# Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3AE8-26282 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** November 7, 2008 - **Citation:** 73 FR 66294 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2002-N-0233] (formerly Docket No. 2002N-0278) RIN 0910-AC41 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Elsewhere in this issue of the Federal Register , FDA is announcing the availability of a draft compliance policy guide (CPG) entitled “Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.” DATES: This rule is effective May 6, 2009. FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 866-521-2297. SUPPLEMENTARY INFORMATION: Table of Contents I. Background and Legal Authority II. Summary of Significant Changes Made to the IFR A. What Definitions Apply to This Subpart? (§ 1.276) B. What is the Scope of This Subpart? (§ 1.277) C. Who is Authorized to Submit Prior Notice? (§ 1.278) D. When Must Prior Notice Be Submitted to FDA? (§ 1.279) E. How Must You Submit Prior Notice? (§ 1.280) F. What Information Must Be in a Prior Notice? (§ 1.281) G. What Must You Do If Information Changes After You Have Received Confirmation of a Prior Notice From FDA? (§ 1.282) H. What Happens to Food That Is Imported or Offered for Import Without Adequate Prior Notice? (§ 1.283) I. What Are the Other Consequences of Failing to Submit Adequate Prior Notice or Otherwise Failing to Comply With This Subpart? (§ 1.284) J. What Happens to Food That Is Imported or Offered for Import From Unregistered Facilities That Are Required to Register Subpart H of This Part? (§ 1.285) III. Comments on the IFR A. General Comments B. Comments on the Legal Authority C. What Definitions Apply to This Subpart? (§ 1.276) 1. The Act (§ 1.276(a)) 2. Calendar Day (§ 1.276(b)(1)) 3. Country From Which the Article Originates (§ 1.276(b)(2)) 4. Country From Which the Article is Shipped (§ 1.276(b)(3)) 5. FDA Country of Production (§ 1.276(b)(4)) 6. Full Address (§ 1.276(b)(6)) 7. Grower (§ 1.276(b)(7)) 8. Registration Number (§ 1.276(b)(13)) 9. United States (§ 1.276(b)(15)) 10. You (§ 1.276(b)(16)) 11. Food (§ 1.276(b)(5)) 12. International Mail (§ 1.276 b)(8)) 13. Manufacturer (§ 1.276(b)(9)) 14. No Longer in Its Natural State (§ 1.276(b)(10)) 15. Port of Arrival (§ 1.276(b)(11)) 16. Shipper (§ 1.276(b)(14)) 17. Comments Requesting Additional Definitions 18. Summary of the Final Rule D. What is the Scope of this Subpart? (§ 1.277) 1. Food for an Individual's Personal Use When Accompanied at Arrival 2. Homemade Food Sent as Personal Gift 3. Food Imported Then Exported Without Leaving Port of Arrival Until Export 4. Food Under the Exclusive Jurisdiction of USDA 5. Additional Exclusions Requested—General 6. Additional Exclusions Requested—Special Programs (C-TPAT/FAST) and Flexible Alternatives 7. Additional Exclusions Requested—Samples 8. Additional Exclusions Requested—Mail 9. Additional Exclusions Requested—Gifts 10. Additional Exclusions Requested—Low-Value 11. Additional Exclusions Requested—Couriers 12. Additional Exclusion Requested—Gift Packs 13. Additional Exclusions Requested—Household Goods and Unaccompanied Baggage 14. Additional Exclusions Requested—Noncommercial Use 15. Additional Exclusions Requested—U.S. Goods Returned 16. Additional Exclusions Requested—In-Transit Shipments 17. Additional Exclusions Requested—Diplomatic Pouch 18. Additional Exclusions Requested—Seeds for Planting E. Who is Authorized to Submit Prior Notice? (§ 1.278) F. When Must Prior Notice Be Submitted to FDA? (§ 1.279) 1. IFR Timeframes (2, 4, and 8 hours) 2. Integration of FDA and CBP Timeframes 3. Phase-In of FDA and CBP Timeframes 4. Prior Notice Confirmation Number 5. 5-Day Maximum Pre-Arrival Limitation 6. International Mail G. How Must You Submit the Prior Notice? (§ 1.280) 1. General Comments 2. English Language 3. Technical Issues Concerning Both Systems 4. ABI/ACS Interface 5. PNSI 6. Security of the Systems 7. Contingency Plans H. What Information Must Be in a Prior Notice? (§ 1.281) 1. General Comments 2. The Submitter 3. The Transmitter 4. The CBP Entry Type 5. The CBP Entry Identifier (e.g., The Customs ACS Entry Number or In-Bond Number) 6. The Product Identity 7. Identity of the Manufacturer 8. The Grower, If Known 9. FDA Country of Production 10. Shipper 11. The Country From Which the Article is Shipped 12. Anticipated Arrival Information 13. The Importer, Owner, Ultimate Consignee, and U.S. Recipient 14. Mode of Transportation 15. Carrier 16. Planned Shipment Information I. What Must You Do If Information Changes After You Have Received Confirmation of a Prior Notice From FDA? (§ 1.282) J. What Happens to Food That Is Imported or Offered for Import Without Adequate Prior Notice? (§ 1.283) 1. General Comments 2. Inadequate Prior Notice (§ 1.283(a)(1)) 3. Status and Movement of Refused Food (§ 1.283(a)(2)) 4. Segregation of Refused Foods (§ 1.283(a)(3)) 5. Costs (§ 1.283(a)(4)) 6. Export After Refusal (§ 1.283(a)(5)) 7. Post-Refusal Prior Notice Submissions (§ 1.283(c)) 8. FDA Review After Refusal (§ 1.283(d)) 9. International Mail (§ 1.283(e)) 10. Prohibitions on Delivery and Transfer (§ 1.283(f)) 11. Relationship to Other Admissibility Decisions (§ 1.283(g)) K. What Are the Other Consequences of Failing to Submit Adequate Prior Notice or Otherwise Failing to Comply With This Subpart? (§ 1.284) L. What Happens to Food That is Imported or Offered for Import From Unregistered Facilities That Are Required to Register Under Subpart H of This Part? (§ 1.285) M. Outreach and Enforcement 1. General Outreach and Enforcement Issues 2. Prior Notice Submission Training Program From Flexible Alternative Question 7 3. Requests for Additional Outreach 4. Enforcement Timeframe 5. Enforcement Penalties N. The Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes 1. Increased Integration 2. General Comments on the Plan IV. Analysis of Economic Impacts A. Final Regulatory Impact Analysis B. Small Entity Analysis (or Final Regulatory Flexibility Analysis) C. Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) Major Rule V. Paperwork Reduction Act of 1995 VI. Analysis of Environmental Impact VII. Federalism VIII. References I. Background and Legal Authority Section 307 of the Bioterrorism Act, which was enacted on June 12, 2002, amended the Federal Food, Drug, and Cosmetic Act (the act) (section 307 of the Bioterrorism Act added section 801(m) to the act (21 U.S.C. 381(m)) and amended section 301 of the act (21 U.S.C. 331)) by changing 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, 1 to issue an implementing regulation by December 12, 2003, to require prior notification to FDA of food that is imported or offered for import into the United States. Beginning on December 12, 2003, food importers were required to provide FDA with advance notice of human and animal food shipments imported or offered for import. 1 Under the Homeland Security Act of 2002 (Public Law 107-296), the Secretary of the Treasury has delegated all relevant Customs revenue authorities to the Secretary of Homeland Security who has, in turn, delegated them to the Commissioner of the Bureau of Customs and Border Protection (CBP or Customs). Thus, the Secretary is issuing this final rule jointly with the Secretary of Homeland Security. FDA and CBP jointly published the proposed prior notice regulation in the Federal Register of February 3, 2003 (68 FR 5428), for comment (proposed rule). On October 10, 2003, FDA and CBP issued the prior notice interim final rule (IFR) (prior notice IFR) (68 FR 58974) (corrected by a technical amendment on February 2, 2004; 69 FR 4851). The IFR implemented section 307 of the Bioterrorism Act, and required that the prior notice be submitted to FDA electronically via either the CBP ABI/ACS or the FDA PNSI. The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land via rail), and 2 hours (for food arriving by land via road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. The IFR responded to comments from the public on the proposed rule, and established a 75-day comment period. In order to ensure that those commenting on the IFR had the benefit of FDA's outreach and educational efforts and had experience with the systems, timeframes, and data elements of the prior notice system, FDA reopened the comment period for 30 days on April 14, 2004 (69 FR 19763), and for an additional 60 days on May 18, 2004 (69 FR 28060), for a total of 165 days. II. Summary of Significant Changes Made to the IFR The highlights of how this final rule compares to the IFR and the rationale for certain changes are described briefly in the following paragraphs and are discussed in more detail later in the preamble. A. What Definitions Apply to This Subpart? (§ 1.276) We retain the following terms without change from the IFR: • “The act;” • “Calendar day;” • “Country from which the article originates;” • “FDA Country of Production;” • “Grower;” • “Port of entry;” and • “United States.” FDA made the following changes in the final rule: • We revised the term, “Country from which the article is shipped,” to read, “* * * or, in the case of food sent by international mail, the country from which the article is mailed.” • We revised the term, “food,” to add the phrase, “except as provided in paragraph (b)(5)(i) of this section,” in the first sentence; and reworded § 1.276(b)(5)(i) to read, “For purposes of this subpart, food does not include”. • We added the term, “full address,” to the final rule. Full address means the facility's street name and number; suite/unit number, as appropriate; city; Province or State as appropriate; mail code as appropriate; and country. • We revised the term, “international mail,” to make the sentence easier to read, and to add the phrase, “unless such service is operating under contract as an agent or extension of a foreign mail service,” at the end of the definition. • We added the term, “manufacturer,” to the final rule. Manufacturer means the last facility, as that word is defined in § 1.227(b)(2), that manufactured/processed the food. A facility is considered the last facility even if the food undergoes further manufacturing/processing that consists of adding labeling or any similar activity of a de minimis nature. If the food undergoes further manufacturing/processing that exceeds an activity of a de minimis nature, then the subsequent facility that performed the additional manufacturing/processing is considered the manufacturer. • We revised the term, “no longer in its natural state,” by deleting “waxed” from the list of actions that render an article of food still in its natural state for purposes of this subpart. • We revised the term, “port of arrival” to read “* * * the water, air, or land port at which the article of food is imported or offered for import into the United States. For an article of food arriving by water or air, this is the port of unloading. For an article of food arriving by land, this is the port where the article of food first crosses the border into the United States. The port of arrival may be different than the port where consumption or warehouse entry or foreign trade zone admission documentation is presented to the U.S. Customs and Border Protection (CBP).” • We revised the term, “registration number,” by changing the phrase, “refers to,” to “means,” and by adding the phrase, “to a facility,” after the word, “assigned,” to clarify that FDA assigns registration numbers by facility. • We revised the term, “shipper,” by adding the phrase, “or express consignment operators or carriers or other private delivery service,” after “international mail” to clarify that a shipper is involved with various types of transactions, and not just international mail shipments. • We revised the term, “you,” to simplify the last phrase of the definition to “i.e., the submitter or the transmitter, if any.” B. What is the Scope of This Subpart? (§ 1.277) We revised this provision and added “Articles of food subject to Art. 27(3) of The Vienna Convention on Diplomatic Relations (1961), i.e., shipped as baggage or cargo constituting the diplomatic bag” to the list of food that does not require prior notice. C. Who is Authorized to Submit Prior Notice? (§ 1.278) We retain this provision without change. D. When Must Prior Notice Be Submitted to FDA? (§ 1.279) FDA revised this provision. Section 1.279(b) of the IFR states that, except for international mail, prior notice may not be submitted more than 5 calendar days before the anticipated date of arrival at the anticipated port of arrival. We revised this section to permit prior notice submissions to be submitted no more than 15 calendar days before the anticipated date of arrival for submissions made through the PNSI and no more than 30 calendar days before the anticipated date of arrival for submission made through the ABI/ACS. E. How Must You Submit Prior Notice? (§ 1.280) FDA revised this provision. Under 21 CFR 1.280(a)(2) (§ 1.280(a)(2)) of the IFR, prior notice must be submitted via PNSI for articles of food that have been refused under section 801(m)(1) of the act. Under the final rule, prior notice for articles that have been refused under section 801(m) of the act must be submitted through PNSI until such time as ACS or its successor system can accommodate such transactions. FDA also simplified the IFR provisions pertaining to system outages at § 1.280(b) through (e) by providing the outage notification at one Web address ( http://www.fda.gov ) and stating that FDA will accept prior notice submissions in the format it deems appropriate during the system(s) outage. F. What Information Must Be in a Prior Notice? (§ 1.281) FDA revised the following information requirements: • Submitter: The IFR states that “if a registration number is provided, city and country may be provided instead of the full address.” For clarity, in the final rule, FDA has revised this phrase to state that “if the business address of the individual submitting the prior notice is a registered facility, then the facility's registration number, city, and country may be provided instead of the facility's full address.” FDA also deleted the requirement for providing the submitter's fax number. • Transmitter: The IFR states that “if a registration number is provided, city and country may be provided instead of the full address.” For clarity, in the final rule, FDA has