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Pennsylvania Code



Subchapter E. SEGREGATION AND STORAGE


Sec.


284.401.    Scope.
284.411.    Segregation.
284.412.    Basic storage requirements.
284.413.    Storage containers.
284.414.    Marking of containers.
284.415.    Duration of storage of regulated medical and chemotherapeutic waste for generators.
284.416.    Duration of storage of regulated medical and chemotherapeutic waste for processors.
284.417.    Reuse of containers.
284.418.    Storage and containment of ash residue from regulated medical or chemotherapeutic waste incineration.
284.419.    Storage and containment of processing residue from a regulated medical or chemotherapeutic waste processing facility.

Cross References

   This subchapter cited in 25 Pa. Code §  284.2 (relating to permits-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements); and 25 Pa. Code §  284.3 (relating to regulated medical or chemotherapeutic waste aggregation facilities).

§ 284.401. Scope.

 This subchapter sets forth operating requirements for a person or municipality that stores regulated medical or chemotherapeutic waste, ash residue from regulated medical or chemotherapeutic waste incineration and processing residue from a regulated medical or chemotherapeutic waste processing facility. The requirements in this chapter are in addition to the applicable requirements in Chapter 271 (relating to municipal waste management—general provisions) and the requirements in § §  285.111—285.115 and 285.121.

Source

   The provisions of this §  284.401 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273307).

§ 284.411. Segregation.

 (a)  Regulated medical waste and chemotherapeutic waste shall be segregated at the point of origin at the generating facility into the following three categories:

   (1)  Regulated medical waste, excluding pathological waste.

   (2)  Pathological waste.

   (3)  Chemotherapeutic waste.

 (b)  Each category of waste segregated under subsection (a) shall be placed in a separate container, except used sharps that qualify as regulated medical waste may be placed in a chemotherapeutic waste used sharps container.

 (c)  When bags are used as containers to segregate the waste, the bags must be fluorescent orange, orange-red or red in color for regulated medical waste or pathological waste.

 (d)  When bags are used as containers to segregate the waste, the bags must be yellow in color for chemotherapeutic waste, unless the chemotherapeutic waste is processed onsite in an incinerator that operates in accordance with §  284.2 (relating to permits-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements) or in accordance with a permit authorized by the Department.

 (e)  When bags are used to segregate and store the waste, the requirements of §  284.413 (relating to storage containers) must be satisfied.

Source

   The provisions of this §  284.411 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273307) to (273308).

§ 284.412. Basic storage requirements.

 (a)  After regulated medical and chemotherapeutic waste has been segregated and collected for transportation to an onsite or offsite processing facility, the waste shall be stored and contained in a manner that:

   (1)  Maintains the integrity of the containers, prevents the leakage or release of waste from the containers, and provides protection from water, rain and wind.

   (2)  Prevents the spread of regulated medical waste or chemotherapeutic agents.

   (3)  Affords protection from animals and does not provide a breeding place or a food source for insects or rodents.

   (4)  Maintains the waste in a nonputrescent state, using refrigeration (‹= 7°C or ‹= 45°F) or freezing (‹= -18°C or ‹= 0°F) when necessary.

   (5)  Prevents odors from emanating from the container.

   (6)  Prevents unauthorized access to the waste. As part of this requirement, the following shall be met:

     (i)   Enclosures and containers used for storage of regulated medical or chemotherapeutic waste shall be secured to deny access to unauthorized persons.

     (ii)   Enclosures and containers shall be marked with prominent warning signs indicating the storage of regulated medical or chemotherapeutic waste.

 (b)  Enclosures at a waste generating or processing facility that are used for the storage of regulated medical or chemotherapeutic waste must be constructed of finish materials that are impermeable and capable of being readily maintained in a sanitary condition. Containers located in enclosures used for the storage of regulated medical or chemotherapeutic waste must be maintained in compliance with §  284.413 (relating to storage containers) and in a manner that minimizes human exposure and vectors. Exhaust air from storage areas must be ventilated to minimize human exposure.

 (c)  Regulated medical and chemotherapeutic waste may not be commingled with other waste in the same container.

 (d)  The generator may store regulated medical waste, chemotherapeutic waste or municipal waste that has been sorted and separately containerized in the same location, including on a cart.

Source

   The provisions of this §  284.412 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273308).

§ 284.413. Storage containers.

