S. 510 – FDA Food Safety Modernization Act – The Small Farms and Businesses Assistance Act
In early 2007, just after the first large-scale peanut butter Salmonella outbreak, I was meeting with Senator Durbin’s staff on legislative language that eventually formed the basis of S. 510. After spending the fifteen minutes making my pitch, I was politely ushered out the door. As I walked down the hallway towards the elevator out of his office came then Senator Obama. In one of those awkward moments that can only happen in a Senate office building, we walked ignoring each other towards the elevator.
As the elevator opened I decided to reintroduce myself, but before I could he asked why I was in Durbin’s office. I explained that I was pitching Durbin’s staff on why food safety legislation was so needed and why it was so important to put “this trial lawyer out of business.” He smiled and said, “I know you, you’re the E. coli guy.” I smiled and we said our goodbyes.
Now President Obama has the opportunity to sign the first major piece of food safety legislation in my lifetime. True, even if S. 510 passes, it will need to be in Conference with legislation passed in 2009 by the House, but it seems the time has come to recognize that sickening 76,000,000, hospitalizing 325,000 and killing 5,000 with food in the USA is not acceptable.
So, what appears to be moving towards a vote in the Senate in September is:
USDA and FDA jurisdiction over foods remains unchanged: Only foods already regulated by FDA will be subject to S. 510. As a memo from Senate staff confirms, “Section 403 maintains the existing firewall between FDA and the USDA regulated foods and agricultural products.” Honestly, whether that is a good or bad idea may well be the subject of another Publisher’s Platform. Roughly, think beef, poultry, lamb as USDA and FDA the rest–except for pepperoni pizzas.
Protections for Farmers Markets, Cottage Industries, and Direct Farm-to-Market Sales: Small entities that produce food for their own consumption or market the majority of their food directly to consumers or restaurants are not subject to registration or new recordkeeping requirements under S. 510. This includes food sold through farmers markets; bake sales, public events, and organizational fundraisers.
Appropriate produce safety standards: In coordination with the Secretary of Agriculture, FDA develops science-based standards for the safe production and harvesting of fruits and vegetables. Priority is given to specific fruits and vegetables that have the highest risk of food borne illness outbreaks. Flexibility is given for different growing, production, and harvesting techniques. FDA has the discretion to limit produce safety standards for small and very small entities that produce or harvest food, which pose little or no serious risk to human health. Consideration is also given to conservation and environmental standards already established by federal natural resource and wildlife agencies.
Only facilities defined under the Bioterrorism Act need to register: Under the Bioterrorism Act of 2002, certain food businesses were considered “facilities” and had to register with FDA. Farms and restaurants were exempted. This definition is not changed in S. 510. If an entity does not need to register now, it will not need to register under S. 510.
Small food processors assisted by legislation: According to Senate staffers, small businesses are given regulatory flexibility throughout S. 510. For example, the Secretary may modify or exempt small processors from new HACCP requirements based on size and risk. The legislation also requires the FDA to publish several user-friendly small entity compliance guides to assist firms with the implementation of new food safety practices.
Flexibility for organic food: Consideration is given to the unique agricultural practices and requirements of organic foods under the Organic Foods Production Act of 1990.
Increased agriculture extension training opportunities: The bill requires FDA to coordinate with the agricultural extension in educating growers and small processors about any new practices required by S. 510. Necessary funds are authorized to conduct these extension activities. The bill also provides for the training and education of state, local, and tribal authorities to facilitate the implementation of new standards under the FDA Food Safety Modernization Act.
Risk-based traceability: The ability to trace back potentially unsafe food in the event of a foodborne illness outbreak is important. For the purpose of traceability, farms and small businesses that are not food facilities are not expected to create new records.
Next week I am having lunch with the President. I only hope it is safe.