Friday, November 7, 2008

Part II

Department of Health and Human Services Food and Drug Administration

21 CFR Part 1 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Draft Compliance Policy Guide; ‘‘Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002;’’ Availability; Final Rule and Notice

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DEPARTMENT OF HEALTH AND II. Summary of Significant Changes Until Export HUMAN SERVICES Made to the IFR 4. Food Under the Exclusive A. What Definitions Apply to This Jurisdiction of USDA Food and Drug Administration Subpart? (§ 1.276) 5. Additional Exclusions Requested— B. What is the Scope of This Subpart? General 21 CFR Part 1 (§ 1.277) 6. Additional Exclusions Requested— [Docket No. FDA–2002–N–0233] (formerly C. Who is Authorized to Submit Prior Special Programs (C–TPAT/FAST) Docket No. 2002N–0278) Notice? (§ 1.278) and Flexible Alternatives D. When Must Prior Notice Be 7. Additional Exclusions Requested— RIN 0910–AC41 Submitted to FDA? (§ 1.279) Samples E. How Must You Submit Prior Prior Notice of Imported Food Under 8. Additional Exclusions Requested— Notice? (§ 1.280) the Public Health Security and Mail F. What Information Must Be in a Bioterrorism Preparedness and 9. Additional Exclusions Requested— Prior Notice? (§ 1.281) Response Act of 2002 Gifts G. What Must You Do If Information 10. Additional Exclusions AGENCY: Food and Drug Administration, Changes After You Have Received Requested—Low-Value HHS. Confirmation of a Prior Notice From 11. Additional Exclusions ACTION: Final rule. FDA? (§ 1.282) Requested—Couriers H. What Happens to Food That Is 12. Additional Exclusion Requested— SUMMARY: The Food and Drug Imported or Offered for Import Gift Packs Administration (FDA) is issuing a final Without Adequate Prior Notice? 13. Additional Exclusions regulation that requires the submission (§ 1.283) Requested—Household Goods and to FDA of prior notice of food, including I. What Are the Other Consequences Unaccompanied Baggage animal feed, that is imported or offered of Failing to Submit Adequate Prior 14. Additional Exclusions for import into the United States. The Notice or Otherwise Failing to Requested—Noncommercial Use final rule implements the Public Health Comply With This Subpart? 15. Additional Exclusions Security and Bioterrorism Preparedness (§ 1.284) Requested—U.S. Goods Returned and Response Act of 2002 (the J. What Happens to Food That Is 16. Additional Exclusions Bioterrorism Act), which required prior Imported or Offered for Import Requested—In-Transit Shipments notification of imported food to begin From Unregistered Facilities That 17. Additional Exclusions on December 12, 2003. The final rule Are Required to Register Subpart H Requested—Diplomatic Pouch requires that the prior notice be of This Part? (§ 1.285) 18. Additional Exclusions submitted to FDA electronically via III. Comments on the IFR Requested—Seeds for Planting either the U.S. Customs and Border A. General Comments E. Who is Authorized to Submit Prior Protection (CBP or Customs) Automated B. Comments on the Legal Authority Notice? (§ 1.278) Broker Interface (ABI) of the Automated C. What Definitions Apply to This F. When Must Prior Notice Be Commercial System (ACS) or the FDA Subpart? (§ 1.276) Submitted to FDA? (§ 1.279) Prior Notice System Interface (FDA 1. The Act (§ 1.276(a)) 1. IFR Timeframes (2, 4, and 8 hours) PNSI). The information must be 2. Calendar Day (§ 1.276(b)(1)) 2. Integration of FDA and CBP submitted and confirmed electronically 3. Country From Which the Article Timeframes as facially complete by FDA for review Originates (§ 1.276(b)(2)) 3. Phase-In of FDA and CBP no less than 8 hours (for food arriving 4. Country From Which the Article is Timeframes by water), 4 hours (for food arriving by Shipped (§ 1.276(b)(3)) 4. Prior Notice Confirmation Number air or land/rail), and 2 hours (for food 5. FDA Country of Production 5. 5-Day Maximum Pre-Arrival arriving by land/road) before the food (§ 1.276(b)(4)) Limitation arrives at the port of arrival. Food 6. Full Address (§ 1.276(b)(6)) 6. International Mail imported or offered for import without 7. Grower (§ 1.276(b)(7)) G. How Must You Submit the Prior adequate prior notice is subject to 8. Registration Number Notice? (§ 1.280) refusal and, if refused, must be held. (§ 1.276(b)(13)) 1. General Comments Elsewhere in this issue of the Federal 9. United States (§ 1.276(b)(15)) 2. English Language Register, FDA is announcing the 10. You (§ 1.276(b)(16)) 3. Technical Issues Concerning Both availability of a draft compliance policy 11. Food (§ 1.276(b)(5)) Systems guide (CPG) entitled ‘‘Sec. 110.310 Prior 12. International Mail (§ 1.276 b)(8)) 4. ABI/ACS Interface Notice of Imported Food Under the 13. Manufacturer (§ 1.276(b)(9)) 5. PNSI Public Health Security and Bioterrorism 14. No Longer in Its Natural State 6. Security of the Systems Preparedness and Response Act of (§ 1.276(b)(10)) 7. Contingency Plans 2002.’’ 15. Port of Arrival (§ 1.276(b)(11)) H. What Information Must Be in a 16. Shipper (§ 1.276(b)(14)) Prior Notice? (§ 1.281) DATES: This rule is effective May 6, 17. Comments Requesting Additional 1. General Comments 2009. Definitions 2. The Submitter FOR FURTHER INFORMATION CONTACT: 18. Summary of the Final Rule 3. The Transmitter Laura Draski, Office of Regulatory D. What is the Scope of this Subpart? 4. The CBP Entry Type Affairs (HFC–100), Food and Drug (§ 1.277) 5. The CBP Entry Identifier (e.g., The Administration, 5600 Fishers Lane, 1. Food for an Individual’s Personal Customs ACS Entry Number or In- Rockville, MD 20857, 866–521–2297. Use When Accompanied at Arrival Bond Number) SUPPLEMENTARY INFORMATION: 2. Homemade Food Sent as Personal 6. The Product Identity Gift 7. Identity of the Manufacturer Table of Contents 3. Food Imported Then Exported 8. The Grower, If Known I. Background and Legal Authority Without Leaving Port of Arrival 9. FDA Country of Production

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10. Shipper VII. Federalism 30 days on April 14, 2004 (69 FR 11. The Country From Which the VIII. References 19763), and for an additional 60 days on Article is Shipped May 18, 2004 (69 FR 28060), for a total I. Background and Legal Authority 12. Anticipated Arrival Information of 165 days. 13. The Importer, Owner, Ultimate Section 307 of the Bioterrorism Act, II. Summary of Significant Changes Consignee, and U.S. Recipient which was enacted on June 12, 2002, Made to the IFR 14. Mode of Transportation amended the Federal Food, Drug, and 15. Carrier Cosmetic Act (the act) (section 307 of The highlights of how this final rule 16. Planned Shipment Information the Bioterrorism Act added section compares to the IFR and the rationale I. What Must You Do If Information 801(m) to the act (21 U.S.C. 381(m)) and for certain changes are described briefly Changes After You Have Received amended section 301 of the act (21 in the following paragraphs and are Confirmation of a Prior Notice From U.S.C. 331)) by changing when FDA will discussed in more detail later in the FDA? (§ 1.282) receive certain information about preamble. J. What Happens to Food That Is imported foods by requiring the A. What Definitions Apply to This Imported or Offered for Import Secretary of Health and Human Services Subpart? (§ 1.276) Without Adequate Prior Notice? (the Secretary), after consultation with (§ 1.283) the Secretary of the Treasury,1 to issue We retain the following terms without 1. General Comments an implementing regulation by change from the IFR: • ‘‘The act;’’ 2. Inadequate Prior Notice December 12, 2003, to require prior • (§ 1.283(a)(1)) ‘‘Calendar day;’’ notification to FDA of food that is • ‘‘Country from which the article 3. Status and Movement of Refused imported or offered for import into the originates;’’ Food (§ 1.283(a)(2)) United States. Beginning on December • ‘‘FDA Country of Production;’’ 4. Segregation of Refused Foods 12, 2003, food importers were required • ‘‘Grower;’’ (§ 1.283(a)(3)) to provide FDA with advance notice of • ‘‘Port of entry;’’ and 5. Costs (§ 1.283(a)(4)) human and animal food shipments • ‘‘United States.’’ 6. Export After Refusal (§ 1.283(a)(5)) imported or offered for import. FDA made the following changes in 7. Post-Refusal Prior Notice FDA and CBP jointly published the the final rule: Submissions (§ 1.283(c)) proposed prior notice regulation in the • We revised the term, ‘‘Country from 8. FDA Review After Refusal Federal Register of February 3, 2003 (68 which the article is shipped,’’ to read, (§ 1.283(d)) FR 5428), for comment (proposed rule). ‘‘* * * or, in the case of food sent by 9. International Mail (§ 1.283(e)) On October 10, 2003, FDA and CBP international mail, the country from 10. Prohibitions on Delivery and issued the prior notice interim final rule which the article is mailed.’’ • Transfer (§ 1.283(f)) (IFR) (prior notice IFR) (68 FR 58974) We revised the term, ‘‘food,’’ to add 11. Relationship to Other (corrected by a technical amendment on the phrase, ‘‘except as provided in Admissibility Decisions (§ 1.283(g)) February 2, 2004; 69 FR 4851). The IFR paragraph (b)(5)(i) of this section,’’ in K. What Are the Other Consequences implemented section 307 of the the first sentence; and reworded of Failing to Submit Adequate Prior Bioterrorism Act, and required that the § 1.276(b)(5)(i) to read, ‘‘For purposes of Notice or Otherwise Failing to this subpart, food does not include’’. prior notice be submitted to FDA • Comply With This Subpart? electronically via either the CBP ABI/ We added the term, ‘‘full address,’’ (§ 1.284) ACS or the FDA PNSI. The information to the final rule. Full address means the L. What Happens to Food That is must be submitted and confirmed facility’s street name and number; suite/ Imported or Offered for Import electronically as facially complete by unit number, as appropriate; city; From Unregistered Facilities That FDA for review no less than 8 hours (for Province or State as appropriate; mail code as appropriate; and country. Are Required to Register Under food arriving by water), 4 hours (for • We revised the term, ‘‘international Subpart H of This Part? (§ 1.285) food arriving by air or land via rail), and mail,’’ to make the sentence easier to M. Outreach and Enforcement 2 hours (for food arriving by land via read, and to add the phrase, ‘‘unless 1. General Outreach and Enforcement road) before the food arrives at the port such service is operating under contract Issues of arrival. Food imported or offered for 2. Prior Notice Submission Training as an agent or extension of a foreign import without adequate prior notice is Program From Flexible Alternative mail service,’’ at the end of the subject to refusal and, if refused, must Question 7 definition. be held. The IFR responded to 3. Requests for Additional Outreach • We added the term, comments from the public on the 4. Enforcement Timeframe ‘‘manufacturer,’’ to the final rule. proposed rule, and established a 75-day 5. Enforcement Penalties Manufacturer means the last facility, as comment period. In order to ensure that N. The Joint FDA-CBP Plan for that word is defined in § 1.227(b)(2), those commenting on the IFR had the Increasing Integration and that manufactured/processed the food. benefit of FDA’s outreach and Assessing the Coordination of Prior A facility is considered the last facility educational efforts and had experience Notice Timeframes even if the food undergoes further 1. Increased Integration with the systems, timeframes, and data manufacturing/processing that consists 2. General Comments on the Plan elements of the prior notice system, of adding labeling or any similar activity IV. Analysis of Economic Impacts FDA reopened the comment period for of a de minimis nature. If the food A. Final Regulatory Impact Analysis undergoes further manufacturing/ 1 Under the Homeland Security Act of 2002 B. Small Entity Analysis (or Final (Public Law 107–296), the Secretary of the Treasury processing that exceeds an activity of a Regulatory Flexibility Analysis) has delegated all relevant Customs revenue de minimis nature, then the subsequent C. Small Business Regulatory authorities to the Secretary of Homeland Security facility that performed the additional Enforcement Fairness Act of 1996 who has, in turn, delegated them to the manufacturing/processing is considered (SBREFA) Major Rule Commissioner of the Bureau of Customs and Border the manufacturer. Protection (CBP or Customs). Thus, the Secretary is • V. Paperwork Reduction Act of 1995 issuing this final rule jointly with the Secretary of We revised the term, ‘‘no longer in VI. Analysis of Environmental Impact Homeland Security. its natural state,’’ by deleting ‘‘waxed’’

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from the list of actions that render an E. How Must You Submit Prior Notice? reasons to use when the registration article of food still in its natural state for (§ 1.280) number is not provided. In the IFR, a registration number is purposes of this subpart. FDA revised this provision. Under 21 • not required for a facility associated We revised the term, ‘‘port of CFR 1.280(a)(2) (§ 1.280(a)(2)) of the with an article of food if the article is arrival’’ to read ‘‘* * * the water, air, or IFR, prior notice must be submitted via imported or offered for import for land port at which the article of food is PNSI for articles of food that have been transshipment, storage, and export, or imported or offered for import into the refused under section 801(m)(1) of the further manipulation and export. We United States. For an article of food act. Under the final rule, prior notice for have removed this from the final rule arriving by water or air, this is the port articles that have been refused under of unloading. For an article of food and are requiring the registration section 801(m) of the act must be number of the manufacturer (or the full arriving by land, this is the port where submitted through PNSI until such time the article of food first crosses the address of the manufacturer and a as ACS or its successor system can reason) in all circumstances. border into the United States. The port accommodate such transactions. of arrival may be different than the port In the final rule, we have removed the FDA also simplified the IFR option provided in the IFR that allows where consumption or warehouse entry provisions pertaining to system outages or foreign trade zone admission the label information in § 101.5 (21 CFR at § 1.280(b) through (e) by providing 101.5) to be submitted instead of the documentation is presented to the U.S. the outage notification at one Web Customs and Border Protection (CBP).’’ name, address, and registration number address (http://www.fda.gov) and stating of the manufacturer for food sent by an • We revised the term, ‘‘registration that FDA will accept prior notice individual as a personal gift (i.e., for number,’’ by changing the phrase, submissions in the format it deems nonbusiness reasons) to an individual in ‘‘refers to,’’ to ‘‘means,’’ and by adding appropriate during the system(s) outage. the United States. FDA notes, however, the phrase, ‘‘to a facility,’’ after the that under the enforcement policy word, ‘‘assigned,’’ to clarify that FDA F. What Information Must Be in a Prior proposed in the Prior Notice Final Rule assigns registration numbers by facility. Notice? (§ 1.281) • Draft CPG, FDA and CBP should We revised the term, ‘‘shipper,’’ by FDA revised the following typically consider not taking any adding the phrase, ‘‘or express information requirements: • regulatory action when no prior notice consignment operators or carriers or Submitter: The IFR states that ‘‘if a is submitted for food imported or other private delivery service,’’ after registration number is provided, city offered for import for noncommercial ‘‘international mail’’ to clarify that a and country may be provided instead of purposes with a noncommercial shipper is involved with various types the full address.’’ For clarity, in the final shipper, irrespective of the type of of transactions, and not just rule, FDA has revised this phrase to carrier. international mail shipments. state that ‘‘if the business address of the • Shipper: The IFR required the name • We revised the term, ‘‘you,’’ to individual submitting the prior notice is and address of the shipper and, if the simplify the last phrase of the definition a registered facility, then the facility’s shipper is required to register, the to ‘‘i.e., the submitter or the transmitter, registration number, city, and country registration number assigned to the if any.’’ may be provided instead of the facility’s shipper’s facility; if a registration full address.’’ FDA also deleted the number is provided, city and country B. What is the Scope of This Subpart? requirement for providing the (§ 1.277) may be provided instead of the full submitter’s fax number. address. The final rule requires the We revised this provision and added • Transmitter: The IFR states that ‘‘if name and full address of the shipper, if ‘‘Articles of food subject to Art. 27(3) of a registration number is provided, city the shipper is different from the The Vienna Convention on Diplomatic and country may be provided instead of manufacturer in order to eliminate Relations (1961), i.e., shipped as the full address.’’ For clarity, in the final duplicative requirements. If the address baggage or cargo constituting the rule, FDA has revised this phrase to of the shipper is a registered facility, the diplomatic bag’’ to the list of food that state that ‘‘if the business address of the submitter may submit the registration does not require prior notice. individual submitting the prior notice is number of the shipper’s registered a registered facility, then the facility’s C. Who is Authorized to Submit Prior facility. registration number, city, and country In the IFR, the shipper’s registration Notice? (§ 1.278) may be provided instead of the facility’s number was not required for a facility We retain this provision without full address.’’ FDA also deleted the associated with an article of food if the change. requirement for providing the article is imported or offered for import transmitter’s fax number. for transshipment, storage, and export, D. When Must Prior Notice Be • Manufacturer, for food no longer in or further manipulation and export. We Submitted to FDA? (§ 1.279) its natural state: have removed this from the final rule FDA revised this provision. Section Under the IFR, the name, address, and because the shipper’s registration 1.279(b) of the IFR states that, except for registration number of the manufacturer number is now optional. international mail, prior notice may not must be submitted; if a registration • Anticipated arrival information: be submitted more than 5 calendar days number is provided, city and country Under the final rule, we removed the before the anticipated date of arrival at may be provided instead of the full requirement for the identity of the the anticipated port of arrival. We address. The final rule requires the anticipated border crossing within the revised this section to permit prior name of the manufacturer and either: (1) port of arrival because FDA and CBP notice submissions to be submitted no The registration number, city and have determined that it is no longer more than 15 calendar days before the country of the manufacturer or (2) both necessary for purposes of anticipated date of arrival for the full address of the manufacturer and communication. For post-refusal submissions made through the PNSI and the reason the registration number is not submissions, actual date the article no more than 30 calendar days before provided. Publishing elsewhere in this arrived is now a required data element the anticipated date of arrival for issue of the Federal Register, the Prior so that FDA knows how long it has been submission made through the ABI/ACS. Notice Final Rule Draft CPG lists the since the refused food shipment arrived

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in the United States and how to connect privately owned vehicle from the J. What Happens to Food That Is the refused prior notice to the post- planned shipment information and Imported or Offered for Import From refusal prior notice submission for added this data element to the section Unregistered Facilities That Are shipments where a previously refused identifying the carrier of the article of Required to Register Under Subpart H of prior notice was filed. food (§ 1.281(a)(16) and (c)(16)). This Part? (§ 1.285) The final rule also includes a new The final rule removes the provision provision for food arriving by express Table 2, which appears later in this in § 1.285(a) that if food is from a consignment operator or carrier since preamble, summarizes the information certain information may not be available required in a prior notice. foreign manufacturer that is not registered as required and is imported or to persons who ship food using an G. What Must You Do If Information express consignment operator or offered for import, it is subject to refusal Changes After You Have Received of admission for failure to provide courier. If the article of food is arriving Confirmation of a Prior Notice From by express consignment operator or adequate prior notice. It also deletes the FDA? (§ 1.282) carrier, and neither the submitter nor text in that provision that states that transmitter is the express consignment failure to provide the manufacturer’s The IFR required that for prior notices registration number renders the identity operator or carrier, and the prior notice submitted via ABI/ACS, the submitter is submitted via PNSI, the express of the facility incomplete for purposes should cancel the prior notice via ACS of prior notice. The final rule retains, consignment operator or carrier tracking by requesting that CBP ‘‘delete’’ the number may be submitted in lieu of the with revisions, the provision that states entry. FDA has revised the final rule to that if food is from a foreign facility that anticipated arrival information. state that the submitter should request • The name and address of the is not registered and is imported or importer, owner, and ultimate that CBP ‘‘cancel’’ the entry. Moreover, offered for import, it is subject to being consignee: The IFR required the name we changed references to ‘‘PN System placed under hold under section 801(l) and address of the importer, owner, and Interface’’ to ‘‘PNSI.’’ of the act. ultimate consignee, unless the shipment H. What Happens to Food That Is III. Comments on the IFR is imported or offered for import for Imported or Offered for Import Without FDA received 320 timely submissions transshipment through the United States Adequate Prior Notice? (§ 1.283) under a Transportation and Exportation in response to the IFR. To make it easier (T&E) entry. In the final rule, FDA is The IFR stated that refused food must to identify comments and FDA’s inserting the word ‘‘full’’ in front of be moved under appropriate custodial responses to the comments, the word ‘‘Comment’’ will appear in parentheses ‘‘address’’ to make clear that the bond. FDA has revised this paragraph in before the description of the comment, complete address is required. the final rule to state that the refused and the word ‘‘Response’’ will appear in Consequently, FDA is revising the food must be moved under appropriate subsequent text to state that if the parentheses before FDA’s response. A custodial bond unless immediately summary follows which includes a business address of the importer, owner, exported under CBP supervision. The or ultimate consignee is a registered description of the appropriate section in final rule clarifies that the refused food facility, then the facility’s registration the final rule. may be held at the port or at a secure number also may be provided in A. General Comments addition to the facility’s full address. facility outside the port. FDA also • Planned shipment information: changed the timeframe for notifying (Comments) Most comments generally FDA revised this provision by clarifying FDA of the hold location from within 24 support the intent of the Bioterrorism that the required planned shipment hours of refusal to before the food is Act and FDA’s efforts to implement its information is applicable by mode of moved to the hold location. For clarity provisions with the IFR. Some transportation and when it exists. and consistency throughout the final comments commend FDA for revising Moreover, FDA added a new provision rule, we are changing the phrase, certain proposed requirements to in the final rule for the Airway Bill ‘‘designated location,’’ to ‘‘designated address the needs of international trade number/Bill of Lading number and secure facility.’’ by shortening timeframes, reducing the amount of information required to be flight number since this information is Under the section describing FDA submitted, and adding a reasonable generally not available to individual review after refusal, FDA revised the submitters. The final rule provides that amount of flexibility for the submission final rule by including the carrier as one of prior notice based on the mode of for food arriving by express of the entities who can submit a request consignment operator or carrier when transportation in the IFR. However, for FDA review. FDA also revised the neither the submitter nor transmitter is several comments assert that the agency final rule to delete acceptance of the express consignment operator or has misinterpreted the Bioterrorism Act carrier, the tracking number can be requests for review by mail and express and some comments suggest that the submitted in lieu of the Bill of Lading courier. We are limiting delivery to fax final rule should be more consistent or Airway Bill number and the flight and e-mail. with the existing trade practices number for prior notices submitted via I. What Are the Other Consequences of established in accordance with CBP. PNSI. Failing to Submit Adequate Prior Notice (Response) FDA drafted the IFR in response to the comments to the FDA also revised the IFR by deleting or Otherwise Failing to Comply With proposed rule, the needs of the requirement to provide the This Subpart? (§ 1.284) Harmonized Tariff Schedule (HTS) code international trade, and the continued since FDA and CBP have determined We corrected the word ‘‘federal’’ in threat of international terrorism and that the HTS code is no longer critical the IFR to read ‘‘Federal.’’ We also other significant risks to public health for communication with CBP. corrected the citation to ‘‘section 303 of posed by imported food. We also drafted In the final rule, we deleted the the act’’ in the IFR to read ‘‘sections 301 the final rule accordingly. requirement for the license plate and 303 of the act.’’ (Comments) Several comments number (and State or Province that support the graduated enforcement issued the license) for food arriving by policy the agency used to implement the

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IFR, noting that this policy facilitated governing the disclosure of information (Comments) Several comments the transition into compliance with the under FOIA, including the disclosure of acknowledge the importance and value prior notice requirements. Comments confidential business information. of FDA’s educational outreach efforts to ask that FDA provide a similar Likewise, the agency’s general policies, the trade industry through scheduled transition period after publication of the procedures, and practices relating to the outreach and education sessions, port- final rule during which time submitters protection of confidential information specific flyers, foreign government may become familiar with new received from third parties apply to training and Web site communications, requirements, understand the new information received under prior notice. especially those that summarize certain procedures and adjust business We do not believe rules, policies, or compliance data. The comments also processes and practices. procedures specific to prior notice are applaud the unprecedented efforts the (Response) After publication of the needed. FDA has made in this regard. IFR, FDA published guidance that (Comments) One comment states that (Response) FDA and CBP will included a transition period during during the period of enforcement continue outreach and education efforts which we emphasized education to discretion, various ports of arrival took as resources permit. See section III.M achieve compliance (the December 2003 different approaches to enforcement and entitled ‘‘Outreach and Enforcement’’ Prior Notice Interim Final Rule CPG) (68 suggests that FDA ensure that all ports later in this document for further FR 69708, December 15, 2003). FDA and all officials act in a similar fashion discussion on this subject. agrees that implementing a graduated to achieve a consistent enforcement (Comments) Several comments enforcement policy using enforcement posture. The comment also suggests that commend FDA for its efforts in discretion has assisted submitters to FDA and CBP conduct ‘‘cross-training’’ developing the prior notice regulation in become accustomed to the new of their officials staffing FDA or CBP an efficient and effective manner, requirements. The new requirements of help desks. reaching out to affected stakeholders for the final rule will not take effect until (Response) All prior notice field input and comment, and acknowledge 180 days after publication. Since the operations and procedures are directed the tremendous effort put forth by the final rule retains most of the by the FDA Prior Notice Center (PNC). agency in the development of the requirements found in the IFR, and with The PNC works to ensure a consistent regulation. Other comments state that the 180-day delay in effective date, we implementation and enforcement the rule lacked real world international are not implementing a graduated program. Since the initial business input and will have both enforcement policy for implementing implementation of the prior notice rule, business and government unable to the final rule. FDA staff has received additional function because of the amount of FDA and CBP have issued elsewhere training and guidance on prior notice paperwork generated, which will not in this issue of the Federal Register a requirements. stop a terrorist attack. In particular, one new CPG (hereinafter the Prior Notice (Comments) Several comments comment notes that tracing a grower of Final Rule Draft CPG) that explains our acknowledge the efforts of CBP and FDA a particular shipment is impossible in proposed policies for enforcing to work together to achieve the common many instances. violations of this final rule. The draft goal of securing the imported food (Response) FDA and CBP systems CPG describes the circumstances under supply. In particular, comments have been able to manage the millions which FDA and CBP should typically congratulate FDA for coordinating with of prior notice submissions received, consider not taking any regulatory CBP to allow transmission of FDA- reviewed, and responded to since action, the types of violations FDA and required information through the ABI to December 12, 2003. The agencies strove CBP intend to focus on, and other CBP’s ACS. In addition, comments to implement the requirements in the enforcement policies. support the integration and cooperation Bioterrorism Act in a manner that (Comments) Several comments thank of both agencies in utilizing CBP’s required only that information deemed FDA for providing an opportunity to targeting system to efficiently and necessary and appropriate to ensure provide comments on the provisions of rapidly spot anomalies in freight FDA could meet its statutory obligation the IFR after a period of active FDA/CBP crossing our borders; reducing the FDA to receive, review and respond to prior enforcement. proposed timeframes for submission of notices and target those shipments (Response) FDA agrees that providing prior notice in the advance electronic needing inspection upon arrival in the several comment periods following information requirements; and the United States. Based on FDA’s and publication of the IFR has permitted commissioning of CBP staff to conduct CBP’s experience since December 2003, affected stakeholders an additional examinations and investigations. One the agencies have revised some of the opportunity to offer specific and comment requests that CBP and FDA requirements in the IFR and eliminated informed comments on the new ensure that there are adequate resources some of the information we no longer requirements. at ports of arrival to mitigate anticipated deem necessary (e.g., HTS codes). FDA (Comments) One comment requests delays at border crossings when the rule notes that the grower of a food in its that FDA clarify that prior notices is enforced. Several comments natural state is required only when submitted to FDA will not be subject to anticipated that trade would collapse on known. public disclosure under the Freedom of December 12, 2003, when the new (Comments) One comment suggests Information Act (5 U.S.C. 552, et seq.) regulations took effect. that the prior notice IFR is ‘‘functionally (FOIA) because information contained (Response) FDA and CBP are redundant’’ because prior notice has in a prior notice is confidential business continuously coordinating efforts to long been a part of FDA protocol long information. Alternatively, the comment receive, review, and respond to prior before the Bioterrorism Act. requests that FDA develop policies to notice submissions. We further note that (Response) While FDA agrees that protect confidential business trade continued without significant most of the information required by the information contained in prior notices interruption on December 12, 2003, or IFR has been submitted to FDA via CBP from public disclosure. anytime after that implementation date. processes for decades, the information (Response) FDA does not believe this Rather, the implementation of the prior has not been required prior to arrival of is necessary. FDA already has relatively notice requirements was relatively the food, making prior notice a new, detailed regulations, in 21 CFR part 20, smooth. unique, and valuable process.

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(Comments) One comment suggests Bioterrorism Act mandates. over which both FDA and USDA have that the IFR was unduly costly, ill- Accordingly, we have made a number of jurisdiction. For example, both FDA and considered and generally more harmful changes in the final rule that minimize USDA’s Animal and Plant Health than useful. An additional comment the impact of prior notice requirements Inspection Service (APHIS) regulate the believes that the prior notice on the food being imported or offered importation of fruits and vegetables into requirements would restrict trade more for import into the United States. We the United States, although the goal of than necessary and hopes that the also note that the registration APHIS’ regulation is to safeguard U.S. United States will implement the requirement applies to domestic agriculture and natural resources from Bioterrorism Act in the least trade- facilities, as well as foreign facilities, the risks associated with the plant pests. restrictive manner. Another comment and that the registration provisions in Nonetheless, FDA does not believe that states that despite efforts to comply with the Bioterrorism Act contain certain there is a need to have USDA the new requirements, massive exclusions that apply only to foreign implement the prior notice problems seem to constantly occur. facilities. (See e.g., 21 CFR 1.226(a), requirements for products for which we Another comment complains about which exempts from the requirement to share jurisdiction, nor do we believe accessibility to the Web site, cost and register a foreign facility, if food from that doing so would lead to an efficient time of the submission procedures, such facility undergoes further enforcement of the prior notice language barriers, and complexity of the manufacturing/processing (including requirements. The Bioterrorism Act information requested. packaging) by another facility outside mandates that advance notice be given (Response) FDA disagrees. The prior the United States; no similar exclusion to FDA for any article of food that is notice process, which allows applies to facilities within the Unites being imported or offered for import submission of the required information States.) into the United States and that the via either ABI/ACS or PNSI, has been (Comments) Other comments suggest Secretary receive, review, and relatively smooth. Although there were that the IFR failed to include a provision appropriately respond to such some technical problems encountered that would ensure that high risk imports notifications. To accomplish this, FDA during the early implementation phase, arrive at ports staffed by FDA inspection established the PNC that operates 24 FDA believes that the graduated personnel and notes that this could be hours a day, 7 days a week, to receive, enforcement process coupled with the accomplished by designating particular review, and respond to these notices as vigorous education and outreach efforts ports of entry for accepting high risk they are submitted. The purpose of prior by both the government and the products or requiring importers of such notice is to enable FDA to conduct industry have supported a relatively products to provide longer notice to inspections of imported foods at U.S. smooth transition to the new procedures ensure adequate inspection coverage. ports upon arrival and target foods that and have improved compliance with the (Response) FDA disagrees. Section may pose a significant risk to public new requirements. FDA also has 307 of the Bioterrorism Act specifically health, based on the information considered its international trade prohibits FDA from limiting the port of submitted. obligations under various World Trade entry by stating, ‘‘Nothing in this Prior Notice is submitted Organization agreements, North section may be construed as a limitation electronically to FDA through either America Free Trade Agreement, and on the port of entry for an article of Customs’ ABI/ACS or FDA’s PNSI. other international agreements food.’’ We also disagree that certain Regardless of the mode of transmission, throughout the rulemaking development shipments require longer timeframes for the prior notice information will processes for both the IFR and this final submission of prior notice to ensure undergo both a validation process and a rule. Both rules are consistent with our adequate inspection coverage. Under a screening in FDA’s Operational and international obligations. Memorandum of Understanding (MOU) Administrative System for Import (Comments) Some comments believe between FDA and CBP, published on Support (OASIS) for food safety and there is a disincentive towards product January 7, 2004 (69 FR 924), FDA has security criteria. If the FDA system does diversification when exporting articles commissioned thousands of CBP not indicate that further evaluation of or of food to the United States because the officers in ports and other locations to action on the notice or article of food is prior notice requirements put them at a conduct, on FDA’s behalf, investigations necessary for prior notice, the system competitive disadvantage compared to and examinations of imported foods. will transmit a message through OASIS shipments that originate in the United This helps ensure that there is adequate to the ABI/ACS interface for CBP that States. inspection coverage, including at ports the article of food may be conditionally (Response) The requirement for prior where FDA does not currently have released. However, if additional notice was established by Congress with personnel. evaluation of the prior notice the passage of the Bioterrorism Act to information is necessary, personnel at improve the ability of the United States B. Comments on the Legal Authority the FDA’s PNC will access the to prevent, prepare for, and respond to (Comments) One comment requests information provided and determine if bioterrorism and other public health that FDA delegate authority to the U.S. that information suggests the potential emergencies. Section 307 of the Department of Agriculture (USDA), as it for a significant risk to public health. Bioterrorism Act requires prior notice of has with CBP, to enable USDA to FDA personnel are able to make this all food imported or offered for import implement prior notice requirements on determination by using their experience into the United States. FDA is aware of products where the USDA shares of imported foods, utilizing the the international trade obligations of the jurisdiction. expertise within the Center for Food United States and has considered these (Response) FDA disagrees. FDA has Safety and Nutrition (CFSAN), the obligations throughout the rulemaking not delegated its authority under section Center for Veterinary Medicine (CVM), process for this final rule and the IFR 801(m) of the act to CBP, although FDA the inspectional information obtained preceding it. Both are consistent with has commissioned CBP officers in ports by the Office of Regulatory Affairs these international obligations. FDA and and other locations to conduct, on (ORA), and utilizing the expertise of CBP have actively explored ways to FDA’s behalf, investigations and CBP staff who are co-located with the reduce the burden on industry to the examinations of imported foods. FDA PNC. If FDA determines that a potential extent feasible while fulfilling the recognizes that there are some products health risk is present, FDA or CBP will

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examine the food or take other made minor revisions to these 6. Full Address (§ 1.276(b)(6)) appropriate action. definitions. We also added a definition The IFR did not have a definition for Evaluations of imported articles of for the term, ‘‘full address,’’ although we the term, ‘‘full address.’’ However, we food are made on an article-of-food by did not get any comments on this term. added this term to the final rule for article-of-food basis. CBP and FDA are 1. The Act (§ 1.276(a)) clarity since this term is used continuously working together to throughout the rule. The final rule incorporate further intelligence gained The final rule defines ‘‘the act’’ to defines ‘‘full address’’ to mean ‘‘the from this process. The recent addition of mean ‘‘the Federal Food, Drug, and facility’s street name and number; suite/ USDA personnel to assist in the sharing Cosmetic Act.’’ unit number, as appropriate; city; of information affecting the safety and Province or State as appropriate; mail 2. Calendar Day (§ 1.276(b)(1)) security of imported foods will help code as appropriate; and country.’’ further this effort. FDA does note that food items that are The final rule defines ‘‘calendar day’’ 7. Grower (§ 1.276(b)(7)) under the exclusive jurisdiction of the to mean ‘‘every day shown on the calendar.’’ The final rule defines ‘‘grower’’ to USDA are not subject to the mean ‘‘a person who engages in growing requirements of prior notice. (See the 3. Country From Which the Article and harvesting or collecting crops discussion on § 1.277 (scope), discussed Originates (§ 1.276(b)(2)) (including botanicals), raising animals infra.) (including fish, which includes (Comments) Another comment The final rule defines ‘‘country from seafood), or both.’’ suggests that to be consistent with the which the article originates’’ to mean Bioterrorism Act, FDA should permit an ‘‘FDA Country of Production.’’ 8. Registration Number (§ 1.276(b)(13)) alternative to prior notice for The final rule defines ‘‘registration administrative flexibility. The 4. Country From Which the Article is Shipped (§ 1.276(b)(3)) number’’ to mean ‘‘the registration comments suggest that this could be number assigned to a facility by FDA accomplished by including in the final The final rule defines ‘‘country from under section 415 of the act (21 U.S.C. rule a provision which states, ‘‘Other which the article is shipped’’ to mean 350d) and subpart H of this part.’’ FDA measures as appropriate that provide an ‘‘the country in which the article of food made a minor change in this definition equivalent level of assurance of is loaded onto the conveyance that in the final rule by adding the phrase compliance with the requirements of brings it to the United States or, in the ‘‘to a facility’’ after the word ‘‘assigned’’ this part.’’ case of food sent by international mail, to clarify that FDA assigns registration (Response) FDA disagrees. Section the country from which the article is numbers by facility. 801(m) of the act requires the submission of prior notice for all food mailed.’’ For clarity, we revised the last 9. United States (§ 1.276(b)(15)) imported or offered for import into the phrase of this definition to change, ‘‘the country in which the article will be The final rule defines ‘‘United States’’ United States, except as outlined in to mean ‘‘the Customs territory of the § 1.277(b). FDA is to use that mailed’’ to ‘‘the country from which the article is mailed.’’ United States (i.e., the 50 States, the information to determine whether it District of Columbia, and the should inspect the food upon arrival in 5. FDA Country of Production Commonwealth of Puerto Rico), but not the United States. Compliance with (§ 1.276(b)(4)) the Territories.’’ prior notice, therefore, means providing the required information within the The final rule defines ‘‘FDA Country 10. You (§ 1.276(b)(16)) specified timeframes. No other of Production’’ to mean, for an article of The final rule defines ‘‘you’’ to mean ‘‘measures’’ would ‘‘provide an food that is in its natural state, the ‘‘the person submitting the prior notice, equivalent level of assurance of country where the article of food was i.e., the submitter or the transmitter, if compliance’’ with the prior notice grown, including harvested or collected any.’’ We made a minor change to this requirements. and readied for shipment to the United definition by simplifying the last phrase States. If an article of food is wild fish, of the definition to ‘‘i.e., the submitter C. What Definitions Apply to This including seafood that was caught or Subpart? (§ 1.276) or the transmitter, if any.’’ harvested outside the waters of the FDA received comments on the Section 1.276 of the IFR provides United States by a vessel that is not definitions for the following terms in definitions for the following terms: The registered in the United States, the FDA the IFR: food, international mail, no act, calendar day, country from which Country of Production is the country in longer in its natural state, port of arrival, the article originates, country from which the vessel is registered. If an and shipper. FDA also received which the article is shipped, FDA article of food that is in its natural state comments that recommend that FDA Country of Production, food, grower, was grown, including harvested or include additional definitions for the international mail, no longer in its collected and readied for shipment, in a following terms in the IFR: Carrier, natural state, port of arrival, port of Territory, the FDA Country of manufacturer, trip number, and ultimate entry, registration number, shipper, Production is the United States. For an consignee. FDA responds to these United States, and you. FDA received article of food that is no longer in its comments in the following paragraphs. no comments on the definitions for the natural state, the country where the act, calendar day, country from which article was made; except that, if an 11. Food (§ 1.276(b)(5)) the article originates, FDA Country of article of food is made from wild fish, The IFR defines ‘‘food’’ as having the Production, grower, and United States, including seafood, aboard a vessel, the meaning given in section 201(f) of the and thus, the final rule retains the FDA Country of Production is the act, except that it does not include food definitions for these terms that were in country in which the vessel is contact substances as defined in section the IFR. Although no comments were registered. If an article of food that is no 409(h)(6) of the act (21 U.S.C. 348(h)(6)) received on the definitions for ‘‘country longer in its natural state was made in or pesticides as defined in 7 U.S.C. from which the article is shipped,’’ a Territory, the FDA Country of 136(u). Examples of food include fruits, ‘‘registration number,’’ and ‘‘you,’’ we Production is the United States. vegetables, fish, including seafood,

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dairy products, eggs, raw agricultural direct food additive is not a food contact to be directed to a food use. This should commodities for use as food or as substance but is a food processing aid, make it clearer that, as explained in the components of food, animal feed then it would be subject to prior notice. preamble to the IFR, the determination (including pet food), food and feed (Comments) Two comments ask the is not based on the intended use of the ingredients, food and feed additives, FDA to clarify the term, ‘‘reasonably article (68 FR 58974 at 58987). dietary supplements and dietary expected to be directed to a food use.’’ In one of the comments, the seed will ingredients, infant formula, beverages One comment states that seed produced ‘‘inevitably’’ contain remnant seed and (including alcoholic beverages and by seed companies is intended to be culls that will be diverted to human or bottled water), live food animals, bakery used for planting crops, but the animal feed. In this case, since at the goods, snack foods, candy, and canned production process inevitably results in time of import, the seed is reasonably foods. remnant or culled seed that is suitable likely to be directed to a food use, prior (Comments) One comment asks FDA for use as animal feed (and to a far lesser notice is required. FDA believes this is to define food contact substances, which degree, as food for human consistent with the purpose of the are exempt from the requirements of consumption), which generally is sold Bioterrorism Act. With respect to the prior notice, to include secondary direct by the seed company as such. The other comment about seeds found food additives. The comment reasons comment states that a similar issue ‘‘unsuitable’’ for planting, there is that secondary direct food additives, arises with some crops, such as onions, insufficient detail in the comment to many of which are food processing aids, for which bulbs sold to farmers may also determine whether these seeds would meet the criteria for food contact be used as feed or, in limited cases, as be considered food. substances as defined in section food if they are determined to be Nonetheless, we note that the Prior 409(h)(6) of the act (21 U.S.C. 348(h)(6)). remnant or culled. The comment Notice Final Rule Draft CPG, announced The comment further reasons that believes that FDA should provide elsewhere in this issue of the Federal secondary direct food additives meet the specific limitations on the definitions of Register, proposes an enforcement criteria that FDA used in the registration ‘‘reasonably believes’’ and ‘‘reasonably policy regarding seeds for planting. IFR to exclude food contact materials expected’’ that take into consideration Under the draft policy, FDA and CBP from the requirements of the registration that the seed produced by seed would typically consider not taking any IFR as they are not ‘‘food for companies is intended to be used for regulatory action regarding seeds that consumption’’ in that ‘‘they are not planting crops, even though it is will be used for cultivation. The policy intentionally eaten for their taste, understood that there inevitably will be would apply when no more than a small aroma, or nutritive value’’ (68 FR 58894 some remnant seed and culls. Without portion of that seed is diverted from at 58911). such limitations, the comment believes cultivation to animal feed or other food (Response) Some secondary direct the rule is unreasonably broad, imposes use. It would not apply, however, where food additives meet the definition of a burden on seed companies primarily the seed is used for the production of food contact substances as given in marketing seeds for planting purposes edible sprouts, such as alfalfa seeds for section 409(h)(6) of the act and, that is out of proportion to the the production of alfalfa sprouts. therefore, would not be subject to the protective goals of the act, and is subject (Comments) One comment states that prior notice requirements to widely varying interpretations. the Bioterrorism Act regulations do not (§ 1.276(b)(5)(i)(A)). The comment, Another comment notes that the seed present a means to provide FDA with however, asks about secondary direct industry’s research and development certification that any of the indicated food additives that are not food contact activities generate very small amounts persons (i.e., submitter, transmitter, substances, for example food processing of seed that may be found ‘‘unsuitable’’ manufacturer, grower, shipper, aids. The IFR concluded that food for planting and end up in the food importer, owner, or ultimate consignee) processing aids that are not food contact supply, and similarly asks for do not reasonably believe that an item substances are subject to prior notice clarification of the ‘‘reasonably is reasonably expected to be directed to ‘‘Whether a food processing aid or believes’’ and ‘‘reasonably expected’’ a food use prior to arrival at a U.S. port. ‘indirect additive’ is subject to prior language. The comment further states that there is notice depends upon whether such a (Response) In the preamble to the IFR, no method to avoid classifying their substance is ‘food’ under this rule. As we state that ‘‘FDA will consider a products as anything other than those noted, for purposes of the interim final product as one that will be used for food flagged as FD4 2 articles requiring prior rule, ‘food’ excludes ‘food contact if any of the persons involved in substances’ as defined at section importing or offering the product for 2 HTS codes are ‘‘flagged’’ in ACS as follows to 409(h)(6) of the FD&C Act. Among other import (e.g., submitter, transmitter, indicate that products are or may be under FDA jurisdiction: things, unlike food processing aids and manufacturer, grower, shipper, FD0—Indicates that FDA has determined the ‘indirect additives,’ ‘food contact importer, owner, or ultimate consignee) article, even though subject to FDA’s laws and substances’ are not ‘intended to have reasonably believes that the substance is regulations, is acceptable for CBP release without any technical effect in food,’ [section reasonably expected to be directed to a further presentation of prior notice or other entry 409(h)(6) of the act]. In addition, ‘food’ food use’’ (68 FR 58974 at 58987). The information to FDA. FD1—Indicates that the article may be subject to excludes pesticides as defined at 7 purpose of this statement was to explain FDA jurisdiction, including FDA review under U.S.C. 136(u). Thus, if the substance is when an article of food would be subject 801(a) of the act. For products not subject to FDA not a pesticide and is intended to have to prior notice if it is capable of multiple jurisdiction, a filer can ‘‘Disclaim’’ product from a technical effect in the food being uses. The comments, and our FDA notification requirements. processed, the substance is not exempt experience with the IFR, have shown FD2—Indicates that the article is under FDA jurisdiction and review of entry information by from the definition of ‘food’ under that there is some confusion as to how FDA under section 801(a) of the act will take place. § 1.276(b)(5) in the interim final rule. to determine when a substance that is However, the article is not ‘‘food’’ for which prior This is a reasonable result in that such capable of a food use and a nonfood use notice information is required. processing aids are intentionally and is a ‘‘food’’ for purposes of prior notice. FD3—Indicates that the article may be subject to prior notice under section 801(m) of the act and 21 directly added to ‘traditional’ foods.’’ To clarify, we will consider such a CFR Part 1, subpart I. , e.g., the article has both food (68 FR 58974 at 58986). We continue to substance to be ‘‘food’’ for the purpose and nonfood uses. hold this view. Thus, if a secondary of prior notice if it is reasonably likely Continued

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notice, thereby providing no means to continuously reviewing and updating (Comments) One comment asks FDA avoid refusal of the goods upon arrival the FD flags associated with the HTS to define international mail to include because the prior notice was not filed. codes. If you have questions regarding express carriers. Another comment asks (Response) FDA disagrees. FDA is whether prior notice is required for a FDA to clarify whether sending an item continuously reviewing the FD3 and particular article of food, contact the by express delivery will be considered FD4 flags associated with HTS codes. PNC for assistance. Furthermore, we ‘‘international mail’’ or ‘‘express The HTS codes are flagged to indicate have established procedures in place to carrier.’’ which products will (FD4) or may (FD3) disclaim articles of food the submitter (Response) FDA declines to make the require prior notice and which product believes does not require prior notice. requested change. The IFR defines will or may require FDA review under This can be accommodated by ABI/ACS ‘‘international mail’’ to mean ‘‘foreign section 801(a) of the act for as an affirmation of compliance. national mail services’’ and expressly admissibility; all FDA-regulated (Comments) One comment states that excluded express carriers, express products are covered, not just foods. If the list of HTS codes flagged for prior consignment operators, or other private you believe that an item has been notice (both FD3 and FD4) (as provided delivery services from the definition. incorrectly flagged, you should contact by Customs Admin message 03–2605 We retain this definition in the final the FDA and provide a statement that dated October 31, 2003) contains 762 rule but revised the wording to make the explains your rationale. The designation tariff numbers. The comment asks if this definition easier to read, and to add the will be reviewed and action taken to is a definitive list at this point, phrase, ‘‘unless such service is correct the flag if deemed appropriate. especially since FDA and CBP estimated operating under contract as an agent or With respect to the comment about the number to be around 2,000. extension of a foreign mail service,’’ at providing certification about the belief (Response) This is not a definitive list. the end of the definition. This phrase of the ‘‘indicated persons,’’ submitters FDA and CBP are continuously was needed to clarify that a contractor may disclaim articles of food marked reviewing and updating the FD flags working for a foreign mail service also FD3 if the article is not reasonably likely associated with the HTS codes. is included in the definition of to be directed to a food use by using an Guidance regarding the HTS flags is ‘‘international mail.’’ International mail affirmation of compliance in ABI/ACS. posted at http://www.cfsan.fda.gov/ is a function of the foreign postal organizations of sovereign countries (Comments) Many comments address ~dms/htsguid3.html. The lack of an who are members of the International the FD flags associated with the HTS FD3 or FD4 designation does not mean Postal Union. International mail codes. Two comments state that they are that prior notice is not required. If the shipments generally do not utilize any currently importing a product that was article of food fits the definition of food of the electronic data transmission flagged FD4, which requires that prior provided in § 1.276 of the final rule, systems commonly used by express notice be submitted for that article. then prior notice is required for that consignment carriers and private However, the item is not an article of article of food. food and the commenter would like the delivery services. (Final rule) Section 1.276(b)(5) of the (Final rule) Section 1.276(b)(8) of the HTS code changed from a FD4 flag to a final rule defines ‘‘food’’ as having the FD3 flag. An additional comment had final rule defines ‘‘international mail’’ to meaning given in section 201(f) of the mean foreign national mail services. concerns about multiple use products, act, except that it does not include food where one use would require prior International mail does not include contact substances as defined in section express consignment operators or notice and another use would not. 409(h)(6) of the act (21 U.S.C. 348(h)(6)) Another comment states that there is no carriers or other private delivery or pesticides as defined in 7 U.S.C. services unless such service is operating clear methodology provided to disclaim 136(u). Examples of food include fruits, an item beyond the initial FD3 under contract as an agent or extension vegetables, fish, including seafood, of a foreign mail service. designation. The comment recommends dairy products, eggs, raw agricultural that the agency outline the elements of commodities for use as food or as 13. Manufacturer (§ 1.276(b)(9)) a due diligence protocol that would components of food, animal feed (Comments) Two comments request become part of the disclaimer process. (including pet food), food and feed that we define the word One comment suggested that the data ingredients, food and feed additives, ‘‘manufacturer.’’ One of these suggests elements in the prior notice submission dietary supplements and dietary that we define ‘‘manufacturer’’ to mean be amended to permit an affirmation ingredients, infant formula, beverages the last entity to conduct a processing that a substance is not directed for a (including alcoholic beverages and operation; e.g., including bottling but food use. This would avoid the article bottled water), live food animals, bakery excluding labeling. of food from being refused if the prior goods, snack foods, candy, and canned (Response/Final rule) As discussed in notice was submitted for a category that foods. section III.H.7.a of this document, FDA required prior notice. Another comment We revised this definition for clarity agrees and has added a definition for wants FDA to develop a method that in the final rule by adding the phrase, manufacturer. Section 1.276(b)(9) of the would allow the submitter or the ‘‘except as provided in paragraph final rule defines manufacturer as the transmitter to disclaim the need for (b)(5)(i) of this section,’’ in the first last facility, as that word is defined in prior notice at the time of the prior sentence; and reworded paragraph § 1.227(b)(2) (in the registration rule), notice transmission. that manufactured/processed the food. (Response) If there is a concern (b)(5)(i) to read, ‘‘For purposes of this A facility is considered the last facility regarding the FD flags associated with subpart, food does not include:’’. even if the food undergoes further the HTS codes, you should contact FDA 12. International Mail (§ 1.276(b)(8)) manufacturing/processing that consists and provide a detailed description of The IFR defines ‘‘international mail’’ of adding labeling or any similar activity why you believe the HTS code is flagged to mean foreign national mail services. of a de minimis nature. If the food incorrectly. FDA and CBP are International mail does not include undergoes further manufacturing/ FD4—Indicates that the article is ‘‘food’’ for express carriers, express consignment processing that exceeds an activity of a which prior notice is required under section 801(m) operators, or other private delivery de minimis nature, then the subsequent of the act and 21 CFR Part 1, subpart I. services.’’ facility that performed the additional

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manufacturing/processing is considered the prior notice requirements. In the on the vehicle or vessel, then the port the manufacturer. second edition of ‘‘Questions and of arrival definition has not been met for Answers Regarding the Interim Final these and only these articles. Another 14. No Longer in Its Natural State Rule on Prior Notice of Imported Food comment reports being told by FDA (§ 1.276(b)(10)) (Edition 2)’’ (the prior notice question representatives that when a ship arrives The IFR defines ‘‘no longer in its and answer guidance document) from Europe, only goods ‘‘off loaded’’ in natural state’’ to mean that ‘‘an article of available at http://www.cfsan.fda.gov/ that port must be given prior notice food has been made from one or more ~pn/pnqagui2.html, issued May 2004, within the timeframes required. If the ingredients or synthesized, prepared, under section B, Definitions, question ship has food destined to be ‘‘off treated, modified, or manipulated. 4.1 of the guidance, we discuss seeds. If loaded’’ in other ports, prior notice must Examples of activities that render food the seed will be used only for sowing or be filed for each port in accordance with no longer in its natural state are cutting, planting, and not directed to food use, the timeframes required by the peeling, trimming, washing, waxing, then no prior notice is required and, regulations. The comments ask FDA to eviscerating, rendering, cooking, baking, therefore, there is no need to determine clarify this definition. freezing, cooling, pasteurizing, whether the seeds are in their natural (Response) FDA agrees to clarify the homogenizing, mixing, formulating, state for the purposes of prior notice. term, ‘‘port of arrival,’’ as it is a required bottling, milling, grinding, extracting Regarding the other comments, the data element in a prior notice and juice, distilling, labeling, or packaging. definition for ‘‘no longer in its natural important for gauging the timeframes for Crops that have been cleaned (e.g., state’’ in the final rule already states that prior notice submission. The interim dusted, washed), trimmed, or cooled trimmed or washed produce is still in final rule defined ‘‘port of arrival’’ as attendant to harvest or collection or its natural state, if those activities are ‘‘the water, air, or land port at which the treated against pests, waxed, or polished attendant to harvest or collection. This article of food is imported or offered for are still in their natural state for same definition states that waxing and import into the United States, i.e., the purposes of this subpart. Whole fish packaging are activities that render food port where the article of food first headed, eviscerated, or frozen attendant no longer in its natural state. arrives in the United States.’’ In essence, to harvest are still in their natural state (Final Rule) Section 1.276(b)(10) of the comments ask us to identify the for purposes of this subpart.’’ the final rule defines ‘‘no longer in its point at which an article of food ‘‘first (Comments) One comment asks FDA natural state’’ to mean that ‘‘an article of arrives’’ in the United States when the to clarify the term, ‘‘no longer in its food has been made from one or more food is arriving by water. natural state’’ by expressly stating that ingredients or synthesized, prepared, The preambles to the proposed rule seed for sowing or planting that are treated, modified, or manipulated. and IFR explained that for FDA to be shucked, sorted and sized remain ‘‘in Examples of activities that render food able to protect U.S. consumers from their natural state’’ for purposes of prior no longer in its natural state are cutting, terrorism or other food-related notice. Another comment believes that peeling, trimming, washing, waxing, emergencies, it was important for FDA activities such as trimming, washing, eviscerating, rendering, cooking, baking, to receive prior notice before the food waxing, and packaging of produce are freezing, cooling, pasteurizing, covered by that notice is shipped part of normal harvesting activities and homogenizing, mixing, formulating, around the country and potentially lost seeks to clarify that produce that has bottling, milling, grinding, extracting to government oversight (68 FR 5428 at been trimmed, washed, waxed, and/or juice, distilling, labeling, or packaging. 5431 and 68 FR 58974 at 58991). The packaged is still ‘‘in its natural state.’’ Crops that have been cleaned (e.g., preambles concluded that prior notice (Response) The IFR defines ‘‘no dusted, washed), trimmed, or cooled must be given before the food first longer in its natural state’’ as meaning attendant to harvest or collection or physically appears in the United States ‘‘an article of food has been made from treated against pests, or polished or so that FDA can inspect the food upon one or more ingredients or synthesized, packaged are still in their natural state arrival. prepared, treated, modified, or for purposes of this subpart. Whole fish As noted in the comments, some manipulated. Examples of activities that headed, eviscerated, or frozen attendant shipments contain both food and render food no longer in its natural state to harvest are still in their natural state nonfood cargo. If the carrier stops at are cutting, peeling, trimming, washing, for purposes of this subpart.’’ multiple ports, the articles of food may waxing, eviscerating, rendering, remain on board at intermediate ports cooking, baking, freezing, cooling, 15. Port of Arrival (§ 1.276(b)(11)) where nonfood articles are unloaded. pasteurizing, homogenizing, mixing, The IFR defines ‘‘port of arrival’’ to The articles of food are then unloaded formulating, bottling, milling, grinding, mean ‘‘the water, air, or land port at at one or more subsequent ports. When extracting juice, distilling, labeling, or which the article of food is imported or food is shipped via water and FDA has packaging. Crops that have been cleaned offered for import into the United bioterrorism or other public health (e.g., dusted, washed), trimmed, or States, i.e., the port where the article of emergency concerns about the food, it cooled attendant to harvest or collection food first arrives in the United States. would inspect the food at the point of or treated against pests, waxed, or This port may be different than the port unloading. This is because before the polished are still in their natural state where consumption or warehouse entry food is unloaded it would remain on the for purposes of this subpart. Whole fish or foreign trade zone admission carrier either at a secured port under headed, eviscerated, or frozen attendant documentation is presented to the U.S. CBP authority or in open water, to harvest are still in their natural state Customs and Border Protection (CBP).’’ preventing intentional or unintentional for purposes of this subpart.’’ In the (Comments) Two comments ask FDA diversion until unloading. The same is final rule, we are deleting the word to clarify what is meant by the term, true for food shipped by air. When an ‘‘waxed’’ in the list of activities that ‘‘port of arrival.’’ One comment notes article of food remains on board at one render the food still in their natural that notwithstanding the definition in airport to be unloaded at a subsequent state because this was included in error. the IFR, FDA representatives have stated airport, FDA would not need to examine After publishing the prior notice IFR, that ‘‘port of arrival’’ means the first the food until the point where that food FDA issued guidance in the form of port where the articles of food are ‘‘off- is unloaded. In contrast, when food is questions and answers to help clarify loaded’’ and that if the articles remain shipped via land, any articles of food

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remaining on board would travel record. Another states that FDA and example it would be the company through the United Stated while outside CBP should typically consider not having the business contract to export of secured ports and, therefore, could be taking any regulatory action when an the food; in the second, assuming that potentially lost to government oversight article of food is imported or offered for the producer is sending the food to a due to off-loading in noncontrolled import for noncommercial purposes firm in the United States, they (the areas. with a noncommercial shipper without producer) would be the shipper. It Therefore, we believe that when an prior notice. One of the examples of should also be noted that a firm may be article of food is shipped via water or foods imported or offered for import both a shipper and a manufacturer with air, the article ‘‘first arrives’’ at the port that may be covered by this policy is respect to the same product if the where it is unloaded. When an article of food in household goods, including product is shipped from the point of food is shipped via land, the article military transfers. manufacture to the United States. ‘‘first arrives’’ at the port where it (Final rule) Section 1.276 (b)(11) of Moreover, we have added the phrase, crosses the border. We are revising the the final rule defines ‘‘port of arrival’’ as ‘‘or express consignment operators or definition of ‘‘port of arrival’’ in the ‘‘the water, air, or land port at which the carriers or other private delivery final rule to clarify this distinction. We article of food is imported or offered for service,’’ after the term, ‘‘international have added a statement that for an import into the United States. For an mail,’’ in the definition of ‘‘shipper’’ to article of food arriving by water or air, article of food arriving by water or air, the port of arrival is the port of this is the port of unloading. For an clarify that a shipper is involved with unloading. For an article of food article of food arriving by land, this is various types of transactions, and not arriving by land, the definition now the port where the article of food first just international mail shipments. states that the port of arrival is the port crosses the border into the United (Final rule) Section 1.276(b)(14) of the where the article of food first crosses the States. The port of arrival may be final rule defines shipper to mean ‘‘the border into the United States. different than the port where owner or exporter of the article of food (Comments) One comment asks FDA consumption or warehouse entry or who consigns and ships the article from to clarify the word ‘‘port.’’ The comment foreign trade zone admission a foreign country or the person who asks whether the IFR applies to U.S. documentation is presented to the U.S. sends an article of food by international Navy ships returning to ‘‘port’’ or to a Customs and Border Protection (CBP).’’ mail or express consignment operators U.S. Naval Base from outside U.S. 16. Shipper (§ 1.276(b)(14)) or carriers or other private delivery territorial waters. The comment notes service to the United States.’’ that U.S. Navy fleet ships always have The IFR defines ‘‘shipper’’ to mean been considered U.S. territory. The ‘‘the owner or exporter of the article of 17. Comments Requesting Additional comment also notes that the CPG states food who consigns and ships the article Definitions that food entering and then leaving the from a foreign country or the person ‘‘port area’’ is not subject to prior notice who sends an article of food by (Comments) Several comments and asks FDA to clarify the term, ‘‘port international mail to the United States.’’ request that we define additional terms area.’’ (Comments) Two comments request in the final rule, including: ‘‘trip (Response) FDA clarifies that the that we clarify the IFR’s definition of number,’’ ‘‘carrier,’’ and ‘‘ultimate term, ‘‘port,’’ is not defined but that ‘‘shipper.’’ One comment asks whether consignee.’’ ‘‘port of arrival’’ and ‘‘port of entry’’ are the shipper is the person who (Response) FDA disagrees. FDA defined. The term, ‘‘port,’’ as used in the physically loads the shipment for its believes these terms are sufficiently rule relates to ports identified by CBP. final journey to the United States, the clear based on our experience since the In 19 CFR 101.1 Definitions, ‘‘Port and company that has the business contract initial implementation of the prior port of entry refer to any place to export the food to the U.S. importer, notice IFR. FDA intends to interpret the designated by Executive Order of the or someone in the middle who removes ‘‘ultimate consignee’’ consistent with President, by order of the Secretary of the shipment from temporary storage for CBP’s use of that term in regards to the the Treasury, or by Act of Congress, at the initial phase of its entire journey to entry of merchandise, which is which a Customs officer is authorized to the United States. Another comment contained in paragraph 6.3 of Customs accept entries of merchandise to collect asks for clarification as to who is the Directive No. 3550–079A, June 27, 2001. shipper when the producer’s shipping duties, and to enforce the various As stated in that CBP Directive, ‘‘if the platform is involved in the shipment— provisions of the Customs and merchandise has not been sold or navigation laws. The terms ‘port’ and the transporter who takes responsibility consigned to a U.S. party at the time of ‘port of entry’ incorporate the for the whole shipment or the entry or release, then the Ultimate geographical area under the jurisdiction producer’s own facility (assuming that Consignee at the time of entry or release of a port director.’’ If CBP changes this neither would be classified as is defined as the proprietor of the U.S. definition in the future, we will evaluate ‘‘manufacturer’’)? whether § 1.276(b)(12) should be revised (Response) In the IFR, we defined premises to which the merchandise is to to incorporate those changes. Proposed ‘‘shipper’’ based upon the description of be delivered.’’ policies in the Prior Notice Final Rule shipper as it is discussed in CBP’s 18. Summary of the Final Rule Draft CPG, would apply to most articles proposed rule ‘‘Required Advance of food on U.S. Navy ships returning to Electronic Presentation of Cargo Section 1.276 of the final rule defines ‘‘port’’ or a U.S. Naval Base from outside Information’’ (July 23, 2003, 68 FR the following terms: The act, calendar U.S. territorial waters. One policy states 43574 at 43577). We have decided to day, country from which the article that FDA and CBP should typically continue to use this definition in the originates, country from which the consider not taking any regulatory final rule. In the examples cited in the article is shipped, FDA Country of action when an article of food is comments above, the shipper is Production, food, full address, grower, imported or offered for import for an considered to be the entity that arranges international mail, manufacturer, no official government purpose without or directs the shipment to be sent to the longer in its natural state, port of arrival, prior notice, provided that a Federal United States, irrespective of who port of entry, registration number, Government agency is the importer of physically transports it. In the first shipper, United States, and you.

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D. What is the Scope of this Subpart? personal use to include all food (Comments) One comment states that (§ 1.277) products carried in personal baggage; or if food moves for immediate export 3 (IE) Section 1.277(a) of the IFR states that to allow declaration of entry to be made out of the same port, it is not subject to the prior notice requirements apply to through existing general CBP entry prior notice. However, if the food moves all food for humans and other animals declaration procedures. on a T&E entry, prior notice is required. (Response) FDA disagrees. Prior that is imported or offered for import The comment provides a scenario where notice is not required for food that is into the United States. This covers food a shipment arrives at Los Angeles carried by or otherwise accompanies an for use, storage, or distribution in the Harbor and then moves to Los Angeles individual entering the United States Airport for export. Los Angeles Harbor United States, and includes food for (e.g., food that is in his or her carry-on and Los Angeles Airport are separate gifts, trade and quality assurance/ or checked baggage) when the food is for ports and each has its own port code quality control samples, food for that individual’s personal use assigned by CBP. The comment states transshipment through the United States (§ 1.277(b)(1)). This means that the food that CBP considers this an IE entry. to another country, food for future is for consumption by the individual or Similarly, the comment questioned if export, and food for use in a U.S. by the individual’s family and friends FDA considers this an IE entry as well, Foreign Trade Zone (FTZ). or if it is considered a T&E entry that Section 1.277(b) of the IFR sets out and is not for sale or other distribution. If the food carried by or otherwise requires prior notice. the exclusions from prior notice. It (Response) If the food arrives in and excludes food for an individual’s accompanying an individual is for commercial purposes, then prior notice is exported from the same port, then it personal use when it is carried by or is not subject to prior notice. FDA otherwise accompanies the individual requirements apply. As we explained in the IFR preamble, considers a port to be the same as when arriving in the United States (i.e., we do not believe that Congress defined by CBP in 19 CFR 101.1; i.e., the for consumption by themselves, family intended for us to characterize travelers term ‘‘port’’ incorporates the and friends, not for sale or other bringing food back from their travels in geographical area under the jurisdiction distribution); food that was made by an their personal baggage for their own use of a port director. The geographical individual in his/her personal residence as ‘‘shippers’’ for purposes of section boundaries of the port of Los Angeles- and sent by that individual as a personal 801(m) of the act. When there is a Long Beach are described in 19 CFR gift (i.e., for nonbusiness reasons) to an commercial purpose involved, there is a 101.3(b)(1). While Los Angeles Harbor individual in the United States; food ‘‘shipper,’’ i.e., the person or entity on and Los Angeles Airport are separate for that is imported then exported without whose behalf the traveler is bringing in CBP management purposes, they are leaving the port of arrival until export; the food. Thus, by its terms, section considered to be within the same port. and meat food products, poultry 801(m) of the act requires that food Accordingly, IE entries may be filed for products, and egg products that, at the carried by or otherwise accompanying movements between Los Angeles Harbor time of importation, are subject to the an individual arriving in the United and Los Angeles Airport followed by exclusive jurisdiction of USDA under States that is not for personal use be exportation of the goods. Similarly, the Federal Meat Inspection Act (21 subject to prior notice. Moreover, we because such movements would not U.S.C. 601 et seq.), the Poultry Products explained that we would potentially leave the port of arrival until export, Inspection Act (21 U.S.C. 451 et seq.), or create a loophole that would defeat the prior notice would not be required. the Egg Products Inspection Act (21 purpose of the prior notice rule if we (Comments) One comment suggests U.S.C. 1031 et seq.). were to exempt all food products carried that articles of food imported and FDA received many comments about in personal baggage. admitted into a FTZ in or adjacent to the § 1.277(b), which are addressed in order (Final rule) Section 1.277(b)(1) of the port of arrival as ‘‘zone restricted status’’ of the exclusions covered in the IFR: final rule continues to state that the rule merchandise, and then exported from Food for an individual’s personal use does not apply to food for an the port of arrival under an IE entry, are when carried by or otherwise individual’s personal use when it is sufficiently similar to an IE entry that accompanying an individual; carried by or otherwise accompanies the the same restrictions as for an IE entry homemade food; food that is imported individual when arriving in the United would apply if the food were refused for immediate exportation; and foods States. admission under 801(m) of the act. The under exclusive USDA/Food Safety and comment, therefore, recommends that Inspection Service jurisdiction. The 2. Homemade Food Sent as Personal these articles should be exempt from the comments concerning requests for Gift prior notice requirements. additional exclusions from the scope of Section 1.277(b)(2) of the IFR (Response) The fact that food is for the prior notice requirements are excludes food that was made by an admission into an FTZ does not, by addressed by issue, beginning with individual in his/her personal residence itself, mean that the food is not subject general comments/requests. and sent by that individual as a personal to the requirements of the prior notice gift (i.e., for nonbusiness reasons) to an regulation (§ 1.277(a)). In the first 1. Food for an Individual’s Personal Use instance described in the comments, When Accompanied at Arrival individual in the United States. (Comments) No comments were where the article of food is imported Section 1.277(b)(1) of the IFR received about this issue. and admitted into an FTZ located in the excludes food for an individual’s (Final rule) Section 1.277(b)(2) is port of arrival and then exported from personal use when it is carried by or retained without change. the port of arrival, prior notice is not otherwise accompanies the individual required (§ 1.277(b)(3)). In the second when arriving in the United States. The 3. Food Imported Then Exported instance, where the article of food is IFR explains that in this situation there Without Leaving Port of Arrival Until imported and admitted into an FTZ was no ‘‘shipper’’ as that term is used Export in section 801(m) of the act. Section 1.277(b)(3) of the IFR 3 Food that is brought to a U.S. port but is then (Comments) One comment requests excludes food that is imported then directly exported from that port of arrival is entered under a CBP IE entry and subject to the limitations that FDA expand the exemption for food exported without leaving the port of of an IE bond. In essence, this food may not leave carried in to the United States for arrival until export. the port of arrival until export.

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located adjacent to the port of arrival does the prior notice for such an article Note that live food animals are not and then exported, prior notice would of food require the manufacturer’s excluded from prior notice under be required since the food has left the registration number. section 801(m)(3)(B) of the act and port of arrival before export and may not (Response) Prior notice is required for § 1.277(b)(4) or (b)(5) because live food be subject to the limitations of an IE food imported or offered for import into animals do not fall within the exclusive bond. An FTZ adjacent to the port of the United States before arrival and not jurisdiction of USDA under the Federal arrival is considered to be outside the when the food is loaded onto a Meat Inspection Act or Poultry Products port of arrival, and therefore not passenger ship in the United States. Inspection Act. If the live animals are sufficiently similar to those IE entries (Final rule) Section 1.277(b)(3) is imported for a nonfood use (i.e., as a that have never left the port of arrival. retained without change in the final rule pet, for show purposes, racing) and are (Comments) Several comments ask and excludes food that is imported then not reasonably likely to be directed to a that FDA exempt the airline industry’s exported without leaving the port of food use, then prior notice is not food service from the requirements of arrival until export. required. USDA/Veterinary Services prior notice. The comments assert that 4. Food Under the Exclusive inspects imported live animals for there is no danger to the American Jurisdiction of USDA animal health, not human health, public from this operation. One purposes. An FD3 flag associated with comment suggests that leftover The IFR in § 1.277(b)(4), (b)(5), and breeder livestock means that the unopened cans of soda, unopened small (b)(6) excludes: Meat food products that livestock may be subject to prior notice bottles of liquor (to be held in bonded at the time of importation are subject to requirements. If the live animal is not storage) or other ‘‘dry-stores’’ items on the exclusive jurisdiction of USDA reasonably likely to be directed to a food flights inbound to the United States and under the Federal Meat Inspection Act use, then the HTS code may be intended for use on later flights should (21 U.S.C. 601 et seq.); poultry products disclaimed because prior notice is not be exempt from prior notice. In that at the time of importation are required. addition, the comment states that it is subject to the exclusive jurisdiction of (Comments) Some comments had a not possible to determine at ‘‘wheels USDA under the Poultry Products concern regarding USDA-regulated up’’ what will remain upon landing in Inspection Act (21 U.S.C. 451 et seq); products. One comment noted that the United States. One comment states and egg products that at the time of USDA-regulated products were that it is impossible to provide detailed importation are subject to the exclusive excluded from the FDA prior notice information about leftover soda and jurisdiction of USDA under the Egg rule, but that an HTS codes document liquor on incoming international Products Inspection Act (21 U.S.C. 1031 released on November 20, 2003, aircraft. One comment proposes the et seq). The IFR explains that these are highlights a number of products that are addition of the following exception to excluded as directed in the Bioterrorism regulated by USDA. Another comment § 1.277(b): ‘‘Food that is imported by a Act. questions why cattle imported for shipper operating an aircraft in (Comments) Comments state that live slaughter are coded FD4 and all other international air transportation, then animals including cattle, pig, chickens, cattle are coded FD3 when the exported by the same shipper, [as] long etc. require prior notice, whereas prior importation of cattle is under the as such food remains on board the notice is not required for products responsibility and jurisdiction of USDA. aircraft at all times from import to exclusively regulated by the Federal (Response) Only items that are under export.’’ Meat Inspection Act. The comments the exclusive jurisdiction of the USDA (Response) If the aircraft food is recommend that animals regulated are excluded from the requirements of consumed on the international flight or exclusively by USDA/Veterinary prior notice. Articles of food that are discarded and is not entered into the Services such as live cattle, pigs, and jointly regulated by FDA and USDA are United States for use, storage, or chickens be exempt from prior notice subject to the requirements of prior distribution or remains on board and is because USDA examines them upon notice. Live animals raised for food, exported from the same port into which importation. One comment further even though not in their final, edible it arrived, it is outside the scope of the suggests that live animals requiring form, are considered to be food under regulation and prior notice is not prior notice should be those animals the act. United States v. Tomahara required. By contrast, prior notice is regulated by FDA, such as turtles, game Enterprises Ltd., Food Drug Cosm. L. required for in-flight food that is moved animals, etc. Another comment asks Rep. (CCH) 38,217 (N.D.N.Y. 1983) (live out of the port of arrival to caterers for whether prior notice is required for calves intended as veal are food) and use on other international or domestic livestock sent to the United States for United States v. Tuente Livestock, 888 flights (§ 1.277). recreational purposes, but after a F. Supp. 1416 (S.D. Ohio 1995) (live (Comments) One comment questions number of years are expected to be hogs are food). whether wines manufactured in a slaughtered and enter the food chain as (Final rule) Section 1.277(b)(4), (b)(5), foreign country and present on a pet food. One comment asks that FDA and (b)(6) of the final rule are retained passenger ship that may cruise or dock exempt breeder livestock not imported without change and exclude meat food in the United States Territorial Sea for immediate slaughter and remove products that at the time of importation require prior notice. ‘‘FD3’’ flags from HTS codes that cover are subject to the exclusive jurisdiction (Response) If the wine remains on the breeder livestock to avoid confusion at of the USDA under the Federal Meat ship, it does not require prior notice the ports of arrival regarding Inspection Act (21 U.S.C. 601 et seq.); (§ 1.277(b)(3)). However, if the wine is applicability of prior notice poultry products that at the time of offloaded from the ship and leaves the requirements. importation are subject to the exclusive port of arrival in the United States, prior (Response) FDA disagrees. Live jurisdiction of USDA under the Poultry notice would be required. animals, such as poultry and cattle, are Products Inspection Act (21 U.S.C. 451 (Comments) One comment asks that if food for purposes of prior notice et seq.); and egg products that at the wines are loaded onto a passenger ship (§ 1.276(b)(5)(ii)) if the article of food is time of importation are subject to the at a U.S. port, but such an article of food reasonably likely to be directed to a food exclusive jurisdiction of USDA under has been previously imported into the use (see discussion supra on the the Egg Products Inspection Act (21 U.S. to be exported or transshipped, definition of food in section III.C.11). U.S.C. 1031 et seq.).

