SUMMARY: The Food and Drug Administration (FDA) is proposing a regulation that would require U.S. purchasers or U.S. importers or 
their agents to submit to FDA prior notice of the importation of food. The proposed regulation implements the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires prior notification of imported food to begin by 
December 12, 2003. The Bioterrorism Act requires FDA to issue final regulations that specify the period of advance notice by this date or a 
statutory notice provision requiring not less than 8 hours prior notice and not more than 5 days prior notice will take effect until a final rule is issued.

DATES: Submit written or electronic comments by April 4, 2003. Submit written or electronic comments on the collection of information by 
March 5, 2003.

ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Submit written comments on the information collection provisions to the Office of Information and Regulatory 
Affairs, Office of Management and Budget (OMB), New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, ATTN: Stuart 
Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Mary Ayling, Center for Food Safety 
and Applied Nutrition (HFS-32), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2428.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background and Legal Authority
II. Preliminary Stakeholder Comments
III. The Proposed Regulation
    A. Highlights of This Rule
    B. General Provisions
    1. What Imported Food is Subject to This Subpart? (Proposed Sec.  
1.276)
    2. What Definitions Apply to This Subpart? (Proposed Sec.  1.277)
    3. What Are The Consequences of Failing to Submit Adequate Prior 
Notice or Otherwise Failing to Comply With This Subpart? (Proposed 
Sec.  1.278)
    C. Requirements to Submit Prior Notice of Imported Food
    1. Who is Authorized to Submit Prior Notice for an Article of Food 
That is Imported or Offered for Import Into the United States? 
(Proposed Sec.  1.285)
    2. When Must the Prior Notice be Submitted to FDA? (Proposed Sec.  
1.286)
    3. How Must You Submit the Prior Notice? (Proposed Sec.  1.287)
    4. What Information Must be Submitted in a Prior Notice? (Proposed 
Sec.  1.288)
    5. What Changes are Allowed to a Prior Notice After it Has Been 
Submitted to FDA? (Proposed Sec.  1.289)
    6. Under What Circumstances Must You Submit a Product Identity 
Amendment to Your Prior Notice After You Have Submitted it to FDA? 
(Proposed Sec.  1.290)
    7. What is the Deadline for Product Identity Amendments Under Sec.  
1.290? (Proposed Sec.  1.291)
    8. How Do You Submit a Product Identity Amendment or an Arrival 
Update to a Prior Notice? (Proposed Sec.  1.292)
    9. What Are the Consequences if You Do Not Submit a Product 
Identity Amendment to Your Prior Notice? (Proposed Sec.  1.293)
    10. What Must You Do if the Anticipated Arrival Information 
(Required Under Sec.  1.288(k)(1)) Submitted in Your Prior Notice 
Changes? (Proposed Sec.  1.294)

IV. Analysis of Economic Impacts
    A. Preliminary Regulatory Impact Analysis
    1. Need for Regulation
    2. The Reason for the Regulation
    3. Proposed Rule Coverage
    4. Regulatory Options Considered
    B. Small Entity Analysis (or Initial Regulatory Flexibility 
Analysis)
    1. Number of Establishments Affected
    2. Costs per Entity
    3. Additional Flexibility Considered
    C. Unfunded Mandates
V. Paperwork Reduction Act of 1995
VI. Analysis of Environmental Impact
VII. Federalism
VIII. Comments
IX. References

I. Background and Legal Authority

    The events of September 11, 2001, highlighted the need to enhance the security of the U.S. food supply. Congress responded by passing the 
Bioterrorism Act, which was signed into law on June 12, 2002. The Bioterrorism Act includes a provision in Title III (Protecting Safety 
and Security of Food and Drug Supply), Subtitle A--Protection of Food Supply, section 307, which amends the Federal Food, Drug, and Cosmetic 
Act (the act) by adding section 801(m) (21 U.S.C. 381(m)). This new provision changes when FDA will receive certain information about 
imported foods by requiring the Secretary of Health and Human Services (the Secretary), after consultation with the Secretary of the Treasury, 
to issue implementing regulations by December 12, 2003, mandating prior notification to FDA of food that is imported or offered for import into 
the United States. Functions of the U.S. Customs Service (U.S. Customs) will soon be a part of the Department of Homeland Security (DHS). 
Future consultations may be with DHS instead of, or in addition to, the Department of Treasury.
    Section 801(a) of the act sets out procedures for imports under FDA's jurisdiction. When an FDA-regulated product is imported or 
offered for import, generally brokers submit entry information to the U.S. Customs on behalf of the importers of record. U.S. Customs then 
provides entry information and may deliver samples to FDA to enable admissibility decisions to be made. Under U.S. Customs authorities, 
entry of the merchandise must be made within 15 days after importation.
    U.S. Customs regulations provide for different kinds of entries. Commonly, merchandise is the subject of an entry for consumption (i.e., 
unrestricted, general use) under a basic importation and entry bond at the first port of arrival, but U.S. Customs authorities also allow for 
the entry of merchandise for transportation under a custodial bond from the port of arrival to another port where the consumption entry will be 
made. If no entry of any kind is made within 15 days, the article cannot move and the carrier or other authorized party must notify U.S. 
Customs and a general order (i.e., bonded or secure) warehouse that the article remains unentered. Generally, at that point, the article is 
moved to the bonded warehouse (or such other facility as the U.S. Customs port director might require) 
and held pending the filing of an entry or other action.    

Accordingly, under current laws and regulations, there are times when FDA does not receive complete information about the food imports it regulates until days after the food has arrived in the U.S. and been moved from the port it arrived in. 

FDA receives information about imported food through its Operational and Administrative System for Import Support (OASIS). Entry information is usually provided electronically to OASIS by U.S. Customs via its Automated Broker Interface (ABI) of the Automated Commercial System (ACS). The information that is currently supplied to FDA through this system includes: the entry type, the entry number (both ACS line number and FDA line identifier); the mode of transportation; the carrier code; the name and address of the manufacturer, shipper, importer, and ultimate consignee; the country of origin; the FDA product code; a written description of the product in common business terms; and the quantity. If neither FDA nor U.S. Customs wishes to examine or detain the entry, the product is allowed to proceed. 

By adding section 801(m) to the act, Congress changed when information about FDA-regulated food imports must be provided to FDA. The major components of new section 801(m) of the act are: 

• Requires prior notice of imported food shipments beginning on December 12, 2003; 

• Provides that, if adequate notice is not provided, the food shall be refused admission and held until adequate notice is given; 

• Amends section 301 of the act to make it a prohibited act to import or offer for import an article of food in violation of any requirements under section 801(m) of the act; and 

Mandates that prior notice be submitted no less than 8 hours and not more than 5 days before it is imported or offered for import, if final rules are not in effect on December 12, 2003, and until such rules become effective. 

In addition to section 307 of the Bioterrorism Act, which establishes the requirement for prior notice for food imported or offered for import into the U.S., FDA is relying on sections 701(a) and 701(b) of the act (21 U.S.C. 371(a) and (b)) in issuing this proposed rule. Section 701(a) authorizes the agency to issue regulations for the efficient enforcement of the act, while section 701(b) of the act authorizes FDA and the Department of Treasury to jointly prescribe regulations for the efficient enforcement of section 801 of the act.II. Preliminary Stakeholder Comments 

On July 17, 2002, FDA sent an open letter to the members of the public interested in food issues outlining the four provisions in Title III of the Bioterrorism Act that require FDA to issue regulations in an expedited time period, and FDA's plans for implementing them (see http://www.cfsan.fda.gov/[tilde]dms/sec-ltr.html). In the letter, FDA invited stakeholders to submit comments to FDA by August 30, 2002, for FDA's consideration as it developed this proposed rule. FDA also held meetings with representatives of industry, consumer groups, other Federal agencies, and foreign embassies after sending out the July 17, 2002, letter, to solicit stakeholder comments. In response to these solicitations, FDA received 37 comments regarding section 307 of the Bioterrorism Act. 

FDA has considered all the comments received by August 30, 2002. FDA will consider all comments we have received so far with the comments we receive during the public comment period on this proposed rule in developing the final rule. Several broad themes emerged from the comments FDA received on or before August 30, 2002, including: 

• Maintaining flexibility when setting the minimum time required for prior notice and taking into account different modes of transportation, the nature of perishable food, and the needs of businesses which operate close to the U.S. border; 

• Permitting the prior notice to be amended; 

• Integrating with U.S. Customs and other agencies to avoid duplication of notification requirements; 

• Allowing a qualified agent to submit prior notices for authorized submitters; 

• Providing immediate acknowledgement of the submission, if prior notice is submitted electronically; 

• Defining ``food'' consistent with the act's definition; 

• Extending FDA's hours of operation; 

• Complying with international trade obligations; and 

• Including a model of the Prior Notice screen.III. 

