ML101460429

Purdue University - 30 Day Request for Additional Information Regarding the PUR-1 License Renewal

ML101460429
Person / Time
Site:	Purdue University
Issue date:	07/06/2011
From:	Duane Hardesty Research and Test Reactors Licensing Branch
To:	Joel Jenkins Purdue University
Hardesty, D NRC/NRR/DPR/PRLB 415-3724
References
TAC ME1594
Download: ML101460429 (12)

Text

July 6, 2011 Mr. Jere H. Jenkins Director of Radiation Laboratories Purdue University Nuclear Engineering Building 400 Central Dr.

West Lafayette, IN 47907-2017

SUBJECT:

PURDUE UNIVERSITY - REQUEST FOR ADDITIONAL INFORMATION REGARDING THE PURDUE UNIVERSITY REACTOR LICENSE RENEWAL APPLICATION (TAC NO. ME1594)

Dear Mr. Jenkins:

The U.S. Nuclear Regulatory Commission (NRC) is continuing our review of your application for renewal of Facility Operating License No. R-87, Docket No. 50-182 for the Purdue University Reactor (PUR-1) dated July 7, 2008, as supplemented by letters dated June 3, and June 4, 2010. During our review of the documentation for your renewal request, questions have arisen for which we require additional information and clarification. Enclosed is a partial request for additional information. We are requesting a response to this request within 30 days of the date of this letter. Additional requests for information containing our remaining questions of a more complex nature have been sent under separate cover.

In accordance with Title 10 of the Code of Federal Regulations (10 CFR), Section 50.30(b), you must execute your response in a signed original document under oath or affirmation. Your response must be submitted in accordance with 10 CFR 50.4, Written Communications. Information included in your response that is considered security, sensitive, or proprietary, that you seek to have withheld from the public, must be marked in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. Following receipt of the additional information, we will continue our evaluation of your renewal request.

J. Jenkins If you have any questions regarding this review, please contact me at (301) 415-3724 or by electronic mail at duane.hardesty@nrc.gov.

Sincerely,

/RA/

Duane A. Hardesty, Project Manager Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 50-182

Enclosure:

As stated cc w/encl: See next page

Purdue University Docket No. 50-182 cc:

Mayor City of West Lafayette 609 W. Navajo West Lafayette, IN 47906 John H. Ruyack, Manager Epidemiology Res Center/Indoor & Radiological Health Indiana Department of Health 2525 N. Shadeland Ave., E3 Indianapolis, IN 46219 Howard W. Cundiff, P.E., Director Consumer Protection Indiana State Department of Health 2 North Meridian Street, 5D Indianapolis, IN 46204 Leah Jamieson, Dean College of Engineering Purdue University 400 Central Dr.

West Lafayette, IN 47907 Mr. Ed Merritt Reactor Supervisor Department of Nuclear Engineering Purdue University 400 Central Dr.

West Lafayette, IN 47907 Test, Research, and Training Reactor Newsletter University of Florida 202 Nuclear Sciences Center Gainesville, FL 32611

ML101460429 TEMPLATE # NRR-088 OFFICE PRLB:PM PRPB:LA PRLB:BC PRLB:PM NAME DHardesty GLappert JQuichocho DHardesty DATE 5/11/2011 5/26/2011 7/6/2011 7/6/2011

OFFICE OF NUCLEAR REACTOR REGULATION REQUEST FOR ADDITIONAL INFORMATION FOR THE RENEWED FACILITY OPERATING LICENSE PURDUE UNIVERSITY RESEARCH REACTOR LICENSE NO. R-87 DOCKET NO. 50-182 The purpose of these questions is to assist the U. S. Nuclear Regulatory Commission (NRC) staff in determining that the renewal application from the Purdue University Research Reactor (PUR-1) meets the requirements of the regulations, in particular the regulations in Title 10 of the Code of Federal Regulations Parts 20 and 50. The questions are based on a review of your application using the NRC staffs standard review plan in NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, Part 2, Standard Review Plan and Acceptance Criteria.

We have divided our questions into three groups; the below questions with a 30-day requested response time, questions that may require outside resources for assistance in completion have a 60-day requested response time, and complex and computational questions that have a 90-day requested response time. The three groups of questions considered together result in a complete set of consecutively numbered questions.

