COVID-19 DAILY ROUND-UP FOR 4/3/20

NCBFAA COVID-19 Daily Round-Up for April 3

With the on-going disruption COVID-19 is causing the Trade community, the NCBFAA intends to keep our members updated on all developments that will affect their businesses and everyday lives.

White House No Longer Considering Duty Payment Deferral

In an interview with  Bloomberg TV ] earlier today, National Economic Council Director Larry Kudlow stated that the White House was not considering a 90-day deferral of tariff payments. Kudlow said, "We never looked at any serious way of rolling back tariffs. The deal with China is in place. That's going to be implemented. USMCA is in place. We looked a little bit at most favored nation customs duties and decided it was too complicated and it might send the wrong signals. I would not expect to see any movement on tariffs right now."

FDA Updates Face Mask Guidance Document

The U.S. Food and Drug Administration (FDA) issued updated guidance for the "Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency." This new guidance document supersedes the "Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency" issued on March 25, 2020. 

Chinese Licenses for PPEs

Please note: The following is a translation of the Chinese government's  National Medical Products Administration  provided to us by an NCBFAA member. It is recommended that each forwarder work with their shippers in China on the specifics.   

Effective from April 1, 2020, enterprises (Exporter of Record) that export COVID-19 test kits, medical masks, medical protective suit, ventilator, infrared thermometers must provide an additional document of a written or electronic statement when submitting for export Customs clearance, evidencing the export products have obtained China's Medical Device Product Registration Certificate (relevant registration information) and meet the quality standards of the importing country or area.

Note that the Medical Device Product Registration Certificate issued by China National Medical Products Administration is not new but more reinforcement that it is a compulsory document for Customs inspection and release. Manufacturers in China producing medical supplies should register with China National Medical Products Administration to obtain the above Medical Device Product Registration Certificate.

China's relevant medical device product registration information as of April 1, 2020, for reference (dynamic update of the  website  of the State Drug Administration), please validate with China exporter or manufacturer in advance.

CARES Act Provisions to Benefit Shipping Industry

Client Alert from GKG Law

Republished with Permission

On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The $2.2 trillion stimulus bill passed by Congress is the largest federal response in history designed to mitigate the impacts of the COVID-19 pandemic. As COVID-19 has greatly affected the shipping industry due to quarantines, travel restrictions, delays in processing cargo, lack of cargo storage space, and millions of containers laying idle, the CARES Act can potentially provide relief to businesses who are experiencing difficulties. The CARES Act includes measures to assist distressed industries and businesses. Although the CARES Act does not specifically provide funding and financing for the shipping industry as it has the aviation industry, the shipping industry should take note of the following provisions and key points that apply to businesses: 

Paycheck Protection Program  

  • The Paycheck Protection Program (PPP) authorizes $349 billion in forgivable loans for small businesses and their workforce. The PPP defines a small business as one with no more than 500 employees ("employee" includes individuals employed on a full-time, part-time and other basis). Sole proprietors, independent contractors, and certain self-employed individuals are also included. 

  • The PPP is meant to incentivize small businesses to keep employees on their payroll. Loans issued under PPP will be forgiven if the business's employee and compensation levels are maintained, and the funds are used for payroll costs, rent, utilities and interest on mortgages for the eight-week period after the loan is made; 75% of the forgiven amount must be used for payroll. Additionally, loan payments will be deferred for six months. 

  • The PPP provides for up to $10 million in small business loans as part of the Small Business Administration's (SBA) 7(a) loan guaranty program for the covered period of February 15, 2020, through June 30, 2020. Additionally, loans under the SBA's Express loan program have been increased from $350,000 to $1 million until December 31, 2020. SBA Express Loans can be processed within 36 hours. 

  • The maximum loan amount under the 7(a) loan guaranty program is $10 million and can be used to cover "payroll costs" (e.g. salaries, wages, commissions, costs related to the continuation of group health care benefits, rent, utilities, etc.). "Payroll costs" does not include compensation for an individual employee in excess of $100,000 per year, prorated for the covered period, employees whose principal residence is outside the United States, certain taxes and qualified sick and family leave subject to certain credits.

  • Under the PPP, borrowers must certify the following: that the loan request is necessary due to the uncertainty of the current economic conditions; that the funds will be used to retain workers and maintain payroll; that borrower does not already have an application pending; and that borrower has not already received funds under this section for the same purpose. Additionally, lenders are required to confirm whether the borrower was in operation on February 15, 2020, and had paid salaries and payroll taxes for its employees (or independent contractors).

  • Small businesses can apply through any existing SBA 7(a) lender, federally insured depository institution, federally insured credit union, and any participating Farm Credit system institution. 

  • Lenders can begin processing applications on April 3, 2020, until June 30, 2020. Additional information on the PPP can be found here. The application for a PPP loan is relatively simple and can be found here. 

Emergency EIDL Grants

  • Provides $10 billion in small business loans as part of the SBA's economic injury disaster loan (EIDL) program for small businesses, private nonprofit organizations and small agricultural cooperatives.

