ML20236X386
| ML20236X386 | |
| Person / Time | |
|---|---|
| Issue date: | 02/15/1987 |
| From: | Murley T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20195F761 | List:
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| References | |
| FOIA-87-714 1620.1, NUDOCS 8712090163 | |
| Download: ML20236X386 (25) | |
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jens4 UNITED STATES
& %, NUCLEAR REGULATORY COMMISSION
[ T+ S REoloN 1 5 j sai PAnn AvsNur xiso or pau$$1 A, PENNSYLVANIA A 19406 RI 1620.1/0 Page 1 of 12 REGION I INSTRUCTION 1620.1, REVISION O PLANT-SPECIFIC BACKFIT PROCEDURES
Reference:
NRC Draft Manual Chapter 0514, "A Program for Management of Plant-Specific Backfitting of Operating Power Reactors" A. Purpose To prescribe procedures for implementation of NRC plant-specific backfit policy in accordance with Draft NRC Manual Chapter 0514 (NRC-0514). Users of this instruction should familiarize themselves with NRC-0514. Any apparent conflict between this instruction and NRC-0514 should be brought to the attention of appropriate managers.
B. Discussion It is the overall objective of this instruction to assure the plant-specific backfitting of nuclear power plants is justified and documented and that Region I senior management is responsible for the proper implementation of the backfit program in their area of responsibility. The specific objective of the backfit program is to provide for improvements in the levels of pro-tection of public health and safety while avoiding any unwarranted burdens on licensees in implementing these backfits. We should assure to the extent possible that back:its to be issued will in fact contribute effectively and significantly to the health and safety of the public or the common defense and security.
It should be clearly understood that backfits are expected to occur and deemed an important part of the regulatory process to provide for the safety of nuc-lear power plants. However, it is important that backfitting be conducted in a controlled process if we are to have effective and consistent regulation.
The management of plant-specific backfitting as described in this instruction in no way is meant to relieve licensees from complying with NRC requirements.
The provisions of this instruction are intended to provide for a cogent re-gional review of new or changed positions that we may desire to impose on licensees who have already implemented previously applicable requirements or positions which were considered by the NRC to have provided acceptable levels of safety. The plant-specific backfit process described in this instruction will enhance both regulatory stability and safety by assuring that changes in staff positions do in fact provide substantial additional safety protection CONTACT:
J. Wiggins, DRP {
Revision Responsibility:
DRP l
8712090163 871204 I PDR FOIA l WEISS87-714 PDR "
PLANT-SPECIFIC BACKFIT PROCEDURE RI 1620.1/0 Page 2 of 12 that are warranted prior to imposing such changes on the licensee. This as-surance will be provided through a regulatory analysis as described in Section 0.3.
A plant-specific backfit is different from a generic backfit in that the former involves the imposition of a position unique to a particular plant, whereas a generic backfit involves the imposition of the same or similar position on two or more plants. Management of generic backfits is not governed by this instruction, but by the CRGR process.
C. Definitions
- 1. Licensee - Except where defined otherwise, the word licensee as used in this Regional Instruction shall mean that person that holds a license to operate a nuclear power plant, or a construction permit to build a-nudear power plant, or a Preliminary Design Approval or Final Design Approval for a Standardized Plant Design.
- 2. Plant-Specific Backfit - Backfitting is defined as the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility; any of which may result from a new or amended provision in the Commission rules or the imposition of a regulatory staff position inter-preting the Commission rules that is either new or different from a pre-viously applicable staff position after certain specified dates. Back-fitting is " plant-specific" when it involves the imposition of a positior.
that is unique to a particular plant.
It should be noted that to be a plant-specific backfit a staff position l must meet conditions involving both (1) the substance of the elements of a proposed staff position and (2) the time of the identification of the staff position.
1 a. A staff position may be a proposed backfit if it would cause a lic-ensee to change the design, construction or operation of a facility
- from that consistent with an already applicable regulatory staff
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position. Applicable regulatory staff positions are described in i NRC-0514.
- b. A staff position as described in C.2.a is a proposed backfit if it is first identified to the licensee after certain important design, construction or operation milestones, involving NRC approvals of 3 varying kind, has been achieved. Those times after which a new or )
revised staff position will be considered a backfit are as follows:
(1) After the date of issuance of the construction permit for the facility (for facilities having construction permits issued after May 1, 1985); or
PLANT-SPECIFIC BACKFIT PROCEDURE RI 1620.1/0 Page 3 of 12
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(2) after 6 months before the date of docketing of the OL applica-tion for the facility (for facilities having construction per-mits issued before May 1, 1985); or '
(3) after the date of issuance of the operating license for the facility (for facilities having an operating license on May 1, 1985); or (4) after the date of issuance of the design approval under 10 CFR 50, Appendix M, N. or 0.
- 3. Applicable Regulatory Staff Positions - Applicable regulatory staff positions are those already specifically imposed upon or committed to by a licensee.at the time of the identification of a plant-specific backfit, and are of several different types and sources:
- a. Legal requirements such as in explicit regulations, orders, plant licenses (amendments, conditions, technical specifications). Note that some regulations have update features built in, as for example, 10 CFR 50.55a, Codes.and Standards. Such update requirements are applicable as described in the regulation.
- b. Written commitments such as contained in the FSAR, LERs, and docketed correspondence, including responses to IE Bulletins, Generic Letters, Confirmatory Action Letters, Inspection Reports, or responses to Notices of Violation.
- c. NRC staf f positions that are documented, approved, explicit inter-pretations of the more general regulations, and are contained in documents such as the SRP, Branch Technical Positions, Regulatory Guides, Generic Letters and IE Bulletins and to which a licensee or an applicant has previously committed to or relied upon. Posi-tions contained in these documents are not considered appli cble staff positions to the extent that staff has, in a previuus licens- i ing or inspection action, tacitly or explicitly excepted the licen- !
see from part or all of the position.
Working level examples of staff positions which constitute backfits and !
those that do not constitute backfits are discussed in Appendix A to this instruction.
D. Procedure Implementation The overall backfit process should be conducted in accordance with the fol-lowing instructions.
- 1. Regional Backfit Identification - Any Regional staff member who identi-fies the need for imposition of a potential backfit will immediately verbally identify this need for imposition to his/her Section Chief.
Licensees may also claim a staff action, not initially identified by the
. PLANT-SPECIFIC BACKFIT PROCEDURE RI 1620.1/0 Page 4 of 12 staff, is a backfit, and this claim should be similarly treated under this section. If the issue is determined to be a backfit candidate by the Section Chief, in accordance with the guidance of Section C above, then a Backfit Identification Form (BIF) (Copy of Form attached as Ap-pendix B) will be completed by the identifying staff member, within two working days, and forwarded by the staff member's Section Chief, through the Branch Chief, to the Division Director for disposition. . Information copies of the BIF should also be forwarded to the responsible DRP Section Chief and Brar;ch Chief.
