The Challenge
The proper classification, packaging, labeling, marking, and shipping of hazardous materials are an increasingly important aspect of remaining competitive in today’s business climate. This is especially the case with biological products and infectious substances used in testing, research, and the treatment of disease. It is often critical for these products to move in a timely and efficient process through the transportation system. In this highly competitive industry, delays that can result from the improper preparation of your shipment can become a ‘make or break’ issue. The correct classification of your existing products, the commodities you are developing, and the wares you are using daily in your production processes or at your facilities, can be the difference between timely delivery and substantial shipping delays and potential enforcement action.
How to classify products as hazardous materials when tendering them into the transportation chain remains a significant source of industry confusion. In addition, constantly evolving and rigorous regulatory requirements further complicate the transportation cycle. The goal of this article is to heighten your awareness of the requirements for tendering your commodities into the transport system, thereby promoting safety, increasing the efficiency of your company, and safeguarding your reputation with the public.
This article will introduce you to: the regulations governing shipments of hazardous materials (known as dangerous goods in international transportation); the training requirements that will help you ensure proper packaging and shipment; the likely sources of hazardous materials within your operation/supply chain; the classification of hazardous materials and biological products; aspects of the enforcement and inspection process; and how to obtain special permits for those items not normally allowed to be transported.
The Regulations
The classification and transportation of Hazardous Materials in the United States is covered by the Hazardous Materials Regulations (HMR) found in the Code of Federal Regulations, Title 49, Parts 171-180. As authorized by 49 C.F.R. § 171.22, shippers may opt to use standards found in the International Civil Aviation Organization’s (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air when shipping to, from, or within the United States. ICAO’s Technical Instructions are developed through consensus by the ICAO Dangerous Goods Panel (DGP), a 19-member group comprised of representatives from 17 countries and two industry associations. The ICAO DGP helps to ensure the uniformity of regulations for hazardous materials throughout the global transportation system.
A clear understanding of your company’s responsibility in the movement of hazardous materials is the best way to avoid shipping delays and possible enforcement action. Many companies involved with biological products may not realize that they use and ship items classified as hazardous materials in the daily course of business. When they do, these companies become a "hazmat employer" that employs "hazmat employees," as defined in 49 C.F.R. § Part 171.8. It is the responsibility of the company that tenders a commodity into the transportation stream, i.e., the shipper, to correctly classify, describe, mark, document, and package the commodity, as outlined in 49 C.F.R. § 173.22.
Employee Hazardous Materials Transportation Training
During the course of our inspections, Federal Aviation Administration (FAA) Special Agents sometimes notice that persons who are unaware of hazardous materials transportation requirements set forth in the HMR are involved in making the determination as to the level or type of hazard posed by a commodity. As defined in 49 C.F.R. § 171.1(b), these persons are preforming a critical pre-transportation function that is vital to the safety of persons and property and training them is essential.
Reviews of our case files and incident data show that improper training and the lack of knowledge are a leading cause of incidents and enforcement actions, and account for a sizeable portion of civil penalties.
Proper and documented training is, in fact, a requirement and must be provided by the "hazmat employer" per 49 C.F.R. § 172.702, for all employees who handle, classify or prepare hazardous materials for transportation. A thorough review of 49 C.F.R. § 172.704 outlines the specific training requirements that are often overlooked by regulated parties. Overlooking these requirements can result in enforcement action, but more importantly, can increase the potential for catastrophic incidents that jeopardize life and property.
When developing a new product for market, or returning product to one of your vendors, the required training helps to ensure the safe and timely processing of your shipments. It is important to note that you may hire an outside organization to perform your training. A quick internet search for "hazardous materials transportation training" will verify the plethora of training available. Experience from the field shows that although most third-party training complies with existing regulations, the standard training programs offered may not be thorough enough for your specific job functions and tailoring the program or offering supplemental training may be necessary. As a hazmat employer you will be held responsible for regulatory compliance, regardless of whether it is your employee(s) or a contractor that is performing the training. Because liability for compliance is imputed to you – the hazmat employer – you need to ensure that you completely review any training program to assure it meets regulatory requirements, not simply your company’s needs.
If you determine you are a company who offers hazardous materials in transportation, you may be interested to know that as a shipper, you are not the only entity that must train employees. Air carriers who accept hazardous materials are fully regulated, trained, and equipped to transport hazardous materials. Those carriers have procedures to ensure the safe handling of your cargo; in fact hazardous materials cargo is often given a higher level of service due to its characteristics and requirements for special handling. Aviation has the unique character of being the timeliest way to get your product to market but it is also the most vulnerable to incidents that can quickly turn serious. As a result, aviation is the most highly restricted mode of transport for hazardous materials. But, be aware that no matter what mode of transportation you select for your products, all must give training to their "hazmat employees" prior to transporting your commodity.
In Addition to your Primary Products, do You have Other Hazardous Materials at Your Facility that you Tender for Transportation?
