Title 21—Food and Drugs--Volume 1
PART 1—GENERAL ENFORCEMENT REGULATIONS
§ 1.680   How and when will FDA monitor eligible entities?
FDA may, at any time, conduct an onsite audit of an eligible entity that has received food or facility certification from an accredited third-party certification body under this subpart. Where FDA determines necessary or appropriate, the unannounced audit may be conducted with or without the accredited third-party certification body or the recognized accreditation body (where applicable) present. An FDA audit conducted under this section will be conducted on an unannounced basis and may be preceded by a request for a 30-day operating schedule.
§ 1.681   How frequently must eligible entities be recertified?
An eligible entity seeking recertification of a food or facility certification under this subpart must apply for recertification prior to the expiration of its certification. For certifications used in meeting the requirements of section 801(q) or 806 of the FD&C Act, FDA may require an eligible entity to apply for recertification at any time FDA determines appropriate under such section.
§ 1.690   How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?
FDA will place on its Web site a registry of recognized accreditation bodies and accredited third-party certification bodies, including the name, contact information, and scope and duration of recognition or accreditation. The registry may provide information on third-party certification bodies accredited by recognized accreditation bodies through links to the Web sites of such recognized accreditation bodies. FDA will also place on its Web site a list of accreditation bodies for which it has denied renewal of recognition, for which FDA has revoked recognition, and that have relinquished their recognition or have allowed their recognition to expire. FDA will also place in its Web site a list of certification bodies whose renewal of accreditation has been denied, for which FDA has withdrawn accreditation, and that have relinquished their accreditations or have allowed their accreditations to expire. FDA will place on its Web site determinations under § 1.670(a)(1) and modifications of such determinations under § 1.670(a)(2).
§ 1.691   How do I request reconsideration of a denial by FDA of an application or a waiver request?
(a) An accreditation body may seek reconsideration of the denial of an application for recognition, renewal of recognition, or reinstatement of recognition no later than 10 business days after the date of the issuance of such denial.
(b) A third-party certification body may seek reconsideration of the denial of an application for direct accreditation, renewal of direct accreditation, reaccreditation of directly accredited third-party certification body, a request for a waiver of the conflict of interest requirement in § 1.650(b), or a waiver extension no later than 10 business days after the date of the issuance of such denial.
(c) A request to reconsider an application or waiver request under paragraph (a) or (b) of this section must be signed by the requestor or by an individual authorized to act on its behalf in submitting the request for reconsideration. The request must be submitted electronically in English and must comply with the procedures described in the notice.
(d) After completing its review and evaluation of the request for reconsideration, FDA will notify the requestor through the issuance of the recognition, direct accreditation, or waiver upon reconsideration or through the issuance of a denial of the application or waiver request under paragraph (a) or (b) of this section upon reconsideration.
§ 1.692   How do I request internal agency review of a denial of an application or waiver request upon reconsideration?
(a) No later than 10 business days after the date of issuance of a denial of an application or waiver request upon reconsideration under § 1.691, the requestor may seek internal agency review of such denial under § 10.75(c)(1) of this chapter.
(b) The request for internal agency review under paragraph (a) of this section must be signed by the requestor or by an individual authorized to act on its behalf in submitting the request for internal review. The request must be submitted electronically in English to the address specified in the denial upon reconsideration and must comply with procedures it describes.
(c) Under § 10.75(d) of this chapter, internal agency review of such denial must be based on the information in the administrative file, which will include any supporting information submitted under § 1.691(c).
(d) After completing the review and evaluation of the administrative file, FDA will notify the requestor of its decision to overturn the denial and grant the application or waiver request through issuance of an application or waiver request upon reconsideration or to affirm the denial of the application or waiver request upon reconsideration through issuance of a denial of an application or waiver request upon reconsideration.
(e) Issuance by FDA of a denial of an application or waiver request upon reconsideration constitutes final agency action under 5 U.S.C. 702.
§ 1.693   How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?
(a) Request for hearing on revocation. No later than 10 business days after the date of issuance of a revocation of recognition of an accreditation body under § 1.634, an individual authorized to act on the accreditation body's behalf may submit a request for a regulatory hearing on the revocation under part 16 of this chapter. The issuance of revocation issued under § 1.634 will contain all of the elements required by § 16.22 of this chapter and will thereby constitute the notice of an opportunity for hearing under part 16 of this chapter.
(b) Request for hearing on withdrawal. No later than 10 business days after the date of issuance of a withdrawal of accreditation of a third-party certification body under § 1.664, an individual authorized to act on the third-party certification body's behalf may submit a request for a regulatory hearing on the withdrawal under part 16 of this chapter. The issuance of withdrawal under § 1.664 will contain all of the elements required by § 16.22 of this chapter and will thereby constitute the notice of opportunity of hearing under part 16 of this chapter.
(c) Submission of request for regulatory hearing. The request for a regulatory hearing under paragraph (a) or (b) of this section must be submitted with a written appeal that responds to the basis for the FDA decision, as described in the issuance of revocation or withdrawal, as appropriate, and includes any supporting information upon which the requestor is relying. The request, appeal, and supporting information must be submitted in English to the address specified in the notice and must comply with the procedures it describes.
(d) Effect of submission of request on FDA decision. The submission of a request for a regulatory hearing under paragraph (a) or (b) of this section will not operate to delay or stay the effect of a decision by FDA to revoke recognition of an accreditation body or to withdraw accreditation of a third-party certification body unless FDA determines that a delay or a stay is in the public interest.
(e) Presiding officer. The presiding officer for a regulatory hearing for a revocation or withdrawal under this subpart will be designated after a request for a regulatory hearing is submitted to FDA.
(f) Denial of a request for regulatory hearing. The presiding officer may deny a request for regulatory hearing for a revocation or withdrawal under § 16.26(a) of this chapter when no genuine or substantial issue of fact has been raised.
(g) Conduct of regulatory hearing. (1) If the presiding officer grants a request for a regulatory hearing for a revocation or withdrawal, the hearing will be held within 10 business days after the date the request was filed or, if applicable, within a timeframe agreed upon in writing by requestor, the presiding officer, and FDA.
(2) The presiding officer must conduct the regulatory hearing for revocation or withdrawal under part 16 of this chapter, except that, under § 16.5(b) of this chapter, such procedures apply only to the extent that the procedures are supplementary and do not conflict with the procedures specified for regulatory hearings under this subpart. Accordingly, the following requirements of part 16 are inapplicable to regulatory hearings under this subpart: § 16.22 (Initiation of a regulatory hearing); § 16.24(e) (timing) and (f) (contents of notice); § 16.40 (Commissioner); § 16.60(a) (public process); § 16.95(b) (administrative decision and record for decision); and § 16.119 (Reconsideration and stay of action).
(3) A decision by the presiding officer to affirm the revocation of recognition or the withdrawal of accreditation is considered a final agency action under 5 U.S.C. 702.
§ 1.694   Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
Records that are established or maintained to satisfy the requirements of this subpart and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.
§ 1.695   Are the records obtained by FDA under this subpart subject to public disclosure?
Records obtained by FDA under this subpart are subject to the disclosure requirements under part 20 of this chapter.
§ 1.700   Who is subject to a user fee under this subpart?
(a) Accreditation bodies submitting applications or renewal applications for recognition in the third-party certification program;
(b) Recognized accreditation bodies participating in the third-party certification program;
(c) Third-party certification bodies submitting applications or renewal applications for direct accreditation; and
(d) Accredited third-party certification bodies (whether accredited by recognized accreditation bodies or by FDA through direct accreditation) participating in the third-party certification program.
§ 1.705   What user fees are established under this subpart?
(a) The following application fees:
(1) Accreditation bodies applying for recognition are subject to an application fee for the estimated average cost of the work FDA performs in reviewing and evaluating applications for recognition of accreditation bodies.
(2) Recognized accreditation bodies submitting renewal applications are subject to a renewal application fee for the estimated average cost of the work FDA performs in reviewing and evaluating renewal applications for recognition of accreditation bodies.
(3) Third-party certification bodies applying for direct accreditation are subject to an application fee for the estimated average cost of the work FDA performs in reviewing and evaluating applications for direct accreditation.
(4) Accredited third-party certification bodies applying for renewal of direct accreditation are subject to an application fee for the estimated average cost of the work FDA performs in reviewing and evaluating renewal applications for direct accreditation.
(b) The following annual fees:
(1) Recognized accreditation bodies are subject to an annual fee for the estimated average cost of the work FDA performs to monitor performance of recognized accreditation bodies under § 1.633.
(2) Third-party certification bodies directly accredited by FDA are subject to an annual fee for the estimated average cost of the work FDA performs to monitor directly accredited third-party certification bodies under § 1.662.
(3) Third-party certification bodies accredited by recognized accreditation bodies are subject to an annual fee for the estimated average cost of the work FDA performs to monitor third-party certification bodies that are accredited by a recognized accreditation body under § 1.662.
§ 1.710   How will FDA notify the public about the fee schedule?
FDA will notify the public of the fee schedule annually. The fee notice will be made publicly available prior to the beginning of the fiscal year for which the fees apply, except for the first fiscal year in which this regulation is effective. Each new fee schedule will be adjusted for inflation and improvements in the estimates of the cost to FDA of performing relevant work for the upcoming year.
§ 1.715   When must a user fee required by this subpart be submitted?
(a) Accreditation bodies applying for recognition and third-party certification bodies applying for direct accreditation must submit a fee concurrently with submitting an application or a renewal application.
(b) Accreditation bodies and third-party certification bodies subject to an annual fee must submit payment within 30 days of receiving billing for the fee.
§ 1.720   Are user fees under this subpart refundable?
User fees accompanying completed applications and annual fees under this subpart are not refundable.
§ 1.725   What are the consequences of not paying a user fee under this subpart on time?
(a) An application for recognition or renewal of recognition will not be considered complete for the purposes of § 1.631(a) until the date that FDA receives the application fee. An application for direct accreditation or for renewal of direct accreditation will not be considered complete for the purposes of § 1.671(a) until FDA receives the application fee.
(b) A recognized accreditation body that fails to submit its annual user fee within 30 days of the due date will have its recognition suspended.
(1) FDA will notify the accreditation body electronically that its recognition is suspended. FDA will notify the public of the suspension on the Web site described in § 1.690.
(2) While an accreditation body's recognition is suspended, the accreditation body will not be able to accredit additional third-party certification bodies. The accreditation of third-party certification bodies that occurred prior to an accreditation body's suspension, as well as food or facility certifications issued by such third-party certification bodies, would remain in effect.
(3) If payment is not received within 90 days of the payment due date, FDA will revoke the accreditation body's recognition under § 1.634(a)(4)(iii), and provide notice of such revocation in accordance with § 1.634.
(c) An accredited third-party certification body that fails to submit its annual fee within 30 days of the due date will have its accreditation suspended.
(1) FDA will notify the third-party certification body that its accreditation is suspended, electronically and in English. FDA will notify a recognized accreditation body, electronically and in English, if the accreditation of one if its third-party certification bodies is suspended. FDA will notify the public of the suspension on the Web site described in § 1.690.
(2) While a third-party certification body's accreditation is suspended, the third-party certification body will not be able to issue food or facility certifications. A food or facility certification issued by a third-party certification body prior to the suspension of the auditor/certification body accreditation will remain in effect.
(3) If payment is not received within 90 days of the payment due date, FDA will withdraw the third-party certification body's accreditation under § 1.664(a)(4), and provide notice of such withdrawal in accordance with § 1.664.
§ 1.900   Who is subject to this subpart?
(a) Except for non-covered businesses as defined in § 1.904 and as provided for in paragraph (b) of this section, the requirements of this subpart apply to shippers, receivers, loaders, and carriers engaged in transportation operations whether or not the food is being offered for or enters interstate commerce. The requirements of this subpart apply in addition to any other requirements of this chapter that are applicable to the transportation of food, e.g., in 21 CFR parts 1, 117, 118, 225, 507, and 589.
(b) The requirements of this subpart do not apply to shippers, receivers, loaders, or carriers when they are engaged in transportation operations:
(1) Of food that is transshipped through the United States to another country; or
(2) Of food that is imported for future export, in accordance with section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act, and that is neither consumed nor distributed in the United States; or
(3) Of food when it is located in food facilities as defined in § 1.227 of this chapter, that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ), the Poultry Products Inspection Act (21 U.S.C. 451 et seq. ), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq. ).
§ 1.902   How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act?
(a) The criteria and definitions of this subpart apply in determining whether food is adulterated within the meaning of section 402(i) of the Federal Food, Drug, and Cosmetic Act in that the food has been transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, loader, or receiver engaged in transportation operations under conditions that are not in compliance with this subpart.
(b) The failure by a shipper, carrier by motor vehicle or rail vehicle, loader, or receiver engaged in transportation operations to comply with the requirements of this subpart is a prohibited act under section 301(hh) of the Federal Food, Drug, and Cosmetic Act.
§ 1.904   What definitions apply to this subpart?
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. The following definitions also apply:
Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice.
Animal food means food for animals other than man, and includes pet food, animal feed, and raw materials and ingredients.
Bulk vehicle means a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, or any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle.
Carrier means a person who physically moves food by rail or motor vehicle in commerce within the United States. The term carrier does not include any person who transports food while operating as a parcel delivery service.
Cross-contact means the unintentional incorporation of a food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act into food, except animal food.
Farm has the meaning given in § 1.227 of this chapter.
Food not completely enclosed by a container means any food that is placed into a container in such a manner that it is partially open to the surrounding environment. Examples of such containers include an open wooden basket or crate, an open cardboard box, a vented cardboard box with a top, or a vented plastic bag. This term does not include food transported in a bulk vehicle as defined in this subpart.
Full-time equivalent employee is a term used to represent the number of employees of a business entity for the purpose of determining whether the business is a small business. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours ( i.e., 40 hours x 52 weeks). If the result is not a whole number, round down to the next lowest whole number.
Loader means a person that loads food onto a motor or rail vehicle during transportation operations.
Non-covered business means a shipper, loader, receiver, or carrier engaged in transportation operations that has less than $500,000, as adjusted for inflation, in average annual revenues, calculated on a rolling basis, during the 3-year period preceding the applicable calendar year. For the purpose of determining an entity's 3-year average revenue threshold as adjusted for inflation, the baseline year for calculating the adjustment for inflation is 2011.
Operating temperature means a temperature sufficient to ensure that under foreseeable circumstances of temperature variation during transport, e.g., seasonal conditions, refrigeration unit defrosting, multiple vehicle loading and unloading stops, the operation will meet the requirements of § 1.908(a)(3).
Pest means any objectionable animals or insects including birds, rodents, flies, and larvae.
Receiver means any person who receives food at a point in the United States after transportation, whether or not that person represents the final point of receipt for the food.
Shipper means a person, e.g., the manufacturer or a freight broker, who arranges for the transportation of food in the United States by a carrier or multiple carriers sequentially.
Small business means a business employing fewer than 500 full-time equivalent employees except that for carriers by motor vehicle that are not also shippers and/or receivers, this term would mean a business subject to § 1.900(a) having less than $27,500,000 in annual receipts.
Transportation means any movement of food in by motor vehicle or rail vehicle in commerce within the United States.
Transportation equipment means equipment used in food transportation operations, e.g., bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, loading systems, and unloading systems. Transportation equipment also includes a railcar not attached to a locomotive or a trailer not attached to a tractor.
Transportation operations means all activities associated with food transportation that may affect the sanitary condition of food including cleaning, inspection, maintenance, loading and unloading, and operation of vehicles and transportation equipment. Transportation operations do not include any activities associated with the transportation of food that is completely enclosed by a container except a food that requires temperature control for safety, compressed food gases, food contact substances as defined in section 409(h)(6) of the Federal Food, Drug, and Cosmetic Act, human food byproducts transported for use as animal food without further processing, or live food animals except molluscan shellfish. In addition, transportation operations do not include any transportation activities that are performed by a farm.
Vehicle means a land conveyance that is motorized, e.g., a motor vehicle, or that moves on rails, e.g., a railcar, which is used in transportation operations.
§ 1.906   What requirements apply to vehicles and transportation equipment?
(a) Vehicles and transportation equipment used in transportation operations must be so designed and of such material and workmanship as to be suitable and adequately cleanable for their intended use to prevent the food they transport from becoming unsafe, i.e., adulterated within the meaning of section 402(a)(1), (2), and (4) of the Federal Food, Drug, and Cosmetic Act during transportation operations.
(b) Vehicles and transportation equipment must be maintained in such a sanitary condition for their intended use as to prevent the food they transport from becoming unsafe during transportation operations.
(c) Vehicles and transportation equipment used in transportation operations for food requiring temperature control for safety must be designed, maintained, and equipped as necessary to provide adequate temperature control to prevent the food from becoming unsafe during transportation operations.
(d) Vehicles and transportation equipment must be stored in a manner that prevents it from harboring pests or becoming contaminated in any other manner that could result in food for which it will be used becoming unsafe during transportation operations.
§ 1.908   What requirements apply to transportation operations?
