Food safety - the US Food Safety Modernization Act

This has been a momentous year regarding food safety in the US not because of any single, high-profile contamination but because the country has witnessed the first comprehensive reform of its food safety laws for 70 years.

The Food Safety Modernization Act

The Food Safety Modernization Act (FSMA) covers three areas, namely improving the capacity of the Food and Drug Administration (FDA) to prevent food safety problems; improving its capacity to detect and respond to problems; and improving the safety of imported food.

While it has enhanced the FDA's reactive powers, the legislation has been characterised as a shift for the agency from a primarily reactive function to a proactive, preventive one. It also takes account of substantially changed priorities for food safety legislation since the FDA was first established. Given that 70 years has elapsed since the primary legislation on food safety was laid down, this is hardly surprising. 

Existing US food safety laws were in essence designed to address problems such as economic adulteration, issues which by and large are less prevalent today, or at least no longer represent the predominant risk to public health that they did in the first part of the 20th century. 

Today, without doubt the key areas such legislation needs to address concern microbial contamination of food causing illnesses, by establishing and if necessary policing the institution of best practice by industry to minimise such problems and optimising the response to and tracing of contaminations when they arise.

Preventive focus

Among the FSMA's preventive stipulations, it requires every food processing facility to have a written plan of hazard analysis and preventive controls which must be made available to the FDA on request. It also gives the FDA the authority to set commodity-specific standards for the safety of fresh produce.

On inspections, it requires the FDA to allocate resources to inspections according to the risk profile of the facility and if necessary increase the frequency of inspections.

The act includes a raft of measures relating to imported food specifically. The FSMA requires importers to perform food safety supplier verification activities to ensure that imported foods are as safe as those manufactured and sold in the United States. It also allows the FDA to require certification or other assurance of safety for 'high-risk' food imports, which could be defined by known safety risks of that food, or known safety risks or inadequate government controls in the particular country of origin.

The FSMA also requires the FDA to develop a comprehensive plan to help expand the technical, scientific and regulatory capacity of foreign governments and their respective food industries, and to enter into agreements with foreign governments to facilitate the inspection of facilities in countries of origin. The FSMA prohibits the entry of food from a foreign facility or country which fails to permit such inspection. 

As well as authorising third-part accreditation of foreign facilities, the FSMA also directs the FDA to establish offices in at least five foreign countries to improve the agency's presence overseas and positively impact the safety of FDA-regulated products.

With regard to reactive capabilities, the FSMA requires the FDA to establish pilot projects to evaluate new methods for rapidly and effectively tracking and tracing food products in order to prevent and mitigate foodborne illness outbreaks.

Critically, it gives the agency authority to order mandatory food recalls and detain food shipments for a short period of time.

Full details of the Act can be viewed at http://www.fda.gov/Food/FoodSafety/FSMA/ucm247546.htm.

A law broadly welcomed

Confirmation that the reforms the FSMA has brought were necessary can be found in the broad support the act received from both industry and campaigners.

The Grocery Manufacturers Association (GMA), which represents food manufacturers, said the "landmark" legislation provided the FDA with "the resources and authorities the agency needs to help strengthen our nation's food safety system by making prevention the focus of our food safety strategies, and will help restore the public's faith in the safety and security of the food supply".

Meanwhile, the Food Marketing Institute, which represents the major retailers, said the FSMA would "enhance the safety of our food supply", highlighting the requirement for companies to provide a food safety plan, the FDA's new recall powers and the adoption of a risk-based approach to food safety inspections as particularly significant.

Support from the produce sector was less effusive. The two leading trade associations, United Fresh and the Produce Marketing Association (PMA), had both been critical of amendments exempting some small producers from certain measures.

However, the PMA said it was encouraged by the "positive aspects and smart reforms that form the bill's backbone". It said it supported many of the provisions, singling out the written food safety plan requirements, as well as the FDA powers to regulate imported foods, mandatory recalls and the commodity-specific protocols for fresh produce.

On the NGO side, the Consumer Federation of America "thanked" President Obama for signing into law the "most comprehensive reform of the Food and Drug Administration's microbiological food safety programme in 70 years", adding that the authorities in the new law would be "critical to protecting consumers from food-borne disease".

The Center for Science in the Public Interest (CSPI) said the passing of the legislation was an "historic victory for consumers, who can now look forward to a future of safer food", and that the implementation of the law would give Americans greater confidence in the safety and security of the food supply and reduce the number of outbreaks of foodborne illness. 

While the passage of the bill had been marked by much discussion and negotiation in Washington, and there are certainly divergences of views between stakeholders, the FSMA is a rare example of food policy which has consistently drawn consensus between industry and campaigners.

As David Plunkett, senior staff attorney in the food safety department at CSPI, remarks: "We actually coordinated a lot of our efforts with industry, which is kind of rare because on one side we're fussing at them and suing them and on the other we are working with them to get this bill passed. But it was a good collaboration. It worked to a good public health end and whatever their motives were, the consumer benefited."

Stakeholder consultation - one hopes with the same degree of concord - is set to continue during the implementation phase of the FSMA, which is discussed in the next section of this briefing.