- 2. Division Director Disposition - Each Division Director receiving a BIF will determine how to process the potential backfit within one week of receipt, as follows:
- a. If the Division Director considers that the position, if imposed, would constitute a backfit, and that imposition of the backfit on the licensee appears to provide substantial additional safety pro-tection, then the backfit will be processed by the originating sec-tion in accordance with Section D.3, 4, 6 and 7 below. If however the Division Director believes that i n diate imposition of the position is required to protect the p.. <
health and safety or the common defense and security, then the hadiate Imposition Procedure of Section D.5 below should be implemented.
- b. If the Division Director determines that the position, if imposed, would not constitute a backfit because the proposed modification is necessery to bring a facility into compliance with a license or the rules or orders of the Commission, or into conformance with written commitments by the licensee, no regulatory analysis is re-quired. Instead, the Division Director is to provide a documented evaluation to support the proposed action to the Regional Admini-strator prior to taking the action. The evaluation shal? include a statement of the objectives of and reasons for the modification.
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- c. If the Division Director determines that the position, if imposed, would constitute a backfit, but that imposition on the licensee would not provide substantial additional safety protection or is otherwise not necessary, then no further action on the issue should f be taken beyond documentation of this determination on the BIF and i in the Plant Specific Backfit System (PSBS), and the BIF should be filed.
- 3. Regulatory Analysis (RA) l
- a. If the originating staff's Division Director determines that the 4 potential backfit constitutes backfitting, and it appears that im- 1 position will provide substantial additional safety protection, then I he is to direct that a RA be prepared. Preparation of the RA will be the responsibility of the Section Chief whose staff identified the backfit issue.
" PLANT-SPECIFIC BACKFIT PROCEDURE RI 1620.1/0 Page 5 of 12
. b. The regulatory analysis shall generally conform to the directives and guidance of NUREG 0058 and NUREG CR-3568, which are the NRC's governing documents concerning the need for and preparation of regulatory analyses. In preparing regulatory analyses, the com-plexity and comprehensiveness of an analysis should be limited to that necessary to provide an adequate basis for decision-making among the alternatives available. NUREG 0058,Section III.A.2, Scope of the Analysis, indicates that "The emphasis in (doing the analysis) should be on simplicity, flexibility, and common sense, both in terms of the type of information supplied and in the level of detail provided." The following information and any other in-formation relevant and material to the backfit shall be included in the regulatory analysis, as available and appropriate to the analysis:
(1) A statement of the specific objective that the proposed backfit is designed to achieve. This should also include a succinct description of the backfit proposed, and how it provides a substantial increase in overall protection.
(2) A general description of the activity that would be required by the licensee in order to complete the backfit.
(3) The potential safety impact of changes in plant or operational complexity, including the relationship to proposed and existing regulatory requirements.
(4) Whether the proposed backfit is interim or final and if interim, the justification for imposing the proposed backfit on an in-terim basis.
(5) A statement that describes the benefits to be achieved and the cost to be incurred. Information should be used to the extent that it is reasonably available, and a qualitative assessment i of benefits may be made in lieu of a quantitative analysis {
where it would provide more meaningful insights, or is the only I analysis practicable. This statement should include considera-tion of at least the following listed factors:
(a) The potential change in risk to the public from the acci-dental offsite release of radioactive material.
(b) The potential impact on radiological exposure of facility employees. Also consider the effects on other onsite workers, due both to installation of procedural or hard-.
ware changes and to the effects of the changes, for the remaining lifetime of the plant. 1
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, PLANT-SPECIFIC BACKFIT PROCEDURE RI 1620.1/0 Page 6 of 12 (c) The installation and continuing costs associated with the backfit, including the cost of facility downtime or the cost of construction delay.
(d) The estimated resource burden on the NRC associated with the proposed backfit and the availability of such re-sources.
(6) A consideration of important qualitative factors bearing on the need for the backfit at the particular facility, such as, but not limited to, operational trends, significant plant events, management effectiveness, or results of performance reports such as the Systematic Assessment of Licensee Perform-ance.
(7) A statement affirming appropriate interoffice coordination re-lated to the proposed backfit and the plan for implementation.
(8) The basis for requiring or permitting implementation on a par-ticular schedule, including sufficient information to demon-strate that the schedules are realistic and provide adequate time for in-depth engineering, evaluation, design, procurement, installation, testing, development of operating procedures, and training of operators and other plant personnel, as appro-priate. For those plants with approved integrated schedules, the integrated scheduling process can be used for implementing this step and the following two procedural steps.
(9) A schedule for staff actions involved in implementation and i verification of implementation of the backfit, as appropriate. l (10) Importance of the proposed backfit considered in light of othe-safety-related activities underway at the affected facility.
- c. The completed RA and updated BIF will be forwarded for review by the cognizant Division Director, and after the cor._urrence of the Division Director is obtained, will be transmitted to the Regional Administrator for approval. The Division Director should not ap-prove the proposed backfit unless the Regulatory Analysis supports the finding that there is a substantial increase in the overall protection of the public health and safety or the common defense and security to be derived from the backfit, and that the direct and indirect costs of implementation for that facility are justified in view of the increased protection. If the Division Director de-termines that further staff action is not warranted the BIF and RA
, shall be filed. Disposition of the matter shall be entered in the l PSBS. ;
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PLANT-SPECIFIC BACKFIT PROCEDURE RI 1620.1/0 Page 7 of 12
- 4. Approval of Backfit Position a.
The Division Director whose staff has initiated the backfit issue will forward the RA and BIF to the Regional Administrator for ap-proval no later than four weeks from the identification of the back-fit. At the same time, the completed RA will be forwarded to the Division Director of the appropriate headquarters office having program responsibility for the backfit issue (see Appendix C). The Program Office will in this manner be formally kept apprised of any backfit issues and will be given the opportunity to comment on the issue prior to its imposition on the licensee. Three workdays should normally be sufficient.
The Regional Administrator, or the Deputy Regional Administrator, will either approve or reject the backfit within one week from re-ceipt of the RA and the BIF. Approval authority may not be redele-gated. If approved, the BIF information will be provided to the DRMA, Programs Staff, Management Analysis for entry into the Backfit Data Base (BDB). If not approved, the BIF and RA will be filed.
- b. When a proposed backfit and supporting analysis are approved by the Regional Administrator, the documents (copy) must be forwarded to the EDO for information prior to transmitting the documents to the licensee. The Region shall forwr.rd the backfit and supporting regulatory analyses to the licerisee without awaiting feedback from the EDO.
- c. If approved for issuance, the backfit position and the RA will be forwarded by the Cognizant Division Director to the licensee. The transmittal should clearly identify the position as a backfit.
