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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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| 10:10:2.0.1.1.13.1.121.1 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | A | Subpart A—General Provisions | § 73.1 Purpose and scope. | NRC | [44 FR 68186, Nov. 28, 1979] | (a) Purpose. This part prescribes requirements for the establishment and maintenance of a physical protection system which will have capabilities for the protection of special nuclear material at fixed sites and in transit and of plants in which special nuclear material is used. The following design basis threats, where referenced in ensuing sections of this part, shall be used to design safeguards systems to protect against acts of radiological sabotage and to prevent the theft or diversion of special nuclear material. Licensees subject to the provisions of § 73.20 (except for fuel cycle licensees authorized under Part 70 of this chapter to receive, acquire, possess, transfer, use, or deliver for transportation formula quantities of strategic special nuclear material), §§ 73.50, and 73.60 are exempt from §§ 73.1(a)(1)(i)(E), 73.1(a)(1)(iii), 73.1(a)(1)(iv), 73.1(a)(2)(iii), and 73.1(a)(2)(iv). Licensees subject to the provisions of § 72.212 are exempt from § 73.1(a)(1)(iv). (1) Radiological sabotage. (i) A determined violent external assault, attack by stealth, or deceptive actions, including diversionary actions, by an adversary force capable of operating in each of the following modes: A single group attacking through one entry point, multiple groups attacking through multiple entry points, a combination of one or more groups and one or more individuals attacking through multiple entry points, or individuals attacking through separate entry points, with the following attributes, assistance and equipment: (A) Well-trained (including military training and skills) and dedicated individuals, willing to kill or be killed, with sufficient knowledge to identify specific equipment or locations necessary for a successful attack; (B) Active (e.g., facilitate entrance and exit, disable alarms and communications, participate in violent attack) or passive (e.g., provide information), or both, knowledgeable inside assistance; (C) Suitable weapons, including hand-held automatic weapons, equipped with silencers and ha… | ||||
| 10:10:2.0.1.1.13.1.121.2 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | A | Subpart A—General Provisions | § 73.2 Definitions. | NRC | [38 FR 35430, Dec. 28, 1973] | As used in this part: (a) Terms defined in parts 50, 52, 70, and 95 of this chapter have the same meaning when used in this part. Adverse firearms background check means a firearms background check that has resulted in a “denied” or “delayed” NICS response from the Federal Bureau of Investigation (FBI). Appropriate Nuclear Regulatory Commission Regional Office listed in appendix A means: (1) For domestic shipments—the Regional Office within whose region the licensee who is responsible for the physical protection arrangements of the shipment is located. (2) For export shipments—the Regional Office within whose region the licensee who is responsible for the physical protection arrangements of the shipment is located, and the Regional Office for the region in which the last point of exit of the shipment from the U.S. is located. (3) For import shipments—the Regional Office within whose region the licensee who is responsible for the physical protection arrangements of the shipment is located, and the Regional Office for the region in which the first point of entry of the shipment into the U.S. is located. Armed escort means an armed person, not necessarily uniformed, whose primary duty is to accompany shipments of special nuclear material for the protection of such shipments against theft or radiological sabotage. Armed response personnel means persons, not necessarily uniformed, whose primary duty in the event of attempted theft of special nuclear material or radiological sabotage shall be to respond, armed and equipped, to prevent or delay such actions. Authorized individual means any individual, including an employee, a student, a consultant, or an agent of a licensee who has been designated in writing by a licensee to have responsibility for surveillance of or control over special nuclear material or to have unescorted access to areas where special nuclear material is used or stored. Background check includes, at a minimum, a Federal Bureau of Investigation (FBI) criminal history records check (in… | ||||
| 10:10:2.0.1.1.13.1.121.3 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | A | Subpart A—General Provisions | § 73.3 Interpretations. | NRC | [38 FR 35430, Dec. 28, 1973, as amended at 90 FR 55632, Dec. 3, 2025] | Except as specifically authorized by the Commission in writing, no interpretations of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be recognized as binding upon the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly. | ||||
| 10:10:2.0.1.1.13.1.121.4 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | A | Subpart A—General Provisions | § 73.4 Communications. | NRC | [68 FR 58819, Oct. 10, 2003, as amended at 73 FR 5725, Jan. 31, 2008; 74 FR 62684, Dec. 1, 2009; 80 FR 74981, Dec. 1, 2015; 83 FR 58723, Nov. 21, 2018; 84 FR 65646, Nov. 29, 2019; 88 FR 57879, Aug. 24, 2023] | Except where otherwise specified, all communications and reports concerning the regulations in this part and applications filed under them should be sent as follows: (a) By mail addressed to: ATTN: Document Control Desk, Director, Office of Nuclear Reactor Regulation, Director, Office of Nuclear Material Safety and Safeguards, or Director, Office of Nuclear Security and Incident Response, as appropriate, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; (b) By hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland 20852-2783; (c) Where practicable, by electronic submission, for example, Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to MSHD.Resource@nrc.gov; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information. (d) Classified communications shall be transmitted to the NRC Headquarters' classified mailing address as specified in appendix A to part 73 of this chapter or delivered by hand in accordance with this paragraph. | ||||
| 10:10:2.0.1.1.13.1.121.5 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | A | Subpart A—General Provisions | § 73.5 Specific exemptions. | NRC | The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security, and are otherwise in the public interest. | |||||
| 10:10:2.0.1.1.13.1.121.6 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | A | Subpart A—General Provisions | § 73.6 Exemptions for certain quantities and kinds of special nuclear material. | NRC | [40 FR 52841, Nov. 13, 1975, as amended at 44 FR 68187, Nov. 28, 1979; 58 FR 31471, June 3, 1993; 78 FR 34250, June 7, 2013; 86 FR 43402, Aug. 9, 2021] | A licensee is exempt from the requirements of 10 CFR part 26 and §§ 73.20, 73.25, 73.26, 73.27, 73.45, 73.46, 73.70 and 73.72 with respect to the following special nuclear material: (a) Uranium-235 contained in uranium enriched to less than 20 percent in the U-235 isotope. (b) Special nuclear material which is not readily separable from other radioactive material and which has a total external radiation level in excess of 1 gray (100 rad) per hour at a distance of 1 meter (3.3 feet) from any accessible surface without intervening shielding. (c) Special nuclear material in a quantity not exceeding 350 grams of uranium-235, uranium-233, plutonium, or a combination thereof, possessed in any analytical, research, quality control, metallurgical or electronic laboratory. (d) Special nuclear material that is being transported by the United States Department of Energy transport system. (e) Special nuclear material at non-power reactors. Licensees subject to § 73.60 are not exempted from §§ 73.70 and 73.72, and licensees subject to § 73.67(e) are not exempted from § 73.72 of this part. | ||||
| 10:10:2.0.1.1.13.1.121.7 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | A | Subpart A—General Provisions | § 73.8 Information collection requirements: OMB approval. | NRC | [62 FR 52189, Oct. 6, 1997, as amended at 67 FR 67101, Nov. 4, 2002; 73 FR 63574, Oct. 24, 2008; 74 FR 13970, Mar. 27, 2009; 77 FR 39909, July 6, 2012; 78 FR 29550, May 20, 2013; 80 FR 67275, Nov. 2, 2015; 80 FR 74981, Dec. 1, 2015; 88 FR 15882, Mar. 14, 2023] | (a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information is it does not display a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control number 3150-0002. (b) The approved information collection requirements contained in this part appear in §§ 73.5, 73.15, 73.17, 73.20, 73.21, 73.24, 73.25, 73.26, 73.27, 73.37, 73.40, 73.45, 73.46, 73.50, 73.54, 73.55, 73.56, 73.57, 73.58, 73.60, 73.67, 73.70, 73.72, 73.73, 73.74, 73.1200, 73.1205, 73.1210, 73.1215, and appendices B and C to this part. (c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. These information collection requirements and control numbers under which they are approved are as follows: (1) In § 73.17, NRC Form 754 is approved under control number 3150-0204; (2) In §§ 73.17 and 73.57, Federal Bureau of Investigation Form FD-258 is approved under control number 1110-0046; and (3) In § 73.1205, NRC Form 366 is approved under control number 3150-0104. | ||||
| 10:10:2.0.1.1.13.11.121.1 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | T | Subpart T—Security Notifications, Reports, and Recordkeeping | § 73.1200 Notification of physical security events. | NRC | (a) 15-minute notifications—facilities. Each licensee subject to the provisions of § 73.20, § 73.45, § 73.46, § 73.51, or § 73.55 of this part must notify the NRC Headquarters Operations Center, as soon as possible but within 15 minutes after— (1) The licensee's initiation of a security response in accordance with its safeguards contingency plan or protective strategy, based on an imminent or actual hostile action against a licensee's facility; or (2) The licensee's notification by law enforcement or government officials of a potential hostile action or act of sabotage anticipated within the next 12 hours against a licensee's facility. (3) Licensee notifications to the NRC must: (i) Identify the facility's name; and (ii) Briefly describe the nature of the hostile action or event, including: (A) The type of hostile action or event (e.g., armed assault, vehicle bomb, bomb threat, sabotage, etc.); and (B) The current status ( i.e., imminent, in progress, or neutralized). (4) Notifications must be made according to paragraph (o) of this section, as applicable. (5) The licensee is not required to notify the NRC of security responses initiated as a result of threat or warning information communicated to the licensee from the NRC. (6) The licensee's request for immediate local law enforcement agency (LLEA) assistance or initiation of a contingency response may take precedence over the notification to the NRC. However, in such instances, the licensee must notify the NRC as soon as possible thereafter. (b) 15-minute notifications—shipments. Each licensee subject to the provisions of § 73.20, § 73.25, § 73.26, or § 73.37 or its designated movement control center must notify the NRC Headquarters Operations Center, as soon as possible but within 15 minutes after— (1) The licensee's initiation of a security response in accordance with its safeguards contingency plan or protective strategy, based on an imminent or actual hostile action against a shipment of Category I SSNM, spent nuclear fuel (SNF), or high-le… | |||||
| 10:10:2.0.1.1.13.11.121.2 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | T | Subpart T—Security Notifications, Reports, and Recordkeeping | § 73.1205 Written follow-up reports of physical security events. | NRC | (a) General requirements. (1) Licensees making a telephonic notification under § 73.1200 of this part must also submit a written follow-up report to the NRC within 60 days of such notifications, in accordance with § 73.4. (2) As an exemption, licensees are not required to submit a written follow-up report subsequent to a telephonic notification made— (i) Under the provisions of § 73.1200(e) and (f) regarding interactions with a Federal, State, or local law-enforcement agency; (ii) Under the provisions of § 73.1200(m) regarding lost or stolen enhanced weapons; or (iii) Under the provisions of § 73.1200(n) regarding adverse findings from the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) for enhanced weapons possessed by the licensee. (3)(i) Licensees are not required to submit a written follow-up report if the licensee subsequently retracts a telephonic notification made under § 73.1200 as invalid, not reportable under § 73.1200, or recharacterized as recordable under § 73.1210 (instead of reportable under § 73.1200), and has not yet submitted a written follow-up report under this section. (ii) If the licensee subsequently retracts a telephonic notification made under § 73.1200 after it has submitted a written follow-up report under this section, then the licensee must submit a revised written follow-up report documenting the retraction. (b) Submission criteria. (1) Each licensee must submit to the NRC written follow-up reports that contain sufficient information for NRC analysis and evaluation and are of a quality that will permit legible reproduction and processing. (2)(i) Licensees subject to § 50.73 of this chapter must prepare the written follow-up report on NRC Form 366. (ii) Licensees not subject to § 50.73 of this chapter must prepare the written follow-up report in a letter format. (3)(i) If significant supplemental information becomes available after the submission of the initial written follow-up report, then the licensee must submit a revised report with the revisions indicated… | |||||
| 10:10:2.0.1.1.13.11.121.3 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | T | Subpart T—Security Notifications, Reports, and Recordkeeping | § 73.1210 Recordkeeping of physical security events. | NRC | (a) Objective and purpose. (1) Licensees with facilities or shipment activities subject to the provisions of § 73.20, § 73.25, § 73.26, § 73.27, § 73.37, § 73.45, § 73.46, § 73.50, § 73.51, § 73.55, § 73.60, or § 73.67, must record the physical security events and conditions adverse to security that are specified in paragraphs (c) through (f) of this section. (2) These records facilitate the licensee's monitoring of the effectiveness of its physical security program. These records also facilitate the licensee's effective tracking, trending, and performance monitoring of these security events and conditions adverse to security; and the subsequent identification and implementation of corrective actions to prevent recurrence. (3) These physical security events and conditions adverse to security include, but are not limited to, human performance security errors; failure to comply with security procedures; insufficient or inadequate security procedures; security equipment failures and malfunctions; security structures, systems, and components design deficiencies; and inadequate or insufficient security structures, systems, and components. This includes events or conditions where the licensee has implemented compensatory measures within the required timeframe specified in its physical security plan. (b) General requirements. (1) Licensees must record within 24 hours of the time of discovery the physical security events and conditions adverse to security specified in paragraphs (c) through (f) of this section. (2) Licensees must retain these records for a period up to 3 years after the last entry is recorded, or until their license is terminated, whichever is later. (3)(i) Licensees must record these physical security events and conditions adverse to security in either a stand-alone safeguards event log or as part of the licensee's corrective action program, as specified under the applicable quality assurance program provisions of parts 50, 52, 60, 63, 70, and 72 of this chapter, or both. (ii) Licensees choosi… | |||||
| 10:10:2.0.1.1.13.11.121.4 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | T | Subpart T—Security Notifications, Reports, and Recordkeeping | § 73.1215 Suspicious activity reports. | NRC | (a) Purpose. This section sets forth the reporting criteria and process for licensees to use in reporting suspicious activities. Licensees are required to report suspicious activities to the local law enforcement agency (LLEA), the Federal Bureau of Investigation (FBI) local field office, the NRC, and the Federal Aviation Administration (FAA) local control tower if aircraft are a part of the suspicious activity. (b) Objective. (1) A licensee's timely submission of suspicious activity reports (SARs) to Federal and local law enforcement agencies is an important part of the U.S. government's efforts to disrupt or dissuade malevolent acts against the nation's critical infrastructure. Despite the increasingly fluid and unpredictable nature of the threat environment, some elements of terrorist tactics, techniques, and procedures remain constant. For example, attack planning and preparation generally proceed through several predictable stages, including intelligence gathering and preattack surveillance or reconnaissance. These preattack stages, in particular, offer law enforcement and security personnel a significant opportunity to identify and disrupt or dissuade acts of terrorism before they occur. However, to use this information most effectively, timely reporting of suspicious activities by licensees to both Federal and local law enforcement is of vital importance. (2) Licensee's timely submission of SARs to the NRC supports one of the agency's primary mission essential functions of threat assessment for licensed facilities, materials, and shipping activities. (c) General requirements. (1)(i) Licensees subject to paragraphs (d), (e), and (f) of this section must report suspicious activities that are applicable to their facility, material, or shipping activity. (ii) If a suspicious activity requires a physical security event notification pursuant to § 73.1200, then the licensee is not required to also report the occurrence as a suspicious activity pursuant to this section. (iii) If a suspicious activity re… | |||||
| 10:10:2.0.1.1.13.2.121.1 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | B | Subpart B—Enhanced Weapons, Preemption, and Firearms Background Checks | § 73.15 Authorization for use of enhanced weapons and preemption of firearms laws. | NRC | (a) Purpose. This section presents the requirements for licensees to obtain approval to use the authority provided to the Commission under Section 161A of the Atomic Energy Act of 1954, as amended (AEA), in protecting Commission-designated classes of facilities, radioactive material, or other property. This authority includes “stand-alone preemption authority” and “combined preemption authority and enhanced weapons authority.” (b) General Requirements. (1) Licensees of facilities, activities, and other property listed in paragraph (c) of this section may apply to the NRC, in accordance with the provisions of this section, to receive stand-alone preemption authority or combined preemption authority and enhanced weapons authority. (2) With respect to the possession and use of firearms by all other NRC licensees, the Commission's requirements in effect before April 13, 2023 remain applicable, except to the extent that those requirements are modified by an NRC order or regulations applicable to these licensees. (c) Applicability. (1) Stand-alone preemption authority. The license holders for the following classes of facilities, radioactive material, or other property are designated by the Commission as eligible to apply for stand-alone preemption authority pursuant to 42 U.S.C. 2201a— (i) Nuclear power reactor facilities; (ii) Facilities authorized to possess or use a formula quantity or greater of strategic special nuclear material, where the material has a radiation level less than or equal to 1 gray (Gy) (100 Rad) per hour at a distance of 1 meter (m) (3.3 feet (ft)), without regard to any intervening shielding; (iii) Independent spent fuel storage installations; and (iv) Spent nuclear fuel transportation. (2) Combined preemption authority and enhanced weapons authority. The license holders for the following classes of facilities, radioactive material, or other property are designated by the Commission as eligible to apply for combined enhanced weapons authority and preemption authority pursuant to 42… | |||||
