cfr_sections
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155 rows where part_number = 106 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:2.0.1.1.6.1.1.1 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | A | Subpart A—General Provisions | § 106.1 Status and applicability of the regulations in part 106. | FDA | (a) The criteria set forth in subparts B, C, and D of this part prescribe the steps that manufacturers shall take under section 412(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b)(2) and (b)(3)) in processing infant formula. If the processing of the formula does not comply with any regulation in subparts B, C, or D of this part, the formula will be deemed to be adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act. (b) The criteria set forth in subpart E of this part prescribe the requirements for quality factors that infant formula shall meet under section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act. If the formula fails to comply with any regulation in subpart E of this part, it will be deemed to be adulterated under section 412(a)(2) of the Federal Food, Drug, and Cosmetic Act. (c) The criteria set forth in subpart F of this part prescribe records requirements for quality factors under section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act and for good manufacturing practices and quality control procedures, including distribution and audit records, under section 412(b)(2). If an infant formula manufacturer fails to comply with the quality factor record requirements in subpart F of this part with respect to an infant formula, the formula will be deemed to be adulterated under section 412(a)(2) of the Federal Food, Drug, and Cosmetic Act. If an infant formula manufacturer fails to comply with the good manufacturing practices or quality control procedures record requirements in subpart F of this part with respect to an infant formula, the infant formula will be deemed to be adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act. The criteria set forth in subpart F of this part also implement record retention requirements under section 412(b)(4) of the Federal Food, Drug, and Cosmetic Act. Failure to comply with any regulation in subpart F of this part is a violation of section 301(e) of the Federal Food, Drug, an… | ||||
| 21:21:2.0.1.1.6.1.1.2 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | A | Subpart A—General Provisions | § 106.3 Definitions. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33070, June 10, 2014] | The definitions in this section and the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) shall apply to infant formula requirements in 21 CFR parts 106 and 107 of this chapter. Eligible infant formula means an infant formula that could be lawfully distributed in the United States on December 8, 2014. Final product stage means the point in the manufacturing process, before distribution of an infant formula, at which the infant formula is homogeneous and is not subject to further degradation due to processing. Indicator nutrient means a nutrient whose concentration is measured during the manufacture of an infant formula to confirm complete addition and uniform distribution of a premix or other substance of which the indicator nutrient is a part. Infant means a person not more than 12 months of age. Infant formula means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk. In-process production aggregate means a combination of ingredients at any point in the manufacturing process before packaging. Major change in an infant formula means any new formulation, or any change of ingredients or processes where experience or theory would predict a possible significant adverse impact on levels of nutrients or bioavailability of nutrients, or any change that causes an infant formula to differ fundamentally in processing or in composition from any previous formulation produced by the manufacturer. Examples of infant formulas deemed to differ fundamentally in processing or in composition include: (1) Any infant formula produced by a manufacturer who is entering the U.S. market; (2) Any infant formula powder processed and distributed by a manufacturer who previously only produced liquids (or vice versa); (3) Any infant formula having a significant revision, addition, or substitution of a macronutrient (i.e., … | |||
| 21:21:2.0.1.1.6.2.1.1 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.5 Current good manufacturing practice. | FDA | (a) The regulations set forth in this subpart define the minimum current good manufacturing practices that are to be used in, and the facilities or controls that are to be used for, the manufacture, processing, packing, or holding of an infant formula. Compliance with these provisions is necessary to ensure that such infant formula provides the nutrients required under § 107.100 of this chapter and is manufactured in a manner designed to prevent its adulteration. A liquid infant formula that is a thermally processed low-acid food packaged in a hermetically sealed container is also subject to the regulations in part 113 of this chapter, and an infant formula that is an acidified food, as defined in § 114.3(b) of this chapter, is also subject to the regulations in part 114 of this chapter. (b) The failure to comply with any regulation in this subpart in the manufacture, processing, packing, or holding of an infant formula shall render such infant formula adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)(3)); the failure to comply with any regulation in part 113 of this chapter in the manufacture, processing, packing, or holding of a liquid infant formula shall render such infant formula adulterated under section 412(a)(3); and the failure to comply with any regulation in part 114 of this chapter in the manufacture, processing, packing, or holding of an infant formula that is an acidified food shall render such infant formula adulterated under section 412(a)(3). | ||||
| 21:21:2.0.1.1.6.2.1.10 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.60 Controls to prevent adulteration during packaging and labeling of infant formula. | FDA | (a) A manufacturer shall examine packaged and labeled infant formula during finishing operations to ensure that all containers and packages in the production aggregate have the correct label, the correct use-by date, and the correct code established under § 106.80. (b) Labels shall be designed, printed, and applied so that the labels remain legible and attached during the conditions of processing, storage, handling, distribution, and use. (c) Packaging used to hold multiple containers of an infant formula product shall be labeled as follows: (1) Where all containers are the same infant formula product and all bear the same code established under § 106.80, the packaging label shall include the product name, the name of the manufacturer, distributor, or shipper, and the code established under § 106.80. (2) Where the containers are not the same infant formula product or do not all bear the same code established under § 106.80, the packaging label shall: (i) Include the product name of each product, the name of the manufacturer, distributor, or shipper of each product, the code established under § 106.80 for each product, and a “use by” date that is no later than the “use by” date of the container exhibiting the closest “use by” date applied to satisfy the requirement of § 107.20(c) of this chapter; or (ii) Include a unique identification number assigned by the packager, provided that the distributor of the package maintains a record linked to such unique number that identifies the product name of each product, the name of the manufacturer, distributor, or shipper of each product, the code established under § 106.80 for each product, and the “use by” date for each product applied to satisfy the requirement of § 107.20(c) of this chapter. | ||||
| 21:21:2.0.1.1.6.2.1.11 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.70 Controls on the release of finished infant formula. | FDA | (a) A manufacturer shall control under a quarantine system designed to prevent use or distribution of each production aggregate of infant formula until it determines that the production aggregate meets all of the manufacturer's specifications, including those adopted to meet the standards of § 106.55 on microbiological contamination and of § 106.91(a) on quality control procedures, or until the documented review of the failure to meet any of the manufacturer's specifications finds that the failure does not result in, or could not lead to, adulteration of the product. (b) Any production aggregate of infant formula that fails to meet any of the manufacturer's specifications shall be quarantined under a system designed to prevent its use in the manufacture of infant formula or its distribution until an individual qualified by education, training, or experience has conducted a documented review and has made and documented a material disposition decision to reject the infant formula; to reprocess or otherwise recondition the infant formula; or to approve and release the infant formula. Any production aggregate of infant formula that is reprocessed or otherwise reconditioned shall be the subject of a documented review and material disposition decision by an individual qualified by education, training, or experience to determine whether it may be released for use or distribution. (c) Any rejected infant formula shall be clearly identified as having been rejected for use and shall be controlled under a quarantine system designed to prevent its release or distribution. (d) A production aggregate of infant formula, including a reprocessed or reconditioned production aggregate, that does not meet the nutrient requirements of section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)) or that has not been manufactured, packaged, labeled, and held under conditions to prevent adulteration under sections 402(a)(1) through (a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) through (a)(4… | ||||
| 21:21:2.0.1.1.6.2.1.12 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.80 Traceability. | FDA | Each production aggregate of infant formula shall be coded with a sequential number that identifies the product and the establishment where the product was packed and that permits tracing of all stages of manufacture of that production aggregate, including the year, the days of the year, and the period during those days that the product was packed, and the receipt and handling of raw materials used. | ||||
| 21:21:2.0.1.1.6.2.1.13 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.90 Audits of current good manufacturing practice. | FDA | (a) A manufacturer of an infant formula, or an agent of such manufacturer, shall conduct regularly scheduled audits to determine whether the manufacturer has complied with the current good manufacturing practice regulations in this subpart. Such audits shall be conducted at a frequency that is required to ensure compliance with such regulations. (b) The audits required by paragraph (a) of this section shall be performed by an individual or a team of individuals who, as a result of education, training, or experience, is knowledgeable in all aspects of infant formula production and of the Agency's regulations concerning current good manufacturing practice that such individual or team is responsible for auditing. This individual or team of individuals shall have no direct responsibility for the matters that such individual or team is auditing and shall have no direct interest in the outcome of the audit. | ||||
| 21:21:2.0.1.1.6.2.1.2 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.6 Production and in-process control system. | FDA | (a) A manufacturer shall conform to the requirements of this subpart by implementing a system of production and in-process controls. This production and in-process control system shall cover all stages of processing, from the receipt and acceptance of the raw materials, ingredients, and components through the storage and distribution of the finished product and shall be designed to ensure that all the requirements of this subpart are met. (b) The production and in-process control system shall be set out in a written plan or set of procedures that is designed to ensure that an infant formula is manufactured in a manner that will prevent adulteration of the infant formula. (c) At any point, step, or stage in the production process where control is necessary to prevent adulteration, a manufacturer shall: (1) Establish specifications to be met; (2) Monitor the production and in-process control point, step, or stage; (3) Establish a corrective action plan for use when a specification established in accordance with paragraph (c)(1) of this section is not met; (4) Review the results of the monitoring required by paragraph (c)(2) of this section, and review and evaluate the public health significance of any deviation from specifications that have been established in accordance with paragraph (c)(1) of this section. For any specification established in accordance with paragraph (c)(1) of this section that a manufacturer fails to meet, an individual qualified by education, training, or experience shall conduct a documented review and shall make a material disposition decision to reject the affected article, to reprocess or otherwise recondition the affected article, or to approve and release the article for use or distribution; and (5) Establish recordkeeping procedures, in accordance with § 106.100(e)(3), that ensure that compliance with the requirements of this section is documented. (d) Any article that fails to meet a specification established in accordance with paragraph (c)(1) of this section shall be control… | ||||
| 21:21:2.0.1.1.6.2.1.3 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.10 Controls to prevent adulteration by workers. | FDA | (a) A manufacturer shall employ sufficient personnel, qualified by education, training, or experience, to perform all operations, including all required recordkeeping, in the manufacture, processing, packing, and holding of each infant formula and to supervise such operations to ensure that the operations are correctly and fully performed. (b) Personnel working directly with infant formula, infant formula raw materials, infant formula packaging, or infant formula equipment or utensil contact surfaces shall practice good personal hygiene to protect the infant formula against contamination. Good personal hygiene includes: (1) Wearing clean outer garments and, as necessary, protective apparel such as head, face, hand, and arm coverings; and (2) Washing hands thoroughly in a hand washing facility with soap and running water at a suitable temperature before starting work, after each absence from the work station, and at any other time when the hands may become soiled or contaminated. (c) Any person who reports that he or she has, or appears by medical examination or supervisory observation to have, an illness, open lesion (including boils, sores, or infected wounds), or any other source of microbial contamination that creates a reasonable possibility that the safety of an infant formula may be adversely affected, shall be excluded from direct contact with ingredients, containers, closures, in-process materials, equipment, utensils, and infant formula product until the condition is corrected or determined by competent medical personnel not to jeopardize the safety of the infant formula. | ||||
| 21:21:2.0.1.1.6.2.1.4 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.20 Controls to prevent adulteration caused by facilities. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33070, June 10, 2014] | (a) Buildings used in the manufacture, processing, packing, or holding of infant formula shall be maintained in a clean and sanitary condition and shall have space for the separation of incompatible operations, such as the handling of raw materials, the manufacture of the product, and packaging and labeling operations. (b) Separate areas or another system of separation, such as a computerized inventory control, a written card system, or an automated system of segregation, shall be used for holding raw materials, in-process materials, and final infant formula product at the following times: (1) Pending release for use in infant formula production or pending release of the final product; (2) After rejection for use in, or as, infant formula; and (3) After release for use in infant formula production or after release of the final product. (c) Lighting shall allow easy identification of raw materials, packaging, labeling, in-process materials, and finished products that have been released for use in infant formula production and shall permit the easy reading of instruments and controls necessary in processing, packaging, and laboratory analysis. Any lighting fixtures directly over or adjacent to exposed raw materials, in-process materials, or bulk (unpackaged) finished product shall be protected to prevent glass from contaminating the product in the event of breakage. (d) A manufacturer shall provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate the infant formula; and shall minimize the potential for contamination of raw materials, in-process materials, final product infant formula, packing materials, and infant formula-contact surfaces, through the use of appropriate measures, which may include the use of air filtration. (e) All rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents shall be stored and used in a manner that protects against contamination of infant formula. … | |||
