MPW BoxesRFQ62220.doc

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1.Requisition or other Purchase Authority:

2. Request for Proposal

(RFP) Number:

RFQ 75N98020Q00006

3. Issue Date:

June 22, 2020

4. Set Aside:

[ ] No

[ X] Yes See “II” of RFQ

1. Title: Bio-hazardous Medical Pathological Waste (MPW) Boxes, Bags, and Ties

ISSUED BY:

Terita Stevenson, Contract Specialist

Office of Acquisitions

Office of The Director

National Institutes of Health

OD OLAO

6011 Executive Boulevard, MSC 7663, Room 539C, Rockville, MD 20852-7663

2. SUBMIT OFFERS TO:

stevenst@od.nih.gov

3. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in the RFQ," until 1:00 pm EST local time on July 22, 2020. Offers will be valid for 90 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

4. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH [subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition,"/HHSAR Clause 352.215-70, "Late Proposals and Revisions"] LOCATED IN SECTION L.1. OF THIS SOLICITATION.

5. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

6. FOR INFORMATION CALL: Terita Stevenson

PHONE: 301-402-3727

e-MAIL: stevenst@od.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

I.: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. Offerors shall submit all questions concerning this solicitation in writing to the Contract Specialist (stevenst@od.nih.gov). Questions shall be received no later than June 29, 2020, at 1:00 pm EST.

II.: The solicitation number is RFQ-75N98020Q00006 and solicitation is issued as a Request for Quotation (RFQ). This is a small business set aside.

III.: The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-04 January 15, 2020.

IV.: The North American Industry Classification (NAICS) is 562211 and the Standard Size is $41.5 million.

V.: A list of contract line item number(s) and items, quantities and units of measure, (including option(s), option years). See below Pricing Schedule Pricing Schedule

The estimated quantities shown below represents the Governments best estimate of the supplies to be ordered under the contract during the stated period of contract performance and are intended for price evaluation and fund obligation purposes only (refer to Addendum to FAR Clause 52.212-4 – Contract Terms and Conditions – Commercial Items, Paragraph 5).

Basic Contract Period: October 1, 2020 through September 30, 2021

[Specific dates to be completed at time of award]

Estimated

Unit Total

Product Description

Quantity

Price Price

1.

Box and Bag, Bio-hazardous Waste Disposal:

NSN 8115-00-L04-0680

Shall provide Box and Bag, Bio-hazardous

Waste Disposal accordance with the specifications herein.

Shall include NIH bar-coding, refer to

NIH Standard #6, latest in effect.

30,000 Pkg $_____ $_____

Bidding on:

Manufacturer ___________________

Brand _________________________

Number _______________________

Option Period One: October 1, 2021 through September 30, 2022

[specific dates to be completed at time of award]

Price Price

31,050

Option Period Two: October 1, 2022 through September 30, 2023

Price Price

32,137

Option Period Three: October 1, 2023 through September 30, 2024

Price Price

33,262

Option Period Four: October 1, 2024 through September 30, 2025

Price Price

34,426

Total Base Year plus four Option Years

160,875 Pkg

C.1

MPW PACAKAGES

SPECIFCATIONS AND MARKINGS

C.2

MEDICAL PATHOLOGICAL WASTE BOX

CONTAINER SPECIFICATIONS

a. Size (inside dimensions) shall be 18 inches (45.72cm) X 14 inches (35.56cm) X 18 inches (45.72cm).

b. Shall be oyster white

c. Shall be certified of meeting the following:

1. Minimum Edge Crush Test (ECT) value of 44.

2. Size limit of 95 inches (215.90cm)

3. Gross weight limit of 95 lbs (36.29kg) (Box and contents).

4. Shall be made of flute corrugated cardboard

5. Joint shall be lapped and glued inside only.

d. Shall have a modified “T” top with locking tabs on flaps B. Flaps are to be labeled A, B, C. Folding instructions for the user to be on the “B” flap.

e. Shall have a “crash” bottom.

f. Boxes shall be manufactured of a minimum of 30% recycled material.

g. Shall be folded flat in package.

h. Boxes shall meet the following certifications:

1. Drop Test per CFR Title 49, Transportation, Part 178.603

2. Stacking Test CFR Title 49,Transportation, Part 178.606

MARKINGS

i. Markings, letters, numbers and symbols, shall be orange.

j. Ink shall be Sun Chemical Corp Number GCMI 81.

k. Boxes shall be specifically marked as follows, in addition to the requirements of the Federal Specifications:

1. Shall provide arrows indicating “Burn Box Up”.

2. “Incinerate Only” on all four (4) sides of the box

3. The biohazard symbol, “Biohazard”, and “Incinerate Only” identification on all four (4) sides of the box.

4. “Special Medical Waste” on all four (4) sides of the box to comply with COMAR Title 26.

5. “Regulated Medical Waste, n.o.s., UN3291” on all four (4) sides of the box to comply with US DOT shipping requirements.