The Proposed Regulation 

This rule would enhance FDA's ability to inspect imported food when it arrives in the U.S. This in turn would result in a significant improvement in FDA's ability to deter, prepare for, and respond effectively to bioterrorism and other public health emergencies that might result from imported food. Additionally, should an outbreak or a bioterrorism event occur, prior notice would enhance FDA's ability to respond to the event by enhancing FDA's ability to prevent entry of shipments that appear related and to facilitate product tracking for containment. This proposed rule would facilitate product tracking because we would know, at the time of receipt of prior notice, the name and address of the actual importer and consignee in the United States. We could then use the U.S. importer and consignee information to follow-up and trace the location of the goods. FDA thus would be better able to ensure that consumers in the United States do not eat food that is contaminated (whether intentionally or otherwise). This information would also assist FDA and other authorities in determining the source and cause of problems and in communicating with affected firms. Finally, we believe that the information provided by prior notice would help us use our foreign inspection resources more effectively. 

In establishing and implementing this proposed rule, FDA will comply fully with its international trade obligations, including the applicable World Trade Organization (WTO) agreements and the North American Free Trade Agreement (``NAFTA''). For example, we believe this proposed rule is not more trade restrictive than necessary to meet the objectives of the Bioterrorism Act.A. Highlights of This Rule 

The key features of this proposed rule are:[bull] The purchaser or importer of an article of food (or their agent) who resides or maintains a place of business in the United States generally is responsible for submitting the notice.[bull] The notice must be submitted by noon of the calendar day before the day of arrival. 

• Amendments relating to product identity information are allowed under specified circumstances. 

• Updates about arrival information are required if plans change.[bull] The notice must be submitted electronically through the Prior Notice System unless the FDA system is not functioning. The FDA Prior Notice System will be designed to provide an automatic electronic acknowledgment of receipt of a complete prior notice submission, with a time and date ``stamp.'' The notice must contain information that identifies: 

• The individual and firm submitting the prior notice; 

• The entry type and U.S. Customs ACS entry number or other U.S. Customs identification number associated with the import; 

• If the article of food is under hold under proposed Sec.  1.278, the location where it is being held;

The identity of the article of food being imported or offered for import: 

• The complete FDA product code; 

• The common or usual name or market name; 

• The trade or brand name, if different from the common or usual name or market name; 

• The quantity described from smallest package size to largest container; and 

• The lot or code numbers or other identifier of the food if applicable; 

• The manufacturer; 

• All growers, if known; 

• The country from which the article originates; 

• The shipper; 

• The country from which the article of food was shipped; 

• The anticipated arrival information; 

• Information related to U.S. Customs entry process; 

• The importer, owner, and consignee; and 

• The carrier.

• Amendments relating to product identity are allowed if complete information about product identity does not exist by the deadline for prior notice for the planned shipment: 

• Information regarding identity of the article may be amended once; 

• Amendments may not be used to change the nature of the article of food; 

• Quantity may be amended; and 

•  Any amendments must be submitted no later than 2 hours prior to arrival.[bull] If a change occurs in the anticipated port of entry or anticipated time of arrival stated in the prior notice, the information must be updated.

The proposed rule does not apply to: 

• Food that is carried by an individual entering the United States in that individual's personal baggage for that individual's personal use; or 

• Meat food products, poultry products, and egg products that at the time of importation are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA).B. General Provisions1. What Imported Food is Subject to This Subpart? (Proposed Sec.  1.276) 

Under new section 801(m)(1) of the act, prior notice is required for all food ``being imported or offered for import into the United States.'' Accordingly, prior notice requirements apply to all food that is brought across the U.S. border (with the following four exceptions) regardless of whether the food is intended for consumption in the United States. In other words, FDA believes that food that is brought into the United States to be put into foreign trade zones, or for transshipment or reexport immediate or otherwise, is ``imported or offered for import'' and thus must comply with the prior notice requirements. 

The proposed rule establishes four categories of imported food that are not subject to the prior notice requirements. In each of these cases, FDA believes that the statutory language requires this result. 

The first category is food that individual travelers carry in their personal baggage for their own personal enjoyment. Although we believe that this food is imported into the United States, the information that section 801(m)(1) of the act requires in a prior notice, in conjunction with the purpose of the provision, demonstrates that Congress did not intend prior notice to apply to food that travelers bring into the United States in their personal baggage for personal use (i.e., consumption by themselves, family or friends, not for sale to anyone). In particular, under section 801(m)(1) of the act, a prior notice must contain the identity of the shipper of the food. When travelers bring food back from their travels in their personal baggage for their own use, we do not believe that Congress intended for us to characterize such travelers as ``shippers'' for purposes of section 801(m) of the act. We seek comment on this reasoning. However, when travelers bring food into the United States in their personal baggage to sell or otherwise distribute in a broader fashion, the travelers would seem to be acting for or on behalf of other entities. Under these circumstances, these travelers would seem to be shippers and subject to the provisions of this proposed rule. 

The remaining three categories of imported food not subject to the prior notice requirement are those foods within the exclusive jurisdiction of USDA. In accordance with section 801(m)(3)(B) of the act, FDA is proposing to exempt from the requirements of this regulation imported foods that, at the time of importation, are subject to USDA's exclusive jurisdiction under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).2. What Definitions Apply to This Subpart? (Proposed Sec.  1.277) 

The following definitions are used throughout the proposed rule: 

a. The act. The proposed rule defines ``the act'' as the Federal Food, Drug, and Cosmetic Act. The proposed rule applies the definitions of terms in section 201 of the act to such terms as used in the proposed rule. 

b. Calendar day. The proposed rule defines ``calendar day'' as ``every day shown on the calendar.'' 

c. Country from which the article of food was shipped. The proposed rule defines ``country from which the article of food was shipped'' as the country in which the article of food was loaded onto the conveyance that brings it to the United States. A conveyance is the means of transportation, e.g., ship, truck, car, van, plane, railcar, etc., not the shipping container that could be moved from a ship to a truck to a train bed. 

FDA is requesting comment on whether this term should include the countries of intermediate destination. 

d. Food. FDA is proposing to refer to the definition of ``food'' in section 201(f) of the act (21 U.S.C. 321(f)), which is: ``(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.'' FDA also is proposing to include examples of products that are considered food under section 201(f) of the act. Examples listed in the proposed rule include: fruits; vegetables; fish; dairy products; eggs; raw agricultural commodities for use as food or components of food; animal feed, including pet food; food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food; dietary supplements and dietary ingredients; infant formula; beverages, including alcoholic beverages and bottled water; live food animals (such as hogs and elk); bakery goods; snack foods; candy; and canned foods. FDA already receives entry information on all these articles of food as defined in section 201(f) of the Act. 

With respect to articles that can be used for food and non-food uses, FDA believes that prior notice is required if the article is being imported for use as food. 

e. Originating country. The proposed rule defines ``originating country'' as ``the country from which the article of food originates.'' FDA is proposing this definition to be consistent with the language used in the Bioterrorism Act. This proposed definition is also consistent with the definition that describes one of the critical data elements that brokers and other filers currently submit to FDA's OASIS via ACS when entry is made. The proposed definition refers to the country where the product that is shipped to the United States was grown or produced, depending on the kind of article. If the article is fresh produce, for example, the originating country is most likely to be the country where it is grown and harvested. If, on the other hand, the article is a processed food, e.g., canned vegetables, the originating country is likely to be the country in which the vegetables were canned. With respect to wild-caught fish or seafood that is harvested in the waters of the United States or by a U.S. flagged vessel or that is processed aboard a U.S. flagged vessel, FDA is proposing that the originating country be the United States. Otherwise, the originating country is the country under which the vessel is flagged. FDA aligned this aspect of the proposed definition of ``originating country'' with the principles proposed by USDA's Agricultural Marketing Service guidance published in the Federal Register on October 11, 2002, in response to the Farm Security and Rural Investment Act of 2002 (commonly known as the 2002 Farm Bill). 

FDA recognizes that this proposed definition may not be identical in all respects to the meaning of the term ``country of origin'' traditionally used by U.S. Customs. However, FDA believes that using the U.S. Customs meaning would not serve the purpose of the Bioterrorism Act. The U.S. Customs term primarily serves tariff, quota, and other trade purposes; it does not provide information needed for the evaluations that Congress has directed FDA to make under the Bioterrorism Act and the act. We seek comment on this interpretation and our proposed definition of ``originating country''. FDA also seeks comment on whether its use of a different term will have any impact, and if so, what that impact will be. 

f. Port of entry. For purposes of the proposed rule, FDA is defining ``port of entry'' as ``the water, air, or land port at which the article of food is imported or offered for import into the United States, i.e., the port where food first arrives in the United States'' FDA is proposing this definition because the port where the food arrives in the United States may be different than the port where the entry of the article of food is processed for U.S. Customs purposes, i.e., where the article is ``entered.'' Under U.S. Customs statutes, products can be imported into one port and then transported to another port under a custodial bond before a consumption entry is filed. For example, food may be imported into the United States from Canada through Buffalo, NY, but not be entered for consumption with U.S. Customs until it reaches St. Louis, MO, several days later. In this example, under FDA's proposed definition, the port of entry is Buffalo, NY. If food is imported into the United States from Mexico through Otay Mesa, CA, for transport through the United States for exportation into Canada, the port of entry under FDA's proposed definition is Otay Mesa, CA. 