  • The maximum EIDL loans is a $2 million working capital loan with a 3.75% interest rate for small businesses and a 2.75% interest rate for non-profits with up to a 30-year term. Payments on an EIDL loan are deferred for one year. 

  • EIDL loans can be used to pay fixed debts, payroll, accounts payable, and other financial obligations for ordinary and necessary operating expenses. However, it should be noted that a borrower that has received a PPP loan for employee salaries, payroll support, etc., cannot then receive an EIDL loan for the same purpose.

  • Under the EIDL grant, a borrower can request an advance on the loan up to $10,000, which will be distributed by the SBA within three days after the application has been submitted. There is no obligation to pay the $10,000 advance. However, unlike the PPP, the remainder of the EIDL loans is not forgivable. 

  • Applications for an EIDL loan are currently being accepted until December 31, 2020. Additional information on the EIDL can be found here and the EIDL application can be found here. 

Coronavirus Economic Stabilization Act of 2020

  • Under the Coronavirus Economic Stabilization Act, $500 billion has been allocated to the Department of Treasury's exchange stabilization fund for use in loans, loan guarantees, and other investments for businesses that do not qualify for small business relief. The $500 billion has been allocated as follows: $25 billion for passenger air carriers; $4 billion for cargo air carriers; $17 billion for businesses determined to be important to national security; and the remaining $454 billion is eligible for direct lending to distressed business, states, and municipalities. 

  • Under this section, the government cannot issue loans or loan guarantees unless the business has issued securities that are traded on a national securities exchange and the Secretary of the Treasury receives a warrant or equity interest in the eligible business. 

  • Loans and Loan guarantees under this section will be subject to certain requirements, which include: borrower must be an eligible business that does not have reasonably available access to credit; loans or guarantees must be sufficiently secured; duration of the loan is as short as practicable and no longer than five years; borrower and its affiliates cannot engage in stock buybacks; borrower must maintain its employment levels as of March 2020, to the extent practicable, until September 30, 2020; borrower must certify that it is a United States domiciled business or has significant operations in and a majority of their employees based in the United States; and the loan cannot be forgiven. 

It's likely that the CARES Act will not be the final action passed by Congress to address the impact that COVID-19 has had on the health and economic well-being of the nation. Future legislation is highly likely in order to provide additional economic assistance to distressed sectors of the economy in order to facilitate long-term recovery. 

If you have any questions, please contact Edward D. Greenberg ( egreenberg@gkglaw.com ; 202-342-5277); David K. Monroe ( dmonroe@gkglaw.com ; 202-342-5235); Brendan Collins ( bcollins@gkglaw.com ; 202-342-6793); or Kristine O. Little ( klittle@gkglaw.com ; 202-342-6751).

ATA Carnet | COVID-19: Expanded Best Practices

By:  Amanda Barlow , Roanoke Trade

Republished with Permission

Editor's note: Thank you to both  Roanoke Trade  and the  IFCBA  for information regarding this topic. 

COVID-19 continues to impact international travel, cargo shipments, and public and private events of all kinds. As such,  ATA Carnet  shipments are more susceptible to disruptions as country's take action to stop the spread of COVID-19. Even in relatively good conditions right now, you may encounter unexpected difficulties booking timely re-exportations to meet ATA Carnet expiration deadlines. We understand the concerns of our clients and partners and will continue to work to keep you informed as this situation progresses.

As of the posting of this article, most ATA Carnet members of countries have not made any specific COVID-19 related changes to policy, except for Italy and the Czech Republic who have set official guidelines and procedures for the handling of expired ATA Carnets in their customs territory.  Italy  is allowing for a one month grace period after the expiration date that does require approval from the Italian Guarantee Association. For longer than one month extensions Italian is recommending that a replacement ATA Carnet be obtained. The  Czech Republic  is allowing all ATA Carnets including expired ones to be treated as valid. This means that any ATA Carnet, even if expired, should be presented to Czech Customs for exportation as soon as possible.

We are working closely with the  U.S. Council for International Business  (USCIB) and the  International Chamber of Commerce  (ICC), seeking leniency around potential ATA Carnet claims in these unusual times. The USCIB is the National Guarantee Association (NGA) in the United States, and they interface directly with foreign customs to handle ATA Carnet claims. We partner with UCSIB and ICC, advocating on behalf of ATA Carnet users. We have received their official statement and recommendations on how our clients can best prepare for and handle possible claims situations.

In bringing together the advice of the USCIB and ICC, we recommend the following best practices to help our clients during these unprecedented times:

1. Be proactive around approaching ATA Carnet expiration dates. If your established re-exportation plans are disrupted, you don't want to get stuck with an ATA Carnet claim fee for late re-exportation in addition to the hassle of cargo rebooking. Reach out to our  ATA Carnet Helpdesk . We can assist with requesting an extension or providing a Replacement ATA Carnet which will allow an additional 12 months in most member countries.