(a) General requirements. (1) Unless stated otherwise in this section, the requirements of this section apply to all shippers, carriers, loaders, and receivers engaged in transportation operations. A person may be subject to these requirements in multiple capacities, e.g., the shipper may also be the loader and the carrier, if the person also performs the functions of those respective persons as defined in this subpart. An entity subject to this subpart (shipper, loader, carrier, or receiver) may reassign, in a written agreement, its responsibilities under this subpart to another party subject to this subpart. The written agreement is subject to the records requirements of § 1.912(d).
(2) Responsibility for ensuring that transportation operations are carried out in compliance with all requirements in this subpart must be assigned to competent supervisory personnel.
(3) All transportation operations must be conducted under such conditions and controls necessary to prevent the food from becoming unsafe during transportation operations including:
(i) Taking effective measures such as segregation, isolation, or the use of packaging to protect food from contamination by raw foods and nonfood items in the same load.
(ii) Taking effective measures such as segregation, isolation, or other protective measures, such as hand washing, to protect food transported in bulk vehicles or food not completely enclosed by a container from contamination and cross-contact during transportation operations.
(iii) Taking effective measures to ensure that food that requires temperature control for safety is transported under adequate temperature control.
(4) The type of food, e.g., animal feed, pet food, human food, and its production stage, e.g., raw material, ingredient or finished food, must be considered in determining the necessary conditions and controls for the transportation operation.
(5) Shippers, receivers, loaders, and carriers, which are under the ownership or operational control of a single legal entity, as an alternative to meeting the requirements of paragraphs (b), (d), and (e) of this section may conduct transportation operations in conformance with common, integrated written procedures that ensure the sanitary transportation of food consistent with the requirements of this section. The written procedures are subject to the records requirements of § 1.912(e).
(6) If a shipper, loader, receiver, or carrier becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the food shall not be sold or otherwise distributed, and these persons must take appropriate action including, as necessary, communication with other parties to ensure that the food is not sold or otherwise distributed unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe.
(b) Requirements applicable to shippers engaged in transportation operations. (1) Unless the shipper takes other measures in accordance with paragraph (b)(3) of this section to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food, i.e., that will prevent the food from becoming unsafe, the shipper must specify to the carrier and, when necessary, the loader, in writing, all necessary sanitary specifications for the carrier's vehicle and transportation equipment to achieve this purpose, including any specific design specifications and cleaning procedures. One-time notification shall be sufficient unless the design requirements and cleaning procedures required for sanitary transport change based upon the type of food being transported, in which case the shipper shall so notify the carrier in writing before the shipment. The information submitted by the shipper to the carrier is subject to the records requirements in § 1.912(a).
(2) Unless the shipper takes other measures in accordance with paragraph (b)(5) of this section to ensure that adequate temperature control is provided during the transportation of food that requires temperature control for safety under the conditions of shipment, a shipper of such food must specify in writing to the carrier, except a carrier who transports the food in a thermally insulated tank, and, when necessary, the loader, an operating temperature for the transportation operation including, if necessary, the pre-cooling phase. One-time notification shall be sufficient unless a factor, e.g., the conditions of shipment, changes, necessitating a change in the operating temperature, in which case the shipper shall so notify the carrier in writing before the shipment. The information submitted by the shipper to the carrier is subject to the records requirements in § 1.912(a).
(3) A shipper must develop and implement written procedures, subject to the records requirements of § 1.912(a), adequate to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of the food, i.e., will prevent the food from becoming unsafe during the transportation operation. Measures to implement these procedures may be accomplished by the shipper or by the carrier or another party covered by this subpart under a written agreement subject to the records requirements of § 1.912(a).
(4) A shipper of food transported in bulk must develop and implement written procedures, subject to the records requirements of § 1.912(a), adequate to ensure that a previous cargo does not make the food unsafe. Measures to ensure the safety of the food may be accomplished by the shipper or by the carrier or another party covered by this subpart under a written agreement subject to the records requirements of § 1.912(a).
(5) The shipper of food that requires temperature control for safety under the conditions of shipment must develop and implement written procedures, subject to the records requirements of § 1.912(a), to ensure that the food is transported under adequate temperature control. Measures to ensure the safety of the food may be accomplished by the shipper or by the carrier or another party covered by this subpart under a written agreement subject to the records requirements of § 1.912(a) and must include measures equivalent to those specified for carriers under paragraphs (e)(1) through (3) of this section.
(c) Requirements applicable to loaders engaged in transportation operations. (1) Before loading food not completely enclosed by a container onto a vehicle or into transportation equipment the loader must determine, considering, as appropriate, specifications provided by the shipper in accordance with paragraph (b)(1) of this section, that the vehicle or transportation equipment is in appropriate sanitary condition for the transport of the food, e.g., it is in adequate physical condition, and free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe during transportation. This may be accomplished by any appropriate means.
(2) Before loading food that requires temperature control for safety, the loader must verify, considering, as appropriate, specifications provided by the shipper in accordance with paragraph (b)(2) of this section, that each mechanically refrigerated cold storage compartment or container is adequately prepared for the transportation of such food, including that it has been properly pre-cooled, if necessary, and meets other sanitary conditions for food transportation.
(d) Requirements applicable to receivers engaged in transportation operations. Upon receipt of food that requires temperature control for safety under the conditions of shipment, the receiver must take steps to adequately assess that the food was not subjected to significant temperature abuse, such as determining the food's temperature, the ambient temperature of the vehicle and its temperature setting, and conducting a sensory inspection, e.g., for off-odors.
(e) Requirements applicable to carriers engaged in transportation operations. When the carrier and shipper have a written agreement that the carrier is responsible, in whole or in part, for sanitary conditions during the transportation operation, the carrier is responsible for the following functions as applicable per the agreement:
(1) A carrier must ensure that vehicles and transportation equipment meet the shipper's specifications and are otherwise appropriate to prevent the food from becoming unsafe during the transportation operation.
(2) A carrier must, once the transportation operation is complete and if requested by the receiver, provide the operating temperature specified by the shipper in accordance with paragraph (b)(2) of this section and, if requested by the shipper or receiver, demonstrate that it has maintained temperature conditions during the transportation operation consistent with the operating temperature specified by the shipper in accordance with paragraph (b)(2) of this section. Such demonstration may be accomplished by any appropriate means agreeable to the carrier and shipper, such as the carrier presenting measurements of the ambient temperature upon loading and unloading or time/temperature data taken during the shipment.
(3) Before offering a vehicle or transportation equipment with an auxiliary refrigeration unit for use for the transportation of food that requires temperature control for safety under the conditions of the shipment during transportation, a carrier must pre-cool each mechanically refrigerated cold storage compartment as specified by the shipper in accordance with paragraph (b)(2) of this section.
(4) If requested by the shipper, a carrier that offers a bulk vehicle for food transportation must provide information to the shipper that identifies the previous cargo transported in the vehicle.
(5) If requested by the shipper, a carrier that offers a bulk vehicle for food transportation must provide information to the shipper that describes the most recent cleaning of the bulk vehicle.
(6) A carrier must develop and implement written procedures subject to the records requirements of § 1.912(b) that:
(i) Specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and transportation equipment that the carrier provides for use in the transportation of food to maintain the vehicles and the transportation equipment in appropriate sanitary condition as required by § 1.906(b);
(ii) Describe how it will comply with the provisions for temperature control in paragraph (e)(2) of this section, and;
(iii) Describe how it will comply with the provisions for the use of bulk vehicles in paragraphs (e)(4) and (5) of this section.
§ 1.910   What training requirements apply to carriers engaged in transportation operations?
(a) When the carrier and shipper have agreed in a written contract that the carrier is responsible, in whole or in part, for the sanitary conditions during transportation operations, the carrier must provide adequate training to personnel engaged in transportation operations that provides an awareness of potential food safety problems that may occur during food transportation, basic sanitary transportation practices to address those potential problems, and the responsibilities of the carrier under this part. The training must be provided upon hiring and as needed thereafter.
(b) Carriers must establish and maintain records documenting the training described in paragraph (a) of this section. Such records must include the date of the training, the type of training, and the person(s) trained. These records are subject to the records requirements of § 1.912(c).
§ 1.912   What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?
(a) Shippers must retain records:
(1) That demonstrate that they provide specifications and operating temperatures to carriers as required by § 1.908(b)(1) and (2) as a regular part of their transportation operations for a period of 12 months beyond the termination of the agreements with the carriers.
(2) Of written agreements and the written procedures required by § 1.908(b)(3), (4), and (5), for a period of 12 months beyond when the agreements and procedures are in use in their transportation operations.
(b) Carriers must retain records of the written procedures required by § 1.908(e)(6) for a period of 12 months beyond when the agreements and procedures are in use in their transportation operations.
(c) Carriers must retain training records required by § 1.910(b) for a period of 12 months beyond when the person identified in any such records stops performing the duties for which the training was provided.
(d) Any person subject to this subpart must retain any other written agreements assigning tasks in compliance with this subpart for a period of 12 months beyond the termination of the agreements.
(e) Shippers, receivers, loaders, and carriers, which operate under the ownership or control of a single legal entity in accordance with the provisions of § 1.908(a)(5), must retain records of the written procedures for a period of 12 months beyond when the procedures are in use in their transportation operations.
(f) Shippers, receivers, loaders, and carriers must make all records required by this subpart available to a duly authorized individual promptly upon oral or written request.
(g) All records required by this subpart must be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records.
(h) Records that are established or maintained to satisfy the requirements of this subpart and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.
(i) Except for the written procedures required by § 1.908(e)(6)(i), offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. The written procedures required by § 1.908(e)(6)(i) must remain onsite as long as the procedures are in use in transportation operations. Electronic records are considered to be onsite if they are accessible from an onsite location.
(j) All records required by this subpart are subject to the disclosure requirements under part 20 of this chapter.
§ 1.914   Under what circumstances will we waive a requirement of this subpart?
We will waive any requirement of this subpart with respect to any class of persons, vehicles, food, or nonfood products, when we determine that:
(a) The waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health; and
(b) The waiver will not be contrary to the public interest.
§ 1.916   When will we consider whether to waive a requirement of this subpart?
We will consider whether to waive a requirement of this subpart on our own initiative or on the petition submitted under § 10.30 of this chapter by any person who is subject to the requirements of this subpart with respect to any class of persons, vehicles, food, or nonfood products.
§ 1.918   What must be included in the Statement of Grounds in a petition requesting a waiver?
In addition to the requirements set forth in § 10.30 of this chapter, the Statement of Grounds in a petition requesting a waiver must:
(a) Describe with particularity the waiver requested, including the persons, vehicles, food, or nonfood product(s) to which the waiver would apply and the requirement(s) of this subpart to which the waiver would apply; and
(b) Present information demonstrating that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and will not be contrary to the public interest.
§ 1.920   What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available?
We will presume that information submitted in a petition requesting a waiver and comments submitted on such a petition does not contain information exempt from public disclosure under part 20 of this chapter and would be made public as part of the docket associated with this request.
§ 1.922   Who will respond to a petition requesting a waiver?
The Director or Deputy Directors of the Center for Food Safety and Applied Nutrition (CFSAN) or the Center for Veterinary Medicine (CVM), or the Director, Office of Compliance, CFSAN, or the Director, Office of Surveillance and Compliance, CVM, will respond to a petition requesting a waiver.
§ 1.924   What process applies to a petition requesting a waiver?
(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a petition requesting a waiver.
(b) Under § 10.30(h)(3) of this chapter, we will publish a notice in the Federal Register, requesting information and views on a filed petition, including information and views from persons who could be affected by the waiver if the petition were to be granted.
(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing.
(1) If we grant the petition, either in whole or in part, we will publish a notice in the Federal Register setting forth any waiver and the reasons for such waiver.
(2) If we deny the petition (including partial denials), our written response to the petitioner will explain the reason(s) for the denial.
(d) We will make readily accessible to the public, and periodically update, a list of filed petitions requesting waivers, including the status of each petition (for example, pending, granted, or denied).
§ 1.926   Under what circumstances may we deny a petition requesting a waiver?
We may deny a petition requesting a waiver if the petition does not provide the information required under § 1.918 (including the requirements of § 10.30 of this chapter), or if we determine that the waiver could result in the transportation of food under conditions that would be unsafe for human or animal health, or that the waiver could be contrary to the public interest.
§ 1.928   What process will we follow when waiving a requirement of this subpart on our own initiative?
If we, on our own initiative, determine that a waiver is appropriate, we will publish a notice in the Federal Register setting forth the waiver and the reasons for such waiver.
§ 1.930   When will a waiver that we grant become effective?
Any waiver that we grant will become effective on the date that notice of the waiver is published in the Federal Register .
§ 1.932   Under what circumstances may we modify or revoke a waiver?
We may modify or revoke a waiver if we determine that the waiver could result in the transportation of food under conditions that would be unsafe for human or animal health or that the waiver could be contrary to the public interest.
§ 1.934   What procedures apply if we determine that a waiver should be modified or revoked?
(a) We will provide the following notifications:
(1) We will notify the entity that initially requested the waiver, in writing at the address identified in its petition, if we determine that a waiver granted in response to its petition should be modified or revoked.
(2) We will publish a notice of our determination that a waiver should be modified or revoked in the Federal Register. This notice will establish a public docket so that interested parties may submit written submissions on our determination.
(b) We will consider timely written submissions submitted to the public docket from interested parties.
(c) We will publish a notice of our decision in the Federal Register. The effective date of the decision will be the date of publication of the notice.
§ 1.980   Administrative detention of drugs.
(a) General. This section sets forth the procedures for detention of drugs believed to be adulterated or misbranded. Administrative detention is intended to protect the public by preventing distribution or use of drugs encountered during inspections that may be adulterated or misbranded, until the Food and Drug Administration (FDA) has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate. Drugs that FDA orders detained may not be used, moved, altered, or tampered with in any manner by any person during the detention period, except as authorized under paragraph (h) of this section, until FDA terminates the detention order under paragraph (j) of this section, or the detention period expires, whichever occurs first.
(b) Criteria for ordering detention. Administrative detention of drugs may be ordered in accordance with this section when an authorized FDA representative, during an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act, has reason to believe that a drug, as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act, is adulterated or misbranded.

(c) Detention period. The detention is to be for a reasonable period that may not exceed 20 calendar days after the detention order is issued, unless the FDA Division Director in whose division the drugs are located determines that a greater period is required to seize the drugs, to institute injunction proceedings, or to evaluate the need for legal action, in which case the Division Director may authorize detention for 10 additional calendar days. The additional 10-calendar-day detention period may be ordered at the time the detention order is issued or at any time thereafter. The entire detention period may not exceed 30 calendar days, except when the detention period is extended under paragraph (g)(6) of this section. An authorized FDA representative may, in accordance with paragraph (j) of this section, terminate a detention before the expiration of the detention period.
(d) Issuance of detention order. (1) The detention order must be issued in writing, in the form of a detention notice, signed by the authorized FDA representative who has reason to believe that the drugs are adulterated or misbranded, and issued to the owner, operator, or agent in charge of the place where the drugs are located. If the owner or the user of the drugs is different from the owner, operator, or agent in charge of the place where the drugs are detained, a copy of the detention order must be provided to the owner or user of the drugs if the owner's or user's identity can be readily determined.
(2) If detention of drugs in a vehicle or other carrier is ordered, a copy of the detention order must be provided to the shipper of record and the owner of the vehicle or other carrier, if their identities can be readily determined.
(3) The detention order must include the following information:
(i) A statement that the drugs identified in the order are detained for the period shown;
(ii) A brief, general statement of the reasons for the detention;
(iii) The location of the drugs;
(iv) A statement that these drugs are not to be used, moved, altered, or tampered with in any manner during that period, except as permitted under paragraph (h) of this section, without the written permission of an authorized FDA representative;
(v) Identification of the detained drugs;
(vi) The detention order number;
(vii) The date and hour of the detention order;
(viii) The period of the detention;
(ix) The text of section 304(g) of the Federal Food, Drug, and Cosmetic Act and paragraphs (g)(1) and (g)(2) of this section;
(x) A statement that any informal hearing on an appeal of a detention order must be conducted as a regulatory hearing under part 16 of this chapter, with certain exceptions described in paragraph (g)(3) of this section; and

(xi) The mailing address, telephone number, and name of the FDA Division Director.
(e) Approval of detention order. A detention order, before issuance, must be approved by the FDA Division Director in whose division the drugs are located. If prior written approval is not feasible, prior oral approval must be obtained and confirmed by written memorandum within FDA as soon as possible.
(f) Labeling or marking a detained drug. An FDA representative issuing a detention order under paragraph (d) of this section must label or mark the drugs with official FDA tags that include the following information:
(1) A statement that the drugs are detained by the U.S. Government in accordance with section 304(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334(g)).
(2) A statement that the drugs must not be used, moved, altered, or tampered with in any manner for the period shown, without the written permission of an authorized FDA representative, except as authorized in paragraph (h) of this section.
(3) A statement that the violation of a detention order or the removal or alteration of the tag is punishable by fine or imprisonment or both (section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333)).
(4) The detention order number, the date and hour of the detention order, the detention period, and the name of the FDA representative who issued the detention order.
