The proposed legislation is the companion bill to the Food Safety Enhancement Act that passed the House back in July, and Hamburg said that she would like to see the Senate version more closely resemble that legislation. Crucially, the Senate bill does not allow the FDA to seize foods that fail to apply hazard analysis and controls as ‘adulterated’, as specified by the House. Hamburg said that this exclusion would blunt the FDA’s tools for enforcing safety requirements.
Speaking at a hearing of the Health, Education, Labor and Pensions (HELP) Committee, Hamburg called the legislation “a major step in the right direction” toward implementing recommendations made by the Food Safety Working Group set up by President Obama in March.
Access to records
However, Hamburg criticized the Senate bill – the Food Safety Modernization Act – for omitting a clause that would give the FDA authority to access food records during safety inspections, as recommended by the group.
“Routine records access is a critical component of a food safety regulatory framework and is one of the most significant gaps in FDA’s existing authority,” she said.
She noted that the US Department of Agriculture has routine records access for the products it regulates, and the FDA also has routine access to records for products other than foods.
Broad backing
On the other hand, the bill does include several measures that have garnered strong bipartisan support as well as broad industry backing, including giving the FDA the authority to order a product recall if a company fails to act voluntarily, increasing the frequency of facility inspections, better verifying that food imports meet US safety requirements, and requiring that manufacturers keep more thorough records. It is co-sponsored by five Republicans and six Democrats.
Funding fears
The House bill had an estimated cost of $3.7bn, partly funded by a $500 annual fee per facility – itself a compromise on an earlier $1,000 per facility proposal – but the Senate version does not specify fees for manufacturers and Hamburg did not estimate its cost.
Although she said that the FDA supports the intent of increased inspections, she added: “However, we are concerned that the bill does not provide a guaranteed consistent funding source to help FDA fulfill its new responsibilities.”
Also speaking at the hearing, food safety director of the Center for Science in the Public Interest Caroline Smith DeWaal said: “It is rare to see the level of consensus reflected among such diverse consumer and industry organizations on the need to fix our national food safety system. Congress can, with simple changes, take action this year to make food safer for American consumers.”
Calls to overhaul America’s food safety system intensified this year on the back of a spate of multi-state foodborne illness outbreaks. Support from food manufacturers also strengthened after a salmonella outbreak in peanut products led to more than 700 illnesses and nine deaths, as well as one of the largest product recalls in US history, at an estimated cost of at least $1bn.