With the close of the Congressional session looming, it looks less and less likely that federal food safety legislation will be enacted before the end of 2010. In particular, a procedural drafting error in the Senate bill means that the Senate will likely need to consider and pass a modified version of its bill in the near future. However, there is a chance that both the Senate and House will push this bill through during the lame duck session. Some of the key elements of Senate Bill 510 are highlighted below. There are some differences between the House and Senate bills that will need to be resolved. A key sticking point is funding. The House bill funds activities through a facility registration fee, whereas the Senate bill would be funded from the general Treasury.
Who is affected?
The bill includes provisions that affect all food producers and others in the supply and distribution chain—foreign and domestic—except producers (and products) regulated by the U.S. Department of Agriculture (USDA).
What producers are not affected?
The proposed legislation does not affect meat, poultry and some egg producers, as they are regulated by USDA. An exception was also added to the Senate bill that exempts farms and small business from the produce safety and preventive control requirements. The exempted producers must have less than $500,000 in annual sales and sell most of their food directly to consumers, restaurants or stores within their state or within a 275-mile radius.
Does the exemption remove all food safety oversight?
No. The exempted establishments must still comply with state and local food safety regulations. In addition, the U.S. Food and Drug Administration (FDA) can withdraw the federal exemption if it is determined that food from the exempted producer was associated with a foodborne illness outbreak.
What sort of preventive measures are included in the legislation?
There are a number of actions set forth in the legislation that are aimed at the prevention of foodborne illness. First, food producers and manufacturers will be required to develop and implement a Hazard Analysis and Critical Control Point (HACCP) plan. FDA would have more access to a company's records in certain circumstances, such as a food emergency. The bill would set stricter standards for importing food, and importers will be required to verify the safety of their food and suppliers, and if requested by FDA, provide certification for certain higher-risk food items.
Another key provision of the bill related to prevention is increased facility inspections, both foreign and domestic. The bill further requires that more resources be directed to facilities producing higher-risk products. Under this bill, most facilities would be inspected at least once in the first five years and then at least once every three years afterward.
What is HACCP?
HACCP is a process where a facility must undertake food safety hazard analyses, put in place preventive measures at critical control points, monitor the effectiveness of those measures, and update plans as necessary to substantially lessen or eliminate food safety problems. To assist regulated facilities, FDA would be required to "promulgate regulations [and a guidance document] to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls..." Although HACCP has been mandatory for several years now in the seafood and juice industries, this bill would extend HACCP requirements to other food producers.
What about FDA's response to outbreaks?
The bill includes provisions related to FDA's abilities to respond to potential foodborne illness outbreaks as well. One of the most significant provisions would give FDA the ability to order a mandatory recall of a food product. Currently, FDA does not have this authority, and can only encourage or negotiate with a company to cooperate and institute a voluntary recall.
In addition, there are provisions related to instituting a traceability system, and projects to develop and test ways to trace food in the instance of an outbreak for both raw and processed foods. FDA would be directed to work with companies to protect food from intentional contamination and to develop a strategy to respond to food emergencies and terrorist threats to the nation's food supply. FDA would also be authorized to suspend a company's registration if there is a probability that products from that facility could cause serious illness or death.
Are producers of fruits and vegetables affected?
Yes. FDA, in coordination with USDA, would develop rules governing certain aspects of the growing, harvesting, sorting, packing and storage of certain high-risk raw agricultural commodities—in effect mandating certain farming, harvesting and packing practices for growers and packers of the affected raw produce types.
Does this create one food safety agency for oversight?
No. USDA and FDA remain the two agencies with the majority of the responsibility for food safety regulation. The legislation currently before Congress addresses only the industries and food products regulated by FDA. However, the bill encourages FDA to work closely with state and local agencies to monitor potential food safety and defense issues. FDA would also be required to work with other federal agencies to develop a national agricultural and food defense strategy.
When will the law be enacted?
At this time, no one is certain that it will be enacted. The Senate passed S.510 on November 30, which initially led many commentators to believe there was time for the House to take up and pass S.510 and send it to President Obama for his signature before the end of the year. However, the Senate may need to take the matter up again, due to the procedural violation mentioned earlier. While there is still some possibility that food safety legislation may make its way through both houses of Congress and a conference before the end of the year, the chances grow slimmer every day.
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