LAW: Import Operations
Import Operations: Legal Background and Regulatory Framework
Every product that crosses a US border enters a layered regulatory system involving Customs and Border Protection, the Food and Drug Administration, the Consumer Product Safety Commission, and in many cases OSHA. Understanding the legal background of import operations is the first step for any importer, compliance officer, or safety professional responsible for ensuring that imported goods meet US safety and regulatory requirements.
Legal Disclaimer: This article provides educational information about import regulations, not legal advice. Consult a licensed customs attorney or regulatory specialist for guidance specific to your import operations.
Law Summary: Key Regulatory Framework
Primary Law
Tariff Act of 1930 (19 U.S.C.)
The foundational statute governing US customs law. Establishes CBP’s authority to regulate the entry of all merchandise into the United States, including requirements for entry documentation, duties, and admissibility determinations.
Product Safety
Consumer Product Safety Act (15 U.S.C. 2051)
Empowers CPSC to establish safety standards for consumer products and to refuse entry of non-compliant imported goods. Importers bear the same obligations as domestic manufacturers for consumer product safety compliance.
Food and Drug
Federal Food, Drug, and Cosmetic Act (21 U.S.C.)
FDA’s authority to inspect, detain, and refuse imported food, drugs, devices, and cosmetics that do not meet US safety standards. FDA has the right to examine any shipment before it is released into US commerce.
Workplace Safety
Occupational Safety and Health Act (29 U.S.C. 651)
OSHA’s standards apply to the workplace handling and use of imported goods. Employers must ensure that imported equipment, chemicals, and materials used in workplaces meet applicable OSHA standards regardless of country of origin.
$3.1T
Annual US Imports
The US processes over $3.1 trillion in imported goods annually, making customs compliance one of the largest regulatory obligations in US commerce.
Source: US Census Bureau
800+
Partner Government Agencies
CBP works with over 40 federal partner government agencies (PGAs) whose regulations apply to specific categories of imported merchandise.
Source: US CBP
30 Days
Formal Entry Filing Deadline
Importers have 15 calendar days to file entry after arrival, and formal entry summary must be filed and duties paid within 10 working days of entry.
Source: 19 CFR Part 142
Who Must Comply
Applicable Standards and Regulations
19 CFR Parts 101-190 (CBP Regulations)
The comprehensive CBP regulations governing all aspects of customs entry including formal and informal entry procedures, classification, valuation, country of origin marking, and liquidation of entries.
21 CFR Parts 1-99 (FDA Import Regulations)
FDA regulations covering prior notice of food imports (21 CFR Part 1), registration of food facilities (21 CFR Part 1, Subpart H), and inspection and detention authority for drugs, devices, and food products.
16 CFR (CPSC Regulations)
Consumer Product Safety Commission regulations applicable to imported consumer products, including flammability standards, electrical safety standards, children’s product requirements, and certification and labelling obligations under 15 U.S.C. 2063.
29 CFR Part 1910 (OSHA General Industry Standards)
OSHA’s general industry standards apply to all employers regardless of where equipment and materials were manufactured. Imported machinery must meet applicable OSHA machine guarding, electrical, and hazard communication standards.
Key Definitions
Importer of Record (IOR)
The individual or entity legally responsible for ensuring that imported merchandise complies with all US laws and regulations and for paying applicable duties. The IOR may be the owner, purchaser, or licensed customs broker acting on behalf of the owner or purchaser. The IOR bears full legal liability for import compliance failures even when a customs broker is used.
Entry
The legal process by which imported merchandise is admitted into the commerce of the United States. Entry requires filing the appropriate documentation with CBP, including the entry summary (CBP Form 7501), commercial invoice, packing list, and any required permits or certificates from partner government agencies.
Harmonized Tariff Schedule (HTS)
The US tariff classification system based on the World Customs Organization’s Harmonized System. Every imported product is classified under an HTS code that determines the applicable duty rate and identifies which partner government agency requirements apply. Incorrect HTS classification is one of the most common and consequential customs compliance errors.
Prior Notice (for FDA-regulated food imports)
A requirement under the Bioterrorism Act of 2002 and 21 CFR Part 1 that importers submit advance notification to FDA before food products arrive at US ports of entry. Prior notice must be submitted no more than 15 days before arrival and no less than two hours before arrival by road, four hours by air, and eight hours by sea.
Reasonable Care
The legal standard under 19 U.S.C. 1484 requiring importers to use reasonable care in making entry, including accurate classification, valuation, and marking of imported merchandise. CBP expects importers to have documented compliance programmes, conduct due diligence on suppliers, and maintain records demonstrating their compliance efforts.
Liquidation
The final computation of duties, taxes, and fees on an import entry by CBP. Liquidation typically occurs within one year of entry but may be extended. Importers have 180 days from liquidation to protest CBP’s determination if they believe duties were assessed incorrectly.
