Sanitary Transport of Food
FDA Amends Requirements for Registration of Food Facilities
July 14, 2016 – The Food and Drug Administration (FDA) pronounced that it will be amending its regulations for registration of food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA. This rule amends and updates FDA’s registration regulations and is part of their implementation of the FDA Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities. FDA notes this new requirement would use this information to better focus and utilize the Agency’s limited inspection resources.
Food facilities that manufacture/process, pack or hold food for consumption in the United States are required to register with the FDA, and this final rule adds new provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of FSMA. Those provisions include the requirement of an email address for registration, required renewal of registration every two years, and that all food facility registrations must contain an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.
In addition, the final rule adds certain new requirements that will improve the food facility registration system. All food facility registrations are required to be submitted to the FDA electronically, although this requirement does not take effect until January 4, 2020.
Registrations are now required to contain the type of activity conducted at the facility for each food product category. The final rule also amends the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore, not required to register with the FDA as food facilities. However, all food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe.
To view the Federal Register notice, please click here.
If you have any questions, contact Chris Burroughs (firstname.lastname@example.org, 703.299.5705).
FDA Sanitary Transportation of Human and Animal Food: Final Rule
The Food and Drug Administration (FDA) released the Final Rule for the Sanitary Transportation of Human and Animal Food on April 6, 2016. This Final Rule will advance FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The earliest compliance dates for some businesses begin on April 6, 2017, while “small businesses” have until April 6, 2018, to comply. The Agency defines a small business as, “businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts.
The Agency amended the definition of a “shipper” to include 3PLs as a responsible party. Specifically, the definition reads:
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.
Furthermore, the Agency notes that shippers or brokers are in the best position to determine the necessary requirements and places the primary responsibility for compliance with them. This would include:
- Appropriate transportation operations
- If the food needs temperature controlled for safety and the relevant operating temperature and mode of temperature monitoring
- If clean out procedures are needed
- If previous cargo should be revealed
The Agency notes that shippers can contractually assign responsibility to other covered parties.
What is covered?
With some important exceptions, the types of “food” covered under the rule represent the full scope of the foods regulated under the Federal Food Drug, and Cosmetic Act (FD&C Act), including animal food (pet food and feed for livestock), food additives, and dietary supplements. Notable exclusions are for:
- Frozen Foods
- Food completely enclosed by a container (unless refrigeration is needed for safety)
- Compressed food gasses
- Food contact substances
- Human food byproducts transported for use as animal food without further processing
- Live food animals, except molluscan shellfish.
Who is covered?
The final applies to shippers (brokers), receivers, loaders, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. It also applies to:
- Persons (shippers/brokers), in other countries who ship food to the United States directly by motor or rail vehicle (Canada and Mexico), or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the U.S.
- The rule does not apply to exporters who ship food through the U.S. by motor or rail vehicles if the food does not enter U.S. distribution.
- Companies involved in the transportation of food intended for export are covered by the rule until the shipment reached a port or U.S. border.
Who is exempt?
- Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue
- Transportation activities performed by a farm
- Transportation of food that is transshipped through the United States to another country
- Transportation of food that is imported for future export and that is neither consumed or distributed in the United States
- Transportation of compressed food gasses (e.g. carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances
- Transportation of human food byproducts transported for use as animal food without further processing
- Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety
- Transportation of live food animals, except molluscan shellfish
*The Agency added a definition for “loaders” and included them as a responsible party. A loader is a person who physically loads food onto a motor or rail vehicle during transportation operations.
The Sanitary Food Transportation Act allows the agency to waive the requirements of this FSMA rule if it determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health.
The FDA announced in the proposed rule that it intended to publish waivers for two groups of people/businesses (see below). The agency intends to publish these waivers in the Federal Register prior to the date firms are required to comply with this rule.
The FDA also received comments asking for a waiver for transportation operations for molluscan shellfish for entities that hold valid state permits under the National Shellfish Sanitation Program. The agency continues to review comments on this request, and will issue a determination in the near future.
The agency intends to publish waivers for:
- Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety program. This waiver only applies when Grade A milk and milk products—those produced under certain sanitary conditions—are being transported. FDA acknowledges that controls for such transportation operations already exist under the NCIMS program, with State enforcement and FDA oversight.
- Food establishments holding valid permits issued by a relevant regulatory authority, such as a state or tribal agency, when engaged as receivers, shippers and carriers in operations in which food is relinquished to customers after being transported from the establishment. Examples of such establishments include restaurants, supermarkets, and home grocery delivery operations. FDA acknowledges that controls for such transportation operations already exist under the Retail Food Program, with state, territorial, tribal and local enforcement and FDA oversight.
What are the key requirements?