The prior notice authority in the Bioterrorism Act is intended to give FDA better tools to deter, prepare for, and respond to bioterrorism and other food related problems. Given this purpose, ``port of entry'' must be defined as the port of arrival, that is, the location where the food first physically appeared in the United States. Allowing food that is presented for importation into the United States without prior notice to be shipped around the country and potentially lost to government oversight simply is not consistent with the Bioterrorism Act's stated purpose. FDA believes that its ability to protect U.S. consumers from terrorism or other food-related emergencies will be strongest if food can be examined, and if necessary, held at the point when it first arrives in the United States. FDA requests comments on the proposed definition of ``port of entry.'' 

g. You. The proposed definition of ``you'' is the description of the party responsible for submitting the prior notice in proposed Sec.  1.285. FDA is proposing to define ``you'' in proposed Sec.  1.277(f) as the ``purchaser or importer of an article of food who resides or maintains a place of business in the United States, or an agent who resides or maintains a place of business in the United States acting on the behalf of the U.S. purchaser or importer'' or, ``if the article of food is imported with the intention of in-bond movement through the United States for export, i.e., Transportation for Exportation or Immediate Export entries, the arriving carrier or, if known, the in-bond carrier.''3. What Are the Consequences of Failing to Submit Adequate Prior Notice or Otherwise Failing to Comply With This Subpart? (Proposed Sec.  1.278) 

As set out in section 801(m)(1) of the act, proposed Sec.  1.278(a) provides that, if an article of food is imported or offered for import with no prior notice or inadequate prior notice, the food shall be refused admission under section 801(m) of the act. Examples of inadequacy are untimely, inaccurate, or incomplete prior notice. 

As set out in section 801(m)(2)(B)(i) of the act, proposed Sec.  1.278(b) provides that if the food is refused admission under section 801(m), it must be held at the port of entry unless FDA directs its removal to a secure facility. 

In accordance with section 801(m)(2)(B)(i), proposed Sec.  1.278(c) provides that FDA may require that an article of food be held in a secure facility as appropriate. FDA may determine such storage is appropriate because of the condition of the product, circumstances of importation, or other information available to the government, e.g., a concern with the safety or security of the article of food or space limitations in the port of entry. 

Examples of secure facilities include U.S. Customs Bonded Warehouses, Container Freight Stations, and Centralized Examinations Stations. Perishables, however, may not be stored in U.S. Customs Bonded Warehouses; thus, FDA may direct fresh produce or seafood that requires storage to another facility. FDA and U.S. Customs plan to issue guidance for their field offices that will identify locations of secure storage facilities that may be used for food required to be held for failure to provide adequate prior notice. 

In order to minimize confusion about who is responsible for making arrangements if food is refused admission under section 801(m) of the act, proposed Sec.  1.278(d) provides that if FDA requires the article of food to be held at the port of entry or in a secure facility, the carrier or the person who submitted the prior notice must arrange for the movement of the food under appropriate custodial bond and promptly notify FDA of the location. This provision also makes clear that the purchaser, owner, importer, or consignee is responsible for transportation and storage expenses. We note that when section 801(m) of the act requires that food be held, it does not appear to mandate that the government take actual physical custody of the goods; instead it limits both the movement of the goods and the potential storage locations, thereby making government oversight straightforward. As described previously, U.S. Customs has identified a well-established network of storage facilities that are secure. When these storage facilities are used, charges are borne by the private parties. We thus believe that although Congress intended strict controls over food refused admission under Sec.  801(m), it did not intend to require FDA or U.S. Customs to take custody of or pay for the holding of such food. We seek comment on this issue. 

In accordance with section 801(m)(2)(B)(i) of the act, proposed Sec.  1.278(e)(1) provides that the article of food must be held at the port of entry or in the secure facility until prior notice is submitted to FDA in accordance with this subpart, FDA has examined the prior notice, FDA has determined that the prior notice is adequate, and FDA has notified the U.S. Customs Service and the person who submitted the prior notice that the article of food no longer is subject to refusal of admission under section 801(m)(1) of the act. 

FDA recognizes that food may be shipped in the same container or truck with non-food items. Since articles that are not food are not subject to this proposed rule, when mixed or consolidated imported freight contains articles of food that must be held at the port of entry or moved to a secure facility, those articles that have been refused must be dealt with before the rest of the shipment proceeds. 

In accordance with section 801(m)(2)(B)(i) of the act, proposed Sec.  1.278(e)(2) makes clear that food under a hold may not be delivered to the importer, owner, or consignee and that section 801(b) of the act does not apply. Therefore, delivery will not be allowed under a basic importation or entry bond. Even though delivery to them is not allowed, FDA believes that importers, owners, and consignees of food that has been refused under 801(m) of the act can make arrangements for food to be held: these arrangements can be made without taking possession of the food. 

The proposed rule (proposed Sec.  1.278(f)) differentiates between a refusal of admission under section 801(m)(1) of the act (prior notice) and refusal of admission under section 801(a) and other provisions of the act or other U.S. laws. The proposed rule makes clear that a determination that an article of food is no longer subject to refusal of admission under section 801(m)(1) of the act does not mean that it will be admitted to the United States. The other provisions of the act and other U.S. laws that currently apply to food imported or offered for import to the United States still apply and also govern admissibility. 

Although FDA believes that information in a prior notice will help facilitate admissibility decisions under section 801(a), FDA is not proposing to specify in the rule that it will make an 801(a) admissibility decision at the time it receives a prior notice. A prior notice is a pre-entry submission to comply with requirements under section 801(m). FDA will make the 801(a) decision when the complete entry information is submitted to U.S. Customs and transmitted to FDA. Normally (in about 98 percent of the cases), this is accomplished by electronically filing certified entry information with U.S. Customs ACS, which electronically transmits it to FDA's OASIS System. FDA's 801(a) admissibility decisions are transmitted from OASIS to the filer. 

In accordance with section 301(ee) of the act, the proposed rule (Sec.  1.278(g)) provides that it is a prohibited act to import or offer for import an article of food without complying with the requirements of section 801(m) of the act or otherwise violate any requirement under section 801(m). The proposed rule explains that, under section 302 of the act, the United States can bring a civil action in federal court to enjoin persons who commit a prohibited act and, under section 303 of the act, can bring a criminal action in Federal court to prosecute persons who commit a prohibited act. The proposed rule also explains that, under section 305a of the act, FDA can seek debarment of any person who has been convicted of a felony relating to importation of food into the United States. 

FDA notes that there are several differences between refusal of admission under sections 801(a) and (b) of the act and refusal of admission under new section 801(m). First, in section 801(m) of the act, Congress did not provide for any kind of application, petition, or appeal of FDA's determination that an article shall be refused admission for failing to comply with prior notice requirements. Congress provided that an article that has been refused admission under section 801(m) of the act can be admitted only if the necessary information is subsequently submitted, examined by FDA, and found to be adequate. Second, food refused admission under section 801(m) cannot be delivered under bond pursuant to section 801(b) and, as we describe elsewhere, must be held at the U.S. port of entry. Finally, the Bioterrorism Act does not provide specific procedures for the disposition of food refused admission under section 801(m) when no subsequent adequate notice is submitted. Section 801(a) and (b) provide that food refused admission under section 801(a) must be destroyed or reexported. FDA thus believes that the general requirements of Title 19 of the United States Code and the U.S. Customs implementing regulations that apply to imports for which entry has not been made apply in these circumstances. 

Under 19 U.S.C. 1448 and 1484, entry of merchandise must be made within the time period prescribed by regulation, which is 15 days after the food arrives in the United States. See 19 CFR Part 1422. If entry is not made within this timeframe, the carrier or other authorized party is required to notify U.S. Customs and a general order warehouse. Generally, at that point the warehouse must arrange to take and store the food at the expense of the consignee. The disposition of this merchandise is governed by 19 U.S.C. 1491 and the implementing regulations at 19 CFR Part 127. Typically, after 6 months, unentered merchandise is deemed unclaimed and abandoned and can be disposed of by the United States. Before this 6 month period runs, however, such merchandise can be reexported. FDA and U.S. Customs plan to develop additional guidance to explain how the agencies will handle food when it must be placed in general order warehouses due to refusal under section 801(m) of the act. 

C. Requirements to Submit Prior Notice of Imported Food

1. Who is Authorized to Submit Prior Notice for an Article of Food That is Imported or Offered for Import Into the United States? (Proposed Sec.  1.285) 

FDA is proposing that a purchaser or importer of an article of food who resides or maintains a place of business in the United States is authorized to submit prior notice. FDA is also proposing that an agent who resides or maintains a place of business in the United States acting on the behalf of the U.S. purchaser or U.S. importer is authorized to submit prior notice. FDA believes that the customs broker/filer should be authorized to be a submitter if it is the U.S. agent of the U.S. importer or U.S. purchaser. 

