Coburn Substitute Amendment (#4696) to Food Safety Bill
Senator Coburn has offered a substitute amendment (#4696) to the food safety bill. This morning Sen. Coburn also filed notice of intent to offer a motion to suspend the rules to allow the consideration of a vote on his amendment. Details and timing of any potential vote are unclear, but a motion to suspend the rules to allow the amendment to be considered would be subject to a 2/3rds vote threshold (i.e., 67 Senators assuming all present and voting).
Summary:
- Requires HHS and the Department of Agriculture to “establish a plan to ensure effective information sharing” between the two agencies regarding food safety and inspection.
- Requires HHS to submit a report to Congress within one year regarding “a strategic plan on information technology” for food safety data collection and electronic recall records, as well as recommendations for a “more expeditious process for approving new technologies” to improve food safety.
- Grants FDA authority to inspect records regarding articles of food “related to” an emergency that “presents a threat of serious adverse health consequences or death.”
- Provides for biennial registration of facilities with the FDA.
- Permits FDA to issue requirements to reduce hazards in high-risk foods. Requires FDA to make “a careful examination of the effect on small businesses” and include exemptions “for firms that will be adversely impacted” by the requirements.
- Allows FDA to issue export certificates and charge a fee of up to $175 for such certification, with such fees to cover salaries and expenses of FDA employees.
- Requires FDA to accredit independent third party entities to inspect domestic and foreign facilities to ensure compliance with federal requirements. Requires such third parties to submit inspection reports to FDA within 10 days of inspection; conditions “that could cause or contribute to an unreasonable risk to the public health” require immediate FDA notification. Requires FDA to consider inspections performed by accredited third parties when establishing inspection schedules for FDA employees.
- Provides that food imports coming from international facilities successfully inspected by accredited third parties “shall not be detained or refused admission but shall receive permission for expedited entry.”
- Requires FDA to participate in frequent meetings with foreign governments to discuss regulatory harmonization.
- Clarifies that provisions of the legislation should not be construed as violating World Trade Organization standards or other international obligations of the United States.