cfr_sections
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63 rows where part_number = 820 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 10:10:5.0.2.5.25.1.16.1 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.1 Purpose and scope. | DOE | [58 FR 43692, Aug. 17, 1993, as amended at 71 FR 68732, Nov. 28, 2006] | (a) Scope. This part sets forth the procedures to govern the conduct of persons involved in DOE nuclear activities and, in particular, to achieve compliance with the DOE Nuclear Safety Requirements by all persons subject to those requirements. (b) Questions not addressed by these rules. Questions that are not addressed in this part shall be resolved at the discretion of the DOE Official. (c) Exclusion. Activities and facilities covered under E.O. 12344, 42 U.S.C. 7158 note, pertaining to Naval nuclear propulsion are excluded from the requirements of subparts D and E of this part regarding interpretations and exemptions related to this part. The Deputy Administrator for Naval Reactors or his designee will be responsible for formulating, issuing, and maintaining appropriate records of interpretations and exemptions for these facilities and activities. | ||||
| 10:10:5.0.2.5.25.1.16.10 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.10 Office of the docketing clerk. | DOE | (a) Docket. The Docketing Clerk shall maintain a docket for enforcement actions commencing with the issuance of a Preliminary Notice of Violation, interpretations issued pursuant to subpart D of this part, exemptions issued pursuant to subpart E of this part, and any other matters designated by the Secretary. A docket for an enforcement action shall contain all documents required to be filed in the proceeding. (b) Public inspection. Subject to the provisions of law restricting the public disclosure of certain information, any person may, during Department business hours, inspect and copy any document filed with the Docketing Clerk. The cost of duplicating documents shall be borne by the person seeking copies of such documents. The DOE Official may waive this cost in appropriate cases. (c) Transcript. Except as otherwise provided in this part, after the filing of a Preliminary Notice of Violation, all hearings, conferences, and other meetings in the enforcement process shall be transcribed verbatim. A copy of the transcript shall be filed with the Docketing Clerk promptly. The Docketing Clerk shall serve all participants with notice of the availability of the transcript and shall furnish the participants with a copy of the transcript upon payment of the cost of reproduction, unless a participant can show that the cost is unduly burdensome. | |||||
| 10:10:5.0.2.5.25.1.16.11 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.11 Information requirements. | DOE | (a) Any information pertaining to a nuclear activity provided to DOE by any person or maintained by any person for inspection by DOE shall be complete and accurate in all material respects. (b) No person involved in a DOE nuclear activity shall conceal or destroy any information concerning a violation of a DOE Nuclear Safety Requirement, a Nuclear Statute, or the Act. | |||||
| 10:10:5.0.2.5.25.1.16.12 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.12 Classified, confidential, and controlled information | DOE | (a) General rule. The DOE Official in charge of a proceeding under this part may utilize any procedures deemed appropriate to safeguard and prevent disclosure of classified, confidential, and controlled information, including Restricted Data and National Security Information, to unauthorized persons, with minimum impairment of rights and obligations under this part. (b) Obligation to protect restricted information. Nothing in this part shall relieve any person from safeguarding classified, confidential, and controlled information, including Restricted Data or National Security Information, in accordance with the applicable provisions of federal statutes and the rules, regulations, and orders of any federal agency. | |||||
| 10:10:5.0.2.5.25.1.16.13 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.13 Direction to NNSA contractors. | DOE | [72 FR 31921, June 8, 2007] | (a) Notwithstanding any other provision of this part, and pursuant to section 3213 of Pub. L. 106-65, as amended (codified at 50 U.S.C. 2403), the NNSA, rather than the Director, signs, issues and serves the following actions that direct NNSA contractors: (1) Subpoenas; (2) Orders to compel attendance; (3) Disclosures of information or documents obtained during an investigation or inspection; (4) Preliminary notices of violations; and (5) Final notices of violations. (b) The NNSA Administrator shall act after consideration of the Director's recommendation. | ||||
| 10:10:5.0.2.5.25.1.16.14 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.14 Whistleblower protection. | DOE | [81 FR 94914, Dec. 27, 2016] | (a) Covered acts. An act of retaliation (as defined in 10 CFR 708.2) by a DOE contractor, prohibited by 10 CFR 708.43, that results from a DOE contractor employee's involvement in an activity listed in 10 CFR 708.5(a) through (c) may constitute a violation of a DOE Nuclear Safety Requirement if it concerns nuclear safety. (b) Commencement of investigation. The Director may not initiate an investigation or take any other action under this part with respect to an alleged act of retaliation by a DOE contractor until 180 days after an alleged violation of 10 CFR 708.43 occurs. (c) Administrative or judicial proceedings. The Director shall immediately suspend any ongoing activities under this part and suspend any time limits under this part when an administrative or judicial proceeding commences based on the same alleged act of retaliation. While an administrative or judicial proceeding, including appeals, is pending, the Director may not exercise any authority under this part based on an alleged violation of 10 CFR 708.43, including issuing enforcement letters, subpoenas, orders to compel attendance, Consent Orders, Preliminary Notices of Violation, or Final Notices of Violation. Once such a proceeding commences, the Director shall not conduct any activities under this part until sixty days after a final decision of an agency or court finds that a retaliation occurred, or otherwise makes a final disposition of the matter on procedural grounds without explicitly finding that retaliation did not occur. (d) Final decision. For the purposes of this section, a final decision of an agency or court includes any of the following: (1) A final agency decision pursuant to 10 CFR part 708; (2) A final decision or order of the Secretary of Labor pursuant to 29 CFR part 24; (3) A decision by the Secretary upon a report by the Inspector General; (4) A decision by a federal or state court. (e) Evidentiary record. If a final decision of an agency or court finds that retaliation occurred, the Director may obtain and … | ||||
| 10:10:5.0.2.5.25.1.16.2 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.2 Definitions. | DOE | [58 FR 43692, Aug. 17, 1993, as amended at 71 FR 68732, Nov. 28, 2006; 72 FR 31921, June 8, 2007; 81 FR 94913, Dec. 27, 2016] | (a) The following definitions apply to this part: Act or AEA means the Atomic Energy Act of 1954, as amended. Administrative Law Judge means an Administrative Law Judge appointed under 5 U.S.C. 3105. Consent Agreement means any written document, signed by the Director and a person, containing stipulations or conclusions of fact or law and a remedy acceptable to both the Director and the person. Contractor means any person under contract (or its subcontractors or suppliers) with the Department of Energy with the responsibility to perform activities or to supply services or products that are subject to DOE Nuclear Safety Requirements. Department means the United States Department of Energy or any predecessor agency. Director means the DOE Official to whom the Secretary has assigned the authority to issue Notices of Violation under subpart B of this part, including the Director of Enforcement, or his designee. With regard to activities and facilities covered under E.O. 12344, 42 U.S.C. 7158 note, pertaining to Naval nuclear propulsion, the Director shall mean the Deputy Administrator for Naval Reactors or his designee. Docketing Clerk means the Office in DOE with which documents for an enforcement action must be filed and which is responsible for maintaining a record and a public docket for enforcement actions commencing with the filing of a Preliminary Notice of Violation. It is also the Office with which interpretations, exemptions, and any other documents designated by the Secretary shall be filed. DOE means the United States Department of Energy or any predecessor agency. DOE Nuclear Safety Requirements means the set of rules, regulations, orders, and other requirements relating to nuclear safety adopted by DOE to govern the conduct of persons in connection with any DOE nuclear activity and includes any program, plan, or other provision required to implement these rules, regulations, orders, or other requirements. DOE Nuclear Safety Requirements include the following: (i) 10 CFR part 830; (… | ||||