You are requested, where appropriate, to provide specific references in the responses to prior analyses from previous SARs and other references, and to provide updates to assumptions and resulting conclusions of these analyses.

NUREG-1537, Part 1, Appendix 14.1 suggests that the format and content of the proposed Technical Specifications (TS) follow the recommendations of American National Standard Institute/American Nuclear Society (ANSI/ANS)-15.1, The Development of Technical Specifications for Research Reactors. The current version of the standard, ANSI/ANS-15.1-2007, is the basis for the questions below. For the following questions, we are requesting a response within 30 days of the date of this letter:

1. ANSI/ANS-15.1-2007, Section 1 provides a definition of Reference Core Condition. The TS for PUR-1 provides no definition for Reference Core Condition although the reference core condition is mentioned in PUR-1 TS 1.10. Please provide a definition for the Reference Core Condition to comply with the modified ANSI/ANS-15.1-2007 standard definition as specified in Appendix 14.1 to NUREG-1537, Part 1.

2. ANSI/ANS-15.1-2007, Section 1 provides definitions for key terminology utilized in the TS. Please review the TS for facility-specific definitions unique to PUR-1 that should be included in the TS. As a minimum, include definitions of Responsible Authority, Rod Control, Rod Regulating, Rod Transient, and Scram Time in TS 1.0 Definitions, or justify why the definitions are not needed, required, or justify the omission.

3. TS 1.32 and TS1.33: The Reactor secured and Reactor shutdown definitions provided in TS 1.32 and TS 1.33 differ from the definitions the NRC has previously found acceptable.

The definitions for Reactor Secured and Reactor Shutdown are provided in ANSI/ANS-15.1-2007, Section 1 as tailored by NUREG-1537. The following are definitions, from guidance provided in NUREG 1537, Appendix 14.1, deemed acceptable:

Reactor secured: A reactor is secured when:

1. Either there is insufficient moderator available in the reactor to attain criticality or there is insufficient fissile material present in the reactor to attain criticality under optimum available conditions of moderation and reflection;

2. Or the following conditions exist:

a. The reactor is shutdown, as required by TS 1.33, and;

b. The requirements of the reactor secure procedure are met.

Reactor shutdown: A reactor is shutdown when the following conditions exist:

a. The minimum number of neutron absorbing control devices is fully inserted or other safety devices are in shutdown position, as required by TS;

b. The console key switch is in the off position, and the key is removed from the lock;

c. No work is in progress involving core fuel, core structure, installed control rods, or control rod drives unless they are physically decoupled from the control rods;

d. No experiments are being moved or serviced that have, on movement, reactivity worth exceeding the maximum value allowed for a single experiment, or one dollar, whichever is smaller.

Note: For subparagraph d., a single value should be chosen to specify the smaller value of either one dollar or the maximum value allowed for a single experiment. Do not specify both options in the definition.

Please evaluate PUR-1 TS 1.33 against the suggested definitions for Reactor secured and Reactor shutdown and propose TS changes or justify your current definitions.

4. TS 1.36 and TS 6.6.2: ANSI/ANS-15.1-2007, Section 6.7.2 provides a schedule of events that require special reports. The Reportable Occurrence definition in PUR-1 TS 1.36 that addresses these special reports does not appear to be consistent with the guidance in ANSI/ANS-15.1-2007, Section 6.7.2. Additionally, per NUREG-1537, Appendix 14.1, TS 6.6.2 should state that special written reports should be sent to the NRC document control desk and special telephone reports of events should be made to the NRC Operations Center. Please propose changes to the TS or provide an explanation describing your reason(s) for not incorporating the changes.

5. TS 1.45: PUR-1 TS 1.45 provides a definition for an Unsecured Experiment. This definition refers to the definition in PUR-1 TS 1.32 for a secured experiment. The

definition for Secured experiment is provided in TS1.37. Please update TS 1.45 to reference the definition for Secured experiment in TS 1.37 or explain the reference to the definition for Reactor Secured provided by TS 1.32 as currently written.

6. TS 2.2. The specification for the Limiting Safety System Setting (LSSS) is 12.0 KW.

Please review this specification to determine if the specification should actually be 12.0 kW(thermal), and update as appropriate.