| 21:21:2.0.1.1.6.2.1.5 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.30 Controls to prevent adulteration caused by equipment or utensils. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014] | (a) A manufacturer shall ensure that equipment and utensils used in the manufacture, processing, packing, or holding of an infant formula are of appropriate design and are installed to facilitate their intended function and their cleaning and maintenance. (b) A manufacturer shall ensure that equipment and utensils used in the manufacture, processing, packing, or holding of an infant formula are constructed so that surfaces that contact ingredients, in-process materials, or infant formula are made of nontoxic materials and are not reactive or absorptive. A manufacturer shall ensure that such equipment and utensils are designed to be easily cleanable and to withstand the environment of their intended use and that all surfaces that contact ingredients, in-process materials, or infant formula are cleaned and sanitized, as necessary, and are maintained to protect infant formula from being contaminated by any source. All sanitizing agents used on such equipment and utensils that are regulated as pesticide chemicals under 21 U.S.C. 346a(a) shall comply with the Environmental Protection Agency's regulations established under such section, and all other such sanitizers shall comply with all applicable Food and Drug Administration laws and regulations. (c) A manufacturer shall ensure that any substance, such as a lubricant or a coolant, that is required for operation of infant formula manufacturing equipment and which would render the infant formula adulterated if such substance were to come in contact with the formula, does not come in contact with formula ingredients, containers, closures, in-process materials, or with infant formula product during the manufacture of an infant formula. (d) A manufacturer shall ensure that each instrument used for measuring, regulating, or controlling mixing time and speed, temperature, pressure, moisture, water activity, or other parameter at any point, step, or stage where control is necessary to prevent adulteration of an infant formula during processing is accurate, easily read, pr… | |||
| 21:21:2.0.1.1.6.2.1.6 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.35 Controls to prevent adulteration due to automatic (mechanical or electronic) equipment. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014] | (a) For the purposes of this section: (1) “Hardware” means all automatic equipment, including mechanical and electronic equipment (such as computers), that is used in production or quality control of infant formula. (2) “Software” means any programs, procedures, rules, and associated documentation used in the operation of a system. (3) “System” means a collection of components (including software and hardware) organized to accomplish a specific function or set of functions in a specified environment. (4) “Validation” means establishing documented evidence that provides a high degree of assurance that a system will consistently produce a product meeting its predetermined specifications and quality characteristics. Validation can be accomplished through any suitable means, such as verification studies or modeling. (b) All systems shall be designed, installed, tested, and maintained in a manner that will ensure that they are capable of performing their intended function and of producing or analyzing infant formula in accordance with this subpart and subpart C of this part. (1) A manufacturer shall ensure, at any point, step, or stage where control is necessary to prevent adulteration of the infant formula, that all hardware is routinely inspected and checked according to written procedures and that hardware that is capable of being calibrated is routinely calibrated according to written procedures. (2) A manufacturer shall check and document the accuracy of input into, and output generated by, any system used in the production or quality control of an infant formula to ensure that the infant formula is not adulterated. The degree and frequency of input/output verification shall be based on the complexity and reliability of the system and the level of risk associated with the safe operation of the system. (3) A manufacturer shall ensure that each system is validated prior to the release for distribution of any infant formula manufactured using the system. (4) A manufacturer shall ensure that any system that … | |||
| 21:21:2.0.1.1.6.2.1.7 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.40 Controls to prevent adulteration caused by ingredients, containers, and closures. | FDA | (a) The only substances that may be used in an infant formula are substances that are safe and suitable for use in infant formula under the applicable food safety provisions of the Federal Food, Drug, and Cosmetic Act; that is, a substance is used in accordance with the Agency's food additive regulations, is generally recognized as safe (GRAS) for such use, or is authorized by a prior sanction. (b) Infant formula containers and closures shall not be reactive or absorptive so as to affect the safety of the infant formula. The following substances may be used as packaging material that comes in contact with an infant formula: (1) A food additive that is the subject of a regulation issued under section 409(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)) and is used consistent with the conditions of use of that regulation; (2) A food contact substance that is the subject of an effective notification under section 409(h) of the Federal Food, Drug, and Cosmetic Act and is used consistent with the conditions of use in that notification; (3) A substance that is exempt from regulation as a food additive under § 170.39 of this chapter and its use conforms to the use identified in the exemption letter; (4) A substance that is generally recognized as safe for use in or on infant formula or for use in infant formula packaging; (5) A substance the use of which is authorized by a prior sanction from the Food and Drug Administration or from the U.S. Department of Agriculture; and (6) A substance that is not a food additive within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)) because the substance is not reasonably expected to become a component of food or otherwise affect the characteristics of food. (c) Ingredients, containers, and closures used in the manufacture of infant formula shall be identified with a lot number to be used in recording their disposition. (d) A manufacturer shall develop written specifications for ingredients, containers, and closur… | ||||
| 21:21:2.0.1.1.6.2.1.8 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.50 Controls to prevent adulteration during manufacturing. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014] | (a) A manufacturer shall prepare and follow a written master manufacturing order that establishes controls and procedures for the production of an infant formula. (1) The manufacturer shall make and retain records, in accordance with § 106.100(e), that include complete information relating to the production and control of the production aggregate. An individual qualified by education, training, or experience shall conduct an investigation of any deviations from the master manufacturing order and document any corrective action taken. (2) Changes made to the master manufacturing order shall be reviewed and approved by a responsible official and include an evaluation of the effect of the change on the nutrient content and the suitability of the formula for infants. (b) A manufacturer shall establish controls to ensure that each raw or in-process ingredient required by the master manufacturing order is examined by one person and checked by a second person or system. This checking shall ensure that the correct ingredient is added during the manufacturing process, that the ingredient has been released for use in infant formula, and that the correct weight or measure of the ingredient is added to the production unit. (c) A manufacturer shall establish a system of identification for the contents of all compounding and storage containers, processing lines, and major equipment used during the manufacture of a production aggregate of an infant formula. The system shall permit the identification of the processing stage and the unique identification number for the particular production unit or production aggregate of infant formula. (d) A manufacturer shall establish controls to ensure that the nutrient levels required by § 107.100 of this chapter are maintained in the formula, and that the formula is not contaminated with microorganisms or other contaminants. Such controls shall include: (1) The mixing time; the speed, temperature, and flow rate of product; and other critical parameters necessary to ensure the addition… | |||
| 21:21:2.0.1.1.6.2.1.9 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | B | Subpart B—Current Good Manufacturing Practice | § 106.55 Controls to prevent adulteration from microorganisms. | FDA | (a) A manufacturer of infant formula shall establish a system of process controls covering all stages of processing that is designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment. (b) A manufacturer of liquid infant formula shall comply, as appropriate, with the procedures specified in part 113 of this chapter for thermally processed low-acid foods packaged in hermetically sealed containers and part 114 of this chapter for acidified foods. (c) A manufacturer of powdered infant formula shall test representative samples of each production aggregate of powdered infant formula at the final product stage, before distribution, to ensure that each production aggregate meets the microbiological quality standards in the table in paragraph (e) of this section. (d) A manufacturer shall make and retain records, in accordance with § 106.100(e)(5)(ii) and (f)(7), on the testing of infant formulas for microorganisms. (e) A powdered infant formula that contains any microorganism that exceeds the M value listed for that microorganism in the table in paragraph (e) of this section shall be deemed adulterated under sections 402(a)(1), 402(a)(4), and 412(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)(3)). The Food and Drug Administration will determine compliance with the M values listed below using the latest edition of the Bacteriological Analytical Manual (BAM) ( http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm ) (accessed April 8, 2013). 1 Number of samples. 2 None detected. | ||||
| 21:21:2.0.1.1.6.3.1.1 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | C | Subpart C—Quality Control Procedures | § 106.91 General quality control. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014] | (a) During manufacture, a manufacturer shall test each production aggregate for nutrients as follows: (1) Each nutrient premix used in the manufacture of an infant formula shall be tested for each nutrient (required under § 107.100 of this chapter or otherwise added by the manufacturer) that the manufacturer is relying on the premix to provide, to ensure that the premix is in compliance with the manufacturer's specifications; (2) During the manufacturing process, after the addition of the premix, or at the final product stage but before distribution, each production aggregate of infant formula shall be tested for at least one indicator nutrient for each of the nutrient premixes used in the infant formula to confirm that the nutrients supplied by each of the premixes are present, in the proper concentration, in the production aggregate of infant formula. (3) At the final product stage, before distribution of an infant formula, each production aggregate shall be tested for vitamins A, C, E, and thiamin. (4) During the manufacturing process or at the final product stage, before distribution, each production aggregate shall be tested for all nutrients required to be included in such formula under § 107.100 of this chapter for which testing is not conducted for compliance with paragraphs (a)(1) or (a)(3) of this section and for any nutrient added by the manufacturer for which testing is not conducted for compliance with paragraph (a)(1) of this section. (b) A manufacturer shall test each production aggregate of finished product for nutrients as follows: (1)(i) For an infant formula that is a new infant formula the manufacturer shall collect, from each manufacturing site and at the final product stage, a representative sample of the first production aggregate of packaged, finished formula in each physical form (powder, ready-to-feed, or concentrate) and evaluate the levels of all nutrients required under § 107.100 of this chapter and all other nutrients added by the manufacturer. The manufacturer shall repeat suc… | |||
| 21:21:2.0.1.1.6.3.1.2 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | C | Subpart C—Quality Control Procedures | § 106.92 Audits of quality control procedures. | FDA | (a) A manufacturer of an infant formula, or an agent of such a manufacturer, shall conduct regularly scheduled audits to determine whether the manufacturer has complied with the requirements for quality control procedures that are necessary to ensure that an infant formula provides nutrients in accordance with section 412(b) and (i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b) and (i)) and is manufactured in a manner designed to prevent adulteration of the infant formula under section 412(a)(1) and (a)(3) of the Federal Food, Drug, and Cosmetic Act. Such audits shall be conducted at a frequency that is required to ensure compliance with the requirements for quality control procedures. (b) The audits required by paragraph (a) of this section shall be performed by an individual or a team of individuals who, as a result of education, training, or experience, is knowledgeable in all aspects of infant formula production and of the regulations concerning quality control procedures that such individual or team is responsible for auditing. This individual or team of individuals shall have no direct responsibility for the matters that such individual or team is auditing and shall have no direct interest in the outcome of the audit. | ||||
| 21:21:2.0.1.1.6.4.1.1 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | D | Subpart D—Conduct of Audits | § 106.94 Audit plans and procedures. | FDA | (a) A manufacturer shall develop and follow a written audit plan that is available at the manufacturing facility for Food and Drug Administration inspection. (b) The audit plan shall include audit procedures that set out the methods the manufacturer uses to determine whether the facility is operating in accordance with current good manufacturing practice, with the quality control procedures that are necessary to ensure that an infant formula provides nutrients in accordance with sections 412(b) and (i) of the Federal Food, Drug, and Cosmetic Act, and in a manner designed to prevent adulteration of the infant formula. (c) The audit procedures shall include: (1) An evaluation of the production and in-process control system established under § 106.6(b) by: (i) Observing the production of infant formula and comparing the observed process to the written production and in-process control plan required under § 106.6(b); (ii) Reviewing records of the monitoring of points, steps, or stages where control is deemed necessary to prevent adulteration; and (iii) Reviewing records of how deviations from any specification at points, steps, or stages where control is deemed necessary to prevent adulteration were handled; and (2) A review of a representative sample of all records maintained in accordance with § 106.100(e) and (f). | ||||
| 21:21:2.0.1.1.6.5.1.1 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | E | Subpart E—Quality Factors for Infant Formulas | § 106.96 Requirements for quality factors for infant formulas. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014] | The regulations set forth in this subpart define the minimum requirements for quality factors for infant formulas: (a) An infant formula shall meet the quality factor of normal physical growth. (b) A manufacturer of an infant formula that is not an eligible infant formula shall demonstrate that a formula supports normal physical growth in infants when fed as a sole source of nutrition by conducting, in accordance with good clinical practice, an adequate and well-controlled growth monitoring study of the infant formula that: (1) Is no less than 15 weeks in duration, enrolling infants no more than 2 weeks old at time of entry into the study; (2) Includes the collection and maintenance of data on formula intake and anthropometric measures of physical growth, including body weight, recumbent length, head circumference, average daily weight increment, and average daily recumbent length increment; (3) Includes anthropometric measurements made at the beginning and end of the study, and at least four additional measurements made at intermediate time points with three of the six total measurements made within the first 4 weeks of the study and three measurements made at approximately 4-week intervals over the remaining 11 weeks of the study; (4) Compares the anthropometric data for the test group to a concurrent control group or groups at each time point and compares the anthropometric data for each infant (body weight for age, body length for age, head circumference for age, and weight for length) in the test group and the control group to the 2009 CDC growth charts, which are incorporated by reference at § 106.160; and (5) Compares the data on formula intake of the test group with a concurrent control group or groups and a scientifically appropriate reference. (c) The Food and Drug Administration will exempt a manufacturer from the requirements of paragraph (b) of this section, if: (1) The manufacturer requests an exemption and provides assurances, as required under § 106.121(b), that the changes made by the ma… | |||
| 21:21:2.0.1.1.6.6.1.1 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | F | Subpart F—Records and Reports | § 106.100 Records. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014; 80 FR 56144, Sept. 17, 2015] | (a) Every manufacturer of infant formula shall maintain the records specified in this regulation in order to permit the Food and Drug Administration to determine whether each manufacturer is in compliance with section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a)). (b) The manufacturer shall maintain all records that pertain to food-packaging materials subject to § 174.5 of this chapter and that bear on whether such materials would cause an infant formula to be adulterated within the meaning of section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(2)(C)). (c) The manufacturer shall maintain all records that pertain to nutrient premix testing that it generates or receives. Such records shall include, but are not limited to: (1) Any results of testing conducted to ensure that each nutrient premix is in compliance with the premix certificate and guarantee and specifications that have been provided to the manufacturer by the premix supplier, including tests conducted when nutrients exceed their expiration date or shelf life (retest date). (2) All certificates and guarantees given by premix suppliers concerning the nutrients required by section 412(i) of the Federal Food, Drug, and Cosmetic Act and § 107.100 of this chapter. (d) The premix supplier shall maintain the results of all testing conducted to provide all certificates and guarantees concerning nutrient premixes for infant formulas. Such records shall include but are not limited to: (1) The results of tests conducted to determine the purity of each nutrient required by section 412(i) of the Federal Food, Drug, and Cosmetic Act or § 107.100 of this chapter and any other nutrient listed in the certificate and guarantee; (2) The weight of each nutrient added; (3) The results of any quantitative tests conducted to determine the amount of each nutrient certified or guaranteed; and (4) The results of any quantitative tests conducted to identify the nutrient levels present when nutrient premixes exceed their ex… | |||
