[Federal Register Volume 71, Number 74 (Tuesday, April 18, 2006)]
[Proposed Rules]
[Pages 19840-19842]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5695]


=======================================================================
-----------------------------------------------------------------------

POSTAL SERVICE

39 CFR Part 111


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),

[[Page 19841]]

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

* * * * *
10.0 Hazardous Materials
* * * * *
10.17 Infectious Substances (Hazard Class 6, Division 6.2)
* * * * *
    [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 [deg]F and as high as 120 [deg]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,

[[Page 19842]]

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 [deg]F and as high as 120 [deg]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.
[FR Doc. E6-5695 Filed 4-17-06; 8:45 am]
BILLING CODE 7710-12-P