7. TS Section 3.0: NUREG-1537 states the content of the TSs follow ANSI/ANS 15.1 guidance. ANSI/ANS-15.1-2007 Section 3.5 provides specifications for the ventilation systems. Section 3 of the PUR-1 TSs does not contain Limiting Conditions for Operation of the Ventilation Systems as referenced by ANSI/ANS-15.1-2007. Please propose TS changes for the ventilation system limiting conditions for operations (LCOs) or provide an explanation describing your reason(s) for not incorporating the changes.

8. Section 13.2.1, p. 13-9 of the PUR-1 Safety Analysis Report (SAR) references TS 3.5(f) established limits of radiation exposure for failure of a singly encapsulated fueled experiment. The proposed PUR-1 TS do not include 3.5(f). Please provide an updated TS references in the SAR for the established limits or justify why they are no longer required.

9. TS 3.5(f) and 3.5(g) relating to singly encapsulated and doubly encapsulated experiments have been eliminated from the proposed PUR-1 TS. For changes made to the TS (both additions and deletions) a justification in the form of an evaluation of a safety analysis must be provided. Please provide a safety evaluation for any TSs added or deleted or refer to where the TS additions or deletions are discussed in the SAR.

10. TS 3.3: ANSI/ANS-15.1-2007, Section 3.3 provides a list of minimum operating equipment or operating limits, or both, for the limiting conditions for operations for the coolant systems. PUR-1 TS 3.3 specifies the limiting conditions for operations for the water chemistry and coolant level specifications. PUR-1 TS 3.3 does not contain specifications for the reactor pool coolant system parameters listed in ANSI/ANS 15.1, Section 3.3, such as pool temperature (core cooling) or leak or loss-of-coolant detection.

Please propose TS changes to meet the specification operating limits for the coolant system by ANSI/ANS 15.1, Section 3.3 or provide an explanation describing your reason(s) for not incorporating the changes.

11. NUREG-1537 states the content of the TSs follow ANSI/ANS 15.1 guidance. In TS 3.4, a specification states that the reactor room will be maintained at a negative pressure of 0.05 inches of water, but doesnt state what equipment maintains that negative pressure.

ANSI/ANS-15.1-2007 states that equipment required to achieve confinement be specified. There is no specification(s) or surveillances for the ventilation system, which is used to maintain confinement during reactor operations. Please update Section 3 of the TS to identify equipment required to achieve confinement and to specify appropriate surveillances in Section 4 of the TSs for the equipment or provide an explanation describing your reason(s) for not incorporating the changes.

12. TS 3.4. TS 3.4(b) specifies requirements for HEPA filters or equivalent. However, there is no corresponding surveillance associated with the HEPA filters. Please update the TS to include a surveillance that indicates when such filters are checked and any criteria for requiring a filter change or justify why this surveillance is not required.

13. TS 3.4. TS 3.4(d) specifies that the reactor operator can secure the air conditioner. The purpose of this TS or the established constraint on the system is not clear nor substantiated in the bases. Please consider if this TS is required and update the TS and/or bases as required.

14. TS 3.5: The bases for TS 3.5 indicate that TS 3.5(f) and 3.5(g) conform to Regulatory Guide 2.2 (1973). In addition, Section 13 of the SAR (p.13-9) states that the exposure rate approaches the limits established in TS 3.5(f) for singly encapsulated experiments of 1.1 g of U-235. TS 3.5(f) and 3.5(g) are not included in your submittal. Please update the TS to provide the missing TS information or requirements or update the bases and SAR to the correct references, as appropriate.

15. TS 4.1: ANSI/ANS-15.1-2007 Section 4.1 provides guidance related to annual measurement of core parameters. TS 4.1(a) contains a requirement for shutdown margin calculations without referring to excess core reactivity measurements. Please update TS 4.1(a) to be in conformance with ANSI/ANS-15.1-2007 Section 4.1 or discuss how conformance is achieved.

