Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 1</CFR> <DEPDOC>[Docket No. FDA-2011-N-0179]</DEPDOC> <RIN>RIN 0910-AI75</RIN> <SUBJECT>Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its prior notice regulation to add a requirement that prior notice and food facility registration information be submitted within a certain timeframe after certain notices of refusal or hold have been issued (“post-refusal” and “post-hold” submission) or responses to requests for FDA review have been issued and beginning October 1, 2026, add a requirement that the prior notice for articles of food arriving by international mail include the name of the mail service and a mail tracking number. The rule will also finalize certain technical changes, including those that reflect expanded capabilities of the Automated Broker Interface/Automated Commercial Environment/International Trade Data System (ABI/ACE/ITDS) and the Prior Notice Systems Interface (PNSI). These amendments will improve program efficiency and better enable FDA to protect the U.S. food supply and public health. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective October 27, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> For access to the docket to read background documents or comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">With regard to the final rule:</E> Christopher Henderson, Office of Inspections and Investigations, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20852, 240-402-8186, <E T="03">Christopher.Henderson@fda.hhs.gov.</E> <E T="03">Regarding the information collection:</E> Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, <E T="03">PRAStaff@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose of the Final Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Final Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Table of Abbreviations/Commonly Used Acronyms in This Document</FP> <FP SOURCE="FP-2">III. Background</FP> <FP SOURCE="FP1-2">A. Need for the Regulation</FP> <FP SOURCE="FP1-2">B. History of This Rulemaking</FP> <FP SOURCE="FP1-2">C. Summary of Comments to the Proposed Rule</FP> <FP SOURCE="FP-2">IV. Legal Authority</FP> <FP SOURCE="FP-2">V. Comments on the Proposed Rule and FDA Response</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. General Comments and FDA Response</FP> <FP SOURCE="FP1-2">C. Comments on Proposal To Require Post-Refusal and Post-Hold Submissions of Registration Within 30 Calendar Days and FDA Response (Proposed § 1.285(i)(1))</FP> <FP SOURCE="FP1-2">D. Comments on Proposal To Require Post-Refusal and Post-Hold Submissions of Prior Notice Within 10 Calendar Days and FDA Response (Proposed § 1.283(c))</FP> <FP SOURCE="FP-2">VI. Effective/Compliance Date(s)</FP> <FP SOURCE="FP-2">VII. Economic Analysis of Impacts</FP> <FP SOURCE="FP-2">VIII. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">IX. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">X. Federalism</FP> <FP SOURCE="FP-2">XI. Consultation and Coordination With Indian Tribal Governments</FP> <FP SOURCE="FP-2">XII. References</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Final Rule</HD> FDA is issuing a final rule to amend the prior notice regulation as follows: (1) amend § 1.281(b)(10) (21 CFR 1.281(b)(10)) to add a requirement, beginning October 1, 2026, for people submitting prior notice for articles of food arriving by international mail to provide the name of the mail service and the mail tracking number;  <SU>1</SU> <FTREF/> (2) amend § 1.283 (21 CFR 1.283) to add a requirement that prior notice be submitted within 10 calendar days from the date a notice of refusal or hold was issued or 10 calendar days from the date the response to a request for FDA review under § 1.283(d) was issued; (3) amend § 1.285 (21 CFR 1.285) to add a requirement that Food Facility Registration (FFR) be submitted within 30 calendar days from the date a notice of refusal or hold was issued or 30 calendar days from the date the response to a request for FDA review under § 1.285(j) was issued; and (4) make certain technical amendments. <FTNT> <SU>1</SU>  Note that FDA generally intends to exercise enforcement discretion when there is no prior notice if the food is offered for import for non-commercial purposes with a non-commercial shipper. See Compliance Policy Guide “Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002,” announced in the <E T="04">Federal Register</E> on May 6, 2009 (74 FR 20955). </FTNT> To effectively carry out its responsibility to detect food articles offered for import that are adulterated or pose a public health risk, FDA must be able to identify and inspect food items that are imported by international mail. Receiving the name of the mail service and a mail tracking number for articles of food arriving by international mail will enable FDA to better coordinate with the U.S. Postal Service (USPS), U.S. Customs and Border Protection (CBP), and other Agencies to track and inspect articles that have been identified as a possible bioterrorism risk. Currently, FDA does not receive the name of the mail service or tracking numbers for articles of food arriving by international mail. This makes it difficult for FDA to stop articles from being delivered to U.S. recipients that FDA believes pose a bioterrorism risk. Having the name of the mail service and tracking numbers for articles of food arriving by international mail will help FDA better plan its operations and stop such articles from being delivered. Many foods are regularly imported by international mail, and in FDA's experience, these foods can present similar risks to the U.S. food supply as other imported foods. Further, based on FDA's experience at international mail facilities, people are increasingly using the mail system to import foods, including foods that could pose a significant risk to public health. The use of the mail system to import foods highlights the need for FDA to have the name of the mail service and tracking number to adequately monitor, inspect, and refuse or hold specific food shipments. Additionally, requiring a reasonable timeframe for post-refusal and post-hold submissions of prior notice and FFR may reduce the amount of time articles subject to refusal or holds are held at ports of entry, thus reducing associated monetary charges. It will also enable FDA to utilize its resources more effectively by delineating the post-refusal and post-hold submission timeframe. Without a date by which such submissions must be made, FDA has spent long periods of time ( <E T="03">e.g.,</E> weeks and months) reviewing multiple replacement non-compliant prior notice or registration submissions. In addition, the final rule amends § 1.280(a)(2) (21 CFR 1.280(a)(2)) to remove the requirement that prior notice of foods arriving by international mail be submitted exclusively through FDA PNSI. This amendment enables prior notice for food arriving by international mail to be submitted through the PNSI or through the U.S. CBP ABI/ACE/ITDS. Further, § 1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) are amended to cross-reference product coding requirements for infant formula under § 106.80 (21 CFR 106.80). These regulations currently cross-reference § 106.90 (21 CFR 106.90) when referring to lot or code number requirements for infant formula. Section 106.90 establishes requirements related to current good manufacturing practice, while § 106.80 establishes product coding requirements for infant formula. Therefore, § 1.281(a)(5)(iv), (b)(4)(iv), and (c)(5)(iv) are amended to refer to § 106.80 instead of § 106.90. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Final Rule</HD> This final rule amends §§ 1.281(b)(10), 1.283(a)(6) and (c), 1.285(g) and (i), and 1.280(a)(2). Currently, § 1.281(b)(10), which applies to articles arriving by international mail, requires only the submission of the anticipated date of mailing. This rule amends § 1.281(b)(10) to include an additional requirement, beginning October 1, 2026, to submit the name of the mail service and mail tracking number in the prior notice to FDA for food articles arriving by international mail. Sections 1.283(a)(6) and (c) and 1.285(g) and (i), with few exceptions and if other requirements are met, require an article of food that has been refused under section 801(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)) (no prior notice or inaccurate prior notice) or held under section 801(1) of the FD&C Act (importation from unregistered foreign facility that is required to register) to be treated as general orde ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 72k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━