ML091170117

Staff Responses to Public Comments on DG-1186 (Rg 1.21, Rev. 2)

ML091170117
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Issue date:	06/01/2009
From:	Office of Nuclear Regulatory Research
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O'Donnell, Edward, RES/DE/RGB, x6265
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ML091170100	List: ML091170117
References
DG-1186 RG-1.021, Rev 2
Download: ML091170117 (54)

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June 1, 2009 1Enclosure 1 Staff Responses to Public Comments on Draft Regulatory Guide DG-1186 (Proposed Revision 2 of Regulatory Guide 1.21)

Public Comments NRC Response ID# Origin pp Sec. Comment Resolution 1 NEI All All Radiation protection overall would be better served if the NRC were to revise all of the regulations and regulatory guidance concurrently to reflect the current radiation protection standard. The current piecemeal approach has resulted in inconsistencies and confusion. This document references ICRP 2, and ICRP 26. The ICRP recently released ICRP 103 and the NRC is actively considering amending the basis for its regulations as a result. NRC should adopt a more holistic approach to revising the regulatory guidance for calculating dose to the public (and workers). There is limited benefit to revising RG 1.21 to reflect ICRP 26 when 10CFR 50 Appendix I, 40 CFR 190, RG 1.109, and NUREG 0133 all continue to use ICRP 2 and the NRC is planning to update 10 CFR 20 to meet ICRP 103. All of the radiation protection-effluent control documents should be revised concurrently to avoid confusion and to minimize the potential for inadvertent non-compliance. The staff disagrees with the comment. The existing guidance is over 30 years old. It is necessary to update this regulatory guide to bring the guidance up to current industry practices. This RG reflects current regulations (10 CFR 20 and Appendix I) that are based on ICRP-26 and ICRP-2 therefore it is necessary to include references to both. 2 NEI All All This draft imposes a number of new approaches in terms of monitoring requirements for radionuclides, characterizing and reporting activity, multiple and divergent methods for assessing and summing dose impacts, etc. and is likely to require, among other things, revision and V&V of dose assessment software. A realistic backfit analysis needs to be performed using the existing regulations and The staff disagrees with the comment. The NRC issues regulatory guides to describe methods the staff considers acceptable for use in implementing specific parts of the agency's regulations, to explain techniques that the staff uses in evaluating specific problems or postulated accidents, and to provide guidance to applicants. Regulatory June 1, 2009 2regulatory guidance as the baseline. In the past, the NRC had stated that it was unnecessary to revise Regulatory Guide 1.109 because the cost to the licensees to revise dose assessment. guides are not substitutes for regulations, and compliance with them is not required. The methods and practices outlined in regulatory guides are one acceptable method for implementing the regulations. Nuclear power reactor licensees may continue to use Revision 1 of Regulatory Guide 1.21, dated June, 1974, or may adopt other procedures or practices that provide for the measuring, evaluating, and reporting radioactive material in liquid and gaseous effluents and solid waste. A backfit analysis is not appropriate for this regulatory guide. 3 NEI 4 B.1 [The last paragraph in B.1] states that NUREG-1301/1302 provide the detailed implementation guidance for effluent and environmental monitoring. Having said that, there should be no need to duplicate, nor expand upon, those requirements in RG 1.21. RG 1.21 should emphasize reporting effluent releases, and assessing the impact of those releases to areas beyond the site boundary, only to the extent necessary to provide additional clarification or guidance that does not exist in NUREG-1301/1302. RG 1.21 should not establish additional requirements above and beyond what is required to show compliance with effluent dose limits, such as imposition of calculation of dose to occupational workers onsite. The staff agrees with the comment. The document was revised to accommodate this comment. Much duplicative information was removed (e.g., the tables for Environmental LLDs and Reporting Levels were removed). Additionally, duplication of information already contained in NUREG-1301/1302 is avoided where practical. However, there are instances where clearly stating the objectives establishes the correct framework for a staff position. It is part of a long-range plan to consolidate various historical documents (Health Physics Position Statements, NUREGS, etc) into staff positions as the regulatory guides on radioactive effluents are revised. 4 NEI 16 18 22 B.5 B.5.7 B.5.11.5.2 There are new requirements in draft RG 1.21 that are inconsistent with other NRC regulations and guidance including: NUREG-1301/1302, RG 1.109, NUREG-0133, NUREG-0543, and the Federal Register for the most recent 10CFR20 revision (FR, The staff disagrees with parts of the comment as described below. RGs are not requirements. Additionally, although licensees Technical Specifications may allow licensees to not calculate 40 CFR June 1, 2009 3Vol. 56, No. 98, 5/21/91), as well as licensee Technical Specifications. Under existing regulations, the licensee is only required to demonstrate compliance with 40CFR190 if a 10CFR50 effluent dose objective is exceeded by a factor of two or more. Federal Register, Vol. 56, No. 98, page 23374, states that demonstrating compliance with 10CFR50, App. I and/or 40CFR190 will be deemed to demonstrate compliance with the 0.1 rem 10CFR20 dose limit. However, DG-1186 requires dose calculations for the 0.1 rem TEDE (10CFR20) limit in addition to 10CFR50, App. I, and 40CFR190 calculations. Further, for 10CFR20 doses, it is technically incorrect to sum whole body doses calculated with ICRP-2 dose factors (RG 1.109 dose conversion factors) to demonstrate compliance with TEDE dose limits from ICRP-30. 190 dose unless radioactive effluents exceed twice the 10 CFR 50 Appendix I design objectives, licensees are nonetheless accountable to the regulatory requirement that the 40 CFR 190 limits will not be exceeded. The staff agrees with parts of the comment as described below. Demonstrating compliance with EPA's 40 CFR 190 is sufficient to demonstrate compliance with NRC's 100 mrem TEDE dose limit for members of the public. Sections B.5, B.5.5, B.5.6, B.5.7, and B.5.11 were revised. 5 NEI 56 Table A-5 As stated above, the summation of liquid and gaseous effluent whole body doses per ICRP-2 in RG 1.109 is incongruent with TEDE dose requirements in 10CFR20. Adding a direct radiation component assessed by TLDs may result in duplication of dose from effluents, and would result in an overestimation of dose impact. See comments on pages 22 and 23 of the draft regulatory guide. In addition, the dose contribution from a direct radiation component most likely will result in a different sector and distance being identified than would occur for effluent releases only. The staff agrees with the comment. The document was revised to accommodate this comment. Table A-5 was deleted. 6 NEI 3 B.1 Since RG 1.109 is referred to by NUREG 1301/1302 and in the draft RG 1.21, it should be included as a reference in section B.1 Regulatory Guidance. The staff agrees with the comment. NUREG-1301 and NUREG-1302 were added to the list of references.

June 1, 2009 47 NEI 4 B.2 In section B.2, the second item (5) should be corrected as follows: "Compliance with the effluent reporting requirements of 10 CFR 50.36a". The staff agrees with the comment. The typographical error was corrected as indicated. 8 NEI 5 1(b) This example of less significant or intermittent release points includes many systems that are most likely not currently captured in many plant's ODCMs, nor identified as required in NUREG-1301/1302.

The NRC should perform a meaningful backfit analysis before proceeding. The staff disagrees with the comment. The ODCM should include some recognition (e.g., a list) of the potentially significant release points for the site. This staff guidance is appropriate based on 10 CFR 50.36a regarding reporting "principal" nuclides in effluents and 10 CFR 50, Appendix I which states, "account shall be taken of all sources and pathways within the plant contributing to the particular type of effluent being considered." In order to underscore the importance of the above regulations and to ease implementation of this RG, the construct of "significant release points" and "less-significant release points" has been revised as follows. Less-significant release points do not have to be listed in the ODCM unless they could become a significant release point based on expected operational occurrences (e.g., primary to secondary leakage for PWRs or failed fuel). This list of potentially significant release points does not need to be exhaustive or all-inclusive with respect to all possible operational occurrences but instead should demonstrate the licensee has reasonably anticipated expected operational occurrences and their effects on radioactive discharges. This RG now recommends less-significant release points should be listed in site documentation.

June 1, 2009 5The issue regarding a backfit analysis is addressed in NRCs comment to NEI question #2. 9 NEI 6 9 1 The Reg. Guide should explicitly state that only plant-related licensed material must be reported in the ARERR. Naturally-occurring and/or background radioactivity, such as K-40 and U/Th progeny, should not be reported in the effluent reports. The staff agrees with the comment. To ensure that background radioactivity would not be included in the reported results, the first sentence of section A was revised to mention "plant-related activity" and to exclude background radiation. 10 NEI 6 1 This revision establishes a new threshold for what is considered "significant" related to release activity or dose impact. Regulatory Guide 1.109 established 10% as the threshold for determining whether an exposure pathway should be factored into dose calculations. This draft RG 1.21 drops that threshold to 1%, and applies it to all activity released and/or to overall dose impact without any meaningful backfit analysis or health-based justification. Other than the subjective phrase "-to the extent reasonable", this revision does not allow licensees to omit an impact less than 1%; licensees are effectively required to continue to track these as "less than significant", with apparently no lower cutoff. The staff disagrees that RG 1.21 Revision 2 revises the threshold for "significant exposure pathways" established by RG 1.109. These criteria (10% in RG 1.109 and 1% in RG 1.21) are used in different ways and for different purposes. The staff agrees that a new 1% threshold is established for purposes of determining the "principal nuclides" and "significant release points." The staff guidance in RG 1.109 section "C" (i.e., 10%) applies to determining the significance of new (or "other") exposure pathways not listed in RG 1.109 (not release points). The guidance in RG 1.109 does not provide guidance for reporting (or not reporting) the activity discharged in radioactive effluents. The guidance in RG 1.109 does not provide a basis for adjusting the sample frequencies for release points. That is why the "1%

concept" in RG 1.21 was developed. The 1% concept in RG 1.21 allows licensees to modify sampling and analysis of less-significant release points. This allows licensees to focus their efforts on significant release points (and nuclides) and address June 1, 2009 6less-significant release points (and not principal nuclides) is an appropriate manner. The 1% staff guidance in RG 1.21 provides licensees a risk-informed method to meet the regulatory requirements of 10 CFR 50 Appendix I, Section III.A.1 -"such that the actual exposure - is unlikely to be underestimated" where "account shall be taken of all sources and pathways within the plant contributing to the particular type of effluent being considered." The issue regarding a backfit analysis is addressed in NRCs comment to NEI question #2. 11 NEI 7 1 The notification of the public is described in detail in NEI 07-07 "INDUSTRY GROUND WATER PROTECTION INITIATIVE - FINAL GUIDANCE DOCUMENT" issued August 31, 2007. There is no known regulatory basis for the inclusion of such a requirement by the staff in this regulatory guide.

We believe this to be good practice and would continue to do so as a part of the GWPI. The staff agrees that NEI 07-07 contains details regarding the voluntary ground water initiative. The staff disagrees that there is no regulatory requirements regarding communication with the public (see 10 CFR 50.72(b)). The section on "Monitoring Leaks and spills was revised to clarify and sharpen the intent. The intent is to (1) prevent the unmonitored release of radioactive materials to offsite areas and (2) ensure proper reporting of materials released offsite. And (3) highlight NRCs interest in notifications to public officials with respect to 10 CFR 50.72(b)(xi). This guidance should be included in this RG since it is concerned with reporting releases. 12 NEI 7 1 The proposed definition of "promptly" with regards to remediation of a leak or spill is unreasonable and is not always practically achievable. Licensees should have the flexibility to define the appropriate timeframe for clean-up of a spill or leak, taking into The staff disagrees with the comment. It is important to include a timeframe in the RG. 48 hour5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> is an example timeframe that the NRC considers to be a reasonably timely response for prompt remediation. This does June 1, 2009 7consideration ALARA, realistic exposure pathways, and the site-specific soil and ground water characteristics. This apparently arbitrary time frame is inconsistent with current requirements for materials and fuel cycle. not exclude the use of other time frames. Licensees may use other timeframes if it is justified. 13 NEI 8 1 This discussion states that the list of nuclides in NUREG-1301/1302 for which LLDs are specified is not a list of principal nuclides and is only a starting point.

