Importing Pandemic Supplies Requirements Laid Out by Customs Broker

Posted April 9, 2020

In customs clearance, International Shipping

Universal Cargo’s house customs broker, INLT gave a great webinar outlining the U.S. requirements around importing pandemic supplies during this COVID-19 crisis. We thought what they shared would be a great resource for organizations trying to get supplies, whether personal protective equipment (PPE) for individuals or medical supplies for hospitals, to the U.S.

Chris Reynolds and the INLT team were gracious enough to let us share their slides here in Universal Cargo’s blog as a resource for you.

Below, you’ll be able to see an image of each slide, covering things from FAQs to requirements and duty information on specific products like masks, gowns, and sanitizers to enforcement guidelines on the issue.

All the information in this post was current as of March 30th, 2020, but it should be noted that things are constantly, sometimes daily, changing when it comes to rules and requirements around the international shipping of pandemic-related items. Because of this, INLT warns that classifications and FDA regulations should be confirmed with your customs broker or attorney when actually shipping items found within this post.

Still, the information found below should be a very useful resource.

Before we get into the good stuff, we at Universal Cargo would just like to give a shout out and thank you to Chris Reynolds and the hard-working INLT team.

INLT’s Pandemic Supplies Webinar Slides

INLT pandemic supplies FAQs

Frequently Asked Questions

U.S. import requirements for products in-demand due to the COVID-19 pandemic

Current as of March 30, 2020

INLT pandemic supplies webinar disclaimers

DISCLAIMERS

The current novel coronavirus (COVID-19) pandemic evolves day-to-day as does the U.S. government’s regulatory response. Amazon, INLT, and its affiliates cannot guarantee that the content of this presentation reflects the latest federal legal requirements.

The information provided in this presentation is general in nature and is provided for educational purposes only. It does not constitute legal advice. Please consult with an attorney if you have questions about your specific legal rights or duties, or your customs broker for prospective shipments.

This training is not a substitute for reading the U.S. Harmonized Tariff Schedule, 21 C.F.R. Subchapter C, D, or H, 40 C.F.R. Parts 152-180, or any other federal regulations.

INLT pandemic supplies webinar commodity requirements

Commodity Requirements

INLT pandemic supplies webinar surgical masks

Surgical Masks

HTSUS 6307.90.9889, 7%
Section 301 duties: exempt pursuant to 85 FR 15244

Regulated by FDA as a Class II Medical Device

If intended to provide liquid barrier protection

510(k) requirement not enforced Product code: FXX

If not marketed or intended for use as a medical device

FDA regulations do not apply

INLT Pandemic Supplies Webinar Medical Masks

IMPORT REQUIREMENTS

Medical Masks

HTSUS 6307.90.9889, 7%
Section 301 duties: exempt pursuant to 85 FR 15244

Regulated by FDA as a Class II Medical Device

If intended for a medical purpose and not intended to provide liquid barrier protection

510(k) requirements and other FD&C Act requirements temporarily are not enforced Product code: FXX

If not marketed or intended for use as a medical device

FDA regulations do not apply

INLT pandemic supplies webinar n95 respirators

IMPORT REQUIREMENTS

N95 Respirators

HTSUS 6307.90.9889, 7%
Section 301 duties: exempt pursuant to 85 FR 15244

Regulated by FDA as a Class II Medical Device

If marketed or intended for use as a medical device

Regulated by FDA under NIOSH standards as a Class II Medical Device; CDC also recognized NIOSH standard equivalent standards
Product code: MSH

If not marketed or intended for use as a medical device

FDA regulations do not apply

INLT Pandemic Supplies N95 Respirators

IMPORT REQUIREMENTS

N95 Respirators

If respirator contains replaceable filters

HTSUS 9020.00.9000, 2.5%
Section 301 duties: does not appear on any published lists

If respirator does not contain replaceable filters

HTSUS 6307.90.9889, 7%
Section 301 duties: exempt pursuant to 85 FR 15244

If marketed or intended for use as a medical device:

Regulated by FDA under NIOSH standards as a Class II Medical Device; CDC also recognized NIOSH standard equivalent standards
Product code: MSH