(g) Appeal of a detention order. (1) A person who would be entitled to claim the drugs, if seized, may appeal a detention order. Any appeal must be submitted in writing to the FDA Division Director in whose division the drugs are located within 5 working days of receipt of a detention order. If the appeal includes a request for an informal hearing, as defined in section 201(x) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(x)), the appellant must request either that a hearing be held within 5 working days after the appeal is filed or that the hearing be held at a later date, which must not be later than 20 calendar days after receipt of a detention order.
(2) The appellant of a detention order must state the ownership or proprietary interest the appellant has in the detained drugs. If the detained drugs are located at a place other than an establishment owned or operated by the appellant, the appellant must include documents showing that the appellant would have legitimate authority to claim the drugs if seized.
(3) Any informal hearing on an appeal of a detention order must be conducted as a regulatory hearing under regulation in accordance with part 16 of this chapter, except that:
(i) The detention order under paragraph (d) of this section, rather than the notice under § 16.22(a) of this chapter, provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter;
(ii) A request for a hearing under this section should be addressed to the FDA Division Director;
(iii) The last sentence of § 16.24(e) of this chapter, stating that a hearing may not be required to be held at a time less than 2 working days after receipt of the request for a hearing, does not apply to a hearing under this section;
(iv) Paragraph (g)(4) of this section, rather than § 16.42(a) of this chapter, describes the FDA employees who preside at hearings under this section.
(4) The presiding officer of a regulatory hearing on an appeal of a detention order, who also must decide the appeal, must be an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA Division Director who is permitted by § 16.42(a) of this chapter to preside over the hearing.
(5) If the appellant requests a regulatory hearing and requests that the hearing be held within 5 working days after the appeal is filed, the presiding officer must, within 5 working days, hold the hearing and render a decision affirming or revoking the detention.
(6) If the appellant requests a regulatory hearing and requests that the hearing be held at a date later than within 5 working days after the appeal is filed, but not later than 20 calendar days after receipt of a detention order, the presiding officer must hold the hearing at a date agreed upon by FDA and the appellant. The presiding officer must decide whether to affirm or revoke the detention within 5 working days after the conclusion of the hearing. The detention period extends to the date of the decision even if the 5-working-day period for making the decision extends beyond the otherwise applicable 20-calendar-day or 30-calendar-day detention period.
(7) If the appellant appeals the detention order but does not request a regulatory hearing, the presiding officer must render a decision on the appeal, affirming or revoking the detention within 5 working days after the filing of the appeal.
(8) If the presiding officer affirms a detention order, the drugs continue to be detained until FDA terminates the detention under paragraph (j) of this section or the detention period expires, whichever occurs first.
(9) If the presiding officer revokes a detention order, FDA must terminate the detention under paragraph (j) of this section.
(h) Movement of detained drugs. (1) Except as provided in this paragraph, no person may move detained drugs within or from the place where they have been ordered detained until FDA terminates the detention under paragraph (j) of this section or the detention period expires, whichever occurs first.
(2) If detained drugs are not in final form for shipment, the manufacturer may move them within the establishment where they are detained to complete the work needed to put them in final form. As soon as the drugs are moved for the purpose in the preceding sentence, the individual responsible for their movement must orally notify the FDA representative who issued the detention order, or another responsible division office official, of the movement of the drugs. As soon as the drugs are put in final form, they must be segregated from other drugs, and the individual responsible for their movement must orally notify the FDA representative who issued the detention order, or another responsible division office official, of their new location. The drugs put in final form must not be moved further without FDA approval.
(3) The FDA representative who issued the detention order, or another responsible division office official, may approve, in writing, the movement of detained drugs for any of the following purposes:
(i) To prevent interference with an establishment's operations or harm to the drugs;
(ii) To destroy the drugs;
(iii) To bring the drugs into compliance;
(iv) For any other purpose that the FDA representative who issued the detention order, or other responsible division office official, believes is appropriate in the case.
(4) If an FDA representative approves the movement of detained drugs under paragraph (h)(3) of this section, the detained drugs must remain segregated from other drugs and the person responsible for their movement must immediately orally notify the official who approved the movement of the drugs, or another responsible FDA division office official, of the new location of the detained drugs.
(5) Unless otherwise permitted by the FDA representative who is notified of, or who approves, the movement of drugs under this paragraph, the required tags must accompany the drugs during and after movement and must remain with the drugs until FDA terminates the detention or the detention period expires, whichever occurs first.
(i) Actions involving adulterated or misbranded drugs. If FDA determines that the detained drugs, including any that have been put in final form, are adulterated or misbranded, or both, it may initiate legal action against the drugs or the responsible individuals, or both, or request that the drugs be destroyed or otherwise brought into compliance with the Federal Food, Drug, and Cosmetic Act under FDA's supervision.
(j) Detention termination. If FDA decides to terminate a detention or when the detention period expires, whichever occurs first, an FDA representative authorized to terminate a detention will issue a detention termination notice releasing the drugs to any person who received the original detention order or that person's representative and will remove, or authorize in writing the removal of, the required labels or tags.
(k) Recordkeeping requirements. (1) After issuance of a detention order under paragraph (d) of this section, the owner, operator, or agent in charge of any factory, warehouse, other establishment, or consulting laboratory where detained drugs are manufactured, processed, packed, or held, must have, or establish, and maintain adequate records relating to how the detained drugs may have become adulterated or misbranded, records on any distribution of the drugs before and after the detention period, records on the correlation of any in-process detained drugs that are put in final form under paragraph (h) of this section to the completed drugs, records of any changes in, or processing of, the drugs permitted under the detention order, and records of any other movement under paragraph (h) of this section. Records required under this paragraph must be provided to FDA on request for review and copying. Any FDA request for access to records required under this paragraph must be made at a reasonable time, must state the reason or purpose for the request, and must identify to the fullest extent practicable the information or type of information sought in the records to which access is requested.
(2) Records required under this paragraph must be maintained for a maximum period of 2 years after the issuance of the detention order or for such other shorter period as FDA directs. When FDA terminates the detention or when the detention period expires, whichever occurs first, FDA will advise all persons required under this paragraph to keep records concerning that detention whether further recordkeeping is required for the remainder of the 2-year, or shorter, period. FDA ordinarily will not require further recordkeeping if the Agency determines that the drugs are not adulterated or misbranded or that recordkeeping is not necessary to protect the public health, unless the records are required under other regulations in this chapter (e.g., the good manufacturing practice regulation in part 211 of this chapter).
§ 1.1101   What documents are incorporated by reference in this subpart
(a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration's Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and is available from the source listed elsewhere in this section. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
(b) International Organization for Standardization (ISO), Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01 11, https://www.iso.org/home.html.
(1) ISO/IEC 17011:2017(E), Conformity assessment—Requirements for accreditation bodies accrediting conformity assessment bodies, Second edition, November 2017, IBR approved for §§ 1.1113(a) and (c), 1.1114(b), 1.1120(c), 1.1131(a).
(2) ISO/IEC 17025:2017(E), General requirements for the competence of testing and calibration laboratories, Third edition, November 2017, IBR approved for §§ 1.1120(c), 1.1121(a), 1.1138(a), 1.1139(b) and (c), 1.1141(a), 1.1152(a) and (d), 1.1153(c), and 1.1161(a).
§ 1.1102   What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart, unless otherwise specified. For the purposes of this subpart, the following definitions also apply:
Analyst means an individual who analyzes samples.
Corrective action means an action taken by an accreditation body or laboratory to investigate and eliminate the cause of a deficiency so that it does not recur.
Directed food laboratory order means an order issued by FDA under § 1.1108 requiring food testing to be conducted under this subpart by or on behalf of an owner or consignee.
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.S.C. 136(u)).
Food testing and testing of food means the analysis of food product samples or environmental samples.
Laboratory accreditation for analyses of foods (LAAF)-accreditation means a determination by a recognized accreditation body that a laboratory meets the applicable requirements of this subpart to conduct food testing under this subpart using one or more methods of analysis.
LAAF-accredited laboratory means a laboratory that a recognized accreditation body has determined meets the applicable requirements of this subpart and has been LAAF-accredited to conduct food testing under this subpart using one or more methods of analysis.
Owner or consignee means any person with an ownership or consignment interest in the food product or environment that is the subject of food testing conducted under § 1.1107(a).
Recognition means a determination by FDA that an accreditation body meets the applicable requirements of this subpart and is authorized to LAAF-accredit laboratories under this subpart.
Recognized accreditation body means an accreditation body that FDA has determined meets the applicable requirements of this subpart and is authorized to LAAF-accredit laboratories under this subpart.
Representative sample means a sample that accurately, to a statistically acceptable degree, represents the characteristics and qualities of the food product or environment from which the sample was collected.
Sampler means an individual who collects samples.
Sampling firm means an entity that provides sampling services.
Scope of LAAF-accreditation refers to the methods of analysis for which the laboratory is LAAF-accredited.
Street address means the full physical address, including the country. For purposes of this rule, a post office box number alone is insufficient; however, a post office box number may be provided in addition to the street address.
§ 1.1103   Who is subject to this subpart?
(a) Accreditation bodies. An accreditation body is subject to this subpart if it has been or is seeking to be recognized by FDA to LAAF-accredit laboratories to conduct food testing under this subpart.
(b) Laboratories. A laboratory is subject to this subpart if it has been or is seeking to be LAAF-accredited by a recognized accreditation body to conduct food testing under this subpart.
(c) Owners and consignees. An owner or consignee is subject to this subpart if it is required to use a LAAF-accredited laboratory to conduct food testing under this subpart.
§ 1.1107   When must food testing be conducted under this subpart?
(a) Food testing must be conducted under this subpart whenever such testing is conducted by or on behalf of an owner or consignee:
(1) In response to explicit testing requirements that address an identified or suspected food safety problem, which are contained in the following provisions:
(i) Sprouts. Section 112.146(a), (c), and (d) of this chapter;
(ii) Shell eggs. Sections 118.4(a)(2)(iii), 118.5(a)(2)(ii) and (b)(2)(ii), and 118.6(a)(2) and (e) of this chapter; and
(iii) Bottled drinking water. Section 129.35(a)(3)(i) of this chapter (for the requirement to test five samples from the same sampling site that originally tested positive for Escherichia coli );
(2) As required by FDA in a directed food laboratory order issued under § 1.1108;
(3) To address an identified or suspected food safety problem and presented to FDA as part of evidence for a hearing under section 423(c) of the Federal Food, Drug, and Cosmetic Act prior to the issuance of a mandatory food recall order, as part of a corrective action plan under section 415(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order under section 304(h)(4)(A) of the Federal Food, Drug, and Cosmetic Act.
(4) In support of admission of an article of food under section 801(a) of the Federal Food, Drug, and Cosmetic Act; and
(5) To support removal from an import alert through successful consecutive testing.
(b) When food testing is conducted under paragraph (a) of this section, analysis of samples must be conducted by a laboratory that is LAAF-accredited for the appropriate analytical method by a recognized accreditation body under this subpart.
(c) Food testing conducted on articles of food offered for import into the United States under section 801(a) of the Federal Food, Drug, and Cosmetic Act pursuant to paragraph (a)(4) or (a)(5) of this section may only be conducted after the articles offered for import have arrived in the United States unless the owner or consignee has written approval from FDA that a sample taken prior to arrival is or would be a representative sample of the article offered for import into the United States.
§ 1.1108   When and how will FDA issue a directed food laboratory order?
(a) FDA may require the owner or consignee to conduct food testing, or to have food testing conducted on their behalf, under this subpart to address an identified or suspected food safety problem, as FDA deems appropriate.
(b) The directed food laboratory order will specify the food product or environment to be tested; whether the food testing may be conducted using a LAAF-accredited laboratory that is owned, operated, or controlled by the owner or consignee; the timeframe in which the food testing must be conducted; and the manner of the food testing, such as the methods that must be used.
(c) The directed food laboratory order will contain all the elements required by § 16.22(a) of this chapter and will thereby constitute the notice of an opportunity for hearing under part 16 of this chapter. An affected owner or consignee may request a regulatory hearing on a directed food laboratory order pursuant to § 1.1174.
§ 1.1109   How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?
FDA will place on its website a publicly available registry listing of:
(a) Recognized accreditation bodies, including for each: the name, contact information, and duration of recognition of the recognized accreditation body;
(b) Accreditation bodies that have a change in recognition, including for each: the name of the accreditation body, the specific change in recognition ( i.e., probation, revocation of recognition, denial of renewal of recognition, relinquishment of recognition, or expiration of recognition) and the effective date of the change;
(c) LAAF-accredited laboratories, including for each: the name, contact information, and scope of LAAF-accreditation, and the name and contact information of the recognized accreditation body that has LAAF-accredited the laboratory; and
(d) Laboratories that have a change in LAAF-accreditation, including for each: the name of the laboratory, the specific change in LAAF-accreditation ( i.e., suspension, reduction of scope, or withdrawal of LAAF-accreditation by the recognized accreditation body, probation or disqualification by FDA, or relinquishment of LAAF-accreditation), and the effective date of the change.
§ 1.1110   What are the general requirements for submitting information to FDA under this subpart?
(a) All applications, reports, notifications, and records submitted to FDA under this subpart must be submitted electronically and in English unless otherwise specified. If FDA requests inspection or submission of records that are maintained in any language other than English, the recognized accreditation body or LAAF-accredited laboratory must provide an English translation within a reasonable time.
(b) A program applicant must provide any translation and interpretation services needed by FDA during the processing of the application, including during any onsite assessments of the applicant by FDA.
§ 1.1113   What are the eligibility requirements for a recognized accreditation body?
A recognized accreditation body or an accreditation body seeking recognition must meet all of the following requirements:
(a) Demonstrates compliance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101).
(b) Demonstrates that it is a full member of the International Laboratory Accreditation Cooperative (ILAC).
(c) Demonstrates that it is a signatory to the ILAC Mutual Recognition Arrangement (MRA) that has demonstrated competence to ISO/IEC 17011:2017(E) with a scope of “Testing: ISO/IEC 17025.”
(d) Will comply with all additional requirements for recognized accreditation bodies under this subpart while recognized.
§ 1.1114   How does an accreditation body apply to FDA for recognition or renewal of recognition?
(a) Application for recognition or renewal of recognition. An accreditation body seeking initial recognition or renewal of recognition must submit an application to FDA demonstrating that it meets the eligibility requirements in § 1.1113.
(b) Documentation of conformance with requirements. The accreditation body must submit documentation of conformance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) and separate documentation of ILAC membership and ILAC MRA signatory status demonstrating competence to ISO/IEC 17011:2017(E) with a scope of “Testing: ISO/IEC 17025,” in meeting the requirements of § 1.1113(a) through (c). The accreditation body also must submit documentation of its compliance with § 1.1113(d).
(c) Signature. An application for recognition or renewal of recognition must be signed in the manner designated by FDA by an individual authorized to act on behalf of the applicant for purposes of seeking recognition or renewal of recognition.
§ 1.1115   How will FDA evaluate applications for recognition and renewal of recognition?
(a) Review of application for recognition or renewal of recognition. FDA will review an accreditation body's application for recognition or renewal of recognition for completeness and notify the applicant of any insufficiencies. FDA generally will review accreditation body applications for recognition or renewal of recognition in the order in which completed applications are received; however, FDA may prioritize the review of specific applications to meet program needs.
(b) Evaluation of application for recognition or renewal of recognition. FDA will evaluate a complete application for recognition or renewal of recognition to determine whether the applicant meets the requirements for recognition. Such evaluation may include an onsite evaluation of the accreditation body. If FDA does not reach a final decision on an application for renewal of recognition before an accreditation body's recognition expires, FDA may extend the existing term of recognition for a specified period of time or until FDA reaches a final decision on the application for renewal of recognition.
(c) Grant of recognition. FDA will notify the applicant that its application for recognition or renewal of recognition has been approved and will include any conditions associated with the recognition.
(d) Duration of recognition. FDA may grant recognition of an accreditation body for a period not to exceed 5 years from the date of recognition, except under the circumstances described in paragraph (b) of this section.
(e) Denial of application for recognition or renewal of recognition. FDA will notify the applicant that its application for recognition or renewal of recognition has been denied and will state the basis for such denial and describe the procedures for requesting reconsideration of the application under § 1.1171.
(f) Notice of records custodian after denial of an application for renewal of recognition. Within 10 business days of the date of FDA's issuance of a denial of an application for renewal of recognition, the applicant must provide the name and contact information of the custodian who will maintain required records and make them available to FDA under § 1.1124. The contact information must include an email address for the records custodian and the street address where the records required under § 1.1124 will be located.
(g) FDA notice to LAAF-accredited laboratories. FDA will promptly notify all laboratories LAAF-accredited by the accreditation body whose application for renewal of recognition was denied, informing them of such denial.
(h) Public notice of denial of an application for renewal of recognition of an accreditation body. FDA will provide public notice on the website described in § 1.1109 of the issuance of a denial of an application for renewal of recognition and will include the date of the issuance of such denial.
§ 1.1116   What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?