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5. Additional Exclusions Requested— that food ingredient was exempt from that there is a conflict between the General prior notice, even if the ingredient is registration and prior notice (Comments) One comment states that known to be used in food. Other requirements. Under the registration cough drops containing OTC (over-the- comments assume that ingredients rule, in general, a facility engaged in the counter) Monograph active ingredients lacking an FD3 or FD4 code that are best manufacturing/processing, packaging, or are regulated as an over-the-counter known as being active ingredients in holding of food for consumption in the drug by the FDA, and therefore, are not drugs, but are also used in dietary United States must be registered. subject to prior notice. However, CBP supplements, are exempt from prior Regardless of whether the facility that categorizes all cough drops, including notice. The comment recommends that manufactured the food manufactured it ones regulated as drugs by the FDA, as these codes should be made as complete for consumption in the United States, as possible and that FDA should candy subject to regulation by FDA as section 801(l) of the act prohibits food indicate that ingredients without a FD3 food. Therefore, due to this that is from an unregistered foreign or FD4 code may still require prior classification by CBP, cough drops facility from being delivered for notice. distribution in the United States until would require prior notice. In addition, (Response) FDA and CBP another comment asks if the facility is registered. Thus, if the continuously evaluate the HTS codes in owners, operators, or agents in charge of pharmaceuticals, such as over-the- order to attach the appropriate FD3 and counter drugs, are exempt from prior facilities want to ensure these types of FD4 designations. However, the lack of food are not subject to being held under notice requirements. an FD3 or FD4 designation does not (Response) CBP classification does section 801(l) of the act, they can mean that prior notice is not required. register in accordance with section 415 not identify foods requiring prior notice. If the article fits the definition of food However, CBP and FDA have worked of the act (21 U.S.C. 350d) (and if the provided in § 1.276 of the final rule, food is for consumption in the United together to provide indicators; i.e., flags then prior notice is required for that associated with HTS codes to indicate States, they must register unless the article of food. If you believe that an facility qualifies for an exemption). An which articles being imported may item has been incorrectly flagged, or is require prior notice submission. The importer can likewise ensure that food not currently flagged, but should be, you is not subject to being held under FD3 flag indicates that the products should contact the FDA and provide a categorized by that HTS code may section 801(l) of the act by not statement with your suggestion and importing or offering for import food require prior notice submission; those basis for the flag designation. products categorized in those HTS that is from an unregistered foreign (Comments) One comment believes facility. codes flagged as FD3 that do not require that there is a conflict between the prior notice submission may be registration (21 CFR part 1, subpart H) Throughout this preamble to the final disclaimed by the filer upon entry. On and prior notice IFRs, where the former rule, we often use the phrase ‘‘food is the other hand, the FD4 flag indicates is based upon the intended use of food subject to being held’’ in describing our that the products categorized by that (i.e., consumption), and the latter enforcement of the registration HTS code require prior notice applies to ‘‘all’’ food. The comment requirement through prior notice. Under submission. FDA has published states that this has caused difficulties section 801(l) of the act, ‘‘[i]f an article guidance regarding these flags and has with the import process by: (1) of food is being imported or offered for published a list of the HTS codes with Requiring foreign facilities to register in import into the United States, and such FD3 and FD4 flags. The guidance is order to meet the prior notice article is from a foreign facility for posted at http://www.cfsan.fda.gov/ requirements and (2) requiring drug and which a registration has not been ~dms/htsguid3.html and the list of device establishments to register as food submitted to the Secretary under section codes is posted at http:// facilities in order to facilitate 415, such article shall be held at the www.cfsan.fda.gov/~pn/htscodes.html. importation of intra-company articles. port of entry for the article, and may not The comment asks about such articles The comment believes this places an be delivered to the importer, owner, or containing OTC monograph active undue burden on drug and device consignee of the article, until the foreign ingredients. HTS Code 3004909176 establishments and hampers the facility is so registered’’ (emphasis (cough and cold preparations) would importation process for articles not added). In this situation, the article of apply to, among other articles, cough intended for use in food, as well as for food is being prevented from moving suppressants that contain OTC food articles not intended for forward past the port of arrival because monograph active ingredients. This HTS consumption. The comment suggests the food is from a foreign facility that Code is not flagged for either FD3 or that section § 1.277 be changed to read: has not registered. This situation is FD4, meaning that prior notice would ‘‘This subpart applies to all food distinct from a situation where, after not be required. Candies, which are intended for consumption by humans FDA reviews the prior notice food, would fall under different HTS and other animals * * *.’’ In addition, information, the food is held upon Codes and would be subject to prior the comment suggests that the HTS arrival for examination because it may notice. codes be modified to allow articles pose a significant risk to public health, (Comments) One comment designated with a FD3 or FD4 code to usually referred to as a ‘‘BT Hold.’’ In recommends that FDA’s food category be disclaimed, with rationale, addition, we do not believe that prior codes for raw materials could be made depending on their intended use. notice places an undue burden on the more complete to cover the range of (Response) FDA disagrees. FDA drug and medical device industry. Items materials known to be used in products disagrees with changing § 1.277 to read designated with a FD4 code are all marketed as foods. The comment states that prior notice is only required for believed to be used exclusively in food, that there are numerous CBP ‘‘Customs food that is intended for consumption. and therefore, require prior notice. Codes’’ that do not contain the In the preamble to the IFR, FDA noted Articles designated by a FD3 code can appropriate FD3 or FD4 codes and that that the determination of whether a have food and nonfood uses. These this causes confusion among the substance is ‘‘food’’ is not a question of items do not require prior notice if the industry with some groups interpreting intended use (See 68 FR 58974 at use of the article does not fit the the lack of an FDA code as meaning that 58987). Moreover, we do not believe definition of food provided in § 1.276 of

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the final rule and may be disclaimed by which are inspected by the Canadian basic prior notice information that will the filer as such upon entry. Food and Inspection Agency. repeat on each prior notice can be (Comments) One comment states that (Response) FDA disagrees. While we created and saved for use on subsequent there is no facility registration welcome any additional information prior notices. A separate prior notice requirement for transshippers; however, that supports our ability to quickly confirmation number is generated for goods processed under CBP’s Form review prior notice submissions and each article of food or recipient. CF7512 (T&Es and ITs) require a prior determine which food to inspect at U.S. (Comments) One comment requests notice to be filed. The comment notes ports of arrival, the Bioterrorism Act that FDA exempt highly perishable food that this cannot be accomplished does not provide for blanket exclusions products. The comment states that without the corresponding facility based on the country from which the highly perishable food products, such as registration number. In addition, T&Es food is shipped or the country in which ice cream, must be delivered in a timely and ITs do not have a designated the food originates. FDA currently is manner. A delay in the delivery submitter. The comment requests that reviewing flexible alternative programs schedule due to holdups at the border T&E and IT transactions be exempt from (e.g., CBP’s Customs-Trade Partnership could potentially ruin these products, prior notice. Against Terrorism (C–TPAT), which and customers inconvenienced by the (Response) FDA disagrees that T&E or was adopted into law (still as a time delay may choose to stop IT transactions should be exempt from voluntary system) by Subtitle B of Title importing them. A number of comments the requirements of prior notice. These II of the SAFE Port Act of 2006 (Public request that FDA exempt fresh produce. articles of food leave the port of arrival Law 109–347), and Free and Secure Several comments note that produce is prior to exportation from the United Trade (FAST) (a voluntary program already carefully monitored by CBP and States or for subsequent movement authorized under 19 U.S.C. 1411) ) to placed on automatic quarantine for through the United States prior to entry. determine their potential for mandatory inspection at the first port of Under § 1.281(a)(9) of the IFR, a streamlining the prior notice review arrival by USDA/CBP. Other comments process, but notes that these programs shipper’s (transshipper’s) registration state that produce is already subject to do not meet or affect the requirement to number was not required for a facility 100 percent USDA inspection and submit prior notice. Moreover, FDA associated with an article of food if the approval prior to release. Another notes that many shipments from Canada article is imported for transshipment. comment requests that produce be and Mexico into the United States in Under the final rule, if the shipper’s exempt from the requirement of prior fact are transshipments from other identity is provided, the shipper’s notice because it already meets the countries, which prior notice registration number is optional. requirements of the Bioterrorism Act. submissions identify with the FDA Therefore, the absence of a shipper’s The comment reasons that the purpose Country of Production data element. registration number should not prevent (Comments) One comment suggests of the prior notification to FDA is to submission of a prior notice under that FDA create a relational database to provide FDA with the information either the IFR or final rule. Moreover, give unique identification numbers to necessary to make a decision (prior to FDA disagrees with the comment’s an importer’s specific items. The arrival) for a possible physical implication that a prior notice requires comment states that this would speed inspection. The comment states that the a designated submitter. Under § 1.278 of submission, reduce time to enter the CBP Agriculture Specialist performs the the IFR and final rule, a prior notice data, and increase compliance with the physical inspection (or reviews original may be submitted by any person with regulation. The comment reasons that documentation that confirms ‘‘pre- knowledge of the required information. most food importers will bring in the inspection’’). Therefore, the comment (Comments) Several comments same product, in the same package, reasons, importations of fresh produce request that FDA generally exempt from the same country, over and over. are already meeting the requirements of Canada and Mexico from submitting Another comment suggests that a single the Bioterrorism Act. The comments prior notice for food shipments. One weekly summary of all shipments by a further state that because prior notice is comment requests that FDA exempt company to individual consumers or a already given for produce, the new Canada, in keeping with the nature of summary of orders received should be procedure created by this new cooperation and shared security risks adequate for this type of commerce. legislation will only increase costs and between the United States and Canada, (Response) FDA disagrees. Not all cause extreme hardship for small in particular the 30 point border plan. importers consistently import the same business. An additional comment states The comment reasons that Canadian types of food. The Bioterrorism Act that their shipments are subject to four origin food is easily traceable through requires submission of prior notice levels of inspection: County, State, existing Canadian registration before an article of food is imported or Federal, Customs and ‘‘Bio Terrorist’’ requirements, while already meeting or offered for import into the United and reasons that the redundancy is exceeding United States standards in States. A weekly summary as suggested wasteful. some instances. The comment further by the comment would not meet this (Response) FDA disagrees. Highly notes that the legislation acknowledges requirement, as such a summary would perishable foods, like all other foods the largest threat is from offshore, yet not provide prior (advance) notice that are covered by the final rule, are the regulations most severely hit before the article of food is imported or subject to prior notice requirements. continental trade between the United offered for import. FDA notes, however, The timeframes are sufficiently short, States, Canada, and Mexico. One that a number of the software programs allowing for submission of prior notice comment suggests that the exemption that customs brokers use to file prior as soon as 2, 4, or 8 hours before arrival could be limited to shipments of food notice and entry submissions with ABI/ in the United States depending on mode which are under similar security ACS do allow for repetitive information of transportation. While the controls, especially small quantity to be saved on the filer’s computer and Bioterrorism Act provides for an shipments of fish imported via package used for future shipments, as exclusion for certain types of food, such delivery. Another comment asks that appropriate. Similarly, FDA’s PNSI has as meat and meat food products subject FDA exempt goods being imported into been designed to accommodate to USDA’s exclusive jurisdiction, it does the United States from companies repetitive information, such that the not exclude perishable foods generally

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or foods jointly regulated by USDA and article of food imported or offered for become eligible for expedited FDA. import, and food imported or offered for processing and reduced inspections, but As we explained in the IFR preamble, import by or for select importers will are not exempt from advance electronic merely obtaining existing information not be excluded from prior notice information requirements. (See CBP’s about the food from other agencies requirements. If an importer does not advance electronic information rule). would not guarantee that FDA has the import articles of food, then no FAST, an acronym for Free and Secure information required by section 801(m) ‘‘exemption’’ would be needed since Trade between the United States and of the act’s prior notice requirements prior notice would not apply to such Canada, and the United States and because there is wide variation in the imports. The FD flags associated with Mexico, is an expedited-clearance purposes and information required by HTS codes are designed to help identify system designed to improve border other government programs (68 FR which products will require prior security without slowing the flow of 58974 at 58992). Moreover, our ability notice. If an import is marked FD3 but legitimate trade across the northern and to respond to bioterrorism incidents or it is not food subject to prior notice, the southern U.S. borders. FAST processing other food-related emergencies in a importer can disclaim this import and is available to importers, carriers and timely manner may be more difficult if prior notice would not need to be foreign manufacturers (southern border) the information is not easily accessible. submitted. who participate in C–TPAT and who (Comments) One comment use a FAST-registered driver. The 6. Additional Exclusions Requested— recommends that the rule be amended initiative builds on the same concepts Special Programs (C–TPAT/FAST) and to include an exemption from prior that drove the rapid, post-9/11 Flexible Alternatives notice for organizations that are construction and implementation of C– importing FD4 materials for nonfood In the explanation of the reduced TPAT. FDA and CBP plan to assess the uses. timeframes and the relationship of feasibility of including the FAST (Response) FDA disagrees. Items special programs to those timeframes, timeframes in FDA’s prior notice final designated with an FD4 code are all FDA stated in the IFR that the ‘‘interim rule, as well as other flexible believed to be used exclusively in food, final rule provides for greatly reduced alternatives raised by comments. and therefore, food encompassed by an timeframes for foods based on mode of To assist in this assessment, FDA and HTS code that is flagged FD4 is subject transportation. These timeframes are CBP requested comments on several to prior notice requirements. Moreover, what FDA has determined are the questions, including three regarding as discussed previously, FDA provided minimum timeframes necessary to allow special programs (69 FR 19763 at extensively its rationale for not limiting it to satisfy the statutory mandate that 19764): the prior notice requirements to food for the timeframes give the agency the time C–TPAT/FAST Questions: consumption in the United States. (See it needs to ‘receive, review, and (1) Should food products subject to 68 FR 58974 at 58990 and 58991.) As respond’ to prior notices. However, FDA FDA’s prior notice requirements be FDA noted in the IFR, Congress did not is also interested in exploring flexible eligible for the full expedited processing explicitly limit the prior notice alternatives for submission of prior and information transmission benefits requirement to articles of food that are notice for foods or firms covered by allowed with C–TPAT and FAST? If so, intended for consumption in the United programs of other agencies, such as C– how should this be accomplished? States even though it could have done TPAT, or imported by other agencies.’’ (2) If the timeframe for submitting so as shown in section 415 of the act (68 FR 58974 at 58995). prior notice for food arriving by land via (requirement to register food facilities). FDA and CBP reopened the comment road is reduced to 1 hour consistent If anyone believes that an HTS code has period for the IFR in the Federal with the timeframe in the advance been flagged FD4 in error, they can Register of April 14, 2004 (69 FR electronic information rule, would a inform FDA and, if we agree, we will 19763). On page 19764 of that shorter timeframe be needed for change the flag accordingly. publication, FDA and CBP wrote ‘‘In the members of FAST? (Comments) Two comments request prior notice [interim final rule], we (3) Should the security and that FDA exempt small businesses. expressed interest in exploring flexible verification processes in C–TPAT be (Response) FDA disagrees. Prior alternatives for submission of prior modified in any way to handle food and notice is required for all FDA-regulated notice for foods or firms covered by animal feed shipments regulated by food that is imported or offered for programs of other agencies, such as FDA? If so, how? import. The Bioterrorism Act does not CBP’s Customs-Trade Partnership The comments received addressing provide for exclusions based upon the Against Terrorism (C–TPAT) and the these issues are discussed in the size or nature of the firms or facilities Free and Secure Trade (FAST) program, following paragraphs in order of the associated with that importation. or food imported by other government questions posed in the Federal Register (Comments) One comment asks FDA agencies (68 FR 58974 at 58995). C– notice, beginning with comments to permit an exemption from prior TPAT is a government/business addressing general issues regarding C– notice, by importer number, to be initiative to increase cargo security TPAT and FAST. recognized in ACS at the time of entry while improving the flow of trade. a. General comments. (Comments) transmission, to importers who Under this program, businesses must Numerous comments address special demonstrate that their products will not conduct comprehensive self- trade programs, such as C–TPAT and reasonably be expected to be directed to assessments of their supply chain using FAST. These comments recommend a food use. the security guidelines developed that FDA and CBP modify these CBP (Response) FDA disagrees. Prior jointly with CBP, and they must programs to reflect the criteria required notice requirements are associated with familiarize companies in their supply by FDA and to develop integrated data food, not the person manufacturing, chain with the guidelines and the elements for low risk FAST/C–TPAT growing, shipping, importing, or owning program. These businesses must provide shipments, which would meet both the food. A product is food for purposes CBP with specific and relevant agencies’ requirements. The comments of prior notice if the article of food is information about their supply chains believe it is necessary to have reasonably likely to be directed to a food and security practices and procedures. harmonization between FDA and CBP use. Prior notice is required for each As C–TPAT members, companies may for ‘‘low-risk’’ shippers.

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Many comments contend that the IFR products will incur increased issue and develop a protocol for food does not take into account the Canada- complexity, increased cost, and will be products that are currently ineligible for United States Smart Border Plan (SBP). subject to making errors. This comment any FAST benefits. A key element of the SBP is the FAST suggests that firms who routinely send A few comments request that C–TPAT bilateral arrangements. Under the C– products across the border could should be open to all foreign operators TPAT and the Canadian Partnerships in provide prior notice on a quarterly willing to participate and that Protection (PIP) programs, companies basis. The facility would track the companies participating in C–TPAT approved by both countries have number of shipments each quarter and should be exempt from the procedures invested in specific counter-terrorism update FDA with any changes to the under the Bioterrorism Act. These and supply-chain integrity measures, anticipated amounts. These shipments comments encourage partnerships and are therefore, accorded more would be permitted to cross the border between the U.S. and E.U. similar to C– expedited treatment at the Canada-U.S. without waiting, but still could be TPAT, which would facilitate trade in border in recognition of the lower risk subjected to FDA or CBP inspection. food and feed between the E.U. and U.S. they present. Another comment questions the cost, and avoid delays at the U.S. border, The comments recommend that FDA benefits, etc. of these programs for small especially with respect to perishable recognize foods imported under these companies. In addition, a few comments products. In addition, one comment programs as low risk and to afford them address the creation of similar programs suggests that food transporters should benefits, such as reduced information and/or the expansion of the current be allowed eligibility in C–TPAT and requirements for each shipment; programs. One comment requests that FAST to ensure that all transporters reduced timeframes for providing prior FDA permit the use of Line Release (i.e., operate on a level playing field. notice; reduced clearance time at the an automated system designed to release One comment notes that C–TPAT is border; and reduced number of and track repetitive shipments) for food not currently offered to Canadian verifications of information. The shipments arriving by rail. The manufacturers unless they are an comments further urge FDA and CBP to comment states that their member Importer of Record for U.S. Customs’ permit importers who are participants railroads participate in C–TPAT and it purposes. in C–TPAT and FAST to comply with would be discriminatory to permit the Finally, one comment expresses their prior notice obligations in a use of an expedited clearance system for concern that any motor carrier who is manner that does not undermine the motor carriers, but not rail not Pre-Arrival Processing System benefits of participation in these transportation. (PAPS)-certified may be required to programs. The comments contend that One comment urges FDA to begin present the prior notice confirmation C–TPAT and FAST improve U.S. working with all interested parties to number upon arrival at the border, even security on a number of levels, identify criteria for qualification and if prior notice was submitted through including reducing the risk of participation in a program like C–TPAT, ACS. The comment states that truck bioterrorism, and help to focus limited FAST, and others as it applies to prior drivers are generally unable to obtain border resources on higher risk cargo. notice. The comment suggests that the prior notice confirmation number The comments suggest that FDA and participation might hinge on the prior to arrival given the short distance CBP therefore should be careful not to submission and verification of between Canada and the United States remove incentives for participation in documentation evidencing the and the fact that prior notice is not these programs by making importation implementation of, and continued generally submitted until after the of food items more cumbersome than adherence to, validated supply chain trucker has left with the load. The other types of entries. Otherwise, the risk management techniques. The comment states that requiring PAPS comments contend prior notice will comment believes that there would be authorization as a way to avoid delays dilute a key advantage offered to FAST/ mutual benefits of such a program. FDA is to mandate that truck companies C–TPAT participants, thereby could reallocate its resources to closer become C–TPAT certified or otherwise weakening the incentive to join the review and examination of shipments comply with the designation program. The companies participating from those importers that do not requirements. The comment notes that in these programs have made a participate in the program and, thus, this is not possible, sometimes for cost substantial commitment to improving have not demonstrated the same level of reasons alone. The comment also has security by putting in place appropriate commitment to food safety and similar concerns regarding the PAPS- security systems, and submitting to shipment security as participating program at the Southern border. periodic review of those systems by importers do. Program participants (Response) While FDA welcomes the CBP. would benefit from the agency’s additional information provided by C– The comments believe that these recognition of their commitment to TPAT and FAST, these programs would programs strengthen FDA’s ability to safety and security, which presumably require relatively significant changes to meet the objectives of the prior notice would be reflected in more efficient and be useful in helping us carry out the rule. They contend that this is achieved timely processing of their entries at the prior notice program. The purpose of in two ways: (1) Through the rigorous border. In that regard, the comment prior notice is to help identify food that security screening that participants suggests that the agency consider potentially poses a significant health must comply with in order to obtain a extending to participating low risk risk to the American public and to low-risk status; and (2) by removing importers the option of submitting a deploy resources to the port of arrival so low-risk shipments from the queue, single prior notice for all entries in a that inspections can be conducted FAST/C–TPAT work to shrink the mixed load container or truck. FDA before the shipment enters the United number of shipments that must be product codes for all line entries would States. Information about the screened, thereby ‘‘freeing up’’ FDA continue to be available to FDA through manufacturing facility is used in officials to focus limited resources on FDA’s existing OASIS system. conducting this risk assessment. The C– higher risk shipments. Another comment hopes that the TPAT assessment, however, does not One comment states that a firm multiple U.S. agencies (FDA, always include the food manufacturing/ having to manage its systems to track C– Department of Homeland Security, and processing operations. Even when it TPAT products and non-C–TPAT USDA) could collectively address this does, C–TPAT focuses on security risks

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whereas the prior notice program time and money, while leading to a comments noted that if the primary considers all health and safety risks to more predictable supply chain. CBP benefits of the C–TPAT program were the food, such as unintentional continues to explore additional benefits, removed, FDA would create a contamination. Moreover, unlike PNC which can be afforded members who disincentive for C–TPAT participation reviewers, the CBP Supply Chain meet or exceed the minimum-security that would ultimately reduce the Specialists who conduct the validation criteria.’’ security of the articles covered by the assessments for C–TPAT are not The document also states that ‘‘CBP Bioterrorism Act. Finally, the comments necessarily trained in assessing the employs a risk management approach in note that these benefits are necessary to potential risks associated to food screening and targeting, and such avoid duplication and inconsistent products and neither FDA nor CBP has shipments, as well as those from application of prior notice requirements the resources to fund the extensive unknown or less established entities, for shipments that meet the stringent training that would be required to do so. receive higher scrutiny from CBP. The FAST criteria. Because knowing that a firm agency does not disclose ATS targeting (Response) FDA continues to use a participates in C–TPAT does not assist rules.’’ risk-based approach for determining FDA in conducting its food safety (Comments) Several comments which foods to inspect for the purposes review, we have decided not to provide suggest that FDA should not establish a of admissibility. FDA will continue to special treatment in terms of reduced duplicative program, but should work with CBP and acknowledges that prior notice information requirements or incorporate additional factors or criteria the additional information provided by reduced timeframes based on C–TPAT necessary for prior notice into existing C–TPAT participation could be helpful participation. programs. in this risk-based assessment. In CBP’s It is important to note that (Response) FDA agrees that it is March 25, 2005, FAQ document cited participation in C–TPAT does not affect generally preferable not to establish previously, CBP states that the information requirements of CBP’s duplicative programs. Thus, while we ‘‘[u]nsolicited shipments will advance electronic information rules; have determined not to provide C– understandably lie outside the the same information is required TPAT members with special treatment capability of the importer to ensure regardless of C–TPAT participation. in terms of reduced prior notice security. CBP employs a risk However, successful participation in C– information requirements or reduced management approach in screening and TPAT does affect the frequency of CBP timeframes, we will continue exploring targeting, and such shipments, as well cargo and trade examination. FDA use of these programs in making as those from unknown or less likewise uses a risk-based approach in decisions regarding which products to established entities, receive higher selecting foods for examination at the inspect for the purposes of admissibility scrutiny from CBP.’’ FDA agrees with border for security and food safety (801(a) decisions). this statement. reasons. FDA, thus, is continuing to b. Special programs. (Comments) Numerous comments explore with CBP and industry use of i. Should food products subject to provide suggestions on how to these programs in making decisions FDA’s prior notice requirements be accomplish processing/transmission regarding which products to inspect for eligible for the full expedited processing benefits for C–TPAT and FAST the purposes of admissibility (801(a) and information transmission benefits participants. Many of the comments cite decisions). allowed with C–TPAT and FAST? If so, a need for better harmonization and Comments addressing which foreign how should this be accomplished? streamlining between FDA and CBP. operators are eligible for participation in (Comments) Numerous comments assert Suggestions from the comments include: FAST and C–TPAT are outside the that businesses that participate in the C– • Enhance coordination between CBP scope of this rule. CBP stated in a TPAT and FAST programs should be and FDA, allowing trained CBP/FDA document entitled ‘‘Frequently Asked eligible for processing/transmission officers to process food shipments Questions Regarding Minimum Security benefits. These comments contend that through the FAST lane, and allowing Criteria for Importers,’’ dated March 25, importers, carriers and drivers who have FAST importers using a FAST driver 2005, (CBP’s March 25, 2005, been approved for C–TPAT and FAST and carrier importing food and/or feed Frequently Asked Questions (FAQ) already have been deemed to be ‘‘low products to submit prior notice to both document) (available at http:// risk’’ by CBP. Importers and carriers the CBP and FDA through the existing www.cbp.gov/xp/cgov/trade/cargo_ have had to demonstrate supply chain CBP/FDA interface. security/ctpat/security_criteria/criteria_ security controls, and drivers have been • Allow for integrated targeting importers/questions.xml (FDA has subjected to rigorous background processes, including a reduction in the verified the Web site address, but FDA screening. Companies have made the risk targeting factors for food shipments, is not responsible for any subsequent security investments and have bolstered as well as other product categories, changes to the Web site after this their operations to provide the requisite which would translate into expedited document publishes in the Federal security and integrity of their trade processing, reduced exams and other Register)), that ‘‘C–TPAT remains a transactions. The federal governments of benefits for food import shipments voluntary, incentive based partnership. the United States and Canada have under the program. However, once a company commits to encouraged FAST participation on the • Integrate the CBP and FDA data the C–TPAT program, there are specific grounds that it will mean expedited systems to allow for one filing of the program requirements that must be border crossings and reduced required information. The C–TPAT adhered to by the company to qualify information requirements. By allowing certification process delves into the for C–TPAT benefits, which are food to move through the FAST critical aspects of a company’s handling significant. C–TPAT importers are six ‘‘stream’’ in the same manner as other and documentation procedures, and times less likely to undergo a security products, FDA would demonstrate the requires a company to demonstrate it related cargo examination, and four commitment to harmonization that has good process controls in place times less likely to be subject to a trade industry has long encouraged and throughout the supply chain. related examination, than non-C–TPAT would provide an incentive for • Modify the CBP and FDA systems members. These significantly fewer additional participation in the C–TPAT for the receipt of advance notice and cargo examinations help save importers and FAST programs. In addition, the prior notice to ‘‘flag’’ importation under

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C–TPAT and FAST. These notices CBP Advance Electronic Information caution that additional FDA inspection should receive priority attention for Rule, the time element for FAST would be redundant. Many of these entry and clearance purposes. participants is 30 minutes. The comments state that C–TPAT is a well- • Establish an MOU between FDA comments state that to have two thought-out program and that with its and CBP to allow the sharing of different time standards for the same current security profile requirements necessary information with the mode of transportation only serves to and present followup verification understanding of the program applicant. create confusion. The comments believe systems, the program is already well • Implement a shorter prior notice that any harmonization of FDA and CBP suited to handle human and animal timeframe for C–TPAT members. security programs would assist the food shipments. The comments suggest • Reduce data element reporting by orderly flow of trade at the border that FDA should rely on CBP’s virtue of having successfully passed the crossing points. successful programs and avoid C–TPAT validation process. Product The comments contend that the key ‘‘recreating the wheel’’ or imposing new information (HTS code, product code, premise behind the FAST program is and potentially inconsistent criteria on manufacturer’s registration numbers, that low-risk parties should receive food companies. The comments further etc.) should be part of the pre-filed expedited treatment at the border, contend that food safety and product information profiles under FAST. freeing up enforcement resources to integrity is already an integral part of Finally, one comment suggests the concentrate on parties of higher or the industry’s own internal policies, following: unknown risk, which is why the which have always been concerned and (1) A statement of proof of acceptance timeframes CBP adopted are shorter for accountable for the safety and security (e.g., copy of acceptance letter from FAST than for other shipments. If FDA of their products without regard to the CBP) into the C–TPAT and/or FAST adopted the 30 minute timeframe, it more recent border security program. programs; would demonstrate a commitment to (2) A detailed statement/description Therefore, companies certified under C– harmonizing with CBP, and prevent a of policies and procedures in place for TPAT have made the critical security situation whereby FAST requirements meeting FDA prior notice requirements. investments and have bolstered their vary depending on the type of This submission should follow the operations to provide the requisite commodity being transported. Finally, format of the supply chain security and integrity of their trade one comment believes that to ensure questionnaire information submitted to transactions, regardless of the consistency with FAST and CBP’s CBP as part of the C–TPAT application commodities (food or nonfood products) Automated Commercial Environment process and should be considered as an that are shipped. Another comment (ACE),4 prior notice should be required addendum to the original submission; stresses that FDA should not impose and calculated from the port of entry and additional conditions of participation (3) FDA should notify the importer in and not the first point of arrival, as is for FAST members because the writing of: (a) its acceptance/agreement currently the case. requirements for FAST participation (Response) Harmonized timeframes with the importer’s FDA prior notice imposed by CBP provide adequate could facilitate the orderly flow of trade procedures; or (b) additional questions assurance that expedited clearance is traffic at the borders. Advance screening to be answered or data to be provided appropriate. of consistent information also would aid to meet FDA requirements for (Response) FDA agrees with the in reducing the review time. However, acceptance into the FDA prior notice statement in CBP’s March 25, 2005, as we discuss later in section II.F of this ‘‘C–TPAT/FAST’’ program. FAQ document that says ‘‘For C–TPAT (Response) As we discussed document (‘‘When must prior notice be to ensure its continued viability, previously, we have determined not to submitted to FDA? (§ 1.279)’’), we are effectiveness, and relevance, the provide C–TPAT members with special maintaining the timeframes that are in program must continue to evolve—as treatment in terms of reduced prior the IFR. These timeframes represent the the terrorist threat and the nature of notice information requirements or minimum amount of time FDA needs to global trade evolves. The impetus for reduced timeframes. FDA, however, is meet the statutory responsibility to strengthening the existing security continuing to explore with CBP and receive, review, and respond to prior guidelines is to provide more detail to industry use of these programs in notice submissions. Our assessment of the membership on the expectations of making decisions regarding which the timeframes and review times the program, and to assist CBP in products to inspect for the purposes of showed that we would not be able to defining a more consistent baseline for admissibility (801(a) decisions). reduce the timeframes to correspond to minimal program requirements and ii. If the timeframe for submitting those used by CBP for land and air better-defined C–TPAT benefits.’’ The prior notice for food arriving by land via shipments. issue of how to modify the processes is road is reduced to 1 hour consistent iii. Should the security and discussed in the next comments and with the timeframe in the advance verification processes in C–TPAT be responses. electronic information rule, would a modified in any way to handle food and (Comments) Numerous comments shorter timeframe be needed for animal feed shipments regulated by provide suggestions on how to modify members of FAST? (Comments) One FDA? If so, how? (Comments) Four the security/verification processes of C– comment suggests that the timeframe for comments respond that the security/ TPAT/FAST. These include: submitting prior notice of one hour is verification processes of C–TPAT/FAST • FDA should investigate security fine, even for express deliveries. should be modified for food. Fourteen plans with actual physical inspections Another comment believes that comments respond that the process of the facilities prior to allowing reducing the timeframes for submission should not be modified for food. Most participation in the programs. of prior notice would not sufficiently comments suggest that the current • FDA should verify that other expedite the clearance of product for validation processes are sufficient and countries’ regulatory systems for food participants of FAST. However, an production and safety are equivalent to 4 The ACE system will replace the current ABI/ overwhelming majority of the comments ACS, as well as combine other CBP entry functions those of the United States. The agency favor reducing the timeframe for FAST and transactions. Prior Notice submissions will be should also perform on-site audits and participants to 30 minutes. Under the compatible with ACE. inspection of production facilities

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before a food manufacturer or carrier c. Flexible alternatives. In the Federal alternatives. Several comments state can be certified. Register document to reopen the that any flexible alternatives should be • It should be mandatory for food comment period, FDA and CBP also incorporated into existing programs manufacturers to provide notice requested comment on the following because the duplication of security concerning any changes in the questions regarding flexible alternatives programs and division of limited manufacturing processes or supplies, as (69 FR 19763 at 19764): resources are not in the best interest of well as those that may affect physical • If timeframes are reduced in FDA’s our security goals and the protection of and personnel security. In addition, the prior notice final rule, would other public health. current requirements that manufacturers flexible alternatives for participants in (Response) FDA believes that periodically review the security FAST or for food imported by other additional flexible alternatives should commitment of their service providers agencies be needed? be incorporated into existing programs • to detect weakness or potential In considering flexible alternatives when appropriate and feasible. FDA weaknesses in security should be for food imported by other government will continue to work with CBP and altered to require that: (1) The review is agencies, what factors or criteria should acknowledges that the additional conducted on an annual basis and (2) a FDA consider when examining information provided by other programs certification that the review has been alternatives? Should participation be such as C–TPAT could be helpful for conducted. voluntary? If so, should FDA consider purposes of admissibility decisions. • FDA and CBP should work together, inspection of companies in the supply i. If timeframes are reduced in FDA’s along with the trade community, to chain from the manufacturer to those prior notice final rule, would other identify potential areas where the C– who may hold the product, including flexible alternatives for participants in TPAT security and verification reviews of their security plans to FAST or for food imported by other processes can or should be modified. determine what procedures are in place agencies be needed? (Comments) CBP and FDA should coordinate these to prevent infiltration of their facilities Several comments encourage incorporation of prior notice processes to address the additional as a condition of participation? • requirements into the C–TPAT and concerns of the FDA in order to allow In considering flexible alternatives FAST programs. Most comments C–TPAT/FAST members expedited for submission of prior notice, should caution that additional requirements processing of food and feed shipments FDA consider additional means of should not be added as separate in addition to CBP shipments. ensuring that all companies subject to • the Registration of Food Facilities programs, but that FDA should C–TPAT requirements should recognize participants in the existing encompass any industry and food Interim Final Rule ((68 FR 58894, October 10, 2003) (21 CFR part 1, programs for expedited review and specific security measures into C– processing of prior notice. One TPAT’s checklist. subpart H)), have an updated registration on file with FDA that has comment further suggests that • These processes must be more been verified? participation in C–TPAT and FAST comprehensive. There are no questions • Are there conditions of should also ensure expedited 801(a) on the Supply Chain Security Profile participation that FDA should consider; admissibility processing. Another Questionnaire to specify the type of e.g., inspections of companies in the comment suggests that CBP be solely freight being hauled. In addition, there supply chain from the manufacturer to responsible for administering both the are no opportunities in the those who may hold the product, or FDA and CBP requirements of C–TPAT questionnaire to indicate different reviews of their security plans to and FAST. locations to which a company is determine what procedures are in place (Response) As we discussed shipping regularly, or insurance a to prevent infiltration of their facilities? previously, we have determined not to company has to cover those states. • Should the food product category provide C–TPAT members with special (Response) FDA notes that CBP has be considered as a criteria or element of treatment in terms of reduced prior continued to expand the C–TPAT expedited prior notice processing or notice information requirements or program, which now includes minimum other flexible alternatives? If so, should reduced timeframes. FDA, however, is security criteria for importers who certain foods be excluded from continuing to explore with CBP and participate in C–TPAT. FDA also notes expedited prior notice processing? If so, industry use of these programs in that as of July 10, 2006, CBP has what should be the basis for making decisions regarding which received over 11,000 C–TPAT determining which foods should be products to inspect for the purposes of applications of which 6,089 have been excluded? admissibility (801(a) decisions). certified and 2,973 have been validated • If FDA adopts reduced timeframes FDA disagrees with the comment’s (certified members provide a complete in the prior notice final rule, should suggestion that CBP be solely security profile that is screened by CBP, FDA phase in the shorter timeframes as responsible for administering both the while validated members also undergo a CBP phases in the advance electronic FDA and CBP requirements for these complete validation of their security information rule? programs, as the expertise related to profile that includes an on-site visit to • Should FDA offer a prior notice food safety and possible additional the company to review the submitted submission training program for participation requirements that address security profile, followed by a physical submitters and transmitters, including food safety resides in FDA. Accordingly, verification of security measures). There brokers, to ensure the accuracy of the FDA and CBP will continue to consider are limited resources at this time to add data being submitted? how to administer FAST and C–TPAT new significant program requirements to This section will address the programs so that they could apply to meet FDA’s needs under the comments to each of those questions FDA regulated products. Bioterrorism Act and verify that those introduced in the Federal Register of ii. In considering flexible alternatives procedures have been incorporated. The April 14, 2004, beginning with general for food imported by other government two agencies will continue to explore comments. agencies, what factors or criteria should the feasibility of the approaches (Comments) One comment said that if FDA consider when examining recommended in the comments in the the final rule is refined, then it is not alternatives? Should participation be future. necessary to offer additional flexible voluntary? If so, should FDA consider

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inspection of companies in the supply CFR part 1, subpart H. FDA also agrees company’s ability to meet the program chain from the manufacturer to those it would be efficient to conduct the standards set by the particular who may hold the product, including verification as part of the C–TPAT government agency. reviews of their security plans to validation process, but neither FDA nor (Response) FDA agrees in part that no determine what procedures are in place CBP has the resources to do so at this product category distinctions should be to prevent infiltration of their facilities time. made. However, FDA acknowledges that as a condition of participation? iv. Are there conditions of some foods are more susceptible to (Comments/Response) There were no participation that FDA should consider; terrorism and food safety problems than comments addressing flexible e.g., inspections of companies in the others, regardless of the processes alternatives for food imported by other supply chain from the manufacturer to within the supply chain. But if we were government agencies. However, FDA those who may hold the product, or to make product category distinctions, has considered imported shipments of reviews of their security plans to such actions could be disruptive to foods for official U.S. federal determine what procedures are in place transportation (e.g., we may need to government use and our draft policy for to prevent infiltration of their facilities? segregate products) and may make such enforcing prior notice in these situations (Comments) Most comments suggest products targets for terrorism since such is contained in the Prior Notice Final that other conditions, such as inspection products may be eligible for special Rule Draft CPG that is announced of other companies in the supply chain (e.g., expedited) treatment. elsewhere in this issue of the Federal would be unnecessary and a repetition vi. If FDA adopts reduced timeframes Register. Under the draft policy, FDA of effort with little return on investment. in the prior notice final rule, should and CBP should typically consider not Another comment states that to begin a FDA phase in the shorter timeframes as taking any regulatory action when an process of examining the security plans CBP phases in the advance electronic article of food is imported or offered for and procedures of foreign food facilities information rule? (Comments/Response) import for an official government would be tremendously expensive, call Comments addressing phase-in of purpose, provided that a Federal into question the validity of the prior timeframes are found under the Government agency is the importer of notice and registration requirements discussion of § 1.279 ‘‘When must prior record. already in place, and the efficacy of the notice be submitted to FDA.’’ (Comments) Many comments advise targeting tools FDA employs. vii. Should FDA offer a prior notice that voluntary participation enhances (Response) We agree that adding submission training program for the success of these programs. conditions for C–TPAT participation submitters and transmitters, including (Response) C–TPAT is a voluntary, and validating them to meet the purpose brokers, to ensure the accuracy of the incentive based partnership. As we of the Bioterrorism Act would be data being submitted? (Comments/ continue exploring use of the C–TPAT extremely expensive and potentially Response) Most comments support and FAST programs in making only benefit a small number of those additional training for submitters and decisions regarding which products to entities subject to this rule. We do not transmitters. Additional discussion of inspect for the purposes of admissibility believe that this is the best use of our training is found under section III. M (801(a) decisions), it will be based on limited resources at this time, (Outreach and Enforcement) of this the assumption that participation particularly as we have not experienced document. should remain voluntary. significant impacts on the flow of trade 7. Additional Exclusions Requested— iii. In considering flexible alternatives as a result of the timeframes in the rule Samples for submission of prior notice, should since the IFR took effect on December FDA consider additional means of 12, 2003. (Comments) Numerous comments ensuring that all companies subject to v. Should the food product category request an exclusion from the the Registration of Food Facilities be considered as a criteria or element of requirements of prior notice for samples Interim Final Rule ((68 FR 58894, expedited prior notice processing or used in trade fairs, market research, October 10, 2003) (21 CFR part 1, other flexible alternatives? If so, should market testing, and laboratory analyses subpart H)), have an updated certain foods be excluded from (i.e., quality analysis/quality control registration on file with FDA that has expedited prior notice processing? If so, (QA/QC) samples, scientific research, been verified? (Comments) Several what should be the basis for compositional analyses, research and comments reiterate that it is not determining which foods should be development, standard of identity necessary for FDA to provide flexible excluded? (Comments) While one confirmation testing or quality alternatives that exceed or augment comment asserts that the food product comparison testing). The comments CBP’s existing programs, including a category be considered an important state that QA/QC samples are clearly not requirement to have an updated and element of expedited processing, most destined for consumption and will verified registration on file with FDA. other comments state that no product never enter the food chain or be However, another comment believes category distinctions should be made. consumed by the general public, thereby that companies eligible to participate in One comment states that to allow items placing samples in a low-risk category. low-risk programs should have an imported under food product categories In addition, the comments note that updated registration and that to qualify for expedited prior notice these samples are often imported in very verification of that registration would be could easily lead to abuse of the system small quantities for a specific purpose. useful in determining low-risk status. intended to protect us from terrorist Samples used for organoleptic analyses Another comment assumes that attack. Other comments suggest that all will be consumed in very small verification of registration with FDA food products be treated in the same quantities as part of the analytic should have been conducted under manner and be subject to the same procedures in a laboratory setting. In the CBP’s current validation aspect of the regulations. Most comments state that case of trade samples, the comments C–TPAT program. no product should be specifically contend that although the food will be (Response) FDA agrees that included or excluded from consumed, the consumption is minor participants designated as low risk participation, but that the criteria for and is contained within a controlled should have an updated and verified participation should be focused solely environment, such as a test kitchen or registration of all facilities subject to 21 on attributes of the company and a trade booth.

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In addition, the comments suggest would not be subject to prior notice Law 107–188.) Moreover, we have had some ways in which the burdens for requirements. In addition, if the sample incidents where small quantities of submitting prior notice for samples is in a form that is not an article of food, samples that had been consumed caused could be less cumbersome. These such as a slurry of lettuce for pesticide serious illness or death. For example, in recommendations include: analysis, then prior notice requirements the preamble to the IFR, FDA noted that • Exempt all samples or some subset would not apply. But where a sample is ‘‘in the summer of 2003, FDA received of samples, e.g., analytical, research, food, as defined under prior notice, the a report from a poison control center in consumer complaint; sample is not excluded from the final country T concerning the acute • Set a limit of the quantity of rule even if it is imported or offered for poisoning of 9 men (one died) from samples in each shipment and do not import for quality assurance, research or ingestion of an herbal fermented wine. require prior notice for quantities below analysis purposes only, not for human Symptoms occurred within minutes. this limit; or animal consumption and not for Reports indicated that this product may • Exempt samples from the resale. However, as outlined in the Prior have been exported to the United States requirement to provide the Notice Final Rule Draft CPG, FDA’s and in small quantities for test marketing in manufacturer’s registration number; CBP’s enforcement discretion policy restaurants. This underscores the • Include a field in the prior notice in would apply to these foods, under importance of FDA receiving prior which a filer can indicate that the which FDA and CBP should typically notice of all food imported or offered for item(s) is a sample, and eliminate consider not taking any regulatory import.’’ (68 FR 58974 at 58993.) certain data elements if this field is action when there is no prior notice and 8. Additional Exclusions Requested— flagged (i.e., registration number); the food is a sample not intended for • Allow a single prior notice without human or animal consumption. Mail registration numbers for commingled Samples of food are considered to be (Comments) One comment sought shipments of many small sample items for quality assurance, research or better information regarding the sending falling under the same or similar FDA analysis purposes, rather than human or of food products as international product codes; animal consumption, when they are in packages or bringing food products into • Allow shippers to provide a pre- small quantities (i.e., quantities the United States personally in their approved list of customers who may consistent with the quality assurance, baggage. receive samples in a particular month, research, or analysis purposes) and the (Response) Information on the on a monthly basis in lieu of filing entire sample is used up by the analysis, sending of food through international individual prior notices; destroyed after analysis, or destroyed mail can be found at: http:// • Specify procedures in the final rule following a reasonable retention period www.cfsan.fda.gov/~pn/pnmail.html. for clearly identifying samples, such as after analysis. The analysis may include Food products for personal use brought the inclusion of a statement on the sensory examination, such as into the United States that accompanies airway bill of lading that says: ‘‘Quality organoleptic examination for an individual are not subject to the Evaluation and Research and determining tea quality or detecting the requirements of prior notice Development Use Only—Resale presence of histamines. Evidence that (§ 1.277(b)(1)). Prohibited;’’ and an article of food is for quality (Comment) One comment questions • Provide a limited exemption for assurance, research, or analysis whether express couriers, such as EMS, intra-corporate (within the same purposes only might include, among FEDERAL EXPRESS, DHL, and TNT, are company) samples. other evidence, markings on the food considered ‘‘international mail.’’ One comment requests that FDA and shipping documents. (Response) Section 1.276(b)(8) of the exempt foods for exhibit at trade shows FDA disagrees with the comments final rule defines international mail to and food samples. The comment reasons that suggest that prior notice should mean foreign national mail services and that these foods are not intended for only be required for food, including further states that international mail consumption in the United States, but samples, that is intended for does not include express consignment are imported for ‘‘show’’ and sampling consumption. In the preamble to the operators or carriers or other private at the trade shows, not for later general IFR, FDA discussed extensively its delivery services unless such service is consumption. The comment further rationale for not limiting the prior operating under contract as an agent or reasons that the quantity involved with notice requirements to food for extension of a foreign mail service. each shipment is minuscule, usually no consumption in the United States. (See Therefore, if food items are shipped more than five hundred consumer units, 68 FR 58974 at 58990 and 58991.) This through one of these services and the which is too small a quantity to pose a rationale still holds. FDA also disagrees food items are not otherwise excluded potential national security threat. with the comments that state samples from prior notice requirements, prior Another comment states that there should be exempted from prior notice if notice is required. should be a de minimus provision for the consumption of the samples is (Comments) One comment questions samples from known shippers/importers minor and is contained within a if the rule applies to the military postal that is ‘‘cross-referenced’’ by shipper controlled environment, such as a test service, which is a subsidiary of the facility registration, manufacturer kitchen or trade booth, or the quantity United States Postal Service that facility registration, importer facility involved with each shipment is operates overseas. registration, low value, and low weight. minuscule, such that it ‘‘is too small a (Response) If the military post offices (Response) Many samples of food, quantity to pose a potential national are located outside of the United States, including those for test marketing, are security threat.’’ The purpose of the as defined for the purposes of prior ‘‘articles of food imported or offered for Bioterrorism Act is not limited to notice, articles of food would be subject import,’’ as stated in section 801(m) of terrorist activity or other national to the requirements of prior notice the act. If, however, the samples are security threats; its purpose is ‘‘[t]o (§ 1.277(a)). items that are in such early stages of improve the ability of the United States (Comments) One comment states that research and development that they to prevent, prepare for, and respond to the costs and resource implications of cannot yet be considered food under bioterrorism and other public health FDA applying this type of approach to § 1.276(b)(5) of the final rule, they emergencies’’ [emphasis added]. (Public single-piece, person-to-person,

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international mailings of manufactured In addition, the comments suggest submission of the express consignment food products may outweigh any that: (1) Private persons should be operator or carrier tracking number in perceived benefits. FDA’s current excluded from prior notice; (2) the lieu of anticipated arrival and certain approach to prior notice forces the U.S. requested information should be limited planned shipment information. Thus, Postal Service (USPS), FDA, and CBP to to some key-information, such as the we do not believe the final rule should dedicate substantial resources simply to submitter and the type of food; (3) all be revised to expand the definition of attempt effective implementation of mail services, including express international mail to include express these regulations. The comment asks carriers, should fall under the definition consignment operators or carriers or that FDA: (1) Exempt these single-piece, of ‘‘international mail;’’ and (4) FDA other private delivery services. personal use mailings from prior notice; should provide on their Web site FDA also does not agree the prior (2) allow CBP to continue using its time- dedicated information for companies notice requirements should not apply to tested strategies for screening and and consumers about international mail, low-value shipments, as neither the selections of items from mail shipments in different languages. Bioterrorism Act nor experience with arriving at the first port of entry; (3) (Response) The act does not exempt samples support this approach. See allow the delivery of mail items noncommercial shipments with a FDA’s responses to comments containing food, even if the contents are noncommercial shipper. FDA explained previously under section III.D.7 of this not accompanied by prior notice this position in the preamble to the IFR document ‘‘Additional Exclusions confirmation numbers to the U.S. (See 68 FR 58992) and believes that this Requested—Samples’’ for further address, as long as the U.S. authorities rationale is still valid. However, under discussion on this point. find no problem with the contents at the Prior Notice Final Rule Draft CPG, (Comments) A few comments suggest border inspection; and (4) work in close when food is purchased or otherwise that FDA modify the existing coordination with CBP and USPS to acquired by an individual for procedures for commercial shipments promote more clarity of understanding nonbusiness purposes and sent to an arriving by international mail. The individual with a noncommercial on the procedures for packages where comments state that complying with the shipper, FDA and CBP would typically the majority of the contents are not food requirements of FDA’s prior notification consider not taking regulatory action if items. The comment states that these procedure results in an unbearable prior notice is not submitted. This policies will need to be uniformly workload for mail order companies, proposed enforcement discretion policy applied, and also must ensure that which sometimes mail thousands of would be continued from the Prior proper accountability is provided to the packages at one time, with each package Notice Interim Final Rule CPG. mailers and recipients whose mailed requiring a prior notice. The comments items might have been refused, seized, Express consignment operators or suggest that manufacturers submit their or destroyed. carriers or other private delivery company information and product Another comment requests an services, unless such service is exemption for manufactured food operating under contract as an agent or information for similar items once and products that are sent via international extension of a foreign mail service, are then add the different recipients’ mail for noncommercial purposes. Some not considered international mail. (See addresses at the end. comments complain that the required § 1.276(b)(8) of the final rule). The IFR (Response) FDA’s PNSI has been data are very complex for the average created a category for international mail designed to accommodate repetitive customer and the system is not very because the rule imposed slightly information so that the basic prior customer-friendly, entries take a long different requirements for such imports. notice can be created and saved, and time, and each single item has to have For example, given the nature of each U.S. recipient can be added at the a separate prior notice. international mail imports, prior notice end of each subsequent prior notice. A A few comments state that most of the required the planned date of mail separate prior notice confirmation required information, such as the instead of the anticipated arrival number is generated for each article of manufacturer’s registration number, is information; it required the food (and recipient). Similarly, a not available to private persons, and identification of the recipient instead of number of the software programs that therefore, not available to international the importer, owner, and consignee; and customs brokers use to file prior notice mail and mail by express carriers. The it did not require the mode of and entry submissions with ABI/ACS do comments note that this is particularly transportation, carrier, planned allow for repetitive information to be problematic, since FDA does not shipment information, and hold saved on the filer’s computer and used provide information on registration of information. In addition, for for future shipments, as appropriate. facilities to private parties. The international mail the prior notice must 9. Additional Exclusions Requested— comments further note that a business be submitted before the article of food Gifts relationship between the buyer of the has been sent in order to allow the prior goods (e.g., a private person), the mail notice confirmation number to (Comments) Several comments service and the manufacturer will in accompany the package. We do not recommend that FDA expand the general not be present. In addition, the believe these changes are relevant for exemption already provided for comments state that to file prior notice, shipments arriving by express homemade food products sent as gifts Internet access and knowledge of the consignment operators or carriers or (§ 1.277(b)(2)) or food items carried in English language is required. The other private delivery services. For for ‘‘personal consumption’’ comments contend that mail users will example, if the express carrier submits (§ 1.277(b)(1)) to include all gifts, have to bear unreasonable disadvantages the prior notice, it will be able to regardless of mode of transportation, and unequal treatment. The comments include the mode of transportation, that are intended for personal use. argue that this seems disproportionate carrier, and other data elements not Another comment asks for clarification because most shipments are of low included in the international mail regarding food articles sent as gifts to value. Therefore, the comments suggest category. In situations where the persons in the United States for that FDA simplify the prior notice submitter and/or transmitter is not the personal consumption. This comment requirements through FDA’s PNSI for express consignment operator or carrier, believes that prior notice is only mail users. the final rule now allows the required for food articles that will be

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distributed or traded in the United explained in the IFR (68 FR 58974 at anticipated arrival information and/or States. 58993). However, under the proposed planned shipment information and if, (Response) If the food was made by an enforcement discretion policy, among other criteria, the prior notice individual in his/her personal residence described in the Prior Notice Final Rule includes the shipment’s tracking and sent by that individual as a personal Draft CPG, when food is sent by an number in lieu of the required gift (i.e., for nonbusiness reasons) to an individual for noncommercial purposes anticipated arrival information and/or individual in the United States, prior with a noncommercial shipper without planned shipment information. A notice is not required (§ 1.277(b)(2)). prior notice, regardless of the article’s person shipping food into the United Other food products sent by an value, FDA and CBP should typically States via an express courier will have individual and imported for consider not taking any regulatory access to the tracking number to use in noncommercial purposes with a action. lieu of the flight number or other noncommercial shipper are not (Comments) Two comments planned shipment information. FDA has excluded from prior notice recommend that FDA consider incorporated this policy in § 1.281 of the requirements. FDA explained this incorporating into the final rule a final rule, which allows the submitter position in the preamble to the IFR (See limited exemption for very small and/or transmitter to submit the express 68 FR 58992) and believes that this quantities of food. One of those consignment operator or carrier tracking rationale is still valid. However, under comments considers a small quantity to number in lieu of anticipated arrival the Prior Notice Final Rule Draft CPG, be under 80 pounds or less than 100 and certain planned shipment when gifts are shipped by an individual bottles. information as long as neither the for nonbusiness reasons to an individual (Response) FDA disagrees and will submitter nor transmitter is the express without prior notice, FDA and CBP not place a weight or quantity consignment operator or carrier and should typically consider not taking restriction on the requirements for prior prior notice is submitted via PNSI. regulatory action. This proposed policy notice. ‘‘Small quantity’’ shipments are would apply regardless of the mode of clearly subject to the terms of section 12. Additional Exclusion Requested— transportation. 801(m) of the act as they are ‘‘articles of Gift Packs food imported or offered for import.’’ (Comments) One comment requests 10. Additional Exclusions Requested— Similar to low-value articles of food, clarification of the interpretation Low-Value small quantity shipments can pose the pertaining to gift baskets. The comment (Comments) Many comments request same threat level to the U.S. food supply states it is unclear whether prior notice a de minimis exemption from prior as do articles of food that arrive in larger is based upon the description of the notice for all low value shipments (less quantities. If we were to exempt small entire gift basket as an entity, which is than $200). The comments assert that quantity food shipments, small currently the case for CBP entry the prior notice requirements can be quantities of poisoned food (with the processing, or on the individual items quite onerous for small shipments and potential to do a high level of damage) within the basket. One comment asks that low value shipments of prepared could be imported into the United FDA to exempt gift baskets because they food sent from and to individuals for States without prior notice, thereby are ‘‘no-risk.’’ their personal use are of little risk to the negating the purpose of the Bioterrorism (Response) Under the final rule, a gift U.S. food supply, especially relative to Act. pack is not considered a single article of the individual size and large number of food (e.g., a gift pack consisting of four commercial shipments entering the 11. Additional Exclusions Requested— articles of food would require four prior country. One comment states that a low Couriers notice submissions). This is because a value exemption from prior notice for (Comments) One comment reports gift pack is not manufactured/processed shipments under $200, whether for that many of the express couriers refuse as a single product, but is packed by personal or commercial use, would be to do the necessary paperwork for consolidating a variety of articles of consistent with CBP’s de minimis shipments being sent via their services. food into a unit, with or without other exemption. In addition, one comment Therefore, the manufacturers are nonfood articles. However, FDA and states that foreign individuals shipping required to submit prior notice. CBP are proposing to continue their low value gifts to the United States will However, the manufacturer does not enforcement discretion policy for gift not know the Bioterrorism Act’s have the necessary information needed packs, which the agencies first requirements and will not be able to to complete the form, such as flight announced in their March 2005 CPG obtain the manufacturer’s phone and number, departure and arrival time, etc. (March 4, 2005; 70 FR 10657). Under registration numbers. The comment The comment suggests that express that policy, ‘‘FDA and Customs Border states that these numbers are not readily courier shipments should be treated in Protection (CBP) staff should typically available to the consumer when the same manner as mail shipments. consider not taking regulatory action if products are purchased in small (Response) FDA disagrees but has there is a prior notice violation because quantities. One comment requests an modified the rule to address the a single prior notice is submitted for a exemption for small dollar value mail- underlying concern. Food imported or gift pack and the identity of the facility order sales to U.S. customers ($100 or offered for import via these private that packed the gift pack is submitted in less) since the prior notice system is delivery services are subject to prior lieu of the identity of the difficult and costly to implement for notice, which must be submitted within manufacturer(s), provided that the gift this type of business. the timeframe of the applicable mode of pack is purchased or otherwise acquired (Response) FDA disagrees. Low-value transportation—water, air, or land by an individual and imported or shipments are clearly subject to the (§ 1.279). In the prior notice CPG offered for import for nonbusiness terms of section 801(m) of the act as published in November 2004 (November purposes.’’ they are ‘‘articles of food imported or 9, 2004; 69 FR 64959), FDA and CBP There is no CBP rule or regulation, offered for import.’’ Moreover, low- stated that they generally would nor is there a General Rule of value articles of food can pose the same consider not taking regulatory action if Interpretation (GRI) under which gift threat level to the U.S. food supply as the prior notice is inadequate because it packs are classified. In the case of ‘‘gift do articles of food that cost more, as we does not include the required packs’’ that contain multiple products,

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CBP tries to classify the gift pack using employed by NATO Headquarters, food imported or offered for import for the concept of a set. That is, if the Supreme Allied Commander noncommercial purposes with a products included in a gift pack are part Transformation Atlantic and their noncommercial shipper without prior of a common activity, the gift pack may immediate families be granted an notice, irrespective of the type of carrier. be classified under the HTS code that is exemption from prior notice. The Under the proposed policy, FDA and most applicable. However, CBP does not comment contends that these CBP should typically consider not consider eating to be a common activity, individuals have undergone an intense taking any regulatory action when an even when all items in a gift pack are screening process prior to being selected article of food is imported or offered for to be consumed. Therefore, unless there for a NATO position. One comment import for noncommercial purposes has been an applicable CBP ruling, requests that FDA exempt Department with a noncommercial shipper without entries of gift packs should be declared of Defense active duty military and prior notice. The noncommercial to CBP using the HTS code for each item civilian personnel unaccompanied shipper, under this policy, would be an included within the gift pack. This baggage and household good shipments. individual (e.g., the individual delivers principle applies even when there are (Response) Section 801(m) of the act the food to a post office or common food and nonfood items in the pack does not authorize an exclusion from carrier for delivery to self, family (e.g., a soup mug and a can of soup) as prior notice for food imported as part of member, or friend for nonbusiness well as for make-your-own gift packs unaccompanied baggage or food purposes). (e.g., if you created a gift pack by included as part of a shipment of When a business ships a food, it is for personally selecting individual items personal household goods. Therefore, a commercial or business purpose. The from a list of available products). food contained in household goods and situation as described in this comment, accompanied baggage are subject to therefore, would not meet the criteria 13. Additional Exclusions Requested— prior notice requirements. covered by the enforcement discretion Household Goods and Unaccompanied However, a proposed enforcement policy since the shipper is a business. Baggage discretion policy in the Prior Notice (Comments) One comment requests (Comments) Many comments suggest Final Rule Draft CPG would apply to that private persons should be excluded that the final rule exempt most or all of the household goods and from the requirements of prior notice. unaccompanied food that is included in unaccompanied baggage shipments The comment states that commercially- a shipment of personal household described in the comments. Under the produced food imported for the goods, if the food is owned by and proposed policy, FDA and CBP should personal use of an individual, even if intended to be consumed by the shipper typically consider not taking any included in a shipment of personal of the household goods, their family or regulatory action when an article of food effects, should not require prior notice. friends, and if the food is not to be is imported or offered for import for (Response) Section 801(m) of the act offered for sale or distribution. In noncommercial purposes with a does not authorize a broad exclusion addition, several comments suggest that noncommercial shipper without prior from prior notice for food imported or food contained in unaccompanied notice. We consider food in household offered for import by private persons. baggage should be exempt from the goods, including military and civilian Therefore, food that is commercially requirements of prior notice. The transfers, to be food imported or offered produced that is imported for the comments state that the owner of the for import for a noncommercial personal use of an individual, as food never changes, and that there is no purpose. This enforcement discretion described in the comment, would be sale or transfer of the goods. The policy would be a continuation of the subject to this final rule. comments believe that shipping food policy in effect since FDA issued the However, we are proposing an items contained in household goods or June 2004 Prior Notice Interim Final enforcement discretion policy in the unaccompanied baggage to the United Rule CPG (June 29, 2004, 69 FR 38906). Prior Notice Final Rule Draft CPG for States is equivalent to carrying the items food imported or offered for import for in baggage for personal use. The 14. Additional Exclusions Requested— noncommercial purposes with a comments further state that household Noncommercial Use noncommercial shipper, irrespective of goods are even more personal than food (Comments) One comment asserts that the type of carrier without prior notice. accompanying a traveler because shipments for personal consignment Under the proposed policy, FDA and although it travels from one personal when sent from a business are, by CBP should typically consider not residence to another, it remains part of definition, noncommercial, due to the taking any regulatory action when an the same household or home. The fact they are purchased for personal use article of food is imported or offered for comments suggest that FDA not require and not for resale. The comment import for noncommercial purposes as many data elements for these types of suggests that FDA define with a noncommercial shipper without shipments, and allow a minimum noncommercial shipments to include prior notice. This policy would cover amount of food/consumables to be any consignment to an individual for the food described in the comment, imported without prior notice. The personal, noncommercial use, as exempt commercially produced food imported comments believe that it will be from the requirements of prior notice, for the personal use of an individual, as unnecessarily tedious and exhaustive regardless of whether the shipper is a long as the shipper is noncommercial. for individuals to input the required business entity or an individual. This enforcement policy would information into the FDA PNSI, and that (Response) FDA disagrees. As we continue the policy initially announced it is unreasonable to ask individuals to described in the IFR, there is no basis in our June 2004 Prior Notice Interim destroy or leave behind hundreds of in the statute for an exemption based on Final Rule CPG. The draft CPG describes dollars of canned goods. shipments that are for personal use, a noncommercial purpose as one where Additionally, one comment suggests regardless of whether the shipper is a the food is purchased or otherwise that persons on duty in the United commercial or noncommercial (i.e., an acquired by an individual for States as members of the armed forces individual) entity (68 FR 58974 at nonbusiness purposes, and a of a North Atlantic Treaty Organization 58992). However, we are proposing an noncommercial shipper is one where (NATO) or Partnership for Peace or enforcement discretion policy in the the shipper is an individual (e.g., the civilian component attached to or Prior Notice Final Rule Draft CPG for individual delivers the food to a post

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office or common carrier for delivery to noncommercial purposes, such as small United States’’ (§ 1.277(a)), regardless of self, family member, or friend for shipments for personal use, with a whether it was initially a U.S. export nonbusiness purposes, i.e., not for sale, noncommercial shipper without prior that was refused by a foreign resale, barter, business use, or notice. However, this proposed government. We would require prior commercial use). Examples of foods enforcement discretion policy would notice for these shipments even if entry imported or offered for import that may not extend to situations where the is not required by CBP. In these cases, be covered by this noncommercial shipper is a commercial entity (e.g., a we recommend that prior notice be category are: (1) Food in household retail store, an Internet company, etc.). submitted via PNSI. goods, including military and civilian 15. Additional Exclusions Requested— 16. Additional Exclusions Requested— transfers; (2) food purchased by a U.S. Goods Returned In-Transit Shipments traveler and mailed or shipped to the traveler’s U.S. address by the traveler, (Comments) A few comments request (Comments) Several comments not the commercial establishment; and exemptions for unadulterated U.S. request that in-transit shipments be (3) gifts purchased at a commercial goods being returned. The comments excluded from the prior notice establishment and shipped by the state that these items do not pose an requirements. The comments express purchaser, not the commercial adequate threat to the nation’s food concern that submitting prior notice for establishment. supply. In addition, these comments such shipments presents a tremendous (Comments) One comment suggests indicate that it is not possible to provide burden on industry. Companies may that older wines already owned by a the manufacturer’s registration number seek to avoid the potential cost and U.S. individual and imported solely for for merchandise that was manufactured disruption by diverting freight to other personal consumption be exempt from in the United States and then exported routes rather than use transshipment prior notice. Another comment provides overseas, where the merchandise can be facilities through U.S. territory for an example of an individual who owns purchased and then shipped back to the destinations in Mexico and Canada. a wine cellar overseas and arranges for United States. The comments state that The comments note that requiring cases of wine to be sent to him/herself the original manufacturer in the United prior notice for shipments not intended in the United States for personal States will not provide their registration for consumption in the United States consumption. number in these scenarios. appears to be beyond the statutory (Response) As discussed previously, (Response) FDA disagrees. As authority provided by the Bioterrorism there is no basis in section 801(m) of the discussed in the IFR, FDA believes that, Act. The comments reason that in- act to exclude food imported or offered for the purpose of section 801(m) of the transit shipments are under strict CBP for import for personal use. Although act, the phrase ‘‘imported or offered for regulations and control by the carrier this importation is subject to the import into the United States’’ applies with respect to movement and are provisions of this final rule, if the wine to articles of food of U.S. origin that are secured by a bond, and thus, the food is imported or offered for import by an ‘‘reimported’’ back into the United cannot be diverted to enter the U.S. food individual for noncommercial purposes States (68 FR 58974 at 58990). FDA supply. and shipped by himself to himself using believes that this interpretation, and the (Response) FDA disagrees. The IFR a noncommercial shipper without prior underlying rationale for it, are still contains FDA’s rationale and legal notice, the proposed enforcement valid. We also believe, as explained in support for determining that for the discretion policy in the Prior Notice the IFR, that section 801(m) of the act purpose of section 801(m) of the act, the Final Rule Draft CPG would apply. does not authorize us to exclude ‘‘low- phrase, ‘‘imported or offered for import Under the proposed policy, FDA and risk’’ food shipments from prior notice into the United States,’’ applies to CBP generally should typically consider requirements (68 FR 58974 at 58993). articles of food of U.S. origin that are not taking regulatory action when an The inability to submit the ‘‘reimported’’ back into the United article of food is imported or offered for manufacturing facility’s registration States, as well as to food that transits the import for noncommercial purposes number is not a valid reason for United States (See 68 FR 58974 at with a noncommercial shipper without excluding such a shipment from prior 58990). FDA continues to believe this prior notice. notice requirements. However, we are determination is correct and is not (Comments) One comment suggests revising § 1.281(a)(6) of the final rule to convinced it should be revised. that small shipments of nominal value provide flexibility in submitting the Moreover, the comment implies that for personal, noncommercial use should identity of the manufacturer. In addition these shipments should be exempt from be exempted from the requirements of to the name of the manufacturer, the prior notice requirements since the prior notice. The comment states that submitter may submit either the shipments are under strict CBP control the express industry handles many of registration number, city, and country of and are secured by a bond, i.e., that these shipments now, which include the manufacturer, or both the full these shipments are low-risk. However, purchases from a growing number of address of the manufacturer and the section 801(m) of the act does not Internet-based sellers. The comment reason why the registration number is authorize an exemption for articles of asserts that these small shipments for not provided. food that are ‘‘low risk’’ or covered by personal use do not qualify as a risk to (Comments) One comment requests programs of other agencies, such as CBP the domestic food supply, and should that FDA provide clear direction or foreign government regulatory be exempt from prior notice. whether prior notice is required for food authorities. (Response) As we discussed shipments of U.S. products that are (Comments) One comment requests previously, section 801(m) of the act returned to the United States after that the final rule exempt foreign-to- does not authorize an exclusion for refusal by a foreign government. foreign transit mail; i.e., mail shipments small quantity or low-value shipments. (Response) FDA requires prior notice that simply transit the United States for FDA notes that under the Prior Notice for an article of food that has been delivery in a third country. The Final Rule Draft CPG, FDA and CBP exported from the U.S. and is being comment reasons that these items are should typically consider not taking ‘‘reimported’’ back into the U.S., as we not intended for U.S. consumption (i.e., regulatory action when an article of food consider such a shipment as being not intended for a U.S. recipient); is imported or offered for import for ‘‘imported or offered for import into the represent the transfer of universal

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service obligation mail between United States if the express carrier, for under which FDA and CBP should sovereign governmental entities; and are example, chooses to consolidate typically consider not taking regulatory items from foreign mailers who would shipments going to South America in action when prior notice is not not know when to submit the required Florida. The proposed enforcement submitted. prior notice data as they do not always discretion policy in the Prior Notice (Comments) Another comment know whether their mail dispatches will Final Rule Draft CPG states that FDA suggests that the FDA work be transiting the United States. and CBP should typically consider not cooperatively with CBP such that (Response) As we explained in the taking any regulatory action when an transshipments that follow the CBP IFR and elsewhere in this notice, food article of food is imported or offered for transshipment procedures are not that is not intended for U.S. import and the carrier is an express required to enter additional information consumption is still within the scope of consignment operator or carrier; neither for FDA prior notice purposes, and that ‘‘imported or offered for import’’ (68 FR the submitter nor transmitter is the shipments that may pose a risk are 58974 at 58991) and is subject to prior express consignment operator or carrier; identified through the CBP process. The notice requirements. However, we and the importer, owner, or recipient/ comment also states that the current understand that in the case of foreign- consignee is not located in the United requirements in the agreement for to-foreign mail, the sender does not States. secure in-transit procedures could be have control over the transportation (Comments) Several comments modified to meet the objective of the route that the foreign-to-foreign request that FDA exempt shipments of prior notice IFR to prevent the entry of shipment will transit. Therefore, we are food that move from Canada to Canada products that have been intentionally proposing an enforcement discretion under bond by rail through Northern adulterated. Shipments that follow the policy in the Prior Notice Final Rule Maine. These comments note that such proposed secure in-transit procedures Draft CPG that would address this shipments moving by rail in bond would not be distributed in the United situation. Under that policy, FDA and cannot be delivered to points within the States and would be of minimal risk to CBP should typically consider not United States, must move from Canada human or animal security and safety. taking any regulatory action when an to Canada, and that the food products in The comment also suggests that FDA article of food is imported or offered for trailers on rail cars cannot be diverted can achieve certainty of safety of import via international mail without to enter the U.S. food supply. The overseas shipments that are transiting to prior notice and there is no U.S. comments state that having to submit the United States through Canada by recipient. prior notice puts the U.S. rail carriers at conducting examinations at the first (Comments) Comments filed by a competitive disadvantage when point of arrival in North America and express carriers request that FDA competing for Canadian rail business. through the expansion of existing exempt all non-U.S. destination Other comments request that FDA bilateral harmonized risk screening and shipments from the requirement to exempt shipments of food that move lockout sharing systems to provide prior notice. The comments from Canada to Canada by marine and accommodate additional high-risk note that the shipment is in the custody trucking companies. The comments commodities. of the express carrier at all times and the reason that their Canada to Canada in- (Response) CBP’s secure in transit risk of diversion from the highly- transit shipments move in sealed procedures cannot substitute for the controlled environment in which containers and that providing detailed submission of prior notice for in transit express shipments move, particularly information for products that are never shipments because they do not meet the in-bond shipments, is low. The going to enter the U.S. food supply is a requirements of the Bioterrorism Act, comments also reason that foreign hardship to U.S. businesses. such as providing FDA with certain shippers and foreign consignees do not (Response) FDA disagrees. The specified information. The information submit the required prior notice data Bioterrorism Act does not create any in a prior notice is necessary for FDA to because they are, by design, not aware exemptions for this situation and determine whether it should examine that their shipments will transit the therefore, there is no basis for excluding the food at the U.S. port of arrival. In United States on their way to a third such business operations from prior addition, section 801(m) of the act does country because express carriers do not notice requirements. The preamble to not authorize an exemption for articles disclose flight routes of packages either the IFR provides our rationale for of food that are covered by programs of to shippers or consignees due to determining that food that transits the other agencies, such as CBP, even if security concerns. If prior notice must United States falls under the scope of those programs would ‘‘prevent the be submitted, express carriers will be this rule (68 FR 58974 at 58990) and we entry of products that have been required to make the customers aware of continue to hold this view. Moreover, intentionally adulterated.’’ routes, nullifying this simple but the comment implies that these (Comments) One comment notes that effective security precaution. shipments should be exempt from prior there are many ocean containers (Response) As described in the notice requirements because they pose a crossing into the United States for previous comment, prior notice applies relatively low risk by moving by rail, in transshipment purposes and prior to food imported or offered for import bond, and/or under seal. Even if such notice is not being submitted. The notwithstanding that the food is not food shipments are a low risk, as comment asks how to ensure that ocean intended for U.S. consumption. discussed elsewhere in this notice, containers that arrive in Canada or However, we recognize that, when section 801(m) of the act does not Mexico and cross into the United States shipping via express carrier or other authorize a ‘‘low risk’’ exemption. by rail have prior notice submitted in a private delivery service, the sender does However, the proposed guidance in the timely fashion, or submitted at all, when not have control over the transportation Prior Notice Final Rule Draft CPG shippers are not always aware of when route that the foreign-to-foreign (which would continue the policy the containers are due to cross or on shipment will transit. For example, a established in the March 2005 revision which train. person in Europe intends to mail an to the Prior Notice Interim Final Rule (Response) FDA addressed this issue article of food to South America via an CPG) addresses imported food arriving in the IFR when it allowed any person express carrier. This person has no from and exiting to the same country. It with knowledge of the required control over the package entering the describes the situations and conditions information to submit prior notice. In

