Part 1 — General Enforcement Regulations
Subpart A — General Provisions
Subpart B — General Labeling Requirements
Subpart D — Electronic Import Entries
- § 1.70— Scope.
- § 1.71— Definitions.
- § 1.72— Data elements that must be submitted in ACE for articles regulated by FDA.
- § 1.73— Food.
- § 1.74— Human drugs.
- § 1.75— Animal drugs and veterinary devices.
- § 1.76— Medical devices.
- § 1.77— Radiation-emitting electronic products.
- § 1.78— Biological products, HCT/Ps, and related drugs and medical devices.
- § 1.79— Tobacco products.
- § 1.80— Cosmetics.
- § 1.81— Rejection of entry filing.
Subpart E — Imports and Exports
- § 1.83— Definitions.
- § 1.90— Notice of sampling.
- § 1.91— Payment for samples.
- § 1.94— Hearing on refusal of admission or destruction.
- § 1.95— Application for authorization to relabel and recondition.
- § 1.96— Granting of authorization to relabel and recondition.
- § 1.97— Bonds.
- § 1.99— Costs chargeable in connection with relabeling and reconditioning inadmissible imports.
- § 1.101— Notification and recordkeeping.
Subpart H — Registration of Food Facilities
- § 1.225— Who must register under this subpart?
- § 1.226— Who does not have to register under this subpart?
- § 1.227— What definitions apply to this subpart?
- § 1.230— When must you register or renew your registration?
- § 1.231— How and where do you register or renew your registration?
- § 1.232— What information is required in the registration?
- § 1.233— Are there optional items included in the registration form?
- § 1.234— How and when do you update your facility's registration information?
- § 1.235— How and when do you cancel your facility's registration information?
- § 1.240— What other registration requirements apply?
- § 1.241— What are the consequences of failing to register, update, renew, or cancel your registration?
- § 1.242— What does assignment of a registration number mean?
- § 1.243— Is food registration information available to the public?
- § 1.245— Waiver request.
Subpart I — Prior Notice of Imported Food
- § 1.276— What definitions apply to this subpart?
- § 1.277— What is the scope of this subpart?
- § 1.278— Who is authorized to submit prior notice?
- § 1.279— When must prior notice be submitted to FDA?
- § 1.280— How must you submit prior notice?
- § 1.281— What information must be in a prior notice?
- § 1.282— What must you do if information changes after you have received confirmation of a prior notice from FDA?
- § 1.283— What happens to food that is imported or offered for import without adequate prior notice?
- § 1.284— What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?
- § 1.285— What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part?
Subpart J — Establishment, Maintenance, and Availability of Records
- § 1.326— Who is subject to this subpart?
- § 1.327— Who is excluded from all or part of the regulations in this subpart?
- § 1.328— What definitions apply to this subpart?
- § 1.329— Do other statutory provisions and regulations apply?
- § 1.330— Can existing records satisfy the requirements of this subpart?
- § 1.337— What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?
- § 1.345— What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?
- § 1.352— What information must transporters establish and maintain?
- § 1.360— What are the record retention requirements?
- § 1.361— What are the record availability requirements?
- § 1.362— What records are excluded from this subpart?
- § 1.363— What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?
- § 1.368— What are the compliance dates for this subpart?
Subpart K — Administrative Detention of Food for Human or Animal Consumption
- § 1.377— What definitions apply to this subpart?
- § 1.378— What criteria does FDA use to order a detention?
- § 1.379— How long may FDA detain an article of food?
- § 1.380— Where and under what conditions must the detained article of food be held?
- § 1.381— May a detained article of food be delivered to another entity or transferred to another location?
- § 1.382— What labeling or marking requirements apply to a detained article of food?
- § 1.383— What expedited procedures apply when FDA initiates a seizure action against a detained perishable food?
- § 1.384— When does a detention order terminate?
- § 1.391— Who approves a detention order?
- § 1.392— Who receives a copy of the detention order?
- § 1.393— What information must FDA include in the detention order?
- § 1.401— Who is entitled to appeal?
- § 1.402— What are the requirements for submitting an appeal?
- § 1.403— What requirements apply to an informal hearing?
- § 1.404— Who serves as the presiding officer for an appeal and for an informal hearing?
- § 1.405— When does FDA have to issue a decision on an appeal?
- § 1.406— How will FDA handle classified information in an informal hearing?
Subpart L — Foreign Supplier Verification Programs for Food Importers
- § 1.500— What definitions apply to this subpart?
- § 1.501— To what foods do the requirements in this subpart apply?
- § 1.502— What foreign supplier verification program (FSVP) must I have?
- § 1.503— Who must develop my FSVP and perform FSVP activities?
- § 1.504— What hazard analysis must I conduct?
- § 1.505— What evaluation for foreign supplier approval and verification must I conduct?
- § 1.506— What foreign supplier verification and related activities must I conduct?
- § 1.507— What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?
- § 1.508— What corrective actions must I take under my FSVP?