| 21:21:2.0.1.1.6.7.1.1 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | G | Subpart G—Registration, Submission, and Notification Requirements | § 106.110 New infant formula registration. | FDA | (a) Before a new infant formula may be introduced or delivered for introduction into interstate commerce, including a new infant formula for export only, the manufacturer of the formula shall register with the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling, and Dietary Supplements, Infant Formula and Medical Foods Staff (HFS-850), 5001 Campus Dr., College Park, MD 20740-3835. (b) The new infant formula registration shall include: (1) The name of the new infant formula; (2) The name of the manufacturer; (3) The street address of the place of business of the manufacturer; and (4) The name and street address of each establishment at which the manufacturer intends to manufacture such new infant formula. | ||||
| 21:21:2.0.1.1.6.7.1.2 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | G | Subpart G—Registration, Submission, and Notification Requirements | § 106.120 New infant formula submission. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014] | (a) At least 90 days before a new infant formula is introduced or delivered for introduction into interstate commerce, a manufacturer shall submit notice of its intent to do so to the Food and Drug Administration at the address given in § 106.110(a). An original and two paper copies of such notice of intent shall be submitted, unless the notice is submitted in conformance with part 11 of this chapter, in which case a single copy shall be sufficient. (b) The new infant formula submission shall include: (1) The name and description of the physical form (e.g., powder, ready-to feed, or concentrate) of the infant formula; (2) An explanation of why the formula is a new infant formula; (3) The quantitative formulation of each form of the infant formula that is the subject of the notice in units per volume or units per weight for liquid formulas, specified either as sold or as fed, and units per dry weight for powdered formulas, and the weight of powder to be reconstituted with a specified volume of water, and, when applicable, a description of any reformulation of the infant formula, including a listing of each new or changed ingredient and a discussion of the effect of such changes on the nutrient levels in the formulation; (4) A description, when applicable, of any change in processing of the infant formula. Such description shall identify the specific change in processing, including side-by-side, detailed schematic diagrams comparing the new processing to the previous processing and processing times and temperatures; (5) Assurance that the infant formula will not be marketed unless the formula meets the requirements for quality factors of section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b)(1)) and the nutrient content requirements of section 412(i) of the Federal Food, Drug, and Cosmetic Act. (i) Assurance that the formula meets the requirements for quality factors, which are set forth in § 106.96, shall be provided by a submission that complies with § 106.121; (ii) Assurance tha… | |||
| 21:21:2.0.1.1.6.7.1.3 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | G | Subpart G—Registration, Submission, and Notification Requirements | § 106.121 Quality factor assurances for infant formulas. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014] | To provide assurance that an infant formula meets the requirements for quality factors set forth in § 106.96, the manufacturer shall submit the following data and information: (a) Unless the manufacturer of a new infant formula can claim an exemption under § 106.96(c)(1) or (c)(2), the following assurances shall be provided to ensure that the requirements of § 106.96(a) and (b) have been met: (1) An explanation, in narrative form, setting forth how requirements for quality factors in § 106.96(b) have been met; (2) Records that contain the information required by § 106.96(b) to be collected during the study for each infant enrolled in the study. The records shall be identified by subject number, age, feeding group, gender, and study day of collection. (3) Data, which shall include: (i) Statistical evaluation for all measurements, including group means, group standard deviations, and measures of statistical significance for all measurements for each feeding group at the beginning of the study and at every point where measurements were made throughout the study, and (ii) Calculations of the statistical power of the study before study initiation and at study completion. (4) A report on attrition and on all occurrences of adverse events during the study, which shall include: (i) Identification of the infant by subject number and feeding group and a complete description of the adverse event, including comparisons of the frequency and nature of occurrence in each feeding group and information on the health of the infant during the course of the study, including the occurrence and duration of any illness; (ii) A clinical assessment by a health care provider of the infant's health during each suspected adverse event; and (iii) A list of all subjects who did not complete the study, including the subject number and the reason that each subject did not complete the study. (b) If the manufacturer is requesting an exemption from the growth monitoring study requirements under § 106.96(c)(1), the manufacturer shall in… | |||
| 21:21:2.0.1.1.6.7.1.4 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | G | Subpart G—Registration, Submission, and Notification Requirements | § 106.130 Verification submission. | FDA | (a) A manufacturer shall, after the first production and before the introduction into interstate commerce of a new infant formula (except for a new infant formula that is for export only for which a submission is received in compliance with § 106.120(c)), verify in a written submission to the Food and Drug Administration at the address given in § 106.110(a) that the infant formula complies with the requirements of the Federal Food, Drug, and Cosmetic Act and is not adulterated. (b) The verification submission shall include the following information: (1) The name of the new infant formula; the filing date for the new infant formula submission, in accordance with § 106.120, for the subject formula; and the identification number assigned by the Agency to the new infant formula submission: (2) A statement that the infant formula to be introduced into interstate commerce is the same as the infant formula that was the subject of the new infant formula notification and for which the manufacturer provided assurances in accordance with the requirements of § 106.120; (3) A summary of test results of the level of each nutrient required by § 107.100 of this chapter and any nutrient added by the manufacturer in the formula, presented in units per 100 kilocalories at the final product stage. (4) A certification that the manufacturer has established current good manufacturing practices, including quality control procedures and in-process controls, and testing required by current good manufacturing practice, designed to prevent adulteration of this formula in accordance with subparts B and C of this part. (c) The submission shall not constitute written verification under section 412(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)(2)) when any data prescribed in paragraph (b) of this section are lacking or are not set forth so as to be readily understood. In such circumstances, the Agency will notify the manufacturer that the notice is not adequate. | ||||
| 21:21:2.0.1.1.6.7.1.5 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | G | Subpart G—Registration, Submission, and Notification Requirements | § 106.140 Submission concerning a change in infant formula that may adulterate the product. | FDA | (a) When a manufacturer makes a change in the formulation or processing of the formula that may affect whether the formula is adulterated under section 412(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)), the manufacturer shall, before the first processing of such formula, make a submission to the Food and Drug Administration at the address given in § 106.110(a). An original and two copies shall be submitted. (b) The submission shall include: (1) The name and physical form of the infant formula (i.e., powder, ready-to-feed, or concentrate); (2)(i) An explanation of why the change in formulation or processing may affect whether the formula is adulterated; and (ii) What steps will be taken to ensure that, before the formula is introduced into interstate commerce, the formula will not be adulterated; and (3) A statement that the submission complies with § 106.120(b)(3), (b)(4), (b)(5), and (b)(6). When appropriate, a statement to the effect that the information required by § 106.120(b)(3), (b)(4), (b)(5), or (b)(6) has been provided to the Agency previously and has not been affected by the changes that are the subject of the current submission, together with the identification number assigned by the Agency to the relevant infant formula submission, may be provided in lieu of such statement. (c) The submission shall not constitute notice under section 412 of the Federal Food, Drug, and Cosmetic Act unless it complies fully with paragraph (b) of this section, and the information that it contains is set forth in a manner that is readily understandable. The Agency will notify the manufacturer if the notice is not adequate because it does not meet the requirements of section 412(d)(3) of the Federal Food, Drug, and Cosmetic Act. | ||||
| 21:21:2.0.1.1.6.7.1.6 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | G | Subpart G—Registration, Submission, and Notification Requirements | § 106.150 Notification of an adulterated or misbranded infant formula. | FDA | [79 FR 8059, Feb. 10, 2014, as amended at 88 FR 17718, Mar. 24, 2023] | (a) A manufacturer shall promptly notify the Food and Drug Administration in accordance with paragraph (b) of this section when the manufacturer has knowledge (that is, actual knowledge that the manufacturer had, or the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care) that reasonably supports the conclusion that an infant formula that has been processed by the manufacturer and that has left an establishment subject to the control of the manufacturer: (1) May not provide the nutrients required by section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)) or by regulations issued under section 412(i)(2); or (2) May be otherwise adulterated or misbranded. (b) The notification made according to paragraph (a) of this section shall be made by telephone, to the Director of the appropriate Food and Drug Administration district office. After normal business hours (8 a.m. to 4:30 p.m.), the Food and Drug Administration's emergency number, 1-866-300-4374 shall be used. The manufacturer shall promptly send written confirmation of the notification to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement (HFS-605), Recall Coordinator, 5001 Campus Dr., College Park, MD 20740, and to the appropriate Food and Drug Administration district office. | |||
| 21:21:2.0.1.1.6.7.1.7 | 21 | Food and Drugs | I | B | 106 | PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS | G | Subpart G—Registration, Submission, and Notification Requirements | § 106.160 Incorporation by reference. | FDA | (a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, the Food and Drug Administration must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection at the Food and Drug Administration library at 10903 New Hampshire Ave., Building 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, and is available from the sources listed below. This material is also available for inspection 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) 3-A Sanitary Standards, Inc., 6888 Elm St., Suite 2D, McLean, VA 22101-3829, 703-790-0295, and may be ordered online at http://www.3-a.org/ : (1) 3-A Sanitary Standards, No. 609-03: A Method of Producing Culinary Steam, adopted November 21, 2004, into § 106.20(h). (2) [Reserved] (c) American Society for Nutrition, 9650 Rockville Pike, Bethesda, MD 20814-3998, 301-634-7279, http://www.nutrition.org : (1) Physical growth: National Center for Health Statistics percentiles, Hamill, P.V.V., T.A. Drizd, C.L. Johnson, R.B. Reed, A.F. Roche, and W.M. Moore, American Journal of Clinical Nutrition, vol. 32, pp. 607-614, dated March 1979, into § 106.96(i)(1)(ii)(c). (2) [Reserved] (d) AOAC International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2417, 301-924-7078: (1) Official Methods of Analysis of AOAC International, 16th ed., dated 1995, into § 106.96(i)(2)(ii): (i) Section 45.3.04, AOAC Official Method 960.48 Protein Efficiency Ratio Rat Bioassay, and (ii) Section 45.3.05, AOAC Official Method 982.30 Protein Efficiency Ratio Calculation Method. (2) Official Methods of Analysis of AOAC International, 18th ed… | ||||
| 28:28:2.0.1.1.45.0.31.1 | 28 | Judicial Administration | I | 106 | PART 106—IMPLEMENTATION OF THE HAVANA ACT OF 2021 | § 106.1 Authority. | DOJ | [A.G. Order No. 5922-2024, 89 FR 28636, Apr. 19, 2024; 89 FR 36671, May 3, 2024] | (a) Under section 3 of the HAVANA Act of 2021, Public Law 117-46, 135 Stat. 391 (2021) (codified at 22 U.S.C. 2680b(i)), the Attorney General or other agency heads may provide a payment to a covered employee or covered dependent who experiences a qualifying injury to the brain on or after January 1, 2016. The authority to provide such payments is at the discretion of the Attorney General or the Attorney General's designees. (b) These regulations are issued in accordance with 22 U.S.C. 2680b(i)(4) and apply to covered employees (current and former employees) and covered dependents. | ||||||
| 28:28:2.0.1.1.45.0.31.2 | 28 | Judicial Administration | I | 106 | PART 106—IMPLEMENTATION OF THE HAVANA ACT OF 2021 | § 106.2 Definitions. | DOJ | For purposes of this part, the following definitions apply: (a) Covered employee. (1) A current or former employee of the Department who, on or after January 1, 2016, became injured by reason of a qualifying injury while they were employed by the Department. (2) The following are considered covered employees for the purposes of this rule: Department of Justice employees as defined in 5 U.S.C. 2105, including employees on Limited Non-Career Appointments, employees on Temporary Appointments, personnel hired on Personal Services Contracts, and students providing volunteer services under 5 U.S.C. 3111. (3) The following are not considered employees of the Department for purposes of this rule: employees or retired employees who were employed by other agencies at the time of the injury. (b) Covered dependent. A family member, as defined in paragraph (c) of this section, of a current or former employee of the Department who, on or after January 1, 2016, became injured by reason of a qualifying injury while their relative was an employee of the Department in a position listed in paragraph (a)(2) of this section. (c) Family member. For purposes of determining who is a “covered dependent,” a family member is defined as follows: (1) Children who at the time of the injury are unmarried and under 21 years of age or, regardless of age, are unmarried and due to mental or physical limitations are incapable of self-support. The term “children” includes natural offspring; stepchildren; adopted children; those under permanent legal guardianship, or comparable permanent custody arrangement, of the employee, spouse, or domestic partner as defined in 5 CFR 875.101 when dependent upon and normally residing with the guardian or custodial party; and U.S. citizen children placed for adoption if a U.S. court grants temporary guardianship of the child to the employee and specifically authorizes the child to reside with the employee in the country of assignment before the adoption is finalized; (2) Parents (including stepparents… | |||||||
| 28:28:2.0.1.1.45.0.31.3 | 28 | Judicial Administration | I | 106 | PART 106—IMPLEMENTATION OF THE HAVANA ACT OF 2021 | § 106.3 Eligibility for payments by the Department of Justice. | DOJ | (a) The Department may, in its discretion, provide a payment to an employee, covered dependent, or former employee if that person suffered a qualifying injury to the brain that was assessed and diagnosed in person by a physician who is currently a neurologist certified by the American Board of Psychology and Neurology (ABPN) or a physician certified by the American Osteopathic Board of Neurology and Psychiatry (AOBNP), the American Board of Physical Medicine and Rehabilitation (ABPMR), or the American Osteopathic Board of Physical Medicine and Rehabilitation (AOBPMR); occurred on or after January 1, 2016; and, for an employee or former employee, occurred while the employee or former employee was a covered employee of the Department or, for a covered dependent, occurred while the covered dependent's relative was an employee of the Department in a position listed in § 106.2(a)(2). (b) Payment for a qualifying injury to the brain will be a non-taxable, one-time lump sum payment, unless a second payment is authorized under paragraph (d) of this section. (c) The amount of the payment is at the Department's discretion. The Department will determine the amount paid to each eligible person based on the following factors: (1) The responses on the “Eligibility Questionnaire for HAVANA Act Payments” form; and (2) Whether the Department of Labor (Office of Workers' Compensation Programs) has determined that the applicant has no reemployment potential, or the Social Security Administration has approved the applicant for Social Security Disability Insurance or Supplemental Security Income benefits, or the applicant's ABPN-certified neurologist or the applicant's AOBNP-, ABPMR-, or AOBPMR-certified physician has certified that the individual requires a full-time caregiver for activities of daily living, as defined by the Katz Index of Independence in Activities of Daily Living. (d) The award thresholds are based on Level III of the Executive Schedule: Base will be 75 percent of Level III pay, and Base+ will be 100 percent … | |||||||
