FDA Food Safety Modernization Act (FSMA) Sanitary Transportation

in Human and Animal Foods

Responsibilities, Potential Food Safety Problems, Sanitary Transportation Practices

Session 1 (12:00 PM EST to 1:30 PM EST)

Half an hour break

Session 2 (2:00 PM EST-400 PM EST)

The final rules on the Sanitary Transportation of Human and Animal Foods establish training requirements for all carrier personnel engaged in food transportation operations.   Training certificates are required for these topics:

1. Responsibilities of the carrier under the final Sanitary Transportation rules
2. Awareness of potential food safety problems that may occur during food transportation
3. Basic sanitary transportation practices to address those potential problems

This training is REQUIRED for all personnel engaged in transportation operations upon hiring and as needed thereafter. 

The full FDA FSMA compliance date for all impacted shippers, carriers and receivers of human and animal foods is April 6, 2018.  All training, food safety transportation plans and system improvements must be completed by that date.

Over 64,000 U.S. companies are impacted by the requirements established by the 2011 passage of this FSMA rule.  The last major set of rules requiring full compliance for large and small companies was published in April 2016.  These rules established April 2018 as the final date for full legal compliance for all carriers by road or rail.  To date, thousands of U.S. carriers have not yet provided training for loaders, unloaders, drivers and all personnel involved in food transportation. 

This 3.5 hour boot camp will provide you with a training certificate and an outline of what you must do to be in compliance with the law.  While training sets the stage, you must have a documented system in place to prove you are adequately protecting transported food from sanitation and temperature problems.

In addition to training, the rules require substantial improvement to procedures and processes involving sanitation and temperature controls designed to prevent adulteration of human and animal foods during transportation processes.  Substantial written agreements between shippers and carriers must also be established and new documentation systems must be in place to provide evidence of rule compliance.

The shortage of support infrastructure involving container and trailer sanitation and the lack of specification by shippers and carriers regarding adequate sanitation procedures is causing many companies to ignore rule compliance.  These topics will be covered in the webinar.

The FDA defines a carrier as a “person who owns, leases, or is otherwise ultimately responsible for the use of a motor vehicle or rail vehicle to transport food. The carrier is responsible for all functions assigned to a carrier in this subpart even if they are performed by other persons, such as a driver that is employed or contracted by a trucking firm. A carrier may also be a receiver or a shipper if the person also performs the functions of those respective persons as defined in this subpart.” 

The new law was published on April 6, 1016, which mean there is little time left for perishable food carrier operations to develop and implement risk reducing preventive food handling, load and un-load, as well as make distribution and transportation process improvements.

What carriers are exempt from these training requirements?

1. Carriers with an average annual income less than $500,000 requirements.
2. Carriers of food completely enclosed by a container
3. Carriers of live food animals, except molluscan shellfish

Required Training

Course 1:  Responsibilities of the Carrier Under the Final Rules (1 hour)

Session 1 covers the Final Rules on the Sanitary Transportation of Human and Animal Foods (now law) as published by the Food and Drug Administration under the Food Safety Modernization Act (FSMA).

Learning objectives:

• Understand US FDA FSMA Law for the Sanitary Transportation of Human and Animal Foods
• Understand changes from the proposed FDA FSMA rules
• Know the different requirements for shippers, carriers and receivers
• Know who is exempted
• Understand the FDA waiver requirements

Course 2:  Awareness of Potential Food Safety Problems That May Occur During Transportation

This session covers bacteria, chemical and physical hazards, preventive control of hazards that can impact food during food load, unload and transportation operations; prevention versus corrective action, misuse of disinfectants and sanitizers, not cleaning bins, trays, pallets and other tools and equipment used in carrier operations, cross contamination, employee personnel hygiene, temperature variation; vehicle, container and trailer traceability and reporting systems, reefer failures, lack of container maintenance, improper or missing container security systems, accidents, recalls

Learning objectives:

• Understand basic bacterial, chemical and physical hazards
• Know what prevention means
• Know how tools and equipment, pallets, trays, bins, gaskets, hoses, load and unload systems, vehicles, containers and trailers can contaminate foods
• Understand the impact of temperature variation on food safety and food quality
• Know what conditions occur in transportation operations that may cause bacterial growth
• Be able to prevent cross contamination
• Know what missing records can mean
• Know what action to take if a reefer fails or a container is out of acceptable maintenance condition
• Understand accident protocols
• Be able to participate in recalls

Course 3:  Basic Sanitary Transportation Practices to Address Food Transportation Sanitation Problems

Course includes contracts of carriage and agreements; system assessment strategy; flowcharting your operations, establishing critical parameters and measurement; standards for management, validation of preventive controls, sanitation, temperature monitoring and container (vehicles, trailers and shipping containers), traceability and training; procedures, record keeping and retention; audit and certification, training, wash, ATP and bacteria testing, inspection and re-inspection requirements, calibration, MSDS, statistical analysis and records retention.

Learning objectives:

• Develop a contract of carriage and other agreements required between carriers and shippers
• Understand basic management, preventive control, sanitation, temperature monitoring and traceability and training standards
• Help to write and implement appropriate container procedures (truck, trailer, sanitation, testing, container traceability and temperature monitoring)
• Learn to keep appropriate records
• Understand the transportation food safety audit and certification process
• Help to establish preventive controls
• Understand how to collect, analyze and take preventive action using statistical data

Course 4:  What your company Must do to fully comply

This brief session outlines the steps your company must have in place in addition to proof of training.   Discussion of your written and approved plan, procedures, contractual agreements, in-transit issues, ground operations and other topics to move your folks from training into operationalization.

Learning objectives:

• Know the next steps to full compliance
• Understand temperature and food transportation data requirements and options
• Begin to develop your compliance plan as part of your overall food safety planning efforts
• Overcome in-transit and ground operations issues
• Know how to become fully certified and to present this certification to your customers

Who must attend all these courses?

• All carrier employees of foods not completely enclosed by a container engaged in food transportation operations regardless of whether or not the food is being offered for or enters interstate commerce
• Interstate, intrastate and import carrier personnel
• Business owners
• Compliance Professionals
• Manages
• Buyers
• Supervisors
• Internal food safety audit team members
• Load and Unload Personnel
• Maintenance Personnel
• Food Safety Employees
• New business development, sales and marketing specialists
• Inspectors
• Trainers

Join this session by expert speaker Dr. John M. Ryan and the Sanitary Cold Chain to get the information and knowledge to comply with FSMA sanitary food transportation law, fulfill carrier training requirements and upgrade your food transportation system. Get armed with the knowledge needed to build a basic plan and learn the difference between preventive and corrective actions.

Arthroscopic procedures performed by orthopaedic surgeons and podiatrists are some of the most common surgeries performed with the insurance companies spending a lot of money on these procedures.  Because of the frequency in which these procedures are performed, insurance guidelines and policies are ever changing, making it difficult to keep up with what is currently payable, and what is not considered medical necessary or experimental and investigational.

Conference Expectation:-

The expectations of this conference is that the attendee upon the completion of the conference should have an understanding of assigning codes and modifiers for reimbursement all arthroscopic procedures, in addition to the other insurance guidelines and rules that have to be followed.  We will also discuss tips on what is the best practice for documentation to be able to pass an insurance audit.

Conference Focus:-

• Hip arthroscopy-Understanding the lack of CPT® codes available and understanding bundling and unbundling of these procedures
• 2018 NCCI Policy Manual guidelines for arthroscopic procedures
• NCCI edit changes and issues in shoulder arthroscopy
• Pre-certification and what to do when the codes are different
• Modifier 58 and 59 usage in arthroscopic procedures
• Reporting CPT® codes for synovectomy and debridement
• Reporting subchondroplasty procedures
• Insurance carrier policies related to arthroscopy

Who Should Attend:-

• Physicians
• Auditors
• Coders
• Billers
• Medical Assistants
• Physicians Assistants
• Nurse Practitioners
• Nurses