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§ 1.285 of the proposed prior notice rule (Response) Whether seeds are subject confusion regarding who is responsible (68 FR 5428, February 3, 2003), FDA to prior notice depends on whether the for submitting prior notice. This causes provided that a purchaser or importer of seeds meet the definition of food. Some particular problems for carriers of in- an article of food who resides or seeds, such as sesame seeds for baking bond cargo transiting the United States. maintains a place of business in the or as a garnish, are food for which prior The comment suggests that exempting United States or an agent thereof was notice must be submitted to FDA before in-bond shipments from prior notice authorized to submit prior notice. FDA the seed is imported or offered for would allow carriers to move the further proposed that if the article of import into the United States. Some shipment without having to submit food is imported for in-bond movement seeds are capable of both food and prior notice and permit the broker at the through the United States for export, the nonfood uses, such as seeds that are port of entry, who does get the prior notice must be submitted by the sometimes processed into cooking oil necessary documents, to properly arriving carrier or, if known, the carrier and other times processed into submit the prior notice. (Response) FDA making the in-bond entry. Many industrial-use oil. As discussed disagrees that there is confusion comments to the proposed rule objected elsewhere in this document, FDA regarding who is responsible for to the limitation that only a person who considers such seed to be food for the submitting prior notice. The IFR and resides or maintains a place of business purpose of prior notice if the seed is this final rule expressly state in § 1.278 in the United States can submit the reasonably likely to be directed to a food that any person with knowledge of the prior notice. In addition, comments use. Even when seed is for a nonfood required information may submit the pointed out that under some use, such as seeds for growing flowers, prior notice. FDA provided this circumstances, the U.S. importer or if a small portion of that seed is flexibility as to who could submit prior purchaser or carrier would not have all reasonably likely to be directed for use notice in response to comments that the information required by prior notice, in animal feed, prior notice would be FDA received on the proposed rule, but that other entities, e.g., the foreign required. Because seeds, including which urged FDA not to limit who manufacturer/ processor, shipper, or seeds for planting, may be subject to could file prior notice to either a exporter, would have the required prior notice under section 801(m) of the purchaser or importer of an article of information. Many comments stated that act, we believe they are properly flagged food who resides or maintains a place entities other than U.S. firms or carriers as FD3. of business in the United States or an should be allowed to submit prior Nonetheless, we note that the draft agent thereof, or to the arriving carrier notice. Prior Notice Final Rule CPG, announced or the carrier making the in-bond entry In response, FDA modified this elsewhere in this issue of the Federal if the article of food is imported for in- provision in the IFR and removed the Register, proposes an enforcement bond movement through the United restriction on who can submit prior policy regarding seeds for planting. States for export. (See 68 FR 58974 at notice. Accordingly, § 1.278 of the IFR Under the draft policy, FDA and CBP 58994.) Comments to the proposed rule provides that any person with should typically consider not taking any also pointed out that under some knowledge of the required information regulatory action regarding seeds that circumstances, the U.S. importer or may submit prior notice to FDA. FDA will be used for cultivation if they are purchaser or carrier would not have all has retained this provision in the final imported or offered for import without the information required by prior notice, rule. prior notice. The policy would apply but that other entities, e.g., the foreign when no more than a small portion of manufacturer/ processor, shipper, or 17. Additional Exclusions Requested— that seed is diverted from cultivation to exporter, would have the required Diplomatic Pouch animal feed or other food use. It would information. Many comments stated that We have determined that prior notice not apply, however, where the seed is entities other than U.S. firms or carriers does not apply to food in diplomatic used for the production of edible should be allowed to submit prior pouches because Art. 27(3) of The sprouts, such as alfalfa seeds for the notice. In response, FDA modified this Vienna Convention on Diplomatic production of alfalfa sprouts. provision in the IFR and removed the Relations (1961) states that: ‘‘The E. Who is Authorized to Submit Prior limitation on who can submit prior diplomatic bag shall not be opened or Notice? (§ 1.278) notice. detained.’’ (Final Rule) Section 1.277(b)(7) of the Section 1.278 of the IFR states that (Response) FDA disagrees that there is final rule adds a new exclusion to the prior notice may be submitted by any confusion regarding who is responsible rule: ‘‘Articles of food subject to Art. person with knowledge of the required for submitting prior notice. The IFR and 27(3) of The Vienna Convention on information and identifies this person as this final rule expressly state in § 1.278 Diplomatic Relations (1961), i.e., the submitter. The IFR also states that that any person with knowledge of the shipped as baggage or cargo constituting the submitter also may use another required information may submit the the diplomatic bag.’’ person to transmit the required prior notice. FDA provided this information on his/her behalf and flexibility as to who could submit prior 18. Additional Exclusions Requested— identifies the person who transmits the notice in response to comments that Seeds for Planting information as the transmitter. The IFR FDA received on the proposed rule, (Comments) One comment requests also states that the submitter and which urged FDA not to limit who that FDA exempt imported seed that is transmitter may be the same person. could file prior notice to either a destined solely for planting purposes, (Comments) Several comments note purchaser or importer of an article of even if small amounts found unsuitable that carriers often do not have access to food who resides or maintains a place for planting will end up in the food the information required to classify of business in the United States or an supply. The comment also requests that articles in the FDA system (the agent thereof, or to the arriving carrier the FD3 flags be removed from HTS commercial invoice and packing list) or the carrier making the in-bond entry codes that cover seed for sowing or because it is proprietary information if the article of food is imported for in- planting or, alternatively, to clarify that that the owners of the goods will not bond movement through the United FD3 flagged HTS codes may be want to give to intermediaries in the States for export. (See 68 FR 58974 at ‘‘disclaimed’’ at entry. transportation chain. Also, there is 58994.) Comments to the proposed rule

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also pointed out that under some notice has the appropriate and correct of admission. Other consequences under circumstances, the U.S. importer or information. the act for those who fail to comply with purchaser or carrier would not have all (Comments) One comment suggests the prior notice requirements, such as the information required by prior notice, that it is improper for a carrier to require by submitting inaccurate or untimely but that other entities, e.g., the foreign the shipper to submit prior notice when notice, are described in § 1.284. manufacturer/processor, shipper, or the shipper is not shipping goods into (Final rule) Section 1.278 of the final exporter, would have the required the United States, but the carrier rule states that prior notice may be information. Many comments stated that unilaterally moves the goods through submitted by any person with entities other than U.S. firms or carriers their hub in the United States, thereby knowledge of the required information should be allowed to submit prior causing the shipment to enter the and identifies this person as the notice. In response, FDA modified this United States. Another comment notes submitter. The final rule also states that provision in the IFR and removed the that the data elements required in a the submitter may use another person to limitation on who can submit prior prior notice are not available to the transmit the required information on notice. shipper, inferring that it is not possible his/her behalf and identifies the person Accordingly, § 1.278 of the IFR for a shipper to submit prior notice. who transmits the information as the provides that any person with (Response) Neither the IFR nor this transmitter. The final rule also states knowledge of the required information final rule specifies who must file prior that the submitter and transmitter may may submit prior notice to FDA. FDA notice. Rather, the rule provides that be the same person. noted in the preamble to the IFR that any person with knowledge of the F. When Must Prior Notice Be Submitted any person may now take responsibility required information may submit prior to FDA? (§ 1.279) for submitting prior notice for a notice to FDA. Accordingly, it is not for particular article of food, as long as that FDA to say whether it is proper for a Section 801(m)(2)(A) of the act states person can provide all the required carrier to require a shipper to submit that FDA shall by regulation prescribe information. This person is referred to prior notice as a condition of shipment, the time of submission of the as the submitter in the IFR. The IFR also as that is a matter between two notification in advance of importation states that the submitter may use contracting parties. We note that the or the offering of the food for import, another person to transmit the required Prior Notice Final Rule Draft CPG which period shall be no less than the information to FDA. For ease of proposes an enforcement policy for minimum amount of time necessary for reference, the person who transmits the foreign-to-foreign mail. Under the the Secretary to receive, review, and prior notice is referred to as the proposed policy, if there is no prior appropriately respond to such transmitter in the IFR. FDA has retained notice FDA and CBP should typically notification, and any timeframe FDA these provisions in the final rule. FDA consider not taking any regulatory adopts in the final rule must be justified further notes that to the extent that there action in the case of international mail under this standard. Section 1.279(a) of is confusion, the parties to the where the recipient is not in the United the IFR requires FDA to receive prior transaction may want to consider a States since the sender does not have notice and confirm it for review no less means for identifying which party is control over the transportation route than 2 hours before arriving at the port responsible for submitting prior notice that the foreign-to-foreign mail will of arrival by land via road, no less than as part of their business arrangements transit. 4 hours before arriving at the port of (e.g., within their contract). (Comments) One comment asks arrival by air and land via rail, and no (Comments) Several comments note whether there are any prior notice less than 8 hours before arriving at the that problems arise because the IFR obligations to fulfill if the exporter is port of arrival by water. We explained creates no particular obligation on any not required to register with the FDA in the preamble to the IFR that the particular party within the distribution under the Bioterrorism Act (21 CFR part ‘‘interim final rule provides for greatly system to submit prior notice. One 1, subpart H). reduced timeframes for foods [from comment states that because prior (Response) Prior notice and what we had proposed] based on mode notice can be submitted by any person registration are separate obligations of transportation. These timeframes are who has the information, there are many under different regulations and with what FDA has determined are the cases of duplicate prior notices filed by differing applicability. For example, minimum timeframes necessary to allow different parties for the same shipment. registration applies to facilities that it to satisfy the statutory mandate that Another comment suggests that FDA manufacture, process, pack or hold food the timeframes give the agency the time select one party to be responsible, that will be consumed by humans or it needs to ‘receive, review, and suggesting the appropriate party would animals in the United States. By respond’ to prior notices.’’ (68 FR 58974 be either the exporter or the importer- comparison, prior notice generally at 58995) broker. applies to FDA-regulated food being Under § 1.279(b) of the IFR, prior (Response) Please see the response to imported or offered for import into the notice may not be submitted more than the previous comments. FDA’s proposed United States, regardless of whether it 5 calendar days before arrival, except in rule did specify a limited class of will be consumed in the United States the case of food imported or offered for individuals who could provide prior and regardless of whether the exporter import by international mail. Under notice and this limitation received must register. § 1.279(c) of the IFR, if the article of significant adverse comment. (Comments) One comment asks for food is arriving by international mail, Accordingly, both the IFR and this final clarification of the legal responsibility of the prior notice must be submitted rule provide that any person with the submitter. before the food is sent to the United knowledge of the required information (Response) Among the requirements States. may submit the prior notice (§ 1.278). of the final rule, the prior notice Section 1.279(d) of the IFR provides FDA notes that the parties to a information must be accurate and that the time of submission is fixed and transaction can elect to take steps timely. As described in § 1.283, if an the prior notice time will start for among them to identify which party article of food is imported or offered for purposes of determining if prior notice should submit the prior notice and import and the notice is inaccurate or is timely when the prior notice ensure that the party submitting prior untimely, the food is subject to refusal submission is confirmed by FDA for

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review. FDA will confirm a prior notice Electronic Information Rule implements receive, review, and respond to all prior once all required information has been the provisions of section 343(a) of the notice submissions with reduced submitted and confirmed as facially Trade Act of 2002, as amended by the timeframes for land and air consistent complete. For example, if the Maritime Transportation Security Act of with CBP’s rule; and implement information submitted failed to include 2002. The relevant timeframes provided necessary changes and make an FDA Product Code, the system will in the Advance Electronic Information appropriate adjustments to ensure we not provide a confirmation for that prior Rule are as follows: could receive, review, and respond to notice. The transmitter has an • For arrival by land via road at ports all prior notice submissions with opportunity to correct the rejected that are fully equipped to accommodate reduced timeframes before issuing the information. When the information is CBP’s Advance Electronic Information final rule, consistent with our obligation corrected, transmitted, and determined Rule, no later than 1 hour prior to the to ensure that any timeframe selected is to be facially valid, the system will then arrival of the truck at the border, or for sufficient to receive, review, and notify the transmitter and provide the Free and Secure Trade (FAST) respond to prior notice submissions, as prior notice confirmation number. participants, 30 minutes; set out in section 801(m)(2)(A) of the • Under § 1.279(e) of the IFR, the prior For arrival by land via rail at ports act. We also emphasized that ‘‘the notice confirmation number must that are fully equipped to accommodate evaluation of whether to reduce the accompany any article of food arriving CBP’s Advance Electronic Information timeframes for prior notice review will by international mail. Under § 1.279(f), Rule, no later than 2 hours prior to the depend on the level of compliance a copy of the confirmation (with the arrival of the train at the border; For industry achieves during the prior notice confirmation number) must arrival by air, no later than the assessment. If we are unable to make accompany any article of food carried departure time (‘‘wheels up’’) of the such an assessment, our intended by or otherwise accompanying an aircraft from any foreign port or place in timeframe for issuing a prior notice final individual (unless excluded under North America, including locations in rule may be delayed.’’ Mexico, Central America, South § 1.277(b)(1)), and be provided to CBP or Comments received on the prior FDA upon arrival. Additionally, under America (from north of the Equator notice IFR addressed the timeframes § 1.279(g) the prior notice confirmation only), the Caribbean, and Bermuda, and required in the IFR, as well as number must accompany any article of from other areas into ports that are fully integration of those timeframes with the food for which the prior notice was equipped to accommodate CBP’s timeframes covered by CBP’s advance submitted through the FDA PNSI when Advance Electronic Information Rule no electronic information rule. Comments arriving in the United States and must later than 4 hours prior to the arrival of also covered the IFR’s requirement that be provided to CBP and FDA upon the aircraft in the United States. prior notice must be submitted at least arrival. On April 14, 2004, FDA and CBP We further stated in the IFR’s announced their ‘‘Joint FDA-CBP Plan 5 days prior to arrival. We respond to preamble that we also were interested in for Increasing Integration and Assessing the issue of timeframes for submitting exploring flexible alternatives for the Coordination of Prior Notice prior notice here, and respond to the submission of prior notice for foods or Timeframes’’ (69 FR 19765), which the other questions raised in our Joint firms covered by programs of other agencies amended in August 2004 Implementation Plan and April 14, agencies, such as C–TPAT, or imported (http://www.cfsan.fda.gov/~pn/ 2004, reopening of the comment period by other agencies. We explained that pnplan2.html). As stated in the plan later in this preamble. FDA and CBP would publish a plan, regarding the agencies’ assessment of 1. IFR Timeframes (2, 4, and 8 hours) including an implementation schedule, reduced timeframes ‘‘FDA and CBP to achieve the goal of a uniform, continuously are assessing the (Comments) One comment asks FDA integrated system, and to coordinate completeness of prior notice to permit prior notice to be submitted at timeframes for import prior notice submissions received as well as the the port of entry, instead of at the port information while fulfilling the amount of time necessary to receive, of arrival, in order to align the prior Bioterrorism Act mandates for air and review, and respond to those notice process with long-standing, truck modes of transportation with submissions requiring a human review. existing CBP clearance processes and timeframes finalized by CBP when they However, that process is not yet infrastructures at the port of entry. The finalize their rule entitled ‘‘Required complete, as we are currently operating comment reasons that since according to Advance Electronic Presentation of under the enforcement policies outlined FDA’s own estimates, 80 to 90 percent Cargo Information’’ (the Advance in the Prior Notice Compliance Policy of prior notice data will be filed by the Electronic Information Rule) (68 FR Guide (CPG). See Compliance Policy ABI filer, it is logical that prior notice 58995). On December 5, 2003, CBP Guide Sec. 110.310—Prior Notice of should be filed at the same port where issued the Advance Electronic Imported Food Under the Public Health clearance entry is filed. The comment Information Rule (68 FR 68140), which Security and Bioterrorism Preparedness also suggests that FDA may want to requires CBP to receive, by way of a and Response Act of 2002. (Issued consider a two-step process for CBP-approved electronic data December 15, 2003, and revised June submitting prior notice, under which interchange system, information and August 2004; http://www.fda.gov/ the CBP ‘‘ACI data’’ is accepted as the pertaining to cargo before the cargo is ora under Compliance References.) We first step, filed at port of arrival as part either brought into or sent from the currently do not receive prior notice for of the ‘‘ACI data,’’ followed by complete United States by any mode of all shipments.’’ prior notice in its current form, filed as commercial transportation (water, air, In our plan, we also stated that we a second step at the port of entry, i.e., rail, or truck). The cargo information would assess existing procedures and concurrent with the clearance entry. required is that which is reasonably staffing needed to receive, review, and Another comment suggests that to necessary to enable high-risk shipments respond to the prior notices submitted ensure consistency with ACE, the prior to be identified for purposes of ensuring in accordance with the Prior Notice IFR; notice should be required and cargo safety and security and preventing identify what changes to work practices calculated from the port of entry and not smuggling under the laws enforced and and staffing would be necessary to the first point of arrival, as is currently administered by CBP. The Advance determine if FDA could continue to the case.

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Another comment recommends that December 3, 2003, FDA has prior notice timeframe for imported to fully achieve the FDA-CBP goal of commissioned thousands of CBP food arriving by water with the CBP coordinating timeframes, FDA should officers in ports and other locations to advanced electronic information rule adopt the ‘‘point of entry,’’ rather than conduct, on FDA’s behalf, investigations timeframe of 24 hours prior to loading the ‘‘point of arrival’’ in the United and examinations of imported foods. on the vessel. The reasons for States to measure the timeliness of the This unprecedented FDA-CBP recommending that prior notice prior notice filing. CBP’s ‘‘point of collaboration significantly strengthens timeframes be the same as CBP’s entry’’ is well known to importers and the implementation of the Bioterrorism advanced electronic information its use for purposes of the Bioterrorism Act to ensure the security of imported timeframes for food arriving by air and Act not only will alleviate unnecessary foods, particularly with respect to land are that it would minimize the confusion, but also will facilitate the implementing the prior notice rule. complexity of the process by presenting stream of U.S. commerce without Building on FDA’s and CBP’s long a more streamlined flow of information compromising food safety. history of close cooperation, the MOU and avoid unnecessary duplication, The comment also states that with the upgrades the two agencies’ teamwork in result in fewer errors, provide better growing partnership between FDA and training, day-to-day operations, and compliance rates, allow for fewer CBP, FDA’s concern regarding limited information sharing. As part of the disruptions at the border, significantly personnel should no longer be an issue MOU, FDA and CBP have provided reduce the burden on the trade now that FDA and CBP collectively are specialized training for the community without creating additional using their respective enforcement commissioned CBP employees who security risks, and allow operators at officials for this joint endeavor. carry out this work, and both agencies close border points to load and verify (Response) FDA discussed the ‘‘port have expanded their existing truck loads and travel routes prior to of entry/port of arrival’’ issue cooperative arrangements to directly submitting notice. One comment extensively in the preamble to the IFR share information affecting the safety suggested that there is no basis for and is not persuaded by the comments and security of imported foods, concluding that more time is needed for that its initial position should be including co-locating FDA’s PNC with food shipments than for other changed (See 68 FR 58974 at 58988). CBP staff. Although the FDA and CBP shipments. Another comment states that The Bioterrorism Act established that partnership benefits the prior notice utilizing one system and one set of prior notice be provided by a specified process in many ways, this partnership timelines should provide adequate period of time in advance of the time of does not mean that the PNC no longer notice to FDA and improve compliance the importation of the article of food would have staffing concerns such that with the prior notice requirements. involved or the offering of the food for the prior notice timeframes could be (Response) The timeframes import, which period shall be no less reduced, as the comment implies. Please established in the final rule represent than the minimum amount of time see the discussion later in this the minimum amount of time FDA necessary for the Secretary to receive, document regarding ‘‘Integration of FDA needs to meet our statutory review, and appropriately respond to and CBP timeframes’’ for further responsibility to receive, review, and such notification, but may not exceed 5 discussion on reducing timeframes. respond to prior notice submissions. In days. That means that prior notice must (Comments) One comment noted that accordance with our Joint be submitted before the article of food the time difference between their Implementation Plan, we evaluated the arrives in the United States. Moreover, country and the United States makes it feasibility of conducting prior notice we explained in the IFR that the overall difficult for the agent to start submitting reviews in a reduced time period in an purpose of the Bioterrorism Act is to prior notice immediately upon the effort to more closely harmonize the improve the ability of the United States receipt of necessary information. submissions with CBP timeframes. As to prevent, prepare for, and respond to Therefore, some food transported by air, part of our assessment, we analyzed bioterrorism and other public health as well as by water, has actually missed data regarding prior notices we received emergencies, thereby making essential the appointed timeframe. The comment in the first 9.75 months of fiscal year the ability to examine or hold a suspect requests that prior notice be accepted (FY) 2005—specifically from prior article of food when it first arrives at a until immediately before the arrival of notices received and responded to by port of entry in the United States, rather the food. the PNC between October 1, 2004, and than later at the port where CBP will (Response) FDA disagrees. FDA’s July 23, 2005. Based on the results of process the entry. Thus, the final rule PNSI is available 24 hours a day to our assessment, in the final rule we uses the term ‘‘port of arrival’’ rather submit prior notice. The timeframes have maintained the timeframes that are than ‘‘port of entry’’ as the food may not established in the final rule are the in the IFR: arrive at the port of entry until long after minimum amount of time that FDA • If the article of food is arriving by it has arrived in the United States. In needs to receive, review, and respond to land by road, no less than 2 hours before addition, CBP’s advance electronic prior notice submissions. arriving at the port of arrival; information rule also requires notice in • 2. Integration of FDA and CBP If the article of food is arriving by advance of ‘‘arrival’’ in the United Timeframes land by rail, no less than 4 hours before States, and not at ‘‘entry.’’ arriving at the port of arrival; The IFR and final rule define ‘‘port of (Comments) One comment states that • If the article of food is arriving by arrival’’ and ‘‘port of entry.’’ Neither, ‘‘no shorter timeframes should be air, no less than 4 hours before arriving however, use the terms ‘‘point of allowed.’’ However, the remainder of at the port of arrival; and arrival’’ or ‘‘point of entry.’’ FDA could the comments addressing consistency of • If the article of food is arriving by not find reference to ‘‘point of entry’’ in timeframes between FDA and CBP water, no less than 8 hours before CBP rules or regulations. recommend that FDA timeframes for arriving at the port of arrival. FDA does agree that FDA’s staffing at imported food arriving by air and land FDA and CBP established these certain U.S. ports is much less of an be reduced and be consistent with those timeframes for the IFR based on the issue. Under an MOU between FDA and set forth by CBP in their advanced information available at the time. By CBP signed by the respective electronic information rule. No necessity, though, these decisions commissioners of both agencies on comments recommend aligning the regarding timeframes were not informed

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by actual experience in operating the notice review are discussed in more diminishing returns. When a shipment prior notice program. We now have that detail below. must undergo intensive review, PNC experience, and the information gained To implement the Prior Notice IFR, staff members are reviewing databases during our assessment shows that the FDA established the PNC that operates and sorting through information to minimum timeframes for submitting 24 hours a day, 7 days a week, all days determine whether the shipment poses prior notices contained in the IFR of the year to receive, review, and a potential threat. Reviewing one source closely match the minimum time adequately responds to these notices as of information leads to other sources of necessary for FDA to receive, review, they are submitted. PNC staff is also information to investigate. It would not and respond to the prior notices. During responsible for responding in real-time necessarily be effective to expend, for the assessment period, FDA was able to (by e-mail, fax, or telephone) to example, five staff members on one receive, review, and respond to almost inquiries they receive from affected intensive review at the start because not all notices within the established parties about pending prior notices and/ all sources of information for review are timeframes. In a relatively small number or operational issues. known at the beginning of an intensive of situations, FDA was not able to make The purpose of prior notice is to help review. Doubling or tripling staff, as a decision regarding whether to inspect identify food that potentially poses a discussed in Option 2B of the Final the food at the port of arrival by the end significant health risk to the American Regulatory Impact Analysis of this of the timeframe. In these situations, public and to deploy resources to the document, also would result in a when the food arrived at the port of port of arrival so that inspections can be significant amount of unused office arrival, it was delayed while FDA conducted before the shipment ever space and equipment during the slowest completed its review. The number of enters the United States. Regardless of time periods. Staffing at increased levels such shipments, however, has been whether a prior notice is submitted at all times would result in wasteful relatively low, and the resulting impact electronically to FDA through CBP’s unproductive staff waiting for on government resources and the flow ABI/ACS or FDA’s PNSI, the prior shipments to arrive. notice information undergoes a of traffic at ports has not been Moreover, the constant validation process and is then screened significant. Thus, we do not believe we unpredictability of the submission times should increase the timeframes to against food safety and security criteria. If the results of our initial validation for high risk prior notices requiring the account for this relatively small number indicate that the prior notice shortest timeframe review (2 hours for of outliers whose review takes longer requirements have been met and the food arriving by land via road) is a than the IFR’s timeframes. results of our screening indicate that the significant issue. The exact busiest Our assessment also shows that, shipment does not appear to be a times are variable, and are very difficult because the IFR’s timeframes closely potential bioterrorism or significant to predict on a daily basis. In addition, match the minimum time necessary for public health threat, the submission is PNC targeting for high risk shipments FDA to receive, review, and respond to considered to have satisfied prior notice also varies based on contemporaneous the prior notices, those timeframes requirements and the associated article targeting intelligence and changing risk could not be significantly reduced. If we of food is allowed to proceed for further assessment strategies. Having constant were to change the timeframes to be processing, including FDA admissibility two to three times the number of staff consistent with those of CBP’s advance review under section 801(a) of the act. to cover those short bursts of time when electronic information rule, not only Alternatively, if the results of the initial the highest volume of high risk would this go against the statutory screening of the prior notice information shipments, with the lowest timeframes standard for setting the timeframes, but indicate there is a potential bioterrorism are at their peak would be inefficient it would also significantly increase the or other significant public health threat, and wasteful. number of shipments where FDA would the prior notice undergoes additional In addition, it has been suggested that not be able to decide whether it should intensive review by the PNC using other the PNC reduce their time frames and examine the food at the port of arrival databases and sources of information to hold only those shipments it needs by the end of the timeframe. Based on determine whether the article of food more time to review. There are two very current and projected staffing levels in should be held at the port of arrival for significant reasons why this would be the PNC, such shipments would be examination or should be allowed to impractical. First, from a security delayed at the port of arrival until FDA proceed into 801(a) status for perspective, doing so would result in has either completed its review or admissibility review. PNC personnel holding only potential high risk decided to examine or not examine the make this determination using their shipments at the border and would food at the port of arrival without the experience with imported foods and the make PNC targeting strategies widely benefit of a complete review. FDA could expertise within FDA’s CFSAN for visible and predictable to both those expend additional resources to increase human food or FDA’s CVM for animal involved in legitimate trade, and those capacity to review and reduce the feed, the inspectional information with nefarious pursuits looking to timeframe, but it would be at obtained by FDA’s ORA, and the exploit weaknesses in U.S. food cargo considerable cost to assist a small expertise of CBP. FDA’s goal is to security. Second, the holding of high number of shipments that have complete its review within the 2, 4, or risk shipments at the port would cause difficultly meeting these timeframes. In 8 hour timeframe for submitting prior logistical challenges for port operators, the nearly 4 years since the end of the notice so that the review is complete and would almost certainly have a transition enforcement period for the before the shipment arrives at the port negative impact on all food and nonfood interim final rule, very few shipments of arrival. If the intensive review takes shipments processed through those have arrived without prior notice and as longer than the timeframe and the ports. In contrast, with the current PN such, the timeframes are both shipment arrives at the port of arrival, timeframes which have been in place for reasonable, and economically efficient. then FDA may delay the shipment at the more than 4W years, these logistical The prior notice review process, port of arrival until its review is challenges have been almost information from our assessment, and completed. FDA could increase staffing nonexistent, and PNC targeting the consequences of reducing the at the PNC in order to decrease strategies are virtually transparent to the timeframes for conducting the prior timeframes, but the effect has import trade.

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The other factor to consider is the FDA received the prior notice and timeframes, as we do not know how tremendous growth of imported foods confirmed it for review. Using data many articles of food arriving in the year to year (approximately 14 percent collected on articles of food arriving by United States subject to the prior notice growth over the past 4 years), which far land via truck and car during our requirements are from FAST and C– exceeds what FDA projected in the IFR. assessment period, the PNC expended TPAT participants. Moreover, there are FDA has been able to maintain the an average of 61 minutes to receive, other impediments to integrating prior existing timeframes without adversely review, and make a decision on whether notice with the C–TPAT and FAST impacting trade. Given that we continue or not a shipment should be refused or programs. These are discussed in to expect imports to increase in volume, held for examination under section section III.D.6 of this document FDA does not believe that reducing 801(m) of the act, or allowed to proceed (‘‘Additional Exclusions Requested— timeframes is warranted. For all the into 801(a) status for admissibility Special Programs (C–TPAT/FAST) and above reasons, FDA believes that its review. The PNC completed about 99 Flexible Alternatives’’). current and projected staffing levels are percent of its intensive reviews of prior We also conducted a similar sufficient and appropriate, and the notices submitted for land/road border assessment on prior notices submitted timeframes are both reasonable, and arrivals within 120 minutes of receiving for articles of food arriving by air economically efficient. and confirming the prior notice for between October 1, 2004, and July 23, FDA receives approximately 167,000 review. Only about 57 percent of the 2005. The IFR requires prior notices for prior notices each week. The intensive reviews were completed these shipments to be submitted and distribution of prior notices by mode of within 1 hour. Reviews for the confirmed for review at least 4 hours transportation during our assessment remaining 43 percent (8,900 prior before the food arrives at the U.S. port that were flagged by the initial screening notices for the assessment period, or of arrival. If the timeframes for articles and that received an intensive prior more than 10,000 for FY 2005) took of food arriving by air during our notice review by the PNC is as follows: longer. If the timeframe were set at 1 assessment period had been reduced to hour for these articles of food instead of ‘‘wheels up,’’ the PNC would not have TABLE 1.—PROPORTION OF PRIOR the IFR’s 2 hours, the PNC would have completed approximately 21 percent of NOTICES FLAGGED AT THE INITIAL had to either delay the food at the port the intensive prior notice reviews for articles of food with flight times less SCREENING, BY MODE OF TRANS- of arrival until it completed its review than 3 hours. These articles of food PORTATION or decide whether to examine the food at the port or arrival without the benefit (2,700 for our assessment period, or an Truck 27.6% of a complete review, based on current estimated 3,230 for FY 2005) also would and projected staffing levels in the PNC. have been subject to cargo delays and/ Car 2.9% or increased cargo examinations, based FDA does not have data to accurately on current and projected staffing levels Air 17.6% analyze the impact of changing the in the PNC. timeframe to 30 minutes for FAST Neither FDA nor CBP have sufficient Rail 0.8% participants because FAST membership personnel or resources to accommodate is not one of the data elements that we Sea 39.2% the number of additional cargo delays currently require in a prior notice and/or food shipment examinations that Mail 11.1% submission. FDA instead did the would result under either 60- or 30- analysis based on the total number of minute timeframes for articles of food Other 0.8% prior notices submitted that the PNC arriving by land by road. This would could review based on a timeframe of 30 include the significant additional As indicated, a significant portion minutes. The PNC completed less than personnel and resources needed to (approximately 31 percent) of the prior 10 percent of its intensive reviews of track, facilitate, and coordinate the notices reviewed by the PNC on a daily prior notices submitted for land/road evaluation and/or examination of the basis are land/road border entries, border arrivals within 30 minutes of delayed cargo. Coordination of the which under the IFR are subject to receiving and confirming the prior handling of delayed shipments is a submission timeframes of at least 2 notice for review. If the timeframe for all resource intensive process that can last hours before arrival. On average, during articles of food arriving by land by truck for multiple days per shipment, and the assessment period, the PNC and car during our assessment period includes communicating with both FDA conducted intensive security reviews on had been 30 minutes (i.e., the and CBP personnel at the border, and 225 to 250 prior notices per day from all timeframes for FAST participants) the brokers/filers and importers modes of transportation, which means instead of 2 hours, the PNC would not involved in the shipment. that, on average, the PNC conducted have completed approximately 68 To handle the extra work, the PNC intensive security reviews on about 77 percent of its intensive reviews (over would need to shift its personnel based prior notices (31 percent of 250) each 14,000 during the assessment period, on current and projected staffing levels day that are subject to the 2–hour which equates to approximately 16,000 in the PNC, resulting in fewer staff being timeframe. Moreover, the prior notices for FY 2005 of the land/road border available to review prior notices for all are not evenly distributed over an 8 prior notices) within the applicable categories of shipments including hour shift or 24–hour day. The actual timeframe. As a result, the PNC would shipments arriving by water. The PNC’s dispersal pattern of the prior notice have had to either delay the food at the current approximate average time for submissions is not uniform; an port of arrival until it completed its the PNC intensive review for shipments overwhelming majority of prior notice review or decide whether to examine arriving by water is 5 hours, which is submissions arrive between a certain the food at the port of arrival without within the 8 hour submission 12–hour period. the benefit of a complete review, based timeframe. We would expect, based on The amount of time the PNC has on current and projected staffing levels our assessment, that the time taken needed for its intensive review has in the PNC. This assessment is an away from prior notice review work for ranged from 20 minutes to 315 minutes overestimate of the number of articles of the increase in coordination due to the (5 hours and 25 minutes) from when food that would be eligible for FAST increase in delays and examinations for

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land and air shipments would increase number of intensive reviews to continue CBP is planning to bring its ACE system the time needed to complete intensive to increase relative to the assessment on line in the next few years, which will review of prior notices for shipments period, resulting in even more food accommodate prior notice submissions arriving by water by 25 percent at the shipments that would be delayed or and eliminate or change ABI/ACS and minimum. As a result, over 7,000 held for examination under shortened PNSI prior notice submissions. FDA shipments by water during our timeframes. will continue to assess and pursue the assessment period (estimated as 7,370 We did not get any comments asking integration of timeframes as policies, for FY 2005) would have been delayed us to coordinate the timeframes for processes, and strategic IT systems are at the port of arrival while the PNC articles of food arriving by water in our improved. FDA believes that the most completed its intensive review and prior notice rule (8 hours before arrival) opportune time for coordinating determined whether the shipment in with those in CBP’s rule (24 hours timeframes will coincide with the fact presented a significant health before arrival). We received one startup of CBP’s ACE. We will threat, based on current and projected comment asking us to reduce the time determine at that time or after ACE is staffing levels in the PNC. for articles arriving by water. We stated operational whether the prior notice In setting the timeframes, the act in the preamble to the IFR ‘‘In timeframes should and can be reduced provides that we may consider, among determining the actual timeframes for further. Until that time, the timeframes other considerations, the effect on submission of prior notice for each for submission of prior notice will commerce (section 801(m)(2)(A) of the mode of transportation, FDA considered remain the same in the final rule as act). Assuming current and projected the need to provide sufficient time for issued under the IFR (see § 1.279). PNC resources, lowering the timeframes the agency to review and respond to the to 60 or 30 minutes would likely result information submitted, as well as the 3. Phase-In of FDA and CBP Timeframes in delays at the border, not only for current ability of the food industry to When FDA reopened the comment those shipments delayed for intensive provide the information required within period for the IFR on April 14, 2004 (see review longer than the timeframe, but the stated timeframe given the 69 FR 19763), FDA asked Flexible also for other shipments passing differences in lead time before arrival Alternative Question 6: ‘‘If FDA adopts through the port, especially at the among different modes of reduced timeframes in the prior notice busiest land border ports where traffic transportation. We determined that final rule, should FDA phase in the lanes, parking, and inspection facilities information for shipments whose shorter timeframes as CBP phases in the are extremely limited. In some ports, the transport time is measured in days or advance electronic information rule?’’ lack of holding facilities could result in weeks (e.g., ocean shipments) is (Comments) Most comments an increase in trucks being turned available further in advance of arrival recommend integration of the phase-in around at the border. As we have than shipments whose transport time is of reduced timeframes in association mentioned above, there have been a measured in hours (e.g., land and air with CBP’s schedule to promote relatively small number of situations shipments.) Staggered prior notice consistency between the programs, where FDA was not able to make a submission timeframes will allow FDA reduce errors, and minimize disruption decision regarding whether to inspect reviewers to direct additional resources of supply chains through conflicting the food at the port of arrival by the end to shipments with short transport times requirements. However, one comment, of the timeframe, causing a small and to defer review of shipments with in addition to recommending adherence number of shipments to be delayed longer transport times. Based on these to CBP’s phase-in schedule, also notes when it arrived at the port of arrival. considerations, FDA established the that they would not want FDA to delay Since the impact of these small number prior notice timeframes in the interim adopting a reduced timeframe for of delays on trade has not been final rule to associate with the mode of submitting prior notice merely because significant, continuing to maintain that transportation.’’ (69 FR at 58995). We CBP is not yet ready to implement the the current IFR timeframes is the most continue to hold this view for counterpart provisions of its advance efficient use of resources. shipments arriving by water in light of notice programs. In addition, they state Thus, based on current and projected our assessment for articles of food that the deadlines are minimum resources and other high-priority arriving by land and air. periods, and any shipper can provide activities FDA is addressing, reducing For all of the previously stated more notice of imports, to FDA, CBP or the timeframes would lead to an reasons, we did not reduce the both, than the minimum timeframes in increase in delays at the ports of arrival, timeframes for submitting prior notice either regulation. They recommend that causing FDA to shift some resources in the final rule for any mode of FDA should shorten its lead times to away from conducting intensive reviews transportation, as these timeframes still match those in the CBP regulations, of prior notices so they can conduct the are the minimum amount of time FDA even if the CBP requirements are not yet coordination and other activities needs to fulfill its statutory obligation to in place. Another comment states that necessary for these delayed shipments. receive, review and respond to prior the phase-in plan, which is a port-by- The shift in resources away from notices while having the minimal port implementation according to a time conducting intensive reviews would, in impact on trade. schedule, would be very problematic to turn, further increase the number of (Comments) One comment suggests industry. The comment further explains shipments that are delayed because FDA that it would be preferable for FDA to that systems and operations do not has not been able to finish its intensive harmonize the prior notice timelines to necessarily have the flexibility to switch review within the applicable the future ACE transmission timelines, on by individual site or location and the submission timeframe. This ultimately ensuring consistency and compliance of current plan would introduce would cause a delay in getting cargo to the trade community and efficiencies in complication and confuse the trade its final destination, which would have both agency and industry workforces. community. The comment recommends an adverse impact on trade. (Response) FDA agrees that further discussion with CBP and FDA as Moreover, the number of prior notices timeframes for submission of prior to development of a more viable and identified for intensive review has notice may be further evaluated in light achievable implementation plan. increased over time, as intelligence and of new trade programs such as ACE, (Response) This issue is moot, as the other risks are identified. We expect the when it is implemented and in effect. final rule retains the timeframes

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established in the IFR, for the prior notice confirmation number must shipment allowed to proceed. This previously stated reasons. accompany any article of food for which would not be the case if there was only the prior notice was submitted through one prior notice confirmation number 4. Prior Notice Confirmation Number the FDA PNSI when arriving in the for the entire shipment. (Comments) One comment asks for United States and must be provided to 5. 5-Day Maximum Pre-Arrival clarification regarding when the prior CBP and FDA upon arrival. How Limitation notice confirmation number is required persons importing or offering for import to accompany the food. food into the United States choose to (Comments) Many comments (Response) The prior notice comply with this requirement is a requested that prior notice be allowed to confirmation number must accompany private matter (e.g., persons may decide be submitted more than 5 days before any article of food arriving by to specify these obligations in the arrival. This would allow exporters to international mail, when the food is contract between the exporting complete their documentation at the carried by or otherwise accompanying company and the carriers to ensure that same time the bill of lading and health an individual, or when the prior notice the logistics are worked out in advance). certification is usually completed in the was submitted via FDA’s PNSI. (Comments) Comments stated that the case of food shipped by water. One Under § 1.279(e), the prior notice data requirements should be reassessed comment contends that the 5 day limit confirmation number must accompany to simplify and make the requirements does not reflect the variable and any article of food arriving by more manageable. The comment states unpredictable nature of transport and international mail. Under § 1.279(f), a that one data element should link all does not reflect a risk-based approach to copy of the confirmation (with the prior information secured by prior notice, a potential bioterrorism threat. Another notice confirmation number) must which would be beneficial for locating comment contends that the limitation of accompany any article of food carried shipments in the event of a possible the timeframe to 5 days is problematic by or otherwise accompanying an crisis. The comments suggest that FDA and is due to a misinterpretation of the individual (unless excluded under use bill of lading numbers as a single statute. The comment asserts that the § 1.277 (b)(1)), and be provided to CBP reference point because all shipments statutory language does not preclude a or FDA upon arrival. Additionally, that are moved are repeatedly covered party from voluntarily providing prior under § 1.279(g) the prior notice by this number. This would render the notice more than 5 days in advance. The confirmation number must accompany prior notice confirmation number comment also maintains that 10 days any article of food for which the prior currently used redundant. prior to arrival would provide the notice was submitted through the FDA (Response) FDA does not agree that necessary flexibility for their industry. PNSI when arriving in the United States the waybill/Bill of Lading can be used A foreign government, apparently and must be provided to CBP and FDA as a single reference point for all assuming that prior notice must be upon arrival. shipments instead of the prior notice submitted by the foreign shipper or (Comments) One comment asked FDA confirmation number. A Bill of Lading exporter, recommends that the time to confirm whether it is sufficient for an number is not always assigned to a should be extended because it may take ocean carrier to have the prior notice shipment at the time of prior notice the shipment 2 weeks to reach a U.S. confirmation number on arrival or submission. For certain shipments, such port. whether they are required to have the as those sent by international mail, no (Response) In response to the actual prior notice confirmation also. Bill of Lading may exist. Thus, FDA has concerns raised by the comments, we (Response) Under § 1.279(e), the prior determined that it is better to use a have revised § 1.279(b) to allow notice confirmation number must unique confirmation number provided submission of prior notice more than 5 accompany any article of food arriving by the FDA system to transmitters. days before arrival (except for articles of by international mail. Additionally, (Comments) One comment notes that food imported or offered for import by under § 1.279(g) the prior notice a separate prior notice is required for international mail). Specifically, this confirmation number must accompany each distinct food product and a prior provision permits prior notice any article of food for which the prior notice confirmation number is returned submissions to be submitted no more notice was submitted through the FDA for each prior notice. Therefore, if a than 30 calendar days before the PNSI when arriving in the United States shipment consists of multiple food anticipated date of arrival for and must be provided to CBP and FDA products, the carrier would have submissions made through ABI/ACS upon arrival. Therefore, although a prior multiple prior notice confirmations and no more than 15 calendar days notice confirmation number is required, upon arrival. The comment states before the anticipated date of arrival for the final rule does not require that the multiple prior notice confirmations do submissions made through PNSI. Due to actual prior notice confirmation has to not align well with the commercial system limitations, the timeframes be supplied for food arriving by ocean realities of international trade, where between ABI/ACS and PNSI are not carrier. the focus is on the entire shipment, not identical. Also, because of the way ABI/ (Comments) One comment states that the individual components. The ACS is programmed, when prior notice when food arrives in the United States, comment recommends that FDA is submitted through ABI/ACS, the prior the carrier should present a copy of the provide a prior notice confirmation notice confirmation number cannot be prior notice confirmation and the food number that encompasses the entire provided more than 5 calendar days to CBP. The comment asks if the shipment. before the anticipated date of arrival. submitter should send the prior notice (Response) FDA disagrees. The carrier Please note that if any of the prior confirmation to the carrier company or could be carrying articles of food for notice information, except the to the vessel that transported the food to different submitters or recipients. If it anticipated arrival information, the the United States. was necessary to hold an article of food, estimated quantity, or the planned (Response) As stated previously, the entire shipment would be held shipment information, changes after § 1.279(e) requires the prior notice under the above scenario suggested by FDA has confirmed the prior notice confirmation number to accompany any the comment. Under the final rule, the submission for review, the prior notice article of food arriving by international article of food that is subject to a hold must be resubmitted, as provided by mail. Additionally, under § 1.279(g) the can be offloaded and the rest of the § 1.282(a). The resubmission must be

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confirmed by FDA for review no less confirmation number, must accompany 1. General Comments than 2, 4, or 8 hours before arriving at any article of food that is subject to this the port of arrival, with the minimum subpart when it is carried by or (Comments) One comment suggests time depending on the mode of otherwise accompanies an individual that FDA should have CBP collect and transportation (§ 1.279(a)). If prior when arriving in the United States. The review all prior notices with one prior notice is resubmitted, the previous prior copy of the confirmation must be notice submission timeframe for all notice should be cancelled (§ 1.282(b), provided to CBP or FDA upon arrival. agencies. (c)). Under § 1.279(g), the prior notice (Response) FDA disagrees. The Bioterrorism Act, while providing for 6. International Mail confirmation number must accompany any article of food for which the prior the ability to commission other agencies (Comments) There were no comments notice was submitted through the FDA to help implement the provisions of the received regarding the timeframes PNSI when the article arrives in the Bioterrorism Act, specifies that the established for prior notice covering United States and must be provided to Secretary is to receive prior notice for food arriving by international mail. CBP or FDA upon arrival. all food imported or offered for import (Response) FDA retained the into the United States. FDA personnel timeframes for submission of prior G. How Must You Submit the Prior are trained and knowledgeable about the notice for food arriving by international Notice? (§ 1.280) risks and hazards involving food mail that are in the IFR. Section 1.280 of the IFR required that products under its jurisdiction and have (Final rule) The final rule at § 1.279(a) prior notice must be submitted the expertise to review the prior notice requires that you must submit prior electronically to FDA in the English submissions. The integration of prior notice to FDA and the prior notice language, except that an individual’s notice submission timeframes is submission must be confirmed by FDA name, the name of a company, and the discussed earlier in this document for review as follows: If the article of name of a street may be submitted in a under the discussion for § 1.279. food is arriving by land by road, no less foreign language. All information, (Comments) Several comments than 2 hours before arriving at the port including these items, must be suggest allowing the option of of arrival; if the article of food is submitted using the Latin (Roman) submitting prior notice by fax or mail arriving by land by rail, no less than 4 alphabet. The IFR provided for two because not everyone has Internet hours before arriving at the port of methods of electronic submission of capability, access to a computer, or arrival; if the article of food is arriving prior notice: (1) The CBP ABI/ACS; or proficiency in English. One comment by air, no less than 4 hours before (2) FDA PNSI at http:// asks that they be allowed to continue arriving at the port of arrival; or if the www.access.fda.gov. sending prior notice by fax (as is article of food is arriving by water, no The IFR required submission of prior allowed during certain contingency less than 8 hours before arriving at the notice via FDA’s PNSI for articles of situations). Several other comments port of arrival. food imported or offered for import by suggest that international mail shippers Under § 1.279(b), except in the case of international mail, other transaction are at a disadvantage because many mail an article of food imported or offered for types that cannot be made through ABI/ customers have no access to the import by international mail, prior ACS, and articles of food that have been Internet, the pre-notification system is notice may be submitted no more than refused under section 801(m)(1) of the not customer-friendly, entries take a 30 calendar days before the anticipated act and 21 CFR part 1, subpart I. long time, and the data requirements are date of arrival for submissions made The IFR also provided for too complex and difficult for customers through ABI/ACS and no more than 15 to determine. calendar days before the anticipated contingencies if certain systems were (Response) FDA does not agree that a date of arrival for submissions made not working, e.g., a custom broker’s or process for manual transmission is through PNSI. self-filer’s system, ABI/ACS, PNSI, or Under § 1.279(c), if the article of food OASIS. The IFR required that prior needed, except on a contingency basis. is arriving by international mail, the notice must be submitted through PNSI FDA believes that persons engaged in prior notice must be submitted before if a custom broker’s or self-filer’s system international commerce have, or can get, the article of food is sent to the United or if the ABI/ACS interface is not access to the Internet. If the Internet is States. working. The IFR also required that not accessible by the submitter, he or Under § 1.279(d), FDA will provide prior notice must be submitted via e- she can use a customs broker to submit notification that the prior notice has mail or fax if PNSI or OASIS is not prior notice through ABI/ACS or been confirmed for review with a reply working. The IFR did not exempt any another person to transmit prior notice message that contains a prior notice specific categories of food articles from through the FDA PNSI. Allowing confirmation number. The prior notice prior notice if systems are not manual transmission would not give will be considered submitted and the performing. adequate time for FDA personnel to prior notice review time will start when In August 2004, FDA and CBP receive, review, and respond, unless the FDA has confirmed the prior notice for published guidance covering a timeframes for prior notice in the final review. Contingency Plan for System Outages. rule were greatly extended. Thus, Under § 1.279(e), the prior notice This guidance can be accessed at http:// manual transmission will be used only confirmation number must accompany www.cfsan.fda.gov/~pn/pndguid.html. as a contingency alternative. any article of food arriving by Comments addressing contingencies FDA also notes that the data quality international mail. The prior notice will be discussed later in this section. of manual systems is usually less than confirmation number must appear on Comments regarding how to submit satisfactory, because no automated data the Customs Declaration that prior notice are addressed according to validation takes place during data entry. accompanies the package. We provide issue: General comments; comments The U.S. Government has a strong CN22 or CN23 or a U.S. equivalent as about the ABI/ACS and PNSI systems, commitment to reducing paper-based examples of the Customs Declaration. including technical issues and security processes and moving toward e- Under § 1.279(f), a copy of the of the systems; and comments about commerce for all business transactions. confirmation, including the prior notice contingencies. Accordingly, under the final rule, paper-

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based submissions will not be allowed, FDA again notes that it has determination and the admissibility except on a contingency basis. compliance policies that address some determination.) In response to the comment that of the concerns raised by the comments. (Comments) One comment suggests international mail shippers are Its compliance policy under the IFR had the agencies should synchronize the disadvantaged, FDA also notes that it been that ‘‘FDA and CBP should different filing systems so as to ensure has compliance policies to address this typically consider not taking any that all notices can be made via situation. Its compliance policy under regulatory action when an article of food Automated Manifest System (AMS). the IFR had been that ‘‘FDA and CBP is imported or offered for import for Other comments request FDA to should typically consider not taking any non-commercial purposes with a non- coordinate prior notice with CBP’s AMS regulatory action when an article of food commercial shipper’’ without prior to eliminate duplication of data is imported or offered for import for notice. This applied to all such food submissions. non-commercial purposes with a non- subject to prior notice, including food (Response) FDA disagrees. No commercial shipper’’ without prior shipped by international mail. The Prior interface currently exists between AMS notice. This applied to all such food Notice Final Rule Draft CPG, announced and the existing interface with FDA’s subject to prior notice, including food elsewhere in this issue of the Federal OASIS through the ABI/ACS entry shipped by international mail. The Prior Register, would continue that processes, which means FDA does not Notice Final Rule Draft CPG, announced enforcement policy. FDA believes that have access to AMS data. FDA and CBP elsewhere in this issue of the Federal this proposed compliance policy should have discussed interfacing with AMS Register, would continue that not be extended to food that is imported for manifest data and determined that enforcement policy. or offered for import for commercial the general cargo data in AMS are not suitable to accommodate the detailed (Comments) One comment suggests purposes or with a noncommercial information requirements of section that instead of submitting prior notice shipper without prior notice. Mail 801(m) of the act. For example, AMS via PNSI, mail shippers be allowed to shipments associated with a commercial does not collect the country of origin. In complete an alternate form requiring purpose pose a higher risk with respect addition, its collection of the identities minimal information that is similar to to ability to reach a greater number of of the article of food and its the Customs Declaration form in the people, and most commercial entities manufacturer differs from the way those native language to be completed at the already are familiar with submitting information to FDA and CBP. are collected under the prior notice post office. This comment argues that interim final and final rules in such a (Comments) One comment proposes a the current requirements are too way that the data would not meet our two-step process for filing prior notice, cumbersome for the average consumer. needs in carrying out the purpose of whereby FDA would accept the same Similarly, another comment suggests section 801(m) of the act. that FDA accept Customs Declaration data submitted for CBP ABI to satisfy (Comments) One comment urges FDA Forms CN22 and CN23 in lieu of the prior notice requirements at the first to upgrade its systems to coincide with submitting prior notice via PNSI for port of arrival. Then, after accepting ABI normal commercial flow times and mail shippers. This comment argues data at the port of arrival, complete recommends that FDA consider the that such forms are much easier to prior notice data would be filed at the approach used by the Census Bureau, complete and are official documents port of entry as step two of the process. i.e., providing a range of automated prescribed by the Universal Postal The comment contends that utilizing filing options for meeting electronic Convention and are used around the ABI data for prior notice at the port of filing requirements by offering an world. In the alternative, this comment arrival would allow faster processing, Internet application, a direct link for suggests that FDA accept data submitted which is a significant issue considering certified filers, and a personal computer by mail shippers via PNSI in a FDA’s concern about timely processing (PC)-based application. condensed form determined by the of prior notice under a shorter time (Response) FDA provides two foreign government’s postal agency. schedule. This more complete data methods for submitting prior notice: (Response) FDA disagrees. Section would be filed concurrent with the CBP One via ABI/ACS (a PC-based link for 801(m) of the act requires the prior clearance entry, and therefore provide certified filers) and another via PNSI (an notice submission to contain certain FDA with the level of data desired, Internet-based application). Prior notice data elements, such as the identity of while removing the issue of time is not required to be filed at a specific the article of food, manufacturer and constraints under a reduced schedule time or during specific hours of the day, shipper of the article, grower, country measured against the port of arrival. but may be submitted 24 hours/day, 365 from which the article originates, (Response) FDA disagrees. The days of the year. The rule requires FDA country from which the article is purpose of section 801(m) of the to receive the prior notice before the shipped, and the anticipated port of Bioterrorism Act is to ensure that FDA food arrives in the United States, and entry of the article. Customs Declaration has sufficient information before arrival the time frame is based on the mode of Forms are not adequate substitutes for so it can determine what foods to transportation (see § 1.279). providing this information to FDA since inspect at the border. Therefore, all (Comments) One comment suggests such forms do not typically require this information required for prior notice that FDA participate in the International kind of comprehensive information. must be submitted prior to arrival, not Trade Data System (ITDS), which Likewise, allowing a foreign just a portion of the information. provides for one-window filing of trade- government’s postal agency to Additional information may be related information by motor carriers determine which information to submit required after arrival and for entry and other parties through CBP’s ACE to FDA also does not guarantee that we admissibility decisions. That process is system, to more effectively execute its will receive the information required by completed after arrival for those foods Bioterrorism Act mission. section 801(m) of the act. Therefore, offered for consumption in the United (Response) FDA is actively FDA has not provided an alternative States. (See 68 FR 58974 at 58976 in the participating in the development of form of prior notice submission for food preamble to the IFR for additional CBP’s ACE system and has long been a arriving by mail for commercial discussion about the relationship and participant in the ITDS. However, ACE purposes. differences between the prior notice is not yet a complete reality and prior

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notice requirements have been in effect this time. The cost of updating the 3. Technical Issues Concerning Both since December 12, 2003. FDA is translations as new versions of the Systems working with CBP and others in the system are developed would also be (Comments) One comment suggests international trade community to ensure substantial. In addition, FDA notes that that both systems provide a link to HTS that the prior notice requirements are other import documents required by codes. reflected in ACE once ACE is fully FDA and by CBP must be filed in (Response) FDA agrees. Both PNSI operational. English. Therefore, FDA does not plan and ABI/ACS provide a link to HTS (Comments) One comment notes that to program PNSI in other languages and codes. FDA also has provided guidance exporters use different kinds of the final rule will continue to require regarding HTS codes and a companion transmission formats to send prior submission of prior notice in the list of HTS codes flagged with prior notice-related information to importers notice indicators. The guidance is or brokers in the United States. The English language. posted at http://www.cfsan.fda.gov/ comment further states that since none FDA and CBP nonetheless have taken ~dms/htsguid3.html and the updated of its member companies have received into account many of the concerns list is posted at http:// any notice from FDA requesting changes referenced in the comments. For www.cfsan.fda.gov/~pn/htscodes.html. in content or formatting of the example, the final rule does not apply (Comments) One comment states that transmitted information, they assume to homemade foods shipped from an railroads will not load cargo until a that FDA is satisfied with their individual to an individual in the prior notice confirmation number is industry’s approach to regulatory United States (see § 1.277, Scope, provided, and a prior notice compliance. In the event that FDA discussed supra). In addition, the confirmation number cannot be requires a change to format or content agencies’ compliance policy under the of the reporting now conducted, the provided without complete planned IFR had been that ‘‘FDA and CBP shipment information, including a comment requests that FDA notify should typically consider not taking any companies well in advance of any such railcar number. regulatory action when an article of food requested change. (Response) FDA notes that, while this (Response) FDA receives prior notice is imported or offered for import for situation seemed to be an issue early in information via ABI/ACS or PNSI. FDA non-commercial purposes with a non- the implementation of the prior notice expects that the transmitted information commercial shipper’’ without prior IFR, it is our understanding and discussed in the comment is submitted notice. This applied to all such food experience that the rail industry has to FDA via one of these two methods in subject to prior notice, including food now changed business practices to the proper format. If the information is shipped by international mail. The Prior address this concern. FDA received only inaccurate, the food is subject to refusal. Notice Final Rule Draft CPG, announced one comment on this issue and has not Customs brokers are notified using elsewhere in this issue of the Federal received any other feedback to suggest typical procedures regarding any Register, would continue that this matter is still of concern. A check changes relating to the rule that require enforcement policy. with a large rail shipping company an IT change to ABI/ACS, including a revealed that the restrictions for loading (Comments) One comment requests cargo are not at issue; i.e. rail cars can 90-day lead time before implementation that other pieces of the prior notice of the IT change. FDA also provides be physically loaded with shipments system also be available in other tutorials on its Web site that explain containing food prior to obtaining prior languages, such as the tutorials for changes to PNSI (see http:// notice (Ref. 1). Therefore, the prior www.cfsan.fda.gov/~pnts/pnsitut.html). determining the FDA product code. notice filer does have the ability to Another comment suggests that FDA obtain the rail car number in order to 2. English Language provide foreign governments and trade file prior notice. The rail company did (Comments) Many comments suggest organizations with a detailed outline of however indicate that rail cars are not that FDA program PNSI in other the ‘‘prior notice form’’ with connected/added/attached to the U.S. languages, such as Japanese, Korean, explanations of the individual in-bound train until the rail company German, and Spanish. These comments requirements so that they could be receives documentation that prior notice state that ‘‘mail users’’ must rely on translated into a foreign language and has been filed. PNSI to submit prior notice, and in provided to affected companies. (Comments) One comment states that many cases, English may not be the (Response) While many of the the FDA Help Desk, and other methods now established for resolution of native language for many of these users documents regarding prior notice operational issues, simply are not and puts them at a disadvantage, e.g., requirements have been translated into foreign filers experience higher burdens yielding a workable ‘‘fix’’ to the ‘‘kinks’’ other languages, the PNSI tutorials and are frequently being timed out of in the new PNSI/ABI system. Another (available at http://www.cfsan.fda.gov/ PNSI because it takes them longer to comment recommends the ~pnts/pnsitut.html) and the FDA complete a prior notice. One comment establishment of a system for swift argues that a reason for noncompliance Harmonized Tariff Schedule Codes resolution of technical and operational guidance (available at http:// of prior notice requirements is the ~ problems for both systems. inability to understand English well www.cfsan.fda.gov/ dms/ (Response) FDA agrees and has enough to submit prior notice via PNSI. htsguid3.html) have not been translated. established an FDA Help Desk to deal (Response) FDA agrees that a system FDA intends to continue translating with technical issues involving PNSI. available in multiple languages would these and other prior notice documents Questions and concerns about be advantageous for some users. as resources permit. Documents that are operational, rather than technical, However, the agency has assessed the available in other languages are posted problems involving prior notice should feasibility of providing and maintaining at http://www.cfsan.fda.gov/~mow/ be directed to FDA’s PNC. While the PNSI in multiple languages, and has internat.html. Foreign governments and FDA PNC is available 24 hours a day, determined that the cost of developing trade organizations are welcome to 7 days a week to respond to operational translations into one or more additional translate these documents and provide issues, it is not equipped to resolve languages cannot be accommodated at them to affected companies. technical issues involving PNSI or ABI.

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However, the PNC has a process in take an hour or more to receive the prior OA Record,5 as has always been done place to handle calls involving technical notice confirmation number that is for FDA disclaims. issues and will forward those calls to needed to move the cargo. Another (Comments) One comment believes the Help Desk. CBP also has a well- comment states that there have been there is a problem with the in-bond established system of client several instances when the confirmation system. The comment states that if it is representatives to deal with technical response has been delayed and asks assumed that a shipment arrives in Los problems involving ABI/ACS. CBP FDA to improve the timeliness of this Angeles, but is destined for in-bond client representatives are available to response. travel to New York, the shipment is assist users with ABI issues. ABI subject to prior notice upon arrival. In operational issues are the sole (Response) Generally, for prior notice order to properly comply with CBP responsibility of CBP. submission via PNSI, the user should requirements, the arrival date is entered (Comments) One comment states that receive their confirmation number based upon the expected arrival date in the systems go down from time to time, immediately upon submission of the New York. The data exchange between and all the time-consuming entry-work correctly completed form. For those CBP and FDA is then triggered by the has to be repeated. prior notices submitted via ABI on the New York arrival date rather than the (Response) PNSI has been enhanced anticipated date of arrival, users can Los Angeles arrival date. The comment to allow copying and saving of prior expect to receive a response message is concerned that prior notice could be notices within a Web entry and copying (confirmation number or rejection) transmitted in a timely manner to CBP, of a Web entry, with or without the within 15 minutes of submission. For but be held up due to computer associated prior notices. Copying allows ABI submissions submitted prior to the programming, making the prior notice you to avoid repetitive data entry for anticipated date of arrival, users can untimely. The brokers have fixed this similar Web Entries and associated Prior expect to receive their response message problem in the short term by inputting Notices. You also may cancel a Web no later than midnight (Eastern Time) the Los Angeles arrival date in both Entry and then copy it, to correct errors on the anticipated date of arrival. places for prior notice purposes and in a Web Entry you have already then changing it after prior notice has (Comments) One comment states that completed. Instructions for copying a concluded. Web entry prior notice are available on there are glitches in the software that (Response) The anticipated arrival FDA’s Web site at http:// has been released. The comment notes ~ date is a requirement of prior notice and www.cfsan.fda.gov/ pn/ that perfume is a nonfood product that is independent of CBP entry pnstep2.html#copywe. ABI users are is subject to FDA’s 801(a) jurisdiction, requirements. The Bioterrorism Act responsible for their own software and but it does not require prior notice. requires submission of prior notice its capability to save and/or copy However, in a procedures memorandum before the food arrives in the United information that has not been from CBP, it appears that if you disclaim States, and not upon arrival as stated in transmitted. FDA in FD3, it is disclaimed for all the comment. Therefore, in the example (Comments) One comment urges FDA purposes. Similarly, if you acknowledge provided, prior notice is required before to harmonize their efforts with CBP with FDA jurisdiction in FD3, then prior the article of food arrives in Los Angeles respect to the prior notification of food notice must be submitted whether or not notwithstanding any other CBP entry articles and to work with CBP to the importation involves food. requirements. integrate its joint administration and For ABI entries requiring prior notice, enforcement of prior notice for both CBP (Response) We have provided the filer must enter separate dates for and FDA. One comment recommends instructions describing how to disclaim purposes of entry and prior notice. The that both the FDA and CBP systems be an article for prior notice, while still filer enters an anticipated arrival date at simplified to allow for both a decrease sending information required for FDA the entry header level for CBP. For in data entry time and a more efficient 801(a) admissibility. The instructions purposes of prior notice, the filer also method for multiple data entries. were included in at least four separate enters the anticipated arrival date as an (Response) FDA agrees and is ABI Administrative Messages issued by affirmation of compliance code ‘‘ADA.’’ continuously working with CBP to make CBP beginning in March 2004 (e.g., Therefore, there should not be a the administration and enforcement of Administrative Message 04–0586, dated problem with choosing which date to prior notice as integrated and efficient March 24, 2004). If merchandise marked submit as raised by the comment. as possible. Both agencies recognize that FD3 in the Tariff Record is subject to (Comments) One comment suggests ACE, when initiated, will allow for a prior notice and 801(a) reporting that the systems provide a drop down more harmonized process. requirements, the required prior notice list of reasons that provide an With respect to multiple data entries, and 801(a) information should be PNSI does offer several features that explanation for the absence of the transmitted. In cases where 801(a) registration number. make prior notice data entry faster and information is required, and prior notice reduce the amount of redundant data (Response) FDA agrees. In the information is not required, filers November 2004 revision of the CPG that entry, such as the Copy Web Entry should transmit the ‘‘PN disclaimer’’ feature, Copy Prior Notice feature, and explained how FDA intended to enforce (PND) and the information required for the prior notice IFR, a list of reasons other shortcuts. Please refer to Time 801(a). In this case, the PND Affirmation Saving Tips from the FDA PNC for PNSI was provided as Appendix 1, Reason of Compliance (AofC) code must be the (http://www.cfsan.fda.gov/~pn/ Codes for Registration Number of first AofC code recorded (FD01 Record- pntips.html) for a description of these Manufacturer Not Provided. This list of Positions 20–22) in the ABI features. Many private ABI software reasons is available in both PNSI and programs also have features that provide transmission. The PND affirmation does ABI/ACS, and the reasons are available a means for multiple data entries. not require a qualifier. If the as a drop down menu in PNSI. ACS is (Comments) Several comments merchandise marked FD3 represents an 5 express concern about the timeliness of article exempt from all FDA reporting This is a ‘‘Conditional Other Government requirements, the line should be Agency Declaration’’ input record that provides a receipt of the prior notice confirmation code indicating that there are/are not other number. One comment states that it can disclaimed using the FD0 marker in the government agency review requirements.

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programmed in ‘‘batch mode’’ which (Comments) One comment points out who contracts with a filer who is does not lend itself to drop down that some problems with electronic licensed and approved by CBP to use menus. CBP also has issued submission of prior notice are being ABI/ACS. The submitter provides the Administrative Messages to ABI filers in encountered by virtue of the fact that filer with the information necessary to December 2004 and March 2005 not all brokers interact with FDA in a transmit a complete prior notice through concerning these reason codes. The completely electronic environment. ABI ABI/ACS to FDA. This process is often Prior Notice Final Rule Draft CPG that allows for the fully electronic used to combine the prior notice and is announced elsewhere in this issue of transmission of CBP and FDA data, but entry processes and many importers and the Federal Register provides an ‘‘dual mode’’ brokers must also submit foreign exporters find this to be the most updated list of reasons to be used in information to FDA in paper form. The advantageous process. FDA and CBP certain limited situations when the comment recommends that FDA provided the ability to use ABI/ACS in manufacturer’s facility registration encourage all brokers to participate in response to comments to the proposed number is not provided in a prior notice paperless electronic processing. rule. As expected, the ABI/ACS process submission. (Response) ‘‘Dual mode’’ filers are is used in around 83 percent of prior (Comments) One comment those who must submit paper entries notice transmissions. PNSI was recommends that the required data when transmitting entry information for developed for those submissions that elements be identified so that shippers FDA admissibility consideration. cannot be accommodated by ABI/ACS, will know which elements are However, for prior notice, any customs and for those who choose not to use a mandatory and which are not. broker or self-filer, including ‘‘dual customs broker for prior notice (Response) In the preamble to the IFR, mode’’ filers, may transmit using ABI/ submissions, and these transmissions FDA provided a table of the data ACS or PNSI. represent about 17 percent of the total (Comments) One comment urges that elements for reference describing in prior notice submissions. for rail intermodal shipments between which situations the information is (Comments) One comment asks that points in Canada where the mandatory (68 FR 58974 at 58980). The the customs broker be allowed access to transportation transits the United States, preamble of this final rule also contains all pertinent information by electronic FDA should agree that data submitted to table 2 which describes the information means in order to reduce the amount of the CBP via AMS constitutes advance requirements. FDA also notes that PNSI paperwork required by the prior notice notice under the FDA regulations. is programmed such that if a data process. (Response) FDA disagrees. Under (Response) The means by which the element does not apply, the data section 801(m) of the act, FDA, not CBP, submitter provides the transmitter with element is not requested during the must receive prior notice. Furthermore, the required information is a matter of prior notice submission process. no interface currently exists between communication between the submitter (Comments) One comment states that AMS and the existing interface with and transmitter. The final rule neither when a prior notice confirmation FDA’s OASIS through the ABI/ACS requires nor precludes processes the number is submitted to CBP and FDA, entry processes, which means FDA does parties select to handle these it is sometimes returned with a different not have access to AMS data. FDA and communications. prior notice confirmation number. The CBP have discussed interfacing with (Comments) Several comments comment asks why this is and what AMS for manifest data and determined request that the agencies change the happens to the original prior notice that the general cargo data in AMS are process for resubmission of prior notice confirmation number. not suitable to accommodate the after the original prior notice or entry (Response) FDA acknowledges that detailed information requirements of the has been cancelled and when prior this problem occurred in the early stages prior notice rule. For example, AMS notice is submitted after the food is of prior notice; however, we have does not collect the country of origin. In already in the United States. One rectified the situation. When we addition, its collection of the identities comment asks that the system interface received a report concerning this prior of the article of food and its be modified so that the resubmission notice confirmation number problem, manufacturer differs from the way those automatically cancels the original. we immediately modified our software data points are collected under the prior Another comment suggests that in the to prevent the reported problem from notice final rule in such a way that the case where the foods are already in the reoccurring. data would not meet our needs in United States and the CBP entry has had 4. ABI/ACS Interface carrying out the purpose of section to be cancelled and resubmitted, it 801(m) of the act. should not be necessary to repeat the (Comments) One comment states that (Comments) One comment reports prior notice filing; filing entry should be the ABI system has been proven to be that foreign exporters are obliged to use sufficient. Another suggests that when the most efficient means for meeting the FDA’s PNSI as they cannot register as the second entry is made, CBP allow for prior notice time requirements. users of CBP’s ABI. The comment submission of the previous prior notice (Response) FDA agrees that for many contends that these exporters, not being confirmation number rather than the submitters, the ABI interface is the most able to combine prior notice and a creation of a new prior notice with an efficient means for providing prior customs declaration for import in one accompanying new prior notice notice, as it allows the data to be saved operation, will be in a disadvantaged confirmation number. Other comments and used for entry purposes. FDA also position compared to U.S. importers suggest that ABI submission of prior acknowledges that not all submitters because the foreign exporter, after notice be allowed for food in the United have a custom broker, nor does ABI having completed his prior notice, will States. An additional comment states accommodate all transactions subject to receive a prior notice confirmation that CBP entry can be made for articles prior notice (e.g., food imported by number, which he then has to transmit of food that are already in the United international mail or inside personal to his U.S. importer or customs broker. States without adequate prior notice. baggage not for personal use). (Response) FDA disagrees. Prior Another comment recommends that Accordingly, the final rule continues to notice may be submitted electronically FDA consider allowing the submission provide for electronic submission of through either ABI/ACS or PNSI. of prior notice through the ABI interface prior notice via either ABI/ACS or PNSI. Typically, ABI/ACS is used by a person even when that prior notice will not be

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timely. Finally, one comment suggests requirements) and current system system, which is how the majority of that a new prior notice should not be configurations can make it impossible to prior notices are being transmitted, required when errors are made and that comply with both CBP and prior notice requires the name and country and does an easier way should be created to requirements. The comment not provide the SCAC option. provide for corrections. recommends that CBP and FDA create a (Response) FDA disagrees. The SCAC (Response) In the case of a prior procedure in ABI/ACS that allows the or International Air Transportation notice submitted after the food has CBP entry to be generated, but not filed, Association (IATA) codes can be arrived, the prior notice is inadequate at the time a prior notice is submitted. transmitted via ABI/ACS via an because of no prior notice and the food Another comment states that filers are Affirmation of Compliance. The CBP may be refused. The post-refusal prior insisting on submitting the entry requirement to provide the name and notice (i.e., the prior notice submitted information to CBP via ABI at the same country of the carrier is for purposes after arrival) may only be submitted via time that they are submitting the prior other than prior notice. PNSI until such time as ACS or its notice information to the FDA. This (Comments) Several comments successor system can accommodate apparently creates situations where the recommend an interface between the such transactions. The changes to the food is loaded and ready for shipment CBP manufacturer identity (MID) codes system requested by the comments before there is a form of electronic and the FDA food facility registration cannot be accommodated since such release and this situation negates CBP’s numbers. Specific recommendations revisions would require programming Customs-Trade Partnership Against include that: (1) CBP allow the MID changes to ACS, which CBP is currently Terrorism (C–TPAT) and the Free and system to be updated via prior notice only maintaining, and not enhancing Secure Trade (FAST) program submissions; (2) FDA develop an since its replacement system (ACE) is requirements. The proximity of certain interface with CBP that allows for being developed. border points means that although the validation and coordination of data (Comments) One comment suggests timeframe has been met with CBP for between these two systems; (3) ABI that because errors in the ABI system electronic release via CBP’s PAPS, it is provide a notification to the filer if the need to be corrected in a timely manner difficult to meet the present timeframes information from the MID does not to facilitate transmission of prior notice, of the prior notice as the filer takes a match the facility registration CBP should be required to be available longer time to submit both entries via information on file with FDA; and (4) 24 hours a day, 7 days a week to allow ABI. the agencies permit incorrect and for correction of these clerical errors. (Response) We disagree. Prior notice duplicate MID information to be (Response) Inasmuch as the filer has and entry need not be made at the same corrected though a secure CBP system. submitted a certified summary that the time. Prior notice is a precondition of Another comment recommends the filer wishes to change, the cancellation entry and must be made first but may establishment of a system that validates of the entry is more than just a simple be done independently of the entry by data and resolves any conflict between correction to an ABI transmission. This use of FDA’s PNSI or CBP’s ‘‘WP’’ CBP and FDA data. change requires review because it affects transaction in ABI. These systems allow (Response) With respect to correcting the integrity of cargo release. for an independent submission of prior and updating MIDs, CBP does not Accordingly, any corrections to certified notice even if no entry has been filed. believe it is possible to eliminate all entry information must be done during The entry filer may then provide the differences between MIDs and related normal business hours. prior notice confirmation number to FDA manufacturing facility registration (Comments) Several comments CBP as part of the entry. The entry will numbers. The same manufacturer may suggest that PNSI, in its validation be validated in the CBP/FDA interface have numerous MIDs, and conversely, a processes, should include a check to see and will be allowed if the prior notice MID may identify more than one if other notices are already on file for has been completed. The importer and manufacturer due to the nature of the the same article and that a warning filer may make a business decision to algorithm that is employed. message should be established to file the prior notice with the entry, and With respect to the comment that asks indicate a duplicate prior notice is being FDA and CBP’s systems can that FDA develop an interface with CBP filed. accommodate this practice. to allow for validation and coordination (Response) FDA disagrees. The prior Because the entry and prior notice of data, FDA and CBP currently notice submission process allows for submissions may be completed exchange facility data electronically as transmission through either ABI/ACS or independently, the timeframes are part of the prior notice and 801(a) PNSI. The prior notice confirmation dependent on how the parties at interest processes. CBP sends FDA the MID and number is unique to a transmission choose to file entry and prior notice: facility information (including through either system but cannot be The one-step (prior notice with entry) or registration number, when applicable). matched against other transmissions at two-step (independent prior notice FDA performs edits to ensure that the this time. Programming PNSI to locate followed by entry) process. This allows MID matches the firm represented by duplicate prior notices would require a them to meet both timeframes, which the registration number. In certain cases, considerable amount of resources, represent two agencies, two processes, FDA will reject a prior notice which would yield minimal benefit and two different sets of requirements. submission that does not match a MID since the submitter would know about (Comments) One comment contends submission. Filers will receive an ABI the duplicate submission after that the lack of uniformity between the rejection communication identifying the transmitting the prior notice. PNSI and CBP requirements for mismatch when this occurs. Once the (Comments) Several comments transmission of carrier information facility and all other required request resolution of a PN/ABI system causes confusion to filers and FDA/CBP information has been received and interface obstacle that requires that CBP staff. The comment contends that validated, FDA will confirm the prior entry and prior notice be made at the providing the Standard Carrier notice submission. same time. The comment contends that Abbreviated Code (SCAC) code for the (Comments) Several comments prior notice must be submitted before carrier in lieu of the carrier’s name and suggest that when a prior notice is entry can be made (e.g., for quota class country is only available when transmitted via ABI/ACS and confirmed merchandise subject to CBP ‘‘live entry’’ transmitting via PNSI because the CBP for review by FDA, the data should be