6. All markings shall be orange and placed directly on the exterior surface of the box.

7. Markings shall be the approximate size indicated on illustrations.

8. Markings shall not be camouflaged by the manufacturer’s name, address, product information, etc.

l. Markings of packaging for transportation shall be in accordance with code of federal regulations (CFR) Title 49, Transportation, Part 178.503

MEDICAL PATHOLOGICAL WASTE

CABLE TIE SPECIFICATION

a. Plastic “electrical” cable ties, exactly 12” inches (30 cm) long.

b. Shall be white/natural

c. Shall automatically lock at any diameter.

d. Shall be a minimum of 120 lb (54.43 kg) tinsile strength fasteners.

e. Shall have 10 cable ties per package.

MEDICAL PATHOLOGICAL WASTE

LINER SPECIFICATIONS AND CERTIFICATION

a. Polyethylene, low density, not less than .003 inches (.00762cm) thickness, Tolerance on thickness shall be minus 0 and + (plus) the standard of the industry. (no less than 3 MIL)

b. Shall be 19 ½” inches (49.53cm) wide X 17 ½” inches (44.45cm) deep X 44 ½” inches (113.03cm) long, dimensions shall be inside measurements + ½” inch (1.27cm)

1. Type – flat, shall be one piece construction.

2. Style – sides shall be gusseted and the bottom shall be heat sealed.

3. Material – Shall be Grade A Polyethylene, untreated.

c. Shall be one piece construction, and shall have a tuck on sides between face and back of bag. Tucks shall be approximately 9 inches (22.86cm) wide from crease to edge and crease shall be parallel to the sides.

d. Bags shall be marked showing certification of also meeting the following:

1. Impact resistance as prescribed in ASTM D 1709.04

2. Tear resistance as prescribed in ASTM D 1922.03a C.3

SKID PACKAGING

MEDICAL PATHOLOGICAL WASTE

SKID PACKAGING

Skid packaging:

a. Each individual package shall contain 5 boxes, 10 ties, And 10 black bags.

b. Each package shall be strapped with strapping to avoid slippage from skid.

c. Ten packages shall be banded together making a bundle. Shall have 4 (four) “bundles” per skid.

d. Each package shall have a cardboard slip sheet on the top and bottom to protect the packages from damage.

e. Bundles shall be strapped to pallet and shrink wrapped to stabilize for shipping.

BUNDLES:

10 MPW Packages are banded together to create a “bundle”. Each bundle containers 50 boxes, 100 liners, and 100 cable ties. Cardboard is utilized to protect the packages within the bundles.

SKIDS:

4 Bundles of MPW Packages are banded together to create a “skid”. Each skid contains 40 MPW Packages, or 200 boxes, 400 liners, and 400 cable ties.

Once the four bundles are put on a skid, they are protected with cardboard, shrink wrapped, and then banded to the pallet to protect the supplies during transport. The additional banding to the skid ensures the integrity of the medical pathological waste packaging supplies.

(SF-1449 – Block 15 – Delivery :)

Every delivery must be coordinated in advance, at least one business day prior to shipping, with the NIH, GDC, and Customer Service Department at (301) 496-3395. Unless otherwise specified, deliveries shall be made to the delivery point specified below Monday through Friday, excluding Federal Holidays, between 8:30a.m. and 3:30 p.m., only. The day for delivery will be in accordance with the delivery schedule faxed with each order. Trucks arriving after the specified time will not be allowed to remain overnight at the delivery point and must return the following day for unloading. Supplies scheduled for delivery on a Federal Holiday should be made the following workday.

Satisfactory performance of this contract shall be deemed to occur upon delivery and acceptance by the Contracting Officer or the duly authorized representative of the item(s) described herein. Deliveries shall be made f.o.b. destination, within consignee’s premises to the following locations:

Line Item

Deliver to

Item #1 National Institutes of Health

Gaithersburg Distribution Center

16050 Industrial Drive, Suite 300

Gaithersburg, MD 20877

(301) 496-9156

The government requires delivery to made within 7 calendar days from the date the contractor receives an order. The government will evaluate, as regards to time of delivery, offers that propose delivery within an applicable delivery period specified above. Offers that propose delivery that will not clearly fall within the applicable required delivery period specified above will be considered non-responsive and rejected. The Government reserves the right to award either the required delivery schedule or the proposed delivery schedule, when an offeror offers an earlier delivery schedule than required above. If the offeror proposes no other delivery schedule, the required schedule above will apply.

Offeror’s Proposed Delivery Schedule:

Within __________ calendar days after receipt of order.

C.4 [Code of Federal Regulations]

[Title 49, Volume 2]

[Revised as of October 1, 2002]

From the U.S. Government Printing Office via GPO Access

[CITE: 49CFR178.603]

[Page 962-964]

TITLE 49--TRANSPORTATION

CHAPTER I--RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION, DEPARTMENT OF

TRANSPORTATION

PART 178--SPECIFICATIONS FOR PACKAGINGS--Table of Contents

Subpart M--Testing of Non-bulk Packaging’s and Packages

Sec. 178.603 Drop test.

