In July 2008, Brian Grubbs of Dolores, Colorado, fell violently ill. After suffering severe dehydration, weakness and weight loss, symptoms all commonly associated with food poisoning, he traced the cause of his troubles to an innocuous purchase he had recently made at his local Walmart.

Grubbs’s case was just one of 1,300 across the US involving individuals poisoned by the salmonella bacteria that year. A subsequent investigation by FDA concluded that most had succumbed after consuming contaminated jalapeño and serrano peppers imported from Mexico and later sold in US supermarkets.

The episode was far from unique. The previous year had seen the first case of botulism attributed to US canned goods since the 1970s as well as the second-largest recall of beef products in the country’s history thanks to an E coli contamination. These incidents fuelled fears across the US that food safety regulation was in a state of crisis.

In response, US Congress passed the Food Safety Modernisation Act (FSMA). Signed by President Obama on 4 January 2011, the act aimed to completely overhaul the emphasis of the work of FDA by attacking the problem of contamination at source, irrespective of whether that is at home or abroad. Through a phased implementation of the law – its full provisions are set to come into full effect next year – FDA is now seeking to evolve from a purely reactive to a preventative force against contamination.

No compromise

Before the passage of FSMA, FDA inspectors would enforce food import regulations at the border. Now, with an ever-increasing volume of foodstuffs passing into the US, this framework is proving unsustainable. Although only 15% of food consumed in the country is imported, this figure includes 80% of seafood, half of all its fresh fruit and nearly a quarter of its fresh vegetables.

Undeniably, these patterns across imported foodstuffs reflect an expectation among US consumers that their food supply can remain diverse without compromising on quality and safety.

To assure this, FSMA provided for the implementation of a foreign inspection regime in line with international standards on food quality.

"Our proposed Foreign Supplier Verification Program would greatly strengthen the oversight of foods imported on behalf of the American consumer," says Jason Strachman-Miller, a health communications specialist and spokesperson for FDA. "Importers will be required to perform specific risk evaluations to verify that the food they export to the US has been produced in ways that provide identical levels of public health protection as those required of domestic food producers.

"The approach that we’re proposing will provide importers with the flexibility in determining what they consider to be appropriate verification measures based on food and supplier risks, while still acknowledging the greater risk to public health posed by the most serious hazards in foods."

Addressing an international conference on food safety in Shanghai last year, FDA deputy commissioner Michael Taylor outlined the progress his agency is making in this area south of the border: "We have worked well with Mexico for many years and share a strong public health purpose with our counterparts.

"FSMA is bringing new produce safety standards and greatly heightened demand for verification that standards are being met. To meet this demand, Mexico and the US are building a true operational partnership on produce safety," Taylor said.

In July 2014, this existing arrangement was deepened with the announcement of a "produce safety partnership" between FDA and its Mexican food regulatory agency equivalents SENASICA and COFEPRIS.

"FSMA is bringing new produce safety standards and greatly heightened demand for verification that standards are being met." 

Additionally, FDA is forging greater links with regulatory authorities in the country where the US sources the majority of its imported goods.

"Our important collaboration with China is at a different level of development, which is understandable given the greater physical distance, and our different legal, regulatory and technical starting points," said Taylor. "We have made real progress in the exchange of regulatory and technical information, laboratory improvement and harmonisation, training on US practices for Chinese inspectors and food companies, and mutual understanding," he added.

There are still areas where improvements could me made – currently, there are only four permanent FDA staff in China, while issues in quality control covering low-acid canned foods, pet treats and farm-raised seafood remain unresolved – but the agency is keen to emphasise it’s a relationship that is deepening with each passing year.

An additional rule proposed on third-party certification would also see the creation and accreditation of external auditing organisations, which would then be able to confirm that importers are abiding by the strict regulations mandated by FDA while remaining independent of the federal agency.

"An accreditation body can be a foreign government, agency or a private third party," says Strachman-Miller. "Additionally, it would have to meet high standards in the realms of legal authority, capacity, impartiality, quality assurance and records procedures."