 (a)  Regulated medical or chemotherapeutic waste shall be placed in containers that are:

   (1)  Leakproof on the sides and bottom and maintained in an upright position.

   (2)  Impervious to moisture.

   (3)  Sufficient in strength to prevent puncturing, tearing or bursting during storage.

 (b)  In addition to the requirements of subsection (a), used sharps shall be placed in containers that are:

   (1)  Rigid.

   (2)  Tightly lidded.

   (3)  Puncture resistant.

 (c)  In addition to the requirements of subsection (a), regulated medical waste fluids in quantities greater than 20 cubic centimeters and chemotherapeutic waste fluids shall be placed in containers that are:

   (1)  Break resistant.

   (2)  Tightly lidded or tightly stoppered.

 (d)  When bags are used as the only container, double or multiple bagging shall be employed and the following requirements shall be met:

   (1)  Upon packaging, the bags shall be securely tied.

   (2)  The bags must be constructed of material of sufficient single thickness strength to meet the following:

     (i)   The ASTM Standard D1709, Test Method for Impact Resistance of Polyethylene Film by the Free Falling Dart Method, with an impact resistance of 165 grams or greater (Method A).

     (ii)   The ASTM Standard D1922, Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method, with a tearing resistance, parallel and perpendicular to the length of the bag of 480 grams.

     (iii)   If the standards in subparagraphs (i) and (ii) are modified by ASTM, the standard that is in effect on the date of manufacture of the bags shall be applied.

   (3)  Bags must include one of the following certifications indicating that the ASTM standards have been met:

     (i)   Each bag must contain a printed certification by the manufacturer.

     (ii)   The manufacturer may issue a certification letter to the regulated medical or chemotherapeutic waste generator and print a certification on each packaged lot of the bags.

   (4)  Bags must have sufficient seam strength that is at least equal in resistance to tearing and equally impermeable as the other portions of the bag.

   (5)  Bags must be fluorescent orange, orange-red or red in color for regulated medical waste and yellow in color for chemotherapeutic waste and contain colorants that are organic pigments with no heavy metal content.

Source

   The provisions of this §  284.413 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273309).

Cross References

   This section cited in 25 Pa. Code §  284.411 (relating to segregation); 25 Pa. Code §  284.412 (relating to basic storage requirements); 25 Pa. Code §  284.512 (relating to transportation of regulated medical and chemotherapeutic waste; general provisions); 25 Pa. Code §  284.513 (relating to transportation of regulated medical and chemotherapeutic waste; additional provisions); and 25 Pa. Code §  284.724 (relating to transportation limitations).

§ 284.414. Marking of containers.

 (a)  For onsite or offsite transportation of regulated medical or chemotherapeutic waste, the outermost containers of regulated medical or chemotherapeutic waste must be labeled with the following:

   (1)  The words ‘‘chemotherapeutic waste’’ if chemotherapeutic waste is placed in the container.

   (2)  Until November 8, 2016, the words ‘‘infectious waste’’ or ‘‘regulated medical waste’’ if regulated medical waste is placed in the container.

   (3)  After November 8, 2016, the words ‘‘regulated medical waste’’ if regulated medical waste is placed in the container.

   (4)  The universal biohazard symbol that conforms to the design in 29 CFR 1910.1030(g)(1)(i)(B) (relating to bloodborne pathogens) and the word ‘‘BIOHAZARD.’’

   (5)  The date the container was full or the date that the generator sealed the container, whichever occurs earlier.

   (6)  The name, address and telephone number of the generator if the waste is transported offsite.

 (b)  The requirements of subsection (a) do not apply if the outermost container is a vehicle or conveyance, including a roll-off, and all of the following are satisfied:

   (1)  The waste in the vehicle or conveyance is from a single generator.

   (2)  The vehicle or conveyance is transported offsite for processing or disposal every 30 days.

   (3)  The vehicle or conveyance complies with the requirements of §  284.513 (relating to transportation of regulated medical and chemotherapeutic waste; additional provisions).

   (4)  The outside of the vehicle or conveyance displays the information required in subsection (a)(5), except when a record of the date the vehicle or conveyance is full or sealed, whichever occurs earlier, is maintained by the generator and available for inspection by the transporter or Department for 1 year.

   (5)  The outside of the vehicle or conveyance displays the information required in subsection (a)(6).

 (c)  Nonwall-mounted used sharps containers storing regulated medical waste must have fluorescent orange, orange-red or red markings and chemotherapeutic waste must have yellow markings. The markings must sufficiently identify the waste as regulated medical or chemotherapeutic waste.

