FSMA—What You Need To Know An online informational session Module V. Sanitary Transportation Aurora A. Saulo, Ph.D. Professor and Extension Specialist in Food Technology University of Hawaii at Manoa aurora@hawaii.edu 1
Important Notice • Because sections were abbreviated for this presentation, the information provided is only an overview and should not be relied upon as a substitute for reading the final rule, or obtaining legal advice, or as a summary of all regulatory requirements. • Every company must conduct its own detailed review of the final rule.
MODULE V. SANITARY TRANSPORTATION OF HUMAN AND ANIMAL FOOD Final Rule issued April 6, 2015 3
Primary Concepts of the Rule • To prevent practices during food transportation that create food safety risks, such as: – Failure to properly refrigerate food (e.g., eggs, milk), including pre-cooling if necessary – Inadequate cleaning of vehicles between loading – Failure to properly protect food • From allergen cross-contact • From contamination – E.g., fresh produce not typically completely enclosed by its container may require a carrier to pick up only other similar fresh produce or good packaged in a sealed container along its route 4
Primary Concepts of the Rule (cont’d) • Three major focus areas defined by FDA to provide assurance: 1. That the vehicles and equipment used are in appropriate sanitary condition 2. That for bulk cargo, a previous cargo does not make the food unsafe 3. That for foods that require refrigeration for safety, there is adequate temperature control during transport of food. 5
Other Characteristics of the Rule • Focus is on food safety • Covers only motor and rail vehicles (air and water transportation are not included) • Does not address – Food security/Food defense • Designed to be flexible, non-prescriptive, more GMP-like 6
Key Provisions • Vehicles and transportation equipment (includes shipment and storage equipment that contact food) • Transportation operations – Primary responsibility is on the shipper but may assign their responsibilities to other parties through written contractual agreements • Records • Training • Waivers 7
Who Is Covered Shipper : arranges for the transportation of the food in the U.S. by a • carrier(s) sequentially – E.g., Retailers with distribution facilities, wholesalers Loader : loads food onto a motor or rail vehicle during • New transportation operations Carrier : physically moves food by motor or rail vehicle in commerce • in the U.S.; responsible for all functions assigned to a carrier even if performed by others, e.g., driver – Does not include parcel delivery service Receiver : receives food at a point in the U.S. after transportation • whether or not receiver is the final point of receipt for the food (but not a consumer and not distributing food) May be one entity • Does not matter if food is/isn’t in interstate commerce • 8
What Is Covered • Bulk food • Food requiring TCS ( temperature control for safety ) even if completely enclosed by container • Human food byproducts used as an ingredient in manufactured food or further processed 9
What Is Covered (cont’d) • Food not completely enclosed by a container – Food is partially open to the surrounding environment • Open wooden basket or crate • Open cardboard box • Vented cardboard box or plastic bag • Food transported in a bulk vehicle (unpackaged food in direct contact with vehicle) including food additives (except for food contact substances) and GRAS • E.g., cooking oil, fruit juices, sugar, seeds, flour 10
FDA Definition of “Completely Enclosed By Container” • Container – Physically separates the food from the environment – Functions to protect the food from environmental contamination during transportation – Examples: cans, bottles, sealed bag, or box, including paper bag or box permeable to moisture 11
FDA Definition of “Completely Enclosed By Container” (cont’d) • Pallet wrap is not a food container because it primarily facilitates handling. • Definition does not include vented cardboard cartons that are susceptible to environmental contamination – But if flaps are sealed by tape, may be considered a “completely enclosed container.” 12
Who Is Not Covered • Farms performing transportation operations on or off the farm premises • Non-covered businesses (Shippers, loaders, carriers, or receivers) – < $500,000/yr average revenue over a 3-year period – When food is only transshipped through the U.S. to another country – When food is imported for future export but not consumed or distributed in the U.S. • Is food produced in the U.S. for export covered? – When engaged in operations of food located in a USDA- regulated facility • Food is under FDA and USDA oversight as soon as it is transported • DOT is involved only to notify FDA and USDA if there’s an issue 13
What Is Not Covered Food completely enclosed by a • container – Shelf-stable CPG – Unless TCS is required – Frozen foods – Packaged foods refrigerated for quality • E.g., cookies completely enclosed in container – Note: Pallet wrap is not a food container Live food animals • (except molluscan shellfish) Compressed food gases • (e.g., nitrogen, oxygen, carbon dioxide) Food contact substances (FFDCA §409(h)(6), • such as packaging materials Packaged alcoholic beverage products • 14
What Is Not Covered (cont’d) • Small parcel deliveries • UPS, FedEx, etc. – Full carrier not generally functioning in interactive mechanism, not in dedicated food transport (covered in the preamble section) – Usually in fully enclosed containers – If TCS, are subject to previous regulations 15
What Is Not Covered (cont’d) • Human food byproducts transported for use as animal food not subject to further processing (e.g., goes directly to the farm to feed directly to livestock) – Note : Human food byproducts used as an ingredient in manufactured food or further processed are covered. 16
Are These Covered By the Rule? No Yes Yes No 17
Are These Covered By the Rule? (cont’d) No Yes 18
Are These Covered By the Rule? (cont’d) Farm carrier hauling grain Non-farm carrier hauling grain Yes, unless a non-covered No business 19
General Requirements – Vehicle & Transportation Equipment • Designed and made of materials to be suitable and adequately cleanable to prevent the food from becoming unsafe • Maintained in sanitary condition that prevents food from becoming unsafe during transport ( Methods? How often? ) • Stored to prevent harborage of pests or contamination to render food unsafe • If for TCS food, designed, maintained, and equipped to provide adequate temperature control to prevent food from becoming unsafe. 20
General Requirements – Transportation Operations • Competent supervisory personnel: responsible for ensuring compliance • Must take effective measures, such as segregation, isolation, packaging or other measures (e.g., hand washing) – To protect food from contamination by raw food and on-food items in the same load – To protect food in bulk vehicles or food not completely enclosed by a container from • Contamination • Cross-contact – To protect food from unsafe temperature fluctuations 21
General Requirements – Transportation Operations (cont’d) • If a shipper, loader, carrier, or receiver is aware of a possible material failure that will render the food unsafe (e.g., temperature deviation), food cannot be sold or distributed in the U.S. unless a qualified individual determines that the condition did not render the food unsafe. • Qualified Individual ( differently defined): qualified by training or experience and has “…scientific understanding of how temperature deviation could affect the growth of pathogens or production of toxins in the food” (81 FR 20143). 22
Requirements -- Shipper • Shipper has the most responsibility and is expected to “ know whether a food falls within the scope of the exclusion from the definition of ‘transportation operations’ applicable to food completely enclosed by a container and does not require temperature control for safety .” • Shipper must develop and implement written procedures to assure meeting the three major focus areas: – That the appropriate sanitary condition of vehicles and equipment keeps the food safe – That a previous cargo does not make the food unsafe if transported in bulk (and look back ONE cargo load only) – That there is adequate temperature control for food requiring TCS 23
Requirements – Shipper (cont’d) • Shipper must specify in writing to the carrier(s), and when necessary to loader(s), – All necessary sanitary specifications for the carrier’s vehicle and transportation equipment, including specific design specifications, cleaning procedures, and maintenance – An operating temperature for the transportation operation including, if necessary, the pre-cooling phase, that is sufficient to keep the food safe, if temperature control for safety is required 24
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