- § 1.509— How must the importer be identified at entry?
- § 1.510— How must I maintain records of my FSVP?
- § 1.511— What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?
- § 1.512— What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers?
- § 1.513— What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system?
- § 1.514— What are some consequences of failing to comply with the requirements of this subpart?
Subpart M — Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
- § 1.600— What definitions apply to this subpart?
- § 1.601— Who is subject to this subpart?
- § 1.610— Who is eligible to seek recognition?
- § 1.611— What legal authority must an accreditation body have to qualify for recognition?
- § 1.612— What competency and capacity must an accreditation body have to qualify for recognition?
- § 1.613— What protections against conflicts of interest must an accreditation body have to qualify for recognition?
- § 1.614— What quality assurance procedures must an accreditation body have to qualify for recognition?
- § 1.615— What records procedures must an accreditation body have to qualify for recognition?
- § 1.620— How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?
- § 1.621— How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?
- § 1.622— How must a recognized accreditation body monitor its own performance?
- § 1.623— What reports and notifications must a recognized accreditation body submit to FDA?
- § 1.624— How must a recognized accreditation body protect against conflicts of interest?
- § 1.625— What records requirements must an accreditation body that has been recognized meet?
- § 1.630— How do I apply to FDA for recognition or renewal of recognition?
- § 1.631— How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?
- § 1.632— What is the duration of recognition?
- § 1.633— How will FDA monitor recognized accreditation bodies?
- § 1.634— When will FDA revoke recognition?
- § 1.635— What if I want to voluntarily relinquish recognition or do not want to renew recognition?
- § 1.636— How do I request reinstatement of recognition?
- § 1.640— Who is eligible to seek accreditation?
- § 1.641— What legal authority must a third-party certification body have to qualify for accreditation?
- § 1.642— What competency and capacity must a third-party certification body have to qualify for accreditation?
- § 1.643— What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?
- § 1.644— What quality assurance procedures must a third-party certification body have to qualify for accreditation?
- § 1.645— What records procedures must a third-party certification body have to qualify for accreditation?
- § 1.650— How must an accredited third-party certification body ensure its audit agents are competent and objective?
- § 1.651— How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
- § 1.652— What must an accredited third-party certification body include in food safety audit reports?
- § 1.653— What must an accredited third-party certification body do when issuing food or facility certifications?
- § 1.654— When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?
- § 1.655— How must an accredited third-party certification body monitor its own performance?
- § 1.656— What reports and notifications must an accredited third-party certification body submit?
- § 1.657— How must an accredited third-party certification body protect against conflicts of interest?
- § 1.658— What records requirements must a third-party certification body that has been accredited meet?
- § 1.660— Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application?
- § 1.661— What is the duration of accreditation by a recognized accreditation body?
- § 1.662— How will FDA monitor accredited third-party certification bodies?
- § 1.663— How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?
- § 1.664— When would FDA withdraw accreditation?
- § 1.665— What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?
- § 1.666— How do I request reaccreditation?
- § 1.670— How do I apply to FDA for direct accreditation or renewal of direct accreditation?
- § 1.671— How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application?
- § 1.672— What is the duration of direct accreditation?
- § 1.680— How and when will FDA monitor eligible entities?
- § 1.681— How frequently must eligible entities be recertified?
- § 1.690— How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?
- § 1.691— How do I request reconsideration of a denial by FDA of an application or a waiver request?
- § 1.692— How do I request internal agency review of a denial of an application or waiver request upon reconsideration?
- § 1.693— How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?
- § 1.694— Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
- § 1.695— Are the records obtained by FDA under this subpart subject to public disclosure?
- § 1.700— Who is subject to a user fee under this subpart?
- § 1.705— What user fees are established under this subpart?
- § 1.710— How will FDA notify the public about the fee schedule?
- § 1.715— When must a user fee required by this subpart be submitted?
- § 1.720— Are user fees under this subpart refundable?
- § 1.725— What are the consequences of not paying a user fee under this subpart on time?
Subpart O — Sanitary Transportation of Human and Animal Food
- § 1.900— Who is subject to this subpart?
- § 1.902— How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act?
- § 1.904— What definitions apply to this subpart?
- § 1.906— What requirements apply to vehicles and transportation equipment?
- § 1.908— What requirements apply to transportation operations?
- § 1.910— What training requirements apply to carriers engaged in transportation operations?
- § 1.912— What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?
- § 1.914— Under what circumstances will we waive a requirement of this subpart?
- § 1.916— When will we consider whether to waive a requirement of this subpart?
- § 1.918— What must be included in the Statement of Grounds in a petition requesting a waiver?
- § 1.920— What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available?
- § 1.922— Who will respond to a petition requesting a waiver?
- § 1.924— What process applies to a petition requesting a waiver?
- § 1.926— Under what circumstances may we deny a petition requesting a waiver?
- § 1.928— What process will we follow when waiving a requirement of this subpart on our own initiative?
- § 1.930— When will a waiver that we grant become effective?
