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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER GGSANITARY TRANSPORTATION OF HUMAN FOODS
RULE §229.804Transportation Operations

(a) General requirements.

  (1) Unless stated otherwise in this section, the requirements of this section apply to all shippers, food transporters, 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 food transporter, if the person also performs the functions of those respective persons as defined in this subchapter. An entity subject to this subchapter (shipper, loader, food transporter, or receiver) may reassign, in a written agreement, its responsibilities under this subchapter to another party subject to this subchapter. The written agreement is subject to the records requirements of §229.806(d) of this title (relating to Records).

  (2) Responsibility for ensuring that transportation operations are carried out in compliance with all requirements in this subchapter 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 adulterated during transportation operations including:

    (A) 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.

    (B) 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.

    (C) Taking effective measures to ensure that food that requires temperature control for safety is transported under food specific adequate temperature control.

  (4) The type of 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 food transporters, which are under the ownership or operational control of a single legal entity, as an alternative to meeting the requirements of subsections (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 §229.806(e) of this title.

  (6) If a shipper, loader, receiver, or food transporter becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food adulterated 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 adulterated.

(b) Requirements applicable to shippers engaged in transportation operations.

  (1) Unless the shipper takes other measures in accordance with paragraph (3) of this subsection 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 adulterated, the shipper must specify to the food transporter and, when necessary, the loader, in writing, all necessary sanitary specifications for the food transporter'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 food transporter in writing before the shipment. The information submitted by the shipper to the food transporter is subject to the records requirements in §229.806(a) of this title.

  (2) Unless the shipper takes other measures in accordance with paragraph (5) of this subsection 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 food transporter, except a food transporter 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 food transporter in writing before the shipment. The information submitted by the shipper to the food transporter is subject to the records requirements in §229.806(a) of this title.

  (3) A shipper must develop and implement written procedures, subject to the records requirements of §229.806(a) of this title, 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 food transporter or another party covered by this subchapter under a written agreement subject to the records requirements of §229.806(a) of this title.

  (4) A shipper of food transported in bulk must develop and implement written procedures, subject to the records requirements of §229.806(a) of this title, 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 food transporter or another party covered by this subchapter under a written agreement subject to the records requirements of §229.806(a) of this title.

  (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 §229.806(a) of this title, 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 food transporter or another party covered by this subchapter under a written agreement subject to the records requirements of §229.806(a) of this title and must include measures equivalent to those specified for food transporters under subsection (e)(1) - (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 subsection (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 subsection (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 food transporters engaged in transportation operations. When the food transporter and shipper have a written agreement that the food transporter is responsible, in whole or in part, for sanitary conditions during the transportation operation, the food transporter is responsible for the following functions as applicable per the agreement:

  (1) A food transporter 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.

Cont'd...

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