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HHS/FDA

RIN: 0910-AC41

Publication ID: Fall 2006

Title: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Abstract: This rulemaking is one of a number of actions being taken to improve FDA's ability to respond to threats of bioterrorism. Section 801(m) of the Federal Food, Drug, and Cosmetic Act (the act), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), requires notification to FDA prior to the entry of imported food. The required prior notice would provide the identity of the article of food; the manufacturer; the shipper; the grower, if known at the time of notification; the originating country; the shipping country; and the anticipated port of entry. The regulation identifies the parties responsible for providing the notice and explains the information that the prior notice is required to contain, the method of submission of the notice, and the minimum and maximum period of advance notice required. Section 307 also states that if FDA does not receive prior notice or receives inadequate prior notice, the imported food shall be refused admission and held at the port of entry until proper notice is provided. Section 307 authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. FDA and the Bureau of Customs and Border Protection (CBP) issued an interim final rule (IFR) on October 10, 2003 (68 FR 58974). The IFR originally provided a 75-day comment period to ensure that those that comment on the IFR have the benefit of our outreach and educational efforts and have the experience with the systems, timeframes, and data elements. We reopened the comment period for an additional 90 days in April through July 2004 to allow for additional comment on the industry's experience with the prior notice system, and comment on the Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes. The final rule currently is under development, and it will confirm or amend the IFR, as appropriate. This final rule is not expected to have a significant impact on a substantial number of small entities.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Final Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 1.276 et seq
Legal Authority: PL 107-188, sec 307

Legal Deadline:

Action	Source	Description	Date
Final	Statutory		12/12/2003

Overall Description of Deadline: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 307, directs the Secretary, through FDA, to issue final regulations establishing prior notice requirements for all imported food by December 12, 2003. If FDA fails to issue final regulations by this date, the statute is self-executing on this date, and requires FDA to receive prior notice of not less than eight hours, nor more than five days until final regulations are issued.

Statement of Need: This final rule is needed to complete the rulemaking process to implement section 307 of the Bioterrorism Act. The proposed rule was published on February 3, 2003 (68 FR 5428) and the interim final rule on October 10, 2003 (68 FR 58974).

Summary of the Legal Basis: Section 307 of the Bioterrorism Act amended the act by adding section 801(m), which authorizes the Secretary through FDA to establish by regulation requirements for the notification to FDA prior to the entry of imported food. In addition, section 307 of the Bioterrorism Act also amends section 301 of the act by making the offering of a food for import or the importing of a food without prior notification, as required by the new regulations, a prohibited act.

Alternatives: An alternative is to leave the IFR in place and not to issue a final rule. However, we received numerous comments in response to the IFR that require a response. Finalizing this rule will assist industry and the public in better understanding and complying with the prior notice requirements.

Anticipated Costs and Benefits: The final rule will amend the interim final rule already in place. We do not expect the changes from the interim final rule to be economically significant. This final rule will require that FDA be notified prior to the arrival of the food. Having prior notice of imported food will help deter deliberate and accidental contamination of food shipments. Knowledge of when, where, and how imported food will enter the United States will help mitigate the effects of any potential food contamination issues.

Risks: Regulations implementing legislation to protect the health of citizens against bioterrorism and other public health threats would advance the development, organization and enhancement of public health prevention systems and tools. The magnitude of the risks addressed by such systems and tools is at least as great as the other risk reduction efforts within HHS' jurisdiction. These regulations will improve the FDA's ability to address bioterrorism events and public-health threats associated with imported food.

Timetable:

Action	Date	FR Cite
NPRM	02/03/2003	68 FR 5428
Interim Final Rule	10/10/2003	68 FR 58974
Interim Final Rule Comment Period Reopened	04/14/2004	69 FR 19763
Interim Final Rule Comment Period Reopened End	07/13/2004
Final Rule	05/00/2007

Regulatory Flexibility Analysis Required: No	Government Levels Affected: Federal
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: Yes
Agency Contact: Gerie Voss Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration HFS-32, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993 Phone:877 287-1373 Email: ctpregulations@fda.hhs.gov