ML20205E374
| ML20205E374 | |
| Person / Time | |
|---|---|
| Issue date: | 09/24/1985 |
| From: | Philips J NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | NRC |
| References | |
| RTR-NUREG-BR-0053, RTR-NUREG-BR-53 NUDOCS 8510170284 | |
| Download: ML20205E374 (75) | |
Text
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[ o g UNITED STATES o NUCLEAR REGULATORY COMMISSION 3 E WASHINGTON, D. C. 20555
%.....)
SEP 2 41985 MEMORANDUM FOR: Users of NRC Regulations' Handbook FROM: John Philips, Chief Rules and Procedures Branch Division of Rules and Records Office of Administration
SUBJECT:
NRC REGULATIONS HANDBOOK Enclosed is the third set of revised pages for the NRC Regulations Handbook (NUREG/BR-0053). These revisions reflect the Commission's regulations con-cerning the notice and comment provisions of the Administrative Procedure Act, the ED0's program for the review and approval of rulemaking actions, and the recently implemented regulatory history procedures. The part con-cerning petitions for rulemaking and the appendix detailing procedures for submitting documents for Federal Register publication have been revised to reflect current agency practice. These revisions contain a revised sample document concerning NRC action on a petition for rulemaking and a new sample policy statement. Additional changes are made to update the List of Subject Index Terms and the list of Congressional committees routinely informed of NRC regulatory activities.
REMOVE INSERT pp 7 - 12b pp 7 - 12b pp 15 - 18 pp 15 - 18 pp 33 - 34 pp 33 - 34a pp 97 - 98 pp 97 - 98 pp 119 - 120 pp 119 - 120 pp 199 - 219 pp 199 - 217 pp 265 - 266 pp 265 - 266 pp 297 - 298 pp 297 - 298 pp 305 - 306 pp 305 - 306 pp 317 - 321 pp 317 - 321 Appendices Table of Contents Appendices Table of Contents Appendix A Appendix A Appendix C Appendix C Appendix D Index Index in Philips, Chief Rules and Procedures Branch Division of Rules and Records 8510170284 e50924- ce of Wnisuadon PDR NUREG BR-OO53 R PDR
n 1.5 The Federal Register, s
The Federal Register is published each business day by the Office of the Federal Register (0FR), National Archives and Recor'ds Service. It l provides a uniform system for publishing Presidential documents, final rules, proposed rules, advance notices of proposed rulemaking, petitions i
for rulemaking, general notices, policy statements, semi-annual agendas of regulations, meeting announcements, and other public documents for the conduct of agency business. These documents are discussed in subsequent sections of the handbook.
The publication requirements of the OFR are covered in this handbook.
i However, the OFR occasionally modifies these requirements. Questions regarding the most current 0FR requirements or special publication requests should be directed to the Rules and Procedures Branch, Division of Rules and Records, Office of Administration (extension 27086). The NRC staff is requested not to call the OFR directly. This will permit the NRC to maintain l consistent and uniform guidelines and coordination '.n the publishing of NRC l
documents.
( 7 September 1985
1.7 The NRC rulemaking process.
The need for a new NRC regulation normally arises from --
(a) Congressional promdgation of a new statute requiring new regulatory requirements; (b) Commission or staff initiative indicating a need fcr further regulation to re.cieve a safety, safeguards, or environmental problem; or (c) Comission receipt of a petition for rulemaking.
Action on a regulation is normally assigned to a member of the technical or legal staff most familiar with the subject area. In the case of a technical regulation, the responsible staff person reviews the problem and develops a preliminary range of alternatives designed to resolve the problem.
Each specific rulemaking action sponsored by an office reporting to the Executive Director for Operations (E00) must be approved by the EDO. The sponsoring office shall obtain ED0 approval before it begins the rulemaking action. Until the E00 approves a rulemaking action, the sponsoring office may not expend resources for the action and the rule may not be included in the NRC Regulatory Agenda (NUREG-0936). The sponsoring office may obtain EDO approval for a rulemaking action by following the " Procedures For Conduct-ing RES Independent Review of Rulemakings" (May 1984). (Questions concerning 8 September 1985 4
p these procedures and requirements may be directed to the Regulatory V) i Analysis Branch, Division of Risk Analysis, Office of Nuclear Regulatory Research). After the ED0 has initially approved the rulemaking. action, it must be reviewed and reapproved by the ED0 on an annual basis until the final rule is issued.
After ED0 approval has been obtained, discussions may be held with the staff of other offices and the Advisory Committee on Reactor Safeguards (ACRS) to obtain additional inftmation and to refine the list of alter-natives. If the proposed regW ation will have an impact on Agreement State licensees, the staff also works with the Office of State Programs I
(OSP) to solicit the views of Agreement States at an early stage in the development process.
The staff then prepares the analyses required to substantiate the w/ contemplated rulemaking action. A regulatory analysis, prepared in accordance with the Regulatory Analysis Guidelines issued by the Execu-tive Director for Operations in a memorandum dated December 13, 1982 (SECY-82-187; September 30,1982), is required for each proposed regula-tion (NUREG/BR-0058, Rev. 1; May 1984). The regulatory analysis contains information sufficient to either constitute a regulatory flexibility analysis or support a certification that the proposed regulation will not have a significant economic impact on a substantial number of small entities as required by the Regulatory Flexibility Act. The regulatory analysis also contains the information necessary to obtain Office of Management and Budget (OMB) approval for new or amended information collection i
- requirements contained in the rulemaking as required by the Paperwork Reduction Act.
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9 September 1985
If the proposed regulation is likely to have a significant impact on the quality of the human environment, the staff prepares an environ-mental impact statement under the National Environmental Policy Act (NEPA) and the regulations in 10 CFR Part 51. If an environmental impact statement is required for the proposed regulation, a summary of the environmental impact statement may be substituted for sections III.
B. 1, 2,,3, 4 of the regulatory analysis.
After completing the required analyses, the staff prepares a draft of the regulation. The draft regulation is based on an evaluation of the most appropriate method of accomplishing the desired regulatory objective in view of the safety needs, impacts, costs, and benefits of the alternative approaches considered.
The Commission paper, which includes the draft regulation, the regulatory analysis, and any other relevant material, is then circulated for review and comment at the Division Director level. The package is also submitted to the ACRS, the Committee to Review Generic Requirements, if appropriate, the OSP, which will coordinate Agreement State review, and other NRC offices which have knowledge concerning the subject of the regulation or which may be affected by, or otherwise interested in, the regulation. A copy of the package is also sent to the Division of Rules and Records (DRR), ADM, the Office of the Executive Legal Director (0 ELD),
and the Regional 0'fices for review. The Cost Analysis Group, Office of Resource Management reviews any cost analysis that is prepared as part of 10 September 1985 O
the package and included in the regulatory analysis or regulatory flexibility
( analysis. (See the Memorandum from the ED0 to Office Directors and Regional Administrators dated January 4, 1984).
The responsible staff person then incorporates the comments received into the regulation and, if necessary, meets with the staff of the other offices to resolve any problems or differences. If it is not possible to resolve differing views among the offices, a meeting may also be held at this point with the ED0 to resolve the issue. Depending upon the complexity of the issues, there may be several rounds of staff comments.
After all comments have been received, a revised package consisting of the Comission paper, the proposed regulation, the regulatory analysis, appropriate Congressional letters, the public announcement, and any other relevant material is sent to the offices for formal concurrence.
Y After the offices have had an opportunity to review the final package, it is sent to the DRR, ADM and then to the E00 for review and, if the ED0 approves the package, it is sent to the Commission for signature and publi-cation. If, when the package is submitted to the EDO, disagreement remains among the offices, the ED0 may try to resolve the issue, or the unresolved issue will be sent to the Comission as a dissenting view. The ED0 has been delegated the authority to issue regulations that do not involve significant questions of policy or do not amend 10 CFR Parts 7, 8, and 9 Supbart C.
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If a regulation contains a reporting, application, or recordkeeping requirement affecting 10 or more persons, the staff office originating the regulation prepares the supporting statement necessary to request approval of the new or amended information collection requirement. The staff sends the supporting statement and a copy of the draft regulation to the Division of Technical Information and Document Control (TIDC), ADM, for review and transmittal to 0MB for clearance under the Paperwork Reduction Act. The package requesting OMB approval must be submitted to 0MB before the proposed rule may be submitted for signature and publica-tion in the Federal Register.
When the regulation is received at the Commission, it is scheduled by the Office of the Secretary (SECY) for Comission consideration, with or without oral presentations, at a Comission meeting. Usually, the Commission meetings on these matters are open under the Government in the Sunshine Act; in some cases, such as those involving classified or safeguards matters, the meetings may be closed to the public. Copies of the paper are sent to every Commission level office that may have an interest in the regulation. The Comission may approve the regulation as submitted by the EDO, approve the regulation subject to specified changes, disapprove the regulation entirely, or direct that the regula- -
tion be revised and resubmitted to the Comission for reconsideration.
The Commission's decision on a regulation is reflected in a Staff 12 September 1985 O
4 Requirements Memorandum issued by SECY. If the Comission orders changes
\ to be made in the regulation, the Staff Requirements Memorandum sets forth the nature of these changes and the deadline for resubmission, usually fourteen days from the date of the memorandum.
If the Comission approves the regulation, the staff prepares it for publication by making any changes directed by the Comission and any remaining editorial or format changes. The staff then prepares the rulemaking package, consisting of the regulation and all necessary accompanying documents. (For additional information on submitting a rulemaking package for publication, see Appendix A to this handbook.)
The staff then submits the rulemaking package to DRR at least.two l working days before the deadline for resubmission of the regulation to
, SECY.
. DRR conducts a final review of the regulation to ensure compliance with the publication requirements of the OFR and to verify that the
) regulation is complete. DRR then transmits'the regulation to SECY for signature and transmittal to the OFR for filing and publication. A regulation signed by the ED0 is routed through DRR for transmittal to i the OFR.
i DRR forwards letters to appropriate Congressional Comittees with i enclosed copies of the regulation to the Office of Congressional Affairs i to ensure that Comittees with oversight responsibility for the NRC are ,
12a September 1985 o
notified of the agency's regulatory activities. The originating office coordinates with the Office of Public Affairs so that the issuance of the public annocncement coincides with the publication of the regulation in the Federal Register.
If the regulation is likely to have a significant impact on the quality of the human environment, the staff ensures that the draft environmental impact statement, prepared as required under NEPA and 10 CFR Part 51, is made available for public comment. If the regulation is subject to the Regulatory Flexibility Act, DRR sends a copy of the regulation and any related analyses to the Chief Counsel for Advocacy of the Small Business Administration. After the regulation is published in the Federal Register, TIDC, ADM sends copies of the published document to all affected licensees as well as any interested person that has requested placement on a mailing list for NRC notices.
After the close of the comment period on the proposed regulation, the responsible staff person analyzes the comments received and makes any change to the regulation that may be appropriate. This rulemaking process is essentially repeated for the final rule.
12b September 1985 O
(i) Extend a comment period;
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(ii) Announce a public hearing or meeting on a proposed regulation; (iii) Publish or announce the availability of information supplemental to a rulemaking; (iv) Withdraw a proposed rule; (v) Terminate a proposed rule proceeding; or (vi) Correct a previously published proposed rule.
(3) Documents that begin a rulemaking proceeding. The OFR classifies any document that serves as the first public notice that a rulemaking proceeding is anticipated as a proposed rule for publication in the Federal Register.
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(i) Advance notices of proposed rulemaking. These documents generally describe a problem or situation and may outline NRC's antici-pated regulatory response. The advance notice of proposed rulemaking seeks public comment on the need for regulating in the problem area, t
and often on the merits of NRC's anticipated regulatory response to the problem. The NRC may propose several alternative solutions in an advance notice of proposed rulemaking and solicit public comment on each i
4 alternative.
I (ii) Petitions for rulemaking. The NRC publishes petitions for rulemaking filed with the Commission under its rulemaking procedures (10 CFR 2.802). Because these petitions propose to amend, add to, 1
revise, or remove existing regulations in 10 CFR Chapter I, they are classified as proposed rules for publication in the Federal Register.
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(iii) Meetings or hearings. The OFR' classifies a document that announces a meeting or hearing that may be the first step in a rulemaking proceeding as a proposed rule for publication in the Federal Register.
(4) Regulatory agendas. The NRC publishes in the Federal Register each April and October an agenda of regulations under agency development approved by the Executive Director for Operations (ED0). This agenda is intended to comply with the requirements of the Regulatory Flexibility Act (Pub. L.96-354; 5 U.S.C. 601 et seq.) and to cooperate with the Admini-station's program for reform of Federal regulaticr set out in Executive Order 12291, Federal Regulation. Because these documents often provide the public with advance notice of anticipc+ . WRC rulemaking activities, the OFR classifies them as proposed rules for publication in the Federal Register. The NRC also issues a quarterly update of its agenda of regula-tions approved by the ED0 for development (NUREG-0936). The NRC also includes its sumary of petitions for rulemaking pending before the Comission (10 CFR 2.802(g)) in this updated agenda of regulations. The NRC announces the availability of the January and July updated agenda in a document published in the Proposed Rule section of the Federal Register and places a copy of the updated agenda in the NRC Public Document Room, 1717 H Street NW, Washington, DC.
(5) Policy statements. The Administrative Procedure Act (5 U.S.C.