(a) General. The drop test must be conducted for the qualification of all packaging design types and performed periodically as specified in

Sec. 178.601(e). For other than flat drops, the center of gravity of the test packaging must be vertically over the point of impact. Where more than one orientation is possible for a given drop test, the orientation most likely to result in failure of the packaging must be used. The number of drops required and the packages' orientations are as follows:

No. of tests Drop orientation of

Packaging (samples) samples

Steel drums, Aluminum drums, Six--(three for First drop (using three

Metal drums (other than each drop). samples): The package steel or aluminum), Steel must strike the target

Jerricans, Plywood drums, diagonally on the chime

Wooden barrels, Fiber drums, or, if the packaging

Plastic drums and Jerricans, has no chime, on a

Composite packagings which circumferential seam or are in the shape of a drum. an edge. Second drop

(using the other three samples): The package must strike the target on the weakest part not tested by the first drop, for example a closure or, for some 7 cylindrical drums, the welded longitudinal seam of the drum body.

[[Page 963]]

Boxes of natural wood, Five--(one for First drop: Flat on the

Plywood boxes, Reconstituted each drop). bottom (using the first wood boxes, Fiberboard sample). Second drop:

boxes, Plastic boxes, Steel Flat on the top (using or aluminum boxes, Composite the second sample).

packaging which are in the Third drop: Flat on the shape of a box. long side (using the third sample). Fourth drop: Flat on the short side (using the fourth sample). Fifth drop: On a corner (using the fifth sample).

Bags--single-ply with a side Three--(three First drop: Flat on a seam. drops per bag). wide face (using all three samples). Second drop: Flat on a narrow face (using all three samples). Third drop:

On an end of the bag

(using all three samples).

Bags--single-ply without a Three--(two First drop: Flat on a side seam, or multi-ply. drops per bag). wide face (using all three samples). Second drop: On an end of the bag (using all three samples).

(b) Exceptions. For testing of single or composite packaging constructed of stainless steel, nickel, or monel at periodic intervals only (i.e., other than design qualification testing), the drop test may be conducted with two samples, one sample each for the two drop orientations. These samples may have been previously used for the hydrostatic pressure or stacking test. Exceptions for the number of steel and aluminum packaging samples used for conducting the drop test are subject to the approval of the Associate Administrator.

(c) Special preparation of test samples for the drop test. Testing of plastic drums, plastic jerricans, plastic boxes other than expanded polystyrene boxes, composite packaging (plastic material), and combination packaging with plastic inner packaging other than plastic bags intended to contain solids or articles must be carried out when the temperature of the test sample and its contents has been reduced to -18 deg.C (0 deg.F) or lower. Test liquids shall be kept in the liquid state, if necessary, by the addition of anti-freeze. Test samples prepared in this way are not required to be conditioned in accordance with Sec. 178.602(d).

(d) Target. The target must be a rigid, non-resilient, flat and horizontal surface.

(e) Drop height. Drop heights, measured as the vertical distance from the target to the lowest point on the package, must be equal to or greater than the drop height determined as follows:

(1) For solids and liquids, if the test is performed with the solid or liquid to be transported or with a non-hazardous material having essentially the same physical characteristic, the drop height must be determined according to packing group, as follows:

(i) Packing Group I: 1.8 m (5.9 feet).

(ii) Packing Group II: 1.2 m (3.9 feet).

(iii) Packing Group III: 0.8 m (2.6 feet).

(2) For liquids, if the test is performed with water--

(i) Where the materials to be carried have a specific gravity not exceeding 1.2, drop height must be determined according to packing group, as follows:

(A) Packing Group I: 1.8 m (5.9 feet).

(B) Packing Group II: 1.2 m (3.9 feet).

(C) Packing Group III: 0.8 m (2.6 feet).

(ii) Where the materials to be transported have a specific gravity exceeding 1.2, the drop height must be calculated on the basis of the specific gravity (SG) of the material to be carried, rounded up to the first decimal, as follows:

(A) Packing Group I: SG x 1.5 m (4.9 feet).

(B) Packing Group II: SG x 1.0 m (3.3 feet).

(C) Packing Group III: SG x 0.67 m (2.2 feet).

(f) Criteria for passing the test. A package is considered to successfully pass the drop tests if for each sample tested--

(1) For packaging containing liquid, each packaging does not leak when equilibrium has been reached between the internal and external pressures, except for inner packaging of combination packaging when it is not necessary that the pressures be equalized;

(2) For removable head drums for solids, the entire contents are retained by an inner packaging (e.g., a plastic bag) even if the closure on the top head of the drum is no longer sift-proof;

(3) For a bag, neither the outermost ply nor an outer packaging exhibits

[[Page 964]] any damage likely to adversely affect safety during transport;

(4) For a composite or combination packaging, there is no damage to the outer packaging likely to adversely affect safety during transport, and there is no leakage of the filling substance from the inner packaging;

(5) Any discharge from a closure is slight and ceases immediately after impact with no further leakage; and

(6) No rupture is permitted in packaging for materials in Class 1 which would permit spillage of loose explosive substances or articles from the outer packaging.