FDA is proposing that, if the article of food is imported for in-bond movement through the United States for export, the prior notice must be submitted by the arriving carrier or, if known, the in-bond carrier. The types of entries that cover these importations are known to FDA and U.S. Customs as Transportation for Exportation (TE) and Immediate Export (IE). 

FDA believes that the proposed rule should specify which parties are responsible for submitting prior notice and that this specificity will minimize confusion about who should or will submit prior notice among the several parties who can be involved in importing food. Less confusion will lead to greater compliance. Less confusion will also mean that fewer imports will be delayed for lack of prior notice. 

FDA chose the U.S. entities in proposed Sec.  1.285(a) for several reasons. First, we do not believe that there is importation of food to the United States that does not involve one of the U.S. entities identified, except in those instances where the food is imported with the intention of in-bond movement through the United States for export (where the proposed rule authorizes submission by the arriving carrier or, if known, the in-bond carrier). We also believe that it is the U.S. importer or U.S. purchaser who orders or buys the article of food, thereby initiating its importation into the United States. These persons thus should possess, or have the ability to obtain, the information required to be submitted in the prior notice within the time period in proposed Sec.  1.286. As U.S. businesses, these persons are also more likely to already have web access than some foreign businesses, which reduces potential costs and impacts on trade. Finally, placing responsibility on these U.S. entities will facilitate FDA's ability to conduct audits, investigations, and inspections, which will facilitate efficient enforcement of section 801(m). 

FDA notes that the submitter is the entity responsible for ensuring the adequacy and accuracy of the prior notice. For the reasons described above, FDA believes that these entities are in the best position to do so. 

FDA seeks comment on whether others should be authorized to provide prior notice and, if so, why.2. When Must the Prior Notice be Submitted to FDA? (Proposed Sec.  1.286) 

Based on consideration of the factors set out in the statute, FDA is proposing that the prior notice must be submitted to FDA no later than noon of the calendar day before the day the article of food will arrive at the border crossing in the port of entry. 

Section 801(m)(1) of the act makes clear that a primary purpose of prior notice is to enable inspections or other FDA action upon arrival of food in the United States to protect consumers in the United States from food imports that may be at risk of intentional adulteration or that may pose other risks. Section 801(m)(2)(A) of the act states that the deadline for prior notice ``shall be no less than the minimum amount of time necessary for [FDA] to receive, review, and appropriately respond to such notification.'' In addition, section 801(m)(2)(A) provides that FDA may take other factors into consideration when deciding on the deadline for prior notice, specifically: its effect on commerce; the locations of various ports; various modes of transportation; types of food; and any other consideration. However, although the statute gives FDA some latitude in setting the deadline for prior notice, it nonetheless makes clear that we must establish a timeframe for prior notice that allows FDA to receive, review, and appropriately respond to all prior notices. Finally, section 801(m)(1) states, ``Nothing in this section may be construed as a limitation on the port of entry for an article of food.'' 

Reading section 801(m) as a whole and in conjunction with other provisions in the Bioterrorism Act, FDA believes that Congress intended that FDA assess the information in the prior notice to determine if inspection upon arrival or other action is appropriate. For FDA to inspect, upon arrival, food imports that may be at risk of intentional adulteration or that may pose other risks to U.S. consumers, FDA must be able to effectively deploy its staff. Although FDA inspectors are located throughout the United States, FDA does not have staff located at or near all of the 250 ports where over 4.7 million entry lines of food were entered in fiscal year (FY) 2001. Port locations are established by U.S. Customs and, under the statute, FDA cannot limit ports at which food may be imported or offered for import. Thus, FDA must have enough time, on a daily basis, to process the information in the approximately 20,000 prior notices we expect to receive and to send inspectors to any port in the United States if necessary. FDA believes that the minimum amount of time necessary to ensure it can plan and that its staff can travel to the arrival point is noon of the calendar day before the day the article arrives at the border crossing. FDA believes that this timeframe will give it the minimum time it needs to conduct its assessments and provide the information to its field offices so they can allocate their inspectional resources on a daily basis and plan any necessary travel. 

Before proposing this deadline FDA also considered its potential effects on imported food. FDA believes that in most circumstances information regarding imports is generated when the article to be imported is ordered or purchased, not when it is shipped to the United States. FDA has examined a selection of imported food documents and compared dates of these documents with the dates of arrival in the United States and U.S. Customs entry. FDA asked several field offices to send entry documents with invoices covering imported foods. Sixty-four packages of entry documents were received in response to this request. The dates of the invoices were compared to the dates of arrival and receipt in OASIS. In 48 cases (75 percent), the invoice date or date of sale preceded the arrival date by least 1 day. In 31 cases (48 percent), the invoice or sale date preceded the arrival date by 2 or more days. In 16 cases (25 percent), the invoice date was the same as the arrival date. FDA invites comment on the representativeness of this sampling. Based on this examination, we believe that orders are normally placed a day or more prior to shipment. See the compilation of imported food documents that FDA has placed in the administrative record and the docket (Ref. 1). FDA believes that the information required for prior notice therefore generally does exist by noon of the calendar day before the day of arrival. FDA recognizes, however, that currently one person may not possess all of the information and that some practices regarding the flow of information about food imports will have to change to ensure that the submitter has all of the information needed to submit a prior notice for the food shipment by the deadline. 

FDA believes that this proposed deadline will have the most impact on those who import food by truck and rail over the land borders, with less effect at airports, and almost no effect at water ports. However, even on the land borders, FDA believes that the information required by prior notice will be, in most cases, sufficiently fixed by noon of the calendar day before arrival to allow the U.S. importer or U.S. purchaser, or their U.S. agents, to submit prior notice to FDA that meets the proposed requirements without slowing down the shipment. 

FDA is proposing to allow submitters to amend prior notices for that portion of the product identity information that cannot be completed, because it does not yet exist by noon of the calendar day prior to arrival. We believe this may be the case with product identity for fresh products imported from countries close to the United States (e.g., Canada or Mexico). For example, fresh seafood may be ordered as ``catch-of-the-day'' from Canada or Mexico; the importer intends to import the fish the day after the order is placed, but cannot find out what exact species and quantity will arrive by the deadline for prior notice because the boat is not due back until late afternoon on the day prior notice is due. Another example is an importer who orders fresh lettuce for import the day after the order but cannot find out the exact variety and quantity of lettuce that will be shipped by the deadline for prior notice because the field has not been harvested or the supplier has not yet received the day's harvest by the time prior notice of the planned shipment is due. In these instances, the importer knows generally what kind of product has been ordered, but not the exact type (species for fish and variety for lettuce). The proposed amendment process would allow submitters who cannot report complete product identity information to FDA by the prior notice deadline because it does not yet exist to maintain current business practices. However, it would provide FDA some of the information that it needs to begin the assessment of whether a particular shipment of food should be investigated and if so, to ensure that FDA personnel can be available when the food arrives at the port. FDA does not intend this amendment process to apply when a shipper ``tops off a container'' by filling unused space in the container or truck bed with additional different food products. 

FDA also recognizes that information concerning the anticipated arrival may change after the article is ordered due to unforeseen traffic or weather issues and has accommodated those potential changes by requiring updates of that information. 

``Noon'' means 12:00 p.m. in the time zone in which the FDA office with responsibility over the anticipated port of entry resides. For example, if the anticipated port of entry is the Peace Bridge in the Buffalo, NY, and the anticipated date of entry is January 9, 2004, the prior notice must be submitted to the FDA Prior Notice System before noon Eastern Standard Time (EST) on January 8, 2004. 

FDA is proposing that prior notice may not be submitted until all of the information required by Sec.  1.288 exists except as provided in Sec.  1.288(e)(2) and Sec.  1.290, both of which relate to product identity amendments. FDA is also proposing that the prior notice may not be submitted more than 5 days before the anticipated date of arrival of the food at the anticipated port of entry. For example, if the anticipated date of arrival is January 12, 2004, the prior notice may not be submitted before January 7, 2004. This 5 day limitation is consistent with the limitation set by Congress in section 307(a)(2)(A) of the Bioterrorism Act. Such limitations are necessary to ensure that FDA's Prior Notice System is not overburdened with premature information or submissions that may need to be cancelled and resubmitted. 

3. How Must You Submit the Prior Notice? (Proposed Sec.  1.287) 

FDA is proposing that the prior notice, amendments, and updates must be submitted electronically to FDA through FDA's Prior Notice System. The web-based FDA Prior Notice System is under development with an anticipated completion date of no later than October 12, 2003. A ``mock-up'' of the Prior Notice Screen a submitter would see once he or she accessed this system is part of this proposed rule. 