Specifically, the rule would establish requirements for:
- Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become unsafe. For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
- Transportation operations: The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact, i.e., the unintentional incorporation of a food allergen.
- Training: Training of carrier personnel in sanitary transportation practices and documentation of the training. This training is required when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport.
- Records: Maintenance of records of written procedures, agreements, and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.
What are the specific requirements for shippers or brokers?
- Responsible for ensuring that transportation operations are carried out in compliance with all requirements, and those requirements must be assigned to competent supervisory personnel.
- All transportation operations must be conducted under such conditions and controls necessary to prevent the food from becoming unsafe during transportation operations including:
- 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.
- 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.
- Taking effective measures to ensure that food that requires temperature control for safety is transported under adequate temperature control.
- The type of food (For example, animal fee, pet food, human food) and its production stage must be considered in determining the necessary conditions and controls for the transportation operation.
- 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 listed, may conduct transportation operations with common, integrated written procedures that ensure the sanitary transportation of food consistent with the requirements of this rule.
- If the shippers, loader, receiver or carriers 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.
Requirements applicable to shippers/brokers engaged in transportation
- The shipper (broker) 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 sanitary conditions. 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 notify in writing before the shipment.
- The shipper (broker) 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 (conditions of the shipment) change based upon the type of food being transported, in which case the shipper shall notify in writing before the shipment.
- A shipper must develop and implement written procedures, subject to the records requirements, adequate to ensure that vehicles and equipment used in its transportation operations are in appropriate sanitary condition for the transportation of food.
- A shipper of food transported in bulk must develop and implement written procedures, which ensure that a previous cargo does not make the food unsafe.
- The shipper of food that requires temperature control for safety under the conditions of shipment must develop and implement written procedures, to ensure that the food is transported under adequate temperature control.
- Shippers/brokers must retain records:
- That demonstrate that they provide specifications and operating temperatures to carriers, as a regular part of their transportation operations for a period of 12 months beyond the termination of the agreements with the carriers.
- Written agreements and written procedures, for a period of 12 months beyond when the agreements and procedures are in use in their transportation operations.
- Shippers, receivers, loaders, and carriers, which operate under the ownership or control of a single legal entity, must retain records of the written procedures for 12 months beyond when the procedures are in use in their transportation operations.
- Shippers, receivers, loaders, and carriers must make all records required available to a duly authorized individual promptly upon written or oral request.
- All records required 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.
- Except for written procedures, offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request. Electronic records are considered onsite if they are accessible from an onsite location.
Food and Drug Administration Proposed Rule: Sanitary Transportation of Human and Animal Food
Executive Summary: The Food and Drug Administration (FDA) is proposing to establish requirements for shippers, motor carriers, railroads, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. This applies to both interstate and intrastate commerce. This rule making is part of a larger effort to focus on prevention of food safety problems throughout the food chain, and is part of the Agency's implementation of the Sanitary Food Transportation Act of 2005 and the FDA Food Safety Modernization Act of 2011 (FSMA).
While the proposed rule does not specifically affect Department of Transportation (DOT) licensed property brokers, as one of the largest users of motor carriers, the brokerage industry will be required to play a significant role in the implementation of these rules. A DOT licensed property broker will likely be required by their customers to have knowledge of the rules, and make thorough business decisions by contracting with Food and Drug Administration (FDA) compliant motor carriers and railroads on their behalf. As previously mentioned, the proposed rule does not specifically mention DOT licensed property brokers, but there is a section within the proposed rule asking industry stakeholders for suggestions of other “parties” that should be subject to these requirements, and the best defense is a good offense.
Outbreaks and illnesses caused by contamination of food during transport have resulted in concerns. The goal of the proposed rule is to ensure that transportation practices do not create food safety risks. Practices that create such risk include: failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food during transportation.
The proposed rule builds upon current safe food transport practices. It allows the transportation industry to continue to use best practices concerning cleaning, inspection, maintenance, loading and unloading, and operations of vehicles and transportation equipment, that it has developed to ensure that food is transported under conditions and controls necessary to prevent contamination and other safety hazards.
The proposed rule would not cover shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in total annual sales. In addition, the requirements in the proposed rule would not apply to the transportation of fully packaged shelf-stable foods, live foods, animals, and raw agricultural commodities (RACs) when farms transport RACs.
Cost and Benefits: FDA estimates that the proposed rule would cover 83,609 firms and a total first year cost of $149.1 million (with an average of $1,784 per firm) and total annual cost is estimated to be $30.08 million (with an average of $360 per firm). FDA cites that they lack sufficient data to quantify potential benefits; nevertheless, improving food transportation systems could reduce the number of recalls, reduce the risks of adverse health effects related to such contaminated human and animal food and feed, and reduce the losses of contaminated human, animal, and feed ingredients and products.