| 28:28:2.0.1.1.45.0.31.4 | 28 | Judicial Administration | I | 106 | PART 106—IMPLEMENTATION OF THE HAVANA ACT OF 2021 | § 106.4 Consultation. | DOJ | When a covered employee or covered dependent seeks payment for an incident that occurred overseas under Chief of Mission security responsibility, the Department will coordinate with the Department of State as appropriate in evaluating whether the incident is an “other incident” under the HAVANA Act or should be so designated. | |||||||
| 28:28:2.0.1.1.45.0.31.5 | 28 | Judicial Administration | I | 106 | PART 106—IMPLEMENTATION OF THE HAVANA ACT OF 2021 | § 106.5 Procedures. | DOJ | (a) Application. (1) A covered employee or covered dependent may apply for a HAVANA Act payment if the covered individual has sustained a qualifying injury to the brain on or after January 1, 2016. To apply for the benefit, the applicant must submit the “Eligibility Questionnaire for HAVANA Act Payments” claim form to the appropriate email address or fax number set forth in this paragraph (a). The claim form must be completed by a person eligible to file a claim under the HAVANA Act or by that person's legal guardian and must be signed by a currently certified physician as listed in § 106.3(a) of this part. The claim form must be emailed or faxed to the following address: HRD_AHI_QUESTIONNAIR@FBI.GOV or fax number (202) 323-9420 (covered FBI employees and dependents) or HavanaActClaims@usdoj.gov or fax number (202) 616-3200 (covered DOJ employees and dependents). (2) The applicant must furnish additional documentation upon request. (3) Copies of the claim form, as well as the regulations and other information, may be obtained by requesting the document or publications via an email to HRD_AHI_QUESTIONNAIR@FBI.GOV (covered FBI employees and dependents) or HavanaActClaims@usdoj.gov (covered DOJ employees and dependents). (b) Review. For FBI covered employees and dependents, the Human Resources Division (HRD) of the FBI is responsible for reviewing the applications to determine their completeness. For other DOJ covered employees and dependents, the Justice Management Division (JMD) is responsible for reviewing the applications to determine their completeness. (c) Other incident. The Department will determine whether a covered employee or covered dependent has a qualifying injury to the brain as set forth in § 106.2, and whether the incident causing the injury was in connection with war, insurgency, hostile act, or terrorist activity. The Department will as appropriate or necessary make a recommendation to the Secretary of State that the incident should be deemed an “other incident designated by the … | |||||||
| 33:33:1.0.1.8.55.1.26.1 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | A | Subpart A—General | § 106.100 Definitions. | USCG | Except as specifically stated in this subpart, the definitions in part 101 of this subchapter apply to this part. | ||||
| 33:33:1.0.1.8.55.1.26.10 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | A | Subpart A—General | § 106.145 Right to appeal. | USCG | Any person directly affected by a decision or action taken under this part, by or on behalf of the Coast Guard, may appeal as described in § 101.420 of this subchapter. | ||||
| 33:33:1.0.1.8.55.1.26.2 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | A | Subpart A—General | § 106.105 Applicability. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended by USCG-2006-24196, 72 FR 55048, Sept. 28, 2007] | (a) The requirements in this part apply to owners and operators of any fixed or floating facility, including MODUs not subject to part 104 of this subchapter, operating on the Outer Continental Shelf (OCS) of the United States for the purposes of engaging in the exploration, development, or production of oil, natural gas, or mineral resources that are regulated by 33 CFR subchapter N, that meet the following operating conditions: (1) Hosts more than 150 persons for 12 hours or more in each 24-hour period continuously for 30 days or more; (2) Produces greater than 100,000 barrels of oil per day; or (3) Produces greater than 200 million cubic feet of natural gas per day. (b) The TWIC requirements found in this part do not apply to mariners employed aboard vessels moored at U.S. OCS facilities only when they are working immediately adjacent to their vessels in the conduct of vessel activities. | |||
| 33:33:1.0.1.8.55.1.26.3 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | A | Subpart A—General | § 106.110 Compliance dates. | USCG | [USCG-2007-28915, 81 FR 57713, Aug. 23, 2016] | (a) OCS facility owners or operators must submit to the cognizant District Commander for each OCS facility— (1) The Facility Security Plan described in subpart D of this part for review and approval; or (2) If intending to operate under an approved Alternative Security Program, a letter signed by the OCS facility owner or operator stating which approved Alternative Security Program the owner or operator intends to use. (b) OCS facilities built on or after July 1, 2004 must submit a Facility Security Plan for approval 60 days prior to beginning operations. | |||
| 33:33:1.0.1.8.55.1.26.4 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | A | Subpart A—General | § 106.115 Compliance documentation. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003; USCG-2007-28915, 81 FR 57713, Aug. 23, 2016] | Each OCS facility owner or operator subject to this part must ensure that copies of the following documentation are available at the OCS facility and are made available to the Coast Guard upon request: (a) The approved Facility Security Plan (FSP) and any approved revisions or amendments thereto, and a letter of approval from the cognizant District Commander dated within the last 5 years; (b) The FSP submitted for approval and current written acknowledgment from the cognizant District Commander, stating that the Coast Guard is currently reviewing the FSP submitted for approval and that the OCS facility may continue to operate so long as the OCS facility remains in compliance with the submitted FSP; or (c) For OCS facilities operating under a Coast Guard-approved Alternative Security Program as provided in § 106.135, a copy of the Alternative Security Program the OCS facility is using, including a facility specific security assessment report generated under the Alternative Security Program, as specified in § 101.120(b)(3) of this subchapter, and a letter signed by the OCS facility owner or operator, stating which Alternative Security Program the OCS facility is using and certifying that the OCS facility is in full compliance with that program. | |||
| 33:33:1.0.1.8.55.1.26.5 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | A | Subpart A—General | § 106.120 Noncompliance. | USCG | [USCG-2003-14759, 68 FR 60558, Oct. 22, 2003] | When an OCS facility must temporarily deviate from the requirements of this part, the OCS facility owner or operator must notify the cognizant District Commander, and either suspend operations or request and receive permission from the District Commander to continue operating. | |||
| 33:33:1.0.1.8.55.1.26.6 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | A | Subpart A—General | § 106.125 Waivers. | USCG | Any OCS facility owner or operator may apply for a waiver of any requirement of this part that the OCS facility owner or operator considers unnecessary in light of the nature or operating conditions of the OCS facility. A request for a waiver must be submitted in writing with justification to the cognizant District Commander. The cognizant District Commander may require the OCS facility owner or operator to provide additional data for use in determining the validity of the requested waiver. The cognizant District Commander may grant a waiver, in writing, with or without conditions only if the waiver will not reduce the overall security of the OCS facility, its personnel, or visiting vessels. | ||||
| 33:33:1.0.1.8.55.1.26.7 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | A | Subpart A—General | § 106.130 Equivalents. | USCG | For any measure required by this part, the OCS facility owner or operator may propose an equivalent, as provided in § 101.130 of this subchapter. | ||||
| 33:33:1.0.1.8.55.1.26.8 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | A | Subpart A—General | § 106.135 Alternative Security Program. | USCG | An OCS facility owner or operator may use an Alternative Security Program approved under § 101.120 of this subchapter if: (a) The Alternative Security Program is appropriate to that OCS facility; (b) The OCS facility does not serve vessels on international voyages; and (c) The Alternative Security Program is implemented in its entirety. | ||||
| 33:33:1.0.1.8.55.1.26.9 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | A | Subpart A—General | § 106.140 Maritime Security (MARSEC) Directive. | USCG | All OCS facility owners or operators subject to this part must comply with any instructions contained in a MARSEC Directive issued under § 101.405 of this subchapter. | ||||
| 33:33:1.0.1.8.55.2.26.1 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.200 Owner or operator. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003; USCG-2006-24196, 72 FR 3585, Jan. 25, 2007; USCG-2007-28915, 81 FR 57713, Aug. 23, 2016] | (a) Each OCS facility owner or operator must ensure that the OCS facility operates in compliance with the requirements of this part. (b) For each OCS facility, the OCS facility owner or operator must: (1) Define the security organizational structure for each OCS facility and provide each person exercising security duties or responsibilities within that structure the support needed to fulfill those obligations; (2) Designate in writing, by name or title, a Company Security Officer (CSO) and a Facility Security Officer (FSO) for each OCS facility and identify how those officers can be contacted at any time; (3) Ensure that a Facility Security Assessment (FSA) is conducted; (4) Ensure the development and submission for approval of a Facility Security Plan (FSP); (5) Ensure that the OCS facility operates in compliance with the approved FSP; (6) Ensure that the TWIC Program is properly implemented as set forth in this subchapter, including: (i) Ensuring that only individuals who hold a TWIC and are authorized to be in the secure area are permitted to escort; and (ii) Identifying what action is to be taken by an escort, or other authorized individual, should individuals under escort engage in activities other than those for which escorted access was granted. (7) Ensure that adequate coordination of security issues takes place between OCS facilities and vessels, including the execution of a Declaration of Security (DoS) as required by this part; (8) Ensure, within 12 hours of notification of an increase in MARSEC level, implementation of the additional security measures required by the FSP for the new MARSEC level; (9) Ensure all breaches of security and security incidents are reported in accordance with the requirements in part 101 of this subchapter; (10) Ensure consistency between security requirements and safety requirements; (11) Inform OCS facility personnel of their responsibility to apply for and maintain a TWIC, including the deadlines and methods for such applications, and of their obligation to … | |||
| 33:33:1.0.1.8.55.2.26.10 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.245 Procedures for interfacing with vessels. | USCG | The OCS facility owner or operator must ensure that there are measures for interfacing with vessels at all MARSEC Levels. | ||||
| 33:33:1.0.1.8.55.2.26.11 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.250 Declaration of Security (DoS). | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended at 68 FR 60558, Oct. 22, 2003] | (a) Each OCS facility owner or operator must ensure procedures are established for requesting a DoS and for handling DoS requests from vessels. (b) At MARSEC Level 1, owners or operators of OCS facilities interfacing with a manned vessel carrying Certain Dangerous Cargoes, in bulk, must: (1) Prior to the arrival of a vessel to the OCS facility, ensure the Facility Security Officer (FSO) and Master, Vessel Security Officer (VSO), or their designated representatives coordinate security needs and procedures, and agree upon the contents of a DoS for the period of time the vessel is at the OCS facility; and (2) Upon the arrival of the vessel at the OCS facility, the FSO and Master, VSO, or their designated representatives, must sign the written DoS. (c) Neither the OCS facility nor the vessel may embark or disembark personnel, or transfer stores or industrial supplies until the DoS has been signed. (d) At MARSEC Levels 2 and 3, the FSOs of OCS facilities interfacing with manned vessels subject to part 104 of this chapter, or their designated representatives, must sign and implement DoSs as required in paragraphs (b)(1) and (b)(2) of this section. (e) At MARSEC Levels 1 and 2, FSOs of OCS facilities that frequently interface with the same vessel may implement a continuing DoS for multiple visits, provided that: (1) The DoS is valid for a specific MARSEC Level; (2) The effective period at MARSEC Level 1 does not exceed 90 days; and (3) The effective period at MARSEC Level 2 does not exceed 30 days. (f) When the MARSEC Level increases beyond that contained in the DoS, the continuing DoS is void and a new DoS must be executed in accordance with this section. | |||
| 33:33:1.0.1.8.55.2.26.12 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.255 Security systems and equipment maintenance. | USCG | (a) Security systems and equipment must be in good working order and inspected, tested, calibrated, and maintained according to manufacturers' recommendations. (b) Security systems must be regularly tested in accordance with the manufacturers' recommendations; noted deficiencies corrected promptly; and the results recorded as required in § 106.230(b)(5) of this part. (c) The Facility Security Plan (FSP) must include procedures for identifying and responding to security system and equipment failures or malfunctions. | ||||
| 33:33:1.0.1.8.55.2.26.13 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.258 Risk Group classification for OCS facilities. | USCG | [USCG-2007-28915, 81 FR 57713, Aug. 23, 2016] | For the purposes of this subchapter, no OCS facilities are considered Risk Group A. | |||
| 33:33:1.0.1.8.55.2.26.14 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.260 Security measures for access control. | USCG | [USCG-2006-24196, 72 FR 3586, Jan. 25, 2007, as amended by USCG-2007-28915, 81 FR 57713, Aug. 23, 2016] | (a) General. The OCS facility owner or operator must ensure the implementation of security measures to: (1) Deter the unauthorized introduction of dangerous substances and devices, including any device intended to damage or destroy persons, vessels, or the OCS facility; (2) Secure dangerous substances and devices that are authorized by the OCS facility owner or operator to be on board; (3) Control access to the OCS facility; and (4) Prevent an unescorted individual from entering the OCS facility unless the individual holds a duly issued TWIC and is authorized to be on the OCS facility. (b) The OCS facility owner or operator must ensure that the following are specified: (1) All locations providing means of access to the OCS facility where access restrictions or prohibitions are applied for each security level to prevent unauthorized access, including those points where TWIC access control procedures will be applied; (2) The identification of the types of restriction or prohibition to be applied and the means of enforcing them; (3) The means used to establish the identity of individuals not in possession of a TWIC and the means by which they will be allowed access to the OCS facility; and (4) Procedures for identifying authorized and unauthorized persons at any MARSEC level. (c) The OCS facility owner or operator must establish in the approved Facility Security Plan (FSP) the frequency of application of any access controls, particularly if they are to be applied on a random or occasional basis. (d) MARSEC Level 1. The OCS facility owner or operator must ensure the following security measures are implemented at the facility: (1) Implement TWIC as set out in subpart E of part 101 of this subchapter and in accordance with the OCS facility's assigned Risk Group, as set out in § 106.258. (2) Screen persons and personal effects going aboard the OCS facility for dangerous substances and devices at the rate specified in the approved FSP; (3) Conspicuously post signs that describe security measures current… | |||
| 33:33:1.0.1.8.55.2.26.15 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.262 Security measures for newly-hired employees. | USCG | [USCG-2006-24196, 72 FR 3587, Jan. 25, 2007, as amended by USCG-2007-28915, 81 FR 57713, Aug. 23, 2016; USCG-2022-0323, 88 FR 10029, Feb. 16, 2023] | (a) Newly-hired OCS facility employees may be granted entry to secure areas of the OCS facility for up to 30 consecutive calendar days prior to receiving their TWIC provided all of the requirements in paragraph (b) of this section are met, and provided that the new hire is accompanied by an individual with a TWIC while within the secure areas of the OCS facility. If TSA does not act upon a TWIC application within 30 days, the cognizant Coast Guard COTP may further extend access to secure areas for another 30 days. The Coast Guard will determine whether, in particular circumstances, certain practices meet the condition of a new hire being accompanied by another individual with a TWIC. (b) Newly-hired OCS facility employees may be granted the access provided for in paragraph (a) of this section if: (1) The new hire has applied for a TWIC in accordance with 49 CFR part 1572 by completing the full enrollment process, paying the user fee, and is not currently engaged in a waiver or appeal process. The OCS facility owner or operator or Facility Security Officer (FSO) must have th enew hire sign a statement affirming this, and must retain the signed statement until the new hire receives a TWIC; (2) The OCS facility owner or operator or the FSO enters the following information on the new hire into the Coast Guard's Homeport Web site ( https://homeport.uscg.mil ): (i) Full legal name, including middle name if one exists; (ii) Date of birth; (iii) Social security number (optional); (iv) Employer name and 24 hour contact information; and (v) Date of TWIC enrollment. (3) The new hire presents an identification credential that meets the requirements of § 101.515 of this subchapter; (4) There are no other circumstances that would cause reasonable suspicion regarding the new hire's ability to obtain a TWIC, and the OCS facility owner or operator or FSO have not been informed by the cognizant COTP that the individual poses a security threat; and (5) There would be an adverse impact to OCS facility operations if the ne… | |||