| 10:10:2.0.1.1.13.2.121.2 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | B | Subpart B—Enhanced Weapons, Preemption, and Firearms Background Checks | § 73.17 Firearms background checks for armed security personnel. | NRC | [88 FR 15882, Mar. 14, 2023, as amended at 89 FR 51810, June 20, 2024] | (a) Purpose. This section presents the requirements for completion of firearms background checks pursuant to Section 161A of the Atomic Energy Act, as amended (AEA) (42 U.S.C. 2201a), for security personnel whose official duties require access to covered weapons at Commission-designated classes of facilities, radioactive material, or other property specified in § 73.15(c). Firearms background checks are intended to verify that such armed security personnel are not prohibited from receiving, possessing, transporting, importing, or using covered weapons under applicable Federal, State, or local law. (b) General Requirements. (1) Licensees that have applied to the NRC under § 73.15 of this part for stand-alone preemption authority or for combined preemption authority and enhanced weapons authority must comply with the provisions of this section. Such licensees must establish a Firearms Background Check Plan. Licensees must establish this plan as part of their overall NRC-approved Training and Qualification plan for security personnel whose official duties require access to covered weapons. (2) For the purposes of § 73.15 and this section only, the term security personnel whose official duties require access to covered weapons includes, but is not limited to, the following groups of individuals: (i) Security officers using covered weapons to protect a Commission-designated facility, radioactive material, or other property; (ii) Security officers undergoing firearms training on covered weapons; (iii) Firearms-training instructors conducting training on covered weapons; (iv) Armorers conducting maintenance, repair, and testing of covered weapons; (v) Individuals with access to armories and weapons storage lockers containing covered weapons; (vi) Individuals conducting inventories of enhanced weapons; (vii) Individuals removing enhanced weapons from the site for repair, training, and escort-duty purposes; and (viii) Individuals whose duties require access to covered weapons, whether the individuals are emp… | ||||
| 10:10:2.0.1.1.13.3.121.1 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | C | Subpart C—General Performance Objective for Protection of Strategic Special Nuclear Material | § 73.20 General performance objective and requirements. | NRC | [44 FR 68188, Nov. 28, 1979, as amended at 57 FR 33430, July 29, 1992] | (a) In addition to any other requirements of this part, each licensee who is authorized to operate a fuel reprocessing plant pursuant to part 50 of this chapter; possesses or uses formula quantities of strategic special nuclear material at any site or contiguous sites subject to control by the licensee; is authorized to transport or deliver to a carrier for transportation pursuant to part 70 of this chapter formula quantities of strategic special nuclear material; takes delivery of formula quantities of strategic special nuclear material free on board (f.o.b.) the point at which it is delivered to a carrier for transportation; or imports or exports formula quantities of strategic special nuclear material, shall establish and maintain or make arrangements for a physical protection system which will have as its objective to provide high assurance that activities involving special nuclear material are not inimical to the common defense and security, and do not constitute an unreasonable risk to the public health and safety. The physical protection system shall be designed to protect against the design basis threats of theft or diversion of strategic special nuclear material and radiological sabotage as stated in § 73.1(a). (b) To achieve the general performance objective of paragraph (a) of this section a licensee shall establish and maintain, or arrange for, a physical protection system that: (1) Provides the performance capabilities described in § 73.25 for in-transit protection or in § 73.45 for fixed site protection unless otherwise authorized by the Commission; (2) Is designed with sufficient redundancy and diversity to ensure maintenance of the capabilities described in §§ 73.25 and 73.45; (3) Includes a safeguards contingency capability that can meet the criteria in appendix C to this part “Licensee Safeguards Contingency Plans;” and (4) Includes a testing and maintenance program to assure control over all activities and devices affecting the effectiveness, reliability, and availability of the physical p… | ||||
| 10:10:2.0.1.1.13.4.121.1 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | D | Subpart D—Protection of Safeguards Information | § 73.21 Protection of Safeguards Information: Performance requirements. | NRC | [73 FR 63574, Oct. 24, 2008, as amended at 77 FR 34205, June 11, 2012; 79 FR 58671, Sept. 30, 2014; 89 FR 106253, Dec. 30, 2024] | (a) General performance requirement. (1) Each licensee, certificate holder, applicant, or other person who produces, receives, or acquires Safeguards Information (including Safeguards Information with the designation or marking: Safeguards Information—Modified Handling) shall ensure that it is protected against unauthorized disclosure. To meet this general performance requirement, such licensees, certificate holders, applicants, or other persons subject to this section shall: (i) Establish, implement, and maintain an information protection system that includes the applicable measures for Safeguards Information specified in § 73.22 related to: Power reactors; a formula quantity of strategic special nuclear material; transportation of or delivery to a carrier for transportation of a formula quantity of strategic special nuclear material or more than 100 grams of irradiated reactor fuel; uranium hexafluoride production or conversion facilities; fuel fabrication facilities; uranium enrichment facilities; independent spent fuel storage installations; and geologic repository operations areas. (ii) Establish, implement, and maintain an information protection system that includes the applicable measures for Safeguards Information specified in § 73.23 related to: non-power reactors that possess special nuclear material of moderate strategic significance or special nuclear material of low strategic significance. (iii) Protect the information in accordance with the requirements of § 73.22 if the Safeguards Information is not described in paragraphs (a)(1)(i) and (a)(1)(ii) of this section. (2) Information protection procedures employed by Federal, State, Tribal, and local law enforcement agencies are presumed to meet the general performance requirement in paragraph (a)(1) of this section. (b) Commission authority. (1) Pursuant to Section 147 of the Atomic Energy Act of 1954, as amended, the Commission may impose, by order or regulation, Safeguards Information protection requirements different from or in addition t… | ||||
| 10:10:2.0.1.1.13.4.121.2 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | D | Subpart D—Protection of Safeguards Information | § 73.22 Protection of Safeguards Information: Specific requirements. | NRC | [73 FR 63574, Oct. 24, 2008, as amended at 80 FR 67275, Nov. 2, 2015; 88 FR 15890, Mar. 14, 2023] | This section contains specific requirements for the protection of Safeguards Information in the hands of any person subject to the requirements of § 73.21(a)(1)(i) and related to power reactors; a formula quantity of strategic special nuclear material; transportation of or delivery to a carrier for transportation of a formula quantity of strategic special nuclear material or more than 100 grams of irradiated reactor fuel; uranium hexafluoride production or conversion facilities, fuel fabrication facilities, and uranium enrichment facilities; independent spent fuel storage installations; geologic repository operations areas and Safeguards Information in the hands of any person subject to the requirements of § 73.21(a)(1)(iii). (a) Information to be protected. The types of information and documents that must be protected as Safeguards Information include non-public security-related requirements such as: (1) Physical protection. Information not classified as Restricted Data or National Security Information related to physical protection, including: (i) The composite physical security plan for the facility or site; (ii) Site-specific drawings, diagrams, sketches, or maps that substantially represent the final design features of the physical security system not easily discernible by members of the public; (iii) Alarm system layouts showing the location of intrusion detection devices, alarm assessment equipment, alarm system wiring, emergency power sources for security equipment, and duress alarms not easily discernible by members of the public; (iv) Physical security orders and procedures issued by the licensee for members of the security organization detailing duress codes, patrol routes and schedules, or responses to security contingency events; (v) Site-specific design features of plant security communications systems; (vi) Lock combinations, mechanical key design, or passwords integral to the physical security system; (vii) Documents and other matter that contain lists or locations of certain safety-r… | ||||
| 10:10:2.0.1.1.13.4.121.3 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | D | Subpart D—Protection of Safeguards Information | § 73.23 Protection of Safeguards Information—Modified Handling: Specific requirements. | NRC | [73 FR 63577, Oct. 24, 2008, as amended at 88 FR 15890, Mar. 14, 2023; 89 FR 106253, Dec. 30, 2024] | This section contains specific requirements for the protection of Safeguards Information in the hands of any person subject to the requirements of § 73.21(a)(1)(ii) and non-power reactors that possess special nuclear material of moderate strategic significance or special nuclear material of low strategic significance. The requirements of this section distinguish Safeguards Information requiring modified handling requirements (SGI-M) from the specific Safeguards Information handling requirements applicable to facilities and materials needing a higher level of protection, as set forth in § 73.22. (a) Information to be protected. The types of information and documents that must be protected as Safeguards Information—Modified Handling include non-public security-related requirements such as protective measures, interim compensatory measures, additional security measures, and the following, as applicable: (1) Physical protection. Information not classified as Restricted Data or National Security Information related to physical protection, including: (i) The composite physical security plan for the facility or site; (ii) Site specific drawings, diagrams, sketches, or maps that substantially represent the final design features of the physical security system not easily discernible by members of the public; (iii) Alarm system layouts showing the location of intrusion detection devices, alarm assessment equipment, alarm system wiring, emergency power sources for security equipment, and duress alarms not easily discernible by members of the public; (iv) Physical security orders and procedures issued by the licensee for members of the security organization detailing duress codes, patrol routes and schedules, or responses to security contingency events; (v) Site specific design features of plant security communications systems; (vi) Lock combinations, mechanical key design, or passwords integral to the physical security system; (vii) The composite facility guard qualification and training plan/measures disclosin… | ||||
| 10:10:2.0.1.1.13.5.121.1 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | E | Subpart E—Physical Protection Requirements of Special Nuclear Material and Spent Nuclear Fuel in Transit | § 73.24 Prohibitions. | NRC | [44 FR 68188, Nov. 28, 1979, as amended at 53 FR 19257, May 27, 1988] | (a) Except as specifically approved by the Nuclear Regulatory Commission, no shipment of special nuclear material shall be made in passenger aircraft in excess of (1) 20 grams or 20 curies, whichever is less, of plutonium or uranium-233, or (2) 350 grams of uranium-235 (contained in uranium enriched to 20 percent or more in the U-235 isotope). (b) Unless otherwise approved by the Nuclear Regulatory Commission, no licensee may make shipments of special nuclear material in which individual shipments are less than a formula quantity, but the total quantity in shipments in transit at the same time could equal or exceed a formula quantity, unless either of the following conditions are met: (1) The licensee shall confirm and log the arrival at the final destination of each individual shipment and retain the log for three years from the date of the last entry in the log. The licensee shall also schedule shipments to ensure that the total quantity for two or more shipments in transit at the same time does not equal or exceed the formula quantity, or (2) Physical protection in accordance with the requirements of §§ 73.20, 73.25, and 73.26 is provided by the licensee for such shipments as appropriate so that the total quantity of special nuclear material in the remaining shipments not so protected, and in transit at the same time, does not equal or exceed a formula quantity. | ||||
| 10:10:2.0.1.1.13.5.121.2 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | E | Subpart E—Physical Protection Requirements of Special Nuclear Material and Spent Nuclear Fuel in Transit | § 73.25 Performance capabilities for physical protection of strategic special nuclear material in transit. | NRC | [44 FR 68188, Nov. 28, 1979] | (a) To meet the general performance objective and requirements of § 73.20 an in-transit physical protection system shall include the performance capabilities described in paragraphs (b) through (d) of this section unless otherwise authorized by the Commission. (b) Restrict access to and activity in the vicinity of transports and strategic special nuclear material. To achieve this capability the physical protection system shall: (1) Minimize the vulnerability of the strategic special nuclear material by using the following subfunctions and procedures: (i) Preplanning itineraries for the movement of strategic special nuclear material; (ii) Periodically updating knowledge of route conditions for the movement of strategic special nuclear material; (iii) Maintaining knowledge of the status and position of the strategic special nuclear material en route; and (iv) Determining and communicating alternative itineraries en route as conditions warrant. (2) Detect and delay any unauthorized attempt to gain access or introduce unauthorized materials by stealth or force into the vicinity of transports and strategic special nuclear material using the following subsystems and subfunctions: (i) Controlled access areas to isolate strategic special nuclear material and transports to assure that unauthorized persons shall not have direct access to, and unauthorized materials shall not be introduced into the vicinity of, the transports and strategic special nuclear material, and (ii) Access detection subsystems and procedures to detect, assess and communicate any unauthorized penetration (or such attempts) of a controlled access area by persons, vehicles or materials so that the response will satisfy the general performance objective and requirements of § 73.20(a). (3) Detect attempts to gain unauthorized access or introduce unauthorized materials into the vicinity of transports by deceit using the following subsystems and subfunctions: (i) Access authorization controls and procedures to provide current authorization sched… | ||||
| 10:10:2.0.1.1.13.5.121.3 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | E | Subpart E—Physical Protection Requirements of Special Nuclear Material and Spent Nuclear Fuel in Transit | § 73.26 Transportation physical protection systems, subsystems, components, and procedures. | NRC | [44 FR 68190, Nov. 28, 1979, as amended at 46 FR 2025, Jan. 8, 1981; 53 FR 19257, May 27, 1988; 57 FR 33430, July 29, 1992; 57 FR 61787, Dec. 29, 1992; 59 FR 50689, Oct. 5, 1994; 67 FR 3586, Jan. 25, 2002; 68 FR 14530, Mar. 26, 2003; 68 FR 23575, May 5, 2003; 74 FR 62684, Dec. 1, 2009; 83 FR 58723, Nov. 21, 2018] | (a) A transportation physical protection system established pursuant to the general performance objectives and requirements of § 73.20 and performance capability requirements of § 73.25 shall include, but are not necessarily limited to, the measures specified in paragraphs (b) through (l) of this section. The Commission may require, depending on the individual transportation conditions or circumstances, alternate or additional measures deemed necessary to meet the general performance objectives and requirements of § 73.20. The Commission also may authorize protection measures other than those required by this section if, in its opinion, the overall level of performance meets the general performance objectives and requirements of § 73.20 and the performance capability requirements of § 73.25. (b) Planning and scheduling. (1) Shipments shall be scheduled to avoid regular patterns and preplanned to avoid areas of natural disaster or civil disorders, such as strikes or riots. Such shipments shall be planned in order to avoid storage times in excess of 24 hours and to assure that deliveries occur at a time when the receiver at the final delivery point is present to accept the shipment. (2) Arrangements shall be made with law enforcement authorities along the route of shipments for their response to an emergency or a call for assistance. (3) Security arrangements for each shipment shall be approved by the Nuclear Regulatory Commission prior to the time for the seven-day notice required by § 73.72. Information to be supplied to the Commission in addition to the general security plan information is as follows: (i) Shipper, consignee, carriers, transfer points, modes of shipment, (ii) Point where escorts will relinquish responsibility or will accept responsibility for the shipment, (iii) Arrangements made for transfer of shipment security, and (iv) Security arrangements at point where escorts accept responsibility for an import shipment. (4) Hand-to-hand receipts shall be completed at origin and destination and … | ||||
