paragraphs (114), (117) and (126). Version: 11 September 2006 (11) The introduction already uses some fundamental concepts (for example “planned exposure situations” in the paragraph (11)) These fundamental concepts should be immediately followed by an appropriate reference. (12) In the last sentence “any changes” should be replaced by “any substantial changes”. (13) Move last sentence up to end of (12). (26) Replace "economic" by "societal". (30) Delete "maximum" in "limitation of maximum doses". (33) First sentence: add, "… the type of source, exposure situation or exposed individual". (34) The last sentence is actually repeated in the second sentence in the paragraph (161). (38) The word "endeavour" helps to clarify the concept of practice; however it is debatable whether the last sentence (action on the source) is essential. (39) The second part of the last sentence is unclear ("… are the only options."). (42) Delete, "… it may not be sufficient" in 3rd sentence from bottom. (44) Delete last sentence. (45) In the second bullet the word “optimised” which has usually a specific meaning in radiation protection is applied using its general meaning. It would be appropriate to use different wording for optimisation of protection and optimisation of regulatory resources. (46) In the last sentence “10 micro Sv/y” should be changed to “around 10 micro Sv/y” (74) Delete this paragraph: it is unnecessarily speculative. (125) Consistent symbol Hp [small p, cf. (133)]. (126) The paragraphs (126) and (130) should be structured in the same way. (128) This recommendation should also be made in relation to constraints. (130) The paragraphs (126) and (130) should be structured in the same way. (132) In the third sentence a word “quantities” is too general. Instead the sentence could introduce “direct” and “indirect” methods. (145) In the fourth sentence a word “quantity” should be replaced with “unit.” (146) Delete, "… and combines several areas of uncertainty". In some cases the uncertainty is less for the collective dose than for individual doses (e.g., for the food inspection pathway)". (147) Delete, "based on epidemiological studies". (148) Delete this paragraph: the dis-aggregation of collective dose can be done in many different ways, and integrating over a range of effective doses will rarely be appropriate. (157) Delete "of patients" (see 5.4.2: "including their comforters and carers".) (162) This paragraph is still not very clear. Delete the last sentences of the two first bullets; the described circumstances do not address unambiguously whether long-term remedial action belongs to emergency situations or existing exposure situations. The word “planned” seems to be limited to already functioning facilities and sources ("practices in operation"). The definition should also explain the relationship between exposures in the present facilities, or exposures related to a present source as appropriate, and future planned exposures for examples due to a new NPP. (165) Delete in first sentence, "… with the exception of…" (167) The issue of the exposure of the foetus needs to be addressed separately, in order not to make other definitions cumbersome; while the foetus should receive a level of protection similar to that of the public, it is not therefore "public exposure". The public exposure should be carefully redefined, namely “pregnant patient undergoing a radiological procedure” is mentioned in the second sentence. (171) The first sentence should have a reference to a definition of “controlled area”. The last sentence should be more prudent so “are treated” should be replaced by “could be usually treated”. (173) Delete second sentence for inclusion in 5.8.1 The first part of the first sentence should be replaced as for example “Exposures could incur in the care and support of patient.” The same is valid for the second sentence of the paragraph (215). (178) In the first sentence “designated radiation areas” are mentioned so it could be appropriate to give a reference to present paragraph (395). (183) In the first sentence a term “regulated source” is used here for the first time. The sentence should be rewritten in order to avoid misinterpretation. (184) In the third sentence “class of exposure” is used. The term should be explained. (185) Both terms “Source related:” and “Individual related:” should be introduced with a sentence. (188) Replace: "not dependent on external factors …" by "common to specific practices of the same type". The choice of a site might be subject to justification, and potential population doses are highly site-dependent. (190), (197), (224), (378) Too many terms are used for a “regulator” (i.e. government agency, national authority, responsible agency, regulatory authority). (193) Definition is not clear and should be rewritten. (200) Delete 3rd sentence: since optimisation will yield doses below the constraint, the latter can very well be equal to the dose limit. (201) Delete 2nd sentence: the dose limits would not apply to these cases. (205) Delete 1st sentence: "…but not necessarily from the exposure or the source of the exposure itself." This is obvious except for medical exposures. (206) Delete last two sentences. (207) 1st sentence: delete "incremental", delete second sentence (and "however" in third). (208) Address long-term exposure after an accident; explain why a time horizon of one year was chosen. (209) Delete last two sentences. (210) The first step should