The draft goes on to say that "principal" nuclides may be site specific and could make compliance with "requirements" difficult.

This definition conflicts with the definition in the NUREGS and is likely to result in confusion and potential non-compliance.

Further, the risk-based approach could have the unintended consequence of allowing licensees to trim the list of "principal" nuclides to only one or two nuclides. For example, if gaseous tritium releases account for curie-level quantities and 99.99% of the total activity and also account for 95% of the dose (with the other 5% coming from I-131 and C-14), then potentially, all other nuclides would not be analyzed or reported as long as they contribute less that 1% of the activity or dose.

In addition, this allowance for licensees to drop nuclides from the principal nuclides list directly conflicts with the requirement to report ALL activity as established on page 6 [of the proposed draft RG 1.21]. The staff agrees that RG 1.21 Revision 2 introduces a risk-informed concept with respect to determining principal nuclides and establishing the appropriate analytical sensitivity (e.g., LLD) for analyses. The staff also agrees that the risk-informed concept could be improved by including some of the ideas presented in this comment. As a result, the words "starting point" have been deleted. This staff guidance applies a risk-informed philosophy that allows licensees to focus the appropriate attention on those radionuclides that predominate at a nuclear power plant site (i.e., those that are most important contributors to the dose to members of the public or the total activity at a site). The staff guidance does not conflict with NUREG-1301/1302 since the guidance suggests licensees may continue to use the guidance in NUREG-1301/1302. Two methods of determining principal radionuclides are provided in RG 1.21; (1) use the existing list of principal radionuclides from NUREG-1301/1302, and (2) use a risk informed approach. Both methods are acceptable, and licensees may choose another method provided it is documented and it satisfies the regulation (10 CFR 50.36a).

June 1, 2009 8The choice is left to the licensee. The NRC thinks it is important to allow licensees the choice to use the existing approach (NUREG-1301/1302) or a risk informed approach. The use of a risk informed approach (involving "principal radionuclides") allows licensees some options with respect to selecting LLDs for analysis of waste streams that do not provide significant contribution to effluent dose or activity. This flexibility may be desirable to some licensees and is consistent with a risk-informed philosophy. Licensees are not required to implement a risk-informed approach. Licensees may consider other approaches or may continue to use the (historical) approach outlined in NUREG-1301/1302. The NRCs intent is to allow licensees the option to shift toward a risk-informed approach that provides guidance acceptable to meet the regulations to ensure adequate protection of the public. NUREG-1301 and NUREG-1302 provide a definition of "principal gamma emitter," but do not define the term "principal radionuclide." NUREG-1301/1302 list 11 gamma emitters in liquid effluents for which the LLD control applies (17 gamma emitters for gaseous effluents), and says that other "gamma peaks" should be analyzed and reported. Analytical sensitivity levels for the other gamma peaks are not provided in NUREG-1301/1302. As a result, NUREG-1301/1302 does not provide analytical sensitivity levels for all radionuclides that may be present at a site. Providing June 1, 2009 9sensitivity levels for all nuclides present at a site is desirable from the NRCs perspective of ensuring adequate protection of the public. Rev 1 of RG 1.21 (1974) listed a common sensitivity level of 5E-7 uCi/ml for all gamma emitters in liquid effluents. Although this was reasonable and appropriate guidance when RG 1.21 was published in 1974, this is no longer possible for some gamma emitting nuclides (e.g., Te-125m) unless licensees adopt significantly longer count times or employ alternate analytical techniques. The risk informed approach of "principal nuclides" addresses this issue while ensuring adequate protection of the public. The regulation that forms the basis for the ARERR (10 CFR 50.36a) says licensees "shall submit a report to the Commission annually that specifies the quantities of each of the principal radionuclides released to the unrestricted area-." The guidance in RG 1.21 is intended to outline a staff position the NRC considers acceptable to meet this regulation. NUREG-1301/1302 do not address the term "principal radionuclide." The concept of principal radionuclide may not be used as a basis to not report nuclides detected in a waste stream. As described in DG-1186, the concept of "principal nuclide" may be used by the licensee to select an appropriate LLD for analysis. Page 6 of the proposed RG 1.21 said if a nuclide is detected, it should be reported. That statement is consistent with NUREG-1301/1302 and it does not conflict with the June 1, 2009 10concept of principal nuclide. 14 NEI 9 1 The reg. guide requires the reporting of carbon 14 which is a new reporting requirement for U. S. reactors. Carbon 14 is a very low energy beta release with very low dose conversion factor. The basis for the new reporting requirement is discussed in Section 1. The option to calculate C-14 effluent discharge is a reasonable alternative to monitoring. Since we are required to report uncertainties on our measurements, the NRC needs to provide guidance on how licensees should determine what uncertainties would apply to C-14 release estimated by scaling the power rating of the reactor. The staff agrees with the comment, and the following guidance has been added to the document. Licensees need to account for and report all principal radionuclides; i.e.,

those contributing more than 1% by dose or activity. C-14 may be a principal radionuclide contributing more than 1% of the total radioactive effluent by activity or by dose, and if so, should be considered a principal radionuclide and reported in the annual report. The following statement was added to the document: It is not necessary to calculate uncertainties for C-14 nor include C-14 uncertainty in any subsequent calculation of overall uncertainty. 15 NEI 9 2 The words "up to three volumes" implies that anything in excess of 3 volumes is not desirable, and that even 1/10th of a tank volume would be adequate, since it meets the definition of "up to three". The language needs to be clarified. The staff agrees with the comment. The wording was changed to reflect the actual intent (to recirculate at least 3 volumes). 16 NEI 10 2 There are several concerns about short-lived nuclides and the proposed changes to regulatory guidance, chief among which is the conflict with current regulation in 10 CFR 50, and guidance in RG 1.109 and NUREG-1301/1302. Also, there seems to be confusion in the basis and a potential misleading statement made regarding decay-correcting short lived activity to sample midpoint. Short-lived activity collected on days 1 through 6 of a 1-week sample period should be accounted for in the buildup-decay equation in gamma spec software. However, if the activity is decay-corrected to the sample mid-point, the The staff agrees with the comment. This section was revised.

June 1, 2009 11activity level will be grossly OVERESTIMATED by several orders of magnitude, potentially by as much as a factor of 1E+47 for 138Cs and other short-lived nuclides. One option to avoid this overestimation would be to delay the counting of particulate filters for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> following collection to allow these nuclides, and any naturally-occurring radon progeny, to decay before counting the filters. 17 NEI 10 11 3 Not all existing plants are committed to RG 1.23. Each plant's licensing basis identifies the regulatory guide commitments. The staff agrees with the comment. The reference to RG 1.23 on meteorology is provided as an acceptable method of measuring and determining meteorological parameters. Regulatory guides are not substitutes for regulations, and compliance with them is not required. The methods and practices outlined in regulatory guides are one acceptable method for implementing the regulations. The verbiage was changed from "should use" to "should consider using" 18 NEI 11 12 3 The NRC "Liquid Radioactive Release Lessons Learned Taskforce Final Report" (LRRLLTF) concluded that no regulatory requirement exist for the monitoring of groundwater onsite exists {"- there are no specific regulatory requirements for licensees to conduct routine on-site environmental surveys and monitoring for potential abnormal spills and leaks of radioactive liquids" page 19 of the LRRLLTF report}. The staff agrees with the LRRLLTF Final Report. The LRRLLTF Final Report concluded no routine on-site surveys are required for potential abnormal spills and leaks of radioactive liquids. However as noted in the following sentence of the LRRLLTF report, surveys are required for on-site spills and leaks in order to satisfy the records requirements of 10 CFR 50.75(g). 19 NEI 11 3 The emphasis on on-site groundwater monitoring for inadvertent subsurface contamination from leaks and spills is unjustified given that the NRC's Liquid Effluent Releases Task Force Lessons Learned Final Report issued September 1, 2006 stated, "The most significant conclusion of the task force regarded public health impacts. Although The staff disagrees with the comment. Due to ground water contamination events over the last 4 years, NEI and the industry have made changes to industry guidance documents. Because subsurface contamination events may impact reporting of radioactive effluents, it is appropriate to June 1, 2009 12there have been a number of industry events where radioactive liquid was released to the environment in an unplanned and unmonitored fashion, based on the data available, the task force did not identify any instances where the health of the public was impacted." (page 4 LRRLLTF report) include such discussions in this guidance document. 20 NEI All All The NRC has now generated several guidance documents on the same subject of groundwater monitoring that are duplicative and are likely to have the unintended consequence of resulting in conflicting guidance. These include Regulatory Guide 4.21, Regulatory draft Regulatory Guide 4.1 and the Draft Guidance to Implement Survey and Monitoring Requirements Pursuant to Proposed Rule Text in 10 CFR 20.1406(c) and 10 CFR 20.1501(a) that supports the Decommissioning Planning Rulemaking. All of the proposed guidance documents should be withdrawn and, if risk-justified, a single guidance document provided. These all claim to be implementing the same regulatory requirements but with different results. These multiple regulatory guidance documents create a high likelihood for conflict and confusing licensees. The staff disagrees with the comment. The NRC has issued or plans to issue regulatory guides on a number of topics. Regulatory Guide 4.21 was issued to provide guidance to new reactor licensees. This document contains information about groundwater monitoring that is applicable to new reactor license applicants but is not (at this time) applicable to existing reactors. Similarly, RG 4.22 will be issued to provide guidance to licensees on decommissioning funding. That document addresses ground water in a limited regard with respect to decommissioning funding and surveys. RG 4.1 (scheduled to be issued 2009) addresses ground water with respect to environmental programs. RG 1.21 (scheduled to be issued in 2009) provides staff guidance on sampling, monitoring, and evaluating and reporting ground water results in the annual report. Each document has a different scope and it is not practical to combine all the guidance into a single document. 21 NEI 1 A The Regulatory Guide needs to clearly state the applicability of the on-site environmental monitoring program for the existing as well as new plants.

NRC should give licensees the option to continue using the current version of R.G. 1.21, as The staff has clarified the position on monitoring, evaluating, and reporting leaks and spills in the context of the Annual Radiological Effluent Release Report. The guidance is the same for new license applicants and existing power reactors.

June 1, 2009 13referenced by licensing documents. Clarification was added to section A specifying licensees could continue to use RG 1.21 Rev 1. 22 NEI 6 1 Draft RG 1.21 appropriately recognizes the need for a graded approach to ground water monitoring and characterization studies even though the proposal to impose requirements for on-site monitoring of ground water is not justified from a risk-informed perspective. The staff disagrees that no on-site monitoring is justified for leaks and spills since the survey requirements of 10 CFR 20.1501 and the records requirements of 10 CFR 50.75(g) would apply. The staff positions in RG 1.21 Revision 2 relate to monitoring, evaluating, and reporting effluents from nuclear power plants. This includes contributions from leaks and spills. The verbiage regarding a graded approach will be retained. 23 NEI 12 3 The reference to an unapproved and unpublished standard (ANSI 2.17) is inappropriate; delete The staff disagrees with the comment. The reference will be retained. Although the document is still in draft form, it is expected to be approved within 6 months of issuance of RG 1.21. The NRC has reviewed this document and it is considered appropriate to reference this document as one source of information. No changes required. 24 NEI 12 3 The EPRI Groundwater Protection Guidelines (1015118, Ref. 32) should be referenced directly in the text and not left to the imagination of the reader as to what the reference to various other industry documents might include. There is a public version of EPRI Groundwater Protection Guidelines and therefore no transparency issues. The staff agrees with the comment. A direct reference to the EPRI Groundwater Protection Guidelines (1015118, Ref. 32) was added to the text (under the section on spills and leaks to ground water). 25 NEI 12 3 The quoted statement implies that sites with residual contamination more than a factor of 10 to 100 above laboratory LLDs require extensive site characterization or monitoring. This statement does The staff agrees with the comment. Reference to a factor of 10 to 100 was removed from the document.