| 10:10:2.0.1.1.13.5.121.4 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | E | Subpart E—Physical Protection Requirements of Special Nuclear Material and Spent Nuclear Fuel in Transit | § 73.27 Notification requirements. | NRC | [44 FR 68192, Nov. 28, 1979, as amended at 67 FR 3586, Jan. 25, 2002; 68 FR 14530, Mar. 26, 2003; 68 FR 23575, May 5, 2003; 74 FR 62684, Dec. 1, 2009; 83 FR 58723, Nov. 21, 2018; 88 FR 15890, Mar. 14, 2023] | (a)(1) A licensee who delivers formula quantities of strategic special nuclear material to a carrier for transport shall immediately notify the consignee by telephone, telegraph, or teletype, of the time of departure of the shipment, and shall notify or confirm with the consignee the method of transportation, including the names of carriers, and the estimated time of arrival of the shipment at its destination. (2) In the case of a shipment (f.o.b.) the point where it is delivered to a carrier for transport, a licensee shall, before the shipment is delivered to the carrier, obtain written certification from the licensee who is to take delivery of the shipment at the f.o.b. point that the physical protection arrangements required by §§ 73.25 and 73.26 for licensed shipments have been made. When a contractor exempt from the requirements for a Commission license is the consignee of a shipment, the licensee shall, before the shipment is delivered to the carrier, obtain written certification from the contractor who is to take delivery of the shipment at the f.o.b. point that the physical protection arrangements required by the United States Department of Energy Order Nos. 5632.1 or 5632.2, as appropriate, have been made. (3) A licensee who delivers formula quantities of strategic special nuclear material to a carrier for transport or releases such special nuclear material f.o.b. at the point where it is delivered to a carrier for transport shall also make arrangements with the consignee to be notified immediately by telephone and telegraph, teletype, or cable, of the arrival of the shipment at its destination or of any such shipment that is lost or unaccounted for after the estimated time of arrival at its destination. (b) Each licensee who receives a shipment of formula quantities of strategic special nuclear material shall immediately notify by telephone and telegraph or teletype, the person who delivered the material to a carrier for transport and the Director, Division of Physical and Cyber Security Policy, Offi… | ||||
| 10:10:2.0.1.1.13.5.121.5 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | E | Subpart E—Physical Protection Requirements of Special Nuclear Material and Spent Nuclear Fuel in Transit | § 73.28 Security background checks for secure transfer of nuclear materials. | NRC | [72 FR 3027, Jan. 24, 2007] | Licensees are excepted from the security background check provisions in Section 170I of the AEA if they have not received Orders from the Nuclear Regulatory Commission containing requirements for background checks for trustworthiness and reliability that include fingerprinting and criminal history record checks as a prerequisite for unescorted access to radioactive materials. | ||||
| 10:10:2.0.1.1.13.5.121.6 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | E | Subpart E—Physical Protection Requirements of Special Nuclear Material and Spent Nuclear Fuel in Transit | § 73.35 Requirements for physical protection of irradiated reactor fuel (100 grams or less) in transit. | NRC | [78 FR 17021, Mar. 19, 2013, as amended at 86 FR 43402, Aug. 9, 2021] | Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a quantity of irradiated reactor fuel weighing 100 grams (0.22 pounds) or less in net weight of irradiated fuel, exclusive of cladding or other structural or packaging material, which has a total external radiation level in excess of 1 Gray (100 rad) per hour at a distance of 1 meter (3.3 feet) from any accessible surface without intervening shielding, shall follow the physical protection requirements for category 1 quantities of radioactive material in subpart D of part 37 of this chapter. | ||||
| 10:10:2.0.1.1.13.5.121.7 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | E | Subpart E—Physical Protection Requirements of Special Nuclear Material and Spent Nuclear Fuel in Transit | § 73.37 Requirements for physical protection of irradiated reactor fuel in transit. | NRC | [78 FR 29550, May 20, 2013, as amended at 79 FR 75741, Dec. 19, 2014; 80 FR 74981, Dec. 1, 2015; 83 FR 30288, June 28, 2018; 83 FR 58723, Nov. 21, 2018; 86 FR 43403, Aug. 9, 2021; 88 FR 15890, Mar. 14, 2023] | (a) Performance objectives. (1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a quantity of irradiated reactor fuel 1 in excess of 100 grams (0.22 lbs) in net weight of irradiated fuel, exclusive of cladding or other structural or packaging material, which has a total external radiation level in excess of 1 gray (100 rad) per hour at a distance of 1 meter (3.3 feet) from any accessible surface without intervening shielding, shall establish and maintain, or make arrangements for, and assure the proper implementation of, a physical protection system for shipments of such material that will achieve the following objectives: 1 For purposes of 10 CFR 73.37, the terms “irradiated reactor fuel” and “spent nuclear fuel” are used interchangeably. (i) Minimize the potential for theft, diversion, or radiological sabotage of spent nuclear fuel shipments; and (ii) Facilitate the location and recovery of spent nuclear fuel shipments that may have come under the control of unauthorized persons. (2) To achieve these objectives, the physical protection system shall: (i) Provide for early detection and assessment of attempts to gain unauthorized access to, or control over, spent nuclear fuel shipments; (ii) Delay and impede attempts at theft, diversion, or radiological sabotage of spent nuclear fuel shipments; and (iii) Provide for notification to the appropriate response forces of any attempts at theft, diversion, or radiological sabotage of a spent nuclear fuel shipment. (b) General requirements. To achieve the performance objectives of paragraph (a) of this section, a physical protection system established and maintained, or arranged for, by the licensee shall include the following elements: (1) Preplan and coordinate spent nuclear fuel shipments. Each licensee shall: (i) Ensure that each armed escort, as defined in § 73.2, is instructed on the use of force sufficient to counter the force directed at the person, including the use of deadly force when the armed… | ||||
| 10:10:2.0.1.1.13.5.121.8 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | E | Subpart E—Physical Protection Requirements of Special Nuclear Material and Spent Nuclear Fuel in Transit | § 73.38 Personnel access authorization requirements for irradiated reactor fuel in transit. | NRC | [78 FR 29553, May 20, 2013] | (a) General. (1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a quantity of spent nuclear fuel as described in § 73.37(a)(1) of this part shall comply with the requirements of this section, as appropriate, before any spent nuclear fuel is transported or delivered to a carrier for transport. (2) Each licensee shall establish, implement, and maintain its access authorization program under the requirements of this section. (i) Each licensee shall be responsible for the continuing effectiveness of the access authorization program. (ii) Each licensee shall ensure that the access authorization program is reviewed at an appropriate frequency to confirm compliance with the requirements of this section and that prompt comprehensive actions are taken to correct any noncompliance that is identified. (iii) The review shall evaluate all program performance objectives and requirements. (iv) Each review report must document conditions that are adverse to the proper performance of the access authorization program, the cause of the condition(s), and when appropriate, recommended corrective actions, and corrective actions taken. The licensee shall review the audit findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated. (3) By August 19, 2013, each licensee that is subject to this provision shall implement the requirements of this section through revisions to its physical security plan or transportation security plan. (b) General performance objective. The licensee's access authorization program must ensure that the individuals specified in paragraph (c) of this section are trustworthy and reliable such that they do not constitute an unreasonable risk to public health and safety or the common defense and security. (c) Applicability. (1) Licensees shall subject the following individuals to an access authorization program: (i) Any individual to whom a licensee inte… | ||||
| 10:10:2.0.1.1.13.6.121.1 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | F | Subpart F—Physical Protection Requirements at Fixed Sites | § 73.40 Physical protection: General requirements at fixed sites. | NRC | [58 FR 13700, Mar. 15, 1993] | Each licensee shall provide physical protection at a fixed site, or contiguous sites where licensed activities are conducted, against radiological sabotage, or against theft of special nuclear material, or against both, in accordance with the applicable sections of this Part for each specific class of facility or material license. If applicable, the licensee shall establish and maintain physical security in accordance with security plans approved by the Nuclear Regulatory Commission. | ||||
| 10:10:2.0.1.1.13.6.121.2 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | F | Subpart F—Physical Protection Requirements at Fixed Sites | § 73.45 Performance capabilities for fixed site physical protection systems. | NRC | [44 FR 68193, Nov. 28, 1979] | (a) To meet the general performance requirements of § 73.20 a fixed site physical protection system shall include the performance capabilities described in paragraphs (b) through (g) of this section unless otherwise authorized by the Commission. (b) Prevent unauthorized access of persons, vehicles and materials into material access areas and vital areas. To achieve this capability the physical protection system shall: (1) Detect attempts to gain unauthorized access or introduce unauthorized material across material access or vital area boundaries by stealth or force using the following subsystems and subfunctions: (i) Barriers to channel persons and material to material access and vital area entry control points and to delay any unauthorized penetration attempts by persons or materials sufficient to assist detection and permit a response that will prevent the penetration; and (ii) Access detection subsystems and procedures to detect, assess and communicate any unauthorized penetration attempts by persons or materials at the time of the attempt so that the response can prevent the unauthorized access or penetration. (2) Detect attempts to gain unauthorized access or introduce unauthorized materials into material access areas or vital areas by deceit using the following subsystems and subfunctions: (i) Access authorization controls and procedures to provide current authorization schedules and entry criteria for both persons and materials; and (ii) Entry controls and procedures to verify the identity of persons and materials and assess such identity against current authorization schedules and entry criteria before permitting entry and to initiate response measures to deny unauthorized entries. (c) Permit only authorized activities and conditions within protected areas, material access areas, and vital areas. To achieve this capability the physical protection system shall: (1) Detect unauthorized activities or conditions within protected areas, material access areas and vital areas using the following subsys… | ||||
| 10:10:2.0.1.1.13.6.121.3 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | F | Subpart F—Physical Protection Requirements at Fixed Sites | § 73.46 Fixed site physical protection systems, subsystems, components, and procedures. | NRC | [44 FR 68194, Nov. 28, 1979, as amended at 53 FR 19258, May 27, 1988; 53 FR 23383, June 22, 1988; 53 FR 45452, Nov. 10, 1988; 57 FR 33430, July 29, 1992; 58 FR 29522, May 21, 1993; 58 FR 45784, Aug. 31, 1993; 59 FR 38348, July 28, 1994; 79 FR 75741, Dec. 19, 2014; 84 FR 65646, Nov. 29, 2019] | (a) A licensee physical protection system established pursuant to the general performance objective and requirements of § 73.20(a) and the performance capability requirements of § 73.45 shall include, but are not necessarily limited to, the measures specified in paragraphs (b) through (h) of this section. The Commission may require, depending on individual facility and site conditions, alternate or additional measures deemed necessary to meet the general performance objective and requirements of § 73.20. The Commission also may authorize protection measures other than those required by this section if, in its opinion, the overall level of performance meets the general performance objective and requirements of § 73.20 and the performance capability requirements of § 73.45. (b) Security organization. (1) The licensee shall establish a security organization, including guards. If a contract guard force is utilized for site security, the licensee's written agreement with the contractor will clearly show that (i) the licensee is responsible to the Commission for maintaining safeguards in accordance with Commission regulations and the licensee's security plan, (ii) the NRC may inspect, copy, and take away copies of all reports and documents required to be kept by Commission regulations, orders, or applicable license conditions whether such reports and documents are kept by the licensee or the contractor, (iii) the requirement, in § 73.46(b)(4) of this section that the licensee demonstrate the ability of physical security personnel to perform their assigned duties and responsibilities, include demonstration of the ability of the contractor's physical security personnel to perform their assigned duties and responsibilities in carrying out the provisions of the Security Plan and these regulations, and (iv) the contractor will not assign any personnel to the site who have not first been made aware of these responsibilities. (2) The licensee shall have onsite at all times at least one full time member of the security org… | ||||
| 10:10:2.0.1.1.13.6.121.4 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | F | Subpart F—Physical Protection Requirements at Fixed Sites | § 73.50 Requirements for physical protection of licensed activities. | NRC | [38 FR 35430, Dec. 28, 1973, as amended at 42 FR 64103, Dec. 22, 1977; 43 FR 11965, Mar. 23, 1978; 43 FR 37426, Aug. 23, 1978; 44 FR 68198, Nov. 28, 1979; 53 FR 19259, May 27, 1988; 57 FR 33430, July 29, 1992; 57 FR 61787, Dec. 29, 1992; 59 FR 50689, Oct. 5, 1994; 63 FR 26962, May 15, 1998; 72 FR 49561, Aug. 28, 2007; 86 FR 43403, Aug. 9, 2021; 88 FR 57879, Aug. 24, 2023] | Each licensee who is not subject to § 73.51, but who possesses, uses, or stores formula quantities of strategic special nuclear material that are not readily separable from other radioactive material and which have a total external radiation level in excess of 1 gray (100 rad) per hour at a distance of 1 meter (3.3 feet) from any accessible surfaces without intervening shielding other than at a nuclear reactor facility licensed under parts 50 or 52 of this chapter, shall comply with the following: (a) Physical security organization. (1) The licensee shall establish a security organization, including guards, to protect his facility against radiological sabotage and the special nuclear material in his possession against theft. (2) At least one supervisor of the security organization shall be on site at all times. (3) The licensee shall establish, maintain, and follow written security procedures that document the structure of the security organization and detail the duties of guards, watchmen, and other individuals responsible for security. The licensee shall retain a copy of the current procedures as a record until the Commission terminates each license for which the procedures were developed and, if any portion of the procedures is superseded, retain the superseded material for three years after each change. (4) The licensee may not permit an individual to act as a guard, watchman, armed response person, or other member of the security organization unless the individual has been trained, equipped, and qualified to perform each assigned security job duty in accordance with appendix B, “General Criteria for Security Personnel,” to this part. Upon the request of an authorized representative of the Commission, the licensee shall demonstrate the ability of the physical security personnel to carry out their assigned duties and responsibilities. Each guard, watchman, armed response person, and other member of the security organization shall requalify in accordance with appendix B to this part at least every 12 mont… | ||||
| 10:10:2.0.1.1.13.6.121.5 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | F | Subpart F—Physical Protection Requirements at Fixed Sites | § 73.51 Requirements for the physical protection of stored spent nuclear fuel and high-level radioactive waste. | NRC | [63 FR 26962, May 15, 1998, as amended at 63 FR 49414, Sept. 16, 1998; 66 FR 55816, Nov. 2, 2001; 88 FR 15890, Mar. 14, 2023] | (a) Applicability. Notwithstanding the provisions of §§ 73.20, 73.50, or 73.67, the physical protection requirements of this section apply to each licensee that stores spent nuclear fuel and high-level radioactive waste pursuant to paragraphs (a)(1)(i), (ii), and (2) of this section. This includes— (1) Spent nuclear fuel and high-level radioactive waste stored under a specific license issued pursuant to part 72 of this chapter: (i) At an independent spent fuel storage installation (ISFSI) or (ii) At a monitored retrievable storage (MRS) installation; or (2) Spent nuclear fuel and high-level radioactive waste at a geologic repository operations area (GROA) licensed pursuant to part 60 or 63 of this chapter; (b) General performance objectives. (1) Each licensee subject to this section shall establish and maintain a physical protection system with the objective of providing high assurance that activities involving spent nuclear fuel and high-level radioactive waste do not constitute an unreasonable risk to public health and safety. (2) To meet the general objective of paragraph (b)(1) of this section, each licensee subject to this section shall meet the following performance capabilities. (i) Store spent nuclear fuel and high-level radioactive waste only within a protected area; (ii) Grant access to the protected area only to individuals who are authorized to enter the protected area; (iii) Detect and assess unauthorized penetration of, or activities within, the protected area; (iv) Provide timely communication to a designated response force whenever necessary; and (v) Manage the physical protection organization in a manner that maintains its effectiveness. (3) The physical protection system must be designed to protect against loss of control of the facility that could be sufficient to cause a radiation exposure exceeding the dose as described in § 72.106 of this chapter. (4)(i) The licensee must ensure that the firearms background check requirements of § 73.17 of this part are met for all members o… | ||||
| 10:10:2.0.1.1.13.6.121.6 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | F | Subpart F—Physical Protection Requirements at Fixed Sites | § 73.54 Protection of digital computer and communication systems and networks. | NRC | [74 FR 13970, Mar. 27, 2009, as amended at 80 FR 67275, Nov. 2, 2015] | By November 23, 2009 each licensee currently licensed to operate a nuclear power plant under part 50 of this chapter shall submit, as specified in § 50.4 and § 50.90 of this chapter, a cyber security plan that satisfies the requirements of this section for Commission review and approval. Each submittal must include a proposed implementation schedule. Implementation of the licensee's cyber security program must be consistent with the approved schedule. Current applicants for an operating license or combined license who have submitted their applications to the Commission prior to the effective date of this rule must amend their applications to include a cyber security plan consistent with this section. (a) Each licensee subject to the requirements of this section shall provide high assurance that digital computer and communication systems and networks are adequately protected against cyber attacks, up to and including the design basis threat as described in § 73.1. (1) The licensee shall protect digital computer and communication systems and networks associated with: (i) Safety-related and important-to-safety functions; (ii) Security functions; (iii) Emergency preparedness functions, including offsite communications; and (iv) Support systems and equipment which, if compromised, would adversely impact safety, security, or emergency preparedness functions. (2) The licensee shall protect the systems and networks identified in paragraph (a)(1) of this section from cyber attacks that would: (i) Adversely impact the integrity or confidentiality of data and/or software; (ii) Deny access to systems, services, and/or data; and (iii) Adversely impact the operation of systems, networks, and associated equipment. (b) To accomplish this, the licensee shall: (1) Analyze digital computer and communication systems and networks and identify those assets that must be protected against cyber attacks to satisfy paragraph (a) of this section, (2) Establish, implement, and maintain a cyber security program for the protectio… | ||||