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moved from ACS to OASIS regardless of Automated Commercial Environment, systematic screening to assist FDA in the estimated time of arrival (ETA) date. which will replace ACS. making admissibility decisions. (Response) The ABI/ACS system is (Comments) One comment (Comments) Several comments not configured to certify information nor recommends that for a short trial period, request extension of the time one is transfer information to FDA in real-time the full prior notice edits, with warning permitted to be logged into a session as PNSI does. ACS is programmed to messages, should be turned on without using PNSI. Comments state that it is collect data in batch mode and does not rejection of CBP entry processing. The difficult to complete entering data transmit the data to FDA comment reasons that this would be a before the system times out. Several instantaneously. Therefore, prior notices method of alerting ABI/ACS comments suggest that completing the submitted via PNSI will continue to transmitters to errors without process in time was difficult for many receive a real-time system response jeopardizing the movement of the food. persons whose native language is not when the prior notice is confirmed for Another comment suggests that a English. review by FDA. However, prior notices significant reason for a high rate of (Response) For security reasons, PNSI submitted via ABI/ACS will continue to noncompliance on data submissions is is currently configured with a 30-minute be transmitted in a batch mode and to the lack of the automated systems’ time-out. FDA notes that Internet receive systematic confirmation capability to advise filers of data commerce systems are typically responses in the pre-arranged inadequacies. configured with a similar, or more timeframes developed by CBP. For those (Response) The systems provide for stringent, time-out setting. FDA also prior notices submitted via ABI on the error messages to be transmitted to filers notes that the time-out setting applies anticipated date of arrival, users can that identify the reasons for errors in only to a period of user inactivity; no expect to receive a response message prior notice submissions that can be limit is set on the total amount of time (confirmation number or rejection) determined during the data entry the user may be logged into a particular within 15 minutes of submission. For process (e.g., certain required data session, nor is there a limit to the ABI submissions submitted prior to the elements are missing or product code amount of time taken to prepare and anticipated date of arrival, users can submitted is invalid). Over time, the save or submit a specific Web entry or expect to receive a response message no agencies have seen the prior notice prior notice. Users are ‘‘timed-out’’ only later than midnight (Eastern Time) on rejection rate go down. Both agencies if their session remains inactive for the anticipated date of arrival, i.e., the have been providing industry with longer than the time-out setting. message generally is sent before 11:59 information regarding error messages. Users may also save their entry while p.m. on the day before the anticipated (Comments) One comment points out it is partially completed. The data are date of arrival. that the PNSI Web portal has changed retained and will be available when the (Comments) Several comments state to allow multiple containers to be user logs back into the system. that although PNSI is designed to not reported against a single prior notice (Comments) Several comments require changes in the location of the line but that CBP has not changed their express concern about the capacity of anticipated port of arrival (thus allowing specifications to allow more than a the FDA computer systems to process a shipment to be diverted to a port other single container to be reported on a the volume of submissions. These than the intended port of arrival prior notice line in ABI. The comment comments suggest that the system needs transmitted in the prior notice), the CBP recommends that this change to the additional capacity to meet the loads ABI system precludes the CBP entry FDA Web portal be communicated to expected when full enforcement is from being accepted at other than the CBP so they may change their ABI instituted. Several comments also reported port of entry. When this specifications. believe that performance issues (e.g., occurs, the CBP entry and original prior (Response) ABI currently allows filers slow response) are hampering their notice must be deleted and a new entry to submit multiple container numbers usage of the system. must be submitted with a new prior per FDA line by sending multiple FD05 (Response) FDA recognizes these notice creating a new timeframe. The records containing affirmation of concerns and is committed to providing comments recommend that the compliance code ‘‘CNO.’’ The first systems that will meet user needs. FDA requirement be consistently applied and affirmation goes in the FD01 record, designed the prior notice systems to that the ABI/ACS system be revised to with subsequent affirmations in the process a volume of users far in excess allow for changes to the port of entry FD05 record which can be repeated as of the projected usage. Prior to without causing cancellation of the CBP often as necessary. Filers are able to implementation, FDA thoroughly tested entry. submit multiple records using the the performance of its system against (Response) FDA disagrees. The prior affirmation of compliance code ‘‘CNO’’ loads in excess of that anticipated. notice rule does not require a new prior and provide a different container These tests have shown the system notice when the anticipated port of number in each record. capable of maintaining acceptable arrival changes after the prior notice has response even at these loads. Currently, been confirmed for review by FDA. CBP 5. PNSI FDA handles approximately 167,000 does require cancellation of entry (Comments) One comment suggests prior notices each week and could documentation for entry purposes when that to more effectively screen handle a much higher volume without the port of entry changes. The shipments entering the United States, a capacity problem. cancellation of an electronic ABI entry FDA must work to integrate OASIS with Many factors influence the for CBP results in the cancellation of the prior notice system. responsiveness of an Internet based any associated prior notices filed with (Response) FDA’s OASIS has always system, including factors beyond the the entry in ABI. Amending ABI/ACS to been an integral part of the prior notice FDA’s control, such as the user’s allow amendments, such as when the process as OASIS provides for internal computer system (hardware, software, port of entry changes, would entail systematic screening of prior notice and Internet connection) and traffic on substantial and costly revisions to the submissions in order to assist the the Internet as a whole. Since prior system; such technical changes are not agency in making a determination notice was implemented in December cost-effective or a good use of limited regarding inspection of the food at the 2003, FDA has carefully monitored both resources given the development of the border. OASIS also provides for PNSI and OASIS system usage and

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performance. During this period, no additional system would be significant. required for an article of food that issues related to load on these systems Therefore, FDA is not prepared to requires prior notice. The comment have been identified. FDA has worked undertake the development of a batch questions why the FDA Web Portal does to resolve specific issues, such as system at this time; following not accept an entry number when a CBP hardware failures, which have completion of any system upgrades that entry is required and known at the time hampered system performance and will be released in conjunction with of filing prior notice. Another comment availability for short periods. implementation of the final rule, FDA recommends that the Web Portal FDA and CBP also have increased the will reassess the need for and feasibility software be redesigned in order for filers capacity of the communications link of developing a batch submission to receive the relevant entry identifier between their systems to ensure that system. FDA notes that some submitters information with the prior notice additional bandwidth is available for have created their own internal confirmation number. future increases in load. FDA continues programs that are designed to organize (Response) FDA disagrees. PNSI does to monitor its system and to test for data in ‘‘batch’’ mode, which in turn accept the CBP entry number. If there is performance as the system is upgraded submits their prior notices to PNSI in no entry number or other entry and enhanced. Users may obtain current rapid succession. identifier, PNSI will provide a system- system status information for PNSI at (Comments) One comment states that generated entry identifier to the prior the FDA Industry Systems home page they frequently ship the same article of notice submission. We also posted (http://www.access.fda.gov) and are food in multiple containers. The guidance on FDA’s Web site at http:// requested to contact the Help Desk if comment believes that since there is www.cfsan.fda.gov/~pn/pnentgui.html they encounter any performance issues only one article of food, only one prior that describes the entry types and the currently not identified on the system notice should be required. The comment entry identifiers. (See also discussion status page. notes that the FDA Web Portal only infra on the CBP entry identifier in (Comments) Several comments allows the input of one container per section III.H.5 of this document.) recommend that FDA develop an prior notice; therefore, they have to (Comments) Several comments alternate system that supports batch submit multiple prior notices instead of express concern about system outages submission of prior notices. The only one. The comment requests that for PNSI and/or ABI. These comments comments suggest that a batch system the FDA Web Portal be changed to allow suggest that one or both systems had not would save submitters a vast amount of for the input of multiple containers per been available for extended periods in input time and allow the agency faster article of food. the past or were frequently unavailable. processing capability. The comments (Response) FDA agrees. The FDA Web Comments also recommend that FDA also assert that a batch system would Portal has been changed to allow provide an alternate method, such as reduce the costs incurred due to double multiple containers to be reported facsimile, for submission during periods entry between the user’s existing against a single prior notice line in the when the systems are not available. One systems, e.g., for order entry and filing above situation. comment notes that PNSI has not been with FDA. One comment proposes that (Comments) One comment states that functioning properly. The comment they be given a defined quantity of most of their orders contain multiple states that the System Status update registration numbers at their disposal food items in one box and the process pages indicates that the system is for printing onto their dispatch labels of filing prior notice in PNSI for each operating as ‘‘normal,’’ but the system is (presumably by registration number item is very time consuming because really down. they are referring to the prior notice one can only enter one item at a time. (Response) FDA recognizes that confirmation number). The comment The comment suggests updating PNSI to system outages could have the potential says they would like a fully automated allow users to enter multiple items on to disrupt trade. To minimize outages, process, where all data relevant for prior one screen (i.e., the user creates a Web FDA has built redundancy into these notice would be created and then entry for each shipment and the system computer systems (e.g., multiple servers transmitted electronically to CBP and then allows them to specify all items in and backup systems) and, to the extent FDA, instead of the current procedure of that shipment on one screen). possible, combined planned manual input of all details. (Response) A prior notice contains maintenance activities to be (Response) FDA agrees that a information on not just the article of accomplished during a single outage. mechanism to facilitate batch/fully food being imported, but also the Planned outages are scheduled for a automated filing would provide some facilities related to that article such as timeframe with the minimum possible advantage to certain filers. However, the manufacturer, shipper, owner and impact to users and notice is provided FDA believes that the existing systems ultimate consignee. Since this as far in advance as possible, allowing (PNSI and ABI) currently provide information can be unique for each users to plan their access to the system. substantial capabilities in this area. article, it must be provided for each System status information, including PNSI offers several features that make article individually. PNSI does offer planned outages, is posted at http:// prior notice data entry faster and several features that make prior notice www.access.fda.gov and at http:// reduces the amount of redundant data data entry faster and reduce the amount www.cfsan.fda.gov/~furls/fisstat.html. entry such as the Copy Web Entry of redundant data entry such as the Users are requested to contact the Help feature, Copy Prior Notice feature and Copy Web Entry feature, Copy Prior Desk if any performance issues not other shortcuts. Please refer to Time Notice feature and other shortcuts. identified on the system status page are Saving Tips from FDA’s PNC for PNSI Please refer to Time Saving Tips from encountered. (http://www.cfsan.fda.gov/~pn/ FDA’s PNC for PNSI (http:// FDA also provides alternate options pntips.html) for a description of these www.cfsan.fda.gov/~pn/pntips.html) for users to file prior notice during features. ABI software can often provide for a description of these features. system outages. Filers who use CBP’s similar copying features, depending on (Comments) One comment states that ABI/ACS system can utilize PNSI when the ABI software package used by the FDA’s Web Portal does not accept the ABI, ACS, and/or OASIS are transmitter. input of CBP entry numbers. The unavailable. In addition, FDA has FDA also recognizes that the comment further states that there are provided a method for filing via resources to develop and maintain an times when an entry number is not facsimile or e-mail when PNSI is

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unavailable for an extended period (see as well as to changing business the Help Desk using the telephone the Contingency Plan for System requirements. number or e-mail provided at http:// Outages at http://www.cfsan.fda.gov/ (Comments) One comment asks if www.cfsan.fda.gov/~furls/helpf.html. ~pn/pndguid.html). These contingency PNSI will provide guidance on 6. Security of the Systems plans are designed to ensure that the formatting of the information for flow of trade is not interrupted when identification of the submitter, (Comments) One comment suggests system outages cannot be avoided (see transmitter, and manufacturer. The that FDA create a mechanism whereby also the discussion on contingency comment is concerned that PNSI may interested parties may assert protection plans below). only accept certain formatting, without from public disclosure under FOIA for (Comments) One comment notes that providing guidance to the submitter, information contained in prior notices companies continue to report technical thereby, causing problems with PNSI that they believe is confidential difficulties when using PNSI, including accepting and processing prior notice. business information. the inability to access reliable technical (Response) PNSI is supported by (Response) We believe that there is no advice through the hot-line. Another several tutorials and help screens which need to create such a mechanism comment indicates that the waiting time lead the user through correct inputting because the agencies would review the for the helpline is very long, with a of data. prior notice information to determine if minimum wait time of 15 minutes. (Comments) Several comments it is protected by a FOIA exemption address specific issues with the PNSI (Response) FDA has made a number before disclosure to the public. software (potential ‘‘bugs’’) or (Comments) One comment states that of enhancements and has fixed several suggestions for enhanced capabilities. in order to complete the PNSI issues with earlier releases of PNSI. Examples include questions about the submission, several security settings on FDA also continues to work to provide completeness of the lists of values their respective computers had to be the best possible service addressing (drop-down lists), issues with browser disabled. technical issues through the Help Desk. settings and compatibility, and (Response) PNSI is designed to work Users are encouraged to continue to suggestions for additional bar code with the browsers listed at http:// contact the Help Desk for technical printouts. www.access.fda.gov/, using standard assistance. The Help Desk is available (Response) FDA welcomes user settings. PNSI requires that the browser Monday through Friday from 7:30 a.m. suggestions for improvements to the be set to accept cookies. FDA does not to 11 p.m. Eastern Time. Users may PNSI system. Discrepancy reports are believe that these settings present a leave a message or send e-mail at other investigated thoroughly to ensure the security risk to users. Users are times, which will be addressed on the system meets both FDA’s requirements encouraged to contact the Help Desk for next business day. and user needs to the extent possible. assistance with specific issues regarding (Comments) Several comments Suggested improvements are also access and system settings. address the complexity of PNSI. The prioritized and reviewed by a Change comments state that the system requires Control Board who continue to 7. Contingency Plans the complete re-creation of all data for determine appropriate and feasible In § 1.280(b), (c), (d), and (e) of the each prior notice even when shipments improvements to the system. FDA IFR, FDA requires that if a custom are repetitive with minimal variables in encourages users to continue to contact broker’s or self-filer’s system is not information; that the full address should the Help Desk with any technical working or if the ABI/ACS interface is not be necessary for registered facilities; questions, issues, or suggestions. not working, prior notice must be and that PNSI should allow submitters (Comments) One comment suggests submitted through PNSI. It further states to save and store data for replication or that PNSI should be revised to create a that if the PNSI is not working and/or provide for self-populating fields. One view screen similar to the printed OASIS is not working, FDA will issue comment, however, notes that their confirmation with all the information in an Internet notification, and submission users have had relatively little problem one place before submission. The of prior notice must be by e-mail or by using PNSI. comment also suggests that when facsimile to FDA. FDA posts the e-mail (Response) FDA continues to provide, creating a prior notice for different or facsimile information on its Web site. to the extent possible, a ‘‘user-friendly’’ commodities, the system should not The prior notice information will only PNSI application. Several features have have all commodities default onto prior be accepted at the posted e-mail or been added since the initial release notice, but should allow the user to use facsimile locations if FDA determines (PNSI 1.0) to assist users, including a a check box to choose a commodity, that PNSI or OASIS is not working. feature that allows users to copy rather than to cancel the commodity. On August 12, 2004, FDA and CBP individual prior notices and Web (Response) FDA agrees. The PNSI published guidance covering a Entries, with or without the associated software has been enhanced to provide Contingency Plan for System Outages prior notices. Where possible, lists of a screen that includes all of the (see http://www.cfsan.fda.gov/~pn/ standard values (e.g., entry types, SCAC information about the prior notice prior pndguid.html/). FDA and CBP identified & IATA Codes, firm types, quantity and to a transmitter completing the seven potential system downtime packaging descriptions) are provided to submission step. PNSI also has been scenarios that could impact facilitate entry of these values. These enhanced to allow copying of prior transmission, confirmation, and enhancements minimize the need for notices within a Web Entry and copying processing of prior notice submissions users to enter repetitive information. of a Web Entry, with or without the and developed alternative submission Similar to the IFR, the prior notice final associated prior notices. A user thus can options for each of the identified rule does not require the full address in copy a Web Entry with all associated scenarios. all cases. When a registration number is prior notices, then use the cancel (Comments) One comment states that provided, name, city and country can function to remove any prior notices not FDA and CBP need to formulate and usually be provided instead of the name required for the new entry. communicate a realistic contingency and full address (e.g., § 1.281(a)(6)). FDA welcomes any additional plan for commercial importations that FDA continues to work to enhance the comments or suggestions on how to takes into account CBP ABI downtime, system, in response to user comments, improve PNSI; these can be submitted to FDA OASIS downtime, and broker

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downtime. Two comments express various contingencies, the final rule has that the usual flow of goods should be concern that contingency plans include also been revised by stating that FDA allowed to continue unhindered, with a dependency on PNSI and their will accept prior notice submissions in the paperwork sorted out afterwards. experience has shown that PNSI was the format it deems appropriate during One comment further suggests that intended for the casual importer and the system(s) outage. rather than providing for PNSI as a never intended for commercial FDA has posted information on the contingency system when ABI is down, operations. The comment states that Systems Status Web site located at prior notice submissions should significant delays will be experienced if http://www.cfsan.fda.gov/~furls/ function according to all other 80 percent of the transactions are fisstat.html regarding system downtime submissions processed through ABI suddenly routed from the ABI/ACS that states ‘‘Most problems will be when CBP declares either a ‘‘national system to the PNSI system. temporary. Try accessing the system snow day’’ or ‘‘power outage.’’ The (Response) FDA is committed to again in 15 minutes.’’ This site also comment recommends that if ABI is not providing systems that will meet user provides information about scheduled working, the shipment should be needs. FDA designed PNSI to process a maintenance, which states that allowed to proceed, pending later volume of users far in excess of the ‘‘Periodically FDA Industry Systems issuance of a prior notice confirmation projected usage, and tested performance will need to undergo maintenance and via ABI. at these volumes. As noted previously, upgrades. All scheduled maintenance (Response) FDA does not agree that if FDA and CBP published guidance will take place on Saturdays 3 a.m. to ABI is not working the shipment should covering a Contingency Plan for System 8 a.m. Eastern Time (Saturday 8 a.m. to be allowed to proceed. In that instance, Outages (see http://www.cfsan.fda.gov/ 1 p.m. GMT). If you are having trouble prior notice can, and therefore should, ~pn/pndguid.html/) and anyone may accessing FDA Industry Systems during be submitted via PNSI. submit comment on it. that time, please try again after 8 a.m. In all contingency situations, except (Comments) One comment suggests Eastern Time on Saturday (1 p.m. for power failure, some electronic that FDA and CBP provide guidance GMT).’’ This site also provides a status means of prior notice submission is that defines an appropriate timeframe to history of the system. required, either by PNSI, e-mail, or fax. wait for prior notice confirmation before (Comments) One comment suggests However, in the case of a localized or assuming the system is down and/or that FDA should develop and publish a regional power failure, the Contingency that resubmission is required. form that could be used if it were ever Plan guidance recommends that filers (Response) Generally, for prior notice necessary to file prior notice by fax. The should submit the required prior notice submissions via PNSI, the user should comment asserts that a form also would information to FDA at the port of receive a confirmation number assist importers in gathering the arrival, or if there is no FDA officer at immediately upon submission of the information necessary to file a prior a given port, to CBP via a paper copy correctly completed form. For those notice and also would clear up the of the prior notice e-mail contingency prior notices submitted via ABI on the confusion that currently exists in form (FDA 3540) at the time of cargo anticipated date of arrival, users can foreign countries. The comment believes release. expect to receive a response message that it was obvious that FDA (Comments) One comment explains (confirmation number or rejection) contemplated issuing a form when it that various companies are organizing within 15 minutes of submission. For first proposed the prior notice contingency plans whereby the prior ABI submissions submitted prior to the regulations and complains that no notice confirmation number will be anticipated date of arrival, users can explanation has been given by FDA for included in the delivery order, which expect to receive a response message no not producing the form. then will be faxed to the office of the later than midnight (Eastern Time) on (Response) FDA disagrees. A form to steamship line at the port of entry so the anticipated date of arrival, i.e., the be used during contingencies is posted that the requisite paperwork is in hand message generally is sent before 11:59 on FDA’s Web site only when an when the product is offloaded from the p.m. on the day before the anticipated applicable system outage is carrier. The comment further explains date of arrival. encountered. During a system outage that this contingency plan takes into The FDA/CBP Contingency Plan when fax submissions are being account the unique circumstances posed states that ‘‘notice advising of any accepted, FDA will publish the fax by transporting goods by steamship line available downtime specifics will be telephone number for the PNC at http:// insofar as the customs broker or posted at http://www.access.fda.gov, www.access.fda.gov, http:// purchaser may not always be able to http://www.fda.gov, http:// www.fda.gov, http://www.cfsan.fda.gov/ send the prior notice confirmation www.cfsan.fda.gov/~furls/fisstat.html, ~furls/fisstat.html, and http:// number to the carrier prior to the and http://www.cfsan.fda.gov/~pn/ www.cfsan.fda.gov/~pn/pnoview.html, carrier’s arrival. The comment asserts pnoview.html, and through messages in as well as through messages in ABI/ that the procedure satisfies FDA’s ABI/ACS (see 21 CFR 1.280(d)).’’ ACS. Fax transmission is not allowed requirements that the prior notice Section 1.280(c), (d), and (e) of the IFR except when posted and submitted confirmation number must accompany also lists three of these four Web sites during PNSI downtimes or specified the food when it ‘‘arrives in the United to advise of system downtimes, and emergencies. FDA believes that if the States’’ and be provided to CBP or FDA specifies in what form prior notice form was available and posted even as ‘‘upon arrival.’’ The comment further should be submitted during certain a reference, there is the potential for urges FDA to include this course of system outages (i.e., e-mail or fax). In misuse or confusion. Our experience action in its guidance documents. order to simplify the Web addresses for with use of the fax form is that (Response) FDA agrees that the these notifications and the instructions submitters will continue to fax the form described scenario satisfies the for submitting prior notice when PNSI even after they have been instructed that requirement under § 1.279(g) that the or OASIS is not working, the final rule the form will not be accepted. prior notice confirmation number must has been revised by providing the (Comments) Some comments express accompany any article of food for which outage notification at one Web address concern that submission of all prior the prior notice was submitted through (http://www.fda.gov). In order to notices relies on electronic systems PNSI when the article arrives in the provide more flexibility to respond to (even the fax). The comments suggest United States and must be provided to

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CBP or FDA upon arrival. FDA does not (Final rule) The final rule in § 1.280(a) 1.281(a) covers general information believe, however, that it is necessary to requires that prior notice must be requirements which apply to all include this specific business practice submitted electronically to FDA in the shipments except those arriving by in its guidance documents, as there are English language, except that an international mail; section 1.281(b) various means that private entities may individual’s name, the name of a covers limited information requirements choose to use to comply with the company, and the name of a street may for food arriving by international mail; regulation. be submitted in a foreign language. All and section § 1.281(c) covers As described in the contingency plan information, including these items, information requirements for food guidance, if prior notice already has must be submitted using the Latin refused under section 801(m) of the act been submitted via ABI/ACS prior to an (Roman) alphabet. (e.g., food that has already arrived in the interface outage, and confirmation from Section 1.280(a)(1) and (a)(2) of the United States). FDA already has been received, then the final rule provides for two methods of The preamble to the IFR discusses the submitter may proceed with prior notice electronic submission of prior notice: (1) term, ‘‘an article of food,’’ and states using the standard process under the The CBP Automated Broker Interface of that ‘‘the description of an ‘article’ of following scenarios: the Automated Commercial System food is not the same as the definition of • ACS, OASIS, and PNSI are all (ABI/ACS); or (2) The FDA PN System ‘food’ in § 1.276(b)(5). An ‘article’ refers operational, but the link between ACS Interface (PNSI) at http:// to a single food that is associated with and OASIS is down on FDA’s or CBP’s www.access.fda.gov. We corrected a the same complete FDA Product Code, side of the system interface; reference in paragraph (a) to state that the same package size, and the same • ACS, PNSI, and the link between unless § 1.280(c) applies, prior notice manufacturer or grower. These ACS and OASIS are operational, but must be submitted through either ABI/ requirements are found in the OASIS is non-operational; ACS or PNSI. information required in the IFR in • ACS and the link between ACS and The final rule requires submission of § 1.281(a)(5), (a)(6), or (a)(7) and again in OASIS are operational, but OASIS is prior notice via PNSI for articles of food § 1.281(b) and (c)’’ (68 FR 58974 at non-operational and PNSI is non- imported or offered for import by 59003). operational or unavailable due to international mail, and other transaction The comments are discussed in order Internet service interruptions; types that cannot be made through ABI/ of the information requirement in the • OASIS, PNSI and the link between ACS. Prior notice for articles of food IFR, beginning with comments generally ACS and OASIS are operational but that have been refused under section addressing the information ACS is non-operational; or 801(m)(1) of the act must be submitted requirements. • ACS is non-operational, PNSI is through PNSI until such time as ACS or 1. General Comments non-operational or unavailable due to its successor system can accommodate Internet service interruptions, and such transactions. (Comments) Several comments OASIS and the link between ACS and The final rule also provides for express concern that the IFR requires OASIS are either operational or non- contingencies if involved systems were significantly more information than the operational. not working, e.g., a custom broker’s or Bioterrorism Act requires and ask that The standard process does not self-filer’s system, ABI/ACS, PNSI, or FDA reduce the number of data include presentation of the prior notice OASIS. The final rule requires that prior elements. One comment notes that the confirmation number to FDA or CBP notice must be submitted through PNSI Bioterrorism Act names only six or upon arrival if the prior notice was if a customhouse broker’s or self-filer’s seven specific items that must be submitted by ABI/ACS. system or if the ABI/ACS interface is not provided. One comment indicates that If prior notice already has been working. The final rule states that if the information required for prior notice submitted via ABI/ACS and PNSI or OASIS is not working, FDA will is far in excess of that required in the confirmation from FDA has not been post prominent notification and Codex Committee on Food Import and received prior to the interface outage, instructions at http://www.fda.gov. FDA Export Inspection and Certification FDA and CBP recommend that rather will accept prior notice submissions in Systems Guidelines for Generic Official than resubmitting via PNSI, submitters the format it deems appropriate during Certificate Formats and the Production should provide to CBP officers, at the the system(s) outage. The final rule does and Issuance of Certificates (CAC/GL time of cargo release, an endorsed not exempt any specific categories of 38–2001). One comment adds that the (signed) copy of the ABI transmission or food articles from prior notice if systems required information far exceeds what is some other evidence adequate to show are not performing. necessary to enable FDA to identify that prior notice has been submitted via articles of food that need to be ABI/ACS. H. What Information Must Be in a Prior inspected. Another comment suggests If prior notice has been submitted via Notice? (§ 1.281) that some of the information required PNSI prior to the system outage and a The Bioterrorism Act requires the for a prior notice is already ‘‘covered’’ confirmation number already has been submission to the Secretary of a notice by the registration requirement of received, the confirmation number must providing the identity of each of the section 305 of the Bioterrorism Act (see accompany the article of food following: The article; the manufacturer the Registration of Food Facilities Under (§ 1.279(g)). In addition, FDA and CBP and shipper of the article; if known the Public Health Security and recommend that the submitter also within the specified period of time that Bioterrorism Preparedness and provide the PNSI confirmation page, notice is required to be provided, the Response Act of 2002 interim final rule, including the prior notice confirmation grower of the article; the country from 21 CFR part 1, subpart H, confirmed 70 number and time stamp, to CBP officers which the article originates; the country FR 57505, October 3, 2005), so FDA will for cargo release. If the prior notice from which the article is shipped; and already have this information. Another confirmation page is not provided, this the anticipated port of entry for the comment suggests that the prior notice may delay cargo release while the CBP article. could be simplified, thus reducing the officer contacts FDA for verification of The IFR requires in § 1.281(a), (b), and possibility of errors and potential trade the prior notice confirmation number(s) (c) that specific information be disruptions, by quoting the registration and time of submission. submitted in prior notice: Section number and only adding information

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specific to a particular shipment. One of the Bioterrorism Act that FDA receive multiple entities that may be involved comment notes that CBP’s data fulfill information about a shipment before it in a traditional commercial importation. FDA’s needs; therefore, the IFR’s arrives in the United States. The final rule does not require an entry duplicate system is a waste of resources, FDA also does not agree that some of identifier because international mail and FDA should use CBP’s system. the prior notice information is already will always receive a system-generated (Response) FDA disagrees with the ‘‘covered’’ by the food facility identifier, as international mail comments that ask for a reduction in the registration requirement. For example, shipments cannot be submitted via ABI/ number of required data elements. FDA facilities typically provide general ACS. Because the port of entry and time has selected those data elements that product categories as part of the and date of entry are completely subject will allow FDA to meet its statutory registration process. This generalized to the international mail process, the obligation to receive, review, and information would not provide the IFR requires only that the submitter respond to prior notices efficiently and identity of the article being imported or identify the date of shipment, i.e., the effectively. In addition to the offered for import and, therefore, would date the food is shipped, which Bioterrorism Act’s requirements of the not meet the prior notice requirements provides the most information possible identities of the article of food, the as defined in section 801(m) of the act. to satisfy the anticipated port of entry. manufacturer and shipper, the grower, if Therefore, we do not agree that some of Moreover, since international mail is known, the country from which the the registration information could be always in the custody of CBP until it is article originates, the country from used to meet the prior notice released for delivery to the recipient, no which the article is shipped, and the information needs. Moreover, a facility’s additional shipment information is anticipated port of entry for the article, registration contains all of the general necessary for communication between FDA determined that certain additional food product categories the facility FDA and CBP. information is required for efficient manufactures, processes, packs or holds; FDA also disagrees that information, enforcement of the Bioterrorism Act, and would not allow FDA to know such as the entry type and identifier, the primarily for the means of identifying specifically which article of food is the port of entry, and the FDA Product Code the article of food and effective subject of the prior notice, which should be eliminated from the prior enforcement of refusals. For example, precludes an effective assessment of notice requirements. The anticipated the identification of the individual and risk. port of entry is specifically required by the firm, if applicable, submitting the (Comments) Several comments the statute and FDA has determined that prior notice is needed so that FDA recommend that the limited information the best possible method of determining knows who is responsible for the requirements associated with food product identity is the FDA Product information in the prior notice and can arriving by international mail in Code. We have eliminated the HTS code communicate with them when § 1.281(b) be applied to all importations. in the final rule because it has not been necessary via mail, phone, or e-mail. One comment suggests that by a necessary factor for enhancing The information also is necessary to eliminating such data as the entry type communication between FDA and CBP follow up when audits, inspections, or and identifier, the port of entry, the FDA for the purpose of inspection at the port enforcement are necessary. Therefore, Product code, and the HTS code, all of arrival. However, the entry type and FDA does not agree with one of the prior notices could be submitted via identifier are critical elements in comment’s assertions that the prior FDA’s PNSI at an earlier time. The communications between FDA and CBP notice rule should only require the comment further asserts that the so that the appropriate food is either registration number and other requirement for these types of data is held at the port of arrival as appropriate, information specific to a particular the primary reason that 80 to 90 percent or allowed to proceed. shipment. of prior notices are submitted via ABI/ FDA also disagrees with the The goals of the Bioterrorism Act and ACS rather than PNSI. Another suggestion that the manufacturer and the Codex Committee differ, and thus, comment reasons that as the facility registration numbers are not the requirements of the prior notice rule manufacturer and facility identification provided for homemade food or postal will differ from that of the Codex numbers are not provided for shipments and, therefore, should not be Committee on Food Import and Export homemade food or postal shipments, required for other types of shipments. Inspection and Certification Systems. the necessity of providing this The IFR excludes homemade food from The purpose of prior notice is to enable information for other types and modes prior notice requirements entirely, and FDA to conduct inspections of imported should be examined. Another comment this exclusion also is in the final rule. foods at U.S. ports upon arrival and recommends that the notification Both the IFR and the final rule require target foods that may pose a significant procedure should be simplified, and submission of the identity of the risk to public health, based on the that the data elements should be limited manufacturer and the manufacturer’s information submitted. The Codex to the minimum, such as the shipper’s registration number in the prior notice Committee on Food Import and Export name and its contact point, the food for food arriving by international mail. Certification and Inspection Systems is facility registration number, and food FDA agrees with the comments that charged with developing principles and product codes. prior notice requirements should be guidelines for food import and export (Response) FDA disagrees. The type of limited to the minimum, and has certification and inspection systems. information required for prior notice selected those data elements that will We also do not agree with the submissions of food arriving by allow FDA to expeditiously meet its comment’s assertion that FDA should international mail are limited because of statutory obligation to receive, review, use CBP’s data to fulfill FDA’s needs the process by which international mail and respond to prior notices. FDA, under the Bioterrorism Act. Information enters the United States. For however, does not agree with the that is submitted at the time of CBP international mail shipments, the IFR comments that the shipper’s name and entry processing is not useful for prior and the final rule requires the its contact point, the registration notice as this information can be identification of the U.S. recipient number of food facility, and food submitted or changed after the food has rather than the importer, owner, or product codes are the only data already arrived in the United States and ultimate consignee because mail is sent elements FDA needs to fulfill this thus does not fulfill the express intent only to a U.S. recipient rather than the mandate. In addition to the Bioterrorism

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Act requirements of the identities of the accommodate the detailed information requirements. The comment particularly article of food, the manufacturer and requirements of section 801(m) of the focuses on FAST and C–TPAT and shipper, the grower, if known, the act. For example, its collection of the recommends that prior notice country from which the article identities of the article of food and its submissions for those participating in originates, the country from which the manufacturer differs from the way those these programs should be subject to article is shipped, and the anticipated are collected under the prior notice fewer information requirements. port of entry for the article, FDA interim final and final rules in such a (Response) FDA disagrees. All of the determined that certain additional way that the data would not meet our information required in a prior notice is information is required for efficient needs in carrying out the purpose of necessary for determining what articles enforcement of the Bioterrorism Act, section 801(m) of the act. to inspect upon arrival and otherwise primarily for the means of identifying (Comments) Many comments suggest carrying out section 801(m) of the act. the article of food and effective that submitters consolidate similar prior The information is initially screened enforcement of refusals. notices into one prior notice based on a electronically in order to expedite the FDA also notes that it is not variety of reasons, e.g., one prior notice PNC’s review. If less information is surprising that 80 to 90 percent of prior per consignee with all food products provided, regardless of whether the food notices are submitted via ABI/ACS. consolidated; one prior notice per is covered by some other program, then Numerous comments on the proposed shipment with all information the result of that screening would be rule urged FDA to use the existing ACS– consolidated; one prior notice per less reliable. This issue is discussed OASIS interface between CBP and FDA commodity regardless of the quantity, further in section III.D.6.a of this to accept prior notice information. As size, color or species; one prior notice document (‘‘Additional Exclusions stated in the IFR, FDA and CBP agreed per bill of lading; one prior notice per Requested—Special Programs (C–TPAT/ with the recommendation that the truck or conveyance and one prior FAST) and Flexible Alternatives— agencies provide a single point of data notice for the same food type regardless General Comments’’) entry for CBP and FDA for as many of brand. (Comments) Two comments refer to kinds of entries as possible, and (Response) The Bioterrorism Act submission of ‘‘blanket’’ prior notices; modified our systems to allow prior requires notice for each article of food one referencing repetitive shipments of notice to be filed by either CBP’s ABI/ and requires in that notice, for each analytical samples and the other ACS or FDA’s PNSI beginning with the article of food, certain information. As suggesting a summary of daily December 12, 2003, effective date of the stated in the IFR, an ‘‘article’’ refers to shipments. IFR. FDA also noted at that time that it a single food that is associated with the (Response) FDA disagrees that it expected approximately 90 percent of same complete FDA Product Code, the should change its approach from the prior notice submissions for all same package size, and the same IFR. As stated in the preamble to the IFR importations of foods to be transmitted manufacturer or grower (68 FR 58974 at (see 68 FR at 59003), an article of food by a customs broker or self-filer through 59003). This is consistent with how is a unique item related to a specific the ABI/ACS interface to FDA. (See 68 entry is filed with CBP. An article of manufacturer or grower and a specific FR 58974 at 58976, October 10, 2003.) food is a unique item related to a process or size. All of these pieces of Since implementation, this estimate has specific manufacturer or grower and a information are critical for a risk-based proven true, as approximately 83 specific process or size. All of these assessment of the food. FDA currently percent of all prior notices are filed pieces of information are critical for a receives most of this information from through the ABI/ACS interface. risk-based assessment of the food. The customs brokers or self-filers via ABI/ (Comments) Several comments ABI/ACS system provides the capability ACS. The ABI/ACS system also suggest that all prior notice information to submit information for multiple food provides the capability to submit requirements that are duplicative of items as lines in a single entry, when information for multiple food items as information requirements for CBP via entry level information is consistent for lines in a single entry, when entry level AMS for Advanced Electronic a number of articles in a shipment. For information is consistent for a number Information or in ABI/ACS for Entry example, shipment level information, of articles in a shipment. For example, should be eliminated. One comment such as estimated time of arrival, can be shipment level information, such as recommends that prior notice be aligned captured once for all articles within a estimated time of arrival, can be with CBP ‘‘ACI’’ rules, for both timing shipment. The ability to minimize data captured once for all articles within a and data elements. The comment entry by copying specific information shipment. The ability to minimize data believes that this could lead to a from one article, or line, to another entry by copying specific information possible reduction in data elements. depends upon the sophistication of the from one article, or line, to another (Response) FDA disagrees. software being used by the submitter to depends upon the sophistication of the Information that is submitted for CBP create the submission to CBP. The FDA software being used to create the entry processing is not useful for prior PNSI allows for simplified submission submission to CBP. The FDA PNSI is notice as this information can be of similar articles of food by allowing designed to allow for simplified submitted or changed after the food the submitter to easily repeat common submission of similar articles of food by already has arrived in the United States information (e.g., FDA product code, allowing the submitter to easily repeat and prior notice is required before the manufacturer, etc.) while entering common information (e.g., FDA product food arrives. different quantities (e.g., amount and code, manufacturer, etc.) while entering Moreover, no interface currently package size). Both systems thus different quantities (e.g., amount and exists between AMS and the existing significantly reduce the amount of package size). Both systems will thus interface with FDA’s OASIS through the repetitive entry. The prior notice significantly reduce the amount of ABI/ACS entry processes, which means requirements in the IFR or the final rule repetitive entry of information while FDA does not have access to AMS data. do not require the submission of the preserving the identity of each article of FDA and CBP have discussed brand for the article of food. food. Moreover, the purpose of prior interfacing with AMS for manifest data (Comments) One comment suggests notice is for FDA to receive, prior to and determined that the general cargo that different programs should not arrival, information about each article of data in AMS are not suitable to require different information food being imported or offered for

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import for the purpose of enabling such with the submitter. See section III.J.1 of notice IFR are silent regarding which article to be inspected at ports of entry this document regarding inadequate person(s) will be contacted by FDA and/ into the United States. Receiving prior notice (§ 1.283(a)(1)) for a or CBP when an issue or problem arises blanket prior notices would not provide discussion of communication of regarding a prior notice and urges FDA the necessary information nor would a refusals. to clarify that in refusal circumstances, daily summary, which by definition (Comments) One comment suggests the agency will contact the person who would be after-the-fact, not prior to that there should be an option to submitted the prior notice (i.e., the arrival. identify whether or not the submitter is submitter or the transmitter.) The C–TPAT certified. 2. The Submitter comment further states that due to his (Response) As we previously or her knowledge and/or access to the In § 1.281(a)(1), (b)(1), and (c)(1), the explained in the discussion under our necessary information, as well as the IFR requires submission of the name of assessment of timeframes (see section implicit authority and responsibility for the individual submitting the prior III.F of this document), C–TPAT properly filing the prior notice, the notice and his/her business address, participation will not affect timeframes, submitter or transmitter typically will telephone number, fax number, e-mail the amount of information required to be in the best position to take corrective address, and the name and address of be submitted under prior notice, or action as expeditiously as possible. the submitting firm, if applicable. If a decisions made during the prior notice (Response) FDA agrees. The registration number is provided, city review process. Thus, the costs to identification of the individual or the and country may be provided instead of submitters and the government of firm, if applicable, transmitting the prior the full address. submitting such information would not notice is needed so that FDA knows (Comments) Several comments assert provide benefits. FDA will continue to who is responsible for transmitting the that it is duplicative and unnecessary to coordinate with CBP for administration information in the prior notice and can require not only the corporate name and of C–TPAT as it applies to FDA- communicate with them when address of the submitter but an regulated products, particularly as it necessary via mail, phone, fax, or e- individual’s name, telephone number, relates to admissibility decisions under mail. Moreover, the information fax number and e-mail address as well. section 801(a) of the act. However, the submitted must provide sufficient The comments contend that this prior notice final rule will not require information already should exist in the information to enable FDA to that the submitter self-declare as C– communicate questions, concerns, or FDA registration database and that the TPAT certified or not C–TPAT certified. name of the submitting firm should be enforcement information with the (Comments) One comment asks if it is transmitter. See section III.J.1 of this sufficient. The comments assert that in possible for a submitter to have his/her today’s job market, individuals change document regarding inadequate prior legal residence in the country of origin. notice (§ 1.283(a)(1)) for a discussion of jobs more frequently, thereby making (Response) Neither the IFR nor the communication of refusals. the maintenance of this level of final rule limits the residence or specificity in a database time consuming location of the submitter. Section 1.278 (Comments) Some comments ask if with minimal benefit. of the final rule states that any person FDA would clarify what distinguishes However, another comment states that with the knowledge of the required the submitter from a transmitter and if the regulatory provisions in the prior information may submit a prior notice. it is possible for an authorized notice IFR are silent regarding which (Final rule) The final rule requires in transmitter to have his/her legal person(s) will be contacted by FDA and/ § 1.281(a)(1), (b)(1), and (c)(1) the residence in the USA. or CBP when an issue or problem arises submission of the name of the (Response) The submitter is any regarding a prior notice and urge FDA individual submitting the prior notice person with knowledge of the required to clarify that in refusal circumstances, and his/her business address, telephone information. The transmitter is the the agency will contact the person who number, and e-mail address, and the person who transmits the required submitted the prior notice (i.e., the name and address of the submitting information on behalf of the submitter. submitter or the transmitter.) The firm, if applicable. We reworded the last The submitter and transmitter may be comment further states that by reason of sentence of these paragraphs for clarity the same person. (See § 1.278) The final his or her knowledge and/or access to to state that if the business address of rule does not limit the residence or the necessary information, as well as the individual submitting the prior location of the transmitter. having the implicit authority and notice is a registered facility, then the (Final rule) If the prior notice is responsibility to properly file the prior facility’s registration number, city, and transmitted by a person other than the notice, the submitter or transmitter country may be provided instead of the submitter, the final rule in § 1.281(a)(2), typically will be in the best position to facility’s full address. (b)(2), and (c)(2) requires the name of take corrective action as expeditiously the individual and firm, if applicable, as possible. 3. The Transmitter transmitting the prior notice on behalf (Response) FDA has determined that Section 1.281(a)(2), (b)(2), and (c)(2) of the submitter and his/her business a fax number is not necessary for of the IFR requires the submission of the address, telephone number, fax number, communication with the submitter. identity of the transmitter, if different and e-mail address. We reworded the However, the identification of the from the submitter. The IFR requires the last sentence of these paragraphs for individual and the firm, if applicable, name of the individual and firm, if clarity to state that if the business submitting the prior notice is needed so applicable, transmitting the prior notice address of the individual transmitting that FDA knows who is responsible for on behalf of the submitter and his/her the prior notice is a registered facility, the information in the prior notice and business address, and phone number, then the facility’s registration number, can communicate with them when fax number, and e-mail address. If a city, and country may be provided necessary via mail, phone, or e-mail. registration number is provided, city instead of the facility’s full address. The information submitted must and country may be provided instead of 4. The CBP Entry Type provide sufficient information to enable the full address. FDA to communicate questions, (Comments) A comment states that Section 1.281(a)(3), (b)(3), and (c)(3) concerns, or enforcement information the regulatory provisions in the prior of the IFR require submission of the

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entry type, which for § 1.281(b)(3) will for use of the house air waybill as a CBP There is guidance posted on FDA’s be a mail entry. identifier. Web site at http://www.cfsan.fda.gov/ (Comments) Two comments ask for (Response) FDA disagrees. The CBP ~pn/pnentgui.html that describes the clarification of the CBP entry type data entry identifier information is necessary entry types and the entry identifiers element and request a list of all of the for proper identification of the (§ 1.281(a)(4) and (c)(4)) associated with options for entry type. information in a prior notice with the those entry types. (Response) FDA needs this appropriate articles for inspection. The (Final rule) The final rule requires in information both for screening to submission of the entry identifier also is § 1.281(a)(4) and (c)(4) the CBP entry identify the appropriate articles for critical for matching the prior notice to identifier (e.g., CBP entry number or in- inspection and for communication the corresponding CBP entry, which is bond number), if available. necessary to assess the adequacy of the between the FDA and CBP staff at the 6. The Product Identity port. Also, the entry type determines prior notice when shipments arrive and Section 801(m)(1) of the Bioterrorism which entry identifiers should be used are presented for review. Act requires that a prior notice must (entry number, in-bond number) to For in-bond entries and FTZ contain the identity of the article of food identify the shipment. In addition, the admissions, and for prior notices being imported or offered for import. CBP entry type tells us if the article of submitted through the FDA PNSI, an Section 1.281 (a)(5), (b)(4), and (c)(5) of food is for consumption in the United entry identifier is critical for matching the IFR requires the identity of the States or is for export or other uses. the prior notice to the corresponding CBP entry if a consumption entry is article of food being imported or offered Some examples of CBP entry types submitted so FDA and CBP can ensure for import, as follows: the complete are: consumption entries, warehouse that prior notice requirements were FDA product code; the common or entries, and temporary importation satisfied. FDA does not agree that the usual name or market name; the bond entries. Each of these types has a waybill/Bill of Lading can be used as a estimated quantity of food that will be designated CBP code. For prior notice CBP identifier, nor do we believe that shipped, described from largest submissions made through ABI/ACS, there is a problem with obtaining a CBP container to smallest package size; and the entry type will consist of the CBP identifier. If the submitter does not have the lot or code numbers or other entry code specific for that type of entry; a CBP identifier, a system-generated identifier of the food if required by the e.g., ‘‘01’’ for a consumption entry, ‘‘21’’ entry identifier can be provided upon act or FDA regulations; e.g., low-acid for a warehouse entry, ‘‘23’’ for a request. The Airway Bill number and canned foods, at § 113.60(c) (21 CFR temporary importation bond entry, etc. Bill of Lading number is a separate data 113.60(c)); acidified foods, at § 114.80(b) These codes are ones customs brokers element found in the planned shipment (21 CFR 114.80(b)); and infant formula, and self-filers provide to CBP at entry. information (§ 1.281(a)(17)(i)). A Bill of at § 106.90 (21 CFR 106.90). For prior notice submissions made Lading number is not always assigned to (Comments) One comment suggests through the FDA PNSI, applicable entry a shipment at the time of prior notice that the definition of ‘‘article of food’’ types will be provided for selection in submission. For certain shipments, such should be amended to eliminate a drop-down menu; e.g., consumption, as those sent by international mail, no quantity and product code as IT, T&E, mail, FTZ, etc. Explanations of Bill of Lading may exist. Thus, FDA has distinguishing factors that require a the different entry types are available on determined that we cannot allow for the separate prior notice and that separate PNSI to help the transmitter choose the use of the house air waybill number as prior notices should be based on the right one. There also is guidance posted a CBP identifier. uniformity of entry level food data. The on FDA’s Web site located at http:// (Comments) Two comments request comment further asserts that the www.cfsan.fda.gov/~pn/pnentgui.html clarification of the CBP entry identifier integrity, or lack thereof, of the food that describes the entry types and the data element and where it can be product will not be compromised based entry identifiers (§ 1.281(a)(4) and (c)(3)) located. on the product type, size and/or associated with those entry types. (Response) For transmitters quantity. (Final Rule) The final rule in submitting prior notice with CBP entry (Response) FDA disagrees. FDA § 1.281(a)(3), (b)(3), and (c)(3) requires information through the ABI/ACS continues to believe that estimated submission of the entry type. For interface, the CBP entry number quantity, including base units and total articles arriving by international mail assigned by CBP is also the entry quantity, is a necessary component of (§ 1.281(b)(3)), the entry type will identifier. For customs brokers or self- product identity. This information is always be a mail entry. filers submitting prior notice for a food important for communications with entering the United States as an IT FDA and CBP staff at the border and for 5. The CBP Entry Identifier (e.g., the entry, a T&E entry, or FTZ admission, examinations to determine whether the Customs ACS Entry Number or In-Bond the CBP in-bond number or FTZ amount ordered matches the amount Number) admission number assigned by CBP also received. For example, as discussed in Sections 1.281(a)(4) and (c)(4) of the is the entry identifier. If prior notice is the preamble to the IFR, if more was IFR require the submission of the CBP being submitted through PNSI, the entry received than was ordered, FDA entry identifier (e.g., CBP entry number identifier will depend on the entry type guidance recommends an investigation or in-bond number), if available. This and the reason for the Web submission. to determine the cause of the requirement does not apply to articles If available to the transmitter (e.g., the discrepancy as additional and unwanted arriving by international mail, nor to prior notice is for a CBP entry but the articles may have been added to those carried by or accompanying an ABI/ACS interface is not available), the intentionally contaminate the shipment individual, unless entry is otherwise CBP entry number must be used. When (68 FR 58974 at 59005). If less product required by CBP and an associated CBP appropriate, the in-bond number must is received than ordered or than entry identifier has been assigned. In be used as the entry identifier. If one of shipped, some of the product may have these cases, the FDA PNSI will apply a the entry identifiers described above been intentionally diverted. Moreover, system-generated entry identifier. does not exist, the transmitter can the agency’s risk-based decisions are (Comments) One comment suggests request a system-generated entry based upon the food type and size of that PNSI should be modified to allow identifier. that product as many foods are

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processed differently and the health- to CBP using the HTS code for each item Moreover, the HTS code has never been based problems result from these included with the gift pack. This would sufficient for FDA admissibility differences. For example, a apply even when there are food and decisions; at entry, the FDA product manufacturer may have two different nonfood items in the pack; e.g. a soup code has been required on FDA- low acid canned food (LACF) mug and a can of soup, as well as for regulated products. Therefore, the FDA production lines that are used for filling make-your-own gift packs; e.g., if you product code should be familiar to most and sealing different size cans. A created a gift pack by selecting submitters of prior notice. Prior notice problem with pulling a vacuum on one individual items from a list of available requires that we now get this LACF line may cause the food in those products. information before arrival of the article size cans to become adulterated; this The final rule requires a prior notice of food into the United States. would not apply to the cans sealed on submission for each article of food. As (Comments) One comment asserts that the other LACF line. FDA would be able we explained in the preamble to the FDA has issued an interim final to target shipments from this IFR, an ‘‘article’’ refers to a single food regulation that requires prior notice manufacturer for the size cans that may that is associated with the same needlessly. The comment provides an similarly be adulterated. As stated complete FDA Product Code, the same example of a container containing red previously, the PNSI system also allows package size, and the same wine, under 14 percent alcohol and in for automatic repeating of like manufacturer or grower (68 FR 58974 at multiple varietals and sizes from the information (e.g., identity of the 59003). Moreover, the ‘‘packer’’ of a gift same manufacturing facility and asserts manufacturer), which decreases pack is not the facility that that multiple prior notice submissions repetitive entry of information that is manufactured/processed the food pack. should not be required. the same for multiple articles of food Therefore, each article of food in a gift (Response) FDA disagrees. For prior within a shipment. This also can be pack must be covered by a separate notice to accomplish its intended accomplished with submission via ABI/ prior notice. However, the Prior Notice purpose and help FDA protect ACS, dependent on the filer’s own Final Rule Draft CPG, published American consumers, a prior notice software. elsewhere in this issue of the Federal must be submitted for each article of (Comments) One comment requests Register, describes our proposed food. If the food is identified by a single clarification of the interpretation enforcement policy for gift packs FDA product code, size, and pertaining to gift packs. The comment purchased or otherwise acquired by an manufacturer, then only one prior asserts that CBP currently processes gift individual and imported or offered for notice is required. Currently there are packs according to the description of the import for nonbusiness purposes. This only seven FDA product code entire gift pack as an entity. The draft guidance states that for these types designations covering wine: White/still, comment asks if prior notice is required of gift packs FDA and CBP staff should red/still, rose/still, naturally carbonated on the individual items within the gift typically consider not taking regulatory sparkling, artificially carbonated pack. Another comment recommends action if there is a prior notice violation sparkling, Champagne, and wine that FDA show flexibility and further because a single prior notice is coolers. The identity of the size of the develop policies that do not create submitted for a gift pack and the article of food is covered under the excessive costs for exporters who are identity of the facility that packed the requirement to submit the estimated shipping multiple food products in the gift pack is submitted in lieu of the quantity of the article of food (see same package. identity of the manufacturer(s) and/or § 1.281(a)(5)(iii), (b)(4)(iii), and (Response) A gift pack may contain grower(s) for each article of food within (c)(5)(iii)). In the previous example, various articles of food subject to prior the gift pack. although the shipment contains only red notice requirements. In addition, a gift (Comments) One comment states that wine from the same manufacturer, there pack may also contain various nonfood the regulations should require a separate are different sizes of bottles within the articles that are not subject to prior prior notice for each HTS number in the container and each package size notice requirements. A package with container and that a detailed description requires a separate prior notice. The multiple food products, though not a of the product is not necessary. reason is that a problem in sealing one gift pack, is another example of various (Response) FDA disagrees. For prior size bottle of wine, but not the other size articles of food. A prior notice is notice to accomplish its intended bottles, may result in serious adverse required for each article of food, even purpose and help FDA protect health consequences. As we explained when multiple articles of food are American consumers, a more precise in the preamble to the IFR, FDA believes designated as a gift pack or are description of the product is necessary that package size is necessary and part otherwise packaged together. than that provided by the HTS number. of product identity. Moreover, the base There is no CBP rule or regulation nor As we explained in the preamble to the unit of measure is a characteristic of is there a General Rule of Interpretation IFR, although the HTS codes are product identity and is thus necessary (GRI) under which gift packs are currently utilized by CBP and FDA to for effective review of the prior notice classified for tariff purposes. In the case identify generally which imports are information. Base unit is critical to of ‘‘gift packs’’ that contain multiple subject to an FDA admissibility review, processing safety requirements and is products, for entry purposes, CBP will these codes are often not sufficient to particularly important when evaluating try to classify the gift pack using the specifically identify a product for FDA the safety of low-acid canned foods (68 concept of a set. That is, if the products decisionmaking. For example, in many FR 58974 at 59005). included in a gift pack are part of a cases, the tariff code does not describe (Comments) One comment requests common activity, the gift pack may be how the product was processed (e.g., that a single prior notice should cover classified under the HTS code that is commercially sterile or shelf-stable) or one commodity and alternately suggests most applicable. However, CBP does not how the product is packaged. Thus, that a single prior notice be required for consider eating to be a common activity several products that FDA considers each FDA Product Code. As an example, even when all items in a gift pack are different from each other (because these the comment suggests that a separate to be consumed. Therefore, unless there differences affect the potential safety of prior notice is required for each size of has been an applicable CBP ruling, the food) may be combined under one apples in a load with 10 sizes of apples entries of gift packs should be declared HTS code. (See 68 FR 58974 at 59004.) representing one FDA Product Code.

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Another comment suggests that all synonyms for foods covered by the same that will be shipped, described from products covered by the same FDA product code designations; e.g., Rice largest container to smallest package product code should require a single Flour (FDA Product Code 02C–01) has size and for articles of food that have prior notice entry. the synonyms of Bot Gao (Vietnamese been refused under section 801(m) of (Response) A separate prior notice is rice flour), Harina De Arroz (Latin the act in § 1.281(c)(5)(iii), the quantity required for each article of food American rice flour), and Joshinko of food that was shipped, described represented in a shipment or a load. In (Japanese fine, white rice flour, used to from largest container to smallest the example of different sizes of apples, make taffy-like sweets). At this time due package size. because apples are identified by one to resource constraints, FDA does not (Comments) Several comments FDA Product Code, and assuming that plan to translate the FDA Product Code recommend elimination of the all the apples represent the same Builder into foreign languages. A submission of quantity for each article grower, if known, and the remainder of product code builder tutorial is of food, and recommend that such the required information is the same for available at http://www.cfsan.fda.gov/ situations involving various sizes and all the apples, then one prior notice ~pn/pcb-tut.html. quantities of similar articles of food would be sufficient. However, if the As stated previously (see the (e.g., same FDA product code and same articles of food represent the same FDA discussion on the identity of the article manufacturer) be covered by one prior product code but contain different of food being imported or offered for notice submission. package sizes, then these are different import), a gift pack is not a single article (Response) FDA disagrees. FDA articles of food and a separate prior of food, but multiple articles of food continues to believe that quantity is a notice is required for each. packed together. Each article of food in necessary component of product (Comments) One comment states that a gift pack must be covered by a identity. FDA also believes that package prior notice would need to be submitted separate prior notice with an FDA size is a necessary part of product for each brand, and then each bottle size product code for each article. However, identity. The base unit of measure is a and format. FDA is proposing an enforcement policy critical characteristic of product identity (Response) In response to comments whereby FDA should typically not take and is thus necessary for effective to the proposed rule, FDA determined regulatory action if a single prior notice review of the prior notice information. that the brand is not critical for risk- is submitted for a gift pack. More details Base unit also is critical to processing based screening and the IFR did not about this proposed enforcement policy safety requirements and is particularly require identification of the brand of the are described in the Prior Notice Final important when evaluating the safety of article of food. This determination has Rule Draft CPG, published elsewhere in low-acid canned foods. Both base unit been retained in the final rule. this issue of the Federal Register. and total quantity (which includes Identification of the size of the article of b. The common or usual or market knowing the smallest ‘‘package size’’) food is covered under the requirement name. The IFR in § 1.281(a)(5)(ii), are necessary for response (examination) to submit the estimated quantity of the (b)(4)(ii), and (c)(5)(ii) requires the and communication with FDA and CBP article of food (see § 1.281(a)(5)(iii), submission of the common or usual staff at the port. As noted in FDA’s (b)(4)(iii), and (c)(5)(iii)). name or market name of the article of ‘‘Food Security Preventive Measures a. The complete FDA product code. food as an element of the identity of the Guidance for Importers’’ (‘‘Guidance for FDA’s product code is a unique numeric article of food. (See 21 CFR 102.5 for Industry, Importers and Filers, Food code currently used by FDA and additional information about common Security Preventive Measures customs brokers and self-filers to or usual names.) Guidance,’’ March 2003), these elements describe food products, as well as other (Comments) Several comments ask for are also critical for food security products regulated by FDA. The IFR clarification about the appropriate examinations to determine if the requires in § 1.281(a)(5)(i), (b)(4)(i), and common, usual, or market name to use amount ordered is the amount received. (c)(5)(i), the complete FDA Product for specific products and for guidance For example, if more was received than Code be submitted. concerning specific types of products. was ordered, the guidance recommends (Comments) Several comments ask for One comment asks if a sufficient an investigation to determine the cause clarification about the appropriate FDA common, usual, or market name would of the discrepancy, as additional and product code to use for specific be the name or names of products listed unwanted articles may have been added products and for guidance concerning in the FDA Product Code Builder. to intentionally contaminate the specific types of products. Several (Response) The final rule does not shipment. If less is received than comments request that the FDA Product attempt to clarify appropriate common, ordered or than shipped, some of the Code Builder be translated into various usual, or market names for specific food may have been intentionally foreign languages. Two comments products. The FDA Product Code diverted. Both base unit and total request clarification regarding the Builder contains many synonyms, quantity are currently data elements that appropriate product code for gift packs. which are common, usual, or market can be submitted via ABI/ACS to One comment requests that submitters names, for foods covered by the same OASIS. be advised of the correct product code product code designations; e.g., FDA (Comments) One comment asks for for foods subject to prior notice Product Code 16A—4 Ocean Perch is clarification as to the requirements in requirements. also known as Pacific Perch, Red Perch, § 1.281(a)(5)(iii) and (b)(4)(iii) for (Response) The final rule does not Red Rockfish, and Rosefish. Therefore, estimated quantity and the requirement attempt to clarify appropriate coding for anyone needing information about the in § 1.281(c)(5)(iii) for the actual specific products. The FDA product appropriate common, usual or market quantity. codes are frequently updated, revised name to use should consult the FDA (Response) The requirement for and changed. The active codes are Product Code Builder, which is providing estimated quantity in available in the FDA Product Code accessible at http://www.cfsan.fda.gov/ § 1.281(a)(5)(iii) and (b)(4)(iii) apply to Builder at http:// ~pn/pcb-tut.html. those prior notices provided in www.accessdata.fda.gov/SCRIPTS/ c. The estimated quantity of food. The accordance with the requirements in the ORA/PCB/PCB.HTM. The FDA Product IFR in § 1.281(a)(5)(iii) and (b)(4)(iii) final rule; i.e., those submitted before Code Builder also contains many requires the estimated quantity of food the food arrives at the port of arrival in

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the United States as required in § 1.279. not require that a prior notice be the smallest package size. For articles of The requirement for providing the cancelled and resubmitted if the food that have been refused under actual quantity in § 1.281(c)(5)(iii) estimated quantity changes after section 801(m) of the act, the final rule applies only to those articles of food confirmation. in § 1.281(c)(5)(iii) requires submission refused under section 801(m) of the act, d. The lot or code numbers or other of the quantity of food that was shipped, i.e., prior notices submitted after the identifier. The IFR in § 1.281(a)(5)(iv), described from largest container to article of food has arrived at the port of (b)(4)(iv), and (c)(5)(iv) requires the smallest package size. The final rule in arrival without adequate prior notice submission of the lot or code numbers § 1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) and has been refused. In this case, since or other identifier of the food if required requires the submission of lot or code the article of food already has arrived, by the act or FDA regulations; e.g., low- numbers or other identifiers for articles the quantity is set and the actual acid canned foods, at § 113.60(c); of food if required to bear such numbers quantity can be determined and acidified foods, at § 114.80(b); and by the act or by FDA regulations. infant formula, at § 106.90. submitted in the post-refusal prior 7. Identity of the Manufacturer notice. (Comments) One comment requests (Comments) One comment asserts that clarification concerning when a lot or Section 801(m)(1) of the act states that a slide entitled ‘‘Article of Food vs. code number or other identifier is a prior notice must contain the identity Shipment of Food’’ in an FDA required for an article of food. of the manufacturer of the article of food presentation about the IFR provides a (Response) The lot or code numbers being imported or offered for import. conflict of interpretation about the are the identification numbers or code Section 1.281(a)(6), (b)(5), and (c)(6) of requirement to provide the estimated of a production lot, which can more the IFR requires that prior notice for an quantity. The comment asserts that the specifically identify a product for article of food that is no longer in its illustration suggests a separate prior screening and examination purposes natural state include the name and notice is required for each and asks that and for communication within FDA and address of the manufacturer and the FDA clarify this presentation. with CBP and the manufacturer, etc. For registration number assigned to the (Response) The illustration in example, recalls involving serious facility that is associated with the article question (see http://www.cfsan.fda.gov/ health risks are often associated with a of food. The IFR further states that a ~dms/fsbtac17/sld014.htm) provides specific production lot, such as registration number is not required for the following example: counterfeit infant formula or under- a facility associated with an article of processed canned food. FDA screening food if the article is imported or offered TABLE 1A.—‘‘ARTICLE OF FOOD’’ VS. can target these food products for for import for transshipment, storage, examination based on information of and export, or further manipulation and SHIPMENT OF FOOD1 public health emergencies or recalls in export. The IFR also provides that if the Tuna 24/12 oz. 2,000 Company 1 foreign countries. article of food is sent by an individual cans cases FDA regulations require lot/code as a personal gift (i.e., for nonbusiness identifiers for certain foods. Currently, reasons) to an individual in the United Tuna 48/6 oz. 1,000 Company 1 low acid canned foods, acidified foods, States, he or she may provide the name cans cases and infant formula are required to bear and address of the firm that appears on lot codes or other identifiers (see the label under 21 CFR 101.5 instead of Tuna 24/12 oz. 300 cases Company 2 § 113.60(c) (low-acid canned foods); cans the name, address, and registration § 114.80(b) (acidified foods); and number of the manufacturer. If a Tuna 6/66 oz. 2,400 Company 3 § 106.90 (infant formula low-acid registration number is provided, city cans cases canned foods)). The interim final and and country may be provided instead of final rules require lot/code or other 1 One shipment; 4 different products; 4 prior the full address. notices identifiers only for these kinds of FDA received many comments on the articles of foods. Many other foods may requirement to provide the name, FDA reiterates that the previously have lot or code identifiers that are not address and registration number, when shown chart illustrates a situation with required by FDA regulation; submission applicable, as the identity of the four different articles of food, each of these identifiers is optional under the manufacturer. For ease in discussing requiring a separate prior notice. The final rule. these comments, we are presenting the example provides three different Submission of the required lot/code issues they raise into the following manufacturers of the canned tuna; thus, identifier is accommodated by ABI/ACS general categories: canned tuna from each of these as an affirmation of compliance or • Does ‘‘the manufacturer’’ in section manufacturers requires a separate prior through PNSI as a production identifier. 801(m) of the act mean the place where notice submission. Further, the 12 ACS currently allows for submission of the food was actually manufactured or ounce (oz) cans and the 6 oz cans more than one affirmation of can it include other entities? What if manufactured by Company 1 are compliance per article of food. PNSI more than one entity was involved in different sizes and thus are different also accepts more than one lot identifier the manufacture of the article of food? articles of food. Accordingly, each per article of food. • Does FDA have the authority to requires a separate prior notice (Final rule) The final rule requires in require the registration number of the submission. § 1.281(a)(5)(i), (b)(4)(i), and (c)(5)(i) the manufacturer of the article of food being The final rule continues to require complete FDA product code. The final imported or offered for import as a data submission of the estimated quantity of rule in § 1.281(a)(5)(ii), (b)(4)(ii), and element in prior notice? food that will be shipped, described (c)(5)(ii) requires the submission of the • Assuming FDA can require the from largest container to smallest common or usual name or market name manufacturer’s registration number in a package size. A prior notice will not be of the article of food as an element of prior notice submission, should FDA inadequate if the estimated quantity the identity of the article of food. The continue to do so in the final rule and/ changes between the confirmation of final rule in § 1.281(a)(5)(iii) and or should FDA provide an alternative prior notice and the time of arrival. (b)(4)(iii) requires the estimated quantity means for submitters to provide the Similar to the IFR, the final rule does described from the largest container to identity of the manufacturer? and

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• Questions Seeking Clarification. ‘‘the manufacturer’’ in section 801(m) of mean the place where the food was a. Does ‘‘the manufacturer’’ in section the act. In construing the prior notice actually manufactured/processed (i.e., 801(m) of the act mean the place where provision of the Bioterrorism Act, FDA the site-specific manufacturing facility). the food was actually manufactured or is confronted with the question of We believe that this interpretation is can it include other entities? What if whether Congress has directly spoken to reasonable and consistent with the goals more than one entity was involved in the precise question presented of the Bioterrorism Act. the manufacture of the article of food? (‘‘Chevron step one’’). Chevron, U.S.A., In considering whether it is (Comments) Section 1.281(a)(6) of the Inc. v. NRDC, Inc., 467 U.S. 837, 842 reasonable to interpret the manufacturer IFR requires the submission of the (1984). To find no ambiguity, Congress as being the actual place where the food identity of the manufacturer of each must have clearly manifested its was manufactured, we considered the article of food no longer in its natural intention with respect to the particular language and purpose of the prior notice state. Several comments recommend issue. Young v. Community Nutrition provision, as well as the other that the final rule define ‘‘the Institute, 476 U.S. 974, 980 (1986). If provisions of the Bioterrorism Act. The manufacturer.’’ Some comments note Congress has spoken directly and purpose of the Bioterrorism Act is ‘‘to that for ‘‘gray market’’ or ‘‘parallel plainly, the agency must implement improve the ability of the United States market’’ importations (food purchased Congress’s unambiguously expressed to prevent, prepare for, and respond to outside the manufacturer’s distribution intent. Chevron, 467 U.S. at 842–843. If, bioterrorism and other public health chain and imported to the United however, the Bioterrorism Act is silent emergencies’’ (Public Law 107–188). States), the only identifiable product or ambiguous as to the meaning of ‘‘the The prior notice provision contributes information is that which is on the manufacturer,’’ FDA may define this to this goal by providing the agency product itself. The comments suggest term in a reasonable fashion (‘‘Chevron with the information it needs to that in lieu of the name, address, and step two’’). Chevron, 467 U.S. at 842– determine whether, due to significant registration number of the manufacturer 843; FDA v. Brown & Williamson concerns about an article of imported of the food, the prior notice submission Tobacco Corp., 529 U.S. 120, 132 food, it should inspect the food upon should include the name and address of (2000). arrival in the United States. Having the the entity that appears on the label on We have determined that in enacting identity of the actual place where the the food. A comment notes that while section 801(m) of the act, Congress did food was manufactured (i.e., the site- this information is not as detailed as not clearly manifest its intention with specific manufacturing facility) will that required for other imports, it respect to the meaning of ‘‘the inform these risk-based decisions much relieves importers of ‘‘gray market’’ manufacturer.’’ When an article of food better than having the identity of the foods from having to provide is made from one or more raw packer or distributor or even the name information that in most instances ingredients, there could be several and address of the manufacturer’s would never be available to them. Other entities involved in its manufacture. For principal place of business. comments suggest that shipments of example, boxed macaroni and cheese Information about the manufacturer gifts to individuals but with a might involve preparing the dried contributes to FDA’s inspection commercial purpose, such as business macaroni, preparing the dried cheese, decisions under prior notice in two gifts to generate goodwill among combining these materials, and principal ways. One way is that when colleagues, should be permitted to packaging and labeling the finished FDA receives intelligence regarding reference the manufacturer’s name and product. Where multiple steps are potential areas of concern about food address as shown on the label in lieu of carried out by multiple entities, the act shipments, this intelligence is often the registration number of the does not directly and plainly set forth linked to a site-specific manufacturing manufacturer. which entity or entities Congress facility. For example, FDA received Several comments request that FDA intended as the manufacturer to be intelligence regarding alleged provide guidance regarding how to submitted as part of the prior notice. contamination with a harmful chemical complete prior notice for imported food Another question regarding ‘‘the substance of certain imported food from multiple manufacturing facilities. manufacturer’’ whose answer is not products from a certain specific foreign One comment suggests that the final clearly manifested in the act is whether manufacturing facility. FDA flagged rule should define the manufacturer as the manufacturer means the specific shipments from this facility for further the last entity to conduct a processing facility where the article is PNC review, and subsequently operation; e.g., including bottling, but manufactured or the entity that owns, or recommended the examination and excluding labeling. Another comment contracts with, the manufacturing sampling of several shipments from the provides an example of wine that is facility. Additionally, Congress did not site specific facility due to the produced and bottled at winery ‘‘X’’ and plainly address whether the entity listed significant public health threat posed by sent to winery ‘‘B’’ for labeling, which on a product’s label could be considered the articles of food. Because the identity sends the wine to another facility for the manufacturer. The entity listed on a of the site-specific manufacturing storage, which then transfers the wine to product’s label can be, as provided by facility was included in the prior the freight forwarder ‘‘F’’ who stores 21 CFR 101.5, the packer or distributor. notices, FDA was able to match the and consolidates the wine with other Additionally, under that regulation, the intelligence with the relevant food wines for shipment to the United States. label may state the principal place of shipments, without affecting the Another comment provides an example business of the manufacturer, packer, or importation of similar products from of fresh fruit that is processed in one distributor in lieu of the actual place other manufacturers. If prior notice only facility in a foreign country and then is where the food was manufactured or included the name and address listed on transported to one or several other packed or is to be distributed, unless the the label, FDA could not have facilities that re-palletize the fruit, statement would be misleading. confidence that it could flag shipments resulting in a finished pallet containing For the reasons given in the following of the food manufactured at the specific boxes that have been packaged at paragraphs, we have determined that, facility, either for further PNC review or several packing facilities. for purposes of section 801(m) of the for inspection. Matching a third-party (Response) These comments address, act, the phrase, ‘‘the identity of the distributor or packer with the actual directly or indirectly, the meaning of manufacturer,’’ should be interpreted to manufacturer that FDA wants to flag

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based on intelligence would be very distributor would be much less would have a detrimental impact on difficult and time consuming, and may meaningful than one based on the actual trade), in many situations FDA may not even be impossible to do with the manufacturer because the actual be able to ascertain the identity of each information available to the agency. If manufacturer has much more control of the firm’s manufacturing facilities. prior notice included the principal over the product’s quality and security Alternatively, FDA could attach a risk to place of business of the manufacturer than the product’s distributor. the headquarters location, but doing so (e.g., the corporate headquarters For example, when researching the would result in a less meaningful prior location) instead of the site-specific site-specific manufacturer listed in a notice risk assessment and may result in manufacturing facility, FDA’s ability to prior notice to investigate potential articles of food being assigned a lower correctly target shipments would not be security concerns, FDA found or higher risk than they should have much better. More often than not, when information in a government database based on the specific manufacturing FDA receives intelligence regarding a suggesting the facility had ties to facility. manufacturer, it is specific to the site- terrorism. Based on this and other Our interpretation of ‘‘the specific manufacturing facility and not information, FDA decided to examine manufacturer’’ to mean the actual place just the manufacturer’s corporate the product covered by the prior notice. where the food was manufactured also identity. In these situations, if the prior If the name and address of a different furthers the purposes of the notice that has been submitted contains firm, such as the distributor, had been Bioterrorism Act by helping to ensure only corporate-level information, FDA provided in the prior notice instead, it that imported food is from registered would have to target every relevant is unlikely that FDA’s research would facilities. Under section 801(l) of the act, shipment from every plant the firm have turned up this association and food that is imported or offered for owns or contracts with, which could be unlikely that this shipment would have import is subject to being held if it ‘‘is dozens, or even hundreds. As a result, been flagged for inspection. In its from a foreign facility for which a much time would be spent experience under the IFR, when prior registration has not been submitted to unnecessarily reviewing many notice has not included the identity of [FDA] under section 415’’ of the act. shipments that may not be of interest the actual manufacturer, FDA has had to FDA checks the information about the but whose risk could not be discounted attempt to determine the site-specific site-specific manufacturing facility based on the supplied manufacturer manufacturer by using alternative provided in prior notice to verify that information. means such as inspection, contacting facility’s registration status. If the prior the submitter, and/or contacting the notice provided only the name and The other way information about the firm listed on the label, a process that address listed on the label of the food manufacturer contributes to FDA’s in some cases has taken days and even rather than the actual manufacturing inspection decisions under prior notice weeks. The only other way to be sure facility, FDA would have no practicable is the agency’s use of this information that the subject article of food is not a means to readily determine whether the during its manual review of a prior threat is to have the food stopped and manufacturing facility is registered. As notice. Regardless of the reason a examined at the port of arrival to explained previously, the name and shipment is flagged for manual review determine if it is a threat. Stopping address on the label could be, for by the PNC, the identity of the shipments while FDA conducts example, the distributor or the parent manufacturer is one of the key elements additional research or an inspection company of the facility. FDA relies on in further assessing the would require significant agency Collecting information regarding the potential risk a shipment poses to the resources and could create inefficiencies manufacturing facility of an imported United States. FDA does this by using for the agency, CBP, industry, and product and its registration status goes the identity of manufacturer, as consumers as food shipments back-up at back to well before prior notice. As part provided in prior notice, to gather the border. of the admissibility review process for additional information from a variety of Similarly, if the prior notice included the various types of imported goods it sources, such as FDA’s and other the principal place of business of the regulates, FDA collects, among other government agencies’ databases and manufacturer rather than the specific information, the ‘‘FDA Manufacturer’’ research using publicly available manufacturing facility, this information and applicable registration numbers. information. For example, FDA will is likely to be too broad to be helpful, (See, for example, 70 FR 69576, often try to determine whether the particularly if it is a large company. November 16, 2005.) article of food being imported is Each manufacturing facility is different, The Bioterrorism Act expanded the consistent with the type or types of food in terms of its employees, the food it registration requirement with respect to the facility usually makes and ships to manufactures for the United States, its food facilities. New section 415 of the the United States, whether the facility’s manufacturing processes, and its act requires domestic and foreign owners, agents, or workers have security standards and procedures. One facilities that manufacture, process, potential ties to security concerns, and location of a company may have a pack, or hold food for human or animal whether FDA has found problems with higher standard for the security of its consumption in the United States to be prior shipments from the facility. The employees and manufacturing processes registered with FDA, unless the facility more closely that this information is than another location. In those cases is exempted. Under new section 801(1) tied with the site-specific manufacturing where the parent company owns or of the act, food from a foreign facility facility, the more reliable the risk contracts with multiple manufacturing that has not registered under section 415 assessment will be. If prior notice could facilities, FDA would have to determine of the act is subject to being held until include the name and address of the the risk associated with each of these the foreign facility has registered. It firm on the label (in lieu of the site facilities to ensure our review is could be argued that FDA should make specific manufacturer), and this firm is adequate. Because FDA is under strict its determination about the food the product’s distributor, then FDA timeframes to review, assess risk, and manufacturing facility’s registration would be able to gather additional respond to the prior notices, conducting status as part of the entry and information about the distributor but such wide-ranging research is not admissions process. The reason it is not the manufacturer. A risk assessment practical. Not only would this be necessary to make this determination at based on information concerning the prohibitively time-consuming (which the time FDA is reviewing prior notice

