March 22, 2005

Office of Hazardous Materials Standards
Pipeline and Hazardous Materials Safety Administration
Attention: DHM-10
US Department of Transportation
400 7th St. SW
Washington, DC 20590-0001

Petition for Rulemaking

The Dangerous Goods Advisory Council (DGAC) petitions for rulemaking pursuant to 49 CFR 106.95, for the addition of a new paragraph (e) to 49 CFR 173.4.

INTRODUCTION
DGAC is a non-profit educational organization that promotes hazmat transportation safety by providing classroom training, seminars and conferences, and participation in domestic and international regulatory activities in its promotion of not only safe, but also efficient transportation of hazardous materials/dangerous goods in commerce.

BACKGROUND AND SUPPORT FOR PROPOSED AMENDMENT
The pharmaceutical industry ships thousands of compounds annually in their efforts to discover innovative therapies for cardiovascular disease, metabolic and infectious disease, and cancer. The primary facilities involved in supporting their research activities include, but are not limited to, hospitals, universities, research and analytical laboratories, and clinics, a number of which operated by state and federal government agencies.

Most of these compounds are packaged for shipment in inner receptacles, each containing less than one gram of a solid or one milliliter of a liquid. For example, a presently used shipping configuration for shipment of compounds for support of high throughput screening processes is the use of inner units called well plates. Each well (inner receptacle) of a plate contains less than one gram or milliliter of a compound and is sealed to prevent contamination or commingling with other materials. The well plates are then placed in strong boxes, the result being combination packagings as defined in 49 CFR 171.8. While various configurations of well plates are utilized, a well plate containing 96 wells is common. I should add that the Food and Drug Administration heavily regulates these containment units for maintenance of compound integrity.

Many materials shipped by the industry are novel compounds. Some have been synthesized in quantities totaling no more than two or three grams at a cost of many thousands of dollars. Experience has demonstrated that most of these compounds do not meet the criteria for classification as hazardous materials. Of the few that do, most fall within Division 6.1, Packing Group III. Based on the desired therapeutic properties of the compounds, their potential toxicity is expected to be the primary concern. However, a retrospective analysis of compounds that have been advanced to a research stage (their therapeutic properties justify further development) show that few are ultimately classed as hazardous materials for transport. For example, we offer the following table submitted by a member company that analyzes their current research compounds for their classification status:

	NUMBER OF COMPOUNDS	PERCENT OF TOTAL
Current Number of research compounds in active development that are classed for transport	1547	---
Of those, the total number classed in Division 6.1	241	15.6
Of those, the total number classed in Division 6.1, PG I	3	0.19

We believe that, due to their quantity and form, shipments of these compounds, including those novel compounds with incomplete classification profiles, in quantities of less than one gram or one milliliter per inner receptacle, present such a low potential risk under any conditions of transport they should not be considered subject to the hazardous materials regulations if the conditions we propose are followed. Therefore, we request a new exception be added to the Hazardous Materials Regulations to eliminate unnecessary impediments to the discovery and development of medicines that will enhance the quality of life of people throughout the world.

By “impediments” we mean costly delays, limited access to service, and per package surcharges as high as $40 per package. One DGAC member alone estimates an annual cost of approximately $1 million because of such impediments.

We recognize that it may not be appropriate for certain classes of hazardous materials to be included in this type of exception. Therefore, we are not requesting that the exception we propose, based on a shipper’s knowledge, apply to PG I classification of any hazard class; nor to the following classes and division: 1, 2, 7, and Division 6.2.

PROPOSED AMENDMENT
We petition PHMSA to amend the Departments Hazardous Materials Regulations by adding a new paragraph (e) to existing §173.4 as follows:

Due to the significance of this petition for the advancement of public health, we request expedited handling of this petition. If there are any doubts or concerns about any aspect of what we propose, we will come to your office with experts, samples of packages, or any other information you require to move this action to completion. We thank you in advance for taking prompt action on the matter.

Sincerely,

Alan I. Roberts
President