PHMSA Proposed Rule Would Revise Transportation Requirements for Infectious Substances

PHMSA explains that these proposed regulations are designed to ensure an acceptable level of safety for the transportation of infectious substances and to facilitate domestic and international transportation.

Specifically, this proposed rule would harmonize the Hazardous Materials Regulations (HMR) for the transportation of infectious substances with those adopted, or expected to be adopted, for the United Nations (UN) Recommendations on the Transport of Dangerous Goods and the International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air.

Proposed Rule Would Change Classification of Infectious Substances, Etc.

The following are highlights of PHMSA's proposed rule on transportation requirements for infectious substances (partial list):

Proposed rule would classify infectious substances in two categories rather than Risk Groups 1 through 4. PHMSA explains that the HMR currently require Division 6.2 materials (infectious substances) to be assigned to Risk Groups 1, 2, 3, or 4, with Risk Group 4 denoting highest risk, based on the degree of risk associated with laboratory manipulation of the pathogen. However, PHMSA is now proposing to adopt the following UN Recommendations' two-tiered classification system for such material:

Category A. PHMSA explains that Category A infectious substances pose a higher degree of risk than those in Category B. Category A materials are infectious substances that are transported in forms that are capable of causing permanent disability or life-threatening or fatal disease to otherwise healthy humans or animals when exposure occurs. PHMSA notes that the proposed definition of Category A could include cultures of materials currently considered to be Risk Group 2 and 3 materials.

PHMSA states that the proposed transportation requirements for Category A infectious substances would be identical to current requirements under both the HMR and the UN Recommendations for Risk Group 4 infectious substances. Category A infectious substances, including RMW containing Category A infectious substances, would be required to be transported in accordance with requirements applicable to UN 2814 (infectious substance affecting humans) or UN 2900 (infectious substance affecting animals only).

Category B. Category B infectious substances do not cause permanent disability or life-threatening or fatal disease to humans or animals when exposure occurs. PHMSA notes that certain Risk Group 2 or 3 substances could now be assigned to Category B and would be subject to less stringent regulatory requirements. Under the UN Recommendations, Category B infectious substances would be described as "biological substances." Category B infectious substances would be assigned the identification number UN 3373, which would be required to appear in certain labeling detailed in proposed 49 CFR 173.199(a)(5).

Under the proposed rule, Category B infectious substances would be eligible for certain regulatory exceptions, including the Materials of Trade (MOTS) exception. In addition, PHMSA is proposing to clarify in 49 CFR 172.200 that the shipping paper requirements do not apply to Category B infectious substances prepared in accordance with proposed 49 CFR 173.199.

(PHMSA notes that Category A and B designations developed for purposes of transportation are different from the Category A and B designations for agents of bioterrorism developed by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). The criteria for inclusion in these categories differ, and although there is some overlap, the lists should not be confused.)

Amended Packaging Instructions. The PHMSA proposed rule would amend 49 CFR 173.196 to reflect the proposed packaging requirements for Category A infectious substances. According to PHMSA, the proposed revisions are generally editorial and would not change current packaging requirements; however, PHMSA is proposing to add a requirement that outer packagings be rigid. In addition, 49 CFR 173.199 would contain the proposed packaging requirements for Category B infectious substances and used health care substances.

PHMSA would also modify the RMW packaging requirements in 49 CFR 173.197 to incorporate Category A and B infectious substances; however, the proposed revisions would not substantially change the current packaging requirements for non-bulk or bulk shipments of RMW.

Security Plans would be required for agents and toxins listed in 9 CFR Part 121. PHMSA explains that currently, persons who offer for transportation or transport certain infectious substances in commerce must develop and implement security plans in accordance with Subpart I of 49 CFR Part 172. Because select agents and toxins affecting animals could be used to compromise public health, PHMSA is now proposing to add the select agents and toxins listed in 9 CFR Part 121 and regulated by the Animal and Plant Health Inspection Service (APHIS) to the list of hazardous materials (hazmats) for which a security plan is required.

As proposed, persons who offer or transport any of the materials regulated under 9 CFR Part 121 would be required to develop and implement security plans that conform to HMR requirements. PHMSA is proposing to provide six months from the effective date of a final rule for shippers and carriers to come into compliance with this proposed requirement.

Furthermore, PHMSA invites commenters to address whether it should also require persons who offer or transport select agents and toxins that have been found to pose a severe threat to plant health or plant products, regulated by APHIS under 7 CFR Part 331 to develop and implement transportation security plans. PHMSA explains that such materials could also be used illegitimately to compromise public health.

Manufacturers and distributors of Category B packagings would have to provide 'clear' instructions to consignor. This proposed rule would require that the manufacturer and subsequent distributors of packagings (including testing laboratories) authorized for the transportation of Category B infectious substances under proposed 49 CFR 173.199 would have to provide clear instructions on filling, preparing, and closing the packaging to the consignor or the person who prepares the package for transportation.

Proposed closure requirements for regulated medical waste and sharps containers. PHMSA states that it is proposing to add specific closure requirements in a number of sections applicable to the transportation of RMV, including sharps, because enforcement experience indicates that closures currently being used for sharps containers may not adequately assure that no contents will be released during transportation.

Shipments of routine, unknown, or 'suspected' samples/substances. Routine samples. This proposed rule would generally allow routine samples that are (1) unlikely to contain an infectious substance, or (2) where the pathogenicity of the infectious substance is at a level naturally encountered in the environment that will not cause disease when exposure to it occurs, to be transported as non-regulated materials.

Unknown samples. In most other cases, the proposed rule would permit unknown samples shipped for analysis and diagnosis to be transported in accordance with requirements for Category B infectious substances.

Suspected Category A infectious substances. For situations where the identity of the agent or pathogen is not known, but sufficient information is available to strongly suspect a Category A infectious substance, the proposed rule would require an indication on shipping papers that the sample contains a Category A infectious material, as follows: "Infectious substances, affecting humans (suspected Category A infectious substance), 6.2, UN 2814." Such suspected substances would have to be shipped in accordance with all applicable hazard communication and packaging requirements for Category A infectious substances. See proposed rule for further guidance on making a Category determination for unknown substances.

See proposed rule for additional information on the proposed changes and additions to 49 CFR Parts 171 - 173, and 175.

(See ITT's Online Archives or 08/27/02 news, 02082799 2, for BP summary of an August 2002 final rule which revised transportation requirements for infectious substances.)

- written comments must be received by July 18, 2005.

PHMSA Contact - Eileen Edmonson (202) 366-8553

PHMSA Proposed Rule (D/N PHMSA-2004-16895 (HM-226A), FR Pub 05/19/05) available at http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-9717.pdf