New Mailing Standards for COVID-19 Related Category B Infectious Substances
| Published date | 29 April 2020 |
| Citation | 85 FR 23745 |
| Record Number | 2020-08256 |
| Section | Rules and Regulations |
| Court | Postal Service |
Federal Register, Volume 85 Issue 83 (Wednesday, April 29, 2020)
[Federal Register Volume 85, Number 83 (Wednesday, April 29, 2020)]
[Rules and Regulations]
[Pages 23745-23746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08256]
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POSTAL SERVICE
39 CFR Part 113
New Mailing Standards for COVID-19 Related Category B Infectious
Substances
AGENCY: Postal ServiceTM.
ACTION: Temporary final rule.
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SUMMARY: The Postal Service is revising its Hazardous, Restricted and
Perishable Mail regulations by replacing Publication 52, Hazardous,
Restricted, and Perishable Mail, Appendix C, Packaging Instructions 6C,
currently incorporated by reference, to support the rapid deployment of
coronavirus (COVID-19) diagnostic tests using the mail during this
public health emergency. In addition to the updated packaging
instructions, all shippers of COVID-19 related Infectious Substances
Category B UN3373 must obtain authorization from the Postal Service
prior to mailing. These measures are necessary to ensure that
diagnostic kits potentially containing Category B Infectious Substances
are packaged, marked and labelled properly to ensure safety and
containment throughout transport.
DATES: Effective: April 27, 2020 until the Federal public health
emergency first declared on March 13, 2020 is terminated (following
procedures prescribed in 50 U.S. Code Sec. 1622). The Postal Service
will publish a document announcing the termination date in the Federal
Register.
FOR FURTHER INFORMATION CONTACT: Mary J. Collins at (202) 268-5551 or
Dale Kennedy at (202) 268-6592 or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
Overview
The United States Postal Service is currently experiencing a
greater demand for the transportation of Infectious Substances,
Category B UN3373 as a result of the ongoing COVID-19 pandemic. Due to
the infectious nature of these materials, there exists a need for
higher levels of awareness, safety and compliance in order to protect
our employees, customers, and transportation partners.
When a package containing infectious substances is moved between
the point of origin and its destination, it may be subjected to
physical challenges, including movement, vibration, and changes of
temperature, humidity and pressure. It is therefore, essential that the
packaging used to contain infectious substances meets all required
standards, and is able to withstand the normal conditions of
transportation. It is the responsibility of the shipper to ensure they
comply with all applicable regulations. The revisions will provide
conformity and harmonization with other regulatory entities, prevent
the shipment of fraudulent test kits in the mail, and reduce risk to
employees and the general public by preventing exposure to this
infectious substance.
The current packaging requirements incorporated by reference in
Publication 52 Appendix C, Packaging Instruction 6C are replaced with
new required shipper authorization and updated packaging requirements
added as Sec. 113.3. Section 113.3 will be in place until the end of
this public health emergency.
The Postal Service will publish a document announcing the
termination date in the Federal Register. If you want to know whether
this rule has been terminated, email or call either person identified
in FOR FURTHER INFORMATION CONTACT.
The specific requirements to be used in place of Appendix C,
Packaging Instruction 6C to Publication 52, Hazardous, Restricted, and
Perishable Mail adopted in this document will be published in Postal
Bulletin 22544 on April 23, 2020, and can be viewed at http://about.usps.com/postal-bulletin.
List of Subjects in Part 113
Administrative practice and procedure, Postal Service.
For the reasons set forth above, the Postal Service amends 39 CFR
part 113 as follows:
PART 113--HAZARDOUS, RESTRICTED, AND PERISHABLE MAIL
0
1. The authority citation for part 113 continues to read as follows:
Authority: 5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-
1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219,
3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
0
2. Amend Sec. 113.1 by adding a final sentence to read as follows:
Sec. 113.1 Scope and purpose.
