E7-18626. New Standards for Mailing Sharps Waste and Other Regulated Medical Waste

AGENCY:

Postal Service.

ACTION:

Final rule.

SUMMARY:

The Postal Service^TM is revising its standards for mailing medical waste so that medical professionals as well as individuals can use a larger container to mail medical waste to disposal sites. The new standards allow a maximum mailpiece weight limit of 35 pounds for packages approved as “Medical Professional Packaging.”

EFFECTIVE DATE:

September 25, 2007.

FOR FURTHER INFORMATION CONTACT:

Bert Olsen, 202-268-7276.

SUPPLEMENTARY INFORMATION:

Background

We published a proposed rule in the Federal Register (72 FR 20462, April 25, 2007) to revise the standards for mailing sharps and other regulated medical waste containers. Our proposal allowed 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. The weight limit of the mailpiece would be 35 pounds.

Comments Received

We received comments from two entities: a USPS-authorized sharps vendor and a coalition of parties interested in the safe disposal of needles. Both were in support of the changes and offered the following comments:

1. Comment: The term “Medical Professional Packaging” implies that only medical professionals can use it. Change the name so it is clear that it can be used by anyone.

The Postal Service believes the term, “Medical Professional Packaging” is an appropriate term that represents a mailpiece most often used by medical professionals. However, we will include language in the Domestic Mail Manual (DMM) that clarifies that individuals as well as other entities can use “Medical Professional Packaging.”

2. Comment: Require that pre-primary receptacles comply with Food and Drug Administration (FDA) 510(k) approval rather than Occupational Safety and Health Administration (OSHA) standards.

The Postal Service believes that requiring pre-primary receptacles to meet OSHA standards as identified in 29 CFR 1910.1030 is the best method of verifying governmental compliance for sharps and other regulated medical waste receptacles containing bloodborne pathogens. These pre-primary receptacles are then triple packaged in accordance with further parcel preparation requirements for the mailing of sharps mailpieces. Therefore, the final rule adopts the requirement that pre-primary receptacles meet OSHA compliance standards as published in the proposed rule.

We adopt the following amendments 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 111.4.

List of Subjects in 39 CFR Part 111

• Administrative practice and procedure
• Postal Service

Accordingly, 39 CFR part 111 is 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, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3626, 5001.

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

* * * * *

601.10 Hazardous Materials

* * * * *

10.17 Infectious Substances (Hazard Class 6, Division 6.2)

* * * * *

10.17.5 Sharps Waste and Other Mailable Regulated Medical Waste

* * * * *

10.17.5b Packaging

* * * * *

[Revise first sentence to 10.17.5b5 as follows]

Each mailpiece must not weigh more than 25 pounds, except for Medical Professional Packages as identified in 10.17.5c, that may not weigh more than 35 pounds.* * *

* * * * *

[Add a new 10.17.5c, and renumber current items 5c through 5f as new 5d through 5g:]

10.17.5c Medical Professional Packages

Medical Professional Packages, while intended for use by small medical offices, are not limited to use by medical offices only. 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 601.10.17.5 except for the primary receptacle capacity limits of 10.17.5b1.

2. Only rigid, securely closed, puncture and leak-resistant pre-primary sharps receptacles that meet or exceed Occupational Safety and Health Administration standards as identified in 29 CFR 1910.1030, 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 must 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.

* * * * *

601.10.17.5d Mailpiece Labeling, Marking, and Documentation

[Add new number 1, and renumber current items 1 through 7 as new 2 through 8:]

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 at the beginning of redesignated 10.17.5f as follows:]

601.10.17.5f Testing Criteria

Packages tested for approval as Medical Professional Packages may not be tested using pre-primary containers that are currently or have previously been approved as USPS primary containers. Test reports must identify by brand name the pre-primary containers used during testing. * * *

* * * * *

Neva R. Watson,

Attorney, Legislative.