June 1, 2009 14not appear to be risk-informed. Tritium, for example, has a required LLD of 2000 pCi/l. At a concentration of 20,000 pCi/l (10 times the LLD),

the potential dose impact is less than 1 mrem/year using ICRP 30 methodology (see also Federal Guidance Report 11) to calculate the MCL at 86,000 pCi/l for [tritium]. 26 NEI 13 3 This requires reporting of on-site ground water sample results in the AREOR. This creates unnecessary conflict with NEI 07-07 Objective 2.2 acceptance criterion b, which requires the reporting of non-REMP ground water samples in the ARERR, and REMP ground water samples in the AREOR. The staff agrees with the comment. The guidance for the environmental monitoring program was relocated to RG 4.1. 27 NEI 15 22 5.11.3 The discussion of elements to include in measurement uncertainty identifies some contributions that may not be obvious but does not appear to include uncertainties contributing to dose assessment, such as meteorology measurements, dispersion (X/Q, D/Q) factors, environmental buildup and transport factors, dose conversion factors, TLDs, etc. Also, using the square root of the sum of squares of the pooled uncertainties is a bit of an oversimplification and potentially misleading. The uncertainties presented in tables A-1 and A-2 pool all release points and all nuclides within a given category, including those release points that contribute much less than 1% of the total activity or dose. The pooled uncertainty needs to be somehow weighted with respect to the release point's relative contribution, and the simplified approach of taking the square root of the sum of squares of pooled. The staff agrees that additional clarification is needed for uncertainties. Staff guidance on uncertainty was revised to clarify the intent to provide a reasonable estimate of the uncertainty. A rigorous calculation involving every possible contributor to uncertainty is not necessary. The staff guidance in RG 1.21 allows licensees to calculate uncertainty in different ways provided licensees include an estimate of the uncertainty in the annual report. 28 NEI 16 5.3 [The definition of member of the public may be inconsistent with 10 CFR 50.]. Is the correct verb The usage of "reside" is correct. Reworded June 1, 2009 15"reside"? and note that this definition continues to be inconsistent with 10 CFR 50 Appendix I definition - see 5.7.2 paragraph 5.7.2. 29 NEI 16 5.2 The discussion about "Occupational Workers" in section B.5.2 is not appropriate for the effluent control program. These individuals' exposure are managed under the Radiation Protection Program The staff agrees with the comment. Discussion on occupational workers has been deleted. 30 NEI 16 5.3 The on-site monitoring program in the draft RG 1.21 promulgates the unintended confusion caused by the 1991 revision to 10 CFR 20 without the concurrent revision to 10 CFR 50 Appendix I or RG 1.109, particularly with regards to the definition of a "member of the public." As stated earlier, all of the regulations and regulatory guidance should be revised in a comprehensive effort to implement the most recent radiation protection recommendations. The staff disagrees with the comment. The existing guidance is over 30 years old. It is necessary to update this regulatory guide to bring the guidance up to current industry practices. This RG reflects current regulations for part 20 particularly for 10 CFR 20.1302 that requires surveys of radiation levels and radioactive materials in effluents in controlled areas for purposes of complying with dose limits for members of the public. 31 NEI 18 18 22 5.6.4 5.7.7 5.11.4 Licensees already account for and report dose impacts from releases to the environment. Requiring licensees to effectively reduce (handicap) the dose limit by taking into account that residual dose is not risk-justified, particularly when considering RIS 2008-03 and given that the licensee must include any dose from residual activity at decommissioning. The discussion in this section is misleading and incorrect. While dose contributions from tritium and other nuclides dissolved or suspended in water continue after the release has occurred but may not have been included in the ARERR, it does not apply to all effluent exposure pathways. To the contrary, the RG 1.109 methodologies for sediment exposure, ground plane shine, and vegetable+milk+meat pathways already assume a The staff agrees that additional clarification with respect to residual radioactivity was warranted. Paragraph 5.6.4 was deleted. Paragraph 5.11.4 was deleted.

The issue regarding a backfit analysis is addressed in NRCs comment to NEI question #2.

June 1, 2009 1615-year buildup period. As such, these exposure pathways already account for radioactivity remaining in the environment from prior years' effluent releases. This imposes new requirements that will result in licensees potentially overestimating dose to the public. A meaningful backfit analysis should also be performed. In addition, there is no guidance in existing Reg Guides or NUREGs on how to assess dose contributions from previous years' discharges. The NRC needs to provide methodologies and a means of assessment for this additional pathway source term. 32 NEI 20 5.8.6 This section essentially requires licensees to perform a land use census. Under current guidance in NUREG-1301/1302, licensees are allowed to forego a land use census if they sample and monitor vegetation from the two sectors yielding the highest D/Q. This new requirement in RG 1.21 conflict with existing guidance and allowances in other NUREGs. Conversely, there needs to be an allowance to permit licensees to omit an exposure pathway (e..g, cow or goat milk) if it does not exist. This section should be retained, but clarified to state that it does not impose the requirement for a land use census. The staff disagrees with the comment. A land use census is required, but a garden census may be replaced by sampling vegetation as outlined in the NUREG-1301/1302. NUREG-1301/1302 says "-a LUC shall be conducted and shall identify the-nearest milk animal, - residence, and garden*." The footnote reference on garden provides clarification by saying, "-vegetation sampling.. may be performed at the site boundary- in lieu of the garden census." This provision only affects the "garden census" and it does not eliminate the requirements for the remainder of the land use census (e.g., nearest milk animal or nearest residence). Section 9.4.1.1 says dose calculations do not need to be performed if the pathway does not exist. 33 NEI 10 19 2 5.8.2.2 The reporting of gaseous effluents requires the reporting short lived airborne particulate activities such as Cesium 138 with a 2 minute half life.

The staff disagrees with the comment. Page 10, section 2, "Short-lived Nuclides" provides general staff guidance for short-lived nuclides. That particular section does not June 1, 2009 17There is no apparent technical justification for reporting isotopes with a half-life of less than eight days in air particulate matter. Some of the "particulate" nuclides listed in the example airborne tables, such as Tc-99m, Nb-95m, Te-132m, Cs-138, La-142, etc. have half lives much less than 8-days. Note this requires the reporting short lived airborne particulate activities such as Cesium 138 with a 2 minute half life.

If we report nuclides with half life less than 8 days, do we now have to perform dose assessments for those nuclides? This is inconsistent with NUREG-1301/1302 and Reg Guide 1.109 dose assessment guidance/requirements and even section 5.8.2.2 of the draft. require reporting of short lived nuclides. That staff guidance is located on page 6, where it says, "If activity is detected when monitoring a - release point, it must be reported in the effluent totals-." That guidance is consistent with NUREG-1301/1302 (which says, "Other gamma peaks that are identifiable, together with those of the above nuclides, shall also be analyzed and reported in the Annual Radioactive Effluent Release Report.") It is also consistent with 10 CFR 50 Appendix I, Section III.A.1 ("account shall be taken of the cumulative effect of all pathways and sources-"). NUREG-1301 and each licensee's technical specifications/ODCM specify calculating doses for (1) nuclides with half-lives greater than 8 days, and (2) I-131 and I-133. . The half-life criterion only applies to dose calculations. If short lived nuclides (less than 8 days) are detected, they should be reported in the annual report. According to NUREG-1301/1302 (3.11.2.3) and the licensee's ODCM, dose assessments only need to include (1) nuclides with half-lives less than 8 days, and (2) I-131 and I-133. The regulatory logic is that the short lived nuclides would not NORMALLY have significant contribution to the dose. The NRC may always impose additional restrictions per 10 CFR 50 Appendix I II.B.2(a). For example, if there is significant failed fuel at a site and the dose calculations indicated doses may exceed design objectives, the NRC could request June 1, 2009 18the licensee to include I-135 and I-132 in the dose calculations. 34 NEI 20 5.9.1.2 Draft RG 1.21 directs licensees to sum maximum organ doses from liquid and gaseous effluent pathways even though the releases will most likely affect different organs. Summing the GI-LLI In the case of liquid effluents, in which dose will likely occur from activation products such as Mn-54 or Co-60, the critical organ is most likely going to be GI-LLI. In the case of gaseous doses, which will likely be dominated by H-3, C-14, and I-131, the critical organ will be the thyroid. When organ doses are summed as in Section 5.11.5.1.2 one will be adding GI-LLI dose to thyroid dose. Such summation of doses across different organs is inappropriate and incorrect. The staff agrees with the comment. Section 5.9 was deleted. The example calculation in 5.11.5.1.2 was deleted. 35 NEI 22 5.11.3 TLDs do not selectively respond only to direct radiation from ISFSI and shine but are also responsive to exposure/dose from noble gas plumes and immersion, as well as any dose from particulate radioactivity deposited on the ground. These latter exposure pathways are already calculated and accounted for in RG 1.109 effluent dose calculations. Further, most environmental TLDs are specifically "calibrated" against Cs-137 exposure in air, and as such do NOT precisely measure deep-dose equivalent (i.e., total body dose) received by an individual. Deep-dose equivalent is usually considered to be some fraction of the air exposure. Summing effluent doses and TLD exposure in such situations will likely result in overestimating total dose. The staff agrees with the comment. The example calculation in 5.11 was deleted. 36 NEI 22 5.11.3.2 Typographical Error. Should that be TLDs (not Tads)? The staff agrees with the comment. The example calculation in 5.11 was deleted.

June 1, 2009 1937 NEI 22 5.11.3 The average "background" dose should be calculated from both Control TLDs as opposed to one control TLD to account for uncertainty. As such, the pooled uncertainty for background radiation assessed from the two control locations must incorporate the between-location-based variance in addition to the within-location uncertainty. The NRC should also consider and provide guidance on reporting direct radiation when the difference from background is not statistically different from zero. The staff agrees that licensees may choose to perform background subtraction by a number of techniques. The RG was modified to provide guidance. The example calculation in 5.11 was deleted. 38 NEI 22 5.11.4 Section 5.11.4 requires performing dose calculations from on-site pond H-3 evaporation. Unless this pathway represents a "significant exposure pathway" (contributes 10% of the total dose from all pathways considered), dose calculations should not be required. In addition, the NRC needs to provide clear guidance, and possibly an example of a dose calculation for this pathway. The staff agrees the 10% guidance in RG 1.109 (Section C) is sometimes misinterpreted. Pond evaporation involves a release point (e.g., the pond) and an exposure pathway (e.g., inhalation). The 10% provision of RG 1.109 applies to exposure pathways, not release points. As a result, dose calculations for an on-site pond would be required as part of a hazard assessment associated with an adequate survey (see 10 CFR 20.1501). See also the response to NEI comment #10 regarding the 10% provision in RG 1.109. Staff guidance for calculation of inhalation dose associated with the evaporation of water (e.g., from a pond) is given in RG 1.109 (C.3.b or Appendix C.2) and duplication in RG 1.21 is not needed. The example calculation in 5.11 was deleted. 39 NEI 23 5.11.5.2 Draft RG 1.21 directs licensees to sum 10CFR50 Appendix I whole body doses calculated based on ICRP-2 methodologies to approximate TEDE dose for 10CFR20, which are based on assumptions of ICRP-26/30. ICRP-26/30 uses different The staff agrees the example calculation in the draft guide had technical faults. The example calculation in 5.11 was deleted.

June 1, 2009 20methodologies, different metabolic models, different organ weighting factors and different dose factors than ICRP-2. This is technically incorrect; the NRC should revise all of the radiation protection regulations and regulatory guidance in a comprehensive, holistic manner rather than piecemeal See also the NRC response to NEI comment 1 above regarding revision of all regulations. 40 NEI 23 6 Table A3 NRC should give consideration to deleting any Solid Radioactive Waste reporting requirements from RG 1.21 since DOE is already charged with collecting LLRW disposal data nationally (via the Manifest Information Management System (MIMS) "and irradiated fuel transport via the SNM Form 741"). This would align the two Federal government agencies and reduce the burden on licenses for redundant reporting. The staff agrees that the Solid Radioactive Waste reporting guidance should be more closely aligned with MIMS where possible.