552(a)(1)(D)) requires that each agency publish "... statements of general policy or interpretations of general applicability formulated and adopted by the agency ..." in the Federal Register. Therefore, each policy statement 16 September 1985 l
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prepared by the NRC should comply with the format requirements specified in 3.7 of this handbook. When the staff develops a policy statement, it should contact the Division of Rules and Records (DRR) to determine whether the policy statement meets all procedural and format requirements for publication and can be properly integrated into the NRC Rules and Regulations after it is published in the Federal Register.
l (b) NRC is responsible for verifying the accuracy and completeness of each document it publishes in the Proposed Rule section of the Federal Register. Within NRC, the originating office has the primary responsi-bility for identifying and correcting errors that. appear in a published proposed rule document. See 9.3 of this handbook for information on preparing a correction document. The originating office shall coordinate the preparation of a correction notice with the Rules and Procedures Branch, DRR.
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- 3. 3 Proposed rule documents: Anatomy.
This section presents a dissection of a typical proposed rule document. Each essential element of a proposed rule is identified.
This section is designed to help a writer identify the required elements of a prop.osed rule document and create a complete and correct document.
The section of this handbook that discusses each required element in detail is indicated in parentheses. The format used in this and other examples to present document text generally reflects the format used in printing the Federal Register. However, the format used in the sample proposed rule document (see 15.2 of this handbook) reflects the format used in typing a document for publication in the Federal Register.
SAMPLE: PROPOSED RULE Agency Heading NUCLEAR REGULATORY COMMISSION HEADINGS: CFR Part Heading 10 CFR Part 50 (3.5)
Subject Heading Reporting Changes to the Quality Assurance Program PREAMBLE: Captioned AGENCY: Nuclear Regulatory Commission.
Headings (3.7) ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission is proposing to amend its regulations to require holders of nuclear power plant construction permits and holders of oper-ating licenses to implement the approved quality assurance program and to inform the Commission in writing of certain quality assurance program changes that affect the description of the quality assurance program included in their Safety Analysis Report and accepted by the Commission, within 30 days of making any change. The amendments will provide 18 June 1984
g BACKGROUND l Under current NRC regulations, no person may possess, V use, or transfer technetium-99 or low-enriched uranium (defined in'10 CFR 70.51(a)(2) as that uranium whose isotope content is less than 20 percent uranium-235 by weight) as contaminants in metals except as authorized in a specific license issued by the NRC under 10 CFR Part 39, " Rules of General Applicability to Domestic Licensing of Byproduct Material," or 10 CFR Part 70,
" Domestic Licensing of Special Nuclear Materials," as appro-priate. The effect of the requirements for specific licenses has been to inhibit trade in metal scrap contaminated with small amounts of these two radioactive materials and prevent recycling by the secondary metals industry of smelted alloys containing these two radioactive materials as residual contamination.
RULEMAKING INITIATION The Department of Energy has underway Cascade Improvement O Programs and Cascade Upgrading Programs begun by the AEC at all three U.S. uranium enrichmervt plants -- Oak Ridge, TN, Portsmouth, OH, and Paducah, KY. In the early 1970s, a market survey showed that no scrap dealers or processors would purchase any of the metal scrap generated by the programs if their customers would be required to hold specific licenses to possess or use recycled contaminated scrap.
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- a m (c) The Supplementary Information section should not contain a list of the changes made in the regulation that simply restates amenda- i tory language in the preamble. If a detailed breakdown of the changes made in a large regulation is necessary, the information may be presented 33 v
in tabular form. Where appropriate, a detailed description of the substantive changes made in the regulation may be included.
(d) If the NRC published an advance notice of proposed rulemaking, it must discuss the substantive coments received on the ANPRM in the Supplementary Information section of the preamble to the proposed rule.
The discussion should indicate any new material or suggested alternatives presented in the comments and indicate any substantive changes made in the proposed rule as a result of public comments. In addition, the discussion should indicate the substantive coments received that were not adopted and NRC's reasons for rejecting those coments.
(1) Coment analysis is not a vote count. Logic and reasoning are more important than numbers.
(2) Fairness is essential in responding to public coments. This is true in both characterizing the comment and in explaining why the comment was accepted or rejected.
(3) Each individual comment need not be addressed separately. If several comments raise the same substantive issue, they may be treated generically in the comment analysis. Coments of a minor or clarifying nature should be lumped together for discussion in comment analysis.
(4) Specific commenters need not be identified although it may be helpful to characterize the commenter by affiliation or organization (i.e., licensee, vendor, environmental concern, or private citizen).
(e) If a proposed rule references an NRC publication (NUREG), the NRC shall include a statement in the Supplementary Information section of the preamble to the proposed rule that indicates how an interested 34 September 1985 l
a person may obtain a copy of the referenced material. The statement is inserted as a single spaced footnote following the first reference to a
- NUREG in the proposed rule. In addition, when referencing a draft i
NUREG, the drafter shall check with the Division of Technical Information and Document Control, ADM to ensure that the NRC has an adequate stock of 4
the referenced NUREGs before the proposed rule is published in the Federal l
Register.
- (1) If the referenced NUREG is in draft form, the NRC shall use the following statement of availability.
Example:
I A free single copy of draft NUREG-XXXX, to the extent of l
supply, may be obtained by writing to the Publications Services Section, Document Management Branch, Division of
- Technical Information and Document Control, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A copy is also available for inspection and/or copying in the NRC Public Document Room, 1717 H Street, NW, Washington, DC 20555.
(2) If the referenced NUREG is in final form, the NRC shall use the following statement of availability.
Example:
I I C.opies of NUREGS may be purchased through the U.S.
Government Printing Office by calling (202) 275-2060 or by
. writing to the U.S. Government Prir. ting Office, P.O. Box ;
37082, Washington, DC 20013-7082. Copies may also be purchased from the National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161. A copy is available for inspection and/or copying for a fee in the NRC Public Document Room,1717 H Street, NW, Washington, DC 20555.
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34a September 1985 i.
(CFR) and provides an effective date for each amendment. When issuing an interim or temporary rule, the NRC may request public coninent and consider adjustments to the regulation before adopting it in final form.
An interim or temporary rule must meet the format requirements outlined for final rules in this part.
(3) Documents that relate to previously published final rules.
The 0FR classifies each document that relates to a previously published final rule as a final rule for purposes of publication in the Federal Register. This type of document may --
(i) Correct a previously published final rule; (ii) Announce a meeting or hearing on a previously published final rule; (iii) Change or suspend the effective date of a previously published w
final rule; (iv) Withdraw an interim or final rule before it goes into effect; (v) Change the comment period of an interim or temporary rule; or (vi) Publish or announce the availability of additional information concerning a previously published rinal rule.
(4) Policy statements. The Administrative Procedure Act (5 U.S.C.
552(a)(1)(D)) requires that each agency publish "... statements of general policy or interpretations of general applicability formulated and indopted by the agency ..." in the Federal Register. Therefore, each policy statement prepared by the NRC should comply with the format requirements specified in 5.7 of this handbook. When the staff O
97 September 1985
develops a policy statement, it should contact the Division of Rules and Records (DRR) to determine whether the policy statement meets all procedural and format requirements for publication and can be properly integrated into the "NRC Rules and Regulations" after it is published in the Federal Register.
(b) NRC is responsible for verifying the accuracy and completeness of each document it publishes in the Final Rule section of the Federal Register. Within NRC, the originating office has the primary responsi-bility for identifying and correcting errors that appear in a published final rele document. See 9.3 of this handbook for information on preparing a correction document. The originating office shall coordinate the preparation of a correction document with the Rules and Procedures Branch, DRR.
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x accomplishes termination of the proceedings when it appears to be an unwarranted accusation.
(e) If a final rule references an NRC publication (NUREG), the NRC shall include a statement in the Supplementary Information section of the preamble to the final rule that indicates how an interested person may obtain a copy of the referenced material. The statement is 4
inserted as a single spaced footnote following the first reference to a NUREG in the final rule. In addition, when referencing a draft NUREG, the drafter shall check with the Division of Technical Information and Document Control, ADM to ensure that the NRC has an adequate stock of the referenced NUREGs before the final rule is published in the Federal Register.
(1) If the referenced NUREG is in draft form, the NRC shall use the w following statement of availability.
1 Example:
1 A free single copy of draft NUREG-XXXX, to the extent of supply, may be obtained by writing to the Publications Services Section, Document Management Branch, Division of Technical Information and Document Control, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A copy is also available for inspection and/or copying in the NRC Public Document Room, 1717 H Street, NW, Washington, DC.
(2) If the referenced NUREG is in final form, the NRC shall use the following statement of availability.
119 September 1985 Q
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Example:
I Copies of NUREGS may be purchased through the U.S.
Government Printing Office by calling (202) 275-2060 or by writing to the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20013-7082. Copies may also be purchased from the National Technical Information Service.
U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161. A copy is available for inspection and/or copying for a fee in the NRC Public Document Room, 1717 H Street, NW, Washington, DC 20555.
(f) The Administrative Procedure Act (APA) generally requires that an agency publish a notice of proposed rulemaking in order to provide an interested person with notice of the proceeding and afford him or her with an opportunity to comment on the contemplated action before the agency issues the rule in final form (5 U.S.C 553(b)). The APA also generally requires that a final rule become effective at least 30 days after the final rule is published in the Federal Register (5 U.S.C. 553(d)). An agency may waive either or both of these requirements for a rulemaking action that meets the exceptions to the requirements specified in the APA.
(1) If the NRC has not published a notice of proposed rulemaking, the NRC shall indicate the APA exemption under which it waives notice and comment procedures.
(1) The NRC may determine that the publication of a proposed rule is unnecessary if the --
(A) Rule is an interpretive rule that is not, of itself, substantive or binding; (B) Rule is a general statement of policy that does not establish a binding norm imposing substantive rights or obligations; 119a September 1985
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V (C) Rule is a rule of agency organization, procedure, or practice; or (D) NRC can show good cause that notice and coment are impracticable, unnecessary, or contrary to the public interest.
(ii) The NRC shall allow a 30 day post-promulgation comment period for --
(A) A final rule for which the notice and comment requirements are waived under the good cause exception if the basis of the waiver is that the notice and comment procedure is impractical or contrary to the public interest; and (B) An interpretative rule or general statement of policy adopted without notice and coment unless the NRC determines that notice and coment procedures serve no useful purpose or would be so burdensome that any forseeable gain would be outweighed.
(iii) If the NRC determines that a proposed rule is not required, D the NRC shall insert a statement indicating that decision and the APA exemption under which the NRC waives notice and coment in the Supple-mentary Information section of the preamble to the final rule.
Example: ,
Because these amendments deal solely with agency practice and procedure, the notice and comment provisions of the Administrative Procedure do not apply under 5 U.S.C.
553(b)(A).
(2) If the NRC determines that a final rule should become effective when it is published in the Federal Register, the NRC shall indicate the APA exception under which it waives the deferred effective date requi ren.' qts .
119b September 1985
(i) The NRC may waive the deferred effective date requirement --
(A) For a substantive rule granting or recognizing an exception or relieving a restriction; (B) For an interpretative rule; (C) For a statement of policy; or (D) When the NRC can show good cause for making the rule effective imediately.
(ii) If the NRC determines that the deferred effective date requirement may be waived for a final rule, the NRC shall insert a statement indicating that decision and the APA exception under which the NRC waives the deferred effective date requirement in the Supplementary Information section of the preamble to the final rule.
+
Example:
The NRC finds that good cause exists to waive the 30-day ,
deferred effective date provisions of the Administrative Procedure sd Act (5 U.S.C. 553 (d)). Delaying the effective date of this rule would be contrary to the public interest because physicians would not be able to immediately provide the added diagnostic services for patient care described in this rule. Therefore, the rule is effective on publication in the Federal Register.
(3) If the NRC determines that both the notice and comment procedure and the deferred effective date requirement may be waived for a final rule, the NRC may combine the statements indicating these waivers and the provisions of the APA under which the NRC waives the notice and comment procedure and the deferred effective date requirement in a single statement inserted in the Supplementary Information section of the preamble to the final rule.
119c September 1985
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, Example:
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Because these are amendments dealing with agency practice and j procedures, the notice and comment provisions of the Administrative
- Procedure Act do not apply pursuant to 5 U.S.C. 553 (b)(A). The i
- amendments are effective upon publication in the Federal Register. 1 f Good cause exists to dispense with the usual 30-day delay in the
! effective date because the amendments are of a minor and administra- l tive nature dealing with a matter of agency conduct, a change
! in the price of making copies of documents in the PDR.
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5.11 Procedural requirements for rulemaking.
(a) Sections 5.13 through 5.19 of this handbook discuss the portion of the Supplementary Information section of the preamble relating to the procedural requirements the NRC follows in developing and issuing a final rule. The requirements are intended to ensure that the NRC consider the impact of each regulatory alternative in the process of developing a final rule. The regulatory procedures the NRC follows in developing a final rule include --
(1) An assessment of the environmental impact of the final rule under the National Environmental Policy Act and 10 CFR Part 51 (see 5.13 of this handbook);
(2) Obtaining the approval of the Office of Management and Budget (OMB) for each new or changed information collection requirement under the Paperwork Reduction Act (see 5.15 of this handbook);
(3) A regulatory analysis prepared in accordance with the Regulatory Analysis Guidelines issued by the Executive Director for Operations on December 13, 1982 (SECY-82-187; September 30,1982) (see 5.17 of this handbook). A regulatory analysis examines the economic impact, in terms of costs and benefits, of alterantives considered in developing the final rule; and (4) An analysis of the economic impact of the final rule on small entities under the Regulatory Flexibility Act (see 5.19 of this handbook).