FDA has consulted with the U.S. Customs Service of the Department of the Treasury about this proposed rule. FDA and U.S. Customs considered modifying ACS to accommodate the new prior notice requirement. However, during these consultations, U.S. Customs determined that ACS could not be modified to accommodate the data requirements of the prior notice regulation by the December 12, 2003, statutory deadline. Currently, U.S. Customs is focusing its resources on developing the Automated Commercial Environment (ACE) as a replacement for ACS, and integrating its other electronic systems, such as the Automated Manifest System (AMS). FDA is participating in the development of ACE through the International Trade Data System (ITDS) Board and directly through integration of FDA and U.S. Customs business practices, policies, and border cooperation. FDA intends to allow prior notice to be submitted through ACE when it is fully operational. However, implementation of ACE is not expected before 2005. Given these circumstances, FDA and U.S. Customs agreed that to meet the statutory deadline, an FDA stand-alone, web-based electronic system to execute receipt of prior notice would be necessary until ACE is fully operational. 

FDA seeks to minimize the submission of duplicative information. The Bioterrorism Act requires certain prior notice information to be submitted to FDA. FDA seeks comments on the extent to which these proposed prior notice requirements would result in persons submitting duplicative prior notice information to more than one federal agency. FDA also seeks comments on whether there is any way, consistent with the requirements and purpose of the Bioterrorism Act, to minimize the duplication of information required to be submitted to the federal government under these prior notice requirements. As discussed previously, FDA and U.S. Customs are working together on their systems to allow prior notice to be submitted to FDA through U.S. Customs System when ACE is fully operational. 

FDA is proposing to require electronic submission of prior notice because we believe an electronic system will be the least burdensome and most efficient way to implement and enforce the requirement of section 801(m) of the act. Nationwide, in FY 2001 FDA received over 4.7 million food entry lines; therefore, we believe a paper system would be unmanageable for FDA, require a longer deadline, and could slow down imports for some food products. Moreover, we currently receive the majority of information we base admissibility decisions on electronically from U.S. Customs. Thus, we already have the electronic capability to process and screen the information. We also believe that an electronic system will mean fewer errors than a paper system. Another important benefit of electronic submission will be immediate and accurate communication between FDA offices and between FDA offices and U.S. Customs about arrivals and adequacy of the prior notice. 

An electronic prior notice system will have several key features that will benefit firms that export to the United States, U.S. importers, and FDA. First, the volume of submissions on a daily basis is expected to be such that electronic submission and processing are the only practical way for FDA to manage prior notice--FDA expects, upon average, 20,000 submissions per day. Second, an electronic system will be able to provide instantaneous confirmation of receipt of the prior notice. Third, an electronic system will be able to ensure that the form is filled out completely (though not accurately) by being set to reject submissions until all of the mandatory fields are completed. Finally, an electronic system will make it more likely that information in the submissions is ``legible'' to FDA. 

In contrast, prior notice by mail, fax, or e-mail would have several significant downsides for firms that export to the United States, U.S. importers, and FDA. All three of these methods would require FDA to input the data manually to process it, which means that FDA would need to set a longer deadline for submission or devote resources on data entry that are better spent on tasks like inspections. Those whose paper submissions were not legible or complete would not know until their shipments arrived at the port and were refused admission. 

Moreover, FDA believes that almost all proposed submitters have access to the Internet, either within their companies or through public libraries, copy centers, schools, or Internet cafes, as well as through agents or brokers. FDA requests comments on this assumption. Because most of the persons responsible for submitting the prior notice must reside or maintain a place of business in the United States, the FDA Prior Notice System will be in English. This will also allow for the information to be placed in standard data elements that can then be maintained in a database, screened against standard criteria, and used for communication among field offices. 

In proposed Sec.  1.287(b), FDA is proposing that if its Prior Notice System is unable to receive prior notice electronically, the prior notice, amendments, and updates must be submitted using a printed version of the Prior Notice Screen delivered in person, by fax, or by e-mail to the FDA field office with responsibility over the geographical area in which the anticipated port of entry is located. If the submitter does not receive electronic acknowledgement from the FDA Prior Notice System then it should check to see if its system is working. If it is, then the submitter should assume that the FDA system might be down and attempt to contact the appropriate FDA field office to confirm. 

The Prior Notice System will not provide a response to the submitter of the agency's decision regarding the adequacy or timeliness of the prior notice as this assessment will turn on information that will not be available until the food arrives in the United States. FDA anticipates the system will date and time stamp an electronic confirmation of the system's receipt of each prior notice, amendment, and update, which the system will send to the submitter automatically. 

FDA believes that the prior notice process under section 801(m) precedes the review process under section 801(a). Thus, FDA's response to the prior notice will not constitute entry review. The section 801(a) review process will be separate from, and subsequent to, the prior notice process. Therefore, the FDA Prior Notice System's electronic confirmation of a prior notice submission is not an 801(a) admissibility decision and should never be construed as an FDA ``release'' or ``may proceed.'' 

If a person wishing to submit prior notice to the FDA is unable to do so because his or her own system is not operating, FDA expects the submitter to use an alternative Internet system for submission (e.g., a local library or copy-center with Internet access). FDA is developing a web-based system to reduce the likelihood that intermittent system outages will impact prior notice submissions. 

Although the system may be developed in a way that will allow for establishment of a personal account, users will not have to be licensed or otherwise pre-approved or have specialized software. FDA also plans to develop and provide guidance and training to potential submitters and their agents that will further describe the data elements and the submission process before December 12, 2003, which is when the requirement to provide prior notice begins. The Prior Notice Screen of FDA's Prior Notice System also identifies the information that must be submitted.4. What Information Must be Submitted in a Prior Notice? (Proposed Sec.  1.288) 

Proposed Sec.  1.288 lists the information or data elements that must be included in each prior notice. Much of this list is taken directly from section 801(m)(1) of the act. The remainder of the list, although not explicitly listed in section 801(m), is information that FDA believes is necessary for the efficient enforcement of section 801(m) of the act and is thus authorized under section 701(b) of the act. We explain below why each of these items is necessary for the efficient enforcement of section 801(m). Accordingly, as set out in proposed Sec.  1.278(a), FDA is proposing that a prior notice that does not contain all of the information listed in proposed Sec.  1.288 will be considered inadequate. FDA solicits comments on this approach. 

Most of this information is already supplied by the filer to FDA through ACS as part of the U.S. Customs entry process, including the entry type; the entry number (both ACS line number and FDA line identifier); the FDA product code; a written description of the product in common business terms; brand name; the quantity; lot numbers; the manufacturer; country of origin; shipper; importer; ultimate consignee; and the carrier (the mode of transportation and the carrier code). 

Before discussing each data element in the context of prior notice, we want to emphasize that the prior notice requirement does not apply to a whole shipment; for the purpose of section 801(m) of the act, it applies to ``each article of food.'' FDA believes that in section 801(m) ``each article of food'' means each article of food produced by each manufacturer. Thus, any food product identified by a specific FDA product code and quantity description produced by a single manufacturer (or grower, if fresh) associated with a single entry line number (U.S. Customs entry number plus ACS line number plus OASIS/FDA line number) must be covered by a prior notice. Therefore, each article of food that is represented by an FDA line must be covered by a prior notice. 

Thus, if a shipment consists of four different kinds of food products, e.g., 1,000 cases of 48/6 oz. cans each of Brand X tuna, 240 cases of 24/15.25 oz. cans each of yellow corn, 300 cases of 24/12 oz cans each of Brand X tuna, and 1,500 cases of 48/6 oz. cans each of Brand P tuna, four prior notices are required. These four prior notices may be contained in one submission. If the shipment consists of only one product, e.g., 2,400 cases of 24/15.25 oz. cans each of yellow corn, one prior notice is required. If this corn came from two different manufacturers, however, two prior notices would be needed. In its Prior Notice System FDA will give the submitter the option of completing additional prior notices for other articles after each notice is completed. We are working with the developers of the Prior Notice System to accept ``header'' information that will permit repeated information to be automatically entered. This ``header'' would contain information consistent across several articles of food within the same submission, i.e., U.S. Customs entry. This will reduce the amount of data entry and potentially reduce typing and transcription errors. FDA plans to develop its Prior Notice System to allow submitters to automatically repeat information already entered in the submission where appropriate (e.g., all information is the same except for the identity of the article or the manufacturer). 

FDA is proposing to require the following information in the prior notice identifying the following details for each article of food: 

2. The submitter. FDA is proposing to require the identity of the submitter and the associated submitting firm. This information is needed so that FDA may communicate the adequacy or non-adequacy of the prior notice to the responsible party and to follow up when audits, inspections, or enforcement are necessary. 

Generally, for all firms that the proposed rule requires to be identified in a prior notice (submitter, importer, owner, consignee, manufacturer, growers (if known), shipper), FDA is proposing that the prior notice include the firm's name, address, phone number, fax number, and e-mail address, and if the firm is required to register a facility associated with the article of food, the facility's registration number. The registration requirement is contained in a separate provision of the Bioterrorism Act (section 305). FDA believes that it needs identifying information in addition to the[[Page 5436]]registration number (if one exists) to minimize the chance that typographical errors in registration numbers will lead to prior notices being considered incorrect and thus inadequate. We are considering designing the Prior Notice System to require at least one ``confirmatory'' data element (firm name or city or country) in addition to the registration number to allow for validation edits before automatically filling in the remaining data fields. 

