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Sanitary Transportation of Human and Animal Food (proposed regulation)

Also see Federal Register, Vol. 79, No. 24, Wednesday, February 5, 2014. Part II, Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 1, Sanitary Transportation of Human and Animal Food; Proposed Rule at http://www.gpo.gov/fdsys/pkg/FR-2014-02-05/pdf/2014-02188.pdf
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Congress directed the FDA to develop and implement regulations overseeing the transportation of food.  The underlying statutory authority is found at 21 U.S.C. 350e; the proposed regulation is copied below.
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Subpart O—Sanitary Transportation of Human and Animal Food

Proposed for 21 C.F.R. 1.900 et. seq.
 
General Provisions
 
§1.900 Who is subject to this subpart?
(a) Except for non-covered businesses as defined in § 1.904, the requirements of this subpart apply to shippers, receivers, 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, 110, 118, 225, and 589).
(b) The requirements of this subpart do not apply to shippers, receivers, or carriers when they are engaged in transportation operations of:
(1) Food that is transshipped through the United States to another country; or
(2) Food that is imported for future export and that is neither consumed nor distributed in the United States.
 
§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 (21 U.S.C. 342(i)) in that the food has been transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, 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, 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 (21 U.S.C. 331(hh)).
 
§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 (21 U.S.C. 321) 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 owns,leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food.  The carrier is responsible for all functions assigned to a carrier in this subpart even if they are performed by other persons, such as a driver that is employed or contracted by a trucking firm. A carrier may also be a receiver or a shipper if the person also performs the functions of those respective persons as defined in this subpart.
  • 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 means a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. The term ‘‘farm’’ includes facilities that pack or hold food, regardless of whether all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership.
  • Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and includes raw materials and ingredients. Food includes animal food and food also subject to the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. 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.
  • Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species having public health significance. The term ‘‘undesirable microorganisms’’ includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated.
  • Non-covered business means a shipper, receiver, or carrier engaged in transportation operations that has less than $500,000 in total annual sales.
  • Pest means any objectionable animals or insects including birds, rodents, flies, and larvae.
  • Receiver means any person who receives food after transportation, whether or not that person represents the final point of receipt for the food. A receiver may also be a carrier or a shipper if the person also performs those functions as defined in this subpart. A receiver does not include an individual consumer or a person who receives or holds food on behalf of an individual consumer and who is not also a party to the transaction and who is not in the business of distributing food.
  • Shelf stable food means a food that can be stored under ambient temperature and humidity conditions and, if the package integrity is maintained will not spoil or become unsafe throughout its storage life. Examples of shelf stable food include canned juice, canned vegetables, canned meat, bottled water and dry food items such as rice, pasta, flour, sugar, and spices.
  • Shipper means a person who initiates a shipment of food by motor vehicle or rail vehicle. The shipper is responsible for all functions assigned to a shipper in this subpart even if they are performed by other persons, such as a person who only holds food and physically transfers it onto a vehicle arranged for by the shipper. A shipper may also be a carrier or a receiver if the shipper also performs those functions as defined in this subpart.
  • Small business means a business subject to §1.900(a) employing fewer than 500 persons 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 $25,500,000 in annual receipts.
  • Time/temperature control for safety (TCS) Food means a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation.
  • Transportation means any movement of food in commerce by motor vehicle or rail vehicle.
  • Transportation equipment means equipment used in food transportation operations, other than vehicles, 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 solely of shelf stable food that is completely enclosed by a container, compressed food gases or live food animals. In addition, transportation operations do not include any transportation activities for raw agricultural commodities 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 rail car, which is used in transportation operations.