16. TS Section 4.0: NUREG-1537 states the content of the TSs follow ANSI/ANS 15.1 guidance. ANSI/ANS-15.1-2007 Section 4.5 provides surveillance requirements for the ventilation systems. There are no TS under Section 4, Surveillance Requirements, for Ventilation Systems as required by ANSI/ANS-15.1-2007. Please propose TS changes for surveillance of the ventilation system or provide an explanation describing your reason(s) for not incorporating the changes.

17. TS Section 4.0: ANSI/ANS-15.1-2007, Section 4 states that for each surveillance requirement (SR), it should be specified if the surveillance activity can or cannot be deferred during reactor shutdown, as well as, guidance pertaining to deferred SR that must be performed prior to reactor operations.

a. Please identify those surveillances that may be deferred during reactor shutdown, and;

b. Identify systems and/or components that require surveillance after any addition, modification, or maintenance before declaring that system operational in accordance with the original specifications to which the systems were designed and fabricated.

18. TS 4.3: TS 4.3(c) should reference the minimum 13 foot depth as specified in the LCO (TS 3.3(c)) for primary coolant and provided in the bases for TS 4.3. Please update the TS to include the numerical minimum depth and surveillance interval for this surveillance or justify why an alternative measure related to the height of the skimmer trough in TS 4.3(c) is more appropriate for specifying the minimum performance level of TS 3.3(c).

Additionally, prescribe the frequency, scope and minimum water level of this surveillance when the reactor is secured or shutdown or justify why a minimum level is not required.

19. TS 4.3. TS 4.3(d) specifies a monthly primary coolant sampling requirement for gross alpha and beta activity. Please update the TS to indicate under which modes of reactor operation monthly sampling is required. Also, consider whether a corresponding LCO for this surveillance is required in TS 3.3

20. TS 4.4(d): TS 4.4(d) specifies inspection requirements for the fuel cladding. Per the guidance of ANSI/ANS-15.1-2007, fuel inspections, if appropriate, are normally included as part of reactor core parameters (Section 3.1 / Section 4.1). Please consider moving TS 4.4(d) for inspecting fuel assemblies into a separate TS from confinement surveillance. Additionally, please identify the Section 3 LCO that establishes the minimum performance level for this surveillance or add an LCO, if needed.

21. TS 4.5: ANSI/ANS-15.1-2007, Section 6.5. provides the review and approval process to comply with the guidance provided in Section 6.2.3, unless it is a tried experiment.

PUR-1 TS 4.5 does defer the proper review and approval of the experiment to Section 6 of the TSs. However, PUR-1 TS 6.2.4(a) and 6.2.4(c) do not provide any of the formal review requirements or established and approved procedures for experiments. Please update the formal review and approval requirements for experiments in PUR-1 TS 6.2.4 to include the requirements of ANSI/ANS-15.1-2007, Section 6.5, identify where the provisions are contained in the PUR-1 TS, or justify why they are not required.

22. ANSI/ANS-15.1-2007, Section 4.7.2 provides for dosimetry monitoring of effluents at the boundary of the facility and for environmental monitoring, e.g., sampling of soil, vegetation, or water in the vicinity of the facility. TS 6.6.1.a.4. discusses results of surveillances required by these TSs, but the PUR-1 TS do not appear to contain any such surveillance requirements. Please propose TSs to address these requirements, reference where the requirements exist, or provide an explanation describing your reason(s) for not incorporating the changes.

23. TS 5.0: NUREG-1537 states the content of the TSs follow ANSI/ANS 15.1 guidance.

ANSI/ANS-15.1-2007 Section 5.0 provides the requirements for Design Features. There are no PUR-1 TSs under Section 5, Design Features, for the following systems:

a. Control Elements, as required by ANSI/ANS-15.1-2007 TS 5.2,

b. Reactor Coolant System, as required by ANSI/ANS-15.1-2007 TS 5.2,

c. Ventilation Systems, as required by ANSI/ANS-15.1-2007 TS 5.1 Please propose changes to TS for the aforementioned systems or provide an explanation describing your reason(s) for not incorporating the changes.

24. TS 5.3. Guidance in ANSI/ANS-15.1-2007, Section 5.3 states there should be requirements for periodic fuel inspection and conditions for operation, as appropriate for operation of the reactor with damaged fuel. Please update the TS to establish surveillance for fuel condition and limiting conditions for operation when and if the reactor can operate with damaged fuel (LCO) or justify why these are not required.