2. Keep all documentation related to your trip. Airline tickets, cancellations, and rebooking confirmations, bills of lading or airway bills, hotel reservation extensions, and anything related to travel delays can help us as we work with the  U.S. Council for International Business  (USCIB) to mitigate any ATA Carnet claim issued against you that is the unforeseen and unavoidable result of this virus.

3. If you decide to obtain a  Replacement  (aka an extension ATA Carnet) please ensure to retain a copy of US Customs and Border Protection's validation of the green cover before sending it overseas. We want to ensure we have all supporting evidence that you did everything in a timely manner to comply with the ATA Carnet requirements even during the impacts of the global pandemic.

4. Reach out as early as possible if your trip is disrupted. We have been working closely with the USCIB regarding the COVID-19 impact on ATA Carnets, and we are here to advocate for you. The USCIB has a direct line to foreign guarantee associations and foreign customs, and together we can help. The sooner we start the process though, the better for you.

5. For ATA Carnet shipments in Italy seeking to take advantage of the grace period being offered, you need to send an email to the Italian NGA at  estero@legalmail.it , as well as include USCIB in the CC at  replacements@uscib.org ,  gsung@uscib.org , and  tsample@uscib.org . The email should include: a statement explaining that the reason for the delay in re-exportation is due to COVID-19 related complications, the ATA Carnet number, the expiration date and the name of the Customs office where the ATA Carnet is intended to be presented for re-exportation.

6. When returning ATA Carnets to Roanoke for cancellation please retain a copy in the event our courier deliveries are interrupted due to Safer At Home orders.

The following is the ICC's statement regarding the impact of COVID-19 on ATA Carnet Shipments:

"ICC has been closely following developments related to the very challenging COVID-19 pandemic and its potential impact on ATA Carnet holders, SMEs, and the business community more broadly.

 We noticed that many countries have issued travel bans and suspended flights to and from infected countries, regions and cities. Some countries and cities are under strict quarantine. Carnet holders and representatives in these affected areas are required to stay at home, rendering them unable to complete customs clearance and leave the border on time. The delivery of replacement carnets is also challenging given the potential suspension or delay in postal services in affected countries and regions. More importantly, not all customs authorities accept replacement ATA Carnets. All these facts made the use of ATA Carnets difficult, especially re-exportation of goods under Carnets expiring.

A letter from ICC Secretary General John Denton had been sent to Mr. Kunio Mikuriya, WCO Secretariat General, describing issues encountered and appealing that short delays in re-exportation attributable to the COVID-19 outbreak do not impact negatively NGAs and Carnet holders.

We are now waiting for WCO's response. However, please note that even if a general recommendation can be given by WCO, decisions related to ATA Carnet claims are eventually made at the national Customs' level. All National Guaranteeing Associations are advised to contact your Customs authorities immediately to see how your customs would like to deal with these problems. Please take active actions, no NGA can rest aside since NGAs are working as a chain.

In case your holder failed to re-export goods on time due to the COVID-19 pandemic, these incidents must be analyzed case by case, and the final decision of regularization can only be made by Customs authorities where temporary admissions were granted. For your interest, please collect as much documentation (e.g. alternative proofs of re-exportation, government notice of lockdown, airline ticket cancellations/rebookings, hotel reservation extension, etc..) as possible to support future claim cases.

 The only country we have received instructions on how to handle the delay is Italy."     

We recognize that this is an evolving situation, and encourage you to reach out to our team with any questions or concerns. Please let our experienced team of  ATA Carnet professionals  use their expertise to help.

If you have any questions or concerns please contact your ATA Carnet Team at 1.800.ROANOKE (800.762.6653) or  carnet@roanokegroup.com .

Helping Your Clients with ACH 

Tne NCBFAA Customs Committee reached out to U.S. Customs and Border Protection's (CBP) Financial Operations Division to inquire what brokers could do to help their clients apply for their own ACH statements. CBP was kind enough to share two sets of information. Here is an example of a well prepared ACH Application and a poorly prepared ACH Application.  

CBP also reports a high incidence of application rejections and questions, which can cause delays. Here is information from CBP that will help with questions you may have regarding the process:

When companies sign up for ACH, CBP initiates a pre-note, which is a test financial transaction to ensure they have a valid bank account and routing number. The company won't receive the ok from CBP until this pre-note is successful. This pre-note doesn't check for various actions that companies and/or banks include on accounts for internal control and fraud prevention purposes and these actions can result in debit vouchers, basically a stop payment from their bank two days after the funds are initially withdrawn (a.k.a. a bounced payment). CBP doesn't have visibility into these actions, but, some of the most common reasons that importers have communicated to the agency:

  • CBP wasn't an authorized party

  • The bank account had a per transaction limit. As an example, the bank account had a $5000 per transaction limit, so when CBP/Treasury attempted to withdraw a $6500 payment, a debit voucher resulted

  • The bank account had a cumulative limit. As an example, the bank account had a $100,000 per day (or week or month) limit, so when CBP/Treasury attempted to withdraw a payment for $70,000 it was successful but the subsequent payment attempt for $40,000 bounced because the cumulative of the two transactions was over the limit.