- 5. Immediate Imposition Procedure
- a. If the Division Director whose staff has originated the backfit position believes that immediate imposition of the position is necessary to protect the public health and safety or the common defense and security, then the backfit may be processed without performance of the RA. In such cases, the EDO shall be promptly notified of the action and a documented evaluation as described in Section 042 of NRC-0514 will be performed, if possible, prior to the imposition of the backfit,
- b. In this instance a backfit pariel will convene, chaired by the Re-gional Administrator or Deputy Regional Administrator, attended by the Projects Division Director or Deputy Director, and the Division Director and Branch Chief whose staff initiated the backfit. A representative from the headquarters office having program responsi-bility for the backfit requirement should attend the backfit panel meeting or participate via telecon. The headquarters representative
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. PLANT-SPECIFIC BACKFIT PROCEDURE RI 1620.1/0 Page 8 of 12 will be designated by the Office Director. The cognizant Section Chief will be responsible for presenting the issue including the rationale for immediate imposition.
- c. If the backfit panel agrees with the need for immediate imposition, the backfit will be forwarded, by the Regional Administrator, to the Offir.e Director of the headquarters office having program re-sponsibility for the backfit issue. The Office Director will be expected to act on immediate issuance of the backfit position within two working days from receipt of the request.
- d. If approval for immediate issuance is not given by the Office i Director, then the backfit will be processed in accordance with l Sections D.3, 4, 6 and 7.
- e. Whether approval is given by the Office Director or not, the BDB will be updated by the originating Section Chief by the forwarding of a completed BIF to the DRMA, Programs Staff, Management Analyst following the action by the Office Director.
- 6. Appeal Process
- a. The appeal processes are of two types:
(1) A licensee may appeal for withdrawal or modification of a staf f identified backfit position in accordance with this section; or (2) When a licensee is informed that a claimed backfit is, in the judgment of the NRC, not a backfit, the licensee may appeal this determination to the Director of the program office having responsibility for the program area relevant to the staff position. A copy of the appeal should be sent to the EDO.
- b. The rest of this section deals with the disposition of only staff-identified backfits. Licensees should address appeals to the Re-gional Administrator and should send a copy of the appeal to the i EDO. When an appeal is received in the Regional Office, it should be forwarded to the Projects Division along with the other docket related mail. The initiating Section Chief will arrange and issue appropriate documentation for a first level appeals meeting in ac-cordance with Regional Instruction 0550.1, Control of Significant Licensee Meetings, with the appealing licensee in order to attempt to resolve the issue. This meeting will be chaired by the cognizant Division Director and be attended by the applicable Projects Divi-sion Section Chief, and the Branch Chief and Section Chief whose staff initiated the appealed backfit position or staff action. A copy of the RA (if appropriate) will also be provided to the licen-see, by the initiating Section Chief, in preparation for the appeals
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meeting. The first level meeting should normally occur within 2 '
weeks of receipt of the appeal, or, in the case of a licensee iden-tified backfit, within 2 weeks of the approval of the RA. I
- c. The initiating Section Chief will draft a memorandum by which the Regional Administrator will inform the EDO of the planned disposi-tion of the appeal. The Regional Administrator is required to notify the EDO of the planned disposition within 3 weeks of receiv-ing an appeal. A copy of this memorandum will be forwarded to the headquarters office having program responsibility for the backfit {
or staff action and the BDB updated accordingly. This action should normally be completed within 3-working days from the first level appeals meeting.
- d. A summary of the appeals meeting will be prepared by the initiating Section Chief and forwarded to the licensee with copies to the EDO and PDR. The result of the meeting with the licensee should take the form of one of the following:
(1) The licensee agrees with the NRC staff that the backfit should be implemented as imposed. In this instance, the appeal pro-cess in effect will be terminated pursuant to this instruction.
(2) The NRC agrees with the licensee that a backfit should be withdrawn or modified If the backfit is to be modified, then the backfit should be reissued in accordance with Section D.4.c above, or if the Division Director whose staff originated the staff action determines not to pursue the issue as a backfit then it should be withdrawn.
(3) No agreement or final disposition is reached and a second level meeting is scheduled.
- e. If no agreement was reached at the meeting in Section 6.d above, then the applicable initiating Section Chief will arrange for a second level meeting with the appealing licensee in order to re-attempt to resolve the issue. Normally, it should be attempted to hold this meeting on the same day as the initial meeting. This second meeting will be attended by the applicable Projects Division Section Chief, the Division Director and Section Chief whose staff initiated the appealed backfit or staff action and the Projects Division Director or Deputy Director. The meeting will be chaired by the Regional Administrator or Deputy Regional Administrator.
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- f. A summary of this second appeals meeting will be prepared by the initiating Section Chief and forwarded to the licensee with copies to the EDO and PDR. The results of this second meeting with the licensee should take one of the forms specified in step D.6.d above and the BDB will be updated accordingly.
PLANT-SPECIFIC BACKFIT PROCEDURE RI 1620.1/0-Page 10 of 12
- g. If no agreement was reached at the meeting in Section 6.e above, then the initiating Section Chief will arrange for and issue,appro-priate documentation for a third meeting with the appealing licensee in order to again attempt te resolve the issue. This third meeting will be held in headquarters and coordinated with the office having program responsibility for the backfit or staff action. This third meeting will be attended by the applicable Program Office Director or Deputy Director, the Regional Administrator or Deputy Regional Administrator, and other appropriate managers whose staff initiated the appealed backfit position or staff action. The meeting will be chaired by'the cognizant Program Office Director or Deputy Direc-tor. The cognizant program offices are identified in. Appendix C.
The third level meeting should normally be conducted within two j weeks of the second. level meeting,
- h. A summary of this third meeting will be prepared by the initiating Section Chief and forwarded to the licensee with copies to the EDO and PDR.
- i. At the conclu: un of this third meeting, the appeals process will be considered concluded, regardless of whether the position of the licensee or NRC staff was modified. All information regarding the appeals process will be updated in a timely manner and the results of appeals process updated in the BDB by the initiating Section Chief using revised BIFs.
- 7. Backfit Imposition Following approval of the backfit position by the Regional Administrator, and issuance to the licensee, the licensee will either implement the backfit or appeal it. It should be noted that immediate effective Orders must be implemented by the licensee, and are not subject to the backfit appeal process since the licensee may request a hearing under 10 CFR Part i
- 2. After an appeal and subsequent final decision by the NRC, the licen-see may elect to implement a position resulting from the decision. If the licensee does not elect to implement the position, the position may j be imposed by Order of the appropriate Program Office Director.
Implementation of plant-specific backfit positions will be accomplished on a schedule negotiated between the licensee and the Cognizant Division Director. Scheduling criteria should include the priority of the backfit relative to other safety-related activities underway or construction or maintenance planned for the facility, and schedules and reasonable con-straints thereon to maintain high quality construction and operations.
For plants that have integrated schedules, the integrated scheduling process can be used for this purpose.