* * * Follow the requirements of Sec. 113.3 in place of
Publication 52, Appendix C, Packaging Instruction 6C.
0
3. Add Sec. 113.3 to read as follows:
Sec. 113.3 Mailing Standards for COVID-19 related Category B
Infectious Substances.
(a) Required Shipper Authorization. (1) All shippers of COVID-19
related Infectious Substances Category B must obtain an authorization
from the Postal Service prior to mailing. It is the responsibility of
the shipper to ensure that they are aware of, and comply with, all
other applicable requirements and regulations for the mailing of these
materials; and they must be able to provide evidence of compliance
before a written request is submitted to the manager of Product
Classification, Postal Service Headquarters.
(2) Under this section, only tests developed and being performed by
laboratories certified under the Clinical Laboratory Improvement
Amendments (CLIA) or equivalent clinical oversight regulations, and
commercial tests and home collection kits authorized by
[[Page 23746]]
either the FDA or an Institutional Review Board will be considered for
mailing.
(b) Required Packaging. The materials must be triple-packaged,
meeting the packaging requirements in 49 CFR 173.199. Such materials
must be properly packaged to withstand shocks, pressure changes, and
other conditions related to ordinary handling in transit, and
surrounded by absorbent material sufficient to protect the primary
receptacle and to absorb the total amount of liquid should the primary
receptacle leak or break. The outer packaging must be of adequate size
to accommodate all required shipping information and marks and will
include the size of the mark on each side must not be less than 50 mm
(1.97 inches) in length, the width of the border lines at least 2 mm,
and letter and numbers must be at least 6 mm (0.24 inches) high.
(c) Package Drop Test. The completed triple packaging must be
capable of successfully passing the drop test in 49 CFR 178.609(d) at a
drop height of at least 1.2 meters (3.9 feet). Following the drop test,
there must be no leakage from the primary receptacle, which must remain
protected by absorbent material, when required, in the secondary
packaging.
(d) Instructions. Shippers must provide clear instructions to users
regarding the procedures to be followed for preparing the samples and
packaging used to transport an Infectious Substance Category B.
Shippers must instruct users to adhere to all applicable mail related
preparation requirements before mailing, to ensure the package is
properly prepared for safe transportation.
(e) Optional Outer Packaging. A polybag covering may be acceptable
as the outer packaging, providing that the interior triple packaging is
complete, the selvage edge of the wrapping is less than 2 inches, all
required markings and address information are applied both on the
interior rigid box and the additional outer polybag wrapping.
(f) Use of a Refrigerant (If Applicable). (1) Only cold packs or
dry ice may be used as a refrigerant and must be placed outside of the
secondary packaging. Interior supports must be provided to secure the
secondary packaging in the original position. If a cold pack is used,
the packaging must be leak-proof. If dry ice is used, the outside
packaging must permit the release of carbon dioxide gas and otherwise
meet the provisions in 49 CFR 173.217. The primary receptacle and
secondary packaging must maintain their integrity at the temperature of
the refrigerant used, as well as the temperatures and pressures of
transport by aircraft they could be subjected to if refrigeration were
lost, and sufficient absorbent material must be provided to absorb all
liquid, including melted ice.
(2) When dry ice is used, the package must include the markings
``Carbon dioxide, solid'' or ``Dry ice'' and an indication that the
material being refrigerated is used for diagnostic or treatment
purposes (e.g., frozen medical specimens). Marking requirements in USPS
Packaging Instruction 9A are not applicable.
(g) Other Allowance. Only small quantities of Class 3, Class 8,
Class 9, or other materials in Packing Groups II and III may be used to
stabilize or prevent degradation of the sample, provided the quantity
of such materials does not exceed 30 mL (1 ounce) or 30 g (1 ounce) in
each inner packaging.
Joshua J. Hofer,
Attorney, Federal Compliance.
[FR Doc. 2020-08256 Filed 4-27-20; 11:15 am]
BILLING CODE 7710-12-P