The experience we have gained as FAA Special Agents monitoring the hazardous materials industry, suggests that readers of Pharmaceutical Outsourcing may use, ship, or receive products that are classed as hazardous materials. Biological, Semiconductor, and Healthcare organizations are examples of the many industries that offer these materials in the transportation chain on a frequent basis.
In addition to the primary products that your company produces and ships, there may be parts of your organization that use hazardous materials for various purposes. For example, the cleaning supplies that the custodial staff buys for use at your facility or the paint that your maintenance staff uses for building repair may also be regulated. Many companies that use and ship these materials are unaware of the fact that they have these commodities on hand and are tendering them into the transportation chain either incorrectly or completely undeclared - compromising safety and increasing the risk of a catastrophic incident. A cursory inspection of your facility will quickly illuminate the amount of hazardous materials that you have. A simple rule: if you have any Material Safety Data Sheets (MSDS) covering products in your facilities, then you most likely have regulated hazardous materials onsite.
For the organization that deals with biological products and many other businesses on the cutting edge, your biggest challenge from hazardous materials frequently originates in your Research & Development (R&D) departments. There, engineers, medical researchers and anyone involved in R&D are constantly formulating new compounds, delivery systems, and products that keep you on the front line of your industry. Unfortunately, these same substances can present a hazard when shipped. Many of the constituents used to make these products are hazardous by nature. As we review shipments as FAA Special Agents, we sometimes note that employees, who are developing materials that may eventually be transported, do not appear to understand the classification requirements for hazardous materials. Further, it is sometimes found that parties are incorrect in their classification of the product and so jeopardize the entire transportation chain in the process.
Classification of Your Hazardous Materials
As stated in the preceding paragraphs, the person/company who prepares and tenders the hazardous materials into the transportation network is responsible for the correct classification of the commodity.
The definitions and standards that determine the hazard class or division associated with your commodity are found in 49 C.F.R. Part 173. There is a helpful table contained in 49 C.F.R. § 173.2 that provides the location of each hazard class definition in 49 C.F.R. Part 173. These standards are used to determine the classification of your commodity. In reviewing the appropriate sections one quickly sees that "guessing" the hazard associated with any suspected hazardous commodity is not only dangerous, it is a violation of the regulations per 49 C.F.R. § 171.2(e) when the guess turns out incorrect. When your company formulates a new product, it is the full responsibility of your company to certify that the product is properly classified per the regulations.
The best method for complying with the correct classification is to have your product tested to see which hazard classes are applicable to your commodity per the regulations. A person who understands the classifications in the HMR is the one who should make the determination as to the hazards applicable to the commodity. It is important to note that one or more hazards may be applicable to your product and discovered when the product is tested. If such a case arises a primacy of the hazards is found in 49 C.F.R. § 173.2a.
Classification of Biological Products and Infectious Substances
Many companies are utilizing infectious substances or biological agents within the context of research or are offering them into the transportation system to aid in various medical applications for humans or animals. These substances present a difficult challenge in their classification. A substance that meets the criteria of 49 C.F.R. § 173.134(a) (1) must be handled and transported as a ‘Category A’ infectious substance or ‘Category B’ infectious substance. 49 C.F.R. § 134 (a)(1)(i) and (a)(1)(ii) provide the information on how to classify your substance.
We sometimes see a misclassification of ‘Category A’ infectious substances as ‘Category B’ infectious substances, which is less stringent in its requirements for transport. You are encouraged to keep in mind the definitions and the hazards presented by these substances. Reviewing 49 C.F.R. § 173.134 in its entirety can provide you with the information you need to make a correct determination. The Pipeline and Hazardous Materials Safety Administration (PHMSA) has produced a helpful brochure titled "Transporting Infectious Substances Safely," which can be found at: Http://www.phmsa.dot.gov/staticfiles/PHMSA/ DownloadableFiles/Files/Transporting_Infectious_ Substances_brochure.pdf. This information should provide you with answers to the many questions you may have about transporting infectious substances.
Not Just Training and Classification
Although I have focused on classification and training in this article, you should be aware that the HMR has additional detailed requirements for communicating the hazards of the materials being shipped, documenting the shipment, emergency response information, and packaging. These can be found in 49 C.F.R. Parts 172 and 173.
Inspection and Enforcement
The FAA and other administrations within the Department of Transportation (DOT) have oversight over the movement of hazardous materials in their respective modes of transportation, i.e., air, highway, rail, ship. Often, your products use multiple modes of transportation to get from the origination point to their destination.
We work to ensure compliance with the HMR by evaluating through observation hazardous materials packages and associated documentation offered from shippers and transported by air carriers. Remember, training is required for all transportation modes, both for the shipper and the carrier. FAA Agents visit shippers of hazardous materials like you to ensure your compliance with the applicable regulations. When a FAA Special Agent or an Inspector from a different modal administration of DOT appears at your facility to perform an inspection, please remember that this is part of their efforts to ensure a safe transportation system and they are required to conduct these inspections by the Secretary of Transportation.
