Minnesota Administrative Rules
Agency 167 - Pollution Control Agency
Chapter 7035 - SOLID WASTE
INFECTIOUS WASTE
Part 7035.9120 - REQUIRED PRACTICES FOR FACILITY OWNERS AND OPERATORS AND COMMERCIAL TRANSPORTERS
Universal Citation: MN Rules 7035.9120
Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1. Packaging and labeling requirements.
No commercial transporter shall receive any infectious waste that is not packaged according to items A to G. No facility owner or operator shall receive for offsite decontamination, storage, or disposal, any infectious waste that is not packaged according to items A to G.
A. Sharps must be in rigid,
puncture-resistant containers that have lids or caps that are designed to
preclude loss or leakage of the contents.
B. Sharps must remain packaged throughout
collection, storage, decontamination, and any handling processes that precede
disposal, unless the sharps have been treated by a process that renders them
incapable of inducing subdermal inoculation. This item does not prevent the use
of sharps containers that are designed to be reusable if parts
7035.9100 to
7035.9150 are complied
with.
C. Sharps containers, or
infectious waste containers that include sharps containers, that will be
transported to an offsite facility must be labeled, on the outer container,
with "Sharps" in letters at least one inch high with a stroke width of
one-eighth inch and with either the international biohazard symbol, at least
three inches by three inches, or the words "Infectious Waste" in letters at
least one inch in height with a stroke width of one-eighth inch.
D. Infectious waste, except for sharps, must
be contained in plastic bags that are impervious to moisture, and of sufficient
strength to preclude ripping, tearing, or bursting under normal conditions of
use and handling. Each plastic bag must be constructed of material of
sufficient single thickness and strength to pass the 165-gram dropped dart
impact resistance test as prescribed by ASTM Standard D 1709-75, which is
incorporated by reference, and is not subject to frequent change. The standard
appears in the Annual Book of ASTM Standards, issued by the American Society of
Testing and Materials (Philadelphia, 1975), and is available at the Minnesota
State Law Library or through the statewide interlibrary loan system. The bags
must be secured to prevent leakage of waste during handling, decontamination,
storage, transport, or disposal.
E.
Plastic bags of infectious waste that will be shipped offsite must be packaged
for storage or handling by placement in corrugated fiberboard boxes or
equivalent rigid containers such as reusable pails, cartons, or portable bins.
Containers must have tight-fitting covers and be securely sealed.
F. Boxes and rigid containers of infectious
waste must be conspicuously labeled with the words "Infectious Waste" in
letters at least one inch high, with a stroke width of one-eighth inch, or the
international biohazard symbol, at least three inches by three
inches.
G. Containers that have
been in direct contact with infectious waste must be disinfected before further
use. The disinfection methods in subpart
6, item C, must be
used.
Subp. 2. Storage requirements.
Offsite facility owners and operators must store waste according to items A to E.
A.
Infectious or pathological waste must be segregated from other wastes in a
storage area designed to prevent the entry of vermin. Storage areas for
infectious or pathological waste must be secured to deny access by unauthorized
persons and must be prominently marked with the international biohazard symbol
and with the words "Infectious Waste" on or adjacent to the exterior of entry
doors and access gates.
B. Interior
surfaces of storage areas must be constructed of materials that are easily
cleaned.
C. Offsite storage areas
must be designed to contain spills.
D. Infectious or pathological waste must not
be allowed to become putrescent during storage or at any time.
E. Storage facility owners and operators must
comply with the spill response requirements in subpart
6.
Subp. 3. Decontamination requirements.
Facility owners and operators may use incineration, autoclaving, or other decontamination methods that have been approved by the commissioner for the decontamination of infectious waste. Facility owners and operators shall use handling and storage practices that comply with subparts 1 and 2, and decontamination methods that comply with items A to C and subpart 6.
A. Incinerators must be operated in
compliance with chapters 7001, 7005, 7007, 7009, 7011, 7017, 7019, 7021, 7023,
7025, and 7028.
B. Offsite
decontamination of infectious waste by autoclaving must be achieved in the
following manner:
(1) Infectious waste must
be autoclaved at 250 degrees Fahrenheit at 15 pounds per square inch of gauge
pressure for one hour or at least equivalent settings.
(2) Loading of infectious waste must not
exceed the design capacity of the autoclave.
(3) An operating log for each load of
infectious waste decontaminated must be kept onsite for three years and must
contain the date, time, temperature, pressure, and operator name.
C. Other methods for
decontaminating infectious waste offsite, such as grinding, microwaving, or
disinfecting technologies must receive commissioner approval. To obtain
approval, the facility owner or operator proposing the decontamination method
must submit to the commissioner information demonstrating that the proposed
method decontaminates the waste. The commissioner may request additional
information to determine whether the method is effective. In making this
decision, the commissioner shall consult with the Centers for Disease Control
and the Minnesota Department of Health.
