Shortly before the summer recess, the House overwhelmingly passed HR 2749 – The Food Safety Enhancement Act. The Senate may now either adopt the House version, or S 510 – The Food Safety Modernization Act. Both Acts have similar goals; however, the real question is whether they will succeed achieving their goals, and by what means each bill will seek success.
- Exempts all food products regulated by USDA/FSIS
- Exempts farms; private residences; restaurants; other retail establishments; and nonprofit food establishments
- Requires yearly registration of a factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food
- Assesses annual fees of $500 for each registered facility, not to exceed $175,000 for multiple-owned facilities
- Requires Hazard Analysis, Risk-based Prevention Controls, a Food Safety Plan, and Finished Product Tests for Class I facilities (those where high risk products are manufactured) by FDA regulation
- Allows FDA to exempt pet food , and requires FDA to consider the impact regulations will have on small businesses
- States that FDA shall establish scientific-based regulations for growing, harvesting, processing, packing, sorting, transporting and holding raw agricultural commodities and shall take into consideration the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed protection practices and organic production methods
- Requires that domestic and foreign manufactures be inspected on a risk-based schedule, with Category 1 – high-risk facilities – inspected once every 6-12 months and Category 2 – low risk facilities – inspected once every 18 months to 3 years
- Requires facility record keeping and traceability
- Requires auditors and laboratories to be certified and food test results and environmental sampling to be reported to FDA
- States that CDC shall enhance foodborne illness surveillance by coordinating Federal, State and Local foodborne systems
- Requires the FDA to conduct food safety research and a national public education program on food safety
- Gives FDA the authority to seize and quarantine food likely to cause serious health consequences. FDA with have recall procedures for food that is deemed to be dangerous, with the basis for this determination resting in whether the Secretary of Agriculture has “reason to believe” the food poses a health risk
- Increases Criminal and Civil penalties
- Requires country of origin labeling
- Requires an inspection of manufacturing, processing, packing, distribution, receipt, holding, or food import records, with the exclusion of farm and restaurant records
- Requires bi-annual facility registration with assurance that entry is allowed on the property. Registration can be suspended if the FDA determines the food product is reasonably probable to cause adverse health consequences to humans or animals
- Requires facilities to utilize Hazard Analysis and Risk-based prevention controls
- Allows FDA to modify regulations of animal food facilities
- Requires the review of foodborne health data every two years to determine the most significant contaminants
- Requires the creation of standards for produce safety to establish science-based minimum standards for the safe production and harvesting of fruits and vegetables
- Requires FDA to promulgate rules for protection against intentional adulteration
- Allows FDA to collect fees from domestic facilities and importers subject to re-inspection to cover re-inspection-related costs
- Requires FDA to report to Congress within two years of the act on the need for other programs and practices to promote food safety. This would include regulations, food testing, and potential sources of emerging threats, communication strategies, surveillance strategies and education strategies
- Requires risk-based inspection of domestic, foreign facilities, and Ports of Entry – once every two years for high risk and once every four years for less risk
- Requires laboratory accreditation
- Requires traceback and recordkeeping after a pilot project on selected fruits and vegetables
- Requires enhanced surveillance by CDC, State, and Local Health Departments
- Allows for mandatory recall authority – if there is a reasonable probability to believe an article of food is adulterated, FDA will allow the facility to issue a recall. If the facility does not recall the product, FDA can
- Allocates $825,000,000 for food safety in 2010
- Increases the number of field staff to 3,800 in 2010, 4,000 in 2011, 4,200 in 2012, 4,600 in 2013 and 5,000 in 2014
The bottom-line is that these bills are pretty similar. Here are my suggestions as things move to the Senate, Conference Committee, and the President’s desk:
Raise more money – have a sliding scale based upon risk of contamination and size of operation. The $500 flat fee per facility up to a $175,000 for multiple facilities under same ownership is not exactly a progressive financing system. Frankly, I would require registration of all who produce and sell food, but charge little, if anything, to farms that sell directly to consumers. At the same time, I have no problem whatsoever taking a few million from some of the multi-billion dollar food conglomerates for regulatory services that greatly benefit them. Raise enough money to actually fund all of this.
Give resources so that state and local health and agriculture authorities can work with farmers to produce safe food. Clearly excluded in these bills are all direct sales between farmer and customer (including direct sales to consumers, restaurants, and farmer’s markets) from the necessity of most, if not all, the provisions of this legislation. Regardless of size, if food is produced and put into the larger stream of commerce, the producer, small or large, must play by the same food safety rules.
Finally, perhaps these bills are not the appropriate place to begin, but we need to start dealing with creating a sustainable and regionalized agriculture. We need to balance safety with environmental policy – both energy/climate change and protection of biodiversity. We need a food policy that promotes healthy humans.
Farmers Market photo courtesy CDC/ Dr. Edwin P. Ewing, Jr.