| 10:10:2.0.1.1.13.6.121.7 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | F | Subpart F—Physical Protection Requirements at Fixed Sites | § 73.55 Requirements for physical protection of licensed activities in nuclear power reactors against radiological sabotage. | NRC | [74 FR 13971, Mar. 27, 2009, as amended at 77 FR 39909, July 6, 2012; 88 FR 15891, Mar. 14, 2023] | (a) Introduction. (1) By March 31, 2010, each nuclear power reactor licensee, licensed under 10 CFR part 50, shall implement the requirements of this section through its Commission-approved Physical Security Plan, Training and Qualification Plan, Safeguards Contingency Plan, and Cyber Security Plan referred to collectively hereafter as “security plans.” Current applicants for an operating license under 10 CFR part 50, or combined license under 10 CFR part 52 who have submitted their applications to the Commission prior to the effective date of this rule must amend their applications to include security plans consistent with this section. (2) The security plans must identify, describe, and account for site-specific conditions that affect the licensee's capability to satisfy the requirements of this section. (3) The licensee is responsible for maintaining the onsite physical protection program in accordance with Commission regulations through the implementation of security plans and written security implementing procedures. (4) Applicants for an operating license under the provisions of part 50 of this chapter or holders of a combined license under the provisions of part 52 of this chapter, shall implement the requirements of this section before fuel is allowed onsite (protected area). (5) The Tennessee Valley Authority Watts Bar Nuclear Plant, Unit 2, holding a current construction permit under the provisions of part 50 of this chapter, shall meet the revised requirements in paragraphs (a) through (r) of this section as applicable to operating nuclear power reactor facilities. (6) Applicants for an operating license under the provisions of part 50 of this chapter, or holders of a combined license under the provisions of part 52 of this chapter that do not reference a standard design certification or reference a standard design certification issued after May 26, 2009 shall meet the requirement of § 73.55(i)(4)(iii). (b) General performance objective and requirements. (1) The licensee shall establish and m… | ||||
| 10:10:2.0.1.1.13.7.121.1 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | G | Subpart G—Access Authorization and Access Control Requirements for the Physical Protection of Special Nuclear Material | § 73.56 Personnel access authorization requirements for nuclear power plants. | NRC | [74 FR 13979, Mar. 27, 2009, as amended at 77 FR 39909, July 6, 2012, 81 FR 86910, Dec. 2, 2016] | (a) Introduction. (1) By March 31, 2010, each nuclear power reactor licensee, licensed under 10 CFR part 50, shall implement the requirements of this section through revisions to its Commission-approved Physical Security Plan. (2) The licensee shall establish, implement and maintain its access authorization program in accordance with the requirements of this section. (3) Each applicant for an operating license under the provisions of part 50 of this chapter, and each holder of a combined license under the provisions of part 52 of this chapter, shall implement the requirements of this section before fuel is allowed on site (protected area). (4) The licensee or applicant may accept, in part or whole, an access authorization program implemented by a contractor or vendor to satisfy appropriate elements of the licensee's access authorization program in accordance with the requirements of this section. Only a licensee shall grant an individual unescorted access. Licensees and applicants shall certify individuals' unescorted access authorization and are responsible to maintain, deny, terminate, or withdraw unescorted access authorization. (b) Applicability. (1) The following individuals shall be subject to an access authorization program: (i) Any individual to whom a licensee intends to grant unescorted access to nuclear power plant protected or vital areas or any individual for whom a licensee or an applicant intends to certify unescorted access authorization; (ii) Any individual whose duties and responsibilities permit the individual to take actions by electronic means, either on site or remotely, that could adversely impact the licensee's or applicant's operational safety, security, or emergency preparedness; (iii) Any individual who has responsibilities for implementing a licensee's or applicant's protective strategy, including, but not limited to, armed security force officers, alarm station operators, and tactical response team leaders; and (iv) The licensee or applicant access authorization program re… | ||||
| 10:10:2.0.1.1.13.7.121.2 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | G | Subpart G—Access Authorization and Access Control Requirements for the Physical Protection of Special Nuclear Material | § 73.57 Requirements for criminal history records checks of individuals granted unescorted access to a nuclear power facility, a non-power reactor, or access to Safeguards Information. | NRC | [52 FR 6314, Mar. 2, 1987; 52 FR 7821, Mar. 13, 1987] | (a) General. (1) Each licensee who is authorized to engage in an activity subject to regulation by the Commission shall comply with the requirements of this section. (2) Each applicant for a license to engage in an activity subject to regulation by the Commission, as well as each entity who has provided written notice to the Commission of intent to file an application for licensing, certification, permitting, or approval of a product subject to regulation by the Commission shall submit fingerprints for those individuals who will have access to Safeguards Information. (3) Before receiving its operating license under 10 CFR part 50 or before the Commission makes its finding under § 52.103(g) of this chapter, each applicant for a license to operate a nuclear power reactor (including an applicant for a combined license) or a non-power reactor may submit fingerprints for those individuals who will require unescorted access to the nuclear power facility or non-power reactor facility. (b) General performance objective and requirements. (1) Except those listed in paragraph (b)(2) of this section, each licensee subject to the provisions of this section shall fingerprint each individual who is permitted unescorted access to the nuclear power facility, the non-power reactor facility in accordance with paragraph (g) of this section, or access to Safeguards Information. The licensee will then review and use the information received from the Federal Bureau of Investigation (FBI) and, based on the provisions contained in this section, determine either to continue to grant or to deny further unescorted access to the nuclear power facility, the non-power reactor facility, or access to Safeguards Information for that individual. Individuals who do not have unescorted access or access to Safeguards Information shall be fingerprinted by the licensee and the results of the criminal history records check shall be used before making a determination for granting unescorted access to the nuclear power facility, non-power reactor f… | ||||
| 10:10:2.0.1.1.13.7.121.3 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | G | Subpart G—Access Authorization and Access Control Requirements for the Physical Protection of Special Nuclear Material | § 73.58 Safety/security interface requirements for nuclear power reactors. | NRC | [74 FR 13987, Mar. 27, 2009] | (a) Each operating nuclear power reactor licensee with a license issued under part 50 or 52 of this chapter shall comply with the requirements of this section. (b) The licensee shall assess and manage the potential for adverse effects on safety and security, including the site emergency plan, before implementing changes to plant configurations, facility conditions, or security. (c) The scope of changes to be assessed and managed must include planned and emergent activities (such as, but not limited to, physical modifications, procedural changes, changes to operator actions or security assignments, maintenance activities, system reconfiguration, access modification or restrictions, and changes to the security plan and its implementation). (d) Where potential conflicts are identified, the licensee shall communicate them to appropriate licensee personnel and take compensatory and/or mitigative actions to maintain safety and security under applicable Commission regulations, requirements, and license conditions. | ||||
| 10:10:2.0.1.1.13.7.121.4 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | G | Subpart G—Access Authorization and Access Control Requirements for the Physical Protection of Special Nuclear Material | § 73.59 Relief from fingerprinting, identification and criminal history records checks and other elements of background checks for designated categories of individuals. | NRC | [73 FR 63580, Oct. 24, 2008, as amended at 77 FR 34206, June 11, 2012] | Fingerprinting, and the identification and criminal history records checks required by section 149 of the Atomic Energy Act of 1954, as amended, and other elements of background checks are not required for the following individuals prior to granting access to Safeguards Information, including Safeguards Information designated as Safeguards Information-Modified Handling as defined in 10 CFR 73.2: (a) An employee of the Commission or the Executive Branch of the United States government who has undergone fingerprinting for a prior U.S. government criminal history records check; (b) A member of Congress; (c) An employee of a member of Congress or Congressional committee who has undergone fingerprinting for a prior U.S. government criminal history records check; (d) The Comptroller General or an employee of the Government Accountability Office who has undergone fingerprinting for a prior U.S. Government criminal history records check; (e) The Governor of a State or his or her designated State employee representative; (f) A representative of a foreign government organization that is involved in planning for, or responding to, nuclear or radiological emergencies or security incidents who the Commission approves for access to Safeguards Information, including Safeguards Information designated as Safeguards Information—Modified Handling; (g) Federal, State, or local law enforcement personnel; (h) State Radiation Control Program Directors and State Homeland Security Advisors or their designated State employee representatives; (i) Agreement State employees conducting security inspections on behalf of the NRC pursuant to an agreement executed under section 274.i. of the Atomic Energy Act of 1954, as amended; (j) Representatives of the International Atomic Energy Agency (IAEA) engaged in activities associated with the U.S./IAEA Safeguards Agreement who have been certified by the NRC; (k) Any agent, contractor, or consultant of the aforementioned persons who has undergone equivalent criminal history records and back… | ||||
| 10:10:2.0.1.1.13.7.121.5 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | G | Subpart G—Access Authorization and Access Control Requirements for the Physical Protection of Special Nuclear Material | § 73.60 Additional requirements for physical protection at non-power reactors. | NRC | [38 FR 35430, Dec. 28, 1973, as amended at 44 FR 68199, Nov. 28, 1979; 57 FR 33431, July 29, 1992; 58 FR 13700, Mar. 15, 1993; 86 FR 43403, Aug. 9, 2021; 89 FR 106253, Dec. 30, 2024] | Each non-power reactor licensee who, pursuant to the requirements of part 70 of this chapter, possesses at any site or contiguous sites subject to control by the licensee uranium-235 (contained in uranium enriched to 20 percent or more in the U-235 isotope), uranium-233, or plutonium, alone or in any combination in a quantity of 5000 grams or more computed by the formula, grams = (grams contained U-235) + 2.5 (grams U-233 + grams plutonium), shall protect the special nuclear material from theft or diversion pursuant to the requirements of paragraphs 73.67 (a), (b), (c), and (d), in addition to this section, except that a licensee is exempt from the requirements of paragraphs (a), (b), (c), (d), and (e) of this section to the extent that it possesses or uses special nuclear material that is not readily separable from other radioactive material and that has a total external radiation level in excess of 1 gray (100 rad) per hour at a distance of 1 meter (3.3 feet) from any accessible surface without intervening shielding. (a) Access requirements. (1) Special nuclear material shall be stored or processed only in a material access area. No activities other than those which require access to special nuclear material or equipment employed in the process, use, or storage of special nuclear material, shall be permitted within a material access area. (2) Material access areas shall be located only within a protected area to which access is controlled. (3) Special nuclear material not in process shall be stored in a vault equipped with an intrusion alarm or in a vault-type room, and each such vault or vault-type room shall be controlled as a separate material access area. (4) Enriched uranium scrap in the form of small pieces, cuttings, chips, solutions or in other forms which result from a manufacturing process, contained in 30-gallon or larger containers, with a uranium-235 content of less than 0.25 grams per liter, may be stored within a locked and separately fenced area which is within a larger protected area prov… | ||||
| 10:10:2.0.1.1.13.7.121.6 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | G | Subpart G—Access Authorization and Access Control Requirements for the Physical Protection of Special Nuclear Material | § 73.61 Relief from fingerprinting and criminal history records check for designated categories of individuals permitted unescorted access to certain radioactive materials or other property. | NRC | [72 FR 4948, Feb. 2, 2007] | Notwithstanding any other provision of the Commission's regulations, fingerprinting and the identification and criminal history records checks required by section 149 of the Atomic Energy Act of 1954, as amended, are not required for the following individuals prior to granting unescorted access to radioactive materials or other property that the Commission determines by regulation or order to be of such significance to the public health and safety or the common defense and security as to warrant fingerprinting and background checks: (a) An employee of the Commission or of the Executive Branch of the U.S. Government who has undergone fingerprinting for a prior U.S. Government criminal history check; (b) A Member of Congress; (c) An employee of a member of Congress or Congressional committee who has undergone fingerprinting for a prior U.S. Government criminal history check; (d) The Governor of a State or his or her designated State employee representative; (e) Federal, State, or local law enforcement personnel; (f) State Radiation Control Program Directors and State Homeland Security Advisors or their designated State employee representatives; (g) Agreement State employees conducting security inspections on behalf of the NRC pursuant to an agreement executed under section 274.i. of the Atomic Energy Act; (h) Representatives of the International Atomic Energy Agency (IAEA) engaged in activities associated with the U.S./IAEA Safeguards Agreement who have been certified by the NRC. | ||||
| 10:10:2.0.1.1.13.7.121.7 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | G | Subpart G—Access Authorization and Access Control Requirements for the Physical Protection of Special Nuclear Material | § 73.67 Licensee fixed site and in-transit requirements for the physical protection of special nuclear material of moderate and low strategic significance. | NRC | [44 FR 43283, July 24, 1979. Redesignated at 44 FR 68198, Nov. 28, 1979, as amended at 45 FR 19215, Mar. 25, 1980; 47 FR 19114, May 4, 1982; 52 FR 21657, June 9, 1987; 53 FR 19260, May 27, 1988; 57 FR 33431, July 29, 1992, 59 FR 14087, Mar. 25, 1994; 67 FR 3586, Jan. 25, 2002; 67 FR 78143, Dec. 23, 2002; 68 FR 14530, Mar. 26, 2003; 68 FR 23575, May 5, 2003; 73 FR 32463, June 9, 2008; 74 FR 62684, Dec. 1, 2009; 83 FR 58723, Nov. 21, 2018; 85 FR 65664, Oct. 16, 2020; 86 FR 43403, Aug. 9, 2021; 88 FR 15891, Mar. 14, 2023] | (a) General performance objectives. (1) Each licensee who possesses, uses or transports special nuclear material of moderate or low strategic significance shall establish and maintain a physical protection system that will achieve the following objectives: (i) Minimize the possibilities for unauthorized removal of special nuclear material consistent with the potential consequences of such actions; and (ii) Facilitate the location and recovery of missing special nuclear material. (2) To achieve these objectives, the physical protection system shall provide: (i) Early detection and assessment of unauthorized access or activities by an external adversary within the controlled access area containing special nuclear material; (ii) Early detection of removal of special nuclear material by an external adversary from a controlled access area; (iii) Assure proper placement and transfer of custody of special nuclear material; and (iv) Respond to indications of an unauthorized removal of special nuclear material and then notify the appropriate response forces of its removal in order to facilitate its recovery. (b)(1) A licensee is exempt from the requirements of this section to the extent that he possesses, uses, or transports: (i) Special nuclear material which is not readily separable from other radioactive material and which has a total external radiation level in excess of 1 gray (100 rad) per hour at a distance of 1 meter (3.3 feet) from any accessible surface without intervening shielding, or (ii) Sealed plutonium-beryllium neutron sources totaling 500 grams or less contained plutonium at any one site or contiguous sites, or (iii) Plutonium with an isotopic concentration exceeding 80 percent in plutonium-238. (2) A licensee who has quantities of special nuclear material equivalent to special nuclear material of moderate strategic significance distributed over several buildings may, for each building which contains a quantity of special nuclear material less than or equal to a level of special nuclear mat… | ||||
