Why we need to wake up and truly consider the meaning of the FSMA

The key concepts that exist in US food regulation are those of adulteration and misbranding, essentially making sure that neither is food contaminated nor its packaging misleading.To European eyes until relatively recently quite a number of the key US pieces of food law could look quite dated.

For adulteration some parts of the original 1906 Federal Meat Inspection Act still apply and elsewhere for misbranding there is the Federal Food, Drug & Cosmetic Act 1938 with important amendments for food additives in 1958 and for colour additives in 1960.

The fact that they have survived for so long means that one can only assume that the legislators did a great job first time around. The food industry has, however, been continually changing in the subsequent time and the overall US regulatory framework was starting to creak a little at the seams. According to FDA statistics each year 48 million Americans get sick from food related issues, that is about one in six of the population, with about 128,000 being hospitalised and 3,000 dying.

Enter then the Food Safety Modernization Act (FSMA) signed into US law by President Obama on 4th January 2011. Described as the biggest change in decades it sets out a new approach to food safety, moving from a reactive to a proactive regime. Despite being a lengthy document the FSMA lays down broad terms leaving the FDA as the government body to fill in the contours via seven pieces of regulation known as rules:

• Preventive controls for human food
• Preventive controls for animal food
• Produce safety
• Foreign supplier verification programme (FSVP)
• Accredited third-party certification
• Sanitary transportation of human and animal food
• Intentional adulteration

The FDA legislates for around 80% of the food and drink sold in the US. The FSMA only applies to the FDA leaving other US agencies such as the USDA (meat, poultry and egg products) and TTB (alcohol) untouched.

Businesses exporting food and drink to the US need to be particularly aware of the FSMA because of the final rule on foreign supplier verification published in November 2015. The US imports around 15% of its food, with some commodity areas being more significant than others.

For example, 80% of seafood consumed in the US is imported, as is 50% of its fresh fruit and 20% of its fresh vegetables. The volumes are increasing; in the 1990s imports consisted of about 400,000 skus rising to 11,000,000 now.

This imported food comes from around 130,000 manufacturers in more than 150 countries so it is a challenge for the FDA to ensure the same level of safety as domestic products. Whilst the FSVP places the emphasis on the importer in the US to ensure that safety is being demonstrably achieved it will inevitably have an impact on companies exporting to the US. A food business operator here in the UK/EU cannot rely on existing systems and certification to satisfy FDA as there are some subtle differences with FDA preventive controls.

Associated with the FSVP is the final rule on third party accreditation, also published in November 2015. This rule establishes framework procedures for accreditation of certification bodies. It also requires such certification on some specific imported foods, largely based on the risk they present. It also allows for voluntary certification so the participating company may benefit by facilitating the ease with which foods can enter the US through their prior notice procedures.

Conclusion

The changes in US food safety legislation brought about by the Food Safety Modernization Act are significant indeed, being seen as the most substantive change in many decades. Businesses in the UK and EU who export to the US cannot afford to ignore its effect as the FDA’s reach beyond its own borders has been greatly strengthened and a company’s processes might need some attention to ensure compliance with the new legislation.