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Interpretation Response #12-0247 ([Curtis Bay Energy] [Mr. Edward Petrullo])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: Curtis Bay Energy

Individual Name: Mr. Edward Petrullo

Location State: MD Country: US

View the Interpretation Document

Response text:

May 1, 2013

 

Mr. Edward Petrullo
Director, EH&S
Curtis Bay Energy
3200 Hawkins Point Road
Baltimore, MD  21226

Reference No. 12-0247

Dear Mr. Petrullo:

This is in response to your October 25 and 26, 2012 e-mails; October 22, 2012 telephone call with a member of my staff; and October 23, 2012 conference telephone call with employees of Curtis Bay Energy and a member of my staff.  You ask if two different United Nations (UN) 4H2 red polyethylene containers with polyethylene lids designed to transport a “UN 3291, Regulated medical waste, n.o.s., 6.2 (Category B infectious), Packing Group (PG) II,” (RMW) including sharps, comply with the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) when transported in different packaging configurations.  We summarized the descriptions you provided for each packaging and paraphrased and answered your questions below.

Packaging 1:  UN 4H2 with Sliding Lid

You enclosed a test report prepared by Container-Quinn Testing Laboratories, Inc., for Rotonics Manufacturing, Inc., that describes the first packaging as a 17-gallon oblong, trapezoid-shaped, red-polyethylene container with handles, and with extended edges on both longitudinal sides on the top of the packaging that would permit it to be suspended from the side rails of an appropriately sized wheeled-metal rack.  The test report also states the polyethylene lid on this packaging slides and locks, is securely closed with a 1/8th-inch wide reinforced polyethylene cable tie, and that the packaging can be stacked.  In addition, the test report states this container’s inner packagings consist of RMW contents placed inside one 3-ml red polyethylene bag with a bottom seam that is heat-sealed and a top that is twisted and knotted tightly closed.  This bag is then placed inside of another identical polyethylene bag that is also closed in the same manner.  The test report describes the inner packaging’s test contents as consisting of a one-gallon sharps container, one gallon of water in four one-quart glass jars, miscellaneous polyethylene test tubes, rags, paper and cloth towels, empty glass jars, polyethylene trays, corrugated paper, and paper dunnage that together weigh a total of 21.3 pounds.  The test report further states the gross weight of the completed package is 28.4 pounds (12.9 kg) and the package is marked “UN 4H2/Y 12.9/S/**/USA/CQ12160,” but does not include drawings or a photograph of the packaging.  You provided photographs of these packagings, both empty and filled.  

Packaging 2:  UN 4H2 with Hinged Lid

You enclosed a test report prepared by Gaynes Labs, Inc., for the Rehrig Pacific Company that describes the second packaging as a 17-gallon oblong, trapezoid-shaped, red-polyethylene container with two integral handles and extended edges on both longitudinal sides on the top of the packaging that would permit it to be suspended from the side rails of an appropriately sized medical waste transport rack.  The test report also states that the packaging has a rectangular polyethylene (main) lid attached to its base by a continuous hinge located on one long side at the top of the packaging, a second inner (sub) lid attached to the main lid by three hinges and one latch, and that the packaging can be stacked.  In addition, the test report describes the test contents for this packaging as consisting of a solid mixture of sand and vermiculite placed directly inside each packaging without any liner to a maximum fill capacity of 95% and a gross weight of 22.6 kg.  The test report includes two drawings of the packaging and states it is marked “UN 4H2/Y 22.6/S/11/USA/+AB2091.”  You did not provide a photograph of this packaging.  

Questions

Q1. Do both packagings comply with the HMR when transporting RMW: 1) on the floor of a truck as an individual packaging; 2) inside of a fiberboard box; 3) strapped or shrink-wrapped to a pallet; or 4) suspended in rows from a wheeled-metal rack?