revised this phrase to state that “if the business address of the individual submitting the prior notice is a registered facility, then the facility's registration number, city, and country may be provided instead of the facility's full address.” FDA also deleted the requirement for providing the transmitter's fax number. • Manufacturer, for food no longer in its natural state: Under the IFR, the name, address, and registration number of the manufacturer must be submitted; if a registration number is provided, city and country may be provided instead of the full address. The final rule requires the name of the manufacturer and either: (1) The registration number, city and country of the manufacturer or (2) both the full address of the manufacturer and the reason the registration number is not provided. Publishing elsewhere in this issue of the Federal Register , the Prior Notice Final Rule Draft CPG lists the reasons to use when the registration number is not provided. In the IFR, a registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage, and export, or further manipulation and export. We have removed this from the final rule and are requiring the registration number of the manufacturer (or the full address of the manufacturer and a reason) in all circumstances. In the final rule, we have removed the option provided in the IFR that allows the label information in § 101.5 (21 CFR 101.5) to be submitted instead of the name, address, and registration number of the manufacturer for food sent by an individual as a personal gift (i.e., for nonbusiness reasons) to an individual in the United States. FDA notes, however, that under the enforcement policy proposed in the Prior Notice Final Rule Draft CPG, FDA and CBP should typically consider not taking any regulatory action when no prior notice is submitted for food imported or offered for import for noncommercial purposes with a noncommercial shipper, irrespective of the type of carrier. • Shipper: The IFR required the name and address of the shipper and, if the shipper is required to register, the registration number assigned to the shipper's facility; if a registration number is provided, city and country may be provided instead of the full address. The final rule requires the name and full address of the shipper, if the shipper is different from the manufacturer in order to eliminate duplicative requirements. If the address of the shipper is a registered facility, the submitter may submit the registration number of the shipper's registered facility. In the IFR, the shipper's registration number was not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage, and export, or further manipulation and export. We have removed this from the final rule because the shipper's registration number is now optional. • Anticipated arrival information: Under the final rule, we removed the requirement for the identity of the anticipated border crossing within the port of arrival because FDA and CBP have determined that it is no longer necessary for purposes of communication. For post-refusal submissions, actual date the article arrived is now a required data element so that FDA knows how long it has been since the refused food shipment arrived in the United States and how to connect the refused prior notice to the post-refusal prior notice submission for shipments where a previously refused prior notice was filed. The final rule also includes a new provision for food arriving by express consignment operator or carrier since certain information may not be available to persons who ship food using an express consignment operator or courier. If the article of food is arriving by express consignment operator or carrier, and neither the submitter nor transmitter is the express consignment operator or carrier, and the prior notice is submitted via PNSI, the express consignment operator or carrier tracking number may be submitted in lieu of the anticipated arrival information. • The name and address of the importer, owner, and ultimate consignee: The IFR required the name and address of the importer, owner, and ultimate consignee, unless the shipment is imported or offered for import for transshipment through the United States under a Transportation and Exportation (T&E) entry. In the final rule, FDA is inserting the word “full” in front of “address” to make clear that the complete address is required. Consequently, FDA is revising the subsequent text to state that if the business address of the importer, owner, or ultimate consignee is a registered facility, then the facility's registration number also may be provided in addition to the facility's full address. • Planned shipment information: FDA revised this provision by clarifying that the required planned shipment information is applicable by mode of transportation and when it exists. Moreover, FDA added a new provision in the final rule for the Airway Bill number/Bill of Lading number and flight number since this information is generally not available to individual submitters. The final rule provides that for food arriving by express consignment operator or carrier when neither the submitter nor transmitter is the express consignment operator or carrier, the tracking number can be submitted in lieu of the Bill of Lading or Airway Bill number and the flight number for prior notices submitted via PNSI. FDA also revised the IFR by deleting the requirement to provide the Harmonized Tariff Schedule (HTS) code since FDA and CBP have determined that the HTS code is no longer critical for communication with CBP. In the final rule, we deleted the requirement for the license plate number (and State or Province that issued the license) for food arriving by privately owned vehicle from the planned shipment information and added this data element to the section identifying the carrier of the article of food (§ 1.281(a)(16) and (c)(16)). Table 2, which appears later in this preamble, summarizes the information required in a prior notice. G. What Must You Do If Information Changes After You Have Received Confirmation of a Prior Notice From FDA? (§ 1.282) The IFR required that for prior notices submitted via ABI/ACS, the submitter should cancel the prior notice via ACS by requesting that CBP “delete” the entry. FDA has revised the final rule to state that the submitter should request that CBP “cancel” the entry. Moreover, we changed references to “PN System Interface” to “PNSI.” H. What Happens to Food That Is Imported or Offered for Import Without Adequate Prior Notice? (§ 1.283) The IFR stated that refused food must be moved under appropriate custodial bond. FDA has revised this paragraph in the final rule to state that the refused food must be moved under appropriate custodial bond unless immediately exported under CBP supervision. The final rule clarifies that the refused food may be held at the port or at a secure facility outside the port. FDA also changed the timeframe for notifying FDA of the hold location from within 24 hours of refusal to before the food is moved to the hold location. For clarity and consistency throughout the final rule, we are changing the phrase, “designated location,” to “designated secure facility.” Under the section describing FDA review after refusal, FDA revised the final rule by including the carrier as one of the entities who can submit a request for FDA review. FDA also revised the final rule to delete acceptance of requests for review by mail and express courier. We are limiting delivery to fax and e-mail. I. What Are the Other Consequences of Failing to Submit Adequate Prior Notice or Otherwise Failing to Comply With This Subpart? (§ 1.284) We corrected the word “federal” in the IFR to read “Federal.” We also corrected the citation to “section 303 of the act” in the IFR to read “sections 301 and 303 of the act.” J. What Happens to Food That Is Imported or Offered for Import From Unregistered Facilities That Are Required to Register Under Subpart H of This Part? (§ 1.285) The final rule removes the provision in § 1.285(a) that if food is from a foreign manufacturer that is not registered as required and is imported or offered for import, it is subject to refusal of admission for failure to provide adequate prior notice. It also deletes the text in that provision that states that failure to provide the manufacturer's registration number renders the identity of the facility incomplete for purposes of prior notice. The final rule retains, with revisions, the provision that states that if food is from a foreign facility that is not registered and is imported or offered for import, it is subject to being placed under hold under section 801(l) of the act. III. Comments on the IFR FDA received 320 timely submissions in response to the IFR. To make it easier to identify comments and FDA's responses to the comments, the word “Comment” will appear in parentheses before the description of the comment, and the word “Response” will appear in parentheses before FDA's response. A summary follows which includes a description of the appropriate section in the final rule. A. General Comments (Comments) Most comments generally support the intent of the Bioterrorism Act and FDA's efforts to implement its provisions with the IFR. Some comments commend FDA for revising certain proposed requirements to address the needs of international trade by shortening timeframes, reducing the amount of information required to be submitted, and adding a reasonable amount of flexibility for the submission of prior notice based on the mode of transportation in the IFR. However, several comments assert that the agency has misinterpreted the Bioterrorism Act and some comments suggest that the final rule should be more consistent with the existing trade practices established in accordance with CBP. (Response) FDA drafted the IFR in response to the comments to the proposed rule, the needs of international trade, and the continued threat of international terrorism and other significant risks to public health posed by imported food. We also drafted the final rule accordingly. (Comments) Several comments support the graduated enforcement policy the agency used to implement the IFR, noting that this policy facilitated the transition into compliance with the prior notice requirements. Comments ask that FDA provide a similar transition period after publication of the final rule during which time submitters may become familiar with new requirements, understand the new procedures and adjust business processes and practices. (Response) After publication of the IFR, FDA published guidance that included a transition period during which we emphasized education to achieve compliance (the December 2003 Prior Notice Interim Final Rule CPG) (68 FR 69708, December 15, 2003). FDA agrees that implementing a graduated enforcement policy using enforcement discretion has assisted submitters to become accustomed to the new requirements. The new requirements of the final rule will not take effect until 180 days after publication. Since the final rule retains most of the requirements found in the IFR, and with the 180-day delay in effective date, we are not implementing a graduated enforcement policy for implementing the final rule. FDA and CBP have issued elsewhere in this issue of the Federal Register a new CPG (hereinafter the Prior Notice Final Rule Draft CPG) that explains our proposed policies for enforcing violations of this final rule. The draft CPG describes the circumstances under which FDA and CBP should typically consider not taking any regulatory action, the types of violations FDA and CBP intend to focus on, and other enforcement policies. (Comments) Several comments thank FDA for providing an opportunity to provide comments on the provisions of the IFR after a period of active FDA/CBP enforcement. (Response) FDA agrees that providing several comment periods following publication of the IFR has permitted affected stakeholders an additional opportunity to offer specific and informed comments on the new requirements. (Comments) One comment requests that FDA clarify that prior notices submitted to FDA will not be subject to public disclosure under the Freedom of Information Act (5 U.S.C. 552, et seq. ) (FOIA) because information contained in a prior notice is confidential business information. Alternatively, the comment requests that FDA develop policies to protect confidential business information contained in prior notices from public disclosure. (Response) FDA does not believe this is necessary. FDA already has relatively detailed regulations, in 21 CFR part 20, governing the disclosure of information under FOIA, including the disclosure of confidential business information. Likewise, the agency's general policies, procedures, and practices relating to the protection of confidential information received from third parties apply to information received under prior notice. We do not believe rules, policies, or procedures specific to prior notice are needed. (Comments) One comment states that during the period of enforcement discretion, various ports of arrival took different approaches to enforcement and suggests that FDA ensure that all ports and all officials act in a similar fashion to achieve a consistent enforcement posture. The comment also suggests that FDA and CBP conduct “cross-training” of their officials staffing FDA or CBP help desks. (Response) All prior notice field operations and procedures are directed by the FDA Prior Notice Center (PNC). The PNC works to ensure a consistent implementation and enforcement program. Since the initial implementation of the prior notice rule, FDA staff has received additional training and guidance on prior notice requirements. (Comments) Several comments acknowledge the efforts of CBP and FDA to work together to achieve the common goal of securing the imported food supply. In particular, comments congratulate FDA for coordinating with CBP to allow transmission of FDA-required information through the ABI to CBP's ACS. In addition, comments support the integration and cooperation of both agencies in utilizing CBP's targeting system to efficiently and rapidly spot anomalies in freight crossing our borders; reducing the FDA proposed timeframes for submission of prior notice in the advance electronic information requirements; and the commissioning of CBP staff to conduct