| 10:10:5.0.2.5.25.1.16.3 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.3 Separation of functions. | DOE | (a) Separation of functions. After a respondent requests an on-the-record adjudication of an assessment of a civil penalty contained in a Final Notice of Violation, no person shall participate in a decision-making function in an enforcement proceeding if he has been, is or will be responsible for an investigative or prosecutorial function related to that proceeding or if he reports to the person responsible for the investigative or prosecutorial function. (b) Director. The Director shall be responsible for the investigation and prosecution of violations of the DOE Nuclear Safety Requirements. After the request for an enforcement adjudication, the Director shall not discuss ex parte the merits of the proceeding with a DOE Official or any person likely to advise the DOE Official in the decision of the proceeding. (c) Presiding Officer. A Presiding Officer shall perform no duties inconsistent with his responsibilities as a Presiding Officer, and will not be responsible to or subject to the supervision or direction of any officer or employee engaged in the performance of an investigative or prosecutorial function. The Presiding Officer may not consult any person other than a member of his staff or a special assistant on any fact at issue unless on notice and opportunity for all parties to participate, except as required for the disposition of ex parte matters as authorized by law. | |||||
| 10:10:5.0.2.5.25.1.16.4 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.4 Conflict of interest. | DOE | A DOE Official may not perform functions provided for in this part regarding any matter in which he has a financial interest or has any relationship that would make it inappropriate for him to act. A DOE Official shall withdraw at any time from any action in which he deems himself disqualified or unable to act for any reason. Any interested person may at any time request the General Counsel to disqualify a DOE Official or request that the General Counsel disqualify himself. In the case of an enforcement adjudication, a motion to disqualify shall be made to the Presiding Officer. The request shall be supported by affidavits setting forth the grounds for disqualification of the DOE Official. A decision shall be made as soon as practicable and information may be requested from any person concerning the matter. If a DOE Official is disqualified or withdraws from the proceeding, a qualified individual who has none of the infirmities listed in this section shall replace him. | |||||
| 10:10:5.0.2.5.25.1.16.5 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.5 Service. | DOE | (a) General rule. Any document filed with the Docketing Clerk must be served on the addressee of the document and shall not be considered filed until service is complete and unless accompanied by proof of service; provided that the filing with the Docketing Clerk of any document addressed to the DOE Official shall be considered service on the DOE Official. (b) Service in an Enforcement Adjudication. Any document filed in an enforcement adjudication must be served on all other participants in the adjudication. (c) Who may be served. Any paper required to be served upon a person shall be served upon him or upon the representative designated by him or by law to receive service of papers. When an attorney has entered an appearance on behalf of a person, service must be made upon the attorney of record. (d) How service may be made. Service may be made by personal delivery, by first class, certified or registered mail or as otherwise authorized or required by the DOE Official. The DOE Official may require service by express mail. (e) When service is complete. Service upon a person is complete: (1) By personal delivery, on handing the paper to the individual, or leaving it at his office with his clerk or other person in charge or, if there is no one in charge, leaving it in a conspicuous place therein or, if the office is closed or the person to be served has no office, leaving it at his usual place of residence with some person of suitable age and discretion then residing there; (2) By mail, on deposit in the United States mail, properly stamped and addressed; or (3) By any other means authorized or required by the DOE Official. (f) Proof of service. Proof of service, stating the name and address of the person on whom served and the manner and date of service, shall be shown for each document filed, and may be made by: (1) Written acknowledgement of the person served or his counsel; (2) The certificate of counsel if he has made the service; (3) The affidavit of the person making the service; or … | |||||
| 10:10:5.0.2.5.25.1.16.6 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.6 Computation and extension of time. | DOE | (a) Computation. In computing any period of time set forth in this part, except as otherwise provided, the day of the event from which the designated period begins to run shall not be included. Saturdays, Sundays, and Federal legal holidays shall be included. When a stated time expires on a Saturday, Sunday or Federal legal holiday, the stated time period shall be extended to include the next business day. (b) Extensions of time. A DOE Official may grant an extension of any time period set forth in this part. (c) Service by mail. Where a pleading or document is served by mail, five (5) days shall be added to the time allowed by these rules for the filing of a responsive pleading or document. Where a pleading or document is served by express mail, only two (2) days shall be added. | |||||
| 10:10:5.0.2.5.25.1.16.7 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.7 Questions of policy or law. | DOE | (a) Certification. There shall be no interlocutory appeal from any ruling order, or action decision of a DOE Official except as permitted by this section. A Presiding Officer in an enforcement adjudication may certify, in his discretion, a question to the Secretary, when the order or ruling involves an important question of law or policy concerning which there is substantial grounds for difference of opinion, and either an immediate decision will materially advance the ultimate termination of the proceeding, or subsequent review will be inadequate or ineffective. (b) Decision. The certified question shall be decided as soon as practicable. If the Secretary determines that the question was improvidently certified, or if he takes no action within thirty days of the certification, the certification is dismissed. The Secretary may decide the question on the basis of the submission made by the Presiding Officer or may request further information from any person. | |||||
| 10:10:5.0.2.5.25.1.16.8 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.8 Evidentiary matters. | DOE | (a) General. A DOE Official may obtain information or evidence for the full and complete investigation of any matter related to a DOE nuclear activity or for any decision required by this part. A DOE Official may sign, issue and serve subpoenas; administer oaths and affirmations; take sworn testimony; compel attendance of and sequester witnesses; control dissemination of any record of testimony taken pursuant to this section; subpoena and reproduce books, papers, correspondence, memoranda, contracts, agreements, or other relevant records or tangible evidence including, but not limited to, information retained in computerized or other automated systems in possession of the subpoenaed person. (b) Special Report Orders. A DOE Official may issue a Special Report Order (SRO) requiring any person involved in a DOE nuclear activity or otherwise subject to the jurisdiction of DOE to file a special report providing information relating to a DOE Nuclear Safety Requirement, the Act, or a Nuclear Statute, including but not limited to written answers to specific questions. The SRO may be in addition to any other reports required by this part. (c) Extension of Time. The DOE Official who issues a subpoena or SRO pursuant to this section, for good cause shown, may extend the time prescribed for compliance with the subpoena or SRO and negotiate and approve the terms of satisfactory compliance. (d) Reconsideration. Prior to the time specified for compliance, but in no event more than 10 days after the date of service of the subpoena or SRO, the person upon whom the document was served may request reconsideration of the subpoena or SRO with the DOE Official who issued the document. If the subpoena or SRO is not modified or rescinded within 10 days of the date of the filing of the request, the subpoena or SRO shall be effective as issued and the person upon whom the document was served shall comply with the subpoena or SRO within 20 days of the date of the filing. There is no administrative appeal of a subpoena or SRO. (… | |||||
