Interpretation Response #10-0153

Interpretation Response Details

December 8, 2010

Mr. William Perry
Health and Environmental Investigator II
Public Health, Seattle and King County
401 Fifth Avenue, Suite 1100
Seattle, WA 98104

Reference No. 10-0153

Dear Mr. Perry:

This is in response to your telephone conversation with a member of my staff, and your subsequent e-mail and attachments requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to waste pharmaceuticals. Specifically, you present two transportation plans pertaining to a pilot program the City of Seattle and King County, Washington, would like to begin in these communities to collect waste pharmaceuticals from consumers and transport them for disposal by common carriers using motor vehicles. You described the plans for collecting these materials and conditions common to both, and ask if a special permit or competent authority approval is needed to transport these materials on a one-time or long-term operational basis. You also ask how long it would take to obtain this type of permission. We have paraphrased your questions and answered them in the order you provided.

You state conditions common to the pharmaceuticals in both scenarios are these materials are: 1) Drug Enforcement Administration Schedule 2-5 controlled substances; 2) household hazardous waste exempt under the Environmental Protection Agency"s Resource Conservation and Recovery Act and Washington State Dangerous Waste Regulations; and 3) unwanted medications delivered by residents to approved drop-off locations or collected by law enforcement offices in Snohomish County, WA.

Before packing, you state: 1) all the materials collected will be reviewed by a pharmacist experienced at screening returned medicines and sorted by this pharmacist into controlled and non-controlled categories; 2) unacceptable items under the program"s criteria will be removed (e.g., sharps, liquid mercury, aerosol cans, etc.); 3) non-controlled medicines will be packaged by a permitted hazardous waste disposal vendor; and 4) controlled medicines will be packaged in a 4 milliliter thick plastic drum liner that is closed with a zip-tie and placed in a 10 or 15 gallon, UN 1G standard fiber drum. You also state full packages will be sealed with tamper-evident tape, tracked and shipped by a common carrier from the Bothell, WA, Police Department to the Sauget, IL, Police Department, and disposed of using an approved method, such as incineration. You provided one photograph of typical medicines collected, one photograph of a completed package, and two website links that contain examples of the fiber drum packaging.

Scenario A

Medicines will be left in their original consumer packagings. As items containing liquids are packed, the integrity and tightness of their lids will be checked and corrected as needed. Liquid containers will be packed upright and pill vial packagings will be used to separate the liquid containers from each other and the sides of the fiber drum. By weight, an estimate of the contents, based on inventories of materials collected from another pilot program (PH:ARM), is 66 percent will be medications and 34 percent will be packaging materials and containers, and 70 percent of the medicines will be solids and 30 percent will be liquids. The materials packed according to Scenario A will be marked and labeled as "Consumer commodity, ORM-D." This completed package will weigh 66 pounds or less.

Scenario B

Solid medicines will be removed from their original packagings and transferred into an approved outer packaging. Liquids and ointments will remain in their original consumer packagings. As items containing liquids are packed, the integrity and tightness of their lids will be checked and corrected as needed. Liquid containers will be packed upright and loose pills will be used to separate the liquid containers from each other and the sides of the fiber drum. Additional commercial absorbent (e.g., kitty litter) will be used as needed to provide protective cushioning and absorb any leaked liquid contents. By weight, an estimate of the contents, based on inventories of materials collected from another pilot program (PH:ARM), is 90 percent of the contents will be solids, and 10 percent will be liquids or ointments and their containers. The materials packed according to this scenario will be marked, labeled, and described as "UN 3249, Medicine, solid, toxic, n.o.s., 6.1 (poisonous), Packing Group (PG) II" or "UN 1851, Medicine, liquid, toxic, n.o.s., 6.1, Packing Group (PG) II." This completed package will weigh approximately 60 pounds.

Based on the information you submitted, the materials packaged as described in both scenarios are permitted in transportation under the HMR provided these materials are compatible with the packaging materials and do not react dangerously with each other (see §§ 173.21, 173.24, 173.24a, and 173.153). Completed packages that contain liquids must be marked with directional arrows to indicate the correct (upright) orientation of these inner packagings and their closures within the outer packaging (see § 172.312(a)(2)). Also, please note materials prepared in conformance with Scenario B must have the technical name entered in parentheses as a part of the proper shipping description on a shipping paper either after the proper shipping name or at the end of the basic description (see § 172.203(k)). As defined in § 171.8 of the HMR, "technical name" means a recognized chemical name or microbiological name currently used in scientific and technical handbooks, journals, and texts. A generic description may be used as a technical name for a Division 6.1 material provided it readily identifies the general chemical group.

If the packaging and accompanying materials do not meet the criteria prescribed in the HMR, the packaging will have to be approved under the terms of a special permit. The application process is described in 49 CFR Part 107, Subpart B. Processing times for the issuance of a special permit vary based on the complexity and completeness of the application, but this agency requests that the application be submitted at least 120 days before the requested date the applicant want the special permit becomes effective. For a special permit to be issued, the Pipeline and Hazardous Materials Safety Administration must find that the procedure the applicant has requested maintains a level of safety at least equal to the level required under the HMR.

I hope this satisfies your request.

Sincerely,

T. Glenn Foster
Chief, Regulatory Review and Reinvention
Standards and Rulemaking Division

172.101, 171.8, 173.21

Regulation Sections