examinations and investigations. One comment requests that CBP and FDA ensure that there are adequate resources at ports of arrival to mitigate anticipated delays at border crossings when the rule is enforced. Several comments anticipated that trade would collapse on December 12, 2003, when the new regulations took effect. (Response) FDA and CBP are continuously coordinating efforts to receive, review, and respond to prior notice submissions. We further note that trade continued without significant interruption on December 12, 2003, or anytime after that implementation date. Rather, the implementation of the prior notice requirements was relatively smooth. (Comments) Several comments acknowledge the importance and value of FDA's educational outreach efforts to the trade industry through scheduled outreach and education sessions, port-specific flyers, foreign government training and Web site communications, especially those that summarize certain compliance data. The comments also applaud the unprecedented efforts the FDA has made in this regard. (Response) FDA and CBP will continue outreach and education efforts as resources permit. See section III.M entitled “Outreach and Enforcement” later in this document for further discussion on this subject. (Comments) Several comments commend FDA for its efforts in developing the prior notice regulation in an efficient and effective manner, reaching out to affected stakeholders for input and comment, and acknowledge the tremendous effort put forth by the agency in the development of the regulation. Other comments state that the rule lacked real world international business input and will have both business and government unable to function because of the amount of paperwork generated, which will not stop a terrorist attack. In particular, one comment notes that tracing a grower of a particular shipment is impossible in many instances. (Response) FDA and CBP systems have been able to manage the millions of prior notice submissions received, reviewed, and responded to since December 12, 2003. The agencies strove to implement the requirements in the Bioterrorism Act in a manner that required only that information deemed necessary and appropriate to ensure FDA could meet its statutory obligation to receive, review and respond to prior notices and target those shipments needing inspection upon arrival in the United States. Based on FDA's and CBP's experience since December 2003, the agencies have revised some of the requirements in the IFR and eliminated some of the information we no longer deem necessary (e.g., HTS codes). FDA notes that the grower of a food in its natural state is required only when known. (Comments) One comment suggests that the prior notice IFR is “functionally redundant” because prior notice has long been a part of FDA protocol long before the Bioterrorism Act. (Response) While FDA agrees that most of the information required by the IFR has been submitted to FDA via CBP processes for decades, the information has not been required prior to arrival of the food, making prior notice a new, unique, and valuable process. (Comments) One comment suggests that the IFR was unduly costly, ill-considered and generally more harmful than useful. An additional comment believes that the prior notice requirements would restrict trade more than necessary and hopes that the United States will implement the Bioterrorism Act in the least trade-restrictive manner. Another comment states that despite efforts to comply with the new requirements, massive problems seem to constantly occur. Another comment complains about accessibility to the Web site, cost and time of the submission procedures, language barriers, and complexity of the information requested. (Response) FDA disagrees. The prior notice process, which allows submission of the required information via either ABI/ACS or PNSI, has been relatively smooth. Although there were some technical problems encountered during the early implementation phase, FDA believes that the graduated enforcement process coupled with the vigorous education and outreach efforts by both the government and the industry have supported a relatively smooth transition to the new procedures and have improved compliance with the new requirements. FDA also has considered its international trade obligations under various World Trade Organization agreements, North America Free Trade Agreement, and other international agreements throughout the rulemaking development processes for both the IFR and this final rule. Both rules are consistent with our international obligations. (Comments) Some comments believe there is a disincentive towards product diversification when exporting articles of food to the United States because the prior notice requirements put them at a competitive disadvantage compared to shipments that originate in the United States. (Response) The requirement for prior notice was established by Congress with the passage of the Bioterrorism Act to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. Section 307 of the Bioterrorism Act requires prior notice of all food imported or offered for import into the United States. FDA is aware of the international trade obligations of the United States and has considered these obligations throughout the rulemaking process for this final rule and the IFR preceding it. Both are consistent with these international obligations. FDA and CBP have actively explored ways to reduce the burden on industry to the extent feasible while fulfilling the Bioterrorism Act mandates. Accordingly, we have made a number of changes in the final rule that minimize the impact of prior notice requirements on the food being imported or offered for import into the United States. We also note that the registration requirement applies to domestic facilities, as well as foreign facilities, and that the registration provisions in the Bioterrorism Act contain certain exclusions that apply only to foreign facilities. (See e.g., 21 CFR 1.226(a), which exempts from the requirement to register a foreign facility, if food from such facility undergoes further manufacturing/processing (including packaging) by another facility outside the United States; no similar exclusion applies to facilities within the Unites States.) (Comments) Other comments suggest that the IFR failed to include a provision that would ensure that high risk imports arrive at ports staffed by FDA inspection personnel and notes that this could be accomplished by designating particular ports of entry for accepting high risk products or requiring importers of such products to provide longer notice to ensure adequate inspection coverage. (Response) FDA disagrees. Section 307 of the Bioterrorism Act specifically prohibits FDA from limiting the port of entry by stating, “Nothing in this section may be construed as a limitation on the port of entry for an article of food.” We also disagree that certain shipments require longer timeframes for submission of prior notice to ensure adequate inspection coverage. Under a Memorandum of Understanding (MOU) between FDA and CBP, published on January 7, 2004 (69 FR 924), FDA has commissioned thousands of CBP officers in ports and other locations to conduct, on FDA's behalf, investigations and examinations of imported foods. This helps ensure that there is adequate inspection coverage, including at ports where FDA does not currently have personnel. B. Comments on the Legal Authority (Comments) One comment requests that FDA delegate authority to the U.S. Department of Agriculture (USDA), as it has with CBP, to enable USDA to implement prior notice requirements on products where the USDA shares jurisdiction. (Response) FDA disagrees. FDA has not delegated its authority under section 801(m) of the act to CBP, although FDA has commissioned CBP officers in ports and other locations to conduct, on FDA's behalf, investigations and examinations of imported foods. FDA recognizes that there are some products over which both FDA and USDA have jurisdiction. For example, both FDA and USDA's Animal and Plant Health Inspection Service (APHIS) regulate the importation of fruits and vegetables into the United States, although the goal of APHIS' regulation is to safeguard U.S. agriculture and natural resources from the risks associated with the plant pests. Nonetheless, FDA does not believe that there is a need to have USDA implement the prior notice requirements for products for which we share jurisdiction, nor do we believe that doing so would lead to an efficient enforcement of the prior notice requirements. The Bioterrorism Act mandates that advance notice be given to FDA for any article of food that is being imported or offered for import into the United States and that the Secretary receive, review, and appropriately respond to such notifications. To accomplish this, FDA established the PNC that operates 24 hours a day, 7 days a week, to receive, review, and respond to these notices as they are submitted. The purpose of prior notice is to enable FDA to conduct inspections of imported foods at U.S. ports upon arrival and target foods that may pose a significant risk to public health, based on the information submitted. Prior Notice is submitted electronically to FDA through either Customs' ABI/ACS or FDA's PNSI. Regardless of the mode of transmission, the prior notice information will undergo both a validation process and a screening in FDA's Operational and Administrative System for Import Support (OASIS) for food safety and security criteria. If the FDA system does not indicate that further evaluation of or action on the notice or article of food is necessary for prior notice, the system will transmit a message through OASIS to the ABI/ACS interface for CBP that the article of food may be conditionally released. However, if additional evaluation of the prior notice information is necessary, personnel at the FDA's PNC will access the information provided and determine if that information suggests the potential for a significant risk to public health. FDA personnel are able to make this determination by using their experience of imported foods, utilizing the expertise within the Center for Food Safety and Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the inspectional information obtained by the Office of Regulatory Affairs (ORA), and utilizing the expertise of CBP staff who are co-located with the PNC. If FDA determines that a potential health risk is present, FDA or CBP will examine the food or take other appropriate action. Evaluations of imported articles of food are made on an article-of-food by article-of-food basis. CBP and FDA are continuously working together to incorporate further intelligence gained from this process. The recent addition of USDA personnel to assist in the sharing of information affecting the safety and security of imported foods will help further this effort. FDA does note that food items that are under the exclusive jurisdiction of the USDA are not subject to the requirements of prior notice. (See the discussion on § 1.277 (scope), discussed infra.) (Comments) Another comment suggests that to be consistent with the Bioterrorism Act, FDA should permit an alternative to prior notice for administrative flexibility. The comments suggest that this could be accomplished by including in the final rule a provision which states, “Other measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of this part.” (Response) FDA disagrees. Section 801(m) of the act requires the submission of prior notice for all food imported or offered for import into the United States, except as outlined in § 1.277(b). FDA is to use that information to determine whether it should inspect the food upon arrival in the United States. Compliance with prior notice, therefore, means providing the required information within the specified timeframes. No other “measures” would “provide an equivalent level of assurance of compliance” with the prior notice requirements. C. What Definitions Apply to This Subpart? (§ 1.276) Section 1.276 of the IFR provides definitions for the following terms: The act, calendar day, country from which the article originates, country from which the article is shipped, FDA Country of Production, food, grower, international mail, no longer in its natural state, port of arrival, port of entry, registration number, shipper, United States, and you. FDA received no comments on the definitions for the act, calendar day, country from which the article originates, FDA Country of Production, grower, and United States, and thus, the final rule retains the definitions for these terms that were in the IFR. Although no comments were received on the definitions for “country from which the article is shipped,” “registration number,” and “you,” we made minor revisions to these definitions. We also added a definition for the term, “full address,” although we did not get any comments on this term. 1. The Act (§ 1.276(a)) The final rule defines “the act” to mean “the Federal Food, Drug, and Cosmetic Act.” 2. Calendar Day (§ 1.276(b)(1)) The final rule defines “calendar day” to mean “every day shown on the calendar.” 3. Country From Which the Article Originates (§ 1.276(b)(2)) The final rule defines “country from which the article originates” to mean “FDA Country of Production.” 4. Country From Which the Article is Shipped (§ 1.276(b)(3)) The final rule defines “country from which the article is shipped” to mean “the country in which the article of food is loaded onto the conveyance that brings it to the United States or, in the case of food sent by international mail, the country from which the article is mailed.” For clarity, we revised the last phrase of this definition to change, “the country in which the article will be mailed” to “the country from which the article is mailed.” 