New FSMA Food Transportation Regulations - Are You Ready?Holly Mockus | Laura McMillan

August 19, 2015

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Today’s Speakers

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Holly MockusAlchemy

Diana PeñaModerator

Laura McMillanInstructional Technologies,

Inc.

Agenda

• Proposed Sanitary Transport Rule Overview

• Using Driver Training to Help Prepare

• Q&A

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Proposed Sanitary Transport Rule Overview

What?

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• The proposed rule covers: – general sanitation of transport vehicles, – refrigeration of food, – proper cleaning between loads and – protecting food during transport from all forms of adulterations

(allergens, contaminants and spoilage).

• The proposed rule addresses:– foods that require time/temperature control for safety (ex -

fresh-cut leafy greens, fresh-cut fruits and vegetables and spouts)

– foods that require temperature control to prevent microbial spoilage (ex - meat, poultry, pasteurized juice, frozen foods).

Who?

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Receiver Person who receives food after transportation, whether or not they represent the final point of receipt for the food (e.g., retail distribution center).

NOT an individual consumer or a person that receives the food on behalf of a consumer

Shipper Person who initiates a shipment of food by motor or rail vehicle (e.g., the food manufacturer who arranges for their food to be shipped).

Carrier Person who owns, leases, or otherwise is ultimately responsible for the use of a motor or rail vehicle to transport food (e.g., the carrier that physically transports the food).

Where?

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• Applies to: – Food to be consumed in the United

States. – Food directly transported into the

U.S.

Types of Transportation

Affected?

Motor

Vehicle

Air*

Water*

*exceptions may apply to some air/water transportation

New Regulatory Requirements Timetable

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Final Rule Published

Large Businesses: 1 Year to Comply

Small Businesses: 2 Years to Comply

March 31, 2016 March 31, 2017 March 31, 2018

FDA will carry out inspections but the Agency will also be working with the U.S. Department of Transportation (U.S. DOT) to establish procedures for transportation safety inspections to be conducted by U.S. DOT or state personnel.

Survey Question

How many firms within food transportation and food facilities does FDA estimate will be covered by the Sanitary Transport rule?o 53,609o 75,609o 83,609o 95,609

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The Cost of Driver Non-Compliance with Existing Regulations

Incident Cost 4% Margin 3% Margin 2% Margin

$25,000 $625,000 $833,333 $1.25 million

$50,000 $1.25 million $1.7 million $2.5 million

$100,000 $2.5 million $3.3 million $5 million

$200,000 $5 million $6.7 million $10 million

$500,000 $12.5 million $16.7 million $25 million

$1 million $25 million $33.3 million $50 million

The case for training: avoiding just one incident

The Hidden Costs of Incidents

Indirect Costs

Direct Costs

5 – 50 times the direct cost

Areas of Focus

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• Vehicles and transportation equipment

• Transportation operations

• Information exchange

• Training

• Records

• Waivers

Areas of Focus

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#1 Vehicles and transportation equipment:

• The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become contaminated.

– Vehicles used to transport food for commercial purposes, must be designed for clean-ability, suitable for intended use and maintained in a sanitary condition.

Areas of Focus

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#2 Transportation operations:

• The measures taken during transportation to ensure food is not contaminated, such as adequate temperature controls and separation of food from non-food items in the same load.

– Food requiring temperature control, must use vehicles designed to maintain the food at proper temperature.

– Consider mixed loads, bulk loads

Area of Focus

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#3 Information exchange:

• Procedures for exchange of information about prior cargos, cleaning of transportation equipment, and temperature control between the shipper, carrier, and receiver, as appropriate to the situation.

– Sets protocols for shippers, carriers & receivers about prior cargo, temperature control and cleaning to prevent cross contamination.

• Wash Tickets - a carrier transporting bulk liquid would want to ensure that tankers are clean and free of allergens prior to loading (milk for example)

Area of Focus

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#4 Training:

• Training of carrier personnel in sanitary transportation practices and documentation of the training.

– Training to cover food safety preventive controls• For example - sanitation requirements, time / temperature

requirements, record keeping best practices– Includes documentation of training

Area of Focus

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#5 Records:

• Maintenance of written procedures and records by carriers, shippers and receivers for transportation equipment cleaning, prior cargos, and temperature control.

– Requires records be maintained in general for one year and be made available for inspection upon oral or written request by FDA.

Shippers Carriers

SanitationWritten agreements assigning responsibility for temperature monitoring or regarding bulk vehicle cargoes and cleaning

Temperature Control Written procedures

Training Records

Area of Focus

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#6 Waivers:

• Procedures by which the FDA will waive any of these requirements if it determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health and that it is in the public interest.

Exemptions

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– Food that is transshipped through the United States to another country

– Food that is imported for future export and that is neither consumed or distributed in the United States

– Transportation of shelf stable food that is completely enclosed by a container

– Transportation of compressed food gases– Transportation of live food animals– Shippers, receivers, or carriers engaged in food transportation

operations that have less than $500,000 in total annual sales.– Transportation activities for raw agricultural commodities

performed by a farm.

