E6-5695. New Standards for Mailing Sharps and Other Regulated Medical Waste

AGENCY:

Postal Service.

ACTION:

Proposed rule.

SUMMARY:

The Postal Service is proposing new standards for mailing sharps and other regulated medical waste containers. Our proposal includes changes to the packaging, the package testing, and the process for authorizing and suspending authorization.

DATES:

We must receive your comments on or before May 18, 2006.

ADDRESSES:

Mail or deliver written comments to the Manager, Mailing Standards, U.S. Postal Service, 475 L'Enfant Plaza SW., Room 3436, Washington, DC 20260-3436. You may inspect and photocopy all written comments at USPS 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:

Customers requesting authorization to mail sharps and other medical waste containers must submit to the Postal Service the results of package testing performed by an independent testing facility. In the past, we have found that container testing methods were not applied consistently. This proposal provides pass/fail criteria to support uniform testing methods for all sharps and medical waste containers and new standards to enhance the integrity of these mailpieces.

In many cases, we authorize containers for vendors who distribute them to third parties. This proposal would require that vendors provide the name and address of their distributors, and update that information on a quarterly basis. We also clarify that vendors, as part of the application process, must accept responsibility for the containers they distribute and cover disposal or cleanup costs if spills occur while the containers are in our possession.

All currently authorized sharps and other regulated medical waste containers will maintain their authorization until it expires: 24 months from the most recent approval, or when a change is made to the container or mailpiece. Customers applying for authorization or reauthorization after the effective date of this change must follow the new standards.

Although we are exempt from the notice and comment requirements of the Administrative Procedure Act [5 U.S.C. 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.

We provide the new standards below. We propose to implement these standards on July 6, 2006.

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.

2. Revise the following sections of 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

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10.17 Infectious Substances (Hazard Class 6, Division 6.2)

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[Revise title of 10.17.7 to read as follows:]

10.17.7 Sharps Medical Waste and Regulated Medical Waste

[Replace “distributor or manufacturer” with “vendor” throughout 10.17.7.]

* * * * *

[Revise the authorization information in item a1 to read as follows:]

1. An irrevocable and continual $50,000 surety bond or letter of credit. The surety bond or letter of credit serves as proof of sufficient financial responsibility to cover disposal costs if the vendor or its distributors cease doing business before all its waste container systems are disposed of or to cover cleanup costs if spills occur while the containers are in USPS possession. The surety bond or letter of credit must be issued in the name of the vendor seeking the authorization and must name the USPS as the beneficiary. Vendors who market their containers to distributors are responsible for disposal and cleanup costs for those containers.

[Add new item a2 to read as follows; renumber items a3 through a8 as items a4 though a9:]

2. A list of distributors, including firm name, address, and phone number.

Vendors must provide this list to the USPS on a quarterly basis and when a distributor is added or removed.

* * * * *

[Revise item a4 to add “name” and “phone number,” to read as follows:]

4. The name, address, and phone number of each storage and disposal site.

* * * * *

[Add text at the end of item a9 to read as follows:]

9. * * * and verification that the merchandise return service (MRS) permit fee and accounting fee have been paid.

[Add new item a10 to read as follows:]

10. The post office or postage due unit where the containers are delivered.

* * * * *

[Revise the package testing information in item b1 by adding a new last sentence to read as follows:]

1. * * * Package testing results must show that the primary container was not penetrated by its contents during package testing and that the primary container can maintain its integrity at temperatures as low as 0 °F and as high as 120 °F.

[Revise item b2 to read “4 mil” in the third sentence:]

2. * * * If one of the components is a plastic bag, it must be at least 4 mil in thickness and be used in conjunction with a fiberboard box. * * *

[Revise the fourth sentence in item b3 to read as follows:]

3. * * * Fiberboard boxes with interlock bottom flaps are not permitted as outer shipping containers. * * *

[Add two new sentences at the end of item b4 as follows:]

4. * * * The secondary container system must consist of a fiberboard box inside a secured plastic bag. Package testing results must show that the secondary container can be turned upside down for 5 minutes without evidence of leakage after placing 150 ml of deionized water into the secondary box.

[Revise item b5 to read as follows:]

5. Each mailpiece must not weigh more than 25 pounds. The container's maximum allowable weight must be printed on the outside of the box and on the assembly and closure instructions included with each mailpiece. The mailpiece must be tested at the maximum allowable weight identified by the vendor.

* * * * *

[Add a new sentence at the end of item c1 to read as follows:]

1. * * * Place the label on the top or on a side of the container.

[Add a new sentence at the end of item c2 to read as follows:]

2. * * * The symbol must be at least 3 inches high and 4 inches wide.

* * * * *

[Add new item c7 to read as follows:]

7. Vendors must retrieve mailpieces held at processing facilities due to improper labeling, such as no return address, or due to improperly completed shipping papers.

* * * * *

[Revise item d to read as follows:]

d. Package Testing. Vendors must submit to the manager, Mailing Standards (see 608.8 for address) package testing results from an independent testing facility for each package for which the vendor is requesting authorization. In addition, vendors must submit package testing results from an independent testing facility when the design of a container system changes or every 24 months, whichever occurs first. The test results must show that if every mailpiece prepared for mailing were subject to the environmental and test conditions in 49 CFR and the additional test requirements in 10.17.7e, there would be no release of the contents to the environment and no significant reduction in the effectiveness of the packaging. The Postal Service may require proof of accreditation or other documentation to support the credentials of an independent testing facility.