(a) Notice to FDA of intent to relinquish or not to renew recognition. At least 60 calendar days before voluntarily relinquishing its recognition or before allowing its recognition to expire without seeking renewal, a recognized accreditation body must notify FDA of its intention to leave the program, specifying the date on which the relinquishment or expiration will occur. The recognized accreditation body must provide the name and contact information of the custodian who will maintain and make available to FDA the records required by §  1.1124 after the date of relinquishment or the date recognition expires, as applicable. The contact information must include an email address for the records custodian and the street address where the records required under §  1.1124 will be located.
(b) Notice to LAAF-accredited laboratories of intent to relinquish or not to renew recognition. At least 60 calendar days before voluntarily relinquishing its recognition or before allowing its recognition to expire without seeking renewal, a recognized accreditation body must notify the laboratories it LAAF accredits of its intention to leave the program, specifying the date on which relinquishment or expiration will occur.
(c) Public notice of voluntary relinquishment or expiration of recognition. FDA will provide notice on the website described in §  1.1109 of the voluntary relinquishment or expiration of recognition of an accreditation body.
§ 1.1117   How may an accreditation body request reinstatement of recognition?
(a) Application following revocation of recognition. An accreditation body that has had its recognition revoked by FDA (as described in § 1.1131) may seek reinstatement by submitting a new application for recognition under §  1.1114. The accreditation body must also submit evidence to FDA with its application to demonstrate that the issues resulting in revocation of recognition have been resolved, including evidence addressing the cause or condition of the grounds for revocation of recognition. The evidence also must identify measures that have been implemented to help ensure that such cause or condition is unlikely to recur.
(b) Application following relinquishment or expiration of recognition. An accreditation body that previously relinquished its recognition or allowed its recognition to expire (as described in § 1.1116) may seek reinstatement by submitting a new application for recognition under §  1.1114.
§ 1.1119   What are the conflict of interest requirements for a recognized accreditation body?
(a) In addition to meeting the impartiality and conflict of interest requirements of § 1.1113(a), a recognized accreditation body must:
(1) Ensure that the recognized accreditation body (and its officers, employees, or other agents involved in LAAF-accreditation activities) does not own or have a financial interest in, manage, or otherwise control any laboratory (or any affiliate, parent, or subsidiary) it LAAF-accredits, subject to the exceptions in paragraphs (c) and (d) of this section; and
(2) Prohibit, subject to the exceptions in paragraph (e) of this section, officers, employees, or other agents involved in LAAF-accreditation activities of the recognized accreditation body from accepting any money, gift, gratuity, or other item of value from any laboratory the recognized accreditation body LAAF-accredits or assesses for LAAF-accreditation.
(b) The financial interests of any children younger than 18 years of age or a spouse of a recognized accreditation body's officers, employees, and other agents involved in LAAF-accreditation activities are considered the financial interests of such officers, employees, and other agents involved in LAAF-accreditation activities.
(c) An accreditation body (and its officers, employees, or other agents involved in LAAF-accreditation activities) may have an interest in a publicly traded or publicly available investment fund ( e.g., a mutual fund), or a widely held pension or similar fund if the accreditation body (and its officers, employees, or other agents involved in LAAF-accreditation activities) neither exercises control nor has the ability to exercise control over the financial interests held in the fund.
(d) A recognized accreditation body's agent that is a contract assessor will be permitted to own or have a financial interest in, manage, or otherwise control a LAAF-accredited laboratory if all of the following circumstances apply:
(1) The contract assessor's primary occupation is owning or having a financial interest in, managing, or otherwise controlling a LAAF-accredited laboratory;
(2) The assessor contracts with the recognized accreditation body to provide assessment services on an intermittent or part-time basis;
(3) The contract assessor does not assess the LAAF-accredited laboratory that the assessor owns or has a financial interest in, manages, or otherwise controls; and
(4) The contract assessor and the recognized accreditation body inform any laboratory that the contract assessor may assess or reassess for LAAF-accreditation that the contract assessor owns or has a financial interest in, manages, or otherwise controls a LAAF-accredited laboratory. The laboratory seeking LAAF-accreditation assessment or reassessment must acknowledge that the contract assessor owns or has a financial interest in, manages, or otherwise controls a LAAF-accredited laboratory and be provided the option to be assessed by a different representative of the recognized accreditation body.
(e) The prohibited items of value specified in paragraph (a)(2) of this section do not include:
(1) Money representing payment of fees for LAAF-accreditation services or reimbursement of direct costs associated with an onsite assessment or reassessment of the laboratory; or
(2) Meal of de minimis value provided during the course of an assessment or reassessment and on the premises where the assessment or reassessment is conducted, if necessary for the efficient conduct of the assessment or reassessment.
§ 1.1120   How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
(a) A recognized accreditation body must conduct an initial assessment of a laboratory seeking LAAF-accreditation in accordance with the requirements of this subpart, to determine whether the laboratory meets the requirements of § 1.1138.
(b) Subject to the exception in paragraph (c) of this section, the initial assessment must be conducted onsite, although certain assessment activities may be conducted remotely if it will not aid the assessment to conduct them onsite.
(c) If, within the previous 2 years, the recognized accreditation body conducted an onsite assessment of the laboratory in accordance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) to assess whether the laboratory meets the requirements of ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101), then the initial assessment under this section:
(1) May be conducted remotely, and
(2) Need only address whether the laboratory meets the requirements of § 1.1138(a)(2) and (3) and (b).
(d) A recognized accreditation body must oversee the performance of a laboratory it LAAF-accredits in accordance with the requirements of § 1.1113(a), except as otherwise provided by this subpart, to determine whether the LAAF-accredited laboratory continues to meet the applicable requirements of this subpart.
(e) A recognized accreditation body must conduct a reassessment of a LAAF-accredited laboratory in accordance with this subpart at least every 2 years. Such reassessment must be conducted onsite, although certain reassessment activities may be conducted remotely if it will not aid in the reassessment to conduct the activities onsite.
(f) If the recognized accreditation body conducted the initial assessment of the LAAF-accredited laboratory remotely in accordance with paragraph (c) of this section, the recognized accreditation body must conduct its first reassessment of the LAAF-accredited laboratory no later than 2 years after the recognized accreditation body last conducted an onsite assessment of the laboratory.
(g) The reassessment at the end of the LAAF-accredited laboratory's ISO/IEC 17025:2017-accreditation cycle, which the recognized accreditation body must conduct in accordance with this subpart, must be conducted onsite, although certain reassessment activities may be conducted remotely if it will not aid the reassessment to conduct them onsite.
(h) Any assessments or reassessments conducted by a recognized accreditation body in addition to the assessments or reassessments referred to in paragraphs (a), (e), and (g) of this section may be conducted remotely if it will not aid the assessment or reassessment to conduct it onsite.
§ 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?
(a) Corrective action. A recognized accreditation body may require corrective action using the procedures described by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 8.7 to address any deficiencies identified while assessing and overseeing a LAAF-accredited laboratory.
(1) The recognized accreditation body must notify the LAAF-accredited laboratory of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the LAAF-accredited laboratory to submit a corrective action plan and timeframe for implementation to the recognized accreditation body for approval.
(2) The LAAF-accredited laboratory must implement appropriate corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit the results of the corrective action to the recognized accreditation body.
(3) The recognized accreditation body will review the corrective action and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
(b) Suspension. If a recognized accreditation body determines that a laboratory it LAAF-accredits has not effectively implemented corrective action or otherwise fails to address deficiencies identified, the recognized accreditation body may temporarily suspend the LAAF-accredited laboratory for one or more LAAF-accredited methods, and require corrective action under paragraph (a) of this section.
(1) The recognized accreditation body must notify the LAAF-accredited laboratory of the grounds for the suspension, the LAAF-accredited methods subject to the suspension, and all deficiencies that must be addressed via the process described in paragraph (a) of this section.
(2) The recognized accreditation body must notify FDA of the suspension under this section in accordance with the requirements of § 1.1123(d)(5). FDA will provide notice of the LAAF-accredited laboratory's suspension on the website described in § 1.1109.
(3) The recognized accreditation body will review the corrective action required under paragraph (b) of this section and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
(4) A LAAF-accredited laboratory shall remain suspended until it demonstrates to the recognized accreditation body's satisfaction that the LAAF-accredited laboratory has successfully implemented appropriate corrective action.
(5) If the recognized accreditation body determines that a LAAF-accredited laboratory on suspension has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, the recognized accreditation body may reduce the scope of or withdraw the LAAF-accreditation of the laboratory under paragraph (c) of this section.
(c) Reduction of scope or withdrawal of LAAF-accreditation. A recognized accreditation body must reduce the scope of or withdraw the LAAF-accreditation of a laboratory it LAAF-accredits when the laboratory substantially fails to comply with this subpart. When only certain methods within the laboratory's scope of LAAF-accreditation are affected by the noncompliance, the recognized accreditation body may reduce the scope of the laboratory's LAAF-accreditation for only those affected methods. If all methods are affected, the recognized accreditation body must withdraw the laboratory's LAAF-accreditation.
(d) Procedures for reduction of scope or withdrawal of LAAF-accreditation. (1) The recognized accreditation body must notify the laboratory of any reduction of scope or withdrawal of LAAF-accreditation, including:
(i) The grounds for the reduction of scope or withdrawal of LAAF-accreditation;
(ii) The method(s) to which the reduction of scope applies;
(iii) The procedures for appealing the reduction of scope or withdrawal of LAAF-accreditation as described in § 1.1122; and
(iv) The date the reduction of scope or withdrawal of LAAF-accreditation is effective.
(2) The recognized accreditation body must notify FDA of the reduction of scope or withdrawal of LAAF-accreditation under this section in accordance with the requirements in § 1.1123(d)(4). FDA will provide notice of the reduction of scope or withdrawal of the laboratory's LAAF-accreditation on the website described in § 1.1109.
(e) Records request associated with suspension, reduction of scope, or withdrawal of LAAF-accreditation. To assist the recognized accreditation body in determining whether a suspension, reduction of scope, or withdrawal of LAAF-accreditation is warranted under this section, the recognized accreditation body may require the submission of records that the LAAF-accredited laboratory is required to maintain under § 1.1154.
(f) Consequences of suspension, reduction of scope, or withdrawal of LAAF-accreditation. (1) A LAAF-accredited laboratory may not conduct food testing under this subpart using suspended methods.
(2) If the recognized accreditation body withdraws the laboratory's LAAF-accreditation, the laboratory is immediately ineligible to conduct any food testing under this subpart. If the recognized accreditation body reduces the laboratory's scope of LAAF-accreditation, the laboratory is immediately ineligible to use the methods to which the reduction of scope applies to conduct food testing under this subpart.
§ 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?
A recognized accreditation body must consider a laboratory's appeal regarding a decision to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation in accordance with the requirements of § 1.1113(a). Appeals must be reviewed and decided by a competent person(s) free from bias or prejudice who has not participated in the LAAF-accreditation decision and is not the subordinate of a person who participated in the LAAF-accreditation decision. For the purposes of appeals, the competent person(s) may be external to the recognized accreditation body.
§ 1.1123   What reports, notifications, and documentation must a recognized accreditation body submit to FDA?
(a) General requirements. All reports and notifications required by this section must include:
(1) The name, street address, telephone number, and email address of the recognized accreditation body associated with the report or notification, and the name of an appropriate point of contact for the recognized accreditation body, and
(2) If the report or notification concerns a LAAF-accredited laboratory, the name, street address, telephone number, and email address of the LAAF-accredited laboratory, and the name of an appropriate point of contact for the LAAF-accredited laboratory.
(b) Internal audit reports. A recognized accreditation body must submit to FDA a report of the results of the internal audit conducted pursuant to § 1.1125 within 45 calendar days of completing the audit. The audit report must include:
(1) A description of the internal audit conducted;
(2) A description of any identified deficiencies;
(3) A description of any corrective action taken or planned, including the timeline for such corrective action; and
(4) A statement disclosing the extent to which the internal audit was conducted by personnel different from those who perform the activity or activities that were audited.
(c) Changes affecting recognition. A recognized accreditation body must notify FDA within 48 hours when the recognized accreditation body is aware of a change that would affect the recognition of such accreditation body, and the notification must include:
(1) A description of the change, and
(2) If the change is one made by the recognized accreditation body, an explanation of the purpose of the change.
(d) Changes in LAAF-accreditation. A recognized accreditation body must notify FDA and submit a certificate reflecting the scope of accreditation within 48 hours when any of the following occur:
(1) The recognized accreditation body grants or extends LAAF-accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation requested by the laboratory,
(ii) The scope of LAAF-accreditation granted, and
(iii) The effective date of the grant or extension;
(2) The recognized accreditation body denies LAAF-accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation requested by the laboratory,
(ii) The scope of LAAF-accreditation denied, and
(iii) The grounds for the denial;
(3) The recognized accreditation body receives notice that a laboratory it LAAF-accredits intends to relinquish its LAAF-accreditation and the laboratory has not provided notice to FDA 60 calendar days prior to relinquishment as required under § 1.1140. The recognized accreditation body's notification must include:
(i) The scope of LAAF-accreditation to which the relinquishment applies, as applicable, and
(ii) The effective date of the relinquishment;
(4) The recognized accreditation body reduces the scope of or withdraws the LAAF-accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation to which the reduction applies,
(ii) The grounds for the reduction of scope or withdrawal, and
(iii) The effective date of the reduction of scope or withdrawal;
(5) The recognized accreditation body suspends or lifts the suspension of a LAAF-accredited laboratory, and the notification must include:
(i) The scope of LAAF-accreditation to which the suspension applies,
(ii) The grounds for the suspension or for lifting the suspension, and
(iii) The effective date of the suspension or date the suspension is lifted.
(e) Laboratory fraud. A recognized accreditation body must notify FDA within 48 hours if the recognized accreditation body knows that a laboratory it LAAF-accredits has committed fraud or submitted material false statements to FDA, and the notification must include:
(1) A description of the basis for the recognized accreditation body's knowledge of the fraud or material false statements,
(2) A description of the fraud or material false statements, and
(3) The action(s) taken by the recognized accreditation body with respect to such LAAF-accredited laboratory.
§ 1.1124   What are the records requirements for a recognized accreditation body?
(a) In addition to meeting the requirements of § 1.1113(a) related to records, a recognized accreditation body must maintain, for 5 years after the date of creation of the records, records created while it is recognized demonstrating its compliance with this subpart, including records relating to:
(1) Applications for LAAF-accreditation;
(2) Assessments, reassessments, and decisions to grant, extend the scope of, renew, deny, reduce the scope of, or withdraw LAAF-accreditation or to suspend or lift the suspension of a LAAF-accredited laboratory;
(3) Appeals of suspensions, denials, reductions of scope of, and withdrawals of LAAF-accreditation, final decisions on such appeals, and the bases for such final decisions;
(4) Its oversight of laboratories it has LAAF-accredited;
(5) Its oversight of its own performance, including all records related to internal audits, complaints, and corrective actions;
(6) Any reports or notifications required to be submitted to FDA under § 1.1123, including any supporting information;
(7) Records of fee payments and reimbursement of direct costs; and
(8) Any documents demonstrating compliance with the requirements for assessment activities by contract assessors with certain financial interests described in § 1.1119(d).
(b) A recognized accreditation body must make the records it is required to maintain by paragraph (a) of this section available for inspection and copying or for electronic submission upon written request of an authorized officer or employee of FDA. If FDA requests records for inspection and copying, the recognized accreditation body must make such records promptly available at the physical location of the recognized accreditation body or at another reasonably accessible location. If FDA requests electronic submission, the records must be submitted within 10 business days of the request.
(c) A recognized accreditation body must not prevent or interfere with FDA's access to the records the LAAF-accredited laboratories it LAAF-accredits are required to maintain under § 1.1154.
§ 1.1125   What are the internal audit requirements for a recognized accreditation body?
As part of the internal audit a recognized accreditation body is required to conduct pursuant to § 1.1113(a), the recognized accreditation body must audit its compliance with the requirements of § 1.1113(d).
§ 1.1130   How will FDA oversee recognized accreditation bodies?
(a) FDA will evaluate each recognized accreditation body to determine its compliance with the applicable requirements of this subpart no later than:
(1) Year 4 of a 5-year recognition period; or
(2) The midpoint of a recognition period less than 5 years.
(b) An FDA evaluation of a recognized accreditation body may include review of records, an onsite evaluation of the accreditation body, and onsite reviews of one or more LAAF-accredited laboratories the recognized accreditation body LAAF-accredits, with or without the recognized accreditation body present. Certain evaluation activities may be conducted remotely if it will not aid in the evaluation to conduct them onsite.
(c) FDA may conduct additional evaluations of a recognized accreditation body at any time to determine whether the recognized accreditation body complies with the applicable requirements of this subpart.
§ 1.1131   When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?
(a) Corrective action. FDA may require corrective action to address any deficiencies identified while evaluating a recognized accreditation body under this subpart.
(1) FDA will notify the recognized accreditation body of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the recognized accreditation body to submit a corrective action plan and timeframe for implementation to FDA for approval.
(2) The recognized accreditation body must handle FDA's notification as a complaint under ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) section 7.12, implement appropriate corrective action under ISO/IEC 17011:2017(E) section 9.5, and submit both the results of the complaint investigation and subsequent corrective action to FDA.
(3) FDA will review the corrective action and will notify the recognized accreditation body whether the corrective action is acceptable.