[Amdt. 178-97, 55 FR 52723, Dec. 21, 1990, as amended at 56 FR 66286, Dec. 20, 1991; 57 FR 45465, Oct. 1, 1992; Amdt. 178-99, 58 FR 51534, Oct. 1, 1993; Amdt. 178-106, 59 FR 67522, Dec. 29, 1994; 65 FR 50462, Aug. 18, 2000; 66 FR 45386, Aug. 28, 2001; 67 FR 61016, Sept. 27, 2002]

[Code of Federal Regulations]

[Title 49, Volume 2]

[Revised as of October 1, 2002]

From the U.S. Government Printing Office via GPO Access

[CITE: 49CFR178.606]

[Page 965-966]

TITLE 49--TRANSPORTATION

CHAPTER I--RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION, DEPARTMENT OF

TRANSPORTATION

PART 178--SPECIFICATIONS FOR PACKAGINGS--Table of Contents

Subpart M--Testing of Non-bulk Packagings and Packages

Sec. 178.606 Stacking test.

(a) General. All packaging design types other than bags must be subjected to a stacking test.

(b) Number of test samples. Three test samples are required for each different packaging. For periodic retesting of packaging constructed of stainless steel, monel, or nickel, only one test sample is required.

Exceptions for the number of aluminum and steel sample packaging used in conducting the stacking test are subject to the approval of the

Associate Administrator. Notwithstanding the provisions of

Sec. 178.602(a) of this subpart, combination packaging may be subjected to the stacking test without their inner packaging, except where this would invalidate the results of the test.

(c) Test method--(1) Design qualification testing. The test sample must be subjected to a force applied to the top surface of the test sample equivalent to the total weight of identical packages which might be stacked on it during transport; where the contents of the test sample are non-hazardous liquids with specific gravities different from that of the liquid to be transported, the force must be calculated based on the specific gravity that will be marked on the packaging. The minimum height of the stack, including the test sample, must be 3.0 m (10 feet).

The duration of the test must be 24 hours, except that plastic drums, jerricans, and composite packaging 6HH intended for liquids shall be subjected to the stacking test for a period of 28 days at a temperature of not less than 40 deg.C (104 deg.F). Alternative test methods which yield equivalent results may be used if approved by the Associate

Administrator. In guided load tests, stacking stability must be assessed after completion of the test by placing two filled packaging of the same type on the test

[[Page 966]] sample. The stacked packages must maintain their position for one hour.

Plastic packaging must be cooled to ambient temperature before this stacking stability assessment.

(2) Periodic retesting. The test sample must be tested in accordance with:

(i) Section 178.606(c)(1) of this subpart; or

(ii) The packaging may be tested using a dynamic compression testing machine. The test must be conducted at room temperature on an empty, unsealed packaging. The test sample must be centered on the bottom platen of the testing machine. The top platen must be lowered until it comes in contact with the test sample. Compression must be applied end to end. The speed of the compression tester must be one-half inch plus or minus one-fourth inch per minute. An initial preload of 50 pounds must be applied to ensure a definite contact between the test sample and the platens. The distance between the platens at this time must be recorded as zero deformation. The force A to then be applied must be calculated using the formula:

Liquids: A = (n - 1) [w + (s x v x 8.3 x .98)] x 1.5;

Solids: A = (n - 1) [w + (s x v x 8.3 x .95)] x 1.5

Where:

A = applied load in pounds.

n = minimum number of containers that, when stacked, reach a height of 3 m.

s = specific gravity of lading.

w = maximum weight of one empty container in pounds.

v = actual capacity of container (rated capacity + outage) in gallons.

And:

8.3 corresponds to the weight in pounds of 1.0 gallon of water.

1.5 is a compensation factor that converts the static load of the stacking test into a load suitable for dynamic compression testing.

(d) Criteria for passing the test. No test sample may leak. In composite packaging or combination packaging, there must be no leakage of the filling substance from the inner receptacle, or inner packaging.

No test sample may show any deterioration which could adversely affect transportation safety or any distortion likely to reduce its strength, cause instability in stacks of packages, or cause damage to inner packaging likely to reduce safety in transportation. For the dynamic compression test, a container passes the test if, after application of the required load, there is no buckling of the sidewalls sufficient to cause damage to its expected contents; in no case may the maximum deflection exceed one inch.

[Amdt. 178-97, 55 FR 52723, Dec. 21, 1990, as amended at 56 FR 66286, Dec. 20, 1991; 57 FR 45465, Oct. 1, 1992; Amdt. 178-102, 59 FR 28494, June 2, 1994; Amdt. 178-106, 59 FR 67522, Dec. 29, 1994; 65 FR 58632, Sept. 29, 2000; 66 FR 45386, Aug. 28, 2001]

[Code of Federal Regulations]

[Title 49, Volume 2]

[Revised as of October 1, 2002]

From the U.S. Government Printing Office via GPO Access

[CITE: 49CFR173.197]

[Page 516-518]

TITLE 49--TRANSPORTATION

CHAPTER I--RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION, DEPARTMENT OF

TRANSPORTATION

PART 173--SHIPPERS--GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS--Table of Contents

Subpart E--Non-bulk Packaging for Hazardous Materials Other Than Class 1 and Class 7

Sec. 173.197 Regulated medical waste.

