The Sanitary Transportation Rule…
In this post, we’re going to cover the final rule of Sanitary Transportation of Human Food & Animal Food. The final rule was issued on April 5th 2016 and the compliance dates are:
for the small businesses is April 5th 2018
for all other businesses is April 5th 2017
The rule builds on the existing regulation of the 2005 Sanitary Food Transportation Act. It applies to:
(motor or rail)
When the rule refers to a ‘shipper’, it doesn’t necessarily mean the company that has responsibility for moving the product, but the company that actually instructs the movement of the product. This is a key element about the responsibilities. FDA have lent most of the responsibilities for meeting this rule upon the shipper, this is reiterated in how they’ve laid out the responsibilities:
Receivers are responsible for inspecting the load on receipt for signs of temperature abuse.
Loaders are responsible for inspecting the vehicle to ensure that it is free from contamination and is pre-cooled to the required temperature.
Carriers are responsible, on request by the shipper, and as stated in the contract with the shipper, to demonstrate that:
- the temperature requirements have been met,
- that the last bulk load is disclosed
- and that the cleaning log is complete for bulk loads
The rule applies to all shippers, receivers, loaders and carriers, except:
- Small businesses with a revenue of less than $500,000
- Farm product transportation.
- Transportation that travels through the US, but is not destined for the US, e.g. product sent from Canada to Mexico.
- Food that will be exported outside the US.
- Food that is fully enclosed in its packaging, which does not require temperature control for food safety purposes.
- Live food (except molluscs).
- Gases that will be used for food contact purposes, e.g. for modified atmosphere packaging.
- Food by-products to be used as animal feed without further processing.
The rule focuses on three areas of control, for food safety purposes, which are:
Control of bulk food, in tankers or containers where the product comes directly into contact with the vehicle equipment.
Food that is not fully enclosed by packaging
(and therefore is not fully protected).
Food that requires temperature control
(remember this is for food safety purposes only).
Note, the FDA is very clear:
- that food that is fully enclosed (and therefore protected) by packaging is not covered by the rule.
- Food that is not fully enclosed (and therefore not totally protected) is covered by the rule, and furthermore is their focus.
I have described this as fully enclosed by its packaging, or not fully enclosed by its packaging, as this makes sense to me (and hopefully to you). But you need be aware of the fact that the FDA do not describe it this way – they describe it as being not fully enclosed by the ‘container’, or fully enclosed by the ‘container’.
When the FDA refer to the ‘container’ they are talking about the packaging around the food, therefore the packaging that it is contained within.
I have not described it this way as I find it confusing, especially when we are talking about transportation, when a ‘container’ is probably better known to be a shipping container. Please do not make the mistake I did and think they are referring to any food that is transported in a shipping container, as this is not what they mean.
§1.906 states that any vehicle and transport equipment must be:
- Of the required design and construction to minimise the risk of contamination
- Maintained sufficiently to prevent contamination
- Capable of consistently providing the required temperature control
§1.908 states that controls must be in place to ensure:
- The equipment is in a sanitary condition
- That the previous bulk load does not pose a risk of contamination or cross-contact
- That temperature meets specification at all times
This must be controlled through documented procedures, training and records. Because the shipper is responsible for the product during transportation, the FDA will expect the shipper to provide the evidence of compliance. To do this, the shipper must have provided the carrier with a contract which contains their expectations for compliance, plus standard operating procedures (SOPs) of the processes that they expect them to adhere to.
Comparison to BRC…
Through compliance to either BRC Food Safety or BRC Storage & Distribution will ensure compliance with the Sanitary Transportation rule. The requirements of the rule are embedded in a number of sections of the BRC, for example the Food Safety Standard would cover the FDA’s rule through:
- 5.2 Raw Material & Packaging Acceptance & Monitoring Procedures: intake inspections
- 5.3 Management of Suppliers of Services: approval and monitoring of transport and distribution contractors
- 16 Dispatch & Transport: inspection prior to loading, temperature control, maintenance and hygiene, transport procedures and 3rd party contractors (i.e. carriers)
As always, if I can be of any help at all to you, please just let me know – happy to answer any of your questions, if you want to pop them in the comments box below!
We've tagged this article as: FSMA