The following was contributed by Leslie Krasny, a partner in the San Francisco office of law firm Keller and Heckman LLP, and a longtime advisor to Food Processing.
Food safety reform is a key government priority right now, with significant changes under consideration or being implemented. At the top of the list is overhauling the FDA. The House of Representatives passed comprehensive food safety legislation for FDA-regulated foods, the Food Safety Enhancement Act (H.R. 2749) on July 30. The Senate is expected to address the issue this fall, although the timing is unclear due to the current legislative focus on health care reform.
One of the most important changes would be to give FDA, for the first time, the power to order recalls. Most consumers find it hard to believe the agenciesy responsible for food safety that protects them does not have the ability to recall dangerous items.
The House bill also would require mandatory hazards analysis and critical control points (HACCP) plans, food safety and food defense plans, an FDA-mandated product tracing system, greater records access during inspections, increased frequency of inspections pursuant to a risk-based schedule (although there are no definitions of high and low risk facilities in the bill), and mandatory reporting, by high risk facilities, of finished product test results showing the presence of contaminants in food that pose a risk of severe adverse health consequences or death.
How to fund all this new enforcement activity? The House proposal also includes an annual registration fee of $500 for each facility holding, processing, or manufacturing food (up to $175,000 per company) and fees for reinspection (if due to violations) and recalls.
Issues in the Senate include concerns that some provisions of H.R. 2749 would be too burdensome for small farmers and processors. The Congressional Budget Office estimated that the user fees would generate $1.4 billion over the next five years, but that an additional $2 billion would be required to cover the costs of increased inspections. Although there have been suggestions to divide FDA into two agencies, one to oversee food safety and the other to regulate drugs and medical devices, the House bill did not address the structure of FDA.
Reportable Food Registry (RFR): This FDA program became operational on Sept. 8 but will not see full enforcement until the new year. The program requires “responsible parties” to inform FDA within 24 hours, by an electronic portal, if there is a reasonable probability that a food will cause severe health problems or death to a person or animal. There is an exemption from reporting, however, if the adulteration originated with the responsible party and that party corrected the adulteration or destroyed the food prior to it being shipped. FDA takes the position that otherwise reportable food transferred only within a “vertically integrated company” may be eligible for the exemption. But once food is transferred outside the company, such as to a third party warehouse, the exemption is not applicable even if title to the food has not passed.
The law provides that the filing of a report is not considered “an admission that the food involved is adulterated or caused or contributed to a death, serious injury or illness.” Responsible parties are required to maintain records of reports and notifications for two years. Reports will not be publicly available but are subject to Freedom of Information Act (FOIA) requests, with redactions for confidential information.
The statutory purpose of the RFR was “to provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by FDA to target limited inspection resources to protect the public health.” FDA posted a detailed manual for completing the RFR report and also set up a help desk to assist companies in filing reports. During the first three months, FDA plans to exercise enforcement discretion.
Safer produce and eggs: On July 31, FDA published three draft guidances that are intended to help minimize or eliminate microbial contamination in tomatoes, leafy greens and melons. FDA’s goal is to finalize these guidances as soon as possible after public comment, and to issue regulations within two years after that. The new draft guidances are consistent with, and supplement, past guidances for fresh and fresh-cut produce items. FDA has stated that the draft guidances represent a shift in regulatory strategy, from a primarily reactive food safety system to one focused on preventing foodborne hazards.
On July 7, FDA issued a final rule (effective Sept. 8), requiring shell egg producers to implement measures to prevent Salmonella Enteritidis from contaminating eggs on the farm and from further growth during storage and transportation, including recordkeeping and registration. The new regulation is expected to prevent approximately 79,000 cases of salmonellosis and 30 deaths annually due to consumption of contaminated eggs.