| 10:10:2.0.1.1.13.8.121.1 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | H | Subpart H—Records and Postings | § 73.70 Records. | NRC | [53 FR 19261, May 27, 1988, as amended at 57 FR 33431, July 29, 1992; 83 FR 30288, June 28, 2018; 84 FR 63568, Nov. 18, 2019] | Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. Each licensee subject to the provisions of §§ 73.20, 73.25, 73.26, 73.27, 73.45, 73.46, 73.55, or 73.60 shall keep the following records: (a) Names and addresses of all individuals who have been designated as authorized individuals. The licensee shall retain this record of currently designated authorized individuals for the period during which the licensee possesses the appropriate type and quantity of special nuclear material requiring this record under each license that authorizes the activity that is subject to the recordkeeping requirement and, for three years thereafter. Copies of superseded material must be retained for three years after each change. (b) Names, addresses, and badge numbers of all individuals authorized to have access to vital equipment or special nuclear material, and the vital areas and material access areas to which authorization is granted. The licensee shall retain the record of individuals currently authorized this access for the period during which the licensee possesses the appropriate type and quantity of special nuclear material requiring this record under each license that authorizes the activity that is subject to the recordkeeping requirement and, for three years thereafter. Copies of superseded material must be retained for three years… | ||||
| 10:10:2.0.1.1.13.8.121.2 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | H | Subpart H—Records and Postings | § 73.71 [Reserved] | NRC | ||||||
| 10:10:2.0.1.1.13.8.121.3 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | H | Subpart H—Records and Postings | § 73.72 Requirement for advance notice of shipment of formula quantities of strategic special nuclear material, special nuclear material of moderate strategic significance, or irradiated reactor fuel. | NRC | [52 FR 9653, Mar. 26, 1987, as amended at 53 FR 4111, Feb. 12, 1988; 60 FR 24552, May 9, 1995; 67 FR 3586, Jan. 25, 2002; 68 FR 58820, Oct. 10, 2003; 74 FR 62684, Dec. 1, 2009; 78 FR 29557, May 20, 2013; 83 FR 58723, Nov. 21, 2018; 84 FR 63568, Nov. 18, 2019; 84 FR 67659, Dec. 11, 2019; 85 FR 65664, Oct. 16, 2020] | (a) A licensee, other than one specified in paragraph (b) of this section, who, in a single shipment, plans to deliver to a carrier for transport, to take delivery at the point where a shipment is delivered to a carrier for transport, to import, to export, or to transport a formula quantity of strategic special nuclear material, special nuclear material of moderate strategic significance, or irradiated reactor fuel 1 required to be protected in accordance with § 73.37, shall: 1 For purposes of 10 CFR 73.72, the terms “irradiated reactor fuel” as described in 10 CFR 73.37 and “spent nuclear fuel” are used interchangeably. (1) Notify in writing by mail addressed to ATTN: Director, Office of Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or by using any appropriate method listed in § 73.4 of this part. Classified notifications shall be sent to the NRC headquarters classified mailing address listed in appendix A to this part. (2) Assure that the notification will be received at least 10 days before transport of the shipment commences at the shipping facility; (3) Include the following information in the notification: (i) The name(s), address(es), and telephone number(s) of the shipper, receiver, and carrier(s); (ii) A physical description of the shipment: (A) For a shipment other than irradiated fuel, the elements, isotopes, enrichment, and quantity; (B) For a shipment of irradiated fuel, the physical form, quantity, type of reactor, and original enrichment; (iii) A listing of the mode(s) of shipment, transfer point(s), and route(s) to be used; (iv) The estimated time and date that shipment will commence and that each country along the route is scheduled to be entered; and (v) The estimated time and date of arrival of the shipment at the destination; (4) The NRC Headquarters Operations Center shall be notified about the shipment status by telephone at the phone numbers listed in appendix A to this part. Classified and safeguards notifications shall… | ||||
| 10:10:2.0.1.1.13.8.121.4 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | H | Subpart H—Records and Postings | § 73.73 Requirement for advance notice and protection of export shipments of special nuclear material of low strategic significance. | NRC | [52 FR 9653, Mar. 26, 1987, as amended at 53 FR 4112, Feb. 12, 1988; 60 FR 24553, May 9, 1995; 67 FR 3586, Jan. 25, 2002; 68 FR 58820, Oct. 10, 2003; 74 FR 62684, Dec. 1, 2009; 83 FR 58723, Nov. 21, 2018; 86 FR 67843, Nov. 30, 2021] | (a) A licensee authorized to export special nuclear material of low strategic significance shall: (1) Notify in writing the Director, Office of Nuclear Security and Incident Response, by email (preferred method) to AdvanceNotifications.Resource@nrc.gov or by using any appropriate method listed in § 73.4; (2) Assure that the notification will be received at least 10 days before transport of the shipment commences at the shipper's facility; (3) Include the following information in the notification: (i) The name(s), address(es), and telephone number(s) of the shipper, receiver, and carrier(s); (ii) A physical description of the shipment (the elements, isotopes, form, etc.); (iii) A listing of the mode(s) of shipment, transfer points, and routes to be used; (iv) The estimated time and date that shipment will commence and that each country along the route is scheduled to be entered; and (v) The estimated time and date of arrival of the shipment at the destination; (4) Assure that during transport outside the United States, the shipment will be protected in accordance with Annex I to the Convention on the Physical Protection of Nuclear Material (see appendix E of this part). (b) A licensee who needs to amend a written advance notification required by paragraph (a) of this section may notify the NRC Headquarters Operations Center by telephone at the numbers listed in appendix A to this part. | ||||
| 10:10:2.0.1.1.13.8.121.5 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | H | Subpart H—Records and Postings | § 73.74 Requirement for advance notice and protection of import shipments of nuclear material from countries that are not party to the Convention on the Physical Protection of Nuclear Material. | NRC | [52 FR 9654, Mar. 26, 1987, as amended at 53 FR 4112, Feb. 12, 1988; 60 FR 24553, May 9, 1995; 67 FR 3586, Jan. 25, 2002; 68 FR 58820, Oct. 10, 2003; 74 FR 62684, Dec. 1, 2009; 83 FR 58723, Nov. 21, 2018; 86 FR 67843, Nov. 30, 2021] | (a) A licensee authorized to import special nuclear material of low strategic significance from a country not a party to the Convention on the Physical Protection of Nuclear Material ( i.e. , not listed in appendix F of this part) shall: (1) Notify in writing the Director, Office of Nuclear Security and Incident Response, by email (preferred method) to AdvanceNotifications.Resource@nrc.gov or by using any appropriate method listed in § 73.4; (2) Assure that the notification will be received at least 10 days before transport of the shipment commences at the shipper's facility; and (3) Include the following information in the notification: (i) The name(s), address(es) and telephone number(s) of the shipper, receiver, and carrier(s); (ii) A physical description of the shipment (the isotopes, enrichment, quantity, etc.); (iii) A listing of mode(s) of shipment, transfer points, and routes to be used; (iv) The estimated time and date that shipment will commence and that each country along the route is scheduled to be entered; and (v) The estimated time and date of arrival of the shipment at the destination. (b) A licensee who needs to amend a written advance notification required by paragraph (a) of this section may notify the NRC Headquarters Operations Center by telephone at the numbers listed in appendix A to this part. (c) A licensee authorized to import from a country not a party to the Convention on the Physical Protection of Nuclear Material ( i.e. , not listed in appendix F of this part) a formula quantity of special nuclear material, special nuclear material of moderate strategic significance, special nuclear material of low strategic significance, or irradiated reactor fuel shall assure that during transport outside the United States the shipment will be protected in accordance with Annex I to the Convention on the Physical Protection of Nuclear Material (see appendix E of this part). | ||||
| 10:10:2.0.1.1.13.8.121.6 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | H | Subpart H—Records and Postings | § 73.75 Posting. | NRC | [74 FR 52674, Oct. 14, 2009] | (a) This section applies to: (1) Production or utilization facilities; (2) High-level waste storage or disposal facilities and independent spent fuel storage installations; (3) Uranium enrichment, uranium conversion, or nuclear fuel fabrication facilities. (b)(1) Licensees or certificate holders operating facilities described in paragraph (a) of this section that have a protected area shall conspicuously post notices at every vehicle and pedestrian entrance to the protected area. (2) Licensees or certificate holders operating facilities described in paragraph (a) of this section that include buildings not within a protected area that nonetheless contain special nuclear material, byproduct material, or source material shall conspicuously post notices at the personnel and vehicle entrances to each such building, except with respect to buildings for which no security plan is required under this part. (3) The required notices must state: “The willful unauthorized introduction of any dangerous weapon, explosive, or other dangerous instrument or material likely to produce substantial injury or damage to persons or property into or upon these premises is a Federal crime. (42 U.S.C. 2278a.)” (4) Every notice posted under this section must be easily readable day and night by both pedestrian and vehicular traffic entering the facility or installation. (5) These notices may be combined with other notices. (c) This section does not apply to facilities that, in addition to being regulated by the NRC under a license or certificate of compliance issued by the Commission, are also covered by U.S. Department of Energy regulations imposing criminal penalties, and associated posting requirements, under section 229 of the Atomic Energy Act with respect to unauthorized introduction of dangerous weapons, explosives, or other dangerous instruments or materials likely to produce substantial injury or damage to persons or property. | ||||
| 10:10:2.0.1.1.13.9.121.1 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | I | Subpart I—Enforcement | § 73.77 Cyber security event notifications. | NRC | [80 FR 67275, Nov. 2, 2015] | (a) Each licensee subject to the provisions of § 73.54 shall notify the NRC Headquarters Operations Center via the Emergency Notification System (ENS), in accordance with paragraph (c) of this section: (1) Within one hour after discovery of a cyber attack that adversely impacted safety-related or important-to-safety functions, security functions, or emergency preparedness functions (including offsite communications); or that compromised support systems and equipment resulting in adverse impacts to safety, security, or emergency preparedness functions within the scope of § 73.54. (2) Within four hours: (i) After discovery of a cyber attack that could have caused an adverse impact to safety-related or important-to-safety functions, security functions, or emergency preparedness functions (including offsite communications); or that could have compromised support systems and equipment, which if compromised, could have adversely impacted safety, security, or emergency preparedness functions within the scope of § 73.54. (ii) After discovery of a suspected or actual cyber attack initiated by personnel with physical or electronic access to digital computer and communication systems and networks within the scope of § 73.54. (iii) After notification of a local, State, or other Federal agency (e.g., law enforcement, FBI, etc.) of an event related to the licensee's implementation of their cyber security program for digital computer and communication systems and networks within the scope of § 73.54 that does not otherwise require a notification under paragraph (a) of this section. (3) Within eight hours after receipt or collection of information regarding observed behavior, activities, or statements that may indicate intelligence gathering or pre-operational planning related to a cyber attack against digital computer and communication systems and networks within the scope of § 73.54. (b) Twenty-four hour recordable events. (1) The licensee shall use the site corrective action program to record vulnerabilities, weaknes… | ||||
| 10:10:2.0.1.1.13.9.121.2 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | I | Subpart I—Enforcement | § 73.80 Violations. | NRC | [57 FR 55078, Nov. 24, 1992] | (a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of— (1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3) A regulation or order issued pursuant to those Acts. (b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act: (1) For violations of— (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act of 1954, as amended: (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; (iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section. (2) For any violation for which a license may be revoked under Section 186 of the Atomic Energy Act of 1954, as amended. | ||||
| 10:10:2.0.1.1.13.9.121.3 | 10 | Energy | I | 73 | PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS | I | Subpart I—Enforcement | § 73.81 Criminal penalties. | NRC | [57 FR 55079, Nov. 24, 1992, as amended at 74 FR 52674, Oct. 14, 2009] | (a) Section 223 of the Atomic Energy Act of 1954, as amended, provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b, 161i, or 161o of the Act. For purposes of section 223, all the regulations in part 73 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section. (b) The regulations in part 73 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 73.1, 73.2, 73.3, 73.4, 73.5, 73.6, 73.8, 73.25, 73.45, 73.75, 73.80, and 73.81. (c)(1) No person without authorization may carry, transport, or otherwise introduce or cause to be introduced any dangerous weapon, explosive, or other dangerous instrument or material likely to produce substantial injury or damage to persons or property into or upon a protected facility or installation. Willful violations of this provision are punishable by the criminal penalties set forth in sections 229b and 229c of the Atomic Energy Act of 1954, as amended. (2) As used in this section: (i) “Protected facility or installation” means any production or utilization facility, high-level waste storage or disposal facility, independent spent fuel storage installation, uranium enrichment, uranium conversion, or nuclear fuel fabrication facility, but does not include those portions of such facilities that are not required under § 73.75(b) of this part to be identified by notices posted at their pedestrian and vehicle entrances, and does not include facilities described in § 73.75(c) of this part. (ii) “Without authorization” means not authorized as part of one's official duties to carry the weapon, explosive, or other instrument or material; (iii) “Dangerous weapon” includes any firearm, as defined in either 18 U.S.C. 921 or 26 U.S.C. 5845, or dangerous weapon, as defined in 18 U.S.C. 930; (iv) “Explosive” means any explosive as defined in 18 U.S.C. 844(j). (3) An item, such as … | ||||
| 14:14:2.0.1.2.8.1.1.1 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | A | Subpart A—General | § 73.1 Applicability. | FAA | The airspace that is described in subpart B and subpart C of this part is designated as special use airspace. These parts prescribe the requirements for the use of that airspace. | ||||
| 14:14:2.0.1.2.8.1.1.2 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | A | Subpart A—General | § 73.3 Special use airspace. | FAA | (a) Special use airspace consists of airspace of defined dimensions identified by an area on the surface of the earth wherein activities must be confined because of their nature, or wherein limitations are imposed upon aircraft operations that are not a part of those activities, or both. (b) The vertical limits of special use airspace are measured by designated altitude floors and ceilings expressed as flight levels or as feet above mean sea level. Unless otherwise specified, the word “to” (an altitude or flight level) means “to and including” (that altitude or flight level). (c) The horizontal limits of special use airspace are measured by boundaries described by geographic coordinates or other appropriate references that clearly define their perimeter. (d) The period of time during which a designation of special use airspace is in effect is stated in the designation. | ||||
| 14:14:2.0.1.2.8.1.1.3 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | A | Subpart A—General | § 73.5 Bearings; radials; miles. | FAA | (a) All bearings and radials in this part are true from point of origin. (b) Unless otherwise specified, all mileages in this part are stated as statute miles. | ||||
| 14:14:2.0.1.2.8.2.1.1 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | B | Subpart B—Restricted Areas | § 73.11 Applicability. | FAA | This subpart designates restricted areas and prescribes limitations on the operation of aircraft within them. | ||||
| 14:14:2.0.1.2.8.2.1.2 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | B | Subpart B—Restricted Areas | § 73.13 Restrictions. | FAA | No person may operate an aircraft within a restricted area between the designated altitudes and during the time of designation, unless he has the advance permission of (a) The using agency described in § 73.15; or (b) The controlling agency described in § 73.17. | ||||
| 14:14:2.0.1.2.8.2.1.3 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | B | Subpart B—Restricted Areas | § 73.15 Using agency. | FAA | (a) For the purposes of this subpart, the following are using agencies; (1) The agency, organization, or military command whose activity within a restricted area necessitated the area being so designated. (b) Upon the request of the FAA, the using agency shall execute a letter establishing procedures for joint use of a restricted area by the using agency and the controlling agency, under which the using agency would notify the controlling agency whenever the controlling agency may grant permission for transit through the restricted area in accordance with the terms of the letter. (c) The using agency shall— (1) Schedule activities within the restricted area; (2) Authorize transit through, or flight within, the restricted area as feasible; and (3) Contain within the restricted area all activities conducted therein in accordance with the purpose for which it was designated. | ||||
| 14:14:2.0.1.2.8.2.1.4 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | B | Subpart B—Restricted Areas | § 73.17 Controlling agency. | FAA | For the purposes of this part, the controlling agency is the FAA facility that may authorize transit through or flight within a restricted area in accordance with a joint-use letter issued under § 73.15. | ||||
| 14:14:2.0.1.2.8.2.1.5 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | B | Subpart B—Restricted Areas | § 73.19 Reports by using agency. | FAA | [Docket 15379, 42 FR 54798, Oct. 11, 1977, as amended by Amdt. 73-5, 54 FR 39292, Sept. 25, 1989; Amdt. 73-6, 58 FR 42001, Aug. 6, 1993; Amdt. 73-8, 61 FR 26435, May 28, 1996; Amdt. 73-8, 63 FR 16890, Apr. 7, 1998; Docket FAA-2022-1355, Amdt. 73-9, 87 FR 75845, Dec. 9, 2022] | (a) Each using agency must prepare a report on the use of each restricted area assigned thereto during any part of the preceding 12-month period ended September 30, and transmit it by the following January 31 of each year to the Manager, Operations Support Group in the ATO Service Center office of the Federal Aviation Administration having jurisdiction over the area in which the restricted area is located, with a copy to the Manager, Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591. (b) In the report under this section the using agency must: (1) State the name and number of the restricted area as published in this part, and the period covered by the report. (2) State the activities (including average daily number of operations if appropriate) conducted in the area, and any other pertinent information concerning current and future electronic monitoring devices. (3) State the number of hours daily, the days of the week, and the number of weeks during the year that the area was used. (4) For restricted areas having a joint-use designation, also state the number of hours daily, the days of the week, and the number of weeks during the year that the restricted area was released to the controlling agency for public use. (5) State the mean sea level altitudes or flight levels (whichever is appropriate) used in aircraft operations and the maximum and average ordinate of surface firing (expressed in feet, mean sea level altitude) used on a daily, weekly, and yearly basis. (6) Include a chart of the area (of optional scale and design) depicting, if used, aircraft operating areas, flight patterns, ordnance delivery areas, surface firing points, and target, fan, and impact areas. After once submitting an appropriate chart, subsequent annual charts are not required unless there is a change in the area, activity or altitude (or flight levels) used, which might alter the depiction of the activities originally reported. If no change is to be submitted, a statement ind… | |||