SDA APHIS Modifies Mail Service Hours at Headquarters and Hub Facilities

The United States Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) is modifying mailroom service hours at its Riverdale, Maryland, headquarters as well as at its three hub locations in Fort Collins, Colorado, Minneapolis, Minnesota, and Raleigh, North Carolina, until further notice. These changes will help ensure employee safety during the COVID-19 pandemic response while continuing business operations. Stakeholders are encouraged to utilize all available electronic resources if available to submit bills, permits, Freedom of Information Act Requests, etc. to ensure a timely response by our employees.

New Mail Room Service Hours:

If you have questions about the best way to send time-sensitive communications, please reach out to your usual USDA APHIS point of contact.

Covid-19 Update - 3/30/20

CBP

U.S. Customs and Border Protection has notified Customs Trade Partnership Against Terrorism members that processing of the paper annual notification letters via the trade compliance mailbox will be delayed. CBP is encouraging members to begin using the trade compliance portal to complete their profile information and submit their ANLs.

FDA

The Food and Drug Administration has provided the following instructions to the import community regarding the submission of entry information for personal protective equipment and certain other medical devices. The FDA states that following these instructions will help facilitate the import process for all, especially goods related to the COVID-19 public health emergency.

Personal protective equipment for general purpose or industrial use (i.e., products not intended for use to prevent disease or illness) is not regulated by the FDA and entry information for these types of products should not be transmitted to the FDA. Instead, importers should transmit entry information to U.S. Customs and Border Protection using an appropriate HTSUS code with (1) no FD flag or (2) an FD1 flag and a ‘disclaim’ for FDA.

For products authorized for emergency use pursuant to an emergency use authorization (click here for current list), entry information should be submitted to the FDA. However, only a reduced amount of FDA information is required for review; i.e., at the time of entry importers should transmit an intended use code of 940.000 (compassionate use/emergency use device) and an appropriate FDA product code.

For products regulated by the FDA as a medical device that are not authorized by a EUA but for which an enforcement discretion policy has been published in guidance, entry information should be submitted to the FDA. To date, guidance documents have been issued for the following products related to COVID-19: face masks and respirators, ventilators and accessories and other respiratory devices, non-invasive remote monitoring devices, and diagnostic tests. At the time of entry, importers should transmit intended use code 081.006 (enforcement discretion per final guidance) and an appropriate FDA product code.

Under both intended use codes listed above, the affirmations of compliance for medical devices (e.g., registration, listing, and pre-market numbers) are optional in the Automated Commercial Environment.

ITA

The International Trade Administration has modified through at least May 19 certain requirements for serving documents containing business proprietary information in antidumping and countervailing duty cases to facilitate the effectuation of service through electronic means. However, the ITA will continue to require the normal means of service for requests for administrative review, new shipper review, changed circumstances review, expedited review, scope ruling, and anti-circumvention inquiry.

USDA

The Department of Agriculture’s Animal and Plant Health Inspection Service states that it is continuing to provide all its regular plant and plant product import and export services, including (1) accepting and processing permit applications, (2) inspecting imported plants and plant products, (3) monitoring phytosanitary treatment activities, and (4) inspecting and certifying plants and plant products for export.

In addition, to help facilitate the clearance of imported plants and plant products during the COVID-19 emergency, APHIS and CBP are accepting electronically-produced versions of phytosanitary certificates. Importers and brokers may upload the electronic documents to the Automated Commercial Environment using the Document Imaging System or provide them by other means, such as email attachments. Acceptable phytosanitary certificates include scanned copies of original certificates, electronic certificates created through a participating country’s ePhyto system, or signed paper forms. Certificates should be legible and include APHIS-required statements.

In addition, APHIS will allow precleared consignments to be accompanied by an email from APHIS Plant Protection and Quarantine with an electronic copy of PPQ Form 203 attached if the original form is not available.

USTR

Medical and Other Goods Excluded from China Tariff; Retroactive Refunds Available Friday, March 27, 2020 Additional medical products and other goods have been excluded from the Section 301 additional 7.5 percent tariff on List 4A goods from China. These exclusions apply to the following.

- HTSUS 0505.10.0050 [feathers of a kind used for stuffing]

- HTSUS 3926.90.9925 [reflective triangular warning signs for road use]

- HTSUS 6506.10.3045 [athletic, recreational, and sporting headgear of reinforced or laminated plastics]

- HTSUS 8512.10.2000 [lighting equipment of a kind used on bicycles]

- HTSUS 8528.72.6420 [flat-panel TVs incorporating video recording or reproducing apparatus] - coverings, of plastics, designed to fit over wound sites or casts thereby forming a protective seal for keeping the covered area dry and debris free while showering or bathing (described in HTSUS 3926.90.9990)

- Pouches of plastics, of a kind used with manually operated pill or tablet crushers to capture the powdered medicaments (described in HTSUS 3926.90.9990)