Subp. 4. Commercial transporter requirements.
A. A commercial
transporter must possess a valid transporter registration as described in part
7035.9140, subpart
3.
B. The commercial transporter's management
plan required in part
7035.9130 must be kept at the
address identified as the commercial transporter's principal place of
business.
C. A commercial
transporter who transports infectious waste offsite and facilities that receive
the waste must be in compliance with subitems (1) to (9).
(1) A commercial transporter must not accept
infectious waste from a generator who does not have a management plan
acknowledgment card issued by the Minnesota Department of Health or a storage
facility or treatment facility that does not have a management plan as
described in part
7035.9130.
(2) Infectious waste must be transported in a
fully enclosed vehicle compartment.
(3) Infectious waste must be delivered for
decontamination, storage, or disposal only to a facility owner or operator that
has an approved management plan onsite or to a facility owner or operator that
is exempt from the requirements for a management plan.
(4) A commercial transporter must not deliver
infectious waste to a facility owner or operator prohibited from accepting the
waste.
(5) Surface areas of
equipment used to transport infectious waste must be smooth and easily
cleaned.
(6) Infectious waste must
not be compacted during transport. Sharps containers, or infectious waste
containers that include sharps containers, must never be compacted, whether or
not the sharps have been decontaminated. Containers must be secured to prevent
movement during transport.
(7)
Infectious waste must not be allowed to become putrescent during
transportation.
(8) A person must
not transport or receive for transport infectious waste that is not packaged
and labeled according to subpart
1.
(9) Commercial transporters must comply with
subpart
6.
D. Commercial transporter vehicles must bear
labels or placards that comply with subitems (1) and (2).
(1) Vehicles transporting infectious waste
must be identified on each side of the vehicle, and on the access doors to any
area holding infectious waste, with the name of the transporter and the words
"Infectious Waste" in letters six inches high with a stroke width of
three-fourths inch or with the international biohazard symbol, eight inches by
eight inches.
(2) The vehicle
identification number that is issued by the commissioner under part
7035.9140, subpart
3, must be displayed on the
single unit vehicle or trailer to which it is assigned in letters and numbers
at least four inches in height with a stroke width of one-half inch.
Subp. 5. Generator transport requirements.
A. Generators who transport their own
infectious waste to an offsite decontamination, storage, or disposal facility
must comply with the packaging, labeling, and storage requirements of subparts
1 and
2.
B. Generators who provide
not-for-compensation or at cost infectious waste collection and transport
services for other generators or groups of generators that provide
not-for-compensation infectious waste collection and transport service for the
group must comply with the packaging, labeling, and storage requirements of
subparts
1 and
2 and the commercial
transporter requirements of subpart
4, item C.
C. Generator transport vehicles that exceed
7,000 pounds gross vehicle weight must be identified on each side of the
vehicle, and on the access doors to any area holding infectious waste, with the
name of the transporter and the words "Infectious Waste" in letters six inches
high with a stroke width of three-fourths inch or with the international
biohazard symbol, eight inches by eight inches. Magnetic placards that meet
these specifications are acceptable.
D. Generators who transport infectious waste
in vehicles that exceed 7,000 pounds gross vehicle weight must comply with
subpart
8, items B and C, in addition
to providing the name and title of the individual responsible for the
implementation of infectious waste activities that are consistent with parts
7035.9100 to
7035.9150.
Subp. 6. Spill response plan.
Spill response plans must comply with items A to C.
A. A spill cleanup kit must be available for
use in areas used for the storage, decontamination, or disposal of infectious
waste and also on each transport vehicle. The cleanup kit must include at
least:
(1) absorbent material for spilled
liquids;
(2) one gallon of hospital
grade disinfectant or disinfectant made of a formula listed in item
C;
(3) packaging and labeling, as
required in subpart
1;
(4) scoop shovel, push brooms, and plastic
buckets; and
(5) disposable
coveralls, latex and neoprene gloves, surgical type face mask, and
goggles.
B. Response to
a spill must include the following minimum procedures:
(1) access to the spill area by unauthorized
personnel must be prevented;
(2)
broken containers and spillage must be packaged and labeled as required in
subpart
1;
(3) absorbent material must be applied to
surface areas that have been contaminated with infectious waste; and
(4) reusable items must be cleaned and
disinfected using the procedures in item C.
C. Procedures for disinfecting contaminated
surfaces include, but are not limited to, agitation to remove visible soil and
application of one of the following chemical sanitizers for the contact time
required by the manufacturer's label:
(1)
hypochlorite solution (500 ppm available chlorine);
(2) phenolic solution (500 ppm active
ingredient);
(3) iodoform solution
(100 ppm active ingredient); or
(4)
other chemical sanitizer solutions of equivalent disinfectant
strength.
