Houses Passes Food Safety Bill

July 31, 2009

After an attempt to pass the Food Safety Enhancement Act of 2009 (H.R. 2749) by a special process requiring a two-thirds majority vote failed on July 29, 2009, the U.S. House of Representatives moved forward the first major change to food-safety laws since 1938 late on July 30, 2009.

The approved version contains some new provisions since our first report on the proposed legislation.  The bill, which is primarily intended to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, if passed, would give broader authority to the U.S. Food and Drug Administration (FDA); impose new fees and reporting requirements on food producers, importers, and customs brokers; and establish stiff fines and criminal penalties for violations.

According to a summary of the key provisions reported by the House, the Act would:

• Require each food facility to: (1) conduct a hazard analysis; (2) implement preventive controls; and (3) implement a food safety plan.
• Require the Secretary of Health and Human Services to: (1) issue science-based performance standards to minimize the hazards from food borne contaminants; (2) establish science-based standards for raw agricultural commodities; (3) inspect facilities at a frequency determined pursuant to a risk-based schedule; (4) establish a food tracing system; (5) assess fees relating to food facility reinspection and food recall; and (6) establish a program for accreditation of laboratories that perform analytical testing of food for import or export.
• Authorize the Secretary to: (1) order an immediate cessation of distribution, or a recall, of food; (2) establish an importer verification program; and (3) quarantine food in any geographic area within the United States.
• Require country of origin labeling on food.
• Require annual registration of importers with the payment of a $500 fee.
• Require annual registration of customs brokers (no fee).
• Provide for unique identifiers for food facilities and food importers.
• Deem a food to be adulterated if an inspection is delayed or refused.
• Require the Secretary to establish a corps of inspectors dedicated to inspections of foreign food facilities.
• Set forth provisions governing the reorganization of Food and Drug Administration (FDA) field laboratories and district offices.
• Give the Commissioner of Food and Drugs subpoena authority with respect to a food proceeding.
• Establish whistleblower protections.

In addition, the Act includes severe penalty provisions.  The legislation establishes new and increased civil penalties for violations relating to food, including $20,000 - $50,000 penalties for individuals and $250,000 - $1,000,000 penalties for companies.   The penalties for “knowing” violations could reach $100,000 for individuals and $7,500,000 for companies.  It also creates new criminal penalties for the misbranding or adulteration of food, including imprisonment for up to 10 years or substantial fines or both.

The same version of the bill must still pass the Senate and be signed by the President before it becomes law.  The Senate is not expected to take up its version of the bill until after the August recess.  Although the Act provides for limited exemptions for small farms and growers and ranchers and farmers currently regulated by the U.S. Department of Agriculture (USDA), if signed into law, the Food Safety Enhancement Act of 2009 would create sweeping changes and is expected to have a significant impact on how food and related goods are imported into the United States.

We will continue to provide information on our website as to the status of this legislation as it develops.  For additional information concerning the Act, please contact a Barnes/Richardson attorney.