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HHS/FDA RIN: 0910-AC41 Publication ID: Fall 2004 
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 (FFDCA), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. Section 801(m) 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  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: The events of September 11, 2001, highlighted the need to enhance the security of the U.S. food supply. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which was signed into law on June 12, 2002. The regulations implement section 307 of the Bioterrorism Act.

Summary of the Legal Basis: Section 307 of the Bioterrorism Act amended the FFDCA 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 FFDCA 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: None, based on clear statutory directive to establish regulations.

Anticipated Costs and Benefits: The prior notification provision is an economically significant regulatory action. For the calendar year 2002, there were approximately 5.2 million human and animal food line items imported into U.S. commerce by airplane, train, vessel, and truck. This final rule will require that FDA be notified prior to the arrival of the food. This rule may cause changes in current business practices for some importers, most likely those persons importing fresh produce and seafood. Costs will include the costs of preparing the prior notice, and the costs associated with delayed entry of fresh produce and seafood. FDA costs will include the labor hours, hardware, and software costs to develop a stand-alone technology system to handle prior notice entries. 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. It is not possible to directly estimate the benefits of averting a terrorist attack, as we do not know what form an attack might take or the probability of an attack occurring. However, we can look at some outbreaks attributed to imported foods to estimate the benefits of having prior notice.

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.

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  06/00/2005    
Regulatory Flexibility Analysis Required: Yes  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, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426

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