Visits are traditionally unannounced and the inspection can last from several hours to a full day or more depending on your facility. Usually, copies of some paperwork are required to be provided by you, the shipper. Under the Federal hazardous materials law, at 49 U.S.C. § 5121(b), you are required to maintain records and property, make reports and provide information that the DOT requires by regulation and to produce this material to a DOT agent available for inspection. Further delegation of authority for FAA Special Agents is found in 49 U.S.C. § 40113 and 14 C.F.R. § 13.3.
Non-compliance with the regulations and incidents involving your shipments will result in an investigation and can result in large civil penalties, or even criminal prosecution, as well as potentially adverse publicity for your company. Unfortunately, a review of our incident data shows that compliance with the regulations is an ongoing struggle and that incidents involving spills and release of hazardous materials are all too frequent.
Pipeline & Hazardous Materials Safety Administration (PHMSA) and Special Permits
Special Permits
PHMSA is the modal administration within the DOT that is responsible for writing the regulations contained in the HMR. Once issued, regulated entities must comply with the rules. Sometimes however, pharmaceutical, medical research and other hazardous materials shippers may wish to transport materials in a manner that is not otherwise permitted by the HMR.
In such instances, these parties apply to PHMSA for a "special permit" to authorize them to perform certain functions. Recently, PHMSA has improved the process for applying for these alternative measures by bringing the Special Permit application process online. Special Permits could be a useful tool that allows a company to get product moving that might otherwise not be authorized for transport. The important point to remember about special permits is that PHMSA may grant requests for special permits only when the alternative approach that a company proposes meets an equivalent level of safety when compared with the regulation from which they are seeking relief. Otherwise, a special permit will not be granted.
"Special Permits" are occasionally used incorrectly or by entities that are not a party to the special permit. When obtaining or utilizing a Special Permit you must review and comply with all requirements laid out in the permit. Bear in mind, this usually includes documented training and testing on the provisions of the permit by any employee involved in a function of that permit.
Compliance with a special permit requires the permit holder to abide by ALL requirements that are expressly set forth in the permit PLUS all other applicable requirements in the HMR.
Interpretations of the HMR
PHMSA also allows you to ask for interpretations of the regulations and if you have a question about classification or any uncertainty about the regulations, PHMSA can provide a "Letter of Interpretation" to assist in providing clarity on an uncertainty you may have. Previously issued letters are located on the PHMSA website and are open for your review. The PHMSA website also contains may other useful tools that can assist in your company shipping responsibly. The website is a wonderful resource in this regard.
The Future
We live and work in a world that is now a global community. Commerce is dynamic, improvement in transport chain development is ongoing, regulations are changing rapidly, and there is a significant effort to harmonize regulation worldwide. Industry has an opportunity and the associated challenge to get products delivered worldwide to emerging and developed markets. As a result, training and education remains your best tool to keep abreast of the changes that occur so rapidly in the world of global commerce. This is especially the case when you are involved with the transportation of hazardous materials.
All of us have the responsibility to keep safety as a top priority -- when safety is neglected or bypassed; the results can be loss of life and property. This includes hazardous materials shipments that have been improperly offered for transportation by air. Each year, the FAA investigates numerous cases of problems caused on board aircraft by hazardous materials. In fact, FAA investigators have recently been asked to assist in two accident investigations overseas that are looking into the possibility that hazardous materials may have contributed to these major aviation-related accidents. Other hazardous materials incidents can be reviewed through reports that can be found at the National Transportation Safety Board (NTSB) website.
Safety is a critical part of any business operation. A properly prepared shipment of hazardous materials should make it to its destination without delay. Help your business succeed without delay. Be compliant with the HMR, and be safe.
References
1. PHMSA: http://phmsa.dot.gov/home.
2. FAA: http://www.faa.gov/about/office_org/headquarters_offices/ash/.
3. NTSB: http://www.ntsb.gov/.
4. International Civil Aviation Organization (ICAO): http://www.icao.int/icao/en/m_about.html.
5. International Air Transport Association (IATA): http://www.iata.org/Pages/default.aspx.
Michael Burdick has over twenty years of working for a major charter airline that provided cargo and passenger services throughout the world including Asia, the Middle East, South America, Europe, Africa, and throughout the USA. In the performance of his duties, he worked successfully with foreign governments, foreign airlines, and company employees applying his knowledge of Federal Aviation Regulations, foreign government regulations, and company policy. Mr. Burdick worked in various positions with in the airline including: Operation Representative Cargo and Passenger, Ground Security Coordinator, Flight Attendant Trainer, In-flight Supervisor and Manager of in-flight Catering. He came to the FAA in 2002 and has worked in the Hazardous Materials Branch of FAA as a Special Agent focusing on enforcement and compliance of the Hazardous Materials Regulations (HMR: 49 CFR parts 171-180), providing outreach to stakeholders, and other tasks as necessary to ensure the safety of aviation for the public.