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Title 21

Displaying title 21, up to date as of 9/10/2026. Title 21 was last amended 9/10/2026.
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  1. Title 21 —Food and Drugs
  2. Chapter I —Food and Drug Administration, Department of Health and Human Services
  3. Subchapter A —General
  4. Part 1 —General Enforcement Regulations
  5. Subpart R   View Full Text
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter AGeneral1 – 99
Part 1General Enforcement Regulations1.1 – 1.1465
Subpart RLaboratory Accreditation for Analyses of Foods1.1101 – 1.1200
General Provisions1.1101 – 1.1103
§ 1.1101What documents are incorporated by reference in this subpart
§ 1.1102What definitions apply to this subpart?
§ 1.1103Who is subject to this subpart?
General Requirements1.1107 – 1.1110
§ 1.1107When must food testing be conducted under this subpart?
§ 1.1108When and how will FDA issue a directed food laboratory order?
§ 1.1109How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?
§ 1.1110What are the general requirements for submitting information to FDA under this subpart?
FDA Recognition of Accreditation Bodies1.1113 – 1.1117
§ 1.1113What are the eligibility requirements for a recognized accreditation body?
§ 1.1114How does an accreditation body apply to FDA for recognition or renewal of recognition?
§ 1.1115How will FDA evaluate applications for recognition and renewal of recognition?
§ 1.1116What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?
§ 1.1117How may an accreditation body request reinstatement of recognition?
Requirements for Recognized Accreditation Bodies1.1119 – 1.1125
§ 1.1119What are the conflict of interest requirements for a recognized accreditation body?
§ 1.1120How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
§ 1.1121When 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?
§ 1.1122What procedures must a recognized accreditation body provide for appeals of decisions to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?
§ 1.1123What reports, notifications, and documentation must a recognized accreditation body submit to FDA?
§ 1.1124What are the records requirements for a recognized accreditation body?
§ 1.1125What are the internal audit requirements for a recognized accreditation body?
FDA Oversight of Recognized Accreditation Bodies1.1130 – 1.1131
§ 1.1130How will FDA oversee recognized accreditation bodies?
§ 1.1131When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?
LAAF-Accreditation of Laboratories1.1138 – 1.1142
§ 1.1138What are the eligibility requirements for a LAAF-accredited laboratory?
§ 1.1139How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
§ 1.1140What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?
§ 1.1141What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?
§ 1.1142How does a laboratory request reinstatement of LAAF-accreditation?
Requirements for LAAF-Accredited Laboratories1.1147 – 1.1154
§ 1.1147What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?
§ 1.1149What oversight standards apply to sampling?
§ 1.1150What are the requirements for analysis of samples by a LAAF-accredited laboratory?
§ 1.1151What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?
§ 1.1152What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
§ 1.1153What are the requirements for submitting abridged analytical reports?
§ 1.1154What other records requirements must a LAAF-accredited laboratory meet?
FDA Oversight of LAAF-Accredited Laboratories1.1159 – 1.1162
§ 1.1159How will FDA oversee LAAF-accredited laboratories?
§ 1.1160How will FDA review test results and analytical reports?
§ 1.1161When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?
§ 1.1162What 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 Subpart1.1171 – 1.1174
§ 1.1171How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?
§ 1.1173How 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?
§ 1.1174How does an owner or consignee request a regulatory hearing on a directed food laboratory order?
Electronic Records and Public Disclosure Requirements1.1199 – 1.1200
§ 1.1199Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
§ 1.1200Are the records obtained by FDA under this subpart subject to public disclosure?
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