Attachment 3 - Full Specifications of MPW Boxes with Bags.pdf

Salient Characteristics Medical Pathological Waste Boxes with Bags and Ties

Each bundle shall consist of: 5 boxes 10 Black plastic bags 12 cable ties.

1. Markings shall have the following characteristics:

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

b. Ink shall be Sun Chemical Corp Number GCMI 81. Material Safety Data Sheets (MSDS) shall be provided by contractor.

c. 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. The biohazard symbol and “Biohazard Incinerate Only” identification on all four

(4) sides of the box.

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

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

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

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

2. Boxes shall be:

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. Bursting test of 250 lbs (113.40kg) per square inch.

2. Minimum Edge Crush Test (ECT) value of 40.

3. Minimum combined weight of facings, 111 pounds (50.35kg) per thousand square feet.

4. Size limit of 85 inches (215.90cm).

5. Gross weight limit of 80 lbs (36.29kg) (Box and contents).

6. Shall be made of flute corrugated cardboard.

7. 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 be marked showing certification of meeting the following:

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

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

3. Plastic bags shall be:

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.

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).

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

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

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

f. 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.

g. 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

4. Ties shall be:

a. Plastic “electrical” cable ties, approximately 12 inches (30.48cm) long.

b. Shall be white.

c. Shall automatically lock at any diameter.

d. Shall be a minimum of 70 lb (31.75kg) fasteners.

e. Shall have 12 cable ties per package.

6. Testing Requirements:

The box (non-bulk packaging) and the inner bags (Plastic film bags) shall be tested and certified to meet the following specifications:

CFR Title 49, Transportation Part 173.197 (a) General Provisions

173.197 (b) Non-bulk Packagings.

173.197 (e) Inner packagings authorized for Large Packagings, Carts, and

BOPs., and 178 Subpart M – Testing of Non-bulk Packagings and Packages.

See below for box details and examples.

Document#: ASTM D1709-04

Tit le: Standard Test Methods for Impact Resistance of Plastic Fi lm by the Free-Fall ing Dart Method

Abstract: These test methods cover the determination of the energy that causes plastic f i lm to fail under specif ied conditions of impact of a free-fal l ing dart. This energy is expressed in terms of the weight (mass) of the missi le fall ing from a specif ied height which would result in 50 % fai lure of specimens tested. 1.2 Two test methods are described: 1.2.1 Test Method A employs a dart with a 38.10 0.13-mm [1.500 0.005-in.] diameter hemispherical head dropped from a height of 0.66 0.01 m [26.0 0.4 in.]. This test method may be used for f i lms whose impact resistances require masses of about 50 g or less to about 2 kg to fracture them. 1.2.2 Test Method B employs a dart with a 50.80 0.13 -mm [2.000 0.005-in.] diameter hemispherical head dropped from a height of

1.50 0.03 m [60.0 + 0.25, 1.70 in.]. Its range of applicabil i ty is from about 0.3 kg to about 2 kg. 1.3 Two test ing techniques are described: 1.3.1 The standard technique is the staircase method.

By this technique, a uniform missi le weight increment is employed during test and the missi le weight is decreased or increased by the uniform increment after test of each specimen, depending upon the result (fai l or not fail) observed for the specimen. 1.3.2 The alternative technique provides for testing specimens in successive groups of ten. One missile weight is employed for each group and missi le weight is varied in uniform increments from group to group. 1.3.3 The staircase technique and the alternative technique give equivalent results both as to the values of impact failure weight which are obtained and as to the precisions with which they are determined. 1.4 The values stated in SI units are to be regarded as standard. The values stated in parentheses are for information only. Note 1 - Tests on materials that do not break, for any reason, are not considered to be valid. It has been noted that certain materials may stretch so far as to bottom out at the base of certain test instruments without actually rupturing. Subcommittee D20.19 is currently considering methods for testing these materials. Anyone interested in participating in a Task Group should contact the Chairman of Subcommittee D20.19 through ASTM International Headquarters. Note 2 - This test method is technically equivalent to ISO 7765-1: 1988, with the exception of a larger tolerance on the drop height in Test Method B. Also, the ISO method does not allow the alternative testing technique described in Section of this test method. 1.5 This standard does not purport to address the safety concerns, if any, associated with its use. It is the responsibi l ity of the user of this standard to establish appropriate safety and health pract ices and determine the applicabili ty of regulatory limitations prior to use.