If not marketed or intended for use as a medical device

FDA regulations do not apply

INLT Pandemic Supplies Webinar Plastic Gloves

IMPORT REQUIREMENTS

Plastic Gloves

Surgical and for medical purposes only for best results

HTSUS 3926.20.1010, free
Section 301 duties: List 4B, not currently active

Regulated by FDA as a Class I Medical Device

510(k) required
Product codes: multiple based on material and use

INLT Pandemic Supplies Webinar Plastic Gloves Non Medical

IMPORT REQUIREMENTS

Plastic Gloves (not marketed or intended for use as medical device)

Seamless disposable gloves

HTSUS 3926.20.1020, free
Section 301 duties: List 4B, not currently active

Seamless gloves for repetitive use

HTSUS 3926.20.1050, free
Section 301 duties: List 4B, not currently active

Disposable gloves with seams

HTSUS 3926.20.4010, 6.5%
Section 301 duties: List 4B, not currently active

Repetitive use gloves with seams

HTSUS 3926.20.4050, 6.5%
Section 301 duties: List 4B, not currently active

INLT Pandemic Supplies Webinar Rubber Gloves 1

IMPORT REQUIREMENTS

Rubber Gloves Part I

Regulated by FDA as a Class I Medical Device
510(k) required
Product code: multiple depending on material and use

Surgical gloves of natural rubber

HTSUS 4015.11.0110, free
Section 301 duties: does not appear on any published lists

Surgical gloves of synthetic rubber

HTSUS 4015.11.0150, free
Section 301 duties: does not appear on any published lists

INLT Pandemic Supplies Webinar Rubber Gloves 2

IMPORT REQUIREMENTS

Rubber Gloves Part II

Regulated by FDA as a Class I Medical Device
510(k) required
Product code: multiple depending on material and use

Medical gloves of natural rubber

HTSUS 4015.19.0510, free
Section 301 duties: exempt pursuant to 85 FR 13970

Medical gloves of synthetic rubber

HTSUS 4015.19.0550, free
Section 301 duties: exempt pursuant to 85 FR 13970

INLT Pandemic Supplies Webinar Rubber Gloves 3

IMPORT REQUIREMENTS

Rubber Gloves Part III (not marketed or intended for use as a medical device)

Seamless disposable gloves

HTSUS 4015.19.1010, 3%
Section 301 duties: exempt pursuant to 85 FR 15015

Seamless gloves for repetitive use

HTSUS 4015.19.1050, 3% Section 301 duties: List 3, 25%

Gloves with seams, either disposable or repetitive use

HTSUS 4015.19.5000, 14% Section 301 duties: List 3, 25%

INLT Pandemic Supplies Webinar Gowns 1

IMPORT REQUIREMENTS

Gowns Part I

Nonwoven disposable designed for use in hospitals, clinics, laboratories or contaminated areas, made of felt or nonwovens, whether or not impregnated, coated, covered, or laminated, including spun-bonded.
HTSUS 6210.10.5000, free

Section 301 duties: exempt pursuant to 85 FR 13970
Most gowns are regulated by FDA as a Class II Medical Device

Product codes

FME: exam gowns
FYA: surgical gowns
FYB: patient gowns
FYC: surgical isolation gowns
OEA: non-surgical isolation gowns
FXO: surgical suit

INLT Pandemic Supplies Webinar Gowns 2

IMPORT REQUIREMENTS

Gowns Part II

Other garments not marketed or intended for use as a medical device, made of felt or nonwovens, whether or not impregnated, coated, covered, or laminated, including spun- bonded.

Overalls and coveralls

HTSUS 6210.10.9010, 16%
Section 301 duties: List 4B, not currently active

Other garments

HTSUS 6210.10.9040, 16%
Section 301 duties: List 4B, not currently active

INLT Pandemic Supplies Webinar Isolation Suits & Biohazard Suits

IMPORT REQUIREMENTS

Isolation Suits & Biohazard Suits

Regulated by FDA as a Class II Medical Device Product code: FXO

Of plastic sheeting marketed or intended for medical use

HTSUS 3926.20.9050, 5%
Section 301 duties: excluded pursuant to 85 FR 15015

Of plastic sheeting and not marketed or intended for medical use (e.g. industrial or other general use)
HTSUS 3926.20.9050, 5%
Section 301 duties: excluded pursuant to 85 FR 15015

