FDA entry reject? Could be a food facility registration issue…


If your entry was subject to an FDA reject, perhaps the food facility involved was not properly registered.

Per CSMS #17-000078:

FDA invalidated food facility registrations that failed to renew during the 2016 biennial registration period. In addition, food facility registration were invalidated for failure of confirmation by a US Agent and/or foreign manufacturer (registered by a third party) as required under the FDA Food Safety Modernization Act (FSMA), Section 415 of the Federal Food, Drug, and Cosmetics Act (FD&C Act) [21 U.S.C. § 350D] and in accordance with 21 CFR 1.231(a)(5) and (b)(7). (Please see related CSMS message 16-001052). [And see our related blog post]

  • If you are receiving an entry rejection for an invalid registration, you will need to confirm the status of the registration with the manufacturer. The manufacturer may check the status of their registration by logging into their FURLS Food Facility Registration Module account to verify the status of the individual registration.
  • Registrations that have been invalidated cannot be renewed and a new registration will have to be created. The US Agent or the owner must confirm the receipt of the registration within 30 days for it to be valid in the FDA reference database.
  • Failure to have a valid registered manufacturer can cause a shipment delay greater than 24 hours, therefore it is not recommended to file a prior notice if the registration is pending or use a facility registration that was invalidated due to failure to renew or confirmed by the US Agent/Owner.

ACE information: For this reject the sub-reason code 112 is sent back in the SO transaction for entries, SO71 record. For Stand-Alone prior notice filings, in the PO transaction the code 112 is in the PO71 record.

  • Contact FURLS Registration Help Desk at FURLS@fda.gov or 800-216-7331 to verify the current status of the your Food Facility Registration. Please expect long wait times for phone calls.
  • Contact FDA ACE Support 24/7 at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries to determine the rejection reason.
  • Contact Division of Food Defense Targeting at prior.notice@fda.hhs.gov or 866-521-2297 for assistance with valid food registrations verified by FURLS Registration Desk that may be rejecting improperly.

NCBFAA comments to CBP’s proposed electronic notice of liquidation rules



In follow up to our recent post regarding US Customs’ proposal to modernize the paper-based Notice of Liquidation process by making it a paperless electronic system, NCBFAA has submitted comments to the proposed regulations.  The comments are generally supportive of CBP’s efforts, but include suggestions to improve the new process:


  • The NCBFAA supports the posting of liquidation information to the www.CBP.gov website provided that the link is indeed conspicuous. In this regard, we believe that the regulation should specify that the liquidation link will be visible on the CBP home page so that it is indeed conspicuous and remains so without regard to current or future website design. The trade should not have to search the website to locate the liquidation link.
  • The commentary to the NPRM provides that once the liquidation information has been posted electronically, the information will be available on www.cbp.gov for a minimum of 15 months. This commitment is not echoed in the draft regulation and it should be. This is critical for issues relating to the timeliness of claims and jurisdiction in the Court of International Trade. Similarly, the process for requesting access to notices that are no longer available on the website should be codified in the regulations.
  • The NPRM proposes to modify section 159.9(c)(2)(i) but continue to provide that for entries that liquidate by operation of law, notice “will be posted on www.cbp.gov within a reasonable period after each liquidation by operation of law.” In the electronic environment, CBP has the ability to post these liquidations immediately when they occur. There is no longer a basis for delayed notification and the regulation should be revised to provide that notice of liquidation for these entries will be posted on the date of liquidation. There is no basis to distinguish these entries from entries which are manually liquidated.



CBP: Notice of Liquidation process to leave the Stone Age



Protest filers rejoice! As part of the ACE modernization process, US Customs is proposing to convert the cumbersome, paper-based Notice of Liquidation process to a more efficient paperless electronic system.

In today’s Federal Register, CBP has announced a proposal to post official notice of liquidation for all entries, including entries filed in paper form, as well as official notices regarding the extension or suspension of liquidation, at www.cbp.gov.

