Sanitary Transportation of Human and Animal Food Seminar Presented by Ted L. Perryman

Statutory Scheme Sanitary Food Transportation Act (SFTA) 2005 Food Safety Modernization Act (FSMA) 2011 These statutes require the FDA to issue regulations requiring shippers, motor carriers and others to use sanitary transportation practices. 2005 SFTA set the first key guidelines: Required FDA to promulgate regulations establishing sanitary transportation practices addressing sanitation, vehicle use limitations, packaging isolation/protective measures, recordkeeping, and information disclosure Once future regulations become effective, food transported under conditions not in compliance with regulations deemed “adulterated” “Transportation” defined under the law only encompasses the movement of food in the U.S. by motor vehicle or rail, thus transport by any other mode, for example a barge hauling grain, is not covered by this statute Applicable to shippers, carriers, receivers, and others engaged in food transport 2011 FSMA set the timeframe for SFTA regulations

Sanitary Transportation of Human and Animal Food Rule Each Year 1 out 6 Americans get sick 128,000 are hospitalized 3,000 fatalities Transportation plays a crucial role This Rule is one of 7 rules issued since 2013 by FDA Goal is to prevent practices during transportation that create food safety risks This is the only rule of the seven directly applicable to transportation. The other rules are as follows: Good Manufacturing Practice and Hazard Analysis and Risk Based Preventitive Controls for Human Food (78 FR 3646) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (78 FR 3504) Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventive Controls for Food for Animals (78 FR 64736) Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (78 FR 45730) Accreditation of Third Party Auditors/Certification Bodies to Conduct Food Safety Audits (78 FR 45782) Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (78 FR 78014) The numbers for those getting sick are based on recent CDC analysis of Americans getting sick from foodborne diseases

Who Must Comply? Shippers, Loaders, Receivers and Motor Carriers This includes brokers Considered a “shipper” under the new Rule Applies to both interstate and intrastate transportation by motor vehicle or rail (but not to sea or air transport) Costs: Estimated costs of the Rule between $113 million - $117 million/year FDA did not have sufficient data to fully quantify benefits of regulation, but hope is to create savings in the area of public health

Who Does Not Have to Comply? Small Business Exception. Less than $500,000 in annual revenue Farmers Food transshipped through the US to another country Food imported for future export not consumed in US Food shipped by air or sea Frozen Food (by comment) Livestock For farms, means transportation of raw agricultural commodities (RACs) by a farm. Transportation of shelf stable food fully enclosed by a container, nor are compressed food gases covered by Rule

When Do you have to Comply? Rule was published on April 6, 2016 Deadline for Compliance: April 6, 2017 Exception: Small Businesses: April 6, 2018 (under 500 employees or less than $27.5 mm in revenue if motor carrier)

Key Definitions for Motor Carriers Transportation “any movement of food in commerce by motor vehicle…” Carrier “any person who physically moves food…by truck in commerce.” Bulk Vehicle “any car, tank or container in which food is shipped in bulk with food coming into direct contact with the vehicle”

More Definitions Transportation Equipment Transportation Operations Bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, load systems and unloading systems. Transportation Operations All activities associated with food transportation that may affect the sanitary condition of food including cleaning, inspection, maintenance, loading, unloading and operating vehicles.

4 Key Aspects of Rule Vehicles and Transportation Equipment Transportation Operations Training Record Keeping

Equipment Applies both to design and maintenance of equipment Cleanable to prevent cross-contact and contamination between loads (but, does not impose methods of cleaning) Maintained and stored in sanitary condition Able to manage temperature shipments that require temperature control (does not dictate how temp is measured or recorded) Stored in a manner to prevent contamination from pests, etc.

