Part 6201 Supplemental Standards of Ethical Conduct for Employees of the Export-Import Bank of the United States

Terms Used In CFR > Title 5 > Chapter LII

  • Accreditation: means a determination by a recognized accreditation body (or, in the case of direct accreditation, by FDA) that a third-party certification body meets the applicable requirements of this subpart. See 43 CFR 9180.1
  • Accreditation body: means an authority that performs accreditation of third-party certification bodies. See 43 CFR 9180.1
  • Accredited third-party certification body: means a third-party certification body that a recognized accreditation body (or, in the case of direct accreditation, FDA) has determined meets the applicable requirements of this subpart and is accredited to conduct food safety audits and to issue food or facility certifications to eligible entities. See 43 CFR 9180.1
  • Adequate: means that which is needed to accomplish the intended purpose in keeping with good public health practice. See 43 CFR 8365.1-1
  • Advisory committee: means any committee, council, or board established or utilized for purposes of obtaining advice or recommendations. See 43 CFR 1784.0-5
  • Audit: means the systematic, independent, and documented examination (through observation, investigation, discussions with employees of the audited entity, records review, and, as appropriate, sampling and laboratory analysis) to assess an audited entity's food safety processes and procedures. See 43 CFR 8365.1-1
  • Audit: means the systematic and functionally independent examination of an eligible entity under this subpart by an accredited third-party certification body or by FDA. See 43 CFR 9180.1
  • Authorized officer: means any employee of the Bureau of Land Management who has been delegated the authority to perform the duties described in this part. See 43 CFR 8360.0-5
  • Authorized officer: means any employee of the Bureau of Land Management designated to perform the duties described in this subpart:

    (b) Fossil means the remains or trace(s) of an organism or assemblage of organisms which have been preserved by natural processes in the earth's crust. See 43 CFR 8224.0-5

  • Authorized officer: means any employee of the Bureau of Land Management to whom has been delegated the authority to perform the duties described in this subpart. See 43 CFR 9212.0-5
  • Bureau: means the Bureau of Land Management. See 43 CFR 8340.0-5
  • Campfire: means a controlled fire occurring out of doors used for cooking, branding, personal warmth, lighting, ceremonial or esthetic purposes. See 43 CFR 9212.0-5
  • Closed area: means public lands closed to entry by a Bureau of Land Management fire prevention order. See 43 CFR 9212.0-5
  • Designated Federal officer: means the Federal officer or employee designated by an advisory committee charter who approves meeting agendas and attends all meetings of the committee and its subcommittees, if any. See 43 CFR 1784.0-5
  • Developed recreation sites and areas: means sites and areas that contain structures or capital improvements primarily used by the public for recreation purposes. See 43 CFR 8360.0-5
  • Dietary supplement: has the meaning given in section 201(ff) of the Federal Food, Drug, and Cosmetic Act. See 43 CFR 8365.1-1
  • Dietary supplement component: means any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement. See 43 CFR 8365.1-1
  • Direct accreditation: means accreditation of a third-party certification body by FDA. See 43 CFR 9180.1
  • Director: means the Director of the Bureau of Land Management. See 43 CFR 1784.0-5
  • Eligible entity: means a foreign entity in the import supply chain of food for consumption in the United States that chooses to be subject to a food safety audit under this subpart conducted by an accredited third-party certification body. See 43 CFR 9180.1
  • Facility: means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of subpart H of this part. See 43 CFR 8365.1-1
  • Facility: means any structure, or structures of an eligible entity under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, holds, grows, harvests, or raises animals for food for consumption in the United States. See 43 CFR 9180.1
  • Facility certification: means an attestation, issued for purposes of section 801(q) or 806 of the FD&C Act by an accredited third-party certification body, after conducting a regulatory audit and any other activities necessary to establish whether a facility complies with the applicable food safety requirements of the FD&C Act and FDA regulations. See 43 CFR 9180.1
  • Farm: means farm as defined in §1. See 43 CFR 8365.1-1
  • Fire: means the burning of timber, trees, slash, brush, tundra, grass or other flammable material such as, but not limited to, petroleum products, trash, rubbish, lumber, paper, cloth or agricultural refuse occurring out of doors and includes campfire as defined in this section. See 43 CFR 9212.0-5
  • Food: has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act, except that food does not include pesticides (as defined in 7 U. See 43 CFR 8365.1-1
  • Food: has the meaning given in section 201(f) of the FD&C Act, except that food does not include pesticides (as defined in 7 U. See 43 CFR 9180.1
  • Food safety audit: means a regulatory audit or a consultative audit that is conducted to determine compliance with the applicable food safety requirements of the FD&C Act, FDA regulations, and for consultative audits, also includes conformance with industry standards and practices. See 43 CFR 9180.1
  • Hazard: means any biological, chemical (including radiological), or physical agent that is reasonably likely to cause illness or injury. See 43 CFR 8365.1-1
  • Hazard requiring a control: means a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the probability that the hazard will occur in the absence of controls or measures and the severity of the illness or injury if the hazard were to occur), establish one or more controls or measures to significantly minimize or prevent the hazard in a food and components to manage those controls or measures (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the control or measure and its role in the facility's food safety system. See 43 CFR 8365.1-1
  • Holding: means storage of food and also includes activities performed incidental to storage of a food (e. See 43 CFR 8365.1-1
  • Importer: means the U. See 43 CFR 8365.1-1
  • Lot: means the food produced during a period of time and identified by an establishment's specific code. See 43 CFR 8365.1-1
  • Off-road vehicle: means any motorized vehicle capable of, or designed for, travel on or immediately over land, water, or other natural terrain, excluding:

    (1) Any nonamphibious registered motorboat. See 43 CFR 8340.0-5

  • Packing: means placing food into a container other than packaging the food and also includes re-packing and activities performed incidental to packing or re-packing a food (e. See 43 CFR 8365.1-1
  • Pathogen: means a microorganism of public health significance. See 43 CFR 8365.1-1
  • Permit: means authorization in writing by the authorized officer. See 43 CFR 9212.0-5
  • Person: means individuals, corporations, companies, associations, firms, partnerships, societies or joint stock companies. See 43 CFR 9212.0-5
  • Public lands: means any lands the surface of which is administered by the Bureau of Land Management. See 43 CFR 8340.0-5
  • Public lands: means any lands and interests in lands owned by the United States and administered by the Secretary of the Interior through the Bureau of Land Management without regard to how the United States acquired ownership. See 43 CFR 8360.0-5
  • Public lands: means any lands and interest in lands owned by the United States within the several States and administered by the Secretary of the Interior through the Bureau of Land Management, without regard to how the United States acquired ownership, except:

    (1) Lands located on the Outer Continental Shelf. See 43 CFR 9212.0-5

  • Public lands: means any lands and interest in lands owned by the United States administered by the Secretary of the Interior through the Bureau of Land Management, except:

    (1) Lands located on the Outer Continental Shelf. See 43 CFR 1784.0-5

  • Qualified auditor: means a person who is a qualified individual as defined in this section and has technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function as required by §1. See 43 CFR 8365.1-1
  • Qualified individual: means a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under this subpart, and can read and understand the language of any records that the person must review in performing this activity. See 43 CFR 8365.1-1
  • Raw agricultural commodity: has the meaning given in section 201(r) of the Federal Food, Drug, and Cosmetic Act. See 43 CFR 8365.1-1
  • Receiving facility: means a facility that is subject to subparts C and G of part 117 of this chapter, or subparts C and E of part 507 of this chapter, and that manufactures/processes a raw material or other ingredient that it receives from a supplier. See 43 CFR 8365.1-1
  • Recognized accreditation body: means an accreditation body that FDA has determined meets the applicable requirements of this subpart and is authorized to accredit third-party certification bodies under this subpart. See 43 CFR 9180.1
  • Restricted area: means public lands restricted as to use(s) by a Bureau of Land Management fire prevention order. See 43 CFR 9212.0-5
  • Secretary: means Secretary of the Interior. See 43 CFR 1784.0-5
  • Vehicle: means any motorized transportation conveyance designed and licensed for use on roadways, such as an automobile, bus, or truck, and any motorized conveyance originally equipped with safety belts. See 43 CFR 8360.0-5
  • You: means a person who is subject to some or all of the requirements in this subpart. See 43 CFR 8365.1-1