INLT Pandemic Supplies Webinar Thermometers

IMPORT REQUIREMENTS

Thermometers

Regulated by FDA as a Class II medical device

Product codes

FLK: mercury thermometer
FLL: electric thermometer

Liquid filled thermometer

HTSUS 9025.11.2000, free
Section 301 duties: does not appear on any published lists

Digital thermometers

HTSUS 9025.19.8040, free
Section 301 duties: if valued at not over $11 then excluded pursuant to 84 FR 52552, otherwise they appear on List 2, 25%

INLT Pandemic Supplies Webinar Hand Sanitizers

IMPORT REQUIREMENTS

Hand Sanitizers

Regulated by FDA as a drug

80% or more by ethyl alcohol

HTSUS 2207.10.6090, 2.5% Section 301 duties: List 3, 25%

Liquid or gel, non-aromatic compounds (e.g. ethyl alcohol and isopropyl alcohol)

HTSUS 3808.94.5000, 5% Section 301 duties: List 3, 25%

Liquid or gel, aromatic compound (e.g. benzalkonium chloride)

HTSUS 3808.94.1000, 6.5% Section 301 duties: List 3, 25%

INLT Pandemic Supplies Webinar Surface Disinfectants

IMPORT REQUIREMENTS

Surface Disinfectants

Regulated by EPA as a pesticide

Hydrogen peroxide, put up for sale as a cleaning solution for surfaces

HTSUS 3808.94.5000, 5% Section 301 duties: List 3, 25%

Surface disinfectants, put up for retail sale containing aromatic compounds (e.g. benzalkonium chloride)
HTSUS 3808.94.1000, 6.5%
Section 301 duties: List 3, 25%

Surface disinfectants, put up for retail sale containing non-aromatic compounds (e.g. peroxyacids alcohol)
HTSUS 3808.94.1000, 6.5%
Section 301 duties: List 3, 25%

INLT Pandemic Supplies Webinar Medical Waste Bags

IMPORT REQUIREMENTS

Medical Waste Bags

Not regulated by FDA

Of polyethylene with any side over 75mm in length

HTSUS 3923.21.0095, 3%
Section 301 duties: excluded pursuant to 85 FR 15015

Of other plastics

HTSUS 3923.29.000, 3% Section 301 duties: List 3, 25%

INLT Pandemic Supplies Webinar Wash Cloths

IMPORT REQUIREMENTS

Wash Cloths

Not regulated by FDA, unless marketed for medical use

Microfiber cleaning cloths

HTSUS 6307.10.2030, 5.3% Section 301 duties: List 4A, 7.5%

Cotton cleaning cloths

HTSUS 6307.10.1090, 4.1% Section 301 duties: List 4A, 7.5%

INLT Pandemic Supplies Webinar FDA Regulations

FDA Regulations
Enforcement Guidelines in Light of COVID-19

INLT Pandemic Supplies Webinar FDA Overview

FDA Overview

The Food and Drug Administration (FDA) is the federal agency that enforces the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Products qualifying as medical devices or drugs cannot be imported or sold in the U.S. unless they comply with requirements of the FD&C Act.

INLT Pandemic Supplies Webinar Non-Medical Devices

Non-Medical Devices

U.S. Customs and Border Protection issued the following guidance for non-FDA-regulated personal protective equipment (PPE) imported for general purpose or industrial use:

PPE for general purpose or industrial use, i.e. products that are not intended for use to prevent disease or illness, are not regulated by FDA

PPE imports conforming to a general purpose or industrial use cannot be imported if they are intended to be distributed or marketed for medical use, absent compliance with applicable FDA requirements

INLT Pandemic Supplies Webinar Enforcement Policy for Face Masks and Respirators in Light of COVID-19 1

Enforcement Policy for Face Masks and Respirators in Light of COVID-19

In light of the COVID-19 pandemic and as of March 30, 2020, FDA has temporarily changed its enforcement policy for certain face masks and respirators. In an attempt to expand the availability of general use face masks for the general public and respirators for health care professionals, FDA will not enforce certain requirements under the FD&C Act with respect to these products.