5. FDA Country of Production (§ 1.276(b)(4)) The final rule defines “FDA Country of Production” to mean, for an article of food that is in its natural state, the country where the article of food was grown, including harvested or collected and readied for shipment to the United States. If an article of food is wild fish, including seafood that was caught or harvested outside the waters of the United States by a vessel that is not registered in the United States, the FDA Country of Production is the country in which the vessel is registered. If an article of food that is in its natural state was grown, including harvested or collected and readied for shipment, in a Territory, the FDA Country of Production is the United States. For an article of food that is no longer in its natural state, the country where the article was made; except that, if an article of food is made from wild fish, including seafood, aboard a vessel, the FDA Country of Production is the country in which the vessel is registered. If an article of food that is no longer in its natural state was made in a Territory, the FDA Country of Production is the United States. 6. Full Address (§ 1.276(b)(6)) The IFR did not have a definition for the term, “full address.” However, we added this term to the final rule for clarity since this term is used throughout the rule. The final rule defines “full address” to mean “the facility's street name and number; suite/unit number, as appropriate; city; Province or State as appropriate; mail code as appropriate; and country.” 7. Grower (§ 1.276(b)(7)) The final rule defines “grower” to mean “a person who engages in growing and harvesting or collecting crops (including botanicals), raising animals (including fish, which includes seafood), or both.” 8. Registration Number (§ 1.276(b)(13)) The final rule defines “registration number” to mean “the registration number assigned to a facility by FDA under section 415 of the act (21 U.S.C. 350d) and subpart H of this part.” FDA made a minor change in this definition in the final rule by adding the phrase “to a facility” after the word “assigned” to clarify that FDA assigns registration numbers by facility. 9. United States (§ 1.276(b)(15)) The final rule defines “United States” to mean “the Customs territory of the United States (i.e., the 50 States, the District of Columbia, and the Commonwealth of Puerto Rico), but not the Territories.” 10. You (§ 1.276(b)(16)) The final rule defines “you” to mean “the person submitting the prior notice, i.e., the submitter or the transmitter, if any.” We made a minor change to this definition by simplifying the last phrase of the definition to “i.e., the submitter or the transmitter, if any.” FDA received comments on the definitions for the following terms in the IFR: food, international mail, no longer in its natural state, port of arrival, and shipper. FDA also received comments that recommend that FDA include additional definitions for the following terms in the IFR: Carrier, manufacturer, trip number, and ultimate consignee. FDA responds to these comments in the following paragraphs. 11. Food (§ 1.276(b)(5)) The IFR defines “food” as having the meaning given in section 201(f) of the act, except that it does not include food contact substances as defined in section 409(h)(6) of the act (21 U.S.C. 348(h)(6)) or pesticides as defined in 7 U.S.C. 136(u). Examples of food include fruits, vegetables, fish, including seafood, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods. (Comments) One comment asks FDA to define food contact substances, which are exempt from the requirements of prior notice, to include secondary direct food additives. The comment reasons that secondary direct food additives, many of which are food processing aids, meet the criteria for food contact substances as defined in section 409(h)(6) of the act (21 U.S.C. 348(h)(6)). The comment further reasons that secondary direct food additives meet the criteria that FDA used in the registration IFR to exclude food contact materials from the requirements of the registration IFR as they are not “food for consumption” in that “they are not intentionally eaten for their taste, aroma, or nutritive value” (68 FR 58894 at 58911). (Response) Some secondary direct food additives meet the definition of food contact substances as given in section 409(h)(6) of the act and, therefore, would not be subject to the prior notice requirements (§ 1.276(b)(5)(i)(A)). The comment, however, asks about secondary direct food additives that are not food contact substances, for example food processing aids. The IFR concluded that food processing aids that are not food contact substances are subject to prior notice “Whether a food processing aid or ‘indirect additive’ is subject to prior notice depends upon whether such a substance is ‘food’ under this rule. As noted, for purposes of the interim final rule, ‘food’ excludes ‘food contact substances’ as defined at section 409(h)(6) of the FD&C Act. Among other things, unlike food processing aids and ‘indirect additives,’ ‘food contact substances’ are not ‘intended to have any technical effect in food,’ [section 409(h)(6) of the act]. In addition, ‘food’ excludes pesticides as defined at 7 U.S.C. 136(u). Thus, if the substance is not a pesticide and is intended to have a technical effect in the food being processed, the substance is not exempt from the definition of ‘food’ under § 1.276(b)(5) in the interim final rule. This is a reasonable result in that such processing aids are intentionally and directly added to ‘traditional’ foods.” (68 FR 58974 at 58986). We continue to hold this view. Thus, if a secondary direct food additive is not a food contact substance but is a food processing aid, then it would be subject to prior notice. (Comments) Two comments ask the FDA to clarify the term, “reasonably expected to be directed to a food use.” One comment states that seed produced by seed companies is intended to be used for planting crops, but the production process inevitably results in remnant or culled seed that is suitable for use as animal feed (and to a far lesser degree, as food for human consumption), which generally is sold by the seed company as such. The comment states that a similar issue arises with some crops, such as onions, for which bulbs sold to farmers may also be used as feed or, in limited cases, as food if they are determined to be remnant or culled. The comment believes that FDA should provide specific limitations on the definitions of “reasonably believes” and “reasonably expected” that take into consideration that the seed produced by seed companies is intended to be used for planting crops, even though it is understood that there inevitably will be some remnant seed and culls. Without such limitations, the comment believes the rule is unreasonably broad, imposes a burden on seed companies primarily marketing seeds for planting purposes that is out of proportion to the protective goals of the act, and is subject to widely varying interpretations. Another comment notes that the seed industry's research and development activities generate very small amounts of seed that may be found “unsuitable” for planting and end up in the food supply, and similarly asks for clarification of the “reasonably believes” and “reasonably expected” language. (Response) In the preamble to the IFR, we state that “FDA will consider a product as one that will be used for food if any of the persons involved in importing or offering the product for import (e.g., submitter, transmitter, manufacturer, grower, shipper, importer, owner, or ultimate consignee) reasonably believes that the substance is reasonably expected to be directed to a food use” (68 FR 58974 at 58987). The purpose of this statement was to explain when an article of food would be subject to prior notice if it is capable of multiple uses. The comments, and our experience with the IFR, have shown that there is some confusion as to how to determine when a substance that is capable of a food use and a nonfood use is a “food” for purposes of prior notice. To clarify, we will consider such a substance to be “food” for the purpose of prior notice if it is reasonably likely to be directed to a food use. This should make it clearer that, as explained in the preamble to the IFR, the determination is not based on the intended use of the article (68 FR 58974 at 58987). In one of the comments, the seed will “inevitably” contain remnant seed and culls that will be diverted to human or animal feed. In this case, since at the time of import, the seed is reasonably likely to be directed to a food use, prior notice is required. FDA believes this is consistent with the purpose of the Bioterrorism Act. With respect to the other comment about seeds found “unsuitable” for planting, there is insufficient detail in the comment to determine whether these seeds would be considered food. Nonetheless, we note that the Prior Notice Final Rule Draft CPG, announced elsewhere in this issue of the Federal Register , proposes an enforcement policy regarding seeds for planting. Under the draft policy, FDA and CBP would typically consider not taking any regulatory action regarding seeds that will be used for cultivation. The policy would apply when no more than a small portion of that seed is diverted from cultivation to animal feed or other food use. It would not apply, however, where the seed is used for the production of edible sprouts, such as alfalfa seeds for the production of alfalfa sprouts. (Comments) One comment states that the Bioterrorism Act regulations do not present a means to provide FDA with certification that any of the indicated persons (i.e., submitter, transmitter, manufacturer, grower, shipper, importer, owner, or ultimate consignee) do not reasonably believe that an item is reasonably expected to be directed to a food use prior to arrival at a U.S. port. The comment further states that there is no method to avoid classifying their products as anything other than those flagged as FD4 2 articles requiring prior notice, thereby providing no means to avoid refusal of the goods upon arrival because the prior notice was not filed. 2 HTS codes are “flagged” in ACS as follows to indicate that products are or may be under FDA jurisdiction: FD0—Indicates that FDA has determined the article, even though subject to FDA's laws and regulations, is acceptable for CBP release without further presentation of prior notice or other entry information to FDA. FD1—Indicates that the article may be subject to FDA jurisdiction, including FDA review under 801(a) of the act. For products not subject to FDA jurisdiction, a filer can “Disclaim” product from FDA notification requirements. FD2—Indicates that the article is under FDA jurisdiction and review of entry information by FDA under section 801(a) of the act will take place. However, the article is not “food” for which prior notice information is required. FD3—Indicates that the article may be subject to prior notice under section 801(m) of the act and 21 CFR Part 1, subpart I. , e.g., the article has both food and nonfood uses. FD4—Indicates that the article is “food” for which prior notice is required under section 801(m) of the act and 21 CFR Part 1, subpart I. (Response) FDA disagrees. FDA is continuously reviewing the FD3 and FD4 flags associated with HTS codes. The HTS codes are flagged to indicate which products will (FD4) or may (FD3) require prior notice and which product will or may require FDA review under section 801(a) of the act for admissibility; all FDA-regulated products are covered, not just foods. If you believe that an item has been incorrectly flagged, you should contact the FDA and provide a statement that explains your rationale. The designation will be reviewed and action taken to correct the flag if deemed appropriate. With respect to the comment about providing certification about the belief of the “indicated persons,” submitters may disclaim articles of food marked FD3 if the article is not reasonably likely to be directed to a food use by using an affirmation of compliance in ABI/ACS. (Comments) Many comments address the FD flags associated with the HTS codes. Two comments state that they are currently importing a product that was flagged FD4, which requires that prior notice be submitted for that article. However, the item is not an article of food and the commenter would like the HTS code changed from a FD4 flag to a FD3 flag. An additional comment had concerns about multiple use products, where one use would require prior notice and another use would not. Another comment states that there is no clear methodology provided to disclaim an item beyond the initial FD3 designation. The comment recommends that the agency outline the elements of a due diligence protocol that would become part of the disclaimer process. One comment suggested that the data elements in the prior notice submission be amended to permit an affirmation that a substance is not directed for a food use. This would avoid the article of food from being refused if the prior notice was submitted for a category that required prior notice. Another comment wants FDA to develop a method that would allow the submitter or the transmitter to disclaim the need for prior notice at the time of the prior notice transmission. (Response) If there is a concern regarding the FD flags associated with the HTS codes, you should contact FDA and provide a detailed description of why you believe the HTS code is flagged incorrectly. FDA and CBP are continuously reviewing and updating the FD flags associated with the HTS codes. If you have questions regarding whether prior notice is required for a particular article of food, contact the PNC for assistance. Furthermore, we have established procedures in place to disclaim articles of food the submitter believes does not require prior notice. This can be accommodated by ABI/ACS as an affirmation of compliance. (Comments) One comment states that the list of HTS codes flagged for prior notice (both FD3 and FD4) (as provided by Customs Admin message 03-2605 dated October 31, 2003) contains 762 tariff numbers. The comment asks if this is a definitive list at this point, especially since FDA and CBP estimated the number to be around 2,000. (Response) This is not a definitive list. FDA and CBP are continuously reviewing and updating the FD flags associated with the HTS codes. Guidance regarding the HTS flags is posted at http://www.cfsan.fda.gov/~dms/htsguid3.html . The lack of an FD3 or FD4 designation does not mean that prior notice is not required. If the article of food fits the definition of food provided in § 1.276 of the final rule, then prior notice is required for that article of food. (Final rule) Section 1.276(b)(5) of the final rule defines “food” as having the meaning given in section 201(f) of the act, except that it does not include food contact substances as defined in section 409(h)(6) of the act (21 U.S.C. 348(h)(6)) or pesticides as defined in 7 U.S.C. 136(u). Examples of food include fruits, vegetables, fish, including seafood, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods. We revised this definition for clarity in the final rule by adding the phrase, “except as provided in paragraph (b)(5)(i) of this section,” in the first sentence; and reworded paragraph (b)(5)(i) to read, “For purposes of this subpart, food does not include:”. 