Transportation Operations During the transport of food: Competent supervisory personnel in charge Shipper must specify to motor carrier all necessary sanitary conditions including operating temperatures (plus pre-cooling phase, if needed) Adequate temperature controls Segregate ready to eat from raw food Segregate food from non-food in same load Protect from cross-contact Sections 1.908(b) and (d) of the Rule contain provisions specific to shippers and carriers respectively: Shipper specifies all necessary sanitary requirements for the vehicle, including conditions necessary for a temperature-controlled food Carrier must supply a vehicle that meets shipper’s specifications, including pre-cooling Carrier must demonstrate to shipper (and receiver on request) that appropriate temperature conditions were maintained during transport, as appropriate Flexible and consistent w/ current practices Does not require massive documentation such as time-temperature strip chart recordings for every load of refrigerated food transported and show these records to the FDA. Carrier must only be able to, in the form of a record, provide FDA w/ records demonstrating they conduct information exchange w/ shipper, such as an SOP. Carriers must disclose information to shippers about 3 prior cargoes and recent cleaning for a bulk food transport vehicle. Disclosure of information about prior cargoes and cleaning for bulk food transport vehicle a routine practice for much of the industry. Shipper verifies vehicle pre-cooling and sanitary condition, as appropriate

Training Motor Carriers are required to train all personnel in sanitary practices: Basic sanitary practices Records kept for 12 months. FDA declined to prescribe the content, frequency and length of training If contractually required to do so Training must be documented including type, date and persons trained Awareness of potential food safety problems that may occur

Recordkeeping Motor Carriers must maintain records of written procedures, agreements and training. Typically must be kept for 12 months. Training records for 12 months. Specifications from shipper for 12 months. Electronic storage is allowed. Must make records promptly available (24 hours). Records required of carriers: Written procedures (SOPs) for cleaning and inspection of vehicles, and describe how it will meet the requirements to provide information to shippers about temperature condutions and bulk cargo protection, as appropriate Training records Records required of shippers: Records demonstrating shipper provides information to carriers about the necessary sanitary requirements for a vehicle, and the necessary temperature conditions for a temperature-controlled food, as appropriate Both shippers and carriers must be able to demonstrate to FDA through their records that they do disclose information to one another as required in Sections 1.908(b) and (d).

Waivers? FDA can waive any part of the rule if it will not affect safety and not contrary to public interest Likely difficult to obtain Will be a public record Certain waivers meant for future publication FDA intends to publish waivers for: Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety program. This waiver will likely only apply when Grade A milk and milk products, produced under certain sanitary conditions, are in transport. Food establishments holding valid permits issued by a relevant regulatory authority, such as a state or tribal agency, when engaged as receivers, shippers and carriers in operations in which food is relinquished to customers after being transported from the establishment. Examples of such establishments include restaurants, supermarkets, and home grocery delivery operations.

Contractual Agreements Can responsibilities be Assigned by Agreement? Yes! Shippers/brokers are going to shift responsibility to motor carriers during transportation Temps can be included in BOL Recommend that if motor carrier you get specs for each load

Contractual Agreements Can responsibilities be Assigned by Agreement? Yes! Must be in writing and include: Conditions must be specifically express (sanitary) Operating temperatures Rule allows a one-time notification (does not have to be on all BOLs)

Claim Management Strategies Review your cargo insurance and make sure you have coverage paying attention to exclusions. Carmack still applies. Notice to shippers/brokers that presumption is that tenders do not include food unless prior written notice. Surcharges for loads that require special handling?

Claim Management Strategies Take immediate action and document everything. Mitigate freight damages. Understand shipping specifications. Make sure process are in place to get specifications. Make sure intake process protects you. Read and understand all Agreements and BOLs.

More Claim Management Make sure shipper knows you are exempt if “small” carrier. If you also “broker” food loads, make sure motor carriers are in compliance. Procedures to make sure motor carrier gets specs. Obtain specs from shipper Contractual language in place Can apply to anyone in the logistics chain. Technical non-compliance? Minimum operational standards that apply in absence of specifics from shipper?

More Claim Management Keep good records on: Training Temps Cleaning Inspections Sanitization Each load and specs Previous cargo information (especially if bulk)

Enforcement Injunction and criminal prosecution Civil penalties and fines Periodic Inspections by FDA FDA and FMCSA will work together This is in addition to any other statute or rule that may apply. Lawsuits (cargo and personal injury) If motor carriers becomes aware that food may be unsafe, it cannot be sold or distributed. Must communicate to all that food cannot be sold/distributed If temp deviation, only a qualified individual can make determination

Any Questions? Ted L Perryman 314-421-1850 tperryman@robertsperryman.com