Employer Responsibilities in Import Operations
1
Establish an Import Compliance Programme
CBP expects importers to have documented procedures for classifying merchandise, determining country of origin, valuing goods, and ensuring compliance with all applicable regulations. A written import compliance programme that assigns clear responsibilities, establishes internal controls, and includes periodic self-audits is the foundation of the “reasonable care” standard.
2
Ensure Imported Products Meet US Safety Standards
When importing products regulated by CPSC, FDA, or other agencies, the importer bears responsibility for confirming compliance before the goods enter US commerce. For CPSC-regulated children’s products, this means obtaining third-party testing and maintaining a Children’s Product Certificate (CPC). For FDA-regulated devices, it means ensuring the device is cleared or approved for the US market.
3
Apply OSHA Standards to Imported Equipment and Chemicals
Employers who use imported machinery, tools, or chemicals in US workplaces must ensure that those products comply with applicable OSHA standards. Imported machinery must have appropriate machine guarding regardless of what standards applied in the country of manufacture. Imported chemicals must have Safety Data Sheets (SDS) in English meeting OSHA’s Hazard Communication Standard (29 CFR 1910.1200).
4
Maintain Records for the Required Retention Period
Under 19 U.S.C. 1508, importers must maintain all records related to import transactions for five years from the date of entry. This includes entry documents, commercial invoices, packing lists, supplier documentation, and any certificates or permits from partner government agencies. CBP may request these records during a CF-28 Request for Information or a focused assessment audit.
Employee Rights in Import Operations
What Workers Can Expect and Demand
Right to safe imported equipment
Workers have the right under the OSH Act to a workplace free from recognised hazards. When imported machinery or equipment does not meet applicable OSHA standards, workers can refuse to use it and report the hazard to OSHA. The country of manufacture is not a defence for an employer who provides unsafe equipment to workers.
Right to SDS for imported chemicals
Under OSHA’s Hazard Communication Standard, workers must receive Safety Data Sheets in English for all hazardous chemicals used in the workplace, including imported chemicals. Employers cannot substitute a foreign-language SDS or a SDS that does not meet 29 CFR 1910.1200 format requirements.
Right to report unsafe imported products
Workers and consumers can report unsafe imported products directly to CPSC through SaferProducts.gov, to FDA through MedWatch or the voluntary reporting portal, and to OSHA through an OSHA complaint. OSHA Anti-retaliation protections under Section 11(c) of the OSH Act protect workers who report hazardous conditions.
Whistleblower protections for customs violations
The False Claims Act protects employees who report customs fraud (such as deliberate misclassification or undervaluation to avoid duties) from retaliation. Whistleblowers who report customs fraud leading to a government recovery may be entitled to a portion of the recovery under the FCA’s qui tam provisions.
Core Compliance Requirements
Customs Entry Documentation
Every formal entry requires: Entry summary (CBP Form 7501), commercial invoice showing the price actually paid, packing list, bill of lading or air waybill, and any PGA permits or certificates. Informal entries (generally for shipments valued under $2,500) have simplified requirements but are still subject to admissibility review.
Country of Origin Marking
Under 19 U.S.C. 1304, most imported articles must be marked with the country of origin in a conspicuous location that can be seen by the ultimate purchaser. Failure to mark correctly can result in marking duties of 10 percent of the entered value, CBP holds, and re-exportation requirements.
Partner Government Agency Requirements
Many imported products require permits, certificates, or prior approval from PGAs before CBP will release the shipment. Common examples: FDA prior notice for food, EPA pesticide registrations, USDA permits for agricultural products, Fish and Wildlife Service permits for wildlife products, and NHTSA conformance declarations for motor vehicles.
Antidumping and Countervailing Duty Orders
CBP administers ADD/CVD orders issued by the Department of Commerce covering hundreds of imported product categories. Importers must check whether their goods are subject to ADD/CVD orders and pay the applicable cash deposit rates at entry. Failure to pay ADD/CVD deposits is one of the most costly customs compliance failures, as rates can reach several hundred percent of the entered value.
Common Violations
Most Frequent Import Compliance Failures
Incorrect HTS classification
Most Common
Classifying merchandise under the wrong HTS code, whether to reduce duty rates or through genuine error. CBP may assess unpaid duties, interest, and penalties up to four times the unpaid duties for negligent misclassification.
Undervaluation of merchandise
Very Common
Declaring a lower transaction value than was actually paid to reduce duty liability. CBP transaction value rules under 19 CFR Part 152 require declaration of the price actually paid or payable, including all dutiable additions.
Country of origin misrepresentation
Common
Declaring a false country of origin to avoid ADD/CVD orders, sanctions, or to falsely claim preferential trade agreement treatment. This can constitute customs fraud under 18 U.S.C. 542 and 545, with criminal penalties including imprisonment.