| 33:33:1.0.1.8.55.2.26.16 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.265 Security measures for restricted areas. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003] | (a) General. The OCS facility owner or operator must ensure the designation of restricted areas in order to: (1) Prevent or deter unauthorized access; (2) Protect persons authorized to be in the OCS facility; (3) Protect the OCS facility; (4) Protect vessels using and serving the OCS facility; (5) Protect sensitive security areas within the OCS facility; (6) Protect security and surveillance equipment and systems; and (7) Protect stores and industrial supplies from tampering. (b) Designation of restricted areas. The OCS facility owner or operator must ensure restricted areas are designated within the OCS facility. They must also ensure that all restricted areas are clearly marked and indicate that access to the area is restricted and that unauthorized presence within the area constitutes a breach of security. The OCS facility owner or operator may designate the entire OCS facility as a restricted area. Restricted areas must include, as appropriate: (1) Areas containing sensitive security information; (2) Areas containing security and surveillance equipment and systems and their controls, and lighting system controls; and (3) Areas containing critical OCS facility infrastructure equipment, including: (i) Water supplies; (ii) Telecommunications; (iii) Power distribution system; (iv) Access points for ventilation and air-conditioning systems; (v) Manufacturing areas and control rooms; (vi) Areas designated for loading, unloading or storage of stores and industrial supplies; and (vii) Areas containing hazardous materials. (c) The OCS facility owner or operator must ensure that the Facility Security Plan (FSP) includes measures for restricted areas to: (1) Identify which OCS facility personnel are authorized to have access; (2) Determine which persons other than OCS facility personnel are authorized to have access; (3) Determine the conditions under which that access may take place; (4) Define the extent of any restricted area; and (5) Define the times when access restrictions apply. (d) … | |||
| 33:33:1.0.1.8.55.2.26.17 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.270 Security measures for delivery of stores and industrial supplies. | USCG | (a) General. The OCS facility owner or operator must ensure that security measures relating to the delivery of stores or industrial supplies to the OCS facility are implemented to: (1) Check stores or industrial supplies for package integrity; (2) Prevent stores or industrial supplies from being accepted without inspection; (3) Deter tampering; and (4) Prevent stores and industrial supplies from being accepted unless ordered. For any vessels that routinely use an OCS facility, an OCS facility owner or operator may establish and implement standing arrangements between the OCS facility, its suppliers, and any vessel delivering stores or industrial supplies regarding notification and the timing of deliveries and their documentation. (b) MARSEC Level 1. At MARSEC Level 1, the OCS facility owner or operator must ensure the implementation of measures to: (1) Inspect stores or industrial supplies before being accepted; and (2) Check that stores or industrial supplies match the order prior to being brought on board. (c) MARSEC Level 2. In addition to the security measures required for MARSEC Level 1 in this section, at MARSEC Level 2, the OCS facility owner or operator must also ensure the implementation of additional security measures, as specified for MARSEC Level 2 in the approved Facility Security Plan (FSP). These additional security measures may include: (1) Intensifying inspection of the stores or industrial supplies during delivery; or (2) Checking stores or industrial supplies prior to receiving them on board. (d) MARSEC Level 3. In addition to the security measures for MARSEC Level 1 and MARSEC Level 2, at MARSEC Level 3, the OCS facility owner or operator must ensure the implementation of additional security measures, as specified for MARSEC Level 3 in the approved FSP. These additional security measures may include: (1) Checking all OCS facility stores or industrial supplies more extensively; (2) Restricting or suspending delivery of stores or industrial supplies; or (3) Refusing to acce… | ||||
| 33:33:1.0.1.8.55.2.26.18 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.275 Security measures for monitoring. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended at 68 FR 60558, Oct. 22, 2003] | (a) General. (1) The OCS facility owner or operator must ensure the implementation of security measures in this section and have the capability to continuously monitor, through a combination of lighting, watchkeepers, security guards, deck watches, waterborne patrols, automatic intrusion-detection devices, or surveillance equipment as specified in their approved Facility Security Plan (FSP), the: (i) OCS facility; (ii) Restricted areas on board the OCS facility; and (iii) The area surrounding the OCS facility. (2) The following must be considered when establishing the appropriate level and location of lighting: (i) OCS facility personnel should be able to detect activities on and around OCS facilities; (ii) Coverage should facilitate personnel identification at access points; and (iii) Lighting effects, such as glare, and their impact on safety, navigation, and other security activities. (b) MARSEC Level 1. At MARSEC Level 1, the OCS facility owner or operator must ensure the implementation of security measures, which may be implemented in coordination with a vessel interfacing with the OCS facility, to: (1) Monitor the OCS facility, particularly OCS facility access points and restricted areas; (2) Be able to conduct emergency searches of the OCS facility; (3) Ensure that equipment or system failures or malfunctions are identified and corrected; (4) Ensure that any automatic intrusion detection device, sets off an audible or visual alarm, or both, at a location that is continuously attended or monitored; and (5) Light deck and OCS facility access points during the period between sunset and sunrise and periods of limited visibility sufficiently to allow visual identification of persons seeking access to the OCS facility. (c) MARSEC Level 2. In addition to the security measures required for MARSEC Level 1 in this section, at MARSEC Level 2, the OCS facility owner or operator must also ensure the implementation of additional security measures, as specified for MARSEC Level 2 in the approved FSP. … | |||
| 33:33:1.0.1.8.55.2.26.19 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.280 Security incident procedures. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003] | For each MARSEC Level, the OCS facility owner or operator must ensure the Facility Security Officer (FSO) and OCS facility security personnel are able to: (a) Respond to security threats or breaches of security and maintain critical OCS facility and OCS facility-to-vessel interface operations; (b) Deny access to the OCS facility, except to those responding to an emergency; (c) Evacuate the OCS facility in case of security threats or breaches of security; and (d) Report security incidents as required in § 101.305 of this subchapter; (e) Brief all OCS facility personnel on possible threats and the need for vigilance, soliciting their assistance in reporting suspicious persons, objects, or activities; and (f) Secure non-critical operations in order to focus response on critical operations. | |||
| 33:33:1.0.1.8.55.2.26.2 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.205 Company Security Officer (CSO). | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended at 68 FR 60558, Oct. 22, 2003; USCG-2006-24196, 72 FR 3585, Jan. 25, 2007] | (a) General. (1) An OCS facility owner or operator may designate a single CSO for all its OCS facilities to which this part applies, or may designate more than one CSO, in which case the owner or operator must clearly identify the OCS facilities for which each CSO is responsible. (2) A CSO may perform other duties within the owner's or operator's organization, including the duties of a Facility Security Officer, provided he or she is able to perform the duties and responsibilities required of the CSO. (3) The CSO may delegate duties required by this part, but remains responsible for the performance of those duties. (4) The CSO must maintain a TWIC. (b) Qualifications. The CSO must have general knowledge, through training or equivalent job experience, in the following: (1) Security administration and organization of the OCS facility; (2) OCS facility and vessel operations and conditions; (3) OCS facility and vessel security measures including the meaning and consequential requirements of the different MARSEC Levels; (4) Emergency preparedness and response and contingency planning; (5) Security equipment and systems and their operational limitations; (6) Methods of conducting audits, inspection, control, and monitoring; and (7) Techniques for security training and education, including security measures and procedures. (c) In addition to the knowledge and training in paragraph (b) of this section, the CSO must have general knowledge, through training or equivalent job experience, in the following, as appropriate: (1) Relevant international conventions, codes, and recommendations; (2) Relevant government legislation and regulations; (3) Responsibilities and functions of other security organizations; (4) Methodology of Facility Security Assessment. (5) Methods of OCS facility security surveys and inspections; (6) Handling sensitive security information (SSI) and security related communications; (7) Knowledge of current security threats and patterns; (8) Recognition and detection of dangerous su… | |||
| 33:33:1.0.1.8.55.2.26.3 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.210 OCS Facility Security Officer (FSO). | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended by USCG-2006-24196, 72 FR 3585, Jan. 25, 2007] | (a) General. (1) The FSO may perform other duties within the owner's or operator's organization, provided he or she is able to perform the duties and responsibilities required of the FSO of each such OCS facility. (2) The same person may serve as the FSO for more than one OCS facility, provided the facilities are within a reasonable proximity to each other. If a person serves as the FSO for more than one OCS facility, the name of each OCS facility for which he or she is the FSO must be listed in the Facility Security Plan (FSP) of each OCS facility for which he or she is the FSO. (3) The FSO may assign security duties to other OCS facility personnel; however, the FSO remains responsible for these duties. (4) The FSO must maintain a TWIC. (b) Qualifications. The FSO must have general knowledge, through training or equivalent job experience, in the following: (1) Those items listed in § 106.205(b), and as appropriate § 106.205(c), of this part; (2) OCS facility layout; (3) The FSP and related procedures; and (4) Operation, testing and maintenance of security equipment and systems. (c) Responsibilities. In addition to any other responsibilities specified elsewhere in this part, the FSO must, for each OCS facility for which he or she has been designated: (1) Regularly inspect the OCS facility to ensure that security measures are maintained in compliance with this part; (2) Ensure the maintenance of and supervision of the implementation of the FSP, and any amendments to the FSP, in compliance with this part; (3) Ensure the coordination and handling of stores and industrial supplies in compliance with this part; (4) Where applicable, propose modifications to the FSP to the Company Security Officer (CSO); (5) Ensure that any problems identified during audits or inspections are reported to the CSO, and promptly implement any corrective actions; (6) Ensure security awareness and vigilance on board the OCS facility; (7) Ensure adequate security training for OCS facility personnel in compliance with th… | |||
| 33:33:1.0.1.8.55.2.26.4 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.215 Company or OCS facility personnel with security duties. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended by USCG-2006-24196, 72 FR 3586, Jan. 25, 2007] | Company and OCS facility personnel responsible for security duties must maintain a TWIC, and must have knowledge, through training or equivalent job experience, in the following, as appropriate: (a) Knowledge of current and anticipated security threats and patterns. (b) Recognition and detection of dangerous substances and devices; (c) Recognition of characteristics and behavioral patterns of persons who are likely to threaten security; (d) Recognition of techniques used to circumvent security measures; (e) Security related communications; (f) Knowledge of emergency procedures and contingency plans; (g) Operation of security equipment and systems; (h) Testing, calibration, and maintenance of security equipment and systems; (i) Inspection, control, and monitoring techniques; (j) Methods of physical screenings of persons, personal effects, stores and industrial supplies; (k) Familiarity with all relevant aspects of the TWIC program and how to carry them out; (l) Relevant provisions of the Facility Security Plan (FSP); and (m) The meaning and the consequential requirements of the different MARSEC Levels. | |||
| 33:33:1.0.1.8.55.2.26.5 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.220 Security training for all other OCS facility personnel. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003; USCG-2006-24196, 72 FR 3586, Jan. 25, 2007] | All other OCS facility personnel, including contractors, whether part-time, full-time, temporary, or permanent, must have knowledge, through training or equivalent job experience, of the following, as appropriate: (a) Relevant provisions of the Facility Security Plan (FSP); (b) The meaning and the consequential requirements of the different MARSEC Levels including emergency procedures and contingency plans; (c) Recognition and detection of dangerous substances and devices; (d) Recognition of characteristics and behavioral patterns of persons who are likely to threaten security; and (e) Recognition of techniques used to circumvent security measures. (f) Familiarity with all relevant aspects of the TWIC program and how to carry them out. | |||
| 33:33:1.0.1.8.55.2.26.6 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.225 Drill and exercise requirements. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003] | (a) General. (1) Drills and exercises must test the proficiency of facility personnel in assigned security duties at all MARSEC Levels and the effective implementation of the Facility Security Plan (FSP). They must enable the Facility Security Officer (FSO) to identify any related security deficiencies that need to be addressed. (2) A drill or exercise required by this section may be satisfied with the implementation of security measures required by the FSP as the result of an increase in the MARSEC Level, provided the FSO reports attainment to the cognizant District Commander. (b) Drills. (1) From the date of the FSP approval, the FSO must ensure that at least one security drill is conducted every 3 months. Security drills may be held in conjunction with non-security drills, where appropriate. (2) Drills must test individual elements of the FSP, including response to security threats and incidents. Drills should take into account the types of operations of the OCS facility, OCS facility personnel changes, the types of vessels calling at the OCS facility, and other relevant circumstances. Examples of drills include unauthorized entry to a restricted area, response to alarms, and notification of appropriate authorities. (3) If a vessel is conducting operations with the OCS facility on the date the OCS facility has planned to conduct any drills, the OCS facility may include, but cannot require, the vessel or vessel personnel to participate in the OCS facility's scheduled drill. (c) Exercises. (1) From the date of the FSP approval, exercises must be conducted at least once each calendar year, with no more than 18 months between exercises. (2) Exercises may be: (i) Full scale or live; (ii) Tabletop simulation; (iii) Combined with other appropriate exercises held; or (iv) A combination of the elements in paragraphs (c)(2)(i) through (iii) of this section. (3) Exercises may be facility-specific or part of a cooperative exercise program. (4) Each exercise must test communication and notification proced… | |||
