ML19240B379
| ML19240B379 | |
| Person / Time | |
|---|---|
| Issue date: | 07/01/2020 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| Harriet Karagiannis | |
| Shared Package | |
| ML19240B377 | List: |
| References | |
| RG 7.4, Rev. 2 | |
| Download: ML19240B379 (11) | |
Text
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Leakage Tests on Packages for Shipment of Radioactive Material Proposed Revision 2 of Regulatory Guide 7.4 On April 8, 2019, the U.S. Nuclear Regulatory Commission (NRC) published a notice in the Federal Register (84 FR 13969) announcing that Draft Regulatory Guide (DG)-7010 (proposed Revision 2 of Regulatory Guide 7.4) was available for public comment.
The public comment period closed on June 7, 2019 and the NRC staff received the following comments:
Ms. Barbara Warren Telephone: (845) 754-7951 Email: warrenba@msn.com ADAMS Accession No.: ML19239A152 Mr. Lawrence Gelder Telephone: (803) 645-3490 Email: lawrence.gelder@em.doe.gov ADAMS Accession No.: ML19239A153 Ms. Janet Schlueter Nuclear Energy Institute, 1201 F Street, NW, Suite 1100 Washington, DC 20004 Telephone: (202) 739-8098 Email: jrs@nei.org ADAMS Accession No.: ML19158A455 Mr. Gerard van Noordennen EnergySolutions 250 Berryhill Road, Suite 400 Columbia, SC 29210 Telephone: (860) 462-9707 Email:
gpvannoordennen@energysolutions.com ADAMS Accession No.: ML19158A459 No. Commenter Comment NRC Resolution 1
Ms. Barbara Warren The DG-7010 references ANSI N14.5-2014, there is no way to review the changes without purchasing the $87.00 document, this is not a public way to deal with this. The relevant regulations should be copied that are pertinent, this makes it impossible for the average person to comment. How can we get the relevant material to review?
The NRC notes the comment, but no changes were made to DG-7010 in response to this comment.
All aspects of the ANSI N14.5-2014 standard are applicable to this regulatory guide, so it is not practical to copy only selected portions. The standard is also copyrighted.
Revising this regulatory guide to endorse a consensus standard is consistent with the NRC policy of evaluating the latest versions of national consensus standards to determine their suitability for endorsement by regulatory guides.
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Rev. 2 2
No. Commenter Comment NRC Resolution This is in accordance with Public Law 104-113, National Technology Transfer and Advancement Act of 1995. This approach is described in the NRCs Management Directive (MD-6.5) - NRC Participation in the Development and Use of Consensus Standards (ML18073A164).
However, there is no requirement to make all standards used in regulatory documents publicly available for free. Charging a fee for standards is how some standards development organizations are able to fund the ongoing resources necessary to continue to develop standards that benefit many organizations. The NRC does not have the authority to require such organizations to make their documents available for free, particularly if the standards are copyrighted.
The NRC believes that the standard is reasonably available to interested members of the public. ANSI N14.5-2014 can potentially be requested at a local public library or University library through inter-library loan.
However, Management Directive (MD-3.52) -
Availability and Retention of Voluntary Consensus Standards (ML17263B174) in Section I.C states, Copies of industry voluntary consensus standards used in a substantive manner in the NRC regulatory process are maintained at the NRC Technical Library, 11545 Rockville Pike, Rockville, Maryland, and are available there for reference by the public.
Therefore, the NRC Technical Library purchased a hard copy of ANSI N14.5-2014 for the NRC
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Rev. 2 3
No. Commenter Comment NRC Resolution Technical Library and it is available there for reference by the public.
The NRC has issued Information Notice (IN) 2016-04, titled, ANSI N14.5-2014 Revision and Leakage Rate Testing Considerations, which highlights many changes (but not necessarily all) that enhance safety in the ANSI N14.5-2014 revision. IN 2016-04 can be found at:
https://www.nrc.gov/docs/ML1606/ML16063A287
.pdf This Draft Regulatory Guide references and endorses the ANSI N14.5-2014 standard to meet the applicable regulations, and those applicable regulations are included in the Section titled, Applicable Regulations, of the Draft Regulatory Guide. The prior revision (Revision 1) of Regulatory Guide 7.4 also referenced and endorsed ANSI N14.5-1997.