Regulated medical waste must be packaged in packaging conforming to the requirements of part 178 of this subchapter at the Packing Group II performance level. The packaging must be:

(a) Rigid;

(b) Leak resistant;

(c) Impervious to moisture;

(d) Of sufficient strength to prevent tearing or bursting under normal conditions of use and handling;

(e) Sealed to prevent leakage during transport;

(f) Puncture resistant for sharps and sharps with residual fluids;

and

(g) Break-resistant and tightly lidded or stoppered for fluids in quantities greater than 20 cubic cm.

[Amdt. 173-224, 56 FR 66271, Dec. 20, 1991, as amended at 64 FR 51919, Sept. 27, 1999; 66 FR 45380, Sept. 28, 2001]

Effective Date Note: At 67 FR 53140, Aug. 14, 2002, Sec. 173.197 was revised, effective Oct. 1, 2002. At 67 FR 54967, Aug. 27, 2002, the effective date was corrected to Feb. 14, 2003. For the convenience of the user, the revised text is set forth as follows:

[[Page 517]]

Sec. 173.197 Regulated medical waste.

(a) General provisions. Non-bulk packaging, large packaging, and bulk outer packaging used for the transportation of regulated medical waste must be rigid containers meeting the provisions of subpart B of this part.

(b) Non-bulk packagings. Except as otherwise provided in

Sec. 173.134 of this subpart, non-bulk packagings for regulated medical waste must be DOT specification packagings conforming to the requirements of Part 178 of this subchapter at the Packing Group II performance level. A non-bulk packaging must be puncture-resistant for sharps and sharps with residual fluid as demonstrated by conducting the performance tests in Part 178, Subpart M, of this subchapter on packagings containing materials representative of the sharps and fluids

(such as sterile sharps) intended to be transported in the packagings.

(c) Large Packagings. Large Packagings constructed, tested, and marked in accordance with the requirements of the UN Recommendations and conforming to other requirements of this paragraph (c) may be used for the transportation of regulated medical waste, provided the waste is contained in inner packagings conforming to the requirements of paragraph (e) of this section. Each Large Packaging design must be capable of meeting the vibration test specified in Sec. 178.819 of this subchapter. Each Large Packaging is subject to the periodic design requalification requirements for intermediate bulk containers in

Sec. 178.801(e) of this subchapter and to the proof of compliance requirements of Sec. 178.801(j) and record retention requirements of

Sec. 178.801(l) of this subchapter. Inner packagings used for liquids must be rigid.

(1) Authorized packagings. Only the following Large Packagings are authorized for the transportation of liquid or solid regulated medical waste:

(i) Metal: 50A, 50B, or 50N.

(ii) Rigid plastic: 50H.

(2) Additional requirements. Each Large Packaging used to transport liquid regulated medical waste must contain absorbent material in sufficient quantity and appropriate location to absorb the entire amount of liquid present in the event of an unintentional release of contents.

Each Large Packaging design intended for the transportation of sharps containers must be puncture resistant and capable of retaining liquids.

The design must also be tested and certified as meeting the performance tests specified for intermediate bulk containers intended for the transportation of liquids in subpart O of part 178 of this subchapter.

(d) Non-specification bulk packaging. A wheeled cart (Cart) or bulk outer packaging (BOP) is authorized as an outer packaging for the transportation of regulated medical waste in accordance with the provisions of this paragraph (d).

(1) General requirements. The following requirements apply to the transportation of regulated medical waste in Carts or BOPs:

(i) Regulated medical waste in each Cart or BOP must be contained in non-bulk inner packagings conforming to paragraph (e) of this section.

(ii) Each Cart or BOP must have smooth, non-porous interior surfaces free of cracks, crevices, and other defects that could damage plastic film inner packagings or impede disinfection operations.

(iii) Except as otherwise provided in this paragraph (d), each Cart or BOP must be used exclusively for the transportation of regulated medical waste. Prior to reuse, each Cart or BOP must be disinfected by any means effective for neutralizing the infectious substance the packaging previously contained.

(iv) Untreated cultures and stocks of infectious substances containing Risk Group 4 materials may not be transported in a Cart or

BOP.

(v) Division 6.1 toxic waste or Class 7 radioactive waste, with the exception of chemotherapeutic waste, may not be transported in a Cart or

BOP.

(vi) Division 6.1 or Class 7 chemotherapeutic waste; untreated stocks and cultures of infectious substances containing Risk Group 2 or

3 pathogenic organisms; unabsorbed liquids; and sharps containers may be transported in a Cart or BOP only if packaged in rigid non-bulk packagings conforming to paragraph (a) of this section.

