FDA Update September and October 2016

On September 26, 2016, FDA issued the guidance "Necessity ofthe Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories," amending the food product categories available for registration of food facilities. Some of the food product categories that have been amended are: (i) acidified foods and low-acid canned foods, which are no longer listed as food product categories but activity types; (ii) the animal food categories, which now add botanicals and herbs, direct-fed microbials, animal protein products, forage products, human food by-products not otherwise listed and technical additives (the "animal protein products" category replaces the previous "animal derived products" category, and the "processed animal waste products" category replaces the "recycled animal waste products" category); and (iii) the molluscan shellfish optional activity type, which is now a food product category. FDAstatedthese amendments will help the agency's ability to respond quickly and accurately to food-related emergencies and to verify that imported products are correctly identified by where and when they were produced.

In theSeptember 19, 2016,Federal Register, FDA announced the effective date for the definition of "qualified auditor" included in 21 C.F.R. § 117.3 (80 FR 55098at 56147) and § 507.3 (80 FR 56170at 56339). The definition of "qualified auditor" was included in the final rule for "Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" of September 17, 2016, which reads, "An audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M of this chapter." The preamble of the rule stated that FDA would announce the effective date for the definition once it finalized the rule, "Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits to Issue Certifications." Such final rule was published on November 27, 2015, with an effective date of January 26, 2016, and thus FDA announcedthe definition's effective date was September 19, 2016.

Sanitary Food Transportation Rule Updated as of October 18, 2016

What's the scope of the Sanitary Transportation Rule?

The new Rule applies to entities that are engaged in the shipping, receiving, loading and carrying of food as defined under 21 U.S.C. §321(f) in the Food, Drug and Cosmetics Act. Loading and loaders are a new category found in the final Rule. This Rule does include exemptions for small businesses (less than $500,000 in annual revenue), foods which are simply passing through the U.S. en route to foreign countries (also known as "transshipping"), and food in facilities that only handle food regulated by the USDA. Transportation activities conducted by farms are not covered by the Rule, although consideration by the FDA is underway for a companion rule outlining what it considers to be good farm practices. These exemptions apply only to the requirements of the Sanitary Food Transport Rule and do not exempt these entities from other transportation sanitation requirements under other regulations.

Furthermore, the Rule explicitly states that the new regulations apply in addition to any other transportation requirements, and do not supplant them, including the new cGMPs and HARPC requirements in 21 C.F.R. §117 (human foods) and §507 (animal feeds), the regulations covering the handling of eggs in 21 C.F.R. § 118, and the cGMPs for medicated feeds under 21 C.F.R. §225.Finally, the Rule states that any food that is not transported in a manner compliant with the Sanitary Transport Rule may be deemed adulterated under 21 U.S.C. §342.

To whom does the Sanitary Transportation Rule apply?

The Rule is expansive and serves to include a large segment of the transportation market and the most common shipping methods in the U.S. A handful of definitions in 21 C.F.R. §1905 provide the scope of the Rule:

  • Bulk vehiclemeans 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.
  • Carriermeans a person who physically moves food by rail or motor vehicle in commerce within the U.S. The term carrier does not include any person who transports food while operating as a parcel delivery service.
  • Transportationmeans any movement of food by motor vehicle or rail vehicle in commerce within the U.S.
  • Transportation equipmentmeans 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.

The 2005 SFTA did not mandate that FDA issue regulations applicable to the sanitary transportation of food by any other conveyances, including barges or ships and aircraft. However, if FDA finds that there is a public health need to regulate air and barge or ship transportation, FDA will consider whether it wants to pursue covering these routes under a non-SFTA authority in the future. At this time, the Sanitary Transport Rule does not generally apply to food products while they are being transported by air or water.

Are there new requirements for transportation equipment?

The new Rule requires equipment used in transportation (trucks, containers, tanks, etc) to be adequate for its intended uses, specifically considering the types of food products that will be transported. Under the Rule, this equipment must be:

  • Adequately cleanable to prevent allergen cross-contact and contamination between loads
  • Adequately maintained
  • Able to properly manage temperature for shipments that require temperature control
  • Stored in a manner to prevent contamination by pests or other materials

Although it would be expected with the implementation of the HARPC rules that these covered activities are already in place, the Rule now clearly makes these activities required activities regardless of the applicability of HARPC. Further, it is well worth noting that the FDA intends to work with the Department of Transportation to develop procedures for safety inspections designed to identify contamination or adulteration of food products in transit.

How do covered entities respond to suspected contamination or adulteration of food during transport?

Under 21 C.F.R. § 1.908(6), if a company involved in the transportation of food products detects or suspects possible contamination, the Rule establishes procedures to be followed. These possible contamination situations which require action include (1) failure to adequately clean the transport container, (2) cross-contamination, (3) a possible material failure of temperature controls, or (4) other conditions that may render the food unsafe during transportation. When these conditions are suspected, the covered transport entity must take all appropriate steps to ensure that the food is not sold or otherwise distributed until a qualified individual makes a determination that the suspected failure did not render the food unsafe. These covered entities will need to have in place written corrective action plans which include FDA-mandated actions, such as reporting to the reportable food registry, as well as corrective actions including, but not limited to, ensuring that the food is not used or sold, possible market withdrawal or recall.

Shippers are required to supply to the transporter, in writing, shipping conditions that ensure safe transport of the food. If these conditions vary per load, these conditions must be provided before each shipment.

What records-keeping responsibilities does the new Rule impose?

Under 21 C.F.R. § 1.912, each entity in the chain of transportation has specific records-keeping requirements. Some entities involved with multiple steps of the transportation process (manufacturers that act as shippers, loaders and carriers, for example) must complete all requirements relevant to the steps in which they are involved. Some examples of these records- keeping requirements are:

  • Shippers must retain records that demonstrate they provided specifications and written agreements under 21 C.F.R. § 1.908(b) for 12 months after they were in use.
  • Carriers must retain records of the specifications received from shippers under 21 C.F.R. § 1.908 for 12 months after they were in use. Carriers must also keep records of all training of employees as required by 21 C.F.R. § 1.908 for 12 months after any trained employee ceases performing the procedures that were the subject of the training.
  • Electronic storage of records is allowed. Also, off-site storage of some records is also allowed if they can be retrieved within 24 hours.
    It is important to note that these records-keeping requirements are in addition to requirements already under other applicable federal or state requirements.