2Property "ANSI code" (as page type) with input value "ANSI N14.5-1997.</br></br>2" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. Mr. Lawrence Gelder This version of ANSI N14.5, Section 7.5.2, states the Frequency Periodic leakage rate testing shall be performed within 12 months prior to each shipment, unless an alternate frequency is justified and approved by the applicable regulatory authority. Periodic leakage rate testing need not be performed for out-of-service packagings.
Has NRC developed acceptance criteria or guidelines for reviewing 10 CFR Part 71 applications that include alternate periodic maintenance frequency beyond 12 months?
The NRC notes the comment, but no changes were made to DG-7010 in response to this comment.
The NRC has not developed guidelines for reviewing a Title 10 of the Code of Federal Regulations (CFR), Part 71, Packaging and Transportation of Radioactive Material, application that includes a periodic leakage rate test alternate frequency; the acceptance criteria would depend on the justification provided by the applicant who would need to show that the containment regulations shall be met at the alternate frequency.
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Rev. 2 4
No. Commenter Comment NRC Resolution If an applicant is considering an alternate periodic leakage rate test frequency, it would be beneficial for the applicant to request a public pre-application meeting to discuss the proposed periodic leakage rate test alternate frequency, as well as the justification the applicant is providing. Depending on the applicant provided justification, the NRC might: ask requests for additional information, propose a different alternate frequency, or continue to request that a periodic leakage rate test shall be performed within 12 months prior to each shipment.
It is noted that the comment also refers to maintenance leakage rate test frequency.
However, the frequency for the maintenance leakage rate test has not changed in ANSI N14.5-2014.
3Property "ANSI code" (as page type) with input value "ANSI N14.5-2014.</br></br>3" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. Ms. Janet Schlueter, Nuclear Energy Institute Fundamental Process Concerns with DG-7010:
NRC states on page 3 of DG-7010 that regulatory guides are not substitutes for regulations and compliance with them is not required. We would add, neither are Information Notices (e.g., IN 2016-04). Contrary to that statement, industry is aware of more than one case where NRC imposed the ANSI N14.5-2014 standard during the renewal process for a current transportation package certificate of compliance. As stated above, we fully support the implementation of new industry standards when properly justified and clearly warranted from a safety perspective. However, such standards should not and cannot legally be imposed on existing licensees without a proper analysis as required by NRCs own rules (e.g., 10 CFR 50.109 and 70.76) and the Administrative Procedure Act (APA). Such analysis must include a well-documented and vetted cost-benefit The NRC notes the comment, but no changes were made to DG-7010 in response to this comment.
Revising this regulatory guide to endorse a consensus standard is consistent with the NRC policy of evaluating the latest versions of national consensus standards to determine their suitability for endorsement by regulatory guides.
This is in accordance with Public Law 104-113, National Technology Transfer and Advancement Act of 1995. This approach is described in the NRCs Management Directive (MD-6.5) - NRC Participation in the Development and Use of Consensus Standards (ML18073A164).
ANSI N14.5-2014 supersedes ANSI N14.5-1997, which was issued by the American National
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Rev. 2 5
No. Commenter Comment NRC Resolution analysis developed with stakeholder input. The specific NRC licensing actions referenced above where NRC imposed ANSI N14.5-2014 without any such analysis has already resulted in significant costs to industry, both to the package certificate holders and shippers of radioactive material including commercial power plants.
Even in the renewal context, imposition of new standards without the consideration of costs violates the backfit rule and the APA in the absence of an adequate protection issue.
Standards Institute in 2014 and contains new information, corrections, and clarifications. The NRC has discussed and made known the issuance of the updated ANSI N14.5-2014 consensus standard in public meetings and Information Notice (IN) 2016-04.
As stated in DG-7010, Section D, Implementation, the NRC staff does not intend to impose implementation of the ANSI N14.5-2014 standard on existing CoC holders and licensees.
These current CoC holders and licensees may continue to use the guidance that the NRC has already found acceptable for complying with the identified regulations as long as their current licensing basis remains unchanged.
If a CoC holder or licensee believes that the NRC improperly requires implementation of ANSI N14.5-2014 then the CoC holder or licensee may file a backfit appeal with the NRC in accordance with the guidance in Management Directive 8.4.
This statement is included in DG-7010, Section D, Implementation, to inform applicants of the process to follow.