(b) Probation. If FDA determines that a recognized accreditation body has not effectively implemented corrective action or otherwise fails to address deficiencies identified, FDA may put the recognized accreditation body on probation and require corrective action under paragraph (a) of this section.
(1) FDA will notify the recognized accreditation body of the grounds for the probation and all deficiencies requiring corrective action via the process described in paragraph (a) of this section.
(2) FDA will notify all laboratories LAAF-accredited by the recognized accreditation body that the recognized accreditation body is on probation and will provide notice of the probation on the website described in § 1.1109.
(3) FDA will review the corrective action and will notify the recognized accreditation body whether the corrective action is acceptable.
(4) A recognized accreditation body shall remain on probation until the recognized accreditation body demonstrates to FDA's satisfaction that it has successfully implemented appropriate corrective action.
(5) If FDA determines that a recognized accreditation body on probation has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, FDA may revoke recognition of the recognized accreditation body under paragraph (c) of this section.
(c) Revocation of recognition. FDA will revoke the recognition of an accreditation body if it fails to meet the requirements of this subpart, if FDA determines the accreditation body has committed fraud or submitted material false statements to FDA, or if FDA determines that a recognized accreditation body on probation has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified.
(d) Revocation of recognition procedures. (1) FDA will issue a notice of revocation of recognition to the recognized accreditation body that will include the grounds for revocation, the date on which revocation is effective, the procedures for requesting a regulatory hearing on the revocation under § 1.1173, and the procedures for requesting reinstatement of recognition under § 1.1117.
(2) FDA will notify all laboratories LAAF-accredited by the recognized accreditation body that recognition has been revoked and will provide notice of the revocation of recognition of an accreditation body on the website described in §  1.1109.
(3) Within 10 business days of the date of issuance of revocation, the accreditation body must provide the name and contact information of the custodian who will maintain records and make them available to FDA as required by § 1.1124. The contact information must include an email address for the records custodian and the street address where the records required by § 1.1124 will be located.
(e) Effect of probation or revocation of recognition on the accreditation body. (1) A recognized accreditation body that is put on probation by FDA must continue to oversee laboratories that it has LAAF-accredited under this subpart and may continue to LAAF-accredit laboratories under § 1.1120.
(2) An accreditation body that has had its recognition revoked by FDA may not LAAF-accredit laboratories under this subpart or continue to oversee the laboratories it has previously LAAF-accredited while the accreditation body is not recognized.
§ 1.1138   What are the eligibility requirements for a LAAF-accredited laboratory?
(a) A laboratory that is LAAF-accredited or seeking LAAF-accreditation must demonstrate it is capable of conducting each method of food testing for which it is or will be LAAF-accredited by meeting all of the following requirements:
(1) For each method, the laboratory is accredited by a recognized accreditation body to ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101).
(2)(i) Except as provided in paragraph (a)(2)(ii) of this section, the laboratory has successfully passed a proficiency test provided by a competent proficiency testing organization within the last 12 months for each method within the scope of LAAF-accreditation.
(ii) If the laboratory determines there is no proficiency testing program available or practicable for a method, it may use a comparison program. A laboratory must request approval from the recognized accreditation body regarding the determination prior to using a comparison program in lieu of an annual proficiency test. The laboratory is required to demonstrate competency through participation in the comparison program.
(iii) A laboratory must submit all proficiency test and comparison program results, regardless of outcome, to the recognized accreditation body within 30 calendar days of receipt.
(3) The laboratory ensures that its procedures for monitoring the validity of the results of testing it conducts under this subpart include the use of reference materials or quality control samples with each batch of samples it tests under this subpart.
(b) Will comply with all additional requirements for LAAF-accredited laboratories under this subpart while LAAF-accredited.
§ 1.1139   How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
(a) Application for LAAF-accreditation. A laboratory seeking LAAF-accreditation or extension of its scope of LAAF-accreditation must submit its application for LAAF-accreditation to a recognized accreditation body identified on the website described in § 1.1109. The recognized accreditation body will review and assess the application in accordance with the requirements of this subpart. If the laboratory seeking LAAF-accreditation had its LAAF-accreditation withdrawn or one or more methods within its scope of LAAF-accreditation reduced by a recognized accreditation body or has been previously disqualified by FDA, the laboratory must meet the additional requirements specified by § 1.1142(a).
(b) Documentation of conformance with ISO/IEC 17025:2017(E). The laboratory may use documentation of conformance with ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101), as applicable and supplemented as necessary, in meeting the applicable requirements of this subpart.
(c) Duration of accreditation. If a LAAF-accredited laboratory maintains compliance with all requirements of this subpart, including accreditation to ISO/IEC 17025:2017(E), the laboratory's LAAF-accreditation will not end until reduced in scope, withdrawn, relinquished, or the laboratory is disqualified, under this subpart.
§ 1.1140   What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?
(a) Notice to FDA and the recognized accreditation body of intent to relinquish. A LAAF-accredited laboratory must notify FDA and its recognized accreditation body at least 60 calendar days before voluntarily relinquishing LAAF-accreditation or any method within the scope of LAAF-accreditation. The notice must include the date on which relinquishment will occur. If the laboratory will relinquish all methods within its scope of LAAF-accreditation, the notification must also include the name and contact information of the custodian who will maintain the records required by § 1.1154 after the date of relinquishment. The contact information for the records custodian must include an email address and the street address where the records required by § 1.1154 will be located.
(b) Public notice of voluntary relinquishment of accreditation. FDA will provide notice on the website described in § 1.1109 of the voluntary relinquishment of LAAF-accreditation of a laboratory.
§ 1.1141   What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?
If a recognized accreditation body has its application for renewal of recognition denied, relinquishes its recognition or allows its recognition to expire, or has its recognition revoked, any laboratory LAAF-accredited by the accreditation body must take either the actions in paragraph (a) of this section or the action in paragraph (b) of this section no later than 30 calendar days after receiving the notice to the LAAF-accredited laboratory required under § 1.1115(g), § 1.1116(b), or § 1.1131(d)(2):
(a)(1) The LAAF-accredited laboratory must submit to FDA documentation of the LAAF-accredited laboratory's most recent internal audit, required under § 1.1154(a)(5), documentation showing compliance with the conflict of interest requirements in § 1.1147, and documentation of the most recent proficiency test or comparison program result for each test method within the laboratory's scope of LAAF-accreditation, to show compliance with § 1.1138(a)(2); and
(2) The laboratory must become LAAF-accredited by another recognized accreditation body before the laboratory's ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) accreditation lapses or not later than 1 year after the LAAF-accredited laboratory receives the applicable notice under § 1.1115(g), § 1.1116(b), or § 1.1131(d)(2), whichever is sooner.
(b) The LAAF-accredited laboratory initiates relinquishment of its LAAF-accreditation under § 1.1140, with the relinquishment to occur within 90 calendar days.
§ 1.1142   How does a laboratory request reinstatement of LAAF-accreditation?
(a) Application following reduction of scope or withdrawal of LAAF-accreditation by a recognized accreditation body or disqualification by FDA. A laboratory that has had any methods within its scope of LAAF-accreditation reduced or has had its LAAF-accreditation withdrawn by a recognized accreditation body or that has been disqualified by FDA may seek reinstatement of LAAF-accreditation by submitting a new application for LAAF-accreditation to a recognized accreditation body under § 1.1139. The laboratory must also:
(1) Notify FDA prior to submitting a new application for LAAF-accreditation to the recognized accreditation body, including in the notification the name of the laboratory, contact information for the laboratory, the name of the recognized accreditation body to which the laboratory will be submitting the application, and the date that the laboratory expects to submit the new application for LAAF-accreditation; and
(2) Demonstrate, to the satisfaction of the recognized accreditation body to which it is submitting the new application, that the grounds for the reduction of scope or withdrawal of LAAF-accreditation or disqualification have been resolved and that the laboratory has implemented measures to prevent such grounds from recurring.
(b) Application following voluntary relinquishment of LAAF-accreditation. A laboratory that voluntarily relinquished any methods within the scope of its LAAF-accreditation pursuant to § 1.1140, may seek reaccreditation by submitting a new application for LAAF-accreditation to a recognized accreditation body under § 1.1139.
§ 1.1147   What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?
(a) In addition to the impartiality and conflict of interest requirements in § 1.1138(a)(1), a LAAF-accredited laboratory must, subject to the exceptions in paragraph (b) of this section, prohibit the LAAF-accredited laboratory's employees, contractors, and agents involved in food testing under this subpart and related activities from accepting any money, gift, gratuity, or other item of value from the owner or consignee of the food that is being tested or will be tested by the LAAF-accredited laboratory.
(b) The prohibited items of value in paragraph (a) of this section do not include:
(1) Payment of fees for food testing under this subpart and related services;
(2) Reimbursement of direct costs associated with the food testing by the LAAF-accredited laboratory; and
(3) With respect to a LAAF-accredited laboratory that is owned by the owner or consignee of the food that is or will be tested, payment of the officer's, employee's, contractor's, or agent's compensation in the normal course of business.
(c) The LAAF-accredited laboratory must require the owner's or consignee's payment to the LAAF-accredited laboratory of fees for food testing services and reimbursement of direct costs associated with food testing to be independent of the outcome of the test results.
§ 1.1149   What oversight standards apply to sampling?
(a) Documents. Before analyzing a sample, the LAAF-accredited laboratory must develop (if it collected the sample) or obtain (if another firm collected the sample) the following information to be submitted with test results (see § 1.1152(c)):
(1) Written documentation of the sampler's applicable qualifications by training and experience. A LAAF-accredited laboratory only needs to develop or obtain documentation of a sampler's qualifications the first time that sampler collects a sample for the LAAF-accredited laboratory under this subpart. If a LAAF-accredited laboratory has previously submitted the sampler's qualifications to FDA under § 1.1152(c), the LAAF-accredited laboratory may refer to its previously submitted qualifications.
(2) The written sampling plan used to conduct the sampling. The written sampling plan must identify the sampler and sampling firm and must list factors that will be controlled to ensure the sampling does not impact the validity of the subsequent analytical testing, including controlling for the representational nature of the sample; and
(3) A written sample collection report for each sample collected. The written sample collection report must include:
(i) The product code of the food product (if product is being sampled) or the location and a description of the environment (if environment is being sampled);
(ii) The date of the sampling;
(iii) The lot number, size, identity, and quantity of the sample;
(iv) Documentation of sample collection procedures and any sample preparation techniques; and
(v) Documentation of the chain of custody of the sample and of measures taken to ensure the validity of the subsequent analytical testing, including controlling for the representational nature of the sample.
(b) Potential consequences. If any of the requirements in paragraph (a) of this section is not met, FDA may consider the analysis of the sample to be invalid.
(c) Advance notice of sampling. (1) If FDA determines that sampling conducted may materially differ from the sampling documented in the associated sampling plan or sample collection report, or if FDA determines that the sampling otherwise may have been improper, FDA may require the LAAF-accredited laboratory that analyzed the associated sample, and other LAAF-accredited laboratories that have analyzed samples previously collected by the sampling firm, to obtain from the sampling firm, and submit, or require the sampling firm to submit, an advance notice of sampling. The advance notice of sampling must be submitted to FDA at least 48 hours before each of the next 10 occasions that the sampling firm will collect a sample that the LAAF-accredited laboratory will analyze under this subpart.
(2) FDA may, as appropriate:
(i) Specify that the requirement applies to samples collected by a particular sampler;
(ii) Specify the type of food product or environment that requires advance notice of sampling under this subpart;
(iii) Determine that an amount of time other than 48 hours in advance is required, from a minimum of 24 hours up to 7 business days in advance;
(iv) Determine that a number of occasions other than 10 is required, from a minimum of 1 occasion to a maximum of 20 occasions;
(v) Notify affected LAAF-accredited laboratories that submission of additional notices of sampling are not required; and
(vi) Notify the owner or consignee that the advance notice applies to sampling for food testing being conducted on their behalf.
(3) The advance notice of sampling must contain:
(i) A unique identification for the advance notice of sampling;
(ii) The name of the LAAF-accredited laboratory that will conduct analysis of the sample;
(iii) The name and street address of the sampling firm that will conduct the sampling;
(iv) A primary contact (name and phone number) for the sampling firm;
(v) The reason why the food product or environment will be sampled;
(vi) The location of the food product or environment that will be sampled, including sufficient information to identify the food product or environment to be sampled;
(vii) As applicable, the U.S. Customs and Border Protection entry and line number;
(viii) The product code of the food product (if product is being sampled) or the location and a description of the environment (if environment is being sampled); and
(ix) The date and approximate time the sampling will begin.
§ 1.1150   What are the requirements for analysis of samples by a LAAF-accredited laboratory?
In addition to the sample analysis requirements of § 1.1138(a):
(a) The analysis must be conducted on either the sample received from the sampling firm or, if appropriate, on a representative sample of the sample received from the sampling firm.
(b) The analyst must:
(1) Be qualified by appropriate education, training, and/or experience to conduct the analysis;
(2) Have appropriately demonstrated their ability to perform the method properly in the specific context of the food testing to be conducted; and
(3) Be in compliance with the conflict of interest requirements of §§ 1.1138(a) and 1.1147.
(c) The method used to conduct the food testing must meet the requirements of § 1.1151.
(d) The LAAF-accredited laboratory must document the testing information and test results to the extent necessary to account for all information that is required to be included in a full analytical report ( see § 1.1152(d)).
§ 1.1151   What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?
In addition to the requirements of § 1.1138(a), a LAAF-accredited laboratory must meet the following requirements:
(a) The method of analysis used to conduct food testing under this subpart must be:
(1) Fit for purpose;
(2) Within the laboratory's scope of LAAF-accreditation;
(3) Appropriately validated for use in such food testing, in accordance with paragraph (c) of this section; and
(4) Appropriately verified by the LAAF-accredited laboratory for use in such food testing, in accordance with paragraph (d) of this section.
(b) Food testing must be conducted using the specified method:
(1) Under § 1.1107(a)(1), if the Federal Food, Drug, and Cosmetic Act or implementing regulations prescribe a test method.
(2) Under § 1.1107(a)(2), if the directed food laboratory order prescribes a test method.
(c)(1) A LAAF-accredited laboratory must validate methods in accordance with the requirements of § 1.1138(a).
(2) A LAAF-accredited laboratory performing validation of a method under this subpart must record the information required by § 1.1138(a) and the supporting analytical data.
(d)(1) Before a LAAF-accredited laboratory conducts food testing under this subpart using a method for a specific intended use for which the method has been validated, but for which the LAAF-accredited laboratory has not previously applied the method under this subpart, the LAAF-accredited laboratory must have verified it can properly perform the method for the specific intended use.
(2) A LAAF-accredited laboratory performing verification of a method under this subpart must record the method that is the subject of the verification, the intended purpose of the analysis, the results of the verification, the procedure used for the verification, supporting analytical data, and whether the LAAF-accredited laboratory is able to properly perform the method.
(e) A LAAF-accredited laboratory may submit a written request to FDA requesting permission to use a method outside of its scope of LAAF-accreditation for food testing. FDA may approve the request if both following conditions are satisfied:
(1) A new method or methodology has been developed and validated but no reasonably available laboratory has been LAAF-accredited to perform such method or methodology, and
(2) The use of such method is necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak.
§ 1.1152   What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
(a) General requirements. (1) All notifications, results, reports, and studies required to be submitted to FDA by a LAAF-accredited laboratory under this subpart must:
(i) Include the name and street address of the LAAF-accredited laboratory;
(ii) Identify a point of contact for the LAAF-accredited laboratory, including email and telephone number, whom FDA may contact with questions or comments;
(iii) Display an identification unique to the test results, report, notification, or study; and
(iv) Be true, accurate, unambiguous, and objective.
(2) The LAAF-accredited laboratory that conducts the analysis of the sample under this subpart is responsible for the submission of all notifications, results, reports, and studies to FDA as required by this section.
(3) If the LAAF-accredited laboratory becomes aware that any aspect of the submitted material is inaccurate, the LAAF-accredited laboratory must immediately inform FDA and submit a corrected version. Such corrections must meet the requirements for amendments to reports specified by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 7.8.8.
(4) Any opinions and interpretations in any notification, result, report, or study submitted to FDA under this subpart must meet the requirements in ISO/IEC 17025:2017(E) section 7.8.7 and any statements of conformity to a specification or standard in any notification, result, report, or study submitted to FDA under this subpart must meet the requirements of ISO/IEC 17025:2017(E) section 7.8.6.
(b) Test results. (1) The LAAF-accredited laboratory must submit the results of all testing required to be conducted under this subpart directly to FDA via the location specified by the website described in § 1.1109, unless another location is specified by FDA regarding testing conducted under § 1.1107(a)(2) or (3).
(2) The test results must be clear and identify:
(i) The name and street address of the owner or consignee for which the testing was conducted,
(ii) As appropriate, the U.S. Customs and Border Protection entry and line number(s), and
(iii) The associated notifications, reports, and studies required to be submitted with the test results under this subpart.