The MIMS data base tracks waste disposal at licensed waste disposal facilities, but does not track information regarding shipments of nuclear waste from nuclear power plants. If MIMS is updated/revised to track solid waste generation and shipment from nuclear power plants, then RG 1.21 can be revised. Until that time, solid waste reporting should be reported under RG 1.21. The Solid Radioactive Waste reporting guidance in RG 1.21 was revised an aligned more closely to MIMS. 41 NEI 23 6 Table A3 If NRC believes it needs Solid Radwaste Shipment data, then a means should be provided within Rev 2 of RG 1.21 for DOE MIMS data to be transferred or released to the NRC. This will enable electronic reporting in compliance with the paperwork reduction act and again unburden licenses from redundant reporting of the same data to two different Federal Agencies. The staff agrees with this comment. NRC contacted MIMS and other industry personnel and revised section 6 and Table A-3 so that the data format requested in RG 1.21 matches the data format in common industry software packages. This will facilitate reporting data for the Annual Radioactive Effluent Release Report. 42 NEI 23 6 7.1 The presentation of "small errors" in sections 7.1.1 and 7.1.2 can be mutually exclusive. For example, a Sr-90 activity with an associated error of 300% after all of the error terms are pooled may only contribute 0.0001% of the total dose from all The staff agrees the discussion of errors should be related to dose to the public. The RG incorporates a provision that discusses errors with respect to dose to the public. The staff also considers completeness and June 1, 2009 21gaseous effluents, resulting in a impact. The discussion of small versus large errors needs to somehow incorporate the relative impact on dose/risk to a member of the public. accuracy should also apply to quantities other than dose. It is recognized that the relationship between activity and dose will be nuclide dependent, and that a small amount of activity may translate into a dose impact that may not be considered small. Licensees need to supply the appropriate information for both activity and dose in the ARERR. If an error is discovered in either quantity (or with other related quantities such as volumes, flow rates, etc), licensees should submit amended data as indicated in sections 7.1.1 and 7.1.2 as appropriate. 43 NEI 24 8 Given that there has been a marked decrease in radioactive effluents from nuclear power plants over time, what is the purpose for the new requirement for data trending over a 10 year period? The new requirement is not risk-informed and will not result in any improvement in radiation protection As a minimum, the NRC should clarify whether the source term to be trended is by site or by release point. The staff agrees with this comment. The section of data trending was eliminated with the exception that licensees should still ensure the provisions of 10 CFR 50 Appendix I, Section IV.B.2 (i.e., to evaluate the relationship between quantities of radioactive material released in effluents and resultant radiation doses to individuals) are addressed. 44 NEI 24 9 Typically Gross Alpha has been identified as less than a given curie level. The wording here seems to suggest that the whole cell will be left BLANK if no Alpha counts come back positive. If a nuclide is detected in one quarter but not others, and entry of "NDA" should be made to indicate "No Detectable Activity" as opposed to leaving the table cell empty. This indicates that that nuclide was actually assessed during that period. (need more editorial work) The staff agrees with this comment. RG 1.21 section 8 was revised as suggested. The guidance in RG 1.21 suggests that if a nuclide is not detected in a quarter, an entry of N/D (or other designation) may be used to denote the nuclide was not detected. 45 NEI 26 9.2.1 The discussion about dilution flow needs to be The staff agrees with this comment. RG June 1, 2009 22clarified. Does the licensee account for dilution flow only during the summation of periods when the discharges are occurring, or total dilution flow over the entire quarterly or annual period? For example, if I have a single discharge during a quarter in which I release 1 Curies of tritium in a discharge which takes 100 minutes while the dilution flow rate is 100,000 Liters/min, then my effective concentration of tritium during period of discharge is 1 Ci divided by 10 million liters, or 1E-7 Ci/L, or 1E-4 uCi/mL. I would use this to determine my compliance with the Effluent Control Limit (ECL) in 10CFR20 Appendix B, Table 2, Column 2 value of 1E-3 uCi/mL. However, the effective tritium concentration in the environment over the course of the quarter is orders of magnitude lower. The buildup of tritium in fish, shellfish, and crops is not going to be based on a tritium concentration of 1E-4 uCi/mL for the entire quarter, but instead the effective concentration will be based on a total dilution volume of over 1E+10 Liters (100,000 L/min

• 60 min/hr

• 24 hr/day

• 91 days/qtr), yielding an effective tritium concentration of 8E-8 uCi/L. Perhaps two definitions of dilution volume are in order. The first definition of dilution volume would refer to that available only during actual releases, as used to demonstrate compliance with 10CFR20 Appendix B ECL values, whereas the second dilution volume would apply to the total dilution volume available during the entire release period, as would be used to calculate exposure pathway media concentrations. 1.21 Revision 1 indicated licensees should list the diluted concentration at the point of entry into the receiving waters in the unrestricted area. RG 1.21 Revision 1 specifies the volume should be calculated based on the flow rate ant the duration of the release; however, HPPOS-099 was issued as clarification. RG 1.21 Revision 2 applies the clarification from HPPOS-099 as the staff position. 46 NEI 26 9.3 Is the terminology of "principal isotopes" as used in Table A-3 for reporting solid waste synonymous with "principal radionuclides" as defined for effluent releases? Does the same 1% threshold apply? If There staff agrees there are two issues related to this comment, and both have now been corrected. The first issue is that the document used the terms "principal nuclide" June 1, 2009 23not, this needs to be clarified. and "principal isotope." These two terms were used interchangeably. To avoid any confusion, all instances of "principal isotope" were replaced with "principal nuclide." The second issue is that the term "principal isotope" was used with respect to reporting solid radioactive waste shipments. The proper (and historically used term) with respect to solid waste reporting is "major nuclides." The document now uses "major nuclides" when discussing reporting solid waste. 47 NEI 27 9.5.13 The 100 gallon threshold is a very low threshold established to establish transparent public disclosure. This standard was not established as part of any regulatory requirement and does not of itself represent any health and safety significance. The staff agrees that the guidance regarding 100 gallons is not a requirement. The regulatory basis for reporting effluents is 10 CFR 50.36a, that states in part, "Each holder of an operating license - shall submit a report to the Commission annually that specifies the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in gaseous effluents during the previous 12 months, including any other information as may be required by the Commission to estimate maximum potential annual radiation doses to the public resulting from effluent releases." Licensees should report their effluents even though it is recognized that these effluents may not have any health or safety significance. Since effluents released onsite have the potential to expose members of the public either in the controlled area or the unrestricted area, this information is relevant. The 100 gallon criterion is a reasonable quantity, and is already being reported to June 1, 2009 24local and State authorities under the NEI ground water protection initiative.

48 NEI 27 9.4.1.2 Does the terminology of "...could be occupied" imply a real individual at a real residence (house, apartment, etc.)? Or could it be construed as to applying to a "fencepost" individual at the site boundary? Since licensees do not control the area beyond their site boundary, they cannot assume zero occupancy for the "fencepost" location. Can licensees take credit for occupancy factor in such cases? If so, this needs to be clarified. Discussion of member of the public on Page 17 goes to length to emphasize that doses are to be calculated to REAL individuals. This discussion also needs to mesh correctly with "realistic individual" as described in NUREG-0133 and 40CFR190, as well as the definition of maximally-exposed individual in the context of RG 1.109 and 10CFR50. The staff agrees that additional clarification to the guidance is appropriate. That clarification has been added. For purposes of calculating air doses (mrad) licensees should use a conservative location. This has historically been assumed to be a "fence post individual" with 100% occupancy. This would be the most conservative calculation of dose and may also be the easiest to calculate. If a licensee would calculate an air dose using the above guidance, and the resulting doses would exceed the 10 CFR 50 Appendix I, Section B.1 design objectives, then the NRC may apply 10 CFR 50 Appendix I, Section B.2(b) and allow the licensee to show compliance. Definitions of hypothetical exposure pathway and maximum individual were added to the glossary. The use of realistic exposure pathway was removed from the document except in reference to the Attachment 6 to SECY 0069. The guidance provided in RG 1.21 is only one method the staff finds acceptable to meet the regulations. Licensees need to conduct a land use census. If licensees choose to use hypothetical exposure pathways to provide bounding estimates of exposures to demonstrate compliance with station technical specifications (Appendix I design objectives), the assumptions and June 1, 2009 25methodology should be listed in the ODCM (or supporting documents). 49 NEI 27 9.5.1 The specific definition of "Abnormal Releases" imposes new requirements above and beyond what is currently in RG 1.21. This is especially true as related to groundwater and onsite contamination that is of interest to future decommissioning, but is not related to offsite effluent releases and dose impact. This appears to be an attempt to codify the groundwater monitoring program, and to carry over requirements for onsite radiological controls as related to 10CFR50.75g and decommissioning. The staff disagrees with this comment. A regulatory guide does not impose requirements. The concept of abnormal releases is included in the original version of RG 1.21 (1974) to provide guidance for reporting non-routine radioactive material releases from nuclear power plants (i.e., releases that are not controlled or planned).

That overarching concept with respect to reporting releases still applies, however operating experience gained during the last 35 years has revealed situations in which the original definition is lacking. For example, there have been situations in which occurrences at a NPP were clearly abnormal releases, but they did not fit the strict definition as outlined in RG 1.21 (1974). Conversely, there have been situations in which releases were being categorized as abnormal releases when in fact they were not. This clarification in the definition of abnormal release is intended to satisfy the original intent for licensees to provide information (in the body of the ARERR) on abnormal releases (and abnormal discharges) that may impact the environment. 50 NEI 28 9.5.2.1 Ground water that is released through an ODCM-credited release point is already included in the ARERR. The staff agrees with this comment. Section 9.5.2.1 was revised so that only those remediation efforts not identified in the ODCM should be reported in the supplemental section of the ARERR. 51 NEI 28 9.5.8 [A typographical error] should be ARERR not The staff agrees with this comment. The June 1, 2009 26Arrears. typographical errors were corrected. 52 NEI 31 D.3.2 The NRC is asserting under Alternative 2 that the industry's implementation of the voluntary Ground Water Protection Initiative results in minimal impact from the expanded scope of draft RG 1.21. The NRC should perform a back fit analysis, using existing regulatory requirements as the baseline. The staff disagrees with this comment. This is addressed by NRCs response to NEI comment #2. 53 NEI 32 Glossary Terms in the glossary need to be consistent with existing regulations, regulatory guidance, and proposed revisions to regulatory guidance (i.e. RG 4.1). For example: a priori; abnormal release; effluent discharge; impacted areas; lower limit of detection; monitoring; restricted area; significant exposure pathway; significant residual radioactivity; site environs; unrestricted area. See below for additional details The staff agrees with this comment. The following definitions were revised: Channel Calibration, Channel Check, Member of the public, Residual Radioactivity, Restricted Area, Site Boundary, and Unrestricted Area.

54 NEI 33 Glossary [The definition of] "Effluent Discharge" should be revised for consistency as follows "A discharge of licensed material from a liquid or gaseous release point from a facility into the site environs." The staff agrees the definition of effluent discharge should be clarified. The definition was revised. 55 NEI 33 Glossary Revise [definition of] "Effluent Monitor Inoperability" to avoid confusion - a monitor that is classified as not inoperable. It is reportable in the ARERR if the instrument is unavailable for a period of time greater than 30 continuous days (in accordance with NUREG-1301 or and NUREG-1302, Section 3.3.3.10.b)." The monitor is inoperable whenever it is not operable. However, it is only included in the ARERR if it remains not operable for more than 30 days. The staff agrees with this comment. The entry was removed from the glossary because it was not a definition. 56 NEI 33 Glossary "Impacted Area": Draft RG 1.21 imposes new requirements related to onsite radioactivity, 10CFR50.75g, and decommissioning criteria do not belong in RG 1.21 as it relates to effluents and The staff disagrees with this comment. A regulatory guide does not impose requirements and compliance with this regulatory guide is optional. The discussion June 1, 2009 27offsite dose impact. of impacted area is applicable with respect to monitoring, evaluating, and reporting spills and leaks.