| 14:14:2.0.1.2.8.3.1.1 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | C | Subpart C—Prohibited Areas | § 73.81 Applicability. | FAA | This subpart designates prohibited areas and prescribes limitations on the operation of aircraft therein. | ||||
| 14:14:2.0.1.2.8.3.1.2 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | C | Subpart C—Prohibited Areas | § 73.83 Restrictions. | FAA | No person may operate an aircraft within a prohibited area unless authorization has been granted by the using agency. | ||||
| 14:14:2.0.1.2.8.3.1.3 | 14 | Aeronautics and Space | I | E | 73 | PART 73—SPECIAL USE AIRSPACE | C | Subpart C—Prohibited Areas | § 73.85 Using agency. | FAA | For the purpose of this subpart, the using agency is the agency, organization or military command that established the requirements for the prohibited area. | ||||
| 21:21:1.0.1.1.27.1.98.1 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.1 Diluents in color additive mixtures for food use exempt from certification. | FDA | [42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992; 69 FR 24511, May 4, 2004] | The following substances may be safely used as diluents in color additive mixtures for food use exempt from certification, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. If a specification for a particular diluent is not set forth in this part 73, the material shall be of a purity consistent with its intended use. (a) General use. (1) Substances that are generally recognized as safe under the conditions set forth in section 201(s) of the act. (2) Substances meeting the definitions and specifications set forth under subchapter B of this chapter, and which are used only as prescribed by such regulations. (3) The following: (b) Special use —(1) Diluents in color additive mixtures for marking food —(i) Inks for marking food supplements in tablet form, gum, and confectionery. Items listed in paragraph (a) of this section and the following: (ii) Inks for marking fruit and vegetables. Items listed in paragraph (a) of this section and the following: (2) Diluents in color additive mixtures for coloring shell eggs. Items listed in paragraph (a) of this section and the following, subject to the condition that there is no penetration of the color additive mixture or any of its components through the eggshell into the egg: Alcohol, denatured, formula 23A (26 CFR part 212), Internal Revenue Service. Damar gum (resin). Diethylene glycol distearate. Dioctyl sodium sulfosuccinate. Ethyl cellulose (as identified in § 172.868 of this chapter). Ethylene glycol distearate. Japan wax. Limed rosin. Naphtha. Pentaerythritol ester of fumaric acid-rosin adduct. Polyethylene glycol 6000 (as identified in § 172.820 of this chapter). Polyvinyl alcohol. Rosin and rosin derivatives (as identified in § 172.615 of this chapter). Alcohol, denatured, formula 23A (26 CFR part 212), Internal Revenue Service. Dam… | |||
| 21:21:1.0.1.1.27.1.98.10 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.70 Calcium carbonate. | FDA | [82 FR 51557, Nov. 7, 2017, as amended at 87 FR 58448, Sept. 27, 2022] | (a) Identity. (1) The color additive calcium carbonate is a fine, white powder consisting essentially of calcium carbonate (CaCO 3 ) prepared either by grinding naturally occurring limestone or synthetically, by precipitation. (2) Color additive mixtures for food use made with calcium carbonate may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Calcium carbonate must meet the specifications given in calcium carbonate (FCC 13) and limestone, ground (FCC 13). (c) Uses and restrictions. Calcium carbonate may be safely used in amounts consistent with good manufacturing practice to color dietary supplement tablets and capsules (including coatings and printing inks), soft and hard candies and mints, and in inks used on the surface of chewing gum, except that it may not be used to color chocolate for which standards of identity have been promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act unless added color is authorized by such standards. (d) Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and, therefore, batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act. (f) Incorporation by reference. Material listed in this paragraph (f) is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration and at the National Archives and Records Administration (NARA). Contact the Food and Drug Administration between 9 a.m. and 4 p.m., Monday through Friday at: Dock… | |||
| 21:21:1.0.1.1.27.1.98.11 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.75 Canthaxanthin. | FDA | [42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985; 63 FR 14817, Mar. 27, 1998] | (a) Identity. (1) The color additive canthaxanthin is β-carotene-4,4′-dione. (2) Color additive mixtures for food use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Canthaxanthin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Physical state, solid. 1 percent solution in chloroform, complete and clear. Melting range (decomposition), 207 °C. to 212 °C. (corrected). Loss on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Total carotenoids other than trans-canthaxanthin, not more than 5 percent. Lead, not more than 10 parts per million. Arsenic, not more than 3 parts per million. Mercury, not more than 1 part per million. Assay, 96 to 101 percent. Physical state, solid. 1 percent solution in chloroform, complete and clear. Melting range (decomposition), 207 °C. to 212 °C. (corrected). Loss on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Total carotenoids other than trans-canthaxanthin, not more than 5 percent. Lead, not more than 10 parts per million. Arsenic, not more than 3 parts per million. Mercury, not more than 1 part per million. Assay, 96 to 101 percent. (c) Use and restrictions. (1) The color additive canthaxanthin may be safely used for coloring foods generally subject to the following restrictions: (i) The quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food; and (ii) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (2) Canthaxanthin may be safely used in broiler chicken feed to enhance the yellow color of broiler chi… | |||
| 21:21:1.0.1.1.27.1.98.12 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.80 Calcium phosphate. | FDA | [90 FR 20100, May 12, 2025] | (a) Identity. (1) The color additive calcium phosphate is a white, synthetically prepared powder consisting predominantly of precipitated Ca 5 OH(PO 4 ) 3. (2) Color additive mixtures for food use made with calcium phosphate may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Calcium phosphate must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: (1) Loss on ignition, not more than 10 percent. (2) Assay (Ca): 36.0-40.0 percent. (3) Fluoride, not more than 75 milligrams/kilogram (mg/kg) (75 parts per million (ppm)). (4) Lead, not more than 0.25 mg/kg (0.25 ppm). (5) Arsenic, not more than 3 mg/kg (3 ppm). (c) Uses and restrictions. Calcium phosphate may be safely used for coloring foods intended for human consumption, subject to the following restrictions: (1) In ready-to-eat chicken products in an amount not exceeding 1.5 percent by weight of the finished food. (2) In white candy melts in an amount not exceeding 0.25 percent by weight of the finished food. (3) In doughnut sugar in an amount not exceeding 2.0 percent by weight of the finished food. (4) In sugar for coated candies in an amount not exceeding 5.25 percent by weight of the finished food. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act. | |||
| 21:21:1.0.1.1.27.1.98.13 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.85 Caramel. | FDA | (a) Identity. (1) The color additive caramel is the dark-brown liquid or solid material resulting from the carefully controlled heat treatment of the following food-grade carbohydrates: Dextrose. Invert sugar. Lactose. Malt sirup. Molasses. Starch hydrolysates and fractions thereof. Sucrose. Dextrose. Invert sugar. Lactose. Malt sirup. Molasses. Starch hydrolysates and fractions thereof. Sucrose. (2) The food-grade acids, alkalis, and salts listed in this subparagraph may be employed to assist caramelization, in amounts consistent with good manufacturing practice. (i) Acids: Acetic acid. Citric acid. Phosphoric acid. Sulfuric acid. Sulfurous acid. Acetic acid. Citric acid. Phosphoric acid. Sulfuric acid. Sulfurous acid. (ii) Alkalis: Ammonium hydroxide. Calcium hydroxide U.S.P. Potassium hydroxide. Sodium hydroxide. Ammonium hydroxide. Calcium hydroxide U.S.P. Potassium hydroxide. Sodium hydroxide. (iii) Salts: Ammonium, sodium, or potassium carbonate, bicarbonate, phosphate (including dibasic phosphate and monobasic phosphate), sulfate, and sulfite. (3) Polyglycerol esters of fatty acids, identified in § 172.854 of this chapter, may be used as antifoaming agents in amounts not greater than that required to produce the intended effect. (4) Color additive mixtures for food use made with caramel may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Caramel shall conform to the following specifications: Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 0.1 part per million. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 0.1 part per million. (c) Uses and restrictions. Caramel may be safely used for coloring foods generally, in amounts consistent with good manufacturing p… | ||||
| 21:21:1.0.1.1.27.1.98.14 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.90 β-Apo-8′-carotenal. | FDA | (a) Identity. (1) The color additive is β-apo-8′-carotenal. (2) Color additive mixtures for food use made with β-apo-8′-carotenal may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. β-Apo-8′-carotenal shall conform to the following specifications: Physical state, solid. 1 percent solution in chloroform, clear. Melting point (decomposition), 136 °C.-140 °C. (corrected). Loss of weight on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Assay (spectrophotometric), 96-101 percent. Physical state, solid. 1 percent solution in chloroform, clear. Melting point (decomposition), 136 °C.-140 °C. (corrected). Loss of weight on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Assay (spectrophotometric), 96-101 percent. (c) Uses and restrictions. The color additive β-apo-8′-carotenal may be safely used for coloring foods generally, subject to the following restrictions: (1) The quantity of β-apo-8′-carotenal does not exceed 15 milligrams per pound of solid or semisolid food or 15 milligrams per pint of liquid food. (2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | ||||
| 21:21:1.0.1.1.27.1.98.15 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.95 β-Carotene. | FDA | (a) Identity. (1) The color additive is β-carotene prepared synthetically or obtained from natural sources. (2) Color additive mixtures for food use made with β-carotene may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. β-carotene shall conform to the following specifications: Physical state, solid. 1 percent solution in chloroform, clear. Loss of weight on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Assay (spectrophotometric), 96-101 percent. Physical state, solid. 1 percent solution in chloroform, clear. Loss of weight on drying, not more than 0.2 percent. Residue on ignition, not more than 0.2 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Assay (spectrophotometric), 96-101 percent. (c) Uses and restrictions. The color additive β-carotene may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color those foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | ||||
| 21:21:1.0.1.1.27.1.98.16 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.100 Cochineal extract; carmine. | FDA | [42 FR 15643, Mar. 22, 1977, as amended at 74 FR 216, Jan. 5, 2009] | (a) Identity. (1) The color additive cochineal extract is the concentrated solution obtained after removing the alcohol from an aqueous-alcoholic extract of cochineal ( Dactylopius coccus costa ( Coccus cacti L.)). The coloring principle is chiefly carminic acid. (2) The color additive carmine is the aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of the coloring principles, chiefly carminic acid, obtained by an aqueous extraction of cochineal ( Dactylopius coccus costa ( Coccus cacti L.)). (3) Color additive mixtures for food use made with cochineal extract or carmine may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. (1) Cochineal extract shall conform to the following specifications: pH, not less than 5.0 and not more than 5.5 at 25 °C. Protein (N × 6.25), not more than 2.2 percent. Total solids, not less than 5.7 and not more than 6.3 percent. Methyl alcohol, not more than 150 parts per million. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Carminic acid, not less than 1.8 percent. pH, not less than 5.0 and not more than 5.5 at 25 °C. Protein (N × 6.25), not more than 2.2 percent. Total solids, not less than 5.7 and not more than 6.3 percent. Methyl alcohol, not more than 150 parts per million. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Carminic acid, not less than 1.8 percent. (2) Carmine shall conform to the following specifications: Volatile matter (at 135 °C. for 3 hours), not more than 20.0 percent. Ash, not more than 12.0 percent. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Carminic acid, not less than 50.0 percent. Volatile matter (at 135 °C. for 3 hours), not more than 20.0 percent. Ash, not more than 12.0 percent. Lead (as Pb), not more than 10 parts per mil… | |||
| 21:21:1.0.1.1.27.1.98.17 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.125 Sodium copper chlorophyllin. | FDA | [67 FR 35431, May 20, 2002] | (a) Identity. (1) The color additive sodium copper chlorophyllin is a green to black powder prepared from chlorophyll by saponification and replacement of magnesium by copper. Chlorophyll is extracted from alfalfa ( Medicago sativa ) using any one or a combination of the solvents acetone, ethanol, and hexane. (2) Color additive mixtures made with sodium copper chlorophyllin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Sodium copper chlorophyllin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: (1) Moisture, not more than 5.0 percent. (2) Solvent residues (acetone, ethanol, and hexane), not more than 50 parts per million, singly or, in combination. (3) Total copper, not less than 4 percent and not more than 6 percent. (4) Free copper, not more than 200 parts per million. (5) Lead (as Pb), not more than 10 parts per million. (6) Arsenic (as As), not more than 3 parts per million. (7) Mercury (as Hg), not more than 0.5 part per million. (8) Ratio of absorbance at 405 nanometers (nm) to absorbance at 630 nm, not less than 3.4 and not more than 3.9. (9) Total copper chlorophyllins, not less than 95 percent of the sample dried at 100 °C for 1 hour. (c) Uses and restrictions. Sodium copper chlorophyllin may be safely used to color citrus-based dry beverage mixes in an amount not exceeding 0.2 percent in the dry mix. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | |||
| 21:21:1.0.1.1.27.1.98.18 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.140 Toasted partially defatted cooked cottonseed flour. | FDA | (a) Identity. (1) The color additive toasted partially defatted cooked cottonseed flour is a product prepared as follows: Food quality cottonseed is delinted and decorticated; the meats are screened, aspirated, and rolled; moisture is adjusted, the meats heated, and the oil expressed; the cooked meats are cooled, ground, and reheated to obtain a product varying in shade from light to dark brown. (2) Color additive mixtures for food use made with toasted partially defatted cooked cottonseed flour may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Toasted partially defatted cooked cottonseed flour shall conform to the following specifications: Arsenic: It contains no added arsenic compound and therefore may not exceed a maximum natural background level of 0.2 part per million total arsenic, calculated as As. Lead (as Pb), not more than 10 parts per million. Free gossypol content, not more than 450 parts per million. Arsenic: It contains no added arsenic compound and therefore may not exceed a maximum natural background level of 0.2 part per million total arsenic, calculated as As. Lead (as Pb), not more than 10 parts per million. Free gossypol content, not more than 450 parts per million. (c) Uses and restrictions. The color additive toasted partially defatted cooked cottonseed flour may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and … | ||||
| 21:21:1.0.1.1.27.1.98.19 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.160 Ferrous gluconate. | FDA | [42 FR 15643, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984] | (a) Identity. The color additive ferrous gluconate is the ferrous gluconate defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 122-123, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b) Specifications. Ferrous gluconate shall meet the specifications given in the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a) of this section. (c) Uses and restrictions. Ferrous gluconate may be safely used in amounts consistent with good manufacturing practice for the coloring of ripe olives. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | |||
| 21:21:1.0.1.1.27.1.98.2 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.30 Annatto extract. | FDA | (a) Identity. (1) The color additive annatto extract is an extract prepared from annatto seed, Bixa orellana L., using any one or an appropriate combination of the food-grade extractants listed in paragraph (a)(1) (i) and (ii) of this section: (i) Alkaline aqueous solution, alkaline propylene glycol, ethyl alcohol or alkaline solutions thereof, edible vegetable oils or fats, mono- and diglycerides from the glycerolysis of edible vegetable oils or fats. The alkaline alcohol or aqueous extracts may be treated with food-grade acids to precipitate annatto pigments, which are separated from the liquid and dried, with or without intermediate recrystallization, using the solvents listed under paragraph (a)(1)(ii) of this section. Food-grade alkalis or carbonates may be added to adjust alkalinity. (ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene. (2) Color additive mixtures for food use made with annatto extract may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods. (b) Specifications. Annatto extract, including pigments precipitated therefrom, shall conform to the following specifications: (1) Arsenic (as As), not more than 3 parts per million; lead as Pb, not more than 10 parts per million. (2) When solvents listed under paragraph (a)(1)(ii) of this section are used, annatto extract shall contain no more solvent residue than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter. (c) Uses and restrictions. Annatto extract may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards. (d) Labeling. The label of the color additive and any mixtures pr… | ||||
