Highlights of the (new) Senate bill
After months of disagreements and negotiations on the Food Safety Modernization Act and FDA overhaul in the Senate, the bi-partisan Health, Education, Labor and Pensions (HELP) Committee on Aug. 13 modified the Senate version of the food safety bill – S. 510 -- and drafted the 148-page "Manager's Package," which will be adopted if and when the bill comes to the Senate floor (expected after the summer recess).
The Manager's Package will cost more than $1.4 billion over the next five years, according to the Congressional Budget Office -- a tough sell in this economy and with upcoming midterm elections. The gross spending for the FDA to administer the new regulatory activities authorized under the legislation — about $1.3 billion over the 2011-2015 period — would be partially covered by fees assessed on registered food facilities, importers and exporters.
In 2010, the FDA received about $780 million in funding for the Center for Food Safety and Applied Nutrition and related activities. Under S. 510, funding for those activities would grow over time, with an increase of approximately $583 million (excluding fees) by 2015.
This compromise version:
- Gives FDA recall authority if the food will cause serious adverse health consequences or death and a company has failed to voluntarily recall the product upon FDA's request.
- Sets mandatory inspection rates for food production facilities (currently, FDA-regulated facilities can go a decade or more without inspection).
- Gives FDA additional resources to hire new inspectors.
- Gives government inspectors new powers to suspend or shut down plants with poor safety records.
- Enhances FDA authority to access records.
- Enhances FDA authority to administratively detain food.
- Strengthens other federal agencies and programs meant to identify and track food-borne illnesses.
Highlights of House bill (H.R. 2749)
- FDA will have the authority to order recalls.
- FDA will have explicit authority to inspect high-risk food processing facilities every 6-12 months, low-risk facilities at a minimum of every 18 months to three years, and storage warehouses every five years.
- Food processing facilities will be required to meet strong performance standards to ensure they are qualified to handle food.
- An enhanced trace-back system will allow the FDA to more quickly determine the source of contamination in case an outbreak does occur.
- Foreign foods will be more closely inspected to ensure that they meet all U.S. safety standards.
- Contains a flat $500 facility registration fee, regardless of size or income, to help pay for the bill.
The Congressional Budget Office said the House-approved bill's requirement for more frequent inspections and other enforcement steps would cost an estimated $3.7 billion over five years, partly paid for by the $500 annual fee on food processing facilities.