| 33:33:1.0.1.8.55.2.26.7 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.230 OCS facility recordkeeping requirements. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003] | (a) Unless otherwise specified in this section, the Facility Security Officer (FSO) must keep records of the activities as set out in paragraph (b) of this section for at least 2 years and make them available to the Coast Guard upon request. (b) Records required by this section may be kept in electronic format. If kept in an electronic format, they must be protected against unauthorized access, deletion, destruction, amendment, and disclosure. The following records must be kept: (1) Training. For training under § 106.215, the date of each session, duration of session, a description of the training, and a list of attendees; (2) Drills and exercises. For each drill or exercise, the date held, a description of the drill or exercise, a list of participants, and any best practices or lessons learned which may improve the FSP; (3) Incidents and breaches of security. Date and time of occurrence, location within the OCS facility, a description of the incident or breach, the identity of the individual to whom it was reported, and a description of the response; (4) Changes in MARSEC Levels. Date and time of the notification received, and the time of compliance with additional requirements; (5) Maintenance, calibration, and testing of security equipment. For each occurrence of maintenance, calibration, and testing, record the date and time, and the specific security equipment involved; (6) Security threats. Date and time of occurrence, how the threat was communicated, who received or identified the threat, a description of the threat, to whom it was reported, and a description of the response; (7) Declaration of Security (DoS). A copy of each DoS for at least 90 days after the end of its effective period; and (8) Annual audit of the Facility Security Plan (FSP). For each annual audit, a letter certified by the FSO stating the date the audit was conducted. | |||
| 33:33:1.0.1.8.55.2.26.8 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.235 Maritime Security (MARSEC) Level coordination and implementation. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003] | (a) The OCS facility owner or operator must ensure the OCS facility operates in compliance with the security requirements in this part for the MARSEC Level in effect for the OCS facility. (b) When notified of an increase in the MARSEC Level, the OCS facility owner or operator must ensure: (1) Vessels conducting operations with the OCS facility and vessels scheduled to arrive at the OCS facility within 96 hours of the MARSEC Level change are notified of the new MARSEC Level and the Declaration of Security (DoS), if applicable, is revised as necessary; (2) The OCS facility complies with the required additional security measures within 12 hours; and (3) The OCS facility reports compliance or noncompliance to the cognizant District Commander. (c) For MARSEC Levels 2 and 3, the Facility Security Officer (FSO) must inform all OCS facility personnel about identified threats, emphasize reporting procedures, and stress the need for increased vigilance. (d) An OCS facility owner or operator whose facility is not in compliance with the requirements of this section must so inform the cognizant District Commander and obtain approval prior to interfacing with another vessel or prior to continuing operations. | |||
| 33:33:1.0.1.8.55.2.26.9 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | B | Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements | § 106.240 Communications. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003] | (a) The Facility Security Officer (FSO) must have a means to effectively notify OCS facility personnel of changes in security conditions at the OCS facility. (b) Communication systems and procedures must allow effective and continuous communications between the OCS facility security personnel, vessels interfacing with the OCS facility, the cognizant District Commander, and national and local authorities with security responsibilities. (c) Facility communications systems must have a backup means for both internal and external communications. | |||
| 33:33:1.0.1.8.55.3.26.1 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | C | Subpart C—Outer Continental Shelf (OCS) Facility Security Assessment (FSA) | § 106.300 General. | USCG | (a) The Facility Security Assessment (FSA) is a written document that is based on the collection of background information, the completion of an on-scene survey and an analysis of that information. (b) A single FSA may be performed and applied to more than one OCS facility to the extent they share physical characteristics, location, and operations. (c) Third parties may be used in any aspect of the FSA if they have the appropriate skills and if the Company Security Officer (CSO) reviews and accepts their work. (d) Those involved in a FSA must be able to draw upon expert assistance in the following areas, as appropriate: (1) Knowledge of current and anticipated security threats and patterns; (2) Recognition and detection of dangerous substances and devices; (3) Recognition of characteristics and behavioral patterns of persons who are likely to threaten security; (4) Recognition of techniques used to circumvent security measures; (5) Methods used to cause a security incident; (6) Effects of dangerous substances and devices on structures and essential services; (7) OCS facility security requirements; (8) OCS facility and vessel interface business practices; (9) Contingency planning, emergency preparedness and response; (10) Physical security requirements; (11) Radio and telecommunications systems, including computer systems and networks; (12) Marine or civil engineering; and (13) OCS facility and vessel operations. | ||||
| 33:33:1.0.1.8.55.3.26.2 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | C | Subpart C—Outer Continental Shelf (OCS) Facility Security Assessment (FSA) | § 106.305 Facility Security Assessment (FSA) requirements. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended at 68 FR 60558, Oct. 22, 2003] | (a) Background. The OCS facility owner or operator must ensure that the following background information, if applicable, is provided to the person or persons who will conduct the assessment: (1) The general layout of the OCS facility, including: (i) The location of each access point to the OCS facility; (ii) The number, reliability, and security duties of OCS facility personnel; (iii) Security doors, barriers, and lighting; (iv) The location of restricted areas; (v) The emergency and stand-by equipment available to maintain essential services; (vi) The essential maintenance equipment and storage areas; (vii) Location of escape and evacuation routes and assembly stations; and (viii) Existing security and safety equipment for protection of personnel; (2) Response procedures for fire or other emergency conditions; (3) Procedures for monitoring OCS facility and vessel personnel; (4) Procedures for controlling keys and other access prevention systems; (5) Response capability for security incidents; (6) Threat assessments, including the purpose and methodology of the assessment, for the OCS facility's location; (7) Previous reports on security needs; and (8) Any other existing security procedures and systems, equipment, communications, and OCS facility personnel. (b) On-scene survey. The OCS facility owner or operator must ensure that an on-scene survey of each OCS facility is conducted. The on-scene survey examines and evaluates existing OCS facility protective measures, procedures, and operations to verify or collect the information required in paragraph (a) of this section. (c) Analysis and recommendations. In conducting the FSA, the OCS owner or operator must ensure that the Company Security Officer (CSO) analyzes the OCS facility background information and the on-scene survey, and considering the requirements of this part, provides recommendations to establish and prioritize the security measures that should be included in the FSP. The analysis must consider: (1) Each vulnerability found d… | |||
| 33:33:1.0.1.8.55.3.26.3 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | C | Subpart C—Outer Continental Shelf (OCS) Facility Security Assessment (FSA) | § 106.310 Submission requirements. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003] | (a) A completed FSA report must be submitted with the Facility Security Plan (FSP) required in § 106.410 of this part. (b) An OCS facility owner or operator may generate and submit a report that contains the FSA for more than one OCS facility subject to this part, to the extent that they share similarities in physical characteristics, location and operations. (c) The FSA must be reviewed and validated, and the FSA report must be updated each time the FSP is submitted for reapproval or revisions. | |||
| 33:33:1.0.1.8.55.4.26.1 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | D | Subpart D—Outer Continental Shelf (OCS) Facility Security Plan (FSP) | § 106.400 General. | USCG | (a) The OCS facility owner or operator must ensure the FSO develops and implements a Facility Security Plan (FSP) for each OCS facility for which he or she is designated as FSO. The FSP: (1) Must identify the FSO by name or position and provide 24-hour contact information; (2) Must be written in English; (3) Must address each vulnerability identified in the Facility Security Assessment (FSA); (4) Must describe security measures for each MARSEC Level; and (5) May cover more than one OCS facility to the extent that they share similarities in physical characteristics and operations, if authorized and approved by the cognizant District Commander. (b) The FSP must be submitted for approval to the cognizant District Commander in a written or electronic format in a manner prescribed by the cognizant District Commander. (c) The FSP is sensitive security information and must be protected in accordance with 49 CFR part 1520. (d) If the FSP is kept in an electronic format, procedures must be in place to prevent its unauthorized deletion, destruction, or amendment. | ||||
| 33:33:1.0.1.8.55.4.26.2 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | D | Subpart D—Outer Continental Shelf (OCS) Facility Security Plan (FSP) | § 106.405 Format and content of the Facility Security Plan (FSP). | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended by USCG-2006-24196, 72 FR 3587, Jan. 25, 2007; USCG-2007-28915, 81 FR 57713, Aug. 23, 2016] | (a) An OCS facility owner or operator must ensure that the FSP consists of the individual sections listed in this paragraph (a). If the FSP does not follow the order as it appears in this paragraph, the OCS facility owner or operator must ensure that the FSP contains an index identifying the location of each of the following sections: (1) Security organization of the OCS facility; (2) Personnel training; (3) Drills and exercises; (4) Records and documentation; (5) Response to change in MARSEC Level; (6) Procedures for interfacing with vessels; (7) Declaration of Security (DoS); (8) Communications; (9) Security systems and equipment maintenance; (10) Security measures for access control, including the OCS facility's TWIC Program; (11) Security measures for restricted areas; (12) Security measures for delivery of stores and industrial supplies; (13) Security measures for monitoring; (14) Security incident procedures; (15) Audits and FSP amendments; and (16) Facility Security Assessment (FSA) report. (b) The FSP must describe in detail how the requirements of subpart B of this part will be met. | |||
| 33:33:1.0.1.8.55.4.26.3 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | D | Subpart D—Outer Continental Shelf (OCS) Facility Security Plan (FSP) | § 106.410 Submission and approval. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003; USCG-2013-0397, 78 FR 39173, July 1, 2013; USCG-2007-28915, 81 FR 57713, Aug. 23, 2016] | (a) The owner or operator of each OCS facility currently in operation must either— (1) Submit one copy of the Facility Security Plan (FSP) for review and approval to the cognizant District Commander and a letter certifying that the FSP meets the applicable requirements of this part; or (2) If intending to operate under an Approved Alternative Security Program, submit a letter signed by the OCS facility owner or operator stating which approved Alternative Security Program the owner or operator intends to use. (b) Owners or operators of OCS facilities not in service on or before December 31, 2003, must comply with the requirements in paragraph (a) of this section 60 days prior to beginning operations. (c) The cognizant District Commander will examine each submission for compliance with this part and either: (1) Approve it and specify any conditions of approval, returning to the submitter a letter stating its acceptance and any conditions; (2) Return it for revision, returning a copy to the submitter with brief descriptions of the required revisions; or (3) Disapprove it, returning a copy to the submitter with a brief statement of the reasons for disapproval. (d) An FSP may be submitted and approved to cover more than one OCS facility where they share similarities in physical characteristics, location, and operations. (e) Each OCS facility owner or operator that submits one FSP to cover two or more OCS facilities of similar design, location, and operation must address OCS facility-specific information that includes the physical and operational characteristics of each OCS facility. (f) An FSP that is approved by the cognizant District Commander is valid for 5 years from the date of its approval. The cognizant District Commander will issue an approval letter, as indicated in § 106.115 of this part. | |||
| 33:33:1.0.1.8.55.4.26.4 | 33 | Navigation and Navigable Waters | I | H | 106 | PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES | D | Subpart D—Outer Continental Shelf (OCS) Facility Security Plan (FSP) | § 106.415 Amendment and audit. | USCG | [USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60559, Oct. 22, 2003] | (a) Amendments. (1) Amendments to a Facility Security Plan (FSP) that are approved by the cognizant District Commander may be initiated by: (i) The OCS facility owner or operator; or (ii) The cognizant District Commander, upon a determination that an amendment is needed to maintain the OCS facility's security. The cognizant District Commander will give the OCS facility owner or operator written notice and request that the OCS facility owner or operator propose amendments addressing any matters specified in the notice. The OCS facility owner or operator will have at least 60 days to submit its proposed amendments. Until amendments are approved, the OCS facility owner or operator shall ensure temporary security measures are implemented to the satisfaction of the cognizant District Commander. (2) Proposed amendments must be sent to the cognizant District Commander. If initiated by the OCS facility owner or operator, the proposed amendment must be submitted at least 30 days before the amendment is to take effect unless the cognizant District Commander allows a shorter period. The cognizant District Commander will approve or disapprove the proposed amendment in accordance with § 106.410 of this subpart. (3) Nothing in this section should be construed as limiting the OCS facility owner or operator from the timely implementation of such additional security measures not enumerated in the approved FSP as necessary to address exigent security situations. In such cases, the owner or operator must notify the cognizant District Commander by the most rapid means practicable as to the nature of the additional measures, the circumstances that prompted these additional measures, and the period of time these additional measures are expected to be in place. (4) If the owner or operator has changed, the Facility Security Officer (FSO) must amend the Facility Security Plan (FSP) to include the name and contact information of the new OCS facility owner(s) or operator(s) and submit the affected portion of the FSP for review and … | |||
| 34:34:1.2.1.1.5.1.113.1 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | A | Subpart A—Introduction | § 106.1 Purpose. | ED | [89 FR 33882, Apr. 29, 2024] | The purpose of this part is to effectuate Title IX, which is designed to eliminate (with certain exceptions) discrimination on the basis of sex in any education program or activity receiving Federal financial assistance, whether or not such program or activity is offered or sponsored by an educational institution as defined in this part. This part is also intended to effectuate section 844 of the Education Amendments of 1974, Public Law 93-380, 88 Stat. 484. | ||||
| 34:34:1.2.1.1.5.1.113.2 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | A | Subpart A—Introduction | § 106.2 Definitions. | ED | [89 FR 33832, Apr. 29, 2024] | As used in this part, the term: Administrative law judge means a person appointed by the reviewing authority to preside over a hearing held under § 106.81. Administratively separate unit means a school, department, or college of an educational institution (other than a local educational agency), admission to which is independent of admission to any other component of such institution. Admission means selection for part-time, full-time, special, associate, transfer, exchange, or any other enrollment, membership, or matriculation in or at an education program or activity operated by a recipient. Applicant, as used in the definition of educational institution in this section and as used in § 106.4, means one who submits an application, request, or plan required to be approved by a Department official, or by a recipient, as a condition to becoming a recipient. Assistant Secretary means the Assistant Secretary for Civil Rights of the Department. Complainant means: (1) A student or employee who is alleged to have been subjected to conduct that could constitute sex discrimination under Title IX or this part; or (2) A person other than a student or employee who is alleged to have been subjected to conduct that could constitute sex discrimination under Title IX or this part and who was participating or attempting to participate in the recipient's education program or activity at the time of the alleged sex discrimination. Complaint means an oral or written request to the recipient that objectively can be understood as a request for the recipient to investigate and make a determination about alleged discrimination under Title IX or this part. Confidential employee means: (1) An employee of a recipient whose communications are privileged or confidential under Federal or State law. The employee's confidential status, for purposes of this part, is only with respect to information received while the employee is functioning within the scope of their duties to which privilege or confidentiality applies; (2) A… | ||||