(2) Wheeled cart (Cart). A Cart is authorized as an outer packaging for the transportation of regulated medical waste if it conforms to the following requirements:

(i) Each Cart must consist of a solid, one-piece body with a nominal volume not exceeding 1,655 L (437 gallons).

(ii) Each Cart must be constructed of metal, rigid plastic, or fiberglass fitted with a lid to prevent leakage during transport.

(iii) Each Cart must be capable of meeting the requirements of

Sec. 178.603 (drop test), as specified for solids at the Packing Group

II performance level.

(iv) Inner packaging must be placed into a Cart and restrained in such a manner as to minimize the risk of breakage.

(3) Bulk outer packaging (BOP). A BOP is authorized as an outer packaging for regulated medical waste if it conforms to the following requirements:

(i) Each BOP must be constructed of metal or fiberglass and have a capacity of at least 3.5 cubic meters (123.6 cubic feet) and not more than 45 cubic meters (1,590 cubic feet).

[[Page 518]]

(ii) Each BOP must have bottom and side joints of fully welded or seamless construction and a rigid, weatherproof top to prevent the intrusion of water (e.g., rain or snow).

(iii) Each opening in a BOP must be fitted with a closure to prevent the intrusion of water or the release of any liquid during all loading, unloading, and transportation operations.

(iv) In the upright position, each BOP must be leakproof and able to contain a liquid quantity of at least 300 liters (79.2 gallons) with closures open.

(v) Inner packaging must be placed in a BOP in such a manner as to minimize the risk of breakage. Rigid inner packaging may not be placed in the same BOP with plastic film bag inner packaging unless separated from each other by rigid barriers or dividers to prevent damage to the packaging caused by load shifting during normal conditions of transportation.

(vi) Division 6.1 or Class 7 chemotherapeutic waste, untreated cultures and stocks of infectious substances containing Risk Group 2 or

3 pathogenic organisms, unabsorbed liquids, and sharps may be transported in a BOP only if separated and secured as provided by paragraph (d)(3)(v) of this section.

(e) Inner packaging authorized for Large Packagings, Carts, and

BOPs. After September 30, 2003, inner packaging must be durably marked or tagged with the name and location (city and state) of the offeror, except when the entire contents of the Large Packaging, Cart, or BOP originates at a single location and is delivered to a single location.

(1) Solids. A plastic film bag is authorized as an inner packaging for solid regulated medical waste transported in a Cart, Large

Packaging, or BOP. Waste material containing absorbed liquid may be packaged as a solid in a plastic film bag if the bag contains sufficient absorbent material to absorb and retain all liquid during transportation.

(i) The film bag may not exceed a volume of 175 L (46 gallons). The film bag must be marked and certified by its manufacturer as having passed the tests prescribed for tear resistance in ASTM D 1709-01, Standard Test Methods for Impact Resistance of Plastic Film by the Free-

Falling Dart Method (see Sec. 171.7 of this subchapter), and for impact resistance in ASTM D 1922-00a, Standard Test Method for Propagation Tear

Resistance of Plastic Film and Thin Sheeting by Pendulum Method (see

Sec. 171.7 of this subchapter). The film bag must meet an impact resistance of 165 grams and a tearing resistance of 480 grams in both the parallel and perpendicular planes with respect to the length of the bag.

(ii) The plastic film bag must be closed with a minimum of entrapped air to prevent leakage in transportation. The bag must be capable of being held in an inverted position with the closed end at the bottom for a period of 5 minutes without leakage.

(iii) When used as an inner packaging for Carts or BOPs, a plastic film bag may not weigh more than 10 kg (22 lbs.) when filled.

(2) Liquids. Liquid regulated medical waste transported in a Large

Packaging, Cart, or BOP must be packaged in a rigid inner packaging conforming to the requirements of paragraph (a) of this section. Liquid materials are not authorized for transportation in inner packaging having a capacity greater than 19 L (5 gallons).

(3) Sharps. Sharps transported in a Large Packaging, Cart, or BOP must be packaged in a puncture-resistant inner packaging (sharps container). Each sharps container exceeding 76 L (20 gallons) in volume must be capable of passing the performance tests in Sec. 178.601 of this subchapter at the Packing Group II performance level. A sharps container may be reused only if it conforms to the following criteria:

(i) The sharps container is specifically approved and certified by the U.S. Food and Drug Administration as a medical device for reuse.

(ii) The sharps container must be permanently marked for reuse.

(iii) The sharps container must be disinfected prior to reuse by any means effective for the infectious substance the container previously contained.

(iv) The sharps container must have a capacity greater than 7.57 L

(2 gallons) and not greater than 151.42 L (40 gallons) in volume.

