Current through Register Vol. 35, No. 18, September 24, 2024
A. This section
applies:
(1) without regard to the quantity
of infectious waste generated, to any generator of infectious waste including,
but not limited to:
(a) general acute care
hospitals;
(b) skilled nursing
facility or convalescent hospitals;
(c) intermediate care facilities;
(d) in-patient care facilities for the
developmentally disabled;
(e)
dialysis clinics;
(f) free
clinics;
(g) community
clinics;
(h) employee
clinics;
(i) health maintenance
organizations;
(j) home health
agencies;
(k) surgical
clinics;
(l) urgent care
clinics;
(m) acute psychiatric
hospitals;
(n) blood/plasma
centers;
(o)
laboratories;
(p) medical
buildings;
(q) physicians
offices;
(r)
veterinarians;
(s) dental
offices;
(t)
acupuncturists;
(u) funeral
homes;
(v) eye clinics;
and
(w) tattoo parlors and
body-piercing establishments; and
(2) to all infectious waste storage areas,
processing, transformation, transfer and disposal facilities, other than sewage
treatment systems that provide secondary treatment of waste.
B. All material that has been
rendered non-infectious is not subject to the handling requirements of this
section, provided:
(1) if it is an otherwise
regulated, hazardous, special, or radioactive waste, it shall be handled
according to regulations applicable to that type of waste;
(2) any person that processes or transforms
infectious waste shall certify in writing on at least an annual basis, or upon
any change that could affect the efficacy of the treatment that the waste has
been rendered non-infectious by sterilization, incineration or another method
approved by the secretary; a certification that the waste has been rendered
non-infectious shall be provided to the generator, transporter, and disposal
facility; the generator, processing or transformation facility, and disposal
facility shall maintain copies of certifications for a period of three years
and the records shall be made available to the department upon request;
and
(3) the operator of the
disposal facility applies daily cover as required in 20.9.5.9 NMAC prior to any
compaction of the sharps.
C. The following storage and containment
requirements apply to all infectious waste.
(1) Containment shall be in a manner and
location which affords protection from animal intrusion, does not provide a
breeding place or a food source for insects and rodents, and minimizes exposure
to the public.
(2) Infectious waste
shall be segregated by separate containment from other waste at the point of
origin.
(3) Except for sharps,
infectious waste shall be contained in plastic bags inside rigid containers.
The bags shall meet the testing requirements specified by 40 CFR 173.197. All
bags used for containment purposes shall be red or orange and clearly
identified as specified in
29 CFR
1910.145(f). The bags shall
be securely tied to prevent leakage or expulsion of solid or liquid wastes
during storage, handling or transport.
(4) Sharps shall be contained for storage,
transportation, transfer, processing, transformation, and disposal in
leak-proof, rigid, puncture-resistant containers which are manufactured for the
purpose of sharps containment and are taped closed or tightly lidded to
preclude loss of contents.
(5)
Rigid containers shall be labeled "biomedical waste", or otherwise
conspicuously labeled as holding infectious waste, or placed in disposable bags
used for other infectious waste. Rigid containers shall meet or exceed the
requirements of
49 CFR
173.197 including that the containers be:
(a) rigid;
(b) leak resistant;
(c) impervious to moisture;
(d) of sufficient strength to prevent tearing
or bursting under normal conditions of use;
(e) sealed to prevent leakage during
transport; and
(f) puncture
resistant for sharps and sharps with residual fluids.
(6) If other waste is placed in the same
container as regulated infectious waste, then the generator shall package,
label and mark the container and its entire contents as infectious
waste.
(7) Rigid infectious waste
containers may be reused for infectious or non-infectious waste if they are
thoroughly washed and decontaminated each time they are emptied or the surfaces
of the containers have been completely protected from contamination by
disposable, unpunctured or undamaged liners, bags, or other devices that are
removed with the infectious waste, and the surface of the containers have not
been damaged or punctured.
(8)
Storage and containment areas shall protect infectious waste from the elements,
be ventilated to the outdoors (unless refrigerated), provide refrigeration as
necessary, be only accessible to authorized persons, and be marked with
prominent warning signs on, or adjacent to, the exterior doors or gates. The
warning signs shall be easily read during daylight from a distance of 25
feet.
(9) Generators of infectious
waste, shall place sufficient absorbent material inside the rigid container or
liner of the rigid container sufficient to absorb the entire amount of liquid
present in the event of an unintentional release of contents, as specified in
49 CFR
173.197.
(10) Compactors, grinders or similar devices
shall not be used to reduce the volume of infectious waste before the waste has
been rendered non-infectious unless prior approval has been obtained from the
department.
D. All
generators of infectious waste shall dispose of the infectious waste at a
facility permitted to process, store or dispose of infectious waste.
E. All infectious waste generation,
processing, transformation, transfer, storage and disposal facilities subject
to this section shall comply with the following operational requirements.
(1) Every person who generates, transports,
stores, processes, or disposes of infectious waste shall prepare and maintain
on file a management plan for the waste that identifies the type of waste the
person generates or handles, the segregation, packaging, labeling, collection,
storage, method of storage, and transportation procedures to be implemented,
the processing, transformation or disposal methods that will be used, the
transporter and disposal facility that will be used, and the person responsible
for the management of the infectious waste.