| 34:34:1.2.1.1.5.1.113.3 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | A | Subpart A—Introduction | § 106.3 Remedial and affirmative action and self-evaluation. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30572, 30579, May 19, 2020; 89 FR 33885, Apr. 29, 2024] | (a) Remedial action. If the Assistant Secretary finds that a recipient has discriminated against persons on the basis of sex in an education program or activity under this part, or otherwise violated this part, such recipient must take such remedial action as the Assistant Secretary deems necessary to remedy the violation, consistent with 20 U.S.C. 1682. (b) Affirmative action. In the absence of a finding of discrimination on the basis of sex in an education program or activity, a recipient may take affirmative action to overcome the effects of conditions which resulted in limited participation therein by persons of a particular sex. Nothing herein shall be interpreted to alter any affirmative action obligations which a recipient may have under Executive Order 11246. | ||||
| 34:34:1.2.1.1.5.1.113.4 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | A | Subpart A—Introduction | § 106.4 Assurance required. | ED | [45 FR 30955, May 9, 1980, as amended at 45 FR 86298, Dec. 30, 1980; 65 FR 68056, Nov. 13, 2000; 85 FR 30579, May 19, 2020] | (a) General. Every application for Federal financial assistance shall as condition of its approval contain or be accompanied by an assurance from the applicant or recipient, satisfactory to the Assistant Secretary, that the education program or activity operated by the applicant or recipient and to which this part applies will be operated in compliance with this part. An assurance of compliance with this part shall not be satisfactory to the Assistant Secretary if the applicant or recipient to whom such assurance applies fails to commit itself to take whatever remedial action is necessary in accordance with § 106.3(a) to eliminate existing discrimination on the basis of sex or to eliminate the effects of past discrimination whether occurring prior or subsequent to the submission to the Assistant Secretary of such assurance. (b) Duration of obligation. (1) In the case of Federal financial assistance extended to provide real property or structures thereon, such assurance shall obligate the recipient or, in the case of a subsequent transfer, the transferee, for the period during which the real property or structures are used to provide an education program or activity. (2) In the case of Federal financial assistance extended to provide personal property, such assurance shall obligate the recipient for the period during which it retains ownership or possession of the property. (3) In all other cases such assurance shall obligate the recipient for the period during which Federal financial assistance is extended. (c) Form. The Director will specify the form of the assurances required by paragraph (a) of this section and the extent to which such assurances will be required of the applicant's or recipient's subgrantees, contractors, subcontractors, transferees, or successors in interest. | ||||
| 34:34:1.2.1.1.5.1.113.5 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | A | Subpart A—Introduction | § 106.5 Transfers of property. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020] | If a recipient sells or otherwise transfers property financed in whole or in part with Federal financial assistance to a transferee which operates any education program or activity, and the Federal share of the fair market value of the property is not upon such sale or transfer properly accounted for to the Federal Government both the transferor and the transferee shall be deemed to be recipients, subject to the provisions of subpart B of this part. | ||||
| 34:34:1.2.1.1.5.1.113.6 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | A | Subpart A—Introduction | § 106.6 Effect of other requirements and preservation of rights. | ED | [45 FR 30955, May 9, 1980, as amended at 65 FR 68056, Nov. 13, 2000; 85 FR 30573, 30579, May 19, 2020; 89 FR 33885, Apr. 29, 2024] | (a) Effect of other Federal provisions. The obligations imposed by this part are independent of, and do not alter, obligations not to discriminate on the basis of sex imposed by Executive Order 11246, as amended; sections 704 and 855 of the Public Health Service Act (42 U.S.C. 292d and 298b-2); Title VII of the Civil Rights Act of 1964 (42 U.S.C. 2000e et seq. ); the Equal Pay Act (29 U.S.C. 206 and 206(d)); and any other Act of Congress or Federal regulation. (b) Effect of State or local law or other requirements. The obligation to comply with Title IX and this part is not obviated or alleviated by any State or local law or other requirement that conflicts with Title IX or this part. (c) Effect of rules or regulations of private organizations. The obligation to comply with this part is not obviated or alleviated by any rule or regulation of any organization, club, athletic or other league, or association which would render any applicant or student ineligible to participate or limit the eligibility or participation of any applicant or student, on the basis of sex, in any education program or activity operated by a recipient and which receives Federal financial assistance. (d) Constitutional protections. Nothing in this part requires a recipient to: (1) Restrict any rights that would otherwise be protected from government action by the First Amendment of the U.S. Constitution; (2) Deprive a person of any rights that would otherwise be protected from government action under the Due Process Clauses of the Fifth and Fourteenth Amendments of the U.S. Constitution; or (3) Restrict any other rights guaranteed against government action by the U.S. Constitution. (e) Effect of Section 444 of General Education Provisions Act (GEPA)/Family Educational Rights and Privacy Act (FERPA). The obligation to comply with Title IX and this part is not obviated or alleviated by FERPA, 20 U.S.C. 1232g, or its implementing regulations, 34 CFR part 99. (f) Title VII of the Civil Rights Act of 1964. Nothing in this par… | ||||
| 34:34:1.2.1.1.5.1.113.7 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | A | Subpart A—Introduction | § 106.7 Effect of employment opportunities. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19 2020] | The obligation to comply with this part is not obviated or alleviated because employment opportunities in any occupation or profession are or may be more limited for members of one sex than for members of the other sex. | ||||
| 34:34:1.2.1.1.5.1.113.8 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | A | Subpart A—Introduction | § 106.8 Designation of coordinator; nondiscrimination policy; grievance procedures; notice of nondiscrimination; training; students with disabilities; and recordkeeping. | ED | [89 FR 33885, Apr. 29, 2024] | (a) Designation of a Title IX Coordinator. (1) Title IX Coordinator. Each recipient mustdesignate and authorize at least one employee, referred to herein as a Title IX Coordinator, to coordinate its efforts to comply with its responsibilities under Title IX and this part. If a recipient has more than one Title IX Coordinator, it must designate one of its Title IX Coordinators to retain ultimate oversight over those responsibilities and ensure the recipient's consistent compliance with its responsibilities under Title IX and this part. (2) Delegation to designees. As appropriate, a recipient may delegate, or permit a Title IX Coordinator to delegate, specific duties to one or more designees. (b) Adoption, publication, and implementation of nondiscrimination policy and grievance procedures. (1) Nondiscrimination policy. Each recipient must adopt, publish, and implement a policy stating that the recipient does not discriminate on the basis of sex and prohibits sex discrimination in any education program or activity that it operates, as required by Title IX and this part, including in admission (unless subpart C of this part does not apply) and employment. (2) Grievance procedures. A recipient must adopt, publish, and implement grievance procedures consistent with the requirements of § 106.45, and if applicable § 106.46, that provide for the prompt and equitable resolution of complaints made by students, employees, or other individuals who are participating or attempting to participate in the recipient's education program or activity, or by the Title IX Coordinator, alleging any action that would be prohibited by Title IX or this part. (c) Notice of nondiscrimination. A recipient must provide a notice of nondiscrimination to students; parents, guardians, or other authorized legal representatives of elementary school and secondary school students; employees; applicants for admission and employment; and all unions and professional organizations holding collective bargaining or professional agreements … | ||||
| 34:34:1.2.1.1.5.1.113.9 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | A | Subpart A—Introduction | § 106.9 Severability. | ED | [85 FR 30573, May 19, 2020] | If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby. | ||||
| 34:34:1.2.1.1.5.2.113.1 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | B | Subpart B—Coverage | § 106.10 Scope. | ED | [89 FR 33886, Apr. 29, 2024] | Discrimination on the basis of sex includes discrimination on the basis of sex stereotypes, sex characteristics, pregnancy or related conditions, sexual orientation, and gender identity. | ||||
| 34:34:1.2.1.1.5.2.113.2 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | B | Subpart B—Coverage | § 106.11 Application. | ED | [89 FR 33886, Apr. 29, 2024] | Except as provided in this subpart, this part applies to every recipient and to all sex discrimination occurring under a recipient's education program or activity in the United States. For purposes of this section, conduct that occurs under a recipient's education program or activity includes but is not limited to conduct that occurs in a building owned or controlled by a student organization that is officially recognized by a postsecondary institution, and conduct that is subject to the recipient's disciplinary authority. A recipient has an obligation to address a sex-based hostile environment under its education program or activity, even when some conduct alleged to be contributing to the hostile environment occurred outside the recipient's education program or activity or outside the United States. | ||||
| 34:34:1.2.1.1.5.2.113.3 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | B | Subpart B—Coverage | § 106.12 Educational institutions controlled by religious organizations. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30573, 30579, May 19, 2020; 85 FR 59980, Sept. 23, 2020] | (a) Application. This part does not apply to an educational institution which is controlled by a religious organization to the extent application of this part would not be consistent with the religious tenets of such organization. (b) Assurance of exemption. An educational institution that seeks assurance of the exemption set forth in paragraph (a) of this section may do so by submitting in writing to the Assistant Secretary a statement by the highest ranking official of the institution, identifying the provisions of this part that conflict with a specific tenet of the religious organization. An institution is not required to seek assurance from the Assistant Secretary in order to assert such an exemption. In the event the Department notifies an institution that it is under investigation for noncompliance with this part and the institution wishes to assert an exemption set forth in paragraph (a) of this section, the institution may at that time raise its exemption by submitting in writing to the Assistant Secretary a statement by the highest ranking official of the institution, identifying the provisions of this part which conflict with a specific tenet of the religious organization, whether or not the institution had previously sought assurance of an exemption from the Assistant Secretary. (c) Eligibility. Any of the following in paragraphs (c)(1) through (6) of this section shall be sufficient to establish that an educational institution is controlled by a religious organization, as contemplated under paragraph (a) of this section, and is therefore eligible to assert a religious exemption to the extent application of this part would not be consistent with its religious tenets: (1) That the educational institution is a school or department of divinity. (2) That the educational institution requires its faculty, students, or employees to be members of, or otherwise engage in religious practices of, or espouse a personal belief in, the religion of the organization by which it claims to be controlled. (3)… | ||||
| 34:34:1.2.1.1.5.2.113.4 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | B | Subpart B—Coverage | § 106.13 Military and merchant marine educational institutions. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020] | This part does not apply to an educational institution whose primary purpose is the training of individuals for a military service of the United States or for the merchant marine. | ||||
| 34:34:1.2.1.1.5.2.113.5 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | B | Subpart B—Coverage | § 106.14 Membership practices of certain organizations. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020] | (a) Social fraternities and sororities. This part does not apply to the membership practices of social fraternities and sororities which are exempt from taxation under section 501(a) of the Internal Revenue Code of 1954, the active membership of which consists primarily of students in attendance at institutions of higher education. (b) YMCA, YWCA, Girl Scouts, Boy Scouts and Camp Fire Girls. This part does not apply to the membership practices of the Young Men's Christian Association, the Young Women's Christian Association, the Girl Scouts, the Boy Scouts and Camp Fire Girls. (c) Voluntary youth service organizations. This part does not apply to the membership practices of voluntary youth service organizations which are exempt from taxation under section 501(a) of the Internal Revenue Code of 1954 and the membership of which has been traditionally limited to members of one sex and principally to persons of less than nineteen years of age. | ||||
| 34:34:1.2.1.1.5.2.113.6 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | B | Subpart B—Coverage | § 106.15 Admissions. | ED | [45 FR 30955, May 9, 1980, as amended at 45 FR 86298, Dec. 30, 1980; 85 FR 30579, May 19, 2020; 89 FR 33886, Apr. 29, 2024] | (a) Admissions to educational institutions prior to June 24, 1973, are not covered by this part. (b) Administratively separate units. For purposes only of this section and subpart C, each administratively separate unit shall be deemed to be an educational institution. (c) Application of subpart C. Except as provided in paragraphs (d) and (e) of this section, subpart C applies to each recipient. A recipient to which subpart C applies shall not discriminate on the basis of sex in admission or recruitment in violation of that subpart. (d) Educational institutions. Except as provided in paragraph (e) of this section as to recipients which are educational institutions, subpart C applies only to institutions of vocational education, professional education, graduate higher education, and public institutions of undergraduate higher education. (e) Public institutions of undergraduate higher education. Subpart C does not apply to any public institution of undergraduate higher education which traditionally and continually from its establishment has had a policy of admitting only students of one sex. | ||||
| 34:34:1.2.1.1.5.2.113.7 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | B | Subpart B—Coverage | § 106.16 Severability. | ED | [85 FR 30573, May 19, 2020. Redesignated at 89 FR 33886, Apr.29, 2024] | If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby. | ||||
| 34:34:1.2.1.1.5.3.113.1 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | C | Subpart C—Discrimination on the Basis of Sex in Admission and Recruitment Prohibited | § 106.21 Admission. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020; 89 FR 33886, Apr. 29, 2024] | (a) Status generally. No person shall, on the basis of sex, be denied admission, or be subjected to discrimination in admission, by any recipient to which this subpart applies. (b) Specific prohibitions. (1) In determining whether a person satisfies any policy or criterion for admission, or in making any offer of admission, a recipient to which this subpart applies shall not: (i) Give preference to one person over another on the basis of sex, by ranking applicants separately on such basis, or otherwise; (ii) Apply numerical limitations upon the number or proportion of persons of either sex who may be admitted; or (iii) Otherwise treat one individual differently from another on the basis of sex. (2) A recipient shall not administer or operate any test or other criterion for admission which has a disproportionately adverse effect on persons on the basis of sex unless the use of such test or criterion is shown to predict validly success in the education program or activity in question and alternative tests or criteria which do not have such a disproportionately adverse effect are shown to be unavailable. (c) Parental, family, or marital status; pregnancy or related conditions. In determining whether a person satisfies any policy or criterion for admission, or in making any offer of admission, a recipient to which this subpart applies: (1) Must treat pregnancy or related conditions in the same manner and under the same policies as any other temporary medical conditions; and (2) Must not: (i) Adopt or implement any policy, practice, or procedure concerning the current, potential, or past parental, family, or marital status of a student or applicant that treats persons differently on the basis of sex; (ii) Discriminate against any person on the basis of current, potential, or past pregnancy or related conditions, or adopt or implement any policy, practice, or procedure that so discriminates; and (iii) Make a pre-admission inquiry as to the marital status of an applicant for admission, including whether… | ||||
| 34:34:1.2.1.1.5.3.113.2 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | C | Subpart C—Discrimination on the Basis of Sex in Admission and Recruitment Prohibited | § 106.22 Preference in admission. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020] | A recipient to which this subpart applies shall not give preference to applicants for admission, on the basis of attendance at any educational institution or other school or entity which admits as students only or predominantly members of one sex, if the giving of such preference has the effect of discriminating on the basis of sex in violation of this subpart. | ||||
