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

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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”

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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)

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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.”

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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”?

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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.

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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?

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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.”

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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…”

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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

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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

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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

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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”

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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

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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)

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Carriers (cont’d)

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

necessary, and inspecting vehicles and transportation equipment;

  (ii) Describe how it will comply with the provisions for temp control and;

  (iii) Describe how it will comply with the provisions for the use of bulk vehicles

 Must train personnel engaged in operations

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Receivers

 Any person who receives food after transportation, whether or not that person represents the final point of receipt for the food

 Does not include an individual consumer  Must provide vehicle operators expected to

handle the food with hand washing facility  Additional requirements if temp control is needed

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Records (no surprise there)

 Must maintain records of exchange of information, written agreements, procedures, and training for 12 months

 Must make records available to a “duly authorized individual” promptly upon oral or written request

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The hammer

 Criteria and definitions in rule apply in determining whether a food is adulterated in that the food has been transported by a shipper, carrier, or receiver under conditions not in compliance with the regulation

 Failure to comply with the regulation is a prohibited act

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Waivers

 Can petition for waiver  FDA will waive a requirement “with respect to any

class of persons, vehicles, food, or nonfood products” if FDA determines that waiver:   will not result in transportation under conditions

that would be unsafe for human or animal health; and

  will not be contrary to the public interest

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Non-covered business

 A shipper, receiver, or carrier engaged in transportation operations with < $500k in sales

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High-risk foods: recordkeeping

 Comments due April 7  Resulting rule would likely extend existing one-up/

down requirement  Based on data or FDA’s experience (e.g., RFR)  Would take into account what is known based on

implementation of preventive controls  Peer-review is likely

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Criteria for designation

 Frequency of outbreaks and occurrence of illnesses;

 Severity of illness, taking into account illness duration, hospitalization and mortality;

 Likelihood of contamination;  Growth potential/shelf life;  Manufacturing process contamination probability/

intervention;  Consumption; and  Economic impact.

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FDA requests comment

 How should allergens be considered in developing a list of HRF?

 FDA has indicated special interest in animal foods  FDA’s focus is on acute affects, but also wants to

assess public health impact of chronic exposure to chemical hazards (e.g. chemicals formed during processing (aflatoxin))

  “The likelihood of contamination for chemical hazards would be determined by the percent positive above action levels (e.g., aflatoxins) or above allowable levels”

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QUESTIONS?

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