New Standards for Mailing Sharps and Other Regulated Medical Waste Containers, 64118-64121 [E6-18063]

Agencies

• Postal Service

[Federal Register Volume 71, Number 211 (Wednesday, November 1, 2006)]
[Rules and Regulations]
[Pages 64118-64121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18063]


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POSTAL SERVICE

39 CFR Part 111


New Standards for Mailing Sharps and Other Regulated Medical 
Waste Containers

AGENCY: Postal Service.

ACTION: Final rule.

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SUMMARY: The Postal Service revises the standards for mailing sharps 
and other regulated medical waste containers. The new standards include 
improvements to the packaging, the package testing, and the process for 
authorizing and suspending authorization.

DATES: Effective Date: November 9, 2006.

FOR FURTHER INFORMATION CONTACT: Bert Olsen, 202-268-7276.

SUPPLEMENTARY INFORMATION:

Background

    We published a proposed rule in the Federal Register (71 FR 19840, 
April 18, 2006) to revise the standards for mailing sharps and other 
regulated medical waste containers. Our proposal included the following 
changes:
    1. To require container vendors to provide the Postal Service with 
the names and addresses of their distributors and to provide updates on 
a quarterly basis.
    2. To revise the process for authorizing and suspending 
authorization for mailing sharps and other regulated medical waste 
containers to enhance monitoring and control of medical waste in the 
mail.
    3. To revise container standards and container testing standards to 
ensure that container testing is performed on a consistent basis for 
all sharps and other regulated medical waste containers.

Comments Received

    We received comments from four authorized sharps container vendors 
and one potential vendor. All commenters supported the concept of 
revising the rules to promote uniform testing methods and to ensure the 
integrity of mailpieces containing sharps and other medical waste.

Documentation Requirements

    Three commenters objected to the requirement that vendors provide a 
list of distributors to the Postal Service. All three commenters argued 
that requiring vendors to provide a quarterly list of distributors 
could lead to disclosure of sensitive proprietary vendor information. 
We agree that the Postal Service can identify a vendor's distributors, 
if needed, by requiring vendors to provide this information on request. 
Therefore, the final rule requires vendors to provide the names, 
addresses, and telephone numbers of their distributors to the Postal 
Service only on request.

Packaging

    One commenter objected to a minimum size limit for the biohazard 
symbol placed on the outer shipping container. The commenter stated 
that requiring a 3 inch by 4 inch symbol would be excessively large on 
a small mailpiece. The Postal Service notes that currently no approved 
medical waste mailpieces are so small as to not easily accommodate a 3 
inch by 4 inch biohazard symbol. The new standard will clarify that the 
3 inch by 4 inch label requirement applies to the outer shipping 
container. For safety reasons, medical waste containers must be easily 
identified as containing biohazardous materials. Therefore, this final 
rule adopts the standard as published in the proposal.
    Three commenters did not want the Postal Service to eliminate the 
use of outer shipping containers with interlocking bottoms. All three 
commenters stated that current requirements that allow for the use of 
shipping containers with interlocking bottom flaps reinforced with tape 
are more than adequate, especially considering the overall rigorous 
testing mandates. After further consultation with package testing 
professionals, we conclude that interlocking bottom flaps sufficiently 
contain the primary receptacle, particularly when reinforced with tape. 
Therefore, we will maintain our current standards that allow 
interlocking bottoms when they are reinforced with water-resistant 
tape.
    Two commenters requested clarification of the proposed changes to 
the secondary container requirements. The commenters stated that 
increasing the plastic bag thickness requirement from 3 mil to 4 mil 
was not necessary. In addition, they stated that it was not 
advantageous to require the plastic bag

[[Page 64119]]

to be placed around the secondary box. We believe that increasing the 
thickness of the plastic bag will help maintain the contents of the 
primary container should it break. Therefore, we will require plastic 
bags to be 4 mil thick. However, we will not require the plastic bag to 
be placed outside the secondary box.
    Two commenters requested clarification of the proposed standards in 
section 601.10.17.7b4 of Mailing Standards of the United States Postal 
Service, Domestic Mail Manual (DMM). We revised this section to clarify 
that the absorbent material must be placed in the primary receptacle. 
Item e10 will serve as the required test to ensure that the secondary 
system is watertight.
    One commenter suggested that the Postal Service require screw caps 
for primary containers. Historical data on safely mailing these 
mailpieces does not indicate a need to require screw caps. Therefore, 
this final rule adopts the standard as published in the proposal.