| 34:34:1.2.1.1.5.3.113.3 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | C | Subpart C—Discrimination on the Basis of Sex in Admission and Recruitment Prohibited | § 106.23 Recruitment. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020] | (a) Nondiscriminatory recruitment. A recipient to which this subpart applies shall not discriminate on the basis of sex in the recruitment and admission of students. A recipient may be required to undertake additional recruitment efforts for one sex as remedial action pursuant to § 106.3(a), and may choose to undertake such efforts as affirmative action pursuant to § 106.3(b). (b) Recruitment at certain institutions. A recipient to which this subpart applies shall not recruit primarily or exclusively at educational institutions, schools or entities which admit as students only or predominantly members of one sex, if such actions have the effect of discriminating on the basis of sex in violation of this subpart. | ||||
| 34:34:1.2.1.1.5.3.113.4 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | C | Subpart C—Discrimination on the Basis of Sex in Admission and Recruitment Prohibited | § 106.24 Severability. | ED | [85 FR 30574, May 19, 2020] | If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby. | ||||
| 34:34:1.2.1.1.5.4.113.1 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.31 Education programs or activities. | ED | [45 FR 30955, May 9, 1980, as amended at 47 FR 32527, July 28, 1982; 65 FR 68056, Nov. 13, 2000; 85 FR 30579, May 19, 2020; 89 FR 33887, Apr. 29, 2024] | (a) General. (1) Except as provided elsewhere in this part, no person shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or otherwise be subjected to discrimination under any academic, extracurricular, research, occupational training, or other education program or activity operated by a recipient that receives Federal financial assistance. (2) In the limited circumstances in which Title IX or this part permits different treatment or separation on the basis of sex, a recipient must not carry out such different treatment or separation in a manner that discriminates on the basis of sex by subjecting a person to more than de minimis harm, except as permitted by 20 U.S.C. 1681(a)(1) through (9) and the corresponding regulations §§ 106.12 through 106.15, 20 U.S.C. 1686 and its corresponding regulation § 106.32(b)(1), or § 106.41(b). Adopting a policy or engaging in a practice that prevents a person from participating in an education program or activity consistent with the person's gender identity subjects a person to more than de minimis harm on the basis of sex. (3) This subpart does not apply to actions of a recipient in connection with admission of its students to an education program or activity of: (i) A recipient to which subpart C does not apply; or (ii) An entity, not a recipient, to which subpart C would not apply if the entity were a recipient. (b) Specific prohibitions. Except as provided in this subpart, in providing any aid, benefit, or service to a student, a recipient shall not, on the basis of sex: (1) Treat one person differently from another in determining whether such person satisfies any requirement or condition for the provision of such aid, benefit, or service; (2) Provide different aid, benefits, or services or provide aid, benefits, or services in a different manner; (3) Deny any person any such aid, benefit, or service; (4) Subject any person to separate or different rules of behavior, sanctions, or other treatment; (5) Apply any rule concern… | ||||
| 34:34:1.2.1.1.5.4.113.10 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.40 Parental, family, or marital status; pregnancy or related conditions. | ED | [89 FR 33887, Apr. 29, 2024] | (a) Status generally. A recipient must not adopt or implement any policy, practice, or procedure concerning a student's current, potential, or past parental, family, or marital status that treats students differently on the basis of sex. (b) Pregnancy or related conditions. (1) Nondiscrimination. A recipient must not discriminate in its education program or activity against any student based on the student's current, potential, or past pregnancy or related conditions. A recipient does not engage in prohibited discrimination when it allows a student, based on pregnancy or related conditions, to voluntarily participate in a separate portion of its education program or activity provided the recipient ensures that the separate portion is comparable to that offered to students who are not pregnant and do not have related conditions. (2) Responsibility to provide Title IX Coordinator contact and other information. A recipient must ensure that when a student, or a person who has a legal right to act on behalf of the student, informs any employee of the student's pregnancy or related conditions, unless the employee reasonably believes that the Title IX Coordinator has been notified, the employee promptly provides that person with the Title IX Coordinator's contact information and informs that person that the Title IX Coordinator can coordinate specific actions to prevent sex discrimination and ensure the student's equal access to the recipient's education program or activity. (3) Specific actions to prevent discrimination and ensure equal access. A recipient must take specific actions under paragraphs (b)(3)(i) through (vi) of this section to promptly and effectively prevent sex discrimination and ensure equal access to the recipient's education program or activity once the student, or a person who has a legal right to act on behalf of the student, notifies the Title IX Coordinator of the student's pregnancy or related conditions. The Title IX Coordinator must coordinate these actions. (i) Responsibility t… | ||||
| 34:34:1.2.1.1.5.4.113.11 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.41 Athletics. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020; 89 FR 33888, Apr. 29, 2024] | (a) General. No person shall, on the basis of sex, be excluded from participation in, be denied the benefits of, be treated differently from another person or otherwise be discriminated against in any interscholastic, intercollegiate, club or intramural athletics offered by a recipient, and no recipient shall provide any such athletics separately on such basis. (b) Separate teams. Notwithstanding the requirements of paragraph (a) of this section, a recipient may operate or sponsor separate teams for members of each sex where selection for such teams is based upon competitive skill or the activity involved is a contact sport. However, where a recipient operates or sponsors a team in a particular sport for members of one sex but operates or sponsors no such team for members of the other sex, and athletic opportunities for members of that sex have previously been limited, members of the excluded sex must be allowed to try-out for the team offered unless the sport involved is a contact sport. For the purposes of this part, contact sports include boxing, wrestling, rugby, ice hockey, football, basketball and other sports the purpose or major activity of which involves bodily contact. (c) Equal opportunity. A recipient which operates or sponsors interscholastic, intercollegiate, club or intramural athletics shall provide equal athletic opportunity for members of both sexes. In determining whether equal opportunities are available the Director will consider, among other factors: (1) Whether the selection of sports and levels of competition effectively accommodate the interests and abilities of members of both sexes; (2) The provision of equipment and supplies; (3) Scheduling of games and practice time; (4) Travel and per diem allowance; (5) Opportunity to receive coaching and academic tutoring; (6) Assignment and compensation of coaches and tutors; (7) Provision of locker rooms, practice and competitive facilities; (8) Provision of medical and training facilities and services; (9) Provision of housing a… | ||||
| 34:34:1.2.1.1.5.4.113.12 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.42 Textbooks and curricular material. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020] | Nothing in this regulation shall be interpreted as requiring or prohibiting or abridging in any way the use of particular textbooks or curricular materials. | ||||
| 34:34:1.2.1.1.5.4.113.13 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.43 Standards for measuring skill or progress in physical education classes. | ED | [71 FR 62543, Oct. 25, 2006, as amended at 85 FR 30579, May 19, 2020] | If use of a single standard of measuring skill or progress in physical education classes has an adverse effect on members of one sex, the recipient shall use appropriate standards that do not have that effect. | ||||
| 34:34:1.2.1.1.5.4.113.14 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.44 Recipient's response to sex discrimination. | ED | [89 FR 33888, Apr. 29, 2024] | (a) General. (1) A recipient with knowledge of conduct that reasonably may constitute sex discrimination in its education program or activity must respond promptly and effectively; and (2) A recipient must also comply with this section to address sex discrimination in its education program or activity. (b) Barriers to reporting. A recipient must require its Title IX Coordinator to: (1) Monitor the recipient's education program or activity for barriers to reporting information about conduct that reasonably may constitute sex discrimination under Title IX or this part; and (2) Take steps reasonably calculated to address such barriers. (c) Notification requirements. (1) An elementary school or secondary school recipient must require all of its employees who are not confidential employees to notify the Title IX Coordinator when the employee has information about conduct that reasonably may constitute sex discrimination under Title IX or this part. (2) All other recipients must, at a minimum, require: (i) Any employee who is not a confidential employee and who either has authority to institute corrective measures on behalf of the recipient or has responsibility for administrative leadership, teaching, or advising in the recipient's education program or activity to notify the Title IX Coordinator when the employee has information about conduct that reasonably may constitute sex discrimination under Title IX or this part; and (ii) All other employees who are not confidential employees and not covered by paragraph (c)(2)(i) of this section to either: (A) Notify the Title IX Coordinator when the employee has information about conduct that reasonably may constitute sex discrimination under Title IX or this part; or (B) Provide the contact information of the Title IX Coordinator and information about how to make a complaint of sex discrimination to any person who provides the employee with information about conduct that reasonably may constitute sex discrimination under Title IX or this part. (3) A postseco… | ||||
| 34:34:1.2.1.1.5.4.113.15 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.45 Grievance procedures for the prompt and equitable resolution of complaints of sex discrimination. | ED | [89 FR 33891, Apr. 29, 2024] | (a)(1) General. A recipient's grievance procedures for the prompt and equitable resolution of complaints of sex discrimination must be in writing and include provisions that incorporate the requirements of this section. The requirements related to a respondent apply only to sex discrimination complaints alleging that a person violated the recipient's prohibition on sex discrimination. When a sex discrimination complaint alleges that a recipient's policy or practice discriminates on the basis of sex, the recipient is not considered a respondent. (2) Complaint. The following persons have a right to make a complaint of sex discrimination, including complaints of sex-based harassment, requesting that the recipient investigate and make a determination about alleged discrimination under Title IX or this part: (i) A complainant; (ii) A parent, guardian, or other authorized legal representative with the legal right to act on behalf of a complainant; (iii) The Title IX Coordinator, after making the determination specified in § 106.44(f)(1)(v); (iv) With respect to complaints of sex discrimination other than sex-based harassment, in addition to the persons listed in paragraphs (a)(2)(i) through (iii) of this section, (A) Any student or employee; or (B) Any person other than a student or employee who was participating or attempting to participate in the recipient's education program or activity at the time of the alleged sex discrimination. (b) Basic requirements for grievance procedures. A recipient's grievance procedures must: (1) Treat complainants and respondents equitably; (2) Require that any person designated as a Title IX Coordinator, investigator, or decisionmaker not have a conflict of interest or bias for or against complainants or respondents generally or an individual complainant or respondent. The decisionmaker may be the same person as the Title IX Coordinator or investigator; (3) Include a presumption that the respondent is not responsible for the alleged sex discrimination until a determina… | ||||
| 34:34:1.2.1.1.5.4.113.16 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.46 Grievance procedures for the prompt and equitable resolution of complaints of sex-based harassment involving student complainants or student respondents at postsecondary institutions. | ED | [89 FR 33893, Apr. 29, 2024] | (a) General. A postsecondary institution's written grievance procedures for prompt and equitable resolution of complaints of sex-based harassment involving a student complainant or student respondent must include provisions that incorporate the requirements of § 106.45 and this section. (b) Student employees. When a complainant or respondent is both a student and an employee of a postsecondary institution, the postsecondary institution must make a fact-specific inquiry to determine whether the requirements of this section apply. In making this determination, a postsecondary institution must, at a minimum, consider whether the party's primary relationship with the postsecondary institution is to receive an education and whether the alleged sex-based harassment occurred while the party was performing employment-related work. (c) Written notice of allegations. Upon the initiation of the postsecondary institution's sex-based harassment grievance procedures under this section, a postsecondary institution must provide written notice to the parties whose identities are known with sufficient time for the parties to prepare a response before any initial interview. (1) The written notice must include all information required under § 106.45(c)(1)(i) through (iii) and also inform the parties that: (i) The respondent is presumed not responsible for the alleged sex-based harassment until a determination is made at the conclusion of the grievance procedures under this section and that prior to the determination, the parties will have an opportunity to present relevant and not otherwise impermissible evidence to a trained, impartial decisionmaker; (ii) They may have an advisor of their choice to serve in the role set out in paragraph (e)(2) of this section, and that the advisor may be, but is not required to be, an attorney; (iii) They are entitled to an equal opportunity to access the relevant and not otherwise impermissible evidence or an investigative report that accurately summarizes this evidence as set out in p… | ||||
| 34:34:1.2.1.1.5.4.113.17 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.47 Assistant Secretary review of sex-based harassment complaints. | ED | [89 FR 33895, Apr. 29, 2024] | The Assistant Secretary will not deem a recipient to have violated this part solely because the Assistant Secretary would have reached a different determination in a particular complaint alleging sex-based harassment than a recipient reached under § 106.45, and if applicable § 106.46, based on the Assistant Secretary's independent weighing of the evidence. | ||||
| 34:34:1.2.1.1.5.4.113.18 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.48 Severability. | ED | [85 FR 30578, May 19, 2020. Redesignated at 89 FR 33893, Apr. 29, 2024] | If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby. | ||||
| 34:34:1.2.1.1.5.4.113.2 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.32 Housing. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020] | (a) Generally. A recipient shall not, on the basis of sex, apply different rules or regulations, impose different fees or requirements, or offer different services or benefits related to housing, except as provided in this section (including housing provided only to married students). (b) Housing provided by recipient. (1) A recipient may provide separate housing on the basis of sex. (2) Housing provided by a recipient to students of one sex, when compared to that provided to students of the other sex, shall be as a whole: (i) Proportionate in quantity to the number of students of that sex applying for such housing; and (ii) Comparable in quality and cost to the student. (c) Other housing. (1) A recipient shall not, on the basis of sex, administer different policies or practices concerning occupancy by its students of housing other than provided by such recipient. (2) A recipient which, through solicitation, listing, approval of housing, or otherwise, assists any agency, organization, or person in making housing available to any of its students, shall take such reasonable action as may be necessary to assure itself that such housing as is provided to students of one sex, when compared to that provided to students of the other sex, is as a whole: (i) Proportionate in quantity and (ii) Comparable in quality and cost to the student. A recipient may render such assistance to any agency, organization, or person which provides all or part of such housing to students only of one sex. | ||||
| 34:34:1.2.1.1.5.4.113.3 | 34 | Education | I | 106 | PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE | D | Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited | § 106.33 Comparable facilities. | ED | [45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020] | A recipient may provide separate toilet, locker room, and shower facilities on the basis of sex, but such facilities provided for students of one sex shall be comparable to such facilities provided for students of the other sex. |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);