Failure to file required PGA documentation
Common
Failing to submit required prior notice to FDA, missing EPA pesticide registration documentation, or omitting USDA permits for agricultural commodities. PGA non-compliance results in CBP holds, FDA detention, and potential refusal of admission.
Importing OSHA non-compliant equipment
Ongoing Risk
Using imported machinery or electrical equipment in US workplaces without verifying compliance with OSHA standards. Employers can receive OSHA citations for hazardous conditions created by non-compliant imported equipment, regardless of the equipment’s origin.
Penalties and Consequences
Source: CBP | CBP Trade Fraud and Penalty Enforcement
Compliance Checklist: Import Operations
Before Shipment
Confirm correct HTS classification with a licensed broker or binding ruling
Identify all PGA requirements for the product category
Verify country of origin and eligibility for any applicable trade agreements
Check for applicable ADD/CVD orders via CBP’s ADCVD search tool
Obtain required certificates, permits, or test reports from the supplier
At Entry
File entry documentation accurately and on time (within 15 days of arrival)
Submit prior notice to FDA for food shipments before arrival
Pay correct duties including any ADD/CVD deposits
Ensure country of origin marking is correct before goods are released
Respond to any CBP CF-28 or CF-29 requests promptly
After Entry
Retain all import records for minimum five years
Verify imported equipment meets OSHA standards before workplace use
Obtain English-language SDS for all imported chemicals
Monitor liquidation notices for duty assessments
Conduct periodic import compliance self-audits
Key Takeaways
The importer of record owns every compliance obligation
Using a customs broker does not transfer legal liability to the broker. The IOR is responsible for accurate classification, correct valuation, proper marking, payment of all applicable duties, and compliance with every PGA requirement. Due diligence on these obligations cannot be delegated away.
OSHA standards follow the product, not the country of origin
Employers who bring imported machinery, equipment, or chemicals into US workplaces are responsible for ensuring those products comply with applicable OSHA standards. “It was certified in Germany” or “It meets CE standards” is not a defence for OSHA non-compliance. US workplace safety standards apply in US workplaces regardless of where the equipment was made.
Reasonable care is a legal standard, not a general concept
CBP’s reasonable care standard requires importers to take positive steps to ensure accuracy, not just to avoid obvious errors. A documented import compliance programme, written procedures for classification and valuation, periodic self-audits, and maintained records are all evidence of reasonable care. The absence of a compliance programme is itself evidence of a failure to exercise reasonable care, and it dramatically increases penalty exposure when violations are found.
Frequently Asked Questions
What is the difference between a formal and informal customs entry?
An informal entry applies to commercial shipments generally valued at $2,500 or less, with simplified documentation and no bond required. A formal entry is required for shipments above $2,500 and for certain regulated commodities regardless of value, such as textiles and quota merchandise. Formal entries require CBP Form 7501, a continuous or single-entry bond, and full compliance with all partner government agency requirements. The value threshold for informal entry does not exempt goods from PGA admissibility requirements; a $1,000 food shipment still requires FDA prior notice even though it qualifies as an informal entry from a customs standpoint.
Can an employer be cited by OSHA for hazards created by imported equipment that was legally imported through CBP?
Yes. CBP’s release of a shipment means the goods met customs admissibility requirements at the time of entry. It does not mean the goods comply with OSHA workplace safety standards. These are separate and independent regulatory systems. An employer who installs imported machinery that lacks required guarding under 29 CFR 1910.212 can receive an OSHA citation regardless of whether the equipment cleared customs without issue. CBP compliance and OSHA compliance are not interchangeable.
What happens if FDA detains an imported shipment?
The importer receives a Notice of FDA Action and the shipment is held. The importer may submit evidence or request a hearing. If the detention is upheld, goods must be re-exported or destroyed within 90 days at the importer’s expense. Repeated refusals can result in placement on FDA’s Import Alert list, subjecting future shipments to automatic detention.
Government and Regulatory Sources
- CBP – Basic Importing and Exporting
- FDA – Import Program Overview
- CPSC – Import Safety Requirements for Businesses
- OSHA – Occupational Safety and Health Act of 1970
- CBP – Customs Fraud and Trade Enforcement
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Understanding Import Law Is the Starting Point
Import compliance is not a one-time exercise at the port of entry. It is an ongoing obligation that spans classification decisions made before goods are ordered, entry filing during shipment, and workplace safety verification after goods arrive. The legal framework covering US imports is complex precisely because it involves multiple agencies with overlapping but distinct jurisdictions. CBP handles customs entry; FDA, CPSC, and other PGAs handle product safety; OSHA handles workplace conditions. A shipment that clears all three is a compliant import. A gap in any one of them creates legal exposure. Find more import compliance and workplace safety resources at velsafe.com.