Mailpiece Testing

    One commenter objected to the requirement that mailpieces be tested 
at the vendor's identified maximum weight and that the container's 
maximum allowable weight be printed on the outer shipping container. 
The commenter stated that it was impossible to predict the maximum 
weight of the materials that might be placed into a container and that 
end users would not have scales to weigh the mailpiece. We believe, in 
the interest of safety, that these mailpieces should be tested at the 
highest possible weight determined by the vendor, not to exceed 25 
pounds, to ensure that the mailpiece can safely contain the maximum 
weight. Therefore, this final rule adopts the requirements as published 
in the proposal.
    One commenter suggested that the Postal Service require 
accreditation of package testing facilities. Section 601.10.17.7d of 
the proposed rule states ``the Postal Service may require proof of 
accreditation or other documentation to support the credentials of an 
independent testing facility.'' We believe that this standard provides 
the authority to require proof of credentials as necessary. Therefore, 
this final rule adopts the standard as published in the proposal.
    One commenter questioned the need for a reference to 49 CFR 
178.604, Leak-proof test. The commenter stated that we should not refer 
to the test because our pass/fail criteria were not the same as the 
criteria in 49 CFR. The test in 49 CFR 178.604 requires that the 
primary container hold 20 kPa without leakage. Our criteria allow for 
air leakage around the opening of the primary container as long as 
there is no air leakage anywhere else and no leakage of water. We agree 
that it would be clearer, in this case, to eliminate the reference and 
to provide only the USPS test procedure and pass/fail criteria.
    One commenter requested clarification on the height of the required 
drop tests. Our proposed rule requires 30-foot drops for the wet and 
cold tests as identified in 49 CFR 178.609e and f. The impact test 
requires a drop of 3 feet as identified in 49 CFR 178.609h. While we 
understand that the test identified in 49 CFR consists of requirements 
for packaging infectious substances, we believe that the Postal 
Service's handling and transportation systems are different from those 
of commercial carriers and require more stringent acceptance criteria. 
Therefore, this final rule adopts the standard as published in the 
proposal.
    One commenter suggested that testing material should be simulated 
medical waste. We disagree. The testing material should consist of 
sharps or other regulated medical waste as defined in DMM 601.10.17.2e 
and g. Vendors are on notice that contaminated medical waste will not 
be used for testing purposes. Therefore, this final rule adopts the 
standard as published in the proposal.

Mailpiece Acceptance

    One commenter objected to requirements that vendors retrieve 
improperly labeled containers when identified and held at plants. The 
commenter suggested that the Postal Service should confirm the 
mailpiece was properly marked and labeled before accepting it. While we 
continually educate employees on acceptance criteria, the mailer 
remains responsible for properly labeling the mailpiece. Therefore, 
this final rule adopts the requirement as published in the proposal.
    This final rule will be effective on November 9, 2006. Sharps and 
other regulated medical waste containers that are currently approved 
for mailing can maintain their authorization until it expires (24 
months from the most recent approval). Containers must meet the new 
standards if they are submitted for authorization (or renewal of 
authorization) on or after November 9.
    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 111.1.

List of Subjects in 39 CFR Part 111

    Administrative practice and procedure, Postal Service.


0
Accordingly, 39 CFR part 111 is amended as follows:

PART 111--[AMENDED]

0
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.


0
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 as follows:]

10.17.7 Sharps Medical Waste and Regulated Medical Waste Containers

    [Replace ``distributor or manufacturer'' with ``vendor'' throughout 
10.17.7.]
* * * * *
    [Add new authorization information to the end of item a1 as 
follows:]
    1. * * * Vendors that market their containers to distributors are 
responsible for disposal and cleanup costs attributed to those 
containers. In addition, vendors must provide a list of distributors, 
including firm names, addresses, and telephone numbers, to the Postal 
Service on request.
* * * * *
    [Revise item a3 to add ``name'' and ``phone number'' as follows:]
    3. Name, address, and phone number of each storage and disposal 
site.
* * * * *
    [Add text at the end of item a8 as follows:]
    8. * * * and verification that the merchandise return service (MRS) 
permit fee and accounting fee have been paid.
    [Add new item a9 as follows:]
    9. Address of the post office or postage due unit where the 
containers are delivered.
* * * * *
    [Revise the package testing information in item b1 by replacing the 
last sentence as follows:]

[[Page 64120]]

    1. * * * Package testing results must show that the contents of the 
primary container did not penetrate through the primary container 
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 the third sentence of item b2 to read ``4 mil'' as 
follows:]
    2. * * * If one of the components is a plastic bag, the bag must be 
at least 4 mil in thickness and must be used in conjunction with a 
fiberboard box. * * *
* * * * *
    [Revise item b4 by replacing ``a watertight barrier'' with ``the 
primary receptacle'' as follows:]
    4. There must be enough material within the primary receptacle * * 
*
    [Revise item b5 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 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 as follows:]
    2. * * * The symbol on the outer shipping container must be at 
least 3 inches high and 4 inches wide.
* * * * *
    [Add new item c7 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 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, no contents would be released 
into the environment and the effectiveness of the packaging would not 
be significantly reduced. The Postal Service may require proof of 
accreditation or other documentation to support the credentials of an 
independent testing facility.
    [Add new item e as follows:]
    e. Testing Criteria. Each mailpiece must pass each of the tests 
described below:
    1. Leak-proof test. The test must be conducted on one 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 air leakage 
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 watertightness 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 criterion is: 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 178.609e. 
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 178.609f. 
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 178.609h. 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 
during all of the previous tests, the contents did not penetrate 
through the primary container.
    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

[[Page 64121]]

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 containment system and the entire system turned upside down 
for 5 minutes.
    [Add new item f as follows:]
    f. Suspension of Authorization.
    1. The Postal Service may suspend a vendor's 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. When a vendor is notified that its authorization to mail sharps 
or other regulated medical waste containers has been suspended, the 
vendor must immediately: (1) Recall all identified containers. (2) 
Notify all customers that they cannot mail the identified containers. 
(3) Suspend sales and distribution of all identified containers. (4) 
Collect the identified containers from distributors, consumers, and the 
Postal Service without using the mail and in accordance with all 
Federal and State regulations.
* * * * *

Neva R. Watson,
Attorney, Legislative.
 [FR Doc. E6-18063 Filed 10-31-06; 8:45 am]
BILLING CODE 7710-12-P