This proposed electronic posting will replace both the physical posting or lodging of bulletin notices in the customhouse as the legal evidence of liquidation and the mailed notices of extension or suspension as official notice.


Some details:

  • The information will instead be accessible via a conspicuous link on the www.cbp.gov, labeled “Bulletin Notices of Liquidation. “
  • The electronic bulletin notices will be searchable on the CBP Web site by 10 data elements, such as entry number, IOR number, filer, etc.
  • The liquidation information posted electronically will be updated daily.
  • The information will be available on www.cbp.gov for a minimum of 15 months.
  • Electronic filers, using their ACE Portal Account, will be able to access historical liquidation information that is no longer available on the CBP Web site, run queries for information on recent liquidations, extensions, and suspensions, run targeted reports to conduct in-house audits, identify systemic errors, and more.

The public comment period on this proposed regulatory change is open until November 14, 2016.

CBP: Proposed regs to modernize TSCA importation process

man in white coat pouring orange liquid with into a glass












US Customs, in conjunction with EPA, is proposing to amend the regulations regarding the requirement to file a Toxic Substances Control Act (TSCA) certification when importing chemicals into the United States as follows:

  1. Revise/clarify the definitions of “chemical substance”, “chemical substance in bulk form” and  ‘‘chemical substances, mixtures, or articles’’
  2. Provide an electronic option for filing TSCA certifications in ACE
  3. Eliminate the existing paper-based blanket certification process.
  4. Allow importers to provide electronic notice of exportation and abandonment as an alternative to the paper-based written notice process allowed under the existing regulations

The public comment period closes on September 28, 2016


CBP/EPA: Harmonize import entry requirements for different classes of vehicles, engines and allow e-filing of docs


From today’s Federal Register:

In an effort to provide consistency in the administration of CBP’s vehicle and engine imports program so that importers of both road vehicles and engines, as well as stationary and nonroad engines (including engines incorporated into vehicles or equipment), are subject to the same filing and recordkeeping requirements, CBP is proposing to conform the entry filing requirements applicable to the EPA Declaration Form 3520-21 to those that currently exist for EPA Declaration Form 3520-1

CBP proposes to amend existing regulations to permit the electronic filing of EPA Declaration Forms 3520-1 and 3520-21 to CBP in the ACE or to any other CBP-authorized electronic data interchange system. (The EPA declaration forms may also still be filed with CBP in paper with a paper entry filing at the time of entry.)

The electronic transmission to CBP of EPA declaration forms will

  • automate and enhance the interaction between the EPA and CBP by facilitating electronic collection, processing, sharing, and review of requisite trade data and documents during the cargo import and export process.
  • provide for a quicker and more efficient clearance process and enhance CBP’s ability to conduct targeting and enforcement of importation requirements.
  • permit CBP to analyze and flag problems immediately, whereas paper filings result in an ad-hoc process that requires a physical inspection by a CBP or EPA inspector.

Comments on the proposed rule must be received on or before September 16, 2016.

CBP wants to collect more information on Form 5106

5106As posted in the Federal Register, US Customs has proposed changes to its Importer ID Input Record (CBP Form 5106) to gather additional information about an importing company and its officers.  The 5106 form, which is filed with an importer’s first formal entry, enables CBP to “make an informed assessment of risk prior to the initial importation…”  The new data sought on the form “will provide CBP with a greater knowledge about the company and its previous business practices.”

US Customs is seeking comments that address whether the proposed 5106 changes will comply with the Paperwork Reduction Act of 1995.  And in that regard, the trade is preparing to comment.  For example, according to John Pellegrini, Customs Counsel for the United States Fashion Industry Association:

The major change in the form is to require much more information about the company and its officers. Specifically, the form requires personal information (SSN, Passport No., etc.) for those officers who have importing and financial business knowledge of the company and the legal authority to make decisions on behalf of the company. This information is not required on the current form.

Other new information required includes the D-U-Ns number, the company’s primary banking institution, the state or country in which the company was incorporated and a unique identifying number for the appropriate Certificate of Incorporation.