(c) Documentation required to be submitted with test results. The following documentation must be included with each full analytical report (see paragraph (d) of this section) and each abridged analytical report (see § 1.1153) submitted to FDA under this subpart:
(1) All sampling plans and sample collection reports related to the food testing conducted as developed or obtained by the LAAF-accredited laboratory in accordance with § 1.1149;
(2) Written documentation of the sampler's qualifications or an indication that the sampler's qualifications have been submitted previously, in accordance with § 1.1149(a)(1);
(3) For any validation studies required by § 1.1151(c)(1), the documentation required by § 1.1151(c)(2);
(4) For any verification studies required by § 1.1151(d)(1), the documentation required by § 1.1151(d)(2);
(5) The justification for any modification to or deviation from the method(s) of analysis used and documentation of the LAAF-accredited laboratory's authorization for the modification or deviation; and
(6) A certification from one or more members of the LAAF-accredited laboratory's management certifying that the test results, notifications, reports, and studies are true and accurate; and that the documentation includes the results of all tests conducted under this subpart. The certification must include the name, title, and signature of any certifiers.
(d) Full analytical report contents. In addition to the documentation required to be submitted with all test results (see paragraph (c) of this section), a full analytical report must include:
(1) All information described by ISO/IEC 17025:2017(E) sections 7.8.2.1(a) through (p) and 7.8.3.1(a) through (d);
(2) Documentation of references for the method of analysis used;
(3) Name and signature of the analyst who conducted each analytical step, including any applicable validation and verification steps, and the date each step was performed;
(4) Calculations, presented in a legible and logical manner;
(5) As applicable, references to chromatograms, charts, graphs, observations, photographs of thin layer chromatographic plates, and spectra. References must be in color when appropriate and presented in a clear order;
(6) Identification of the source and purity of reference standards used, and, as applicable: Certified reference materials, certified reference cultures traceable to a nationally or internationally recognized type culture collection (including concentration, units, preparation, and storage conditions), and reference standard preparation information (including who prepared the reference standard, date of preparation, expiration date, chemical balance, and solvent used);
(7) A copy of the label from any immediate container sampled, if available, and any additional labeling needed to evaluate the product;
(8) All original compilations of raw data secured in the course of the analysis, including discarded, unused, or re-worked data, with the justification for discarding or re-working such data, corresponding supporting data, and quality control results (including the expected result and whether it is acceptable), all identified with unique sample identification, date, and time, associated with the test;
(9) Any other relevant additional supporting information such as the storage location of analyzed samples, appropriate attachments such as instrument printouts, computer generated charts and data sheets, and photocopies or original labels for the product analyzed;
(10) Identification of any software used;
(11) Any certificate of analysis for standards and software; and
(12) The following information about the qualifications of each analyst involved in the analysis conducted under this subpart, if the LAAF-accredited laboratory has not previously submitted documentation of the analyst's qualifications to FDA or the analyst's qualifications have significantly changed since the LAAF-accredited laboratory last submitted documentation of the analyst's qualifications to FDA:
(i) The analyst's curriculum vitae;
(ii) Training records for the applicable methods that the analyst is qualified to perform, including the dates of such training and the name of the trainer or training provider; and
(iii) Any other documentation of the analyst's ability to perform the method properly in the context of the food testing to be conducted, pursuant to § 1.1150(b).
(e) Additional information about non-standard methods. If the LAAF-accredited laboratory conducts the analysis using a method that is not published in a reputable international or national standard or that is otherwise not publicly and readily available, upon request by FDA the LAAF-accredited laboratory must submit documentation of the method to FDA.
(f) Immediate notification of significant changes. The LAAF-accredited laboratory must notify FDA and the recognized accreditation body that LAAF-accredited the laboratory of changes that affect the LAAF-accreditation of the laboratory within 48 hours, including a detailed description of such changes, and an explanation of how such changes affect the LAAF-accreditation of the laboratory. LAAF-accredited laboratories are not required to notify FDA of changes that a recognized accreditation body must provide to FDA under § 1.1123(d).
(g) Consequence of omission. If FDA does not receive all information required to be submitted to FDA under this section, FDA may consider the related food testing to be invalid.
§ 1.1153   What are the requirements for submitting abridged analytical reports?
(a) Requesting permission. A LAAF-accredited laboratory may request permission to submit abridged analytical reports for each major food testing discipline: Biological, chemical, and physical.
(1) FDA will grant permission to submit abridged analytical reports for a single major food testing discipline if all of the following conditions are met:
(i) The LAAF-accredited laboratory is not on suspension or probation for any method within the major food testing discipline that is the subject of its request (see § 1.1121(b) or § 1.1161(b));
(ii) The LAAF-accredited laboratory has successfully implemented any required corrective action under § 1.1121(a) or § 1.1161(a); and
(iii) The last five full analytical reports for the major food testing discipline contain no shortcomings that call into question the validity of the test results or repeated administrative errors.
(2) FDA will notify the LAAF-accredited laboratory if permission is granted or denied.
(b) FDA review of abridged analytical reports. (1) FDA will review all abridged analytical reports submitted.
(2) FDA will notify the LAAF-accredited laboratory if FDA identifies a shortcoming that calls into question the validity of the test results or repeated administrative errors, will require corrective action under § 1.1161(a), and may revoke permission to submit abridged analytical reports for the specific major food testing discipline.
(3) If FDA identifies a shortcoming that calls into question the validity of the test results or repeated administrative errors in abridged analytical reports from a LAAF-accredited laboratory that has previously had its permission to submit abridged analytical reports revoked for any major food testing discipline, FDA may put the LAAF-accredited laboratory on probation for one or more methods under § 1.1161(b). Under § 1.1162(a), a laboratory on probation for one or more methods may not submit abridged analytical reports for the major food testing disciplines of which the probationary methods are a part.
(4) A LAAF-accredited laboratory that has had permission to submit abridged analytical reports revoked for one or more major food testing disciplines may request permission to submit abridged analytical reports as described in paragraph (a) of this section for each major food testing discipline.
(c) Contents of abridged analytical reports. In addition to the documentation required to be submitted with all test results (see § 1.1152(c)), an abridged analytical report must include:
(1) All information described by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) sections 7.8.2.1(a) through (p) and 7.8.3.1(a) through (d); and
(2) Quality control results (including the expected result and whether it is acceptable).
(d) Exceptions. FDA may require additional documentation or a full analytical report from a LAAF-accredited laboratory permitted to submit abridged analytical reports in the following circumstances:
(1) FDA may require a full analytical report related to an FDA investigation or FDA enforcement proceeding.
(2) Occasionally, for the purposes of auditing abridged analytical reports and otherwise protecting the public health and the integrity of this food testing program, FDA will require additional documentation or a full analytical report within 72 hours of FDA's request.
(e) Consequence of omission. If FDA does not receive all information required to be submitted to FDA under paragraph (c) of this section, FDA may consider the related food testing to be invalid.
§ 1.1154   What other records requirements must a LAAF-accredited laboratory meet?
(a) In addition to the records requirements of § 1.1138(a), a LAAF-accredited laboratory must maintain, for 5 years after the date of creation, records created and received while it is LAAF-accredited that relate to compliance with this subpart, including:
(1) Documents related to the LAAF-accredited laboratory's grant of LAAF-accreditation (and, if applicable, extensions and reductions of scope of LAAF-accreditation) from its recognized accreditation body, including all required proficiency test and comparison program records for each method within the scope of LAAF-accreditation under § 1.1138(a)(2);
(2) Documentation of food testing the LAAF-accredited laboratory conducted under this subpart sufficient to account for all information required by § 1.1152(d), in accordance with § 1.1150(d);
(3) All documents that the LAAF-accredited laboratory was required to submit to FDA under §§ 1.1152 and 1.1153, and associated correspondence between the LAAF-accredited laboratory (and its officers, employees, and other agents) and the owner or consignee (and its officers, employees, and other agents) regarding food testing under this subpart;
(4) All requests for food testing from an owner or consignee that would be conducted under this subpart;
(5) Documentation of any internal investigations, internal audits, and corrective action taken to address any problems or deficiencies related to activities under this subpart;
(6) All documentation related to suspension, probation, reduction of scope, or withdrawal of LAAF-accreditation, or laboratory disqualification under this subpart; and
(7) Documentation of changes to its management system or food testing activities that may affect its compliance with this subpart.
(b) Make the records required by paragraph (a) of this section available for inspection and copying or for electronic submission upon written request of an authorized officer or employee of FDA. If FDA requests records for inspection and copying, the laboratory must make such records promptly available at the physical location of the laboratory or at another reasonably accessible location. If the authorized officer or employee of FDA requests electronic submission, the records must be submitted within 10 business days of the request.
(c) Ensure that significant amendments to records described by this section can be tracked to previous and original versions. If such a significant amendment is made, both the original document and amended document must be maintained by the LAAF-accredited laboratory during the time period for which the amended document must be maintained under this subpart. The laboratory must also document the date of amendment, the personnel responsible for the amendment, and a conspicuous indication on the original document stating that the document has been altered and that a more recent version of the document exists.
§ 1.1159   How will FDA oversee LAAF-accredited laboratories?
(a) FDA may review the performance of LAAF-accredited laboratories at any time to determine whether the LAAF-accredited laboratory continues to comply with the applicable requirements of this subpart and whether there are deficiencies in the performance of the LAAF-accredited laboratory that, if not corrected, would warrant corrective action, probation, or disqualification under § 1.1161.
(b) In evaluating the performance of a LAAF-accredited laboratory, FDA may review any of the following:
(1) Records the LAAF-accredited laboratory is required to maintain under this subpart;
(2) Records the recognized accreditation body that LAAF-accredited the laboratory is required to maintain under this subpart;
(3) Information obtained by FDA during a review of the LAAF-accredited laboratory conducted pursuant to paragraph (c) of this section;
(4) Information obtained by FDA during an evaluation of the recognized accreditation body that LAAF-accredits the laboratory;
(5) Analytical reports and test results submitted to FDA; and
(6) Any other information obtained by FDA, including during FDA's inspections or investigations of one or more owners or consignees.
(c) FDA may conduct an onsite review of a LAAF-accredited laboratory at any reasonable time, with or without a recognized accreditation body (or its officers, employees, and other agents) present, to review the performance of a LAAF-accredited laboratory under this subpart. Certain review activities may be conducted remotely if it will not aid in the review to conduct them onsite.
(d) FDA may report any observations and deficiencies identified during its review of LAAF-accredited laboratory performance under this subpart to the recognized accreditation body.
§ 1.1160   How will FDA review test results and analytical reports?
(a) If FDA finds that any test result, analytical report, related documents, or the associated analysis contains deficiencies or otherwise indicates that any aspect of the food testing is not being conducted in compliance with this subpart, FDA will notify the LAAF-accredited laboratory that submitted the analytical report of any deficiency and may:
(1) Require the laboratory to correct the test result, analytical report, related documents, or the associated analysis;
(2) Revoke permission to submit abridged reports for that major food testing discipline under § 1.1153(b);
(3) Require a corrective action under § 1.1161(a);
(4) Consider the analysis to be invalid; and/or
(5) Notify the owner or consignee of the deficiency.
(b) FDA may report any deficiencies identified during its review of any test results, reports, and related documents under this subpart to the recognized accreditation body that LAAF-accredits the laboratory.
(c) Nothing in this subpart shall be construed to limit the ability of FDA to review and act on information received about food testing, including determining the sufficiency of such information and testing.
§ 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?
(a) Corrective action. FDA may require corrective action to address any deficiencies identified while reviewing a LAAF-accredited laboratory's performance under this subpart.
(1) FDA will notify the LAAF-accredited laboratory of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the LAAF-accredited laboratory to submit a corrective action plan and timeframe for implementation to FDA for approval.
(2) The LAAF-accredited laboratory must handle FDA's notification as a complaint under ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 7.9, implement appropriate corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit both the results of the complaint investigation and subsequent corrective action to FDA.
(3) FDA will review the corrective action and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
(b) Probation. If FDA determines that a LAAF-accredited laboratory has not effectively implemented corrective action or otherwise fails to address deficiencies identified, FDA may put the LAAF-accredited laboratory on probation for one or more methods and require corrective action under paragraph (a) of this section.
(1) FDA will notify the LAAF-accredited laboratory and its recognized accreditation body of the grounds for the probation, the method(s) covered by the probation, and all deficiencies requiring corrective action via the process described in paragraph (a) of this section.
(2) FDA will provide notice of a LAAF-accredited laboratory's probation on the website described in § 1.1109.
(3) FDA will review the corrective action and will notify the LAAF-accredited laboratory and its recognized accreditation body whether the corrective action is acceptable.
(4) A LAAF-accredited laboratory will remain on probation until the LAAF-accredited laboratory demonstrates to FDA's satisfaction that it has successfully implemented appropriate corrective action.
(5) If FDA determines that a LAAF-accredited laboratory on probation has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, FDA may disqualify the LAAF-accredited laboratory under paragraph (c) of this section.
(c) Disqualification. FDA may disqualify a LAAF-accredited laboratory from submitting analytical reports under this subpart for one or more methods for good cause, which may include any of the following reasons:
(1) Deliberate falsification of analytical reports, testing results, or other records submitted to FDA.
(2) Failure of a LAAF-accredited laboratory on probation to effectively implement corrective action or otherwise address identified deficiencies.
(3) Other failure to substantially comply with this subpart where the laboratory's recognized accreditation body has not reduced the scope of or withdrawn LAAF-accreditation of the laboratory.
(d) Disqualification procedures. (1) FDA will issue a notice of disqualification to a LAAF-accredited laboratory and its recognized accreditation body, which will include:
(i) The grounds for disqualification;
(ii) The method or methods to which the disqualification applies;
(iii) The date the disqualification will be effective;
(iv) The procedures for requesting a regulatory hearing on the disqualification under § 1.1173; and
(v) The procedures for requesting reinstatement after disqualification under § 1.1142.
(2) FDA will provide notice of a LAAF-accredited laboratory's disqualification on the website described in § 1.1109.
§ 1.1162   What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?
(a) A LAAF-accredited laboratory that FDA has put on probation for one or more methods is permitted to continue to conduct food testing under this subpart; however, a LAAF-accredited laboratory that is on probation for one or more methods is not permitted to submit abridged analytical reports for the major food testing discipline of which the probationary methods are part.
(b) If FDA disqualifies a LAAF-accredited laboratory for all methods within its scope of LAAF-accreditation, the laboratory is immediately ineligible to conduct food testing under this subpart. If FDA disqualifies a LAAF-accredited laboratory for specific methods within the scope of LAAF-accreditation, the laboratory is immediately ineligible to use the methods for which the laboratory has been disqualified to conduct food testing under this subpart.
(c) With respect to food testing conducted by the laboratory prior to its disqualification, FDA may refuse to consider results and associated reports of food testing conducted under this subpart if the basis for the disqualification of the laboratory indicates that the specific food testing conducted by the laboratory may not be reliable.
(d) Within 10 business days of the date of issuance of disqualification, the laboratory must provide the name and email address of the custodian who will maintain and make available to FDA the records required by § 1.1154, and the street address where the records will be located.
(e) Within 10 business days of the date of issuance of a notice of probation or disqualification, the laboratory must notify any owners or consignees for which it is conducting food testing using methods for which it is being placed on probation or disqualified under this subpart, that it is on probation or has been disqualified.
§ 1.1171   How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?
(a) Timing of request. An accreditation body may seek reconsideration of FDA's decision to deny its application for recognition or renewal of recognition under § 1.1114, or reinstatement of recognition under § 1.1117, no later than 10 business days after the date of the issuance of such denial.
(b) Submission of request. The request to reconsider an application under paragraph (a) of this section must be signed by the accreditation body, as appropriate, or by an individual authorized to act on its behalf. The accreditation body must submit the request, together with any supporting information, to FDA in accordance with the procedures described in the notice of denial.
(c) Notification of FDA's decision. After completing its review and evaluation of the request for reconsideration and any supporting information submitted pursuant to paragraph (b) of this section, FDA will notify the accreditation body of its decision to grant or deny recognition upon reconsideration.
§ 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?
(a) Request for hearing. No later than 10 business days after the date FDA issued a revocation of recognition of an accreditation body pursuant to § 1.1131 or disqualification of a LAAF-accredited laboratory under § 1.1161, the accreditation body, laboratory, or an individual authorized to act on the accreditation body's or laboratory's behalf, may submit a request for a regulatory hearing, conducted pursuant to part 16 of this chapter, on the revocation or disqualification. The notice of revocation issued under § 1.1131 or notice of disqualification issued under § 1.1161, as applicable, will contain all the elements required by § 16.22(a) of this chapter and will thereby constitute the notice of an opportunity for hearing under part 16 of this chapter.
(b) Submission of request for regulatory hearing. The request for a regulatory hearing under this subpart must be submitted with a written appeal that responds to the bases for the FDA decision described in the written notice of revocation or disqualification, together with any supporting information. The request, appeal, and supporting information must be submitted to FDA in accordance with the procedures described in the notice of revocation or disqualification.
(c) Effect of submitting a request for a regulatory hearing on an FDA decision. The submission of a request for a regulatory hearing under this subpart will not operate to delay or stay the effect of a decision by FDA to revoke the recognition of an accreditation body or disqualify the LAAF-accredited laboratory unless FDA determines that delay or a stay is in the public interest.