- § 1.932— Under what circumstances may we modify or revoke a waiver?
- § 1.934— What procedures apply if we determine that a waiver should be modified or revoked?
Subpart Q — Administrative Detention of Drugs Intended for Human or Animal Use
Subpart R — Laboratory Accreditation for Analyses of Foods
- § 1.1101— What documents are incorporated by reference in this subpart
- § 1.1102— What definitions apply to this subpart?
- § 1.1103— Who is subject to this subpart?
- § 1.1107— When must food testing be conducted under this subpart?
- § 1.1108— When and how will FDA issue a directed food laboratory order?
- § 1.1109— How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?
- § 1.1110— What are the general requirements for submitting information to FDA under this subpart?
- § 1.1113— What are the eligibility requirements for a recognized accreditation body?
- § 1.1114— How does an accreditation body apply to FDA for recognition or renewal of recognition?
- § 1.1115— How will FDA evaluate applications for recognition and renewal of recognition?
- § 1.1116— What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?
- § 1.1117— How may an accreditation body request reinstatement of recognition?
- § 1.1119— What are the conflict of interest requirements for a recognized accreditation body?
- § 1.1120— How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
- § 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?
- § 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?
- § 1.1123— What reports, notifications, and documentation must a recognized accreditation body submit to FDA?
- § 1.1124— What are the records requirements for a recognized accreditation body?
- § 1.1125— What are the internal audit requirements for a recognized accreditation body?
- § 1.1130— How will FDA oversee recognized accreditation bodies?
- § 1.1131— When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?
- § 1.1138— What are the eligibility requirements for a LAAF-accredited laboratory?
- § 1.1139— How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
- § 1.1140— What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?
- § 1.1141— What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?
- § 1.1142— How does a laboratory request reinstatement of LAAF-accreditation?
- § 1.1147— What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?
- § 1.1149— What oversight standards apply to sampling?
- § 1.1150— What are the requirements for analysis of samples by a LAAF-accredited laboratory?
- § 1.1151— What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?
- § 1.1152— What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
- § 1.1153— What are the requirements for submitting abridged analytical reports?
- § 1.1154— What other records requirements must a LAAF-accredited laboratory meet?
- § 1.1159— How will FDA oversee LAAF-accredited laboratories?
- § 1.1160— How will FDA review test results and analytical reports?
- § 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?
- § 1.1162— What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?
- § 1.1171— How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?
- § 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?
- § 1.1174— How does an owner or consignee request a regulatory hearing on a directed food laboratory order?
- § 1.1199— Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
- § 1.1200— Are the records obtained by FDA under this subpart subject to public disclosure?
Subpart S — Additional Traceability Records for Certain Foods
- § 1.1300— Who is subject to this subpart?
- § 1.1305— What foods and persons are exempt from this subpart?
- § 1.1310— What definitions apply to this subpart?
- § 1.1315— What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?
- § 1.1320— When must I assign traceability lot codes to foods on the Food Traceability List?
- § 1.1325— What records must I keep and provide when I harvest or cool a raw agricultural commodity on the Food Traceability List?
- § 1.1330— What records must I keep when I am performing the initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List?
- § 1.1335— What records must I keep when I am the first land-based receiver of a food on the Food Traceability List that was obtained from a fishing vessel?
- § 1.1340— What records must I keep and provide when I ship a food on the Food Traceability List?
- § 1.1345— What records must I keep when I receive a food on the Food Traceability List?
- § 1.1350— What records must I keep when I transform a food on the Food Traceability List?
- § 1.1360— Under what circumstances will FDA modify the requirements in this subpart that apply to a food or type of entity or exempt a food or type of entity from the requirements of this subpart?
- § 1.1365— When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?
- § 1.1370— What must be included in a petition requesting modified requirements or an exemption from the requirements?
- § 1.1375— What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?
- § 1.1380— What process applies to a petition requesting modified requirements or an exemption?
- § 1.1385— What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?
- § 1.1390— When will modified requirements that we adopt or an exemption that we grant become effective?
- § 1.1395— Under what circumstances may FDA revise or revoke modified requirements or an exemption?
- § 1.1400— What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked?
- § 1.1405— Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?
- § 1.1410— When will FDA consider whether to waive a requirement of this subpart?
- § 1.1415— How may I request a waiver for an individual entity?
- § 1.1420— What process applies to a request for a waiver for an individual entity?
- § 1.1425— What must be included in a petition requesting a waiver for a type of entity?
- § 1.1430— What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?
- § 1.1435— What process applies to a petition requesting a waiver for a type of entity?
- § 1.1440— What process will FDA follow when waiving a requirement of this subpart on our own initiative?
- § 1.1445— Under what circumstances may FDA modify or revoke a waiver?
- § 1.1450— What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?
- § 1.1455— How must records required by this subpart be maintained and made available?
- § 1.1460— What consequences could result from failing to comply with the requirements of this subpart?
- § 1.1465— How will FDA update the Food Traceability List?