Comments on the proposal are due on or before December 8, 2014.


CBP may stiffen “first sale” rule

US Customs and Border Protection logoAs the European Union and Japan have taken steps to eliminate their “first sale” rules for imports int0 their jurisdictions, US Customs is proposing changes that may make it more difficult for US importers to avail themselves of the rule.

The first sale rule has been popular among importers since it allows them to value their imported goods — and calculate duties owed — at the price paid at the “first sale” of those goods in the transaction chain, rather than the actual price paid to the exporting entity, if certain conditions are satisfied.

To determine whether the requirements for first sale are satisfied, CBP has proposed, in a draft Informed Compliance Publication, a checklist of documents that Customs may request in an audit.  As pointed out by Drinker Biddle & Reath LLP, the checklist now “includes many financial-related documents that in the past have not been consistently requested by CBP.”  These documents would allow CBP to request “exhaustive financial detail for all parties to the transaction, which would likely prove to be a laborious and intrusive process for related-party first sale scenarios.”

This is the second time in recent years that CBP has attempted to tighten the first sale rules.


FDA: Importers must vouch for safety of food brought to US

fdalogoUnder the US Food and Drug Administration’s newly proposed regulations, US food importers for the first time must ensure that imported food for humans and animal is as safe as domestically produced food.

Promulgated under the Food Safety Modernization Act (FSMA), the rules, if adopted, would set parameters for foreign supplier verification programs (FSVPs) that importers must create and follow to safeguard the nation’s food supply.  The proposed rules also call for an accreditation program for third-party auditors of imported food.

According to last week’s FDA press release,

[t]he new measures respond to the challenges of food safety in today’s global food system.  Imported food comes into the United States from about 150 different countries and accounts for about 15 percent of the U.S. food supply, including about 50 percent of the fresh fruits and 20 percent of the fresh vegetables consumed by Americans.

If food importers fail to comply with the new rules, they are subject to entry and/or eligibility denials to participate in FDA’s voluntary qualified importer program (VQIP) for expedited review and entry of food, which is currently in development.  The public comment period on the proposed rules closes on November 26.





Keeping manifest information confidential in ACE

As a common practice, importers and consignees may submit a request to US Customs, pursuant to 19 CFR 103.31, to keep manifest information confidential.  Our previous blog post on this topic includes several tips to ensure these requests result in the broadest degree of confidentiality.

Recently, importers and consignees who have submitted confidentiality requests have complained to CBP that confidential shipping data — party/shipper/consignee name and address — for ocean freight have nevertheless been disclosed to the public.  After reviewing the matter, Customs has determined that “improper data entry” was the cause.  To avoid this, CBP advises in a recent CSMS publication, when filing e-Manifests in ACE, “the commercial party name fields must ONLY contain commercial party name data.”  Otherwise,

“…the name of the party stored in the ACE database is corrupted because it includes address data. This inaccurate party name data fails the confidentiality edits resulting in confidential business information being shared publicly. This inadvertent disclosure is tied directly to the way in which data is transmitted by users.”

Additional information can be found in CBP’s CSMS #13-000064.

CBP updates “informal entry” threshold

Effective January 7, 2013, US Customs will increase the threshold value to $2,500 for merchandise to qualify for “informal entry” treatment.

From the Federal Register website:

Currently, for any merchandise valued over $2,000, CBP requires importers to provide a surety bond, complete CBP form 7501, and pay a minimum of $25 in Merchandise Processing Fees (MPF). The final rule increases the limit, from $2,000 to $2,500, for which merchandise may qualify for an “informal entry”, thereby eliminating the need for a surety bond, expediting the customs clearance process, and reducing the required MPF amount to $2 (assuming the entries are filed electronically). CBP is increasing the informal entry limit to mitigate the effects of inflation and in addition, to meet a commitment of the Beyond the Border Initiative between the United States and Canada, to increase and harmonize the value thresholds to $2,500 for expedited customs clearance from the current levels of $2,000 for the United States and $1,600 for Canada.