12. International Mail (§ 1.276(b)(8)) The IFR defines “international mail” to mean foreign national mail services. International mail does not include express carriers, express consignment operators, or other private delivery services.” (Comments) One comment asks FDA to define international mail to include express carriers. Another comment asks FDA to clarify whether sending an item by express delivery will be considered “international mail” or “express carrier.” (Response) FDA declines to make the requested change. The IFR defines “international mail” to mean “foreign national mail services” and expressly excluded express carriers, express consignment operators, or other private delivery services from the definition. We retain this definition in the final rule but revised the wording to make the definition easier to read, and to add the phrase, “unless such service is operating under contract as an agent or extension of a foreign mail service,” at the end of the definition. This phrase was needed to clarify that a contractor working for a foreign mail service also is included in the definition of “international mail.” International mail is a function of the foreign postal organizations of sovereign countries who are members of the International Postal Union. International mail shipments generally do not utilize any of the electronic data transmission systems commonly used by express consignment carriers and private delivery services. (Final rule) Section 1.276(b)(8) of the final rule defines “international mail” to mean foreign national mail services. International mail does not include express consignment operators or carriers or other private delivery services unless such service is operating under contract as an agent or extension of a foreign mail service. 13. Manufacturer (§ 1.276(b)(9)) (Comments) Two comments request that we define the word “manufacturer.” One of these suggests that we define “manufacturer” to mean the last entity to conduct a processing operation; e.g., including bottling but excluding labeling. (Response/Final rule) As discussed in section III.H.7.a of this document, FDA agrees and has added a definition for manufacturer. Section 1.276(b)(9) of the final rule defines manufacturer as the last facility, as that word is defined in § 1.227(b)(2) (in the registration rule), that manufactured/processed the food. A facility is considered the last facility even if the food undergoes further manufacturing/processing that consists of adding labeling or any similar activity of a de minimis nature. If the food undergoes further manufacturing/processing that exceeds an activity of a de minimis nature, then the subsequent facility that performed the additional manufacturing/processing is considered the manufacturer. 14. No Longer in Its Natural State (§ 1.276(b)(10)) The IFR defines “no longer in its natural state” to mean that “an article of food has been made from one or more ingredients or synthesized, prepared, treated, modified, or manipulated. Examples of activities that render food no longer in its natural state are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled attendant to harvest or collection or treated against pests, waxed, or polished are still in their natural state for purposes of this subpart. Whole fish headed, eviscerated, or frozen attendant to harvest are still in their natural state for purposes of this subpart.” (Comments) One comment asks FDA to clarify the term, “no longer in its natural state” by expressly stating that seed for sowing or planting that are shucked, sorted and sized remain “in their natural state” for purposes of prior notice. Another comment believes that activities such as trimming, washing, waxing, and packaging of produce are part of normal harvesting activities and seeks to clarify that produce that has been trimmed, washed, waxed, and/or packaged is still “in its natural state.” (Response) The IFR defines “no longer in its natural state” as meaning “an article of food has been made from one or more ingredients or synthesized, prepared, treated, modified, or manipulated. Examples of activities that render food no longer in its natural state are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled attendant to harvest or collection or treated against pests, waxed, or polished are still in their natural state for purposes of this subpart. Whole fish headed, eviscerated, or frozen attendant to harvest are still in their natural state for purposes of this subpart.” In the final rule, we are deleting the word “waxed” in the list of activities that render the food still in their natural state because this was included in error. After publishing the prior notice IFR, FDA issued guidance in the form of questions and answers to help clarify the prior notice requirements. In the second edition of “Questions and Answers Regarding the Interim Final Rule on Prior Notice of Imported Food (Edition 2)” (the prior notice question and answer guidance document) available at http://www.cfsan.fda.gov/~pn/pnqagui2.html , issued May 2004, under section B, Definitions, question 4.1 of the guidance, we discuss seeds. If the seed will be used only for sowing or planting, and not directed to food use, then no prior notice is required and, therefore, there is no need to determine whether the seeds are in their natural state for the purposes of prior notice. Regarding the other comments, the definition for “no longer in its natural state” in the final rule already states that trimmed or washed produce is still in its natural state, if those activities are attendant to harvest or collection. This same definition states that waxing and packaging are activities that render food no longer in its natural state. (Final Rule) Section 1.276(b)(10) of the final rule defines “no longer in its natural state” to mean that “an article of food has been made from one or more ingredients or synthesized, prepared, treated, modified, or manipulated. Examples of activities that render food no longer in its natural state are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled attendant to harvest or collection or treated against pests, or polished or packaged are still in their natural state for purposes of this subpart. Whole fish headed, eviscerated, or frozen attendant to harvest are still in their natural state for purposes of this subpart.” 15. Port of Arrival (§ 1.276(b)(11)) The IFR defines “port of arrival” to mean “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 the article of food first arrives in the United States. This port may be different than the port where consumption or warehouse entry or foreign trade zone admission documentation is presented to the U.S. Customs and Border Protection (CBP).” (Comments) Two comments ask FDA to clarify what is meant by the term, “port of arrival.” One comment notes that notwithstanding the definition in the IFR, FDA representatives have stated that “port of arrival” means the first port where the articles of food are “off-loaded” and that if the articles remain on the vehicle or vessel, then the port of arrival definition has not been met for these and only these articles. Another comment reports being told by FDA representatives that when a ship arrives from Europe, only goods “off loaded” in that port must be given prior notice within the timeframes required. If the ship has food destined to be “off loaded” in other ports, prior notice must be filed for each port in accordance with the timeframes required by the regulations. The comments ask FDA to clarify this definition. (Response) FDA agrees to clarify the term, “port of arrival,” as it is a required data element in a prior notice and important for gauging the timeframes for prior notice submission. The interim final rule defined “port of arrival” 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 the article of food first arrives in the United States.” In essence, the comments ask us to identify the point at which an article of food “first arrives” in the United States when the food is arriving by water. The preambles to the proposed rule and IFR explained that for FDA to be able to protect U.S. consumers from terrorism or other food-related emergencies, it was important for FDA to receive prior notice before the food covered by that notice is shipped around the country and potentially lost to government oversight (68 FR 5428 at 5431 and 68 FR 58974 at 58991). The preambles concluded that prior notice must be given before the food first physically appears in the United States so that FDA can inspect the food upon arrival. As noted in the comments, some shipments contain both food and nonfood cargo. If the carrier stops at multiple ports, the articles of food may remain on board at intermediate ports where nonfood articles are unloaded. The articles of food are then unloaded at one or more subsequent ports. When food is shipped via water and FDA has bioterrorism or other public health emergency concerns about the food, it would inspect the food at the point of unloading. This is because before the food is unloaded it would remain on the carrier either at a secured port under CBP authority or in open water, preventing intentional or unintentional diversion until unloading. The same is true for food shipped by air. When an article of food remains on board at one airport to be unloaded at a subsequent airport, FDA would not need to examine the food until the point where that food is unloaded. In contrast, when food is shipped via land, any articles of food remaining on board would travel through the United Stated while outside of secured ports and, therefore, could be potentially lost to government oversight due to off-loading in noncontrolled areas. Therefore, we believe that when an article of food is shipped via water or air, the article “first arrives” at the port where it is unloaded. When an article of food is shipped via land, the article “first arrives” at the port where it crosses the border. We are revising the definition of “port of arrival” in the final rule to clarify this distinction. We have added a statement that for an article of food arriving by water or air, the port of arrival is the port of unloading. For an article of food arriving by land, the definition now states that the port of arrival is the port where the article of food first crosses the border into the United States. (Comments) One comment asks FDA to clarify the word “port.” The comment asks whether the IFR applies to U.S. Navy ships returning to “port” or to a U.S. Naval Base from outside U.S. territorial waters. The comment notes that U.S. Navy fleet ships always have been considered U.S. territory. The comment also notes that the CPG states that food entering and then leaving the “port area” is not subject to prior notice and asks FDA to clarify the term, “port area.” (Response) FDA clarifies that the term, “port,” is not defined but that “port of arrival” and “port of entry” are defined. The term, “port,” as used in the rule relates to ports identified by CBP. In 19 CFR 101.1 Definitions , “Port and port of entry refer to any place designated by Executive Order of the President, by order of the Secretary of the Treasury, or by Act of Congress, at which a Customs officer is authorized to accept entries of merchandise to collect duties, and to enforce the various provisions of the Customs and navigation laws. The terms ‘port’ and ‘port of entry’ incorporate the geographical area under the jurisdiction of a port director.” If CBP changes this definition in the future, we will evaluate whether § 1.276(b)(12) should be revised to incorporate those changes. Proposed policies in the Prior Notice Final Rule Draft CPG, would apply to most articles of food on U.S. Navy ships returning to “port” or a U.S. Naval Base from outside U.S. territorial waters. One policy states that FDA and CBP should typically consider not taking any regulatory action when an article of food is imported or offered for import for an official government purpose without prior notice, provided that a Federal Government agency is the importer of record. Another states that FDA and CBP should typically consider not taking any regulatory action when an article of food is imported or offered for import for noncommercial purposes with a noncommercial shipper without prior notice. One of the examples of foods imported or offered for import that may be covered by this policy is food in household goods, including military transfers. (Final rule) Section 1.276 (b)(11) of the final rule defines “port of arrival” as “the water, air, or land port at which the article of food is imported or offered for import into the United States. For an article of food arriving by water or air, this is the port of unloading. For an article of food arriving by land, this is the port where the article of food first crosses the border into the United States. The port of arrival may be different than the port where consumption or warehouse entry or foreign trade zone admission documentation is presented to the U.S. Customs and Border Protection (CBP).” 