This selective enforcement policy will remain in effect for the duration of the COVID-19 public health emergency as declared by the Department of Health and Human Services, but could change at any time.

INLT Pandemic Supplies Webinar Enforcement Policy for Face Masks and Respirators in Light of COVID-19 2

Enforcement Policy for Face Masks and Respirators in Light of COVID-19

THIS POLICY APPLIES TO

(See table in image above.)

INLT Pandemic Supplies Webinar Enforcement Policy for Face Masks and Respirators in Light of COVID-19 3

Enforcement Policy for Face Masks and Respirators in Light of COVID-19

Face masks intended for a medical purpose, that are not intended to provide liquid barrier protection:

Where the face mask does not create an undue risk in light of the public health emergency, these masks can be distributed both to the general public and medical personnel without compliance with:

510(k) requirements—2.1 C.F.R. Part 807.81
Reports or corrects and removals—21 C.F.R. Part 806
Registration and Listing requirements—21 C.F.R. Part 807
And Unique Device Identification requirements—21 C.F.R. Part 830

Quality system regulation requirements—21 C.F.R. Part 820

So long as…

The product includes labeling that accurately describes the product as a face mask (as opposed as a surgical mask) and includes a list of the body contacting materials (which does not include any drugs or biologics)

The product includes labeling that recommends against use in a surgical setting, or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high

The product is not intended for any use that would create an undue risk, for example, the labeling does not include users for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related issues and does not include particulate filtration claims

INLT Pandemic Supplies Webinar Enforcement Policy for Face Masks and Respirators in Light of COVID-19 4

Enforcement Policy for Face Masks and Respirators in Light of COVID-19

Surgical masks intended to provide liquid barrier protection:

Where the face mask does not create an undue risk in light of the public health emergency, these masks can be distributed and used without prior submission of a premarket notification under section 510(k) if:

The product meets fluid resistance testing (liquid barrier performance) consistent with standard ASTM F1862

The product meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas)

The product includes labeling that accurately describes the product as a surgical mask and includes a list of the body contacting materials (which does not include any drugs or biologics)

The product is not intended for any use that would create an undue risk, for example the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses, and does not include particulate filtration claims

INLT Pandemic Supplies Webinar FAQ

FAQ

Q: WHAT IS THE EUA ISSUED BY FDA FOR FACEMASKS?

Answer: On March 2, 2020, FDA issued an Emergency Use Authorization (EUA) in response to the insufficient supply of filtering facepiece respirators (FRRs). The EUA applies to:

All FRRs approved by the National Institute for Occupational Safety and Health (NIOSH) as non-powered air-purifying particulate FFRs
All NIOSH approved FRRs that have passed the manufacturers’ recommended shelf-life for use in healthcare settings

MORE INFO

The EUA applies mostly to manufacturers and strategic stockpilers of these items.
Manufacturers and stockpilers can request authorization from FDA to distribute these FRRs to healthcare personnel only even though they do not comply with federal regulations.
FRRs distributed under this EUA cannot be used by the general public.
On March 24, 2020, FDA issued a second EUA allowing for the distribution of certain non-NIOSH-approved FRRs so long as they were manufactured in specific non-U.S. jurisdictions to specific standards and/or have marketing authorization in certain non-U.S. regulatory jurisdictions. Authorization allows these products to be distributed to healthcare personnel only.

INLT Pandemic Supplies Webinar Thank You

A “thank you” from INLT.

INLT Pandemic Supplies Webinar Resources

Resources

FDA

EPA

Important Reminder from INLT

PLEASE CONFIRM CLASSIFICATION AND FDA REGULATIONS FOR YOUR SHIPMENT WITH YOUR CUSTOMS BROKER OR ATTORNEY.

coronavirus, COVID-19, importing pandemic supplies, INLT

Jared Vineyard

For more than ten years, Jared has researched and written about the international shipping industry for the freight forwarder Universal Cargo. His work has been republished on the web and in print, including the maritime news magazine Inside Marine. When first joining Universal Cargo, Jared trained in the freight forwarding process and helped customers with their imports and exports, giving him his initial international shipping sea legs.