food safety modernization act (fsma) - cline wood · the transportation of food, including food for...

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Food Safety Modernization Act (FSMA):

A brief discussion of the FDA’s proposed rule for the “Sanitary Transportation of Human and Animal Food.”

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DISCLAIMER

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Informational Purposes Only

This material may not be reproduced in any form without the expressed written consent of Great West Casualty Company. The material is intended to be a broad overview of the subject matter and is provided for informational purposes only. Great West Casualty Company does not provide legal advice to its customers; therefore the subject matter is not intended to serve as legal advice for any legal issue(s) that may arise in the operations of its insureds. Legal advice should always be sought from the insured’s legal counsel. Great West Casualty Company shall have neither liability nor responsibility to any person or entity with respect to any loss alleged to be caused directly or indirectly as a result of the information contained in this presentation.



Sanitary Transportation of Human and Animal Food

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•  What? • On February 5, 2014, the Food and Drug Administration (FDA)

published proposed rules that would establish requirements for the transportation of food, including food for animals. The proposed rules are part of the implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the FDA Food Safety Modernization Act of 2011 (FSMA).

•  Where? • 79 FR 7005 (Feb. 5, 2014) (to be codified at 21 C.F.R. pt. 1, at §

1.900 et seq.).




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•  Why? • To ensure sanitary transportation practices in the transportation of

food in order to ensure that food is not transported under conditions that may render the food adulterated. The proposed rules seek to establish criteria and definitions that would apply in determining whether food is adulterated.

•  When? • The final rule is expected to be published on or before March 31,

2016. It is proposed that it shall be effective 60 days after publication in the Federal Register with staggered compliance dates. Compliance dates:

•  Two (2) years after publication of the final rule for “small businesses.” •  One (1) year after publication of the final rule for other businesses.

Ø A shipper, receiver, and carrier with less than $500,000 in annual sales is exempt.

See § 1.904.




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•  What is the scope and applicability? • Applies to shippers, receivers, and carriers engaged in

transportation operations for food whether or not the food is offered or enters interstate commerce.

• Applies to a foreign entity that ships food to the U.S. for later consumption or distribution in the U.S.

• Does not apply to raw agricultural commodities (RACs)

transported by farm. •  Is not intended to apply to the transportation of food that is

neither consumed nor distributed in the United States (e.g., From Mexico, through the US, and on to Canada).

• Does not apply to transportation of: shelf-stable food fully enclosed by a container; live food animals; and compressed food gases.

• See § 1.900.




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•  Current Definitions at § 1.904 – watch to see if they change in final rule.

•  “Carrier means a person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food….”

•  “Receiver means any person who receives food after transportation, whether or not that person represents the final point of receipt for the food. A receiver may also be a carrier or a shipper if the person also performs those functions as defined in this subpart….”

•  “Shipper means a person who initiates a shipment of food by motor vehicle or rail vehicle. The shipper is responsible for all functions assigned to a shipper in this subpart even if they are performed by other persons, such as a person who only holds food and physically transfers it onto a vehicle arranged for by the shipper. A shipper may also be a carrier or a receiver if the shipper also performs those functions as defined in this subpart.”




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•  Effects on Carriers: •  Vehicle & Transportation Equipment (proposed § 1.906) •  Vehicles and transportation equipment must be designed, maintained,

equipped, and stored in a manner to prevent food from becoming filthy, putrid, decomposed or otherwise unfit or rendered injurious to health.

•  For temperature controlled cargo, the equipment must be equipped with an indicating thermometer, temperature-measuring device, or temperature-recording device installed to show the temperature accurately within the compartment.




•  Effects on Carriers cont’d: •  Transportation Operations (proposed § 1.908)

Ø Unless a requirement set forth in proposed § 1.908 specifically only applies to shippers, receivers or carriers, the requirement applies to all of these persons.

•  The shipper must specify to the carrier, in writing, all necessary sanitary requirements for the carrier’s vehicle and transportation equipment, including any specific design requirements and cleaning procedures to ensure that the vehicle is in appropriate sanitary condition for the transportation of the food….

•  The shipper must determine that the vehicle or transportation equipment is in appropriate sanitary condition for the transport of the food….

