Interpretation Response #02-0222 ([Solutions, Inc.] [Victor B. Anderson])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 05/23/2003

Company Name: Solutions, Inc.

Individual Name: Victor B. Anderson

Location State: KY Country: US

View the Interpretation Document

Response text:

May 23, 2003

Mr. Victor B. Anderson                    Reference No. 02-0222
Solutions, Inc.
5948 Timber Ridge Drive, Ste. 102
Prospect, Kentucky 40059

Dear Mr. Anderson:

This is in further response to your letter and telephone conversations with Ms. Eileen Edmonson of my staff.  You asked if a hazardous materials carrier may transport sharps described as "Regulated medical waste, 6.2 (infectious), UN 3291, PG II," packaged in UN standard or nonDOT specification packagings under the Hazardous Materials Regulations (HMR; 49 CFR Part 171-180) that do not meet the sharps packaging requirements of the U.S. Food and Drug Administration (FDA).

We recently revised the requirements in the HMR for infectious substances, including sharps meeting the definition of RMW, to harmonize them with international standards and incorporate several RMW exemptions (67 FR 53118, August 14, 2002).  While certain of these revised requirements, some of which are discussed below, refer to FDA requirements for sharps containers, the FDA is the lead agency in approving single-use and reusable medical devices, such as sharps containers.  The HMR do not supercede these requirements.  For more information on the FDA's requirements, you may wish to contact Ms. Diane Goldsberry or Ms. Carolyn Niebauer of the FDA's Centers for Devices and Radiological Health, Office of Compliance, Division of Enforcement, General Hospital Devices Branch, HFZ-333, 2094 Gaither Road, Rockville, MD, 20850, at (301) 594-4618.

Under the new HMR requirements, the following RMW packagings are authorized for Division 6.2 (infectious) sharps that are not a Risk Group 4 material: (1) a non-bulk, puncture-resistant packaging that meets the Packing Group II performance level requirements in 49 CFR Part 178, Subpart M, as specified in § 173.197(b); (2) a puncture-resistant Large packaging capable of retaining liquids that meets the testing requirements for an intermediate bulk container prescribed in 49 CFR Part 178, Subpart O, as specified in § 173.197(c); (3) a non-specification wheeled cart (Cart) as specified in § 173.197(d)(1) and (d)(2); or 4) a bulk outer packaging (BOP) as specified in § 173.197(d)(1) and (d)(3).  Inner packagings used in a Large packaging, Cart, or BOP must conform to the requirements in § 173.197(e).

You also asked if an inner packaging containing sharps and a polyethylene bag containing RMW may be placed in the same outer packaging under the HMR.  For non-bulk packagings, the answer is yes.  However, inner packagings in a Cart or BOP must be restricted in a manner that minimizes breakage.  See §§ 173.197(d)(2)(iv) and 173.197(d)(3)(v). Further, in a BOP, a rigid packaging must be separated from a plastic-film bag with rigid barriers or dividers that will prevent damage to inner packagings from load shifts.  See § 173.197(d)(3)(v).

Sharps may be transported as RMW in a non-specification, non-bulk packaging by a private or contract carrier under the provisions in §§ 173.134(c)(1) and (2).  A sharps container intended for reuse in a Large packaging, Cart, or BOP must be approved and certified as a medical device for reuse by the FDA and meet additional requirements under § 173.197(e)(3). Sharps meeting the definition of a Risk Group 4 material must be classed and transported as a UN 2814 or UN 2900 infectious substance in packagings tested and marked as required under §§ 173.196 and 173.503(f), respectively.  See § 173.134(a)(4).

I hope this satisfies your request.

Sincerely,

Hattie L. Mitchell
Chief, Regulatory Review and Reinvention
Office of Hazardous Materials Standards

173.197

Regulation Sections