Overall Provisions of the Proposed Rule:
- FDA seeks comments on “other” entities engaged in the transportation of food whose function in food transportation would be expected to affect the sanitary condition of food, and as such should be subject to the requirements of this rule.
- FDA tentatively concludes that the provisions in the proposed rule should be applicable to activities that are intrastate in character.
- This proposed rule sets forth sanitary transportation practices for shippers, carriers, and receivers who transport food that will be consumed or distributed in the United States.
- Additionally, this proposed rule would apply “in addition” not replace other FDA regulations that are applicable to food transportation. Including, cleaning of equipment requirements for current manufacturing practices (CGMP) for medicated animal feeds and addressing substances prohibited from use in animal food and feed.
“Shipper” is defined to mean a person who initiates a shipment of food by motor vehicle or rail vehicle. This does not include licensed property brokers, per discussion with FDA staff.
Summary of the Major Provisions of the Proposed Rule: The proposed rule would define transportation as any movement of food in commerce by motor vehicle or rail vehicle. The proposed rule would also establish requirements for sanitary transportation practices applicable to shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in food transportation operations.
Specifically, the proposed rule would establish requirements for:
- Vehicles and transportation equipment;
- Transportation operations;
- Records; and
Vehicle and Transportation Equipment Requirements (Proposed Section 1906):
- Requires that the design of the vehicles and transportation equipment used in transportation operations, the materials used in their manufacture and their workmanship to be suitable and that they are adequately cleanable for their intended use to prevent the food that they transport from becoming filthy, putrid, decomposed, or otherwise unfit for food.
- Requires that vehicles and equipment be maintained in such a sanitary condition as to prevent food that they transport from becoming filthy, putrid, decomposed, or otherwise unfit for food.
- Requires that vehicles and equipment used in transportation operations that can support the rapid growth of undesirable microorganisms, be so designed, maintained, and equipped to be able to maintain the food under temperature conditions that will prevent it from supporting such microbial growth.
- Requires that each freezer and mechanically refrigerated cold storage compartment in vehicles or equipment for food that can support the rapid growth of undesirable microorganisms, be equipped with an indicating thermometer, temperature-measuring device, or temperature-recording device to show the temperature accurately within the compartment.
- Requires that vehicles and equipment are stored in such a manner as to prevent the harboring of pest or becoming contaminated in any other way.
- Recommends that cleaned and sanitized portable equipment with food-contact surfaces and utensils be stored in a location and manner that protects food-contact surfaces from contamination.
Transportation Operations (Proposed Section 1908):
- Shippers (Section 1908(b):
- Requirements apply to all shippers, carriers, and receivers engaged in transportation operations unless specifically stated otherwise.
- Requires that responsibility for ensuring that transportation operations are carried out in compliance with all requirements as proposed be assigned to competent supervisory personnel.
- Require that all transportation operations be conducted in a manner and under such conditions as are necessary to ensure food does not become filthy, putrid, decomposed, or otherwise unfit for food.
- Would require that persons take effective measures such as segregation or isolation to protect food from contamination during transportation operations of raw foods and non-food items in the same load.
- Would require that persons take 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.
- Would require persons to ensure that food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation is transported in a manner, including temperature conditions to ensure the food does not become contaminated.
- Requires that shippers 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 deemed necessary by the shipper.
- Requires that before loading food not completely enclosed by a container onto a vehicle or into transportation equipment, the shipper must visually inspect the vehicle or the transportation equipment provided by the carrier for cleanliness and determine the vehicle is in appropriate sanitary condition for the transport of food.
- Requires that a shipper of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation, specify in writing to the carrier, (except a carrier who transports the food in a thermally insulated tank) the temperature condition necessary during the transportation operation, including the pre-cooling phase, to ensure that the operation will maintain the temperature conditions.
- Requires that a shipper of food that can support the rapid growth of undesirable microorganisms in the absence of temperature control during transportation, verify that each freezer and mechanically refrigerated cold storage compartment or container has been pre-cooled in accordance with the information submitted by the shipper as required.
- Requires the shipper to assume the requirements of providing demonstration to the receiver, if the shipper and carrier have agreed in writing, that the shipper is responsible for ensuring that the food was held under acceptable temperature conditions during transportation operations.
- Require that before offering a vehicle or transportation equipment with an auxiliary refrigeration unit for the transportation of food, a carrier must pre-cool each mechanically refrigerated freezer and cold storage compartment as specified by the shipper.
- Require carrier that offers a bulk vehicle for food transportation to provide information to the shipper that identifies the three previous cargoes transported in the vehicle.
- Require carrier that offers a bulk vehicle for food transportation to provide information to the shipper that describes the most recent cleaning of the bulk vehicle.
- Require carriers to develop and implement specified written procedures subject to the records requirements.