| 10:10:5.0.2.5.25.1.16.9 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | A | Subpart A—General | § 820.9 Special assistant. | DOE | A DOE Official may appoint a person to serve as a special assistant to assist the DOE Official in the conduct of any proceeding under this part. Such appointment may occur at any appropriate time. A special assistant shall be subject to the disqualification provisions in § 820.5. A special assistant may perform those duties assigned by the DOE Official, including but not limited to, serving as technical interrogators, technical advisors and special master. | |||||
| 10:10:5.0.2.5.25.2.16.1 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.20 Purpose and scope. | DOE | [58 FR 43692, Aug. 17, 1993, as amended at 74 FR 11843, Mar. 20, 2009; 81 FR 94914, Dec. 27, 2016] | (a) Purpose. This subpart establishes the procedures for investigating the nature and extent of violations of DOE Nuclear Safety Requirements, for determining whether a violation of DOE Nuclear Safety Requirements has occurred, for imposing an appropriate remedy, and for adjudicating the assessment of a civil penalty. (b) Basis for civil penalties. DOE may assess civil penalties against any person subject to the provisions of this part who has entered into an agreement of indemnification under 42 U.S.C. 2210(d) (or any subcontractor or supplier thereto), unless exempted from civil penalties as provided in paragraph (c) of this section, on the basis of a violation of a DOE Nuclear Safety Requirement. (c) Exemptions. With respect to a violation occurring under a contract entered into before August 8, 2005, the following contractors, and subcontractors and suppliers to that prime contract only, are exempt from the assessment of civil penalties under this subpart with respect to the activities specified below: (1) The University of Chicago for activities associated with Argonne National Laboratory; (2) The University of California for activities associated with Los Alamos National Laboratory, Lawrence Livermore National Laboratory, and Lawrence Berkeley National Laboratory; (3) American Telephone and Telegraph Company and its subsidiaries for activities associated with Sandia National Laboratories; (4) University Research Association, Inc. for activities associated with FERMI National Laboratory; (5) Princeton University for activities associated with Princeton Plasma Physics Laboratory; (6) The Associated Universities, Inc. for activities associated with the Brookhaven National Laboratory; and (7) Battelle Memorial Institute for activities associated with Pacific Northwest Laboratory. (d) Nonprofit educational institutions. With respect to a violation occurring under a contract entered into before August 8, 2005, any educational institution that is considered nonprofit under the United States Inter… | ||||
| 10:10:5.0.2.5.25.2.16.10 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.29 Hearing. | DOE | (a) General. Except as otherwise provided by this part or the Presiding Officer, a hearing shall be conducted in accordance with the Federal Rules of Evidence. The Presiding Officer shall have the discretion to admit all evidence that is not irrelevant, immaterial, unduly repetitious, or otherwise unreliable or of little probative value, if he believes the evidence might facilitate the fair and expeditious resolution of the proceeding. But such evidence may be reasonably limited by the Presiding Officer in scope and length in order to permit prompt resolution of the proceeding. In the presentation, admission, disposition, and use of evidence, the Presiding Officer shall preserve the confidentiality of trade secrets and other commercial and financial information, and shall protect classified and unclassified controlled nuclear information, as well as any other information protected from public disclosure pursuant to law or regulation. The confidential, trade secret, or classified or otherwise protected status of any information shall not, however, preclude its being introduced into evidence. The Presiding Officer may make such orders as may be necessary to consider such evidence in camera, including the preparation of a supplemental initial decision to address questions of law, fact, or discretion that arise out of that portion of the evidence that is confidential, includes trade secrets, is classified, or is otherwise protected. (b) Subpoenas. The attendance of witnesses or the production of documentary evidence may be required by subpoena. (c) Examination of witnesses. There shall be no direct oral testimony by witnesses, except as permitted by the Presiding Officer. In lieu of oral testimony, the Presiding Officer shall admit into the record as evidence verified written statements of fact or opinion prepared by a witness. The admissibility of the evidence contained in the statement shall be subject to the same rules as if the testimony were produced under oral examination. Before any such statement is r… | |||||
| 10:10:5.0.2.5.25.2.16.11 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.30 Post-hearing filings. | DOE | Within fifteen days after the filing of the transcript of the hearing, or within such longer time as may be fixed by the Presiding Officer, any party may file for the consideration of the Presiding Officer, proposed findings of fact, conclusions of law, and a proposed order, together with briefs in support thereof. Reply briefs may be filed within ten days of the filing of briefs. All filings shall be in writing, shall be served upon all parties, and shall contain adequate references to the record and authorities relied on. | |||||
| 10:10:5.0.2.5.25.2.16.12 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.31 Initial decision. | DOE | (a) Initial Decision. The Presiding Officer shall file an Initial Decision as soon as practicable after the period for filing reply briefs under 820.30 has expired. The Initial Decision shall contain findings of fact, conclusions regarding all material issues of law or discretion, as well as reasons therefor, any remedy and a proposed Final Order. A party may file comments on an Initial Decision within fifteen days of its filing. (b) Amount of civil penalty. If the Presiding Officer determines that a violation has occurred and that a civil penalty is appropriate, the Initial Decision shall set forth the dollar amount of the civil penalty. If the Presiding Officer decides to assess a penalty different in amount from the penalty assessed in the Final Notice of Violation, the Initial Decision shall set forth the specific reasons for the increase or decrease. | |||||
| 10:10:5.0.2.5.25.2.16.13 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.32 Final order. | DOE | (a) Effect of Initial Decision. The Initial Decision shall be deemed filed as a Final Order thirty days after the filing of the Initial Decision unless the Secretary files a Final Order that modifies the Initial Decision or the Secretary files a Notice of Review. (b) Notice of review. If the Secretary files a Notice of Review, he shall file a Final Order as soon as practicable after completing his review. The Secretary may, at his discretion, order additional procedures, remand the matter or modify the remedy, including an increase or decrease in the amount of the civil penalty from the amount recommended to be assessed in the Initial Decision. (c) Payment of a civil penalty. The respondent shall pay the full amount of any civil penalty assessed in the Final Order within thirty (30) days after the Final Order is filed unless otherwise agreed by the parties. | |||||