Subp. 7. Financial assurance.
As a condition of management plan approval, an offsite storage facility owner or operator shall provide to the agency evidence of financial assurance according to item A, B, or C.
A. An offsite storage facility owner or
operator may satisfy the requirements of this subpart by depositing acceptable
securities with the commissioner of management and budget in accordance with
subitems (1) to (9). The value of the securities to be deposited shall at least
equal the estimated costs of final waste disposal that is approved in the
management plan.
(1) Acceptable securities,
for the purposes of this item, are:
(a)
United States government bonds;
(b)
bonds or securities that are issued by the state of Minnesota and that are
secured by the full faith and credit of this state; and
(c) certificates of deposit issued by a bank
that has deposits insured by the Federal Deposit Insurance
Corporation.
(2) An
offsite storage facility owner or operator must send a copy of the commissioner
of management and budget's receipt to the commissioner within ten days after
the deposit is made.
(3) Securities
must be assigned to the state of Minnesota. The assignment of securities must
be signed by an officer, partner, or owner of the offsite storage facility. The
assignment must state: "Assigned to the state of Minnesota for the purpose of
providing financial assurance required by Minnesota Rules, part
7035.9120, under the Infectious
Waste Control Act."
(4) All
securities shall be deposited with the commissioner of management and budget.
The commissioner and the commissioner of management and budget shall be
authorized to sell and collect, if stored wastes are allowed to putresce, as
much of the deposited securities as is needed to pay for final waste disposal.
The commissioner's order to sell securities must be approved by the
agency.
(5) Interest accruing on
any securities deposited under this item shall be collected and transmitted to
the depositor, provided that the depositor has not allowed stored wastes to
putresce.
(6) All deposits shall
remain in the custody of the commissioner of management and budget until three
months after the facility operator stops accepting infectious waste.
(7) Any securities deposited with the
commissioner of management and budget may be exchanged or replaced by the
depositor with other acceptable securities so long as the market value of the
securities equals the amount of deposit required.
(8) No securities on deposit with the
commissioner of management and budget may be released without a written order
from the commissioner. The commissioner shall refuse to release securities on
deposit if the offsite storage facility owner or operator fails to dispose
properly of any infectious wastes remaining after the facility permanently
stops accepting waste.
(9) The
offsite storage facility owner or operator may request that deposited
securities be returned. Such requests must be submitted in writing by certified
mail. The commissioner shall direct the commissioner of management and budget
to return the securities to the depositor if:
(a) the offsite storage facility owner or
operator has stopped taking waste and no wastes remain on the site;
(b) the offsite storage facility owner or
operator has substituted other securities of equal or greater value for the
securities that are requested; or
(c) another person has received approval to
operate the offsite storage facility.
The commissioner shall refuse to order return of the securities if the conditions for return have not been met. The commissioner shall have 60 days in which to determine whether to order return of the securities. If the commissioner does not order return of the securities, the commissioner shall, within 30 days of the decision, provide the offsite storage facility owner or operator with written reasons for not ordering return of the securities.
B. An offsite storage facility owner or
operator may satisfy the requirements of this subpart by sending to the
commissioner a surety bond that conforms to the requirements of subitems (1) to
(8). The surety company issuing the bond must be among those listed as
acceptable sureties on federal bonds in Circular 570, issued by the United
States Department of the Treasury, as published annually in the Federal
Register on July 1.
(1) The penal sum of the
bond shall at least equal the estimated costs of final waste disposal that is
approved in the management plan.
(2) The wording of the surety bond must be
identical to the wording specified in part
7035.9150, subpart
1.
(3) The bond must guarantee that the offsite
storage facility owner or operator will:
(a)
properly dispose of all stored wastes after the offsite storage facility has
stopped accepting wastes;
(b)
provide alternate financial assurance as specified in this subpart;
and
(c) obtain the commissioner's
written approval of the assurance provided within 90 days after receipt by the
commissioner of a notice of cancellation of the bond from the surety.
(4) Under the terms of the bond,
the surety must become liable on the bond obligation when the offsite storage
facility owner or operator fails to perform as guaranteed by the bond.
Following a determination by the commissioner that the offsite storage facility
owner or operator has failed to properly dispose of all stored wastes after the
offsite storage facility has stopped accepting wastes or has not provided
alternate financial assurance as specified in this subpart and obtained the
commissioner's written approval of the assurance provided, within 90 days after
receipt by the commissioner of a notice of cancellation of the bond from the
surety, under the terms of the bond the surety shall pay the amount of the
penal sum to the agency.
(5)
Whenever the estimated costs of final waste disposal become greater than the
penal sum, the offsite storage facility owner or operator, within 60 days after
the increase, shall either increase the penal sum to equal the new cost
estimate, or obtain other financial assurance as specified in this subpart.