25. TS 6.2.4, TS 6.2.5: Guidance in ANSI/ANS-15.1-2007 states there should be an individual or group responsible for implementing the radiation protection program at PUR-1 and an individual or group that performs periodic audits of the program. In TS 6.2.4 and TS 6.2.5 there is no mention of who is responsible for the radiation protection program at PUR-1 or who performs the periodic audits. Please propose changes to TS or provide an explanation describing your reason(s) for not incorporating the changes

26. TS 6.2.6(b): PUR-1 TS 6.2.6(b) references PUR-1 TS 6.2.5(g). However, there does not appear to be a PUR-1 TS 6.2.5(g). Please update the TS, as required to provide the appropriate reference in the TS.

27. TS 6.2.4(c): ANSI/ANS-15.1-2007, Section 6.2.3 provides guidance for the review function for experiments as well as other activities. PUR-1 TS 6.2.4(c) indicates that the Committee on Reactor Operations (CORO) shall review and approve proposed tests or experiments which are significantly different from previous approved tests or experiments. Please explain what is meant by significantly different and propose a quantitative, less subjective, revision to PUR-1 TS 6.2.4.c. that incorporates CORO review for all of the items outlined in ANSI/ANS-15.1-2007, Section 6.2.3 or provide an explanation describing your reason(s) for not incorporating the changes.

28. The regulations in 10 CFR 20.1101 require that each licensee develop, document, and implement a radiation protection program. NUREG-1537, Chapter 12.1 states that the organization should meet the non-power reactor standard ANSI/ANS-15.1-2007.

ANSI/ANS-15.1, Section 6.3 states that the facility shall implement a radiation protection program in accordance with the guidelines in ANSI/ANS-15.1. However the radiation protection program is not presented or discussed in the PUR-1 TS 6.0. Please provide a TS to meet the criteria in 10 CFR 20.1101 and ANSI/ANS-15.1, Section 6.3 or provide an explanation describing your reason for not incorporating the change.

29. TS 6.1.11, TS 6.1.14: ANSI/ANS-15.1-2007, Section 6.1.3(3) provides guidance for events requiring the presence at the facility of the senior reactor operator. Please update PUR-1 TS 6.1.11 and 6.1.14 for compliance with the requirements in ANSI/ANS-15.1-2007, Section 6.1.3(3) and 10 CFR 50.54(m)(1) or provide an explanation describing your reason(s) for not incorporating the changes.

30. TS 6.6.2: ANSI/ANS-15.1-2007, Section 6.6.2 and 6.7.2(1) provide guidance on licensee actions following a reportable occurrence. It is not specified in the PUR-1 TS 6.6.2 who can authorize restart of the reactor after a reportable occurrence where the reactor was shut down. Please clarify this authority.

31. ANSI/ANS-15.1-2007, Section 6.7.2(2) provides guidance for a TS requirement to provide a written report to the NRC within 30 days of permanent changes in the PUR-1 organization involving Level 1 or 2 personnel and significant changes in transient or accident analyses as described in the SAR. This requirement does not seem to appear in TS 6.6. Please amend PUR-1 TS 6.6 to include these requirements, provide reference to where these requirements exist in the TS, or provide an explanation describing your reason(s) for not incorporating the changes.

32. TS 6.5: Regulation 10 CFR 50.59(c)(5)(i) requires that the facility licensee shall retain operator requalification documentation records until the operator's license is renewed. In addition, ANSI/ANS-15.1-2007, Section 6.8.2 contains the requirement that training records for reactor operators be maintained at all times the individual is employed or until the certification is renewed. Please amend PUR-1 TS 6.5 to satisfy this requirement.

33. Section 5.0 Design Features - This section of the TS requires applicability, objective and bases statements per 10 CFR 50.36. Please update the PUR-1 TS to satisfy this regulatory requirement.

34. Section 5.1 Site and Facility Description. ANSI/ANS-15.1-2007, Section 5.1 provides guidance to provide a general description of the site and facility including location and exclusion areas. Please update TS 5.1 to describe in detail which areas are under the jurisdiction of the reactor license (licensed area) and include a description of the facility location, as well as, the location of exclusion and restricted areas, as appropriate.