•  For temperature controlled loads, the shipper must specify to the carrier, in writing, the temperature requirements (including pre-cooling). The shipper must also verify the trailer has been pre-cooled in accordance with the instructions.

•  The shipper and receiver must provide drivers who handle food not enclosed by a container during loading/unloading with access to a hand washing facility.




•  Effects on Carriers cont’d: •  Transportation Operations cont’d (proposed § 1.908) •  The carrier must supply a vehicle and transportation equipment that

meets any requirements specified by the shipper and is otherwise appropriate to prevent the food from becoming adulterated.

•  The carrier must pre-cool each refrigerated unit as specified by the shipper.

• Once the transportation operation is complete, the carrier must demonstrate to the shipper and if requested, to the receiver, that temperature conditions were maintained “consistent” with those specified by the shipper. This can be done by any appropriate means agreeable to the carrier and shipper. Ø  The carrier is not subject to this requirement if the carrier and

shipper agree in writing, before transportation operations, that the shipper is responsible for monitoring the temperature conditions during the transportation operation or otherwise ensuring that the food was held under acceptable temperature conditions.




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•  Effects on Carriers cont’d: •  Transportation Operations cont’d (proposed § 1.908) •  For bulk vehicles, the carrier must provide information to the

shipper that identifies the three previous cargoes transported in the vehicle, unless otherwise agreed in writing.

•  For bulk vehicles, the carrier must provide information to the shipper that describes the most recent cleaning of the bulk vehicle, unless otherwise agreed in writing.

•  The carrier must develop and implement written procedures that: (1) specify practices for cleaning, sanitizing if necessary, and inspecting vehicles/equipment the carrier provides; (2) describe how it will comply with provisions for temperature control; and (3) describe how it will comply with provisions for use of bulk vehicles.




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•  Effects on Carriers cont’d: •  Training (proposed § 1.910) •  Carriers must provide training to personnel that provides an

awareness of potential food safety problems that may occur during food transportation, basic sanitary transportation practices to address those potential problems, and the responsibilities of the carrier. The training must be provided upon hiring and as needed thereafter.

•  Carriers must establish and maintain records documenting the training. The records must include the date of the training, the type of training, and the person(s) trained.

•  The FDA envisions that training could be provided in half-day online format similar to training referred to as DOT HM 181 basic hazmat employee training, readily available in the private sector.




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•  Effects on Carriers cont’d: •  Records (proposed § 1.912) •  Carriers must retain any written agreements required by the rules as

well as records of the written procedures required by the rules for a period of 12 months beyond when the agreements and procedures are in use in their transportation operations.

•  Carriers must retain training records for a period of 12 months beyond when the person identified in any such records continues to perform the duties for which the training was provided.

•  Shippers and carriers must make all records required by the rules available to a duly authorized individual promptly upon request.




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•  Concerns •  More cargo claims and related issues:

Ø Mitigation

Ø Testing

Ø Seals

Ø Salvage




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•  Concerns cont’d: •  Contracts:

• The proposed rules contemplate written agreements. See § 1.908.

Ø Look for language that addresses technical non-compliance

Ø Look for language regarding seals

Ø Look for language addressing salvage

Ø Look for limitations of liability




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•  Final Thoughts • The final rules may have changes or revisions when they are

published (expected to be March 31, 2016)!

• Resources:

• FDA: http://www.fda.gov/fsma (subscription to FSMA updates available)

• FMSCA: http://www.fmcsa.dot.gov/regulations/hazardous-materials/training-

education



DISCLAIMER

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This material may not be reproduced in any form without the expressed written consent of Great West Casualty Company. The material is intended to be a broad overview of the subject matter and is provided for informational purposes only. Great West Casualty Company does not provide legal advice to its customers; therefore the subject matter is not intended to serve as legal advice for any legal issue(s) that may arise in the operations of its insureds. Legal advice should always be sought from the insured’s legal counsel. Great West Casualty Company shall have neither liability nor responsibility to any person or entity with respect to any loss alleged to be caused directly or indirectly as a result of the information contained in this presentation.

Informational Purposes Only



QUESTIONS?

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