Six months ago, President Obama signed into law the Food Safety Modernization Act, a mammoth overhaul of the food-safety system in the US, and an effort by the federal government to give more food-regulation authority to the FDA.
The legislation passed by Congress and signed by the president is designed to give FDA more power and put more requirements on food processors, retailers, growers, importers and manufacturers, since 80 percent of the food manufactured in the US is regulated by FDA or delegated by the agency to state agriculture and health departments.
Rulemaking stemming from the new food-safety law comes at a time when new concerns have been raised about the US food-safety system, largely due to the allegedly new form of E. coli that struck in Europe recently.
Dr. Robert Tauxe of the Centers for Disease Control and Prevention is raising concerns about the rise of lesser-known strains of E. coli, while most attention up to now has been focused on E. coli O157:H7. In fact, USDA has already begun working on a plan to address some of the other types of E. coli found in beef.
Sen. Kirsten Gillibrand (D-N.Y.) has introduced legislation targeting all unregulated strains of E. coli as adulterants, as well as seeking more funding for FSMA.
Boosting FDA’s power
For a long time, in the view of many food industry observers, the FDA’s ability to regulate food processing has not been as forceful as USDA, whose authority extends over meat, poultry and processed egg products. The idea of new regulatory authority is to give FDA the power to prevent adulteration or contamination in food, rather than merely responding to it after it happens. In the past, in plants where it has authority, FDA has conducted infrequent inspections, often every few years, compared to USDA which is supposed to check plants on a daily basis whenever plants are operating.
One new step FDA is taking under the FSMA is a regulation requiring preventive control measures to be used by food facilities. FDA would be requiring HACCP plans for all food it regulates. The agency is seeking public comment on this idea.
The FSMA requires registered food and feed facilities to evaluate food-safety hazards affecting food and feed they process, manufacture, pack or hold, and to identify and implement preventive controls to stop these hazards. FDA has set up a public comment docket soliciting specific recommendations from its stakeholderson what preventive control measures would be appropriate, including measures that could be used by small processors and industry.
Under the food modernization law, FDA will have to issue guidance on HACCP and hazard analysis. Comments submitted to the public docket will be taken into account when that guidance from FDA is developed. Michael Taylor, deputy FDA commissioner for foods, said the preventive-controls requirement from the FSMA is one of the most important aspects of the new law on food safety. These controls would include information about how to evaluate hazards affecting food safety, and the controls to be put in place to eliminate or minimize these hazards. Facilities must also state how controls will be monitored to insure they are working, how monitoring records will be kept and what actions plants will take to correct problems.
Under the FSMA, FDA is required to issue a rule on preventive controls for food facilities, which should be published this fall.
The agency has also issued two interim final rules stemming from the food-safety law and has invited comments on the rulemaking. The rules, which went into effect July 3, allow FDA to detain human or animal food if there is reason to believe food is adulterated. Before the food modernization law was passed, FDA needed to have evidence the food could cause serious adverse health consequences or death to humans or animals. The new rule gives FDA a new food-safety weapon with more power, and makes it easier for it to detain food it believes could result in a Class II recall, situations causing temporary or less serious health problems, rather than more serious, life-threatening health concerns.
The other interim final rule requires companies submitting prior notice about imported food must tell the FDA instances about any other country where the food was refused entry. More rulemaking is also expected from the FSMA. Although the rules kicked in this month, comments will be taken until Aug. 3.
Bernard Shire is a contributing editor based in Lancaster, Pa. Shire also works as a food safety consultant and writer for Shire & Associates LLC.