The manager's version of the FDA Food Safety Modernization Act was released late Aug. 12, and Sen. Tom Harkin believes the legislation to overhaul the U.S. food safety system will enjoy strong bipartisan support when the Senate takes it up.

"I am confident that the remaining details will be worked out and am hopeful that the measure will come to the Senate floor as soon as possible,' Harkin said in a statement released late Aug. 12.

Harkin, D-Iowa and chairman of the Senate Health, Education, Labor and Pensions Committee, said the legislation is supported by dozens of consumer and industry groups.

However, the Washington, D.C.-based Consumer Federation of America released a statement that said while it continues to support the legislation, it found the manager's amendment lacking in some respects.

"We are extremely disappointed that the Senate, in order to reduce the estimated cost of the legislation, reduced the frequency of FDA inspections of food processing facilities," the group said in a statement on its web site. The manager's amendment calls for an inspection frequency of once every five years for high risk plants and once every seven years for other facilities.

The 225-page manager’s package is available here.

Highlights of the manager’s package, as detailed in news release from Harkin, include:

Hazard analysis and preventive controls:
Requires facilities that manufacture, process, pack or hold food to have in place risk-based preventive control plans to address identified hazards and prevent adulteration, and gives FDA access to these plans and relevant documentation. These requirements do not apply to restaurants or most farms.

Imports: Requires importers to verify the safety of foreign suppliers and imported food. Allows FDA to require certification for high-risk foods, and to deny entry to a food that lacks certification or that is from a foreign facility that has refused U.S. inspectors. Creates a voluntary qualified importer program in which importers with a certification of safety for their foreign supplier can pay a user-free for expedited entry into the U.S.

Inspection: Gives FDA additional resources to hire new inspectors and requires FDA to inspect food facilities more frequently.

Mandatory Recall Authority
: Gives FDA the authority to order a mandatory recall of a food product if the food will cause serious adverse health consequences or death and a company has failed to voluntarily recall the product upon FDA’s request.

Regulatory Balance
: Achieves new requirements without being excessively burdensome. The legislation provides training for facilities to come into compliance with new safety requirements and includes special accommodations for small businesses and farms. It does not interfere with current organic farming practices and does not change the current definition of farm under the 2002 Bioterrorism Act. Any farm that is not currently required to register with FDA will not be required to do so under this legislation.

: Enhances surveillance systems to detect foodborne illnesses.

Traceback: Requires FDA to establish a pilot project to test and evaluate new methods for rapidly tracking foods in the event of a food-borne illness outbreak.

Increased FDA Resource
s: Increases funding for FDA’s food safety activities through increased appropriations and targeted fees for food facility reinspection, food recalls, and the voluntary qualified importer program.