(b) It is important that the environmental assessment and economic analyses precede, or are prepared concurrently with, the development of l
120 September 1985
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l PART 11 - PROCEDURES FOR HANDLING PETITIONS FOR RULEMAKING Page 11.1 Prelimi na ry contacts and filing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 11.3 Preliminary processing and threshold determination.......... 202 11.5 Petitions not meeting threshold requirements................ 204 11.7 Determining whether a petition is eligible for fast track
' processing.................................................. 205 l
l 11.9 Fast track processing....................................... 208 4
l 11.11 Routine processing.......................................... 209 i
{ 11.13 Processing after publication for public comment............. 210 1
11.15 Compl eting actica on a peti tion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213 i
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199 September 1985 i
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11.1 Preliminary contacts and filing.
(a) The Administrative Procedure Act provides any interested 9
person with the right to petition an agency for the issuance, amendment, or repeal of a rule (5 U.S.C. 553(e)). The Nuclear Regulatory Commission (NRC) implements this statute in regulations that establish the procedures by which any interested person may file a petition for rulemaking with the Commission (10 CFR 2.802).
(b) A prospective petitioner is encouraged to confer with the staff before filing a petition for rulemaking. A pre-filing conference may--
(1) Resolve questions regarding applicable NRC regulations sought to be amended; (2) Clarify the procedures for filing a petition for rulemaking; or (3) Result in a meeting with appropriate NRC staff to discuss the issues involved in the petition.
(c) A request for information or assistance concerning a petition or a meeting with the staff should be addressed to: The Director, Division of Rules and Records, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Chief, Rules and Procedures Branch. A prospective petitioner may also telephone the Rules and Proce-dures Branch on 301-492-7086 or on the toll free number for inquiries concerning NRC regulations: 800-368-5642, 200 September 1985
4 (d) A request for a meeting received by any other office, should 5,j be coordinated with the Director, Division of Rules and Records (DRR),
or the Chief, Rules and Procedures Branch (RPB). All offices that would be affected by the prospective petitioner's suggested amendment to the regulations will be invited to attend the meeting. DRR will prepare a memorandum for the record summarizing the substance of the meeting.
This memorandum will be included in the official file on the petition.
(e) A prospective petitioner may file the petition with the NRC by ;
, addressing it to: The Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20556, Attention: Docketing and Service Branch. If any other NRC employee receives a petition for rulemaking or a document which may qualify as a petition, the employee shall forward the document imediately to the Chief, Docketing and Service Branch, Office of the Secretary.
~
l 201 September 1985
, .-, s - , . , - - - , , - - , , , -
11.3 Preliminary processing and threshold determination.
(a) When the Office of the Secretary (SECY) receives a petition /or rulemaking or a document which may qualify as a petition for rulemaking, it logs in the document, establishes docket control, and sends a copy of the document to DRR. DRR then determines whether or not the document meets the threshold requirements for a petition for rulemaking.
(b) As set out in 10 CFR 2.802(c), to meet the threshold require-ments, a petition for rulemaking must --
(1) Set forth a general solution to the problem or present the substance or text of any proposed regulation or amendment or specify the regulation which is to be revoked or amended; (2) State clearly and concisely the petitioner's grounds for and interest in the action requested; and (3) Include a statement in support of the petition that sets forth the specific issues involved, the petitioner's views or arguments with respect to those issues, relevant technical, scientific, or other data involved that is reasonably available to the petitioner, and any other pertinent information necessary to support the action sought. In support of the petition, the petitioner should note any specific cases of which the petitioner is aware where the current rule is unduly burdensome, deficient, or needs to be strengthened.
202 September 1985
_ (c) If the document meets the requirements for a petition for rulemaking, DRR will assign a docket number to the petition and i
forward a copy of the petition to the appropriate office. Within ten working days, DRR will forward a request for a decision from the staff l
5 office on whether the petition should be processed routinely or handled as a " fast-track" petition. A " fast-track" petition is initially published for comment in the Federal Register as a proposea rule in accordance with 92.802(e). DRR will enclose a draft notice of receipt of the petition with the " fast-track" request. If the staff office determines that the petition for rulemaking is not suitable for " fast-track" processing, the staff office is requested to connent or concur on the draft notice of
, receipt and return it to DRR for publication in the Federal Register.
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203 September 1985 i \
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11.5 Petitions not meeting threshold requirements.
(a) If a petition does not include sufficient information to meet O
the threshold require;nents for a petition for rulemaking (see 11.3(b) of this handbook), the Executive Director for Operations (ED0) will make a determination that a petition is deficient. This determination, based upon the reconinendation of the cognizant office, the Office of the Executive Legal Director (0 ELD), or DRR, should ordinarily be made within 30 days from the date of receipt of the petition by SECY. DRR prepares a memorandum to the ED0 containing this recommendation. The memorandum includes a draft letter to the petitioner pointing out the aspects in which the petition is deficient.
(b) The petitioner is informed as to how the petition is deficient and is given an opportunity to submit additional information. If a petitioner does not correct the deficiency within 90 days from the date of notification by the EDO that the petition is incomplete, the petition may be returned to the petitioner without prejudice to the petitioner's right to file a new petition. When this occurs, DRR will draft the appropriate letter to the petitioner, obtain the concurrence of 0 ELD and the cognizant office, and forward the letter to the ED0 for signature.
(c) The Commissioners are placed on distribution for any letter to a petitioner which states that a petition is deficient or which returns a petition to a petitioner because it is incomplete.
204 September 1985 l
i 11.7 Determining whether a petition is eligible for " fast-track" processing.
O (a) Occasionally, NRC receives a petition for rulemaking that
- requests a minor amendment to the regulations that is obviously meritor-i
! ious. In order to expedite the rulemaking process, these petitions for rulemaking may be published initially for public coment as a proposed rule. This " fast-track" procedure eliminates the usual step of '
j publishing a notice of receipt of a petition for rulemaking and inviting public comment on the petition when the additional procedural step is unnecessary. " Fast-track" petitions are processed by the staff according to the procedures specified in this section and 11.9 of this handbook. The " fast-track" procedure may not be used for the expedi-tious denial of a petition for rulemaking.
f (b) following a determination that a petition for rulemaking meets t
the threinold requirements for a petition, DRR assigns the petition to I
the appropriate staff office to determine whether the petition is eligible for " fast-track" processing. The assigned staff office assigns a contact person to handle the petition. The contact person then makes i
the " fast-track" determination within 10 working days.
(c) The NRC may consider a petition eligible for " fast-track" processing if it --
(1) Proposes action granting or recognizing an exemption from requirements in 10 CFR Chapter I or granting relief from restrictions
- O 205 September 1985
while not imposing additional burdens upon or, increasing the risks to, the health and safety of any segment of industry or the public; (2) Proposes action involving interpretive rules, rules of agency organization, procedure or practice, and rules for the orderly conduct of Commission business; (3) Proposes action involving an amendment to 10 CFR Cl. apter I that is corrective or of a minor or nonpolicy nature and that does not substantially modify existing regulations; (4) Proposes actiun involving --
(i) A minor safety, safeguards, or environmental issue; (ii) An increase in NRC efficiency; or (iii) A reduction in the regulatory burden on licensees.
(5) Proposes action involving a request already under consideration in an ongoing rulemaking proceeding (Note however, that NRC consideration of a request already included in an ungoing rulemaking depends on the status of the rulemaking proceeding);
(6) Proposes other action that is clearly meritorious and will not adversely affect the rights of other licensees or persons.
(d) The NRC normally will not consider a petition eligbile for
" fast-track" processing if the proposed action will --
(1) Require the preg ration of an Environmental Impact Statement; (2) Impose new or increased reporting, application, or recordkeeping requirements subject to clearance by the Office of Management and Budget; 206 September 1985
i I
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.(3) Have a significant economic impact.on a substantial number of i small entities (see discussion of Regulatory Flexibility Act requirements in sections 3.19 and 5.19 of this handbook);
i (4) Have a significant impact on NRC staff and resource i commitments; or (5) Result in denial of the petition for rulemaking.
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207 September 1985
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11.9 Procedures: Fast track processing.
(a) If the contact person determines that the " fast-track" process 9
is appropriate for a petition for rulemaking, the assigned office shall inform DRR of this decision. The assigned office begins processing the petition under " fast-track" procedures by developing a notice of propcsed rulemaking that addresses the issues in the petition.
(b) Under " fast-track" procedures, the assigned office shall develop the proposed rule for transmittal to the ED0 or the Commission for approval within 90 days after DRR assigns a docket number.
(c) The assigned office is responsible for implementing E00 or Commission action for a proposed rule (see NRC rulemaking process section 1.7 of this handbook).
O 208 September 1985 O
11.11 Routine processing.
1 Q (a) If the contact person determines that the " fast-track" process is not appropriate for a petition for rulemaking, the assigned office shall inform DRR of this decision. The assigned office shall also concur or provide comment on the draft notice of receipt of petition for rulemaking prepared by DRR for Federal Register publication. The notice of receipt describes the contents of the petition and allows at least 60 days for public coment.
(b) The assigned office shall establish a schedule and target date for completion of staff action on the petition. The schedule and target date are meant to indicate the period from initial staff review to transmittal of the response to the petition to the Commission or to the E00. The response would recomend granting the petition and publication d of a proposed rule or denial of the petition.
(c) The staff should note that in approving SECY-77-526, " Procedures for Petitions," in November 1977, the Commission stated:
"Schedul for responding to specific petitions should be set individu,41y, taking into account the priority and difficulty of the issues. However, the Comission believes that the time for response should seldom exceed 6 months for minor petitions or 12 months for major ones. When the response is rulemaking, the 6 and 12 month schedule limits can be interpreted as applying to the date of publication of the proposed rule in the Federal Register.
"On petitions of substantial policy significance, the staff should submit an information paper or present a briefing to the Comission, about three months after receipt of the petition, identifying issues and options, and any preliminary staff views."
G 209 September 1985
i 11.13 Processing after publication for public comment.
(a) " Fast-track" petition (published as proposed rule). At the conclusion of the comment period specified in the proposed rule, the contact person in the assigned office sends a letter to the petitioner enclosing copies of any comments that were received in response to the publication of the proposed rule in the Federal Register. The letter also states the initial target date for completion of staff review of the coments received and development of a final rule. The assigned office is responsible for notifying the petitioner of any subsequent changes in the target date or of the contact person to whom the petition is assigned.
(b) Routine petition (notice of receipt published for comment).
(1) At the conclusion of the comment period specified in the Federal Register notice of receipt of petition (normally 60 days), DRR sends a letter to the petitioner enclosing copies of any coments that have been received concerning the petition. The letter will also state the initial target date for completion of staff review of the petition and the name and telephone number of the contact person responsible for the petition. The assigned office is responsible for notifying the petitioner of any subsequent changes in the target date or of the contact person to whom the petition is assigned.
l 210 September 1985
1 l
i n (2) A petition for rulemaking may remain active for a considerable l
[d \
ti Te following publication for comment in the Federal Register. The contact person should contact the petitioner every three months with a status report on the petition. A petitioner may, over a period of time, 4 charge positions on a particular issue or determine that an initial concern has been satisfied by actions occurring after the petition was filed with the Commission. Thus, periodic contact with petitioners may result in withdrawal of part or all of a petition by the petitioner.
Routine correspondence to the petitioner may be signed by an appropriate official in the responsible office. The assigned office shall send copies of correspondence sent to a petitioner to DRR and to the official docket file maintained by the Office of the Secretary.
(3) If an assigned office believes that action on the petition has p been completed through administrative measures other than publication of b a Federal Register notice, it should consult with DRR and OELD for a final determination. Following a review of the staff actions taken during the processing of the petition, DRR will notify the assigned office if all necessary action on the petition has been completed and describe how the proceeding is to be terminated.
(c) Assistance during processing.-
(1) RPB is available to assist with the preparation and review of Federal Register notices required during the processing of petitions for rulemaking.
(2) OELD is available to provide legal advice to the staff during the processing of petitions for rulemaking.
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V 211 September 1985
(d) Staff response to significant actions. The contact person for a petition for rulemaking is responsible for notifying DRR, and where appropriate, OELD, of any significant action or change that occurs during the processing of the petition. Negotiations or understandings reached with a petitioner can materially affect the handling and dispost-tion of a petition. Coordination of staff plans with DRR is necessary for actions such as the potential or actual withdrawal of a petition to enable DRR to keep the Commission informed of the status of petitions for rulemaking by means of the quarterly Regulatory Agenda.
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11.15 Completing action on a petition.
, J Action on a petition for rulemaking is considered complete when the petition, or each of its parts, has been withdrawn, denied, or granted.
(a) Withdrawal of petition for rulemaking.
(1) Only the petitioner may withdraw a petition or part of a petition. If the withdrawal is made by telephone, the contact person should request that the petitioner submit an official letter of withdrawal to provide a record of the request. If the petitioner does not submit a written request for withdrawal, the contact person should make a record of the conversation noting the date, name, and position of the person claiming to represent the petitioner. The contact person should send a follow-up letter to the petitioner that confirms the withdrawal.
(2) If the petition is withdrawn, DRR, after consultation with the
> V contact person, prepares a Federal Register notice that informs the public of the action. The Federal Register notice is circulated to the assigned office and OELD for concurrence before it is submitted to the ED0 for signature.
(b) Denial of petition for rulemaking.
(1) A petition or part of a petition is denied through the publication of a Federal Register notice and official written notification to the petitioner. If part of a petition is denied, the assigned office is responsible for processing the remaining parts of the petition until each remaining part has been withdrawn, denied, or granted.
l T 1 213 September 1985 l
(2) The assigned office prepares the following documents in the case of a denial of a petition:
(1) A memo to the E00 or a Commission paper.
(ii) A Federal Register notice of denial (to be signed by either the ED0 or the Secretary of the Comission). The delegation of rulemaking authority to the E00 set out in 10 CFR 1.40 provides the criteria for determining whether the E00 or the Secretary is to sign a denial of a petition for rulemaking.