16. Shipper (§ 1.276(b)(14)) The IFR defines “shipper” to mean “the owner or exporter of the article of food who consigns and ships the article from a foreign country or the person who sends an article of food by international mail to the United States.” (Comments) Two comments request that we clarify the IFR's definition of “shipper.” One comment asks whether the shipper is the person who physically loads the shipment for its final journey to the United States, the company that has the business contract to export the food to the U.S. importer, or someone in the middle who removes the shipment from temporary storage for the initial phase of its entire journey to the United States. Another comment asks for clarification as to who is the shipper when the producer's shipping platform is involved in the shipment—the transporter who takes responsibility for the whole shipment or the producer's own facility (assuming that neither would be classified as “manufacturer”)? (Response) In the IFR, we defined “shipper” based upon the description of shipper as it is discussed in CBP's proposed rule “Required Advance Electronic Presentation of Cargo Information” (July 23, 2003, 68 FR 43574 at 43577). We have decided to continue to use this definition in the final rule. In the examples cited in the comments above, the shipper is considered to be the entity that arranges or directs the shipment to be sent to the United States, irrespective of who physically transports it. In the first example it would be the company having the business contract to export the food; in the second, assuming that the producer is sending the food to a firm in the United States, they (the producer) would be the shipper. It should also be noted that a firm may be both a shipper and a manufacturer with respect to the same product if the product is shipped from the point of manufacture to the United States. Moreover, we have added the phrase, “or express consignment operators or carriers or other private delivery service,” after the term, “international mail,” in the definition of “shipper” to clarify that a shipper is involved with various types of transactions, and not just international mail shipments. (Final rule) Section 1.276(b)(14) of the final rule defines shipper to mean “the owner or exporter of the article of food who consigns and ships the article from a foreign country or the person who sends an article of food by international mail or express consignment operators or carriers or other private delivery service to the United States.” 17. Comments Requesting Additional Definitions (Comments) Several comments request that we define additional terms in the final rule, including: “trip number,” “carrier,” and “ultimate consignee.” (Response) FDA disagrees. FDA believes these terms are sufficiently clear based on our experience since the initial implementation of the prior notice IFR. FDA intends to interpret the “ultimate consignee” consistent with CBP's use of that term in regards to the entry of merchandise, which is contained in paragraph 6.3 of Customs Directive No. 3550-079A, June 27, 2001. As stated in that CBP Directive, “if the merchandise has not been sold or consigned to a U.S. party at the time of entry or release, then the Ultimate Consignee at the time of entry or release is defined as the proprietor of the U.S. premises to which the merchandise is to be delivered.” 18. Summary of the Final Rule Section 1.276 of the final rule defines the following terms: The act, calendar day, country from which the article originates, country from which the article is shipped, FDA Country of Production, food, full address, grower, international mail, manufacturer, no longer in its natural state, port of arrival, port of entry, registration number, shipper, United States, and you. D. What is the Scope of this Subpart? (§ 1.277) Section 1.277(a) of the IFR states that the prior notice requirements apply to all food for humans and other animals that is imported or offered for import into the United States. This covers food for use, storage, or distribution in the United States, and includes food for gifts, trade and quality assurance/quality control samples, food for transshipment through the United States to another country, food for future export, and food for use in a U.S. Foreign Trade Zone (FTZ). Section 1.277(b) of the IFR sets out the exclusions from prior notice. It excludes food for an individual's personal use when it is carried by or otherwise accompanies the individual when arriving in the United States (i.e., for consumption by themselves, family and friends, not for sale or other distribution); food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for nonbusiness reasons) to an individual in the United States; food that is imported then exported without leaving the port of arrival until export; and meat food products, poultry products, and egg products that, at the time of importation, are subject to the exclusive jurisdiction of USDA 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. ). FDA received many comments about § 1.277(b), which are addressed in order of the exclusions covered in the IFR: Food for an individual's personal use when carried by or otherwise accompanying an individual; homemade food; food that is imported for immediate exportation; and foods under exclusive USDA/Food Safety and Inspection Service jurisdiction. The comments concerning requests for additional exclusions from the scope of the prior notice requirements are addressed by issue, beginning with general comments/requests. 1. Food for an Individual's Personal Use When Accompanied at Arrival Section 1.277(b)(1) of the IFR excludes food for an individual's personal use when it is carried by or otherwise accompanies the individual when arriving in the United States. The IFR explains that in this situation there was no “shipper” as that term is used in section 801(m) of the act. (Comments) One comment requests that FDA expand the exemption for food carried in to the United States for personal use to include all food products carried in personal baggage; or to allow declaration of entry to be made through existing general CBP entry declaration procedures. (Response) FDA disagrees. Prior notice is not required for food that is carried by or otherwise accompanies an individual entering the United States (e.g., food that is in his or her carry-on or checked baggage) when the food is for that individual's personal use (§ 1.277(b)(1)). This means that the food is for consumption by the individual or by the individual's family and friends and is not for sale or other distribution. If the food carried by or otherwise accompanying an individual is for commercial purposes, then prior notice requirements apply. As we explained in the IFR preamble, we do not believe that Congress intended for us to characterize travelers bringing food back from their travels in their personal baggage for their own use as “shippers” for purposes of section 801(m) of the act. When there is a commercial purpose involved, there is a “shipper,” i.e., the person or entity on whose behalf the traveler is bringing in the food. Thus, by its terms, section 801(m) of the act requires that food carried by or otherwise accompanying an individual arriving in the United States that is not for personal use be subject to prior notice. Moreover, we explained that we would potentially create a loophole that would defeat the purpose of the prior notice rule if we were to exempt all food products carried in personal baggage. (Final rule) Section 1.277(b)(1) of the final rule continues to state that the rule does not apply to food for an individual's personal use when it is carried by or otherwise accompanies the individual when arriving in the United States. 2. Homemade Food Sent as Personal Gift Section 1.277(b)(2) of the IFR excludes food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for nonbusiness reasons) to an individual in the United States. (Comments) No comments were received about this issue. (Final rule) Section 1.277(b)(2) is retained without change. 3. Food Imported Then Exported Without Leaving Port of Arrival Until Export Section 1.277(b)(3) of the IFR excludes food that is imported then exported without leaving the port of arrival until export. (Comments) One comment states that if food moves for immediate export 3 (IE) out of the same port, it is not subject to prior notice. However, if the food moves on a T&E entry, prior notice is required. The comment provides a scenario where a shipment arrives at Los Angeles Harbor and then moves to Los Angeles Airport for export. Los Angeles Harbor and Los Angeles Airport are separate ports and each has its own port code assigned by CBP. The comment states that CBP considers this an IE entry. Similarly, the comment questioned if FDA considers this an IE entry as well, or if it is considered a T&E entry that requires prior notice. 3 Food that is brought to a U.S. port but is then directly exported from that port of arrival is entered under a CBP IE entry and subject to the limitations of an IE bond. In essence, this food may not leave the port of arrival until export. (Response) If the food arrives in and is exported from the same port, then it is not subject to prior notice. FDA considers a port to be the same as defined by CBP in 19 CFR 101.1; i.e., the term “port” incorporates the geographical area under the jurisdiction of a port director. The geographical boundaries of the port of Los Angeles-Long Beach are described in 19 CFR 101.3(b)(1). While Los Angeles Harbor and Los Angeles Airport are separate for CBP management purposes, they are considered to be within the same port. Accordingly, IE entries may be filed for movements between Los Angeles Harbor and Los Angeles Airport followed by exportation of the goods. Similarly, because such movements would not leave the port of arrival until export, prior notice would not be required. (Comments) One comment suggests that articles of food imported and admitted into a FTZ in or adjacent to the port of arrival as “zone restricted status” merchandise, and then exported from the port of arrival under an IE entry, are sufficiently similar to an IE entry that the same restrictions as for an IE entry would apply if the food were refused admission under 801(m) of the act. The comment, therefore, recommends that these articles should be exempt from the prior notice requirements. (Response) The fact that food is for admission into an FTZ does not, by itself, mean that the food is not subject to the requirements of the prior notice regulation (§ 1.277(a)). In the first instance described in the comments, where the article of food is imported and admitted into an FTZ located in the port of arrival and then exported from the port of arrival, prior notice is not required (§ 1.277(b)(3)). In the second instance, where the article of food is imported and admitted into an FTZ located adjacent to the port of arrival and then exported, prior notice would be required since the food has left the port of arrival before export and may not be subject to the limitations of an IE bond. An FTZ adjacent to the port of arrival is considered to be outside the port of arrival, and therefore not sufficiently similar to those IE entries that have never left the port of arrival. (Comments) Several comments ask that FDA exempt the airline industry's food service from the requirements of prior notice. The comments assert that there is no danger to the American public from this operation. One comment suggests that leftover unopened cans of soda, unopened small bottles of liquor (to be held in bonded storage) or other “dry-stores” items on flights inbound to the United States and intended for use on later flights should be exempt from prior notice. In addition, the comment states that it is not possible to determine at “wheels up” what will remain upon landing in the United States. One comment states that it is impossible to provide detailed information about leftover soda and liquor on incoming international aircraft. One comment proposes the addition of the following exception to § 1.277(b): “Food that is imported by a shipper operating an aircraft in international air transportation, then exported by the same shipper, [as] long as such food remains on board the aircraft at all times from import to export.” (Response) If the aircraft food is consumed on the international flight or discarded and is not entered into the United States for use, storage, or distribution or remains on board and is exported from the same port into which it arrived, it is outside the scope of the regulation and prior notice is not required. By contrast, prior notice is required for in-flight food that is moved out of the port of arrival to caterers for use on other international or domestic flights (§ 1.277). (Comments) One comment questions whether wines manufactured in a foreign country and present on a passenger ship that may cruise or dock in the United States Territorial Sea require prior notice. (Response) If the wine remains on the ship, it does not require prior notice (§ 1.277(b)(3)). However, if the wine is offloaded from the ship and leaves the port of arrival in the United States, prior notice would be required. (Comments) One comment asks that if wines are loaded onto a passenger ship at a U.S. port, but such an article of food has been previously imported into the U.S. to be exported or transshipped, does the prior notice for such an article of food require the manufacturer's registration number. (Response) Prior notice is required for food imported or offered for import into the United States before arrival and not when the food is loaded onto a passenger ship in the United States. (Final rule) Section 1.277(b)(3) is retained without change in the final rule and excludes food that is imported then exported without leaving the port of arrival until export. 