- refillable dispensers of plastics, designed for mounting on a vertical wall, of a kind used to store and dispense emesis containment bags in medical settings (described in HTSUS 3926.90.9990)

- sterile urology drain bags of plastics, designed to fit over a urology table extension, with a flap extension that provides sterile separation of the patient from the table surface and directs fluids into and through a filter at the top of an attached drain hose leading to a collection container (described in HTSUS 3926.90.9990)

- Ice bags of textile materials, for treating injuries or soreness, each refillable (described in HTSUS 6307.90.9889)

- Identification wristbands of textile materials, each with a blank panel (described in HTSUS 6307.90.9889)

- apparatus suitable for wearing on the wrist, having time-display functions, each article having an accelerometer and being capable of displaying and transmitting data sent to it by a network (e.g., portable ADP unit, LAN or cellular network) (described in HTSUS 8517.62.0090)

These exclusions, which must be claimed using new HTSUS subheading 9903.88.44, will be retroactive to Sept. 1, 2019, and remain in place until Sept. 1, 2020. Importers should therefore review the list of excluded products and apply for refunds of any tariffs paid on such goods since Sept. 1, 2019.

While these exclusions cover 36 separate exclusion requests, the scope of each exclusion is governed by the descriptions given above and not by the description in any particular request (note that for the first five items above, the entire HTSUS number is covered and the product description in brackets is given for reference only). In addition, importers may utilize these exclusions for any product that meets the above descriptions, even if they did not request it.

COVID-19 Daily Round-Up for 3/27/20

With the on-going disruption COVID-19 is causing the Trade community, the NCBFAA intends to keep our members updated on all developments that will affect their businesses and everyday lives.

 

President Trump Signs Stimulus Package into Law 

President Trump today signed into law the $2 trillion bipartisan Coronavirus Aid, Relief, and Economic Security (CARES) Act bill, which hopes to grant relief to American workers and businesses who have been impacted by COVID-19.

This bill "includes $1,200 one-time payments to many Americans; sets up a $500 billion corporate liquidity fund to help struggling industries like airlines; allocated $377 billion for aid to small businesses; and boosts the maximum unemployment benefit by $600 per week for four months, among other provisions," writes the Hill. 

CBP/FDA Conference Call for March 27

Today's U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) focused on information needed for filing PPE and medical devices during the COVID-19 outbreak.

Sean Boyd, Director, Office of Regulatory Programs at FDA, began with a high-level overview of challenges the Center for Devices and Radiological Health have found when dealing with the COVID-19 outbreak. The agency has taken critical steps to try and respond and are doing everything in their power to increase access while keeping safe and secure. They do this through a couple of different mechanisms, one of which, is the Emergency Use Authorization (EUA). The EUA (EUA) authority allows FDA to help strengthen the nation's public health protections against chemical, biological, radiological and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures (MCM) needed during public health emergencies. In this case, the threat is COVID-19 and the products used to counter it are personal protective equipment (PPE), diagnostic tests and other devices. The second mechanism is the establishment of enforcement for guidance. FDA is putting together policy documents for COVID-19 and the EUA. Both policies are intended to remain in effect for the duration of this public health emergency. The guidance will also last only as long as the public health emergency. This guidance is for testing as well as policies. This currently includes face masks and respirators.  

John Verbeten, Acting Director, Office of Enforcement and Import Operations at FDA, spoke next about the different categories of PPE. These are FDA regulated for handling the same as before as long as those are products that don't fall into one of the other categories. For those products, FDA has provided additional information to make entry declarations regarding which "bucket." FDA issued a CSMS earlier in the week and sent out an updated version yesterday. The most recent and current info can be found in the CSMS #42168200. The first bucket is non-FDA regulated general-purpose PPE. These are items by their nature that are not indicated for medical use. For these, no entry declarations are required to FDA. You will transmit through ACE using the appropriate HTS codes with no FDA flag. The second bucket is for products authorized for emergency use under EUA. You may find these FDA.gov. Importers should check their supplier on the FDA.gov website. These products are regulated by FDA and entry info needs to be submitted to the agency. Luckily, FDA has information on streamlining that process. The agency recognizes that a decent number of importers may not be normal medical device importers and may not be familiar with the process. For ACE entry, the entry filer should transmit intended use code 940.000 and the appropriate product code. Using that, the affirmations of compliance FDA would usually expect would become optional in ACE and do not need to be transmitted to FDA. Full information may be found on FDA.gov. The next bucket includes products that are medical devices and regulated as such. No EUA. The same idea applies to these as well. Look on the FDA.gov website. Importers should transmit information to FDA.

During the question and answer section of the call, a question was raised about binding rulings on masks and AD/CVD applicability on N95 masks. FDA said they would look into it. In the meantime, the current opinion of NCBFAA counsel is that while active ADD cases with products under the 6307.90.9889 tariff classification apply to "narrow woven ribbon" and "plastic decorative ribbon," N95 Respirator Masks are not in scope and the broker should disclaim ADD on these masks.