(iii) A letter to the petitioner to be sent to the petitioner prior to publication of the notice of denial in the Federal Register (to be signed by either the Executive Director for Operations or the Secretary of the Commission).
(iv) Congressional letters (to be signed by the Director of the responsible office).
(v) A draft public announcement, if appropriate, and; (vi) An analysis and response to comments received on the petition.
(3) In preparing the Federal Register notice of denial of a petition, the assigned office shall ensure that each of the issues raised by the petitioner has been addressed. The NRC's response to each of the issues raised and the reasoning presented for denying the petition must be presented in a manner and with sufficient detail to indicate that the NRC has adequately considered each of the petitioner's requests. Each Federal Register notice of denial of a petition must include --
(i) A complete summary of each of the issues raised in the petition; l 214 September 1985 l
4 (ii) A sumary and analysis of any public coment received; (iii) NRC's response to each of the issues raised; and '
(iv) NRC's reasons for denying the petition.
(4) The ED0 is authorized to deny petitions for rulemaking concerning issues of a minor or nonpolicy nature where the grounds for denial do not substantially modify existing precedent (10 CFR 1.40(o)). Petitions that address major or policy issues require action by the Comission.
(5) When preparing a Federal Register notice of denial of a petition, the following format items are omitted from the Comission Paper and Federal Register notice --
(i) The standard statements concerning the regulatory analysis, Paperwork Reduction Act, Regulatory Flexibility Act, and National Environmental Policy Act; (ii) The. authority citation; and
- (iii) The list of subject index terms.
See 15.10 of this handbook for a sample denial of a petition for rulemaking.
_(c) Granting a petition for rulemaking. A petition or part of a petition is granted through issuance of a final rule that responds to the petitioner's request or other Comission action acceptable to the petitioner.
Other acceptable actions may include the issuance of a Regulatory Guide, Policy Statement, or legal interpretation.
(d) Incorporation of petition for rulemaking. When similar or related issues are involved, it is frequcntly possible to incorporate a petition or part of a petition into an ongoing rulemaking. This can be done provided that i
215 September 1985 V
three factors are taken into consideration. First, incorporation of the petition or part of the petition into an ongoing rulemaking may delay the completion of the rulemaking to an extent that is undesirable given the Commission's established priorities. Second, incorporation of the petition or part of the petition into an ongoing rulemaking could delay the resolution of the petitioner's request to the point that the delay in reaching a final decision on the merits of the petition amounts to a denial of the petition. Finally, the action to incorporate the petition should occur at a stage in the rulemaking that permits adequate consideration of the issue involved. If any of these factors exist, the petition or the part of a petition under review should be treated separately.
(e) Points to remember.
(1) Incorporation of a petition or part of a petition into an ongoing rulemaking does not cause the petition or its parts to lose the identity of a discrete agency action item that must eventually be withdrawn, denied, or granted. Incorporation, by itself, does not " grant" or
" complete" action on a petition for rulemaking. Also, the intermediate procedural or administrative steps and milestones used by NRC offices to control the processing of petitions for rulemaking (e.g., review, analysis, reports, studios, position papers, issuance of NUREGs series publications) do not " grant", " deny", or " complete" action on a petition or its parts. These steps are satisfied only as noted in paragraphs (a),
(b), and (c) of this section.
216 September 1985 i
(2) SECY maintains the official docket file on a petition for rulemaking. The assigned office should send a copy of all petition-related documents for inclusion in the official docket. The assigned office should also send a copy of petition-related documents to DRR so that DRR can monitor the current status of each ongoing action.
(3) A file of petitions for rulemaking that have been filed with the NRC is maintained in RPB, DRR. Documents concerning current petitions and petitions that have been completed through EDO or Commission action are published in the NRC Rules and Regulations. Questions concerning the status of any petition for rulemaking may be directed to the RPB, ext. 27086.
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PART 15 - SAMPLE DOCUMENTS Pase 15.1 Advance notice of proposed rulemaking............................ 266 15.2 Proposed rule.................................................... 273 15.3 Final ru1e....................................................... 282 15.4 Package prepared for ED0 signature............................... 294 15.5 Ex te n s i o n o f c onsne n t pe r i o d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307 15.6 Withdrawal of proposed rule...................................... 309 15.7 Withdrawal of advance notice of proposed rulemaking.. ... . . ... . . . . 312 15.8 Correction....................................................... 314 15.9 Notice of availability........................................... 316 15.10 Denial of a petition for rulemaking.............................. 317 15.11 Policy Statements................................................ 331
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265 September 1985
13.1 Advance notice of proposed rulemaking. [7590-01]
O NUCLEAR REGULATORY COMMISSION 10 CFR Part 50 Consideration of Degraded or Melted Cores in Safety Regulation AGENCY: Nuclear Regulatory Commission.
ACTION: Advance notice of proposed rulemaking.
SUMMARY
- The Nuclear Regulatory Commission is considering amending its regulations to determine to what extent commercial nuclear power plants should be designed to cope with reactor accidents beyond those considered in the current " design basis accident" approach. In particular, this rulemaking will consider the need for nuclear power plant designs to be evaluated against a range of degraded core cooling events and assess the need for design improve-ments to cope with these events and the resulting core damage. This advance notice of proposed rulemaking is being issued to invite advice and recommenda-tions on several questions concerning design and operational improvements for dealing with degraded core cooling.
l DATE: The comment period expires . Comments received l
after this date will be considered if it is practical to do so but assurance l
of consideration cannot be given except as to comments received before this date.
O 266 June 1984 l
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Approved For Publication In a final rule published March 19, 1982 (47 FR 11816), the Commission delegated to the ED0 (10 CFR 1.40(c) and (d)) the authority to develop and premulgate rules as defined in the APA (5 U.S.C. 551(4)) subject to the limi-tations in NRC Manual Chapter 0103, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213, 038, 039, and 0310.
The enclosed rule, entitled " Group Licensing for Certain Medical Uses," will amend Part 35 by adding to 10 CFR 35.100(f)(9) authorization to use a device for imaging with the low energy radiation from an iodine-125 sealed source.
l This final rule does not constitute a significant question of policy, nor does it amend regulations contained in 10 CFR Parts 7, 8, or 9 Subpart C. I there-t fore find that this rule is within the scope of my rulemaking authority and am proceeding to issue it.
Date William J. Dircks, Executive Director for Operations J
I 297 September 1985
Part 2 - The Federal Register Document. [7590-01]
NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 Group Licensing for Certain Medical Uses AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulations to add a device used for instantaneous imaging to its list of devices that may
~be used by licensed physicians. The hand-held devices uses the low energy radiation from an iodine-125 sealed source to produce images of bones or foreign bodies. NRC is adding the device to its list so that physicians, who are adequately trained and licensed to use similar devices, may use the device without having to amend their licenses.
EFFECTIVE DATE:
FOR FURTHER INFORMATION CONTACT: (Name of contact person), Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: (301) 492-4444.
SUPPLEMENTARY INFORMATION: On March 30, 1983, the Nuclear Regulatory Commission (the Commission) published i'i the Federal Register (48 FR 13189) a proposed rule to add a medical device to the group of devices listed in 6 35.100(f) of its regulations (Group VI). Group VI provides for the use of sources and O
298 . June 1984
Part 3 - Note for the Daily Staff Notes (final rule) or the Weekly Report
\ (proposed rule).
FOR A FINAL RULE:
DAILY STAFF NOTES OFFICE OF NUCLEAR REGULATORY RESEARCH Final Rule to be Signed by ED0_
On ,1985, the Executive Director for Operations approved a final rule that amends 10 CFR Part 35, " Human Uses of Byproduct Material," by adding a portable device containing Iodine-125 as a sealed source, used for bone imaging and foreign body detection, to the list of groups of authorized radioactive drugs, sources, and devices in 635.100(f). This action will enable NRC Group VI medical licensees to use this device without applying for a license amendn ent.
This constitutes notice to the Commission that, in accordance with the
' n rulemaking authority delegated to the EDO, the ED0 has received this final rule and proposes to forward it on tu the Office of the (U) Secretary for FR publication, unless otherwise directed by the Commission.
FOR A PROPOSED RULE:
WEEKLY REPORT TO THE COMMISSION OFFICE OF NUCLEAR REGULATORY RESEARCH Proposed Rule to be Signed by ED0 On ,1985, the Executive Director for Operations approved a proposed rule that would amend 10 CFR Part 35, " Human Uses of Byproduct Material,"
by adding a portable device containing Iodine-125 as a sealed source, used for bone imaging and foreign body detection, to the list of groups of authorized radioactive drugs, sources, and devices in 635.100(f). This action would enable NRC Group VI medical licensees to use this device without applying for a license amendment.
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305 September 1985
This constitutes notice to the Commission that, in accordance with the rulemaking authority delegated to the EDO, the E00 has received this proposed rule and proposes to forward it on to the Office of the Secretary for FR publication.
O 306 September 1985
15.10 Denial of a petition for rulemaking.
O Q- [7590-01]
NUCLEAR REGULATORY COMMISSION 10 CFR Part 71
[ Docket No. PRM-71-6]
Critical Mass Energy Project, et al., Denial of Petition for Rulemaking AGENCY: Nuclear Regulatory Commission.
ACTION: Denial of petition for rulemaking.
SUMMAF.Y: The Nuclear Regulatory Comission (NRC) is denying a petition for rulemaking (PRM-71-6) from Richard P. Pollock on behalf of the Critical Mass Energy Project, Congressmen Theodore S. Weiss (NY) and Timothy E. Wirth (CO),
and 11 citizen organizations. The petition is being denied on the basis that issues raised by the petitioners are being resolved as a result of actions taken since the petition was filed. The petitioners requested that the NRC adopt regulations in four areas pertaining to the transportation of radioactive materials. The NRC has carefully considered the issues raised in the petition, and has taken them into account in reaching a decision on the areas which fall within its jurisdiction.
ADDRESSES: Copies of the petition for rulemaking, the public comments received, and the NRC's letter of denial are available for public inspection or copying in the NRC Public Document Room,1717 H Street, NW, Washington, DC.
G 317 September 1985
FOR FURTHER INFORMATION CONTACT: (Name of Contact Person), Regulatory Analysis and Materials Risk Branch, Division of Risk Analysis and Operations, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 443-1010.
SUPPLEMENTARY INFORMATION:
The Petition By letter dated October 31, 1977, Mr. Richard Pollock, on behalf of the Critical Mass Energy Project; Congressman Theodore S. Weiss; Congressman Timothy E. Wirth; California Citizen Action Group; Community Action Research Group of Ames, Iowa; Environmental Action of Colorado; Massachusetts Public Interest Research Group; Michigan Public Interest Research Group; National Intervenors, Inc., New York Friends of the Earth; New York Public Interest Research Group; North Carolina Public Interest Research Group; Southwest Research and Information Center; and Vermont Public Interest Research Group, filed with the NRC a petition for rulemaking to amend NRC regulations.
The petitioners requested that the NRC adopt regulations that would, at a minimum, impose the following conditions on NRC licensees;
- 1. The use of special routes for the transportation of radioactive materials of all types to ensure that the shipments avoid densely populated areas and mountainous terrain.
- 2. The adoption of emergency plans for transportation accidents involving radioactive materials, including (a) the organization of emergency response ur.its to carry out the plans and (b) semiannual drills with local and State law enforcement officials.
318 September 1985
- 3. The assumption of financial responsibility for any shipping '
(3 v' accident that involves the dispersal of radioactive materials.
- 4. The adoption of a plan for informing drivers of vehicles about the nature of the materials they are shipping and about emergency actions they should undertake in the event of an accident.
Basis for Request As a basis for the requested action, the petitioner stated that experts both inside and outside the Federal government have concluded that there is a need for emergency response plans to protect the public in the event of an accident in transporting radioactive materials.
The petitioners also stated that although there has not yet been a transportation accident resulting in widespread injury to the public, the p experience of the September 27, 1977 accident in southeastern Colorado shows that the present system is " wholly inadequate to deal with the risk to the public health from a transportation accident, and regulations by the Comission are essential."
The petitioners further stated that the NRC requires nuclear power reactor licenses to adopt emergency response plans, but "there is no similar requirement for licensees of nuclear materials to be transported, even though a transportation accident would involve shippers [ meaning carriers or transporters] and localities wholly unfamiliar with radioactive materials."
(O V
i 319 September 1985
Public comments on the Petition A notice of filing of petition for rulemaking was published in the Federal Register on December 1, 1977 (42 FR 61089). Interested persons were invited to submit written comments or suggestions concerning the petition by January 30, 1978. The NRC received 40 comments in response to the notice:
35 from industry, industrial representative organizations, and industrial associations; three from individuals; and two from governmental agencies.
A majority of the commerters (34) opposed the petition. The main reasons cited by these commenters were:
- 1. The petitioners failed to provide sufficient safety, environmental, or legal justifications for implementing the actions proposed.
- 2. The implementation of the actions proposed would be extremely costly without corresponding public benefits.
- 3. Consideration should be given to transportation accidents for all hazardous materials, not just radioactive materials, and therefore, the Department of Transportation is the proper agency to address the overall transportation problem.
- 4. The current regulatory system is adequate to protect the public health and safety, and, therefore, it is unnecessary to implement the actions proposed.
Of the remaining six commenters, four suggested that the proposed actions exempt shipments containing small amounts of radioactive materials for medical, research, or industrial uses. The fifth commenter states that I
l the proposed actions should apply to all hazardous materials. The sixth 320 September 1985 l
l i
commenter disagreed with parts of the petition but suggested that action on the petition be deferred until NUREG/CR-0743 (Transportation of Radionuclides in Urban Environs: Draft Environmental Assessment) had been completed and issued for comment. The report was published in July 1980.