4 Ms. Janet Schlueter, Nuclear Energy Institute Fundamental Process Concerns with DG-7010:
The reality is that several currently licensed Type B transport casks, built prior to 1999, were not subject to nor did they undergo a containment boundary leak test during fabrication; and the containments cannot now be accessed for leak testing in accordance with the ANSI N14.5-2014 standard. These casks were designed and manufactured to the then current standards and neither NRC nor industry has identified any safety issue with their continued use. Before imposing ANSI N14.5-2014 The NRC notes the comment, but no changes were made to DG-7010 in response to this comment.
As stated in DG-7010, Section D, Implementation, the NRC staff does not intend to impose implementation of the ANSI N14.5-2014 standard on existing CoC holders and licensees.
In the event that the NRC considers imposing the new standard on an existing CoC holder or
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Rev. 2 6
No. Commenter Comment NRC Resolution on these casks, the NRC would need to demonstrate that such a backfitting action would: (1) result in a substantial increase in protection to the occupational or public health and safety; and (2) the direct and indirect costs of implementation are justified in light of this increased protection. Absent such a showing, NRC should grandfather these casks to avoid the unnecessary and costly burden for processing exemption requests to ANSI N14.5-2014 or attempting to develop new methods for conducting leak tests for existing casks.
licensee subject to regulatory backfit provisions, the NRC will first determine whether a backfit is appropriate in accordance with all relevant NRC regulations and guidance.
5 Ms. Janet Schlueter, Nuclear Energy Institute Resource Impacts of Imposing New Standard:
Logistics - Utilities have already been forced to expend resources to meet the standard since not all power plants have available indoor space or the appropriate controlled conditions to meet the specifications of ANSI N14.25, e.g., temperature and insolation controls. In order to use the subject transportation package for the routine shipment of radioactive material, more than one utility has been forced to establish a well-controlled, temporary, cordoned outdoor space in which to perform the leak test.
Another utility will have to lease the cask for several additional days to move the cask from an indoor leak test area out to the waste container loading area and back again. Also, most if not all hospitals and research facilities do not have indoor space to house large Type B transportation casks when needed (e.g., re-location of large blood irradiators).
Imposing this standard results in additional costs for everyone involved: 1) the package certificate holder who must modify leak testing equipment, develop new procedures, and train and qualify staff to a new standard;
- 2) shippers costs for increased cask lease rates (to reimburse the certificate holders additional cost); 3) personnel and contractors to set up the controlled The NRC notes the comment, but no changes were made to DG-7010 in response to this comment.
ANSI N14.5-2014 was issued by the American National Standards Institute in 2014 to provide new information, corrections, and clarifications to the superseded ANSI N14.5-1997; there are no new temperature or insolation control specifications in the new revision of the standard.
For an approved package as long as the current licensing basis remains unchanged, ANSI N14.5-1997 can continue to be used.
Alternative approaches to ensure accurate testing for leakage of radioactive material may be proposed by applicants. The ANSI N14.5 standard leakage test is only one approach.
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Rev. 2 7
No. Commenter Comment NRC Resolution conditions and space; 4) on-site time and travel cost for use of contracted leak test personnel qualified to meet the training standards in ANSI N14.5-2014; and 5) additional cask rental fees for the added time on-site to conduct the leak test in a controlled space. All these new costs to industry in the absence of a clearly articulated safety concern cannot be justified and have not been justified through a rulemaking. Rather, the staff has and, if DG-7010 is finalized, will likely continue to impose these new standards through the licensing process licensee-by-licensee. This practice must stop and the agency must follow its regulation, the APA, and the new instruction recently issued Management Directive 8.4.
6 Ms. Janet Schlueter, Nuclear Energy Institute Resource Impacts of Imposing New Standard:
In addition, significant new and costly training and qualification of leak test personnel is required to meet the additional training standards in ANSI N14.5-2014.
Specifically, ANSI N14.5-1997 required that trained and qualified personnel perform leak testing in accordance with a Quality Assurance program. The 2014 version of the standard is much more costly and burdensome in that leak test procedures must be approved by an ASNT NDT Level III qualified person. Further, the testing must be performed by personnel certified based on SNT-TC-1A.
This means that the leak test will have to be performed by personnel certified at the Level II or Level III level.