Updated COVID-19 Product Import Instructions for Industry

Yesterday evening, the U.S. Food and Drug Administration provided an update to CSMS 42124872 for instructions to the import community regarding the submission of entry information for personal protective equipment and certain other devices. Following the instructions below will help facilitate the import process for all; especially for products related to the COVID-19 public health emergency. It is in the best interest of the U.S. to facilitate and expedite the importation of products into the U.S. market that address immediate, urgent public health needs. 

Non-FDA-regulated general-purpose personal protective equipment (masks, respirators, gloves, etc.)

Personal protective equipment for general purpose or industrial use (that is, products that are not intended for use to prevent disease or illness) is not regulated by FDA. 

For these types of products, entry information should not be transmitted to FDA. At the time of entry for these products, Importers should transmit entry information to U.S. Customs and Border Protection (CBP) using an appropriate HTS code with no FD Flag; or using an appropriate HTS code with an FD1 flag and do a 'disclaim' for FDA.

Products authorized for emergency use pursuant to an Emergency Use Authorization (EUA)

When importing such products, entry information should be submitted to FDA; however reduced FDA information is required for review.

At the time of entry, Importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use Device, and an appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE. 

Below is a list of products and the appropriate product codes that are currently authorized by an EUA:

  • Diagnostic tests: 83QKP, 83QKO, 83QJR   

  • Masks/Respirators: 80NZJ

A full list of Emergency Use Authorizations currently in place for the COVID-19 emergency is also available on FDA's website. Please check this site regularly for current information on products authorized by an EUA.

Products regulated by FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance.

When importing such devices, entry information should be submitted to FDA.

At the time of entry, Importers should transmit Intended Use Code 081.006: Enforcement discretion per final guidance, and an appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE. 

Below is a listing of guidance documents that have been issued for specific products related to COVID-19, which reference applicable product codes and policy for those products:

A full list of all guidance documents related to COVID-19 is also available on FDA's website. Please check this site regularly for current information on these and other product areas. This message will be updated to specifically include additional guidance as it becomes available.

All questions regarding these instructions, product code assistance for these products, or to resolve entry issues can be submitted to FDA at: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov or 301-796-0356.

Step-by-Step instructions on how to register and list can be found here. 

For additional assistance with completing initial registration, firms should contact the CDRH Registration and Listing Helpdesk at reglist@cdrh.fda.gov.

For assistance with paying the annual registration user fee, firms can reach out to the User Fee Helpdesk at userfees@fda.gov.

For further information regarding entry submission requirements in the Automated Commercial Environment (ACE) system, see the FDA Supplemental Guide for ACE here. 

As usual, FDA may request additional information on a case-by-case basis for making its final admissibility decision.

FDA, Other Agencies Looking to Deny Entry to Fraudulent COVID-19 Products

The U.S. Food and Drug Administration (FDA), along with their partners at U.S. Customs and Border Protection (CBP), is taking all available steps to deny entry to illegally imported products that claim to cure, treat or prevent coronavirus disease 2019 (COVID-19), or are test kits for in-home testing for COVID-19, as they are not currently authorized in the U.S. 

FDA is providing this information to make importers and entry filers aware, so that filer/importers will be able to recognize and appropriately identify products that are not admissible into the U.S. and should not be imported or offered for import into the U.S.

As indicated in FDA's Consumer Update from 3/24/2020, there are currently no vaccines to prevent or drugs to treat COVID-19 approved by the FDA.

  • These fraudulent products that claim to cure, treat, or prevent COVID-19 haven't been evaluated by the FDA for safety and effectiveness and might be dangerous to U.S. consumers. The FDA is particularly concerned that these deceptive and misleading products might cause Americans to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. It's likely that the products do not do what they claim, and the ingredients in them could cause adverse effects and could interact with, and potentially interfere with, essential medications.

  • Earlier this month, FDA and the Federal Trade Commission (FTC) warned seven firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19. The FDA and FTC will continue to monitor social media, online marketplaces and incoming complaints to help ensure that the companies do not continue to sell fraudulent products under a different company name or on another website.

On March 20, 2020, the FDA alerted the American public that, at this time, the FDA has not authorized any test that is available to purchase for at-home testing for COVID-19.

FDA appreciates the diligence importers and entry filers display over their part of the entry process and trust this update will prove useful.

EXIM Takes Action in Response to COVID-19 to Support U.S. Exporters and Jobs with Financing Flexibility

On March 25, the Export-Import Bank of the United States' (EXIM) Board of Director's announced they would provide relief to U.S. businesses, their buyers, financial institutions, and American workers negatively impacted by COVID-19 with the following programs: 

  • Bridge Financing Program;

  • Pre-Delivery / Pre-Export Financing Program;

  • Supply Chain Financing Guarantee Program; and

  • Working Capital Guarantee Program

"We are focused on helping our great American businesses-especially our nation's small businesses-have the support and flexibility they require, meet their liquidity needs, and succeed as our nation and the world grapple with the unprecedented challenges brought on by the COVID-19 global pandemic," said EXIM President and Chairman Kimberly A. Reed. "EXIM leadership and staff have engaged in robust outreach to U.S. exporters and lenders to understand how we can help in this time of uncertainty and need. Today's actions are a direct result of those conversations."