| 10:10:5.0.2.5.25.2.16.14 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.33 Default order. | DOE | (a) Default. The Presiding Officer, upon motion by a party or the filing of a Notice of Intent to issue a Default Order sua sponte, may find a party to be in default if the party fails to comply with the provisions of this part or an order of the Presiding Officer. The alleged defaulting party shall have ten days to answer the motion or the Notice of Intent. No finding of default shall be made against the respondent unless the Director presents sufficient evidence to the Presiding Officer to establish a prima facie case against the respondent. Default by respondent constitutes, for purposes of the pending action only, an admission of all facts alleged in the Final Notice of Violation and a waiver of respondent's rights to an on-the-record adjudication of such factual allegations. Default by the Director shall result in an order to dismiss the Final Notice of Violation with prejudice. (b) Effect of default order. When the Presiding Officer finds a default has occurred, he shall file a Default Order against the defaulting party. This order shall constitute an Initial Decision. (c) Contents of a default order. A Default Order shall include findings of fact showing the grounds for the order, conclusions regarding all material issues of fact, law or discretion, and the remedy. | |||||
| 10:10:5.0.2.5.25.2.16.15 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.34 Accelerated decision. | DOE | (a) General. The Presiding Officer, upon motion of any party or sua sponte, may at any time render an Accelerated Decision in favor of the Director or the respondent as to all or any part of the adjudication, without further hearing or upon such limited additional evidence, such as affidavits, as he may require, if no genuine issue of material fact exists and a party is entitled to judgment as a matter of law, as to all or any part of the adjudication. In addition, the Presiding Officer, upon motion of the respondent, may render at any time an Accelerated Decision to dismiss an action without further hearing or upon such limited additional evidence as he requires, on the basis of failure to establish a prima facie case or other grounds that show no right to relief on the part of the Director. (b) Effect of Accelerated Decision. (1) If an Accelerated Decision is rendered as to all the issues and claims in the adjudication, the decision constitutes an Initial Decision of the Presiding Officer, and shall be filed with the Docketing Clerk. (2) If an Accelerated Decision is rendered on less than all issues or claims in the adjudication, the Presiding Officer shall determine what material facts exist without substantial controversy and what material facts remain controverted in good faith. He shall thereupon file an interlocutory order specifying the facts that appear substantially uncontroverted, and the issues and claims upon which the adjudication will proceed. | |||||
| 10:10:5.0.2.5.25.2.16.16 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.35 | DOE | At no time after a respondent has requested an on-the-record adjudication of the assessment of a civil penalty shall a DOE Official, or any person who is likely to advise a DOE Official in the decision on the case, discuss ex parte the merits of the proceeding with any interested person outside DOE, with any DOE staff member who performs a prosecutorial or investigative function in such proceeding or a factually related proceeding, or with any representative of such person. Any ex parte memorandum or other communication addressed to a DOE Official during the pendency of the proceeding and relating to the merits thereof, by or on behalf of any party shall be regarded as argument made in the proceeding and shall be served upon all other parties. Any oral communication shall be set forth in a written memorandum and served on all other parties. The other parties shall be given an opportunity to reply to such memorandum or communication. | |||||
| 10:10:5.0.2.5.25.2.16.17 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.36 Filing, form, and service of documents. | DOE | (a) Filing in an enforcement proceeding. The original and three copies of any document in an enforcement proceeding shall be filed with the Docketing Clerk commencing with the filing of a Preliminary Notice of Violation. (b) Form of documents in an enforcement proceeding. (1) Except as provided herein, or by order of the DOE Official, there are no specific requirements as to the form of documents filed in an enforcement proceeding. (2) The first page of every document shall contain a caption identifying the respondent and the docket number. (3) The original of any document (other than exhibits) shall be signed by the person filing it or by his counsel or other representative. The signature constitutes a representation by the signer that he has read the pleading, letter or other document, that to the best of his knowledge, information and belief, the statements made therein are true, and that it is not interposed for delay. (4) The initial document filed by any person shall contain his name, address and telephone number. Any changes in this information shall be communicated promptly to the Docketing Clerk and all participants to the proceeding. A person who fails to furnish such information and any changes thereto shall be deemed to have waived his right to notice and service under this part. (5) The Docketing Clerk may refuse to file any document that does not comply with this section. Written notice of such refusal, stating the reasons therefor, shall be promptly given to the person submitting the document. Such person may amend and resubmit any document refused for filing. | |||||
| 10:10:5.0.2.5.25.2.16.18 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.37 Participation in an adjudication. | DOE | (a) Parties. In an enforcement adjudication, the Director and the respondent shall be the only parties; provided that the Presiding Officer may permit a person to intervene as a party if the person demonstrates it could be liable in the event a civil penalty is assessed. (b) Appearances. Any party to an enforcement adjudication may appear in person or by counsel or other representative. A partner may appear on behalf of a partnership and an officer may appear on behalf of a corporation. Persons who appear as counsel or other representative must conform to the standards of conduct and ethics required of practitioners before the courts of the United States. (c) Amicus Curiae. Persons not parties to an enforcement adjudication who wish to file briefs may so move. The motion shall identify the interest of the person and shall state the reasons why the proposed amicus brief is desirable. If the motion is granted, the Presiding Officer shall issue an order setting the time for filing such brief. An amicus curiae is eligible to participate in any briefing after his motion is granted, and shall be served with all briefs, reply briefs, motions, and orders relating to issues to be briefed. | |||||
| 10:10:5.0.2.5.25.2.16.19 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.38 Consolidation and severance. | DOE | (a) Consolidation. The Presiding Officer may, by motion or sua sponte, consolidate any or all matters at issue in two or more enforcement adjudications under this part where there exists common parties or common questions of fact or law, consolidation would expedite and simplify consideration of the issues, and consolidation would not adversely affect the rights of parties engaged in otherwise separate adjudications. (b) Severance. The Presiding Officer may, by motion or sua sponte, for good cause shown order any enforcement adjudication severed with respect to any or all parties or issues. | |||||
