Domestic Mail
DMM REVISION
New Mailing Standards for Sharps and Other Regulated Medical Waste Containers
Effective November 9, 2006, we are revising 601.10.17
of the Mailing Standards of the United States Postal
Service, Domestic Mail Manual (DMM®) for sharps and
other regulated medical waste containers. Our new standards promote uniform container testing methods and
ensure the integrity of mailpieces containing sharps and
other medical waste. Specifically, the new standards:
• 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.
• Require container vendors to provide us with the
names and addresses of their distributors on request.
• 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.
Sharps and other regulated medical waste containers
approved for mailing prior to November 9 can maintain their
authorization until it expires (24 months from the most
recent approval). Containers submitted for authorization or
renewal of authorization on or after November 9 must meet
the new standards.
Mailing Standards of the United States Postal
Service, Domestic Mail Manual (DMM)
* * * * *
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 as follows:]
10.17.7 Sharps Medical Waste and Regulated Medical
Waste Containers
[Replace "manufacturer or distributor" 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:]
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°F and as high as 120°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°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
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.
* * * * *
We will incorporate these revisions into the November 9,
2006, update of the online DMM on Postal Explorer® at
http://pe.usps.com and into the next printed edition of the
DMM.
— Mailing Standards,
Pricing and Classification, 10-26-06
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