Whenever the estimated costs of final waste disposal decrease, the penal sum
shall be reduced to equal the new cost estimate following written approval by
the commissioner.
(6) Under the
terms of the bond, the surety may cancel the bond by sending notice of
cancellation by certified mail to the offsite storage facility owner or
operator and to the commissioner. However, cancellation is not effective until
120 days after the commissioner has received the notice of cancellation, as
evidenced by the return receipt.
(7) The offsite storage facility owner or
operator may cancel the bond if the commissioner has given prior written
approval. The commissioner shall approve cancellation if:
(a) the offsite storage facility owner or
operator properly disposes of all stored wastes after the offsite storage
facility has stopped accepting wastes; or
(b) the offsite storage facility owner or
operator provides alternate financial assurance as specified in this
subpart.
(8) The surety
shall not be liable for deficiencies in the performance of final waste disposal
after the commissioner releases the offsite storage facility owner or operator
from the requirements of this subpart.
C. An offsite storage facility owner or
operator may satisfy the requirements of this subpart by sending to the
commissioner a letter of credit that conforms to the requirements of subitems
(1) to (8). The issuing institution must be an entity which has the authority
to issue letters of credit. Its letter-of-credit operations must be regulated
and examined by a federal or Minnesota state agency.
(1) The letter of credit must be issued in an
amount that is at least equal to the estimated costs of final waste disposal
that is approved in the management plan.
(2) The wording of the letter of credit must
be identical to the wording specified in part
7035.9150, subpart
2.
(3) The letter of credit must be accompanied
by a letter from the offsite storage facility owner or operator referring to
the letter of credit by number, issuing institution, and date, and providing
the following information:
(a) the
identification number;
(b) the name
and address of the facility; and
(c) the amount of funds assured by the letter
of credit for final disposal of wastes at the facility.
(4) The letter of credit must be irrevocable
and issued for a period of at least one year. The letter of credit must provide
that the expiration date will be extended automatically for a period of at
least one year unless, at least 120 days before the current expiration date,
the issuing institution notifies both the offsite storage facility owner or
operator and the commissioner by certified mail of a decision not to extend the
expiration date. Under the terms of the letter of credit, the 120 days must
begin on the date when the commissioner has received the notice, as evidenced
by the return receipt.
(5) Whenever
the estimated costs of final waste disposal become greater than the amount of
the letter of credit, the offsite storage facility owner or operator, within 60
days after the increase, shall either increase the amount of the letter of
credit to equal the new cost estimate, or obtain other financial assurance as
specified in this subpart. Whenever the estimated costs of final waste disposal
decrease, the amount of the letter of credit shall be reduced to equal the new
cost estimate following written approval by the commissioner.
(6) Following a determination by the
commissioner that the offsite storage facility owner or operator has failed to
properly dispose of all stored wastes after the offsite storage facility has
stopped accepting wastes, the commissioner shall draw on the letter of
credit.
(7) The commissioner shall
draw on the letter of credit if the offsite storage facility owner or operator
does not establish alternate financial assurance as specified in this subpart
and obtain written approval of the alternate financial assurance from the
commissioner within 90 days after the commissioner receives notice from the
issuing institution that it has decided not to extend the letter of credit
beyond the current expiration date. The commissioner may delay the drawing if
the issuing institution grants an extension of the term of the credit. During
the last 30 days of any extension the commissioner shall draw on the letter of
credit if the offsite storage facility owner or operator has failed to provide
alternate financial assurance as specified in this subpart and obtain written
approval of the alternate financial assurance from the commissioner.
(8) The commissioner shall return the letter
of credit to the issuing institution for termination if:
(a) the offsite storage facility owner or
operator properly disposes of all stored wastes after the offsite storage
facility has stopped accepting wastes; or
(b) the offsite storage facility owner or
operator provides alternate financial assurance as specified in this
subpart.
Subp. 8. Reporting and record keeping.
Facility owners and operators and commercial transporters must maintain records for a minimum of three years. If the three-year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action. Facility owners and operators and commercial transporters shall report the following information annually to the commissioner on the anniversary date of management plan approval:
A. the title and name
of the individual responsible for implementation of the management plan as
specified in part
7035.9130, item A;
B. the incidences in which infectious waste
is released to the environment; and
C. the amounts of infectious waste managed;
storage and decontamination facility owners and operators must submit the
following information for the management of infectious waste that is generated
both in and outside of Minnesota; commercial transporters must submit the
following information only for the transport of infectious waste that is
generated in Minnesota:
(1) the weight or
number and size of containers of infectious waste transported, decontaminated,
stored, and disposed of, giving the decontamination and disposal methods used;
and
(2) the weight or number and
size of containers of sharps transported, decontaminated, stored, and disposed
of, giving the decontamination and disposal method used.
Statutory Authority: MS s 116.75
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