[Add new item e to read as follows:]

e. Testing Criteria. Each mailpiece must pass each of the tests described below:

1. Leak-proof test. One primary receptacle must withstand the test in 49 CFR 178.604. The test must be conducted on the primary receptacle with the lid in place, without the secondary and outer packaging. The test duration must be at least 5 minutes and must be conducted at 20 kPa (3 psi). The pass/fail criterion is: No leakage of air from anywhere other than the closure of the primary receptacle. Air leakage at the closure is not considered a failure if the primary receptacle passes the test for water tightness as determined by placing 50 ml of deionized water into the primary receptacle, securing the closure, and then turning the container on its side and observing for any evidence of leakage. Any evidence of water leaking from the primary receptacle is a failure.

2. Stacking test. One mailpiece must withstand the test in 49 CFR 178.606. The dynamic compression test must be conducted on the empty, unsealed mailpiece assembled for mailing, without the primary receptacle(s). The test mass is the vendor-identified maximum weight, not to exceed 25 pounds, as indicated on the outer shipping container and on the assembly and closing instructions. A compensation factor of 1.5 must be used to compute the test load, based on the vendor-identified weight. The pass/fail criteria are: No buckling of the sidewalls sufficient to cause damage to the contents in the primary container, and in no case does the deflection exceed 1 inch.

3. Vibration test. One mailpiece filled with sharps or other regulated medical waste must withstand the test in 49 CFR 178.608. The test mailpiece is filled with sharps or other regulated medical waste to the vendor-identified maximum weight, not to exceed 25 pounds, as indicated on the outer shipping container and on the assembly and closing instructions. The test sample is prepared as it would be for mailing. The pass/fail criteria are: No rupture, cracking, or splitting of any primary receptacle.

4. Wet drop test. Five mailpieces filled with sharps or other regulated medical waste must withstand the test in 49 CFR 178.609(e). Each test mailpiece is filled with sharps or other regulated medical waste to the vendor-identified maximum weight, not to exceed 25 pounds, as indicated on the outer shipping container and on the assembly and closing instructions included with each mailpiece. Each mailpiece is prepared as it would be for mailing and subjected to the water spray as described in the test. A separate, untested mailpiece is used for each drop orientation: Top, longest side, shortest side, and corner. The pass/fail criteria are: No rupture, cracking, or splitting of any primary receptacle, and no contents may penetrate into or through the body or lid of any primary receptacle.

5. Cold drop test. Five mailpieces filled with sharps or other regulated medical waste must withstand the test in 49 CFR 178.609(f). Each test mailpiece is filled with sharps or other regulated medical waste to the vendor-identified maximum weight, not to exceed 25 pounds, as indicated on the outer shipping container and on the assembly and closing instructions included with each mailpiece. Each mailpiece is prepared as it would be for mailing and chilled as described in the test. A separate, untested mailpiece is used for each drop orientation: Top, longest side, shortest side, and corner. The pass/fail criteria are: No rupture, cracking, or splitting of any primary receptacle, and no contents may penetrate into or through the body or lid of any primary receptacle.

6. Impact test. One mailpiece filled with sharps or other regulated medical waste must withstand the test in 49 CFR 178.609(h). The test mailpiece is filled with sharps or other regulated medical waste to the vendor-identified maximum weight, not to exceed 25 pounds, as indicated on the outer shipping container and on the assembly and closing instructions included with each mailpiece. The mailpiece is prepared as it would be for mailing. The pass/fail criteria are: No rupture, cracking, or splitting of any primary receptacle, and no contents may penetrate into or through the body or lid of any primary receptacle.

7. Puncture-resistant test. Package testing results must show that the primary container was not penetrated by its contents during all of the previous testing.

8. Temperature test. Package testing results must show that each primary receptacle maintained its integrity when exposed to temperatures as low as 0 °F and as high as 120 °F.

9. Absorbency test. Package testing results must show that the primary receptacle(s) contain enough absorbent material to absorb three times the total liquid allowed within the primary receptacle in case of leakage. Absorbency is determined by pouring 150 ml of deionized water into the primary receptacle(s), then turning the receptacle(s) upside down and observing for any evidence of free liquid not absorbed on contact. Any evidence of free liquid is a failure.

10. Watertight test. Package testing results must show that no leakage occurred when 50 ml of deionized water was placed into the secondary box, a plastic bag was secured around the box with a tie closure, and the entire secondary container was turned upside down for 5 minutes.

[Add new item f to read as follows:]

f. Suspension of Authorization.

1. The Postal Service may suspend an authorization based on information that a mailpiece no longer meets the standards for mailing sharps medical waste and regulated medical waste containers, or that the mailpiece poses an unreasonable safety risk to Postal Service employees or the public. The suspension can be made immediately, making the mailpiece nonmailable immediately. The vendor may contest a decision to suspend authorization by writing to the manager, Mailing Standards (see 608.8 for address) within 7 days from the date of the letter of suspension. The appeal should provide evidence demonstrating why the decision should be reconsidered. Any order suspending authorization remains in effect during an appeal or other challenge.

2. Vendors notified that their authorization to mail sharps or other regulated medical waste is suspended must immediately:

a. Recall all identified containers.

b. Notify all customers that they cannot mail the identified containers.

c. Suspend sales and distribution of all identified containers.

d. Collect the identified containers from distributors, consumers, and the Postal Service without using the mail and in accordance with all Federal and State regulations.

* * * * *

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.