| (a) Personnel functions.
(1) A description of functions and minimum qualifications
for each category of key personnel to be employed at the facility
and for the supervisory personnel in the chain of command;
(2) A description of the general instructions that
the operating personnel shall follow concerning the operational requirements
of this subchapter; and
(3) Procedures for the detection and prevention of
the receipt of prohibited wastes; which must include:
(A) random inspections of packaging for incoming loads;
(B) records of all inspections; and
(C) training for appropriate facility personnel responsible
for inspecting or observing loads to recognize prohibited waste.
(b) Waste acceptance. The applicant shall identify
the sources and characteristics of medical wastes proposed to be received
for storage and processing or disposal, the maximum amount of medical
waste to be received daily, the maximum amount of medical waste to
be stored, the maximum lengths of time that medical waste is to remain
at the facility (specify the maximum allowable period of time that
unprocessed and processed wastes are to remain on-site), and the intended
destination of the medical waste received at this facility. Medical
waste facilities may not receive regulated hazardous waste as defined
in §326.3(45) of this title (relating to Definitions). Materials
accepted for recycling may only be accepted from health care-related
facilities as long as the recyclable materials have not been mixed
or come into contact with medical waste. Materials mixed or contacting
medical waste shall be managed as medical waste.
(c) Facility-generated waste.
(1) All liquids resulting from the facility operations
shall be disposed of in a manner that will not cause surface water
or groundwater pollution. The owner or operator may send wastewater
off-site to an authorized facility or shall provide for the treatment
of wastewaters resulting from managing the waste or from cleaning
and washing. Except as provided in subsection (b) of this section,
the owner or operator shall provide a connection into a public sewer
system, a septic system, or a small wastewater treatment plant. On-site
wastewater treatment systems shall comply with Chapter 285 of this
title (relating to On-site Sewage Facilities). The owner or operator
shall obtain any permit or other approval required by state or local
code for the system installed.
(2) Contaminated water shall be collected and contained
until properly managed.
(3) Wastes generated by a facility must be processed
or disposed at an authorized solid waste management facility.
(4) Off-site discharge of contaminated waters shall
be made only after approval under the Texas Pollutant Discharge Elimination
System authority.
(5) The owner or operator shall provide a copy of the
authorization to discharge wastewater to a treatment facility permitted
under Texas Water Code, Chapter 26.
(d) Storage requirements.
(1) All solid waste shall be stored in such a manner
that it does not create a nuisance.
(2) Storage area(s) for source-separated or recyclable
materials from medical waste facilities must be provided that are
separate from solid waste processing areas. Control of odors, vectors,
and windblown waste from the storage area shall be maintained.
(3) Containers must be maintained in a clean condition
so that they do not constitute a nuisance. Containers to be mechanically
handled must be designed to prevent spillage or leakage during storage,
handling, or transport.
(4) If a stationary compactor is utilized, it shall
be operated and maintained in such a way as not to create a public
nuisance through material loss or spillage, odor, vector breeding
or harborage, or other condition.
(e) Recordkeeping and reporting requirements.
(1) A copy of the registration, the approved registration
application, and any other required plan or other related document
shall be maintained at the medical waste facility at all times. These
plans shall be made available for inspection by agency representatives
or other interested parties. These documents shall be considered a
part of the operating record for the facility.
(2) The owner or operator shall promptly record and
retain in an operating record:
(A) all location-restriction demonstrations;
(B) inspection records and training procedures;
(C) closure plans, cost estimates, and financial assurance
documentation relating to financial assurance for closure;
(D) copies of all correspondence and responses relating
to the operation of the facility, modifications to the registration,
approvals, and other matters pertaining to technical assistance; and
(E) all documents, manifests and any other document(s)
as specified by the approved authorization or by the executive director.
(3) For signatories to reports, the following conditions
apply.
(A) The owner or operator shall sign all reports and
other information requested by the executive director as described
in §305.128 of this title (relating to Signatories to Reports)
and §305.44(a) of this title (relating to Signatories to Applications)
or by a duly authorized representative of the owner or operator. A
person is a duly authorized representative only if:
(i) the authorization is made in writing by the owner
or operator as described in §305.44(a) of this title;
(ii) the authorization specifies either an individual
or a position having responsibility for the overall operation of the
regulated facility or activity or for environmental matters for the
owner or operator, such as the position of plant manager, environmental
manager, or a position of equivalent responsibility. A duly authorized
representative may thus be either a named individual or any individual
occupying a named position; and
(iii) the authorization is submitted to the executive
director.
(B) If an authorization under this section is no longer
accurate because of a change in individuals or position, a new authorization
satisfying the requirements of this section must be submitted to the
executive director prior to, or together with, any reports, information,
or applications to be signed by an authorized representative.
(C) Any person signing a report shall make the certification
in §305.44(b) of this title.
(4) All information contained in the operating record
shall be furnished upon request to the executive director and shall
be made available for inspection by the executive director.
(5) The owner or operator shall retain all information
contained within the operating record and the different plans required
for the facility for the life of the facility.
(6) The executive director may set alternative schedules
for recordkeeping and notification requirements as specified in paragraphs
(1) - (5) of this subsection.
(7) Owners or operators of a medical waste processing
facility accepting delivery of untreated medical waste for which a
shipping document is required for processing shall ensure each of
the following requirements are met:
(A) a shipping document accompanies the shipment, which
designates the facility to receive the waste;
(B) the owner or operator signs the shipping document
and immediately gives at least one copy of the signed shipping document
to the transporter;
(C) the owner or operator retains one copy of the shipping
document;
(D) within 45 days after the delivery, the treatment
facility owner or operator sends a written or electronic copy of the
shipping document to the generator that includes the total weight
of waste received and a statement that the medical waste was treated
in accordance with 25 TAC §1.136 (relating to Approved Methods
of Treatment and Disposition).
(f) Fire protection.
(1) An adequate supply of water under pressure must
be available for firefighting purposes.
(2) Firefighting equipment must be readily available.
(3) A fire protection plan shall be established, and
all employees shall be trained in its contents and use. This fire
protection plan shall describe the source of fire protection (a local
fire department, fire hydrants, fire extinguishers, water tanks, water
well, etc.), procedures for using the fire protection source, and
employee training and safety procedures. The fire protection plan
shall comply with local fire codes.
(g) Access control.
(1) Public access to all medical waste facilities shall
be controlled by means of artificial barriers, natural barriers, or
a combination of both, appropriate to protect human health and safety
and the environment. Uncontrolled access to other operations located
at a medical waste facility shall be prevented.
Cont'd... |