A staff proposed position may be imposed prior to completing any of the procedures set forth in this Regional Instruction, provided the appro-priate headquarters Office Director determines that prompt imposition l
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' PLANT-SPECIFIC BACKFIT PROCEDURE RI 1620.1/0 Page 11 of 12 is necessary to protect the health and safety or the common defense and security. In this instance, the procedures of Section D.5 above will be followed. In such cases, the EDO shall be notified promptly of the action.
If prompt imposition is not necessary, staff proposed positions shall not be imposed, and plant operation shall not be interrupted during tte staff's initial evaluation and transmittal process, or a subsequent appeel process, until a final action is completed by either the licensee or by the NRC staff.
- 8. Information Requests Pursuant to 10 CFR 50.54(f)
A revision to 10 CFR 50.54(f) was issued with the September 20, 1985 re-vision to 10 CFR 50.109. The revision generally requires that the NRC prepare reasons for issuing information requests prior to issuance. Only information requests seeking to verify licensee compliance with the cur-rent licensing basis for the facility are exempt from the necessity te prepare the reason or reasons for the request. Requests for information '
to determine compliance with existing f acility requirements including fact-finding reviews, inspections and investigations of accidents or incidents, usually are not made pursuant to Section 50.54(f), nor are such requests normally considered within the scope of the backfit rule.
All requests for information pursuant to 10 CFR 50.54(f) must be evalu-ated to determine whether the burden imposed by the information request is justified in view of the potential safety significance of the issue to be addressed. The information request and the staff evaluation must be approved by the Regional Administrator prior to transmittal of the request for information to a licensee.
The Division initiating the request shall prepare the evaluation, which shall include at least the following elements:
- a. A problem statement that describes the need for the information in terms of potential safety benefit.
- b. The licensee actions required and the cost to develop a response to the information request.
- c. An anticipated schedule for NRC use of the information.
E. Data and Recording Requirements The data identified in the Backfit Identification Form shall be entered into the Backfit Data Base within 3 working days after any action which requires updating of the BIF. The cognizant Section Chief is responsible for providing the updated BIF to the DRMA, Programs Staff, Management Analyst for BDB entry.
PLANT-SPECIFIC BACKFIT PROCEDURE RI 1620.1/0 Page 12 of 12 F. EDO Review The E00 may review and modify any plant-specific backfit decision, at EDO initiative or at the request of a licensee, in accordance with NRC-0514.
G. Effective Date This instruction supers 2 des Region I Instruction 1600.100 Revision 1 dated August 15, 1986 and is effective upon issuance.
Approved:
Thomas E. Murley Regional Administrator Date: $
Enclosures:
- 1. Appendix A - Guidance for Backfit Determinations
- 2. Appendix B - Backfit Identification Form
- 3. Appendix C - Cognizant Headquarter Program Offices
- 4. Appendix D - Plant-Specific Backfit flowchart Distribution:
Office of the Regional Administrator Division Directors Chief, Administrative Management Branch (original)
Resident Offices I
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PLANT-SPECZFIC BACKFIT PROCEDURES Appendix A RI 1620.1/0 l
APPENDIX A 1
Guidance for Backfit Determinations
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General l
In this section selected regulatory activities or documents are discussed in order to enable regional staff to better understand the conditions under which a plant-specific backfit may be recognized. It is important to understand that the neces-sity for making backfit determinations should not inhibit the normal informal dialogue between the inspector and the licensee. The intent of this process is to manage backfit imposition, not to quell it. The discussion in this Appendix is intended to aid in identifying backfits in accordance with the principles that should be implemented by all staff members. This Appendix is not intended to be an exhaustive, comprehensive workbook in which can be found a parallel example for each situation that may arise. There will be some judgment necessary to determine whether a staff position would cause a licensee to change the design, construction or operation of a facility. In making this determination, the fundamental question is whether the staff's action is directing, telling, or coercing, or is merely suggesting or asking the licensee to consider a staff proposed action.
Actions proposed by the licensee are not backfits when the actions result from normal discussions between staff and Ticensee concerning an issue, even though the change or additions may meet the definitions of Section C of this instruction.
Standard Review Plan (SRP)
The SRP delineates the scope and depth of staff review of licensee submittals associated with various review activities. It is a definitive NRC staff interpre-tation of measures which, if taken, will satisfy the requirements of the more generally stated, legally binding body of regulations, primarily found in title 10 CFR. Since October 1981, changes to the SRP are to have been reviewed and approved through a generic review process involving the Committee to Review Generi-c Requirements (CRGR), and the extent to which the changes apply to classes of plants is defined. Consequently, application of a current SRP in a specific operating license (OL) review generally is not a plant-specific backfit, if the SRP was effective 6 months prior to OL review (i.e., 6 months prior to docketing of the OL application). Asking an applicant for an operating license questions to clarify staff understanding of proposed actions in order to determine whether the actions will meet the intent of the SRP is not considered a backfit.
On the other hand, using acceptance criteria more stringent than those contained in the SRP or proposing licensee actions more stringent than or in addition to those specified in the SRP, whether in writing or orally, are plant-specific back-fits. During meeting with the licensee, staff discussion or comments regarding issues and licensee actions volunteered which are in excess of the criteria in the SRP generally do not constitute plant-specific backfits; however, if the staff implies or suggests that a specific action in excess of already applicable staff positions is the only way for the staff to be satisfied, the action is considered a plant-specific backfit whether or not the licensee agrees to take such action, i A-1 l
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PLANT-SPECZF2C BACKFfT PROCEDURES Appendix A RI 1620.1/0 i
However, the staff should recognize that a verbally implied or suggested action should not be accepted by a licensee as an NRC position of any kind, backfit or not; only written and authoritatively approved statements should be taken as NRC positions.
Application of an SRP to an operating plant after the license is granted generally is considered a backfit unless the SRP was approved specifically for operating plant implementation and-is applicable to such operating plant.
Regulatory Guides As part of the generic review process pursuant to the CRGR Charter, it is decided which plants or groups of plants should be affected by new or modified Regulatory Guide provisions. Such implementation is therefore not governed by the plant-specific backfit procedures. However, any staff proposed plant-specific implemen-tation of a Regulatory Guide provision, whether orally or in writing, for a plant not encompassed by the generic implementation determination is considered a plant-specific backfit. A staff action with respect to a specific licensee that expands on, adds to, or modifies a generically approved regulatory guide, so that the position taken is more demanding than intended in the generic positions, is a plant-specific backfit.