Apparently, there are less than 100 certified individuals available nationwide to perform such tests for the entire nuclear industry. The basis for this resource intensive, costly, unnecessary and burdensome increase in the training standard for leak test personnel is not justified yet it has been imposed by NRC.
The NRC notes the comment, but no changes were made to DG-7010 in response to this comment.
The importance of having qualified individuals approving leakage rate test procedures and performing leakage rate tests is due to the sensitivity of leakage rate test variables, sophistication of leakage rate testing equipment, subtleties of achieving accurate measurements, and often rigorous leakage rate test acceptance criterion. Recognizing this, ANSI N14.5-1997 and ANSI N14.5-2014 indicated the need for qualifications.
ANSI N14.5-2014 states that leakage rate testing procedures shall be approved by personnel whose qualification and certification in the nondestructive method of leak testing includes certification by a nationally recognized society at a level appropriate to the writing and/or review of leakage rate testing procedures. An individual who has obtained certification as an American
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Rev. 2 8
No. Commenter Comment NRC Resolution Society for Nondestructive Testing (ASNT) nondestructive testing (NDT) Level III in leak testing has the qualification necessary to develop and approve written instruction for conducting leakage rate testing as well as the knowledge to consider practical leakage rate testing issues, as described above.
The American Society for Nondestructive Testing Inc., Recommended Practice No. SNT-TC-1A, states that an NDT Level I individual should be qualified to properly perform specific calibrations, specific NDT, and specific evaluations for acceptance or rejection determinations according to written instructions and to record results. The NDT Level I should receive the necessary instruction and supervision from a certified NDT Level II or III individual. Therefore, an individual qualified and certified to Level I in leak testing can perform a leakage rate test depending on certain conditions. The staff notes that industry personnel involved in other nondestructive testing, such as ultrasonic testing and radiographic testing, are also qualified and certified according to Recommended Practice No. SNT-TC-1A.
7 Ms. Janet Schlueter, Nuclear Energy Institute Cost Estimate Comments:
Alternative 3 in the Draft Regulatory Analysis discusses the minimal cost to NRC to revise and implement the final RG 7.4. It goes on to state that the public could be impacted by reviewing and providing comments to NRC but it ignores the cost impact to the cask certificate holders and cask users as discussed above. For example, in one case, a utility that has an indoor space expects to expend approximately $10,000 for a single The NRC notes the comment, but no changes were made to DG-7010 in response to this comment.
Regarding the example cost of a single utility provided in the comment, without knowing details it is not possible to account for the additional amount associated with the consensus standard.
However, it is noted that NRC has endorsed the ANSI N14.5 standard since 1975 and the
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Rev. 2 9
No. Commenter Comment NRC Resolution leak test performed on site. This increased cost in the absence of a clearly defined regulatory safety issue with the current standard or industry practice is unacceptable.
industry has used the ANSI N14.5 standard.
Similar to other consensus standards, ANSI N14.5 is revised on a regular basis to incorporate new information, corrections, and clarifications.
As stated in DG-7010, Section D, Implementation, the NRC staff does not intend to impose implementation of the ANSI N14.5-2014 standard on existing CoC holders and licensees.
These current CoC holders and licensees may continue to use the guidance that the NRC has already found acceptable for complying with the identified regulations, including ANSI N14.5-1997, as long as their current licensing basis remains unchanged.
As noted in DG-7010 the regulatory guide (RG) describes methods and procedures acceptable to the U.S. Nuclear Regulatory Commission (NRC) staff to meet the requirements in 10 CFR Part 71, for leakage tests of packages to ensure the integrity of radioactive material containers and to minimize the distribution of contamination to the environment. The NRC issues RGs to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the agencys regulations, to explain techniques that the staff uses in evaluating specific problems or postulated events, and to provide guidance to applicants.
Regulatory guides are not substitutes for regulations and compliance with them is not required. Methods and solutions that differ from those set forth in RGs will be deemed acceptable if they provide a basis for the findings required
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Rev. 2 10 No. Commenter Comment NRC Resolution for the issuance or continuance of a permit or license by the Commission.
