I will be discussing Let’s Ask Marion with Clark Wolf as part of the Fales Library Critical Topics Series at 5:00 p.m., via Zoom. It’s free but registration is required—here.
S. 510 inches toward passage
It looks like S. 510, the Senate’s version of the food safety bill passed by the House a year ago, may actually have a chance of passing. According to summaries by Bill Marler and by Food Safety News, there is now bipartisan agreement on the bill’s key provisions:
Hazard analysis and preventive controls: Requires facilities that manufacture, process, pack, or hold food to have in place risk-based preventive control plans to address identified hazards and prevent adulteration, and gives FDA access to these plans and relevant documentation. These requirements do not apply to restaurants or most farms.
Imports: Requires importers to verify the safety of foreign suppliers and imported food. Allows FDA to require certification for high-risk foods, and to deny entry to a food that lacks certification or that is from a foreign facility that has refused U.S. inspectors. Creates a voluntary qualified importer program in which importers with a certification of safety for their foreign supplier can pay a user-free for expedited entry into the U.S.
Inspection: Gives FDA additional resources to hire new inspectors and requires FDA to inspect food facilities more frequently.
Mandatory Recall Authority: Gives FDA the authority to order a mandatory recall of a food product 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.
Regulatory Balance: Achieves new requirements without being excessively burdensome. The legislation provides training for facilities to come into compliance with new safety requirements and includes special accommodations for small businesses and farms. It does not interfere with current organic farming practices and does not change the current definition of farm under the 2002 Bioterrorism Act. Any farm that is not currently required to register with FDA will not be required to do so under this legislation.
Surveillance: Enhances surveillance systems to detect foodborne illnesses.
Traceback: Requires FDA to establish a pilot project to test and evaluate new methods for rapidly tracking foods in the event of a foodborne illness outbreak.
Increased FDA Resources: Increases funding for FDA’s food safety activities through increased appropriations and targeted fees for food facility reinspection, food recalls, and the voluntary qualified importer program.
Carole Tucker Foreman of Consumers Federation of America (CFA), sends its statement on the bill. CFA, like many others, is disappointed in some of the bill’s provisions but supports it because the FDA so desperately needs more authority and resources:
Consumer Federation of America commends the Senate HELP Committee for reaching a bipartisan agreement that should remove any further barriers to bringing S. 510, the FDA Food Safety Modernization Act, to the floor of the Senate in early September. At a time when bipartisanship is in short supply, this is a notable achievement.
We are extremely disappointed that the Senate, in order to reduce the estimated cost of the legislation, reduced the frequency of FDA inspections of food processing facilities. Regular and frequent inspection is a basic part of prevention.
Inspectors are cops on the beat—checking to be sure that corporate process controls are operating as intended. Even the most sophisticated and well intentioned company can make a mistake and history shows some plants are careless and not concerned with protecting their customers.
CFA advocated increasing the number of inspections that were required in the bill reported by the Committee last year. Instead, the Senate has reduced the frequency to once every five years for high risk plants and once every seven years for other facilities.
Despite our dismay with this glaring weakness, CFA supports passage of S. 510 and will encourage our members to communicate with their Senators urging its passage. We believe that establishing an affirmative legal mandate for FDA to prevent foodborne illness will help save lives.
The current version of the Senate bill is available for scrutiny. If passed, it still needs to go to the House for reconciliation of the two versions. So it is still interim and worth reading carefully. Read it and decide for yourself what it says and is likely to mean.