The phone and fax numbers and e-mail address are required (if they exist) so that FDA can communicate with the firm, if necessary. If the firm does not have a fax number or e-mail address, the prior notice submission should declare this. FDA plans to develop its Prior Notice System to allow submitters to repeat information already entered in the submission where appropriate (e.g., where the submitter is also the importer and consignee of the article). 

b. The U.S. Customs entry type. FDA is proposing to require the submission of the U.S. Customs entry type associated with the article of food being imported or offered for import (proposed Sec.  1.288(b)). Some examples of types of entries are Consumption entries, Warehouse entries, Temporary Importation Bond entries, Transportation for Exportation Bond entries, Trade Fair entries, mail entries, and baggage entries. Each of these types has a pre-designated U.S. Customs entry type code. That code must be submitted in the prior notice. This information will tell us if the article of food is intended for consumption in the U.S. or is intended for export or other uses. We need this information for proper screening of the information and identification of the appropriate articles for inspection. FDA also believes that submission of this information is critical for matching the prior notice to the corresponding U.S. Customs entry in order to assess the adequacy of the prior notice when shipments arrive and are presented for review. 

c. The U.S. Customs ACS entry line number or other U.S. Customs identification number. FDA is proposing to require the submission of the U.S. Customs ACS entry line number, consisting of the entry number, the U.S. Customs ACS line number, and the FDA entry line number, which will be associated with the entry of the food for U.S. Customs purposes (proposed Sec.  1.288(c)). For each entry number, there may be one or more U.S. Customs ACS lines and for each U.S. Customs ACS line there may be one or more FDA lines. For example, U.S. Customs entry number 0123456789-0 may identify an entry of peppers; the U.S. Customs ACS line 123456789-0-001 may identify fresh peppers; and the FDA entry line 0123456789-0-001-001 may identify fresh sweet peppers and FDA entry line 0123456789-0-001-002 may identify fresh hot peppers. 

If the article of food is not intended for consumption entry, FDA is proposing to require submission of the U.S. Customs identification number associated with that type of entry. Some examples of other types of entries are Warehouse entries, Temporary Importation Bond entries, Transportation for Exportation Bond entries, and Trade Fair entries. 

FDA believes that this information is necessary for proper screening of the information and identification of the appropriate articles for inspection. FDA also believes that submission of this information is critical for matching the prior notice to the corresponding U.S. Customs entry in order to assess the adequacy of the prior notice when shipments arrive and are presented for review. FDA believes that these numbers can be obtained by the proposed deadline for prior notice. We seek comment on this issue. 

d. The location where the food is being held under proposed Sec.  1.278, if applicable. FDA is proposing to require that, if the article of food has been refused admission due to inadequate prior notice and thus is required to be held at the port of entry or in a secure facility, the submitter of the prior notice must inform FDA both that the article is under hold, and the location where the shipment is being held (proposed Sec.  1.288(d)). Additionally, FDA is proposing to require the date that the article will arrive at that location as well as the identification of a contact at that location. This information is necessary to ensure FDA can locate the food for inspection and to ensure that the hold requirement is being compiled with. 

e. The product identity. Section 801(m)(1) states that a prior notice must contain the identity of the article of food being imported or offered for import. FDA is proposing the following data elements to ensure that each prior notice adequately and completely identifies the food being imported or offered for import. 

i. The complete FDA product code. FDA is proposing to require the submission of the complete FDA product code as an element of the identity of the product (proposed Sec.  1.288(e)(1)(i)). The FDA product code is a unique code currently used for classification and analysis of merchandise. The FDA product code is currently available via the Internet at www.accessdata.fda.gov/scripts/ora/pcb/pcb.htm as a ``buildable'' code which is used to describe the food by industry, industry class, subclass, container/packaging, process, and specific product. We will work with the developers of the FDA prior notice system to ensure that there is a link from that system to the product code builder. We are working with the developers to design the link to the product code builder which will allow the product code selected to be automatically pasted back to the Prior Notice Screen. We will also design the system so that if the submitter already knows the product code, it can be entered directly into the Prior Notice Screen. 

The FDA product code for canned tuna fish is 16AEE45, which translates as 16= fishery/seafood products, A= fish, E= subclass metal (cans), E= commercially sterile, 45= tuna. The filer currently submits the FDA product code to U.S. Custom's ACS when entry is made; it subsequently is transmitted to FDA's OASIS for each entry line. 

FDA is proposing that if all of the information concerning the product identity exists by noon of the calendar day before the article will arrive at the port of entry, it must be included in the prior notice and the prior notice may not be subsequently amended. (Proposed Sec.  1.288(e)(2)). If any of the product identity information does not exist by the deadline, the information that does exist must be provided to FDA, and the submitter must indicate that it will amend the prior notice. FDA identifies the conditions appropriate for amendments related to product identity in proposed Sec.  1.290. FDA notes that, in determining whether the information exists, the standard set out in the proposed rule is not whether the submitter knows the information when filing the prior notice, but whether the information could be known by the submitter by the noon deadline. In the discussion of proposed Sec.  1.289, we describe under what circumstances we think complete product identity will not exist. FDA solicits comment on this standard and whether it is sufficiently flexible to achieve our goals. 

ii. The Common or usual or market name. FDA is proposing to require the submission of the common or usual or market name of the article of food as an element of the identity of the product (proposed Sec.  1.288(e)(1)(ii)). This is a description, in common terms, detailed enough to allow the kind of product to be identified. (See 21 CFR Sec.  102.5 for additional information about common or usual names.) The filer currently submits the common or usual or market name to U.S. Custom's ACS when entry is made, and it subsequently is transmitted to FDA's OASIS for each entry line. This information is necessary to confirm the accuracy of the product code. 

iii. The trade or brand name. FDA is proposing to require the submission of the trade or brand name of the article of food, if it is different than the common or usual or market name, as an element of the identity of the product (proposed Sec.  1.288(e)(1)(iii)). For example, the brand name of canned tuna would be XYZ brand tuna. This information is necessary to ensure that FDA knows the brand identity of the product, which is often a critical piece of information when making inspection decisions. The filer currently submits the trade or brand name to U.S. Custom's ACS when entry is made, and it subsequently is transmitted to FDA's OASIS for each entry line. 

iv. The quantity. FDA is proposing to require the submission of the quantity of food described from smallest package size to largest container as an element of the identity of the product (proposed Sec.  1.288(e)(1)(iv)). The number of container units and units of measure are to be submitted in decreasing size of packing unit (starting with the largest). Some examples of quantity descriptions are: 100 cartons of 48/6 oz. cans each of tuna; 100 pallets of 2/100 lb. totes each of frozen tuna loins for a total of 20,000 pounds; 100 pallets of 2/100 lbs. cartons each of dehydrated pig ears for a total of 20,000 lbs.; and 100 cartons of 20 lbs. of fresh watermelons each for a total of 2000 lbs. The filer currently submits the quantity of each line entry to U.S. Custom's ACS when entry is made, and it subsequently is transmitted to FDA's OASIS. FDA requests comment on whether changes in quantity will occur after the deadline for prior notice and, if so, how commonly changes occur and how significant the changes usually are. 

v. The lot or code numbers or other identifier. FDA is proposing to require the submission of the lot or code numbers or other identifiers that are specific to the article of food, if applicable, as an element of the identity of the product (proposed Sec.  1.288(f)(1)(v)). These numbers are the identification number or code of a production lot and are needed to more specifically identify a product. Currently, there may be more than one identifier represented in an entry line. The prior notice system will be developed to accept more than one lot identifier per article. 

f. The manufacturer. As provided for in section 801(m)(1), FDA is proposing to require the submission of the identity of the manufacturer of each article of food (proposed Sec.  1.288(f)). The filer currently submits the identity of the manufacturer to U.S. Custom's ACS when entry is made, and it subsequently is transmitted to FDA's OASIS. 

g. The growers, if known. As required by section 801(m)(1), FDA is proposing to require the submission of the identity of all growers of each article and the growing location if different from the grower's business address, if known at the time of submission of the prior notice (proposed Sec.  1.288(g)). If the submission is amended, the proposed rule provides that the identity of all growers must be provided if known at the time of the amendment (proposed Sec.  1.290(d)). FDA wants to emphasize that section 801(m)(1) of the act states that grower information must be submitted if it is known. Thus, this information is not optional: if it is known, it must be submitted. If a product is sourced from more than one grower, the prior notice must provide the identification of all growers, if known. The FDA Prior Notice System will be developed to accommodate submission of up to three different growers. 