Plant-Specific Orders An order issued to cause a licensee to take actions which are not otherwise applic- j able regulatory staff positions is a plant-specific backfit. An order effecting i prompt imposition of a backfit may be issued prior to completing any of the proce-dures set forth in this instruction provided that the appropriate Headquarters Office Director determines that prompt imposition is necessary. j l
An order issued to confirm a licensee commitment to take specific action even if l that action is in excess of previously applicable staff positions, is not a plant- )
specific backfit provided the commitment was not solicited by the staff with the J expressed or implied emphasis that such a commitment is necessary to gain accept-ance in the staff review process. Discussion or comments by the NRC staff iden-tifying deficiencies observed, whether in meetings or written reports, do not con-stitute backfits. Definitive statements to the licensee directing a specific action to satisfy staff positions are backfits unless the action is an explicit already applicable regulatory staff positions.
Inspections NRC inspection procedures are to govern the scope and depth of staff inspections associated with licensee activities such as design, construction and operation.
As such, they define those items the staff is to consider in its determination of whether the licensee is conducting its activities in a safe manner. The conduct of inspection establishes no new staff positions for the licensee and is not a plant-specific backfit.
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PLANT-SPECIFIC BACKFlT PROCEDURES Appendix A RI 1620.1/0 Staff suggestions to the licensee that the contents of an NRC inspection procedure are positions that must be met by the licensee constitute a plant-specific backfit I unless the item is are applicable regulatory staff position. Discussion or comment by the NRC staff regarding deficiencies observed in the licensee conduct of acti-vities, whether in meetings or in written inspection reports, do not constitute backfits, unless the staff suggests that specific corrective actions different from previous staff positions applicable to the licensee are the only way to satisfy the staff. In the normal course of inspecting to determine whether the licensee's activities are being conducted safely, inspectors may examine and make findings l in specific technical areas wherein prior NRC positions and licensee commitments do not exist. Examination of such areas and making findings is not considered a backfit. Likewise, discussion of findings with the licensee is not considered a backfit. If during such discussions, the licensee agrees that it Ts appropriate to take action in response to the inspector's findings, such action is not a back-fit provided the inspector does not indicate that the specific actione are the only way to satisfy the staff and the TIcensee freely volunteers to take such action, q On the other hand, if the inspector indicates that a specific' action must be taken, i such action is a backfit unless it constitutes an applicable regulatory staff j position. '
For example, if the licensee commits to ANSI N18.7 in the SAR and the inspector finds the licensee's implementing procedures do not contain all the elements re-quired by ANSI N18.7, telling the licensee he must take action to include all the elements in its implementing procedures is not a backfit. Likewise, if the in-spector finds the licensee has included all the required elements of ANSI N18.7, but has not included certain of the optional elements in its implementing proce-dures, inspector discussion with the licensee regarding the merits of including the optional elements is not a backfit. On the other hand if the inspector tells the licensee that the implementing procedures must include any or all of the op-tional elements in order to satisfy the staff, inclusion of such elements is a backfit, whether or not agreed to by the licensee.
Notice of Violation (NOV)
A NOV requesting description of a licensee's proposed corrective action is not a backfit. The licensee's commitments in the description of corrective action are not backfits. A request by the staff for the licensee to consider some specific action in response to an NOV is not a backfit. However, if the staff is not satis-fied with the licensee's proposed corrective actions and requests that the licensee take additional actions, those additional actions (whether requested orally or in writing) are a backfit unless they are an applicable regulatory staff position.
Discussions during enforcement conferences and responses to the licensee's requests for advice regarding corrective actions are not backfits; however, definitive statements to the licensee directing a speciTTc action to satisfy staff positions are backfits, unless the action is an explicit applicable regulatory staff position.
A-3
\ _ _ .____-___ -
PLANT-SPECIFfC BACKFZT PROCEDURES Appendix A RI 1620.1/0 Bulletins IE Bulletins and resultant actions requested of licensees undergo the generic re-view process pursuant to the CRGR Charter.
Therefore, in general, it is not necessary to apply the plant-specific backfit process to the actions requested in a Bulletin. However, if the staff expands the action requested by a Bulletin during its application to a specific licensee, such expansion is considered a planc-specific backfit.
Reanalysis of Issues l
Throughout plant lifetime, many inspectors have an opportunity to review the re-quirements and commitments incumbent upon a licensee. Undoubtedly, there will be occasions when ar inspector concludes the previously NRC approved licensee's pro-gram in a specific area does not satisfy a regulation, license condition or com-mitment. In the case where the staff previously accepted the licensee's program ,
as adequate, any staff specified change in the program would be classified as a i backfit.
For example, in the case of an NTOL, once the SER is issued signifying staff ac-ceptance of the program contained in the SAR, the licensee should be able to con-clude that his commitments in the SAR satisfy the NRC requirements for a particular area. If the staff was to subsequently require that the licensee commit to addi-tional action other than that specified in the SAR for the particular area, such action would constitute a backfit. If there was tacit acceptance by staff, being silent on the issue for an extended period of time, then staff action to force change would be a backfit.
A-4
l 4
-PLANT-SiECIFIC EACKFIT PROCEDURES Appendix E RI 1620.1/0 APPENDIX B BACKFIT IDENTIFICATION FORM
- Person Authorizing Date:
Data Entry:
ENTER BACXFIT-IDENTIFIER BELOW:
BACKFIT IDENTIFIER 123 45 Format (Starting position): I 1 Office resp. for initiating backfit determination = R,S,E, or 1-5'.
2 Identifier of backfit = R,S,E,L, or 1-5 R=NRR, S=NMSS, E=IE, L= Licensee, 1= Region 1 .. 5= Region 5 3 Plant abbreviation (5 positions) 4 Year ir<itiated (must be numeric, 2 positions) 5 Sequential number of backfit (must be numeric, 3 positions)
IDENTIFYING BACKFIT INFORMATION BACKFIT/PETITICN DDCUMENT DESCRIPTION (360 CHARACTER MAXIMUM):
BACKFIT ISSUE SUBSTANCE (660 CHARACTER MAXIMUM):
BACKFIT DETERMINATION DATE (PREDICTED): (YYMMDD)
)
BACKFIT DETERMINATION INFORMATION )
BACKFIT DETERMINATION DATE (COMPLETED): (YYMMDD)
WAS THIS DETERMINED TO BE A BACKFIT? (Y-YES,N-ND)
BACKFIT DETERMINATION SUBSTANCE (360 CLARACTERS MAXIMUM):
BACKFIT DETERMINATION ORGANIZATION (E.G. NRR/DL):
BACKFIT DETERMINATION OFFICIAL (LAST NAME, IST INIT.):
REGULATORY ANALYSIS COMPLETION DATE: (YYMMDD) l B-1
PLANT-SPECIFIC BACKFIT PROCEDURES Appendix B RI 1620.1/0-Person' Authorizing Date:
Data Entry:
APPEAL INFORMATION APPEAL DATE (PREDICTED): (YYMMDD)
APPEAL DATE (COMPLETED): (YYMMDD)
APPEAL DESCRIPTION / STATUS (360 CHARACTERS MAXIMUM):
APPEAL ORGANIZATION (E.G., NRR/DL):
APPEAL OFFICIAL (LAST NAME, IST INIT.):
CLO5ING ACTION INFORMATION CLOSING ACTION DATE (PREDICTED): (YYMMJD)
CLOSING ACTION DATE (COMPLETED): (YYMMDD)
CLOSING ACTION DESCRIPTION (360 CHARACTERS MAXIMUM):
CLOSING ACTION ORGANIZATION (E.G., NRR/DL):
CLOSING ACTION OFFICIAL (LAST NAME, IST INIT.):
I 2
i 1
l B-2 i
PLANT-SPECIFIC BACKFIT PROCEDURES Appendix C
, RI 1620.1/0.