Receiver Requirements:

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• Provide a hand washing facility to vehicle operators if they are expected to handle foods that are not completely enclosed while unloading

Shipper Requirement:

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• Provide written specifications to the carrier regarding all necessary sanitary requirements for the carrier’s vehicle and transportation equipment, including any specific design requirements and cleaning procedures to prevent adulteration

• Visually inspect transportation equipment for cleanliness before loading food – Especially for food not completely enclosed by a container

• Provide written specifications to the carrier for required temperature controls for the transported food

• Verify pre-cooling of transport compartment when refrigeration during transport is required

• Provide a hand washing facility to vehicle operators if they handle foods not completely enclosed during loading or unloading

• Load foods which require temperature control for safety to prevent the rapid growth of microorganisms

Adapted from the Network for Public Health Law - https://www.networkforphl.org/_asset/hhnvyp/Primer-for-Section-111-of-FSMA-FIN.pdf

Carrier Requirements:

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• Provide transportation equipment that meets shipper requirements that is clean and appropriate for use to prevent adulteration or cross contamination

• Pre-cool transport compartments to the shipper’s required temperature

• Demonstrate to the shipper and to the receiver that the carrier has maintained required temperature

– The shipper may be responsible for temperature monitoring of the shipment and the associated record keeping requirement (Use own temperature monitoring device(s) and recovers the device(s) upon delivery).

• Implement written procedures and practices for cleaning, sanitizing (if necessary), and inspecting transportation equipment to maintain appropriate sanitary condition

• Implement written procedures to comply with the temperature control monitoring requirements

• Provide and document training to transportation operations personnel– food safety issues that may occur during food transportation,– sanitary transportation preventive controls and practices– the carrier’s responsibilities

Adapted from the Network for Public Health Law - https://www.networkforphl.org/_asset/hhnvyp/Primer-for-Section-111-of-FSMA-FIN.pdf

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Using Driver Training to Help Prepare

Survey Question

Are the drivers you work with ready for the sanitary transport rule? o Yeso Noo I don’t know

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Drivers Are the Conduit

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• Drivers: – Transfer product between shippers and receivers– Maintain the cold chain– Responsible for meeting delivery requirements– Must drive safely to meet timelines– DOT requirements– …and now, FSMA

Compliance Training: What is the best approach?

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• A blended learning strategy is correlated to best outcomes

• Consider online lessons to introduce/reinforce knowledge of new FSMA regulations– Benefits: economical, consistent message, 24/7 accessibility, self-paced and

automated recordkeeping

• Use “hands-on” for refresher or intro to proper vehicle inspections, reefer unit checks, cargo securement etc.

– Subject matter experts should lead training using ‘skills check off’ approach to document driver’s abilities.

– Benefits: assure driver ability to perform to standard

• Group or prioritize drivers based on compliance history of drivers

• Use online lessons or safety messages proactively to sustain compliance and performance

– Quarterly is most common practice– The safest fleets ‘touch’ the fleet monthly. (i.e. safety message monthly, online course

quarterly.)

Unsafe Driv-ing

Fatigued Driving

Driver Fitness

Controlled Substance

Vehicle Maintenance

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

50.4

64.2

79.8

54.258.5

30.5

44.241.3

20.1

43.4

25.9

36.6 38.9

18.0

37.7

CSA Score Comparison

Entire Industry

All Pro-TREAD clients

Pro-TREAD clients taking 4+ lessons/user/year

A lower score means a safer fleet.

Source: DOT, December 2011

Does Training Make a Difference?

Scores Fall as Training Increases

Alchemy – Instructional Technologies, Inc. Partnership

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• 74 PRO-TREAD courses available through Alchemy

• Targeted training to the right person at the right time

• Consistent messaging to all drivers

• Easy-to-use technology

• Create and track learning plans for individuals or groups

Additional Driver Training Courses Coming

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• 6 courses in development – Driver Food Safety: SOPs Trailer Maintenance– Driver Food Safety: SOPs Pre-Chilling Procedures– Driver Food Safety: SOPs Maintaining Proper Temperature– Driver Food Safety: SOPs Less Than Load (LTL) Delivery Stops– Basic Food Defense for Drivers– Effective Record Keeping Practices

Conclusion

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• Reinforce business relationships between all stakeholders now

• Make sure you have written procedures in place

• Follow those procedures

• Use training to ensure compliance and increase performance

• The benefit of training far outweighs the cost

Federal Register:https://www.federalregister.gov/articles/2014/02/05/2014-02188/sanitary-transportation-of-human-and-animal-food

Proposed Rule Info from FDA: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm

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Q & A

THANK YOUTelephone: 888.988.8832

contactus@alchemysystems.comTelephone: 706.483.4400

Holly Mockusholly.mockus@alchemysystems.com

Laura McMillan

laura@instructiontech.net

http://www.alchemysystems.com/industries/distribution/