Document#: ASTM D1922-03a

Tit le: Standard Test Method for Propagation Tear Resistance of Plast ic Fi lm and Thin Sheeting by Pendulum Method

Abstract: This test method covers the determination of the average force to propagate tearing through a specified length of plastic f i lm or non-rigid sheeting after the tear has been started, using an Elmendorf-type tearing tester. Two specimens are cited, a rectangular type, and one with a constant radius test ing length.

The latter shall be the preferred or referee specimen.1.2 Because of (1) diff icult ies in select ing uniformly identical specimens, (2) the varying degree of orientat ion in some plastic f i lms, and (3) the diff iculty found in test ing highly extensible or highly oriented materials, or both, the reproducibil ity of the test results may be variable and, in some cases, not good or misleading. Provisions are made in the test method to compensate for oblique direct ional tearing which may be found with some materials.1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.1.4 This standard does not purport to address all of the safety concerns, if any, associated with i ts use. It is the responsibi l i ty of the user of this standard to establish appropriate safety and health pract ices and determine the applicabil ity of regulatory l imitat ions prior to use.

Specif ic precautionary statements are given in 13.1.Note 1 -This standard and ISO 6383-2 are technically equivalent.

[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]

[Revised as of October 1, 2002]

[CITE: 49CFR178.606]

[Page 965-966]

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]

[Revised as of October 1, 2002]

[CITE: 49CFR173.197]

[Page 516-518]

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.

[Revised as of October 1, 2002]

[CITE: 49CFR178.601]

[Page 957-961]

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 was the same or greater than the specific gravity of the liquid used in the design type tests of the packaging with replacement closure devices or gasketing.)

(6) The provisions in Variations 1, 2, and 4 in paragraphs (g)(1),

(2) and (4) of this section for combination packaging may be applied to packaging containing articles, where the provisions for inner packaging are applied analogously to the articles. In this case, inner packaging need not comply with Sec. 173.27(c)(1) and (c)(2) of this subchapter.

(7) Approval of selective testing. In addition to the provisions of

Sec. 178.601(g)(1) through (g)(6) of this subpart, the Associate

Administrator may approve the selective testing of packaging that differ only in minor respects from a tested type.

(8) For a steel drum with a capacity greater than 50 L (13 gallons) manufactured from low carbon, cold-rolled sheet steel meeting ASTM designations A366/A366M or A568/A568M, variations in elements other than the following design elements are considered minor and do not constitute a different drum design type, or ``different packaging'' as defined in paragraph (c) of this section for which design qualification testing and periodic retesting are required. Minor variations authorized without further testing include changes in the identity of the supplier of component material made to the same specifications, or the original manufacturer of a DOT specification or UN standard drum to be remanufactured. A change in any one or more of the following design elements constitutes a different drum design type:

(i) The packaging type and category of the original drum and the remanufactured drum, i.e., 1A1 or 1A2;

(ii) The style, (i.e., straight-sided or tapered);

(iii) Except as provided in paragraph (g)(3) of this section, the rated (marked) capacity and outside dimensions;

(iv) The physical state for which the packaging was originally approved (e.g., tested for solids or liquids);

(v) An increase in the marked level of performance of the original drum (i.e., to a higher packing group, hydrostatic test pressure, or specific gravity to which the packaging has been tested);

(vi) Type of side seam welding;

(vii) Type of steel;

(viii) An increase greater than 10% or any decrease in the steel thickness of the head, body, or bottom;

(ix) End seam type, (e.g., triple or double seam);

(x) A reduction in the number of rolling hoops which equal or exceed the diameter over the chimes;

(xi) The location, type or size, and material of closures (other than the cover of UN 1A2 drums); and

(xii) For UN 1A2 drums:

(A) Gasket material (e.g., plastic), or properties affecting the performance of the gasket;

(B) Configuration or dimensions of the gasket;

(C) Closure ring style including bolt size, (e.g., square or round back, 0.625'' bolt); and

(D) Closure ring thickness.