ADFECIX C COGNIZANT HEAD 0VARTERS PROGRAM OFFICES Inspection Related Eackfit Positions - Office of Inspection and Enforcer..er,t Enforcement Related Backfit Positions - Office of Inspection and Enforcement Licensing Related Backfit Positions - Office of Nuclear Reactor Regulation, except for:
Safeguards Issues - NMSS QA Issues - IE ED Issues - IE l
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. ' Federal Register / Vol. 50. No.183 / Friday. September 20, 1985 / Rules and Regulations sein
- p. process es it stands (what with the methods would reaffirm existing Regulatory f1stibility Acs Certification existing Committee to Review Generic Commission guidelines to the Staff e
Requirements and the Commission's without opening the door to additional pg,x$coorda111ty Actof$ U e incontestable authority and ineluctable needless litigation as a consequence of the Commisalon hereb'y certines thst responsibility to instruct the staff), then vague new. legally enforceable. this final rule. If promulgated, will not I doubt that rule laid upon rule will do Commiselon created rights added to have a significant emnomic impact on a much to teach the Commission the virtue those already available to all parties substantial number of small antities. The o self disciP under the ApA. affected facilities are licensed under the oft speci y. mm on The entire backfit rulemaking wee provisions of10 CFR 50.21(b) and to 3
undertaken to bring order and CFR 30.22.'The companlas that own ek t hre ho d teria pp accountability to plant modifications rulemaking would apply not just on a these facilities do not fall within the heretofore sometimes imposed without scope of "small entities" as set forth in plant-specific basis (which it should be recalled was the intent of the original the benefit of systematic evaluation and the Regulatory flexibility Act or the
'h" justification. In rulemaking per se. that Small Business Size Standards set forth
' backniting initiative). but lo seneric in mgulatiore issued by the Small decisions that may affect dozens of objective has always been well within plants. and in fact to rulemaking on o# the Commission's grasp-.4t is, efler all. Business AdmhOtration in 13 CFR l' art the Commission that makes rules. For 121.
but procedural matters, rulemaking that
,, may or'may not have the remotest good measure, the Commission stao has gwy gg connection to what the public and our the Administrative Procedures Act as a he licensees normally consider a plant matter of law, and its own Commtitee tp 10 CTR Port 2 '
"backfit".ne scope of Commission Review Ceneric Requirements as a Administrative practice and rulemaking responsibilities thus often mattet of internal edinmistrs0ve policy procedurs. Nuclear power plants and or involves broad public pohey to assist it in carrying out such reactors, basardous waste.
considerations, and those considered decision-making. Casti.y the considerations can rise above elements r.et of the new backfit rule over 20 CTR M so es simple as cost-benefit analysis to Commission rule-making (almost as an Antitrust. Classified informa tion. Fire reach issues as fundamental as fairness a fierthought. as it happened in this case) prevention. incorporation by reference.
and individual rights.ne Commission s is thus at best an exercise in pointless Intergovernmental relations. Nuclear backfit rule. If applied to rulemaking symbolism. and at worst potentially power plants and rtactors. Penalty, itself, will thus serve only to trivialae in destructive of the Commission's entire Radiation protection. Reactor siting appearance and confuse in practice the rule-making process, criteria. Reporting and recordheeping ts to be weighed in requirements.
Q"[ As one small example of the morass Unneeded law is bad law. and unneeded regulation is bad regulation. For the reasons set out in th2
' into which the Commission mejonty has The Commission majority has imposed preamble and under the authority of the wandered, consider (as the Commission on this agency new regulatory Atomic Energy Act of 1954. as amended.
currently is considering) whether there obligations in rulemsking that are not the Energy Reorganization Act of 1974.
' should be a requirement that radiation only urusteded, but which the as arnended. and 5 U.S.C. 553. the NRC workers be provided their dose records Commission majority itself hopes and is adopting the following amendments to annually.The " benefit" of this "backfit" trusts will be of little practical (i.e. to CFR Parts 2 and 50.
of Commission rules may seem clear. legally enforceable) consequence. To the but it might very well never pass the extent that this rule will effect PART 50-DOMESTIC UCENSING OF cost. benefit test. indeed. it is difficult to rulemaking. it will therefore be a bad PRDDUCTION AND,UTILtIATION imagine a rule that woutd involve the rule. In sum, the Commission majority FACILITIES ;
human. factors element of plant has inexplicably insisted on fixing not 4 1 The authority citation for Part 50 operations, and that would also be only what is, but what ain't broke.1 will continues to read as follows:
amenable to straightforward cost- not be a party to auch poor judgment.
s benefit analysis. Autbertir Secs.103.104. set.1e2.1s3. tea. .
Rulemaking as it exists involves EnvironmentalImpact: Categorical t es. es Sta t saa. 837. $46, ess. 954. ess. em e e !
numerous inherent procedural checks Exclualon amended sec. *H 83 Stat.1244. u amended !
142 U.S C 2133. 21M. 2201. 2232, 22:3. 2236.
end baIances toinaure that each %e NRC bas determined that this I 223e. 22a2) esca sm. 302 son. se Stat 1242.
proposalis carefully considered prior to final rule is the type of action described 1244.1248. n amended (42 USC sa41. Sa42 adoption. Indeed. rulemakmg is the in categorical exclusion 10 CFR a 46). unten atherwtu acted.
forum which provides the greatest $1.22(c)(3) %erefore, neither an Sec. 30.7 also leeued under Pub. I. es-act.
number of checks against arbitrary environmental impact statement not an see to s2 Stat 2951(42 U.S C sastl Secuens action by the Staff or Commission. Much enmonmentag assessment ga,9en So 57[d). 40.58. 50 ft. and sos 2 also issued of the analysis (including cost ber,efit) under Pub. t.87-415,96 Stat 2o71. 2073 (42 which the new backfitting rule would Prepared for this final rule. U.S C 2133. 22391 Section so.7e also istued require is already done informally Paperwork Reduction Act Statement under sec 122. as Stat sse (42 UAC 21521 Sections 50 a0-5041 also inued under sec.
throughout the process of considenng 164. es Stat s54, as amended (42 UAC 22M1 and adopting new regulations. . his final rule does not contain a new or amended information collection Sections 50100-50102 atso inued under sec.