A1.      A polyethylene box that meets the requirements in the HMR for a UN 4H2 packaging
      at the PG II performance level is an authorized hazardous materials packaging.  Provided it complies with all applicable requirements of the HMR, including being prepared and closed for transportation in the manner described in the manufacturer’s closure instructions, a completed authorized package containing RMW may be transported:  

• As a single package;
• On the floor of a truck if properly secured and blocked against shifting, including motion between packages (see § 177.834(a)); and
• Inside an overpack, as defined in § 171.8, such as inside a fiberboard box, strapped or shrink-wrapped to a pallet, or properly enclosed and suspended from the side rails of a wheeled-metal rack.  

However, please note to demonstrate the packaging’s puncture resistance for sharps and sharps with residual fluids, § 173.197(b) requires that before they are performance tested non-bulk RMW packagings used as sharps containers must be filled with materials representative of the sharps and fluids (such as sterile sharps) intended to be transported in the packagings.  Section 178.602(c) also states:  

If the material to be transported is replaced for test purposes by a non-hazardous material, the material used must be of the same or higher specific gravity as the material to be carried, and its other physical properties (grain, size, viscosity) which might influence the results of the required tests must correspond as closely as possible to those of the hazardous material to be transported.  Water may also be 23used for the liquid drop test under the conditions specified in § 178.603(e) and additives, such as bags of lead shot, to achieve the requisite total package mass, so long as they are placed so that the test results are not affected.  See §§ 173.197(b) and 178.602(b) and (c).  

Based on the test report prepared by The Rehrig Pacific Company, the UN 4H2 packaging with the hinged lid (Packaging 2) passed the tests at the PG II performance level to transport materials with the same physical characteristics present in a solid sand-vermiculite mixture but has not passed tests authorizing it to transport sharps, as this term is defined in § 173.134(a)(6), and liquids, as this term is defined in § 171.8.  In addition, the HMR permits sharps to be transported in non-bulk, non-specification sharps packagings that meet the general packaging requirements in 49 CFR 173.24 and 173.24a, and the U.S. Department of Labor’s bloodborne pathogen requirements in 29 CFR 1910.1030 when transported by only private or contract carrier.  See § 173.134(c)(1)(ii).  

Because the packaging you described is an authorized UN standard packaging, it may also be placed inside of an overpack.  An overpack is a container or enclosure used by a single consignor to provide protection or convenience in handling or to consolidate two or more packages (see § 171.8).  Examples of an overpack include packages:  1) placed or stacked on a pallet that are secured to it by strapping, shrink wrapping, stretch wrapping, or other suitable means; or 2) placed in a protective outer packaging, such as a box, crate, or wheeled-metal rack.  For a completed authorized package of hazardous material to be placed in an overpack, it must comply with the requirements prescribed in § 173.25, which include the following:  

• Forbidden hazardous materials and packages, as prescribed in § 173.21, are not permitted;
• The authorized package must comply with general packaging requirements prescribed in § 173.24;
• When applicable, required marks and labels representing each of the hazardous materials contained in an authorized package must be visible when one or more of these packages is placed in an overpack, if they are not, this information must be repeated on the outside of the overpack; and
• When packagings placed inside of the overpack are required to be Department of Transportation (DOT) specification or UN standard packagings and the marks that specify the package’s design type are not visible, the word “OVERPACK” must be marked on the outside of the overpack.

Q2. Must we use a wheeled cart if our 17-gallon reusable container is not gasketed?  

A2. No.  Based on the information you provided, both packagings satisfied the HMR’s performance tests without the use of gaskets; therefore, placing them in a wheeled cart or a wheeled-metal rack is not required.  However, a wheeled cart or wheeled-metal rack may be used as an overpack as described in Answer A1.  

Q3. Is a gasket required on a packaging for it to be "leak proof"?  

A3. No.  A packaging is considered leakproof under the HMR if it satisfies the leakproofness test prescribed in § 178.604.  However, please note inner packagings of combination packagings are not subject to the leakproofness test requirements of § 178.604 (see § 178.604(a)(2)).  