4. Food Under the Exclusive Jurisdiction of USDA The IFR in § 1.277(b)(4), (b)(5), and (b)(6) excludes: Meat food products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ); poultry products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Poultry Products Inspection Act (21 U.S.C. 451 et seq); and egg products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq). The IFR explains that these are excluded as directed in the Bioterrorism Act. (Comments) Comments state that live animals including cattle, pig, chickens, etc. require prior notice, whereas prior notice is not required for products exclusively regulated by the Federal Meat Inspection Act. The comments recommend that animals regulated exclusively by USDA/Veterinary Services such as live cattle, pigs, and chickens be exempt from prior notice because USDA examines them upon importation. One comment further suggests that live animals requiring prior notice should be those animals regulated by FDA, such as turtles, game animals, etc. Another comment asks whether prior notice is required for livestock sent to the United States for recreational purposes, but after a number of years are expected to be slaughtered and enter the food chain as pet food. One comment asks that FDA exempt breeder livestock not imported for immediate slaughter and remove “FD3” flags from HTS codes that cover breeder livestock to avoid confusion at the ports of arrival regarding applicability of prior notice requirements. (Response) FDA disagrees. Live animals, such as poultry and cattle, are food for purposes of prior notice (§ 1.276(b)(5)(ii)) if the article of food is reasonably likely to be directed to a food use (see discussion supra on the definition of food in section III.C.11). Note that live food animals are not excluded from prior notice under section 801(m)(3)(B) of the act and § 1.277(b)(4) or (b)(5) because live food animals do not fall within the exclusive jurisdiction of USDA under the Federal Meat Inspection Act or Poultry Products Inspection Act. If the live animals are imported for a nonfood use (i.e., as a pet, for show purposes, racing) and are not reasonably likely to be directed to a food use, then prior notice is not required. USDA/Veterinary Services inspects imported live animals for animal health, not human health, purposes. An FD3 flag associated with breeder livestock means that the livestock may be subject to prior notice requirements. If the live animal is not reasonably likely to be directed to a food use, then the HTS code may be disclaimed because prior notice is not required. (Comments) Some comments had a concern regarding USDA-regulated products. One comment noted that USDA-regulated products were excluded from the FDA prior notice rule, but that an HTS codes document released on November 20, 2003, highlights a number of products that are regulated by USDA. Another comment questions why cattle imported for slaughter are coded FD4 and all other cattle are coded FD3 when the importation of cattle is under the responsibility and jurisdiction of USDA. (Response) Only items that are under the exclusive jurisdiction of the USDA are excluded from the requirements of prior notice. Articles of food that are jointly regulated by FDA and USDA are subject to the requirements of prior notice. Live animals raised for food, even though not in their final, edible form, are considered to be food under the act. United States v. Tomahara Enterprises Ltd. , Food Drug Cosm. L. Rep. (CCH) 38,217 (N.D.N.Y. 1983) (live calves intended as veal are food) and United States v. Tuente Livestock , 888 F. Supp. 1416 (S.D. Ohio 1995) (live hogs are food). (Final rule) Section 1.277(b)(4), (b)(5), and (b)(6) of the final rule are retained without change and exclude meat food products that at the time of importation are subject to the exclusive jurisdiction of the USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ); poultry products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Poultry Products Inspection Act (21 U.S.C. 451 et seq. ); and egg products that at the time of importation are subject to the exclusive jurisdiction of USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq. ). 5. Additional Exclusions Requested—General (Comments) One comment states that cough drops containing OTC (over-the-counter) Monograph active ingredients are regulated as an over-the-counter drug by the FDA, and therefore, are not subject to prior notice. However, CBP categorizes all cough drops, including ones regulated as drugs by the FDA, as candy subject to regulation by FDA as food. Therefore, due to this classification by CBP, cough drops would require prior notice. In addition, another comment asks if pharmaceuticals, such as over-the-counter drugs, are exempt from prior notice requirements. (Response) CBP classification does not identify foods requiring prior notice. However, CBP and FDA have worked together to provide indicators; i.e., flags associated with HTS codes to indicate which articles being imported may require prior notice submission. The FD3 flag indicates that the products categorized by that HTS code may require prior notice submission; those products categorized in those HTS codes flagged as FD3 that do not require prior notice submission may be disclaimed by the filer upon entry. On the other hand, the FD4 flag indicates that the products categorized by that HTS code require prior notice submission. FDA has published guidance regarding these flags and has published a list of the HTS codes with FD3 and FD4 flags. The guidance is posted at http://www.cfsan.fda.gov/~dms/htsguid3.html and the list of codes is posted at http://www.cfsan.fda.gov/~pn/htscodes.html . The comment asks about such articles containing OTC monograph active ingredients. HTS Code 3004909176 (cough and cold preparations) would apply to, among other articles, cough suppressants that contain OTC monograph active ingredients. This HTS Code is not flagged for either FD3 or FD4, meaning that prior notice would not be required. Candies, which are food, would fall under different HTS Codes and would be subject to prior notice. (Comments) One comment recommends that FDA's food category codes for raw materials could be made more complete to cover the range of materials known to be used in products marketed as foods. The comment states that there are numerous CBP “Customs Codes” that do not contain the appropriate FD3 or FD4 codes and that this causes confusion among the industry with some groups interpreting the lack of an FDA code as meaning that that food ingredient was exempt from prior notice, even if the ingredient is known to be used in food. Other comments assume that ingredients lacking an FD3 or FD4 code that are best known as being active ingredients in drugs, but are also used in dietary supplements, are exempt from prior notice. The comment recommends that these codes should be made as complete as possible and that FDA should indicate that ingredients without a FD3 or FD4 code may still require prior notice. (Response) FDA and CBP continuously evaluate the HTS codes in order to attach the appropriate FD3 and FD4 designations. However, the lack of an FD3 or FD4 designation does not mean that prior notice is not required. If the article fits the definition of food provided in § 1.276 of the final rule, then prior notice is required for that article of food. If you believe that an item has been incorrectly flagged, or is not currently flagged, but should be, you should contact the FDA and provide a statement with your suggestion and basis for the flag designation. (Comments) One comment believes that there is a conflict between the registration (21 CFR part 1, subpart H) and prior notice IFRs, where the former is based upon the intended use of food (i.e., consumption), and the latter applies to “all” food. The comment states that this has caused difficulties with the import process by: (1) Requiring foreign facilities to register in order to meet the prior notice requirements and (2) requiring drug and device establishments to register as food facilities in order to facilitate importation of intra-company articles. The comment believes this places an undue burden on drug and device establishments and hampers the importation process for articles not intended for use in food, as well as for food articles not intended for consumption. The comment suggests that section § 1.277 be changed to read: “This subpart applies to all food intended for consumption by humans and other animals * * *.” In addition, the comment suggests that the HTS codes be modified to allow articles designated with a FD3 or FD4 code to be disclaimed, with rationale, depending on their intended use. (Response) FDA disagrees. FDA disagrees with changing § 1.277 to read that prior notice is only required for food that is intended for consumption. In the preamble to the IFR, FDA noted that the determination of whether a substance is “food” is not a question of intended use (See 68 FR 58974 at 58987). Moreover, we do not believe that there is a conflict between the registration and prior notice requirements. Under the registration rule, in general, a facility engaged in the manufacturing/processing, packaging, or holding of food for consumption in the United States must be registered. Regardless of whether the facility that manufactured the food manufactured it for consumption in the United States, section 801(l) of the act prohibits food that is from an unregistered foreign facility from being delivered for distribution in the United States until the facility is registered. Thus, if the owners, operators, or agents in charge of facilities want to ensure these types of food are not subject to being held under section 801(l) of the act, they can register in accordance with section 415 of the act (21 U.S.C. 350d) (and if the food is for consumption in the United States, they must register unless the facility qualifies for an exemption). An importer can likewise ensure that food is not subject to being held under section 801(l) of the act by not importing or offering for import food that is from an unregistered foreign facility. Throughout this preamble to the final rule, we often use the phrase “food is subject to being held” in describing our enforcement of the registration requirement through prior notice. Under section 801(l) of the act, “[i]f an article of food is being imported or offered for import into the United States, and such article is from a foreign facility for which a registration has not been submitted to the Secretary under section 415, such article shall be held at the port of entry for the article , and may not be delivered to the importer, owner, or consignee of the article, until the foreign facility is so registered” (emphasis added). In this situation, the article of food is being prevented from moving forward past the port of arrival because the food is from a foreign facility that has not registered. This situation is distinct from a situation where, after FDA reviews the prior notice information, the food is held upon arrival for examination because it may pose a significant risk to public health, usually referred to as a “BT Hold.” In addition, we do not believe that prior notice places an undue burden on the drug and medical device industry. Items designated with a FD4 code are all believed to be used exclusively in food, and therefore, require prior notice. Articles designated by a FD3 code can have food and nonfood uses. These items do not require prior notice if the use of the article does not fit the definition of food provided in § 1.276 of the final rule and may be disclaimed by the filer as such upon entry. (Comments) One comment states that there is no facility registration requirement for transshippers; however, goods processed under CBP's Form CF7512 (T&Es and ITs) require a prior notice to be filed. The comment notes that this cannot be accomplished without the corresponding facility registration number. In addition, T&Es and ITs do not have a designated submitter. The comment requests that T&E and IT transactions be exempt from prior notice. (Response) FDA disagrees that T&E or IT transactions should be exempt from the requirements of prior notice. These articles of food leave the port of arrival prior to exportation from the United States or for subsequent movement through the United States prior to entry. Under § 1.281(a)(9) of the IFR, a shipper's (transshipper's) registration number was not required for a facility associated with an article of food if the article is imported for transshipment. Under the final rule, if the shipper's identity is provided, the shipper's registration number is optional. Therefore, the absence of a shipper's registration number should not prevent submission of a prior notice under either the IFR or final rule. Moreover, FDA disagrees with the comment's implication that a prior notice requires a designated submitter. Under § 1.278 of the IFR and final rule, a prior notice may be submitted by any person with knowledge of the required information. (Comments) Several comments request that FDA generally exempt Canada and Mexico from submitting prior notice for food shipments. One comment requests that FDA exempt Canada, in keeping with the nature of cooperation and shared security risks between the United States and Canada, in particular the 30 point border plan. The comment reasons that Canadian origin food is easily traceable through existing Canadian registration requirements, while already meeting or exceeding United States standards in some instances. The comment further notes that the legislation acknowledges the largest threat is from offshore, yet the regulations most severely hit continental trade between the United States, Canada, and Mexico. One comment suggests that the exemption could be limited to shipments of food which are under similar security controls, especially small quantity shipments of fish imported via package delivery. Another comment asks that FDA exempt goods being imported into the United States from companies which are inspected by the Canadian Food and Inspection Agency. (Response) FDA disagrees. While we welcome any additional information that supports our ability to quickly review prior notice submissions and determine which food to inspect at U.S. ports of arrival, the Bioterrorism Act does not provide for blanket exclusions based on the country from which the food is shipped or the country in which the food originates. FDA currently is reviewing flexible alternative programs (e.g., CBP's Customs-Trade Partnership Against Terrorism (C-TPAT), which was adopted into law (still as a voluntary system) by Subtitle B of Title II of the SAFE Port Act of 2006 (Public Law 109-347), and Free and Secure Trade (FAST) (a voluntary program authorized under 19 U.S.C. 1411) ) to determine their potential for streamlining the prior notice review process, but notes that these programs do not meet or affect the requirement to submit prior notice. Moreover, FDA notes that many shipments from Canada and Mexico into the United States in fact are transshipments from other countries, which prior notice submissions identify with the FDA Country of Production data element. (Comments) One comment suggests that FDA create a relational database to give unique identification numbers to an importer's specific items. The comment states that this would speed submission, reduce time to enter the data, and increase compliance with the regulation. The comment reasons