8 Mr. Gerard van Noordennen, EnergySolutions Currently, there are several licensed Type B transport casks for which containment boundary leak tests have not been performed during fabrication. Most of these casks (low-level waste and dual-purpose used nuclear fuel casks) were built prior to 1999. ANSI N14.5-2014 requires performing a fabrication leak test on containment boundary components during manufacturing of these casks; however, it is no longer feasible due to limited access to containment boundary elements after cask fabrication was completed. In such cases, exception from ANSI N14.5-2014 associated with fabrication leak test requirements for already built casks will have to be made and alternative approaches to demonstrate compliance may be developed by cask CoC license holders and considered by the NRC. We propose that existing casks be grandfathered to the standards they were designed and built to so there is no need to obtain an exception to the standard.
The NRC notes the comment, but no changes were made to DG-7010 in response to this comment.
As stated in DG-7010, Section D, Implementation, the NRC staff does not intend to impose implementation of the ANSI N14.5-2014 standard on existing CoC holders and licensees.
These current CoC holders and licensees may continue to use the guidance that the NRC has already found acceptable for complying with the identified regulations, including ANSI N14.5-1997, as long as their current licensing basis remains unchanged. Packages approved under ANSI N14.5-1997 can continue to be used according to those standards.
9 Mr. Gerard van Noordennen, EnergySolutions ANSI N14.5-2014 introduced significant changes associated with requirements for training/certification of the personnel performing leak testing. ANSI N14.5-1997 requires that Trained and Qualified Personnel shall perform leakage testing in accordance with written procedures and a written quality assurance program.
ANSI N14.5-2014 requires that all leak test procedures are approved by ASNT NDT Level III personnel in Leak Testing (LT) and testing is performed by personnel certified based on SNT-TC-1A (Recommended Practice for Personnel Qualification and Certification in Nondestructive Testing). Historically, leak-testing activities have been performed by Trained and Qualified personnel based on the users quality assurance program. The 2014 version of the standard requires the leak tests to be performed by Certified Level II or Level III The NRC notes the comment, but no changes were made to DG-7010 in response to this comment.
As noted in the response to Comment #6, the importance of having qualified individuals approving leakage rate test procedures and performing leakage rate tests is due to the sensitivity of leakage rate test variables, sophistication of leakage rate testing equipment, subtleties of achieving accurate measurements, and often rigorous leakage rate test acceptance criterion. Recognizing this, ANSI N14.5-1997 and ANSI N14.5-2014 indicated the need for qualifications.
Response to Public Comments on Draft Regulatory Guide (DG)-7010, Rev. 2 11 No. Commenter Comment NRC Resolution personnel In LT. We anticipate a large impact on the industry associated with pre-shipmen leak test measurements (required to verify proper cask assembly
/closure prior to shipment) of low-level waste Type B packages due to the new requirements of ANSI N14.5-2014. Because of the existing very limited pool of ASNT NDT Level III, LT expertise available in the U.S.A. (less than 100 certified individuals), the cask users will be forced to make a choice between developing their own Level II or Level III, LT personnel or subcontracting these activities to organizations providing such services. This change may result in improved consistency of training/experience and qualifications among leak testing personnel, however, it will provide additional financial/administrative burden on cask users and cask CoC license holders with little or no benefit to safety. We propose that existing qualified leak test personnel be given a five-year implementation period to obtain their ASNT Level II or III leak test certification.
The American Society for Nondestructive Testing Inc., Recommended Practice No. SNT-TC-1A, states that an NDT Level I individual should be qualified to properly perform specific calibrations, specific NDT, and specific evaluations for acceptance or rejection determinations according to written instructions and to record results. The NDT Level I should receive the necessary instruction and supervision from a certified NDT Level II or III individual. Regarding existing qualified leak test personnel, an individual qualified and certified to Level I in leak testing can perform a leakage rate test depending on certain conditions. The staff notes that industry personnel involved in other nondestructive testing, such as ultrasonic testing and radiographic testing, are also qualified and certified according to Recommended Practice No. SNT-TC-1A. Since there are many individuals that would meet the qualifications, the staff does not consider this to be a significant burden.
The NRC staff has performed a more extensive regulatory analysis (ADAMS ML20034F254) and has estimated the regulatory guide revision recommendation to result in minimal net quantitative costs to the NRC, certificate of compliance (CoC) holders, and licensees.
Relative to the regulatory analysis no-action baseline, the NRC staff concluded that the regulatory guide revision is acceptable when considering all costs and benefits, because the nonquantified benefits justify the minor costs.