For more information, please see the EXIM release here. 

APHIS Interim Guidance for Phytosanitary Submission

Due to the COVID-19 outbreak, U.S. Customs and Border Protection (CBP) has released interim guidance for the submission of Phytosanitary Certificates for the imports of plants and plant products to CBP Agricultural Specialists. 

CBP's guidance may be found here. 

WCO Secretary General Requests Greater Facilities for ATA Carnet Procedures

On Thursday, the World Customs Organization's (WCO) Secretary-General Dr. Kunio Mikuriya sent a letter "encouraging Contracting Parties to the Conventions on temporary admission[1] to provide sufficient facilities for ATA Carnet holders and representatives to re-export temporarily imported goods, without unexpected additional costs, in cases where delays in re-exporting were due to preventive measures taken by governments of the Contracting Parties against the spread of the COVID-19 virus."

This measure was carried out in consultation with Mr. John W.H. Denton AO, Secretary-General of the International Chamber of Commerce (ICC), given that many National Guaranteeing Associations (NGAs) have recently raised concerns about the fact that preventive measures implemented to limit the spread of COVID-19 might cause delays in the re-exportation of goods imported using ATA Carnets.

For full details, please click here.

Laredo Field Office Update

In an email to the Trade community, the Laredo Field Office stated that there have been no changes to the hours of operation aany of the commercial cargo facilities located within the Laredo Field Office area of responsibility.

If any changes occur, the Trade will be advised by the Laredo Field Office Trade Division.

CBSA Extension of Timeframes for Payment of Customs Duties

The Canada Border Services Agency (CBSA) published a customs notice today notifying the Trade of an extension of timeframes for payment of customs duties.

For more information, please see here. 

Q&A: How Does the Families First Coronavirus Response Act Affect Your Organization?

Client Alert Republished with Permission: Katharine Meyer, GKG Law

On March 18, 2020, Congress passed, and the President signed, the Families First Coronavirus Response Act (FFCRA), which requires most employers with fewer than 500 employees to provide paid leave to employees affected by the COVID-19 pandemic. The FFCRA tactually consists of two separate acts that provide paid leave to employees. The first act, the Emergency Paid Sick Leave Act (EPSLA), amends the Fair Labor Standards Act (FLSA) and provides paid short-term leave of up to 80 hours for reasons related to COVID-19. The second, the Emergency Family and Medical Leave Expansion Act (EFMLEA), amends the Family Medical Leave Act (FMLA) and provides longer-term leave of up to 12 weeks, 10 of which are paid. However, as discussed below, EFMLEA leave is only provided in certain limited circumstances. The FFCRA becomes effective on April 1, 2020, and terminates on December 31, 2020.

The Emergency Paid Sick Leave Act

EPSLA provides up to two weeks of sick pay for employees who miss work for certain reasons related to COVID-19. Below is a summary of the material provisions of this act:

Which employers are covered?

EPSLA applies to private employers who have 500 or fewer employees, and any public employer with at least one employee.

Which employees are covered?

All full- and part-time employees are eligible for EPSLA paid leave, regardless of how long they have been employed with the organization.

How is part-time employee coverage calculated?

Part-time employees are also covered under EPSLA, however, they receive paid leave for the number of hours they work, on average, over a two-week period.

What events trigger coverage?

EPSLA provides paid sick leave for employees who are unable to work (or telework) for the following reasons:

(1)The employee is subject to a Federal, State, or local quarantine or isolation order related to COVID-19;

(2) The employee has been advised by a health care provider to self-quarantine due to concerns related to COVID-19;

(3) The employee is experiencing symptoms of COVID-19 and seeking a medical diagnosis;

(4) The employee is caring for an individual who is subject to a local quarantine or isolation order or has been advised by a health care provider to self-quarantine;

(5) The employee is caring for a son or daughter of such employee if the school or place of care of the son or daughter has been closed, or the childcare provider of such son or daughter is unavailable, due to COVID-19 precautions; or

(6) The employee is experiencing any other substantially similar condition specified by the Secretary of Health and Human Services.

How much do employees get paid?

The amount a person is paid depends on several factors. If sick leave is being taken for reasons (1)-(3) above, employees are entitled to their regular pay, up to $511 per day, or $5,110 in the aggregate. If sick leave is being taken for reasons (4)-(6) above, they are entitled to either two-thirds pay or minimum wage, whichever is higher. Employers are only required to pay a maximum of $200 per day, or $2,000 in the aggregate.

How do you provide this information to employees?

Each employer must post a notice in conspicuous places on the premises, where notices are customarily posted, setting forth the requirements of the EPSLA. A copy of a sample notice can be located here. Additionally, employers should modify their employee handbooks to include this leave.

Can my employer require an employee to use other paid leave before FLSA?

Employers cannot require an employee to use other paid leave prior to using EPSL.