Staff Action on the Petition The response to the petition for rulemaking was delayed because of the following related actions: (1) After a truck accident in 1977 which resulted in a spill of yellowcake (uranium concentrate), the Department of Transportation (DOT) and the NRC conducted a special study on packaging integrity and emergency response to transportation accidents. Because the study included all four issues raised in the petition, the response to the petition was delayed pending the completion of the study. The study report was published in 1980; and (2) the DOT initialed a rulemaking proceeding on highway routing of radioactive materials in 1978. The NRC forwarded a copy of the petition and the public comments received to D0T for its consideration because one issue raised in the petition addressed highway routing of radioactive materials. D0T published its final rule in 1981, but this rule was challenged by the City and State of New York in Federal court. In February 1984, the rule was declared valid as originally promulgated. Each action affecting the petition is discussed below:
- 1. In June 1978, the NRC notified the petitioners that action on the petition would be delayed pending completion of a related NRC/ DOT study on packaging requirements for yellowcake (uranium concentrate) shipments and on emergency response to transportation accidents.
321 September 1985
This study was begun after a truck accident on September 27, 1977, near Springfield, Colorado, resulted in a spill of a large amount of yellowcake onto a highway. Members of the U.S. Congress representing the State of Colorado and other officials of that State expressed concern about the integrity of packages containing yellowcake and the emergency response to t.3nsportation accidents involving radioactive material. Representatives of NRC and D0T met with Congressman Timothy E. Wirth at his request. As a result of the discussions, the two agencies agreed to conduct a special joint study on package integri':y and emergency response to transportation accident. The study considered, among other things, all four areas addressed by the petitioners.
The study group published a draft report for comment in April 1979. The comeats received on this draft were incorporated in the final study group report, " Review and Assessment of Package Requirements (Yellowcake) and Emergency Response to Transportation Accidents" (NUREG-0535), which was published in July 1980.
- 2. In April 1979, the NRC notified the petitioners that a copy of the petition and the 40 public comments received had been transmitted to the Materials Transportation Bureau (MTB) of the 00T. Because the first part of the petition concerned the use of special routes for highway transportation of radioactive materials, the NRC believed that the petition and the comments received should be considered by MTB in its rulemaking proceeding on highway routing of radioactive materials.
The MTB published an Advance Notice of Proposed Rulemaking on highway routing of radioactive materials on August 17, 1978 (43 FR 36492). The notice stated that the MTB was considering promulgation routing requirements, 322 September 1985
i under the authority of the Hazardous Materials Transportation Act, for i
C/ highway carriers of radioactive materials. The MTB invited public comments on what Federal action would be justified. The large number of comments
, were reflected in the Notice of Proposed Rulemaking, published in the Federal Register January 31, 1980 (45 FR 7140). Public meetings on this proposed rule were held in several major cities. The final rule was
, published on January 19, 1981 (46 FR 5298), and was to become effective on February 1, 1982. (As a result of the litigation discussed below, the U.S. District Court stayed the effective date of the DOT rule until February 19, 1982.
, The final rule was challenged by the City of New York and the State of New York. On May 6, 1982, the District Court for the Southern District of 1
New York declared invalid, in part, the highway routing regulations ,
promulgated by the D0T. The DOT appealed the decision to the United States b Court of Appeals for the Second Circuit. On August 10, 1983, the Circuit '
Court reversed and remanded the matter to the District Court for entry of a Judgment upholding the DOT regulations. The City of New York and the State of New York then petitioned the United States Supreme Court for review of the Circuit Court's decision. On February 27, 1984, the Supreme Court denied the petition and refused to review the Circuit Court's decision. The result of the Supreme Court's action was to give validity to the D0T highway routing regulations as promulgated.
Reasons for Denial i
The petitioners' concern basically related to that portion of transportation when radioactive materials are in the care of the carriers.
The Congress has authorized both the NRC and tne DOT to regulate the lk 323 September 1985
transportation of radioactive materials. These two agencies have agreed, by Memorandum of Understanding (executed June 8, 1979), to partition their regulatory responsibilities. Generally, the 00T is responsible for review and approval of package designs for fissile materials and for other radioactive materials in quantities exceeding type A limits, as defined in 10 CFR Part 71.
The NRC has considered the petition, the public comments received, the conclusions reached by the NRC/00T study group, the DOT's rules on highway routing and financial responsibility, and other related information and has concluded that the issues raised in the petition have been substantively resolved by subsequent Federal action. The following discussions address each part of the petition.
Part 1: The use of special routes for the transportation of radioactive materials of all types to ensure that the shipments avoid densely populated areas and mountainous terrain.
This issue has been considered in a rulemaking proceeding by the 00T, which is the Federal agency with jurisdiction in this matter. The MTB of the DOT has conducted a rulemaking proceeding on highway routing of radio-active material shipments. As stated above, NRC provided MTB a copy of the petition and public comments received thereon for consideration in the rulemaking proceeding. The final rule was published on January 19, 1981, and became effective on February 19, 1982. The final rule was challenged by the 324 September 1985 l
City of New York and the State of New York and was upheld by the Second l Circuit Court of Appeals. On February 27, 1984, the U.S. Supreme Court refused to review the Circuit Court's decision. The result of the Supreme Court's action was to give validity to the D0T highway routing regulations as promu: gated.
The 00T rule requires carriers to use an interstate highway or an alternate " preferred route" that mi:1mizes radiological risk. The DOT rule was based in part on NRC advice and studies concerning transportation risks and was subject both to considerable public review and deliberation and to judicial scrutiny. The NRC does not believe it is necessary to require further restrictions beyond the DOT rule.
Part 2: The adoption of emergency plans for transportation accidents involving radioactive materials, incli! ding (a) the organization of emergency response units to carry out the plan and (b) semiannual drills with local and
, \
b State law enforcement officials.
The NRC considers the public health and safety to be adequately protected by current requirements for emergency response. Several crganizations are
- involved in emergency response to tra ,;ortation accidents: State and local personnel such as fire and police are responsible for emergency actions immediately following an accident; shippers are responsible for providing shipment hazard information; carriers are responsible for isolating and cleaning up the spilled radioactive materials; and certain Federal agencies are responsible for providing assistance to State and local governments. At the Federal level, the Federal Emergency Management Agency (FEMA) coordinates Federal assistance; the DOT and NRC provide assistance to FEMA; and the DOE maintains radiological assistance teams that respond to radiological 1
325 September 1985
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1 emergencies when requested. Ii. is not practicable nor necessary to require l l
shippers to duplicate the existing immediate emergency response capabilities l to respond to the scene of a transportation accident.
The NRC/D0T study group considered the question of carrier's and shipper's emergency plans for transportation accidents. The study group found that, in general, the carrier (transporter) is responsible for proper care of cargo in transit. In an accident, the carrier is responsible for notifying the shippers and government authorities, isolating any spilled material from the public, and clearing up any spilled material.
Because, in many cases, the carrier will have neither the technical expertise nor the experience and equipment to handle radioactive materials, the carrier may find it necessary to make arrangements with others to accomplish these duties. The carrier could make contractual arrangements with tne shipper or any other organization that is capable of handling cleanup activities. However, the basic burden of ensuring that these provisions are made remains with the carrier.
Under existing D0T regulations (49 CFR 177.861), the highway carrier is responsible for promptly notifying the shipper (licensee) and the Federal government of accidents; for isolating spilled radioactive material; and for ensuring that vehicles, buildingt, areas, or equipment in which radioactive material has been spilled are not used until the radiation dose rate of any accessible surface is less than 0.5 millirem per hour and there is no significant removable radioactive contamination on the surfaces.
The shipper, on the other hand, is required by D0T regulations to comply with all applicable provisions concerning packaging, labeling, marking, and otherwise preparing the goods for transportation. For hazardous materials, 326 September 1985
the shipper is required to certify on the shipping papers that the goods are C properly classified, described, packaged, marked, and labeled, and are in proper condition for transport (49 CFR 172.204). The shipper has no specific responsibilities for sending expert advice on the hazards of the shipment and any necessary precautions. However, because the shipper could be involved in a liability suit later, it may offer assistance in confirming and cleaning up spills from any accident involving its shipment, j Concerning the request for semiannual drills with local and State law enforcement officials, it is impractical and probably not cost-effective to
. require each shipper or carrier to conduct semiannual drills with local and State personnel in localities through which the shipment might travel.
However, the training of local and State first-on-the-scene responders (such as law enforcement, fire fighting, and rescue personnel) on handling transportation emergencies involving radioactive materials is important. The i 00T, with assistance from other Federal agencies, including the NRC, continues to develop and update guidance and training materials for first-on-the-scene responders. For these reasons, the NRC will not adopt the petitioners' suggestion concerning semiannual drills with local and State law enforcement officials.
f Part 3: The assumption by licensees of financial responsibility for any
, shipping accident that involves the dispersal of radioactive materials.
The NRC believes that the liability for damages should be determined by the courts considering both the appliqable State tort law and the particular circumstances associated with the accident.
327 September 1985
If the origin or destination of the radioactive material being trans-ported were a facility (for example, a nuclear power plant) for which the NRC required the licensee to have and maintain financial protection, the provisions of the Price-Anderson Act (Sec.170 of the Atomic Energy Act of 1954, as amended) would ensure a source of nc ds of up to $585 million for personal injury or property damage resulting 40m the transportation accident. The Price-Anderson Act does not preempt applicable State tort law, but in the event of an " extraordinary nuclear occurrence" a facility license may be required to waive certain defenses that would otherwise be available.
Section 30 of the " Motor Carrier Act of 1980" (Pub. L.96-296, as amended by Sec. 406 of Pub. L.97-424) requires the Secretary of Transportation, among other things, to establish regulations on minimum levels of financial responsi-bility for the transportation of ha: ardous materials by motor vehicles. The rule implementing this provision on minimum financial responsibility was published by D0T on June 11, 1981 (46 FR 30974) and subsequently amended on February 7, 1983 (48 FR 5560), on June 28, 1983 (48 FR 29699), and on July 2, 1984 (49 FR 27288). For radioactive materials, the minimum levels of financial responsibility are $1 million ($5 million effective January 1, 1985) for any vehicle transporting large quantities of radioactive materials and $500,000
($1 million effective January 1,1985) for transporting radioactive materials in other than large quantities.
Aside from the question of ultimate financial responsibility, the carrier should be prepared to assume the initial costs required to discharge its responsibilities in performing emergency response actions such as confining or cleaning up the spills. In terms of costs for emergency or protective actions that may be taken by the State or local governmental agencies, these 328 September 1985
i l agencies can reasonably be expected to be prepared to assume initial costs
_/
incurred as in other emergency situations such as fires and floods.
Part 4: A plan for informing the drivers of the vehicles about the nature of the material they are shipping and emergency actions they should undertake in the event of an accident.
The NRC considers existing 00T regulations for driver information to be adequate. Present D0T regulations require that a shipment of radioactive materials be accompanied by a description of each radionuclide contained in the shipment including: the name and radioactivity of each radionuclide, the physical and chemical forms, and other information regarding labels, external radiation levels, and fissile class (49 CFR 172.203). These requirements involve a system of labels for packages, placards for vehicles, shipping 3
paper descriptions, and other package markings.
In the final rule on highway routing of radioactive materials published by DOT in January 1981 (46 FR 5298), specific training requirements are mandated for persons transporting large quantities of radioactive materials.
The training includes, among other things, a requirement that the driver receive training on properties and hazards of the radioactive material i transported and procedures to be followed in case of accidents or other emergencies, i
In view of D0T requirements, there does not appear to be a need for NRC to require shippers to provide and carriers to maintain additional detailed emergency procedures for the driver to undertake in case of accident.
329 September 1985 s
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l Because each of the issues raised in the petition has been substantively resovled, the NRC has denied this petition.
Dated at Washington, DC this day of , 1985.
For the Nuclear Regulatory Commission.
Samuel J. Chilk, Secretary of the Commission.
O 330 September 1985
[
15.11 Policy statements.
[7590-01]
NUCLEAR REGULATORY COMMISSION Handling of Late Allegations; Policy Statement AGENCY: Nuclear Regulatory Commission.
ACTION: Policy statement.
SUMMARY
- This policy statement presents the criteria the Commission will follow in addressing late allegations received from sources outside the Commission in the context of licensing reviews. It also directs that the staff's procedures for notifying Atomic Safety and Licensing Boards, Atomic O Safety and Licensing Appeal Boards, and the Commission of the receipt of allegations be revised to provide for an initial, coarse screening prior to issuance of a Board Notification. The Commission is adopting this policy to ensure that all allegations important to safety are considered while preventing unnecessary delay in the licensing process.
EFFECTIVE DATE:
7')R FURTHER INFORMATION CONTACT: (Name of Contact Person), Office of the I Executive Legal Director, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: (301)492-0011.
331 September 1985 i
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SUPPLEMENTARY INFORMATION:
STATEMENT OF POLICY The purpose of this policy statement is to explain the policy which the Commission expects to follow regarding the treatment of late allegations received from sources outside the Comission in operating license reviews and in the board notification process. The focus of this statement is on NRC staff and Comission pre-licensing safety reviews of uncontested issues and Commission pre-licensing imediate effectiveness reviews of contested issues. The treatment of allegations in informal adjudicatory licensing proceedings will continue to be governed by the Rules of Practice in 10 CFR Part 2. Apart from this policy statement, the Comission has initiated a rulemaking to codify NRC case law criteria for reopening a closed evendentiary record in a formal licensing proceedino and to specify further the documentary bases for motions to reopen, including those which may be based on allegations (49 FR 50189; December 27,1984).