[Code of Federal Regulations]

[Title 49, Volume 2]

[Revised as of October 1, 2002]

From the U.S. Government Printing Office via GPO Access

[CITE: 49CFR178.601]

[Page 957-961]

TITLE 49--TRANSPORTATION

CHAPTER I--RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION, DEPARTMENT OF

TRANSPORTATION

PART 178--SPECIFICATIONS FOR PACKAGINGS--Table of Contents

Subpart M--Testing of Non-bulk Packagings and Packages

Sec. 178.601 General requirements.

(a) General. The test procedures prescribed in this subpart are intended to ensure that packages containing hazardous materials can withstand normal conditions of transportation and are considered minimum requirements. Each packaging must be manufactured and assembled so as to be capable of successfully passing the prescribed tests and of conforming to the requirements of Sec. 173.24 of this subchapter at all times while in transportation.

(b) Responsibility. It is the responsibility of the packaging manufacturer to assure that each package is capable of passing the prescribed tests. To the extent that a package assembly function, including final closure, is performed by the person who offers a hazardous material for transportation, that person is responsible for performing the function in accordance with Secs. 173.22 and 178.2 of this subchapter.

(c) Definitions. For the purpose of this subpart:

(1) Design qualification testing is the performance of the drop, leakproofness, hydrostatic pressure, stacking, and cooperage tests, as applicable, prescribed in Secs. 178.603, 178.604, 178.605, 178.606, or

Sec. 178.607, respectively, for each new or different packaging, at the start of production of that packaging.

(2) Periodic retesting is the performance of the drop, leakproofness, hydrostatic pressure, and stacking tests, as applicable, prescribed in Secs. 178.603, 178.604, 178.605, or Sec. 178.606, respectively, at the frequency specified in Sec. 178.601(e) of this subpart.

(3) Production testing is the performance of the leakproofness test prescribed in Sec. 178.604 of this subpart on each single or composite packaging intended to contain a liquid.

(4) A different packaging is one that differs (i.e. is not identical) from a previously produced packaging in structural design, size, material of construction, wall thickness or manner of construction but does not include:

(i) A packaging which differs only in surface treatment;

(ii) A combination packaging which differs only in that the outer packaging has been successfully tested with different inner packaging.

A variety of such inner packaging may be assembled in this outer packaging without further testing;

(iii) A plastic packaging which differs only with regard to additives which conform to Sec. 178.509(b)(3) or Sec. 178.517(b) (4) or

(5) of this part;

(iv) A combination packaging with inner packaging conforming to the provisions of paragraph (g) of this section;

(v) Packagings which differ from the design type only in their lesser design height; or

(vi) For a steel drum, variations in design elements which do not constitute a different design type under the provisions of paragraph

(g)(8) of this section.

(d) Design qualification testing. The packaging manufacturer shall achieve successful test results for the design qualification testing at the start of production of each new or different packaging.

(e) Periodic retesting. The packaging manufacturer shall achieve successful test results for the periodic retesting at intervals established by the manufacturer of sufficient frequency to ensure that each packaging produced by the manufacturer is capable of passing the design qualification tests. Changes in retest frequency are subject to the approval of the Associate Administrator. For single or composite packaging, the periodic retests must be conducted at least once every

12 months. For combination packaging, the periodic retests must be conducted at least once every 24 months.

(f) Test samples. The manufacturer shall conduct the design qualification and periodic tests prescribed in this subpart using random samples of packaging, in the numbers specified in the appropriate test section. In addition, the leakproofness test, when required, shall be performed on each packaging

[[Page 958]] produced by the manufacturer, and each packaging prior to reuse under

Sec. 173.28 of this subchapter, by the reconditioner.

(g) Selective testing. The selective testing of packaging that differ only in minor respects from a tested type is permitted as described in this section. For air transport, packaging must comply with Sec. 173.27(c)(1) and (c)(2) of this subchapter.

(1) Selective testing of combination packaging. Variation 1.

Variations are permitted in inner packaging of a tested combination package, without further testing of the package, provided an equivalent level of performance is maintained, as follows:

(i) Inner packaging of equivalent or smaller size may be used provided--

(A) The inner packaging are of similar design to the tested inner packaging (i.e. shape--round, rectangular, etc.);

(B) The material of construction of the inner packaging (glass, plastic, metal, etc.) offers resistance to impact and stacking forces equal to or greater than that of the originally tested inner packaging;

(C) The inner packaging have the same or smaller openings and the closure is of similar design (e.g., screw cap, friction lid, etc.);

(D) Sufficient additional cushioning material is used to take up void spaces and to prevent significant movement of the inner packaging;

(E) Inner packaging are oriented within the outer packaging in the same manner as in the tested package; and,

(F) The gross mass of the package does not exceed that originally tested.

(ii) A lesser number of the tested inner packaging, or of the alternative types of inner packaging identified in paragraph (g)(1)(i) of this section, may be used provided sufficient cushioning is added to fill void space(s) and to prevent significant movement of the inner packaging.

(2) Selective testing of combination packaging. Variation 2.