(2) All infectious waste management
facilities may only accept infectious waste that is accompanied by a manifest
that contains the information required by 20.9.8.19 NMAC.
(3) Report to the secretary any delivery of
unauthorized waste, contamination of any person, or other emergencies
immediately upon recognition.
(4)
Human fetal remains, as defined by the state medical investigator, when
measured to be 500 grams or greater, shall be disposed by incineration or
interment.
(5) Infectious waste
consisting of recognizable human anatomical remains shall be disposed by
incineration or interment, unless such remains are subject to different
treatment or disposal standards due to contamination by a hazardous or
radioactive substance. Recognizable human anatomical remains may be released to
the patient, proper governmental authority, or designated family member for
interment or incineration, as long as all forensic needs of the facility have
been met and the release is not in violation of any other law.
F. Processing, transformation and
disposal of infectious waste shall be by one of the following methods:
(1) incineration in a controlled air
multi-chambered incinerator which provides complete combustion of the waste to
carbonized or mineralized ash:
(a) ash from
the incinerator shall be sampled in accordance with Subsection B of 20.9.8.11
NMAC;
(b) the sample shall be
analyzed by the U.S. EPA test method 1311: toxic characteristics leaching
procedure (TCLP) to determine if it is a hazardous waste; if hazardous, it
shall be managed by applicable state regulations;
(c) the retention times and temperatures for
each chamber shall be continuously measured and recorded, or other equivalent
tests approved by the department to determine if it is still infectious shall
be performed; if infectious, it shall be reincinerated in accordance with this
section; and
(d) charge rates shall
be maintained and recorded;
(2) sterilization by heating in a steam
sterilizer so as to render the waste non-infectious:
(a) the operator shall have available and
shall certify in writing that she or he understands written operating
procedures for each steam sterilizer including time, temperature, pressure,
type of waste, type of container(s), closure on container(s), pattern of
loading, water content, and maximum load quantity;
(b) infectious waste shall be subjected to
sufficient temperature, pressure and time to kill Geobacillus
stearothermophilus spores or induce a complete color change in an
approved steam sterilization integrator when either indicator is located in the
center of the waste load being decontaminated;
(c) unless a steam sterilizer is equipped to
continuously monitor and generate a printed paper record of time, temperature
and pressure during the entire length of each sterilization cycle, a chemical
indicator shall be attached to each package of infectious waste that will
visually demonstrate at the end of the autoclave cycle that each package was
exposed to a temperature of at least 250 degrees fahrenheit or 121 degrees
celsius in the presence of steam under pressure was reached during the process;
the original printed record generated by the autoclave must be maintained for
three years;
(d) each sterilization
unit shall be evaluated for effectiveness with spores of Geobacillus
stearothermophilus or approved steam sterilization integrator at least
once each 40 hours of operation; and
(e) a written log shall be maintained for
each sterilization unit which contains:
(i)
date, time and load number for each load;
(ii) amount per load;
(iii) duration of the cycle; and
(iv) the operator's name;
(3) discharge to a sewage
treatment system that provides secondary treatment of waste, if the waste is
liquid or semi-solid and approved in writing by the operator of the sewage
treatment system; or
(4) other
products or methods may be approved by order of the secretary which provide:
(a) a 6Log10 reduction in
mycobacteria of Mycobacterium phlei or
Mycobacterium bovis (BCG) or if specifically approved, other
Mycobacterium species;
(b) a 4Log10
reduction in bacterial spores of Geobacillus
stearothermophilus, Bacillus atrophaeus or if
specifically approved, other species of spore-forming bacterium; and
(c) verification that the species used in
Subparagraphs (a) and (b) of Paragraph (4) of this subsection are the species
indicated and that the strain used is appropriate for the proposed
method.
G.
The following requirements and condition shall apply to any person seeking
approval from the secretary for a treatment method under Paragraph (4) of
Subsection F of this section:
(1) the person
shall provide any information requested by the secretary within the time period
specified by the secretary;
(2) the
request for approval shall be approved, approved with terms and conditions, or
denied by the secretary;
(3) within
45 days from the end of each calendar year, manufacturers of on-site treatment
or processing products approved by the secretary shall submit an annual report
to the department that includes:
(i) current
manufacturer's company name, contact names, addresses, and telephone
numbers;
(ii) a current list of
product consumers or clients in New Mexico identified as generators of
infectious waste under Subsection A of 20.9.8.13 NMAC, with contact names,
addresses, and telephone numbers;
(iii) proof of current registration with the
U.S. EPA, if required under the Federal Insecticide, Fungicide, and Rodenticide
Act;
(iv) a current material safety
data sheet for any materials used in the treatment method;
(v) a current copy of the manufacturer's
instructions as printed on the product and a copy of the most recent operator's
manual, if not previously submitted; and
(vi) proof of current registration with the
New Mexico department of agriculture, if required under the New Mexico
Pesticide Control Act;
(4) the secretary may withdraw the approval
of an on-site processing product if the product fails to properly treat
infectious waste as claimed, or if the on-site processing product or method is
altered in any manner; to withdraw the approval, the secretary shall issue an
order withdrawing the approval; the interested person may appeal the
secretary's order by filing a request for hearing within 30 days of the date of
the secretary's order; the procedures set forth in Adjudicatory Procedures -
Environment Department, 20.1.5 NMAC shall apply to the appeal.