The most fundamental tenet flowing from the NRC's statutory mandate under the Atomic Energy Act is that a license may be issued only if it can be found that there is reasonable assurance that the activity to be authorized presents no undue risk to the health and safety of the public. There can be no abdication of the responsibility to make this determination and if there is i
l a serious question as to the ability to make this finding, a license may not be issued and the time necessary to resolve the question must and will be taken. Therefore, in the context of late allegations, it is necessary that dppropriate criteria be applied to enable the decision maker, be it the NRC's staff or the Comission itself, to expeditiously determine the significance, in terms of safe operation of the facility, of any allegations made.
l 332 September 1985 l
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In connection with its review of a number of recent cases, the NRC has O
( been confronted with the task of addressing large numbers of allegations which were brought to its attention very shortly before, and in some cases on the eve of, the date on which a decision on whether to authorize the issuance of an operating license was to be made. Some of these allegations related to matters in controversy and others related to previously uncontested issues not under consideration by a particular adjudicatory tribunal. Significant commitments of staff resources often must be diverted at the last minute to address large numbers of late allegations, many of which have proven to be unsubstantiated or of little, if any, safety significance.
Ideally, all allegations concerning a particular facility will be resolved before any license is authorized. If, however, because of the number of allegations or their tardy submission, all allegations cannot be resolved in a timeframe consistent with reasonable and responsible licensing action, it may be necessary to give priority to those allegations which, because of the potential impact on safety, must be resolved before licensing action can be taken.
Initial Screening of Allegations Any concerns bearing on the safety of a facility should be brought promptly to the attention of the applicant or licensee.1 If, however, this 1 The Commission encourages the establishment of programs by utilities for the propose of identifying and resolving allegations affecting safety in a timely manner as design and construction of a nuclear facility proceeds.
333 September 1985 o
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approach is unsatisfactory, any person is free to bring these concerns directly to the NRC. To eliminate unnecessary delay in the licensing process to the extent possible, any person who has an allegation concerning the design, construction, operation, or management of a nuclear power plant has a duty to bring the information to the Comission's attention as promptly as possible. All allegations should be specific and documented to the fullest extent possible. Those submitting allegations in good faith should be aware that appropriate protection against retaliatory action by an applicant or licensee (including its contractors and subcontractors) is afforded by Section 210 of the Energy Reorganization Act of 1974 (42 U.S.C. 5851). All parties and persons are reminded that Federal law imposes penalties upon any person who intentionally makes any false statement or representation to any agency of the United States.
In reviewing allegations, the appropriate commission staff office will first determine whether, if true, the allegations are material to the licensing decision in that they would require denial of the license sought, the imposition of additional conditions on the license, or further analysis or investigation. Allegations which, even if true, are not material to any licensing decision or which on their face or after initial inquiry are determined to be frivolous or too vague or general in nature to provide suf'icient information for the staff to investigate will receive no further consideration.
As to allegations which are material to the licensing decision, the Comission staff will next determine whether the information presented is new in the sense of raising a matter not previously considered or tending to 334 September 1985
{
corroborate previously received but not yet resolved allegations. In making this determination, all information available to the Commission will be considered, including that previously provided by an applicant or licensee and that obtained by the Commission in the course of its review and inspection efforts or from its investigation of prior allegations. In some cases, information already available to the NRC may be sufficient to resolve certain allegations. However, if an allegation is found to be both material and new, the staff will investigate the allegation further.
Further Review If the staff determines that, as a result of the number of allegations or the timeframe in which they are received, it appears likely that full consideration of all allegations cannot be accomplished consistent with responsible and timely Commission action, the Commission staff will conduct a further screening of the allegations to determine their significance to V safety and therefore what priority should be assigned relative to the activity to be authorized.2 The following screening criteria will be considered.
- 1. The likelihood that the allegation is correct, taking into /
consideration all available information including the apparent level of knowledge, expertise, and reliability of the individual submitting the allegation in terms of the allegation submitted and the possible existence of more credible contrary information.
2 As a general matter, the Commission has authorized issuance of operating licenses for low power testing (up to 5% of rated power) and subsequently for full power operation (operation above 5% of rated power). In some cases these steps have been further refined, for example, into fuel load, hot system 3 testing, criticality and zero power testing. Other refinements are possible and may be authorized.
d 335 September 1985
- 2. The need for prompt consideration of the allegation recognizing the public interest in avoiding undue delay. If the staff determines that an allegation raises a significant safety concern regardirig, for example, the design, construction, or operation of a facility or about quality assurance or control or management conduct, which brings into question the safe operation of the facility at a given stage of operation, the allegation must be addressed prior to authorizing that stage. For proposes of this policy statement, an allegation will be considered safety significant if the allegation would, if true, (1) raise a significant question about the ability of a particular structure, system, or component to perform its intended safety function or (2) raise a significant question of management competence, integrity, or conduct or about implementation of the quality assurance program sufficient to raise a legitimate doubt as to the ability to operate the plant safely. Allegations which are not safety significant will be resolved in the normal course of business independent of license issuance.
Board Notification Procedures Parties to ongoing adjudicatory proceedings have an obligation to bring allegations to the attention of the presiding board. All parties have an obligation to inform boards promptly of relevant and material information that may affect the decisionmaking process.
The Comission's staff, in accordance with its obligations for board notification has in the past submitted allegations to boards promptly and without awaiting their resolution or determination of significance relative to the decisionmaking process. This practice is consistent with the 336 September 1985 O
Comission-approved board notification policy. However, it has resulted, on
[
occasion, in presenting boards with new information, the significance of which
- is not readily apparent. Consequently, in the future, staff board notifications of allegations will not be made until the staff has made at least an initial screening of the allegations. Only those allegations which are found not to be frivolous, which are relevant and material to the decisionmaking process (as determined under existing board notification procedures), and which are determined to warrant further scrutiny will be submitted to the presiding tribunal. Board notification should still be made promptly, consistent with the need and time requiped for screening. The staff's board notification procedures should be revised accordingly.
! Dated at Washington, DC this day of , 1985.
i For the Nuclear Regulatory Comission.
) <
J Samuel J. Chilk, l l
Secretary of the Comission.
4 i
4 337 September 1985 1
_ . -. . -- _ .. _-. . _.. ._. - -.. -. . . .. _ - . _ = - ---- .
3 I
APPENDICES i A - Submitting Rulemaking Documents for Federal Register Publication.
I B - The Administrative Procedure Act (5 U.S.C. 551-553), i
- C - List of Subject Index Tenns.
i D - Regulatory History Procedures. !
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, _ , ., _ , ,,, , _ , , _ _ , , , . _ , ._ _ , _ .. , , _ ,n_,__, , _ , _ _ __ _ , . , - ,_,. _-- , _ . , , . _ _ _ . _ _ , . , _ ,
Appendix A - Submitting Rulemaking Documents for Federal Register Publication U
This appendix describes the information and procedures needed to prepare and submit the packages that are required when a rulemaking document is readied for publication in the Federal Register. The packages necessary to ensure the prompt, complete implementation of Commission and Executive Director for Operations (ED0) rulemaking actions are the Federal Register notice package and the Congressional letter package.
The staff office originating the rulemaking action is responsible for preparing the required packages. The originating office shall submit the packages required to complete action on a rulemaking action to the Rules and Procedures Branch, Division of Rules and Records (DRR), Office of Administration (ADM) (Mail stop: MNBB 4000). The required packages are normally submitted as follows:
L2 (1) If the rulemaking action was approved by the Commission and is to be signed by the Secretary of the Comission, the packages are submitted to DRR at least two working days before the response date indicated in the Staff Requirements Memorandum.
(2) If the rulemaking action was approved and signed by the ED0 under the rulemaking authority delegated to the EDO, the packages are submitted to DRR within 5 days of the ED0's signature.
THE FEDERAL REGISTER NOTICE PACKAGE Each package submitted to DRR for the transmittal of a rulemaking document for publication in the Federal Register must contain the items discussed below.
September 1985
(a) Transmittal memorandum.
The transmittal memorandum for the package is sent from the originating office to John Philips, Chief, Rules and Procedures Branch, DRR, ADM (see Sample 1). The memorandum should indicate, as appropriate, the following:
(1) The effective date for a final rule.
(2) The date by which coments must be received for an advance notice of proposed rulemaking or a proposed rule.
(3) Any places in the notice after the "DATE" line in the preamble where an effective date, a comment period expiration date, or any other date must be inserted before Federal Register publication.
(4) The need for expedited publication, if applicable.
(5) The need for special 0FR publication, such as printing the rule as a separate part of the Federal Register, if applicable.
(6) Whether DRR should dispatch Congressional letters to 0CA.
(7) Whether DRR should dispatch a public announcement to PA.
(8) Whether an Environmental Impact Statement, Regulatory Analysis, or other analysis is to be sent to the PDR.
(9) Whether a marked-up copy of Federal Register notice or errata sheet showing Commission-requested and other changes is enclosed for transmittal to the Office of the Secretary.
(10) Whether, in the case of a rule signed by the EDO, an item for the Daily or Weekly Information Report has been submitted to the EDO.
A-2 September 1985 O
(b) Federal Register notice.
The appropriate number _ of copies of the Federal Register notice to be included in the package depends upon the person who signs the notice.
(1) If the Federal Register. notice is to be signed by the Secretary of the Comission and the notice is --
(i) 14 or fewer pages, include the original and 3 copies of the notice; (ii) 15 or more pages, include the original and 6 copies.1 (2) If the Federal Register notice is signed by the Executive Director for Operations include the signed original and 5 copies of the notice; (c) Public announcement.
A public announcement, if appropriate, is prepared by the originating office in consultation with the Office of Public Affairs. Two copies of any Public Announcement must be received by DRR.
(d) Marked copy of rule.
A marked-up copy of the Federal Register notice that indicates any changes made to the rule after the Comission acted on it is prepared by the originating office. The changes may have been directed by the Comission or be necessary editorial and format corrections.
I The Office of the Secretary makes additional copies of the Federal Register notice after it is signed.
A-3 September 1985
(e) Letter requesting expedited publication.
A letter is sent to the Office of the Federal Register (0FR) requesting O
and justifying expedited publication if, because of exigent circumstances, expedited publication is necessary. Normal publication is three days after receipt by 0FR. The letter must fully indicate why expedited publication is necessary. The letter requesting expedited publication is addressed to Martha B. Girard, Director, Executive Agencies Division, Office of the Federal Register, Washington, DC 20408. The letter must accompany the document for which expedited publication is requested.
THE CONGRESSIONAL LETTERS PACKAGE Congressional letters must be prepared for every significant NRC rule in accordance with Section 303 of the Atomic Energy Act of 1954, as amended, to keep the Congress " fully and currently informed." (See Sample 2 for a list of the current standard addressees in Congress). The office preparing the rulemaking package is responsible for identifying the Congressional oversight comittees that must be notified of this action. Congressional letters (see Sample 3) are signed by the Office Director but are not dated so that the Director, Office of Congressional Affairs, may review, date, and transmit the letters to appropriate Members of Congress. The Congressional package for each rulemaking action forwarded for Federal Register publication must contain the following items:
- 1. One original letter plus enclosures 2to the Chainnan of each Congressional Comittee with oversight responsibility for the rule; 2 Enclosures usually consist of the federal Register notice and the Public Announcement.
A-4 September 1985
- 2. One copy of the original letter to the Chairman plus enclosures 2
(}~T
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to the ranking minority member of each appropriate Congressional Committee with oversight responsibility for the rule;
- 3. One original and three copies of the concurrence page for only one of the Congressional Committee letters. On the concurrence page type:
" Identical letters sent to (and list the remaining Congressional Committees Chairman and ranking minority members)."
USE OF TERM FEDERAL REGISTER Any reference to the Federal Register publication in an NRC ruleraaking document published in the Federal Register or in the accompanying Commission paper or its enclosures is typed in initial caps only and is not underlined.
The proper reference to the publishing organization is the Office of the Federal Register (OFR). (Note that when used in typewriter-prepared publications other than those mentioned above, it is NRC practice to underline the name of the publication (Federal Register). This indicates that the words will appear in italics in a typeset document.)
A-5 September 1985
Sample 1 - The transmittal memorandum.
O MEMORANDUM FOR: John Philips, Chief Rules and Procedures Branch Division of Rules and Records Office of Administration FROM: F. P. Gillespie, Director Division of Risk Analysis and Operations Office of Nuclear Regulatory Research
SUBJECT:
IMPLEMENTATION OF COMMISSION ACTION: PROPOSED NEW 10 CFR PART 39 By memorandum dated February 28, 1985, the Secretary of the Commission indicated that the Comission (with all Comissioners agreeing) has approved the proposed rule on well-logging set out in SECY-85-11, subject to resolving OPE coments of January 30, 1985.
Please implement the Commission's sction by arranging for publication of the enclosed proposed rule in the Federal Register allowing 90 days for public comment.
Enclosed is a marked-up copy of the Federal Register notice showing Comission-requested and other changes for transmittal to the Office of the Secretary.
Also enclosed is a Congressional letter package for transmittal to OCA and two copies of the public announcement for transmittal to PA.
In addition, enclosed are copies of the environmental assessment and finding of no significant impact and the draft regulatory analysis for transmittal to the PDR.
F. P. Gillespie Director Division of Risk Analysis and Operations Office of Nuclear Regulatory Research
Enclosures:
- 1. FR Notice and 5 Copies
- 2. Marked-up Copy of FR Notice
- 3. Congressional Letter Package
- 4. Environmental Assessment
- 5. Draft Regulatory Analysis A-6 September 1985 i
Sample 2 - List of standard Congressional addressees.