(h) Approval of equivalent packaging. A packaging having specifications different from those in Secs. 178.504-178.523 of this part, or which is tested using methods or test intervals, other than those specified in subpart M of this part, may be used if approved by the Associate Administrator. Such packaging must be shown to be equally effective, and testing methods used must be equivalent.

(i) Proof of compliance. Notwithstanding the periodic retest intervals specified in paragraph (e) of this section, the Associate

Administrator may at any time require demonstration of compliance by a manufacturer, through testing in accordance with this subpart, that packaging meet the requirements of this subpart. As required by the

Associate Administrator, the manufacturer shall either--

[[Page 961]]

(1) Conduct performance tests, or have tests conducted by an independent testing facility, in accordance with this subpart; or

(2) Supply packaging, in quantities sufficient to conduct tests in accordance with this subpart, to the Associate Administrator or a designated representative of the Associate Administrator.

(j) Coatings. If an inner treatment or coating of a packaging is required for safety reasons, the manufacturer shall design the packaging so that the treatment or coating retains its protective properties even after withstanding the tests prescribed by this subpart.

(k) Number of test samples. Provided the validity of the test results is not affected and with the approval of the Associate

Administrator, several tests may be performed on one sample.

(l) Record retention. Following each design qualification test and each periodic retest on a packaging, a test report must be prepared. The test report must be maintained at each location where the packaging is manufactured and each location where the design qualification tests are conducted, for as long as the packaging is produced and for at least two years thereafter, and at each location where the periodic retests are conducted until such tests are successfully performed again and a new test report produced. In addition, a copy of the test report must be maintained by a person certifying compliance with this part. The test report must be made available to a user of a packaging or a representative of the Department upon request. The test report, at a minimum, must contain the following information:

(1) Name and address of test facility;

(2) Name and address of applicant (where appropriate);

(3) A unique test report identification;

(4) Date of the test report;

(5) Manufacturer of the packaging;

(6) Description of the packaging design type (e.g. dimensions, materials, closures, thickness, etc.), including methods of manufacture

(e.g. blow molding) and which may include drawing(s) and/or photograph(s);

(7) Maximum capacity;

(8) Characteristics of test contents, e.g. viscosity and relative density for liquids and particle size for solids;

(9) Test descriptions and results; and

(10) Signed with the name and title of signatory.

[Amdt. 178-97, 55 FR 52723, Dec. 21, 1990, as amended at 56 FR 66285, Dec. 20, 1991; 57 FR 45465, Oct. 1, 1992; Amdt. 178-102, 59 FR 28494, June 2, 1994; Amdt. 178-106, 59 FR 67521, 67522, Dec. 29, 1994; Amdt.

178-117, 61 FR 50628, Sept. 26, 1996; 66 FR 45386, Aug. 28, 2001]

Effective Date Note: At 67 FR 53143, Aug. 14, 2002, Sec. 178.601 was amended by revising paragraphs (c)(1), (c)(2), and (e), effective Oct.

1, 2002. At 67 FR 54967, the effective date was corrected to Feb. 14, 2003. For the convenience of the user, the added text is set forth as follows:

Sec. 178.601 General requirements.

(c) * * *

(1) Design qualification testing is the performance of the tests prescribed in Sec. 178.603, Sec. 178.604, Sec. 178.605, Sec. 178.606, Sec. 178.607, Sec. 178.608, or Sec. 178.609, as applicable, 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, as prescribed in Sec. 178.603, Sec. 178.604, Sec. 178.605, or

Sec. 178.606, respectively, at the frequency specified in paragraph (e) of this section. For infectious substances packaging required to meet the requirements of Sec. 178.609, periodic retesting is the performance of the tests specified in Sec. 178.609 at the frequency specified in paragraph (e) of this section.

(e) Periodic retesting. The packaging manufacturer must 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 Hazardous Materials

Safety. 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.