that most food importers will bring in the same product, in the same package, from the same country, over and over. Another comment suggests that a single weekly summary of all shipments by a company to individual consumers or a summary of orders received should be adequate for this type of commerce. (Response) FDA disagrees. Not all importers consistently import the same types of food. The Bioterrorism Act requires submission of prior notice before an article of food is imported or offered for import into the United States. A weekly summary as suggested by the comment would not meet this requirement, as such a summary would not provide prior (advance) notice before the article of food is imported or offered for import. FDA notes, however, that a number of the software programs that customs brokers use to file prior notice and entry submissions with ABI/ACS do allow for repetitive information to be saved on the filer's computer and used for future shipments, as appropriate. Similarly, FDA's PNSI has been designed to accommodate repetitive information, such that the basic prior notice information that will repeat on each prior notice can be created and saved for use on subsequent prior notices. A separate prior notice confirmation number is generated for each article of food or recipient. (Comments) One comment requests that FDA exempt highly perishable food products. The comment states that highly perishable food products, such as ice cream, must be delivered in a timely manner. A delay in the delivery schedule due to holdups at the border could potentially ruin these products, and customers inconvenienced by the time delay may choose to stop importing them. A number of comments request that FDA exempt fresh produce. Several comments note that produce is already carefully monitored by CBP and placed on automatic quarantine for mandatory inspection at the first port of arrival by USDA/CBP. Other comments state that produce is already subject to 100 percent USDA inspection and approval prior to release. Another comment requests that produce be exempt from the requirement of prior notice because it already meets the requirements of the Bioterrorism Act. The comment reasons that the purpose of the prior notification to FDA is to provide FDA with the information necessary to make a decision (prior to arrival) for a possible physical inspection. The comment states that the CBP Agriculture Specialist performs the physical inspection (or reviews original documentation that confirms “pre-inspection”). Therefore, the comment reasons, importations of fresh produce are already meeting the requirements of the Bioterrorism Act. The comments further state that because prior notice is already given for produce, the new procedure created by this new legislation will only increase costs and cause extreme hardship for small business. An additional comment states that their shipments are subject to four levels of inspection: County, State, Federal, Customs and “Bio Terrorist” and reasons that the redundancy is wasteful. (Response) FDA disagrees. Highly perishable foods, like all other foods that are covered by the final rule, are subject to prior notice requirements. The timeframes are sufficiently short, allowing for submission of prior notice as soon as 2, 4, or 8 hours before arrival in the United States depending on mode of transportation. While the Bioterrorism Act provides for an exclusion for certain types of food, such as meat and meat food products subject to USDA's exclusive jurisdiction, it does not exclude perishable foods generally or foods jointly regulated by USDA and FDA. As we explained in the IFR preamble, merely obtaining existing information about the food from other agencies would not guarantee that FDA has the information required by section 801(m) of the act's prior notice requirements because there is wide variation in the purposes and information required by other government programs (68 FR 58974 at 58992). Moreover, our ability to respond to bioterrorism incidents or other food-related emergencies in a timely manner may be more difficult if the information is not easily accessible. (Comments) One comment recommends that the rule be amended to include an exemption from prior notice for organizations that are importing FD4 materials for nonfood uses. (Response) FDA disagrees. Items designated with an FD4 code are all believed to be used exclusively in food, and therefore, food encompassed by an HTS code that is flagged FD4 is subject to prior notice requirements. Moreover, as discussed previously, FDA provided extensively its rationale for not limiting the prior notice requirements to food for consumption in the United States. (See 68 FR 58974 at 58990 and 58991.) As FDA noted in the IFR, Congress did not explicitly limit the prior notice requirement to articles of food that are intended for consumption in the United States even though it could have done so as shown in section 415 of the act (requirement to register food facilities). If anyone believes that an HTS code has been flagged FD4 in error, they can inform FDA and, if we agree, we will change the flag accordingly. (Comments) Two comments request that FDA exempt small businesses. (Response) FDA disagrees. Prior notice is required for all FDA-regulated food that is imported or offered for import. The Bioterrorism Act does not provide for exclusions based upon the size or nature of the firms or facilities associated with that importation. (Comments) One comment asks FDA to permit an exemption from prior notice, by importer number, to be recognized in ACS at the time of entry transmission, to importers who demonstrate that their products will not reasonably be expected to be directed to a food use. (Response) FDA disagrees. Prior notice requirements are associated with food, not the person manufacturing, growing, shipping, importing, or owning the food. A product is food for purposes of prior notice if the article of food is reasonably likely to be directed to a food use. Prior notice is required for each article of food imported or offered for import, and food imported or offered for import by or for select importers will not be excluded from prior notice requirements. If an importer does not import articles of food, then no “exemption” would be needed since prior notice would not apply to such imports. The FD flags associated with HTS codes are designed to help identify which products will require prior notice. If an import is marked FD3 but it is not food subject to prior notice, the importer can disclaim this import and prior notice would not need to be submitted. 6. Additional Exclusions Requested—Special Programs (C-TPAT/FAST) and Flexible Alternatives In the explanation of the reduced timeframes and the relationship of special programs to those timeframes, FDA stated in the IFR that the “interim final rule provides for greatly reduced timeframes for foods based on mode of transportation. These timeframes are what FDA has determined are the minimum timeframes necessary to allow it to satisfy the statutory mandate that the timeframes give the agency the time it needs to ‘receive, review, and respond’ to prior notices. However, FDA is also interested in exploring flexible alternatives for submission of prior notice for foods or firms covered by programs of other agencies, such as C-TPAT, or imported by other agencies.” (68 FR 58974 at 58995). FDA and CBP reopened the comment period for the IFR in the Federal Register of April 14, 2004 (69 FR 19763). On page 19764 of that publication, FDA and CBP wrote “In the prior notice [interim final rule], we expressed interest in exploring flexible alternatives for submission of prior notice for foods or firms covered by programs of other agencies, such as CBP's Customs-Trade Partnership Against Terrorism (C-TPAT) and the Free and Secure Trade (FAST) program, or food imported by other government agencies (68 FR 58974 at 58995). C-TPAT is a government/business initiative to increase cargo security while improving the flow of trade. Under this program, businesses must conduct comprehensive self-assessments of their supply chain using the security guidelines developed jointly with CBP, and they must familiarize companies in their supply chain with the guidelines and the program. These businesses must provide CBP with specific and relevant information about their supply chains and security practices and procedures. As C-TPAT members, companies may become eligible for expedited processing and reduced inspections, but are not exempt from advance electronic information requirements. (See CBP's advance electronic information rule). FAST, an acronym for Free and Secure Trade between the United States and Canada, and the United States and Mexico, is an expedited-clearance system designed to improve border security without slowing the flow of legitimate trade across the northern and southern U.S. borders. FAST processing is available to importers, carriers and foreign manufacturers (southern border) who participate in C-TPAT and who use a FAST-registered driver. The initiative builds on the same concepts that drove the rapid, post-9/11 construction and implementation of C-TPAT. FDA and CBP plan to assess the feasibility of including the FAST timeframes in FDA's prior notice final rule, as well as other flexible alternatives raised by comments. To assist in this assessment, FDA and CBP requested comments on several questions, including three regarding special programs (69 FR 19763 at 19764): C-TPAT/FAST Questions: (1) Should food products subject to FDA's prior notice requirements be eligible for the full expedited processing and information transmission benefits allowed with C-TPAT and FAST? If so, how should this be accomplished? (2) If the timeframe for submitting prior notice for food arriving by land via road is reduced to 1 hour consistent with the timeframe in the advance electronic information rule, would a shorter timeframe be needed for members of FAST? (3) Should the security and verification processes in C-TPAT be modified in any way to handle food and animal feed shipments regulated by FDA? If so, how? The comments received addressing these issues are discussed in the following paragraphs in order of the questions posed in the Federal Register notice, beginning with comments addressing general issues regarding C-TPAT and FAST. a. General comments . (Comments) Numerous comments address special trade programs, such as C-TPAT and FAST. These comments recommend that FDA and CBP modify these CBP programs to reflect the criteria required by FDA and to develop integrated data elements for low risk FAST/C-TPAT shipments, which would meet both agencies' requirements. The comments believe it is necessary to have harmonization between FDA and CBP for “low-risk” shippers. Many comments contend that the IFR does not take into account the Canada-United States Smart Border Plan (SBP). A key element of the SBP is the FAST bilateral arrangements. Under the C-TPAT and the Canadian Partnerships in Protection (PIP) programs, companies approved by both countries have invested in specific counter-terrorism and supply-chain integrity measures, and are therefore, accorded more expedited treatment at the Canada-U.S. border in recognition of the lower risk they present. The comments recommend that FDA recognize foods imported under these programs as low risk and to afford them benefits, such as reduced information requirements for each shipment; reduced timeframes for providing prior notice; reduced clearance time at the border; and reduced number of verifications of information. The comments further urge FDA and CBP to permit importers who are participants in C-TPAT and FAST to comply with their prior notice obligations in a manner that does not undermine the benefits of participation in these programs. The comments contend that C-TPAT and FAST improve U.S. security on a number of levels, including reducing the risk of bioterrorism, and help to focus limited border resources on higher risk cargo. The comments suggest that FDA and CBP therefore should be careful not to remove incentives for participation in these programs by making importation of food items more cumbersome than other types of entries. Otherwise, the comments contend prior notice will dilute a key advantage offered to FAST/C-TPAT participants, thereby weakening the incentive to join the program. The companies participating in these programs have made a substantial commitment to improving security by putting in place appropriate security systems, and submitting to periodic review of those systems by CBP. The comments believe that these programs strengthen FDA's ability to meet the objectives of the prior notice rule. They contend that this is achieved in two ways: (1) Through the rigorous security screening that participants must comply with in order to obtain a low-risk status; and (2) by removing low-risk shipments from the queue, FAST/C-TPAT work to shrink the number of shipments that must be screened, thereby “freeing up” FDA officials to focus limited resources on higher risk shipments. One comment states that a firm having to manage its systems to track C-TPAT products and non-C-TPAT products will incur increased complexity, increased cost, and will be subject to making errors. This comment suggests that firms who routinely send products across the border could provide prior notice on a quarterly basis. The facility would track the number of shipments each quarter and update FDA with any changes to the anticipated amounts. These shipments would be permitted to cross the border without waiting, but still could be subjected to FDA or CBP inspection. Another comment questions the cost, benefits, etc. of these programs for small companies. In addition, a few comments address the creation of similar programs and/or the expansion of the current programs. One comment requests that FDA permit the use of Line Release (i.e., an automated system designed to release and track repetitive shipments) for food shipments arriving by rail. The comment states that their member railroads participate in C-TPAT and it would be discriminatory to permit the use of an expedited clearance system for motor carriers, but not rail transportation. On [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3AE8-26282. Public record. Not legal advice.