 (d)  The information required under this section must be clearly legible and produced with indelible ink in a color that contrasts with the color of the container, such as black. If a label is used to provide the information, the label must be securely attached to the container.

Source

   The provisions of this §  284.414 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273309).

Cross References

   This section cited in 25 Pa. Code §  284.512 (relating to transportation of regulated medical and chemotherapeutic waste; general provisions); and 25 Pa. Code §  284.724 (relating to transportation limitations).

§ 284.415. Duration of storage of regulated medical and chemotherapeutic waste for generators.

 (a)  Regulated medical or chemotherapeutic waste may not be stored for longer than 30 days from the date that the storage container is full or sealed by the generator, whichever occurs earlier.

 (b)  If the regulated medical or chemotherapeutic waste becomes putrescent during the storage period identified in subsection (a), the waste shall be moved offsite within 3 business days for processing or disposal.

Source

   The provisions of this §  284.415 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273309) to (273311).

§ 284.416. Duration of storage of regulated medical and chemotherapeutic waste for processors.

 If the waste processing facility is separate from the waste generating facility, regulated medical or chemotherapeutic waste shall be immediately moved offsite if the waste becomes putrescent or attracts vectors during the storage period and may not be stored at the waste processing facility for more than the following periods unless other periods are approved in the facility’s permit:

   (1)  Seventy-two hours at ambient temperature, unless the waste becomes putrescent or attracts vectors.

   (2)  Seven days in a refrigerator at ‹= 7°C or ‹= 45°F, unless the waste becomes putrescent or attracts vectors.

   (3)  Thirty days in a freezer at ‹= -18°C or ‹= 0°F, unless the waste becomes putrescent or attracts vectors.

Source

   The provisions of this §  284.416 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (373311).

§ 284.417. Reuse of containers.

 (a)  Nonrigid containers shall be managed as either regulated medical or chemotherapeutic waste based upon the contents of the container. These containers may not be reused.

 (b)  Corrugated fiberboard containers used for storage of regulated medical or chemotherapeutic waste may be reused if the surface of the container has been protected from direct contact with the waste.

 (c)  A rigid, nonfiberboard container used for the storage of regulated medical waste or chemotherapeutic waste may be reused if one of the following applies:

   (1)  The container has been decontaminated utilizing a Department-approved decontamination procedure.

   (2)  The surface of the container has been protected from direct contact with regulated medical and chemotherapeutic waste, as applicable.

Source

   The provisions of this §  284.417 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273311) to (273312).

§ 284.418. Storage and containment of ash residue from regulated medical or chemotherapeutic waste incineration.

 (a)  Ash residue from regulated medical or chemotherapeutic waste incineration shall be stored in accordance with the following:

   (1)  In an enclosed container, which may include a properly tarped container, or in an enclosed area, which may include an adequately ventilated building.

   (2)  On a pad for collecting a spill or release of ash that is no more permeable than 1 x 10-7 cm./sec.

   (3)  In a manner to prevent the release, dispersal or discharge of ash residue into the air, water or onto land.

 (b)  Ash residue may be commingled with other municipal waste if the commingled waste is from one generator and if storage of the commingled waste is in accordance with subsection (a).

Source

   The provisions of this §  284.418 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273312).

Cross References

   This section cited in 25 Pa. Code §  284.321 (relating to regulated medical waste monitoring requirements).

§ 284.419. Storage and containment of processing residue from a regulated medical or chemotherapeutic waste processing facility.

 (a)  Processing residue from regulated medical or chemotherapeutic waste processing facilities shall be stored in an enclosed container, which may include a properly tarped container, or in an enclosed area, which may include an adequately ventilated building, to:

   (1)  Prevent the release, dispersal or discharge of processing residue into the air, water or onto land.

   (2)  Afford protection from animals, rain and wind.

   (3)  Prevent the development of a breeding place or food source for insects or rodents.

   (4)  Prevent the leakage of waste from the storage container.

 (b)  Processing residue from a regulated medical or chemotherapeutic waste processing facility may be commingled with other municipal waste if the commingled waste is from one generator and if storage of the commingled waste is in accordance with subsection (a).

Source

   The provisions of this §  284.419 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273312) to (273313).

Cross References

   This section cited in 25 Pa. Code §  284.321 (relating to regulated medical waste monitoring requirements).



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