35. TS 6.1.8 states that a qualified operator is required at the operating console unless the reactor is shutdown. ANSI/ANS-15.1-2007, Section 6.1.3 (1) requires a licensed operator at the controls unless the reactor is secured. Please update the PUR-1 TS to be consistent with ANSI/ANS-15.1-2007 or justify why a qualified operator is not required at the controls when the reactor is shutdown per PUR-1 TS 1.33.

36. Staffing - The minimum requirements for staffing the reactor in Section 6 of the PUR-1 TSs and not readily clear. ANSI/ANS-15.1-2007, Section 6.1.3 provides guidance for minimum staffing as tailored by NUREG-1537. The following wording for minimum staffing as provided in NUREG 1537, Appendix 14.1 was previously deemed acceptable by the NRC:

Staffing requirements

1. The minimum staffing when the reactor is operating shall be:

a. A licensed reactor operator or senior reactor operator in the control room,

b. A second designated person present at the facility complex able to carry out prescribed written instructions. The instructions may, for more complex and higher-power reactors, require initiating the first stages of the emergency plan including evacuation and initial notification procedures.

Unexpected absence for as long as 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> to accommodate a personal emergency may be acceptable provided immediate action is taken to obtain a replacement,

c. A designated senior reactor operator shall be present at the facility or readily available on call. Readily Available on Call means an individual who:

i. has been specifically designated and the designation known to the operator on duty, ii. can be rapidly contacted by phone, by the operator on duty, iii. is capable of getting to the reactor facility within a reasonable time under normal conditions (e.g., 30 minutes or within a 15-mile radius);

2. The minimum staffing when the reactor is shutdown shall be a licensed reactor operator or senior reactor operator in the licensed facility.

3. No licensed reactor operator or senior reactor operator shall be required within the licensed facility if the reactor is secure.

37. PUR-1 Organization: Neither Figure 6.1 nor TS 6.1.5 clearly indicate the organizational level of the Head of Nuclear Engineering. Please update the figure and/or TS to reflect the level of authority for the Head of the school of Nuclear Engineering or justify why it is not required.

38. TS 6.1.6. Please review TS 6.1.6 and correct the typographical error associated with reference to ANSI/ANS-15.4.

39. TS 6.5 Operating Records to be retained for the Lifetime of the Reactor Facility. The regulations in 10 CFR 50.36 require that reviews of exceeding the safety limit (10 CFR 50.36(c)(1)(i)(A)), reviews of the failure of the automatic safety system that protects the limiting safety system settings (LSSSs) (10 CFR 50.36(c)(1)(ii)(A)) and reviews of not meeting limiting conditions for operation (10 CFR 50.36(c)(2)(i)) be retained until the Commission terminates the license. Please add these items to section 6.5 of the TSs.

40. TS 4.2(a) and Table III. The Reactor Safety System channels required to be tested before each reactor startup following a shutdown in excess of 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> are provided in Table III as referenced by TS 4.2(a). The 8 hour9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> requirement for this specification has no basis. Please provide adequate justification for the 8 hour9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> requirement or revise the TS to be consistent with NUREG-1537, Appendix 14.1, which requires surveillance only if the reactor is secured (assuming the updated definitions for reactor shutdown and reactor secured as tailored by NUREG-1537 (see RAI 3)). The following is an example revision based on NUREG 1537, Appendix 14.1 previously found acceptable to the NRC:

a. A channel test of each of the reactor safety system channels listed in Table III shall be performed prior to reactor operation:

i. anytime the reactor has been placed in a secure condition, and ii. monthly, not to exceed 6 weeks, since last channel test

< LIST TABLE III SURVEILLANCES>

41. General Comment. Per NUREG-1537, Appendix 14.1, the bases for the LSSSs and LCOs should include the referenced SAR section for justification, as applicable. The bases for the PUR-1 TS include justification that, in some cases, appears to be derived from analyses contained in the PUR-1 SAR. Please review the TS to ensure the bases correctly reflects the SAR analyses including the requested power uprate or consider replacing the bases text with reference to the updated SAR section, as appropriate.

42. General Comment. In responding to these RAIs, it is requested that justification is provided for any TS that are added or deleted.