Articles or inner packaging of any type, for solids or liquids, may be assembled and transported without testing in an outer packaging under the following conditions:

(i) The outer packaging must have been successfully tested in accordance with Sec. 178.603 with fragile (e.g. glass) inner packaging containing liquids at the Packing Group I drop height;

(ii) The total combined gross mass of inner packaging may not exceed one-half the gross mass of inner packaging used for the drop test;

(iii) The thickness of cushioning material between inner packaging and between inner packaging and the outside of the packaging may not be reduced below the corresponding thickness in the originally tested packaging; and when a single inner packaging was used in the original test, the thickness of cushioning between inner packaging may not be less than the thickness of cushioning between the outside of the packaging and the inner packaging in the original test. When either fewer or smaller inner packaging are used (as compared to the inner packaging used in the drop test), sufficient additional cushioning material must be used to take up void spaces.

(iv) The outer packaging must have successfully passed the stacking test set forth in Sec. 178.606 of this subpart when empty, i.e., without either inner packaging or cushioning materials. The total mass of identical packages must be based on the combined mass of inner packaging used for the drop test;

(v) Inner packaging containing liquids must be completely surrounded with a sufficient quantity of absorbent material to absorb the entire liquid contents of the inner packaging;

(vi) When the outer packaging is intended to contain inner packaging for liquids and is not leakproof, or is intended to contain inner packaging for solids and is not siftproof, a means of containing any liquid or solid contents in the event of leakage must be provided in the form of a leakproof liner, plastic bag, or other equally efficient means of containment. For packaging containing liquids, the absorbent material required in paragraph (g)(2)(v) of this section must be placed inside the means of containing liquid contents; and

(vii) Packagings must be marked in accordance with Sec. 178.503 of this part as having been tested to Packing Group I

[[Page 959]] performance for combination packaging. The marked maximum gross mass may not exceed the sum of the mass of the outer packaging plus one half the mass of the filled inner packaging of the tested combination packaging. In addition, the marking required by Sec. 178.503(a)(2) of this part must include the letter ``V''.

(3) Variation 3. Packagings other than combination packaging which are produced with reductions in external dimensions (i.e., length, width or diameter) of up to 25 percent of the dimensions of a tested packaging may be used without further testing provided an equivalent level of performance is maintained. The packaging must, in all other respects

(including wall thicknesses), be identical to the tested design-type.

The marked gross mass (when required) must be reduced in proportion to the reduction in volume.

(4) Variation 4. Variations are permitted in outer packaging of a tested design-type combination packaging, without further testing, provided an equivalent level of performance is maintained, as follows:

(i) Each external dimension (length, width and height) is less than or equal to the corresponding dimension of the tested design-type;

(ii) The structural design of the tested outer packaging (i.e.

methods of construction, materials of construction, strength characteristics of materials of construction, method of closure and material thicknesses) is maintained;

(iii) The inner packaging are identical to the inner packaging used in the tested design type except that their size and mass may be less; and they are oriented within the outer packaging in the same manner as in the tested packaging;

(iv) The same type or design of absorbent materials, cushioning materials and any other components necessary to contain and protect inner packaging, as used in the tested design type, are maintained. The thickness of cushioning material between inner packaging and between inner packaging and the outside of the packaging may not be less than the thicknesses in the tested design type packaging; and

(v) Sufficient additional cushioning material is used to take up void spaces and to prevent significant movement of the inner packaging.

An outer packaging qualifying for use in transport in accordance with all of the above conditions may also be used without testing to transport inner packaging substituted for the originally tested inner packaging in accordance with the conditions set out in Variation 1 in paragraph (g)(1) of this section.

(5) Variation 5. Single packaging (i.e., non-bulk packaging other than combination packaging), that differ from a tested design type only to the extent that the closure device or gasketing differs from that used in the originally tested design type, may be used without further testing, provided an equivalent level of performance is maintained, subject to the following conditions (the qualifying tests):

(i) A packaging with the replacement closure devices or gasketing must successfully pass the drop test specified in Sec. 178.603 in the orientation which most severely tests the integrity of the closure or gasket;

(ii) When intended to contain liquids, a packaging with the replacement closure devices or gasketing must successfully pass the leakproofness test specified in Sec. 178.604, the hydrostatic pressure test specified in Sec. 178.605, and the stacking test specified in

Sec. 178.606.

Replacement closures and gasketings qualified under the above test requirements are authorized without additional testing for packaging described in paragraph (g)(3) of this section. Replacement closures and gasketings qualified under the above test requirements also are authorized without additional testing for different tested design types packaging of the same type as the originally tested packaging, provided the original design type tests are more severe or comparable to tests which would otherwise be conducted on the packaging with the replacement closures or gasketings. (For example: The packaging used in the qualifying tests has a lesser packaging wall thickness than the packaging with replacement closure devices or gasketing; the gross mass of the packaging used in the qualifying drop test equals or exceeds

[[Page 960]] the mass for which the packaging with replacement closure devices or gasketing was tested; the packaging used in the qualifying drop test was dropped from the same or greater height than the height from which the packaging with replacement closure devices or gasketing was dropped in design type tests; and the specific gravity of the substance used in the qualifying drop test…