| 10:10:5.0.2.5.25.2.16.2 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.21 Investigations. | DOE | [58 FR 43692, Aug. 17, 1993, as amended at 72 FR 31921, June 8, 2007] | (a) The Director may initiate and conduct investigations and inspections relating to the scope, nature and extent of compliance by a person with the Act and the DOE Nuclear Safety Requirements and take such action as he deems necessary and appropriate to the conduct of the investigation or inspection, including any action pursuant to § 820.8. (b) Any person may request the Director to initiate an investigation or inspection pursuant to paragraph (a) of this section. A request for an investigation or inspection shall set forth the subject matter or activity to be investigated or inspected as fully as possible and include supporting documentation and information. No particular forms or procedures are required. (c) Any person who is requested to furnish documentary evidence, information or testimony in an investigation or during an inspection shall be informed, upon written request, of the general purpose of the investigation or inspection. (d) Information or documents that are obtained during any investigation or inspection shall not be disclosed unless the Director directs or authorizes the public disclosure of the investigation. Upon such authorization, the information or documents are a matter of public record and disclosure is not precluded by the Freedom of Information Act, 5 U.S.C. 552 and 10 CFR part 1004. A request for confidential treatment of information for purposes of the Freedom of Information Act shall not prevent disclosure by the Director if disclosure is determined to be in the public interest and otherwise permitted or required by law. (e) During the course of an investigation or inspection any person may submit at any time any document, statement of facts or memorandum of law for the purpose of explaining the person's position or furnish information which the person considers relevant to a matter or activity under investigation or inspection. (f) If facts disclosed by an investigation or inspection indicate that further action is unnecessary or unwarranted, the investigation may be closed wi… | ||||
| 10:10:5.0.2.5.25.2.16.20 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.39 Motions. | DOE | (a) General. All motions in an enforcement adjudication except those made orally, shall be in writing, state the grounds therefor with particularity, set forth the relief or order sought, and be accompanied by any affidavit, certificate, other evidence, or legal memorandum relied upon. (b) Answer to motions. Except as otherwise specified by a particular provision of this part or by the Presiding Officer, a party shall have the right to file a written answer to the motion of another party within 10 days after the filing of such motion. The answer shall be accompanied by any affidavit, certificate, other evidence, or legal memorandum relied upon. If no answer is filed within the designated period, the party may be deemed to have waived any objection to the granting of the motion. The Presiding Officer may set a shorter or longer time for an answer, or make such other orders concerning the disposition of motions as he deems appropriate. (c) Decision. The Presiding Officer shall rule on a motion as soon as practicable after the filing of the answer. The decision of the Presiding Officer on any motion shall not be subject to administrative appeal. | |||||
| 10:10:5.0.2.5.25.2.16.3 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.22 Informal conference. | DOE | The Director may convene an informal conference to discuss any situation that might be a violation of the Act or a DOE Nuclear Safety Requirement, its significance and cause, any correction taken or not taken by the person, any mitigating or aggravating circumstances, and any other useful information. The Director may compel a person to attend the conference. This conference will not normally be open to the public and there shall be no transcript. | |||||
| 10:10:5.0.2.5.25.2.16.4 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.23 Consent order. | DOE | (a) Settlement policy. DOE encourages settlement of an enforcement proceeding at any time if the settlement is consistent with the objectives of the Act and the DOE Nuclear Safety Requirements. The Director and a person may confer at any time concerning settlement. These settlement conferences shall not be open to the public and there shall be no transcript. (b) Consent order. Notwithstanding any other provision of this part, DOE may at any time resolve any or all issues in an outstanding enforcement proceeding with a Consent Order. A Consent Order must be signed by the Director and the person who is its subject, or a duly authorized representative, must indicate agreement to the terms contained therein and must be filed. A Consent Order need not constitute an admission by any person that the Act or a DOE Nuclear Safety Requirement has been violated, nor need it constitute a finding by the DOE that such person has violated the Act or a DOE Nuclear Safety Requirement. A Consent Order shall, however, set forth the relevant facts which form the basis for the Order and what remedy, if any, is imposed. (c) Effect on enforcement adjudication. If a Consent Order is signed after the commencement of an enforcement adjudication, the adjudication of the issues subject to the Consent Order shall be stayed until the completion of the Secretarial Review Process. If the Consent Order becomes a Final Order, the adjudication shall be terminated or modified as specified in the Order. (d) Secretarial review. A Consent Order shall become a Final Order 30 days after it is filed unless the Secretary files a rejection of the Consent Order or a Modified Consent Order. A Modified Consent Order shall become a Final Order if the Director and the person who is its subject sign it within 15 days of its filing. | |||||
| 10:10:5.0.2.5.25.2.16.5 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.24 Preliminary notice of violation. | DOE | (a) If the Director has reason to believe a person has violated or is continuing to violate a provision of the Act or a DOE Nuclear Safety Requirement, he may file a Preliminary Notice of Violation. The Notice and any transmittal documents shall contain sufficient information to fairly apprise the respondent of the facts and circumstances of the alleged violations and the basis of any proposed remedy, and to properly indicate what further actions are necessary by or available to respondent. (b) Within 30 days after the filing of a Preliminary Notice of Violation, the respondent shall file a reply. (c) The reply shall be in writing and signed by the person filing it. The reply shall contain a statement of all relevant facts pertaining to the situation that is the subject of the Notice. The reply shall state any facts, explanations and arguments which support a denial that a violation has occurred as alleged; demonstrate any extenuating circumstances or other reason why the proposed remedy should not be imposed or should be mitigated; and furnish full and complete answers to the questions set forth in the Notice. Copies of all relevant documents shall be submitted with the reply. The reply shall include a discussion of the relevant authorities which support the position asserted, including rulings, regulations, interpretations, and previous decisions issued by DOE. (d) The respondent may terminate an enforcement action if the reply agrees to comply with the proposed remedy and waives any right to contest the Notice or the remedy. If a respondent elects this option, the Preliminary Notice of Violation shall be deemed a Final Order upon the filing of the reply. | |||||
| 10:10:5.0.2.5.25.2.16.6 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.25 Final notice of violation. | DOE | (a) General rule. If, after reviewing the reply submitted by the respondent, the Director determines that a person violated or is continuing to violate a provision of the Act or a DOE Nuclear Safety Requirement, he may file a Final Notice of Violation. The Final Notice shall concisely state the determined violation, any designated penalty, and further actions necessary by or available to respondent. (b) Effect of final notice. (1) If a Final Notice of Violation does not contain a civil penalty, it shall be deemed filed as a Final Order 15 days after the Final Notice is filed unless the Secretary files a Final Order which modifies the Final Notice. (2) If a Final Notice of Violation contains a civil penalty, the respondent must file within 30 days after the filing of the Final Notice: (i) A waiver of further proceedings; (ii) A request for an on-the-record adjudication; or (iii) A notice of intent to seek judicial review. (c) Effect of waiver. If a respondent waives further proceedings, the Final Notice of Violation shall be deemed a Final Order enforceable against the respondent. The respondent must pay any civil penalty set forth in the Notice of Violation within 60 days of the filing of waiver unless the Director grants additional time. (d) Effect of request. If a respondent files a request for an on-the-record adjudication, then an enforcement adjudication commences. (e) Effect of notice of intent. If a respondent files a Notice of Intent, the Final Notice of Violation shall be deemed a Final Order enforceable against the respondent. (f) Amendment. The Director may amend the Final Notice of Violation at any time before an action takes place pursuant to paragraph (b) of this section. An amendment shall add fifteen days to the time periods under paragraph (b) of this section. (g) Withdrawal. The Director may withdraw the Final Notice of Violation, or any part thereof, at any time before an action under paragraph (b) of this section. | |||||