| 21:21:1.0.1.1.27.1.98.20 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.165 Ferrous lactate. | FDA | [61 FR 40319, Aug. 2, 1996, as amended at 66 FR 66742, Dec. 27, 2001; 81 FR 5590, Feb. 3, 2016] | (a) Identity. The color additive ferrous lactate is the ferrous lactate defined in § 184.1311 of this chapter. (b) Specifications. Ferrous lactate shall meet the specifications given in the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (c) Uses and restrictions. Ferrous lactate may be safely used in amounts consistent with good manufacturing practice for the coloring of ripe olives. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act (the act). | |||
| 21:21:1.0.1.1.27.1.98.21 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.167 Galdieria extract blue. | FDA | [90 FR 20108, May 12, 2025] | (a) Identity. (1) The color additive galdieria extract blue is a liquid or powder prepared by the filtered aqueous extraction of the dried biomass of a non-pathogenic and non-toxigenic strain of Galdieria sulphuraria. The biomass is prepared by heterotrophic fermentation of G. sulphuraria. The color additive contains C-phycocyanin as the principal coloring component. (2) Color additive mixtures for food use made with galdieria extract blue may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Galdieria extract blue must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: (1) Lead, not more than 0.5 milligram/kilogram (mg/kg) (0.5 parts per million (ppm)). (2) Arsenic, not more than 0.5 mg/kg (0.5 ppm). (3) Mercury, not more than 0.05 mg/kg (0.05 ppm). (4) Cadmium, not more than 0.5 mg/kg (0.5 ppm). (c) Uses and restrictions. Galdieria extract blue may be safely used for coloring non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives), at levels consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards. (d) Labeling. The label of the c… | |||
| 21:21:1.0.1.1.27.1.98.22 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.168 Gardenia (genipin) blue. | FDA | [90 FR 31590, July 15, 2025, as amended at 90 FR 37793, Aug. 6, 2025] | (a) Identity. (1) The color additive gardenia (genipin) blue is prepared by reacting genipin extracted from the fruit of Gardenia jasminoides Ellis with soy protein hydrolysate. The color additive contains a genipin-peptide polymer as the principal coloring component. (2) Color additive mixtures for food use made with gardenia (genipin) blue may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Gardenia (genipin) blue must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: (1) Genipin, not more than 5 milligram per kilogram (mg/kg) (5 part per million (ppm)). (2) Geniposide, not more than 80 mg/kg (80 ppm). (3) Methanol, not more than 300 mg/kg (300 ppm) (4) Lead, not more than 2 mg/kg (2 ppm). (5) Arsenic, not more than 2 mg/kg (2 ppm). (6) Mercury, not more than 1 mg/kg (1 ppm). (7) Cadmium, not more than 1 mg/kg (1 ppm). (c) Uses and restrictions. Gardenia (genipin) blue may be safely used in amounts consistent with good manufacturing practice for coloring sport drinks, flavored or enhanced noncarbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy, except that it may not be used for coloring foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of added color is authorized by such standards. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes must conform to the requirements of § 70.25 of this chapter. The label of the powdered form of the additive must also declare any additional ingredients used in its manufacture. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, a… | |||
| 21:21:1.0.1.1.27.1.98.23 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.169 Grape color extract. | FDA | [46 FR 47532, Sept. 29, 1981] | (a) Identity. (1) The color additive grape color extract is an aqueous solution of anthocyanin grape pigments made from Concord grapes or a dehydrated water soluble powder prepared from the aqueous solution. The aqueous solution is prepared by extracting the pigments from precipitated lees produced during the storage of Concord grape juice. It contains the common components of grape juice, namely anthocyanins, tartrates, malates, sugars, and minerals, etc., but not in the same proportion as found in grape juice. The dehydrated water soluble powder is prepared by spray drying the aqueous solution containing added malto-dextrin. (2) Color additive mixtures for food use made with grape color extract may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Grape color extract shall conform to the following specifications: Pesticide residues, not more than permitted in or on grapes by regulations promulgated under section 408 of the Federal Food, Drug, and Cosmetic Act. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. (c) Uses and restrictions. Grape color extract may be safely used for the coloring of nonbeverage food, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches are exempt from the certification requirements of section 721(c) of the Act. | |||
| 21:21:1.0.1.1.27.1.98.24 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.170 Grape skin extract (enocianina). | FDA | (a) Identity. (1) The color additive grape skin extract (enocianina) is a purplish-red liquid prepared by the aqueous extraction (steeping) of the fresh deseeded marc remaining after grapes have been pressed to produce grape juice or wine. It contains the common components of grape juice; namely, anthocyanins, tartaric acid, tannins, sugars, minerals, etc., but not in the same proportions as found in grape juice. During the steeping process, sulphur dioxide is added and most of the extracted sugars are fermented to alcohol. The extract is concentrated by vacuum evaporation, during which practically all of the alcohol is removed. A small amount of sulphur dioxide may be present. (2) Color additive mixtures for food use made with grape skin extract (enocianina) may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Grape skin extract (enocianina) shall conform to the following specifications: Pesticide residues, not more than permitted in or on grapes by regulations promulgated under section 408 of the Federal Food, Drug, and Cosmetic Act. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Pesticide residues, not more than permitted in or on grapes by regulations promulgated under section 408 of the Federal Food, Drug, and Cosmetic Act. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. (c) Uses and restrictions. Grape skin extract (enocianina) may be safely used for the coloring of still and carbonated drinks and ades, beverage bases, and alcoholic beverages subject to the following restrictions: (1) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless artificial color is authorized by such standards. (2) Its use in alcoholic beverages shall be in accordance with the provisions of parts 4 and 5, title 27 CFR. (d) Labeling requirements. … | ||||
| 21:21:1.0.1.1.27.1.98.25 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.185 Haematococcus algae meal. | FDA | [65 FR 41584, July 6, 2000] | (a) Identity. (1) The color additive haematococcus algae meal consists of the comminuted and dried cells of the alga Haematococcus pluvialis. (2) Haematococcus algae meal may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with haematococcus algae meal may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Haematococcus algae meal shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Physical state, solid. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals (as Pb), not more than 10 parts per million. Astaxanthin, not less than 1.5 percent. Physical state, solid. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals (as Pb), not more than 10 parts per million. Astaxanthin, not less than 1.5 percent. (c) Uses and restrictions. Haematococcus algae meal may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of astaxanthin in finished feed, from haematococcus algae meal when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (1) The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of … | |||
| 21:21:1.0.1.1.27.1.98.26 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.200 Synthetic iron oxide. | FDA | [42 FR 15643, Mar. 22, 1977, as amended at 59 FR 10578, Mar. 7, 1994; 80 FR 14842, Mar. 20, 2015; 83 FR 54872, Nov. 1, 2018] | (a) Identity. (1) The color additive synthetic iron oxide consists of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is free from admixture with other substances. (2) Color additive mixtures for food use made with synthetic iron oxide may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. (1) Synthetic iron oxide for human food use shall conform to the following specifications: Arsenic (as As), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million (ppm)). Lead (as Pb), not more than 5 mg/kg (5 ppm). Mercury (as Hg), not more than 1 mg/kg (1 ppm). Arsenic (as As), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million (ppm)). Lead (as Pb), not more than 5 mg/kg (5 ppm). Mercury (as Hg), not more than 1 mg/kg (1 ppm). (2) Synthetic iron oxide for dog and cat food use shall conform to the following specifications: Arsenic (as As), not more than 5 parts per million. Lead (as Pb), not more than 20 parts per million. Mercury (as Hg), not more than 3 parts per million. Arsenic (as As), not more than 5 parts per million. Lead (as Pb), not more than 20 parts per million. Mercury (as Hg), not more than 3 parts per million. (c) Uses and restrictions. (1) Synthetic iron oxide may be safely used for human food use subject to the following restrictions: (i) In sausage casings intended for human consumption in an amount not exceeding 0.10 percent by weight of the finished food. (ii) In soft and hard candy, mints, and chewing gum at levels consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards. (iii) In dietary supplement tablets and capsules, including coatings and printing inks, such that the … | |||
| 21:21:1.0.1.1.27.1.98.27 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.225 Jagua (genipin-glycine) blue. | FDA | [88 FR 75494, Nov. 3, 2023] | (a) Identity. (1) The color additive jagua (genipin-glycine) blue is a dark blue powder or liquid prepared from the juice of the unripe fruit of Genipa americana by reacting the genipin in the juice with glycine using mild heat. The color additive contains a polymer as the principal coloring component and three dimers as minor coloring components. (2) Color additive mixtures for food use made with jagua (genipin-glycine) blue may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Jagua (genipin-glycine) blue must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: (1) Arsenic, not more than 1 milligram/kilogram (mg/kg) (1 part per million (ppm)). (2) Cadmium, not more than 1 mg/kg (1 ppm). (3) Lead, not more than 1 mg/kg (1 ppm). (4) Mercury, not more than 1 mg/kg (1 ppm). (5) Genipin, not more than 20 mg/kg (20 ppm). (c) Uses and restrictions. Jagua (genipin-glycine) blue may be safely used for coloring flavored milk; dairy drinks and substitutes; dairy and dairy alternative yogurt; ice cream, frozen dairy and dairy alternative desserts, puddings, gelatins, ices, sorbets; ready-to-eat multicolored cereals; flavored potato chips, tortilla, corn, and other chips; candy and chewing gum; non-alcoholic fruit based/flavored drinks, nutritional beverages and smoothies; flavored cream cheese-based spreads; and icings, frostings, jams, syrups, and fruit toppings and fillings at levels consistent with good manufacturing practice, except that it may not be used for coloring foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of added color is authorized by such standards. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in… | |||
| 21:21:1.0.1.1.27.1.98.28 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.250 Fruit juice. | FDA | [42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995] | (a) Identity. (1) The color additive fruit juice is prepared either by expressing the juice from mature varieties of fresh, edible fruits, or by the water infusion of the dried fruit. The color additive may be concentrated or dried. The definition of fruit juice in this paragraph is for the purpose of identity as a color additive only and shall not be construed as a standard of identity under section 401 of the act. However, where a standard of identity for a particular fruit juice has been promulgated under section 401 of the act, it shall conform to such standard. (2) Color additive mixtures made with fruit juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. Fruit juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | |||
| 21:21:1.0.1.1.27.1.98.29 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.260 Vegetable juice. | FDA | [42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995] | (a) Identity. (1) The color additive vegetable juice is prepared either by expressing the juice from mature varieties of fresh, edible vegetables, or by the water infusion of the dried vegetable. The color additive may be concentrated or dried. The definition of vegetable juice in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as a standard of identity under section 401 of the act. However, where a standard of identity for a particular vegetable juice has been promulgated under section 401 of the act, it shall conform to such standard. (2) Color additive mixtures made with vegetable juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. Vegetable juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | |||
| 21:21:1.0.1.1.27.1.98.3 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.32 Antarctic krill meal. | FDA | [87 FR 27935, May 10, 2022] | (a) Identity. (1) The color additive Antarctic krill meal consists of the cooked, dried, and ground biomass of whole Euphausia superba (Antarctic krill), with or without removal of the lipid fraction. The lipid fraction may be fully or partially extracted with ethanol, followed by removal of residual ethanol, to produce defatted Antarctic krill meal. Whole Antarctic krill meal, produced when the lipid fraction is not removed, may contain ethoxyquin as a preservative. (2) Color additive mixtures for fish feed use made with Antarctic krill meal may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Antarctic krill meal must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: (1) Physical state, solid. (2) Ethoxyquin, not more than 250 milligrams per kilogram (mg/kg) (250 parts per million (ppm)) in whole Antarctic krill meal. (3) Lead, not more than 2 mg/kg (2 ppm). (4) Arsenic, not more than 5 mg/kg (5 ppm). (5) Mercury, not more than 1 mg/kg (1 ppm). (6) Cadmium, not more than 2 mg/kg (2 ppm). (7) Fluoride, not more than 2,500 mg/kg (2,500 ppm). (8) Astaxanthin, not more than 170 mg/kg (170 ppm) in whole Antarctic krill meal; not more than 90 mg/kg (90 ppm) in defatted Antarctic krill meal. (c) Uses and restrictions. Antarctic krill meal may be safely used in salmonid feed in accordance with the following prescribed conditions: (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish; (2) The color additive may be used at levels not to exceed 4 percent by weight in freshwater salmonid feed and 12 percent by weight in marine salmonid feed; (3) The quantity of the color additive incorporated in the feed is such that the finished feed meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 57… | |||
| 21:21:1.0.1.1.27.1.98.30 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.275 Dried algae meal. | FDA | (a) Identity. The color additive dried algae meal is a dried mixture of algae cells (genus Spongiococcum, separated from its culture broth), molasses, cornsteep liquor, and a maximum of 0.3 percent ethoxyquin. The algae cells are produced by suitable fermentation, under controlled conditions, from a pure culture of the genus Spongiococcum. (b) Uses and restrictions. The color additive dried algae meal may be safely used in chicken feed in accordance with the following prescribed conditions: (1) The color additive is used to enhance the yellow color of chicken skin and eggs. (2) The quantity of the color additive incorporated in the feed is such that the finished feed: (i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (b)(1) of this section; and (ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 573.380 of this chapter. (c) Labeling. The label of the color additives and any premixes prepared therefrom shall bear in addition to the information required by § 70.25 of this chapter. (1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein. (2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (b) of this section. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | ||||
| 21:21:1.0.1.1.27.1.98.31 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.295 Tagetes (Aztec marigold) meal and extract. | FDA | (a) Identity. (1) The color additive tagetes (Aztec marigold) meal is the dried, ground flower petals of the Aztec marigold ( Tagetes erecta L.) mixed with not more than 0.3 percent ethoxyquin. (2) The color additive tagetes (Aztec marigold) extract is a hexane extract of the flower petals of the Aztec marigold ( Tagetes erecta L.). It is mixed with an edible vegetable oil, or with an edible vegetable oil and a hydrogenated edible vegetable oil, and not more than 0.3 percent ethoxyquin. It may also be mixed with soy flour or corn meal as a carrier. (b) Specifications. (1) Tagetes (Aztec marigold) meal is free from admixture with other plant material from Tageteserecta L. or from plant material or flowers of any other species of plants. (2) Tagetes (Aztec marigold) extract shall be prepared from tagetes (Aztec marigold) petals meeting the specifications set forth in paragraph (b)(1) of this section and shall conform to the following additional specifications: All determinations, except the hexane residue, shall be made on the initial extract of the flower petals (after drying in a vacuum oven at 60 °C. for 24 hours) prior to the addition of the oils and ethoxyquin. The hexane determination shall be made on the color additive after the addition of the vegetable oils, hydrogenated vegetable oils, and ethoxyquin. (c) Uses and restrictions. The color additives tagetes (Aztec marigold) meal and extract may be safely used in chicken feed in accordance with the following prescribed conditions: (1) The color additives are used to enhance the yellow color of chicken skin and eggs. (2) The quantity of the color additives incorporated in the feed is such that the finished feed: (i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section; and (ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 573.380 of this chapter. (d) Labeling requirements. The label of the color additi… | ||||
| 21:21:1.0.1.1.27.1.98.32 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.297 Myoglobin. | FDA | [90 FR 5594, Jan. 17, 2025] | (a) Identity. (1) The color additive myoglobin is a stabilized product of controlled fermentation of a non-pathogenic and non-toxicogenic strain of the yeast, Komagataella phaffii, genetically engineered to express the myoglobin protein from Bos taurus. Myoglobin protein is the principal coloring component of the color additive and imparts a red color. (2) Color additive mixtures made with myoglobin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Myoglobin must conform to the following specifications and must be free from impurities, other than those named, to the extent that such impurities may be avoided by good manufacturing practice: (1) Myoglobin protein purity on protein basis (weight/weight), not less than 85 percent. (2) Lead, not more than 0.01 milligrams per kilogram (0.01 parts per million). (c) Uses and restrictions. Myoglobin may be safely used in ground meat and ground poultry analogue products ( i.e., plant-based ground meat- and poultry-like food products subject to FDA regulation) where the amount of myoglobin protein does not exceed 2 percent by weight of the uncooked analogue product. (d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes must conform to § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore, batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act. | |||
