fsma update: gmps/preventive controls for animal food ... gmps/preventive controls comments are due

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  • Ricardo Carvajal Hyman, Phelps & McNamara, P.C. www.hpm.com www.fdalawblog.net

    FSMA Update: GMPs/Preventive Controls for Animal Food, Sanitary Transportation, and Recordkeeping for High Risk Foods

    North American Millers Association March 2014

  • The big picture

     August 30, 2015   Preventive Controls for Human Food   Preventive Controls for Animal Food

     October 31, 2015   Foreign Supplier Verification Program   Produce Safety Standards   Accreditation of Third Party Auditors

     March 31, 2016   Sanitary Transport of Food and Feed

     May 31, 2016   Intentional Contamination 2

  • Today’s Agenda

     GMPs/preventive controls for animal feed  Sanitary transportation  Recordkeeping for high risk foods  Whatever is keeping you up at night


  • GMPs/preventive controls

     Comments are due March 31  Proposed rule for animal food closely parallels the

    proposed rule for human food  Applies to facilities that manufacture, process,

    pack, or hold (MPPH) animal food, with certain exceptions

     Same approach to environmental monitoring and finished product testing

     Grinding/milling/cracking/crushing grains characterized as “low risk”


  • Exemption for RACs

     Preventive control requirements would not apply to facilities solely engaged in storage of raw agricultural commodities (RACs) intended for further distribution or processing

     E.g. of RAC: whole grain stored for animal food  GMP requirements would not apply to facilities

    solely engaged in holding or transportation of RACs

     Must still comply with the FDC Act (e.g., maintenance of sanitary conditions)


  • However…

     FDA flags as a concern “the potential for mycotoxins, such as aflatoxins, fumonisins, and DON, to be present in RACs obtained by farms and fed to animals.”


  • FDA could change its mind!

     FDA requests comment on whether   “animal food facilities, such as grain elevators, that

    are solely engaged in the storage of grains that are raw agricultural commodities should be exempt” from preventive controls/GMPs

      How many such facilities/operations are in the U.S.   What is best approach to ensure that RACs

    distributed by such facilities are “free of hazards that would be likely to cause illness or injury to animals or humans”?


  • Differences from human food rule

     “Two types of differences are meant to be substantive: Those relating to ready-to-eat food and those relating to food allergens. Both of those concepts are not applicable in the animal food context.”

     Also, the animal food rule addresses nutrient imbalances, which are generally not relevant to human food.


  • Food vs ingredient manufacturers

      If MPPH animal food for a single species of animal, focus on reducing hazards associated with ingredient and those most likely to occur during MPPH, relevant to that species

      If MPPH ingredient, “focus on reducing hazards associated with the ingredient and those species of animal that may consume animal food containing that ingredient”

     So – burden of identifying and controlling hazards falls on ingredient manufacturer – or does it?


  • Food vs ingredient (cont’d)

      “Facilities that MPPH animal food for a range of species or variety of uses would need to consider a more diverse number and type of hazards. In addition to focusing on hazards associated with their incoming ingredients or the types of equipment they use, a feed mill that manufactures food for multiple species would need to be aware of nutritional sensitivities of the animals for which it makes food.”


  • Food vs ingredient (cont’d)

      “Pet foods usually contain ingredients from the same sources used to make food for livestock and pet foods are sometimes manufactured in the same facilities as food for livestock.”

      “However, the hazards associated with pet food may be significantly different from the risks associated with food for livestock, and the facility [MPPH] would need to identify and address these hazards.”

      “A facility manufacturing pet food would need to address the potential for injury or illness… from the Salmonella hazard in not only animals, but in humans handling that pet food…”


  • Sanitary transportation

     Comments on proposed rule due May 31  Builds on Part 110 GMPs – risk-based  Applies to

      Transportation by motor or rail vehicle within or into U.S.

      “transportation operations”   shippers, carriers, and receivers – and any

    combination thereof (unless transhipping or importing for export)

      Interstate or intrastate activity 12

  • Vehicles and equipment

     Must be so designed and of such material and workmanship as to be suitable and adequately cleanable to prevent adulteration

     Must be maintained in sanitary condition to prevent adulteration

     Must be stored to prevent harborage of pests or becoming contaminated in a manner that could result in adulteration

     Additional requirements if temp control is needed


  • What are “transportation operations”?

      “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.”

     Not activities associated with the transportation solely of shelf stable food that is completely enclosed by a container (e.g., packaged flour)

     Not activities for RACs that are performed by a farm


  • Transportation operations - generally

     Responsibility for compliance must be assigned to “competent supervisory personnel”

     Must conduct operations under conditions and controls needed to prevent adulteration, including   Segregation/isolation - contamination by raw

    foods/non-foods in same load   Bulk vehicles or food not completely enclosed

    by container - segregation/isolation - contamination and cross-contact

      Additional requirements if temp control is needed 15

  • Shippers

     A person who initiates a shipment of food  Maintain responsibility for functions assigned to

    shippers even if performed by others (e.g., holder of food who transfers food onto vehicle)

     E.g., distributor initiates a shipment of food by arranging for a carrier to pick up a shipment at a holding facility – responsible for loading activities of employees of the holding facility


  • Shippers (cont’d)

     Must specify to the carrier, in writing, all necessary sanitary requirements for the carrier’s vehicle and “transportation equipment,” including design requirements and cleaning procedures to ensure that vehicle is in appropriate sanitary condition

     Goal is “to prevent food from becoming filthy, putrid, decomposed or otherwise unfit for food, or being rendered injurious to health from any source during the transportation operation”


  • Shippers (cont’d)

      If loading food not completely enclosed by a container onto vehicle or into transportation equipment:   must first visually inspect and determine that

    vehicle or equipment is in appropriate sanitary condition

      must provide vehicle operators expected to handle the food with hand washing facility

     Additional requirements for foods that can support the rapid growth of undesirable microorganisms in absence of temp control


  • Carriers

     A person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food

     Maintain responsibility for all functions assigned to carrier even if performed by others (e.g., drivers)

     Must supply a vehicle and transportation equipment that meets any requirements specified by shipper, and is otherwise appropriate to prevent adulteration - additional requirements if temp control is needed 19

  • Carriers (cont’d)

     Bulk vehicles – must give shipper info on 3 previous cargoes, unless have written agreement to contrary - presumes that procedures are established to ensure adequacy of vehicle (e.g., dedicated use)

     Bulk vehicles – must give shipper info describing most recent cleaning, unless have written agreement to contrary – presumes that procedures are established to ensure adequacy of vehicle (e.g., contractual agreement to use specified cleaning procedure)


  • Carriers (cont’d)

     Must develop and implement written procedures that:   (i) Specify practices for cleaning, sanitizing if

    necessary, and inspecting vehicles and transportation equip

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