57 NEI 33 Glossary Glossary "Leachate" is one word. The staff agrees with this comment. The typographical error was corrected. 58 NEI 34 Glossary "Minimum Detectable Concentration" - is there any intent to define this term as a priori or a posteriori? There was no intent to define as a priori or a posteriori, however the reference to "a posteriori" was added to the definition. 59 NEI 35 Glossary

[Definition of] "Principal Radionuclide" should also refer to NUREG-1301/1302 as an acceptable basis per the discussion on page 8. Spell check throughout the document - should be "principal" not "principle" The staff agrees with this comment. The definition of principal nuclide was changed to specifically reference NUREG-1301/1302. A spell check was conducted and all usages of "principal" are correct. 60 NEI 35 Glossary

[Definition of] "Restricted Area" seems to be missing part of the definition from 10 CFR 20.1003 The staff agrees with this comment. This was addressed under comment #53 above. 61 NEI 35 Glossary

[Definition of] "Significant Release Point" see earlier comment. Draft RG 1.21 imposes a 1% threshold in delineating minor release point, significant release point, and principal radionuclide and is a significant departure from previously established thresholds in RG 1.109 and other guidance. The staff disagrees with this comment. This was addressed under NEI comment #10 above. 62 NEI 35 Glossary Should there be a definition for "spill or leak"? The staff does not recognize a need to define "leak or spill" in this RG. 63 NEI 35 Glossary "Uncontrolled Release" - replace "release path" with "release point" for consistency. This definition appears to say that unless the uncontrolled release results in (1) not monitored) and (2) results in significant amounts of radioactive material (not defined) being discharged, and (3) did not have a preplanned method for terminating the release, it was (by default) controlled. This also seems to contradict existing requirements to control essentially all detectable concentrations of The staff agrees to replace "release path" with "release point." The staff does not agree that the guidance for uncontrolled releases contradicts any existing requirements. The guidance provided in RG 1.21 Revision 1 regarding abnormal release, unplanned release, and uncontrolled release was not very detailed. This has been the source of much discussion in the industry. The June 1, 2009 28radioactive material. Is this a deliberate choice by the NRC? additional detail provided in RG 1.21, Revision 2, is intended to provide more detailed staff guidance based on experience that has been gained over the last 35 years (since Revision 1 was published). As a result, the guidance provided in Revision 2 of RG 1.21 regarding uncontrolled release provides a common and consistent basis for determining if a release is controlled (only within the context of determining if a release is an abnormal release). 64 NEI 36 Glossary "Unplanned Release" also appears to be a significant change, particularly in the paragraph following (3) The staff agrees RG 1.21 Revision 2 provides more detailed guidance for determining if a release is an unplanned release. The guidance provided in RG 1.21 Revision 1 regarding abnormal release, unplanned release, and uncontrolled release was not very detailed. This has been the source of much discussion in the industry. The additional detail provided in RG 1.21, Revision 2, is intended to provide more detailed staff guidance based on experience that has been gained over the last 35 years (since Revision 1 was published). As a result, the guidance provided in Revision 2 of RG 1.21 regarding unplanned release provides a common and consistent basis for determining if a release is planned (only within the context of determining if a release is an abnormal release). 65 NEI 38 Glossary Several citations relevant to effluent monitoring and compliance need to be added, including NUREG-0133; NUREG-0475; NUREG-0543, "Methods for demonstrating LWR compliance with the EPA uranium fuel cycle standard: 40 CFR Part 190"; and The staff agrees with this comment. The appropriate references were added.

June 1, 2009 29RIS 2008-003. In addition, if it is deemed necessary to maintain requirements for 10CFR50.75g and decommissioning issues within RG 1.21, NUREG/CR-5512. 66 NEI A-1 Table A-1 The term "Alpha" in this table should be replaced with "Gross Alpha" to match Tables A-1A through A-1F, and past-established terminology. Also, this table is missing a column to record total uncertainty, as is presented in Table A-2 for Liquid Effluents on page A-8. The staff agrees with this comment. All instances of "Alpha" were replaced with "Gross Alpha." A column was added to Table A-1 for recording uncertainty. 67 NEI A-1 Table A1A Zinc-72 is a very unusual isotope and is not typically identified in operating reactors The staff agrees with this comment. The list is table A-1A is just an example list and is not intended to be the list used by licensees. Zn-72 was removed from the list. 68 NEI A-1 Table A1A Rhodium 188 is not listed in the table of the isotopes. Is this a typographic error? The staff agrees with this comment. The list is Table A-1A is just an example list and is not intended to be the list used by licensees. The entry "Rh-188" was removed from the list. 69 NEI A-2 Table A1 Requiring the ARERR to include an estimate of overall measurement uncertainty over an entire year for various fission product groups would not provide any more useful or accurate information than the current measurement error requirement has provided.

It's not clear why DG-1186 requires an uncertainty estimate for Liquid Effluents in Table A-2, but not for Gaseous Effluents in Table A-1. In either case the proposed measurement uncertainty requirement for the ARERR would be difficult to accurately determine if done correctly, is redundant to existing QA/QC The staff disagrees that an error estimate provides no useful information. Licensees should make an estimate of the uncertainty. A detailed analysis including all parameters is not necessary. Because it may be difficult to assign error terms for each parameter affecting the final measurement, detailed statistical evaluations of error are not suggested. The omission of a column for "uncertainty" on Table A-1 was corrected by adding a column to the table. It is beneficial to have some measure of uncertainty for several reasons, two of which include (1) uncertainties exist and they June 1, 2009 30should be recognized in a broad sense, at minimum, and (2) uncertainties provide the reader (e.g., the public) with some understanding that the data reported may assume a range of values where each value may be statistically indistinguishable from the next, and (3) evaluation of uncertainties provides additional information from which is derived reasonable assurance that actual exposure of an individual through appropriate pathways is unlikely to be substantially underestimated even when all uncertainties are considered together (10 CFR 50 Appendix I). 70 NEI A2 A3 A4 A5 A6 A7 A9 Table A1A Thru Table A1FThe listing for Xe-131m should use a lower case "M" to follow standard convention. The inclusion of I-132, I-134, and I-135 is a departure away from current requirements in RG 1.21, and is not in accordance with the radioiodines required per NUREG-1301/1302. Also, as pointed out in comments related to nuclides with short half-lives on Page 10, these nuclides could be subject to gross overestimation if decay-corrected to sample midpoint. These tables should be simplified to contain only those nuclides actually detected by the licensee over the course of the reporting period. If a nuclide is detected in one quarter but not others, and entry of "NDA" should be made to indicate "No Detectable Activity" as opposed to leaving the table cell empty. This indicates that that nuclide was actually assessed during that period. The staff agrees the use of a lower-case "m" is appropriate to represent a metastable state for a nuclide. All instances of "Xe-133M" were changed to "Xe-133m." The staff disagrees that the reporting guidance for short lived nuclides in RG 1.21 revision 2 is a departure from current requirements. NUREG-1301/1302 includes a sensitivity level (LLD) for I-131, and states that "other nuclides that are identifiable together with [the principal gamma emitters] shall also be analyzed and reported in the [Annual]

Radioactive Effluent Release Report." As a result, reporting the short-lived iodines is not inconsistent with NUREG-1302/1302. Refer also to the NRCs response to NEI comment #13. Regulatory guides do not establish requirements. The text that describes the tables in RG 1.21 June 1, 2009 31(section 9) has been revised to clearly indicate nuclides that are not detected do not need to be included in the tables. The issue with "blank" entries is addressed in NRCs response to NEI question #44 above. 71 NEI A-13 Table A3 The volumes are listed in cubic feet rather than cubic meters. Is this the intent to change from cubic meters for reporting solid waste volumes as is the current requirement? All other references in this document are in metric units. The staff agrees with this comment. Volume units are in cubic meters.

72 NEI A-13 Table A3 The Table does not provide entry rows for Class C waste. Some plants generate Class C filters and some Class C resin. I suggest the three rows that list "Class B Resins, Filters, Evaporator bottoms" be changed to "Class B/C Resins, Filters, Evaporator bottoms." The staff agrees type "C" waste should be addressed. Although there is very little Class C waste shipped, the format provides for identifying shipments if/when Class C shipments are made. The regulatory guide has been changed to specifically exclude mixed waste and hazardous waste. This section has been revised to include on-site disposals. Information on volumes and Classes of stored waste onsite (e.g., due to Barnwell closure) should be reported in the ARERR. 73 NEI A-13 Table A3 Section header title from "2 LLW Shipped for Processing (before disposal or return to site)" to "LLW shipped by Processor to a LLW disposal site". This change will align the Solid Radwaste Reporting with the DOE MIMS report. The staff agrees with this comment. Title in Table A-3, section 2, was changed from "LLW Shipped for Processing (before disposal or return to site)" to "LLW Shipped for Direct Disposal (to licensed waste disposal facilities)." 74 NEI A-13 Table A3 If NRC Accepts The Recommendation to Use the MIMS Data (See Item 40 Above), [and reflects that change in the] glossary. This change also The staff disagrees with this comment. Reliance on the MIMS data base for all solid radwaste data necessary for the ARERR will June 1, 2009 32eliminates the need for NRC to define what a Waste Processor is and when potential radioactive material is a waste. not be used at this time. Refer to NRCs response to NEI question #40. 75 NEI 23 6 Additional Guidance Needed for LLRW Reporting. There are several items or types of waste materials (e.g. single use protective clothing, secondary filter cake, trash from the RCA, metal, equipment for refurbishing and return) that are being processed or decontaminated, resulting in very little LLRW. Additional clear guidance is needed from the NRC on whether these shipments to waste processors are to be included in the RG 1.21 (ARERR) Report and the volume and activity of the waste to be reported. Further examples where additional guidance is indicated include: 1- Shipments of contaminated laundry for dissolving (the domestic section of NRC has defined this as radiological material for decontamination [not waste], the Import/Export Section of NRC has defined this material as waste). 2-Shipments of contaminated equipment (pumps, valves & motors) for refurbishment. 3- Shipments of contaminated metals for recycling by smelting or decontamination and clearance. 4- Shipments of material for clearance. The staff agrees with this comment. Additional detail was added to sections 6 and 8.3 of the document. This is also reflected in Table A-3. 76 NEI A14 Table A4 The affected Sector/Distance could be different from quarter to quarter. In the case of gaseous effluent discharges, the limiting sector/distance may be driven by the majority of activity released from an elevated release point during routine operation. However, during an outage quarter, ground-level releases may dominate and may result in the highest dose occurring in a totally different sector. The table is too simplistic to accommodate such The staff agrees with this comment. The column for "Sector and Distance" was removed from Table A-4. The guidance in RG 1.21 only required dose assessments for I-131 and I-133 and nuclides with half-lives greater than 8 days.

June 1, 2009 33differences. Also, this table requires assessment of gaseous doses from particulates with half-lives of greater than 8 days, and may be out of step with short-lived activity presented in Tables A-1A through A-1F. 77 NEI A17 Table A8 Table A-8 is a partial list of screening values for soil from NUREG-1757. What values should the licensee use for water? The staff agrees that none of the main objectives of RG 1.21 is to provide decommissioning guidance. Many references to decommissioning were removed from the document. The table A-8 was removed. Licensees may still want to use some screening criteria, but specific criteria (other than significant residual radioactivity) is not explicitly described in RG 1.21. 78 NEI 28 A17 9.5.1.4.15 Table A8 It appears that the NRC is attempting in draft RG 1.21 and other regulatory guidance revisions (i.e.

RG 4.1) to impose, without meaningful backfit analysis, operational remediation requirements that effectively are the 10 CFR 20 Subpart E criteria for unrestricted license termination. Existing programs for radiation protection, recordkeeping under 10CFR50.75g, and decommissioning regulations and guidance already address this issue. These new effluent control requirements are not justified based on public health or protection of the environment and should be assessed under the backfit rule. The staff disagrees with this comment. Regulatory guides are not requirements.