 

Vehicles and Transportation Equipment
 
§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 filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during transportation operations.
(b) Vehicles and transportation equipment must be maintained in such a sanitary condition as to prevent the food they transport from becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during transportation operations.
(c) Vehicles and transportation equipment that are used in transportation operations for food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation must be designed,maintained, and equipped, to maintain the food under temperature conditions that will prevent the rapid growth of undesirable microorganisms.
(d) Each freezer and mechanically refrigerated cold storage compartment in vehicles or transportation equipment used in transportation operations for food that can support the rapid growth of microorganisms in the absence of temperature control during transportation, must be equipped with an indicating thermometer, temperature-measuring device, or temperature-recording device installed to show the temperature accurately within the compartment.
(e) Vehicles and transportation equipment must be stored in a manner as to prevent the vehicles or transportation equipment from harboring pests or becoming contaminated in any other manner that could result in food for which they will be used becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during transportation operations.
 
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, and receivers engaged in transportation operations.
(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 filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during transportation operations, including:
(i) Taking effective measures such as segregation or isolation to protect food from contamination by raw foods and non-food 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) For food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation, ensuring that the food is transported in a manner, including the temperature conditions, such that the transportation operation meets the requirements of paragraph (a)(3) of this section.
(b) Requirements applicable to shippers engaged in transportation operations.
(1) The shipper must specify to the carrier, in writing, all necessary sanitary requirements for the carrier’s vehicle and transportation equipment, including any specific design requirements and cleaning procedures to ensure that the vehicle is in appropriate sanitary condition for the transportation of the food, e.g., that will prevent the food from becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during the transportation operation. The information submitted by the shipper to the carrier is subject to the records requirements in §1.912(a).
(2) Before loading food not completely enclosed by a container onto a vehicle provided by a carrier or into transportation equipment provided by a carrier, the shipper must visually inspect the vehicle or the transportation equipment provided by the carrier for cleanliness. The shipper must determine that the vehicle or transportation equipment is in appropriate sanitary condition for the transport of the food, e.g., it is free of visible evidence of pest infestation and of debris, previous cargo, or dirt that could cause the food to become adulterated.
(3) A shipper of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation, whether a TCS food or a non-TCS food, must specify in writing to the carrier, except a carrier who transports the food in a thermally insulated tank, the temperature conditions necessary during the transportation operation, including the pre-cooling phase, to ensure that the operation will maintain the temperature conditions and meet the requirements of paragraph (a)(3) of this section. The information submitted by the shipper to the carrier is subject to the records requirements in §1.912(a).
(4) Before loading food, a shipper of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation, must verify that each freezer and mechanically refrigerated cold storage compartment or container has been pre-cooled in accordance with information submitted by the shipper as required by paragraph (b)(3) of this section.
(5) The shipper assumes the requirements applicable to the carrier in §1.908(d)(2)(i) with respect to providing a demonstration to the receiver if the shipper and carrier have agreed in writing under §1.908(d)(2)(ii) that the shipper is responsible for ensuring that the food was held under acceptable temperature conditions during transportation operations. When the shipper and carrier have established such an agreement, the shipper also assumes the corresponding records requirements of §§1.908(d)(6)(ii) and 1.912(b).
(c) Requirements applicable to shippers and receivers engaged in transportation operations.
(1) Shippers and receivers must provide vehicle operators who are expected to handle food not completely enclosed by a container during loading and unloading operations with access to a hand washing facility. The hand washing facility must be convenient and provide running water to enable vehicle operators to wash their hands and avoid contamination of food.
(2) Shippers and receivers of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation must carry out loading and unloading operations under conditions that will prevent the food from supporting such microbial growth.
(d) Requirements applicable to carriers engaged in transportation operations.
(1) A carrier must supply a vehicle and transportation equipment that meets any requirements specified by the shipper in accordance with paragraph (b)(1) of this section and is otherwise appropriate to prevent the food from becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during the transportation operation.
(2) A carrier:
(i) Must, once the transportation operation is complete, demonstrate to the shipper and if requested, to the receiver, that it has maintained temperature conditions during the transportation operation consistent with those specified by the shipper in accordance with §1.908(b)(3). Such demonstration may be accomplished by any appropriate means agreeable to the carrier and shipper such as the carrier presenting printouts of a time/temperature recording device or a log of temperature measurements taken at various times during the shipment.
(ii) Is not subject to the requirement of paragraph (d)(2)(i) of this section if the carrier and shipper agree in writing, before transportation operations, that the shipper is responsible for monitoring the temperature conditions during the transportation operation or otherwise ensuring that the food was held under acceptable temperature conditions during the transportation operation. The carrier must provide the written agreement to the receiver, if requested. The written agreement is subject to the records requirements of §1.912(b).
 
