STHAF RULE – NOW FINAL

The rule directly affecting carriers, shippers and brokers is the Sanitary Transportation of Human and Animal Food (STHAF) rule, finalized on April 6, 2016.  The earliest compliance dates for some firms begin one year after publication of the final rule in the Federal Register, which will be April 6, 2017 for most companies.

Key Requirements for Carriers, Shippers, Brokers

The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.

Specifically, the STHAF or STF rule establishes requirements for:

  • Vehicles & Transportation Equipment (Design, Maintenance & Storage)
    Transportation Operations (Temperature Control, Pre-Cool, Sanitation & Product Segregation Or Isolation)
  • Records (Written Procedures, Agreements & Training, Record Keeping)
  • Training (Sanitary Transportation Practices)
  • Good Transportation Practices / GTP (Industry Standard)
  • Waivers (Exemptions to Rule)

Enforcement of New Food Safety Rules

Once the enforcement date has arrived for many companies in 2017, we will see more & more of the tools available to the FDA and supporting partners to aid in enforcing the new regulations.  As this new set of rules will impact such a vast industry, the FDA is relying on industry to help maintain and keep accountable, the industry best practices being put into place. Enforcement will also include judicial actions when necessary to complement non-judicial compliance actions and address matters for which there is no adequate administrative remedy, such as:

  • Seizure actions that are needed to back up administrative detentions
  • Injunction actions when suspension of registration or other measures are inadequate to prevent future non-compliance
  • Criminal prosecution for falsifying records, lying to FDA, knowingly putting consumers at risk, or in other appropriate cases.

FSMA Rules Enforcement – Discussion on How the New FSMA Rules will be Enforced:

Other Enforcement Tools:

  • Enhanced Records Inspection – Ability to inspect food company records.
  • Suspension of Registration – Ability to suspend the registration of a facility when the agency determines that food manufactured, processed, packed, received, or held has a “reasonable probability” of causing serious illness.
  • Mandatory Recall – Suspect that food is adulterated or mis-branded.
  • Administrative Detention – Can hold adulterated or mis-branded food to prevent it from entering the marketplace.
  • Warning Letters – Letters for food adulteration based solely on insanitary conditions and GMP violations.
  • Actions for Injunctions – Companies that fail re-inspection become candidates for an injunction action.
  • Park Doctrine & Criminal Liability – Ability to bring a criminal misdemeanor case against corporate executives based on a strict liability theory.

FDA – Sanitary Transportation of Human & Animal Food Fine Rule – US-FDA Website

Food Safety Modernization Act – US-FDA Website

FDA & CFIA Memoranda of Understanding – US-FDA Website

FSMA – Key Requirements References – US-FDA Website


NEXT STEPS:  Three options to move forward in preparing your company for FSMA requirements.

 

So, what are you supposed to do with all this information?

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The Timeline:

  • April 6, 2016: Rule was published
  • June 6, 2016: Final rules became effective
  • April 6, 2017: Large businesses are required to be in compliance – Enforcement Begins.
  • April 6, 2018: Small businesses are required be in compliance – Enforcement Begins.

There is a grace period to give you time to receive training and make the necessary changes and preparations — enforcement begins on April 6, 2017.

What Types of Industry are Being Affected by the Sanitary Transport Rule?

The final rule applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.  There are some exemptions and waivers to these rules, can be found here.

Who is Responsible for Implementing and Following the new Rules?

Everyone involved with the handling of food throughout your organization, as well as, management and safety teams are responsible to be fully trained and aware of the possible food safety risks and conditions that would render food unsafe.

Shippers/Brokers Responsible For:

  • Sanitary & Temperature Requirements and More

Carriers Responsible For:

  • Written Agreement with Shipper
  • Cleaning, Sanitizing, Temperature Controls & Inspecting Equipment
  • Equipment Meeting Temperature, Sanitary Requirements
  • Producing Accurate Records & Maintain Requirements
  • Training Documents

Receivers / Loaders (if different than Carrier) Responsible For:

  • Sanitary Unloading Activities
  • Inspecting Sanitary of the Trailers Before Loading
  • Inspecting Physical Condition of the Trailers
  • Ensuring the Refrigerated Cold Storage
  • All Inspections Need To Be Properly Documented and Any Deviations Properly Documented and Initiated.