If the Commission wishes to insure ta6. 6a Stat oss (42 U.S C 22361 still more structure in the rulemaking requirement subject to the Paperwork as 5 as process, structure which could take into account every single f actor set forth in Reduction Act of 1980 (44 U.S.C. 3501 et seg ). Existing requirements were
,[*'di Pub sk 4 ,
and (c). 50 44. 60 46. 50 4a. 50.54. and no.aole) the backfit rule and more, there are approved by the Office of Management are tuued under sec.16th. 6a Stat sea. es ample means of doing so by simple and Budget. Approval Number 3150- emended 142 U.S C 2201fbil. Il so 1o fbi and internal agency management. Such 0011. (cl end so.54 ore inued under sec seti. 6a Sh _
___-_s
71 38n2 Federal Regleter / Vol. So, No.183 / Friday. September 30. 1985 / Rules and Regulations.
. ~
Stat pse. es amended (42 UAC asen(tjn; and r (2) De %===la-lam sha5 require s (2) General description of the activity iI so.ss(el. so.se(bl. so M. soft. sofa. sars. sys'ematic and daa==ted analysis that would be required by the licenne
. and safe are isend under ser. seto. se siet. murouant to. ph (c) ofIbde secuan er at in order to complete the esa es amended (e2 U.sc sae (oll. [or backSte . M seeks as impose. be
- 2. In i 80.54. peregraph (f) is revised to imposition of a backRt pursuant te (g) potential change in the tiet to the roed se foHows: peregraph (a)(4Mu) of this section aball 'puhuc Irem the socidentaloff site not relieve the F- - - - af release of seduactive material tseA4 condmens et aseneet performing en analyels after he Anot to
- * * * * (el potential impact on radiological document the seisty mirantaa=== and nya ,, gg ,gty employen:
(f)De licensee shall et any time a tieteness of the acdos takaa.
(6)lastallaties and son oosts before expiration of the licones. upon th==l==8= ebaB segelse the reques; ef the Comtalesics subunit (ting of a facGity sely whea lt ameised wit 6e becHit. ud 8 wrttien eistements signed under oath or determines, based on the analyons . h cost d facWW downume or 6)" co W esastmauen deley.'
affirmetton. to enable the th==halon to describedinparagraph(c)of age de* ermine whether or not the license section, that there is a substantial (6)h poteadal safety impact d she dd be modified. . _ " se increase in the overall protseeles of the che in plant or operational rev \ed. Emeopt for infonnetton sought public beelth and safety or the common ty, including the relationship to to verify licenne compliance with the defense and security to be derived from Proposed and mistbg mgulemn current licensing basis for that facility, the backfit and that the direct and nquiminents; the NRC must prepare the reason or indirect oosts ofimplementation fre that (7)ne sedented moeurce burden en reasons for each information request facility are justified in v6ew of this the NRC eseciated with the posed prior to issuance to ensure that the increasse protec6es. backSt and ee avaHabHuy such ,
burden to be imposed on respondents is (4) De provisions of peregrapha (t)(2) moeuroes.
justified in view of the potential safety and (s)(3) of this section om (8)De P3tentialimpact of differences significance of the lasue to be addressed inapplicable and, therefore, backAt la facility type design or age on the in the requested infonnetion. Each such aralyets is not required and the . min and precucalHy of the justification provided for an evaluation standard does not appyl where the staff Pro backfit; .
performed by the NRC staff must be finds and dulares, wim appropriate 10) Whether the proposed beckfit is approved by the Executive Director for documented evalueuon for its finding. Interim or final and. If interim, the -
Wtiens or his or her designee prior either: Justification for impostos the propwed toissuance of the request. (1) Det a modification is necessary to backfit on en inlede beels. ..
. . . . . bring a facility into compliance with a (d) No licensing action will be Licean or the rules or ordere of the wihld during the pendency of backfit 3 in i 80.100, parasteph (e)is revised. Commission, or into conformance with analyses required by the Commission's paragraph (b)is removed paragraph (c) written cornmitments by the licensee: or is revind and redesignated as (b). and (11 not an knmediately eff>ctive ngu a ry actionis necneary 2 ense rules'ne g,j Executive D rector for edt a e llo a- Operations shall be responsible for that the facility poses no undue risk to implementation of this section and all ieMes asseratens. the public health and safety.' analyses required by this section shall (e)(1) Backfitting is defined as the Such documented evolution shall be approved by the Executive Director modiDestion of or addition to systems. include a statement of the objectivu of for Operauons or his designu.
structures, components, or design of a and reasons for the modification and the besIs for invok the exception. 4. In Appendix 0 to 10 CFR Part 30. a '
facility;or the design approval or manufacturing. license fQT a facility; or (b) Paragraph a)of this section shall new section (8)is edded to read as ggows,.
the procedures or q genide'.fon required not apply to backfits imposed prior to to design, construct er eprate a facility October 21,1985. Appendix 0-StandartR$ Ion of any of wl.ich may result from a new or (c)In reaching the determination Design; Staff Review of Standard amended provision in the Commission required by paragre h (a) of this section.
Designe rules or the imposition of a regulatory the Commission oomsider bow the backfit should be prioritised and * * * *
- staff position interpreting the.
Commission rules that is either new or scheduled in light of other regulatory . E informauon requests to the approvet diffe ent from a previously 6pplicable activides onsoing at the facihty and, in holder re ording en approved design shat! be
'taff posid" *A"" eddition, wifi consider infonnation 'veint* Peter 6n leemance to ensure that the evellable concerning any of the burden to w impond a mpondets te (i)Re date of,inuance of the lwufied m www d the potenual safety construction permit for the facility for , gogge8 ggw y wPProp signmearece d the lesw w be addressed k facilities having construction perrra and any other information relevant and the requated information. Each nch issued after October 21.1985: or material to the proposed backfit: evaluation performed by the NRC staff shall (1) Statement of the specific be in accordance with to CF1t so.64(f) and (ii) Six months befc i the date ci objectives that the proposed backfit is docketing of the o reting license shatt be app oved by the Executive Director appliceuon for the scility for fecilities designed to achieve: ior Operetone or his or her deelsnee preer to havis d or>nstruction permite issued tunnce d the muest
- " the . ma no en rieb EpubEe PART 2-( AMENDED) .