establish the appropriate band of constraints, allowing for the characteristics of the exposure situation and the affected individuals. The second step is to allow for the "practicability of reducing or preventing the exposures". This process of generic optimisation and other approaches ("good practice") will then yield a specific constraint for a type of source. (213) Delete in last sentence: "and, ideally …". (215) Last-but-one sentence: replace "should" by "could". (216) Delete last sentence. (220) Delete 2nd part of last sentence. (230) Delete this paragraph. (234) Delete the last two sentences. (239) Before the second statement related to ICRP60 a proposed current recommendation should be unambiguously given. (240) Add: "There may also be special authorisation for higher doses, with involvement of all the parties concerned. (243) Last sentence: the degree of informed consent does not (always) vary based on the exposure level. But it should vary. (244) Delete last sentence. (246) In the first sentence the recommendation for training should also include other staff, medical physicists, radiographers, etc.. The deliberate nature of the exposure should be deleted. This has nothing to do with training. The last sentence wrongly suggests that there is no regulatory control at all! Add: The final responsibility however lies with the physicians. (247) The justification should also include the analysis if other techniques which do not require exposure to ionising radiation are more appropriate. (249) Third sentence is not clear: …who are not directly connected with the procedure (a secretary of the radiological department is also somehow connected). There should be a balance between the radiation protection of the patient and the staff and members of the public who are directly involved (Protecting the staff during an angiogram increases the dose to the patient due to a longer investigation time. Without any protection, the investigation goes more quickly, but the staff receives a higher dose). (250) Last sentence: Use the term "referral criteria". Add a comment on (non-)justification of "fun" CT scans. (251) This paragraph provides a misleading message. It is not true that due to the justification process less attention is given to optimisation. Both principles should be applied, they are even very important in medical exposures as no dose limits apply. Moreover, more and more attention is given to optimisation in medicine. In the last sentence the word “difficult” should be rewritten to “sometimes difficult”. (252) The second sentences should be rewritten in order to clarify the concept of optimisation. A diagnostic reference level is set for a so called standard patient. As many patients are different from the standard, diagnostic reference levels may often be exceeded for good reasons. (254)-(259) Add the fact that in nuclear medicine a reference level will be aimed at. The doses should not be lower as this reference level, in order not to miss important information. (257) Move after (258). (259) Delete this paragraph. (260)-(264) Pregnant patients: This subchapter gives the impression as if there is never any harm. However, exposures like CT abdomen with contrast should only be performed after careful justification. Add: The patient should always be asked whether she is pregnant, and the dose to the foetus should always be assessed. (262) Delete: however (263) The first sentence is very general and should be omitted. The radiation protection experts should limit their expertise on radiation protection issues and not implicitly recommend any further action if the dose is above 100mGy. (264) More firmly: Delete first sentence; second sentence: "The involvement of pregnant females in … should be prohibited or strongly discouraged." Add a comment that the risk to the foetus is about the same as the risk to young children. (265) Add a comment that the exposure of comforters and carers is received willingly and knowingly. (266) - Delete 2nd sentence (repetition of 265; delete in last sentence, "… i.e., be subject to a constraint." - Last sentence: Should be harmonised with the wording in paragraph (275). Both wordings remain unclear. (267) Change use to participation. Change biomedical to biomedical and medical. Add a sentence about the justification process and ethical committees. (269) Delete this paragraph. (270) Change title: "…after treatment with unsealed radionuclides". (271) This paragraph mixes two aspects of public exposure: discharges of nuclear medicine departments and restrictions to nuclear medicine patients. (272) Delete high-energy. (273) Change controlled to considered, as these doses cannot be controlled. Change "under the age of 15 is highly radiosensitive" to "from the age 15 down, children are more and more radiosensitive". (274) A lot of repetition! See also (276). (275) Change the last sentence: They should be subject to a dose constraint at the level of the public dose limit of 1 mSv/year. (276) Storage of urine at home is no longer practiced. (279) Constraints are labelled "levels of aspiration" which is not consistent with the concept as described elsewhere; the last sentence is difficult to understand: while the statement is correct for a constraint, it is not clear that "no action is required below action levels". (280) Justifiable = justified. Delete last sentence. (282) This paragraph is apologetic and unconvincing; the reason why NORM has not been dealt