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is that if the article of food is held under facility registration provision, section are shipped by an individual to an section 801(l) of the act, it may not be 415(b)(3) of the act, and our individual. delivered to the importer, owner, or implementing rule, 21 CFR part 1, Given the importance of having the consignee and cannot be moved under subpart H (see specifically §§ 1.227(b)(2) site-specific manufacturer, we are also bond under section 801(b) of the act. and 1.226(a)). It also is consistent with proposing a change to the CPG regarding Operationally, the only way to the definition of FDA manufacturer the identity of the manufacturer. The implement these movement restrictions collected as part of the entry and Prior Notice Interim Final Rule CPG had is to conduct the registration status admissibility process, which states that a policy that covered situations where, review before entry is filed, which is if more than one party processed the after a good faith effort, the person when the prior notice review is article, then the manufacturer is the last submitting prior notice did not know conducted. party who substantially transformed the the name and address of the facility that The comments recommending that product. (See, for example, 70 FR 69576, manufactured the food. It stated that if the prior notice rule be expanded to November 16, 2005.) the submitter provided certain allow the identity of the entity shown Applying this definition to the alternative information, such as the on the product label in lieu of the example pertaining to wine in the identity of the facility’s headquarters, identity of the manufacturer are comments, the manufacturer for FDA and CBP should typically consider generally based on the argument that purposes of prior notice would be not taking any regulatory action despite information about the manufacturer, winery ‘‘X’’ since this is the facility that this noncompliance with the prior especially its registration number, is not produced and bottled the wine. The notice requirements. The Prior Notice always available to the submitter, such other facilities involved in this example Final Rule Draft CPG does not continue as when food is purchased outside the perform either manufacturing activities this policy because, as described above, manufacturer’s distribution chain. The of a de minimis nature, such as labeling, FDA and CBP believe that knowing the statute indicates that Congress or other activities not related to identity of the facility involved in the considered the issue of whether it manufacturing, such as storing and food’s production is critical to ensuring would be difficult or impossible to consolidating the wine. Thus, although that FDA can effectively target food for provide the identity of the manufacturer some of these facilities might have to inspection at the border upon arrival but chose to require it nonetheless. register with FDA as required by 21 CFR and can effectively determine whether Among the data required by prior notice part 1, subpart H as holders or packers food should be held because it is from are the identity of the manufacturer and, of food intended for consumption in the an unregistered manufacturing facility. for food in its natural state, the identity United States, the facilities in the Accordingly, section 1.276(b)(9) of the of the grower, if known. Section 801(m) example other than winery ‘‘X’’ are not final rule defines manufacturer for the of the act expressly provides that the considered the last facility under the purpose of prior notice submission as identity of the grower does not need to prior notice final rule’s definition of the last facility, as that word is defined be submitted if it is not known within ‘‘manufacturer.’’ Regarding the in § 1.227(b)(2), that manufactured/ the prior notice timeframes; however, comment on fresh fruit, FDA assumes processed the food. A facility is the act does not include this exemption that the comment is using the term considered the last facility even if the for the identity of the manufacturer. ‘‘processed’’ to mean an activity (such food undergoes further manufacturing/ This indicates that this information as treatment against pests or polishing) processing that consists of adding about the manufacturer must be that leaves the food still in its natural labeling or any similar activity of a de submitted regardless of any potential state, as explained in the definition of minimis nature. If the food undergoes difficulties in obtaining it. With respect ‘‘no longer in its natural state’’ under further manufacturing/processing that to the comments that were concerned § 1.276(b)(10). Although subsequent exceeds an activity of a de minimis about situations where the person facilities palletize the fruit, these would nature, then the subsequent facility that submitting prior notice does not know not be manufacturers because they only performed the additional the registration number of the pack the food and packing is not manufacturing/processing is considered manufacturer, as discussed elsewhere in considered manufacturing/processing. the manufacturer. We have removed in this preamble, FDA and CBP are Under this scenario, no information for the final rule the option that was in the modifying the final rule such that the any manufacturers would be required IFR to provide the label information in identity of the manufacturer can be for the prior notice. Instead, under § 101.5 instead of the name, address, submitted as the name of the § 1.281(a)(7) of the final rule, the prior and registration number of the manufacturer and either the registration notice would require the name and manufacturer for food sent by an number, city, and country of the address of the grower, if known. individual as a personal gift (i.e., for manufacturer, or both the full address of Consistent with the interpretation that nonbusiness reasons) to an individual in the manufacturer and the reason the the identity of the manufacturer requires the United States. Unless excepted registration number is not provided. site-specific information, we are elsewhere in the regulation, the identity Regarding situations where multiple removing the provision in the IFR of the manufacturer must be submitted steps are carried out by multiple stating that if the article of food is sent for an article of food that is no longer entities, we have determined that ‘‘the by an individual as a personal gift to an in its natural state. manufacturer’’ can reasonably be individual in the United States, then the b. Does FDA have the authority to interpreted to mean the last facility that name and address of the firm that require the registration number of the manufactured/processed the article. A appears on the label could be submitted manufacturer of the article of food being facility is the last facility that instead of the identity of the facility that imported or offered for import as a data manufactured/processed the food if the manufactured the food. We note, element in prior notice? (Comments) food does not undergo further however, that under the enforcement Many comments state that the manufacturing/processing, other than policy contemplated in the Prior Notice Bioterrorism Act does not require the addition of labeling or any similar Final Rule Draft CPG, FDA and CBP registration numbers to be submitted in activity of a de minimis nature. This would typically consider not taking prior notice. Some comments further interpretation is based on the definition regulatory action when no prior notice assert that the statute clearly states that of a foreign manufacturer under the food is submitted with respect to gifts that the ‘‘identity of the manufacturer’’ must

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be included for prior notice but it does Another comment states that the U.S. of entry for the article, and may not be not allude to nor require the registration Congress placed the burden upon the delivered to the importer, owner, or number. Another comment explains that FDA to ensure that a facility’s owner, consignee of the article, until the foreign if Congress intended FDA to require the operator or agent in charge complies facility is so registered. In the preamble registration number, it would have with the registration requirements to the IFR, we described how we would specifically articulated this requirement established under the Bioterrorism Act use registration in concert with prior as it did in section 321 of the and while it is reasonable for the FDA notice to carry out our responsibilities Bioterrorism Act for drug and device to request that importers assist them in under section 801(l) of the act imports. The comment concludes that this task by asking for facility ‘‘Registration is designed to work in the failure of the Congress to include registration numbers on prior notice concert with prior notice at the border, registration numbers in the enumerated submissions, the agency must not as reflected in new section 801(l) of the statutory elements of prior notice is condition lawful entry on the provision FD&C Act, which provides that food powerful evidence that Congress did not of this number that may, for a variety of from facilities that must register may not intend for FDA to require it. Another reasons, be unavailable to the importer. be admitted into distribution for comment states that the act does not Another comment claims that FDA consumption in the United States unless prescribe how the identity of the has no jurisdiction to enforce the the relevant facilities have been manufacturer must be provided, and registration requirements upon the registered. To enforce section 801(l) of therefore Congress has not spoken to affected foreign facilities. Another the FD&C Act as intended by Congress, this issue. Accordingly, FDA is entitled comment asserts that domestic food FDA has determined that it must review to deference in crafting a permissible manufacturers are not faced with this registration status of manufacturers and construction of the statutory dilemma because they are already shippers as part of prior notice. The requirements. within the United States, and there are information provided by registration One comment notes that all wineries no equivalent requirements to verify will allow FDA to check prior notice producing wine for consumption in the that domestic foods are produced at submissions against registration data to United States are required under section facilities that are properly registered confirm the identity. Moreover, the 415 of the Bioterrorism Act to provide with FDA. information provided by prior notice (Response) FDA’s position remains to FDA their name, the street addresses submissions can serve as a crosscheck that it has the authority to require the of their facilities and the trade names as to whether these facilities are registration of the manufacturer as a under which they do business. It further registered as required and have data element in prior notice. Under states that as long as the importer provided the necessary updates * * *. section 801(m) of the act, prior notice provides the name and address of the FDA does not agree that it should must include the identity of the confirm registration without requiring manufacturer of the wine, this will be manufacturer. The manufacturer’s that the number be submitted. Each sufficient for FDA to identify whether registration number is an identifier, just registered facility will be assigned a the manufacturer is registered with the as, for example, Employer Identification unique registration number by FDA. FDA, and that additionally requiring the numbers, Social Security numbers, and Thus, the registration number will help importer to furnish a registration driver’s license numbers are regularly identify the manufacturer. Without a number is unnecessary to implement used to help identify establishments and registration number, it may be difficult the Bioterrorism Act. individuals. Such numerical identifiers to determine exactly which registered Another comment asserts that the are much better for matching than name facility to associate with the article: obligation to verify that the and address information alone. For Different firms may have the same or manufacturer of a food article imported example, names and addresses often do or offered for import into the United not have standardize formats, there can similar names and more than one firm States is registered, or is required to do be alternative spellings and may operate from a particular location.’’ so, is an obligation imposed upon the abbreviations, and misspellings are not (68 FR 58974 at 59001). FDA continues FDA by Congress under the Bioterrorism uncommon. In addition, many facilities to believe that it should use the Act, not upon the importer. The have similar names, even facilities in information in prior notice to verify the comment further asserts that for FDA to the same country or city. Unique manufacturer’s registration status, and shift its burden to importers who are not identifiers are all the more important that the registration number is the related to the facilities required to be given the high volume of prior notices simplest and fastest way for us to do registered is, at the very least, unjust that FDA needs to process, FDA’s goal this. FDA further notes that it verifies and certainly was not the intent of of processing them expeditiously, and the registration status of both domestic Congress. The comment further states the need to ensure that FDA can and foreign facilities. FDA’s procedures that FDA has the ability and access to accurately flag shipments of potential for enforcing the registration the information necessary to verify concern. requirements for domestic facilities are registration status of manufacturers; As contemplated by the Registration explained in FDA’s ‘‘Compliance Policy unaffiliated importers do not. Another of Food Facilities rule, § 1.241(c), FDA Guide—Guidance for FDA Staff, comment asserts that FDA’s overly also uses the identity of the Registration of Food Facilities Under the broad interpretation of the prior notice manufacturer collected as part of prior Public Health Security and Bioterrorism provision of the Bioterrorism Act results notice to ensure that imported food is Preparedness and Response Act of in an anticompetitive business from registered facilities. Section 801(l) 2002.’’ See http://www.cfsan.fda.gov/ environment that is contrary to the of the act, which was enacted as part of ~furls/cpgreg2.html. spirit of the Bioterrorism Act. Another the Bioterrorism Act, states that if an c. Assuming FDA can require the comment emphasizes that to enforce the article of food is being imported or manufacturer’s registration number in a registration requirement through the offered for import into the United prior notice submission, should FDA means of prior notice requirements, States, and such article is from a foreign continue to do so in the final rule and/ which affect persons that are completely facility for which a registration has not or should FDA provide an alternative unrelated to the party responsible for been submitted under section 415 of the means for submitters to provide the registering the facility, is inappropriate. act, such article shall be held at the port identity of the manufacturer other than

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the registration number? (Comments) may seek to import food products from therefore already have a strong incentive Several comments recommend manufacturers whose registration to register with the FDA, since that is elimination of the registration number number is unknown or which are not the only way their products can gain as a requirement for identifying the required to register with FDA. entry into the United States. manufacturer of a food no longer in its Other comments recommend Other comments suggest inspection of natural state. One comment suggests alternatives to the requirement to a food shipment to ensure its safety that inclusion of a food facility submit the manufacturer’s registration when the prior notice submission lacks registration number does not ensure the number. The most commonly the required registration number, rather legitimacy of the shipment and that a recommended alternative to submission than refusal of that food as an black market for certain foods could of the manufacturer’s registration acceptable alternative. The comments result if registration numbers continue number is to allow submitters to state that this approach will avoid to be required for prior notice. Many identify the manufacturer by providing situations where shipments are rejected others comments recommend the name and address of the facility while still preserving FDA’s regulatory elimination of the requirement for the with an accompanying reason as to why discretion. Another comment states that manufacturer’s registration number in the registration number was not importers who obtain food from parties various situations: submitted. One comment specifically other than the original food • The food facility is not required to recommends a drop-down menu that manufacturers are willing to bear the register because ingredients or finished allows the submitter to explain the burden of increased inspections when goods manufactured by it are not reason for the lack of a registration they do not provide a manufacturer’s consumed in the United States, and thus number, such as ‘‘product was not registration number in the prior notice. it has no registration number; obtained from the manufacturer.’’ The Other comments agree that the • The manufacturer that has gone out comment reasons that this optional manufacturer’s registration number of business and does not have a facility approach allows FDA to continue to should be required in prior notice registration number; require registration numbers, but does submissions, but that the prior notice • Samples for: not per se invalidate a prior notice should not be deemed inadequate (i.e., Any reason/any type of sample; based on the absence of this single piece the food should not be refused under Any product samples not intended for of information. Another comment 801(m) of the act) if the manufacturer is public consumption or for retail suggests that the submitter affirm that it identified by name and address of the sale; believes, to the best of its knowledge, facility and a reason for lack of Quality control; that the manufacturer is registered with submission of the manufacturer’s Research; FDA. One comment recommends that registration number is provided. Analytical samples that are not only the manufacturer’s name for a Another comment suggests that the intended for human or animal ‘‘gray market’’ food should be sufficient final rule should be amended to provide consumption; for the prior notice when the submitter that the prior notice only need to Quality assurance samples that will does not know the manufacturer’s include such information about the be used for taste testing or quality registration number. manufacturers of older vintage wines control that includes human Another comment asserts that FDA that is readily available to the importer, consumption; must consider alternative means for together with registration numbers for • Fine wines; ensuring that all facilities subject to the all persons who have owned the wine • Registration numbers of the parties Registration of Food Facilities Rule (21 and all facilities that have stored the in possession of the wine over the past CFR part 1, subpart H) have an updated wine over the preceding 2 years. 2 years; registration on file with FDA that has One comment suggests that FDA • All wines and distilled spirits, been verified. The comment further permit the importation of quality when a registration number is not suggests that taking such action will assurance samples that will be used for available; allow the FDA to ensure that the taste testing or quality control that • Wine produced more than 5 years regulations are not implemented in a includes human consumption without prior to the date of its import (the year manner that prevents the lawful import the facility registration number of the of production is typically indicated on of safe and healthy food products based foreign manufacturer or processor. The the bottle’s label, and label approvals solely upon the unavailability of the comment further suggests that in lieu of are required under U.S. Tax and Trade confidential facility registration number. the registration number, the prior notice Bureau regulations); Several comments assert that should include the manufacturer’s name • All food produced prior to confirmation that a facility is registered and location along with the December 12, 2003; can be made without obtaining the identification of the person sending the • All food sent into the country for registration number of the facility. samples. the personal consumption of the One comment states that, though FDA While most comments state that the recipient and not for business use or has indicated that it wants the new name and address of the manufacturer redistribution; facility registration requirement to be could be submitted in prior notice, one • Gifts arriving in the United States enforced through the prior notice comment states that re-sellers will not from one individual to another in a regime, enforcement can be normally supply the name of their business setting; and accomplished without requiring that the supplier or the name of the • Consumer-to-consumer shipments. facility registration numbers be manufacturer of a particular product to Some comments state that the included in the prior notice. With the their customers. The comment asserts requirement to provide the name and address of the manufacturer that supplying the name of the manufacturer’s registration number in included, FDA can look up the manufacturer would allow that the prior notice is overly burdensome manufacturer in its database of customer to circumvent the re-seller and and unreasonable for some segments of registered manufacturers. If the attempt to make direct contact with the the food industry. The comments manufacturer has not registered, then supplier or manufacturer, thus taking suggest that there are numerous the FDA could deny entry to the articles business away from the re-seller. legitimate reasons that food companies of food in question. The manufacturers Another comment states that if only the

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name of the manufacturer is submitted the fact that the manufacturing facility submitted when no manufacturer in a prior notice, the prior notice should submitted as part of prior notice might registration number is provided: not be considered inadequate. not be registered. At best this matching • Situations where the facility is out Other comments support requiring the process may take significantly longer of business, as stated in § 1.235(a); registration number of the original (depending on the number of • Private residence, as stated in processor on prior notice submissions, manufacturers, products, and other § 1.227(b)(2); • particularly when a third-party is factors involved), impeding FDA’s The facility is a restaurant, as exporting the product to the United ability to complete its review within the defined in § 1.227(b)(10), and qualifies States. One comment further prior notice timeframes. At worst, a for the restaurant exemption in recommends that FDA should revise its facility mismatch will result in FDA § 1.226(d); • rules regarding the use of registration conducting its risk assessment based on The facility is a retail food numbers in general, and in the prior incorrect information. establishment, as defined in notice rule in particular, to protect The information provided in a § 1.227(b)(11), and qualifies for the retail legitimate buyers and distributors from registration thus enables FDA to better food establishment exemption in unauthorized ‘‘gray market’’ imports. assess risk of the product itself, as it § 1.226(c); • The facility is a nonprocessing Several comments suggest that the gives the PNC more information upon fishing vessel, as stated in § 1.226(f); manufacturer’s registration number which to base its assessment. PNC should be required and that only the • Nonbottled drinking water reviewers use the registration collection and distribution registration number be submitted, not information to verify whether the the name and country. Additionally, establishment, as stated in § 1.227(b)(2); articles of food in the shipment match • The manufacturer satisfies the some comments suggest that if the food product categories that the manufacturer and facility registration definition of ‘‘farm’’ in § 1.227(b)(3), and owner, operator, or agent-in-charge of qualifies for the farm exemption in numbers are provided and the numbers the facility listed in the site-specific provided are specific to a particular § 1.226(b); or facility’s registration with FDA. The • facility location, the requirement to The submitter is unable to registration information also provides determine the registration number of the complete the address information alternate names for a facility, lists the should be removed to avoid duplication manufacturer. The full address of the parent company and subsidiaries of the manufacturer has been provided by the of information. facility, verifies addresses, and provides (Response) To effectively implement submitter. the identity of the officers of the facility the prior notice and registration The Prior Notice Final Rule Draft CPG and/or their U.S. Agents. This provisions in the Bioterrorism Act, the that is announced elsewhere in this additional information may identify final rule requires the registration issue of the Federal Register lists these number of the manufacturer or, if the potential terrorist threats (e.g., a facility reasons to use when the registration registration number is not provided, the and/or facility official has ties with a number is not provided and describes facility’s full address and reason the terrorist organization). Not providing our proposed enforcement policies. registration is not provided. Reasons for the registration number in a prior notice As discussed previously, without the not providing a registration number leads to prolonged or incomplete registration number, it will be more include, for example, the manufacturing searches, which in turn could lead to difficult and/or may take more time for facility is out of business; the additional cargo delays or examinations us to verify the identity of the manufacturing facility is a private at the port of arrival as the PNC manufacturing facility and its residence and thus is not a ‘‘facility’’ for completes its intensive review (see registration status and to determine the purposes of the registration earlier discussion under timeframes). whether the article of food is subject to requirements; and the submitter is We also note that registered facilities being held under section 801(l) of the unable to determine the registration generally do not make their registration act. Thus, it is in the interest of the number of the manufacturing facility. numbers public, so they generally have parties involved in the import to Matching of facilities is vital for to be obtained directly from the provide the manufacturer’s name and making an initial assessment on the manufacturer or its designee during the registration number, and not simply the accuracy of the prior notice; assessing importation process as part of manufacturer’s name and full address, the risk of the associated article of food completing a prior notice. Thus it is because the registration number will based on the associated manufacturing harder to falsify registration information help us process the shipment more facility, its operations, and history of than the facility’s name and address, expeditiously. The submitter should importations; and verifying registration deterring the submission of false exercise a reasonable amount of effort to status. Without the registration number, manufacturer identification information. obtain and provide the registration PNC reviewers have to conduct this In some cases, the registration number number before using the reason ‘‘the matching using the name and address of the manufacturer is not available to submitter is unable to determine the submitted in a prior notice. Due to the the submitter, and therefore, we have registration number of the potential for human error during data revised the rule to provide an alternate manufacturer.’’ input or deviations in the spelling or means for satisfying the requirement to FDA does not agree with the format of a facility’s name, address or provide the identity of the site-specific comments asserting that the registration city, FDA may incorrectly think it has manufacturer in prior notices. For number is sufficient by itself to found a match between the facility purposes of the prior notice final rule, ‘‘identify’’ a facility in a prior notice described in the prior notice and a the identity of the manufacturer is the submission. The additional information facility in the registration database. name of the manufacturer and either: (1) is needed to verify that the registration Similarly, the facility described in the The registration number, city, and number, which is comprised of eleven prior notice may be close, but not exact, country of the manufacturer or (2) both digits, is accurate. Without additional to several facilities listed in the the full address of the manufacturer and information, there is a significant registration database, causing the reason the registration number is not possibility of typographical errors, uncertainty as to which, if any, is the provided (see § 1.281(a)(6), (b)(5), (c)(6)). leading to misidentification of facilities, correct match. This is complicated by One of the following reasons may be which could lead to foods being stopped

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at the port for inadequate prior notice submitter may submit either the shoppers are hired to collect company and registration. There also is the manufacturer’s registration number, trademark products, package these possibility of someone entering data in city, and country or both the according to company-established an attempt to ‘‘guess’’ at a registration manufacturer’s full address and the protocol, enclose purchase information number. Having identifying information reason why the registration number is and ship these to designated in addition to the registration number not provided. laboratories in the United States. and helps prevent such guessing. Having d. Questions seeking clarification. the shoppers often have no way of this confirmatory information also i. Designation of grower. (Comments) knowing the identity of the specific allows us to notify submitters of a Two comments state that they are manufacturing facility. One comment mismatch before the prior notice is exempt from the registration states that it is not likely that a accepted and confirmed for review, requirements because they are farms; manufacturer’s registration number which allows them to correct any however, they want guidance regarding would be available for competitive inadvertent errors before the food the steps these farms should follow to product samples and for finished arrives at the port, where it otherwise ensure that their products move through product samples used for evaluation may be subject to refusal for an the prior notice system without delays purposes, as well as for articles used for inadequate (inaccurate) prior notice. at the port. research and development purposes. If the prior notice does not contain (Response) If the article of food is no The comment states that the registration either the manufacturer’s registration longer in its natural state, such that the number does not fall under the Freedom number or the reason and name and full identity of the manufacturer is required, of Information Act and in some cases, address, the food is subject to refusal of the submitter can submit a reason for the manufacturer’s facility may not be admission under section 801(m)(1) of why the registration number was not required to register since the article of the act for failure to provide adequate provided; i.e., facility is a grower, meets food was not intended for consumption prior notice, as the identity of the farm exemption. These reasons also are in the United States. Another comment manufacturer is incomplete. The food listed in the Prior Notice Final Rule provides the example of when a also may be subject to a hold under Draft CPG announced elsewhere in this consumer expresses a concern about section 801(l) of the act if the food is issue of the Federal Register. If the either the quality or safety of a from a foreign manufacturer that is not article of food is in its natural state, the purchased food, and the consumer is registered under section 415 of the act. identity of the manufacturer is not instructed to ship that product to the In response to comments from those required and the systems will know that U.S.-based franchise company who are importing food from a facility they do not need to verify the laboratory for a timely analytical that is not registered because food manufacturing facility’s registration assessment. manufactured by it is not intended to be status. (Response) We have revised the final consumed in the United States, FDA ii. Manufacturer cancels registration. rule such that the identity of the notes that these shipments are subject to (Comments) A comment asks what manufacturer must include the name of hold under 801(l) of the act. Under designation is appropriate for the the manufacturer and either the section 801(l) of the act, food is subject scenario where at the time of production registration number, city, and country of to being held if it is imported or offered the manufacturing/processing facility the manufacturer or both the full for import into the United States and it was legitimately registered with the address of the manufacturer and the is from a foreign facility that has not FDA, but cancelled its registration prior reason the registration number is not registered. This provision applies to the importer submitting prior notice. provided. Relevant to these comments, regardless of whether the food was (Response) If the manufacturing one of the reasons for not providing the intended for consumption in the United facility still is operational, but chooses registration number is that the submitter States at the time it was manufactured, to cancel its registration with FDA, then is unable to determine it. However, as for example where an article of food is the food from this facility is subject to described above, if the article of food is made in Country X for consumption in refusal under 801(l) of the act. As stated from an unregistered facility, it is Country X, but is purchased by a third therein, ‘‘If an article of food is being subject to being held under section party who re-labels the product for imported or offered for import into the 801(l) of the act. Moreover, without the import and resale in the United States. United States, and such article is from registration number, it will be more (Comments) One comment a foreign facility for which a registration difficult and/or may take more time for recommends that inter-company gifts be has not been submitted to [FDA], such FDA to verify the identity of the exempt from the requirement to provide article shall be held at the port of entry manufacturing facility and its the manufacturer’s registration number for the article, and may not be delivered registration status. As a result, the food on the prior notice because these items to the importer, owner, or consignee of may be delayed until the verification is have no commercial value and are sent the article, until the foreign facility is so completed. as business gifts. The comment suggests registered.’’ If the facility has canceled While the final rule requires prior that FDA use the same approach for its registration because it has gone out notice, including the identity of the business and nonbusiness gifts, by of business, then this reason may be manufacturer, for shipments of samples, allowing a listing of the manufacturer’s entered on the prior notice. under the enforcement policy proposed name and address as it appears on the iii. Identity of manufacturer for in the Prior Notice Final Rule Draft CPG, product’s label. samples. (Comments) One comment FDA and CBP should typically consider (Response) The provisions in the final states that there are some circumstances not taking any regulatory action with rule regarding the registration number involving market survey and consumer respect to prior notice violations when are being revised, and these revised complaint samples where the an article of food is imported or offered provisions apply to both business and manufacturing facility is unknown to for import for quality assurance, nonbusiness shipments. The final rule the submitter of prior notice and the research or analysis purposes only, not no longer allows for submission of the manufacturing facility may not have a for human or animal consumption name and address as it appears on the registration number because it does not without prior notice. label in any situation. However, the rule do business in the United States. One iv. U.S. manufacturer of product also is being changed such that the comment provides the example of when being imported. (Comments) Two

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comments express concern that FDA encourages the agency to allow unable to determine the registration would reject a prior notice for imported American importers to query a database number of the manufacturer, the food that contains a U.S. manufacturing that would do nothing more than submitter may provide a reason along facility and that facility’s registration confirm whether the details provided with the name and full address of the number. are accurate. Another comment suggests manufacturer. (Response) Both ABI/ACS and PNSI that FDA make the registration database (Final rule) Section 1.281(a)(6), (b)(5), accept the identity of a manufacturing available to authorized customs brokers and (c)(6) of the final rule requires for facility from any internationally only. an article of food that is no longer in its recognized country designation, (Response) FDA does not intend to natural state, the identity of the including the United States. FDA direct registered food facilities to manufacturer, as follows: the name of recognizes that some food imported into divulge their registration numbers on the manufacturer; and either the the U.S. is manufactured in the U.S., documents or upon request. However, registration number, city, and country of exported, and then re-imported. Prior FDA does agree that guidance regarding the manufacturer or both the full notice applies to these articles of food divulging registration numbers and address of the manufacturer and the and identification of the U.S. facility as prior notice submissions may help to reason the registration number is not the manufacturer is correct. clarify the process, and provided this provided. v. Require manufacturer to reveal or guidance in our ‘‘Guidance for Industry, 8. The Grower, if Known conceal the registration number. Questions and Answers Regarding (Comments) Two comments recommend Registration of Food Facilities Final The Bioterrorism Act requires the that FDA compel manufacturers to Guidance’’ available at http:// submission of the identity of the grower divulge their food facility registration www.cfsan.fda.gov/~dms/ffregui4.html. of the article, if that identity is known numbers upon inquiry. Another vi. Exporting facility. (Comments) One within the specified period of time that comment requests that FDA issue comment requests that FDA notice is required to be provided. guidance stating that: FDA does not accommodate the importation of Section 1.281(a)(7), (b)(6), and (c)(7) of require the registration number on previously manufactured food products the IFR requires for an article of food commercial documents; the inclusion of that were purchased at retail outlets that is in its natural state, submission of a registration number on commercial outside the United States and the name and growing location address documents will not facilitate clearance recommends that FDA require only the of the grower, if known. If the submitter by CBP or FDA of the shipment; and registration number of the exporting does not know the identity of the grower FDA recommends that companies reveal facility and information identifying the or, if the article has been consolidated, this confidential information once only company responsible for the product. and the submitter does not know the in a formal letter and ensure by all The comment reasons that this identity of any of the growers, the possible means that their customer (e.g., information, along with other identity submitter may provide the name and distributor, importer, or customs broker) information required by prior notice, address of the firm that has consolidated also respect the confidentiality of this should be sufficient for FDA and CBP to the articles of food from different information. One comment cautions make risk decisions about a particular growers or different growing locations. about reported abusive and misleading import. (Comments) One comment asks that declaration of a registration number in (Response) FDA disagrees. The the requirement to identify the grower a prior notice for shipments that are Bioterrorism Act requires the identity of not be mandatory in the final rule and unconnected with the food facility that the manufacturer as well as the shipper. suggests exempting the growers and actually owns that registration number. The identity of the shipper or the providing the information of growers on Another comment suggests that FDA exporting facility alone is not sufficient a voluntary basis. Another comment should revise both the prior notice and to satisfy the requirements of the statute. asserts that it is virtually impossible to registration rules to clarify that those The facility that manufactured the food identify each grower once grain is doing business with the owner of a must be identified. commingled at the country elevator. facility should not and have no reason vii. Food imported or offered for (Response) The Bioterrorism Act to demand the facility registration import for transshipment, storage, and requires the identity of the grower, if number. export, or further manipulation and known, in the submission of prior Several comments suggest that FDA export. In the IFR, a registration number notice. Therefore, we cannot eliminate provide a means for importers and is not required for a facility associated the requirement to provide the identity others to verify a facility’s registration, with an article of food if the article is of the grower in all cases, as suggested even if such verification does not imported or offered for import for by the comment. If the identity of the disclose any information beyond transshipment, storage, and export, or grower is not known at the time of affirmation or denial. One comment further manipulation and export. We submission of the prior notice, and the suggests that FDA compare have removed this exception in the final food has been consolidated, then the Manufacturer Identity (MID) data rule because we have determined that submitter may, but is not required to, submitted through ABI/ACS to the FDA section 801(m) of the act requires the provide the name and address of the Food Facility Registration database and identity of the manufacturer for food consolidator (§ 1.281(a)(7), (b)(6), and notify the transmitter of a MID imported or offered for import into the (c)(7)). mismatch while keeping actual United States, regardless of whether that (Comments) Another comment states registration information secure. The food will be consumed in the United that a single shipment of fresh fruit may comment reasons that this process States. Likewise, under section 801(l) of represent hundreds of growers, all of would give the submitter and the act, food is subject to being held if whom are known by the submitter of the transmitter of a prior notice a it is imported or offered for import into prior notice. The comment asserts that noncompliance alert and also would the United States and it is from a foreign requiring submission of an individual alert the agency of possible additional facility that has not registered. This prior notice for each article represented intensive review requirements even provision applies even if the food is not by a single grower seems unnecessarily before the prior notice submission has for consumption in the United States. burdensome. The comment suggests that been completed. Another comment As noted previously, if the submitter is in lieu of requiring identification of all

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known growers in the prior notice, the assuming the imports for each grower manufacturing/processing step that rule should require the submitter of the are distinctly packaged. exceeds an activity of a de minimis prior notice to retain a complete list of (Final rule) Section 1.281(a)(7), (b)(6), nature. growers and to make this list available and (c)(7) of the final rule requires for (Final rule) The final rule retains to FDA for inspection and copying upon an article of food that is in its natural without change the provisions in request. state, the submission of the name and § 1.281(a)(8), (b)(7), and (c)(8) of the IFR. growing location address of the grower, (Response) We do not agree. Periodic 10. Shipper access, inspection, and copying of a if known. If the submitter does not complete listing of all growers of an know the identity of the grower or, if the The Bioterrorism Act requires the article of food does not satisfy the article has been consolidated and the submission of the identity of the shipper requirement to identify the grower of submitter does not know the identity of of the article. The IFR at § 1.281(a)(9), the article of food, if known, within the any of the growers, the name and (b)(8), and (c)(9) requires that the specified period of time that notice is address of the firm that has consolidated shipper be included in a prior notice. required to be provided. FDA responded the articles of food from different The IFR defines shipper (§ 1.277(b)(12)) as the owner or exporter who consigns to a similar comment in the prior notice growers or different growing locations and ships the article of food from a IFR and explained that FDA does not may be submitted. foreign country or the person who sends agree that a list would satisfy the 9. FDA Country of Production an article of food in international mail statutory requirement, as it would not The Bioterrorism Act requires the to the United States. tell FDA which grower was associated submission of the identity of the (Comments) One comment states that with the particular article of food as country from which the article the FDA has augmented section 307 of envisioned by the statute (68 FR 58974 originates. The IFR in § 1.281(a)(8), the Bioterrorism Act to require not only at 59006). We affirm the view here. (b)(7) and (c)(8), requires that a prior supply chain party identification but (Comments) One comment requests notice contain the FDA Country of also the registration number of the that FDA reconsider the requirement to Production of the article of food being shipper. The comment further states submit the names of multiple growers, imported or offered for import into the that the requirement to submit the if known, in the prior notice. The United States. As set out in the IFR shipper’s registration number is easily comment notes that submitters of prior definition at § 1.276(b)(4), the FDA met. There were no other comments notices must provide separate notices Country of Production is, for an article received on this issue. for each grower in the case of of food in its natural state, the country (Response) We revised certain consolidated shipments (if the growers where the article of food was grown, sections pertaining to the identity of the are known), which it asserts is onerous including harvested or collected and shipper. The IFR required the and costly for exporters of consolidated readied for shipment to the United registration number of the shipper, if the shipments of horticulture products. The States. If, however, an article of food is shipper is required to be registered. The comment believes that the proposed wild fish, including seafood, that was final rule requires the identity of the recordkeeping rules will cause the caught or harvested outside the waters shipper only if the shipper is different names of the growers to be recorded and of the United States by a vessel that is from the manufacturer. Moreover, the available and the prior notice not registered in the United States, the final rule eliminates the requirement to information is a duplication of effort. FDA Country of Production is the submit the registration number of the The comment asks that, for consolidated country in which the vessel is shipper, if the shipper is required to be shipments, FDA permit the submission registered. For a food that is no longer registered, and made the submission of of one prior notice providing the name in its natural state, the FDA Country of the registration number optional. The of the consolidator or one notice with Production is the country where the identity of the shipper in the final rule the names of all the growers. article of food was made. However, if an is satisfied by submission of the name (Response) FDA disagrees. Adding the article of food is made from wild fish, and full address of the shipper. capability to accept a list of growers including seafood, that was made (Final rule) The final rule in would add considerable complexity to aboard a vessel, the FDA Country of § 1.281(a)(9), (b)(8), and (c)(9) requires both the data entry software (PNSI and/ Production is the country in which the the name and full address of the or ABI) and the screening programs. vessel is registered. The IFR also shipper, if the shipper is different from FDA responded to a similar comment in provides that the FDA Country of the manufacturer. If the address of the the prior notice IFR and explained that Production of food grown and harvested shipper is a registered facility, the FDA does not agree that a list would or collected or made in a U.S. Territory submitter may submit the registration satisfy the statutory requirement, as it is the United States. number of the shipper’s registered would not tell FDA which grower was (Comments) One comment asks what facility. associated with the particular article of is required as the country of production FDA revised this requirement to food as envisioned by the statute (68 FR in a case where spirits are exported in require the shipper’s information only 58974 at 59006). And as we explained bulk to a third-country for local bottling when the shipper is different from the in the previous response, periodic and subsequent export from that third- manufacturer in order to eliminate access, inspection, and copying of a country for consumption in the United duplicative requirements. Moreover, we complete listing of all growers of an States. eliminated the requirement to provide article of food does not satisfy the (Response) For a food that is no longer the registration number of the shipper, requirement to identify the grower of in its natural state (e.g. spirits), the FDA if the shipper is required to be the article of food, if known, within the Country of Production is the country registered, and made the submission of specified period of time that notice is where the article of food was made (e.g. the registration number optional. required to be provided. FDA notes that bottled). For an article of food that In the IFR, the shipper’s registration users of PNSI can create a prior notice undergoes multiple manufacturing number is not required for a facility for one grower, copy that prior notice, steps, as in this comment, the FDA associated with an article of food if the and edit just the grower information and Country of Production would be country article is imported or offered for import the quantity and packaging information, where the last facility performs a for transshipment, storage, and export,

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or further manipulation and export. We border. The coordination procedures OASIS regardless of the estimated time have removed this exception in the final between FDA and CBP should not be of arrival date. rule since the shipper’s registration construed to mean that arrival (Response) Such changes to the ABI number is now optional. information is no longer important nor system are not feasible at this time given that we will not, whenever possible, resource constraints, and the 11. The Country From Which the Article conduct necessary inspections at the development of CBP’s new Automated is Shipped port. Moreover, FDA’s working with Commercial Environment. Moreover, The Bioterrorism Act requires the CBP personnel does not negate our need CBP transfers information to FDA at 8 submission of the identity of the for anticipated time and date of arrival p.m. on the day before arrival for truck country from which the article is since headquarters and field staff still shipments and 9 p.m. on the day before shipped. The IFR requires in need to know when articles of food plan arrival for air shipment. Information is § 1.281(a)(10) and (c)(10) submission of to arrive. transferred to FDA on the same day if the identity of the country from which (Comments) One comment states that that information is submitted the same the article is shipped. In § 1.281(b)(9), the arrival information should be linked day as anticipated arrival of the the IFR requires submission of the to the ABI entry filing at the port of shipment. CBP and FDA believe that identity of the country from which the entry because the FDA prior notice this is sufficient for meeting the article is shipped (i.e., mailed). requirement is inconsistent with the timeframes for receipt, review, and (Comments) There were no comments existing entry clearance processes of response to prior notice submission. received on this issue. CBP. The comment contends that (Comments) Two comments address (Final Rule) The final rule retains requiring prior notice at the port of the difficulty of obtaining exact arrival without change the provisions in arrival will result in severe disruption to information, including a specific time of § 1.281(a)(10), (b)(9), and (c)(10) of the flight schedules, with the possible arrival for air shipments, because many IFR. consequence of aircraft offload for any airlines are often closed at night. The affected food shipment for which prior comment also states that including a 12. Anticipated Arrival Information notice was not submitted. specific date and time for arrivals by Section 1.281(a)(11) of the IFR (Response) FDA disagrees. The ocean vessel is difficult. requires the submission of anticipated Bioterrorism Act requires notification (Response) FDA disagrees. From arrival information to include the about articles of food prior to arrival in FDA’s standpoint, ‘‘time of arrival’’ anticipated port of arrival and the United States. Although prior notice relates to when the food will first anticipated border crossing; the and entry information can be submitted become available for examination at the anticipated date on which the article of together through ABI/ACS, prior notice port. For vessels, this would be when food will arrive at the anticipated port cannot be substituted by the entry the vessel docks in the port. For planes, of arrival; and the anticipated time of process, which legally can occur well this would be when the plane lands. For that arrival. In § 1.281(c)(11), the IFR after the food has arrived in the United land vehicles, such as trucks, buses, and requires the submission of the actual States. Since implementation of the IFR, trains, this would be when they cross port of arrival. Anticipated arrival FDA and CBP have noted no severe the border. FDA believes that someone information is not required for food disruptions, including to flight involved in importing or offering for arriving by international mail. schedules due to lack of prior notice of import an article of food has an A prior notice will not be inadequate some articles of food within an aircraft, indication of anticipated arrival into the if the anticipated port of arrival, the truck, or vessel load. FDA points out United States of that food and can anticipated date of arrival, or the that in December 2003, CBP issued and inform the submitter and/or transmitter anticipated time of arrival changes began implementation of the Advance of the prior notice. FDA also emphasizes between the time of confirmation of Electronic Cargo Information rule, that the information being requested is prior notice and the time of arrival, as which also requires information about ‘‘anticipated’’ information, not ‘‘exact’’ provided by § 1.282(a) of the IFR. cargo before it arrives in the United or ‘‘specific’’ information as the The anticipated arrival information States and allows for prohibition of comment incorrectly describes. must specify the anticipated port of landing authorization if such (Final rule) FDA and CBP have arrival and, if there is more than one information is not provided in advance determined that for the purposes of border crossing location within that of arrival. (See 19 CFR 122.12(c) communication, the identity of the port, the specific anticipated border (international airports), 19 CFR border crossing within the port of crossing where the food will be brought 122.14(d)(4) (landing rights airports); arrival is no longer necessary. Therefore, into the United States. and 19 CFR 122.15(a) (user fee that information is not required in the (Comments) One comment suggests airports).) final rule. The final rule requires in the elimination of the anticipated arrival (Comments) One comment § 1.281(a)(11) the anticipated arrival information as a data element. Another recommends that FDA ask CBP to information, including the anticipated comment suggests that in light of the change their ABI system to provide for port of arrival, the anticipated date on MOU between FDA and CBP, arrival port diversion functionality. The which the article of food will arrive at data are no longer important, as CBP can comment acknowledges that, although the anticipated port of arrival, and the provide the personnel to conduct the the FDA prior notice system is designed anticipated time of that arrival. If the necessary inspections. to allow a shipment to be diverted to a article of food is arriving by express (Response) Section 801(m) of the act port other than the intended port of consignment operator or carrier, and requires the submission of the identity entry reported in the prior notice, CBP’s neither the submitter nor transmitter is of the anticipated port of entry for the ABI system precludes the CBP entry the express consignment operator or article of food, therefore, this data from being accepted at other than the carrier, and the prior notice is submitted element cannot be eliminated. The reported port of entry. Another via PNSI, the express consignment anticipated time and date of arrival are comment requests that when a prior operator or carrier tracking number may needed for planning resources because notice is transmitted via either the Cargo be submitted in lieu of the anticipated it relates to when the food will first or Border Cargo Selectivity application, arrival information. This revision is become available for examination at the the data should be moved from ACS to being made because anticipated arrival

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information is often not available to full address. Providing the registration to the entry of merchandise. In a case people who ship food using an express number will facilitate FDA’s review. where a customer or consignee has not consignment operator or courier (see The identity of the importer is not been identified, as described in the also the discussion in section III.E of required for an article of food that is previous comment, the public storage this document describing the shipper as imported or offered for import for warehouse where the merchandise will it relates to who is authorized to submit transshipment through the United States be delivered and stored should be prior notice). For food that has been under a T&E entry. identified as the ultimate consignee in refused under section 801(m) of the act, b. Owner. (Comments) One comment the prior notice submission. § 1.281(c)(11) of the final rule requires asks that FDA clarify what it means by (Final rule) Section 1.281(a)(14) and the port of arrival. We revised this owner and provide examples. (c)(14) of the final rule requires the provision in the final rule to require the (Response) In the preamble to the IFR, name and full address of the ultimate actual date on which the article of food in response to a comment, we explained consignee. FDA is continuing to require arrived at the port of arrival. This that the ‘‘owner’’ is the entity who owns information is important for shipments the article of food at the time of arrival the identity of the ultimate consignee so where no previous prior notice was filed (68 FR 58974 at 59011). However, if a that FDA can take steps to ensure that so that FDA knows how long it has been prior notice is given after the article is food refused admission under section since the refused food shipment arrived refused under section 801(m)(1) of the 801(m) of the act is not delivered to the in the United States. For shipments act, then the owner is the entity who ultimate consignee illegally. FDA is where a previously refused prior notice owns the article of food at the time the inserting the word ‘‘full’’ in front of was filed, the actual arrival date will prior notice is submitted (Id.). ‘‘address’’ in the final rule to make clear help FDA to connect the refused prior (Final rule) The final rule in that the complete address is required. notice to the post-refusal prior notice § 1.281(a)(13) and (c)(13) requires the Consequently, FDA is revising the submission. Anticipated arrival name and full address of the owner if subsequent sentence to state that if the information is not required for food different from the importer or ultimate business address of the ultimate arriving by international mail. consignee. FDA is continuing to require consignee is a registered facility, then the identity of the owner so that FDA the facility’s registration number also 13. The Importer, Owner, Ultimate can take steps to ensure that food may be provided in addition to the Consignee, and U.S. Recipient refused admission under section 801(m) facility’s full address. The identity of In § 1.281(a)(12) and (c)(12), the IFR of the act is not delivered to the owner the ultimate consignee is not required requires the name and address of the illegally. FDA is inserting the word for an article of food that is imported or importer. In § 1.281(a)(13) and (c)(13), ‘‘full’’ in front of ‘‘address’’ in the final offered for import for transshipment the IFR requires the name and address rule to make clear that the complete through the United States under a T&E of the owner if different from the address is required. Consequently, FDA entry. is revising the subsequent sentence to importer or ultimate consignee. In d. U.S. recipient. (Comments) There state that if the business address of the § 1.281(a)(14) and (c)(14), the IFR were no comments received on this requires the name and address of the owner is a registered facility, then the issue. ultimate consignee. However, the facility’s registration number may be identity of the importer, owner, and provided in addition to the owner’s full (Final rule) The identity of the ultimate consignee are not required for address. The identity of the owner is not importer, owner, or ultimate consignee an article of food that is imported or required for an article of food that is is not required for an article of food that offered for import for transshipment imported or offered for import for is imported or offered for import via through the United States under a T&E transshipment through the United States international mail. Instead, the final rule entry. under a T&E entry. requires in § 1.281(b)(11) the name and The identity of the importer, owner, c. Ultimate consignee. (Comments) address of the U.S. recipient. FDA is or ultimate consignee is not required for One comment states that the ultimate continuing to require the identity of the an article of food that is imported or consignee, as defined by CBP (Customs U.S. recipient so that FDA can take offered for import via international mail. Directive No. 3550–079A), is not steps to ensure that food refused Instead, § 1.281(b)(11) of the IFR necessarily the party to whom the admission under section 801(m) of the requires the name and address of the merchandise is delivered and asks who act is not delivered to the U.S. recipient U.S. recipient. is the ultimate consignee for purposes of illegally. a. Importer. (Comments) There were this rule. Another comment notes that no comments received on this issue. there are a number of manufacturers in 14. Mode of Transportation (Final rule) The final rule in Canada who ship their product to public Section 1.281(a)(15) and (c)(15) of the § 1.281(a)(12) and (c)(12) requires the warehouses in the United States to have IFR requires submission of the identity name and full address of the importer. product available on a just-in-time basis of the mode of transportation. FDA continues to require the identity of for their customers. The comment states the importer so that FDA can take steps that at the time the product crosses the (Comments) There were no comments to ensure that food refused admission border, it is still the property of the received on this issue. under section 801(m) of the act is not manufacturer and it does not have a (Final rule) The final rule retains delivered to the importer illegally. FDA specific customer (consignee) in the without change the provisions in is inserting the word ‘‘full’’ in front of United States other than the § 1.281(a)(15) and (c)(15) of the IFR. The ‘‘address’’ in the final rule to make clear manufacturer because the consignee is mode of transportation data element is that the complete address is required. still to be determined. The comment necessary to calculate whether prior Consequently, FDA also is revising the asks for guidance as to how to comply notice is timely, as well as for subsequent sentence of this paragraph to and fill out the prior notice for these identification of the article of food at the state that if the business address of the types of shipments. time of arrival for the purposes of importer is a registered facility, then the (Response) FDA intends to interpret planning examinations and facility’s registration number also may the ‘‘ultimate consignee’’ consistent communicating with CBP for be provided in addition to the facility’s with CBP’s use of that term in regards enforcement and examination.

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15. Carrier vehicle as the carrier, when applicable, the final rule contains a table of Section 1.281(a)(16) and (c)(16) of the is such a critical factor in the information required at the end of this IFR requires the SCAC or IATA code of identification of the article of food for section (table 2 of this document). Each the carrier which is, or will be, carrying examination and communication, that information requirement listed in the the article of food from the country from we have included this information in table 2 of this document is annotated to which the article is shipped to the § 1.281(a)(16) and (c)(16) of the final indicate when that information is United States, or if codes are not rule. required. Section 1.281(a)(16) and (c)(16) of the (Comments) One comment suggests applicable, then the name and country final rule requires the identity of the an additional requirement for planned of the carrier. carrier by submission of the SCAC or shipment information. The comment (Comments) Several comments ask for IATA code of the carrier which is, or suggests that a number assigned through clarification of identification of the will be, carrying the article of food from CBP’s PAPS be required and that the carrier and provide examples of when the country from which the article is PAPS number could be added after the the article of food is transferred from shipped to the United States to the port prior notice is submitted, but before the one carrier to another both prior to of arrival, or if these codes are not truck arrives at the border. The arrival in the United States and after applicable, then the name of the carrier. comment asserts that this amendment of arrival in the United States. If the carrier is a privately owned a confirmed prior notice, would greatly (Response) In the prior notice vehicle, the final rule requires the decrease a truck’s waiting time at the proposed rule, we had proposed to submission of the license plate number border and aid in quickly clearing require the identity of each carrier or of the vehicle and the State or Province trucks through CBP. transporter firm that transports the that issued the license plate number. (Response) PAPS is a CBP border article of food from the country from Identification of the carrier is not cargo release mechanism that utilizes which the article was shipped into the required for an article of food that is barcode technology to expedite the United States. We agree with the imported or offered for import via release of commercial shipments. FDA comments we received to the proposed international mail. at this time has no plans to utilize PAPS rule that asked FDA to eliminate the Identification of the carrier is in reviewing prior notices or otherwise requirement to identify multiple necessary to enable FDA and CBP to administering the prior notice program, carriers, and revised the proposed identify the appropriate article of food and therefore, FDA is not adding the provisions to require in the IFR the for inspection or holding when the food PAPS number as an additional data submission of the identity of the carrier arrives in the United States. FDA notes element. that is or will be carrying the article of that a carrier typically is a different firm (Comments) One comment requests food from the country from which the than the shipper. The broker or self-filer clarification as to whether the article is shipped to the United States. currently submits carrier information to additional requirement for planned In doing so, FDA acknowledged the ABI/ACS when entry is made, and it shipment information, as applicable suggestion that the only pertinent later is transmitted to OASIS. (carrier, vessel name, voyage flight carrier is the one arriving at the U.S. numbers and bill of lading number), port. The final rule clarifies that the 16. Planned Shipment Information will require a resubmission of prior carrier is the carrier which is, or will be, In § 1.281(a)(17) and (c)(17), the IFR notice when those details change due to carrying the article of food from the requires submission of planned transportation arrangements outside of country from which the article is shipment information as it exists when the control of the supplier. shipped to the United States to the port the prior notice is submitted. FDA (Response) When we issued the IFR, of arrival. recognized that some of this information we recognized that some of this (Final rule) FDA and CBP have may change after the prior notice has information may change after the prior determined that identity of the country been submitted and addressed this in notice has been submitted, and of the carrier is not necessary when the the IFR in § 1.282(a), which specifies addressed this in § 1.282(a) of the IFR, SCAC or IATA codes are not provided; when changes require resubmission to which specifies when changes require the name alone of the carrier is FDA. resubmission to FDA. If planned sufficient for communication between Many comments addressed the shipment information required in the two agencies. However, FDA and planned shipment information. These § 1.281(a)(17) changes after you receive CBP have determined that the license comments are discussed in order of notice that FDA has confirmed your plate number of a privately owned appearance of the specific data elements prior notice submission for review, you vehicle as well as the State or Province in the IFR and preceded by a discussion are not required by the IFR to resubmit that issued the license plate number is of general comments. prior notice. The final rule retains this necessary for such communication. a. General comments. (Comments) provision. While identity of the license plate One comment suggests that a complete b. Airway bill number(s) and bill of number and State or Province that list of ABI mandatory and optional data lading number(s)—§ 1.281(a)(17)(i) and issued the license is needed to identify elements be immediately published via (c)(17)(i). (Comments) One comment the carrier of the food at the port of the CBP Administrative Message stated that FDA should simplify the data arrival, it is more properly categorized system. The comment asserted that requirements and make the as part of the identity of the carrier than some planned shipment information, requirements more manageable. The as part of the identity of the planned such as the vessel carrier flag, is not comment states that one data element shipment information. Therefore, the necessary when the carrier code is should link all information secured by requirement for the submission of the submitted. prior notice, which would be beneficial license plate number (and State or (Response) The ‘‘vessel carrier flag’’ is for locating shipments in the event of a Province that issued the license) for not part of the planned shipment possible crisis. The comment suggests food arriving by privately owned information. For food arriving by ocean that the waybill/bill of lading number be vehicle has been moved to § 1.281(a)(16) vessel, the vessel name and voyage utilized as a single reference point and (c)(16). FDA has found that the number are part of the planned because all shipments that are moved identification of the privately owned shipment information. The preamble to are repeatedly covered by this number.

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(Response) FDA does not agree that regarding examination of that article of entering the United States. One the waybill/Bill of Lading can be used food prior to arrival of that food. It is comment recommends elimination of as a single reference point for all one of the means that FDA and CBP use the mandatory requirement for trip shipments instead of the prior notice to match the prior notice review to the number. confirmation number. A Bill of Lading food when it arrives at the port; e.g., (Response) FDA disagrees. Land number is not always assigned to a what conveyance is carrying the article carriers use the ‘‘Trip’’ number to shipment at the time of prior notice of food. The final rule will continue to signify a train number, bus route submission. For certain shipments, such require the vessel name and voyage number, and/or a truck route number. as those sent by international mail, no number for food arriving by ocean This number normally designates a Bill of Lading may exist. Thus, FDA has vessel. As we discussed in the preamble repetitive route between two locations determined that it is better to use a to the IFR, while we are dedicated to (e.g., Washington, DC to New York, NY) unique confirmation number provided increasing information sharing and may signify the specific truck, bus, by the FDA system to transmitters. capabilities with other agencies, it is or train route (e.g., Train # 138 or Bus (Final rule) The Airway Bill generally difficult to have the required # 4411). This information is necessary number(s) or Bill of Lading number(s) information readily accessible if we for communication between FDA and have been valuable information for need to coordinate with other agencies CBP, and thus, the final rule continues identification, examination and or governments to obtain from them the to require a trip number for food communication; however, this information necessary to respond to arriving by truck, bus, or rail. information is generally not available to bioterrorism incidents or other food- (Final rule) Section 1.281(a)(17)(iv) an individual submitter of an article of related emergencies (68 FR 58974 at and (c)(17)(iv) of the final rule requires food that is arriving via express 58992). submission of the trip number for food consignment operator or carrier. The (Final rule) Section 1.281(a)(17)(ii) arriving by truck, bus, or rail, as express consignment operator or carrier and (c)(17)(ii) of the final rule requires applicable to the mode of transportation tracking number is available to those submission of the vessel name and and when it exists. This information is individuals who send an article of food voyage number for food arriving by not required for an article of food that via express courier. Therefore, we have ocean vessel, when they exist. is imported or offered for import via amended the final rule to allow the d. Flight number—§ 1.281(a)(17)(iii) international mail. submission of the express consignment and (c)(17)(iii). (Comments) There were f. Container number(s)— operator or carrier tracking number in no comments received on this issue. § 1.281(a)(17)(v) and (c)(17)(v). lieu of the Airway Bill or Bill of Lading (Final rule) The final rule requires the (Comments) One comment suggests that numbers when the article of food is flight number for food arriving by air FDA should allow for multiple arriving by express consignment carrier. The flight number has been container submissions on one prior operator or carrier and the submitter is valuable information for identification, notice. not the express consignment operator or examination and communication; (Response) Multiple container carrier. however, this information is generally numbers can be submitted for one prior Section 1.281(a)(17)(i) and (c)(17)(i) of not available to an individual submitter notice on screen via PNSI submission or the final rule requires submission of the of an article of food that is arriving via through use of multiple qualifiers for Bill of Lading number(s) or the Airway express consignment operator or carrier. the Affirmation of Compliance code for Bill number(s), as applicable to the The express consignment operator or container number via ABI/ACS mode of transportation and when it carrier tracking number is available to submission. exists. This information is not required those individuals who send an article of (Final rule) Section 1.281(a)(17)(v) for an article of food that is imported or food via express consignment operator and (c)(17)(v) of the final rule requires offered for import via international mail or carrier. Therefore, § 1.281(a)(17)(iii) the identification of container numbers or when carried by or otherwise and (c)(17)(iii) of the IFR have been for food arriving as containerized cargo accompanying an individual when amended to allow the submission of the by water, air, or land, as applicable to entering the United States. For food express consignment operator or carrier the mode of transportation and when it arriving by express consignment tracking number in lieu of the flight exists. This information is not required operator or carrier when the submitter is number when the article of food is for an article of food that is imported or not the express consignment operator or arriving by express consignment offered for import via international mail carrier, the tracking number may be operator or carrier and the submitter is or when carried by or otherwise submitted in lieu of the Bill of Lading not the express consignment operator or accompanying an individual when or Airway Bill number. carrier. entering the United States. c. Vessel name and voyage number— e. Trip number—§ 1.281(a)(17)(iv) and g. Car number—§ 1.281(a)(17)(vi) and § 1.281(a)(17)(ii) and (c)(17)(ii). (c)(17)(iv). (Comments) Several (c)(17)(vi). (Comments) No comments (Comments) One comment asks the comments request clarification of the were received on this issue. purpose of this requirement because the definition of trip numbers. One (Final rule) The final rule retains the vessel name and voyage number are comment reasons that the load tender provisions of the IFR and requires provided to other U.S. agencies, such as numbers or manifest numbers should be submission of the identity of the car CBP and U.S. Coast Guard, at an even used as trip numbers for food arriving number for food arriving by rail, when earlier stage than required for the prior by truck because loads are tendered to it exists. This information is not notice. carriers with these numbers, and the required for an article of food that is (Response) The planned shipment carrier uses the numbers for billing imported or offered for import via information is necessary to ensure the reference. Another comment reasons international mail or when carried by or effective enforcement of section 801(m) that trip number appears to refer to a otherwise accompanying an individual of the act. Submission of the vessel number that relates to the particular trip when entering the United States. name and voyage number in prior notice or journey rather than the vehicle. h. License plate number and State or associates that information with the Another comment asserts that the trip Province—§ 1.281(a)(17)(vii) and article of food and enables FDA to number should identify the conveyance, (c)(17)(vii). (Comments) No comments effectively communicate with CBP everything onboard a trailer or container were received on this issue.

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(Final rule) FDA has determined that communication between FDA and CBP operator or carrier and the submitter is while identity of the license plate and that the identification of the HTS not the express operator or carrier; number and State or Province that would assist CBP in the efficient • For food arriving by truck, bus, or issued the license is needed to identify processing of prior notice through ACS. rail, the trip number; the carrier of the food at the port of We also thought that, for prior notices • For food arriving as containerized arrival, it is more properly categorized submitted through the FDA’s PNSI, the cargo by water, air, or land, the as part of the identity of the carrier than HTS numbers were needed to ensure container number(s) (not applicable to as part of the identity of the planned that the data collected from the CBP food carried by or otherwise shipment information. Therefore, the entry when it is transmitted through accompanying an individual); and requirement for the submission of the ABI/ACS could be matched to prior • For food arriving by rail, car license plate number (and State or notice. We have found that the HTS number (not applicable to food carried Province that issued the license) for code is neither critical for by or otherwise accompanying an food arriving by privately owned communication with CBP nor for individual). vehicle has been moved to § 1.281(a)(16) identification of the food for We also added the phrase ‘‘to the and (c)(16). The final rule requires the examination purposes. Accordingly, we mode of transportation and when it submission of the license plate number have removed the requirement to submit exists’’ after ‘‘as applicable’’ in the of the vehicle and the State or Province the HTS code as a part of prior notice opening sentence of § 1.281(a)(17) and that issued the license plate number, if planned shipment information. (c)(17) to clarify that the data elements the carrier is a privately owned vehicle. (Comments) One comment suggests under planned shipment information By including the identification of the that FDA and CBP upgrade the flags are applicable by mode of transportation privately owned vehicle as a carrier associated with HTS numbers. The and when the data element exists. For information requirement, when comment also states that prior notice example, rail car number, container applicable, you must resubmit the prior cannot be submitted through ABI/ACS if number, and train trip number may be notice in accordance with this subpart the HTS code does not have a FDA flag. applicable for rail shipments, and vessel (see § 1.282) if the privately owned One comment states that FDA should name, voyage number, and container vehicle information changes after the not rely solely upon HTS flags to number may be applicable for food prior notice has been confirmed by FDA implement the prior notice arriving by ocean vessel. for review. Identification of the license requirements. The final rule does not require that plate number and State or Province that (Response) FDA agrees and monitors prior notice be cancelled and issued the license is not required for an and updates the HTS flags. Guidance resubmitted if this planned shipment article of food that is imported or about the HTS flags is posted at http:// information changes after FDA has offered for import via international mail. www.cfsan.fda.gov/~dms/ confirmed the prior notice for review. A i. Harmonized tariff schedule (HTS) htsguid3.html. Prior notice can be prior notice will not be inadequate if codes—§ 1.281(a)(17)(viii) and submitted on any product because of any of the planned shipment (c)(17)(viii). (Comments) One comment intended use, regardless of the HTS flag. information changes between the suggests the use of the HTS codes in Not having a FDA flag associated with confirmation of prior notice and the lieu of FDA product codes and asserts the HTS code does not prevent time of arrival. that the HTS codes provide all the submission of prior notice via ABI/ACS j. Refused articles. (Comments) One information that the FDA would need or PNSI. comment requests clarification of the for prior notice. (Final rule) Section 1.281(a)(17) and process for resubmission if a prior (Response) The HTS codes often are (c)(17) of the final rule requires notice is refused for reasons other than not sufficient to specifically identify a submission of the following planned failure to satisfy prior notice product for FDA decisionmaking. For shipment information, as applicable, requirements. The comment asks once example, in many cases, the tariff code based on the mode of transportation: the failure is rectified, should does not describe how the product was • Bill of lading number(s), Airway companies use the PNSI or ABI/ACS to processed (e.g., commercially sterile or bill number(s), or express consignment resubmit the load for clearance? shelf-stable) or how the product is operator or carrier tracking number (Response) A food may be refused packaged, which is indicated in the when the article of food is arriving by under 801(m) of the act only if it is Process Indicator Code (PIC) element of express consignment operator or carrier imported or offered for import with FDA’s product code. Several products and the submitter is not the express inadequate prior notice; i.e., no prior that FDA considers different from each consignment operator or carrier (not notice, untimely prior notice, or other (because these differences affect applicable to food carried by or inaccurate prior notice. To resolve a the potential safety of the food) may be otherwise accompanying an individual); refusal, prior notice or a revised prior combined under one HTS code. • For food arriving by ocean vessel, notice must be submitted via PNSI until Therefore, the HTS codes do not vessel name and voyage number; such time as ACS or its successor provide all the information that is • For food arriving by air carrier, system can accommodate such required to identify the food. flight number or the express transactions. Additionally, at the time that FDA consignment operator or carrier tracking The following table 2 summarizes the and CBP issued the IFR, we believed number when the article of food is information required under § 1.281(a), that the HTS code was needed for arriving by express consignment (b), and (c):

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TABLE 2.—PRIOR NOTICE INFORMATION REQUIRED BY CATEGORY

Information Transshipment Carried By or Ac- Food Not in Nat- Food in Natural Mail After Section companying an ural State State 801(m) of the Act Individual Refusal § 1.281 paragraph(s) (a) and (c) (a) (a) (a) (b) (c)

Submitter Y Y Y Y Y Y

Transmitter Y Y Y Y Y Y

Entry type Y Y Y Y Y Y

Entry identifier Y Y Y Y N Y

FDA product code Y Y Y Y Y Y

Common, usual, or Y Y Y Y Y Y market name

Estimated quantity Y Y Y Y Y Actual

Lot/Code # Y Y Y N Y Y

Manufacturer Y Y Y N Y Y

Grower, if known Y Y N Y Y Y

Country of production Y Y Y Y Y Y

Shipper Y Y Y Y Y Y

Country from which arti- Y Y Y Y Y Y cle is shipped

Port of arrival Anticipated1 Anticipated1 Anticipated1 Anticipated1 N Actual1

Date of arrival Anticipated1 Anticipated1 Anticipated1 Anticipated1 N Actual

Time of arrival Anticipated1 Anticipated1 Anticipated1 Anticipated1 N N

Date of mailing N N N N Anticipated N

Importer N Y Y Y N Y

Owner N Y Y Y N Y

Ultimate consignee N Y Y Y N Y

U.S. recipient N N N N Y N

Mode of transport Y Y Y Y N Y

Carrier Y Y Y Y N Y

Bill of lading/airbill Planned1 N Planned1 Planned1 N Actual1

Vessel/Voyage Planned Planned Planned Planned N Actual

Flight # Planned1 Planned1 Planned1 Planned1 N Actual1

Trip # Planned Planned Planned Planned N Actual

Container # Planned N Planned Planned N Actual

Car # Planned N Planned Planned N Actual

Hold information N N N N N Y 1 If the article of food is arriving by express consignment carrier or operator, and the submitter and/or transmitter is not the express consign- ment operator or carrier, and the prior notice is submitted via the FDA PNSI, the express consignment operator or carrier tracking number may be submitted in lieu of this information.