\
The Honorable Edward J. Markey, Chairman Subcommittee on Energy Conservation and Power Committee on Energy and Commerce United States House of Representatives Washington, DC 20515 cc: The Honorable Carlos Moorhead The Honorable Alan Simpson, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510 cc: The Honorable Gary Hart The Honorable Morris K. Udall, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States-House of Representatives Washington, DC 20515 cc: The Henorable Manuel Lujan 1329 LH08 i
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A-7 September 1985
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Sample 3 - Congressional letter.
O The Honorable Alan Simpson, Chairman Subcommittee on Nuclear Regulation Comittee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
The NRC has sent to the Office of the Federal Register for publication the enclosed proposed amendment to the Comission's rules in 10 CFR Part 50. The amendment, if adopted, would require licensees of nuclear power plants for which an operating license has been granted to establish, document, and implement procedures to ensure that personnel with unescorted access to protected areas are not under the influence of drugs, alcohol, or otherwise unfit for duty because of mental or temporary physical impairments that could affect their performance in any way contrary to safety.
The Commission is issuing the proposed rule for public comment and has specifically requested comments with respect to the scope, level of specificity, and methods of implementation of the rule.
Sincerely, O
Robert 8. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
As stated cc: Senator Gary Hart i
l A-8 September 1985 l
Appendix C - List of Subject Index Terms.
LJ Part 0 - Conduct of Employees Conflict of interest Penalty Part 1 - Statement of Organization and General Information Organization and functions Part 2 - Rules of Practice for Domestic Licensing Proceedings Administrative practice and procedure Antitrust Byproduct material Classified information Environmental protection Nuclear materials Nuclear power plants and reactors Penalty Sex discrimination Source material Special nuclear material Waste treatment ar.d disposal Part 4 - P' adiscrimination in Federally Assisted Comission Programs s
Administrative practice and procedure Civil rights Federal aid programs Handtcapped Reporting and recordkeeping requirements Part 7 - Advisory Comittees Advisory comittees Sunshine Act Part 8 - Interpretations Government contracts Insurance Intergovernmental relations Inventions and patents Nuclear power plants and reactors September 1985 O
Part 9 - Public Records Freedom of informatior Penalty Privacy Reporting and recordkeeping requirements Sunshine Act Part 10 - Criteria and Procedures for Determining Eligibility for Access ~
to Restricted Data or National Security Information Administrative practice and proceduie Classified information Government employees Security measures Part 11 - Criteria and Procedures for Determining Eligibility for Access to or Control Over Special Nuclear Material Hazardous materials - transportation Nuclear materials Reporting and recordkeeping requirements Security measures Special nuclear material Part 14 - Administrative Claims Under Federal Tort Claims Act Administrative practice and procedure Tort claims Part 15 - Debt Collection Procedures Administrative practice and procedure Debt collection Part 19 - Notices, Instructions and Reports tc Workers; Inspections Environmental protection Nuclear materials Nuclear power plants and reactors Occupational safety and health Penalty Radiation protection Reporting and recordkeeping requirements Sex discrimination Part 20 - Standards for Protection Against Radiation Byproduct material Licensed material Nuclear materials Nuclear power plants and reactors Occupational safety and health Packaging and containers Penalty C-2 September 1985
Radiation protection Reporting and recordkeeping requirements Special nuclear material Source material Waste treatment and disposal Part 21 - Reporting of Defects and Noncompliance Nuclear power plants and reactors Penalty Radiation protection Reporting and recordkeeping requirements Part 25 - Access Authorization for Licensee Personnel Classified information Investigations Penalty Reporting and recordkeeping requirements Security measures Part 30 - Rules of General Applicability to Domestic Licensing of Byproduct Material Byproduct material Government contracts Intergovernmental relations O Isotopes Nuclear materials Penalty Radiation protection Reporting and recordkeeping requirements Part 31 - General Domestic Licenses for Byproduct Material Byproduct material Labeling Nuclear materials Packaging and containers Penalty Radiation protection Reporting and recordkeeping requirements Scientific equipment Part 32 - S)ecific Domestic Licenses to Manufacture or Transfer Certain Items Containing lyproduct Materials Byproduct material Labeling C-3 September 1985
Nuclear materials Penalty Radiation protection Reporting and recordkeeping requirements Part 33 - Specific Domestic Licenses of Broad Scope for Byproduct Material Byproduct material Nuclear materials Penalty Radiation protection Reporting and recordkeeping requirements Part 34 - Licenses for Radiography and Radiation Safety Requirements for Radiographic Operations Packaging and containers Penalty Radiation protection Radiography Reporting and recordkeeping requirements Scientific equipment Security measures Part 35 Human Uses of Byproduct Material Byproduct material Drugs Health facilities Health professions Incorporation by reference Medical devices Nuclear materials Occupational safety and health Penalty Radiation protection Reporting and recordkeeping requirements Part 39 - Licenses and Radiation Safety Requirements for Well-Logging Operations Byproduct material Nuclear material Oil and gas exploration - well logging Penalty Reporting and recordkeeping requirements Scientific equipment Security measures Source material Special nuclear material C-4 September 1985
Part 40 - Domestic Licensing of Source Material Government contracts Hazardous materials - transportation Nuclear materials Penalty Reporting and recordkeeping requirements Source material Uranium Part 50 - Domestic Licensing of Production and Utilization Facilities Antitrust Classified information Fire protection Incorporation by reference Intergovernmental relations Nuclear power plants and reactors Penalty Radiation protection Reactor siting criteria Reporting and recordkeeping requirements Part 51 - Licensing and Regulatory Policy and Procedures for Environmental Protection Administrative practice and procedure Environmental impact statement Nuclear materials Nuclear power plants and reactors Reporting and recordkeeping requirements Part 53 - Criteria and Procedures for Determining Adequacy of Available Spent Nuclear Fuel Storage Capacity Administrative practice and procedure High-level waste Nuclear materials Nuclear power plants and reactors Reporting and recordkeeping requirements Spent fuel Waste treatment and disposal Part 55 - Operators' Licenses Manpower training programs Nuclear power plants and reactors Penalty Reporting and recordkeeping requirements l
C-5 September 1985 I
Part 60 - Disposal of High-Level Radioactive Wastes in Geologic Repositories High-level waste Nuclear power plants and reactors Nuclear materials Penalty Reporting and recordkeeping requirements Waste treatment and disposal Part 61 - Management and Disposal of Low-level Wastes by Shallow Land Burial and Alternative Disposal Methods Low-level waste Nuclear materials Penalty Reporting and recordkeeping requirements Waste treatment and disposal Part 70 - Domestic Licensing of Special Nuclear Material Hazardous materials - transportation Nuclear materials Packaging and containers Penalty Radiation protection Reporting and recordkeeping requirements Scientific equipment Security measures Special nuclear material Part 71 - Packaging of Radioactive Material for Transport and Transportation of Radioactive Material Under Certain Conditions Hazardous materials - transportation Nuclear materials Packaging and containers Penalty Reporting and recordkeeping requirements Part 72 - Licensing Requirements for the Storage of Spent Fuel in an Independent Spent Fuel Storage Installation (ISFSI)
Manpower training programs Nuclear materials Occupational safety and health Reporting and recordkeeping requirements Security measures Spent fuel C-6 September 1985
- Part 73 - Physical Protection of Plants and Materials Hazardous materials - transportation Incorporation by reference Nuclear materials Nuclear power plants and reactors Penalty Reporting and recordkeeping requirements Security measures Part 74 - Material Control and Accounting of Special Nuclear Material Accounting Hazardous materials - transportation Material control and accounting Nuclear materials Packaging and containers Penalty Radiation protection Reporting and recordkeeping requirements Scientific equipment Special nuclear material Part 75 - Safeguards on Nuclear Material - Implementation of US/IAEA Agreement Intergovernmental relations Nuclear materials Nuclear power plants and reactors Penalty Reporting and recordkeeping requirements Security measures Part 81 - Standard Specifications for the Granting of Patent Licenses Administrative practice and procedure Inventions and patents Part 95 - Security Facility Approval and Safeguarding of National Security Information and Restricted Data Classified information Penalty Reporting and recordkeeping requirements Security measures Part 100 - Reactor Site Criteria Nuclear power plants and reactors Reactor siting criteria C-7 September 1985 v
Part 110 - Export and Import of Nuclear Equipment and Material Administrative practice and procedure Classified information Export Import Incorporation by reference Intergovernmental relations Nuclear materials Nuclear power plants and reactors Penalty Reporting and recordkeeping requirements Scientific equipment Part 140 - Financial Protection Requirement and Indemnity Agreements Extraordinary nuclear occurrence Insurance Intergovernmental relations Nuclear materials Nuclear power plants and reactors Penalty Reporting and recordkeeping requirements Part 150 - Exemptions and Continued Regulatory Authority in Agreement States and in Offshore Waters Under Section 274 Hazardous materials - transportation Intergovernmental relations Nuclear materials Penalty Reporting and recordkeeping requirements Security measures Source material Special nuclear material Part 160 - Trespassing on Commission Property Federal buildings and facilities Penalty Security measures Part 170 - Fees for Facilities and Materials Licenses and Other Regulatory Services Under the Atomic Energy Act of 1954, as amended Byproduct material Nuclear materials Nuclear power plants and reactors Penalty Source material Special nuclear material C-8 September 1985
Appendix D - Regulatory History Procedures.
O In a memorandum dated April 5,1985, the Executive Director for Operations (ED0) established procedures for the compilation of a complete regulatory history for each rulemaking action. The regulatory history is necessary to ensure that all documents of central relevance to a rulemaking proceeding are identified and accessible. The regulatory history procedures apply to each proposed or final rule submitted for publication in the Federal Register after April 5,1985.
(a) The office originating the rulemaking action is responsible for identifying and maintaining the documents that will comprise the regulatory history. The originating office shall include all documents of central relevance to the factual basis, coverage, meaning, and historical development of the rulemaking action.
(1) The originating office shall include the following types of documents in the regulatory history of a proposed or final rule:
(i) The Office of Nuclear Regulatory Research (RES) Independent Review Package (containing the RES recommendations on whether to proceed with the rulemaking, the sponsoring Offices's recommendation to proceed with rulemaking, and the evaluation of the rulemaking proposal against the six criteria required fortheRESIndependentReview).
(ii) Prior drafts of the rulemaking transmitted for interoffice review.
September 1985 o
(iii) Formal office coments on the drafts submitted for interoffice review.
(iv) Source documents relied upon in preparing the draft rule (for example, research studies or consem us standards endorsed in the draft rule).
(v) Documents which synthesize or organize data in a form relied upon in the draft rule.
(vi) Supporting documentation such as the regulatory analysis, the Cost Analysis Group Report, environmental assessment or environmental impact statement, regulatory flexibility analysis, and OMB Clearance Package.
(vii) Public comments submitted in response to a Petition for Rulemaking, an Advanced Notice of Proposed Rulemaking, or a Notice of Proposed Rulemaking.
(viii) Comittee to Review Generic Requirements (CRGR) minutes and recomendation concerning the draft rule.
(ix) ACRS coments on the draf t rule.
(x) The Comission Paper transmitting the draft rule to the Comission or the memorandum transmitting the rule to the E00 for approval.
(xi) Tne transcript or summary of the Commission meeting or briefing on consideration of the draft rule.
(xii) The Staff Requirements memo containing the Commission recommendations on the draft rule.
(xiii) The Federal Register Notice of the rule (Petition for Rulet..aking, Advanced Notice of Proposed Rulemaking, Notice of Proposed Rulemaking, Final Rule, or any other Federal Register notice issued concerning the rule).
(xiv) Any other documents of central relevance (for example, correspondence, agreement state correspondence).
D-2 September 1985
t g (2) In some instances, the originating office will need to use its judgement in determining whether a specific document is of central relevance to a rulemaking proceeding.
(3) Documents that meet the criteria set out in paragraph (a)(1) of this section must be typewritten rather than handwritten. This is necessary to permit conversion into microfiche for use in the Document Control System (DCS). If the only record of substantive office review coments on a draft s rule takes the form of handweitten annotations on the draft itself, the originating cffice shall summarize these comments in a typed note to the file.
(b) After a proposed or final rule is published in the Federal Register, the originating office shall compile an index of the documents that comprise the regulatory history of the proceeding.
(1) The originating office shall identify the DCS accession number or the appropriate bibliographic information for each document listed in the regulatory history index.
(i) The originating office shall ascertain whether each internal document listed in the regulatory history index is available in the DCS. If an internal document is not available, the originating office shall place the document in the DCS. The originating office shall identify each document contained in the DCS by the record's accession number in the regulatory history index.
(ii) If the document is published separately, for example a NUREG, NTIS publication, book, or article, the originating office shall include the appropriate bibliographic citation for the document.
D-3 September 1985 l
(2) Within 60 days after the proposed or final rule is published in the Federal Register, the originating office shall forward the completed index to the Rules and Procedures Branch, Office of Administration (RPB). The originating office shall use the title of the rule and the applicable CFR citation (for example, 10 CFR Part 50) appearing in the Federal Register notice as the title of the regulatory history file and index. The title must also include the complete Federal Register citation for the published proposed or final rule (for example, 50 FR 12345; February 20,1985).
(c) RP8 is responsible for ensuring that a completed index of documents comprising the regulatory history has been prepared for each proposed or final rule. RP8 shall retain the completed each completed index and disseminate copies of any index to interested NRC offices.
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, INDEX TO THE NRC REGULATIONS HANDBOOK t i Action, preamble caption:
- F i n a l ru 1 e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 6 - 10 7 P ro po s e d ru l e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 6 - 2 7 i Action verbs. See Verbs.