FDA solicits comments on two particular aspects of the statutory requirement that the grower be identified. First, does the act give FDA any flexibility to exempt or otherwise treat differently so-called processed foods produced with products from more than one grower? Second, does the term ``grower'' include a harvester or collector of wild products, e.g., some fish and botanicals? 

h. The originating country. As provided for in section 801(m)(1), FDA is proposing to require the submission of the identity of the originating country of the article of food (proposed Sec.  1.288(h)). This term is defined in proposed Sec.  1.277(c)(2). 

i. The shipper. As provided for in section 801(m)(1), FDA is proposing to require the submission of the identity of the shipper of the article of food (proposed Sec.  1.288(i)). FDA considers the shipper to be the person who arranges for a shipment to get to its first destination in the United States. The shipper typically is responsible for initiating the bill of lading or airbill covering the transportation of the article by the carrier. The shipper is usually a foreign firm that is located or maintains an address in the country from which the article was shipped. The shipper is typically not the carrier. 

j. The country of shipping. As provided for in section 801(m)(1), FDA is proposing to require the submission of the identity of the country from which the article of food was shipped (proposed Sec.  1.288(j)). This term is defined in proposed Sec.  1.277(c)(3). 

k. Anticipated arrival information. 

i. The anticipated port of entry. As provided for in section 801(m)(1), FDA is proposing to require the submission of the anticipated port of entry at which the article of food will arrive in the United States (proposed Sec.  1.288(k)(1)(i)). ``Port of entry'' is defined in proposed Sec.  1.277(c)(5). 

ii. The anticipated date of arrival. FDA is proposing to require the submission of the anticipated date when the article of food will arrive at the port of entry in the United States (proposed Sec.  1.288(k)(1)(ii)). FDA believes that this information is necessary to plan inspections. 

iii. The anticipated time of arrival. FDA is proposing to require the submission of the anticipated time when the article of food will arrive at the port of entry in the United States (proposed Sec.  1.288(k)(1)(iii)). FDA believes that this information is necessary to plan inspections. 

FDA is proposing to require the prior notice to be updated if any of the anticipated arrival information changes after the submission of the prior notice (proposed Sec.  1.288(k)(2)). Updates are necessary so FDA can change its plan when anticipated arrival information changes. The conditions appropriate for updates are provided in proposed Sec.  1.294. 

l. The port where entry will be made for U.S. Customs purposes. FDA is proposing to require the submission of the identification of the port where entry will be made for U.S. Customs purposes (proposed Sec.  1.288(l)). Often, this port will be different than the port where the article of food arrived in the United States. FDA believes that this information is necessary to facilitate communication with U.S. Customs and FDA field offices concerning the adequacy of the prior notice. It is also necessary to enable FDA to coordinate resources for inspections, examinations, or sampling. 

m. The anticipated date of U.S. Customs entry. FDA is proposing to require the submission of the anticipated date of entry for U.S. Customs purposes (subpart 1.288(m)). FDA believes that this information is critical to enable it to allocate resources for inspecting imported food shipments and efficient communication with and between U.S. Customs and FDA field offices. 

n. The importer, owner, and consignee. Under section 801(m)(2)(B)(i) and proposed Sec.  1.278(e)(2), food that is offered for import with no or inadequate notice may not be delivered to the[[Page 5438]]importer, owner, or consignee. Thus, FDA is proposing to require their identities so that FDA knows who they are and can take steps to ensure that food refused admission under section 801(m) is not delivered to them illegally. FDA is proposing that only one importer, owner, and consignee can be identified for each prior notice. Under most circumstances, FDA believes the importer will be the importer of record for U.S. Customs Entry Summary purposes. 

o. The carrier. FDA is proposing to require the identity of each carrier or transporter firm that transports the article of food from the country from which the article was shipped into the United States. This identification includes the submission of the Standard Carrier Abbreviation Code. Identification of the carrier is necessary to enable FDA and U.S. Customs to identify the appropriate article of food for inspection or holding when the food arrives in the United States. FDA notes that a carrier typically is a different firm than the shipper. The filer currently submits carrier information to U.S. Custom's ACS when entry is made, and it subsequently is transmitted to FDA's OASIS.5. 

What Changes are Allowed to a Prior Notice After it Has Been Submitted to FDA? (Proposed Sec.  1.289) 

FDA is allowing additional information to be supplied once a prior notice is submitted in two situations. FDA believes that under the standards in section 801(m)(2)(A) for establishing the timeframes for submission of prior notice, amendments are appropriate when complete product identity will not exist by the deadline for the submission of a prior notice. As described in more detail elsewhere, FDA believes that these situations largely involve fresh produce and fish harvested in countries close to the United States, e.g., Mexico and Canada. Second, FDA believes that it must have accurate arrival information in order to ensure it can inspect an article or take other appropriate action. In the event that other information in the prior notice must be changed, no amendment or update is permitted. The submitter must cancel the initial prior notice and submit a new one.6. 

Under What Circumstances Must You Submit a Product Identity Amendment to Your Prior Notice After You Have Submitted It to FDA? (Proposed Sec.  1.290) 

FDA is proposing that the prior notice must be amended if all information about the identity of the food required by proposed Sec.  1.288(e)(1) does not exist by noon of the calendar day before the day of arrival. The submitter must indicate his or her intention to amend the information at the time the initial prior notice is submitted. FDA is proposing that the prior notice may be amended only once. FDA is limiting the number of times a prior notice may be amended because FDA believes that it would be an inefficient use of its review and planning resources to address intermediate, still incomplete submissions. FDA wants to encourage submissions that are as complete as possible to allow FDA to deploy its resources effectively. FDA requests comment on our proposal to restrict the number of amendments to one. 

FDA is proposing that only the information required by proposed Sec.  1.288(e)(1) and indicated in the initial prior notice as being subject to amendment may thereafter be amended. FDA is proposing to limit the information that may be amended in a prior notice to the product identification information required in proposed Sec.  1.288(e)(1). As we explain elsewhere in this preamble, we believe that in most situations, complete product identity will exist by noon of the calendar day before the day of arrival. However, we recognize that in certain limited circumstances, such as wild-caught fresh fish and fresh produce with many varieties that are caught or harvested close to the time of shipment in locations close to the U.S. border, this specificity may not be known by noon of the calendar day before the day of arrival. FDA is proposing that the last two digits of the FDA product code and other product identity information that provides the specific identity of the article may be amended when this information does not exist by the prior notice deadline. 

For example, there may be occasions when an entry of lettuce is ordered and prior notice is submitted by noon the calendar day prior to arrival, but the specific variety of lettuce that will be shipped does not exist because the growers that supply the shippers have not yet harvested their crops. At or before the time when the article is placed in the carrier for shipment, however, the complete identity of the article exists and the prior notice must be amended to identify the specific type of lettuce (e.g., romaine or leaf). 

A prior notice may not be amended to change completely the identity of the article, e.g., a prior notice identifying the food as lettuce may not be amended to identify the food as pears. 

If an article of food is not covered by a specific FDA product code, e.g., a root vegetable not more specifically described by numerical code in the FDA product code builder, then the last two numbers of the product code may be provided as ``99'' which means root vegetables, not elsewhere classified. However, this prior notice cannot be amended later to identify the product as carrots because, even though carrots are root vegetables, there is an FDA product code that is specific to carrots and thus it should have been used in the initial notice. We plan to design the prior notice system so that it will not acknowledge that a prior notice submission is completely filled out if it does not contain a seven-digit product code. The system will be designed to provide, where appropriate, a reminder about the need for amendment with the electronic message acknowledging receipt of the initial submission. 

The information that may be amended also includes the common or usual or trade name, brand name, lot or code or identification numbers, and quantity. 

FDA is proposing that, if the identity of the grower was not provided at the time the prior notice was submitted because it was not known at that time but the identity is known at the time of the amendment, the amendment must include information that identifies all known growers.7. 

What is the Deadline for Product Identity Amendments Under Sec.  1.290? (Proposed Sec.  1.291) 

FDA is proposing a 2 hour minimum deadline for amendments submitted under proposed Sec.  1.291, or updates submitted under proposed Sec.  1.294. 

FDA believes that the deadline will allow submitters to provide FDA the information it needs in order to effectively assess whether a particular shipment of food needs to be investigated and if so, to ensure FDA personnel are present to do so when the food arrives at the port of entry, while allowing submitters to amend and/or update information that may not be known with exact certainty by noon of the prior calendar day. FDA considered the type of food in proposing the deadline for amendment to the product identity and updates to the anticipated arrival information. 

FDA believes that product identity amendments are most likely to be needed to accommodate articles imported by land or air rather than water arrivals. FDA also recognizes that this limitation on amendments may also affect the practice of ``topping off a container'' by filling unused space in the container or truck bed with last-minute shipments of other food products not covered by prior notice.

FDA notes that under its amendment proposal ``topping off'' with the article of food that is already the subject of a prior notice would be allowed. To the extent ``topping off'' with non-food items occurs, this practice would not be affected. FDA believes, however, that this limitation is dictated by the Bioterrorism Act's requirements and moreover is necessary to ensure that FDA has adequate notice of all FDA-regulated food imports such that FDA can deploy its resources effectively. In this case, a separate prior notice would be required for these foods not already covered by a prior notice. FDA solicits comment how common ``topping off'' is and the quantities of food involved.8. 

