Food Safety Act Advisory: House Passes New Food Safety Legislation

According to Rep. Frank Pallone, Jr. the “recent widespread contaminations in [the US] food supply, including E. coli in spinach, salmonella in peppers and the most recent outbreaks of salmonella in peanut butter and pistachios,” prompted the US House of Representatives to pass the Food Safety Enhancement Act of 2009 (H.R. 2749) on July 30, 2009. Rep. Pallone is Chairman of the Health Subcommittee of the House Energy and Commerce Committee.  If signed into law, the bill would amend the Federal Food, Drug and Cosmetic Act (FFDCA) to impose additional food safety requirements on food manufacturers in hopes of preventing food-borne-illness outbreaks and/or allowing them to be more easily identified.

Under the Bill’s provisions, the Secretary of the Food and Drug Administration (FDA) would be required to establish performance standards “to identify the most significant food-borne contaminants and their most significant resulting hazards.”  Based upon these standards, each food facility would be required to: (1) conduct a hazard analysis to evaluate whether any risks of food-borne-illness are present in its manufacturing process due to the source of a product’s ingredients; (2) if a hazard is likely to occur, implement preventative controls to “prevent, eliminate, or reduce to acceptable levels the occurrence of any hazards” identified; and (3) implement a food safety plan that includes the following elements:  hazard analysis, procedures for monitoring preventive controls, corrective actions procedures,  verifications procedures for preventive controls, and recordkeeping. 

With regards to inspections, the Bill would establish a “risk-based inspection schedule” that would “provide a frequency of inspections commensurate with the risk presented by [a] facility.”  For instance, those facilities identified as posing the greatest risks would be randomly inspected at least every 6-12 months while the facilities posing the least food-safety risks would be randomly inspected at least every five years.  During inspection and/or emergencies (i.e., where the Secretary “has a reasonable belief that an article of food presents a threat of serious adverse health consequences to humans or animals”), facilities would be required to produce records kept in accordance with its food safety plan. 

The Bill would additionally authorize FDA to: (1) order an immediate cessation of distribution, or a recall, of food; (2) establish an importer verification program that would allow for the “safe and secure” importation of food; (3) quarantine food in any geographic region within the United States; (4) establish a system to trace the distribution of foods; and (5) assess penalties for violations and impose fees for any additional/necessary inspections.

The Senate is expected to take up the Bill some time after the return from the summer recess on September 8, 2009.

We will continue to keep you informed on the status of this, and other, FDA legislation.  Please contact Sara Beth Watson at 202.429.6460 or by email at swatson@steptoe.com if you have any questions.