Frequently Asked Questions

A DOT Third Party Lab Competent Authority approval is a testing organization that has been recognized by the U.S. Department of Transportation to conduct official performance testing of dangerous goods packaging designs and issue the UN certification marks required under Title 49 CFR. The designation requires formal DOT recognition at each facility where testing is performed, and only a limited number of testing agencies hold it.

TEN-E holds DOT Third Party Lab Competent Authority approval at three U.S. locations: Newport, MN; Ontario, CA; and High Point, NC. TEN-E was the first testing agency in the United States to receive this designation. For companies that manufacture or use dangerous goods packaging, testing performed at a DOT Competent Authority facility is what produces the UN certification marks that appear on compliant packaging. See Dangerous Goods Package Testing and Accreditations & Memberships.

ANAB (American National Accreditation Board) is the U.S. accreditation body that assesses laboratories against the requirements of ISO/IEC 17025. ANAB is a signatory to the International Laboratory Accreditation Cooperation (ILAC) mutual recognition arrangement, which means ANAB-accredited test results are recognized by accreditation bodies in more than 100 countries.

When a test report is issued by an ANAB-accredited laboratory, it carries formal documentation that the lab’s testing meets international competence requirements. That recognition matters for regulatory submissions, retailer compliance programs, and international trade documentation where accredited results are specified.

APASS stands for Amazon Packaging Support and Supplier Network. It is the certification program through which Amazon designates laboratories as qualified to perform the ISTA 6 test procedures required for Amazon’s packaging certification programs: Frustration-Free Packaging (FFP), Ships in Own Container (SIOC), Prep-Free Packaging (PFP), and Over Boxing (OB).

TEN-E is an APASS-certified laboratory, and testing for all four Amazon certification programs must be performed at an APASS-certified lab using ISTA 6 member performance test procedures. Amazon accepts ISTA 6 test reports only from APASS-certified laboratories for packaging certification submissions. For Amazon testing inquiries, contact apass@ten-e.com. See Amazon Package Testing.

An ISTA-certified laboratory has been assessed by the International Safe Transit Association and confirmed to meet ISTA’s requirements for equipment, procedures, and reporting. ISTA laboratory certification is identified by a certification number. TEN-E’s certifications are ST-2135 (Newport, MN) and ST-10492 (High Point, NC).

Many retailer and manufacturer compliance programs require that ISTA testing be performed at an ISTA-certified laboratory: Amazon’s APASS program and Sam’s Club distribution standardsacceptance programs all require it. ISTA requires that test results submitted to retailers and supply chain partners for program compliance come from a certified laboratory. See ISTA Testing and Accreditations & Memberships.

Environmental testing subjects packaging to controlled temperature and humidity conditions to evaluate how packaging materials and configurations respond to environmental stressors over time: accelerated aging, ESCR, UV exposure, and conditioning.

Cold chain testing focuses specifically on packaging that must maintain a controlled temperature range during transport and storage. Cold chain packaging must demonstrate that the product inside stays within its required temperature range throughout the distribution cycle, confirming thermal performance rather than just material durability.

TEN-E performs cold chain testing to ISTA 7D (temperature test for transport packaging), ISTA 7E (thermal transport packaging for parcel delivery), supporting conditioning standards and customers specific profiles. Cold chain testing is relevant for pharmaceutical products, medical devices, biologics, and temperature-sensitive food and beverage products. See Cold Chain Package Testing and Environmental Package Testing.

Title 49 CFR (Code of Federal Regulations) is the U.S. Department of Transportation’s regulatory framework governing the transport of hazardous materials, including dangerous goods packaging requirements for transport within the United States.

The International Civil Aviation Organization (ICAO)governs the transport of dangerous goods by international air. Both frameworks share a common foundation in the UN Model Regulations on the Transport of Dangerous Goods, but have different requirements, packing instructions, and shipper declaration formats. Companies that ship dangerous goods by both ground and air must meet both. TEN-E tests to both Title 49 CFR and ICAO requirements. See DOT / UN / ICAO / IMDG Regulatory Testing.

ISO 11607 is the international standard that defines requirements for packaging used with terminally sterilized medical devices. It covers sterile barrier system design, material selection, forming and sealing, and validation, including seal integrity testing and accelerated aging to establish packaging shelf life.

Compliance with ISO 11607 is required for medical device manufacturers whose packaging must maintain sterility through distribution and up to the point of use. The FDA recognizes ISO 11607 as a consensus standard for sterile packaging, and manufacturers can reference ISO 11607 compliance in regulatory submissions as evidence that packaging meets FDA requirements. TEN-E performs the full range of ISO 11607 testing. See Medical Device Package Testing and ISO Testing.