Q4. Are we allowed to use "secondary containment" for our 10- and 17-gallon containers if we do not use a wheeled cart?  

A4. Yes, see Answer A1.

Q5. Can a container that has a third-party testing lab performance-orientated package testing certification stand on the floor of a trailer or truck without a cart?  

A5. Yes, provided it is properly blocked and braced.  See Answer A1.  

Q6. The Rotonics 17-gallon (Packaging 1) container was tested using two inner red bags.  Please advise what our transportation options are for this packaging under the HMR if we add additional red bags to the container, and what they are if we remove the red bags.  

A6. Any change in structural design (such as the addition or removal of packaging components), size, material of construction, wall thickness, or manner of construction to a UN 4H2 packaging constitutes a different packaging under the HMR that is subject to design qualification testing (see § 178.601(c)(4)).  However, the HMR permits selective testing of non-bulk packagings that differ in only minor respects from tested designs as specified in § 178.601(g).  

Q7. Is use of a wheeled cart or rack required to have a Special Permit if we transport reusable sharps containers?  

A7. If a hazardous materials packaging is authorized as acceptable in transportation under the HMR, it may be transported using a consolidation device like a wheeled cart or rack without having to operate under the terms of a Special Permit.  An unauthorized packaging that contains a hazardous material must not be offered for or entered into transportation in commerce without a competent authority approval in the form of a written Special Permit or Approval, as these terms are defined in § 107.1, that is issued by the Competent Authority of the United States, the Associate Administrator of Hazardous Materials Safety.  The procedures for applying for a Special Permit or to become a party to an existing Special Permit are found in 49 CFR Part 107, Subpart B.  The procedures for applying for an Approval are found in 49 CFR Part 107, Subpart H.  For a more detailed explanation of this application process, see Answer A9.

Q8. You state the owner of Solutions, Inc., told your company through a distribution agreement that your company may use his wheeled racks and containers without separately applying for a Special Permit and ask if this statement is true?  You state his Special Permit number is DOT-SP 13556.

A8. The use of a Special Permit may not be authorized through a private company’s distribution agreement.  As stated in Answer A1, an authorized hazardous materials packaging may be placed inside of an unauthorized packaging, like a wheeled rack, that is used as an overpack without having to apply for specific relief from the HMR under the terms of a Special Permit or Competent Authority Approval.  An unauthorized packaging must not be used to transport a hazardous material in commerce without the specific authorization of the Associate Administrator of the Office of Hazardous Materials Safety.  

Q9. You also ask what your company would need to do to apply for a Special Permit if it were to design its own wheeled cart?

A9.   To initate a request for a new Special Permit, your company may wish to submit an application to the Associate Administrator for Hazardous Materials Safety that conforms with the requirements prescribed in 49 CFR Part 107, Subpart B.  The application must contain sufficient information to demonstrate that, if a Special Permit is issued, the method of relief requested achieves a level of safety that is equal to or greater than that required under the HMR.  You may also obtain this information from our website at http://www.phmsa.dot.gov/hazmat/regs/sp-a.

Packages authorized under a Pipeline and Hazardous Materials Safety Administration (PHMSA) Special Permit (DOT-SP) do not otherwise comply with the HMR, and must be examined and approved for use by PHMSA’s Associate Administrator for Hazardous Materials Safety.  If your company chooses to apply for a Special Permit, it must include in its application sufficient information about the packaging’s design and performance to prove the packaging meets or exceeds the requirements prescribed in the HMR for the hazardous material intended for the packaging.  Also, to learn who may use a packaging authorized under existing Special Permit DOT-SP 13556, please contact the Approvals and Permits Division at either (202) 366-4535 or (202) 366-4511.  

I hope this satisfies your request.

Sincerely,

T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division

171.8, 173.134, 173.197, 178.601

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions
173.197 Regulated medical waste
178.602 Preparation of packagings and packages for testing