| 10:10:5.0.2.5.25.2.16.7 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.26 Enforcement adjudication. | DOE | If a respondent files a request for an on-the-record adjudication, an enforcement adjudication is initiated and the Docketing Clerk shall notify the Secretary who shall appoint an Administrative Law Judge to be the Presiding Officer. | |||||
| 10:10:5.0.2.5.25.2.16.8 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.27 Answer. | DOE | (a) General. If a respondent files a request for an on-the-record adjudication pursuant to § 820.25, a written answer to the Final Notice of Violation shall be filed at the same time the request is filed. (b) Contents of the answer. The answer shall clearly and directly admit, deny or explain each of the factual allegations contained in the Final Notice of Violation with regard to which respondent has any knowledge, information or belief. Where respondent has no knowledge, information or belief of a particular factual allegation and so states, the allegation is deemed denied. The answer shall also state the circumstance or argument that is alleged to constitute the grounds of defense and the facts that respondent intends to place at issue. (c) Failure to admit, deny, or explain. Failure of respondent to admit, deny, or explain any material factual allegation contained in the Final Notice of Violation constitutes an admission of the allegation. (d) Amendment of the answer. The respondent may amend the answer to the Final Notice of Violation upon motion granted by the Presiding Officer. | |||||
| 10:10:5.0.2.5.25.2.16.9 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | B | Subpart B—Enforcement Process | § 820.28 Prehearing actions. | DOE | (a) General. The Presiding Officer shall establish a schedule for the adjudication and take such other actions as he determines appropriate to conduct the adjudication in a fair and expeditious manner. (b) Prehearing conference. The Presiding Officer, at any time before a hearing begins, may direct the parties and their counsel, or other representatives, to appear at a conference before him to consider, as appropriate: (1) The settlement of the case; (2) The simplification of issues and stipulation of facts not in dispute; (3) The necessity or desirability of amendments to pleadings; (4) The exchange of exhibits; (5) The limitation of the number of expert or other witnesses; (6) Setting a time and place for the hearing; and (7) Any other matters that may expedite the disposition of the proceeding. (c) Exchange of witness lists and documents. Unless otherwise ordered by the Presiding Officer, at least five (5) days before any prehearing conference, each party shall make available to all other parties, as appropriate, the names of the expert and other witnesses it intends to call, together with a brief narrative summary of their expected testimony, and copies of all documents and exhibits that each party intends to introduce into evidence. Documents and exhibits shall be marked for identification as ordered by the Presiding Officer. Documents that have not been exchanged and witnesses whose names have not been exchanged shall not be introduced into evidence or allowed to testify without permission of the Presiding Officer. The Presiding Officer shall allow the parties reasonable opportunity to review new evidence. (d) Prehearing conference order. The Presiding Officer shall prepare an order incorporating any action taken at the conference. The summary shall incorporate any written stipulations or agreements of the parties and all rulings and appropriate orders containing directions to the parties. (e) Alternative to prehearing conference. If a prehearing conference is unnecessary or impracticab… | |||||
| 10:10:5.0.2.5.25.3.16.1 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | C | Subpart C—Compliance Orders | § 820.40 Purpose and scope. | DOE | This subpart provides for the issuance of Compliance Orders to prevent, rectify or penalize violations of the Act, a Nuclear Statute, or a DOE Nuclear Safety Requirement and to require action consistent with the Act, a Nuclear Statute, or a DOE Nuclear Safety Requirement. | |||||
| 10:10:5.0.2.5.25.3.16.2 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | C | Subpart C—Compliance Orders | § 820.41 Compliance order. | DOE | The Secretary may issue to any person involved in a DOE nuclear activity a Compliance Order that: (a) Identifies a situation that violates, potentially violates, or otherwise is inconsistent with the Act, a Nuclear Statute, or a DOE Nuclear Safety Requirement; (b) Mandates a remedy or other action; and, (c) States the reasons for the remedy or other action. | |||||
| 10:10:5.0.2.5.25.3.16.3 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | C | Subpart C—Compliance Orders | § 820.42 Final order. | DOE | A Compliance Order is a Final Order that constitutes a DOE Nuclear Safety Requirement that is effective immediately unless the Order specifies a different effective date. | |||||
| 10:10:5.0.2.5.25.3.16.4 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | C | Subpart C—Compliance Orders | § 820.43 Appeal. | DOE | Within fifteen days of the issuance of a Compliance Order, the recipient of the Order may request the Secretary to rescind or modify the Order. A request shall not stay the effectiveness of a Compliance Order unless the Secretary issues an order to that effect. | |||||
| 10:10:5.0.2.5.25.4.16.1 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | D | Subpart D—Interpretations | § 820.50 Purpose and scope. | DOE | This subpart provides for interpretations of the Act, Nuclear Statutes, and DOE Nuclear Safety Requirements. Any written or oral response to any written or oral question which is not provided pursuant to this subpart does not constitute an interpretation and does not provide any basis for action inconsistent with the Act, a Nuclear Statute, or a DOE Nuclear Safety Requirement. | |||||
| 10:10:5.0.2.5.25.4.16.2 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | D | Subpart D—Interpretations | § 820.51 General Counsel. | DOE | The General Counsel shall be the DOE Official responsible for formulating and issuing any interpretation concerning the Act, a Nuclear Statute or a DOE Nuclear Safety Requirement. | |||||
| 10:10:5.0.2.5.25.4.16.3 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | D | Subpart D—Interpretations | § 820.52 Procedures. | DOE | The General Counsel may utilize any procedure which he deems appropriate to comply with his responsibilities under this subpart. All interpretations issued under this subpart must be filed with the Office of the Docketing Clerk which shall maintain a docket for interpretations. | |||||
| 10:10:5.0.2.5.25.5.16.1 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | E | Subpart E—Exemption Relief | § 820.60 Purpose and scope. | DOE | This subpart provides for exemption relief from provisions of DOE Nuclear Safety Requirements at nuclear facilities. | |||||
| 10:10:5.0.2.5.25.5.16.2 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | E | Subpart E—Exemption Relief | § 820.61 Secretarial officer. | DOE | The Secretarial Officer who is primarily responsible for the activity to which a DOE Nuclear Safety Requirement relates may grant a temporary or permanent exemption from that requirement as requested by any person subject to its provisions; provided that, the Secretarial Officer responsible for environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. | |||||