The issue regarding a backfit analysis is addressed in NRCs comment to NEI question #2. Guidance on spills and leaks is appropriate as it relates to measuring, evaluating, and reporting information in the ARERR. Guidance provided regarding residual radioactivity screening values are only provided as one possible means licensees may use to determine how to respond to spills and leaks with respect to measuring, evaluating, and reporting effluents in the ARERR. Licensees may use other means, techniques, or methods provided the appropriate information is contained in the ARERR. 1 STARS 4 B.2 Page 4, last paragraph, The staff agrees with the comment, and the June 1, 2009 34Acronyms used such as ISFSI (Independent Spent Fuel Storage Installation) and ARERR (Annual Radiological Effluent Release Report) should be defined prior to their use. acronyms have been defined. 2 STARS 6 1 Page 6, 4th paragraph, " "Less-significant release points are, to the extent reasonable, required to be listed in the ODCM." It is unclear as to the source of this requirement. NUREG-1301 and NUREG-1302 do not appear to contain this "requirement." This seems to contradict the statement on page 4 that states"NUREG-1301/1302 contains detailed guidance for the content and format of a licensee's ODCM." The staff agrees that the wording, as initially proposed, could be interpreted to be overly restrictive. The staff position is that licensees should effectively demonstrate conformity to guides on design objectives as outlined in 10 CFR 50, Appendix I, Section III, which states, "conformity -shall be demonstrated by calculational procedures based on models and data such that the actual exposure -is unlikely to be underestimated." The wording was revised to allow licensees, to the extent reasonable, to maintain the list of less-significant release points in documents other than the ODCM. The ODCM should contain the list of significant release points and that should include anticipated operational occurrences which may include significant cross-contamination of systems normally not contaminated and primary to secondary leakage (for PWRs). 3 STARS 7 1 Page 7, last paragraph, "Monitoring Batch Releases --For batch releases, measurements should be performed to identify specific radionuclides before a release to the environment.

In those cases in which an analysis of specific-radionuclides (such as strontium-89/90 and iron-55) cannot be done before release (see NUREG-1301 and NUREG-1302), representative samples should be collected for the purpose of subsequent composite analysis. The composite samples should The staff agrees with this comment. A qualifier was added to state the hard-to-detect nuclides listed in the example were applicable to liquid releases.

June 1, 2009 35be analyzed at the scheduled frequencies specified in NUREG-1301 and NUREG-1302." NUREG-1301 and NUREG-1302 only require strontium-89/90 and iron-55 sampling and analysis for Liquid Batch releases. Strontium-89/90 and iron-55 sampling are not required for gaseous batch releases. 4 STARS 9 1 Page 9, 2nd paragraph, "However, the concept of 'principal radionuclides' does not reduce the burden for reporting nuclides detected in effluents. In addition to 'principal radionuclides, ' other radionuclides detected during routine monitoring of release points must be reported in the radioactive effluent release report and included in dose assessments to members of the public. "

Without a standardized lower limit of detection (LLD), how can a licensee ensure they meet the "1 % of the total activity" approach? The concept of a required sensitivity levels for analytical analyses was applicable in RG 1.21 Revision 1, and that concept is still applicable in Revision 2 of RG 1.21. The new guidance provided in Revision 2 (regarding principal nuclides) merely allows licensees to select analytical sensitivity levels that are most appropriate for the radionuclide mixture experienced at their site while still ensuring doses are not underestimated and that consideration is taken of all sources within the facility. As a result, all licensees will specify the required sensitivity levels for nuclides. This approach ensures all licensees (or anyone who inspects the licensee's data) can calculate 1% of the total and determine which nuclides are major contributors at a particular facility. 5 STARS 11 3 Page 11, 3rd paragraph, "Release Height," The Release Height section should reference Regulatory Guide 1.111 for definition or discussion. The staff agrees with this comment. Reference to RG 1.111 was added in the paragraph. 6 STARS 20 5.8.5 Page 20, Section 5.8.5, " ... A pathway is considered significant if a realistic evaluation yields an additional dose increment equal to or more than 10% of the total from all pathways considered (see the regulatory position in Regulatory Guide 1.109)." The staff agrees that the wording is not exactly the same as RG 1.109. It is not the staff's intent to reproduce RG 1.109 within RG 1.21. RG 1.21 captures the significant aspects from RG 1.109 and then refers the June 1, 2009 36This is not the exact wording in Regulatory Guide 1.109: "A pathway is considered significant if a conservative evaluation yields an additional dose increment equal to or more than 10 percent of the total from all pathways considered in this guide." reader to RG 1.109 for more detail. The staff considers this an acceptable approach. The staff agrees that some of the wording could be improved, and the sentence referenced in the STARS comment was revised. 7 STARS 21 5.10.3 Page 21, Section 5.10.3, "The dose contributions from direct radiation may be estimated based on either (1) thermoluminescent dosimetry (TLD) measurements, (2) calculations, or (3) a combination of TLD measurements and calculations." In addition to TLD measurement, there are other methods available for direct radiation measurements (e.g., ion chambers). Recommend changing "TLD measurements" to "direct measurements." The staff agrees with this comment. The changes were made. Licensees are cautioned that if alternate means are used for direct radiation measurements, it could introduce new modes of failure which may impact the availability of the data. Such changes should be carefully evaluated. 8 STARS 24 8 Page 24, Section 8, "Data Trending, " General Comments: There is no stated purpose for Data Trending in the ARERR. Data trending in the ARERR does not provide meaningful information and is redundant to other trending requirements. Total curies released are typically a function of core effective full power days, thermal plant rating and fuel integrity. Dose values are a function of curies released, pathways present, physical location of residences and meteorological data. Generally, a plant has little control over airborne effluent release concentrations. Fuel reliability is already tracked through the INPO Consolidated Data Entry (CDE) process. A comparison of a given plant from year to year is possible but of questionable value. It is not possible to compare different plants, especially when individual plants are allowed to establish The staff agrees that too much emphasis was placed on data trending in DG-1186. The section of data trending was eliminated with the exception that licensees should still ensure the provisions of 10 CFR 50 Appendix I, Section IV.B.2 (i.e., to evaluate the relationship between quantities of radioactive material released in effluents and resultant radiation doses to individuals) are addressed.

June 1, 2009 37LLDs based on "principal nuclides" (see page 8, Principal Radionuclides for Effluent Monitoring). This is implied in Section 9, "The aspect of consistency aids review by members of the public and allows easier industry-wide comparisons of the data." Effluent Release Data was formerly compiled in NUREG/CR-2907 (ADAMS Accession Number:

ML041450170), http://hps.ne.uiuc.eduinatcenviro/eff2000s.htm and http://www.reirs.comieffluent/EDB_Main.asp. The most current data is only available through 2004 at http://www.reirs.comieffluent/EDB_Main.asp The issue of summarizing data was also the subject ofSECY-06-0212 (http://www.nrc.gov/reading-nnldoc-.

collections/commissi0n/secys/2006/secy2006-0212/2006-0212scy.html) If the desire is to provide data for "review by members of the public and allows easier industry-wide comparisons of the data", it would be more appropriate to keep the on-line database current, and provide on-line trending tools, rather than providing this information in each individual ARERR. 9 STARS 24 8.1.1 Page 24, Section 8.1.1, "source term for curies of total mixed fission and activation products, " Is this intended to include tritium, gases, and alpha? If not, change to "curies of fission and activation products (excluding tritium, gases, and alpha)." (See Table A-2). The staff agrees with this comment. The section on data trending was eliminated. 10 STARS 24 8.2.1 Page 24, Sections 8.1.2 and 8.2.4, "source term for The staff agrees with this comment. The June 1, 2009 388.2.4 curies of tritium, " Change to "curies of tritium." section on data trending was eliminated. 11 STARS 24 8.2.1 Page '24, Section 8.2.1, "source term for curies of total mixed fission and activation products, " Change to "curies of fission and activation gases" (see Table A-I). The staff agrees with this comment. The section on data trending was eliminated. 12 STARS 24 8.2.3 Page 24, Section 8.2.3, "source term for curies of iodine, " From a practical perspective and to standardize trending it is more useful to simply trend 1-131. Suggest changing to "curies of I-131." The staff agrees with this comment. The section on data trending was eliminated. 13 STARS A-2 Table A1A Page 24, Section 9.1.1 References Table A-I, "(b) iodines halogens," Table A-I, Column heading states only "iodines," it does not include "halogens." The staff agrees with this comment. Table A-1 was changed. 14 STARS 24 A-2 9.1.2 Table A1A Page~4/25, "9.1.2 Table A-lA, Gaseous Effluents--Ground-Level Release--Batch Mode contains a summation of gaseous effluent releases from ground-level release points in the batch mode of release for the five radionuclide categories of fission gases, iodines/halogens, particulates, tritium, and gross alpha. Report the following: 9.1.2.1 curies of each radionuclide released by quarter and year, and . 9.1.2.2 total curies released in each radionuclide category (fission and activation gases, iodines halogens, particulates, tritium, and gross alpha) by quarter and year. " Section 9.1.2 should state "fission and activation gases" instead of just "fission gases" for consistency with section 9.1.2.2, Table A-IA should state "fission and activation gases" instead of just The staff agrees with this comment. Tables and paragraph were changed.

June 1, 2009 39"fission gases" in the heading row.

15 STARS 25 9.1.3 9.1.4 9.1.5 9.1.6 9.1.7 Sections should state "fission and activation gases" instead of just "fission gases" for consistency-with section 9.1:2.2. Tables A-lA, A-1B, A-1C, A-1D, A-IE, and A-IF should state "fission and activation gases" instead of just "fission gases" in the heading row. The staff agrees with this comment. Tables and paragraphs were changed. 16 STARS 26 9.4 "The annual evaluations of public dose should be calculated."

Change "public dose" to "dose to Members of the Public." This is consistent with the wording in Section 5 and the term in the glossary. The staff agrees with this comment. The paragraph was changed. 17 STARS 27 9.5.1.3.2 " ... minimum detectable activity (MDA) ... , " This is the only occurrence of the term "MDA" in this document. Section 4, Quality Assurance, has a lengthy discussion of RG 4.15, but no discussion of MDA. The staff agrees with this comment. Additional detail was added at the location where MDA is discussed. 18 STARS 28 9.5.1.4.15 Page 28, Section 9.5.1.4.15 [states] "residual radioactivity levels and whether any levels exceed the DCGLs provided in Table H.2 in Appendix H to NUREG-1757, Volume 2," This is a decommissioning requirement. There is no routine sampling requirement for Soil Surface Contamination. The staff agrees with the Liquid Radioactive Release Lessons Learned Task Force Final Report (LLTF) Report. The Liquid Radioactive Release Lessons Learned Task Force Final Report (LLTF) Report concluded no routine on-site surveys are required for potential abnormal spills and leaks of radioactive liquids. However as noted in the following sentence of the LLTF report, surveys are required for on-site spills and leaks in order to satisfy the records requirements of 10 CFR 50.75(g). 19 STARS 28 9.5.5 Page 28, Section 9.5.5 references NUREG-1301/1302, section 3.3.3.10.b, The staff agrees with this comment. The Additional reference was added.

June 1, 2009 40NUREG-1301, section 3.3.3.10.b, is for Liquid effluent monitoring instrumentation channels only. NUREG-1301, Section 3.3.3.11.b for gaseous effluent monitoring instrumentation should also be included. 20 STARS 32 Glossary "Channel Calibration" ... See also the definition in NUREG-1301/1302." This appears to be a typo. The definition should refer to "NUREG-1301/1302." The staff agrees with this comment. The definition of channel calibration was deleted since it was not used in the body of the document. 21 STARS 32 to 35 Glossary "Channel Operational Test (COT), " and "Source Check, " These are not the exact definitions in NUREG-1301. The staff agrees with this comment. The definitions were revised. 22 STARS 33 to 35 Glossary "Controlled Area," "Member of the Public," "Monitoring, " "Restricted Area, " "Site Boundary,"

and "Source Check." These are not the exact definitions in 10CFR20.1003. The staff agrees with this comment. The following definitions were revised: Channel Calibration, Channel Check, Monitoring, Member of the Public, Residual Radioactivity, Restricted Area, Site Boundary, and Unrestricted Area. 23 STARS 35 Glossary "Significant Release Point," See the definition for Minor Release Point. The wording is not consistent. The staff agrees with this comment. Minor release point was deleted. 24 STARS 32 to 36 Glossary Definitions for "A priori," "Abnormal Release," "Effluent Discharge (Radioactive)," "Significant. Contamination," "Significant Residual Radioactivity," "Site Environs," and "Unlicensed Material," do not match definitions listed the Glossary of DG-4013, Radiological Environmental Monitoring for Nuclear Power Plants. The staff agrees the wording should be exactly the same in both documents. Changes were made. 25 STARS A1 to A7 Tables A1A thru A1F Appendix A, Tables A-1A, A-1B, A-1C, A-1D, A-1E and A-1F, Tables A-1A, A-1B, A-1C, A-1D, A-1E, and A-1F should state "fission and activation gases" instead of just "fission gases" in the heading row. The staff agrees with this comment. This is a duplicate of STARS comment #15. See NRCs response to STARS comment #15.