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I. What Must You Do If Information prior notice submissions that have been sensitive and must be shipped in a Changes After You Have Received confirmed by FDA for review because temperature controlled environment. Confirmation of a Prior Notice From CBP also needs finality so it can The comments note that clerical errors FDA? (§ 1.282) complete its own screening of the entry. in the prior notice may not be corrected, In § 1.282 (a)(1) of the IFR, if any of Therefore, to keep the timeframes as and if an error is discovered after a CBP the information required in § 1.281(a) short as possible, we are not permitting entry is certified, the entry must be except the quantity information, the changes to prior notice without cancelled. According to the comments, anticipated arrival information, or the restarting the clock. if CBP is not available to cancel the Moreover, we believe that the prior planned shipment information, changes entry (e.g., the shipment arrives over the notice information required by the final after FDA has confirmed the prior notice weekend), the delay may cause the rule should be sufficiently fixed to be shipment to be destroyed. The submission for review, you must submitted within the timeframes. The comments request that FDA and CBP resubmit prior notice. For food arriving final rule allows for estimates for some find a way to address this problem, by international mail, if any of the information—estimated quantity, either by allowing clerical revisions information required in § 1.281(b), anticipated arrival information, and after the entry has been certified, except the anticipated date of mailing, planned shipment information—and permitting entry deletions under certain changes after FDA has confirmed the changes to any of these data elements circumstances, or ensuring CBP prior notice submission for review, you does not require that the prior notice be availability on a 24 hours/7 days a must resubmit prior notice. resubmitted. week/365 days a year schedule. The IFR also states that the original (Comments) Some comments request (Response) Because we reduced the prior notice should be cancelled in PNSI that FDA create a mechanism to allow timeframes for submitting prior notice or if originally submitted via ABI/ACS, correction of errors in a manner that in the IFR to the least amount of time the entry should be deleted. does not restart the prior notice clock. that we need to meet our statutory (Comments) Some comments request One comment requests the final rule responsibility to receive, review, and that FDA revisit the concepts outlined provide for correction of errors within respond to prior notice submissions, the in §§ 1.289 through 1.294 of the the timeframe of the 2-, 4-, or 8–hour IFR did not provide for amendments or proposed rule, which allowed deadline. The comments suggest that a updates. The timeframes in the final amendments to be made to product streamlined process, possibly through rule also provide the least amount of identity, estimated quantity, and arrival electronic means, of making clerical time we need to receive, review and information, without having to cancel corrections or correcting errors in timely respond to prior notice submissions and the entry and resubmit the prior notice filed prior notice should be a permanent therefore, the final rule also does not under a new entry. The comments feature of the integrated FDA-CBP provide for amendments or updates. contend that such amendments were process. Some comments contend that The use of ABI/ACS precludes acceptable and would not taint the without the opportunity to correct the amendments and updates without adequacy of a prior notice or error post-submission, shippers may substantial and costly revisions to the compromise food security, if the find their shipments frozen in an system; such technical changes are not amendments are made within the extended period of delay, which would cost-effective or a good use of limited applicable 2-, 4-, or 8–hour timeframes frustrate the purpose of the FDA-CBP resources given the development of the per mode of transportation at issue. The Integration Plan that is aimed at Automated Commercial Environment, comments suggest that amendments reducing such timeframes. Comments which will replace ACS. Changes to allow for a degree of flexibility in the also suggest this would create an ABI/ACS submissions that have been prior notice system and acknowledge a unintended legislative loop between the electronically transmitted to FDA’s well-known fact in the industry that this two regulatory frameworks meant by the OASIS and confirmed by FDA for type of information may change after Integration Plan to be seamlessly and review are not feasible because CBP also prior notice has been submitted. Some efficiently integrated. needs finality so it can complete its own comments suggest that allowing the Some comments object to the IFR’s screening of the entry. submitter or filer to update or correct requirements because after the CBP Changes to confirmed prior notice information provided in a prior notice entry or entry summary has been submissions, other than those relating to will facilitate the steady flow of prior certified, there currently is no estimated quantity, anticipated arrival notice submissions, without mechanism for making corrections, information, and planned shipment jeopardizing the security and safety of including corrections of simple clerical information, must be processed by the food supply. errors, without canceling the entry and resubmission of prior notice unless the (Response) Unlike the proposed rule, submitting a new entry. Comments state article of food will not be offered for the IFR does not allow for amendments that the requirement to cancel and import or imported into the United relating to the product identity. After resubmit a prior notice when submitted States. The responsibility is on considering the comments on whether information changes or to correct a submitters to provide accurate prior the final rule should allow amendments, clerical error creates additional work in notice to FDA, and we encourage and based on our experience with the an already overburdened environment. affected parties to take appropriate IFR, we believe the approach in the IFR According to the comments, in the air measures to verify entries for accuracy is sound. The reduced timeframes in the and truck environment where cargo is before sending. FDA notes that both ABI IFR, which are continued in the final processed on weekends and at off-hour and PNSI systems allow for correction rule, provide very little leeway in the operations, CBP is unavailable to of errors that are revealed by the time FDA has to receive, review, and process these entry cancellations. The systems’ validation process. In PNSI, a respond to the prior notice submissions. comments state that in such PN confirmation number will not be Moreover, the timeframes are based, in circumstances, cargo could be forced provided if it detects errors in the part, on not receiving amendments into refused status due to CBP’s submitted data. because allowing amendments would inability to act in a timely manner. Moreover, FDA notes that if CBP is increase the review time. In addition, Similarly, other comments state that unavailable to cancel a prior notice, ACS cannot accommodate changes in many imported articles of food are time submitters can create and submit new

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replacement entries and prior notices prior notice should be cancelled and a and could be subject to civil penalties. using either ABI or a combination of prior notice with the correct information The comment recommends that the ABI and PNSI even when the original must be submitted. Changes to other prior notice system allow custom entry entry has not yet been cancelled. information (i.e., estimated quantity, numbers to be updated after the customs However, the submitter should cancel anticipated arrival information, and entry has been filed by the customs the previously submitted inaccurate ABI planned shipment information) do not brokers and that any penalty entry (via request to CBP) at the first require the submitter to re-submit a considerations be deferred under these chance possible to avoid subsequent revised prior notice. circumstances. administrative and operational (Comments) Some comments suggest (Response) The type of updates problems with entry release. This is a that entry deletions, rather than recommended by this comment is not revision to the IFR in that § 1.282(c) of cancellations, should be permitted for necessary because prior notice can be the final rule uses the correct term legitimate reasons. submitted without a customs entry ‘‘cancel’’ versus ‘‘delete’’ when (Response) FDA believes the comment number. In the situation described, describing what CBP should be misunderstands § 1.282(c) of the IFR where prior notice must be submitted requested to do in this case. When an because that provision states, ‘‘If you before entry can be filed, prior notice entry is ‘‘deleted’’ versus ‘‘cancelled’’ in submitted the prior notice via ABI/ACS, may be submitted using PNSI without a ABI, the filer is able to re-use the you should cancel the prior notice via CBP entry identifier (e.g., a CBP entry original entry number. However, PNSI ACS by requesting that CBP delete the number). PNSI will provide a system- will reject a prior notice submission that entry’’ (emphasis added). However, the generated entry identifier. Once a attempts to re-use a previous entry final rule now recommends that if you customs broker is secured during number. Therefore, we revised the final cancelled a prior notice submitted via normal business hours to file the entry, rule to provide for cancellation of the ABI/ACS, you should cancel the prior the prior notice confirmation number(s) entry, rather than deletion of an entry. notice via ACS by requesting that CBP can be given to the broker who can (Comments) Some comments request cancel, rather than delete, the entry affiliate the prior notice(s) to the that FDA and CBP develop a process for (§ 1.282(c)). When an entry is ‘‘deleted’’ customs entry via the ABI submission. reviewing amendments that do not versus ‘‘cancelled’’ in ABI, the filer is (Comments) Some comments request affect the security of the cargo in less able to re-use the original entry number. clarification on what happens to the than the full eight hours, so that the However, PNSI will reject a prior notice food if the information relating to shipments’ release from the port is not submission that attempts to re-use a product identity, estimated quantity, or delayed unduly. previous entry number. Therefore, we anticipated arrival changes after prior (Response) The requirements for revised the final rule to provide for notice is submitted. amendments set forth in the proposed cancellation of the entry, rather than (Response) The final rule requires that rule were eliminated from the IFR. This deletion of an entry. if required information (except final rule provides that if required (Comments) One comment requested estimated quantity, anticipated arrival information (except estimated quantity, clarification regarding whether the information, including the anticipated anticipated arrival information, additional requirement for planned date of mailing, and planned shipment including the anticipated date of shipment information as applicable information) changes after FDA has mailing, and planned shipment (carrier, vessel name, voyage flight confirmed prior notice for review, the information) changes after FDA has numbers, and bill of lading number) prior notice must be resubmitted. As we confirmed prior notice for review, the will necessitate a resubmission when explained in the preamble to the IFR, prior notice should be cancelled and a those details change due to ‘‘FDA proposed to allow changes to prior notice with the correct information transportation arrangements outside the certain information in the prior notice must be submitted. The reduced control of the supplier. after a prior notice was submitted. timeframes in the IFR, which are (Response) No. The final rule does not * * *. Some comments stated that if the continued in the final rule, provide very require resubmission of prior notice if timeframe for submitting prior notice little leeway in the time FDA has to the planned shipment information was changed, i.e., shortened to 4 hours receive, review, and respond to the prior changes after prior notice has been for land and air and 8 hours for water, notice submissions. Moreover, the submitted and confirmed for review by then amendments and updates would timeframes are based, in part, on not FDA. not be necessary. * * * FDA agrees receiving amendments because allowing (Comments) One comment notes that with the comments that state that if the amendments would increase the review part of the process of completing a prior deadline for submission of prior notice time. In addition, ACS cannot notice is to obtain a CBP entry number, were reduced, amendments and updates accommodate changes in prior notice which many firms use a customs broker would not be necessary. FDA has submissions that have been confirmed to do. The comment states that this chosen timeframes that provide it with by FDA for review because CBP also works well in most cases, but can create very little leeway in the time it has to needs finality so it can complete its own problems for products arriving by boat. ‘receive, review and respond’ to the screening of the entry. Because we are The comment further states that of all prior notice submissions. Thus, we maintaining the IFR timeframes in the the modes of transportation, boats are concluded that we could no longer final rule, it is difficult to accommodate the most unpredictable and can arrive permit changes to prior notice without amendments. earlier or later than expected. Early restarting the clock. In addition, the use (Comments) Some comments state arrivals pose a problem because of the of ABI/ACS precludes amendments and that changes to prior notice should be 8 hour notice period and the relatively updates: changes to ABI/ACS required for material changes only. short timeframe in which a company submissions that have been Materiality would need to be learns of an impending early arrival. electronically transmitted to FDA’s determined. Given the fact that customs brokers may OASIS and confirmed by FDA for (Response) We agree. The final rule not work a 24–hour, 7-day per week review are not feasible because CBP also requires that, if certain required schedule, prior notice shipments that needs finality so it can complete its own information changes after FDA has arrive on the weekend, holiday, or after screening of the entry. Therefore, the confirmed prior notice for review, the normal business hours will be filed late interim final rule does not allow for

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changes to a prior notice after the accommodate such transactions, post- (Comments) Some comments ask if transmitter has been notified that FDA refusal prior notice must be submitted there are any measures that importers has confirmed the prior notice for via PNSI (see § 1.280(a)(2)). should undertake to avoid delays at the review.’’ (68 FR 58974 at 59013 and (Final Rule) Section 1.282 of the final port of entry. 59014) rule requires that if required (Response) FDA advises that most We retain this view and therefore, information (except estimated quantity, delays based on inaccurate and changes in product identity require anticipated arrival information, untimely submission of prior notice are resubmission of a prior notice with the including the anticipated date of avoidable and recommends that correct information. We do not require mailing, and planned shipment importers focus on measures to increase resubmission of a prior notice if the information) changes after FDA has accurate and timely submissions of estimated quantity, anticipated arrival confirmed prior notice for review, the prior notice. information, including the anticipated prior notice should be cancelled and a (Comments) Some comments state date of mailing, and planned shipment prior notice with the updated that the ‘‘Category 3’’ refusal and fine information changes, because these data information must be submitted. provision is excessive for a shipment elements are not firm in the first place. showing up at the border in advance of Moreover, such changes would not alter J. What Happens to Food That Is the 2-hour timeframe elapsing and FDA FDA’s ability to review the prior notice Imported or Offered for Import Without should consider lowering the penalty or to examine the food. Adequate Prior Notice? (§ 1.283) for this type of offense. Other comments (Comments) Some comments request The IFR in § 1.283 identifies request clarification about what will that FDA maintain the flexibility, as consequences and procedures for failure happen to trucks that arrive too early, provided by the IFR, to provide to provide adequate prior notice and i.e., will they be turned away or will anticipated port arrival information for describes the requirements and they be allowed to wait in the date and time of arrival and point of procedures for various situations. compound? crossing. The comments state that this The comments received will be (Response) Section 1.283(a)(1)(iii) of flexibility is critical for minimizing discussed below in the order each issue the final rule provides that if an article trade disruption and note that times of appears in § 1.283 of the IFR, proceeded of food arrives early (i.e., before the arrival and entry locations often change by comments generally addressing prior notice time has elapsed), its arrival and importers need the flexibility to consequences. will not be considered untimely if FDA accommodate these unanticipated already has reviewed the prior notice, 1. General Comments changes without refiling entry determined its response to the prior information. (Comments) Some comments suggest notice, and advised CBP of that (Response) Section 1.281(a)(11), that enforcement actions should be response. However, if FDA has not which requires anticipated arrival based on levels of culpability (e.g., reviewed the prior notice submission information, has been revised in the negligent, grossly negligent, and and responded to CBP before the food final rule. The requirement to provide fraudulent), number of infractions, and arrives, the food is subject to refusal. As the identity of the border crossing seriousness of infractions. noted previously, in determining within the anticipated port of arrival has (Response) FDA and CBP take various whether to refuse the food, assess a CBP been eliminated in the final rule. As considerations, such as the seriousness civil monetary penalty, or take other with the IFR, in the final rule, changes of the violation, into account when regulatory action, we will take into in anticipated port of arrival, deciding whether to take an account the seriousness of the violation anticipated date of arrival, and enforcement action in response to and other considerations. Trucks anticipated time of arrival do not violations of the prior notice rule and, arriving before FDA has processed the require cancellation and resubmission if so, what actions to take. For areas in prior notice will be handled as of the prior notice. which we have established enforcement appropriate under the individual (Comments) Some comments suggest policies for prior notice, these are circumstances. that the requirement that all prior notice contained in, and communicated to the (Comments) Some comments state data be transmitted via the PNSI portal public through a Compliance Policy that the implementation plan for the after the prior notice time limitations or Guide (CPG). Elsewhere in this issue of prior notice rule must include a refusal will increase the load on this the Federal Register, we are announcing contingency plan to ensure that border limited system. The comments state that the availability of the Prior Notice Final traffic can still be cleared and does not the PNSI system capacity must be Rule Draft CPG, which describes our come to a standstill as new systems are dramatically increased before the proposed enforcement policies for the put in place and problems are resolved. August 2004 full enforcement deadline final rule. Comments point out that it is essential in order to ensure that legitimate trade (Comments) Some comments request for FDA and CBP to have appropriate is not impacted due to a failure of the clarification on the penalties for mechanisms and procedures in place system. inadvertent errors, such as clerical (such as referral to a secondary (Response) FDA does not agree that errors, in the prior notice submission. inspection, where appropriate) so that post-refusal prior notice submissions (Response) As described in the border congestion is not increased by have or will impact or overload PNSI. previous response, FDA and CBP take the application of the rules. PNSI has operated effectively since the into account the nature of the violation Some comments request clarification IFR took effect and has sufficient in determining how to respond to prior on arrangements between FDA and CBP, capacity for any increase in submissions notice violations. The validation process the Canada Border Services Agency, and after the effective date of this final rule. built into ABI and PNSI should assist in the bridge authorities to address issues FDA has carefully monitored both PNSI catching inadvertent errors, such as surrounding refusal of entry due to and OASIS system usage and clerical errors, because the systems will missing or incomplete prior notice performance. No issues related to load not accept data with certain errors. This information. The comments indicate on PNSI have been identified since the validation process then allows the that the relevant agencies on both sides IFR took effect. Until such time as ACS submitter to correct errors before final of the border should have a plan in or its successor system can submission of prior notice data. place to deal with the inevitable

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problems posed by larger volumes of means to resolve the refused admission certain actions, including refusals, returning trucks to ensure that busy status. routinely notifying these and other border crossings do not become a ‘‘no (Response) Both the IFR and the final parties about a refusal would take man’s’’ land. Some comments indicate rule provide for a response to an 801(m) limited staff resources away from other that local staff at busy border crossings, refusal to be provided to FDA by mail, functions, such as reviewing prior such as the Peace Bridge and e-mail, fax, or courier. FDA will respond notices. FDA will try to notify other Ambassador Bridge, have indicated that in kind, as we have not experienced any parties (e.g., submitter), in addition to trucks will be turned back for missing/ problems as a result of this flexibility. the carrier, if feasible, and we often do incomplete prior notice if secure storage 2. Inadequate Prior Notice (§ 1.283(a)(1)) contact these other parties as resources cannot be arranged. Comments suggest allow. FDA notes that for the future that CBP could stamp a shipping (Comments) Several comments migration of ABI/ACS to the ITDS/ACE document (such as the bill of lading) request that FDA notify the submitter, environment, FDA has requested the ‘‘Refused—BTA’’ or implement filer, importer, or ultimate consignee, ability to provide electronic prior notice procedures that CBP had in place for either in lieu of or in addition to the ‘‘refusal’’ messaging. This capability refused trucks prior to the Bioterrorism carrier, about inadequacies in a prior does not currently exist. If electronic Act. notice submission that result in refusal prior notice refusal messaging is in of the food. The comments state that the Some comments suggest that carriers place, it would significantly reduce the carrier is not in a position to resolve the should be permitted a variety of options resources required to notify ITDS problem when the article of food is when and if they are advised that one participants of these refusals. refused. The comments note that the or more products within a shipment (Comments) Some comments express carrier has temporary possession of the have been refused due to a failure to concern that trucking companies that product, has minimal vested interest in have an adequate prior notice. pick up FDA-regulated freight in Canada the shipment, particularly if is According to the comments, these or Mexico bound for the United States offloaded, and has little, if any, options may include, permission to hold cannot ascertain that the importer, resources or incentive to resolve the the cargo at the border while the proper shipper, or customs broker has filed the refusal. However, according to the appropriate prior notice. The comments information is submitted to the FDA and comments, the exporter, importer, or before mandatory notice of intended ask what form of proof FDA (or other ultimate consignee has an ownership border regulatory agencies) will destination for delivery; returning the interest in the refused food and a strong cargo to the exporting facility directly; consider acceptable in order to release economic incentive to resolve the the motor carrier from responsibility if holding the cargo at a designated refusal swiftly, or to export or destroy carrier’s closest facility; and/or holding the prior notice was not filed the refused food if the prior notice appropriately. The comments state that the cargo at a designated FDA holding defects cannot be corrected. The facility, not necessarily a general order it is not clear whether FDA will supply comments state that delaying an official document that the importer, bonded warehouse, near the port of notification to the submitter, importer, shipper, or customs broker would issue entry. and ultimate consignee, unduly hinders to the motor carrier to assure the carrier (Response) FDA and CBP have not the resolution of the problem. that prior notice has been filed. experienced any major disruptions in One comment specifies that the filer (Response) Under § 1.279(d) of the border traffic as a result of the of the prior notice, who is in most cases final rule, FDA notifies the submitter implementation of the IFR in December the importer, supplier, owner of the when the prior notice has been 2003. The agencies also have not made merchandise, or a representative of one confirmed for review, with a message any significant revisions to the IFR in of these entities, should be notified containing a prior notice confirmation this final rule that cause us to believe directly, without any intermediate number. Section 1.279(g) of the final there will be major disruptions in trade communication, so that the filer may rule requires that the prior notice once the provisions in this final rule promptly take corrective action and confirmation number must accompany take effect, particularly since we are mitigate any possible adverse regulatory any article of food for which the prior providing a 180-day period between and commercial consequences. Some notice was submitted through PNSI publication of this rule and the effective comments request that FDA or CBP when the article arrives in the United date of its provisions. This period of notify the General Order Manager States and must be provided to CBP or time should allow for full (GOM) when a shipment has been FDA upon arrival. To address the understanding by affected parties of the rejected or denied entry and also concern in the comments, carriers may requirements of the final rule. provide the rationale for that decision. consider, as a matter of business We also note that the automated (Response) FDA disagrees. The IFR practice, requesting from their validation process in ABI and PNSI will does not require FDA or CBP to provide customers proof of confirmation of prior catch most missing and incomplete notice about a refusal, and we continue notice submission prior to transporting submissions before refusal because the to believe this is appropriate. As an the food to the United States, even when systems will not accept submissions operational matter, the carrier would there is no requirement to provide the with certain errors or omissions. If have to be notified of the refusal. The confirmation number to CBP or FDA refusal does occur, the carrier will have carrier can then notify others, such as upon arrival. the option to segregate refused food the entity that hired the carrier to (Comments) Some comments request from the rest of the shipment transport the article of food, that there clarification on whether information for (§ 1.283(a)(3)), the option to export after is a problem with the prior notice. It FDA clearance will be allowed to be refusal with CBP concurrence would be resource-intensive for FDA or transmitted via ABI, PNSI or either, for (§ 1.283(a)(5)), and the option to have CBP to assume responsibility for a shipment of food that will be entered refused food held at the port of entry, notifying various other entities of the after the arrival of a vessel or an aircraft. unless directed otherwise by CBP or refusal. FDA notes that, although we Comments ask what error message will FDA (see § 1.283(a)(1)). collect the contact information for the be sent back to the transmitter for entry (Comments) Some comments submitter and transmitter, which we that is untimely filed, e.g., will the recommend establishing an electronic could use to contact parties about transmitter receive a refused admission

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status or some other error message? In 58931, October 10, 2003), section 305 of (Comments) Some comments ask addition, comments ask what the the Bioterrorism Act states that FDA’s whether an entry of food would be mechanism is for communicating with list of registered facilities and subject to detention if the product code the carrier on the disposition of the registration documents FDA receives does not precisely reflect the nature of prior notice. The comment states that under the rule are not subject to the product. carriers cannot view the FDA ‘‘may disclosure under FOIA. Furthermore, (Response) The final rule requires the proceed’’ messages in CBP’s AMS, and section 305 of the Bioterrorism Act submission of accurate information that the ABI participant (usually the customs provides that any information derived is submitted in the prior notice, broker) is responsible for from the list of facilities or registration including the product code, which is communicating freight holds to the documents that would disclose the required in § 1.281 (a)(5)(i), (b)(4)(i), and various parties involved, including identity or location of a specific (c)(5)(i) of the final rule. If the product importers, container freight stations registered person is not subject to code does not accurately identify the (CFS), and truckers. disclosure under FOIA. This does not food, the food is subject to refusal. (Response) FDA clarifies that if an preclude the registered facility from Section 1.283(a)(1)(ii) of the final rule article of food subject to prior notice disclosing its registration number, such states that if prior notice has been requirements arrives in the United as to the submitter or others with whom submitted and confirmed by FDA for States and prior notice has not been it has a business relationship. review, but upon review of the notice or received for review by FDA in the (Comments) Some comments request examination of the article of food, the timeframes prescribed in the final rule, that FDA clarify the penalties for notice is determined to be inaccurate, the food is subject to refusal under inadequate prior notice. One comment the food is subject to refusal of section 801(m) of the act, unless FDA asks about the consequences when admission under section 801(m)(1) of already reviewed the prior notice, foods are accidentally shipped without the act. determined its response, and advised meeting the prior notice requirements, 3. Status and Movement of Refused CBP of that response. See also the i.e. can they be transshipped? Food (§ 1.283(a)(2)) discussion above regarding (Response) Prior notice is required for communication of refusal status. food imported or offered for import into (Comments) Some comments request (Comments) One comment requests the United States, including shipments that FDA clarify the process for food clarification as to how transmitters may intended for transshipment. If adequate that is refused and later deemed to be confirm the validity and existence of prior notice is not provided, the food is admissible. registration numbers provided by the subject to refusal. Refused food must be (Response) Section 1.283 of the final shippers, importers, and carriers. The held, in accordance with the provisions rule identifies the consequences and comment states that the transmitter of § 1.283(a), unless CBP concurrence is procedures for food that is refused might bring in goods based on obtained for export and the food is because of inadequate prior notice. If erroneous, but good faith information. immediately exported from the port of the refused food is not immediately (Response) FDA will identify arrival under CBP supervision. An exported with CBP concurrence, it is anomalies in the initial submission of article of food that has been refused is considered general order merchandise registration numbers based on review of considered general order merchandise and must be held until adequate prior the information prior to confirmation of and can only be moved under notice is submitted and FDA has receipt of the prior notice, and will appropriate custodial bond unless notified CBP and the transmitter that the respond accordingly. If our subsequent immediately exported under CBP food is no longer refused because of review, after the prior notice is supervision. If the food is held at a inadequate prior notice. If in response to confirmed for review, reveals problems secure facility outside of the port, FDA a request for FDA review, FDA with a submitted registration number must be notified of the location of the determines that the article is not subject that causes the prior notice submission secure facility before the food is moved to the prior notice requirements or that to be deemed inaccurate, the food is there. Post-refusal prior notice can be the prior notice submission is complete subject to refusal under section 801(m) submitted as provided by § 1.283(c). and accurate, it will notify the requester, of the act. Subsequent corrections to the We also note that CBP may seize the transmitter, and CBP that the food submitted information can be provided goods imported contrary to law, assess is no longer subject to refusal under by resubmitting corrected information civil monetary penalties, including section 801(m)(1) of the act. A in a post-refusal prior notice (see those under 19 U.S.C. 1595a(b) against determination that an article of food is § 1.283(c)). every person who directs, assists, no longer refused under section If our subsequent review reveals financially or otherwise, or is in any 801(m)(1) of the act is different than, problems with the submitted way concerned in the importation of and may come before, determinations of registration number such that an article any merchandise contrary to law, and admissibility under other provisions of of food is from a foreign facility that is refer violations for criminal the act or other U.S. laws. Moreover, a not registered under section 415 of the investigation and prosecution. Section determination that an article of food is act and 21 CFR, part 1, subpart H, and 1.284 of the final rule lists other no longer refused under section is imported or offered for import into consequences for failure to submit 801(m)(1) does not mean that it will be the United States, the food is subject to adequate prior notice. For example, granted admission under other hold under section 801(l) of the act. To under 21 U.S.C. 335a, FDA can seek provisions of the act or other U.S. laws resolve a hold, the facility must register debarment of any person who has been (§ 1.283(g)). Further information and obtain a registration number, and convicted of a felony relating to regarding the process may be found in that number must be provided to FDA. importation of food into the United the preamble to the IFR (68 FR 58974 at This is covered under § 1.285(i) of the States or any person who has engaged 59016 through 59022). final rule. in a pattern of importing or offering for (Comments) Some comments state As discussed in response to import adulterated food that presents a that the holding period for prior notice comments 157 and 158 in the preamble threat of serious adverse health should be no longer than the original to the Registration of Food Facilities consequences or death to humans or required prior notice timeframe. The Interim Final Rule (68 FR 58894 at animals. comments contend that exceeding this

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time period does not increase the safety and regulations, general order be the port where legal entry is to the public and may cause a merchandise must generally be held in accomplished. The comments state that bottleneck for all freight movements if a general order warehouse (19 CFR these ports have facilities for proper thousands of shipments are held at their 127.1). CBP regulations also empower food storage, as well as the CBP and port of arrival. Comments suggest that, the port director, if merchandise FDA processes and personnel to deal before the holding period is fully requires specialized storage facilities with any irregularities. The comments implemented, FDA should determine that are unavailable in a bonded facility, point out that international shipments the percentage of shipments that are still to direct the storage of the merchandise are not legally ‘‘entered’’ with CBP at not in conformity with the prior notice by the carrier or by any other the port of arrival, but instead are rule and determine the potential for appropriate means (see 19 CFR 4.37(f), moved under bond to a subsequent port harming the movement of all freight into 122.50(f), or 123.10(f)). Additionally, where CBP entry is made. Further, and out of the United States when prior fruit and other perishables may be held shipments are not released at the port of notice is fully implemented. by the port director in a bonded cold- entry until clearance is obtained from (Response) Section 1.283(a)(2) of the storage warehouse for a reasonable CBP, and carriers are under a strict final rule states that refused food will be period, if it is probable that entry will obligation to retain control of shipments considered general order merchandise. be made at an early date (19 CFR from the port of arrival to the legal entry In the first instance, it is not within our 127.28(c)). port. The comments note that under the control how long it will take the parties FDA and CBP believe that general IFR, shipments of food will not be associated with the article of food being order storage qualifies as secure permitted to be moved from the port of held to satisfy the prior notice facilities for purposes of the first arrival to the port of legal entry if requirements. Moreover, CBP Bioterrorism Act, as it is subject to the prior notice is not provided or is regulations address the length of time an requirements set forth at 19 CFR part 19. inadequate. According to the comments, imported product will be held in In particular, 19 CFR 19.9 contains express carriers may be required to General Order (G.O.) Status (19 CFR part controls that will ensure that refused unload and reload entire planes in order 127). Section 1.283(a)(1) of the final rule food will be adequately controlled while to find one or two shipments. The states that refused food that is not in storage and will not be released from comments state that this is especially immediately exported must be held at general order storage without CBP problematic because proper facilities for the port of entry unless directed by CBP authorization. the storage of food may not be available or FDA. Accordingly, the final rule does FDA also emphasizes that refusal at the ports of arrival. Comments further not require refused food to be held at under section 801(m) of the act occurs note that express consignment operators the port of arrival unless so directed by when no prior notice or inadequate or have invested millions of dollars to CBP or FDA. In § 1.283(c)(3), we state untimely prior notice is submitted, as construct and operate dedicated sorting that FDA will try to review and respond required under the Bioterrorism Act for facilities that use state of the art to post-refusal prior notice submissions articles of food imported or offered for automation and scanning equipment. within the prior notice timeframes. import into the United States. Costs and These facilities are far better suited to (Comments) Some comments request other consequences described by the identifying and detaining food that FDA establish procedures for comments due to refusal for inadequate shipments of concern to FDA than the handling refused merchandise. The prior notice should be avoided when ramps or conventional air freight comments contend that secure storage adequate prior notice is submitted to handling facilities commonly found at facilities and cargo movement FDA. The final rule also outlines the ports of arrival. Other comments procedures have not been established procedures for satisfying the prior state that there are no cold storage for refused merchandise. According to notice requirements after food has been facilities currently available in San the comments, there is no mechanism to refused and procedures for requesting Diego/Otay Mesa. The comments handle refused refrigerated or frozen an FDA review of the refusal. contend that the Mexican authorities shipments. The comments state that (Comments) One comment requests will not permit such shipments to be perishable food that is held or is not that FDA establish a clear definition of returned to Mexico. properly stored may no longer be ‘‘perishable’’ shipments. The comment (Response) The IFR and the final rule commercially viable when it is released states that destroying or selling frozen, at § 1.283(a)(1) require that food refused or sold at auction. Comments also state refrigerated, and fresh merchandise held due to inadequate prior notice food that highly perishable shipments that at a secure facility after 3 days, for must be held within the port of arrival are held past their commercially viable inadequate prior notice, is unreasonable only if directed by CBP or FDA, and that time period and small shipments that and an excessive financial burden on otherwise refused food must be held have little commercial value will international trade. within the port of entry. quickly fill any warehouse, including (Response) FDA does not agree that it As we discussed in the preamble to any G.O. warehouse, with no one to is necessary or pertinent to establish a the IFR, we defined ‘‘port of arrival’’ claim them. Other comments request definition of ‘‘perishable’’ for purposes and ‘‘port of entry’’ to provide flexibility that FDA and CBP develop a joint of implementing the prior notice to ensure that ‘‘food that has been operational plan for handling refused requirements of the Bioterrorism Act, refused may move to the port of merchandise with input from the which requires FDA to receive prior destination where, for example the importing and shipping industries. notice of food imported or offered for consumption or warehouse entry will be Another comment states that directions import into the United States. Financial filed, unless directed by CBP or FDA. on executing CBP 6043 Permit to burdens associated with merchandise Generally, we do not intend to hold Transfer or CBP 7512 ‘‘Restricted in- directed to a secure facility because of shipments at the border unless our bond’’ is needed to avoid major inadequate, untimely or no prior notice assessment of the situation leads us to congestion. generally can be avoided by ensuring believe it is warranted; e.g., the food (Response) Section 1.283(a)(2)(i) of FDA receives adequate prior notice in may present a serious risk to public the final rule provides that food refused accordance with this final rule. health or that the prior notice violation under section 801(m)(1) of the act has (Comments) Some comments request is egregious.’’ (See 68 FR 58974 at ‘‘General Order’’ status. Under CBP laws that FDA consider the ‘‘port of entry’’ to 58988.)

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(Comments) One comment requests notice must be held until prior notice (Comments) Some comments state that FDA notify public food storage requirements have been satisfied, unless that there are an insufficient number of warehouses when a shipment is being the food is immediately exported with general order warehouses to store the held, is not accepted for entry, or when CBP concurrence from the port of food articles that have been refused for such shipments are released. The arrival. The decision to export the noncompliance with these regulations. comment points out that the warehouses refused food is not the responsibility of (Response) FDA disagrees. Under CBP receive shipments via multiple transport FDA or CBP. If no prior notice laws and regulations, general order methods, store them for multiple submission or request for FDA review is merchandise must generally be held in customers, and should be officially submitted in a timely fashion after a a general order warehouse (19 CFR informed of the status of the shipments, food is refused, the food will be dealt 127.1). However, in ports where there is rather than relying on information from with as set forth in CBP regulations no bonded warehouse authorized to the owners of the articles of food. relating to general order merchandise. It accept general order merchandise, CBP (Response) Under § 1.283(a)(2), may only be sold for export or destroyed regulations also empower the port refused food shall not be entered and as agreed to by CBP and FDA. director to direct the storage of the shall not be delivered to the importer, (Comments) One comment requests merchandise by the carrier or by any owner, or consignee. As discussed clarification on the process for other appropriate means (see 19 CFR previously, FDA does not believe it designating a ‘‘secure facility’’ after a 4.37(f), 122.50(f), or 123.10(f)). In should modify the rule to require notice shipment of food is refused admission addition, our experience has not shown of the refusal to any specific entity or status. The comment points out that the that there are an insufficient number of entities. The entity moving the food to CF3461 entry document currently general order warehouses to store food a warehouse can notify the warehouse designates a CBP exam site in box 29 that has been refused under prior notice. of the food’s status, and the warehouse and requests clarification on whether (Comments) Some comments state can likewise ask or require that it be refused goods will be sent automatically that FDA must delay full enforcement of provided this information before to the designated CBP exam site or if the prior notice regulations until it has accepting the food for storage. arrangements can be made to designate done all that is necessary to equip the (Comments) Some comments state another facility. U.S. ports to handle refused perishable that the requirement in § 1.283(a)(2)(ii) (Response) FDA clarifies that a refusal goods. for carriers to notify FDA regarding under section 801(a) of the act, relating (Response) FDA believes that the delivery of refused shipments within 24 to admissibility, differs from a refusal ports are equipped to handle refused hours of arrival and then to make under section 801(m) of the act, relating perishable goods. Since the IFR took delivery immediately imposes an to prior notice. A food refused under effect, we have not been aware of unreasonable burden on carriers. section 801(m) of the act must be held problems relating to perishable goods (Response) We have changed the within the port of entry for the article not being properly maintained while requirement to notify FDA of the of food unless directed to another being held at the ports. location where the food has been or will location by CBP or FDA. If CBP or FDA (Comments) Some comments ask be moved from within 24 hours of directs the food to be delivered to a whether public storage warehouses will refusal to before the food is moved to secure facility, this will not necessarily be stuck with unsaleable food items or that location. FDA needs this be the CBP exam site designated in box whether they will be compelled to re- information before the food is moved to 29 of the CF3461 entry document. export at their own expense if the owner verify that the facility where the food is (Comments) Some comments ask if abandons a shipment that is refused to be held is a secure facility. Moreover, FDA will publish a list of approved entry because of inadequate prior because refused food shall not be ‘‘secure facilities’’ by port so that notice. Comments indicate that a delivered to the importer, owner, or transmitters can designate these warehouse loses its lien abilities if a ultimate consignee, before the food is facilities. refused shipment is not allowed in moved, FDA needs to verify that the (Response) Early in our prior notice interstate/intrastate trade and is re- secure facility is not owned by any of experience, FDA had indicated that we exported. Thus, according to the these parties. would publish a list of secure facilities. comments, if the owner of the food does For clarity and consistency, we also However, our experience has shown us not pay storage and handling for the are changing the phrase ‘‘designated that it is not practicable to maintain product, the warehouse has no collateral location’’ to ‘‘secure facility’’ in such a list since the secure status of to compel payment. Comments also § 1.283(a)(2)(ii) and throughout the final facilities changes very rapidly. While state that even if it does remain at the rule. In addition, § 1.283(a)(2)(ii) of the we will not maintain such a list, FDA warehouse and the owner declines IFR states that refused food must be will verify whether a facility is secure payment, the product has been refused moved under appropriate custodial on a case-by-case basis. entry so it cannot be sold to allow the bond. We have revised this paragraph in (Comments) Some comments request warehouse to recoup its charges. the final rule to state that the refused that FDA and CBP jointly issue a (Response) Under the final rule, food food must be moved under appropriate guidance document explaining in refused under section 801(m) of the act custodial bond, unless immediately greater detail how they intend to hold is considered to be general order exported under CBP supervision. The and store articles of food, particularly merchandise and generally must be held final rule also clarifies that the refused perishable food, refused admission into at a general order warehouse. If the food may be held at the port of entry or the United States. One comment refused food is not immediately at a secure facility. requests that FDA clarify the process for exported and if no prior notice is (Comments) Some comments request food that is held and later deemed to be submitted or resubmitted and no request clarification on whether ‘‘refused admissible. for FDA review of the refusal is goods’’ will have to be exported or (Response) FDA agrees and, as submitted, then the food will be dealt destroyed. resources permit, will publish a with as set forth in CBP regulations (Response) Articles of food that have guidance document that will set out relating to general order merchandise been refused under section 801(m) of procedures for food refused for failure to (19 CFR part 127), except that, unless the act because of inadequate prior meet prior notice requirements. otherwise agreed to by CBP and FDA,

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the article may only be sold for export port of arrival until the prior notice is based on miles driven, and greatly or destroyed (§ 1.283(a)(6)). provided. reduces the number of allowable hours We made a minor change to the final (Response) FDA disagrees. The IFR a driver is allowed to operate under rule by changing the last phrase of and the final rule require that refused Federal Motor Carrier Safety § 1.283(a)(6) from ‘‘* * * except that food must be held within the port of regulations. The comments also indicate the article may only be sold for export entry for the article unless directed to that holding a trailer at a port of entry or destroyed as agreed to by CBP and another location by CBP or FDA. Thus, affects not only the motor carrier’s FDA’’ to ‘‘* * * except that, unless refused food may be permitted to move operations, but also all of the shippers, otherwise agreed to by CBP and FDA, to the port of entry; such food is not importers, and consignees whose goods the article may only be sold for export required to be held at the port of arrival. are on board. Some comments request or destroyed.’’ This change was needed (Comments) Some comments express that FDA require importers to provide because concurrence from FDA is not concern about the time it takes for FDA motor carriers with proof that prior needed whenever a refused article of to release food offered for import into notice was transmitted to FDA. The food is sold for export or destroyed, and the United States, and request that FDA comments state that currently FDA and no prior notice is submitted or examine its inspection procedures and CBP only suggest that motor carriers resubmitted and no request for FDA reduce the time to clear and release the require proof of prior notice filing from review is submitted. We are adding the food. The comments indicate that some customers, but this type of arrangement phrase ‘‘unless otherwise agreed to by shipments of food have been held at the is not required by law or regulation. CBP and FDA’’ to allow for the port of entry for periods ranging from 2 According to the comments, because improbable (but not impossible) weeks to 2 months, which has a serious FDA system’s acknowledgement of scenario when a refused prior notice economic impact on importers of receipt of a prior notice does not mean shipment would need to be transferred perishable foods. The comments point that the information received is correct to another agency for examination or out that there are already additional or complete, carriers are still left investigation; in these cases, we would costs associated with the IFR, such as vulnerable to carrying goods that could want concurrence from both FDA and fees charged by custom brokers to file be turned back at the border. The CBP. the prior notice. The comments further comments indicate that this type of state that the delays are adding more (Comments) Some comments request action by FDA would tie up a carrier’s costs that importers must bear, that FDA revise the requirement to store equipment, negatively affect driver including the cost to store the food refused merchandise at local port wages, and have a serious effect on during this period, additional freight facilities. One comment indicates that carrier productivity. charges, and costs incurred due to (Response) Financial burdens this provision of the IFR does not make spoilage of perishable products. associated with refused food because of sense and does not provide any measure (Response) We know of no instance inadequate or no prior notice generally of security or safety to the food supply. where a food has been held at any port can be avoided by ensuring FDA The comment points out that, before the facility or secure location for an receives adequate prior notice in IFR, shipments were allowed to be held extended period of time as described in accordance with this final rule. For at the importer’s premises and suggested the comment (2 weeks to 2 months) due example, while the final rule requires that this practice should be allowed to to FDA’s review of a prior notice only that the prior notice confirmation continue. According to the comment, submission or due to FDA’s refusal of number accompany any food for which ports and land borders do not have food for failure to provide adequate the prior notice was submitted through sufficient storage capacity to handle the prior notice. Perhaps the comment PNSI when the article arrives in the possibly overwhelming demand for actually is referring to delays caused by United States, it does not preclude the space that will be needed when the FDA’s admissibility review under carrier from requiring proof of prior notice regulations are section 801(a) of the act. Nevertheless, confirmation of prior notice submission implemented. FDA will make every effort to minimize prior to transporting the food to the (Response) FDA disagrees. Section the time necessary to perform prior United States when prior notice is 801(m)(2)(B) of the act specifically notice assessments to minimize delays submitted through ABI/ACS. Moreover, requires that food refused under section in releasing shipments. according to § 1.283(a)(3) of the final 801(m) be held and not delivered to the rule, segregation may take place to importer, owner, or consignee. The IFR 4. Segregation of Refused Foods (§ 1.283(a)(3)) separate food that has not been placed and the final rule require that refused under hold from food refused for food must be held within the port of (Comments) Some comments state inadequate prior notice. entry for the article unless directed to that in an ‘‘LTL’’ (less-than-truckload) (Comments) Some comments request another location by CBP or FDA. environment, where an average trailer clarification on who is responsible for Therefore, an importer’s premises, as contains about 40 shipments, there is a the physical segregation of the refused suggested by the comment, would not potentially serious impact on several food from the rest of the shipment: The be appropriate since the Bioterrorism parties when prior notice is not filed in carrier, FDA or CBP, customs broker, or Act specifically requires that the refused a timely fashion for one of the articles importer. Comments also ask whether food not be delivered to the importer, of food. The comments point out that FDA or CBP officials will always owner, or consignee. Nor would such a the motor carrier’s potential loss of supervise the segregation. location be adequate because it also may productivity from having equipment (Response) The IFR at § 1.283(a)(3) not be secure. tied up when an article of food has been states that segregation may take place to (Comments) Some comments object denied entry or is being held has a separate food that has not been placed because shipments of food for which serious negative impact on the under hold from food refused for prior notice has not been provided will profitability of cross-border trucking inadequate prior notice. The final rule not be permitted to be moved to the port operators. According to the comments, clarifies this paragraph by adding that of entry. According to the comments, this kind of down time has a serious other merchandise not subject to prior the operator will be required to off-load negative impact on truck drivers’ notice requirements may be segregated these shipments and detain them at the compensation, when they are paid from refused food.

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The segregation may be done by any should cancel’’ to indicate that the Amending ABI/ACS would entail person as long as the refused food is cancellation of the prior notice can be substantial and costly revisions to the held as required and not delivered to done by CBP, upon request by the filer, system; such technical changes are not the importer, owner, or consignee. if originally submitted in ABI/ACS or by cost-effective or a good use of limited Neither FDA nor CBP is responsible for the transmitter if originally submitted in resources given the development of the segregation. However, the IFR and final PNSI. Automated Commercial Environment, rule state that FDA or CBP may (Comments) Some comments object which will replace ACS. supervise the segregation. If FDA or CBP because the current ABI system cannot PNSI programming changes should determine that supervision is necessary, accept prior notice after the articles of address the concern raised in the segregation must not take place without food arrive in the United States. Instead, comment about ‘‘submitting false supervision. filers must use the PNSI system. The information.’’ These same concerns (Comments) Some comments indicate comments suggest there is no valid should not arise under the final rule that carriers should have the option of reason for this limitation and request since the final rule requires the actual modifications to allow filers to use the unloading refused articles of food so date of arrival for post-refusal ABI system for submitting prior notice, they can deliver the rest of their load submissions. without being detained any longer than even after cargo has arrived in the necessary. The comments point out that United States. Other comments request FDA made a minor change in the text carriers do not have title or financial removal of edits for date sensitive prior of § 1.283(a)(6) by replacing the phrase, interest in the goods they transport and notice in ABI and PNSI. Some ‘‘in a timely fashion,’’ with the phrase, they cannot provide information to comments point out that if prior notice ‘‘in accordance with paragraph (d) of provide or correct an inadequate prior is transmitted after the articles of food this section,’’ to clarify that the notice. arrive, the filer must enter an incorrect timeliness of a request for FDA review (Response) Carriers already have the anticipated date of arrival, which is on is found at paragraph (d). We made a option to segregate food so that they can or after the actual date of arrival. similar change in § 1.285(g). deliver the rest of their load. As According to the comments, this skews 8. FDA Review After Refusal (§ 1.283(d)) discussed previously, the IFR and the FDA information, prevents FDA from final rule at § 1.283(a)(3) state that determining whether prior notice was (Comments) One comment requests segregation may take place to separate filed timely, and gets the filer in the that the final regulations make it clear food that has not been placed under habit of submitting false information. that the request for the review and/or hold from food refused for inadequate The comments also ask that if prior the participation in the review can be prior notice. notice is submitted in this manner, how conducted by any of the parties named FDA can determine if the date was filed in § 1.283(d) of the IFR or by a 5. Costs (§ 1.283(a)(4)) timely or not? The comments also state designated representative, such as a (Comments) Some comments ask who that because ABI will not accept prior customs broker, freight forwarder, or is responsible for costs associated with notice on articles of food that have attorney. FDA verification of a shipment that is already arrived, this leads to the more (Response) Section 1.283(d)(2) of the initially refused and then it is later time consuming filing of prior notice in final rule provides that the carrier, determined that the shipment’s PNSI and also leads to a corruption of submitter, importer, owner, or ultimate documentation fulfills all requirements the correct data. consignee may submit a written request (Response) Prior notice submitted and complies with regulations; i.e., the asking FDA to review whether the after the food has arrived in the United shipment was improperly refused. article of food is subject to the States is a post-refusal submission. (Response) Section 1.283(a)(4) of the requirements of this subpart under Under § 1.280(a)(2) of the IFR, post- final rule provides that neither FDA nor § 1.277. FDA has added carrier in the refusal submission of prior notice must CBP will be responsible for final rule since the carrier is often the be completed via PNSI. The final rule transportation, storage, or other entity notified of the refusal. Although retains this provision, but re-worded the expenses resulting from refusal. not explicitly stated in the rule, a text to state that post-refusal designated representative of any of the 6. Export After Refusal (§ 1.283(a)(5)) submissions must be submitted in PNSI parties listed (carrier, submitter, (Comments) Some comments request until such time as ACS or its successor importer, owner, and ultimate clarification on procedures for exporting system can accommodate such a consignee) may act on behalf of that fresh vegetables after refusal. The transaction. Post-refusal information party. comments indicate that some ports of requirements are found at § 1.281(c). arrival do not have cold storage Among other data elements, a post- Furthermore, FDA revised facilities. refusal submission requires the location § 1.283(d)(1) to state that the request for (Response) The procedures for and address where the article of refused FDA review may include whether the exporting fresh vegetables after a refusal food will be or is being held, the date information submitted in a prior notice under section 801(m) of the act are no the article has arrived or will arrive at is complete, in addition to accurate. (In different than other exports, with the that location, and identification of a the IFR, we also cited § 1.276(b)(5), but following qualifications: Food refused contact at that location (§ 1.281(c)(18)). we deleted it in the final rule because under section 801(m) must be The final rule now also requires the date it is redundant.) FDA revised immediately exported from the port of the article of food arrived at the port of § 1.283(d)(5) to be consistent with the arrival with CBP concurrence and under arrival. changes made to § 1.283(d)(1). In CBP supervision. Post-refusal submissions cannot be § 1.283(d)(3), FDA revised the final rule submitted via ABI/ACS because CBP’s to delete acceptance of requests for 7. Post-Refusal Prior Notice system cannot be modified at this time review by mail and express courier. We Submissions (§ 1.283(c)) to accept information about the location are limiting delivery to fax and e-mail In § 1.283(c)(2) of the final rule, FDA where the article of refused food will be to ensure that requests are expeditiously revised the text to read ‘‘the prior notice or is being held and the actual date of received and directed to the appropriate should be canceled’’ instead of ‘‘you arrival of the article of refused food. staff.

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9. International Mail (§ 1.283(e)) will be advised of the FDA status of the of the ongoing integration efforts with (Comments) Some comments request articles of food when the shipment CBP. (Response) FDA does not agree that clarification on the disposition of mail involves ‘‘doors moves’’ beyond 50 doing the OASIS review under section for which prior notice is required, but miles from the port of entry. 801(a) of the act concurrently with the is not provided. Comments also ask (Response) Food arriving as an IT or prior notice review under section about the U.S. Postal Service’s T&E entry is subject to FDA review of 801(m) of act would reduce the burden responsibilities for mail lacking prior prior notice before it arrives in the on the industry or FDA. Under section notice. United States. Food that arrives with no 801(m), prior notice for imported food (Response) In the case of food arriving prior notice is subject to refusal and shipments must be provided to FDA by international mail, if prior notice is must be held within the port of entry for before the arrival, and an article of food inadequate or if the prior notice the article unless directed to another is subject to refusal of admission if confirmation number is not affixed, the location by CBP or FDA. Food that is refused under section 801(m) of the act adequate prior notice has not been article will be held by CBP for 72 hours provided. Section 801(m) also provides for FDA inspection and disposition. If is considered G.O. merchandise and cannot be entered or delivered to the that refused food must be held until the article is refused and there is a adequate notice is given and may not be return address, the parcel may be importer, owner, or consignee. For clarity, FDA revised § 1.283(f)(2) delivered to the importer, owner, or returned to the sender. If there is no consignee. Thus, the refusal standard return address or the food in the of the final rule to state that an article of food refused under section 801(m)(1) under section 801(m) is based on shipment appears to present a hazard, whether the requisite information has FDA may dispose of or destroy the of the act may not be transferred by any person from the port or other designated been provided in a timely fashion. parcel at its expense. If FDA does not The refusal standard in section 801(a) secure facility. respond within 72 hours of the CBP of the act is based on, among other hold, CBP may return the parcel back to 11. Relationship to Other Admissibility things, whether the article appears to be the sender or, if there is no return Decisions (§ 1.283(g)) adulterated or misbranded. address, destroy the parcel, at FDA Admissibility decisions under section (Comments) Some comments request expense. Under the prior notice final 801(a) may be made after entry has been that FDA integrate the section 801(m) rule, only FDA and CBP have made. Thus, if prior notice is adequate, responsibilities for the destruction or and the section 801(a) clearance requests for further information, return of refused foods that arrive via processes and develop mechanisms to examination, or sampling of the food international mail. expedite the release of imported food for that is necessary to determine FDA revised § 1.283(e) and § 1.285(k) sale and use in domestic commerce. admissibility under section 801(a) may in the final rule to change the word One comment states that currently occur. The article of food need not be ‘‘stamped ‘No Prior Notice—FDA numerous shipments that are offered for held at the port for FDA to accomplish Refused’’’ to ‘‘marked ‘No Prior Notice— import are cleared for section 801(m), its section 801(a) review. FDA Refused’’’ to more accurately but are held pending section 801(a) Because the section 801(m) review describe the marking that is placed on review. The comments indicate that must occur prior to arrival, concurrent international mail packages arriving little is gained if shipments with section 801(a) and section 801(m) with inadequate prior notice or without adequate prior notice under section reviews also would have to occur prior the prior notice confirmation number 801(m) are permitted to move promptly to arrival. FDA also notes that section affixed as required. In certain cases, the across the borders of the United States, 801(a) reviews typically take longer to package cannot be stamped and a label/ only to encounter delays arising from complete than section 801(m) reviews. sticker is placed on the package. the release process under section 801(a). FDA believes such a concurrent process We also note that the Prior Notice The comments further note that in many would be inefficient and impractical Final Rule Draft CPG proposes an cases, the shipments held for section and would likely increase congestion at enforcement policy for foreign-to- 801(a) review are eventually released the ports of arrival. Thus, FDA generally foreign mail. Under the proposed without another further examination or intends to continue with its current policy, if there is no prior notice FDA sampling. The comments suggest that a practice of reviewing prior notice prior and CBP should typically consider not concurrent section 801(a) and section to arrival to decide whether to inspect taking any regulatory action in the case 801(m) review would eliminate rework, the food at the time of arrival, based on of international mail where the recipient decrease unnecessary holds on information that suggests that the food is not in the United States since the shipments, and decrease the burden on is a potential significant risk to public sender does not have control over the both the importing community and health, and to allow shipments to transportation route that the foreign-to- FDA. proceed beyond the point of arrival to foreign mail will transit. Another comment also suggests that conduct section 801(a) reviews. FDA integrate the prior notice (Comments) One comment asks FDA 10. Prohibitions on Delivery and information collection system with the to clarify expectations at the port Transfer (§ 1.283(f)) existing OASIS (section 801(a) of the regarding ‘‘may proceed’’ decisions. The (Comments) Some comments ask act) information management system as comment notes that the IFR indicates whether CBP will put a manifest ‘‘hold’’ fully as possible. The comment states that ‘‘the system will transmit a message on food cargo until the prior notice that these systems currently function back through OASIS to ABI/ACS confirmation is received. The comments separately, essentially creating two interface for CBP that the article of food state that, at the present time, cargo can sequential FDA reviews. The comment may be conditionally released.’’ The be moved inland on an IT or T&E entry believes that by merging these systems comments continue to state that the IFR without FDA review. The comments ask and resources, food security would be indicates that staff operating ‘‘24 hours if FDA will remind the transmitters that enhanced and productivity for FDA and a day, seven days a week’’ will review products should remain intact until a the industry will be improved. In at the port of arrival or closest ‘‘may proceed’’ message is received. The addition, the comment states that such examination site. The comment notes comments further ask if ocean carriers a merger would be a natural extension that this implies decisions were to be

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made at the port of entry. However, K. What Are the Other Consequences of (Response) CBP, in consultation with companies have reported that since Failing to Submit Adequate Prior Notice FDA, may assess civil monetary December 12, 2003, conditional release or Otherwise Failing to Comply With penalties under 19 U.S.C. 1595a(b) messages have not consistently been This Subpart? (§ 1.284) against any person who directs, assists, received at entry. The comment asks Section 1.284 of the IFR provides that financially or otherwise, or is in any that FDA clarify when this message failure of a person who imports or offers way concerned in the importation of should be received and the implications for import an article of food to submit any merchandise contrary to law. for companies that enter the United prior notice is a prohibited act under During the early implementation phase, States within the ‘‘release.’’ section 301(ee) of the act (21 U.S.C. FDA recommended to CBP that civil (Response) The IFR states, ‘‘If the FDA 331(ee)) and sets out the civil, criminal, monetary penalties (CMPs) be assessed only to those parties who failed to system does not indicate that further and debarment actions that the United submit prior notice. The parties were evaluation of or action on the notice or States may bring against persons who notified via e-mail regarding their article of food is necessary for prior are responsible for the commission of a failure to submit prior notice before notice purposes, the system will prohibited act. transmit a message back through the (Comments) One comment states that FDA recommended CMPs. As of May 2008, CBP has pursued CMPs on a total OASIS to ABI/ACS interface for CBP many of the mistakes made during the of 29 PNC related cases. Any CMPs that that the article of food ‘may be initial implementation of the prior CBP brings are subject to the conditionally released under section notice IFR can be attributed to administrative proceedings described in 801(b) of the act.’ However, if additional difficulties with both government and 19 U.S.C. 1618 and 19 CFR part 171. evaluation of the prior notice industry computer systems. The Furthermore, liquidated damages would information is necessary, FDA comment indicates that such mistakes not apply in the case of prior notice headquarters staff, operating 24 hours a should not be part of an importer’s violations because no bond obligations day, 7 days a week, will review and record. would vest under the basic importation assess the information and may initiate (Response) FDA acknowledges that bond. an examination or other action by FDA some mistakes in prior notice (Comments) Some comments note or CBP of the article of food at the port submissions may have occurred because that there are few options available in of arrival or elsewhere, or in the case of changes were needed in PNSI and CBP’s the current penalty structure to assist rail shipments, within the confines of ABI/ACS or because industry needed to FDA in enforcing compliance other then the closest appropriate examination develop appropriate software to civil and criminal charges. Comments site.’’ (68 FR 58974 at 58976) The IFR facilitate the submission of prior notice. suggest that some form of monetary clearly states that the conditional During the initial implementation of the consequences, in lieu of civil and release message is sent from FDA to IFR that extended for more than 8 criminal charges, should be available to CBP, not to any other person. This is to months after the IFR took effect, FDA allow FDA more flexibility in ensure that CBP staff will know when and CBP exercised enforcement application. the food arrives if prior notice has been discretion to accommodate that (Response) Section 1.284 of the final satisfied and that no further situation. During this period, the two rule provides consequences of failing to examination by FDA is necessary. This agencies focused their resources on comply with the requirements for conditional release does not provide education to achieve compliance with submitting prior notice. These are the information about FDA’s section 801(a) the prior notice requirements, escalating primary enforcement options, aside admissibility decision. Further, the IFR imposition of civil monetary penalties, from refusal of the food, available to clearly states that FDA headquarters and ultimately refusal of shipments. FDA under the Federal Food, Drug, and staff operates 24 hours a day, 7 days a This final rule will take effect 180 days Cosmetic Act. In addition, CBP can week and will review the prior notice after today’s publication date to allow seize goods imported contrary to law, and make the decision regarding further affected parties time to understand the assess civil monetary penalties or take action on the prior notice submission. requirements that differ from those in other enforcement action, including FDA and CBP do not intend to change the IFR, and make appropriate changes, referral to U.S. Immigration and these procedures for implementation of including changes that may be needed Customs Enforcement (ICE), as provided the final rule. to filers’ software. In enforcing prior for under its laws in lieu of or in (Comments) One comment encourages notice, we will continue to take into addition to refusal of the food or other FDA to consider low risk status to account the circumstances, such as civil and criminal penalties. expedite its section 801(a) deliberations. whether a violation is due to mistakes (Comments) Some comments suggest that can be attributed to difficulties in that failure to provide prior notice in a (Response) FDA does use a risk based government and industry computer timely fashion should result in refused approach when making prior notice and systems during initial implementation. entry and the movement of the food to admissibility decisions. FDA screening (Comments) Some comments request a secure facility where the prior notice under section 801(a) is separate from the clarification on the penalties that apply can be secured. The comments state that subject of the final rule, FDA’s screening for food that arrives without proper failure to enter U.S. commerce should under section 801(m) of the act. prior notice. Some specifically request be considered a sufficient deterrent and Therefore, this comment is outside the clarification of civil monetary penalties that monetary penalties would be scope of the final rule. and an explanation of the mechanism counterproductive. The comments (Final rule) Section 1.283 of the final and criteria for application of these suggest that this arrangement would rule describes the consequences for an penalties. One comment notes that, in avoid instances where businesses find article of food that is imported or the absence of clearly defined themselves unable to trade or constantly offered for import with inadequate prior procedures for assessing penalties, the in situations of being in violation, and notice. The final rule sets out current policy of liquidated damages consequently subject to criminal action. procedures for resolving the inadequacy would apply, which has always been (Response) FDA does not agree that as well as for the movement and status unacceptable with the community and refusal and movement of the food to a of the refused food. sureties. secure facility will provide a sufficient

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deterrent in all cases. CBP may assess port interpretations and actions. provide a faster and more efficient civil monetary penalties under 19 U.S.C. Comments note the importance of a response. 1595a(b) and will, in consultation with timely resolution to disputes because of (Response) FDA has established FDA, continue to assess those penalties the potential financial impact to mechanisms for working cooperatively when warranted. FDA may further use commerce if food shipments are with foreign government regulatory the civil, criminal, and debarment detained needlessly. authorities on issues of mutual concern, provisions provided by the Bioterrorism (Response) The initial source for including matters relating to compliance Act. These statutory penalties are used resolving all perceived conflicts is the with the prior notice regulations. When only when warranted, and to date have final rule, and related information, requested and as resources allow, FDA/ been used relatively infrequently. including the responses to comments in PNC personnel have continued to (Comments) One comment notes that this preamble, the Prior Notice Final participate in briefings for foreign importers receive conflicting Rule CPG, and the Prior Notice of governments and organizations and at information as to the enforcement Imported Food Questions and Answers, industry trade meetings. These have guidelines at individual crossing points which may be found through links on included presentations to European and/or from individual FDA and CBP FDA’s Web site at http://www.fda.gov. Community visitors to the United enforcement officers. The comment FDA’s PNC, which directs all prior States, joint FDA-Canadian Food recommends extension of the full notice activities, has been operating Inspection Agency import meetings, and enforcement date, which would allow since the prior notice IFR took effect on other foreign government and industry FDA and CBP to upgrade their current December 12, 2003. The PNC is outreach events widely attended by both training efforts with the officers at all available 24 hours a day, 7 days a week, industry and other government ports of entry to ensure uniform and and 365 days a year to answer questions agencies, e.g., WESCCON (Western consistent enforcement of the IFR. and resolve, as appropriate, operational Cargo Conference). FDA continues to (Response) FDA and CBP will concerns. The PNC can be reached at work with foreign governments to continue to coordinate staff training and 866–521–2297 for calls originating in develop more efficient and effective industry outreach activities to ensure the United States and 703–621–7728 for communications. In addition, consistent enforcement of the final rule. calls originating from outside the United information about compliance with FDA believes that the effective date of States. In addition, FDA notes that prior notice requirements is posted at 180 days after publication of the final based on the current PNC call/inquiry http://www.cfsan.fda.gov/~pn/ rule provides sufficient time to volume levels as compared to those pnsum.html. communicate and implement changes to experienced during the initial 18 (Comments) Some comments request the final rule. As we establish months of implementation, repetitive that FDA provide a sufficient period of enforcement policies, these will be prior notice submitters have now been time for implementation of the final rule made publicly available through our experiencing fewer difficulties in so that affected parties can prepare for compliance policy guides. These submitting prior notice. any changes in the rule. policies and other information about the (Comments) One comment requests (Response) FDA agrees and is final rule may be found through links on that FDA outline what actions will be providing 180 days after publication of FDA’s Web site at http://www.fda.gov. taken against a company that is not the final rule, which should be FDA notes that the communication complying with prior notice sufficient time for implementing issues experienced when the prior requirements, but has committed the changes necessary to comply with the notice IFR initially took effect have been error only by acting on incorrect advice final rule. addressed and we generally have found from an FDA representative. The (Comments) One comment states that the prior notice process to be comment wants to know what recourse FDA and CBP categorize some articles of proceeding smoothly. is available to industry when a company food differently; i.e., some articles that (Comments) Some comments state faces large fines due to inaccurate FDA are ‘‘drugs’’ for FDA purposes are that serious inconsistencies in guidance. classified by CBP as ‘‘foods.’’ The interpretation or application of the prior (Response) The PNC is responsible for comment indicates that such products notice requirements at multiple ports resolution of these actions, on a case-by- should not be denied entry or assessed have caused confusion, delayed case basis. The advice that a submitter monetary penalties and suggests that the shipments, and increased shipment may have received from an agency final rule provide for immediate release costs. Examples provided by the representative is considered when and cancellation of monetary penalties comments include: the shifting determining whether an enforcement for such articles that are not ‘‘food,’’ as percentage of shipments that are action is warranted. FDA notes that defined by the FDA. physically held at the port due to under the proposed enforcement policy (Response) FDA does not agree that a incomplete or inaccurate prior notice in the Prior Notice Final Rule Draft CPG, change in the final rule would alleviate submissions during the initial phases of we intend to take into consideration the the concern expressed by the comment. enforcement, varying information circumstances surrounding a violation, The scope of the final rule is stated regarding whether the carrier must be in including the seriousness of the explicitly in § 1.277. Situations possession of the actual prior notice violation and flagrant and repeat involving discrepancies between FDA confirmation number at the time of violations. and CBP classification of an imported arrival regardless of whether the (Comments) One foreign government article as a food or drug are best submission was made via an ABI agency requests access to the quantity resolved on a case-by-case basis as they transmission, conflicting information as and identity of the industries that are arise. However, because FDA and CBP to whether submissions of bonded not complying with the prior notice IFR have worked closely to identify and freight will be allowed through the ABI so that they could help bring these resolve such issues, the agencies believe system, and failure to notify importers industries into compliance. The that such situations will be rare. In cases of specific errors pertaining to their comment suggests creating a mechanism of doubt, the submitter should contact submissions. Some comments request to notify foreign governments of any the PNC to determine whether a product that FDA establish a national office with noncompliance related to the is an article of food subject to prior authority to resolve various field and Bioterrorism Act to enable them to notice requirements.

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FDA uses a list of HTS codes to inadequate prior notice. The IFR states inaccurate registration number in the indicate which products FDA believes that if an article of food from a foreign prior notice. In more general terms, prior notice is or may be required under manufacturer that is not registered as under § 1.283(a)(1)(ii), articles of food the prior notice regulations. FDA has required under section 415 of the act arriving with an ‘‘inaccurate’’ prior provided this list to CBP so that CBP and subpart H is imported or offered for notice are subject to the same possibility can ‘‘flag’’ the HTS codes in its entry import into the United States, the food of refusal upon arrival. The comments systems to screen for foods for which is subject to being held at the port under state that the language of the regulations prior notice to FDA is required and to section 801(l) of the act and refusal does not guarantee refusal, but provides ensure that, as appropriate, prior notice under section 801(m) of the act and for flexibility and discretionary has been provided. FDA publishes this § 1.283 for failure to provide adequate enforcement. Comments suggest that list to inform the food industry which prior notice. Under the IFR, the failure FDA should not refuse entries for which HTS codes have been ‘‘flagged’’ in CBP to provide the correct registration the importer does not know and cannot entry systems with prior notice number of the foreign manufacturer, if determine the registration number. indicators. Guidance about the HTS registration is required under section (Response) As discussed in the flags is posted at http:// 415 of the act and 21 CFR part 1, previous response, if the prior notice www.cfsan.fda.gov/~dms/ subpart H, renders the identity of that does not include a registration number, htsguid3.html. facility incomplete for purposes of prior it can instead include the full address of (Comments) One comment suggests notice. the manufacturer and the reason why that FDA consider the importer’s (Comments) Several comments state the registration number is not provided. circumstances when denying entry or that FDA should increase inspections of In this situation, the article of food will assessing penalties. The comment states imported food when they arrive at the not be refused admission solely because that, although it is reasonable to expect port, rather than denying admission of the lack of the manufacturer’s a company whose principal business is based on lack of the manufacturer’s registration number, although the food importing food to abide by regulations registration number. is nonetheless subject to being held applicable to food imports, companies (Response) If the prior notice does not under section 801(l) of the act if the that rarely import food products will include a registration number, it can manufacturer has not registered under likely have greater difficulty in instead include the full address of the section 415 of the act. complying with the requirements. The manufacturer and the reason why the Because this is a change from the IFR, comment further states that although registration number is not provided. In in the final rule we have deleted the text these companies should be required to this situation, the article of food will not in ’ 1.285(a) that states that failure to comply before their entries are released, be refused admission solely because of provide the manufacturer’s registration blanket denials of entry or assessments the lack of the manufacturer’s number renders the identity of the of monetary penalties are not registration number. We agree with the facility incomplete for purposes of prior appropriate. comments it is appropriate to consider notice. We have also clarified the text in (Response) Elsewhere in this issue of the fact that the registration number is ’ 1.285(b) by removing the phrase the Federal Register, we are announcing not provided in determining whether ‘‘imported or offered for import from a our Prior Notice Final Rule Draft CPG FDA should inspect the food, either foreign facility that is not registered as which describes our policies for upon arrival or as part of the admissions required under section 415 of the act’’ enforcing prior notice. Under the CPG, process. because it is redundant. we are proposing to take into While an article of food will not be As part of our effort to develop consideration the circumstances refused admission solely because of the policies for enforcing prior notice and surrounding a violation, including the lack of the manufacturer’s registration section 801(l) of the act, we are seriousness of the violation and flagrant number, the food is nonetheless subject publishing the Prior Notice Final Rule and repeat violations. to being held under section 801(l) of the Draft CPG, announced elsewhere in this (Final rule) Section 1.284 of the final act if the manufacturer has not issue of the Federal Register. rule states that the importing or offering registered under section 415 of the act. (Final rule) Section 1.285 of the final for import into the United States of an It may take FDA more time to determine rule describes the consequences and article of food in violation of the the registration status of the processes for food imported or offered requirements of section 801(m) of the manufacturer if the name and full for import in the United States that is act, including the requirements of this address, but not the registration number, from a facility that is not registered subpart, is a prohibited act under is provided as part of prior notice. Thus, under section 415 of the act and 21 CFR section 301(ee) of the act and sets out if the registration number is not part 1, subpart H. The food is subject to the civil, criminal, and debarment provided, this may delay the food at the being held and cannot be delivered to actions that the United States may bring border until this verification is any importer, owner, or consignee. against persons who are responsible for completed. FDA also made other minor changes the commission of a prohibited act. (Comments) Some comments state in this section. that, although the prior notice • We revised the requirement in L. What Happens to Food That is regulations clearly indicate that the § 1.285(c)(2) to notify FDA of the Imported or Offered for Import From manufacturer’s registration number is location where the food has been or will Unregistered Facilities That Are required on the prior notice, even for be moved from within 24 hours of Required to Register Under Subpart H of U.S. Goods Returned, they do not refusal to before the food is moved to This Part? (§ 1.285) expressly indicate that refusal will the hold location. FDA needs this Section 1.285 of the IFR outlines the result when the registration number is information before the food is moved to consequences for food arriving at the not provided. Rather, according to the verify that the facility where the food is port of arrival from facilities that are not comments, § 1.285(a) of the regulations to be held is a secure facility. Moreover, registered as required under section 415 only indicates that articles of food because refused food shall not be of the act and 21 CFR part 1, subpart H. arriving from an unregistered foreign delivered to the importer, owner, or These are similar to provisions in the facility will be subject to refusal, as will ultimate consignee, before the food is IFR for handling food that is refused for articles of food arriving with an moved, FDA needs to verify that the

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hold location is not owned by any of M. Outreach and Enforcement to provide prior notice to FDA. We also these parties. In addition, § 1.285(c)(2) As discussed in the IFR, FDA directed provided (and continue to provide) of the IFR states that food under hold outreach to both domestic and online assistance and the FDA Help must be moved under appropriate international stakeholders after Desk to deal with technical issues custodial bond. We have revised this publication of the IFR (68 FR 58974). involving PNSI after the IFR became paragraph in the final rule to state that Our outreach activities included many effective. When FDA reopened the comment the refused food must be moved under methods of communication: period on the IFR in the Federal appropriate custodial bond, unless • Dissemination of materials to guide Register of April 14, 2004, under immediately exported under CBP affected domestic and international food discussion of Flexible Alternatives in supervision. The final rule also clarifies facilities through the new processes that the refused food may be held at the question 7, we asked: ‘‘Should FDA established to implement prior notice port of entry or at a secure facility. offer a prior notice submission training requirements; • We revised § 1.285(g) for clarity by program for submitters and transmitters, • Numerous domestic and adding the word, ‘‘number,’’ after the including brokers, to ensure the international outreach meetings to the word, ‘‘registration.’’ We also changed accuracy of the data being submitted?’’ the last phrase of § 1.285(g) from ‘‘* * * food industry, trade organizations, and Many comments address various issues State and foreign government regulators; except that the article may only be sold • concerning outreach and enforcement. for export or destroyed as agreed to by A series of videoconferences and a Discussion of these issues by subject CBP and FDA’’ to ‘‘* * * except that, satellite downlink video broadcast to follows, proceeded by a discussion of more than 1,000 sites around the world; unless otherwise agreed to by CBP and • general issues. FDA, the article may only be sold for Materials provided for and events 1. General Outreach and Enforcement export or destroyed.’’ Similar to targeted to the media; • Issues § 1.283(a)(6), this change was needed Presentations by FDA officials and because concurrence from CBP and FDA exhibits at professional and trade (Comments) Several comments is not needed whenever an article of conferences and meetings to inform acknowledge that the outreach activities food placed under hold under section industry and State and local government conducted by FDA and CBP were of representatives of the new requirements; tremendous assistance to affected 801(l) of the act is sold for export or • destroyed, and no registration number Presentations by USDA’s Foreign persons with the implementation of the or request for FDA review is submitted. Agricultural Service (FAS) and U.S. PNSI and encourage continued We are adding the phrase ‘‘unless embassy officials who disseminated communication between the trade otherwise agreed to by CBP and FDA’’ materials and answered questions in community and FDA and CBP. Several various countries; other comments state that FDA and to allow for the improbable (but not • impossible) scenario when such a Cooperative arrangements with CBP CBP’s outreach efforts were ineffective shipment would need to be transferred and other Federal agencies to ensure and encourage continued efforts toward to another agency for examination or that information on the interim final education and outreach. investigation; in these cases, we would regulations and their requirements is (Response) FDA received praise from want concurrence from both FDA and disseminated to affected companies and the Small Business Administration for individuals; and our efforts to address regulatory CBP. • • In § 1.285(h), we added the phrase, Issuance of several guidance flexibility and the impact on small ‘‘is not for personal use,’’ after the documents (all available on the Internet) business of the interim final rule. FDA phrase, ‘‘food carried by or otherwise that explain the prior notice and CBP will continue outreach efforts accompanying an individual arriving in requirements, including, ‘‘Prior Notice to affected industry and other the United States,’’ because if it is for of Imported Food: Questions and governments, as resources allow. These personal use, then it is not subject to Answers,’’ ‘‘What You Need to Know efforts will focus on changes to and prior notice as provided by § 1.277(b)(1). About Prior Notice of Imported Food implementation of the final rule. The • We deleted references and Shipments,’’ and numerous Web-based PNC also will continue to answer provisions in § 1.285(i) and (l) relating tutorials for PNSI. Many of these questions and provide technical to refusals, because the process for guidance documents are available in assistance upon request, and FDA and resolving a prior notice submission for foreign languages; e.g., Arabic, French, CBP will issue and update guidance as an article of food from a facility that is Hindi, Japanese, Malay, Portuguese, and policies change or need clarification. not registered as required is based on Spanish. holds under section 801(l) of the act and Specifics regarding each of these 2. Prior Notice Submission Training not refusals under section 801(m) (see activities are included on FDA’s Web Program From Flexible Alternative discussion above for § 1.285(a)). Under site. In addition, FDA also provided Question 7 § 1.285(i)(2), we are allowing training in new or revised procedures (Comments) Many comments believe submission of the notification resolving for its field personnel, as well as CBP that a training program will improve the the hold by fax and e-mail only, and field personnel. FDA included an initial accuracy of the data being submitted deleting the option to submit the transition period in the December 2003 under the regulations and that a training notification by mail and express courier. prior notice CPG for more than 8 program would resolve many of the We also made other minor revisions to months, during which the agencies other problems being encountered with this § 1.285 to simplify the text. emphasized education to achieve the present rules. One comment • We revised § 1.285(j)(2) of the final compliance, rather than refusal of suggests that, following a detailed rule to allow the carrier to submit a articles of food with inadequate prior analysis of compliance issues, FDA request for review after hold. Under notice. should target its training to specific § 1.285(j)(3), we revised the final rule to Shortly after publication of the IFR, problems and their solutions, and to allow submission of the request for FDA began disseminating at U.S. ports entities new to the process. One review after hold by fax and e-mail only, flyers and posters summarizing the new comment suggests that FDA offer a and deleted the option to submit the requirements and informing training program for brokers and other notification by mail and express courier. representatives of affected entities how transmitters and submitters. Other

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comments recommend that specific Line staffed with individuals with the provided in FDA’s Regulatory outreach and training should be requisite technical expertise and the Procedures Manual, Chapter 9. This conducted for each mode of ability to resolve operational problems guidance is posted at http:// transportation. Another comment as they arise; www.fda.gov/ora/compliance_ref/ cautions that the FDA and CBP should • Creating dedicated e-mail addresses rpm_new2/ch9/default.htm. have resources to implement an within FDA to which specific questions FDA agrees, in part, with the educational campaign before initiating can be addressed and/or specific e-mail recommendation about providing user another training and outreach program. addresses for different technical and guidelines and has provided guidance (Response) FDA and CBP will operations areas; and instructions on the process for filing conduct training focused on changes • Providing prompt information to prior notice. This guidance, along with between the final rule and the IFR. submitters regarding inadequacies or detailed instructions on the use of the Depending on resources, the education inaccuracies in prior notice, including PNSI, including step-by-step help, is and outreach may take the form of shipment level feedback to the filer; and available at http://www.cfsan.fda.gov/ • public meetings, Web-based interactive Holding public meetings before the ~furls/helpf.html. Instructions for training, or posting on our Web sites of final rule takes effect to ensure that all contacting FDA with questions about guidance and other outreach materials. affected parties understand the rule and prior notice are also available at that As resources permit, we also may can be heard. Web site. translate our guidance and other (Response) We will provide outreach FDA cannot provide specific outreach materials into other languages. and training on the final rule as instructions on the use of ABI software resources permit. At a minimum, we to file prior notice, as that software is 3. Requests for Additional Outreach will provide guidance and instructions developed and made available through (Comments) There were many on the process for filing prior notice on private vendors. Users should contact comments that request additional our Web site. This guidance, along with their vendor for specific instructions on outreach and training, as well as some detailed instructions on the use of PNSI, the use of their ABI software. CBP does comments that suggest specific outreach including step-by-step help, is available ~ regularly issue to filers ABI programs, such as: at http://www.cfsan.fda.gov/ furls/ Administrative Messages which provide • Providing an expanded program helpf.html. instruction and guidance regarding We agree with the recommendation to that would educate and train all submission of prior notice through ABI/ establish an effective mechanism for stakeholders, including substantially ACS. more and varied educational programs disseminating answers to specific As part of our outreach efforts for the before the full enforcement of the IFR, questions to industry, and have issued prior notice IFR, we issued a number of and escalating training efforts in the guidance documents for each of the documents explaining the requirements area of shipper and carrier education rules we have issued to implement the of the IFR and/or PNSI and provided and compliance; authorities in the Bioterrorism Act that them on our Web site in English and • Establishing an effective provide our response to the frequently one or more other languages, including: mechanism for disseminating answers asked questions (FAQs), including the • FDA Industry Systems, Index of to specific questions to affected persons; prior notice IFR. We anticipate doing Help Pages at http://www.cfsan.fda.gov/ • Providing enforcement guidance the same for this final rule. These ~furls/helpol.html) (also available in that addresses specific enforcement guidance documents are designed to Spanish); issues, such as enforcement of the food help affected parties comply with the • HELP: Getting Started: Create New facility registration requirements at the legal requirements established by the Account Quick Start Guide) (also time of prior notice submission and various rules. We intend to issue available in Spanish); describing enforcement procedures in additional guidance as new questions • OUTREACH: Overview of Prior detail; arise and as resources permit. Notice Interim Final Rule (Slide • Providing guidelines on the In terms of providing enforcement Presentation) (also available in Arabic, procedures to submit prior notice either guidance, in December 2003, FDA and French, Malay and Spanish); via FDA’s PNSI or CBP’s ABI, such as CBP issued a CPG that stated that, until • Booklet: What You Need to Know instructions on cancellation or change August 12, 2004, the two agencies About Prior Notice of Imported Food of a prior notice and descriptions on generally would utilize communication Shipments (also available in French and what is meant by identifying goods by and education strategies with escalating Spanish); and the common, usual or market name; imposition of civil monetary penalties • Fact Sheet on the Interim Final • Explaining procedures of the rule in rather than refusal of shipments. The Rule—Prior Notice of Imported Food foreign languages and establishing point two agencies revised the CPG in June Shipments (also available in French, of contacts in foreign countries; 2004, August 2004 (August 16, 2004, 69 Malay, Polish, Portuguese, Spanish, • Publicizing the rule to individual FR 50389), November 2004, March Arabic, Chinese, Hindi, and Japanese). Americans who will travel abroad, and 2005, and November 2005 (November We also have an ‘‘FDA Food and making compliance with it a simple, 14, 2005, 70 FR 69160), as our Cosmetic International/Foreign practicable, and straight forward enforcement policies changed and Language Documents and Videos,’’ process; evolved. Published elsewhere in this which is a list of all food (and cosmetic) • Providing a Web-based tutorial; issue of the Federal Register is a notice documents that have been translated • Using CBP’s ABI Administrative of availability for the Prior Notice Final and the languages in which they are Messages to announce changes in PNSI; Rule Draft CPG, which describes FDA’s available on our Web site at http:// • Establishing an FDA and CBP and CBP’s proposed policies for www.cfsan.fda.gov/~mow/ agency-industry working group and/or a enforcing this final rule. A copy of the internat.html. Many of the documents more formal advisory committee with CPG may be found at http:// describing prior notice requirements representatives of various industry www.fda.gov/ora under ‘‘Compliance and guidance have been translated into groups; References.’’ foreign languages. • Improving staffing on the ‘‘hotline’’ Generally, FDA enforcement FDA does not currently maintain staff and/or creation of an exclusive Help procedures regarding imports are in foreign countries. However, FDA has

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developed the Beyond our Borders since December 2003. When understand their obligations under the initiative, which includes plans to build appropriate, information about the PNSI statute and the IFR, the comment period an on-the-ground presence for FDA in system will also be announced both on ended July 13, 2004, and the agencies Asia, Europe, Latin America, and the the FDA Web site and through CBP’s did not consider comments submitted Middle East. In March of 2008, we Administrative Messages. outside of the open comment periods. received approval from the U.S. CBP also has established avenues of (Comments) Several comments Department of State to establish eight communication with trade working recommend that FDA provide feedback full time permanent FDA positions at groups and ensures FDA’s participation to the industry detailing areas of U.S. diplomatic posts in the People’s when the subject for discussion is prior noncompliance and compliance. One Republic of China, pending notice. FDA does not plan to establish foreign government stated its authorization from the Chinese a formal advisory committee to address willingness to work with FDA to government. Furthermore, CBP, U.S. prior notice. increase the level of industry Department of State, and USDA Food FDA agrees with the comment to compliance within their country Agricultural Service staff are located at improve help desk staffing, as resources through outreach and education U.S. Embassies in many foreign permit. Our Web site contains a tutorial activities. It requests that FDA provide countries. These U.S. government on how to submit a registration for a it on a timely basis detailed information entities frequently provided assistance facility subject to the requirements at 21 concerning noncompliance by their to foreign stakeholders, including CFR part 1, subpart H. In addition, the industry. Another comment suggests foreign government officials and private PNC staff can answer questions about that FDA could post on its Web site a companies, in understanding the how to submit prior notice. Questions description of the types of errors most requirements of various U.S. regarding clarification of the rule that commonly observed in filed prior regulations, including those provided in are not addressed in this preamble or notices. our Bioterrorism Act regulations. We existing publications should be (Response) We agree, and have been will routinely update these U.S. officials submitted to FDA at posting on our Web site summary abroad about changes to and [email protected]. We will generally information about submission of prior implementation of this prior notice final not provide an individual response to notice, including data on the types of rule. these questions, but will answer them in errors. See http://www.cfsan.fda.gov/ As resources permit, we also will Question and Answer Guidance ~pn/pnsum.html. We stated that this continue to translate guidance Documents so the information will be information will also be analyzed to documents and system instructions into broadly available. help FDA take appropriate enforcement other languages. FDA has included features in PNSI to action when necessary. FDA presented FDA agrees with the comment inform submitters of many types of the Summary Information in two requesting publicizing the rule to inadequacies in the information categories: (1) General interest— individual Americans who will travel provided, such as missing required Information about the number and types abroad, and making compliance with it fields. FDA also has coordinated with of prior notices that are being submitted, a simple, practicable, and straight CBP to provide prompt messaging back and which systems are being used to forward process. CBP Publication # to users when Prior Notice is filed submit them; and (2) Specific 0000–0512, revised January 13, 2005, through ACS. FDA notes that certain requirements—Information about Know Before You Go—Regulations for inaccuracies cannot be identified submission of the required information. U.S. Residents, is posted at http:// electronically, but could be detected in We provided an initial posting of the www.cbp.gov/xp/cgov/travel/vacation/ an intensive prior notice review (e.g., summary information and two kbyg/. This publication is the primary the packaging of an actual shipment (12 subsequent updates. The August 2004 CBP guidance document concerning oz cans of tuna fish) does not match the update included some summary import regulations targeted to travelers prior notice data submitted for that information from December 2003 and contains information about the shipment (e.g., 6 oz cans of tuna fish)). through April 2004 and some snapshots prior notice final rule’s requirements for With respect to holding public of activity in July 2004, along with importation of food. In addition to meetings to provide an opportunity for information on specific information providing information about prior parties to voice their opinions on the requirements such as registration notice requirements, the publication IFR, FDA and CBP published the IFR on number and carrier information. also provides a link to FDA’s Web site October 10, 2003, and opened the We also posted information at http://www.fda.gov/oc/bioterrorism/ comment period through December 24, summarizing the number of facilities bioact.html. 2003. We reopened the comment period registered pursuant to 21 CFR part 1, FDA also agrees with the comment from April 14, 2004, through July 13, subpart H at: http://www.cfsan.fda.gov/ that requests us to provide a Web-based 2004. We reviewed 320 timely ~furls/ffregsum.html. This summary tutorial. Since October 2003, FDA has comments that raised multiple issues, includes a breakdown of the number of provided a PNSI tutorial in the form of and have considered those comments as registered facilities by country and U.S. step-by-step help on its Web site (http:// we developed this final rule. We also State. www.cfsan.fda.gov/~furls/helpf.html). held numerous outreach meetings both FDA welcomes any additional domestically and abroad—in person and 4. Enforcement Timeframe comments or suggestions on how to by video conferencing—to explain the (Comments) Many comments state improve the help information; these can requirements of the IFR to affected that because FDA and CBP have not be submitted to the PNC using the parties and answer questions of informed prior notice submitters of phone number or e-mail provided on clarification to ensure all were able to specific deficiencies in their that Web page. provide meaningful comment to FDA submissions, FDA must extend the FDA and CBP agree that operational and CBP. The comment period was the enforcement date of the rule to allow issues impacting ABI filers should be time for all parties to be heard on the more time to communicate errors and announced using Administrative provisions of the IFR. While the allow adequate time to fix them. One Messages, and intend to continue to use agencies welcome discussion and comment suggests that the agencies that system, as we have routinely done wanted to ensure that all stakeholders should develop and implement a notice-

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specific informational system that publication of the final rule provides Should Know About: Mitigation provides detailed feedback to submitters sufficient time for the business Guidelines: Fines, Penalties, Forfeitures when a prior notice is deemed to be community to become familiar with all and Liquidated Damages,’’ which is noncompliant. Another comment states the provisions of the final rule. posted at http://www.cbp.gov/ that exporters should be advised of Moreover, we plan to conduct outreach linkhandler/cgov/trade/legal/informed_ noncompliant shipments in order to after publication of the final rule to compliance_pubs/icp069.ctt/icp069.pdf. take corrective action prior to the shift affected industry and other (FDA has verified the Web site to full enforcement. One comment governments, as resources allow. These addresses, but FDA is not responsible believes that part of the phase-in period efforts will focus on changes to the final for any subsequent changes to the Web should include a feedback program to rule. Given the delayed effective date, sites after this document publishes in let brokers know which importers and the fact that the changes in the final rule the Federal Register.) corresponding transactions are handled are not very extensive, and the public’s with inadequate or no prior notice. The experience in complying with the IFR, N. The Joint FDA-CBP Plan for comment states that this program FDA believes there is no need for a Increasing Integration and Assessing the should be developed in conjunction phased-in enforcement approach similar Coordination of Prior Notice with the industry to define to what was done for the IFR. Timeframes (Comments) One comment states that measurements (history profile and/or We stated in the preamble to the IFR transactional), and determine what the if FDA discovers that a large number of problems are experienced during the (68 FR 58974 at 58995) that FDA and notification process should be. One CBP would publish a plan, including an comment encourages FDA to grace period between publication of this implementation schedule, to achieve the expeditiously publish a notice that it final rule and the effective date, FDA goal of a uniform, integrated system and intends to continue outreach and delay should consider extending the effective to coordinate prior notice timeframes for enforcement of the regulation so that the date, especially for first time offenders. air and truck modes of transportation business community may have a greater (Response) FDA believes that the 180 with timeframes finalized by CBP when opportunity for education, training, and day delay in effective date is adequate they finalize their rule entitled continued dialogue with the agencies. for affected parties to become familiar ‘‘Required Advance Electronic Other comments recommend a delay in with all the provisions in the Prior Presentation of Cargo Information,’’ all the final phase of enforcement until all Notice Final Rule. While we do not while fulfilling the Bioterrorism Act systems are fully operational. anticipate extending the effective date past 180 days, we intend to take into mandates. For this reason, as well as to (Response) FDA disagrees. The account the circumstances of the obtain comments on other aspects of the obligation to comply with applicable violation in enforcing the final rule. rule, we issued an IFR, with an regulations is on the parties subject to opportunity for public comment for 75 5. Enforcement Penalties a regulation as specified therein; FDA days. Moreover, to ensure that those does not have an obligation to inform all (Comments) One comment requests who comment on this IFR would have prior notice submitters of specific that the agencies publish procedures had the benefit of actual experience deficiencies in their submissions before that clearly define what types of with the systems, timeframes, and data beginning enforcement of a rule. FDA penalties will be issued for failure to elements, FDA also stated it intended to and CBP, however, were cognizant of comply under § 1.284 and to whom they reopen the comment period for an the potential effect the prior notice IFR will be issued. additional 30 days to coincide with the could have on trade and thus, after (Response) Sections 1.283 and 1.284 issuance of the plan by FDA and CBP publication of the IFR, FDA published of the final rule describe the relating to timeframes. We extended this guidance that included a transition consequences for failing to submit comment period twice on April 14, period during which we emphasized adequate prior notice or otherwise 2004, and May 18, 2004, thereby education to achieve compliance, rather failing to comply with the final rule. We providing an opportunity for affected than general refusal of noncompliant believe these adequately describe the persons to comment for 165 days. shipments (the December 2003 Prior types of penalties. The Prior Notice Notice Interim Final Rule CPG) (68 FR Final Rule Draft CPG describes our In April 2004, FDA and CBP 69708). In addition, during the prior proposed enforcement policies, and announced the Joint Food and Drug notice transition periods from April states, for example, that we intend to Administration-Customs and Border 2004 through April 2005, we provided focus our resources on more serious Protection Plan for Increasing compliance summaries that informed violations and repeat or flagrant Integration and Assessing the submitters, and those who transmit on violations. Coordination of Prior Notice their behalf, of the major areas of Civil monetary penalties, which are Timeframes (the Plan). deficiencies with respect to missing data issued by CBP, may also be assessed in The comments addressing the Plan elements. These represented the general response to a prior notice violation. CBP are discussed in the following deficiencies we were seeing in prior has posted a variety of publications that paragraphs. Comments addressing our notice submissions during the explain both the administrative process assessment of reducing the prior notice educational transition period (see http:// for fines, penalties, forfeitures, and timeframes are found earlier in section www.cfsan.fda.gov/~pn/pnsum.html). liquidated damages, such as: ‘‘What III.F (‘‘When must prior notice be The compliance summaries also Every Member of the Trade Community submitted to FDA?’’ (§ 1.279)) of this generally described the deficiencies in Should Know About: Customs document. We respond to the other prior notices that are not confirmed for Administrative Enforcement Process: questions (e.g., special programs and review (e.g., failure to provide a valid Fines, Penalties, Forfeitures and flexible alternatives) raised in our April registration number). However, we do Liquidated Damages,’’ which is posted 14th reopening of the comment period not plan to communicate submission at: http://www.cbp.gov/linkhandler/ in sections III.D (‘‘What is the Scope of deficiencies to other than the submitter cgov/trade/legal/informed_compliance_ this subpart?’’ (§ 1.277)) and III.M and transmitter. FDA believes that the pubs/icp052.ctt/icp052.pdf, and ‘‘What (Outreach and Enforcement) of this effective date of 180 days after Every Member of the Trade Community document.