| 10:10:5.0.2.5.25.5.16.3 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | E | Subpart E—Exemption Relief | § 820.62 Criteria. | DOE | The criteria for granting an exemption to a DOE Nuclear Safety Requirement are determinations that the exemption: (a) Would be authorized by law; (b) Would not present an undue risk to public health and safety, the environment, or facility workers; (c) Would be consistent with the safe operation of a DOE nuclear facility; and (d) Involves special circumstances, including the following: (1) Application of the requirement in the particular circumstances conflicts with other requirements; or (2) Application of the requirement in the particular circumstances would not serve or is not necessary to achieve its underlying purpose, or would result in resource impacts which are not justified by the safety improvements; or (3) Application of the requirement would result in a situation significantly different than that contemplated when the requirement was adopted, or that is significantly different from that encountered by others similarly situated; or (4) The exemption would result in benefit to human health and safety that compensates for any detriment that may result from the grant of the exemption; or (5) Circumstances exist which would justify temporary relief from application of the requirement while taking good faith action to achieve compliance; or (6) There is present any other material circumstance not considered when the requirement was adopted for which it would be in the public interest to grant an exemption. | |||||
| 10:10:5.0.2.5.25.5.16.4 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | E | Subpart E—Exemption Relief | § 820.63 Procedures. | DOE | The Secretarial Officer shall utilize any procedures deemed necessary and appropriate to comply with his responsibilities under this subpart. All exemption decisions must set forth in writing the reasons for granting or denying the exemption, and if granted, the basis for the determination that the criteria in § 820.62 have been met and the terms of the exemption. All exemption decisions must be filed with the Office of the Docketing Clerk which shall maintain a docket for exemption decisions issued pursuant to this subpart. | |||||
| 10:10:5.0.2.5.25.5.16.5 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | E | Subpart E—Exemption Relief | § 820.64 Terms and conditions. | DOE | An exemption may contain appropriate terms and conditions including, but not limited to, provisions that : (a) Limit its duration; (b) Require alternative action; (c) Require partial compliance; or (d) Establish a schedule for full or partial compliance. | |||||
| 10:10:5.0.2.5.25.5.16.6 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | E | Subpart E—Exemption Relief | § 820.65 Implementation plan. | DOE | With respect to a DOE Nuclear Safety Requirement for which there is no regulatory provision for an implementation plan or schedule, an exemption may be granted to establish an implementation plan which reasonably demonstrates that full compliance with the requirement will be achieved within two years of the effective date of the requirement without a determination of special circumstances under § 820.62(d). | |||||
| 10:10:5.0.2.5.25.5.16.7 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | E | Subpart E—Exemption Relief | § 820.66 Appeal. | DOE | Within fifteen (15) days of the filing of an exemption decision by a Secretarial Officer, the person requesting the exemption may file a Request to Review with the Secretary, or the Secretary may file, sua sponte, a Notice of Review. The Request to Review shall state specifically the respects in which the exemption determination is claimed to be erroneous, the grounds of the request, and the relief requested. | |||||
| 10:10:5.0.2.5.25.5.16.8 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | E | Subpart E—Exemption Relief | § 820.67 Final order. | DOE | If no filing is made under § 820.66, an exemption decision becomes a Final Order fifteen (15) days after it is filed by a Secretarial Officer. If filing is made under § 820.66, an exemption decision becomes a Final Order 45 days after it is filed by a Secretarial Officer, unless the Secretary stays the effective date or issues a Final Order that modifies the decision. | |||||
| 10:10:5.0.2.5.25.6.16.1 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | F | Subpart F—Criminal Penalties | § 820.70 Purpose and scope. | DOE | This subpart provides for the identification of criminal violations of the Act or DOE Nuclear Safety Requirements and the referral of such violations to the Department of Justice. | |||||
| 10:10:5.0.2.5.25.6.16.2 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | F | Subpart F—Criminal Penalties | § 820.71 Standard. | DOE | If a person subject to the Act or the DOE Nuclear Safety Requirements has, by act or omission, knowingly and willfully violated, caused to be violated, attempted to violate, or conspired to violate any section of the Act or any applicable DOE Nuclear Safety Requirement, the person shall be subject to criminal sanctions under the Act. | |||||
| 10:10:5.0.2.5.25.6.16.3 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | F | Subpart F—Criminal Penalties | § 820.72 Referral to the Attorney General. | DOE | If there is reason to believe a criminal violation of the Act or the DOE Nuclear Safety Requirements has occurred, DOE may refer the matter to the Attorney General of the United States for investigation or prosecution. | |||||
| 10:10:5.0.2.5.25.7.16.1 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | G | Subpart G—Civil Penalties | § 820.80 Basis and purpose. | DOE | [62 FR 46184, Sept. 2, 1997, as amended at 81 FR 41794, June 28, 2016] | This subpart implements the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Act) (Pub. L. 101-410), as amended by the Debt Collection Improvement Act of 1996 (Pub. L. 104-134, section 31001) and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. 114-74, section 701). 28 U.S.C. 2461 note. As amended, the Act requires each agency head to adjust by regulation each civil monetary penalty provided by law within the jurisdiction of the Federal agency by the inflation adjustment specified in 28 U.S.C. 2461 note. This subpart increases the civil penalty amount specified in 42 U.S.C. 2282a. | ||||
| 10:10:5.0.2.5.25.7.16.2 | 10 | Energy | III | 820 | PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES | G | Subpart G—Civil Penalties | § 820.81 Amount of penalty. | DOE | [62 FR 46184, Sept. 2, 1997, as amended at 74 FR 66033, Dec. 14, 2009; 79 FR 19, Jan. 2, 2014; 81 FR 41794, June 28, 2016; 81 FR 96352, Dec. 30, 2016; 83 FR 1292, Jan. 11, 2018; 83 FR 66083, Dec. 26, 2018; 85 FR 830, Jan. 8, 2020; 86 FR 2956, Jan. 14, 2021; 87 FR 1064, Jan. 10, 2022; 88 FR 2193, Jan. 13, 2023; 89 FR 1029, Jan. 9, 2024; 89 FR 105407, Dec. 27, 2024] | Any person subject to a penalty under 42 U.S.C. 2282a shall be subject to a civil penalty in an amount not to exceed $262,614 for each such violation. If any violation under 42 U.S.C. 2282a is a continuing one, each day of such violation shall constitute a separate violation for the purpose of computing the applicable civil penalty. | ||||
| 21:21:8.0.1.1.12.1.1.1 | 21 | Food and Drugs | I | H | 820 | PART 820—QUALITY MANAGEMENT SYSTEM REGULATION | A | Subpart A—General Provisions | § 820.1 Scope. | FDA | (a) Applicability. Current good manufacturing practice (CGMP) requirements are set forth in this quality management system regulation (QMSR). The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to assure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act and that the use of other terminology, such as “safety and performance,” in this part does not change this statutory standard or the requirements of this part. Any manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation, or servicing of a finished device must establish and maintain a quality management system that is appropriate for its specific device(s). Manufacturers subject to this part include, but are not limited to, manufacturers that perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, as well as initial distributors of foreign entities that perform these functions. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. (1) Finished devices. The provisions of this part shall apply to any finished device, as defined in this part, intended for human use, that is manufactured in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico, or that is imported or offered for import into the United States. (2) Components or parts. The provisions of this part do not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to consider provisions of this regulation as appropriate. (3) Blood and… | ||||