(3) Before offering a vehicle or transportation equipment with an auxiliary refrigeration unit for use for the transportation of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control, a carrier must pre-cool each mechanically refrigerated freezer and cold storage compartment as specified by the shipper in accordance with paragraph (b)(3) of this section.
(4) A carrier that offers a bulk vehicle for food transportation must provide information to the shipper that identifies the three previous cargoes transported in the vehicle. The shipper and carrier may agree in writing that the carrier will provide information that identifies fewer than three previous cargoes or that the carrier need not provide any such information if procedures have been established that would ensure that the bulk vehicle offered will be adequate for the intended transportation operation, e.g., if the carrier by contract, will only offer vehicles dedicated to hauling a single type of product. The written agreement is subject to the records requirements of §1.912(b).
(5) 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, except that a shipper and carrier may agree in writing that the carrier need not provide any such information, if the carrier follows procedures that would ensure that the bulk vehicle offered will be adequate for the intended transportation operation, e.g., if the carrier has contractually agreed to use a specified cleaning procedure at specified intervals or if the shipper cleans the vehicle at his own facility. The written agreement is subject to the records requirements of § 1.912(b).
(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 (2) of this section, and;
(iii) Describe how it will comply with the provisions for the use of bulk vehicles in paragraphs (d)(4) and (d)(5)of this section.
 
Training
 
§1.910 What training requirements apply to carriers engaged in transportation operations?
(a) Carriers must provide 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).
 
Records
 
§1.912 What record retention and other records requirements apply to shippers and carriers engaged in transportation operations?
(a) Shippers must retain records that demonstrate that they provide information to carriers as required by § 1.908(b)(1) and (3) as a regular part of their transportation operations for a period of 12 months beyond when the shipper is subject to any requirement to provide such information.
(b) Carriers must retain any written agreements required by §1.908(d)(2)(ii) of this subpart and records of the written procedures required by §1.908(d)(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 continues to perform the duties for which the training was provided.
(d) Shippers and carriers must make all records required by this subpart available to a duly authorized individual promptly upon oral or written request.
(e) 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, which must be kept in accordance with part 11 of this chapter.
(f) Except for the written procedures required by §1.908(d)(6), offsite storage of records is permitted after 6 months following the date that the record was made if such records can be retrieved and provided onsite within 24 hours of request for official review. The written procedures required by §1.908(d)(6) 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.
(g) All records required by this subpart are subject to the disclosure requirements under part 20 of this chapter.
 
Waivers
 
§1.914 Under what circumstances will FDA waive a requirement of this subpart?
FDA will waive any requirement of this subpart with respect to any class of persons, vehicles, food, or nonfood products,  when FDA determines 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 FDA consider whether to waive a requirement of this subpart?
FDA will consider whether to waive a requirement of this subpart on FDA’s 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 are 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 FDA 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 FDA follow when waiving a requirement of this subpart on FDA’s own initiative?
If FDA, on its own initiative, determines that a waiver is appropriate, FDA will publish a notice in the Federal Register setting forth the waiver and the reasons for such waiver.
 
§1.930 When will a waiver granted by FDA become effective?
Any waiver granted by FDA will become effective on the date that notice of the waiver is published in the Federal Register.
 
§1.932 Under what circumstances may FDA modify or revoke a waiver?
FDA may modify or revoke a waiver if FDA determines 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 FDA determines 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.
 
 

Email David.Saxowsky@ndsu.edu

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