| 21:21:1.0.1.1.27.1.98.33 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.300 Carrot oil. | FDA | (a) Identity. (1) The color additive carrot oil is the liquid or the solid portion of the mixture or the mixture itself obtained by the hexane extraction of edible carrots ( Daucus carota L.) with subsequent removal of the hexane by vacuum distillation. The resultant mixture of solid and liquid extractives consists chiefly of oils, fats, waxes, and carrotenoids naturally occurring in carrots. The definition of carrot oil in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for carrot oil or carrot oleoresin under section 401 of the act. (2) Color additive mixtures for food use made with carrot oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Carrot oil shall contain no more than 25 parts per million of hexane. (c) Uses and restrictions. Carrot oil may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless the use of added color is authorized by such standards. (d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | ||||
| 21:21:1.0.1.1.27.1.98.34 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.315 Corn endosperm oil. | FDA | (a) Identity. (1) The color additive corn endosperm oil is a reddish-brown liquid composed chiefly of glycerides, fatty acids, sitosterols, and carotenoid pigments obtained by isopropyl alcohol and hexane extraction from the gluten fraction of yellow corn grain. The definition of corn endosperm oil in this paragraph is for the purpose of definition as a color additive only and shall not be construed as a food standard of identity under section 401 of the act. (2) Color additive mixtures for food use made with corn endosperm oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Corn endosperm oil conforms to the following specifications: Total fatty acids, not less than 85 percent. Iodine value, 118 to 134. Saponification value, 165 to 185. Unsaponifiable matter, not more than 14 percent. Hexane, not more than 25 parts per million. Isopropyl alcohol, not more than 100 parts per million. Total fatty acids, not less than 85 percent. Iodine value, 118 to 134. Saponification value, 165 to 185. Unsaponifiable matter, not more than 14 percent. Hexane, not more than 25 parts per million. Isopropyl alcohol, not more than 100 parts per million. (c) Uses and restrictions. The color additive corn endosperm oil may be safely used in chicken feed in accordance with the following prescribed conditions: (1) The color additive is used to enhance the yellow color of chicken skin and eggs. (2) The quantity of the color additive incorporated in the feed is such that the finished feed is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (c)(1) of this section. (d) Labeling requirements. The label of the color additive and any premixes prepared therefrom shall bear, in addition to the information required by § 70.25 of this chapter, a statement of the concentration of xanthophyll contained therein. (e) Exemption from certifi… | ||||
| 21:21:1.0.1.1.27.1.98.35 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.340 Paprika. | FDA | (a) Identity. (1) The color additive paprika is the ground dried pod of mild capsicum ( Capsicum annuum L.). The definition of paprika in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for paprika under section 401 of the act. (2) Color additive mixtures made with paprika may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. Paprika may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | ||||
| 21:21:1.0.1.1.27.1.98.36 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.345 Paprika oleoresin. | FDA | (a) Identity. (1) The color additive paprika oleoresin is the combination of flavor and color principles obtained from paprika ( Capsicum annuum L.) by extraction, using any one or a combination of the following solvents: Acetone Ethyl alcohol Ethylene dichloride Hexane Isopropyl alcohol Methyl alcohol Methylene chloride Trichloroethylene The definition of paprika oleoresin in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for paprika oleoresin under section 401 of the act. (2) Color additive mixtures made with paprika oleoresin may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Paprika oleoresin shall contain no more residue of the solvents listed in paragraph (a)(1) of this section than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in parts 170 through 189 of this chapter. (c) Uses and restrictions. Paprika oleoresin may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | ||||
| 21:21:1.0.1.1.27.1.98.37 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.350 Mica-based pearlescent pigments. | FDA | [71 FR 31929, June 2, 2006, as amended at 78 FR 35117, June 12, 2013; 80 FR 32307, June 8, 2015; 80 FR 58602, Sept. 30, 2015] | (a) Identity. (1) The color additive is formed by depositing titanium salts onto mica, followed by heating to produce titanium dioxide on mica. Mica used to manufacture the color additive shall conform in identity to the requirements of § 73.1496(a)(1). (2) Color additive mixtures for food use made with mica-based pearlescent pigments may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring food. (b) Specifications. Mica-based pearlescent pigments shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: (1) Lead (as Pb), not more than 4 parts per million (ppm). (2) Arsenic (as As), not more than 3 ppm. (3) Mercury (as Hg), not more than 1 ppm. (c) Uses and restrictions. (1) The substance listed in paragraph (a) of this section may be safely used as a color additive in food as follows: (i) In amounts up to 1.25 percent, by weight, in the following foods: Cereals, confections and frostings, gelatin desserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum. (ii) In amounts up to 0.07 percent, by weight, in the following: (A) Distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume. (B) Cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, and cocktails. (C) Non-alcoholic cocktail mixes and mixers, such as margarita mix, Bloody Mary mix, and daiquiri mix, but excluding eggnog, tonic water, and beverages that are typically consumed without added alcohol ( e.g., fruit juices, fruit juice drinks, and soft drinks). (iii) In egg decorating kits used for coloring the shells of eggs in amounts consistent with good manufacturing practice. (2) The color additive may not be used to color foods for which standards of identity have been issued under section 401 of the act, unless the use of… | |||
| 21:21:1.0.1.1.27.1.98.38 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.352 Paracoccus pigment. | FDA | [74 FR 58845, Nov. 16, 2009] | (a) Identity. (1) The color additive paracoccus pigment consists of the heat-killed, dried cells of a nonpathogenic and nontoxicogenic strain of the bacterium Paracoccus carotinifaciens and may contain added calcium carbonate to adjust the astaxanthin level. (2) Color additive mixtures for fish feed use made with paracoccus pigment may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Paracoccus pigment shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such impurities may be avoided by good manufacturing practice: (1) Physical state, solid. (2) Lead, not more than 5 milligrams per kilogram (mg/kg) (5 parts per million (ppm)). (3) Arsenic, not more than 2 mg/kg (2 ppm). (4) Mercury, not more than 1 mg/kg (1 ppm). (5) Heavy metals (as Pb), not more than 10 mg/kg (10 ppm). (6) Astaxanthin, not less than 1.75 percent. (c) Uses and restrictions. Paracoccus pigment may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of astaxanthin in finished feed, from paracoccus pigment when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 mg/kg (72 grams per ton) of finished feed. (d) Labeling requirements. (1) The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section. (2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this sec… | |||
| 21:21:1.0.1.1.27.1.98.39 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.355 Phaffia yeast. | FDA | [65 FR 41587, July 6, 2000] | (a) Identity. (1) The color additive phaffia yeast consists of the killed, dried cells of a nonpathogenic and nontoxicogenic strain of the yeast Phaffia rhodozyma. (2) Phaffia yeast may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with phaffia yeast may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Phaffia yeast shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Physical state, solid. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals (as Pb), not more than 10 parts per million. Astaxanthin, not less than 0.4 percent. Physical state, solid. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals (as Pb), not more than 10 parts per million. Astaxanthin, not less than 0.4 percent. (c) Uses and restrictions. Phaffia yeast may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of astaxanthin in finished feed, from phaffia yeast when used alone or in combination with other astaxanthin color additive sources listed in this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (1) The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of this chapter, and adequate direct… | |||
| 21:21:1.0.1.1.27.1.98.4 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.35 Astaxanthin. | FDA | [60 FR 18738, Apr. 13, 1995] | (a) Identity. (1) The color additive astaxanthin is 3, 3′-dihydroxy-β, β-carotene-4, 4′-dione. (2) Astaxanthin may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with astaxanthin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Astaxanthin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Physical state, solid. 0.05 percent solution in chloroform, complete and clear. Absorption maximum wavelength 484-493 nanometers (in chloroform). Residue on ignition, not more than 0.1 percent. Total carotenoids other than astaxanthin, not more than 4 percent. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals, not more than 10 parts per million. Assay, minimum 96 percent. Physical state, solid. 0.05 percent solution in chloroform, complete and clear. Absorption maximum wavelength 484-493 nanometers (in chloroform). Residue on ignition, not more than 0.1 percent. Total carotenoids other than astaxanthin, not more than 4 percent. Lead, not more than 5 parts per million. Arsenic, not more than 2 parts per million. Mercury, not more than 1 part per million. Heavy metals, not more than 10 parts per million. Assay, minimum 96 percent. (c) Uses and restrictions. Astaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: (1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. (2) The quantity of color additive in feed is such that the color additive shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed. (d) Labeling requirements. (1) The la… | |||
| 21:21:1.0.1.1.27.1.98.40 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.450 Riboflavin. | FDA | [42 FR 15643, Mar. 22, 1977, as amended at 47 FR 947, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984] | (a) Identity. (1) The color additive riboflavin is the riboflavin defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 262-263, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (2) Color additive mixtures made with riboflavin may contain as diluents only those substances listed in this subpart as safe and suitable for use in color additive mixtures for coloring foods. (b) Specifications. Riboflavin shall meet the specifications given in the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a)(1) of this section. (c) Uses and restrictions. Riboflavin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice; except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Act. | |||
| 21:21:1.0.1.1.27.1.98.41 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.500 Saffron. | FDA | (a) Identity. (1) The color additive saffron is the dried stigma of Crocus sativus L. The definition of saffron in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for saffron under section 401 of the act. (2) Color additive mixtures made with saffron may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. Saffron may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. | ||||
| 21:21:1.0.1.1.27.1.98.42 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.520 Soy leghemoglobin. | FDA | [84 FR 37576, Aug. 1, 2019] | (a) Identity. (1) The color additive soy leghemoglobin is a stabilized product of controlled fermentation of a non-pathogenic and non-toxicogenic strain of the yeast, Pichia pastoris, genetically engineered to express soy leghemoglobin protein. Soy leghemoglobin protein is the principal coloring component of the color additive and imparts a reddish-brown color. (2) Color additive mixtures made with soy leghemoglobin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Soy leghemoglobin shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such impurities may be avoided by good manufacturing practice: (1) Soy leghemoglobin protein purity on protein basis (weight/weight), not less than 65 percent, as determined by sodium dodecyl sulfate-polyacrylamide gel electrophoresis. (2) Lead, not more than 0.4 milligrams per kilogram (mg/kg) (0.4 parts per million (ppm)). (3) Arsenic, not more than 0.05 mg/kg (0.05 ppm). (4) Mercury, not more than 0.05 mg/kg (0.05 ppm). (5) Cadmium, not more than 0.2 mg/kg (0.2 ppm). (c) Uses and restrictions. Soy leghemoglobin may be safely used in ground beef analogue products such that the amount of soy leghemoglobin protein does not exceed 0.8 percent by weight of the uncooked ground beef analogue product. (d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes must conform to § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act. | |||
| 21:21:1.0.1.1.27.1.98.43 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.530 Spirulina extract. | FDA | [78 FR 49120, Aug. 13, 2013, as amended at 79 FR 20098, May 13, 2014; 80 FR 50765, Aug. 21, 2015; 82 FR 30734, July 3, 2017; 87 FR 67789, Nov. 10, 2022] | (a) Identity. (1) The color additive spirulina extract is prepared by the filtered aqueous extraction of the dried biomass of Arthrospira platensis. The color additive contains phycocyanins as the principal coloring components. (2) Color additive mixtures for food use made with spirulina extract may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods. (b) Specifications. Spirulina extract must conform to the following specifications and must be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: (1) Lead, not more than 2 milligrams per kilogram (mg/kg) (2 part per million (ppm)); (2) Arsenic, not more than 2 mg/kg (2 ppm); (3) Mercury, not more than 1 mg/kg (1 ppm); and (4) Negative for microcystin toxin. (c) Uses and restrictions. Spirulina extract may be safely used for coloring confections (including candy and chewing gum), frostings, ice cream and frozen desserts (including non-dairy frozen dessert), dessert coatings and toppings, beverage mixes and powders, yogurts (including non-dairy yogurt alternatives), custards, puddings (including non-dairy puddings), cottage cheese, gelatin, breadcrumbs, ready-to-eat cereals (excluding extruded cereals), alcoholic beverages with less than 20 percent alcohol-by-volume content, non-alcoholic beverages, seasoning mixes (unheated), salad dressings, condiments and sauces, dips, coating formulations applied to dietary supplement tablets and capsules, at levels consistent with good manufacturing practice, and to seasonally color the shells of hard-boiled eggs, except that it may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards. (d) Labeling requirements. The label of the color additive and of any mixture prepared therefrom intended solely… | |||
| 21:21:1.0.1.1.27.1.98.44 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.575 Titanium dioxide. | FDA | (a) Identity. (1) The color additive titanium dioxide is synthetically prepared TiO 2 , free from admixture with other substances. (2) Color additive mixtures for food use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods, and the following: Silicon dioxide, SiO 2 and/or aluminum oxide, Al 2 O 3 , as dispersing aids—not more than 2 percent total. (b) Specifications. Titanium dioxide shall conform to the following specifications: Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Antimony (as Sb), not more than 2 parts per million. Mercury (as Hg), not more than 1 part per million. Loss on ignition at 800 °C. (after drying for 3 hours at 105 °C.), not more than 0.5 percent. Water soluble substances, not more than 0.3 percent. Acid soluble substances, not more than 0.5 percent. TiO 2 , not less than 99.0 percent after drying for 3 hours at 105 °C. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million. Antimony (as Sb), not more than 2 parts per million. Mercury (as Hg), not more than 1 part per million. Loss on ignition at 800 °C. (after drying for 3 hours at 105 °C.), not more than 0.5 percent. Water soluble substances, not more than 0.3 percent. Acid soluble substances, not more than 0.5 percent. TiO 2 , not less than 99.0 percent after drying for 3 hours at 105 °C. Lead, arsenic, and antimony shall be determined in the solution obtained by boiling 10 grams of the titanium dioxide for 15 minutes in 50 milliliters of 0.5 N hydrochloric acid. (c) Uses and restrictions. The color additive titanium dioxide may be safely used for coloring foods generally, subject to the following restrictions: (1) The quantity of titanium dioxide does not exceed 1 percent by weight of the food. (2) It may not be used to color foods for which standards of identity have been promulga… | ||||
| 21:21:1.0.1.1.27.1.98.45 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.585 Tomato lycopene extract; tomato lycopene concentrate. | FDA | [70 FR 43045, July 26, 2005, as amended at 81 FR 5590, Feb. 3, 2016; 81 FR 49895, July 29, 2016] | (a) Identity. (1) The color additive tomato lycopene extract is a red to dark brown viscous oleoresin extracted with ethyl acetate from tomato pulp followed by removal of the solvent by evaporation. The pulp is produced from fresh, edible varieties of the tomato by removing the liquid. The main coloring component is lycopene. (2) The color additive tomato lycopene concentrate is a powder prepared from tomato lycopene extract by removing most of the tomato lipids with ethyl acetate and then evaporating off the solvent. (3) Color additive mixtures made with tomato lycopene extract or tomato lycopene concentrate may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring food. (b) Specifications. (1) Tomato lycopene extract shall conform to the following specification: Lycopene, not less than 5.5 percent of oleoresin as determined by the method entitled “Qualitative Analysis of Lycopene, Its Isomers and Other Carotenoids in Different Concentrations of Lyc-O-Mato ® (Tomato Oleoresin) and in Tomato Pulp by High Performance Liquid Chromatography (HPLC),” S.O.P. number : Lab/119/01, Revision 01, dated May 30, 2001, published by LycoRed Natural Products Industries, which is incorporated by reference, or an equivalent method. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy of the method from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. You may inspect a copy at theFood and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html (2) Tomato lycope… | |||
| 21:21:1.0.1.1.27.1.98.46 | 21 | Food and Drugs | I | A | 73 | PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION | A | Subpart A—Foods | § 73.600 Turmeric. | FDA | (a) Identity. (1) The color additive turmeric is the ground rhizome of Curcuma longa L. The definition of turmeric in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for turmeric under section 401 of the act. (2) Color additive mixtures made with turmeric may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Uses and restrictions. Turmeric may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards. (c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. |
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