- Require written procedures to specify practices for cleaning, sanitizing if necessary, and inspecting vehicles and transportation equipment that the carrier provides for use in transportation of food.
- Require written procedures that describe how the carrier will comply with the provisions for temperature control.
- Require written procedures that describe how the carrier will comply with the provisions for the use of bulk vehicles as discussed earlier.
- Shippers and Receivers (Section 1098(c)):
- Require that shippers and receivers 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 that is convenient and that provides running water.
- Require shippers and receivers of food carry out loading and unloading operations under conditions that will prevent the food from supporting such microbial growth.
- Carriers (Section 1908(d):
- Require carriers to supply a vehicle and transportation equipment that meets any requirements specified by the shipper in accordance with proposed rule and is otherwise appropriate to prevent food from becoming filthy, putrid, decomposed, or otherwise unfit for food.
- Require carriers to establish requirements relevant to the maintenance of temperature control of foods.
- Require carrier to demonstrate to shipper and receiver (if requested) after the transportation move, to show that the carrier maintained temperature conditions consistent with those specified by the shipper. Unless the carrier and shipper have agreed in writing that, the “shipper” is responsible for monitoring the temperature conditions.
- Training (Section 1910):
- Establish training requirements for carriers.
- Require carriers to 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 proposed rule. This training would be required upon hiring and as needed thereafter.
- Require carriers to establish and maintain records that document required training of personnel. Such records would be required to include the date of the training, the type of training, and the person(s) trained.
- Records (Section 1912):
- Establish requirements for the retention and availability of records applicable to shippers and carriers engaged in transportation operations.
- Require shippers to retain records that demonstrate that they provide information as required in Section 1908 for a period of 12-months beyond when the shipper is subject to any requirement to provide such information.
- Require carriers to retain records of any written agreements and written procedures required by Section 1908 that describe cleaning, sanitizing, and inspection procedures for vehicles and transportation equipment for a 12-month period beyond when such agreements and procedures are in use in their transportation operations.
- Require carriers to maintain training records for a 12-month period beyond when the person identified in any such records continue to perform duties for which the training was provided.
- Require shippers and carriers make all records required by this proposed rule available to a duly authorized individual promptly upon oral or written request.
- Require all records by this proposed rule be kept as original records, true copies (photocopies, etc.), or electronic records.
- Provide that except for written procedures required by 1908(d)(6) (carriers procedures dealing with cleaning, sanitizing, temperature control, use of bulk vehicles), offsite storage of records is permitted after 6-months following the date the record was made if such records can be retrieved and provided onsite within 24 hours of request for official review.
- Provide that all records subject to this proposed rule are subject to the disclosure requirements under part 20 (CFR part 20 Freedom of Information Act).
- Waivers Sections 1914-1934):
- Provides FDA the authority to waive a requirement with respect to any class of persons, vehicles, food, or nonfood products, if FDA determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and the waiver will not be contrary to the public interest.
- Provide that FDA will consider whether to waive a requirement on FDA’s own initiative or on the petition submitted.
- Provide that a petition requesting a waiver must describe the persons, vehicles, food, or nonfood products to which the waiver would apply.
- Establishes presumption that the information submitted in a petition requesting a waiver and comments submitted on such a petition does not contain information exempt from public disclosure under FOIA and would be made public as part of the docket associated with this request.
- Establish the Director or Deputy Directors of the Center for Food Safety and Applied Nutrition (CFSAN) or the Center for Veterinary Medicine (CVM), of the Director of the Office of Compliance, CFSAN, or the Director of the Office of Surveillance and Compliance, CVGM, as the responsible official for responding to a request for a waiver from one or more requirements.
- Establish the general procedures applying to a petition requesting a waiver from one or more requirements.
- Provide that FDA, on its own initiative, determine that a waiver is appropriate; FDA will publish in the Federal Register a notice setting forth the waiver and the reasons for such waiver.
- Would specify that a waiver granted by FDA becomes effective on the date that notice of the waiver is published in the Federal Register.
- FDA would be able to modify or revoke a waiver if they determine that the waiver could result in transportation of food under conditions that would be unsafe.
- Establish procedures that apply if FDA determines a waiver should be modified or revoked.
- Potential Waivers
- Shippers and carriers who hold valid permits and are inspected under the National Conference on Interstate Mike Shipments (NCIMS) Grade “A” Milk Safety Program, only when engaged in transportation operations involving Grade A milk and milk products.
- Food establishments holding valid permits, only when engaged in transportation operations as receivers, or as shippers and carriers in operations in which food is relinquished to consumers after transportation from the establishment.
Effective Date: The regulation would become effective one year after the date of publication of the final rule for all covered parties except for small businesses, which would be given two years to come into compliance.