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1. Increased Integration concerns. Comments further support the Canadian counterparts to ensure that FDA and CBP have increased their continuing plan to target shipments for information is shared and technologies integration and are continuing to do so which little is known, while are working in parallel to make crossing in the following ways: maintaining expedited processing for the border seamless, efficient, and safe. (Response) FDA agrees that exchange • Co-location of all FDA Prior Notice those shipments and importers that are of information between its international staff with CBP’s targeting staff; well known and have provided FDA counterparts, when feasible, is critical to • Further refinement to FDA’s and CBP with the means by which they evaluation and response to food safety targeting rule sets in CBP’s targeting can assure general compliance. These and security challenges. system, coupled with additional comments also argue that products (Comments) One comment notes that training in targeting techniques; subject to FDA’s prior notice FDA recently announced the signing of • Continued targeting support from requirements should be eligible for full an MOU with CBP to commission CBP CBP and other Federal law enforcement expedited processing and information officers in ports and other locations to analysts; and transmission benefits allowed with C– conduct investigations and • Enhancement of communications TPAT, FAST, and any other similar examinations of imported foods on and cooperation with CBP to facilitate programs established in the future. One comment specifically encourages FDA behalf of FDA. The comment questions information exchange and to ensure and CBP to incorporate the current whether this would have any expeditious access and examination of information contained within these consequences on the selections for food shipments FDA has decided to programs and allow for the removal of controls by CBP officials stationed in EU inspect upon arrival. the maximum number of flags within ports. (Comments) One comment suggests the risk analysis system for those (Response) Investigation and that FDA should consider performing companies that demonstrate their examination of food as a result of prior the OASIS review concurrently with the compliance by participation in these notice is conducted upon or after arrival ‘‘FDA BTA review’’ to eliminate additional security programs. of the food in the United States. duplicative work and burdens on both (Response) FDA agrees that refining Therefore, the MOU should not have the importing community and FDA. our targeting rule sets helps to improve any consequences on CBP operations at Another comment suggests that FDA both agencies’ risk analysis systems. As EU ports. coordinate the prior notice procedure we discussed previously, FDA has 2. General Comments on the Plan with FDA’s ‘‘Hold Intact Notice’’ so that decided not to consider any special FDA can avail itself of the opportunity programs, such as C–TPAT and FAST, The Plan as announced in April 2004 to identify in advance shipments for in implementing the prior notice rule. and revised in November 2004 outlines inspection, sampling or detention, or (Comments) All the comments favor the following: permit the shipment to pass and be initiatives to provide additional training • From November 1, 2004, to January delivered without delay. of FDA staff in targeting techniques that 3, 2005, we plan to assess existing (Response) FDA disagrees. As we will increase the efficiency and procedures and staffing needed to previously explained in an earlier effectiveness of the border crossing receive, review, and respond to the prior response in section III.J.11 of this systems. One comment particularly notices submitted in accordance with document, FDA does not agree that notes that additional training should be the Prior Notice IFR (i.e., 2 hours before doing the OASIS review under section targeted towards those individuals and arrival by land by road; 4 hours before 801(a) of the act concurrently with the issues that will provide measurable arrival by air or by land by rail; and 8 prior notice review under section additional value to the prompt and hours before arrival by water). 801(m) of act would be beneficial to efficient release of compliant cargo. • From January 4, 2005, to February industry or FDA. Because the section (Response) Any effective targeting 3, 2005, we intend to identify what 801(m) review must occur prior to technique allows for the identification changes to work practices and staffing arrival, concurrent section 801(a) and of food likely to be at risk for would be necessary to determine if FDA section 801(m) reviews also would have adulteration based on a scientific risk could continue to receive, review, and to occur prior to arrival. FDA believes assessment. Targeted training will be respond to all prior notice submissions such a concurrent process would be provided, as resources permit. with reduced timeframes (e.g., 1 hour/ inefficient and impractical and would (Comments) Comments support 30 minutes before arrival by land by likely increase congestion at the ports of enhanced communications and road; 2 hours before arrival by land by arrival. cooperation with CBP to facilitate rail; and by ‘‘wheels up’’ for flights (Comments) Comments state that co- information exchange and ensure fast originating in North and Central locating FDA PNC staff with CBP’s access to foods that are subject to prior America, South America (north of the targeting staff is a positive step because notice holds. Comments state that this Equator only), the Caribbean, and the two agencies’ personnel are both will be critical to the food industry, as Bermuda; otherwise 4 hours before accountable for the risk analysis any delays will translate into added arrival by air). process, and thus, both agencies’ costs and inefficiencies to their current • From February 4, 2005, to May 3, personnel can easily interact and share supply chain. One comment encourages 2005, we plan to implement necessary information, leading to increased FDA and CBP to integrate technologies changes and make appropriate efficiencies and integration of the risk used for implementing the Bioterrorism adjustments to ensure we could receive, analysis process. Act with NEXUS, US VISIT, FAST, C– review, and respond to all prior notice (Response) FDA agrees and has co- TPAT, and other programs at the border. submissions with reduced timeframes. located the PNC with CBP’s targeting (Response) FDA agrees that Under the Bioterrorism Act, any staff. exchanging information between the timeframe must be sufficient to receive, (Comments) Comments strongly agencies is important to evaluation of review, and respond to prior notice support further refinement of FDA’s and response to food safety and security submissions, as set out in section targeting rule sets in order to maintain challenges. 801(m)(2)(A) of the act (21 U.S.C. and improve the risk analysis system to (Comments) One comment encourages 801(m)(2)(A)). The agencies emphasized flag specific shipments for security FDA and CBP to work with their that the evaluation of whether to reduce

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the timeframes for prior notice review available at the port, including those of activities for FDA and ensures will depend on the level of compliance the Department of Homeland Security consistent review of submitted prior industry achieves during the (DHS) in order to make better use of notices. If industry is having difficulties assessment. DHS resources at the border. Another with a specific port, they should contact (Comments) Numerous comments comment states that any assessment the PNC to have the issues resolved. concur with the proposed joint FDA- taken up during this timeframe must FDA believes it is likely that the CBP plan for increasing integration of take into account the problems inherent concerns raised in the comments relate both agencies’ activities, as this would in the current systems, as well as the to admissibility decisions being made eliminate the requirement for importers fact that not all submissions will be under section 801(a) of the act, which is to maintain two different timeframes for properly prepared or followed up on, as a separate review than the one made submission of data. One comment this could potentially translate into under section 801(m) of the act, as concurs with the joint plan and states current practices or staffing appearing to described previously. that it would minimize procedures and be inadequate when, in fact, they may (Comments) One comment states that costs for firms. One comment states that not be. FDA personnel should be assigned to all it was confident that, with proper Another comment asserts that some arrival ports, particularly those where planning and development, additional border crossings were not designed for high risk shipments may arrive. integration of the security processes and today’s traffic volumes or the post 9-11 (Response) FDA does not have the the differing timeframes can be environment and recommends that personnel to cover all possible ports of coordinated through the actions these physical resources be included in arrival. Accordingly, under the outlined in the published joint plan. the assessment of existing procedures. authority of section 314 of the (Response) FDA agrees that increased This comment also encourages CBP to Bioterrorism Act, FDA and CBP signed integration of activities, including audit staffing levels at border crossings an MOU in December 2003 that allowed timeframes when appropriate and to determine if additional staff is FDA to commission thousands of CBP feasible, would be advantageous, needed. officers in ports and other locations to provided FDA still is able to meet its (Response) FDA agrees that any conduct, on FDA’s behalf, investigations statutory obligation to receive, review, assessment must take into account the and examinations of imported foods. and respond to prior notice. As availability of all resources, including This FDA-CBP collaboration discussed previously (see section III.F, those resources of agencies with which significantly strengthens the When must prior notice be submitted to we maintain MOU or other agreements implementation of the Bioterrorism Act FDA? (§ 1.279)), FDA conducted an covering inspection and sample to assure the security of imported foods. assessment of FDA response times with collection, which can, or should, be The MOU enables FDA to work more reduced timeframes and determined devoted to the receipt, review, and efficiently with CBP and builds upon that if it changed the prior notice response of prior notice. Accordingly, FDA’s and CBP’s long history of close timeframes to be consistent with those DHS resources are used in cooperation. Additionally, the MOU of CBP’s advance electronic information implementing this rule, as described enhances the two agencies’ teamwork in rule, the agency would not have elsewhere in this preamble. training, day-to-day operations, and adequate time to receive, review, and (Comments) Two comments noted information sharing. As part of the respond to the prior notices. Moreover, that they are experiencing significant MOU, FDA and CBP provide specialized commerce actually would be adversely delays on shipments that cross the training for the commissioned CBP impacted by shorter prior notice border on Fridays due to FDA’s limited employees who will carry out this work, timeframes for submission, because this hours on that day. The comments are and both agencies have expanded their would significantly increase the number concerned about uncertainty regarding existing cooperative arrangements to of shipments where FDA would not be transit times and that customers’ date- directly share information affecting the able to decide whether it should sensitive orders will not be received on safety and security of imported foods. examine the food at the port of arrival time. Another comment noted that (See http://www.fda.gov/oc/ by the end of the timeframe. Such waiting times due to traffic volume has bioterrorism/moucustoms.html.) shipments would be delayed at the port increased at the bridge at Detroit (Comments) One comment states that of arrival until FDA has either because of the inability to move prior there were connection problems with completed its review or decided to notice shipments through the tunnel. FDA’s computer system, perhaps as a examine or not examine the food at the The comment states that these delays result of submission overloads to the port or arrival without the benefit of a have made it very difficult to deliver to system, with session ‘‘timeouts’’ complete review. Accordingly, FDA has U.S. facilities that do not operate 24 occurring. The comment notes that it is retained the timeframes in the IFR. hours and that these delays will crucial that an infrastructure with the (Comments) One comment requests continue to cost exporters and importers capacity to deal with the information that FDA explain why the maritime and may cause U.S. processing facilities being required by FDA be in place in transportation timeframe was not to have unplanned downtime due to a order for stakeholders to meet the considered in the joint plan. lack of raw material. Another comment requirements of prior notice. (Response) FDA did not include the notes that different FDA locations ask (Response) As discussed in section maritime transportation timeframe for more information than the III.G, How must you submit the prior because the CBP advance electronic Bioterrorism regulations or systems can notice? (§ 1.280), FDA has carefully information timeframe for cargo arriving process, thereby holding up shipments monitored both PNSI and OASIS system by water is 24 hours, which is that move freely at other border crossing usage and performance since prior significantly greater than the time locations. notice was implemented in December established by the prior notice IFR for (Response) Prior notice is submitted 2003. During this period, no issues this mode of transportation (8 hours electronically through ABI/ACS or related to load on these systems have before arrival). PNSI. There is no ability for individual been identified. Both systems have (Comments) One comment suggests ports to require different information as experienced occasional outages that assessment of the resources part of the prior notice submission (including planned down times for encompass all potential resources process. The PNC directs all prior notice maintenance and upgrades). During

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these outages, messages between the suggests that other reasons for after the IFR went into effect. During CBP and FDA systems are held in a noncompliance, such as the need for that time, we resolved initial problems queue, resulting in a backlog. Initially, additional discretion on data and with the government’s prior notice we did experience some difficulties education, be included in the systems and processes. Our extensive when trying to clear the queue after evaluation. outreach and focus on education instead returning to normal operations, but In response to the agencies’ statement of refusals and other enforcement these issues have been resolved. FDA that the evaluation of timeframes will actions helped ensure that industry and CBP also have increased the depend on the level of compliance submission rates were at or near 100 capacity of the communications link industry achieves during the percent for most prior notice between their systems to ensure that assessment, one comment asserts that it information by November 2004. In additional bandwidth is available for is not appropriate for the agencies to certain circumstances, such as with the future increases in load. FDA continues place the burden of compliance entirely manufacturer’s registration number, to monitor the production system and to on the trade. The comment further states FDA and CBP continued to provide test for performance as the system is that the trade’s ability to provide the flexible enforcement. With these upgraded and enhanced. information required also depends on measures, prior notice was operating (Comments) One comment suggests the systems working properly, the smoothly during the assessment period. that FDA and CBP take the integrated efficiencies of the government personnel (Comments) One comment fully timeframes further and require only one involved, the educational outreach supports this process and encourages notification that should meet both FDA levels and the feedback individual FDA to provide for any changes that and CBP requirements and prevent importers receive in relation to their may be needed to allow the timing confusion and delays in the case of a current processes. These are areas that reductions that are critical to economic bioterrorism event. are controlled and managed by the prosperity. The comment suggests that (Response) FDA disagrees. The agencies, so they also must be once the program has been operational Bioterrorism Act and the Trade Act have considered when assessing the for a time, and the systems glitches different statutory requirements. In probability of reducing timeframes. One worked out from past experience, the implementing these laws, the agencies comment expresses concern that the assessment would translate into a faster require different information and use implementation schedule of the Plan processing time. different targeting and screening tools. may be delayed due to industry (Response) As stated previously, the FDA and CBP have discussed noncompliance with the IFR. Another prior notice timeframes must ensure interfacing with AMS (the module of comment asserts that this lack of that we have sufficient time to receive, ACS through which carriers, port communication from the agencies to review, and respond to the prior notice. authorities, or service bureaus transmit submitters regarding errors could (Comments) Several comments electronically the cargo declaration negatively impact the assessment of encourage both agencies to ensure that portion of the inward foreign manifest compliance of the trade and they allow for the proper to CBP) for manifest data and subsequently, the agencies’ decisions communications with the trade prior to determined that the general cargo data regarding the trade’s future ability to planning for or implementing any in AMS are not suitable to accommodate provide a high level of compliance. changes as a result of the previously the detailed information requirements of (Response) FDA disagrees. The mentioned assessments, so that the section 801(m) of the act. For example, obligation to comply with applicable interests of all parties involved can be AMS does not collect the country of regulations is on the parties subject to assessed and the best changes can be origin. In addition, its collection of the a regulation as specified therein; FDA implemented. One comment requests identities of the article of food and its does not have an obligation to inform all that sufficient resources be allocated by manufacturer differs from the way those prior notice submitters of specific FDA and CBP to implement the Plan. are collected under the prior notice deficiencies in their submissions before (Response) The IFR included an interim final and final rules in such a beginning enforcement of a rule. extended public comment period, and way that the data would not meet our Nonetheless, after publication of the comments were received and reviewed needs in carrying out the purpose of IFR, FDA published guidance that during the development of this final section 801(m) of the act. included a transition period during rule. We also held numerous outreach (Comments) One comment asserts that which we emphasized education to meetings both domestically and it is redundant for FDA to repeat a achieve compliance, rather than general abroad—in person and by video feasibility analysis of submission refusal of noncompliant shipments (the conferencing—to explain the timeframes because CBP has clearly December 2003 Prior Notice Interim requirements of the IFR to affected addressed those issues. Another Final Rule CPG) (68 FR 69708). In parties and answer questions of comment proposes that FDA accelerate addition, we have provided compliance clarification to ensure all were able to the schedule for implementing the joint summaries that inform submitters, and provide meaningful comment to FDA plan, and make this evaluation with those who transmit on their behalf, of and CBP. The final rule will not take CBP as quickly as possible. One the major areas of deficiencies, in effect until 180 days following comment supports the plan and general, that we were seeing in prior publication. The agencies plan suggested that any short term notice submissions during this additional outreach and guidance assessment take into account the educational transition period (see http:// during that 180-day period. problems involved with the current www.cfsan.fda.gov/~pn/pnsum.html), (Comments) Some comments request systems. Another comment expresses and generally advise the submitter of that FDA issue a final prior notice rule concern that full enforcement of the IFR deficiencies in prior notices that are not only after there has been a period of full will be in effect during the proposed confirmed for review (e.g., failure to enforcement followed by an additional review period and that consequently, provide a valid registration number). comment period. These comments argue industry will be placed in the difficult Moreover, FDA and CBP believe that the that both FDA and industry need the position of trying to comply with level of compliance was sufficiently benefit of experience with active and timeframe requirements that are not high during the assessment period. The full enforcement before fine-tuning the synchronized. Another comment assessment period began almost a year prior notice regulation into a final rule.

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Comments suggest that FDA reopen the U.S.C. 601–612), and the Unfunded there were no security assessments comment period for 60 days after full Mandates Reform Act of 1995 (Public made specifically on imported food enforcement has been in place for 90 Law 104–4). Executive Order 12866 products, and all such shipments were to180 days or for at least 6 months. In directs agencies to assess all costs and allowed to move into the United States the interim, the comments recommend benefits of available regulatory prior to FDA being notified of their that the rule should be maintained as an alternatives and, when regulation is existence, which legally could have IFR for a longer period of time with necessary, to select regulatory occurred up to 15 days after the food phased implementation, as one approaches that maximize net benefits had arrived in the United States and comment suggests, while developing the (including potential economic, been moved to its final destination. final rule. environmental, public health and safety, Requiring prior notice of imported foods (Response) FDA reopened the and other advantages; distributive allows FDA to target food that may pose comment period for a total period of impacts; and equity). The agency a significant risk to public health and almost 6 months to allow parties an believes that this final rule is not a inspect it upon arrival. The prior notice opportunity to provide meaningful significant regulatory action under the submission requirement protects the comment based on their experiences in Executive order. Nation’s food supply against actual or complying with the IFR. FDA also The Regulatory Flexibility Act (RFA) threatened terrorist acts and other food- extended the initial eight-month requires agencies to analyze regulatory related emergencies. It helps ensure that transition period from August 2004 to options that would minimize any imported food shipments that appear to November 2004 for several of the data significant impact of a rule on small pose a significant threat to public health elements that our review indicated had entities. The requirements of this final are stopped at the border upon arrival higher error submission rates while rule have not changed significantly from before they are allowed to move into the continuing educational outreach the IFR, although there are changes, United States. This final rule replaces activities. The implementation date for such as those relating to the identity of the IFR that is already in effect. the manufacturer. Because of these this final rule is 180 days after 2. Final Rule Coverage publication. The IFR remains in effect changes, FDA has determined that this until the time the final rule takes effect. final rule may have a significant This final rule applies to all food for No comment period is associated with economic impact on a substantial humans and other animals that is the publication of the final rule. number of small entities. Under the imported or offered for import into the (Comments) One comment urges the requirements of the RFA, and as United States for use, storage, or FDA to build into the final rule the explained in section IV.B of this distribution in the United States, capability to administratively amend the document, FDA has analyzed the including food for gifts and trade and prior notice provisions quickly, if economic impacts of this rule on small quality assurance or quality control needed. The comment notes that this entities. samples, food for transshipment through would be particularly important for Section 202(a) of the Unfunded the United States to another country, imports from any country with which Mandates Reform Act of 1995 requires food for future export, and food for use the FDA has reached a bilateral that agencies prepare a written in a U.S. Foreign Trade Zone. This final rule does not apply to food arrangement. This arrangement would statement, which includes an for an individual’s personal use when it serve as the basis for having different assessment of anticipated costs and is carried by or otherwise accompanies (e.g., more efficient, effective, or risk benefits, before proposing ‘‘any rule that the individual when arriving in the based) prior notice requirements. The includes any Federal mandate that may United States; food that was made by an comment further notes that this ability result in the expenditure by State, local, individual in his or her personal to administratively amend the rule and tribal governments, in the aggregate, residence and sent by that individual as would be important so that FDA could or by the private sector, of $100,000,000 a personal gift to an individual in the adjust procedures quickly and or more (adjusted annually for inflation) United States; or food that is imported efficiently to reflect actual reductions in in any one year.’’ The current threshold then exported without leaving the port risks through such arrangements. after adjustment for inflation is $130 (Response) FDA disagrees. The million, using the most current (2007) of arrival until export. This final rule also does not apply to Bioterrorism Act requires that FDA Implicit Price Deflator for the Gross meat food products that at the time of receive prior notice for every article of Domestic Product. FDA does not expect importation are subject to the exclusive food imported or offered for import into this final rule to result in any 1-year jurisdiction of USDA under the Federal the United States. There are no expenditure that would meet or exceed Meat Inspection Act (21 U.S.C. 601 et exceptions based on the country of this amount as compared to the IFR. In this regulatory impact analysis for seq.); poultry products that at the time production or the country from which the prior notice final rule we: (1) of importation are subject to the the article of food is shipped. exclusive jurisdiction of USDA under To the extent that FDA and CBP Respond to comments on the economic the Poultry Products Inspection Act (21 believe that changes in our policies analysis of the IFR, (2) revise the U.S.C. 451 et seq.); or egg products that related to enforcing this final rule are economic analysis of the IFR using new at the time of importation are subject to needed, we will announce those as data, (3) present an economic analysis of the exclusive jurisdiction of USDA revisions to the Prior Notice Final Rule the leading alternative to the IFR using under the Egg Products Inspection Act Compliance Policy Guide, a draft of new data, and (4) explain the marginal (21 U.S.C. 1031 et seq.). which we are announcing elsewhere in benefits and costs of the final rule itself, relative to the IFR. Finally, prior notice is not required this issue of the Federal Register. for articles of food subject to Art. 27(3) 1. Need for Regulation IV. Analysis of Economic Impacts of The Vienna Convention on Section 307 of the Bioterrorism Act of Diplomatic Relations (1961), i.e., A. Final Regulatory Impact Analysis 2002 requires prior notice of all food shipped as baggage or cargo constituting FDA has examined the impacts of the imported or offered for import into the the diplomatic bag. final rule under Executive Order 12866 United States. Before the prior notice As required by the Bioterrorism Act, and the Regulatory Flexibility Act (5 requirement was instituted in 2003, prior notice submissions must provide

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the identity of the article, manufacturer, effective. It is also possible some of the labor-intensive process of mailing shipper, and grower (if known), the FDA costs of prior notice could be passed on personal food items will cause a Country of Production, the country from to consumers in the form of higher retail decrease in the items being shipped, which the article is shipped, and the prices for some foods; in this case the thus decreasing the business of the mail anticipated port of arrival. In addition, small importer would not feel the system. the notification must provide the complete impact of the higher broker (Response) When the cost of shipping identity of the person who submits and submission costs. increases, the number of items shipped transmits the prior notice, the importer, (Comment) The costs of the IFR were is indeed likely to decrease. Although the owner, the consignee, the carrier, underestimated because some types of some of the reduction in postal revenues the CBP entry identifier, the anticipated imported fruits and vegetables were not would represent a dead-weight loss, it is time and date of arrival, anticipated included in the ‘‘loss of freshness, loss primarily a transfer, not a social cost shipment information, and, if the food in value’’ calculation. and therefore is not included in the cost has been refused admission and (Response) Some fruits and vegetables estimates for this analysis. required to be held, the location where are regulated by USDA’s APHIS (Comment) Several comments express it is held. For food shipments arriving regulations (certain types of citrus, concern about their continued ability to in the United States through tomatoes, avocados, and other products) import fine wine because although they international mail, notification of the and already have to be inspected or can obtain the name and address of the import must be sent before the article is checked at the port of entry regardless site-specific manufacturer of the wine, mailed. Only the prior notice of the prior notice regulation. For obtaining the manufacturers’ (i.e., the information that is relevant to that type importers of these fruits and vegetables, wineries’) registration numbers for these of shipment must be submitted for the requirement to have certain products often is difficult to those not articles of food arriving by international documentation available at the port of in the winery’s direct distribution chain. mail. entry and coordinating times to be at the The comments state that smaller port of entry is not new. Thus, persons importers, wholesalers, retailers, 3. Comments on the Interim Final importing fruits and vegetables subject restaurants, clubs or hotels will be Regulatory Impact Analysis to APHIS’ requirements are not negatively affected by not having the (Comment) The extra work of included in the ‘‘loss of freshness’’ registration number for the completing prior notices because each calculation as these costs of doing manufacturer of the fine wine. The separate food line in an entry needs a business are already taken into account comments further state that the prior prior notice has forced brokers to raise when scheduling importation of the notice rule will negatively impact small their fees to clients and forced produce. FDA believes we have producers by reducing the number of manufacturers to raise their prices to accounted for every other type of potential representatives and sales U.S. consumers. possible instance where a fruit or venues as secondary fine wine market (Response) FDA agrees this is a vegetable regulated under this importers disappear. possible impact of the rulemaking, and rulemaking could experience a loss in (Response) FDA does not believe that noted in the IFR regulatory impact freshness or value. the fine wine industry will be negatively analysis that the costs of prior notice Several fresh produce importers affected by the prior notice final rule. would likely be partially passed on to commented on the IFR that they The final rule at § 1.281(a)(6) requires consumers in the form of higher retail considered prior notice redundant as the identity of the manufacturer as prices for some foods (68 FR 58974 at their produce shipments already have to follows: The name of the manufacturer 59024). be inspected at the port of entry by and either: (1) The registration number, (Comment) One comment states that USDA. These comments further support city, and country of the manufacturer or smaller U.S. importers cannot afford the the exclusion of some fruits and (2) both the full address of the additional costs charged by a broker to vegetables from the ‘‘loss of freshness’’ manufacturer and the reason the submit the FDA information via the ABI cost calculations presented here and in registration number is not provided system. As a result, they are having their the IFR’s regulatory impact analysis. (hereafter ‘‘the identity of the foreign suppliers submit prior notice. (Comment) The cost to complete a manufacturer’’). Even if a wine Some small companies estimate that, prior notice to send food by mail, for importer, retailer, or wholesaler cannot including Web site disruptions, 80 companies that ship low volumes of obtain the registration number (e.g., the packages would take 40 to 80 hours for inexpensive food products, is higher winery refuses to disclose its prior notice. The comment believes that than the value of the product being registration number because the this is totally unmanageable. shipped and therefore shipping to the importer, retailer, or wholesaler is (Response) We account for increase in United States may be discontinued. outside the winery’s distribution chain), broker costs due to prior notice in our (Response) FDA stated in the analysis the prior notice can include the name analysis; the comment estimate of the of the IFR that the costs of completing and full address of the winery, which time it takes to complete prior notice is prior notice submissions may be comments stated is obtainable. We do accurately reflected in the IFR and final partially passed along to the consumer not include additional costs to fine wine rule analysis. FDA expects importers to in the form of higher retail prices for manufacturers or importers in this final modify their business practices to find some foods (68 FR 58974 at 59024). rule analysis; however, we do refine the the most cost effective way to deal with FDA’s IFR analysis also acknowledged estimate of the difference between the prior notice requirements. In this case, the possibility that companies in the IFR requirements and this final rule the small importer can avoid higher business of sending small shipments of modification. broker fees by having the foreign food to private individuals in the United (Comment) Smaller importers that supplier submit the prior notice. States may stop shipping to U.S. buy from brokers and wholesalers Another alternative would be for the addresses (68 FR 58974 at 59067). because they are too small to buy small importer to submit prior notice (Comment) A number of postal directly from larger food manufacturers themselves through PNSI. We would services take issue with the requiring of will be put out of business. These expect small firms would comply in filing prior notice for personal food smaller importers allege that they will whichever manner is most cost items. The comments state that the not be able to provide the

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manufacturers’ registration numbers on notice submission and prior notice timeframes with the timeframes their prior notices as required by the submission by transport type. The required by CBP’s Advance Manifest final rule. The comments argue that the options regarding shorter submission Rule. registration number requirement timeframes by transport type are similar Option 3 (Final Rule). This option interferes with small businesses’ rights to the options presented in this analysis; includes all components of Option 1, to free trade because now only larger we do not analyze those options with except the final rule now allows, when businesses that deal with the longer minimum submission timeframes the submitter is unable to determine the manufacturers directly, rather than (e.g. 8 hours, 12 hours) or options that registration number of the manufacturer, buying through brokers and do not vary prior notice submission the site-specific facility name and full wholesalers, will be able to obtain the timeframe by transport type again here, address instead of the facility’s, name, manufacturer’s information that is although this final rule analysis updates partial address, and registration number. required for prior notice. the analysis of the chosen IFR option. Option 1: Minimum prior notice time is (Response) The final rule provides an The costs and benefits of all twelve 2 hours for articles of food arriving by alternative for submitters to provide the options analyzed for the prior notice IFR land by road, 4 hours for articles of identity of the manufacturer when the can be found in the Federal Register of food arriving by land by rail and by air, manufacturer’s registration number is October 10, 2003 (68 FR 58974 at and 8 hours for articles of food arriving not obtainable. Under the final rule, 59025). by water; information is submitted submitters may provide the name and This final regulatory impact analysis electronically, most changes in full address of the site-specific emphasizes the differences between the information require resubmission. manufacturing facility along with a IFR and final rule, and compares new This option is already in place as the reason as to why the registration options against the IFR. Each option IFR and will be compared against other number was not used in the prior covers all food subject to the final rule options for assessing costs and benefits notice. that is imported or offered for import of the changes between the IFR and final (Comment) While most comments into the United States; the mode of rule. state that the name and address of the transportation for the food is a. Option 1—Prior Notice IFR. In the manufacturer could be submitted in specifically addressed in options where economic analysis of the IFR we prior notice, one comment states that re- minimum prior notice time constrains calculated the number of entities that sellers will not normally supply the importation. would submit prior notice and the costs name of their supplier or the name of Option 1 (IFR). The minimum prior to those entities of: Learning prior the manufacturer of a particular product notice time will be 2 hours for articles notice, computer acquisition, to their customers. The comment asserts of food arriving by land by road, 4 hours information coordination, submitting that supplying the name of the for articles of food arriving by land by prior notice, creating the PNSI, not manufacturer would allow that rail and by air, and 8 hours for articles being able to use CBP’s BRASS8 system, customer to circumvent the re-seller and of food arriving by water, with and loss of value to fresh produce that attempt to make direct contact with the electronic submission of information. waits longer at the port of arrival than supplier or manufacturer, thus taking Most changes in prior notice before prior notice was required. business away from the re-seller. information require resubmission of i. Number of entities affected. Prior Another comment states, however, that corrected or new information.6 Notice for an article of food may be smaller importers buy from brokers and Option 2. This option includes all submitted by any person with wholesalers specifically because they components of Option 1, but would knowledge of the required information, are too small to buy directly from larger reduce the minimum prior notice time e.g., a foreign food manufacturer, a food manufacturers and other corporations, for food arriving by land by road to 1 exporter or importer, a consignee. The as large entities typically would not find hour for general entries and 30 minutes flexibility of the identity of the prior it cost-effective to deal with smaller for FAST7 participants, reduce notice submitter makes it difficult to get importers. minimum prior notice time for food a precise count of the number of unique (Response) Depending on the business arriving by land by rail to 2 hours, and people or firms who submit at least one atmosphere, FDA believes that it is reduce the minimum prior notice time prior notice annually. In the IFR we likely that many resellers will be willing for food arriving by air on flights estimated, based on FDA OASIS data to supply the name and the address of originating in North and Central from 2001, that there were 77,427 the manufacturers of the products they America, South America (north of the unique people or firms who submitted sell. Unlike the manufacturer’s equator only), the Caribbean, and prior notice. To update the number of registration number, which many may Bermuda to ‘‘wheels-up’’. This option prior notice submitters in the final rule view as confidential business would integrate FDA’s prior notice we use two sources of data: U.S. Census information that is to be disclosed only data and data from OASIS. First we use U.S. Census data by on a ‘‘need to know’’ basis, the name 6 You do not have to resubmit your prior notice and full address of a facility is public if there are changes in: (1) The estimated quantity North American Industry Classification information that not only is typically in of product, (2) the anticipated arrival information, System (NAICS) codes. Six-digit NAICS (3) the planned shipment information, or (4) the phone books and on the Internet, but it codes for Industry, 42–Food anticipated date of mailing for shipments by mail. Wholesalers, indicates that there are also often is provided on documents 7 The Free and Secure Trade (FAST) program is typically exchanged between buyers and a Border Accord Initiative between the United 68,651 U.S. businesses registered under sellers (e.g., receipts, purchase orders, States, Mexico, and Canada designed to ensure this code. We use this information and bills of lading). The issues security and safety of imported and exported because, in general, establishments products. Eligibility for the FAST program requires importing products into the United discussed in these comments are participants (carrier, drivers, importers, and addressed further in Options 1 and 3. southern port of entry manufacturers) to submit an States are classified in Wholesale Trade application, agreement, and security profile 4. Regulatory Options Considered depending on their role in the Customs and Trade 8 Border Release Advance Screening and Partnership Against Terrorism (C–TPAT) and FAST Selectivity (BRASS) is a CBP program that allows In the analysis of the IFR, FDA programs. The FAST program allows known low expedited arrival processing for high-volume, analyzed 12 options. The 12 options risk participants to receive expedited CBP entry repetitive shipments that have been judged by CBP focused on varying timeframes for prior processing. (Ref. 2) to be low risk.

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(Ref. 3) (http://www.naics.com). Thus likely be the number of persons who a breakdown of business by six-digit the number of U.S. businesses engaged submit prior notice for the goods they NAICS code for food wholesalers. in the wholesale food industry could receive. Table 3 of this document shows

TABLE 3.—UPDATED ESTIMATE FOR NUMBER OF PRIOR NOTICE SUBMITTERS NAICS Codes for Wholesale Trade Related to Food From the NAICS Association1

Numbers of 6 digit NAICS Code U.S. Busi- nesses

424210 Drugs and Druggists’ Sundries Merchant Wholesalers2 8,288 424410 General Line Grocery Merchant Wholesalers 8,061 424420 Packaged Frozen Food Merchant Wholesalers 1,250 424430 Dairy Product (except Dried or Canned) Merchant Wholesalers 2,195 424440 Poultry and Poultry Product Merchant Wholesalers 899 424450 Confectionery Merchant Wholesalers 3,202 424460 Fish and Seafood Merchant Wholesalers 4,157 424470 Meat and Meat Product Merchant Wholesalers 3,299 424480 Fresh Fruit and Vegetable Merchant Wholesalers 5,494 424490 Other Grocery and Related Products Merchant Wholesalers 14,763 424510 Grain and Field Bean Merchant Wholesalers 5,217 424520 Livestock Merchant Wholesalers 5,106 424590 Other Farm Product Raw Material Merchant Wholesalers 2,158 424810 Beer and Ale Merchant Wholesalers 2,181 424820 Wine and Distilled Alcoholic Beverage Merchant Wholesalers 2,381

Total Number of Businesses 68,651 1 Source of original data: NAICS Association, September 29, 2008, available online at http://www.naics.com/naics42.htm. 2 This category is included to capture wholesale merchants of botanicals, herbs, and vitamins.

Next, using OASIS data, we are able We use the average of this range, information coordination. We do not to estimate that there were 123,063 108,500, as the number of entities likely update the costs of FDA information unique manufacturers and 25,929 affected by having to submit prior technology here. Table 4 of this unique importers of food in FY 2007. notice. document shows these cost calculations; Combining the OASIS data with the ii. Costs to entities. We update the for a complete discussion of how these Census data we estimate that the cost calculations to the new number of costs were calculated refer to the number of prior notice submitters entities affected for learning prior preamble in the prior notice IFR (68 FR annually ranges from 68,000 to 149,000. notice, buying computers, and 58974 at 59025).

TABLE 4.—COST CALCULATIONS FOR LEARNING PN, INFORMATION TECHNOLOGY, INFORMATION COORDINATION, AND FDA SYSTEM COSTS

Cost to Learn About the Prior Notice Requirements

Manager cost Admin. Worker cost (two workers)

Number of firms 108,500 108,500

Wage rate per hour for manager and admin. worker (including overhead) $56.74 $25.10

1-day learning seminar 8 hours 8 hours

First year one time learning costs $49,250,320 $21,786,800

Total first year learning costs for learning $71,037,000

Annual learning costs for new entrants $7,103,700

Facilities and Responsible Parties Without Initial Internet Access

Number of facilities 4,340 Computer equipment cost per facility $2,000 Annual cost of Internet access ($20 per month x 12) $240 Search costs for equipment and access ($25.10 x 8 hours) $201 Total first year one time cost of electronic transmitting capacity $10,593,940 Annual one time cost of electronic transmitting capacity for firms entering industry in subsequent years $1,059,394

Information Gathering and Coordination Costs

Number of firms submitting notices 108,500 Administrative worker wage rate (doubled to include overhead) $25.10 Time to coordinate existing accounts 16 hours

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TABLE 4.—COST CALCULATIONS FOR LEARNING PN, INFORMATION TECHNOLOGY, INFORMATION COORDINATION, AND FDA SYSTEM COSTS—Continued

First year cost of coordination of information on current accounts $43,573,600 Annual cost of coordination of information on new accounts $4,357,360

FDA Prior Notice System Costs

Infrastructure design and implementation $7,400,000 Contractor services $5,100,000 FDA PN system interface cost $12,500,000 CBP ABI/ACS system modification costs $500,000 Total prior notice system cost $13,000,000

We also have new data on the number TABLE 5.—COST TO COMPLETE A d. Updated costs to submit prior of prior notices submitted based on PRIOR NOTICE BY IMPORT ENTRY notice by mode of transport. 2007 data collected by FDA’s PNC. (MUST BE ELECTRONIC) i. 2-hour minimum prior notice time Therefore, we do update, for the IFR and for food arriving by land by road. Prior all other options, the costs of submitting Broker cost per entry to $75 notices for perishable articles of food prior notices, the costs of not being able submit prior notice from Canada and Mexico that arrive in to use CBP’s BRASS system, and the lost the United States by land by road must Entry total based on 9.8 2,700,000 value of fresh produce and seafood. be submitted at least 2 hours before the million lines food arrives in the United States. In the Also, due to an oversight in the analysis of the IFR, we assumed that Total annual costs of all $202,500,000 calculation of the costs for the IFR, FDA this minimum submission time should did not calculate the costs to importers prior notices, including updates to the informa- eliminate the probability of having to of providing the imported product’s tion resubmit prior notice (due to proximity manufacturer registration number and to the U.S. port of entry) for all but 5 full facility address on prior notice. We percent of those perishable products c. Updated costs to BRASS users. correct that oversight here. imported from Canada and Mexico. Under the prior notice rule, no food Data from the FDA PNC for 2007 b. Updated annual costs to submit product shipments imported into the prior notice. FDA’s PNC received indicate that 85 percent of the articles United States are eligible to take of food arriving from Canada enter the 9,804,050 prior notices for FY 2007, advantage of CBP’s BRASS system. We which is about 3 million more prior United States by land by road; and update the number of entries that used approximately 94 percent of the articles notices than we estimated in the the BRASS system in FY 2002 (242,000) of food arriving from Mexico enter the analysis of the IFR. The difference in to estimate the number of imported food United States by land by road.11 Using number of submissions is in part due to entries that would have used the BRASS these updated estimates, we calculate an increase in the number of prior system in FY 2007 (305,000) if it would the proportion of the total retail value of notices submitted for each imported have been available to them. Table 6 of highly perishable produce and seafood food entry. In the IFR analysis, we this document shows that the updated from Canada and Mexico that arrive in estimated that there were about 2.6 lines costs to BRASS users are $61 million the United States by land by road. We (prior notices) submitted for each food annually; the previous estimate was then calculate the lost product value for shipment.9 New OASIS shipment data about $48 million annually. the 5 percent of highly perishable show that for 2007, the average number produce and seafood from Canada and of lines per entry for food, food related, TABLE 6.—UPDATED ADDITIONAL Mexico for which importers may have to infant food, and food additive industry COSTS FOR BRASS USERS resubmit the prior notice when the codes is 3.6 lines per entry. minimum submission time is 2 hours. Additional Submission Costs We use these new data on entry lines Table 7 of this document shows the to estimate that FDA receives 9,804,050 revised estimated loss in value caused Total Cost per import entry $75 by the cancelled and resubmitted prior prior notices per year, which translates FY2002 BRASS line total for 1,098,054 into approximately 2.7 million imported FDA-regulated products notice information for the 5 percent of food entries (based on 3.6 lines per BRASS yearly entry total 305,015 imported Mexican and Canadian entry10) annually. Table 5 of this (3.6 lines per entry) perishable seafood and produce document shows that the annual costs Additional annual costs of $22,876,125 affected. We do not include the lost value for to complete a prior notice will be $202.5 submissions for BRASS perishable seafood and produce million instead of the $187.5 million users imported from Central America because estimated in the IFR. Additional Border Wait Time perishable products from Central America are most likely to arrive by air 9 As explained in more detail in the economic Cost per half hour $125 into the United States. We also do not analysis of the interim final rule, OASIS data BRASS yearly entry total 305,015 include the cost of additional truck time indicate there are typically more than two different Additional annual border wait $38,126,875 articles of food per import entry; e.g., 100 cases of costs for former BRASS canned tuna and 50 cases of canned peaches in the 11 The mode of transportation field in prior notice same shipment. A prior notice must be filed for users is user defined; thus, the person submitting the each of the lines in an entry. Total Annual additional food $61,003,000 prior notice is responsible for informing FDA by 10 This is likely a slight overestimate of prior importing costs for BRASS what mode of transport the food will enter the notices per entry because food-related items (such users United States. As mode of transport is user defined, as eating utensils) are not subject to prior notice. there is a possibility of error.

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with this option because the minimum prior notice time for articles of food arriving by vehicle is only 2 hours.

TABLE 7.—LOSS IN VALUE CAUSED BY RESUBMITTED PRIOR NOTICE UNDER OPTION 1 FOR ARTICLES OF FOOD ARRIVING BY LAND BY ROAD (2-HOUR MINIMUM NOTICE REQUIREMENT)

Perishable Produce Dollars

2001 Imported Mexican produce total retail value $3,458,525,000

94% of total retail value for Mexican produce $3,251,014,000

1.2% Reduction in value for 5% of Mexican produce $1,951,000

2001 Imported Canadian produce total retail value $401,826,000

85% of total retail value for Canadian produce $341,552,000

1.2% Reduction in value for 5% of Canadian produce $205,000

Total lost value for produce $2,156,000

Perishable Seafood Dollars

2001 Imported Mexican seafood total retail value $112,277,000

94% of total retail value for Mexican seafood $105,540,000

4.2% Reduction in value for 5% of Mexican seafood $222,000

2001 Imported Canadian seafood total retail value $1,863,218,000

85% of total retail value for Canadian seafood $1,583,735,000

4.2% Reduction in value for 5% of Canadian seafood $3,326,000

Total lost value for seafood $3,548,000

ii. 4-hour minimum prior notice time land by rail. Similarly, about 8 percent shows the articles of food arriving by for food arriving by land by rail and by of the articles of food arriving from rail and air from Canada and Mexico air. The 4-hour minimum submission Canada were imported into the United that may have to resubmit prior notice time for prior notice applies to articles States by air, while only about 3 percent when the minimum prior notice of food imported or offered for import of the articles of food arriving from timeframe is 4 hours before arrival in by land by rail and by air. A 4-hour Mexico were imported into the United the United States. minimum prior notice time for railroads States by air. and airplanes could constrain products To estimate potential lost value for For Central American and Caribbean arriving from the countries bordering produce imported from Canada and countries, most, if not all, of their the United States. Data from the PNC for Mexico by rail and air, we adjust the perishable products are imported to the 2007 show that about 4 percent of the total retail value of highly perishable United States by air. Table 8 of this articles of food arriving from Canada produce and seafood from Canada and document shows the loss of value for were imported into the United States by Mexico to account for the 12 percent the estimated 20 percent of air land by rail and only about 2 percent of from Canada and the 5 percent from shipments from Central America for the articles of food arriving from Mexico Mexico that are imported by land by rail which prior notice needs to be were imported into the United States by or by air. Table 5 of this document resubmitted under Option 1.12

TABLE 8.—LOSS IN VALUE CAUSED BY RESUBMITTED PRIOR NOTICE UNDER OPTION 1 FOR SHIPMENTS ARRIVING BY AIR AND BY LAND BY RAIL (4-HOUR MINIMUM NOTICE REQUIREMENT)

Perishable Produce Dollars

2001 Imported Mexican produce total retail value $3,458,525,000

5% of total retail value for Mexican produce $172,926,000

2.4% reduction in value for 20% of Mexican produce $830,000

2001 Imported Canadian produce total retail value $401,826,000

12 The estimated 20 percent cancellation and minimum submission time is 4 hours is used in the resubmission rate for prior notices when the IFR analysis. (See 68 FR 58974 at 59045.)

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TABLE 8.—LOSS IN VALUE CAUSED BY RESUBMITTED PRIOR NOTICE UNDER OPTION 1 FOR SHIPMENTS ARRIVING BY AIR AND BY LAND BY RAIL (4-HOUR MINIMUM NOTICE REQUIREMENT)—Continued

Perishable Produce Dollars

12% of total retail value for Canadian produce $48,219,000

2.4% reduction in value for 20% of Canadian produce $231,000

2.4% reduction in value for 20% of Central American and Caribbean produce $1,044,000

Total lost value for produce $2,105,000

Perishable Seafood Dollars

2001 Imported Mexican seafood total retail value $112,277,000

5% of total retail value for Mexican seafood $5,614,000

8.3% reduction in value for 20% of Mexican seafood $93,000

2001 Imported Canadian seafood total retail value $1,863,218,000

12% of total retail value for Canadian seafood $204,954,000

8.3% Reduction in value for 20% of Canadian seafood $3,712,000

2001 Imported Central American and Caribbean seafood total retail value $251,796,000

8.3% Reduction in value for 20% of Central American and Caribbean seafood $4,180,000

Total lost value for seafood $7,985,000

e. Updated IFR costs to include the not given on the prior notice, the using reason codes A through F, H, and costs of manufacturer name, registration submitter should select the appropriate J would be compliant with IFR number and partial address on prior reason identifying why the requirements because the manufacturer notice. Section 1.281(a)(6), (b)(5), and manufacturer’s registration number and/ would be exempt from being registered (c)(6) of the IFR requires that prior or name and address was not provided. according to the Registration of Food notice for an article of food that is no The reason codes provided by PNSI and Facilities rule (21 CFR part 1, subpart longer in its natural state include the ABI/ACS were: H). Prior notices submitted without name and address of the manufacturer • A—facility is out of business manufacturer registration numbers but and the registration number assigned to • B—facility is a private residence • using reason code G would be the facility that is associated with the C—facility is a restaurant compliant with IFR requirements 13 • D—facility is a retail food article of food. This IFR requirement because the prior notice IFR allows that has not been fully enforced by FDA, as establishment • if an article of food is sent by an described in CPG Sec. 110.310; E—facility is a nonprocessing fishing vessel individual as a personal gift (i.e., for however, it is a requirement of the rule • nonbusiness reasons) to an individual in and therefore we evaluate it as a cost of F—Facility is nonbottled water collection and distribution the United States, the submitter may the IFR. We correct an oversight in the provide the name and address of the calculation of the costs of the IFR by establishment • firm that appears on the label instead of including the costs of submitting the G—Individual gift-label name/ the name, address, and registration food manufacturer registration number address • H—Grower-satisfies farm number of the manufacturer. A prior and facility address on prior notice here. exemption notice submitted without the f. How some importers will be • affected. The November 2004 revision of I—Samples-quality assurance, manufacturer name, address, and/or the IFR CPG stated that if the research or analysis purposes only registration number but using reason • J—U.S. manufacturing facility that manufacturer’s registration number was code I, K through M, or O would not be is not required to register compliant with IFR requirements. • K—Unable to determine the 13 However, FDA’s enforcement policy The interim final rule further states that a registration number of the manufacturer registration number is not required for a facility • was that it should typically consider not associated with an article of food if the article is L—Unable to determine identity of taking any regulatory action for prior imported or offered for import for transshipment, manufacturer-providing identity of notice violations in these cases. storage, and export, or further manipulation and manufacturer’s headquarters export. The interim final rule also provides that if • M—Unable to determine identity of We can use information from the PNC the article of food is sent by an individual as a on the CPG code reasons given for FY personal gift (i.e., for nonbusiness reasons) to an manufacturer or headquarters-providing individual in the United States, he or she may invoicing firm’s identity 2007 to determine how many submitters provide the name and address of the firm that • O—Gift pack for nonbusiness had trouble providing the manufacturer appears on the label under § 101.5 instead of the purposes-providing single prior notice registration number and facility address name, address, and registration number of the as is required by the IFR (submitters manufacturer. If a registration number is provided, and identity of packer city and country may be provided instead of the full Prior notices submitted without who used reason codes I, K through M, address. manufacturer registration numbers but and O).

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The PNC was able to determine that address, and registration number as of prior notice submissions (2.91 about 92.5 percent of prior notices required by the IFR. Table 9 of this percent) for 2007 used reason codes I, K, contained the manufacturer’s name, document shows that about 2.9 percent L, M, and O.

TABLE 9.—NO MANUFACTURER REGISTRATION NUMBER ON PRIOR NOTICE, REASON CODE LINE COUNT FOR FY 2007

PN Lines % of Total Reason Code Description Count Lines

Total prior notice submissions for fiscal year 2007 9,804,050

A Facility is out of business 43,479 0.44%

B Facility is a private residence 30,801 0.31%

C Facility is a restaurant 5,146 0.05%

D Facility is a retail food establishment 47,705 0.49%

E Facility is a nonprocessing fishing vessel 2,488 0.03%

F Facility is a nonprocessing drinking water collection and distribution establishment 1,417 0.01%

G Individual gift label name/address in lieu of registration number 36,808 0.38%

H Grower satisfies farm exemption 267,369 2.73%

I Samples—quality assurance, research or analysis purposes only 55,374 0.56%

J U.S. manufacturing facility that is not required to register 15,142 0.15%

K Unable to determine the registration number of the manufacturer 166,647 1.70%

L Unable to determine identity of the manufacturer—providing identity of manufacturer’s 15,674 0.16% headquarters

M Unable to determine identity of manufacturer or headquarters providing invoicing firms 15,839 0.16% identity

O Gift pack for nonbusiness purposes—providing single prior notice and identity of packer 32,371 0.33%

Total times a reason code was given (includes submission for PNSI and ABI/ACS) for fiscal year 2007 637,153 7.51%

FDA posits that larger entities (e.g., manufacturer registration number, name the importer could not provide the medium to large importers) that deal and partial address being required on name, address, and/or registration directly with foreign manufacturers will prior notice. For our best case scenario number of the actual manufacturing not be impacted by this IFR requirement we subtract the full import value of the facility. While we do not know the (are not part of the 2.91 percent) as they potentially ‘‘unaffected’’ categories value of imported foods for each of the will be able to obtain the manufacturers’ listed in table 10 of this document from prior notice submissions in the 2.91 registration numbers and facility $64.8 billion, the total value of food, percent affected, in the absence of better addresses for the products they are feeds, and beverages imported into the information, for our best case scenario importing. Therefore, it is mostly the United States in 2006 (Ref. 4). In we reduce the value of imported foods small U.S. retailers or individuals that essence, we subtract out those food affected to $843 million, or 2.91 percent buy from other wholesalers or retailers categories that are likely comprised of of $29 billion. For the worst case in foreign countries that may have a foods that are still in their natural state scenario, we apply the 2.91 percent of problem obtaining the registration such that a manufacturer is not required import lines for 2007 that could not number, city, and country of the actual for the prior notice (e.g., green coffee). provide the registration number, city, food manufacturing facility. This is our ‘‘best case’’ scenario because and country of the actual manufacturer Using data from the U.S. Census not all foods imported from the to the entire value of FDA-regulated Bureau, FDA was able to determine that categories below will come from imported food shipments, $59 billion, for 2006, about $64.8 billion foods, facilities that are not required to be giving us a possible $1.7 billion in feeds, and beverages were imported into registered (i.e., vegetables could be farm imported foods value that could be the United States. Some of this value of commodities or could be processed). affected by the prior notice IFR imported food could be affected by the The remaining imported foods value, requiring the name, registration number, IFR requirement that the registration about $29 billion, represents the value and partial address of the manufacturing number, city, and country of the of alcoholic beverages, bakery products, facility on most prior notices. manufacturer be provided on prior non-agricultural, and ‘‘other’’ imported The estimated $843 million to $1.7 notice; to assess how this imported foods, which are products from facilities billion in imported food affected by the value may be affected, we present best more likely to be subject to the food facility name, registration number, and and worst case scenarios. facility registration requirements. partial address requirement for prior In our best case scenario, few About 2.91 percent of the prior notice notice is an overestimate of the imported foods would be affected by submissions for FY 2007 indicated that imported value likely affected for two

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reasons. First, the 2.91 percent of prior with this information for prior notice possible $843 million to $1.7 billion of notice submissions that could not submissions. For the persons who can imported food value is lost. We do this supply the information required by the adjust business practices, the value of because according to the Small Business IFR are most likely goods imported by the food imported will be affected by Administration, about 3 percent of small small or very small U.S. retailers or prior notice, but not lost, because businesses closed between 2003 and individuals. These goods are likely importation of those products will not 2007 (Ref 5). We estimate this value to purchased for import not through the cease. However, some of these be $25 million to about $52 million. manufacturer but through middlemen, businesses will find that the costs thus the importers often do not have associated with changing business To account for the businesses that access to, or knowledge of, the practices to supply the necessary change importing practices, we estimate manufacturer registration number and information on prior notice will cause that 3,157 prior notice submitters (2.91 facility address. These small U.S. importing food products into the United percent of the estimated 108,500 retailers or individuals would not be States to no longer be profitable. These submitters) will spend 80 hours importing large quantities of food; persons will cease importing and the adjusting their supply chain.14 As with therefore, the value of their imported value of these imported goods that is table 4 of this document, we use the shipments should be small, much lost will be a cost of the rule. Thus we manager wage rate, including overhead, smaller in total than the $843 million to must adjust our value of imported food of $56.74 per hour. $1.7 billion estimate. affected by the manufacturer identity Taking the midpoint of the lost value Second, we expect that most of those requirement to reflect that: (1) Most due to cessation of importation ($38.5 persons importing without knowledge importers will adjust business practices million) plus the costs to the 3,157 firms of the manufacturing facility’s to continue importing and (2) some to change business practices, we registration number or address will importers will cease doing so. adjust business practices, and perhaps To account for the businesses that estimate that the cost of the their supply chain, to other entities in cease importing food into the United manufacturer identity requirement in the supply chain that will provide them States, we estimate that 3 percent of the the IFR to be about $52.8 million.

TABLE 10.—IMPORTS OF GOODS BY END USE CATEGORY AND COMMODITY (2006 SEASONALLY ADJUSTED DATA)

Best Case Worst Case Scenario (Millions) Scenario (Millions)

Foods, feeds, and beverages (FFB) total1 $64,782 $64,782

Categories of imported food products subtracted Meat products $5,611 $5,611 Fish and shellfish $9,867 Vegetables $4,943 Cane and beet sugar $1,121 Cocoa beans $520 Tea, spices, etc. $715 Food oils, oilseeds $1,999 Feedstuff and food grains $1,577 Fruits, frozen juices $5,503 Nuts $856 Green coffee $2,035 Dairy products and eggs $1,070

Remaining value of imports that may be affected by the IFR identity of the manufacturer requirement $28,965 $59,171

Imported value reduced further to represent that 2.91% of prior notice submissions could not provide registration number and site-specific information on prior notice for fiscal year 2007 $843 $1,722

3 percent of imported food value lost through cessation of importation into U.S. $25.3 to $51.7 million

Costs that reflect change in business practices for 3,157 submitters (80 hours x $56.74 per hour) $14.3 million

Total Value Affected $52.8 million 1 Source of original data: U.S. Census Bureau, U.S. Bureau of Economic Analysis, US DOC News, November 9, 2007, pages 12 and 15, avail- able online at http://www.bea.gov/newsreleases/international/trade/2007/pdf/trad0907.pdf. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the FEDERAL REGISTER.)

14 These costs are costs incurred beyond the information gathering and coordination costs presented in table 4 of this document.

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Table 11 of this document presents a TABLE 11.—SUMMARY OF UPDATED contamination of food and to deter summary of the revised estimated costs COSTS FOR OPTION 1—IFR— deliberate contamination. associated with Option 1, including the Continued Before prior notice was required, FDA marginal costs to importers who may be received almost no advance notice affected by the IFR requirement that a (In Thou- information about food products facility’s name, registration number and sands of entering the United States from foreign partial address be provided on prior Dollars) sources, or the location of the food’s notice. Also included in the summary anticipated port of arrival. With the Cost for truck time $0 table 11 of this document are the information required by prior notice, discounted present value of the costs at Costs of manufacturer reg- $52,800 FDA does know what articles of food are the OMB-recommended discount rates istration number and full fa- being imported or offered for import of 3 and 7 percent. cility address requirement before they arrive at the port. In the event of a credible threat for a specific TABLE 11.—SUMMARY OF UPDATED Total first year costs for Op- $470,302 product or a specific manufacturer or COSTS FOR OPTION 1—IFR tion 1 processor, for example, FDA will be able Annual costs after first year1 $293,118 to mobilize and assist in the detention (In Thou- and removal of products that may pose sands of PV of costs at 7% for 20 $3,270,884 a serious health threat to humans or Dollars) years animals. Learning costs $71,037 FDA’s PNC reviews prior notices and PV of costs at 3% for 20 $4,532,872 assesses the risk related to imported Coordination costs $43,574 years food shipments. Personnel at the PNC 1 Annual costs include the start-up costs decide on a case-by-case basis whether Computer acquisition costs $10,594 of prior notice to the estimated 10 percent the article of food needs to be held for of new businesses that enter the market examination upon arrival at the port. FDA prior notice system cost $13,000 each year. Having notice of an article of food Annual costs to fill out prior $202,500 g. Benefits of Option 1. FDA’s prior imported or offered for import into the notice screens notice system provides us with United States before it reaches a U.S. enhanced knowledge of what articles of port allows FDA personnel to be ready Additional costs for BRASS $61,003 food are being imported or offered for at any time to respond to shipments that users import into the United States. Requiring appear to pose a significant health risk Lost value for produce $4,261 prior notice of imported food shipments to humans or animals. and defining the required data h. Cost benefit summary table. Table Lost value for seafood $11,533 information improves our ability to 12 presents the costs of Options 1 detect accidental and deliberate annualized over 20 years.

TABLE 12.—UPDATED COST BENEFIT SUMMARY TABLE FOR OPTION 1

Annualized Annualized Costs Over 20 Costs Over 20 Years at 7% Years at 3% Discount Rate Discount Rate (Millions) (Millions)

Option 1—2 hour prior notice for vehicle, 4 hour for rail and air, 8 hour for vessels (IFR) $304 $301

Benefits—FDA will know what articles of food are being imported or offered for import, before they arrive at the port. In the event of a threat of significant public health risk to humans or animals, FDA and CBP will be able to mobilize and assist each other in the detention and removal of those products.

Option 2 (A and B): Minimum prior of CBP for imports arriving by land by (2) the costs and benefits of Option 2 notice time frame would be 1 hour road, by land by rail, and by air.15 For when the PNC has increased its staff to before arrival for articles of food this option’s timeframes we present two review and respond to prior notices arriving by land by road or 30 minutes scenarios: (1) The costs and benefits of received within the minimum for FAST participants, 2 hours before Option 2 when FDA’s PNC is staffed at timeframe required. arrival for articles of food arriving by its current level and must review and Option 2A: PNC is Staffed at its Current land by rail, ‘‘wheels-up’’ for flights respond to prior notices received within Level and Must Review and Respond to originating in North and Central the minimum timeframe required and Prior Notices Within the Minimum America, South America (north of the Timeframe Required equator only), the Caribbean, and 15 We do not examine or integrate timeframes for a. Costs of Option 2A. products arriving by water. Persons that use vessels i. 1-hour or 30 minute minimum prior Bermuda; 4 hours for all other flights, to import their products are usually dealing with notice time for food arriving by land by and 8 hours before arrival for vessels; merchandise that is not highly perishable in nature and thus less time-sensitive. FDA did not receive road. A significant portion information would be submitted (approximately 31 percent) of the prior electronically, most changes in comments requesting the coordination of FDA and CBP timeframes for food arriving by water. FDA’s notices reviewed by the PNC on a daily information would require current minimum prior notice timeframe for basis is for articles of food that arrive in resubmission notification of food being imported by water is 8 hours before arrival; CBP’s current minimum prior the United States by land by road. The This option coordinates FDA notice timeframe for articles being imported by PNC conducts a more intensive security minimum prior notice times with those water is 24 hours before arrival. review on at least 225 to 250 prior

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notices per day. Of these prior notices arriving by land by road is shortened to and seafood as if FDA had the that are flagged as potentially high-risk 30 minutes, the intensive security additional staff necessary to receive, and require a more intensive security reviews (described previously) on review, and respond to prior notices review, about 77 (31 percent of 250) are approximately 69 percent of the high- within the minimum prior notice for articles of food arriving by land by risk targeted land border prior notices submission time16 and then increase road. Complicating matters further is would not be completed within the those costs (in terms of lost value to that prior notice submissions and prior notice timeframe. Again, as a perishable produce and seafood arriving expiration times are not evenly result of the shorter timeframe, it would in the United States by land by road by distributed over an 8-hour shift or 24- be necessary for the PNC to delay the 48 percent—the average of 27 and 69 hour day; an overwhelming majority of movement of these shipments at the percent) to account for the fact that prior notice submissions arrive during a port of arrival in order to complete their some of these articles of food will be certain 12-hour time period. review and risk assessment. held up at the port pending prior notice The PNC has estimated using 2007 The synopsis stated in the previous review completion given the current data that most prior notices submitted paragraph implies that the PNC likely PNC staffing level. for land border entries took between 30 will not be able to review and respond We note that we base this analysis on and 110 minutes to review. This range to all prior notices received for articles the typical (average) prior notice review indicates that if the prior notice of food arriving by land by road within time. Given that most prior notices for minimum submission time frames were the minimum time if the minimum prior land border entries took between 30 and reduced from 2 hours to 1 hour, notice submission time for articles of 110 minutes to review, the typical approximately 27 percent of those high food arriving by land by road is either article of food arriving by land by road risk prior notices for articles of food 1 hour or 30 minutes. The loss of value should not have to wait longer than 2 arriving by land by road that are to fresh produce and seafood calculated hours to enter; which is equivalent to selected for a more intensive review in table 8 of this document reflects that the time that articles of food arriving by would exceed the minimum prior notice some articles of food (about 27 to 69 land by road will have to wait to enter timeframe and would have to be percent of high risk prior notices) will the United States under Option 1. delayed at the port of arrival while the be held at the port of arrival past the 30 However, no matter what the minimum PNC completes its review and risk minutes or 1 hour minimum prior prior notice submission timeframes are, assessment, as discussed earlier in this notice submission time frame while the there will always be some articles of document. PNC completes its review. food whose review will take longer than If the minimum prior notice In table 13 of this document, we first the minimum allotted prior notice submission time for articles of food calculate the lost value to fresh produce review timeframes.

TABLE 13.—LOSS IN VALUE CAUSED BY RESUBMITTED PRIOR NOTICE UNDER OPTION 2A FOR SHIPMENTS ARRIVING BY LAND BY ROAD (1-HOUR OR 30-MINUTE MINIMUM NOTICE REQUIREMENT)

Perishable Produce Dollars

2001 Imported Mexican produce total retail value $3,458,525,000

94% of total retail value for Mexican produce $3,251,014,000

0.6% Reduction in value for 2.5% of Mexican produce $488,000

48% Increase in lost value due wait time past minimum submission timeframe $234,000

Total lost value for Mexican produce $722,000

2001 Imported Canadian produce total retail value $401,826,000

85% of total retail value for Canadian produce $341,552,000

0.6% Reduction in value for 2.5% of Canadian produce $51,000

48% Increase in lost value due wait time past minimum submission timeframe $24,000

Total lost value for Canadian produce $75,000

Total lost value for produce $797,000

Perishable Seafood Dollars

2001 Imported Mexican seafood total retail value $112,277,000

94% of total retail value for Mexican seafood $105,540,000

16 We use the same probability of resubmission perishable products imported from Canada and structure established in the analysis of the IFR (68 Mexico by land by road. FR 58974 at 59025). This minimum submission time should eliminate the probability of having to resubmit prior notice for all but 2.5 percent of those

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TABLE 13.—LOSS IN VALUE CAUSED BY RESUBMITTED PRIOR NOTICE UNDER OPTION 2A FOR SHIPMENTS ARRIVING BY LAND BY ROAD (1-HOUR OR 30-MINUTE MINIMUM NOTICE REQUIREMENT)—Continued

Perishable Seafood Dollars

2.1% Reduction in value for 2.5% of Mexican seafood $55,000

48% Increase in lost value due wait time past minimum submission timeframe $26,000

Total lost value for Mexican seafood $81,000

2001 Imported Canadian seafood total retail value $1,863,218,000

85% of total retail value for Canadian seafood $1,583,735,000

2.1% Reduction in value for 2.5% of Canadian seafood $831,000

48% Increase in lost value due wait time past minimum submission timeframe $399,000

Total lost value for Canadian seafood $1,230,000

Total lost value for seafood $1,311,000

ii. 2-hour minimum prior notice time the need for any resubmission of prior respond to all prior notices for articles for food arriving by land by rail and notice information for those shipments. of food arriving in the United States by ‘‘wheels-up’’ or 4-hour minimum prior Because prior notice does not need to be air when the flight time is less than 3 notice time by air. The 2-hour minimum submitted until ‘‘wheels-up,’’ the hours, we would still not expect the submission time for food imported by probability of not having the correct costs (value loss on perishable produce land by rail should reduce the prior notice information on the and seafood) to importers of these probability of having to resubmit prior shipment is eliminated. articles of food to be less than the costs notice for virtually all articles of food However, according to 2007 data from in Option 1 where the minimum prior the PNC, if the minimum prior notice imported from Canada and Mexico by notice time frame is 4 hours for articles rail. However, with current staffing submission time is reduced from 4 of food arriving by air. Again we note levels at the PNC, the possibility exists hours to ‘‘wheels up’’ for some articles that this analysis is based on the typical that some articles of food arriving by rail of food arriving by air, approximately 5 may be held at the minimum prior percent of the prior notice reviews review time for prior notice for articles notice submission timeframe. would not be completed in time if flight of food arriving by air. No matter what Data from the PNC for 2007 show that time was less than 3 hours given the the minimum prior notice submission only about 4 percent of the articles of current PNC staffing level. Perishable timeframe, there will always be some food imported from Canada and only produce and seafood imported into the articles of food for which the PNC will about 2 percent of the articles of food United States from the Bahamas, Belize, not be able to respond and complete its imported from Mexico are imported by the Dominican Republic, El Salvador, risk assessment within the timeframe land by rail. Thus, articles of food Haiti, Honduras, Jamaica, and Nicaragua allotted. arriving by land by rail represent only can all be flown to Miami, Florida in To estimate the potential loss in value a slight fraction of all prior notices less than 3 hours. Perishable produce for perishable products due to a delay received and are therefore not and seafood imported by air from in PNC review, we use the following necessarily the constraining factor when Canada and Mexico also can be flown information in table 14 of this the PNC is staffed at its current level. into the United States in less than 3 document: (1) The total retail value of Although we cannot rule out the hours. the perishable products from Central possibility that some additional effects Table 14 of this document shows that America, adjusted to encompass may be associated with articles of food while there is no value loss from perishable products coming from imported from by land by rail under perishable produce and seafood having Option 2A, we assume those effects to resubmit prior notice (because the countries whose flight times to the would be negligible. We therefore do minimum prior notice submission United States are less than 3 hours; (2) not estimate additional costs for articles timeframe is ‘‘wheels-up’’), there may be the total retail value of perishable of food arriving by land by rail for a loss of value for about 5 percent of products from Canada and Mexico, Option 2A. perishable produce and seafood coming adjusted to reflect the proportion of Reducing the prior notice submission from the locations listed previously if these articles of food that arrive into the timeframe to ‘‘wheels-up’’ for food the PNC does not have more than its United States by air (8 percent for imported by air on flights originating in current level of personnel to review and Canada and 3 percent for Mexico); and North and Central America, South respond to prior notices when the (3) the estimated loss for the delay in America (north of the equator only), the minimum prior notice time frame is review, which we equate to 1 hour17 of Caribbean, and Bermuda will eliminate ‘‘wheels-up.’’ Even if the PNC cannot the perishable product’s lifespan.

