E7-7816. Revised Standards for Mailing Sharps Waste and Other Regulated Medical Waste

AGENCY:

Postal Service.

ACTION:

Proposed rule.

SUMMARY:

The Postal Service^TM is proposing to revise the mailing standards for medical waste so that medical professionals can more easily use the mail to ship waste to disposal sites. For over 15 years we have safely permitted approved vendors to use the mail for return of sharps and other regulated medical waste for disposal.

Under our current standards, mail-back medical waste containers are most often used by individuals who self-inject medications to control diseases such as diabetes and arthritis. By increasing the maximum allowable weight of medical waste mail-back containers and at the same time requiring additional packaging safeguards, we intend to provide small medical offices the option of using the mail for sending medical waste for disposal. This proposal would allow medical professionals a safe, easy, and cost-effective means of disposing of sharps and other regulated medical waste.

DATES:

We must receive your comments on or before May 25, 2007.

ADDRESSES:

Mail or deliver written comments to the Manager, Mailing Standards, Postal Service, 475 L'Enfant Plaza SW., Room 3436, Washington, DC 20260-3436. You may inspect and photocopy all written comments at the Postal Service Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor N, Washington, DC between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Bert Olsen, 202-268-7276.

SUPPLEMENTARY INFORMATION:

This proposal would increase the use of the mail for shipping medical waste while improving packaging requirements so that these items continue to be safe while transported in the mail. Currently, mailing standards require that primary sharps receptacles not exceed 3 gallons and that primary receptacles for other regulated medical waste not exceed 5 gallons. This proposal would allow for a single larger primary receptacle that could accommodate several pre-primary sharps receptacles (sharps receptacles normally used in doctors' offices) as well as several tie-closed bags of other regulated medical waste. This change would add additional receptacles (pre-primary) to the currently required triple-packaging system and therefore would increase protection of the contents.

The pre-primary receptacles may be different in size and design. The primary receptacle that holds the pre-primary receptacles and the bags of other regulated medical waste must be capable of passing all current package tests. The new standards would set the total mailpiece weight limit to 35 pounds for packages approved as “Medical Professional Packaging.” All other medical waste mailpieces would be required to conform to the current 25-pound weight limit.

Although we are exempt from the notice and comment requirements of the Administrative Procedure Act [5 U.S.C. of 553(b), (c)] regarding proposed rulemaking by 39 U.S.C. 410(a), we invite public comment on the following proposed revisions to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM®), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

List of Subjects in 39 CFR Part 111

• Administrative practice and procedure
• Postal Service

Accordingly, 39 CFR part 111 is proposed to be amended as follows:

PART 111—[AMENDED]

1. The authority citation for 39 CFR part 111 continues to read as follows:

Authority: 5 U.S.C. 552(a); 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3626, 5001; chapter 36 of Title 39: Pub. L. No 109-435, 120 Stat. 3198 (2006).

2. Revise the following sections of the Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), as follows:

* * * * *

600 Basic Standards for All Mailing Services

601 Mailability

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10.0 Hazardous Materials

* * * * *

10.17  Infectious Substances (Hazard Class 6, Division 6.2)

* * * * *

10.17.6 Sharps Waste and Other Mailable Regulated Medical Waste

* * * * *

[Add a new second sentence to item b5 as follows:]

* * * Except for Medical Professional Packages as identified in 10.17.6c, which may not weigh more than 35 pounds.* * *

* * * * *

[Renumber items 6c through 6f as new 6d through 6g. Add new item 6c as follows:]

c. Medical Professional Packaging. One primary receptacle larger than 5 gallons in volume may be used for mailing pre-primary sharps receptacles (sharps receptacles normally used in doctors' offices) and other regulated medical waste under the following conditions:

1. The mailpiece must meet all the requirements in 10.17.6, except for the primary receptacle capacity limits in 10.17.6b1.

2. Only rigid, securely closed, puncture- and leak-resistant pre-primary sharps receptacles that meet or exceed Occupational Safety and Health Administration standards may be placed inside the primary receptacle. Each pre-primary sharps container may contain no more than 50 ml (1.66 ounces) of residual waste liquid. Several pre-primary sharps receptacles may be enclosed in the single primary receptacle.

3. Multiple tie-closed plastic bags of regulated medical waste may be placed inside the single primary receptacle.

4. The primary receptacle must be lined with a plastic bag at least 4 mil in thickness and include sufficient absorbent material within the liner to absorb all residual liquid in the primary receptacle.

5. The mailpiece must not weigh more than 35 pounds.

* * * * *

[Renumber items d1 through d7 as new d2 through d8. Add new number d1 as follows:]

1. For Medical Professional Packages, the additional marking, “Medical Professional Packaging,” must be clearly printed in lettering at least 2 inches high on the address side of the outer shipping container.

* * * * *

[Add two new sentences to the introductory text renumbered item f as follows:]

f. Testing Criteria. Packages tested for approval as Medical Professional Packaging containers may not be tested using pre-primary containers that are currently or have previously been approved as USPS primary containers. In addition, test reports must identify by brand name the pre-primary containers that were used during testing.* * *

* * * * *

We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes if our proposal is adopted.

Neva R. Watson,

Attorney, Legislative.