(mg ahe dana vfinuance Of the and safety ud asM ere nedse'aod is reptre opereting licanse for the facility for unmee iy enait e reevieiary ocuam emely se 5. De authority citeHon for Part 2 facilities having opersting licenses, or ee'ow' red. these eneiy es. however should est continues to read as follows:
(iv)ne date ofissuance of the design approval under Appendix M. N or O oC Z'".,",'g8g,'
es,iove e pt.ue enern.t g
- " g '
ie easuit's .,
Authority: Sees 1et. set, es Stat. sea ess.
u amended (42 U.S.C sant. 2231); eec. tel, se this part. undue n 6 is wu.c Sunn and ure,y. emended. pub L so-eas. M Stat. eos (42 l
l P. *$ .h
4
, Federal Register / Vol. 50. No.183 / Friday. September 20. 1985 / Rules and Regulations 38113
~'~a
. UAC 2241). sec. act. so Stat 1H1 es DEPARTMENT OF NEALTH AND Food and Drug AdmWstration y emended 142 0S C 5641). 5 USC 532 HUM AN SERVICES Sec.1101 as luued under seca. 62A. 63 81. 21 CFR Part $20 los.104.106,se Stat. 330. B32. s23. e35. e30. SocialSecurity Adminiatratlon s37.33t ae amended (42 US C aD*3. 20e2. Oral Dosage Form New Animal Drugs 2003. 2111,2113,2134. 2135). sec 102. Pub L 20 CFR Part 404 Not Subject To Certefecation; Ffunitin F1-190. 83 SteL. 851 as emended (42 USC. Mogtumina Poste 4332), sec. 301. 86 Stat 1348142 US C 5a71) (Regulataon No. 41 Sect.ons 2.102.1103.1104. 2.10A 1721 also Aetncy: Food and Drug Administration.
issued under sece 102,103.104.105.183.1s9. Faderaf Old Ape.Surytvors,and AcTiost Final rule.
as Stat. saa. s37, saa s54. e55. es amended (42 Disability insurance; Listing of US C r:32. 21:3. 2134. 21si t:33. 2230) Impairrnents--Mental Die suarmArtv:ne Food and D t Section 1105 also luued under Pub. L 97- Administration (FDAlis em dmg the 415. es Stat. 3073 (42 US C 223e). Sections Correction animal d regulations to reflect 2Joo-*Joo also tuued under secs. tsa. 234. g In FR Doc. 85-20552 beginning on page se stai e55. 83 Stat. 444. as amended 142 35036 in the Lasue of Wedneaday. August 17e*a ion (N DA) d bYScherin
- UAC 223a 22a2); sec. Sos, se Stat 1246 (42 28.1985, make the following corrections: Corp., providing for flunixin meglumm.8 e US C Saae) Sections 2m2.30s also issued '
1.On page 35040, third column under Pula. L s7-415. 00 $ tat. 3071 (42 U.S C fo al ev inf ion n i p in om 2133). Sections 2;s00-Leos also issued unde' seventh line frem the bottom.*of" should read *or". musculoskeletal disorders.
sec.102. Pub. L si-teo. s3 Stat. ass es **
amended (42 US C. 4232). Sections 2.700s. 2. On page 35044* fiesI column. in the 1.7s1 also issved under 5 US C 554. Sections fath Comment. sixth line, insert the Pom FUsrTHER ledFOAsIATs0es Cost?ACT:
2.754. 2.790.1770. 2.700 also issued under 5 word _only between "aC and "one . Sandra K. Woods. Center for Veterinari s UAC 637. Sectica 1790 also issued under 3. On page 35045. third column. In the Medicine (HFV-114). Food and Drug third Comment sixth line. "by should Administration. 5600 Fishers Lane, sec.103. Se Stat. t36. as amended (42 UAc tead "be . Rockville. MD 20a57,301-443-4420.
2133) and 5 USC 552. Sections 3J00 and taas also inued under a US C 153. Sect cn p _
- 4. On page 35046. first column. In the tios also inued under s US C 553 and sec fourth Comment second line from the Schering Corp. Calloping Hill Rd 29 Pub. L 85-256,71 Stat. 479, ea amended bottC'm. " patient's" should read Kenilworth. N) 07033. has filed NEDA 142 USC 3030). Appendix A etso tuued "patienta", 137-400 for Banamine@ Paste (flunixin under sec 6. Pub. L 01-580. 84 Stat.1473 (42 5. On page 35048. first column,in the meglumine). Flunlain meglumine paste is USC 2135). for the alleviation of inflammation and second Comment. first line, " larger" pain associated wnh musculoskeletal
- 6. Section 2.204 is revised to read a s should rea91 "large".
follows: disorders in horses. The N AD A is
- 6. On page 35049. first column. In the approved and the regulations an first Response, twelfth line "necenery" amended to reflect the approval. The i 2.204 Oriser for modmcation of scen*e. should tead "necessarily". basis for approvalis discussed in the The Commission may modify a license 7. On the same page, second column. freedom ofinformation sumrnary.
by issuing an amendment on notice to in the first Response, second line from
. in accordance with the freedom of the beensee that the licensee may the bottom. " individual" should read information provisions of Part 20(21 demand a hearms with respect to all or " individuals". Also in the third column.
any part of the amendment within CFR Part 20) and i 514.11(c)(2)(ii)(21 "1204 Mento/ Retodotion" should read CFR 51411(e)(2)(ill), a summary of twenty (20) days from the date of the *1105 Mento/ Retodotion", safety and effectiveness dats and notice c.r such longer period as the 8. On page 35066. third column. first information submitted to support notice may provide.The arnendment cornplete paragraph. " including" should approval of this application may be seen will become effective on the expiration read " include".
In the Dockets Managementpranch of the 20-day period during which the *u"* **D' "*** .m (HFA,-305). Food and Drog
< hcensee may demand a bearing. If the Admmistration. Rm. 4-C2. 5000 Fishers g
I' Lane Rockville. MD 20857, from 9 a.m.
h", p,$$,',g['fdng dnt 20 CFR Part 404 to 4 p.m Monday through Friday.
become effective on the date specified Social Security Benefits; Coverage of
, an an order made following the hearing. Employees of Prtvste Hooproftt CF 25 4(d 1 ( i)( p 26.1 R When the Commission finds that the organizations. Work outside United 186361 that this action is of a t that public health, safety, or interest so States, Etc. does not individually or cumu@vely requires, the order may be made have a significant effect on the human immediately effective. If the amend nent Correction environment. Therefore, neither an mvolves a backfit. the provisions of environmental suessment not an in FR Doc. 85-21321, beginning page environmentalimpact statement is
! LO 109 of this chapter shall be followed. 36571 in the issue of Monday. September required.
9.1985. make the following corrections:
D.ted et Washington. D C this 17th day of On pase 36572, first column. in the Wd b n m PM M September. tss5. oaTes paragrsph: Animal drugs, oral use.
For the Nuclear Regulatory Commission. 2 In the first and second lines. "(insert Samuell cha, date of publication)"should have read Therefore under the Federal Food.
Drug. and Cosmetic Act and under Secrrrory of the Comminion " September 9.19859 authority de'egsted to the Comtnissioner trR Doc es-22572 riled S-ilLes a 4s amt 2. In the eleventh line " received" of Food and Drugs and redelegated to should have read " receive", the Center for Veterinary Medicine. Part sumo caos osa6+i.e $20is emended a follows:
m e
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