Active / Passive voice. See Verbs, i
Addresses, preamble caption:
Final rule..................................................... 109 - 110 P ro po s e d ru l e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 9 - 3 0 l
Administrative Procedure Act (APA):
Authority citations, short form................................. 67, 150 Deferred ef fective date , waiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119b - 119d -
Description........................................................... 4 Notice and comment provisions , requi rements. . . . . . . . . . . . . . . . . . . . . . . . . . 14 Notice and comment provisions , wai ver. . . . . . . . . . . . . . . . . . . . . . . 119a - 119d i Pe ti ti ons fo r rul ema ki n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 l . Policy statements................................................ 16, 97
- Text.......................................................... Appendix B
- Advance notices of proposed rulemaking
Authority citati.ons, placement...................................... 185 Description................................................. 15, 178, 179
- Preamble format requirements................................... 182 - 183
! Sample document................................................266 - 272 Text.......................................................... 186 - 188 Wi thdrawal of, sampl e document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 312 - 313
)
Agency, preamble caption:
F i n a l r u l e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 Proposed rule........................................................ 26 j Agenda. See Regulatory agenda, i
Amendatory language:
Description and use...................................56 - 62, 139 - 145 Se c t i o n l e v e l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 0 , 14 3
- Te rms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6 - 6 0 , 13 9 - 14 3 i
Applications. See Information collection.
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j September 1985
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Arrangement. See Organization.
Asterisks in regulatory text...............................81 - 82, 164 - 165 Authority citations:
Content.................................................64, 66, 147, 149 Ge ne ra l re q u i reme n t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63, 14 6 Notice documents............................................... 192 - 193 Placement...........................61, 64 - 66, 82, 144, 147 - 149, 165 Section specific citations............................66 - 67, 149 - 150 Short-form citation..............................67 - 68, 150 - 151, 185 Availabil i ty of NRC publ ications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34, 119
.C-Certification statement. See Regulatory flexibility analysis.
Chapters, CFR, description........................................... 69, 152 Code of Federal Regulations (CFR):
Description........................................................... 6 Structure..........................................6, 69 - 74, 152 - 157 Code of Federal Regulations (CFR), amendment of:
Full text........................................................ 75, 158 Genera 1............................. 56, 60 - 62, 69, 139, 141 - 143, 152 Part leve1............................................ 87 - 88, 170 - 171 Section level......................60 - 61, 80 - 86, 143 - 144, 163 - 169 S u b p a r t l e v e l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 , 171 Codification system.........................................69 - 71, 152 - 154 Coment analysis:
Final rule...................................................... 113 - 119 Proposed rule......................................................... 34 Coment period extens ion , sample document. . . . . . . . . . . . . . . . . . . . . . . . . . . 307 - 308 Commission........................................................... 10 - 12a C om i s s i o n me e t i n g s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 C o m i s s i o n p a p e r . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Conditions...........................................................247 - 248 Correction documents:
Headings............................................................. 196 Preamble format requirements......................................... 196 Procedure............................................... 17, 98, 195 - 196 Sample document............................................ 197, 314 - 315 September 1985 l
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Cross references:
) Format.......................................................... 90, 173 s Organ iza t i on , e f fec t on. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89, 172, 231 Use....................................... 89 - 90, 172 - 173, 231 - 232
_D Dates, preamble caption:
Final rule..................................................... 108 - 109 Proposed ru1e................................................... 28 - 29 Defini tion section; paragraph designation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 73, 156
_E -
Effective dates:
Administrative Procedure Act requirements................... 119b - 119d Delayed provisions.................................................. 109 Final rule..................................................... 108 - 109 Notice documents.................................................... 193 Preamble reouirement. See Dates.
Environmental impact:
Assessment............................................38 - 39, 123 - 124
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Ca tegorical excl usion. . . . . . . . . . . . . . . . . . . . . . . . . . . . 39a - 39b, 124a - 124b
/
) Final rule, preamble statement................................ 122 - 124b Finding of no significant impact. . . . . . . . . . . . . . . . . . . . . 38 - 39, 123 - 124 Proposed rule, preamble statement.............................. 37 - 39b Statements......................................... 37 - 39b, 122 - 124b Executive Director for Operations (ED0):
Approval of rulemaking actions........................................ 8 Conflict resolution.................................................. 11 Petitions for rulemaking, deficiency determination.................. 204 Preparation of signature package, sample document............. 294 - 306 Ru l ema k i n g a u tho ri ty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11, 294
_F.
Federal Register (FR):
Description........................................................... 7 Procedures for preparing package for publication. . . . . . . . . . . . . . A Publication categories.........................................ppendix .. 14, 96 A Final rules:
Description.......................................................... 96 Preambl e forma t requi rements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 - 110 Publ i ca ti on ca tego ry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Related documents.................................................... 97 Sample document......................................99 - 103, 282 - 293 Supplementary information, preamble caption. . . . . . . . . . . . . . . . . . 111 - 119d September 1985
Footnotes.................................................. 75 - 76, 158 - 159 For Further Information Contact, preamble aption:
F i n a l r u l e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 10 Proposed rule........................................................ 30 Full text amendment. See Code of Federal Regulations (CFR), amendment of.
_H Headings:
Advance notice of proposed rulemaking.......................... 180 - 181 CFR units..................................77 - 79, 160 - 162, 226 - 228 Correction documents................................................ 196 Descriptive headings, organizational tool. 32 - 33,112 - 113, 226 - 228 Final rule..................................................... 104 - 105 Notice documents............................................... 190 - 191 Proposed rule................................................... 24 - 25 Strategic repetition..................................78, 161, 227 - 228 Thesaurus of, Indexing Terms, 0FR................................ 77, 160 Hearings. See Meetings and hearings.
Hyphenated numbers; numbers with alpha characters......... 73 - 74, 156 - 157
_I Incorporation by reference (IBR):
Availability of material........................................ 92, 175 De f i n i t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89, 91, 172, 174 Drafting text.........................................92 - 93, 175 - 176 L e g a l e f f e c t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91, 17 4 Requirements..........................................91 - 93, 174 - 176 Index' terms. See List of subject index terms.
Information collection:
Document preparation, consultation, and assistance.............. 43, 129 Final rule, preamble statement................................. 126 - 129 OMB approval......................35 - 36, 40 - 41, 120 - 121, 125 - 129 Proposed rule , preamble sta tement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 - 43 Interim rules........................................................ 96 - 97 September 1985 G
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Legalisms and legal word pairs......................................260 - 261 List of subject index terms. . . . . . . . . . . . . . . . 54, 77, 137, 160, 184, Appendix C Listing, organizational technique............................. 240, 244 - 246 Logical outgrowth standard............................................... 114 M
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! "May".............................................................. 251 - 252 lt 1
"May not"...........................................................251 - 252 l Meetings and hearings: .
Notices section of FR, publication.................................. 190 t Proposed rules section of FR, publication............................ 16 t i
1 "Must"............................................................. 251 - 252
- N [
National Environmental Policy Act (NEPA)....... 35, 37 - 39b, 120, 122 - 124b i
Notice documents: ;
- Authority citations............................................ 192 - 193 Cross references.......'........................................ 193 - 194
, Description......................................................... 190 j Document text.................................................. 191 - 194 i Effective date...................................................... 193 i Preamble format requirements; optional.............................. 191 i Sample document........................................... 191 - 192, 316 i
Notices of intent. See Advance notices of proposed rulemaking.
4 Nouns, singular / plural................................................... 263
. Office of Management and Budget (OMB). See Information collection.
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Office of the Federal Register (0FR); requirements:
Ame n d a t o ry l a n g u a g e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6, 13 9 Amending regulatory text................................56, 69, 139, 152 Correction documents........................................... 195 - 196 Document classification............................ 14 - 16, 96 - 97, 179 Headings........................................................ 25, 105 Incorporation by reference........................... 91 - 93, 174 - 176 List of subject index terms.................................54, 137, 184 P rea mbl e fo rma t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26 - 30, 106 - 110, 182 Organization (writing techniques):
Aud i ence .i den ti fi ca t i on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223 General to specific method.....................................224 - 225 Planning for expansion........................... 74 - 75, 157 - 158, 233 Pl a nn i n g t h e doc ume n t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 3 Ro a d ma p p ro v i s i o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 28 Testing document structure.....................................226 - 230
_P Paperwork Reduction Act:
De s c r i p t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 0, 12 5 Requirements..........................................40 - 43, 125 - 129 Paperwork reduction. See Information collection.
Paragraphs, CFR:
Description..................................................... 70, 153 Headings........................................................ 79, 162 Le n g th a n d s tru c tu re . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 9 Subdivision............................................ 70, 73, 153 - 156 Parts, CFR:
Description..................................................... 69, 152 Headings........................................................ 77, 160 Structure......................................................234 - 238 Passive voice. See Verbs.
Petitions for rulemaking:
Completion of action.................................209, 211, 213 - 216 Continuing contact with petitioner, staff responsibility..... 210 - 211 De fi c i ency de te rmi na t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204 Denial of, description.........................................213 - 215 De n i a l o f , s ampl e doc ume n t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .317 - 330 Description................................................ 15, 200 . 202 Fast-track determination.......................................205 - 207 September 1985
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s Petitions for rulemaking, continued:
, ) Fast-track processing............................................... 208 V Granting of......................................................... 215 Incorporation into ongoing rulemaking. . . . . . . . . . . . . . . . . . . . . . . . . 215 - 216 Prel imi nary contact wi th peti tioner. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 Prel imi na ry proces s i ng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202 Processing after publ ication for comment. . . . . . . . . . . . . . . . . . . . . . 210 - 212 Publ ica ti on fo r comme n t. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209 Receipt........................................................202 - 203 Requirements...................................................202 - 203 Rou ti ne p roc es s i n g. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209 S u bm i s s i o n t o N R C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 01 Threshold determination.........................................202, 204 W i t h d r a wa l o f . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : . . . . . . . . . . . . . . . . . . . . . . 213 Policy Statement:
F i n a l ru l e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 7 - 9 8 Proposed rule................................................... 16 - 17 Sample document................................................331 - 337 Prepositions and prepositional phrases................................... 256 Present tense. See Verbs.
Proposed rules:
Description...................................................... - 15
, n Preamble forma t requi rements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 - 30
(
Pu b l i c a t i o n c a t e g o ry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 - 15 Re l a te d doc u me n t s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 - 15 Sample document....................................... 18 - 23, 273 - 281 Supplementary information, preamble caption. . . . . . . . . . . . . . . . . . . . 31 - 34a Withdrawal of, sample document.................................309 - 311
, R Recordkeeping. See Information collection.
Recordkeeping and reporting provisions, placement. See Information collection.
Regulations. See Final rules.
Regulatory Agenda.................................................... 16, 212 Regulatory Analysis:
Content...............................................44 - 46, 130 - 132 Description...................... 35 - 36, 44 - 46, 120 - 121, 130 - 132
- Fi nal rul e , preambl e s tatement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 Proposed rule, preamble statement.................................... 46 Related analyses.............................36, 45 - 46, 121, 131 - 132 Regulatory Flexibility Act. . . . . . . . . . . . . . . . . . . . . . 36, 47 - 53, 121, 133 - 136a V
September 1985
Regulatory flexibility analysis:
Ce r t i f i ca t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48, 50 - 51, 134 - 135 Content...............................................51 - 53, 135 - 136 Description..................................35 - 36, 47, 120 - 121, 133 Document preparation, consultation, and assistance. . . .. . . 53,136 - 136a Final rule, preamble statement................................. 134 - 135 Proposed rule , preambl e sta temen t. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 - 51 Related analyses........................................36, 47, 121, 133 Regulatory history procedures...................................... Appendix D Regulatory text............................................69 - 79, 152 - 162 Reporting. See Information collection.
R u l e ma k i n g , N R C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 - 12 b Rulemaking petitions. See Petitions for rulemaking.
Rules and regulations. See Final rules.
_S_
Sections, CFR:
Description...........................................70, 153, 234 - 235 Headings.............................................. 77 - 79, 160 - 162 Subdivision. See Paragraph.
Sentences:
Length and structure...........................................240 - 241 Construction...................................................242 - 243 "Shal1"............................................................ 251 - 252 Stars in regulatory text. See Asterisks in regulatory text.
Statement of consideration. See Supplementary information, preamble caption.
Subchapters, CFR, description..............................69 - 70, 152 - 153 Subparts, CFR, description..................... 69 - 70, 152 - 153, 234 - 238 l
l Summary, preamble caption:
Finalrule..................................................... 107 - 108 l
Proposed rule................................................... 27 - 28 l Supplementary information, preamble caption:
Final rule.................................................... 111 - 119d Proposed rule.................................................. 31 - 34a Suspended provisions.............................................59 - 60, 143 September 1985
1 4
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s Table of contents 4 Genera 1......................................................... 32, 112 Part level............................................87 - 88, 170 - 171 4
Temporary rules. See Interim rules.
)
i Ti tl es , CFR , de scri ption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69, 152
! _U i Underlining:
Paragraph designations.......................................... 70, 153 Pa ra g ra p h he a d i n g s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 9, 16 2 Y
1 1
Value/ Impact. See Regulatory analysis.
e i
! Verbs: !
Action verbs.................................. ..................... 250 l Active voice / passive voice.......................................... 249 1 Imposing an obligation to act..................................251 - 252 l
Present tense....................................................... 250 -
W 4
Words:
Ambiguity......................................................262 - 263 Consistency......................................................... 253 Clusters.......................................................256 - 257 i Concrete.......................................................253 - 254 ;
l Familiar............................................................ 254 r j Jargon.........................................................258 - 259 l Modifiers, placement...........................................262 - 263 i
0rder............................................................... 262 i Pairs............................................................... 255 l Redundancy.......................................................... 255 ,
! 1
, Words of issuance:
l Final rule.......................................................... 138 l Proposed rule........................................................ 55 l t
Words to avoid...........................................255 - 257, 260 - 261 1
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