with in the past is not because of a "development of human society" or "industrial developments in recent years". The first part of the first sentence is very general and need not to be a part of radiation protection issues. The sentence should be rewritten. (285) The “mGy” should be probably replaced by “mSv”. (289) Public exposure may result from historic waste accumulation and hence it can be argued that the dose limit does not apply (as for existing situations); there are no different dose constraints for different exposure situations (planned, existing, etc,); public exposure from effluents should be treated as planned exposure. (290), (378) “Graded approach” should be harmonised and defined. (291) Two words are used in the first sentence namely “formally regulated or controlled”. The difference of these two concepts is not explained in the recommendation. (291)-(295) Whole chapter 7.3 should be before 7.2. (294) Delete this paragraph (see chapter 2.3). It could be appropriate to define “trivial” exposure also in this paragraph. (295) Delete this paragraph (not useful and not specific for natural radiation. Also: non-edible material entered twice). (297) Reference to the old conversion conventions based on the detriment among miners in (299) is inconsistent with the sentence in (297) that the "estimation of risk be based on the results of pooled residential case control studies". (303) Link to the dose conversion in (299). (304) It should be explained how the intake of lead-212 can be controlled. Last sentence is just a statement but is should be explained. (309) Potential exposures do not relate to existing situations. (318) Express risk in annual probabilities. (324) The first sentence should mention that the “increasing concern” is related to the last decade. (328) Move to chapter 3.4. (328-330) (332) Examples are not needed; accident in Thailand is of a different type. (333) Move "defence in depth" to chapter 3.4. (342) Delete last sentence. (345) Delete last sentence, it is confusing. (346) Reverse the argument: intervention levels imply justification of intervention for the marginal population that would just exceed these; the exposed population within these boundaries will have a higher projected dose, hence there will be a positive net benefit for the overall affected population. (349) The last two sentences are not quite clear; they could be deleted. (378) Last sentence gives a very peculiar view on the "graded approach". (381) In the first sentence a plant and equipment is mentioned. The paragraph should not be focused just on plants. (386) In the last sentence the “administrative conditions” should be explained in order to avoid misinterpretations. (388) Replace "usually" by "often". (395) The paragraphs (393) – (395) could be given before, probably as a part of 11.2. Management requirements. In addition: • The definitions of terms should be given once and from then on used consistently throughout the text. Example: “Tissue reactions” is used and/or just partly defined in paragraphs (29), (48), (53), (88) and (93). The definition is given in the Glossary. Despite the definition in the Glossary the first sentence in paragraph (88) states “sometimes also, but les precisely, termed deterministic effects”. • In the paragraph (191) a three level system of justification is explained while in the paragraph (247) a two level system is used. • Unnecessary repetition should be avoided. Examples: - last sentence in paragraph (115) and fourth sentence in paragraph (129) - paragraph (90) partly introduces “operational quantities” and paragraph (121) again explains the term taking into account also equivalent doses - paragraphs (158) and (181) both define “individual - related” assessment or approach, while (158) and (182) both define “source - related” concept - First sentence in paragraph (173) and third sentence in the paragraph (215). • The text should avoid the introduction of ideas which later on are not elaborated. Example: in paragraph (36) the idea in the last sentence “….groups that are relevant to…” should be somewhere elaborated. • Some ideas need to be elaborated. Example: The radiation protection of “screening” programmes as a part of medical exposure is just mentioned once, in paragraph (168). The screening program is not mentioned at all in paragraphs (136), (137) and (138). In addition, the fact that all examined persons are not patients should be mentioned and it could be appropriate to mention the issue regarding justification of medical exposure or even include screening in the public exposure. • The references on other paragraphs should be given. An example is given in paragraph (14) where two important concepts are mentioned “source related protection” and “individual related protection”. At least paragraph (158) should be mentioned where terms “source related assessment” and “individual related assessment” are used. • In the section 9 “Emergency situation and existing situation”, the recommendation related to “dose constraints” and “intervention levels” in paragraphs (338) and (348) should be further explained. • Some recommendations related to students and the use of ionising radiation should be given. • Some additional recommendation related to producers and suppliers of sources should be given. • Some editorial improvements: - The abbreviation of AMAD could be omitted. - The definitions should be consistently highlighted using for example italic font.