Implementing Food Safety Revamp will Take Years

Now that President Obama is ready to sign the FDA Food Safety Modernization Act that the 2010 Congress passed in its waning days, implementation of this far reaching legislation will be forthcoming. The Food Institute has pointed out some of the important issues the food industry should be aware of and will be holding a webinar on Understanding the New Food Safety legislation on Jan. 6. But for now, here is a thumbnail summary of what you should know: The new legislation represents a major reform of the food safety provisions of the Federal Food, Drug, and Cosmetic Act and significantly expands the powers of the FDA with respect to food. It should be noted that the new law generally does not apply to meat, poultry, or egg products regulated by the Department of Agriculture but Secretary of Agriculture Tom Vilsack has stated that the Administration is reviewing the Federal Meat Inspection Act, and it is possible that food safety reforms adopted on the FDA side may also to be proposed and adopted on the USDA side in the next Congress. The FDA Food Safety Modernization Act or FSMA represents the most significant expansion of food safety requirements and FDA food safety authorities since 1938. It grants FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA will require FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks. Therefore, implementation of the legislation is likely to take several years.

Now that President Obama is ready to sign the FDA Food Safety Modernization Act that the 2010 Congress passed in its waning days, implementation of this far reaching legislation will be forthcoming. The Food Institute has pointed out some of the important issues the food industry should be aware of and will be holding a webinar on Understanding the New Food Safety legislation on Jan. 6. But for now, here is a thumbnail summary of what you should know:

The new legislation represents a major reform of the food safety provisions of the Federal Food, Drug, and Cosmetic Act and significantly expands the powers of the FDA with respect to food. It should be noted that the new law generally does not apply to meat, poultry, or egg products regulated by the Department of Agriculture but Secretary of Agriculture Tom Vilsack has stated that the Administration is reviewing the Federal Meat Inspection Act, and it is possible that food safety reforms adopted on the FDA side may also to be proposed and adopted on the USDA side in the next Congress.

The FDA Food Safety Modernization Act or FSMA represents the most significant expansion of food safety requirements and FDA food safety authorities since 1938. It grants FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA will require FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks. Therefore, implementation of the legislation is likely to take several years.

The key provisions of the new law are:

New regulatory requirements

• Food facilities are required to register with FDA every two years. Food from an unregistered foreign facility may not be imported into the United States or introduced into interstate or intrastate commerce.
• Food importers are required to implement foreign supplier verification programs and to take steps to verify that the food they import is safe.
• Food facilities and food importers are subject to new fees, including a fee to be paid by each domestic food facility or importer that undergoes a re-inspection because of a material non-compliance identified during an initial inspection.
• Laboratory tests to be used for regulatory purposes must be performed by either a Federal laboratory or an accredited non-Federal laboratory, and lab test results must be sent directly to FDA.
• Food facilities will be inspected with greater frequency and not less often than once every 5 years.

New FDA powers

• FDA has the authority to order a recall of food.
• FDA has the authority to administratively detain food based only on a ¡§reason to believe¡¨ the food is adulterated or misbranded.
• FDA has the power to suspend the registration, and thereby suspend the operations, of any food facility if FDA determines that food manufactured, processed, packed, or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
• FDA is required to review relevant health data every two years and to issue guidance documents or regulations setting contaminant-specific performance standards for the most significant foodborne contaminants.
• FDA is required to establish a product tracing system within FDA to improve the agency’s capacity to effectively and rapidly track and trace food.

A number of provisions of the House bill, and earlier versions of the Senate bill, did not survive the legislative process. These include provisions giving FDA authority to levy civil fines for any prohibited act, giving FDA authority to quarantine food, establishing annual registration fees for registered food facilities and food importers, and establishing a new country-of-origin labeling requirement under the FD&C Act.

To learn more, be sure to sign up for the Food Institute’s upcoming webinar on this important legislation athttp://www.foodinstitute.com/foodsafety2011.cfm.