TAPPI (Technical Association of the Pulp and Paper Industry) publishes test methods for paper, paperboard, corrugated fiberboard, and related packaging materials. TAPPI test methods are the standard reference for evaluating the physical and structural performance of paper-based packaging.

TEN-E performs box compression testing (measuring the load a corrugated box can bear before failing), edgewise crush testing (measuring the column strength of corrugated board), and Cobb water absorption testing (measuring a corrugated material’s resistance to moisture absorption). These tests apply to companies whose products ship in corrugated packaging and need to verify structural performance under distribution and storage conditions. See TAPPI Testing and Distribution Package Testing.

ISTA protocols are specifically designed for transit packaging performance and are often required by retailers. ASTM standards cover a broader range of packaging test methods — including individual test procedures (vibration, drop, compression) and complete distribution simulation sequences. Many packaging programs use both.

TEN-E serves clients internationally across all three lab locations. TEN-E’s ANAB ISO/IEC 17025 accreditation is recognized under the ILAC mutual recognition arrangement, meaning accredited results are accepted by accreditation bodies in more than 100 countries.

For clients with specific requirements under European ADR, Transport Canada TDGR, or other country-specific frameworks, TEN-E’s consulting team can advise on applicable frameworks. See Accreditations & Memberships.

The right standard depends on what your packaging contains, how it ships, and what compliance requirements apply to your product or supply chain.

If you are packaging dangerous goods, the starting point is the regulatory framework for the mode of transport: Title 49 CFR for ground, IATA DGR for air, IMDG Code for sea. If you are validating medical device or pharmaceutical packaging, ISO 11607 and FDA requirements shape the test plan. If you are validating distribution packaging for a retailer or logistics program, ISTA, ASTM D4169, or retailer-specific standards may apply. Many projects require testing under more than one standard.

 The best way to get a project timeline is to submit a quote request. TEN-E will provide a scope and timeline with the quote.

A TEN-E test report documents the test procedures performed, the equipment used, the conditions maintained, and the results of each test including pass or fail determination if  the applicable standard has pass or fail criteria. Reports are issued on TEN-E letterhead and reference the applicable standards and accreditations under which the testing was performed.

For accredited testing, reports reference TEN-E’s ANAB ISO/IEC 17025 accreditation. For UN certification testing, reports support the issuance of UN certification marks by TEN-E as a DOT Competent Authority.

DEA Controlled Substance Registration is a federal authorization from the U.S. Drug Enforcement Administration allowing a laboratory to handle or test packaging associated with Schedule I through V controlled substances. For pharmaceutical companies that package controlled substances, testing at a DEA-registered laboratory is a compliance requirement.

Under Title 49 CFR Part 172, Subpart H, any employee who designs, manufactures, prepares, reconditions, repairs, marks, tests, or ships hazardous materials packaging is required to complete initial hazmat training within 90 days of employment or a job function change, with recurrent training at least every three years. The obligation rests with the employer.

TEN-E offers DOT hazmat packaging training through an annual in-person seminar at Newport, MN and through customized web-based training. The training covers general awareness, function-specific, safety, and security awareness requirements of Title 49 CFR for non-bulk packagings and IBCs. See Hazmat Training.

Package testing produces documented test results: TEN-E runs packaging through defined procedures under a specific standard and issues a test report showing results against the applicable criteria. Testing is the procedural and measurable component of packaging compliance.

Packaging consulting is the interpretive and advisory work that surrounds testing. Consulting covers situations where the right answer requires analysis rather than procedure: when regulations are ambiguous, when a packaging design needs evaluation before testing, when a competent authority approval requires documentation beyond a standard test report, or when a field failure needs root cause analysis. Many clients need both, and TEN-E offers testing and consulting as connected services. See Packaging Consulting and Package Testing Services.

TEN-E’s consulting team has experience across multiple international regulatory frameworks, including UN Model Regulations, IATA DGR, and IMDG Code. For projects involving specific international jurisdictions, we confirm applicable frameworks and documentation requirements at the outset of each engagement.

Package testing produces documented performance data against a defined standard or protocol. Consulting addresses questions that data alone cannot answer: how to interpret a regulation, how to design packaging that will meet a requirement, how to respond when packaging fails, or how to obtain regulatory approval for a non-standard configuration. Many engagements involve both, with consulting framing the test plan and interpreting the results.