Domestic squabbles

FSMA anticipates radical reform in the domestic sphere too, not least in the diffusion of regulatory oversight away from the federal government toward major producers. A newly proposed rule on preventive controls for human food would require foreign and domestic food producers to write and present plans to FDA on how they will individually identify and minimise contamination hazards.

"FDA would then evaluate these plans and inspect the relevant facilities to ensure the firms are implementing them," explains Strachman-Miller. "Additionally, the proposed rule on preventive controls for animal food would establish current good manufacturing procedures and stringent preventative controls for animal feed and pet food, as well as the ingredients for them."

The FSMA also offers provisions for the strengthening of ties with other food agencies at the state and local level. Primarily, this comes in the form of grant money to be invested by FDA in increasing the capability of state authority to enforce local and federal food safety rules. Training programmes on food preparation in production facilities across the US are set to be expanded, with the aim of instilling in staff the importance of mitigating contamination risks as early as possible in the supply chain.

At all stages, FDA has reached out to academia, industry and consumer groups for consultation and advice on the rules being formulated for final FSMA implementation in 2016. However, in recent months, it has made a renewed effort to consult parties affected by the law after pointed criticism of several of its provisions.

A common complaint has been the way in which farms – which, by their very nature, store what are officially termed as ‘raw agricultural commodities’ – would be subject to the same quality-control procedures as larger processing facilities, as well as a proposed rule, since refined, that would have required hop farmers to inspect, properly store and package all of the spent grain prior to being turned into animal feed.

"The proposed rule on preventive controls for animal food would establish current good manufacturing procedures and stringent preventative controls for animal feed and pet food, as well as the ingredients for them." 

Similarly, the obligation on the part of domestic companies to conduct their own audits of foreign importers has been attacked, not least for the reputational difficulties large corporations are likely to face if they are seen to be repeatedly hosting private inspectors.

Subsequent revisions in light of such criticisms are widely considered to have delayed FSMA’s implementation until next year. Nevertheless, Strachman-Miller insists that outside consultation continues to play a fundamental role in determining the final form of the act.

"Already, our outreach has had significant impact on supplemental amendments to four existing rules that aim to prevent food-borne illness," he says. "The proposed supplemental rules include changes to water quality and testing, what the language should be when it comes to organising product testing procedures, environmental monitoring and supplier verification at food facilities. Our collaboration is set to continue. For example, there’s another meeting scheduled for 23-24 April in Washington DC on further aspects of FSMA implementation."

Yet, while the consultation process for new rules is proceeding, Strachman-Miller maintains that congressional funding remains a problem in projecting the overall success of the legislation.

"In implementing FSMA, FDA is mandated to institute reforms in six areas, with $109.5 million in new budgetary authority as requested in the president’s 2016 budget," he says. "These include the modernisation of inspection regimens and training programmes, a national integrated food safety system, expanded education and technical assistance, new import safety systems, and risk analytics and evaluation.

"Without that investment, now and over the next few years, implementation of the FSMA will be disrupted, uneven or just delayed, at an obvious detriment to public health and the food industry."

Although Strachman-Miller is keen not to be drawn into a discussion of politics, it is difficult to see Congress’s current inclination towards spending reductions across government departments relaxing in the near term. Bearing in mind the significant emphasis FSMA brings to bear on corporate responsibility in food safety, it is easy to envisage an industry largely policing itself if FDA is not sufficiently funded to enforce the new regulations.

When one considers the current statistics on food safety in the US, the implications of such an event seem dire. Currently, 48 million Americans – one in six of the population – succumb to food poisoning annually; 128,000 victims are hospitalised, with around 3,000 people ultimately dying from exposure to food-borne contaminants.

In an increasingly globalised world, the importance of governments reaching out to foreign producers and manufacturers to guarantee acceptable standards in food preparation is indisputable. If all parties fail to adapt accordingly, the health of the consumer will become dangerously uncertain.