June 1, 2009 411 PPL A1 to A7 Tables A1A thru A1F Clarify the requirements for reporting of air particulates with half lives less than eight days. Table A1A through A1F reference short lived airborne particulate radioisotopes such as Cesium 138 (which has a 2 minute half life). Dose assessments Section 9.4.1.3 references dose calculations for particulates with half lives greater than 8 days. There does not appear to be reasonable justification for reporting air particulates radioisotopes with half lives of less than 8 days. The staff agrees that additional guidance and clarification is warranted. NUREG-1301/1302 includes a sensitivity level (LLD) for I-131, and states that "other nuclides that are identifiable together with [the principal gamma emitters] shall also be analyzed and reported in the [Annual] Radioactive Effluent Release Report." As a result, reporting the short-lived iodines is not inconsistent with NUREG-1301/1302. RG 1.21 Revision 1 states that when monitoring iodines, "-the samples should be analyzed weekly for I-131. An analysis shall also be made monthly or more often for I-133 and I-135." RG 1.21, Revision 1 also states that for particulates in gaseous effluents, "Measurements should be made to determine the quantities of radionuclides with half-lives greater than 8 days-" An inspection of licensee's Technical Specifications indicates most licensees have adopted the verbiage from NUREG-1301/1302, and as a result nuclides with half-lives less than 8 days are reported if they are detected during an analysis. This reporting of nuclides with half-lives less than 8 days is consistent with 10 CFR 50.36a(a) that states licensees "shall submit a report-annually that specifies the quantity of each of the principal radionuclides released to the unrestricted areas in liquid and gaseous effluents as well as any other information that may be required by the commission to estimate maximum potential June 1, 2009 42annual radiation doses to the public resulting from effluent releases." This is also one of the reasons why the concept of "principal nuclide" is addressed in RG 1.21 Revision 2. It should be noted that for calculation of doses, only I-131 and those particulate nuclides that are greater than 8 days are normally required to be included in the dose assessment. 2 PPL A1 to A7 Tables A1A thru A1F Rh-188 is listed in Tables A1A through A1F. There is no such isotope listed in any of the references available to us. Also included in Tables A1A through A1F is Zn-72. Zn-72 is an isotope (with a short half life of 46 hours5.324074e-4 days <br />0.0128 hours <br />7.60582e-5 weeks <br />1.7503e-5 months <br />) not normally identified in reactor coolant, solid radioactive waste or radioactive effluent samples. This isotope should not be included in the reporting table. The staff agrees with this comment. Changes were made as indicated. 3 PPL 24 8.1 8.2 Source term trending (ten year trend period) is a new requirement. Please clarify the term "source term" as referenced in Section 8.1 and 8.2. The staff agrees with this comment with the exception that regulatory guides are not requirements. The section of data trending was eliminated with the exception that licensees should still ensure the provisions of 10 CFR 50 Appendix I, Section IV.B.2 (i.e., to evaluate the relationship between quantities of radioactive material released in effluents and resultant radiation doses to individuals) are addressed. 4 PPL 22 5.11.5 Section 5.11.5 states, "Based on the above information, the dose calculations are performed as shown below." The referenced dose calculations in Section 5.11.5.1.1, 5.11.5.1.2, 5.11.5.2.1, 5.11.5.3.1 and 5.11.5.3.2 appear to use an incorrect value for Whole Body and Organ dose due to on-site pond H-3 evaporation to nearest The staff agrees with this comment. The example calculation was deleted.

June 1, 2009 43residence (ingestion, leafy vegetables). 0.017 mrem is the value used in the dose calculations but the value referenced (from Section 5.11.4) for use in the calculations is 0.0017 mrem. 5 PPL 25 9.2.1 Section 9.2.1 details reporting of liquid waste dilution flow, specifically, "external dilution flow rate, average (river to stream flow rates)." Please clarify the averaging period for external dilution flow rate (daily during periods of release, monthly, quarterly, annual). The staff agrees with this comment that the dilution flow (dilution volume) should have additional clarification. This was provided in accordance with HPPOS-099 and has been included in the Regulatory Guide. 6 PPL 28 9.5.8.1 "Omissions from previously submitted Arrears" Please correct/clarify/define "Arrears." The staff agrees with the comment. The incorrect spelling has been corrected. G1 Dom 1 All The NRC appears to be taking too much out of the existing Regulatory Guides and restating it in this draft. In some cases guidance is outside the scope of the draft Regulatory Guide. The staff agrees that some level of unnecessary duplication existed, and the unnecessary duplication was eliminated. G2 Dom 1 All Similar to other Regulatory guides, such as RG 4.15, the NRC should give licensees the option to continue using the current version of RG 1.21, as referenced by licensing documents. The staff agrees that Revision 2 of RG 1.21 is just another method of complying with the regulatory requirements. Licensees with licensing commitments to Revision 1 of RG 1.21 may maintain their existing commitments. Licensees are not required to adopt the guidance in RG 1.21 Rev 2. G3 Dom 1 All It would be helpful if this RG included a Table of Contents. The staff agrees with the comment. A Table of Contents was added. G4 Dom 1 All Since one of the objectives listed in Section B.2 is evaluating dose to the public, it seems more appropriate to list the 10 CFR 20.1301 requirements in this RG and not in RG 4.1. Similarly, this RG may be the appropriate document to address the 10 CFR 50.75(g) compliance issue. This is consistent with the General Comments that we provided on DG-4013 (RG 4.1). The staff agrees that dose to the public is addressed in RG 1.21. RG 1.21 will only address 10 CFR 50.75(g) in the context of measuring, evaluating, and reporting effluents. The staff addresses 10 CFR 20.1301 requirements in RG 1.21 and this guidance was removed from RG 4.1.

June 1, 2009 441 Dom 5 1(b) The definition for "less significant release points" is not provided in the glossary. More importantly, the requirement to list these in the ODCM will be a problem since there is no threshold below which a release point is insignificant. Suggest a third category of "insignificant release points." Listing various insignificant release points such as main steam-line safety valves and steam-driven feed water pumps in an ODCM will typically be meaningless (especially when the curie totals and doses will typically be less than 1% of the totals from the other release points). A documented detailed site review of potential unmonitored release points and actions to take depending on changing conditions would seem more appropriate to address the required monitoring/tracking requirements for the less significant and insignificant categories. Suggest that the categories be: significant release points - those listed in NUREG 1301/2 (thus typically already in the ODCM) or have the potential to be greater than 1 % of the Appendix I limits less significant release points - 1% to 0.1% of the Appendix I limits insignificant release points - less than 0.1% of the Appendix I limits This should be much more meaningful and appropriate (e.g. Why penalize plants with the undue burden of additional monitoring if their significant releases are low?) The staff agrees to add definition of less-significant release point to glossary. The staff agrees that less-significant release points do not necessarily need to be included in the ODCM, and that text was revised. It is appropriate to include, to the extent reasonable, the less significant release points in some site documentation (e.g., procedures or basis documents). The staff agrees that a reference to the Appendix I limits as a basis for significant release points has merit, and that has been incorporated into the definition of significant release points (and less significant release points). 2 Dom 5 1.(c) Only the significant release points need to be listed on the map. The staff agrees with the comment. The text was revised. 3 Dom 5 1.(d) Does this apply to direct doses? It should. This means that doses may need to be routinely The staff disagrees with this comment. Paragraph 1.(d) is based on the guidance in June 1, 2009 45calculated for direct radiation even when these are not distinguishable from background (at the location of exposure to the public, however extrapolations may be possible based upon measurements much closer to the "source term" where the direct dose may be distinguishable) since direct radiation can be the most significant dose pathway at many sites. These "calculations" would be more consistent with what is done for the other pathways (e.g., typically don't see any positive activity in REMP samples, but calculations are performed based upon the effluents released and pathway modeling). RG 1.109. Since RG .109 does not include a formula for direct radiation for effluents, direct radiation is not included as a contributor to the (reference to) 10% in RG 1.109, section C. As a result, RG 1.21 does not include direct doses in reference to the 10% guidance of RG 1.109 (Section C). 4 Dom 6 1 (last sentence in both Monitoring a Significant Release Point and Monitoring a Less-significant Release Point) - The requirement to use 3 significant figures can be quite meaningless in many cases. These typically include the cases where there is significant error in the actual values (e.g. containment purges where the RCS leak rate may be changing). Why list 3 significant figures where the errors in the values are +/- 30 or more %? The use of these figures implies a high degree of sensitivity which in realty may not exist The staff agrees the use of the words "significant figures" does not correctly reflect the intent of this regulator position. The word "3 significant figures" will be changed to "3-digit exponential format." Licensee's may choose to round numbers prior to reporting if technically justified. The licensee should report number that are technically correct. 5 Dom 6 1 (first sentence, second paragraph in Monitoring a Less-significant Release Point) - The need to list less-significant release points in an ODCM will be very difficult to implement. This would result in very frequent changes to the ODCM based upon changing plant conditions (e.g., changing activity levels in the secondary, changing safety/steam dump flow rates, changing activity in the RCS, etc.). Therefore, the statement in the last sentence requiring reporting of any activity detected in a less-significant release point will also be difficult to implement. The need to report should be any The staff agrees that the wording, as initially proposed, could be interpreted to be overly restrictive. The staff position is that licensees should effectively demonstrate conformity to guides on design objectives as outlined in 10 CFR 50, Appendix I, Section III, which states, "conformity -shall be demonstrated by calculational procedures based on models and data such that the actual exposure -is unlikely to be underestimated", and that licensees should take account for all sources and pathways at June 1, 2009 46activity that is greater than 1% of the total effluent activity or can contribute to greater than 1% of the dose, regardless of its release classification the facility. The wording in the RG was revised to allow licensees, to the extent reasonable, to maintain the list of less-significant release points in documents other than the ODCM. This eliminates the potential of frequent changes to the ODCM. The ODCM should contain the list of significant release points and that should include anticipated operational occurrences which may include significant cross-contamination of systems normally not contaminated and primary to secondary leakage (for PWRs). 6 Dom 7 1 (last sentence in Monitoring Continuous Releases) - The statement "...used to establish -" should be " - used to verify (or check) -" since in many cases it may not be appropriate to change these factors based upon normal conditions. Many of these monitors are required to function during emergency conditions where other factors may be more appropriate! Tracking the normal effluents from such monitors can easily be accomplished by the use of appropriate correction factors. Being too prescriptive here may be dangerous in certain conditions. The staff agrees with the comment. The document was changed. 7 Dom 8 1 Section C.1 (Principal Radionuclides for Effluent Monitoring) - This section is a potential problem. It has additional requirements that may be difficult to interpret and implement. For instance: the statement that "principal radionuclides" is dependent onsite specific factors (e.g. failed fuel and extent of system leakage among others) and the statement the "principal radionuclides" list is contained in the The staff believes some specificity is necessary to ensure a consistent and reasonable approach to the determination of principal nuclides. However, licensees should remember that a list of principal nuclides is prepared for purposes of ensuring that (1) the appropriate sensitivity levels are used for analyses and (2) the Annual Radioactive Effluent Release Report June 1, 2009 47ODCM means that the ODCM requires changing when fuel conditions or leak rates change. How can this be reasonably implemented?