(d) Presiding officer. The presiding officer for a regulatory hearing under this subpart will be designated after a request for a regulatory hearing is submitted to FDA.
(e) Denial of a request for regulatory hearing. The presiding officer may deny a request for regulatory hearing under this subpart pursuant to § 16.26(a) of this chapter when no genuine or substantial issue of fact has been raised.
(f) Conduct of regulatory hearing. (1) If the presiding officer grants a request for a regulatory hearing, the hearing will be held within 10 business days after the date the request was filed or, if applicable, within a timeframe agreed upon in writing by the accreditation body or laboratory, and the presiding officer and FDA.
(2) The presiding officer must conduct the hearing in accordance with part 16 of this chapter, except that, pursuant to § 16.5(b) of this chapter, the procedures for a regulatory hearing apply only to the extent that such procedures are supplementary and do not conflict with the procedures specified for regulatory hearings under this subpart. Accordingly, the following requirements of part 16 of this chapter are inapplicable to regulatory hearings conducted under this subpart: The requirements of § 16.22 (Initiation of regulatory hearing); § 16.24(e) (timing) and (f) (contents of notice); § 16.40 (Commissioner); § 16.60(a) (public process); § 16.95(b) (administrative decision and record for decision); and § 16.119 (Reconsideration and stay of action).
(3) A decision by the presiding officer to affirm the revocation of recognition or laboratory disqualification is considered a final agency action under 5 U.S.C. 702.
§ 1.1174   How does an owner or consignee request a regulatory hearing on a directed food laboratory order?
(a) Request for hearing. No later than 3 business days after FDA has issued the directed food laboratory order, an owner or consignee may submit a request for a regulatory hearing, conducted pursuant to part 16 of this chapter, on the directed food laboratory order. The directed food laboratory order will contain all of the elements required by § 16.22 of this chapter and will thereby constitute the notice of an opportunity for hearing under part 16 of this chapter.
(b) Submission of request for regulatory hearing. The request for a regulatory hearing must be submitted with a written appeal that responds to the bases, as appropriate, for FDA's determinations described in the directed food laboratory order, together with any supporting information. The request, appeal, and supporting information must be submitted in accordance with the procedures described in the directed food laboratory order.
(c) Presiding officer. The presiding officer for a regulatory hearing under this subpart will be designated after a request for a regulatory hearing is submitted to FDA.
(d) Denial of a request for regulatory hearing. The presiding officer may deny a request for regulatory hearing under this subpart pursuant to § 16.26(a) of this chapter.
(e) Conduct of regulatory hearing. (1) If the presiding officer grants a request for a regulatory hearing, such hearing will be held within 2 business days after the date the request was filed or, if applicable, within a timeframe agreed upon in writing by the requestor and the presiding officer and FDA.
(2) The presiding officer may require that a hearing conducted under this subpart be completed within 1 business day, as appropriate.
(3) The presiding officer must conduct the hearing in accordance with part 16 of this chapter, except that, pursuant to § 16.5(b) of this chapter, the procedures for a regulatory hearing described in part 16 of this chapter apply only to the extent that such procedures are supplementary and not in conflict with the procedures specified for the conduct of regulatory hearings under this subpart. Accordingly, the following requirements of part 16 of this chapter are inapplicable to regulatory hearings conducted under this subpart: § 16.22 (Initiation of regulatory hearing); § 16.24(e) (timing) and (f) (contents of notice); § 16.40 (Commissioner); § 16.60(a) (public process); § 16.95(b) (administrative decision and record for decision); and § 16.119 (Reconsideration and stay of action).
(4) A decision by the presiding officer to affirm the directed food laboratory order is considered a final agency action under 5 U.S.C. 702.
§ 1.1199   Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
Records that are established or maintained to satisfy the requirements of this subpart and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.
§ 1.1200   Are the records obtained by FDA under this subpart subject to public disclosure?
Records obtained by FDA under this subpart are subject to the disclosure requirements under part 20 of this chapter.
§ 1.1300   Who is subject to this subpart?
Except as otherwise specified in this subpart, the requirements in this subpart apply to persons who manufacture, process, pack, or hold foods that appear on the list of foods for which additional traceability records are required in accordance with section 204(d)(2) of the FDA Food Safety Modernization Act (Food Traceability List). FDA will publish the Food Traceability List on its website, www.fda.gov., in accordance with section 204(d)(2)(B) of the FDA Food Safety Modernization Act.
§ 1.1305   What foods and persons are exempt from this subpart?
(a) Exemptions for certain small producers. (1) Certain produce farms. (i) This subpart does not apply to farms or the farm activities of farm mixed-type facilities with respect to the produce they grow, when the farm is not a covered farm under part 112 of this chapter in accordance with § 112.4(a) of this chapter,
(ii) This subpart does not apply to produce farms when the average annual sum of the monetary value of their sales of produce and the market value of produce they manufacture, process, pack, or hold without sale ( e.g., held for a fee) during the previous 3-year period is no more than $25,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment.
(2) Certain shell egg producers. This subpart does not apply to shell egg producers with fewer than 3,000 laying hens at a particular farm, with respect to the shell eggs they produce at that farm.
(3) Certain other producers of raw agricultural commodities. This subpart does not apply to producers of raw agricultural commodities other than produce or shell eggs ( e.g., aquaculture operations) when the average annual sum of the monetary value of their sales of raw agricultural commodities and the market value of the raw agricultural commodities they manufacture, process, pack, or hold without sale ( e.g., held for a fee) during the previous 3-year period is no more than $25,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment.
(b) Exemption for farms when food is sold or donated directly to consumers. This subpart does not apply to a farm with respect to food produced on the farm (including food that is also packaged on the farm) that is sold or donated directly to a consumer by the owner, operator, or agent in charge of the farm.
(c) Inapplicability to certain food produced and packaged on a farm. This subpart does not apply to food produced and packaged on a farm, provided that:
(1) The packaging of the food remains in place until the food reaches the consumer, and such packaging maintains the integrity of the product and prevents subsequent contamination or alteration of the product; and
(2) The labeling of the food that reaches the consumer includes the name, complete address (street address, town, State, country, and zip or other postal code for a domestic farm and comparable information for a foreign farm), and business phone number of the farm on which the food was produced and packaged. FDA will waive the requirement to include a business phone number, as appropriate, to accommodate a religious belief of the individual in charge of the farm.
(d) Exemptions and partial exemptions for foods that receive certain types of processing. This subpart does not apply to the following foods that receive certain types of processing:
(1) Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, provided the conditions set forth in § 112.2(b) of this chapter are met for the produce;
(2) Shell eggs when all eggs produced at the particular farm receive a treatment (as defined in § 118.3 of this chapter) in accordance with § 118.1(a)(2) of this chapter;
(3) Food that you subject to a kill step, provided that you maintain records containing:
(i) The information specified in § 1.1345 for your receipt of the food to which you apply the kill step (unless you have entered into a written agreement concerning your application of a kill step to the food in accordance with paragraph (d)(6) of this section); and
(ii) A record of your application of the kill step;
(4) Food that you change such that the food is no longer on the Food Traceability List, provided that you maintain records containing the information specified in § 1.1345 for your receipt of the food you change (unless you have entered into a written agreement concerning your changing of the food such that the food is no longer on the Food Traceability List in accordance with paragraph (d)(6) of this section);
(5) Food that you receive that has previously been subjected to a kill step or that has previously been changed such that the food is no longer on the Food Traceability List;
(6) Food that will be subjected to a kill step by an entity other than a retail food establishment, restaurant, or consumer; or that will be changed by an entity other than a retail food establishment, restaurant, or consumer, such that the food will no longer be on the Food Traceability List, provided that:
(i) There is a written agreement between the shipper of the food and the receiver stating that the receiver will apply a kill step to the food or change the food such that it is no longer on the Food Traceability List; or
(ii) There is a written agreement between the shipper of the food and the receiver stating that an entity in the supply chain subsequent to the receiver will apply a kill step to the food or change the food such that it is no longer on the Food Traceability List and that the receiver will only ship the food to another entity that agrees, in writing, it will:
(A) Apply a kill step to the food or change the food such that it is no longer on the Food Traceability List; or
(B) Enter into a similar written agreement with a subsequent receiver stating that a kill step will be applied to the food or that the food will be changed such that it is no longer on the Food Traceability List.
(iii) A written agreement entered into in accordance with paragraph (d)(6)(i) or (ii) of this section must include the effective date, printed names and signatures of the persons entering into the agreement, and the substance of the agreement; and
(iv) A written agreement entered into in accordance with paragraph (d)(6)(i) or (ii) must be maintained by both parties for as long as it is in effect and must be renewed at least once every 3 years.
(e) Exemption for produce that is rarely consumed raw. This subpart does not apply to produce that is listed as rarely consumed raw in § 112.2(a)(1) of this chapter.
(f) Exemption for raw bivalve molluscan shellfish. This subpart does not apply to raw bivalve molluscan shellfish that are covered by the requirements of the National Shellfish Sanitation Program, subject to the requirements of part 123, subpart C, and § 1240.60 of this chapter, or covered by a final equivalence determination by FDA for raw bivalve molluscan shellfish.
(g) Exemption for persons who manufacture, process, pack, or hold certain foods subject to regulation by the U.S. Department of Agriculture (USDA). This subpart does not apply to persons who manufacture, process, pack, or hold food on the Food Traceability List during or after the time when the food is within the exclusive jurisdiction of the USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ), the Poultry Products Inspection Act (21 U.S.C. 451 et seq. ), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq. ).
(h) Partial exemption for commingled raw agricultural commodities. (1) Except as specified in paragraph (h)(3) of this section, this subpart does not apply to commingled raw agricultural commodities (which, as defined in § 1.1310, do not include types of fruits and vegetables to which the standards for the growing, harvesting, packing, and holding of produce for human consumption in part 112 of this chapter apply).
(2) Except as specified in paragraph (h)(3) of this section, this subpart does not apply to a raw agricultural commodity that will become a commingled raw agricultural commodity, provided that:
(i) There is a written agreement between the shipper of the raw agricultural commodity and the receiver stating that the receiver will include the commodity as part of a commingled raw agricultural commodity; or
(ii) There is a written agreement between the shipper of the raw agricultural commodity and the receiver stating that an entity in the supply chain subsequent to the receiver will include the commodity as part of a commingled raw agricultural commodity and that the receiver will only ship the raw agricultural commodity to another entity that agrees, in writing, it will either:
(A) Include the raw agricultural commodity as part of a commingled raw agricultural commodity; or
(B) Enter into a similar written agreement with a subsequent receiver stating that the raw agricultural commodity will become part of a commingled raw agricultural commodity;
(iii) A written agreement entered into in accordance with paragraph (h)(2)(i) or (ii) of this section must include the effective date, printed names and signatures of the persons entering into the agreement, and the substance of the agreement; and
(iv) A written agreement entered into in accordance with paragraph (h)(2)(i) or (ii) must be maintained by both parties for as long as it is in effect and must be renewed at least once every 3 years;
(3) With respect to a commingled raw agricultural commodity that qualifies for either of the exemptions set forth in paragraphs (h)(1) and (2) of this section, if a person who manufactures, processes, packs, or holds such commodity is required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic Act with respect to the manufacturing, processing, packing, or holding of the applicable raw agricultural commodity, such person must maintain records identifying the immediate previous source of such raw agricultural commodity and the immediate subsequent recipient of such food in accordance with §§ 1.337 and 1.345. Such records must be maintained for 2 years.
(i) Exemption for small retail food establishments and small restaurants. This subpart does not apply to retail food establishments and restaurants with an average annual monetary value of food sold or provided during the previous 3-year period of no more than $250,000 (on a rolling basis), adjusted for inflation using 2020 as the baseline year for calculating the adjustment.
(j) Partial exemption for retail food establishments and restaurants purchasing directly from a farm. (1) Except as specified in paragraph (j)(2) of this section, this subpart does not apply to a retail food establishment or restaurant with respect to a food that is produced on a farm (including food produced and packaged on the farm) and both sold and shipped directly to the retail food establishment or restaurant by the owner, operator, or agent in charge of that farm.
(2) When a retail food establishment or restaurant purchases a food directly from a farm in accordance with paragraph (j)(1) of this section, the retail food establishment or restaurant must maintain a record documenting the name and address of the farm that was the source of the food. The retail food establishment or restaurant must maintain such a record for 180 days.
(k) Partial exemption for retail food establishments and restaurants making certain purchases from another retail food establishment or restaurant. (1) Except as specified in paragraph (k)(2) of this section, this subpart does not apply to either entity when a purchase is made by a retail food establishment or restaurant from another retail food establishment or restaurant, and the purchase occurs on an ad hoc basis outside of the buyer's usual purchasing practice ( e.g., not pursuant to a contractual agreement to purchase food from the seller).
(2) When a retail food establishment or restaurant purchases a food on the Food Traceability List from another retail food establishment or restaurant in accordance with paragraph (k)(1) of this section, the retail food establishment or restaurant that makes the purchase must maintain a record ( e.g., a sales receipt) documenting the name of the product purchased, the date of purchase, and the name and address of the place of purchase.
(l) Partial exemption for farm to school and farm to institution programs. (1) Except as specified in paragraph (l)(2) of this section, this subpart does not apply to an institution operating a child nutrition program authorized under the Richard B. Russell National School Lunch Act or Section 4 of the Child Nutrition Act of 1966, or any other entity conducting a farm to school or farm to institution program, with respect to a food that is produced on a farm (including food produced and packaged on the farm) and sold or donated to the school or institution.
(2) When a school or institution conducting a farm to school or farm to institution program obtains a food from a farm in accordance with paragraph (l)(1) of this section, the school food authority or relevant food procurement entity must maintain a record documenting the name and address of the farm that was the source of the food. The school food authority or relevant food procurement entity must maintain such record for 180 days.
(m) Partial exemption for owners, operators, or agents in charge of fishing vessels. (1) Except as specified in paragraph (m)(2) of this section, with respect to a food that is obtained from a fishing vessel, this subpart does not apply to the owner, operator, or agent in charge of the fishing vessel, and this subpart also does not apply to persons who manufacture, process, pack, or hold the food until such time as the food is sold by the owner, operator, or agent in charge of the fishing vessel.
(2) With respect to any person who receives the partial exemption set forth in paragraph (m)(1) of this section, if such person is required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic Act with respect to the manufacturing, processing, packing, or holding of the applicable food, such person must maintain records identifying the immediate previous source of such food and the immediate subsequent recipient of such food in accordance with §§ 1.337 and 1.345. Such records must be maintained for 2 years.
(n) Exemption for transporters. This subpart does not apply to transporters of food.
(o) Exemption for nonprofit food establishments. This subpart does not apply to nonprofit food establishments.
(p) Exemption for persons who manufacture, process, pack, or hold food for personal consumption. This subpart does not apply to persons who manufacture, process, pack, or hold food for personal consumption.
(q) Exemption for certain persons who hold food on behalf of individual consumers. This subpart does not apply to persons who hold food on behalf of specific individual consumers, provided that these persons:
(1) Are not parties to the transaction involving the food they hold; and
(2) Are not in the business of distributing food.
(r) Exemption for food for research or evaluation. This subpart does not apply to food for research or evaluation use, provided that such food:
(1) Is not intended for retail sale and is not sold or distributed to the public; and
(2) Is accompanied by the statement “Food for research or evaluation use.”
§ 1.1310   What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart. In addition, the following definitions apply to words and phrases as they are used in this subpart:
Commingled raw agricultural commodity means any commodity that is combined or mixed after harvesting but before processing, except that the term “commingled raw agricultural commodity” does not include types of fruits and vegetables that are raw agricultural commodities to which the standards for the growing, harvesting, packing, and holding of produce for human consumption in part 112 of this chapter apply. For the purpose of this definition, a commodity is “combined or mixed” only when the combination or mixing involves food from different farms under different company management; except that for food obtained from a fishing vessel, a commodity is “combined or mixed” only when the combination or mixing involves food from different landing vessels and occurs after the vessels have landed. Also, for the purpose of this definition, the term “processing” means operations that alter the general state of the commodity, such as canning, cooking, freezing, dehydration, milling, grinding, pasteurization, or homogenization.
Cooling means active temperature reduction of a raw agricultural commodity using hydrocooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process.
Critical tracking event means an event in the supply chain of a food involving the harvesting, cooling (before initial packing), initial packing of a raw agricultural commodity other than a food obtained from a fishing vessel, first land-based receiving of a food obtained from a fishing vessel, shipping, receiving, or transformation of the food.
Farm means farm as defined in § 1.328. For producers of shell eggs, “farm” means all poultry houses and grounds immediately surrounding the poultry houses covered under a single biosecurity program, as set forth in § 118.3 of this chapter.
First land-based receiver means the person taking possession of a food for the first time on land directly from a fishing vessel.
Fishing vessel means any vessel, boat, ship, or other craft which is used for, equipped to be used for, or of a type which is normally used for fishing or aiding or assisting one or more vessels at sea in the performance of any activity relating to fishing, including, but not limited to, preparation, supply, storage, refrigeration, transportation, or processing, as set forth in the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1802(18)).
