Importing Human-Derived Materials into the United States
General
Key takeaways
The CDC regulates the import of human-derived materials with permit and documentation requirements.
Section 508 applies to digital forms submitted to the CDC, not as a form number.
APHIS may regulate shipments with animal-origin content.
Packaging and labeling must meet CDC and IATA standards.
Mercury supports clients by handling documentation, compliance, packaging, and tracking.
Understanding the Regulatory Landscape
Importing human-derived materials into the United States requires navigating a complex web of public health regulations. These rules protect the population and the environment from biological hazards. Organizations shipping samples for diagnostics, clinical trials, or research must comply with regulatory bodies such as the CDC and APHIS.
The Centers for Disease Control and Prevention (CDC) plays a central role in determining what materials require import permits and how shipments must be handled. The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) may also regulate materials that include animal components. Understanding these agencies’ requirements is essential for a smooth import process.
CDC Import Requirements for Human-Derived Materials
The CDC requires an import permit for materials that pose potential infectious risks. This includes human tissues, blood, bodily fluids, and other specimens used in diagnostic or research settings. Permits are evaluated based on the material’s origin, intended use, and containment procedures.
Permit applications must include detailed shipment descriptions, biosafety protocols, and handling information. Approval can take several weeks, so early planning is key. Importing without proper authorization may lead to customs delays, rejections, or fines.
The CDC’s objective is to ensure that all imported materials meet biosafety and security standards. This helps protect lab workers, the public, and the environment from potential biological threats.
Why the CDC Mentions 508 Accessibility
Some shippers may encounter references to CDC 508 compliance when preparing documentation. The downloadable form for import certification is named Importer_Certification_Statement_Form_508.pdf. The “508” here indicates that the file meets accessibility requirements outlined in Section 508 of the Rehabilitation Act.
This regulation ensures digital content is accessible to people with disabilities. When submitting digital files—such as application forms, manifests, or supporting documents—to the CDC, the content must be formatted for screen readers and assistive technologies. While it is not a form number, this designation helps the CDC meet federal accessibility standards.
Ensuring compliance with accessibility helps facilitate timely document processing. Files that don’t meet readability standards may be rejected or delayed, affecting the shipment’s timeline.
When APHIS Oversight Is Required
APHIS monitors imports that involve animal-origin materials, even when used in medical or scientific applications. If the human-derived shipment contains animal proteins, reagents, or is processed using animal cells, APHIS regulations may apply.
For example, cell cultures grown in fetal bovine serum, diagnostic kits containing gelatin, or materials with agricultural impact all fall under APHIS oversight. The agency may require import permits, treatment documentation, or additional screening.
APHIS ensures that animal-related materials do not introduce pests or diseases into the U.S. ecosystem. Their involvement adds a compliance layer but is critical for certain research and healthcare shipments.
Table: Understanding Your Import Requirements
If your shipment... | What CDC requires | Why CDC 508 comes up | Why import permit comes up | Why APHIS comes up |
|---|---|---|---|---|
Is not known or reasonably suspected to contain an infectious agent (e.g., FFPE blocks, slides, cDNA, serum proven non-infectious) | A one-page Importer Certification Statement completed and signed by the U.S. consignee. No actual permit is issued. | The downloadable template is named Importer_Certification_Statement_Form_508.pdf. That "508" just marks the file as Section 508-accessible; it's not a form number. | Demonstrates shipment is non-infectious and eligible for import without a full CDC permit | Typically not required unless animal-derived reagents are present |
May contain a viable pathogen, or you can't rule one out | A full CDC Import Permit issued through the electronic Import Permit Program (eIPP). All applications submitted online. | 508 accessibility standards still apply when submitting supporting digital files, including SOPs, manifests, or correspondence with CDC. | Required for any material that could contain an infectious agent | Not typically involved |
Contains select agents/toxins, livestock pathogens, or plant pests | Both a CDC import permit and USDA APHIS or CDC Form 2 transfer authorization, depending on the organism | Digital submission portals require accessible formats for supporting documents. The "508" label may appear on template files or upload instructions. | Required for high-risk organisms or regulated biological materials | Required when shipment involves plant pests, livestock diseases, or regulated toxins |
Packaging and Labeling for Human-Derived Materials
All human-derived materials must be packaged and labeled according to CDC and IATA guidelines. These include strict standards for leak prevention, temperature control, and biohazard containment.
Typical packaging includes:
A primary sealed container
A secondary leak-proof protective container
A rigid outer box with absorbent material
Labels must clearly display:
UN classification (e.g., UN 3373 for biological substances)
Biohazard symbols, if applicable
Contact information for sender and recipient
Handling instructions and temperature requirements
Clear, readable labeling ensures safe transport and regulatory acceptance. When submitted digitally, label scans or files should be accessible and legible.
How Mercury Supports Regulated Imports
Mercury provides comprehensive logistics solutions for regulated imports, especially in the life sciences sector. Their services are tailored for clients shipping biological substances, diagnostics, reagents, and human-derived samples.
Regulatory Expertise Mercury understands the regulatory landscape. Their team helps clients determine whether CDC permits or APHIS reviews apply. They manage form completion, document submission, and agency coordination to ensure full compliance.
Accessible Documentation Mercury assists in preparing accessible digital files required by federal agencies. Submission forms, manifests, and customs documents are formatted to meet 508 accessibility standards.
Validated Packaging Solutions Clients receive validated packaging that complies with biosafety and transportation regulations. These packaging systems maintain temperature control, protect sensitive contents, and withstand long-distance transit.
Shipment Tracking and Support Mercury monitors every shipment in real time. They provide updates on delivery status, customs interactions, and environmental conditions. Clients can focus on research, not logistics.
Integrated Communication Mercury handles coordination between shippers, customs brokers, and federal agencies. This reduces delays and prevents miscommunication, streamlining the entire process.
When importing human-derived materials, choose a logistics partner that understands the science and the regulations. Mercury ensures your shipment meets CDC, APHIS, and accessibility requirements. Contact Mercury today to keep your logistics compliant, secure, and stress-free.
Contact us today to ensure your regulated shipments are delivered safely, compliantly, and without delay—so your team can focus on advancing science, not navigating red tape.
