US food rule will continue to drive up standards and requirements; beware the contractual negotiations.

The US Food & Drug Administration (FDA) has announced that the Food Safety Modernization Act (FSMA) rule on 'Sanitary Transportation of Human and Animal Food' is now final. TT Club previously highlighted (TT Talk 3 July 2014)

the proposals, aimed at protecting public health in the US, while making them 'as feasible for companies as possible'. For most practical purposes, the final rule takes effect on 6 April 2017, being one year after its publication in the Federal Register.

The rule is, with limited exceptions, applicable to all food transport to and within the USA. It relates to public health safety, rather than issues of quality that do not make goods dangerous to consume. Such food quality issues - spoilage etc - are generally handled under the provisions of the Federal Food, Drug & Cosmetic (FD&C) Act. The rule exempts food that is transhipped through the US to another country, and food that is imported for future export and is neither consumed nor distributed in the United States.

Consultation changes

As might be expected, the final rule reflects a number of changes from the original proposal. Most of the amendments are quite specific to the US shipper community and domestic trades.

There is, for example, recognition for rail operators that their involvement in moving railcars generally precludes ability to ensure that sanitary conditions or temperature controls are met. However, placing the primary responsibility for sanitary conditions on the shipper may be altered by written agreement, which may be seen as a potential theme in implementation.

Further, the final rule adds the 'loader' (known outside the US as 'packer'), being the person responsible for the physical process of putting the food into the transport unit. In essence, the provisions map easily to the

CTU Code

, being to ensure that the transport unit is suitable ('appropriate sanitary condition') and, for temperature controlled cargo, that it is prepared including pre-cooling, if necessary. The latter point about pre-cooling refrigerated equipment continues to be a vexed issue, where opening the unit in a hot humid ambient environment for cargo packing leads to the potential for moisture to condense on the interior surfaces of the transport unit and 'rain' on any exposed cargo or cargo packaging, which itself may compromise the cargo integrity.

Temperature records

While the final rule relaxes the originally proposed requirements around temperature recording devices, one of the more potentially onerous requirements - for carriers to provide temperature records on request - remains. Since temperature monitoring, both in relation to the refrigeration equipment and from devices within the cargo stow, is notoriously difficult to interpret, this may yet prove problematic. Again, the shipper and the carrier can agree by contract on the applied temperature monitoring mechanism, but much in practice depends on the nature of the packaging and the quality of packing process in order to ensure that the air flow is both effective and accurately measured.

As identified previously, there are further potential obligations applicable to carriers. Specifically, where the shipper and carrier agree by contract that the carrier has responsibility for the sanitary conditions during transport operations, the carrier is required to provide personnel with adequate and documented training - to US food safety standards.

More records

Records overall are also of importance. Shippers need to be able to demonstrate that there is appropriate information about the necessary sanitary requirements for any transport unit carrying food, together with temperature information for refrigerated cargo. Conversely, carriers need to maintain records around their procedures for cleaning and inspecting units, as well as how to meet requirements for shippers about temperature conditions, amongst others.

“Overall, this rule is representative of the continuing drive for improvements in the industry”

Overall, this rule is representative of the continuing drive for improvements in the industry. It is likely that - apart from the usual commercial negotiations and maintenance of existing standards - technology will be required to assist in real-time monitoring and systems enhancements to support procedural controls and data exchange.

Further guidance can be found on the

FDA web site

. This includes reference to a broader familiarisation programme, as well as supports such as the Food Safety Technical Assistance Network.

We hope that you have found the above interesting. If you would like further information, or have any comments, please email us, or take this opportunity to forward to any colleagues who you may feel would be interested.

We look forward to hearing from you.

Peregrine Storrs-Fox

Risk Management Director, TT Club