Food Traceability List means the list of foods for which additional traceability records are required to be maintained, as designated in accordance with section 204(d)(2) of the FDA Food Safety Modernization Act. The term “Food Traceability List” includes both the foods specifically listed and foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form ( e.g., fresh) in which it appears on the list.
Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity ( e.g., foliage, husks, roots, or stems). Examples of harvesting also include cooling, field coring, filtering, gathering, hulling, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm.
Holding means storage of food and also includes activities performed incidental to storage of a food ( e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
Initial packing means packing a raw agricultural commodity (other than a food obtained from a fishing vessel) for the first time.
Key data element means information associated with a critical tracking event for which a record must be maintained and/or provided in accordance with this subpart.
Kill step means lethality processing that significantly minimizes pathogens in a food.
Location description means key contact information for the location where a food is handled, specifically the business name, phone number, physical location address (or geographic coordinates), and city, State, and zip code for domestic locations and comparable information for foreign locations, including country.
Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.
Mixed-type facility means an establishment that engages in both activities that are exempt from registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be registered. An example of such a facility is a “farm mixed-type facility,” which is an establishment that is a farm, but also conducts activities outside the farm definition that require the establishment to be registered.
Nonprofit food establishment means a charitable entity that prepares or serves food directly to the consumer or otherwise provides food or meals for consumption by humans or animals in the United States. The term includes central food banks, soup kitchens, and nonprofit food delivery services. To be considered a nonprofit food establishment, the establishment must meet the terms of section 501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)).
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.g., activities performed for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing)), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
Person includes an individual, partnership, corporation, and association.
Point of contact means an individual having familiarity with an entity's procedures for traceability, including their name and/or job title, and their phone number.
Produce means produce as defined in § 112.3 of this chapter.
Product description means a description of a food product and includes the product name (including, if applicable, the brand name, commodity, and variety), packaging size, and packaging style. For seafood, the product name may include the species and/or acceptable market name.
Raw agricultural commodity means “raw agricultural commodity” as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act.
Receiving means an event in a food's supply chain in which a food is received by someone other than a consumer after being transported ( e.g., by truck or ship) from another location. Receiving includes receipt of an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm.
Reference document means a business transaction document, record, or message, in electronic or paper form, that may contain some or all of the key data elements for a critical tracking event in the supply chain of a food. A reference document may be established by you or obtained from another person. Reference document types may include, but are not limited to, bills of lading, purchase orders, advance shipping notices, work orders, invoices, database records, batch logs, production logs, field tags, catch certificates, and receipts.
Reference document number means the identification number assigned to a specific reference document.
Restaurant means a facility that prepares and sells food directly to consumers for immediate consumption. “Restaurant” does not include facilities that provide food to interstate conveyances, central kitchens, and other similar facilities that do not prepare and serve food directly to consumers.
(1) Entities in which food is provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens are restaurants; and
(2) Pet shelters, kennels, and veterinary facilities in which food is provided to animals are restaurants.
Retail food establishment means an establishment that sells food products directly to consumers as its primary function. The term “retail food establishment” includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The term “consumers” does not include businesses. A “retail food establishment” includes grocery stores, convenience stores, and vending machine locations. A “retail food establishment” also includes certain farm-operated businesses selling food directly to consumers as their primary function.
(1) Sale of food directly to consumers from an establishment located on a farm includes sales by that establishment directly to consumers:
(i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers' market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);
(ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and
(iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and internet order, including online farmers' markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.
(2) Sale of food directly to consumers by a farm-operated business includes the sale of food by that farm-operated business directly to consumers:
(i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers' market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);
(ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and
(iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and internet order, including online farmers' markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.
(3) For the purposes of this definition, “farm-operated business” means a business that is managed by one or more farms and conducts manufacturing/processing not on the farm(s).
Shipping means an event in a food's supply chain in which a food is arranged for transport ( e.g., by truck or ship) from one location to another location. Shipping does not include the sale or shipment of a food directly to a consumer or the donation of surplus food. Shipping includes sending an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm.
Traceability lot means a batch or lot of food that has been initially packed (for raw agricultural commodities other than food obtained from a fishing vessel), received by the first land-based receiver (for food obtained from a fishing vessel), or transformed.
Traceability lot code means a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the traceability lot code source.
Traceability lot code source means the place where a food was assigned a traceability lot code.
Traceability lot code source reference means an alternative method for providing FDA with access to the location description for the traceability lot code source as required under this subpart. Examples of a traceability lot code source reference include, but are not limited to, the FDA Food Facility Registration Number for the traceability lot code source or a web address that provides FDA with the location description for the traceability lot code source.
Transformation means an event in a food's supply chain that involves manufacturing/processing a food or changing a food ( e.g., by commingling, repacking, or relabeling) or its packaging or packing, when the output is a food on the Food Traceability List. Transformation does not include the initial packing of a food or activities preceding that event ( e.g., harvesting, cooling).
Transporter means a person who has possession, custody, or control of an article of food for the sole purpose of transporting the food, whether by road, rail, water, or air.
You means a person subject to this subpart under § 1.1300.
§ 1.1315   What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?
(a) If you are subject to the requirements in this subpart, you must establish and maintain a traceability plan containing the following information:
(1) A description of the procedures you use to maintain the records you are required to keep under this subpart, including the format and location of these records.
(2) A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold;
(3) A description of how you assign traceability lot codes to foods on the Food Traceability List in accordance with § 1.1320, if applicable;
(4) A statement identifying a point of contact for questions regarding your traceability plan and records; and
(5) If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods.
(i) Except as specified in paragraph (a)(5)(ii) of this section, the farm map must show the location and name of each field (or other growing area) in which you grow a food on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each field or growing area.
(ii) For aquaculture farms, the farm map must show the location and name of each container ( e.g., pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container.
(b) You must update your traceability plan as needed to ensure that the information provided reflects your current practices and to ensure that you are in compliance with the requirements of this subpart. You must retain your previous traceability plan for 2 years after you update the plan.
§ 1.1320   When must I assign traceability lot codes to foods on the Food Traceability List?
(a) You must assign a traceability lot code when you do any of the following: Initially pack a raw agricultural commodity other than a food obtained from a fishing vessel; perform the first land-based receiving of a food obtained from a fishing vessel; or transform a food.
(b) Except as otherwise specified in this subpart, you must not establish a new traceability lot code when you conduct other activities ( e.g., shipping) for a food 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?
(a) Harvesting. (1) For each raw agricultural commodity (not obtained from a fishing vessel) on the Food Traceability List that you harvest, you must maintain records containing the following information:
(i) The location description for the immediate subsequent recipient (other than a transporter) of the food;
(ii) The commodity and, if applicable, variety of the food;
(iii) The quantity and unit of measure of the food ( e.g., 75 bins, 200 pounds);
(iv) The location description for the farm where the food was harvested;
(v) For produce, the name of the field or other growing area from which the food was harvested (which must correspond to the name used by the grower), or other information identifying the harvest location at least as precisely as the field or other growing area name;
(vi) For aquacultured food, the name of the container ( e.g., pond, pool, tank, cage) from which the food was harvested (which must correspond to the container name used by the aquaculture farmer) or other information identifying the harvest location at least as precisely as the container name;
(vii) The date of harvesting; and
(viii) The reference document type and reference document number.
(2) For each raw agricultural commodity (not obtained from a fishing vessel) on the Food Traceability List that you harvest, you must provide (in electronic, paper, or other written form) your business name, phone number, and the information in paragraphs (a)(1)(i) through (vii) of this section to the initial packer of the raw agricultural commodity you harvest, either directly or through the supply chain.
(b) Cooling before initial packing. (1) For each raw agricultural commodity (not obtained from a fishing vessel) on the Food Traceability List that you cool before it is initially packed, you must maintain records containing the following information:
(i) The location description for the immediate subsequent recipient (other than a transporter) of the food;
(ii) The commodity and, if applicable, variety of the food;
(iii) The quantity and unit of measure of the food ( e.g., 75 bins, 200 pounds);
(iv) The location description for where you cooled the food;
(v) The date of cooling;
(vi) The location description for the farm where the food was harvested; and
(vii) The reference document type and reference document number.
(2) For each raw agricultural commodity (not obtained from a fishing vessel) on the Food Traceability List that you cool before it is initially packed, you must provide (in electronic, paper, or other written form) the information in paragraphs (b)(1)(i) through (vi) of this section to the initial packer of the raw agricultural commodity you cool, either directly or through the supply chain.
§ 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?
(a) Except as specified in paragraph (c) of this section, for each traceability lot of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List you initially pack, you must maintain records containing the following information and linking this information to the traceability lot:
(1) The commodity and, if applicable, variety of the food received;
(2) The date you received the food;
(3) The quantity and unit of measure of the food received ( e.g., 75 bins, 200 pounds);
(4) The location description for the farm where the food was harvested;
(5) For produce, the name of the field or other growing area from which the food was harvested (which must correspond to the name used by the grower), or other information identifying the harvest location at least as precisely as the field or other growing area name;
(6) For aquacultured food, the name of the container ( e.g., pond, pool, tank, cage) from which the food was harvested (which must correspond to the container name used by the aquaculture farmer) or other information identifying the harvest location at least as precisely as the container name;
(7) The business name and phone number for the harvester of the food;
(8) The date of harvesting;
(9) The location description for where the food was cooled (if applicable);
(10) The date of cooling (if applicable);
(11) The traceability lot code you assigned;
(12) The product description of the packed food;
(13) The quantity and unit of measure of the packed food ( e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
(14) The location description for where you initially packed the food ( i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference;
(15) The date of initial packing; and
(16) The reference document type and reference document number.
(b) For each traceability lot of sprouts (except soil- or substrate-grown sprouts harvested without their roots) you initially pack, you must also maintain records containing the following information and linking this information to the traceability lot:
(1) The location description for the grower of seeds for sprouting and the date of seed harvesting, if either is available;
(2) The location description for the seed conditioner or processor, the associated seed lot code, and the date of conditioning or processing;
(3) The location description for the seed packinghouse (including any repackers), the date of packing (and of repacking, if applicable), and any associated seed lot code assigned by the seed packinghouse;
(4) The location description for the seed supplier, any seed lot code assigned by the seed supplier (including the master lot and sub-lot codes), and any new seed lot code assigned by the sprouter;
(5) A description of the seeds, including the seed type or taxonomic name, growing specifications, type of packaging, and (if applicable) antimicrobial treatment;
(6) The date of receipt of the seeds by the sprouter; and
(7) The reference document type and reference document number.
(c) For each traceability lot of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List you initially pack that you receive from a person to whom this subpart does not apply, you must maintain records containing the following information and linking this information to the traceability lot:
(1) The commodity and, if applicable, variety of the food received;
(2) The date you received the food;
(3) The quantity and unit of measure of the food received ( e.g., 75 bins, 200 pounds);
(4) The location description for the person from whom you received the food;
(5) The traceability lot code you assigned;
(6) The product description of the packed food;
(7) The quantity and unit of measure of the packed food ( e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
(8) The location description for where you initially packed the food ( i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference;
(9) The date of initial packing; and
(10) The reference document type and reference document number.
§ 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?
For each traceability lot of a food obtained from a fishing vessel for which you are the first land-based receiver, you must maintain records containing the following information and linking this information to the traceability lot:
(a) The traceability lot code you assigned;
(b) The species and/or acceptable market name for unpackaged food, or the product description for packaged food;
(c) The quantity and unit of measure of the food ( e.g., 300 kg);
(d) The harvest date range and locations (as identified under the National Marine Fisheries Service Ocean Geographic Code, the United Nations Food and Agriculture Organization Major Fishing Area list, or any other widely recognized geographical location standard) for the trip during which the food was caught;
(e) The location description for the first land-based receiver ( i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference;
(f) The date the food was landed; and
(g) The reference document type and reference document number.
§ 1.1340   What records must I keep and provide when I ship a food on the Food Traceability List?
(a) For each traceability lot of a food on the Food Traceability List you ship, you must maintain records containing the following information and linking this information to the traceability lot:
(1) The traceability lot code for the food;
(2) The quantity and unit of measure of the food ( e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
(3) The product description for the food;
(4) The location description for the immediate subsequent recipient (other than a transporter) of the food;
(5) The location description for the location from which you shipped the food;
(6) The date you shipped the food;
(7) The location description for the traceability lot code source, or the traceability lot code source reference; and
(8) The reference document type and reference document number.
(b) You must provide (in electronic, paper, or other written form) the information in paragraphs (a)(1) through (7) of this section to the immediate subsequent recipient (other than a transporter) of each traceability lot that you ship.
(c) This section does not apply to the shipment of a food that occurs before the food is initially packed (if the food is a raw agricultural commodity not obtained from a fishing vessel).
§ 1.1345   What records must I keep when I receive a food on the Food Traceability List?
(a) Except as specified in paragraphs (b) and (c) of this section, for each traceability lot of a food on the Food Traceability List you receive, you must maintain records containing the following information and linking this information to the traceability lot:
(1) The traceability lot code for the food;
(2) The quantity and unit of measure of the food ( e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
(3) The product description for the food;
(4) The location description for the immediate previous source (other than a transporter) for the food;
(5) The location description for where the food was received;
(6) The date you received the food;
(7) The location description for the traceability lot code source, or the traceability lot code source reference; and
(8) The reference document type and reference document number.
(b) For each traceability lot of a food on the Food Traceability List you receive from a person to whom this subpart does not apply, you must maintain records containing the following information and linking this information to the traceability lot:
(1) The traceability lot code for the food, which you must assign if one has not already been assigned (except that this paragraph does not apply if you are a retail food establishment or restaurant);
(2) The quantity and unit of measure of the food ( e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
(3) The product description for the food;
(4) The location description for the immediate previous source (other than a transporter) for the food;
(5) The location description for where the food was received ( i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference;
(6) The date you received the food; and
(7) The reference document type and reference document number.
(c) This section does not apply to receipt of a food that occurs before the food is initially packed (if the food is a raw agricultural commodity not obtained from a fishing vessel) or to the receipt of a food by the first land-based receiver (if the food is obtained from a fishing vessel).
§ 1.1350   What records must I keep when I transform a food on the Food Traceability List?
(a) Except as specified in paragraphs (b) and (c) of this section, for each new traceability lot of food you produce through transformation, you must maintain records containing the following information and linking this information to the new traceability lot:
(1) For the food on the Food Traceability List used in transformation (if applicable), the following information:
(i) The traceability lot code for the food;
(ii) The product description for the food to which the traceability lot code applies; and
(iii) For each traceability lot used, the quantity and unit of measure of the food used from that lot.
(2) For the food produced through transformation, the following information:
(i) The new traceability lot code for the food;
(ii) The location description for where you transformed the food ( i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference;
(iii) The date transformation was completed;
(iv) The product description for the food;
(v) The quantity and unit of measure of the food ( e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds); and
(vi) The reference document type and reference document number for the transformation event.
(b) For each traceability lot produced through transformation of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List that was not initially packed prior to your transformation of the food, you must maintain records containing the information specified in § 1.1330(a) or (c), and, if the raw agricultural commodity is sprouts, the information specified in § 1.1330(b).
(c) Paragraphs (a) and (b) of this section do not apply to retail food establishments and restaurants with respect to foods they do not ship ( e.g., foods they sell or send directly to consumers).
§ 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?
(a) General. Except as specified in paragraph (b) of this section, FDA will modify the requirements of this subpart applicable to a food or type of entity, or exempt a food or type of entity from the requirements of this subpart, when we determine that application of the requirements that would otherwise apply to the food or type of entity is not necessary to protect the public health.
(b) Registered facilities. If a person to whom modified requirements or an exemption applies under paragraph (a) of this section (including a person who manufactures, processes, packs, or holds a food to which modified requirements or an exemption applies under paragraph (a) of this section) is required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic Act (and in accordance with the requirements of subpart H of this part) with respect to the manufacturing, processing, packing, or holding of the applicable food, such person must maintain records identifying the immediate previous source of such food and the immediate subsequent recipient of such food in accordance with §§ 1.337 and 1.345. Such records must be maintained for 2 years.
§ 1.1365   When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?
FDA will consider modifying the requirements of this subpart applicable to a food or type of entity, or exempting a food or type of entity from the requirements of this subpart, on our own initiative or in response to a citizen petition submitted under § 10.30 of this chapter by any interested party.
§ 1.1370   What must be included in a petition requesting modified requirements or an exemption from the requirements?
In addition to meeting the requirements on the content and format of a citizen petition in § 10.30 of this chapter, a petition requesting modified requirements or an exemption from the requirements of this subpart must:
(a) Specify the food or type of entity to which the modified requirements or exemption would apply;
(b) If the petition requests modified requirements, specify the proposed modifications to the requirements of this subpart; and
(c) Present information demonstrating why application of the requirements requested to be modified or from which exemption is requested is not necessary to protect the public health.
§ 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?
FDA will presume that information submitted in a petition requesting modified requirements or an exemption, as well as information in comments submitted on such a petition, does not contain information exempt from public disclosure under part 20 of this chapter and will be made public as part of the docket associated with the petition.