Subpart R. Subpart R—Laboratory Accreditation for Analyses of Foods

• General Provisions

  • SECTION § 1.1101 - What documents are incorporated by reference in this subpart
  • SECTION § 1.1102 - What definitions apply to this subpart?
  • SECTION § 1.1103 - Who is subject to this subpart?

• General Requirements

  • SECTION § 1.1107 - When must food testing be conducted under this subpart?
  • SECTION § 1.1108 - When and how will FDA issue a directed food laboratory order?
  • SECTION § 1.1109 - How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?
  • SECTION § 1.1110 - What are the general requirements for submitting information to FDA under this subpart?

• FDA Recognition of Accreditation Bodies

  • SECTION § 1.1113 - What are the eligibility requirements for a recognized accreditation body?
  • SECTION § 1.1114 - How does an accreditation body apply to FDA for recognition or renewal of recognition?
  • SECTION § 1.1115 - How will FDA evaluate applications for recognition and renewal of recognition?
  • SECTION § 1.1116 - What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?
  • SECTION § 1.1117 - How may an accreditation body request reinstatement of recognition?

• Requirements for Recognized Accreditation Bodies

  • SECTION § 1.1119 - What are the conflict of interest requirements for a recognized accreditation body?
  • SECTION § 1.1120 - How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
  • SECTION § 1.1121 - When must a recognized accreditation body require corrective action, suspend a LAAF-accredited laboratory, or reduce the scope of or withdraw the LAAF-accreditation of a laboratory?
  • SECTION § 1.1122 - What procedures must a recognized accreditation body provide for appeals of decisions to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?
  • SECTION § 1.1123 - What reports, notifications, and documentation must a recognized accreditation body submit to FDA?
  • SECTION § 1.1124 - What are the records requirements for a recognized accreditation body?
  • SECTION § 1.1125 - What are the internal audit requirements for a recognized accreditation body?

• FDA Oversight of Recognized Accreditation Bodies

  • SECTION § 1.1130 - How will FDA oversee recognized accreditation bodies?
  • SECTION § 1.1131 - When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?

• LAAF-Accreditation of Laboratories

  • SECTION § 1.1138 - What are the eligibility requirements for a LAAF-accredited laboratory?
  • SECTION § 1.1139 - How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
  • SECTION § 1.1140 - What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?
  • SECTION § 1.1141 - What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?
  • SECTION § 1.1142 - How does a laboratory request reinstatement of LAAF-accreditation?

• Requirements for LAAF-Accredited Laboratories

  • SECTION § 1.1147 - What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?
  • SECTION § 1.1149 - What oversight standards apply to sampling?
  • SECTION § 1.1150 - What are the requirements for analysis of samples by a LAAF-accredited laboratory?
  • SECTION § 1.1151 - What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?
  • SECTION § 1.1152 - What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
  • SECTION § 1.1153 - What are the requirements for submitting abridged analytical reports?
  • SECTION § 1.1154 - What other records requirements must a LAAF-accredited laboratory meet?

• FDA Oversight of LAAF-Accredited Laboratories

  • SECTION § 1.1159 - How will FDA oversee LAAF-accredited laboratories?
  • SECTION § 1.1160 - How will FDA review test results and analytical reports?
  • SECTION § 1.1161 - When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?
  • SECTION § 1.1162 - What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?

• Requesting FDA Reconsideration or Regulatory Hearings of FDA Decisions Under This Subpart

  • SECTION § 1.1171 - How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?
  • SECTION § 1.1173 - How does an accreditation body or laboratory request a regulatory hearing on FDA's decision to revoke the accreditation body's recognition or disqualify a LAAF-accredited laboratory?
  • SECTION § 1.1174 - How does an owner or consignee request a regulatory hearing on a directed food laboratory order?

• Electronic Records and Public Disclosure Requirements

  • SECTION § 1.1199 - Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
  • SECTION § 1.1200 - Are the records obtained by FDA under this subpart subject to public disclosure?