How Do You Submit a Product Identity Amendment or An Arrival Update to a Prior Notice? (Proposed Sec.  1.292) 

FDA is proposing to limit the way in which a prior notice may be amended or updated. FDA is proposing that a product identity amendment or an arrival update to a prior notice may be submitted only in the same manner as an initial prior notice; that is, electronically to FDA through FDA's Prior Notice System. Only the information concerning product identity and grower identity can be electronically amended under proposed Sec.  1.290. Only the information concerning the anticipated location, date, and time of arrival and grower identity can be electronically updated under proposed Sec.  1.294. 

FDA proposes to design its Prior Notice System to require identification of the type of submission (Initial, Amended, Updated) and to be capable of differentiating amongst them. If FDA's Prior Notice System is unable to receive submissions electronically, amendments or updates may be communicated directly to FDA using a printed version of the Prior Notice Screen, and delivered either in person, by fax, or by e-mail to the FDA field office with responsibility over the geographical area in which the port of entry is located, as provided by proposed Sec.  1.287(b). If the identification of the anticipated port of entry is being updated, and the FDA system is down, the updated printed version of the Prior Notice Screen should be delivered to the FDA field office with responsibility over the port covered by the initial submission. FDA intends to issue guidance for communication between the field office receiving the initial prior notice and the field office covering the updated port of entry.9. 

What Are the Consequences If You Do Not Submit a Product Identity Amendment to Your Prior Notice? (Proposed Sec.  1.293) 

FDA is proposing that if a U.S. importer or U.S. purchaser, or their U.S. agent, informed FDA in a prior notice that the submission would be amended, but subsequently does not amend it appropriately and within the applicable timeframe, then the prior notice is inadequate for the purposes of proposed Sec.  1.278(a). By telling FDA that the prior notice will be amended they are telling us that it is incomplete. We therefore will be waiting for complete information upon which to make our inspection decision. Without complete product identity, FDA cannot complete the assessment of whether to inspect or take other action when the food arrives in the United States. The consequences of inadequate prior notice are the same as the consequences for failing to provide prior notice; the food shall be refused admission and held at the port of entry unless FDA directs its removal to a secure facility. The consequences are more fully described previously in the discussion of proposed Sec.  1.278.10. 

What Must You Do If the Anticipated Arrival Information (Required Under Sec.  1.288(k)(1)) Submitted in Your Prior Notice Changes? (Proposed Sec.  1.294) 

FDA is proposing to require the submitter to update anticipated arrival information submitted in a prior notice, if the anticipated information changes after the submission. The types of information FDA expects may change between submission of prior notice and actual importation are the date, time, and location of arrival. Although the statute requires only anticipated port of entry, accurate, up-to-date arrival information (if different) is necessary for FDA field offices to reschedule inspections. FDA thus believes that it has the authority to require this information. 

If anticipated arrival information submitted in a prior notice changes, FDA is proposing that the submitter be required to provide the new port of entry (proposed Sec.  1.294(a)(1)), and the new time of arrival in an update electronically filed in the Prior Notice System (proposed Sec.  1.294(c)). FDA is proposing that if the time of arrival is expected to be more than 1 hour earlier (proposed Sec.  1.294(a)(2)) or more than 3 hours later (proposed Sec.  1.294(a)(3)) than the anticipated time of arrival, the time of arrival must be updated. FDA is proposing that, if the identity of the grower was not provided at the time the prior notice was submitted and that identity is known at the time of the update, the amendment must include information that identifies growers (proposed Sec.  1.294(b)). 

The FDA Prior Notice System will be designed to accommodate updates. As stated above, FDA is proposing to design its Prior Notice System to require identification of the type of submission (Initial, Amended, Updated) and to be capable of differentiating amongst them. 

FDA is proposing to limit the time within which a prior notice may be updated. The proposed regulation would require updated information to be submitted in accordance with the deadline for amendments under proposed Sec.  1.291, that is, an update to a prior notice must be submitted 2 hours prior to arrival. 

IV. Analysis of Economic Impacts

A. Preliminary Regulatory Impact Analysis 

FDA has examined the economic implications of this proposed rule as required by Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including: having an annual effect on the economy of $100 million, adversely affecting a sector of the economy in a material way, adversely affecting competition, or adversely affecting jobs. A regulation is also considered a significant regulatory action if it raises novel legal or policy issues. FDA has determined that this proposed rule is a significant regulatory action as defined by Executive Order 12866. 

The Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) defines a major rule for the purpose of congressional review as having caused or being likely to cause one or more of the following: An annual effect on the economy of $100 million; a major increase in costs or prices; significant adverse effects on competition, employment, productivity, or innovation; or significant adverse effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets. In accordance with the Small Business Regulatory Enforcement Fairness Act, OMB has determined that this proposed rule, when final, will be a major rule for the purpose of congressional review.1. Need for Regulation 

Section 307 of the Bioterrorism Act (Public Law 107-188), requires advance notice of all food imported or offered for import into the United States. If FDA fails to issue a final regulation by December 12, 2003, section 307 of the Bioterrorism Act provides for a default minimum period of advance notice that is not fewer than 8 hours and not more than 5 days before an article of food is imported or offered for import into the United States. This regulation is needed to implement the statutory provisions.

2. The Reason for the Regulation 

Getting food from the farm or sea to the plate involves a complex system of production and distribution. The system works using local knowledge and information; each participant needs to know only as much about the overall system as is necessary for his or her business. Market prices convey most of the information necessary for the ordinary production and distribution of food. In the event of an actual or suspected contamination of the food supply, however, more complete information is needed where it can be centrally used. The suspect food must be traced backward and forward through the distribution chain, both to protect consumers and to find the source and cause of the event. 

No individual firm or organization has sufficient financial incentive to establish a central information system relating to food safety for the entire economy. The nation's food producers and importers as a whole would benefit from such a system because it would be easier to uncover and solve problems, but the private costs to create the system would probably be prohibitive for any single firm or third party organization. 

The events of September 11, 2001, led Congress to conclude that public creation and provision of an information system is necessary. The Bioterrorism Act and its implementing regulations would establish an information system that would allow FDA to have a more integrated picture of the food distribution system. This particular regulation addresses one important aspect of this information system: the need to know what imported foods are entering the United States, where they came from, and when they will arrive. FDA is proposing three regulations to address these needs so the costs and benefits of any one regulation will be closely associated with related provisions in other proposed rules. With the regulations in place, the agency would have the additional tools necessary to help deter and respond to deliberate threats to the nation's food supply as well as to other food safety problems.

3. Proposed Rule Coverage 

This proposed rule would apply to all FDA-regulated food for human and animal consumption imported or offered for import into the United States with the exception of food carried in a traveler's personal baggage for personal use. As required by the Bioterrorism Act, the notification must provide the identity of the article, the identity of importer, manufacturer, shipper, and grower (if known), the originating country, the country from which the article was shipped, and the anticipated port of entry. In addition, the notification must provide the identity of the person who submits the prior notice, the owner, the consignee, the carrier, the U.S. Customs entry number, anticipated time and date of arrival, and, if the food has already been refused admission and required to be held, the location where it is held. 

A growing percentage of food consumed in the United States is imported; the value of food imports is now close to $50 billion per year. (Ref. 2) In the aftermath of the terrorist attacks on the United States on September 11, 2001, Congress determined that the existing requirements for the importation of FDA-regulated food products were insufficient to protect the safety of the U.S. food supply. 

Before September 11, 2001, FDA had approximately 150 personnel in the field processing imported food entries based on FDA's programs and assignments, all using guidance documents, such as Import Alerts, Compliance Policy guides, and other manuals. After September 11, 2001, FDA hired three hundred additional counterterrorism Consumer Safety Officers primarily for food imports. This step alone is insufficient to ensure the safety of food imported or offered for import into the United States. 

When deciding which imported food shipments to physically inspect and sample, FDA inspectors consider, among other things, compliance programs, assignments, import alerts, and whether the product is a low-risk or high-risk food. New requirements imposed by Section 307 of the Bioterrorism Act will require importers to give notice to FDA of incoming articles of food before the shipment reaches a U.S. border, rather than when the shipment arrives at the U.S. border or as part of the official U.S. Customs entry. Requiring prior notice of imported food shipments will allow FDA inspectors to have earlier information on foods that are coming into the United States, which will enable FDA to better deploy its inspection resources and to use this increased amount of information in cases where FDA action against the food is warranted, e.g., a credible threat to the food supply is suspected.

Number of Establishments Affected 

Using 2001 FY information from FDA's OASIS system (industry codes 02 through 52, 54, and 70 through 72), FDA has determined that there are approximately 77,427 importers and consignees who receive imported food shipments. Under the proposed rule, the U.S. importers or U.S. purchasers (or their agents) of the products will be responsible for submitting a timely and accurate prior notice to FDA. Using information from the OASIS system, FDA was also able to determine that there are approximately 100,000 foreign manufacturers (of a finished product). Foreign manufacturers are not responsible for submitting prior notice, and therefore, while not unaffected by prior notice, foreign manufacturer costs associated with this proposed rule will be assumed to be spread across the supply chain and therefore are not directly addressed in this analysis. 

FDA requests information on the size of establishments likely to be affected by this rule, including the foreign manufacturers of food