17 We chose 1 hour as the loss in value because air when flights are less than 3 hours and prior notice time for articles of food arriving by air is 4 the PNC, staffed at its current level, will not notice is required at ‘‘wheels-up,’’ but generally will hours. complete its review for articles of food arriving by complete its review when the minimum prior

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TABLE 14.—LOSS IN VALUE CAUSED BY DELAYED PRIOR NOTICE REVIEW UNDER OPTION 2A FOR SHIPMENTS ARRIVING BY AIR (‘‘WHEELS-UP MINIMUM NOTICE REQUIREMENT’’)

Perishable Produce Dollars

2001 Imported Mexican produce total retail value $3,458,525,000

3% of total retail value for Mexican produce $103,756,000

5% Experience a 0.6% loss in value due wait time past minimum submission timeframe

Total lost value for Mexican produce $31,000

2001 Imported Canadian produce total retail value $401,826,000

8% of total retail value for Canadian produce $32,146,000

5% Experience a 0.6% in value due wait time past minimum submission timeframe

Total lost for Canadian produce $10,000

2001 Imported Central American produce total retail value (coming from countries that are less than 3 hours by air to U.S.) $62,510,000

5% Experience a 0.6% loss in value due wait time past minimum submission timeframe

Total lost value for Central American produce $19,000

Total lost value for produce $60,000

Perishable Seafood Dollars

2001 Imported Mexican seafood total retail value $112,277,000

3% of total retail value for Mexican seafood $3,368,000

5% Experience a 2.1% loss in value due wait time past minimum submission timeframe

Total lost value for Mexican seafood $4,000

2001 Imported Canadian seafood total retail value $1,863,218,000

8% of total retail value for Canadian seafood $149,057,000

5% Experience a 2.1% loss in value due wait time past minimum submission timeframe

Total lost value for Canadian seafood $157,000

2001 Imported Central American seafood total retail value (coming from countries that are less than 3 hours by air to U.S.) $73,021,000

5% Experience a 2.1% loss in value due wait time past minimum submission timeframe

Total lost value for Central American seafood $77,000

Total lost value for seafood $238,000

Table 15 of this document presents a TABLE 15.—SUMMARY OF COSTS TABLE 15.—SUMMARY OF COSTS summary of the costs associated with FOR OPTION 2A—Continued FOR OPTION 2A—Continued Option 2A, including the costs of the option at the OMB-recommended (In Thou- (In Thou- discount rates of 3 and 7 percent. sands of sands of Dollars) Dollars) ABLE UMMARY OF OSTS T 15.—S C Computer acquisition costs $10,594 Lost value for produce $857 FOR OPTION 2A FDA prior notice system cost $13,000 Lost value for seafood $1,549 (In Thou- sands of Annual costs to fill out prior $202,500 Cost for truck time $0 Dollars) notice screens Costs of manufacturer reg- $52,800 Learning costs $71,037 Additional costs for BRASS $0 istration number and full fa- users cility address requirement Coordination costs $43,574

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TABLE 15.—SUMMARY OF COSTS of food posing a significant health threat port of arrival in order to complete their FOR OPTION 2A—Continued to humans or animals will enter the review and risk assessment. United States unchecked; or To be able to review prior notices (In Thou- (2) The PNC will be unable to within a 1 hour prior notice submission sands of time for articles of food arriving by land Dollars) complete its intensive review process for some or all of the prior notices by road (given the current number and Total first year costs for Op- $395,911 forwarded to it within the shortened dispersion of prior notices by land by tion 2 timeframes, and will frequently cause road and by other modes of transportation), the PNC estimates that an unpredictable delay in the movement Annual costs after first year $218,727 it would need more than twice its of these articles of food at the port of current level of resources. The arrival until the PNC completes its PV of costs at 7% for 20 $2,482,785 additional resources needed would review. This additional time for review years include increasing the number of will result in higher private costs to permanent employees who review prior PV of costs at 3% for 20 $3,426,122 individuals importing articles of food years notices from 27 to at least 50 FTEs, an into the United States than implied by increase in the number of first line the prior notice times. b. Implications for the benefits of supervisors, a tripling of computer Option 2A. If FDA cannot appropriately Had the shortened review time frames access to both FDA and CBP systems, review and respond to submitted prior in Option 2A been in effect in FY 2007, and a tripling of the current number of notices within the reduced submission the PNC would have held at least 6,000 telephone lines. times frames under Option 2A given to 16,000 articles of food arriving by If the minimum timeframe to submit current FDA PNC staffing, there are two land by road. For air shipments, if the prior notices for articles of food arriving possible outcomes: minimum prior notice submission time by land by road was reduced to 30 (1) Prior notice screening and risk frame had been shortened to ‘‘wheels- minutes, the PNC may need 3 times the assessment requirements will have to be up’’, approximately 728 prior notice number of staff to handle the prior relaxed so that fewer prior notices are reviews in FY 2007 would not have notice review volume within this forwarded to the PNC for intensive been completed for flights less than 3 timeframe. review. Taking this action will reduce hours. As a result, it would have been c. Cost benefit summary table. Table the social benefits of the rule by necessary for the PNC to delay the 16 presents the costs of Options 2A increasing the probability that an article movement of these shipments at the annualized over 20 years.

TABLE 16.—UPDATED COST BENEFIT SUMMARY TABLE FOR OPTION 2A

Annualized Costs Annualized Costs Over 20 Years at Over 20 Years at 7% Discount Rate 3% Discount Rate (Millions) (Millions)

Option 2A—1 hour or 30 minute prior notice for food arriving by land by road, 2 hours for rail, ‘‘wheels- up’’ or 4 hours for air, 8 hour for vessels; The PNC is staffed at its current level $230 $227

Benefits—FDA will know what articles of food are being imported or offered for import, before they arrive at the port. In the event of a potential threat of significant health risk to humans or animals, FDA will be able to mobilize and assist in the detention and removal of those products from U.S. commerce.

Option 2B: PNC has Increased Staff to computer access and telephone lines to for perishable articles of food from Review and Respond to Prior Notices FDA and CBP systems. Canada and Mexico that arrive in the within the Minimum Time Frame Assuming that the costs to hire United States by land by road must be Required additional FTEs including overhead is submitted 1 hour or 30 minutes before a. Costs of Option 2B. For Option 2B $150,000 per FTE, then doubling the the food arrives in the United States. we assume the PNC staff has been at number of prior notice reviewers by Using the same probability of least doubled, if not tripled. As stated adding an additional 27 permanent resubmission structure established in earlier in this analysis, the PNC employees to the existing 27 employees the analysis of the IFR (68 FR 58974 at estimates that it would need more than would cost at least $4,050,000; tripling 59025), this minimum submission time twice, and possibly three times its the number of prior notice reviewers should eliminate the probability of current number of permanent would cost at least $8,100,000. These having to resubmit prior notice for all employees to review prior notices if the costs could be higher if additional but 2.5 percent of those perishable minimum submission timeframe was 1 overhead is required. We include products imported from Canada and hour or 30 minutes before arrival for $6,075,000 in our summary cost table Mexico by land by road. articles of food arriving by land by road, for Option 2B as this represents the Using the same formula we used in ‘‘wheels-up’’ for food arriving by air, midpoint in costs between doubling and the analysis of Option 1, we calculate and 2 hours for food arriving by land by tripling the number of permanent the proportion of the total retail value of rail. In addition to increasing prior employees at the PNC. These costs highly perishable produce and seafood notice permanent review staff from 27 to could be higher if additional overhead from Canada and Mexico that arrives in 50 or even 100 or more FTEs, an is required. the United States by land by road. We increase in the number of first line i. 1-hour or 30-minute minimum prior then adjust the new retail value, to supervisors would be necessary, as notice time for food arriving by land by calculate the lost product value (1 hour would a corresponding increase in both road. Under this option, prior notices out of 168 hours for produce, 1 hour out

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of 48 hours for seafood) for the 2.5 submission time is 1 hour or 30 perishable seafood and produce percent of highly perishable produce minutes.18 affected. We do not include the cost of and seafood from Canada and Mexico Table 17 of this document shows the truck time for this option, because the for which prior notices would have to loss in value caused by the cancelled minimum prior notice time for articles be resubmitted due to changes in the and resubmitted prior notice of food arriving by vehicle is only 1 shipment when the minimum information for the 2.5 percent of hour or 30 minutes. imported Mexican and Canadian

TABLE 17.—LOSS IN VALUE CAUSED BY RESUBMITTED PRIOR NOTICE UNDER OPTION 2B FOR SHIPMENTS ARRIVING BY LAND BY ROAD (1-HOUR OR 30-MINUTE MINIMUM NOTICE REQUIREMENT)

Perishable Produce Dollars

2001 Imported Mexican produce total retail value $3,458,525,000

94% of total retail value for Mexican produce $3,251,014,000

0.6% Reduction in value for 2.5% of Mexican produce $488,000

2001 Imported Canadian produce total retail value $401,826,000

85% of total retail value for Canadian produce $341,552,000

0.6% Reduction in value for 2.5% of Canadian produce $51,000

Total lost value for produce $539,000

Perishable Seafood Dollars

2001 Imported Mexican seafood total retail value $112,277,000

94% of total retail value for Mexican seafood $105,540,000

2.1% Reduction in value for 2.5% of Mexican seafood $55,000

2001 Imported Canadian seafood total retail value $1,863,218,000

85% of total retail value for Canadian seafood $1,583,638,000

2.1% Reduction in value for 2.5% of Canadian seafood $831,000

Total lost value for seafood $886,000

ii. 2-hour minimum prior notice time notice information for those shipments. TABLE 18.—SUMMARY OF COSTS for food arriving by land by rail and Because prior notice does not need to be FOR OPTION 2B ‘‘wheels-up’’ or 4-hour minimum prior submitted until ‘‘wheels-up’’, the notice time by air. The 2-hour minimum probability of not having the correct (In Thou- submission time for food imported by prior notice information on the sands of Dollars) land by rail should reduce the shipment is eliminated. probability of having to resubmit prior A 4-hour minimum prior notice time Learning costs $71,037 notice for virtually all articles of food for flights not originating in North and imported from Canada and Mexico by Coordination costs $43,574 that mode of transport. Data from the Central America, South America (north PNC for 2007 show that only about 4 of the equator only), the Caribbean, and Computer acquisition costs $10,594 percent of the articles of food imported Bermuda will not constrain these from Canada and only about 2 percent imports because flights from locations FDA prior notice system cost $19,075 of the articles of food imported from other than those listed will all take and cost of additional FTEs longer than 4 hours. Therefore, the Mexico are imported by land by rail. We Annual costs to fill out prior $202,500 do not calculate any lost value due to probability of having incorrect shipment notice screens prior notice resubmission for products information is all but eliminated as the shipped by rail. shipment information can be verified Additional costs for BRASS $0 Reducing the prior notice submission before the prior notice is sent. users time frame to ‘‘wheels-up’’ for food Table 18 of this document presents a Lost value for produce $539 imported by air on flights originating in summary of the costs associated with North and Central America, South Option 2B, including the costs of the Lost value for seafood $886 America (north of the equator only), the option at the OMB-recommended Caribbean, and Bermuda will eliminate discount rates of 3 and 7 percent. Cost for truck time $0 the need for any resubmission of prior

18 In the IFR, we assumed a 2.5 percent prior submission time for food imported by land by road submission timeframe is 1 hour or 30 minutes for notice resubmission rate when the minimum notice was 1 hour. In this option, that minimum participants of CBP’s accelerated entry programs.

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TABLE 18.—SUMMARY OF COSTS TABLE 18.—SUMMARY OF COSTS because it is less likely that articles of FOR OPTION 2B—Continued FOR OPTION 2B—Continued food will need to ‘‘wait’’ longer than the minimum prior notice time frame before (In Thou- (In Thou- entering the United States. Submitting sands of sands of FDA’s Prior Notice information at the Dollars) Dollars) same time as CBP’s entry information may reduce costs for submitters.19 If Costs of manufacturer reg- $52,800 PV of costs at 7% for 20 $2,483,938 istration number and full fa- years FDA’s Prior Notice and CBP cility address requirement submissions can be done PV of costs at 3% for 20 $3,425,873 simultaneously, submitters may be able Total first year costs for Op- $401,005 years to coordinate the two entry submissions tion 2 so as to reduce total submission costs. b. Benefits of Option 2B. Importers c. Cost benefit summary table. Table Annual costs after first year $218,353 will benefit from the shorter times for 19 presents the costs of Options 2B submitting prior notice under Option 2B annualized over 20 years.

TABLE 19.—UPDATED COST BENEFIT SUMMARY TABLE FOR OPTION 2B

Annualized Costs Annualized Costs Over 20 Years at Over 20 Years at 7% Discount Rate 3% Discount Rate (Millions) (Millions)

Option 2B—1 hour or 30 minute prior notice for food arriving by land by road, 2 hours for rail, ‘‘wheels- up’’ or 4 hours for air, 8 hour for vessels; the PNC has increased staff $229 $226

Benefits—FDA will know what articles of food are being imported or offered for import, before they arrive at the port. In the event of a potential threat of significant health risk to humans or animals, FDA will be able to mobilize and assist in the detention and removal of those products.

Option 3: Minimum prior notice time is along with the reason why the provide only the site-specific facility 2 hours for articles of food arriving by registration number was not provided. name and full address and the reason land by road, 4 hours for articles of Most of the comments concerned with the registration number is not provided. food arriving by land by rail and by air, the identity of the manufacturer were We adjust the costs of the final rule and 8 hours for articles of food arriving concerned about submitters not being to now reflect the requirement that if the by water; information is submitted able to provide registration number; a manufacturer’s registration number is electronically, most changes in smaller percentage of the comments also not available, then the name and full information require resubmission; the raised concerns about being able to address of the site-specific manufacturer registration number is provide the name and address of the manufacturing facility must be not required when the submitter is manufacturer. Unlike the provided. For Option 1, using unable to determine it. manufacturer’s registration number, information from table 9 of this Option 3 represents Option 1 but with which many may view as confidential document, we estimated that about 2.91 business information that is to be a change to the requirement for percent of prior notices submitted for disclosed only on a ‘‘need to know’’ providing the identity of the FY 2007 did not contain the appropriate basis, the name and full address of a manufacturer. manufacturer name, address, and/or facility is public information that not registration number as required by the As stated in Option 1, smaller only is typically in phone books and on codified of the IFR. With the extra importers or individuals that buy food the Internet, but it also often is provided flexibility in manufacturer identity for import into the United States from on documents typically exchanged allowed by Option 3, we expect the brokers, wholesalers, or foreign retailers between buyers and sellers (e.g., percentage of prior notices still affected because they are too small to buy receipts, purchase orders, and bills of by this requirement to be 1.21 percent directly from food manufacturers may lading). (2.91 percent - 1.70 percent). We expect find it difficult to continue importing Even with the flexibility of not those who submitted prior notice under certain products when manufacturer requiring the manufacturer registration the IFR using reason code K—Unable to name, registration number, and partial number on prior notice when the determine the registration number of the address is required on prior notice. submitter is unable to determine it, manufacturer (1.70 percent), should However, the final rule provides an there will likely be some adjustment likely be able to submit the alternative for submitters in providing costs for small importers and manufacturer site-specific name and full the identity of the manufacturer when individuals. These adjustments to address as required by the prior notice they are unable to determine the business practices should be less costly final rule codified. We expect that those manufacturer’s registration number. and occur less often than those in who submitted prior notice under the Under the final rule, submitters may Option 1 because importers no longer IFR using reason codes I, L, M, and O provide the name and full address of the have to provide the manufacturer (0.56 percent, 0.16 percent, 0.16 site-specific manufacturing facility registration number but may instead percent, and 0.33 percent, respectively),

19 Comments on the IFR stated several reasons for the complexity of the process by presenting a more border, (5) it would significantly reduce the burden recommending that prior notice timeframes be the streamlined flow of information and avoid on the trade community without creating additional same as CBP’s advance electronic information unnecessary duplication, (2) it would result in security risks, and (6) it would allow operators at timeframes for food arriving by air and by land fewer errors, (3) it would provide better compliance close border points to load and verify truck loads (both by road and by rail): (1) It would minimize rates, (4) it would allow for fewer disruptions at the and travel routes prior to submitting notice.

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could still have problems submitting the that manufactured the gift must be requirement that either the registration identity of the manufacturer as required included on prior notice.20 Therefore, number or the name and address of the by the final rule. we add 0.38 percent (for reason code site-specific facility be included in prior We must further adjust the 1.21 G—Individual gift label name/address notice. We repeat the data from table 10 percent of prior notices expected to still in lieu of registration number from the here in table 20 of this document. As be affected by the manufacturer identity November 2004 revision of the IFR CPG) with Option 1, we present the best and requirement of prior notice to address to the 1.21 percent we expect may have worst case scenarios to represent the the fact that the final rule is more problems with the manufacturer possible range of imported foods value restrictive than the IFR in regards to identity requirement of the final rule. that may be affected by the final rule providing the identity of the Thus, we expect a total of 1.59 percent requirement and then adjust that value manufacturer on prior notice for food of all prior notices annually to be to reflect changes in business practices sent by an individual as a personal gift. affected by the revised manufacturer In cases of food sent by an individual identity requirement of the final rule as and businesses ceasing importing food as a personal gift, the IFR allows the opposed to the 2.91 percent affected by into the United States. Taking the name and address on the product label the manufacturer identity requirement midpoint of the lost value due to to substitute for the manufacturer’s of the IFR. cessation of importation ($21 million) name, address, and registration number We can again use the data from table plus the costs to the 1,725 firms to on prior notice. The final rule requires 10 of this document, adjusted now by change business practices, we estimate that if the manufacturer’s registration 1.59 percent instead of 2.91 percent, to that the cost of the manufacturer number is not available, the full name determine the potential imported food identity requirement in the final rule to and address of the site-specific facility value affected by the final rule be about $28.8 million.

TABLE 20.—IMPORTS OF GOODS BY END USE CATEGORY AND COMMODITY (2006 SEASONALLY ADJUSTED DATA)

Best Case Sce- Worst Case Sce- nario (Millions) nario (Millions)

Foods, feeds, and beverages (FFB) total1 $64,782 $64,782

Categories of imported food products subtracted Meat products $5,611 $5,611 Fish and shellfish $9,867 Vegetables $4,943 Cane and beet sugar $1,121 Cocoa beans $520 Tea, spices, etc. $715 Food oils, oilseeds $1,999 Feedstuff and food grains $1,577 Fruits, frozen juices $5,503 Nuts $856 Green coffee $2,035 Dairy products and eggs $1,070

Remaining value of imports that may be affected by identity of the manufacturer requirement $28,965 $59,171

Imported value reduced further to represent that only 1.59% of prior notice submissions could not pro- vide manufacturing facility site-specific information on prior notice for CY 2007 $461 $941

3 percent of imported food value lost through cessation of importation into U.S. $13.8 to $28.2 million

Costs that reflect change in business practices for 1,725 submitters (80 hours x $56.74 per hour) $7.8 million

Total Value Affected $28.8 million 1 Source of original data: U.S. Census Bureau, U.S. Bureau of Economic Analysis, US DOC News, November 9, 2007, pages 12 and 15, avail- able online at http://www.bea.gov/newsreleases/international/trade/2007/pdf/trad0907.pdf. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the FEDERAL REGISTER.)

a. Changes in to the final rule that are address, and registration number on provide the site-specific name and full not quantified. The final rule is more prior notice. The final rule requires that address of the manufacturing facility restrictive than the IFR in regards to if the manufacturer’s registration instead of the registration number. providing the identity of the number is not available, the site-specific Also, for the final rule, FDA removed manufacturer on prior notice for the full name and address of the facility that a few of the prior notice data elements importation of transshipments. For manufactured the article of food must be that are required in the IFR. transshipments, the IFR allows the included on prior notice. We do not Specifically, submitters no longer need name and full address of the expect this requirement of the final rule to include the fax number of the manufacturer to substitute for the to affect transshipments significantly as submitter and transmitter, the manufacturer’s name and partial the final rule does allow the importer to anticipated border crossing, the country

20 FDA plans to continue its enforcement policy to individual gifts; however, the final rule does site-specific facility where the gift was that it should typically consider not taking any require at least the name and full address of the manufactured. regulatory action for prior notice violations relating

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of the carrier, or the 6–digit HTS code TABLE 21.—SUMMARY OF COSTS TABLE 21.—SUMMARY OF COSTS on their prior notices. Other changes FOR OPTION 3—THE FINAL RULE FOR OPTION 3—THE FINAL include making the shipper’s RULE—Continued registration number optional but always (In Thou- requiring its full addresses; and the sands of (In Thou- Dollars) option of submitting the tracking sands of Dollars) number for articles of food arriving by Learning costs $71,037 express consignment instead of PV of costs at 3% for 20 $4,509,571 Coordination costs $43,574 anticipated arrival information when years the prior notice is submitted through Computer acquisition costs $10,594 1 Annual costs include the startup costs of PNSI. However, these and other changes prior notice to the estimated 10 percent of in filing requirements, on net, are not FDA prior notice system cost $13,000 new businesses that enter the market each large enough to affect the time needed year. to file prior notice or the costs charged Annual costs to fill out prior $202,500 notice screens by brokers to file prior notice; therefore, b. Benefits of Option 3 (final rule). we do not update the estimated time Option 3 allows for the submission of Additional costs for BRASS $61,003 alternative manufacturer information needed or the estimated costs charged to users file prior notice. that could be used to verify the Lost value for produce $4,261 registration status of the manufacturer. Table 21 of this document presents a This is more flexible to importers than summary of the revised estimated costs Lost value for seafood $11,533 the requirements of Option 1, the IFR. associated with Option 3, the final rule, Cost for truck time $0 Once the facility has been identified in including the marginal costs to the database and a valid registration has importers who may be affected by the Costs of change in manufac- $28,800 been verified, the manufacturer identity of the manufacturer turer identity requirement information required on prior notice for requirement. Also included in table 21 Option 3 provides the same level of of this document are the discounted Total first year costs for Op- $446,302 tion 3 security and assurance as the present value of the costs at the OMB- registration number required by Option recommended discount rates of 3 and 7 Annual costs after first year1 $293,118 1. percent. c. Cost benefit summary table. Table Present value (PV) of costs at $3,248,454 7% for 20 years 22 presents the costs of Option 3 annualized over 20 years.

TABLE 22.—UPDATED COST BENEFIT SUMMARY TABLE FOR OPTION 3

Annualized Costs Annualized Costs Over 20 Years at Over 20 Years at 7% Discount Rate 3% Discount Rate (Millions) (Millions)

Option 3—2-hour prior notice for vehicle, 4-hour for rail and air, 8-hour for vessels; change in the iden- tity of the manufacturer requirement (Final rule) $655 $652

Benefits—FDA will know what articles of food are being imported or offered for import, before they arrive at the port. In the event of a threat of significant public health risk to humans or animals, FDA will be able to mobilize and assist in the detention and removal of those products. The benefits of the final rule are enhanced by the change in the identity of the manufacturer requirement.

Summary Table of All Options Analyzed

TABLE 23.—COSTS AND BENEFITS OF ALL OPTIONS ANALYZED

Option 1 Option 2A Option 2B Option 3 Costs In Thousands of In Thousands of In Thousands of In Thousands of Dollars Dollars Dollars Dollars

Learning costs $71,037 $71,037 $71,037 $71,037

Coordination costs $43,574 $43,574 $43,574 $43,574

Computer acquisition costs $10,594 $10,594 $10,594 $10,594

FDA prior notice system cost $13,000 $13,000 $19,075 $13,000

Annual costs to fill out prior notice screens $202,500 $202,500 $202,500 $202,500

Additional costs for BRASS users $61,003 $0 $0 $61,003

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TABLE 23.—COSTS AND BENEFITS OF ALL OPTIONS ANALYZED—Continued

Option 1 Option 2A Option 2B Option 3 Costs In Thousands of In Thousands of In Thousands of In Thousands of Dollars Dollars Dollars Dollars

Lost value for produce $4,261 $857 $539 $4,261

Lost value for seafood $11,533 $1,549 $886 $11,533

Cost for truck time $0 $0 $0 $0

Costs of change in manufacturer identity requirement $52,800 $52,800 $52,800 $28,800

Total first year costs $470,302 $395,911 $401,005 $446,302

Annual costs $293,118 $218,727 $218,353 $293,118

PV of costs at 7% for 20 years $3,270,884 $2,482,785 $2,483,938 $3,248,454

PV of costs at 3% for 20 years $4,532,872 $3,426,122 $3,425,873 $4,509,571

Benefits for all options (benefits not quantified) FDA will know what articles of food are being imported or offered for import, before they arrive at the port. In the event of a threat of significant public health risk to humans or animals, FDA will be able to mobilize and assist in the detention and removal of those products.

Sensitivity Analysis cost under the final rule taking into Regulatory Flexibility Act requires The prior notice rule is unique in that account information from the final rule agencies to analyze regulatory options the rule is published with an draft CPG is about $5.9 million21 based that would lessen the economic effect of accompanying Compliance Policy Guide on the assumption that if the submitter the rule on small entities consistent (CPG). The CPG provides guidance would otherwise use reason code L or with statutory objectives. FDA finds that regarding enforcement of the prior M in table 9, because it was unable to this final rule may have a significant notice requirements, including determine the identity of the site- economic impact on a substantial describing the circumstances where specific manufacturer, it would now number of small entities. While this FDA and CBP should typically consider change supply chains, find some other final rule provides more flexibility to not taking any regulatory action even means to continue importing the food, small entities than the IFR because the though certain requirements are not or cease importing the food because it final rule allows the full address of the met. In some of these circumstances, the finds it unprofitable to attempt to site-specific manufacturer to be given compliance policy applies when continue to do so under the instead of the partial address and alternative information is submitted. If circumstances (0.32 percent or 31,513 of registration number on prior notice, this we estimate the costs of the IFR taking the 9.8 million entry lines for which information may still be difficult for into account information from the IFR prior notice was submitted in 2007). some businesses to obtain. CPG and compare those costs to the As discussed in more detail elsewhere Comments on the IFR Related to Small final rule taking into account in this document, the benefit of not Businesses information from the final rule draft including reason codes L and M in the (Comment) One comment states that CPG, the main cost difference, as when final rule draft CPG is that knowing the smaller U.S. importers cannot afford the comparing Option 1 and Option 3, is the identity of the facility involved in the additional costs charged by a broker to cost of the change regarding providing food’s production, as opposed to the submit the FDA information via the ABI the manufacturer identity. identity of the facility’s headquarters or system. As a result, they are having their For Option 1 (the IFR) we estimated the invoicing firm, is critical to ensuring foreign suppliers submit prior notice. that this cost was about $52.8 million that FDA can effectively determine Some small companies estimate that, and for Option 3 (the final rule) we whether food should be held because it including Web site disruptions, 80 estimated this cost was about $28.8 is from an unregistered manufacturing packages would take 40 to 80 hours for million. If information based on the CPG facility. prior notice. The comment believes that is included in the estimate of the cost this is totally unmanageable. B. Small Entity Analysis (or Final of the IFR and final rule, then the rule (Response) We account for increase in Regulatory Flexibility Analysis) costs regarding providing the identity of broker costs due to prior notice in our the manufacturer are $0 and $5.9 FDA has examined the economic analysis; the comment estimate of the million respectively. The costs implications of this final rule as time it takes to complete prior notice is regarding providing the identity of the required by the Regulatory Flexibility accurately reflected in the IFR and final manufacturer is $0 under the IFR taking Act (5 U.S.C. 601–612). If a rule has a rule analysis. FDA expects importers to into account information from the IFR significant economic impact on a modify their business practices to find CPG based on the assumption that the substantial number of small entities, the the most cost effective way to deal with submitter would use one of the reason prior notice requirements. In this case, codes in table 9 (A through O) when the 21 We calculated this cost using the same method the small importer can avoid higher submitter is not able to satisfy some or we used in Option 1 (table 10) and Option 3 (table broker fees by having the foreign 20) except we use 0.32 percent for the reduction of all of the requirements regarding imported value and to reduce the number of supplier submit the prior notice. providing the identity of the submitters from 108,500 to reflect changing Another alternative would be for the manufacturer of the product. The same business practices. small importer to submit prior notice

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themselves through PNSI. We would affected by the prior notice final rule. business away from the re-seller. expect small firms would comply in The final rule at § 1.281(a)(6) requires Another comment states, however, that whichever manner is most cost the identity of the manufacturer as smaller importers buy from brokers and effective. It is also possible some of the follows: The name of the manufacturer wholesalers specifically because they costs of prior notice could be passed on and either: (1) The registration number, are too small to buy directly from larger to consumers in the form of higher retail city, and country of the manufacturer or manufacturers and other corporations, prices for some foods; in this case the (2) both the full address of the as large entities typically would not find small importer would not feel the manufacturer and the reason the it cost-effective to deal with smaller complete impact of the higher broker registration number is not provided importers. submission costs. (hereafter ‘‘the identity of the (Response) Depending on the business (Comment) The cost to complete a manufacturer’’). Even if a wine atmosphere, FDA believes that it is prior notice to send food by mail, for importer, retailer, or wholesaler cannot likely that many resellers will be willing companies that ship low volumes of obtain the registration number (e.g., the to supply the name and the address of inexpensive food products, is higher winery refuses to disclose its the manufacturers of the products they than the value of the product being registration number because the sell. Unlike the manufacturer’s shipped and therefore shipping to the importer, retailer, or wholesaler is registration number, which many may United States may be discontinued. outside the winery’s distribution chain), view as confidential business (Response) FDA stated in the analysis the prior notice can include the name information that is to be disclosed only of the IFR that the costs of completing and full address of the winery, which on a ‘‘need to know’’ basis, the name prior notice submissions may be comments stated is obtainable. We do and full address of a facility is public partially passed along to the consumer not include additional costs to fine wine information that not only is typically in in the form of higher retail prices for manufacturers or importers in this final phone books and on the Internet, but it some foods (68 FR 58974 at 59024). rule analysis; however, we do refine the also often is provided on documents FDA’s IFR analysis also acknowledged estimate of the difference between the typically exchanged between buyers and the possibility that companies in the IFR requirements and this final rule sellers (e.g., receipts, purchase orders, business of sending small shipments of modification. and bills of lading). The issues food to private individuals in the United (Comment) Smaller importers that discussed in these comments are States may stop shipping to U.S. buy from brokers and wholesalers addressed further in Options 1 and 3. addresses (68 FR 58974 at 59067). because they are too small to buy Costs per Small Entity (Comment) A number of postal directly from larger food manufacturers FDA does not have detailed services take issue with the requiring of will be put out of business. These information on the approximately filing prior notice for personal food smaller importers allege that they will 108,500 persons (e.g. exporters, U.S. items. The comments state that the not be able to provide the importers or U.S. purchasers or their labor-intensive process of mailing manufacturers’ registration numbers on agents) that will be primarily personal food items will cause a their prior notices as required by the responsible for submitting the prior decrease in the items being shipped, final rule. The comments argue that the notice information; table 3 gives a thus decreasing the business of the mail registration number requirement description of some of these entities. system. interferes with small businesses’ rights Many of these submitters may have (Response) When the cost of shipping to free trade because now only larger fewer than 100 employees22, thus increases, the number of items shipped businesses that deal with the making them small businesses as is indeed likely to decrease. Although manufacturers directly, rather than defined by the Small Business some of reduction in postal revenues buying through brokers and Administration. Because many of the would represent a dead-weight loss, it is wholesalers, will be able to obtain the prior notice submitters are likely to be primarily a transfer, not a social cost manufacturer’s information that is small businesses, all options considered and therefore is not included in the cost required for prior notice. in the Final Regulatory Impact Analysis estimates for this analysis. (Response) The final rule provides an in section IV.A of this document are (Comment) Several comments express alternative for submitters to provide the regulatory relief options. concern about their continued ability to identity of the manufacturer when the FDA does not have enough import fine wine because although they manufacturer’s registration number is information about the 108,500 prior can obtain the name and address of the not obtainable. Under the final rule, notice submitters to perform a detailed site-specific manufacturer of the wine, submitters may provide the name and analysis of the costs per small business obtaining the manufacturers’ (i.e., the full address of the site-specific by industry sector. We do, however, wineries’) registration numbers for these manufacturing facility along with a update some of the costs per submitter products often is difficult to those not reason as to why the registration that were presented in the IFR in the winery’s direct distribution chain. number was not used in the prior Regulatory Flexibility Analysis (68 FR The comments state that smaller notice. 59066). Table 24 of this document importers, wholesalers, retailers, (Comment) While most comments shows the average costs per submitter to restaurants, clubs, or hotels will be state that the name and address of the learn the rule, coordinate information, negatively affected by not having the manufacturer could be submitted in and submit prior notice. Table 24 also prior notice, one comment states that re- registration number for the shows the average costs to the submitter sellers will not normally supply the manufacturer of the fine wine. The to absorb the costs of not being able to name of their supplier or the name of comments further state that the prior use BRASS, to absorb costs of lost value the manufacturer of a particular product notice rule will negatively impact small of perishable products, and the cost to their customers. The comment asserts producers by reducing the number of regarding providing the identity of the that supplying the name of the potential representatives and sales manufacturer. venues as secondary fine wine market manufacturer would allow that importers disappear. customer to circumvent the re-seller and 22 For NAICS industry sector 42-Wholesale Trade, (Response) FDA does not believe that attempt to make direct contact with the a business is defined as small by SBA if it has fewer the fine wine industry will be negatively supplier or manufacturer, thus taking than 100 employees.

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TABLE 24.—COSTS PER SUBMITTER FOR PN FINAL RULE CHOSEN OPTION

Cost per importer (n = Activity Total Costs 108,500)

Learning costs $71,037,000 $655

Coordination costs $43,574,000 $402

Annual costs to fill out prior notice screens $202,500,000 $1,866

Costs for BRASS users $61,003,000 $562

Lost value for perishables $15,794,000 $146

Costs of change in manufacturer identity requirement $28,800,000 $265

Total estimated average costs per submitter $3,896

C. Small Business Regulatory articles of food arriving by express between 9 a.m. and 4 p.m., Monday Enforcement Fairness Act of 1996 consignment instead of anticipated through Friday. (FDA has verified the (SBREFA) Major Rule arrival information when the prior Web site addresses, but FDA is not SBREFA (Public Law 104–121) notice is submitted through PNSI. responsible for any subsequent changes defines a major rule for the purpose of However, these and other changes in to the Web sites after this document Congressional review as having caused filing requirements, on net, are not large publishes in the Federal Register.) or being likely to cause one or more of enough to affect the time needed to file 1. Taube, Anthony C., Memorandum to the following: An annual effect on the prior notice or the costs charged by file, November 13, 2006. 2. U.S. Customs and Border Protection, economy of $100 million or more; a brokers to file prior notice. Therefore we do not re-estimate a Paperwork http://www.cbp.gov/linkhandler/cgov/trade/ major increase in costs or prices; cargo_security/ctpat/fast/fast_ref_guide.ctt/ significant adverse effects on Reduction Act burden for this final rule. fast_ref_guide.pdf. competition, employment, productivity, VI. Analysis of Environmental Impact 3. The NAICS Association, September 29, or innovation; or significant adverse 2008, available online at http:// effects on the ability of United States- The agency has carefully considered www.naics.com. based enterprises to compete with the potential environmental effects of 4. U.S. International Trade in Goods and foreign-based enterprises in domestic or this action. FDA has concluded under Services September 2007, U.S. Census export markets. In accordance with the 21 CFR 25.30(h) that this action is of a Bureau, U.S. Bureau of Economic Analysis, US DOC News, November 9, 2007, pages 12 Small Business Regulatory Enforcement type that does not individually or cumulatively have a significant effect on and 15, available online at http:// Fairness Act, OMB has determined that www.bea.gov/newsreleases/international/ this final rule is not a major rule for the the human environment. Therefore, trade/2007/pdf/trad0907.pdf. purpose of Congressional review. neither an environmental assessment 5. The Small Business Administration, nor an environmental impact statement Office of Advocacy, Frequently Asked V. Paperwork Reduction Act of 1995 is required. Questions Updated September 2008, The collection of information available online at http://www.sba.gov/advo/ VII. Federalism provisions of this final rule are subject stats/sbfaq.pdf. to review by the Office of Management FDA has analyzed this final rule in List of Subjects in 21 CFR Part 1 and Budget (OMB) under the Paperwork accordance with the principles set forth Reduction Act of 1995 (44 U.S.C. 3501– in Executive Order 13132. FDA has Cosmetics, Drugs, Exports, Food 3520). The collections of information in determined that the rule does not labeling, Imports, Labeling, Reporting §§ 1.280, 1.281, 1.282, 1.283, and 1.285 contain policies that have substantial and recordkeeping requirements. have been approved under OMB Control direct effects on the States, on the ■ No. 0910–0520. relationship between the National Therefore, under the Federal Food, From the IFR to the final rule, FDA Government and the States, or on the Drug, and Cosmetic Act and under removed a few of the required prior distribution of power and authority delegated to the Commissioner notice data elements. Specifically, responsibilities among the various of Food and Drugs, 21 CFR part 1 is submitters no longer need to include the levels of government. Accordingly, the amended as follows: fax number of the submitter and agency has concluded that the rule does PART 1—GENERAL ENFORCEMENT transmitter, the anticipated border not contain policies that have REGULATIONS crossing, the country of the carrier, or federalism implications as defined in the 6–digit HTS code in their prior the Executive order and, consequently, ■ notices. Other changes include the a federalism summary impact statement 1. The authority citation for 21 CFR addition of the registration number of is not required. part 1 continues to read as follows: the transshipper for articles of food for Authority: 15 U.S.C. 1453, 1454, 1455; 19 VIII. References transshipment, storage and export, or U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, manipulation and export; flexibility in The following references have been 333, 334, 335a, 343, 350c, 350d, 352, 355, submitting the registration number and placed on display in the Division of 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264. the city and country of the manufacturer Dockets Management (HFA–305), Food and shipper instead of full addresses of and Drug Administration, 5630 Fishers ■ 2. Subpart I, consisting of §§ 1.276 these entities; and the option of Lane, rm. 1061, Rockville, MD 20852, through 1.285, is revised to read as submitting the tracking number for and may be seen by interested persons follows:

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Subpart I—PRIOR NOTICE OF IMPORTED including harvested or collected and performed the additional FOOD readied for shipment, in a Territory, the manufacturing/processing is considered General Provisions FDA Country of Production is the the manufacturer. (10) No longer in its natural state Sec. United States. 1.276 What definitions apply to this (ii) For an article of food that is no means that an article of food has been subpart? longer in its natural state, the country made from one or more ingredients or 1.277 What is the scope of this subpart? where the article was made; except that, synthesized, prepared, treated, if an article of food is made from wild modified, or manipulated. Examples of Requirements to Submit Prior Notice of fish, including seafood, aboard a vessel, activities that render food no longer in Imported Food the FDA Country of Production is the its natural state are cutting, peeling, Sec. country in which the vessel is trimming, washing, waxing, 1.278 Who is authorized to submit prior registered. If an article of food that is no eviscerating, rendering, cooking, baking, notice? 1.279 When must prior notice be submitted longer in its natural state was made in freezing, cooling, pasteurizing, to FDA? a Territory, the FDA Country of homogenizing, mixing, formulating, 1.280 How must you submit prior notice? Production is the United States. bottling, milling, grinding, extracting 1.281 What information must be in a prior (5) Food has the meaning given in juice, distilling, labeling, or packaging. notice? section 201(f) of the act, except as Crops that have been cleaned (e.g., 1.282 What must you do if information provided in paragraph (b)(5)(i) of this dusted, washed), trimmed, or cooled changes after you have received section. attendant to harvest or collection or confirmation of a prior notice from FDA? (i) For purposes of this subpart, food treated against pests, or polished are Consequences does not include: still in their natural state for purposes (A) Food contact substances as Sec. of this subpart. Whole fish headed, 1.283 What happens to food that is defined in section 409(h)(6) of the act eviscerated, or frozen attendant to imported or offered for import without (21 U.S.C. 348(h)(6)); or harvest are still in their natural state for adequate prior notice? (B) Pesticides as defined in 7 U.S.C. purposes of this subpart. 1.284 What are the other consequences of 136(u). (11) Port of arrival means the water, failing to submit adequate prior notice or (ii) Examples of food include fruits, air, or land port at which the article of otherwise failing to comply with this vegetables, fish, including seafood, food is imported or offered for import subpart? dairy products, eggs, raw agricultural into the United States. For an article of 1.285 What happens to food that is commodities for use as food or as food arriving by water or air, this is the imported or offered for import from components of food, animal feed port of unloading. For an article of food unregistered facilities that are required to (including pet food), food and feed register under subpart H of this part? arriving by land, this is the port where ingredients, food and feed additives, the article of food first crosses the General Provisions dietary supplements and dietary border into the United States. The port ingredients, infant formula, beverages § 1.276 What definitions apply to this of arrival may be different than the port (including alcoholic beverages and where consumption or warehouse entry subpart? bottled water), live food animals, bakery (a) The act means the Federal Food, or foreign trade zone admission goods, snack foods, candy, and canned documentation is presented to the U.S. Drug, and Cosmetic Act. foods. (b) The definitions of terms in section Customs and Border Protection (CBP). (6) Full address means the facility’s (12) Port of entry, in section 801(m) 201 of the act (21 U.S.C. 321) apply street name and number; suite/unit and (l) of the act (21 U.S.C. 381(m) and when the terms are used in this subpart, number, as appropriate; city; Province (l)), means the port of entry as defined unless defined in this section. or State as appropriate; mail code as in 19 CFR 101.1. (1) Calendar day means every day appropriate; and country. (13) Registration number means the shown on the calendar. (7) Grower means a person who registration number assigned to a (2) Country from which the article engages in growing and harvesting or facility by FDA under section 415 of the originates means FDA Country of collecting crops (including botanicals), act (21 U.S.C. 350d) and subpart H of Production. raising animals (including fish, which this part. (3) Country from which the article is includes seafood), or both. (14) Shipper means the owner or shipped means the country in which the (8) International mail means foreign exporter of the article of food who article of food is loaded onto the national mail services. International consigns and ships the article from a conveyance that brings it to the United mail does not include express foreign country or the person who sends States or, in the case of food sent by consignment operators or carriers or an article of food by international mail international mail, the country from other private delivery services unless or express consignment operators or which the article is mailed. such service is operating under contract carriers or other private delivery service (4) FDA Country of Production means: as an agent or extension of a foreign to the United States. (i) For an article of food that is in its mail service. (15) United States means the Customs natural state, the country where the (9) Manufacturer means the last territory of the United States (i.e., the 50 article of food was grown, including facility, as that word is defined in States, the District of Columbia, and the harvested or collected and readied for § 1.227(b)(2), that manufactured/ Commonwealth of Puerto Rico), but not shipment to the United States. If an processed the food. A facility is the Territories. article of food is wild fish, including considered the last facility even if the (16) You means the person submitting seafood that was caught or harvested food undergoes further manufacturing/ the prior notice, i.e., the submitter or the outside the waters of the United States processing that consists of adding transmitter, if any. by a vessel that is not registered in the labeling or any similar activity of a de United States, the FDA Country of minimis nature. If the food undergoes § 1.277 What is the scope of this subpart? Production is the country in which the further manufacturing/processing that (a) This subpart applies to all food for vessel is registered. If an article of food exceeds an activity of a de minimis humans and other animals that is that is in its natural state was grown, nature, then the subsequent facility that imported or offered for import into the

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United States for use, storage, or (1) If the article of food is arriving by English language, except that an distribution in the United States, land by road, no less than 2 hours before individual’s name, the name of a including food for gifts and trade and arriving at the port of arrival; company, and the name of a street may quality assurance/quality control (2) If the article of food is arriving by be submitted in a foreign language. All samples, food for transshipment through land by rail, no less than 4 hours before information, including the items listed the United States to another country, arriving at the port of arrival; in the previous sentence, must be food for future export, and food for use (3) If the article of food is arriving by submitted using the Latin (Roman) in a U.S. Foreign Trade Zone. air, no less than 4 hours before arriving alphabet. Unless paragraph (c) of this (b) Notwithstanding paragraph (a) of at the port of arrival; or section applies, you must submit prior this section, this subpart does not apply (4) If the article of food is arriving by notice through: to: water, no less than 8 hours before (1) The U.S. Customs and Border (1) Food for an individual’s personal arriving at the port of arrival. Protection (CBP) Automated Broker (b) Except in the case of an article of use when it is carried by or otherwise Interface of the Automated Commercial food imported or offered for import by accompanies the individual when System (ABI/ACS); or international mail: arriving in the United States; (2) The FDA PNSI at http:// (1) If prior notice is submitted via www.access.fda.gov. You must submit (2) Food that was made by an Automated Broker Interface/Automated prior notice through the FDA Prior individual in his/her personal residence Commercial System (ABI/ACS), you Notice System Interface (FDA PNSI) for and sent by that individual as a personal may not submit prior notice more than articles of food imported or offered for gift (i.e., for nonbusiness reasons) to an 30-calendar days before the anticipated import by international mail, and other individual in the United States; date of arrival. transaction types that cannot be made (3) Food that is imported then (2) If prior notice is submitted via the through ABI/ACS. Prior notice for exported without leaving the port of FDA Prior Notice System Interface (FDA articles that have been refused under arrival until export; PNSI), you may not submit prior notice section 801(m)(1) of the act and under (4) Meat food products that at the time more than 15-calendar days before the this subpart must be submitted through of importation are subject to the anticipated date of arrival. the FDA PNSI until such time as FDA exclusive jurisdiction of the U.S. (c) Notwithstanding paragraphs (a) and CBP issue a determination that ACS Department of Agriculture (USDA) and (b) of this section, if the article of or its successor system can under the Federal Meat Inspection Act food is arriving by international mail, accommodate such transactions. (21 U.S.C. 601 et seq.); you must submit the prior notice before (b) If a customhouse broker’s or self- (5) Poultry products that at the time the article of food is sent to the United filer’s system is not working or if the of importation are subject to the States. ABI/ACS interface is not working, prior exclusive jurisdiction of USDA under (d) FDA will notify you that your notice must be submitted through the the Poultry Products Inspection Act (21 prior notice has been confirmed for FDA PNSI. U.S.C. 451 et seq.); review with a reply message that (c) If FDA determines that FDA PNSI (6) Egg products that at the time of contains a Prior Notice (PN) or the Operational and Administration importation are subject to the exclusive Confirmation Number. Your prior notice System for Import Support (OASIS) is jurisdiction of USDA under the Egg will be considered submitted and the not working, FDA will post prominent Products Inspection Act (21 U.S.C. 1031 prior notice time will start when FDA notification and instructions at http:// et seq.); and has confirmed your prior notice for www.fda.gov. FDA will accept prior (7) Articles of food subject to Article review. notice submissions in the format it (e) The PN Confirmation Number 27(3) of The Vienna Convention on deems appropriate during the system(s) must accompany any article of food Diplomatic Relations (1961), i.e., outage. arriving by international mail. The PN shipped as baggage or cargo constituting Confirmation Number must appear on § 1.281 What information must be in a the diplomatic bag. the Customs Declaration (e.g., CN22 or prior notice? Requirements To Submit Prior Notice of CN23 or U.S. equivalent) that (a) General. For each article of food Imported Food accompanies the package. that is imported or offered for import (f) A copy of the confirmation, into the United States, except by § 1.278 Who is authorized to submit prior including the PN Confirmation Number, international mail, you must submit the notice? must accompany any article of food that information for the article that is A prior notice for an article of food is subject to this subpart when it is required in paragraphs (a)(1) through may be submitted by any person with carried by or otherwise accompanies an (a)(17) of this section: knowledge of the required information. individual when arriving in the United (1) The name of the individual This person is the submitter. The States. The copy of the confirmation submitting the prior notice and his/her submitter also may use another person must be provided to U.S. Customs and business address, phone number, and e- to transmit the required information on Border Protection (CBP) or FDA upon mail address, and the name and address his/her behalf. The person who arrival. of the submitting firm, if applicable. If transmits the information is the (g) The PN Confirmation Number the business address of the individual transmitter. The submitter and must accompany any article of food for submitting the prior notice is a transmitter may be the same person. which the prior notice was submitted registered facility, then the facility’s through the FDA PNSI when the article registration number, city, and country § 1.279 When must prior notice be may be provided instead of the facility’s submitted to FDA? arrives in the United States and must be provided to CBP or FDA upon arrival. full address; (a) Except as provided in paragraph (2) If different from the submitter, the (c) of this section, you must submit the § 1.280 How must you submit prior notice? name of the individual and firm, if prior notice to FDA and the prior notice (a) You must submit the prior notice applicable, transmitting the prior notice submission must be confirmed by FDA electronically to FDA. You must submit on behalf of the submitter and his/her for review as follows: all prior notice information in the business address, phone number, and e-

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mail address. If the business address of (iv) Notwithstanding paragraphs (17) Planned shipment information, as the individual transmitting the prior (a)(11)(i) through (a)(11)(iii) of this applicable to the mode of transportation notice is a registered facility, then the section, if the article of food is arriving and when it exists: facility’s registration number, city, and by express consignment operator or (i) The Airway Bill number(s) or Bill country may be provided instead of the carrier, and neither the submitter nor of Lading number(s), as applicable. This facility’s full address; transmitter is the express consignment information is not required for an article (3) The entry type; operator or carrier, and prior notice is of food when carried by or otherwise (4) The U.S. Customs and Border submitted via the FDA PNSI, the accompanying an individual when Protection (CBP) entry identifier (e.g., express consignment operator or carrier entering the United States. If the article CBP entry number or in-bond number), tracking number may be submitted in of food is arriving by express if available; lieu of the information required in consignment operator or carrier, and (5) The identity of the article of food paragraphs (a)(11)(i) through (a)(11)(iii) neither the submitter nor transmitter is being imported or offered for import, as of this section. Until such time as FDA the express consignment operator or follows: and CBP issue a determination that ACS carrier, and the prior notice is submitted (i) The complete FDA product code; or its successor system can via the FDA PNSI, the express (ii) The common or usual name or accommodate such transactions, the consignment operator or carrier tracking market name; tracking number may not be submitted number may be submitted in lieu of the (iii) The estimated quantity of food in lieu of information required in Airway Bill number(s) or Bill of Lading that will be shipped, described from paragraphs (a)(11)(i) through (a)(11)(iii) number(s), as applicable. Until such largest container to smallest package of this section, if the prior notice is time as FDA and CBP issue a size; and submitted via ABI/ACS. determination that ACS or its successor (iv) The lot or code numbers or other (12) The name and full address of the system can accommodate such identifier of the food if required by the importer. If the business address of the transactions, the tracking number may act or FDA regulations, e.g., low-acid importer is a registered facility, you also not be submitted in lieu of the Airway canned foods, by § 113.60(c) of this may submit the registration number of Bill number(s) or Bill of Lading chapter; acidified foods, by § 114.80(b) the importer’s registered facility. The number(s), if the prior notice is of this chapter; and infant formula, by identity of the importer is not required submitted via ABI/ACS; § 106.90 of this chapter; for an article of food that is imported or (ii) For food arriving by ocean vessel, (6) For an article of food that is no offered for import for transshipment the vessel name and voyage number; longer in its natural state, the identity of through the United States under a (iii) For food arriving by air carrier, the manufacturer, as follows: Transportation and Exportation entry; the flight number. If the article of food (i) The name of the manufacturer; and (13) The name and full address of the (ii) Either the registration number, is arriving by express consignment owner if different from the importer or city, and country of the manufacturer or operator or carrier, and neither the ultimate consignee. If the business both the full address of the submitter nor transmitter is the express address of the owner is a registered manufacturer and the reason the consignment operator or carrier, and the facility, you also may submit the registration number is not provided; prior notice is submitted via the FDA (7) For an article of food that is in its registration number of the owner’s PNSI, the express consignment operator natural state, the name and growing registered facility. The identity of the or carrier tracking number may be location address of the grower, if owner is not required for an article of submitted in lieu of the flight number. food that is imported or offered for known. If the submitter does not know Until such time as FDA and CBP issue import for transshipment through the the identity of the grower or, if the a determination that ACS or its United States under a Transportation article has been consolidated and the successor system can accommodate and Exportation entry; submitter does not know the identity of such transactions, the tracking number (14) The name and full address of the may not be submitted in lieu of the any of the growers, you may provide the ultimate consignee. If the business name and address of the firm that has flight number, if the prior notice is address of the ultimate consignee is a submitted via ABI/ACS; consolidated the articles of food from registered facility, you also may submit different growers or different growing (iv) For food arriving by truck, bus, or the registration number of the ultimate rail, the trip number; locations; consignee’s registered facility. The (8) The FDA Country of Production; (v) For food arriving as containerized (9) If the shipper is different from the identity of the ultimate consignee is not cargo by water, air, or land, the manufacturer, the identity of the required for an article of food that is container number(s). This information is shipper, as follows: imported or offered for import for not required for an article of food when (i) The name of the shipper; and transshipment through the United States carried by or otherwise accompanying (ii) The full address of the shipper. If under a Transportation and Exportation an individual when entering the United the address of the shipper is a registered entry; States; and facility, you also may submit the (15) The mode of transportation; (vi) For food arriving by rail, the car registration number of the shipper’s (16) The Standard Carrier number. This information is not registered facility; Abbreviation Code (SCAC) or required for an article of food when (10) The country from which the International Air Transportation carried by or otherwise accompanying article is shipped; Association (IATA) code of the carrier an individual. (11) Anticipated arrival information which is, or will be, carrying the article (b) Articles arriving by international about the article of food being imported of food from the country from which the mail. For each article of food that is or offered for import, as follows: article is shipped to the United States to imported or offered for import into the (i) The anticipated port of arrival; the port of arrival, or if this code is not United States by international mail, you (ii) The anticipated date on which the applicable, then the name of the carrier. must submit the information for the article of food will arrive at the If the carrier is a privately owned article that is required in paragraphs anticipated port of arrival; vehicle, the license plate number of the (b)(1) through (b)(11) of this section: (iii) The anticipated time of that vehicle and the State or Province that (1) The name of the individual arrival; and issued the license plate number; submitting the prior notice and his/her

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business address, phone number, and e- registration number of the shipper’s (6) For an article of food that is no mail address, and the name and address registered facility; longer in its natural state, the identity of of the submitting firm, if applicable. If (9) The country from which the article the manufacturer, as follows: the business address of the individual is shipped (i.e., mailed); (i) The name of the manufacturer; and submitting the prior notice is a (10) The anticipated date of mailing; (ii) Either the registration number, registered facility, then the facility’s and city, and country of the manufacturer or registration number, city, and country (11) The name and address of the U.S. both the full address of the may be provided instead of the facility’s recipient. manufacturer and the reason the full address; registration number is not provided; (c) Refused articles. If the article of (7) For an article of food that is in its (2) If different from the submitter, the food has been refused under section name of the individual and firm, if natural state, the name and growing 801(m)(1) of the act and under this location address of the grower, if applicable, transmitting the prior notice subpart, you must submit the on behalf of the submitter and his/her known. If the submitter does not know information for the article that is the identity of the grower or, if the business address, phone number, and e- required in paragraphs (c)(1) through mail address. If the business address of article has been consolidated and the (c)(18) of this section. However, if the submitter does not know any of the the individual transmitting the prior refusal is based on § 1.283(a)(1)(iii) notice is a registered facility, then the growers, you may provide the name and (Untimely Prior Notice), you do not address of the firm that has consolidated facility’s registration number, city, and have to resubmit any information country may be provided instead of the the articles of food from different previously submitted unless it has growers or different growing locations; facility’s full address; changed or the article has been exported (3) The entry type (which will be a (8) The FDA Country of Production; and the original prior notice was (9) If the shipper is different from the mail entry); submitted through ABI/ACS. If the (4) The identity of the article of food manufacturer, the identity of the refusal is based on § 1.283(a)(1)(ii), you shipper, as follows: being imported or offered for import, as should cancel the previous submission follows: (i) The name of the shipper; and per § 1.282(b) and (c). (ii) The full address of the shipper. If (i) The complete FDA product code; (1) The name of the individual the address of the shipper is a registered (ii) The common or usual name or submitting the prior notice and his/her facility, you also may submit the market name; business address, phone number, and e- registration number of the shipper’s (iii) The estimated quantity of food mail address, and the name and address registered facility; that will be shipped, described from of the submitting firm, if applicable. If (10) The country from which the largest container to smallest package the business address of the individual article is shipped; size; and submitting the prior notice is a (11) Arrival information about the (iv) The lot or code numbers or other registered facility, then the facility’s article of food being imported or offered identifier of the food if required by the registration number, city, and country for import, as follows: act or FDA regulations, e.g., low-acid may be provided instead of the facility’s (i) The port of arrival; and canned foods, by § 113.60(c) of this full address; (ii) The date on which the article of chapter; acidified foods, by § 114.80(b) (2) If different from the submitter, the food arrived at the port of arrival. of this chapter; and infant formula, name of the individual and firm, if (iii) Notwithstanding paragraph § 106.90 of this chapter; applicable, transmitting the prior notice (c)(11) of this section, if the article of (5) For an article of food that is no on behalf of the submitter and his/her food arrived by express consignment longer in its natural state, the identity of business address, phone number, and e- operator or carrier, and neither the the manufacturer, as follows: mail address. If the business address of submitter nor transmitter is the express (i) The name of the manufacturer; and the individual transmitting the prior consignment operator or carrier, and the (ii) Either the registration number, notice is a registered facility, then the prior notice is submitted via the FDA city, and country of the manufacturer or facility’s registration number, city, and PNSI, the express consignment operator both the full address of the country may be provided instead of the or carrier tracking number may be manufacturer and the reason the facility’s full address; submitted in lieu of the information registration number is not provided; (3) The entry type; required in paragraph (c)(11) of this (6) For an article of food that is in its section. Until such time as FDA and (4) The CBP entry identifier (e.g., CBP natural state, the name and growing CBP issue a determination that ACS or entry number or in-bond number), if location address of the grower, if its successor system can accommodate available; known. If the submitter does not know such transactions, the tracking number (5) The identity of the article of food the identity of the grower or, if the may not be submitted in lieu of being imported or offered for import, as article has been consolidated and the information required in paragraph follows: submitter does not know the identity of (c)(11) of this section, if the prior notice any of the growers, you may provide the (i) The complete FDA product code; is submitted via ABI/ACS; name and address of the firm that has (ii) The common or usual name or (12) The name and full address of the consolidated the articles of food from market name; importer. If the business address of the different growers or different growing (iii) The quantity of food that was importer is a registered facility, you also locations; shipped, described from largest may submit the registration number of (7) The FDA Country of Production; container to smallest package size; and the importer’s registered facility. The (8) If the shipper is different from the (iv) The lot or code numbers or other identity of the importer is not required manufacturer, the identity of the identifier of the food if required by the for an article of food that is imported or shipper, as follows: act or FDA regulations, e.g., low-acid offered for import for transshipment (i) The name of the shipper; and canned foods, by § 113.60(c) of this through the United States under a (ii) The full address of the shipper. If chapter; acidified foods, by § 114.80(b) Transportation and Exportation entry; the address of the shipper is a registered of this chapter; and infant formula, by (13) The name and full address of the facility, you also may submit the § 106.90 of this chapter; owner, if different from the importer or

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ultimate consignee. If the business prior notice is submitted via the FDA Consequences address of the owner is a registered PNSI, the express consignment operator facility, you also may submit the or carrier tracking number may be § 1.283 What happens to food that is imported or offered for import without registration number of the importer’s submitted in lieu of the flight number. adequate prior notice? registered facility. The identity of the Until such time as FDA and CBP issue (a) For each article of food that is owner is not required for an article of a determination that ACS or its imported or offered for import into the food that is imported or offered for successor system can accommodate United States, except for food arriving import for transshipment through the such transactions, the tracking number by international mail or food carried by United States under a Transportation may not be submitted in lieu of the or otherwise accompanying an and Exportation entry; flight number, if the prior notice is individual, the consequences are: (14) The name and full address of the submitted via ABI/ACS; ultimate consignee. If the business (1) Inadequate prior notice—(i) No (iv) For food that arrived by truck, prior notice. If an article of food arrives address of the ultimate consignee is a bus, or rail, the trip number; registered facility, you also may submit at the port of arrival and no prior notice (v) For food that arrived as has been submitted and confirmed by the registration number of the ultimate containerized cargo by water, air, or consignee’s registered facility. The FDA for review, the food is subject to land, the container number(s); however, refusal of admission under section identity of the ultimate consignee is not this information is not required for an required for an article of food that is 801(m)(1) of the act (21 U.S.C. article of food when carried by or 381(m)(1)). If an article of food is imported or offered for import for otherwise accompanying an individual transshipment through the United States refused for lack of prior notice, unless when entering the United States; and U.S. Customs and Border Protection under a Transportation and Exportation (vi) For food that arrived by rail, the entry; (CBP) concurrence is obtained for export car number; however, this information (15) The mode of transportation; and the article is immediately exported (16) The SCAC or IATA code of the is not required for an article of food from the port of arrival under CBP carrier which carried the article of food when carried by or otherwise supervision, it must be held within the from the country from which the article accompanying an individual; port of entry for the article unless is shipped to the United States to the (18) The location and address where directed by CBP or FDA. port of arrival, or if this code is not the article of refused food will be or is (ii) Inaccurate prior notice. If prior applicable, then the name of the carrier. being held, the date the article has notice has been submitted and If the carrier is a privately owned arrived or will arrive at that location, confirmed by FDA for review, but upon vehicle, the license plate number of the and identification of a contact at that review of the notice or examination of vehicle and the State or Province that location. the article of food, the notice is determined to be inaccurate, the food is issued the license plate number; § 1.282 What must you do if information (17) Shipment information, as changes after you have received subject to refusal of admission under applicable to the mode of transportation confirmation of a prior notice from FDA? section 801(m)(1) of the act. If the article and when it exists: of food is refused due to inaccurate (a)(1) If any of the information (i) The Airway Bill number(s) or Bill prior notice, unless CBP concurrence is required in § 1.281(a), except the of Lading number(s), as applicable; obtained for export and the article is information required in: however, this information is not immediately exported from the port of required for an article of food when (i) Section 1.281(a)(5)(iii) (quantity), arrival under CBP supervision, it must carried by or otherwise accompanying (ii) Section 1.281(a)(11) (anticipated be held within the port of entry for the an individual when entering the United arrival information), or article unless directed by CBP or FDA. States. If the article of food arrived by (iii) Section 1.281(a)(17) (planned (iii) Untimely prior notice. If prior express consignment operator or carrier, shipment information), changes after notice has been submitted and and neither the submitter nor you receive notice that FDA has confirmed by FDA for review, but the transmitter is the express consignment confirmed your prior notice submission full time that applies under § 1.279 for operator or carrier, and the prior notice for review, you must resubmit prior prior notice has not elapsed when the is submitted via the FDA PNSI, the notice in accordance with this subpart article of food arrives, the food is subject express consignment operator or carrier unless the article of food will not be to refusal of admission under section tracking number may be submitted in offered for import or imported into the 801(m)(1) of the act, unless FDA has lieu of the Airway Bill number(s) or Bill United States. already reviewed the prior notice, of Lading number(s), as applicable. (2) If any of the information required determined its response to the prior Until such time as FDA and CBP issue in § 1.281(b), except the information notice, and advised CBP of that a determination that ACS or its required in § 1.281(b)(10) (the response. If the article of food is refused successor system can accommodate anticipated date of mailing), changes due to untimely prior notice, unless such transactions, the tracking number after you receive notice that FDA has CBP concurrence is obtained for export may not be submitted in lieu of the confirmed your prior notice submission and the article is immediately exported Airway Bill number(s) or Bill of Lading for review, you must resubmit prior from the port of arrival under CBP number(s), if the prior notice is notice in accordance with this subpart, supervision, it must be held within the submitted via ABI/ACS; unless the article of food will not be port of entry for the article unless (ii) For food that arrived by ocean offered for import or imported into the directed by CBP or FDA. vessel, the vessel name and voyage United States. (2) Status and movement of refused number; (b) If you submitted the prior notice food. (i) An article of food that has been (iii) For food that arrived by air via the FDA PNSI, you should cancel refused under section 801(m)(1) of the carrier, the flight number. If the article the prior notice via the FDA PNSI. act and paragraph (a) of this section of food arrived by express consignment (c) If you submitted the prior notice shall be considered general order operator or carrier, and neither the via ABI/ACS, you should cancel the merchandise as described in section 490 submitter nor transmitter is the express prior notice via ACS by requesting that of the Tariff Act of 1930, as amended consignment operator or carrier, and the CBP cancel the entry. (19 U.S.C. 1490).

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(ii) Refused food must be moved confirmation, the food is subject to required, the parcel will be held by CBP under appropriate custodial bond unless refusal of admission under section for 72 hours for FDA inspection and immediately exported under CBP 801(m)(1) of the act. If before leaving the disposition. If FDA refuses the article supervision. If the food is to be held at port, the individual does not arrange to under section 801(m)(1) of the act and the port, FDA must be notified of the have the food held at the port or there is a return address, the parcel may location where the food is held at that exported, FDA or CBP may destroy the be returned to sender marked ‘‘No Prior port before the food is moved there. If article of food. Notice—FDA Refused.’’ If the article is the food is to be held at a secure facility (c) Post-Refusal prior notice refused and there is no return address outside the port, FDA must be notified submissions. (1) If an article of food is or FDA determines that the article of of the location of the secure facility refused under paragraph (a)(1)(i) of this food in the parcel appears to present a before the food is moved there. The section (no prior notice) and the food is hazard, FDA may dispose of or destroy refused food shall not be entered and not exported, prior notice must be the parcel at its expense. If FDA does shall not be delivered to any importer, submitted in accordance with §§ 1.280 not respond within 72 hours of the CBP owner, or ultimate consignee. If the food and 1.281(c). hold, CBP may return the parcel to the is to be held at a secure facility outside (2) If an article of food is refused sender or, if there is no return address, a port, the food must be taken directly under paragraph (a)(1)(ii) of this section destroy the parcel, at FDA expense. to that secure facility. (inaccurate prior notice) and the food is (f) Prohibitions on delivery and (3) Segregation of refused foods. If an not exported, the prior notice should be transfer. (1) Notwithstanding section article of food that is refused is part of canceled in accordance with § 1.282 and 801(b) of the act, an article of food a shipment that contains articles of food you must resubmit prior notice in refused under section 801(m)(1) of the that have not been placed under hold or accordance with §§ 1.280 and 1.281(c). act may not be delivered to the other merchandise not subject to this (3) Once the prior notice has been importer, owner, or ultimate consignee subpart, the refused article of food may submitted or resubmitted and confirmed until prior notice is submitted to FDA be segregated from the rest of the by FDA for review, FDA will endeavor in accordance with this subpart, FDA shipment. This segregation must take to review and respond to the prior has examined the prior notice, FDA has place where the article is held. FDA or notice submission within the determined that the prior notice is CBP may supervise segregation. If FDA timeframes set out in § 1.279. adequate, and FDA has notified CBP or CBP determines that supervision is (d) FDA review after refusal. (1) If an and the transmitter that the article of necessary, segregation must not take article of food has been refused food is no longer refused admission place without supervision. admission under section 801(m)(1) of under section 801(m)(1) of the act. (4) Costs. Neither FDA nor CBP are the act, a request may be submitted (2) During the time an article of food liable for transportation, storage, or asking FDA to review whether the that has been refused under section other expenses resulting from refusal. article is subject to the requirements of 801(m)(1) of the act is held, the article (5) Export after refusal. An article of this subpart under § 1.277, or whether may not be transferred by any person food that has been refused under the information submitted in a prior from the port or other designated secure paragraph (a) of this section may be notice is complete and accurate. A facility until prior notice is submitted to exported with CBP concurrence and request for review may not be used to FDA in accordance with this subpart, under CBP supervision unless it is submit prior notice or to resubmit an FDA has examined the prior notice, seized or administratively detained by inaccurate prior notice. FDA has determined that the prior FDA or CBP under other authority. If an (2) A request may be submitted only notice is adequate, and FDA has notified article of food that has been refused by the carrier, submitter, importer, CBP and the transmitter that the article admission under paragraph (a) of this owner, or ultimate consignee. A request of food no longer is refused admission section is exported, the prior notice must identify which one the requester under section 801(m)(1) of the act. After should be cancelled within 5-business is. this notification by FDA to CBP and days of exportation. (3) A request must be submitted in transmitter, entry may be made in (6) No post-refusal submission or writing to FDA and delivered by fax or request for review. If an article of food accordance with law and regulation. e-mail. The location for receipt of a (g) Relationship to other admissibility is refused under section 801(m)(1) of the request is listed at http://www.fda.gov— decisions. A determination that an act and no prior notice is submitted or see Prior Notice. A request must include article of food is no longer refused resubmitted, no request for FDA review all factual and legal information under section 801(m)(1) of the act is is submitted in accordance with necessary for FDA to conduct its review. different than, and may come before, paragraph (d) of this section, or export Only one request for review may be determinations of admissibility under has not occurred in accordance with submitted for each refused article. other provisions of the act or other U.S. paragraph (a)(5) of this section, the (4) The request must be submitted laws. A determination that an article of article of food shall be dealt with as set within 5-calendar days of the refusal. food is no longer refused under section forth in CBP regulations relating to FDA will review and respond within 5- 801(m)(1) of the act does not mean that general order merchandise (19 CFR part calendar days of receiving the request. it will be granted admission under other 127), except that, unless otherwise (5) If FDA determines that the article provisions of the act or other U.S. laws. agreed to by CBP and FDA, the article is not subject to the requirements of this may only be sold for export or subpart under § 1.277 or that the prior § 1.284 What are the other consequences destroyed. notice submission is complete and of failing to submit adequate prior notice or (b) Food carried by or otherwise accurate, it will notify the requester, the otherwise failing to comply with this accompanying an individual. If food transmitter, and CBP that the food is no subpart? carried by or otherwise accompanying longer subject to refusal under section (a) The importing or offering for an individual arriving in the United 801(m)(1) of the act. import into the United States of an States is not for personal use and does (e) International mail. If an article of article of food in violation of the not have adequate prior notice or the food arrives by international mail with requirements of section 801(m) of the individual cannot provide FDA or CBP inadequate prior notice or the PN act, including the requirements of this with a copy of the prior notice (PN) confirmation number is not affixed as subpart, is a prohibited act under

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section 301(ee) of the act (21 U.S.C. a port, the food must be taken directly www.fda.gov—see Prior Notice. The 331(ee)). to that secure facility. notification should include the (b) Section 301 of the act prohibits the (d) Segregation of held foods. If an applicable CBP entry identifier. doing of certain acts or causing such article of food that has been placed (3) If FDA determines that the article acts to be done. under hold under section 801(l) of the is no longer subject to hold, it will (1) Under section 302 of the act (21 act is part of a shipment that contains notify the person who provided the U.S.C. 332), the United States can bring articles that have not been placed under registration information and CBP that a civil action in Federal court to enjoin hold, the food under hold may be the food is no longer subject to hold persons who commit a prohibited act. segregated from the rest of the shipment. under section 801(l) of the act. (2) Under sections 301 and 303 of the This segregation must take place where (j) FDA review after hold. (1) If an act (21 U.S.C. 331 and 333), the United the article is held. FDA or CBP may article of food has been placed under States can bring a criminal action in supervise segregation. If FDA or CBP hold under section 801(l) of the act, a Federal court to prosecute persons who determine that supervision is necessary, request may be submitted asking FDA to are responsible for the commission of a segregation must not take place without review whether the facility associated prohibited act. supervision. with the article is subject to the (c) Under section 306 of the act (21 (e) Costs. Neither FDA nor CBP will requirements of section 415 of the act. U.S.C. 335a), FDA can seek debarment be liable for transportation, storage, or A request for review may not be of any person who has been convicted other expenses resulting from any hold. submitted to obtain a registration of a felony relating to importation of (f) Export after hold. An article of food number. food into the United States or any that has been placed under hold under (2) A request may be submitted only person who has engaged in a pattern of section 801(l) of the act may be exported by the carrier, submitter, importer, importing or offering for import with CBP concurrence and under CBP owner, or ultimate consignee of the adulterated food that presents a threat of supervision unless it is seized or article. A request must identify which serious adverse health consequences or administratively detained by FDA or one the requestor is. death to humans or animals. CBP under other authority. (3) A request must be submitted in (g) No registration or request for writing to FDA and delivered by fax or § 1.285 What happens to food that is review. If an article of food is placed e-mail. The location for receipt of a imported or offered for import from under hold under section 801(l) of the request is listed at http://www.fda.gov— unregistered facilities that are required to act and no registration number or see Prior Notice. A request must include register under subpart H of this part? request for FDA review is submitted in all factual and legal information (a) Consequences. If an article of food accordance with paragraph (j) of this necessary for FDA to conduct its review. from a foreign facility that is not section or export has not occurred in Only one request for review may be registered as required under section 415 accordance with paragraph (f) of this submitted for each article under hold. of the act (21 U.S.C. 350d) and subpart section, the food shall be dealt with as (4) The request must be submitted H of this part is imported or offered for set forth in CBP regulations relating to within 5-calendar days of the hold. FDA import into the United States, the food general order merchandise, except that, will review and respond within 5- is subject to being held under section unless otherwise agreed to by CBP and calendar days of receiving the request. 801(l) of the act (21 U.S.C. 381(l)). FDA, the article may only be sold for (5) If FDA determines that the article (b) Hold. Unless CBP concurrence is export or destroyed. is not from a facility subject to the obtained for export and the article is (h) Food carried by or otherwise requirements of section 415 of the act, immediately exported from the port of accompanying an individual. If an it will notify the requestor and CBP that arrival, if an article of food has been article of food carried by or otherwise the food is no longer subject to hold placed under hold under section 801(l) accompanying an individual arriving in under section 801(l) of the act. of the act, it must be held within the the United States is not for personal use (k) International mail. If an article of port of entry for the article unless and is placed under hold under section food that arrives by international mail is directed by CBP or FDA. 801(l) of the act because it is from a from a foreign facility that is not (c) Status and movement of held food. foreign facility that is not registered as registered as required under section 415 (1) An article of food that has been required under section 415 of the act of the act and subpart H of this part, the placed under hold under section 801(l) and subpart H of this part, the parcel will be held by CBP for 72 hours of the act shall be considered general individual may arrange to have the food for FDA inspection and disposition. If order merchandise as described in held at the port or exported. If such the article is placed under hold under section 490 of the Tariff Act of 1930, as arrangements cannot be made, the section 801(l) of the act and there is a amended (19 U.S.C. 1490). article of food may be destroyed. return address, the parcel may be (2) Food under hold under section (i) Post-hold submissions. (1) To returned to sender marked ‘‘No 801(l) of the act must be moved under resolve a hold, if an article of food is Registration—No Admission appropriate custodial bond unless held under paragraph (b) of this section Permitted.’’ If the article is under hold immediately exported under CBP because it is from a foreign facility that and there is no return address or FDA supervision. If the food is to be held at is not registered, the facility must be determines that the article of food in the the port, FDA must be notified of the registered and a registration number parcel appears to present a hazard, FDA location where the food is held at the must be obtained. may dispose of or destroy the parcel at port before the food is moved there. If (2) The FDA Prior Notice Center must its expense. If FDA does not respond the food is to be held at a secure facility be notified of the applicable registration within 72 hours of the CBP hold, CBP outside the port, FDA must be notified number in writing. The notification may return the parcel to the sender of the location of the secure facility must provide the name and contact marked ‘‘No Registration—No before the food is moved there. The food information for the person submitting Admission Permitted’’ or, if there is no subject to hold shall not be entered and the information. The notification may be return address, destroy the parcel, at shall not be delivered to any importer, delivered to FDA by fax or e-mail. The FDA expense. owner, or ultimate consignee. If the food contact information for these delivery (l) Prohibitions on delivery and is to be held at a secure facility outside methods is listed at http:// transfer. Notwithstanding section 801(b)

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of the act, while an article of food is no longer subject to hold under section Dated: October 29, 2008. under hold under section 801(l) of the 801(l) of the act is different than, and Michael Chertoff, act, it may not be delivered to the may come before, determinations of Secretary of Homeland Security. importer, owner, or ultimate consignee. admissibility under other provisions of Dated: July 1, 2008. If an article of food is no longer subject the act or other U.S. laws. A Michael O. Leavitt, to hold under section 801(l) of the act, determination that an article of food is entry may be made in accordance with no longer under hold under section Secretary of Health and Human Services. law and regulation. 801(l) of the act does not mean that it [FR Doc. E8–26282 Filed 10–31–08; 11:15 am] (m) Relationship to other will be granted admission under other admissibility provisions. A BILLING CODE 4160–01–S provisions of the act or other U.S. laws. determination that an article of food is

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