| 21:21:8.0.1.1.12.1.1.2 | 21 | Food and Drugs | I | H | 820 | PART 820—QUALITY MANAGEMENT SYSTEM REGULATION | A | Subpart A—General Provisions | § 820.3 Definitions. | FDA | [89 FR 7523, Feb. 2, 2024; 89 FR 82945, Oct. 15, 2024] | The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title. (a) The following terms, which are either not used or not defined in ISO 13485 or in Clause 3 of ISO 9000, also apply for the purposes of this part: Batch or lot means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly that is intended to be included as part of the finished, packaged, and labeled device. Federal Food, Drug, and Cosmetic Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., as amended. Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) of this chapter and that is also regulated as a device. Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use. (b) All definitions in section 201 of the Federal Food, Drug, and Cosmetic Act shall apply to the regulation of quality management systems under this part and shall supersede the correlating terms and definitions in ISO 13485 ( e.g., the definitions of device and labeling in section 201(h) and (m) of the Federal Food, Drug, and Cosmetic Act apply to this part and supersede the d… | |||
| 21:21:8.0.1.1.12.1.1.3 | 21 | Food and Drugs | I | H | 820 | PART 820—QUALITY MANAGEMENT SYSTEM REGULATION | A | Subpart A—General Provisions | § 820.5 [Reserved] | FDA | |||||
| 21:21:8.0.1.1.12.1.1.4 | 21 | Food and Drugs | I | H | 820 | PART 820—QUALITY MANAGEMENT SYSTEM REGULATION | A | Subpart A—General Provisions | § 820.7 Incorporation by reference. | FDA | Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration, and at the National Archives and Records Administration (NARA). Contact FDA at: Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852; 240-402-7500; https://www.regulations.gov/document/FDA-2013-S-0610-0003. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email fr.inspection@nara.gov. This material may be obtained from the International Organization for Standardization (ISO), BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; +41-22-749-01-11; customerservice@iso.org, https://www.iso.org/store.html. (a) ISO 9000:2015(E) (“ISO 9000”), Quality Management systems—Fundamentals and vocabulary, Clause 3— Terms and definitions, Fourth edition, September 15, 2015. IBR approved for § 820.3. (b) ISO 13485:2016(E) (“ISO 13485”), Medical devices—Quality management systems—Requirements for regulatory purposes, Third edition, March 1, 2016; IBR approved for §§ 820.1, 820.3, 820.10, 820.35, and 820.45. | ||||
| 21:21:8.0.1.1.12.1.1.5 | 21 | Food and Drugs | I | H | 820 | PART 820—QUALITY MANAGEMENT SYSTEM REGULATION | A | Subpart A—General Provisions | § 820.10 Requirements for a quality management system. | FDA | A manufacturer subject to this part as described by § 820.1(a) must: (a) Document. Document a quality management system that complies with the applicable requirements of ISO 13485 (incorporated by reference, see § 820.7) and other applicable requirements of this part; and (b) Applicable regulatory requirements. Comply, as appropriate, with the other applicable regulatory requirements in this title, including, but not limited to the following, to fully comply with the listed ISO 13485 Clause: (1) For Clause 7.5.8 in ISO 13485, Identification, the manufacturer must document a system to assign unique device identification to the medical device in accordance with the requirements of part 830 of this chapter. (2) For Clause 7.5.9.1 in ISO 13485, Traceability—General, the manufacturer must document procedures for traceability in accordance with the requirements of part 821 of this chapter, if applicable. (3) For Clause 8.2.3 in ISO 13485, Reporting to regulatory authorities, the manufacturer must notify FDA of complaints that meet the reporting criteria of part 803 of this chapter. (4) For Clauses 7.2.3, 8.2.3, and 8.3.3, advisory notices shall be handled in accordance with the requirements of part 806 of this chapter. (c) Design and development. Manufacturers of class II, class III, and those class I devices listed in paragraph (c)(1) of this section and table 1 to paragraph (c)(2) of this section must comply with the requirements in Design and Development, Clause 7.3 and its Subclauses in ISO 13485. The class I devices are as follows: (1) Devices automated with computer software; and (2) The devices listed in the following table: Table 1 to Paragraph ( c )(2) (d) Devices that support or sustain life. Manufacturers of devices that support or sustain life, the failure of which to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury, must comply with the requirements in Traceability for Implantable Devi… | ||||
| 21:21:8.0.1.1.12.2.1.1 | 21 | Food and Drugs | I | H | 820 | PART 820—QUALITY MANAGEMENT SYSTEM REGULATION | B | Subpart B—Supplemental Provisions | § 820.20--§ 820.30 [Reserved] | FDA | |||||
| 21:21:8.0.1.1.12.2.1.2 | 21 | Food and Drugs | I | H | 820 | PART 820—QUALITY MANAGEMENT SYSTEM REGULATION | B | Subpart B—Supplemental Provisions | § 820.35 Control of records. | FDA | In addition to the requirements of Clause 4.2.5 in ISO 13485 (incorporated by reference, see § 820.7), Control of Records, the manufacturer must include the following information in certain records: (a) Records of complaints. In addition to Clause 8.2.2 in ISO 13485, Complaint Handling, the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications. If an investigation has already been performed for a similar complaint, another investigation is not necessary, and the manufacturer shall maintain records documenting justification for not performing such investigation. For complaints that must be reported to FDA under part 803 of this chapter, complaints that a manufacturer determines must be investigated, and complaints that the manufacturer investigated regardless of those requirements, the manufacturer must record the following information: (1) The name of the device; (2) The date the complaint was received; (3) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s); (4) The name, address, and phone number of the complainant; (5) The nature and details of the complaint; (6) Any correction or corrective action taken; and (7) Any reply to the complainant. (b) Records of servicing activities. In adhering to Clause 7.5.4 in ISO 13485, Servicing Activities, the manufacturer must record the following information, at a minimum, for servicing activities: (1) The name of the device serviced; (2) Any UDI or UPC, and any other device identification(s); (3) The date of service; (4) The individual(s) who serviced the device; (5) The service performed; and (6) Any test and inspection data. (c) Unique Device Identification. In addition to the requirements of Clauses 7.5.1, 7.5.8, and 7.5.9 in ISO 13485, the UDI must be recorded for each medical device or batch of medical devices. (d) Confidentiality. Records deem… | ||||
| 21:21:8.0.1.1.12.2.1.3 | 21 | Food and Drugs | I | H | 820 | PART 820—QUALITY MANAGEMENT SYSTEM REGULATION | B | Subpart B—Supplemental Provisions | § 820.40 [Reserved] | FDA | |||||
| 21:21:8.0.1.1.12.2.1.4 | 21 | Food and Drugs | I | H | 820 | PART 820—QUALITY MANAGEMENT SYSTEM REGULATION | B | Subpart B—Supplemental Provisions | § 820.45 Device labeling and packaging controls. | FDA | In addition to the requirements of Clause 7.5.1 of ISO 13485 (incorporated by reference, see § 820.7), Control of production and service provision, each manufacturer must document and maintain procedures that provide a detailed description of the activities to ensure the integrity, inspection, storage, and operations for labeling and packaging, during the customary conditions of processing, storage, handling, distribution, and, as appropriate, use of the device. (a) The manufacturer must ensure labeling and packaging has been examined for accuracy prior to release or storage where applicable, to include the following: (1) The correct unique device identifier (UDI) or universal product code (UPC), or any other device identification(s); (2) Expiration date; (3) Storage instructions; (4) Handling instructions; and (5) Any additional processing instructions. (b) The release of the labeling for use must be documented in accordance with Clause 4.2.5 of ISO 13485. (c) The manufacturer must ensure labeling and packaging operations have been established and maintained to prevent mixups, including, but not limited to, inspection of the labeling and packaging before use to assure that all devices have correct labeling and packaging, as specified in the medical device file. Results of such labeling inspection must be documented in accordance with Clause 4.2.5 of ISO 13485. |
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