This section needs to be much more general without many of the specific details that are very difficult to implement. includes the principal nuclides. Licensees are not required to implement the risk-informed concept of principal nuclide as outlined in RG 1.21, Revision 2. For licensees who wish to adopt the risk-informed concept of principal nuclides, the ODCM would not need to be revised immediately, and the ODCM could be revised within approximately 12 months following the determination of the principal nuclides. In a reasonable implementation, the list of principal nuclides for liquid radioactive waste, for example, would be dominated by a very few nuclides (typically less than 12 nuclides), and that list would not change significantly even though plant conditions may change (e.g., failed fuel). 8 Dom 8 1 (Principal Radionuclides for Effluent Monitoring) -

Why 1%?

Would 10% be more appropriate and consistent with C.1.(d) dose calculation statement on page 5 as long as the wording reflects that the aggregate dose (or Curie total) from all the "non-principal" nuclides is what needs to be considered. In many cases [it] may be appropriate to address nuclide groups (e.g., HTD's like Fe-55, Sr-89 and Sr-90) as opposed to individual nuclides; if they don't contribute to 10% or more of the dose, then why analyze for them?

The technical approach and classification scheme The 10% "provision" described in C.1.d (RG-1.109) is applicable to methods for determining significant "exposure pathways" (e.g., inhalation or ingestion) which are unique at a site and for which equations are not provided in RG 1.109. The 1% criteria in DG-1186 is applicable to methods for determining principal radionuclides. Defining methods for determining principal nuclides and significant release points provides guidance that allows licensees to meet the regulatory requirement of 10 CFR 50 Appendix I, Section III.A.1, which states licensees should make estimates of exposure "-such that the actual exposure - is unlikely to be underestimated" where "account shall be June 1, 2009 48listed in EPRI NP-3840 may be worth considering taken of all sources and pathways within the plant contributing to the particular type of effluent being considered." The use of a 10% criteria was tested with typical nuclear power plant data. And was judged not to be appropriate. At this time, the NRC is not prepared to consider 10% to be appropriate criteria when determining principal nuclides. EPRI NP-3840 was reviewed. That report suggested nuclides >1% of the 5 mrem/yr whole body Appendix I design objective were either "significant" or "possibly significant" and listed those as <1% (of the 5 mrem/yr whole body Appendix I design objective) as not significant. If a licensee chooses to implement EPRI NP-3840, documentation of justification should be kept on file for inspection. 9 Dom 9 1 (last paragraph in Principal Radionuclides for Effluent Monitoring) -

Does this mean all sites need to account for C-14?

What about other hard-to-detect nuclides like P-32, Ni-63 and others? C-14 may be a principal radionuclide contributing more than 1% of the total radioactive effluent by activity or by dose, and if so, should be considered a principal radionuclide and accounted for. An evaluation should be made for the principal nuclides. Other radionuclides contributing more than 1% by activity or dose, whether hard to detect or not, should also be accounted for. 10 Dom 9 2 (Sampling Liquid Radwaste, second sentence) - "- recirculated by up to three volumes -" should be "recirculated by at least three volumes -" otherwise it is acceptable to recirculate for less than three volumes which is not the intent The staff agrees with the comment. The text has been changed. (This is a duplicate of NEI comment #15).

June 1, 2009 4911 Dom 15 4 (Measurement Uncertainty) - This whole section should be deleted. In theory this is a nice parameter to calculate, but it is so variable and dependent on many conditions, including actual isotopic mixture, the relative magnitude of this mixture (which can be dependent on dilution in the effluent stream, especially for airborne releases and can change significantly over time) that in most cases it is only a guess based on a specific set of circumstances. The last sentence discusses sampling uncertainty, but the most significant uncertainty occurs for grab samples of continuous release pathways (especially when some of these pathways, especially ventilation have significant flow rate which provides very large dilution resulting in significant measurement error). Most licensees track radiation monitor changes, but there are limitations and the error in the isotopics is significant, especially for routine low level releases and the more difficult to detect nuclides (e.g., Kr-85). Much better sensitivity occurs for the higher activity samples obtained during outages, but these typically occur for shorter periods of time. Therefore, these still may make up a fraction of the quarterly and annual totals and this fraction will change with time. Anyone performing detailed calculations for this uncertainty has significant uncertainty in their calculations, especially since it is grouped as an aggregate (both for nuclides and release points). The staff disagrees with the comment. Licensees should make an estimate of the uncertainty. A detailed analysis including all parameters is not necessary. Because it may be difficult to assign error terms for each parameter affecting the final measurement, detailed statistical evaluations of error are not suggested. (This is a duplicate of NEI comment #69).

12 Dom 18 5.6.4 Why do the 10 CFR 20.1301(c) doses need to include prior-year discharges and the 10 CFR 50 Appendix I do not (see Section C.5.8.4)? It would seem appropriate to be consistent and do the prior-year for both. Appendix I applies to current year releases from effluents only, whereas 10 CFR 20 applies to total dose (from both current year direct radiation, from current year effluents, and prior year effluents).

June 1, 2009 5010 CFR 50 Appendix I is an annual limit for committed dose due to effluents, whereas 10 CFR 20.1301 is an annual limit of effective dose equivalent for both effluents and direct radiation. The occupational dose of 10 CFR 20.1301 is the "dose from licensed operation" which includes dose from previous years effluents. See 20.1001(b) that establishes the purpose as controlling the total dose to an individual (including doses from licensed and unlicensed radioactive material). The unlicensed material includes the previous year's discharges to the environment. 13 Dom 19 5.8.3 The second sentence is not always true; in some cases it is possible that food and/or drink at a downwind location may be obtained from another location. This is especially true for drinking water which may be obtained from a public water supply where the intake may be downstream of the liquid discharge point but not downwind of the airborne release point. Therefore, the third sentence is not a good example since is dependent on site conditions and may not always be true. The staff agrees with the comment. This has been revised to state that only when the downstream drinking water is consumed by the upstream resident should it be added. 14 Dom 21 5.10.2 Similar to Specific [Dominion] comment 3, there can be an issue here.

What is indistinguishable from background?

Best efforts should be performed to calculate direct doses; these can be based upon measurements performed near the source terms and appropriately extrapolated (e.g., based upon "shine" modeling) to the point of exposure and then compared to actual The staff agrees that licensees may use measurements, calculations, or a combination of measurements and calculations to determine direct radiation. Additionally, licensees may use methods (e.g., as outlined in RG 1.21, Revision 2) to make a determination of direct radiation that is distinguishable from background. Licensees may use other methods, but the methods should be clearly documented.

June 1, 2009 51REMP measurements (if possible) similar to what should be done for all pathways. (see Specific comment 3 for more specific details) 15 Dom 21 5.10.3 Based upon previous comments (Specific comments 3 and 14), it would seem appropriate to perform both calculations and measurements for direct radiation, since it is likely the most significant dose pathway for many sites. As mentioned in the previous comment, calculations can be performed using onsite (near the source term) measurements and these can be compared to measurements much closer to the location of public exposure. The staff agrees with the comment. Licensees should perform an evaluation based on their site specific factors to determine the best method of estimating dose from direct radiation. The existing verbiage allows licensees to use a combination of calculations and measurements. No change needed. 16 Dom 22 C.5.11.3 Section C.5.11.3 - This example showing an extrapolation of doses seems like an endorsement of a potentially very unscientific method. Why extrapolate a number that includes both background and direct dose? Extrapolating the station contribution (e.g., subtract background from the 50 ft. away indicator and then extrapolate to the nearest residence based upon modeling) would seem to be more valid and probably lead to less error. As already mentioned, this "source term calculation" could then be compared to the REMP measurement at the location of public exposure. The staff agrees with the comment, the calculation in section 5.11 was deleted. Additional information and references were added regarding extrapolation of background. 17 Dom 22 5.11.4 5.11.5 The 0.0017 values listed in steps 5.11.4.3 and 5.11.4.4 are not consistent with the 0.017 values listed in values 5.11.5.5.1.1 - 5.11.5.3.2. The staff agrees with the comment, the calculation in section 5.11 was deleted. (This is a duplicate of the comment from PPL #4) 18 Dom 24 8 Section C.8 - All the phases "source term" (the real source term is typically the Reactor Coolant System) should more accurately be called "release term." The staff agrees with the comment. Section 8, on data trending, was deleted. 19 Dom 24 8 Section C.8 - 10 year trends are a great practice, but does it really belong in the ARERR? Trends The staff agrees with the comment. The section of data trending was eliminated with June 1, 2009 52are very useful for the release (not source as mentioned above) terms, but trending all the various doses will likely be "overkill." In most cases the doses are well below the limits; why trend these when they usually range from less than 0.01% to 1%. Should the trend be for each unit? In many cases the limits are per unit. Therefore, this will lead to a lot of typically meaningless trends, especially for multiunit stations. Suggest only one "dose" trend should be listed here; the one that seems to be the most useful is: "maximum individual dose" (for whole body, thyroid and maximum organ) for the three "source terms" (airborne, liquid and "radwaste storage" (which includes all the "direct radiation doses," e.g., ISFSI, radwaste, etc.)) versus the 40 CFR 190 limits. Unfortunately the list of items to trend that is presented here is too prescriptive and any deviations will need to be justified (and therefore, potentially open to "interpretation"). Wording should be used to make the list be more "suggestive." the exception that licensees should still ensure the provisions of 10 CFR 50 Appendix I, Section IV.B.2 (i.e., to evaluate the relationship between quantities of radioactive material released in effluents and resultant radiation doses to individuals) are addressed. (This duplicates PPL comment #3, STARS comment #8, and NEI comment #43) 20 Dom 24 8.2 "activation products" should be "activation gases" (particulates are also typically activation products for gaseous releases) to be consistent with Section C.9.1.1. The staff agrees with the comment. The changes were made. 21 Dom 24 9 The statement "the entry should be left blank" requirement for results "determined to be below detectable levels" may be even better handled buy use of a "-" to provide an indication that the actual analysis(es) was (were) performed. Past experience on this issue indicates that without a clear distinction on which analyses were actually performed will raise questions (from the Public and NRC inspectors) even though the sampling The staff agrees with the comment. The guidance was revised to allow licensees to use whatever term is appropriate.

June 1, 2009 53requirements are listed elsewhere in the report. 22 Dom 25 9.1.4 9.1.6 In many cases the batch releases for certain required samples (e.g., containment purges, containment vents, waste gas decay tanks) do not require all the listed radionuclide categories (e.g.,

iodines/halogens, particulates, gross alpha) because they are released via a continuous pathway which already has these radionuclide categories measured (and reported). The staff agrees with the comment. The guidance was revised. 23 Dom 25 9.2.1 The need to report both volume of primary and secondary waste is a good practice. Consistent with this practice would be the need to report dilution flow for both primary and secondary waste since the isotopic mix and dilution flows can be significantly different for these two waste streams. The staff agrees with the comment. The guidance was revised. 24 Dom 26 9.2.3 The four categories listed here should be consistent with Section C.9.2.2 The staff agrees with the comment. The guidance was revised. 25 Dom 31 3.2 Don't agree with Section 3.2. Implementation of this update will have an impact; this depends on how many of our comments are addressed. The staff disagrees with the comment. The guidance in RG 1.21 is not a requirement. Licensees may continue to use RG 1.21 Revision 1 or they may use other equivalent methods of meeting the regulations. The staff does agree that the data trending could have been time consuming; however, the section on data trending was deleted. 26 Dom 32 to 36 Glossary a priori - by definition it is "before the fact" as listed in the definition and as such, it is based upon prior study. How could it be determined before the "actual measurement" if it is not based upon prior study or examination?

Abnormal Release - what is the definition of short release? In outages containment purge exhaust The staff agrees the definition could be improved. The definition of a priori was revised. The definition of abnormal release was June 1, 2009 54fans can be off for several days. Is this short? What about a week?

Effluent Monitor Inoperability - Definition as listed is the requirement for when inoperable monitors need to be reported, not for the definition of when a monitor is considered inoperable.

Less Significant Release Point - where is this definition" Significant Release Point - In the first sentence, the "and" before "(2)" is not consistent with the text (see page 6). More importantly, see Specific comment

1. revised and an example of a short duration was included.

The definition of effluent monitor inoperability was deleted.

A definition for less-significant release point was added to the glossary.

The definition was revised as indicated.