Can EPSLA leave be carried over for payment upon termination?

EPSLA leave cannot be carried over to the following year. Additionally, such paid leave does not need to be paid out when an employee leaves his/her employment or is terminated.

Are there any exemptions to this law?

EPSLA gives the Department of Labor (DOL) the right to exempt small businesses with fewer than 50 employees when it "would jeopardize the viability of the business as a going concern".

Can you take negative employment action against an employee who takes this leave?

An employer cannot retaliate against an employee who takes EPSL.

What are the penalties if an employer does not comply with this act?

Any employer who fails to pay required sick leave under this act shall be in violation of the FLSA. The DOL's Wage and Hour Division has the authority to investigate and enforce compliance with the FFCRA.

The Emergency Family and Medical Leave Expansion Act

EFMLEA amends the FMLA to provide up to 12 weeks of leave, 10 of which are paid at two-thirds pay.

It requires employers with fewer than 500 employees to provide this leave to employees who are unable to work because the employee's child's school or care center is closed, or the child's care provider is unavailable due to COVID-19.

Who is eligible?

Unlike FMLA, EFMLEA covers employees who work for employers with fewer than 500 employees and who have been on the job for a minimum of 30 days.

What circumstances trigger EFMLEA Leave?

Coverage under EFMLEA is triggered only when the employee is unable to work (or telework) because the employee's child's school or care center is closed, or the child's care provider is unavailable due to COVID-19. The child must be under the age of 18. This leave is not available if the employee is sick with COVID-19.

What type of paid leave is available?

EFMLEA provides 12 weeks of leave. While the first two weeks of this leave are unpaid, paid leave will likely be available to an employee under EPSLA during this time period. After the first two weeks, the employee will receive two-thirds of his/her usual pay, with a cap at $200 per day.

Does an employer have to hold a person's job open during this leave?

Generally, employees who take EFMLEA leave are entitled to be restored to the position they held before leave was taken. However, for employers who have fewer than 25 employees, an employer does not need to return the employee to his/her position if:

 

  • The position held by the employee when the leave commenced does not exist due to economic conditions or other changes in operating conditions that affect employment, and were caused by COVID-19;

  • The employer makes reasonable efforts to restore the employee to a position equivalent to the position the employee held when the leave commenced, with equivalent employment benefits, pay, and other terms and conditions of employment; and

  • If the reasonable efforts of the employer to restore the employee to an equivalent position fails, the employer makes reasonable efforts during the "contact period" to notify the employee if an equivalent position becomes available. The EFMLEA states that the "contact period" is the one-year period beginning with the date on which the qualifying need related to a public health emergency concludes; or the date that is 12 weeks after the date on which the employee's leave commences.

Are there any exemptions to this law?

The Secretary of Labor has the authority to exempt small businesses with fewer than 50 employees from the bill's paid leave requirements if those requirements would jeopardize the viability of the business.

Tax Credits for Employers

The FFCRA provides tax credits to employers to offset the costs associated with the paid leave. These tax credits will offset the employer's share of social security taxes. These credits are only available to those employers that are required to offer these benefits under the FFCRA.

What should employers do next?

Employers should amend their employment policies now so that they adhere to these new laws. They should also post proper notices in the workplace as soon as possible. Currently, many offices are closed or working with minimal staff. Therefore, we recommend that employers e-mail the FFCRA notice to all employees.

If you need any assistance in drafting your leave policies or notice, we recommend contacting your attorney. Finally, many states are considering providing additional paid leave to employees. Make sure you are continuing to comply with state and local leave requirements.

CORONAVIRUS UPDATES TO OUR VALUED CUSTOMERS

WE ARE OPEN FOR BUSINESS 

Dear Valued Clients,

MTI Worldwide is considered an Essential Business, therefore we are open for business. For companies affected by STAY-AT-HOME orders (currently IL, CA, CT, IN, DE, NY, LA, MA, MI, NJ, OH, WI, WA), MTI Worldwide Logistics offers solutions for shipments in-transit to your company facilities.

For in-transit shipments that cannot be delivered to your closed facilities, MTI can provide warehousing space to store your inbound shipments and then deliver to you when your company re-opens.

We will continue to provide service to/from anywhere in the USA/World for your freight and warehousing.

Our family-owned business is a freight forwarder, customs broker. We have transportation & warehousing options in every market:

  • Trucks (LTL / TL / Linehaul)

  • Hotshots

  • Aircraft

  • Steamships

  • Local Drayage / Cartage

  • Warehouses

  • Customs Brokerage

Most of our staff is now working from home. We have full operational status of email, phones and other intra-office communications.

Our business is an Essential Business. We provide Customs Clearance, logistics and transportation services which are critical to the functioning of everyday life.

Our goal is seamless service to you.

We all wish all of you and your families and co-workers health and safety during this time where our personal decisions are paramount to our collective well-being. 

Sincerely,

Joe Klein

MTI Worldwide Logistics

VP Import Operations

206-431-4366

www.mti-worldwide.com